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WO2023061148A1 - Implant conveying device - Google Patents

Implant conveying device Download PDF

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Publication number
WO2023061148A1
WO2023061148A1 PCT/CN2022/119267 CN2022119267W WO2023061148A1 WO 2023061148 A1 WO2023061148 A1 WO 2023061148A1 CN 2022119267 W CN2022119267 W CN 2022119267W WO 2023061148 A1 WO2023061148 A1 WO 2023061148A1
Authority
WO
WIPO (PCT)
Prior art keywords
wire
delivery device
implant delivery
fixing
hole
Prior art date
Application number
PCT/CN2022/119267
Other languages
French (fr)
Chinese (zh)
Inventor
张平海
徐佳
李光辉
陶霖
陈国明
吴旭闻
毛婷
Original Assignee
上海微创心通医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202111187574.0A external-priority patent/CN115957045A/en
Priority claimed from CN202111302111.4A external-priority patent/CN116059023A/en
Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Publication of WO2023061148A1 publication Critical patent/WO2023061148A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts

Definitions

  • the invention relates to the technical field of medical devices, in particular to an implant delivery device.
  • Interventional valve prosthesis implantation is a new minimally invasive valve replacement technology developed internationally in recent years. Its principle is that the valve prosthesis is loaded into the delivery system and delivered to the implantation site through a catheter. At the root of the artery, the valve prosthesis is fixed to the aortic annulus after release, replacing the degraded original valve and improving the heart function of the patient. This technology can treat heart valve diseases without thoracotomy and heart beating, eliminating the huge trauma caused by previous surgical thoracotomy and cardiac arrest.
  • valve prosthesis implantation there are mainly two mechanisms for valve prosthesis implantation: self-expanding and ball-expanding, each of which has advantages and disadvantages.
  • the ball-expanding valve prosthesis can provide stable support and stability during release, but due to its The reason for the stent material is that it cannot be recovered after release; the advantage of the self-expanding valve prosthesis is that it can be corrected, and it can be recovered and released again during the implantation process, but due to the nature of the self-expanding stent, it cannot During release, the morphology is not conducive to anchoring.
  • wire-control is to increase wire-control on the basis of self-expanding valve prosthesis, so as to realize a release mechanism similar to ball expansion, and improve the implantation process. stability, thereby improving the success rate of surgery.
  • thread withdrawal that is, the conveyor withdraws the pull wire from the stent. Because of the friction between the wire and the bracket during the withdrawal process, the wire always exerts a force on the bracket, and this force is likely to cause the bracket to shift, resulting in failure of the operation; It is necessary to provide a break point, which is the prerequisite for thread withdrawal.
  • the mechanism of thread breakage will affect the structure of the conveyor, increase the complexity of the operation, and affect the success rate of the operation.
  • the object of the present invention is to provide an implant delivery device to solve the problems of long wire withdrawal path and complicated operation of the existing conveyor.
  • an implant delivery device which includes: a delivery tube assembly and at least one wire control assembly;
  • the wire control assembly includes: a wire fixing part and a wire detachment part;
  • the wire fixing part is used to connect with the fixed end of the stay wire in the stay wire set;
  • the wire detachment part is movably arranged along the axial direction of the delivery tube assembly, and the wire detachment part is used to connect with the detachment end of the pull wire in the pull wire group; when the wire detachment part satisfies the preset condition , the wire disengagement part is disengaged from the disengagement end of the pull wire.
  • the wire fixing component is movably arranged along the axial direction of the delivery tube assembly.
  • the wire detachment part is located at the proximal end of the wire fixing part, and when the wire detachment part does not meet the preset condition, the wire detachment part and the wire fixing part synchronously move along the delivery tube assembly axial movement.
  • the delivery tube assembly includes an inner tube, and the wire fixing component is movably sleeved outside the inner tube.
  • the preset condition includes mechanical movement of the wire breaking away component.
  • the wire detachment part includes a pin-shaped part, the pin-shaped part has an opening, and the pin-shaped part is used for connecting the detachment end of the pull wire;
  • the preset condition includes: the wire detachment part moving relative to the disengagement end of the pull wire, so that the disengagement end of the pull wire disengages from the opening.
  • the delivery device further includes a traction member, the first end of the traction member is connected to the pin-shaped member, and the second end of the traction member extends proximally.
  • the wire disengagement part when the disengagement end of the pull wire is connected to the wire disengagement part, the wire disengagement part is in a connected state, and the axial distance between the wire control assembly and the distal end of the delivery device is not greater than 300mm.
  • the wire fixing part includes a driving part, and the driving part is movably arranged along the axial direction of the delivery tube assembly; the driving part has a first limiting structure, and the first limiting structure uses to limit the circumferential position of the pull wire around the delivery tube assembly.
  • the first limiting structure includes a plurality of first through holes opened along the axial direction of the driving member, or, the first limiting structure includes a plurality of holes along the axial direction of the driving member.
  • a first groove opened on the outer periphery of the driving member; the first through hole or the first groove is used for passing the pull wire.
  • the wire fixing part further includes a fixing structure, and the fixing structure is used for connecting with the fixing end of the pull wire.
  • the two different first through holes are used for the same pull wire to pass through and wind in turn, and the driving member and the two different first through holes thereon are jointly configured as the the fixed structure.
  • the fixing structure includes: a first fixing ring, the first fixing ring is used for wrapping around the fixing end of the pull wire;
  • the radially inner dimension of the first fixing ring is smaller than the radially outer dimension of the driving member, and the first fixing ring is used to abut against the driving member;
  • the first fixing ring is fixedly sleeved on the outer periphery of the driving member.
  • the wire control assembly further includes: a wire deployment component; the delivery tube assembly includes an inner tube;
  • the wire deploying part is fixedly connected with the inner tube; the wire deploying part is used for changing the extending direction of the pulling wire to along the radial direction of the delivery tube assembly after the pulling wire converges on it Axial extension of the delivery tube assembly described above.
  • the wire deployment part includes a transition piece, the transition piece has a second limiting structure, and the second limiting structure is used to limit the circumferential position of the pull wire around the delivery tube assembly.
  • the second limiting structure includes a plurality of second through holes opened along the axial direction of the conversion member; or, the second limiting structure includes a plurality of holes along the axial direction of the conversion member.
  • a second groove is provided on the outer periphery of the conversion member; the second through hole or the second groove is used for passing the pull wire.
  • the wire deployment part further includes a transition structure, and the transition structure is used to gradually change the extension direction of the pull wire.
  • the transition structure includes: a second fixing ring;
  • the second fixing ring is fixedly arranged relative to the conversion element, and the second fixing ring is used for winding the pull wire to change the extending direction.
  • the transition piece has a hole opened along the axial direction of the delivery tube assembly, and the second limiting structure includes a plurality of third holes opened along the radial direction of the transition piece and communicated with the hole.
  • the delivery device of the implant includes more than two wire control assemblies, and the wire fixing parts of the wire control assemblies of the two or more wire control assemblies are used to connect with the pull wire group along the delivery tube.
  • the components are offset radially and/or circumferentially from one another.
  • the wire fixing parts of more than two wire control assemblies are fixed to each other; or, the wire fixing parts of more than two wire control assemblies are mutually independent along the axial direction of the delivery tube assembly of the mobile.
  • the stay wire set includes a plurality of stay wires
  • the wire fixing component is used for converging and connecting fixed ends of the plurality of stay wires.
  • the conveying device further includes at least one pull wire set, and the pull wire set includes at least one pull wire.
  • the implant delivery device includes: a delivery tube assembly and at least one wire control assembly;
  • the wire control assembly includes: a wire fixing part and a wire detachment part;
  • the wire fixing part is used for The fixed ends of the stay wires in the stay wire group are connected;
  • the wire disengagement part is movably arranged along the axial direction of the delivery tube assembly, and the wire disengagement part is used to connect with the disengagement ends of the stay wires in the stay wire group;
  • the wire disengagement part satisfies a preset condition, the wire disengagement part is disengaged from the disengagement end of the pull wire.
  • the wire fixing part is connected to the fixed end of the pull wire
  • the wire detachment part is connected to the detachment end of the pull wire.
  • FIG. 1 is a schematic diagram of an example of a wire-controlled valve prosthesis according to an embodiment of the present invention
  • FIG. 2 is a schematic diagram of another example of a wire-controlled valve prosthesis according to an embodiment of the present invention.
  • Fig. 3 is a schematic diagram of the assembly of the implant delivery device and the wire-controlled valve prosthesis according to the embodiment of the present invention
  • FIG. 4 is a schematic diagram of an implant delivery device according to an embodiment of the present invention.
  • FIG. 5 is a schematic diagram of a delivery tube assembly according to an embodiment of the present invention.
  • Figures 6a to 6c are schematic diagrams of several preferred examples of the pin-shaped member of the embodiment of the present invention.
  • FIGS 7a to 7c are schematic diagrams of several preferred examples of wire fixing components according to embodiments of the present invention.
  • FIGS 8a to 8d are schematic diagrams of several preferred examples of the first through hole and the second through hole according to the embodiment of the present invention.
  • Fig. 9a and Fig. 9b are schematic diagrams of several preferred examples of wire deployment components according to the embodiment of the present invention.
  • Fig. 10 is a schematic diagram of assembly of a dismantling line and a conveying device according to an embodiment of the present invention
  • Fig. 11 is an enlarged view of part A of Fig. 10;
  • Fig. 12 is a schematic diagram of a preferred example of two wire control assemblies of the delivery device according to the embodiment of the present invention.
  • Fig. 13 is an enlarged view of part B of Fig. 12;
  • Fig. 14 is a schematic diagram of another preferred example of two wire control assemblies of the delivery device according to the embodiment of the present invention.
  • Fig. 15 is an enlarged view of part C of Fig. 14;
  • Fig. 16 is a schematic structural view of the inner tube mechanism of the delivery device according to an embodiment of the present invention
  • Fig. 17 is a schematic structural view of the wire deployment part of the delivery device according to an embodiment of the present invention.
  • Fig. 18 is an A-A sectional view of the wire deployment part of the delivery system according to an embodiment of the present invention.
  • Fig. 19 is a schematic diagram of the connection relationship between the pull wire and the medical implant when the delivery system according to an embodiment of the present invention is loaded with the medical implant.
  • the pull wire is connected to the medical implant in the form of radiation;
  • Fig. 20 is a schematic diagram of the connection relationship between the pull wire and the medical implant when the delivery device according to an embodiment of the present invention is loaded with the medical implant.
  • the pull wire surrounds the medical implant in the circumferential direction;
  • Fig. 21 is a schematic structural view of the wire deployment part of the delivery device according to another embodiment of the present invention, the wire deployment part in the illustration does not include a base;
  • Fig. 22 is a schematic structural view of the wire deploying part of the delivery device according to another embodiment of the present invention, the wire deploying part in the illustration includes a base;
  • Fig. 23 is a schematic structural view of the line deployment part of the delivery system according to another embodiment of the present invention, and the viewing directions of Fig. 23 and Fig. 22 are different;
  • Fig. 24 is a schematic diagram of deflection of the extension direction of the pull wire of the delivery system according to another embodiment of the present invention when passing through the hole on the wire deployment component;
  • Fig. 25 is a schematic diagram of a partial structure of a medical device according to an embodiment of the present invention.
  • the medical implant is in a crimped state, and the medical device includes a wire deploying part, which is arranged on the medical implant. distal side;
  • Fig. 26 is a schematic diagram of the expansion of the medical stent in the medical device shown in Fig. 25;
  • Fig. 27 is a schematic diagram of a partial structure of a medical device according to an embodiment of the invention.
  • the medical implant is in a crimped state
  • the medical device includes two wire deployment parts, which are respectively arranged on the medical implant. the proximal and distal sides of the object;
  • Fig. 28 is a schematic diagram of a partial structure of a medical device according to an embodiment of the present invention.
  • the medical device is in a crimped state, and the medical device includes a wire deploying part, and a wire deploying part is arranged inside the medical implant.
  • the angle formed by the part of the pull wire between the wire deployment part and the medical implant and the axis of the delivery system is 90°;
  • Fig. 29 is a schematic diagram of a partial structure of a medical device according to an embodiment of the present invention.
  • the medical device is in a crimped state, and the medical device includes a wire deploying part, and a wire deploying part is arranged inside the medical implant, and The angle formed by the portion of the pull wire between the wire deployment member and the medical implant and the axis of the delivery system is less than 90°.
  • 10-transport tube assembly 11-inner tube; 12-outer tube; 13-sheath tube; 14-tapered head; 20-wire control component; ; 211b-the first groove; 212-guy wire tube; The second through hole; 231b-the second groove; 232-the second fixing ring; 233-the channel; 234-the third through hole.
  • 1000-inner tube mechanism 1100-inner tube, 1200-wire deployment part, 1200a-proximal segment, 1200b-second segment, 1210-threading channel, 1201-guiding surface, 1201a-first sub-guiding surface, 1201b - second sub-guiding surface, 1201c - third sub-guiding surface, 1211 - first hole section, 1212 - second hole section, 1213 - third hole section, 1220 - installation through hole, 1230 - line deployment component body, 1231 -threading slot, 1240-rotating member, 1241-positioning slot, 1250-base, 1251-introduction channel, 2000-outer tube, 200-handle, 20-guy wire, 2-medical implant.
  • the singular forms “a”, “an” and “the” include plural objects, the term “or” is usually used in the sense of including “and/or”, and the term “several” Usually, the term “at least one” is used in the meaning of “at least one”, and the term “at least two” is usually used in the meaning of "two or more”.
  • the terms “first”, “second “Two” and “third” are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features.
  • proximal end is usually the end close to the operator
  • distal end is usually the end close to the patient, that is, the end close to the lesion.
  • One end and “the other end” as well as “proximal end” and “distal end” usually refer to the corresponding two parts, which not only include the end point, the term “installation” , “connected” and “connected” should be understood in a broad sense.
  • connection can be fixed connection, detachable connection, or integrated; it can be mechanical connection or electrical connection; it can be direct connection or through
  • the intermediary is indirectly connected, which can be the internal communication of two elements or the interaction relationship between two elements.
  • an element is arranged on another element, usually only means that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the relationship between the two elements can be direct or indirect through an intermediate element.
  • connection, coupling, fit or transmission but should not be understood as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content Also clearly point out.
  • the object of the present invention is to provide an implant delivery device to solve the problems of long wire withdrawal path and complicated operation of the existing conveyor.
  • FIG. 1 is the schematic diagram of an example of the wire-controlled valve prosthesis of the embodiment of the present invention
  • Fig. 2 is the schematic diagram of another example of the wire-controlled valve prosthesis of the embodiment of the present invention
  • Fig. 3 is a schematic diagram of the implant delivery device of the embodiment of the present invention assembled with the wire-controlled valve prosthesis
  • FIG. 4 is a schematic diagram of the implant delivery device of the embodiment of the present invention
  • FIG. 5 is a delivery device of the embodiment of the present invention
  • a schematic diagram of a pipe assembly
  • Figures 6a to 6c are schematic diagrams of several preferred examples of pin-shaped parts in embodiments of the present invention
  • Figures 7a to 7c are schematic diagrams of several preferred examples of wire fixing components in embodiments of the present invention
  • Figures 8a to Fig. 8d is a schematic diagram of several preferred examples of the first through hole and the second through hole of the embodiment of the present invention
  • FIGS. 9b are schematic diagrams of several preferred examples of the wire deployment part of the embodiment of the present invention.
  • Figure 11 is an enlarged view of part A of Figure 10;
  • Figure 12 is a schematic diagram of a preferred example of two wire control components of the delivery device according to the embodiment of the present invention;
  • Figure 13 is a diagram 12 is an enlarged view of part B;
  • FIG. 14 is a schematic diagram of another preferred example of two wire control assemblies of the delivery device according to an embodiment of the present invention;
  • FIG. 15 is an enlarged view of part C of FIG. 14 .
  • Figure 1 and Figure 2 show an implant, specifically a wire-controlled valve prosthesis, which includes: a stent 01 and at least one puller group 02, the stent 01 is preferably a self-expandable stent, which can expand radially or shrink.
  • a part of the pull wire group 02 is arranged around the stent 01 in a circumferential direction, and the expansion or contraction of the stent 01 can be controlled by driving the pull wire group 02 .
  • a pull wire group 02 includes at least one pull wire.
  • the pull wire can be divided into at least one fixing wire 021 and at least one detachment wire 022 according to different functions.
  • the fixed wire 021 can be understood as a pull wire with fixed ends 022a at both ends, and both fixed ends 022a are connected to the wire fixing part 21 of the conveying device, thereby forming a loop. If there are more than two fixed wires 021, the latter fixed wire 021 passes through the ring of the previous fixed wire 021 to form a relationship of pin connection in turn; 022a is used to connect with the wire fixing part 21 of the delivery device, and the disengagement end 022b is used to be connected with the wire release part 22 of the delivery device. Then dismantling line 022 passes through the loop of the last fixed line 021, and pins the last fixed line 021.
  • the detachment wire 022 is equivalent to releasing the pinning of the last fixing wire 021, and several fixing wires 021 are also releasing the pinning relationship in turn, so that the entire pull wire group 02 and the bracket 01 break away from each other to complete the line withdrawal.
  • the detachment line 022 forms a single coil loop.
  • the detachment line 022 forms a double coil loop.
  • the pull wires are all used for detachment without distinguishing between the fixed wire and the detachment wire, or all the pull wires can be considered as the detachment wire 022 .
  • each pull wire has a fixed end 022a connected to the wire fixing member 21 of the delivery device and a disengaged end 022b connected to the wire release member 22 of the delivery device. With such configuration, after the wire disengagement part 22 is disengaged from the disengagement end 022b of the wire, the disengagement end 022b of the wire is released, so that the wire group 02 and the bracket 01 are disengaged from each other to complete wire withdrawal.
  • the pull wires can be extended to the proximal end for manipulation, which makes it easy for the pull wires to form crossing and entanglement with each other and affect the operation. Therefore, referring to FIG. 3 , FIG. 4 and FIG.
  • an embodiment of the present invention provides an implant delivery device, which includes: a delivery tube assembly 10 and at least one wire control assembly 20; the wire control assembly 20 includes: The wire fixing part 21 and the wire breaking part 22; the wire fixing part 21 is used to connect with the fixed end 022a of the pull wire in the pull wire group 02; The axial direction of the tube 11, see the description of the inner tube 11 below for details), and the wire disengagement part 22 is used to connect with the disengagement end 022b of the pull wire in the pull wire group 02; when the wire disengagement part 22, when the preset condition is met, the wire disengagement component 22 is disengaged from the disengagement end 022b of the pull wire.
  • the wire disengagement part 22 disengages from the disengagement end 022b of the pull wire under preset conditions, and the preset conditions here may be different according to different structures of the wire disengagement part 22, for example, in some embodiments, the wire disengagement part 22 is a mechanical disengagement structure , then the preset condition can be that the wire detachment part 22 moves mechanically, such as the wire detachment part 22 mechanically moves, expands or unlocks, etc.; It may be energized; in some other embodiments, the wire detachment component 22 is a dissolving structure, and the preset condition may be waiting for a certain period of time and so on. Those skilled in the art can set specific preset conditions according to different structures of the wire breaking away part 22.
  • the delivery tube assembly 10 includes an inner tube 11, and the inside of the inner tube 11 can be used for passing a guide wire.
  • the extension direction of the inner tube 11 is its axial direction, that is, the entire The axial direction of the delivery tube assembly 10 . It can be understood that since the inner tube 11 is bendable, its axial direction is not fixed as a straight line, but bends following the bending of the inner tube 11 .
  • the proximal end of the inner tube 11 is connected to the handle 15 , and the wire fixing part 21 of the wire control assembly 20 is movably sleeved outside the inner tube 11 .
  • the delivery tube assembly 10 also includes an outer tube 12 and a sheath tube 13, the outer tube 12 is movably sleeved outside the wire control assembly 20, the sheath tube 13 is movably sleeved outside the outer tube 12, and the implant can be It is accommodated in the sheath tube 13 .
  • the distal end of the inner tube 11 is provided with a tapered head 14 to facilitate the passage of the delivery device.
  • the specific structure of the delivery tube assembly 10 those skilled in the art can understand and configure it according to the prior art, which is not described in detail in the present invention.
  • the wire fixing part 21 is movably arranged along the axial direction of the delivery tube assembly 10, the pull wire group 02 includes a plurality of pull wires, and the wire fixing part 21 is used for fixing a plurality of the pull wires. Terminal 022a is confluently connected.
  • the wire fixing part 21 brings together the fixed ends 022a of multiple stay wires in the pull wire group 02 (it can be understood that if the pull wires include the fixing wires 021 and the dismounting wires 022, then the wire fixing part 21 collects the fixed ends of all the fixing wires 021 and the dismounting wires 022 022a), driving the wire fixing component 21 along the axial direction of the delivery tube assembly 10 can control the retraction and retraction of the pull wire group 02 .
  • the wire fixing part 21 is fixedly arranged along the axial direction of the delivery tube assembly 10, for example, the wire fixing part 21 can be arranged at the handle at the proximal end, and the control is realized by directly driving the proximal end of the pull wire. The retraction and release of the pull wire group 02.
  • the wire detachment member 22 when the detachment end 022b of the pull wire is connected to the wire detachment member 22, the wire detachment member 22 is in a connected state, and at this time the wire control assembly 20 is connected to the shaft at the distal end of the delivery device.
  • the axial distance (should be understood as the axial distance between the proximal end of the wire control assembly 20 and the farthest end of the delivery device) is not greater than 300 mm.
  • the wire fixing part 21 and the wire detaching part 22 are integrated in the distal part of the delivery tube assembly 10 close to each other, which simplifies the wire control structure of the delivery device.
  • the retraction and detachment of the puller group 02 is simple, the friction stroke is less, and the stability of the bracket 01 is less affected during the withdrawal process, which improves the success rate of the operation and overcomes the problems of long withdrawal path and complicated operation of the existing conveyor .
  • the wire detachment member 22 is a mechanical detachment structure, which includes a pin-shaped member 221, and the pin-shaped member 221 has an opening; the preset condition includes: the The wire disengagement member 22 moves relative to the disengagement end 022b of the pull wire, so that the disengagement end 022b of the pull wire disengages from the opening.
  • This embodiment does not limit the specific shape of the pin-shaped member 221.
  • Figures 6a to 6c show spiral, L-shaped and hook-shaped pin-shaped members 221 respectively. Their common feature is that they have openings but not closures.
  • the pin-shaped part 221 When the shaped part 221 moves proximally relative to the disengagement end 022b, the pin-shaped part 221 can be deformed under force, so that the disengagement end 022b of the pull wire slips off from the pin-shaped part 221 .
  • the pin-shaped member 221 is in a spiral shape, and the number of turns of the spiral is between 1-3.
  • the pin-shaped member 221 can be made of metal or non-metallic material, understandably, the force to deform the pin-shaped member 221 should be less than the tensile limit of the pull wire.
  • the delivery device further includes a traction member 222, one end of the traction member 222 is connected to the pin-shaped member 221, and the other end of the traction member 222 extends proximally.
  • the traction member 222 can be a traction wire or the like, which can be connected to the handle after extending proximally, and the operator can pull the traction member 222 through the handle at the proximal end, thereby moving the pin-shaped member 221 toward the proximal end. It should be noted that if the traction member 222 is a component such as a traction wire that can only be pulled but cannot transmit thrust, the pin-shaped member 221 can be configured to disengage from the pull wire when moving toward the proximal end.
  • the guide tube is used as the traction member 222, since it can transmit thrust, the moving direction of the pin-shaped member 221 and the pulling wire can be unrestricted.
  • a pulling member such as a pulling wire as the pulling member 222 .
  • the thread breaking part 22 is located at the proximal end of the thread fixing part 21, and when the thread breaking part 22 does not meet the preset condition, the thread breaking part 22 and the thread fixing part 21 synchronously move along the The axial movement of the delivery tube assembly 10 is described.
  • the preset condition is not met, all the pulling wires have substantially the same function, and they are all used to drive and control the contraction or expansion of the stent 01 . Therefore, the wire disengagement part 22 and the wire fixing part 21 should be configured to move synchronously along the axial direction of the delivery tube assembly 10, so that each pull wire is retracted synchronously.
  • the wire fixing part 21 includes a driving member 211, and the driving member 211 is movably arranged along the axial direction of the delivery tube assembly 10; the driving member 211 has a first stop structure , the first limiting structure is used to limit the circumferential position of the pull wire around the delivery tube assembly 10 .
  • the delivery device also includes a pull-wire tube 212, the proximal end of the driver 211 is connected to the pull-wire tube 212, the pull-wire tube 212 extends to the proximal end and is connected to the handle, the operator can use the handle at the proximal end to Pull or push the pull wire tube 212 to the distal end, thereby driving the driving member 211 to move along the axial direction of the delivery tube assembly 10 .
  • the driving part 211 can be arranged on the part near the distal end of the delivery tube assembly 10, and the driving part 211 can collect the pull wires of the converging pull wire group 02, thus, each pull wire of the pull wire group 02 is at the distal end of the entire delivery device, and the driving part 211 is controlled by the cable tube 212 , the wiring path of the cable group 02 is short, and each cable can be retracted synchronously, so that the release precision of the bracket 10 is high. Further, the setting of the first limiting structure can limit the circumferential position of each of the pull wires of the pull wire set 02, and avoid interlacing and entanglement among them.
  • the first limiting structure includes a plurality of first through holes 211a (as shown in FIG. It includes a plurality of first grooves 211b (as shown in FIG. 7c ) opened on the outer periphery of the driving member 211 along the axial direction of the driving member 211; the first through hole 211a or the first groove 211b is used For the said stay wire to pass through.
  • the driving member 211 is a multi-lumen tube, each of the first through holes 211a can accommodate one or more pull wires to pass through.
  • the first through hole 211a limits the circumferential position of the pull wire.
  • the cross-sectional shape and quantity of the first through hole 211a and the first groove 211b are not limited, and Fig. 8a to Fig. 8d exemplarily show several preferred cross-sectional shapes of the first through hole 211a. It should be understood that Fig. 8a to Fig. 8d are only examples of the cross-sectional shape and quantity of the first through holes 211a rather than limiting the cross-sectional shape and quantity of the first through holes 211a.
  • the driving member 211 is a gear-like structure with a plurality of first grooves 211b on its outer periphery, and each first through hole 211a can accommodate one or more pull wires to pass through. It is also possible to limit the circumferential position of the pull wire.
  • the wire fixing part 21 also includes a fixing structure, and the fixing structure is used for connecting with the fixing end 022a of the pull wire.
  • the different two first through holes 211a are used for the same pull wire to pass through and wind in sequence, and the driving member 211 and the different two first through holes thereon A through hole 211a is commonly configured as the fixing structure.
  • the same pull wire passes through two adjacent first through holes 211a in sequence, that is, the connection between the pull wire and the driving member 211 is completed.
  • the pull wire preferably forms a double-coil loop as shown in FIG. Two first through holes 211a.
  • the fixing structure includes: a first fixing ring 213, and the first fixing ring 213 is used for winding the fixing end 022a of the pull wire so that the pull wire and the wire
  • the fixing part 21 forms the connection.
  • the winding here may be a double wire winding, or a single wire itself forming a loop (such as forming by knotting or welding).
  • the fixing structure includes a first fixing ring 213 additionally attached to the driving member 211.
  • the radial inner dimension of the first fixing ring 213 is smaller than that of the driving member 211 , the first fixing ring 213 is used to abut against the driving member 211 .
  • the radial inner dimension of the first fixing ring 213 refers to the smallest inner dimension of the first fixing ring 213 along the radial direction.
  • the radial inner dimension of the first fixing ring 213 is its inner diameter.
  • the radial inner dimension of the first fixing ring 213 is the diameter of its inscribed circle.
  • the radial outer dimension of the driving member 211 refers to the maximum outer dimension of the driving member 211 along the radial direction.
  • the radial outer dimension of the driving member 211 is its outer diameter.
  • the radial outer dimension of the driving member 211 is the diameter of its circumscribed circle. The same applies to the radial outer dimensions of the other components described below.
  • the first fixing ring 213 is located at the proximal end of the driving member 211, and after the fixing end 022a of the pull wire is wound around the first fixing ring 213, it passes through the first through hole 211a toward the distal end. Extend, and then surround the bracket 01.
  • the driving member 211 is pulled toward the proximal end
  • the first fixing ring 213 is driven by the driving member 211 to move toward the proximal end together, so that the pull wire is pulled toward the proximal end.
  • the self-expanding of the stent 01 drives the pull wire to move toward the distal end, and drives the first fixing ring 213 to move toward the distal end and continue to abut against the driving member 211 .
  • this embodiment does not limit the arrangement of the first fixing ring 213 at the proximal end of the driving member 211.
  • the relationship between the first fixing ring 213 and the driving member 211 may also be reversed, that is, the second A fixing ring 213 is arranged on the distal end of the driving member 211.
  • the stent 01 is driven to shrink for tightening the stay wire, and when the driving member 211 is pulled toward the proximal end, it is for loosening the stay wire. , the stent 01 is expanded.
  • the first fixing ring 213 is fixedly sleeved on the outer periphery of the driving member 211 .
  • the first limiting structure of the driving member 211 includes a plurality of first grooves 211b formed on the outer periphery of the driving member 211 along the axial direction of the driving member 211 .
  • the first fixing ring 213 and the driving member 211 can be connected by means of welding, bonding, mechanical limit, etc., and the inner circumference of the first fixing ring 213 and the first groove 211b form a closed hole, which can be used for fixing the pull wire
  • the terminal 022a is wound around, and its principle is similar to the example shown in FIG. 7b , which will not be repeated here.
  • the wire control assembly 20 further includes: a wire deployment part 23; the wire deployment part 23 is fixedly connected with the inner tube 11; After the radial direction of 10 merges with it, the extension direction of the pull wire is changed to extend along the axial direction of the delivery tube assembly 10 .
  • the wire deployment part 23 is mainly used to change the extension direction of the pull wire.
  • the axial position of the wire deployment part 23 along the delivery tube assembly 10 is adapted to the loading position of the stent 01, more preferably, the distal end of the wire deployment part 23 is adapted to the position where the pull wire wraps around the stent 01, so as to Minimize the angle of the stay wires between the wire deployment part 23 and the bracket 01 relative to the radial direction of the bracket 01 as far as possible, and preferably make this part of the stay wires parallel to the radial direction of the bracket 01 .
  • the wire deployment part 23 includes a conversion piece 231, and the conversion piece 231 has a second limiting structure, and the second limiting structure is used to limit the circumferential direction of the pull wire around the delivery tube assembly 10. Location.
  • the arrangement of the second limiting structure can limit the circumferential position of each of the pull wires of the pull wire set 02 to avoid interlacing and entanglement among them.
  • the second limiting structure includes a plurality of second through holes 231a penetrating through the axial direction of the conversion member 231; or, the second limiting structure includes a plurality of holes 231a along the conversion member 231
  • the second groove 231b axially opened on the outer periphery of the conversion member 231; the second through hole 231a or the second groove 231b is used for passing the pull wire.
  • the structure and setting principle of the second through hole 231a and the second groove 231b are similar to the first through hole 211a and the first groove 211b on the driving member 211.
  • the second through hole 231a and the second groove 231b The cross-sectional shape of is not limited, and the second through hole 231a may be as shown in FIG. 8a to FIG. 8d.
  • the wire deploying part 23 further includes a transition structure, and the transition structure is used to gradually change the extension direction of the pull wire.
  • gradually changing the extension direction of the stay wire here means that the stay wire has a certain turning radius at the transition structure, rather than a sharp corner.
  • the gradual change may be, for example, a smooth change in the shape of an arc, or a multi-fold change formed by multiple fold lines. The arrangement of the transition structure can effectively reduce the abrasion of the stay wire.
  • the transition structure includes: a second fixing ring 232; It is used for changing the extending direction of the pulling wires.
  • the outer circumference of the conversion member 231 has a second groove 231b opened in the axial direction, and the second fixing ring 232 and the conversion member 231 can be connected by means of welding, bonding, mechanical limit, etc.
  • the inner circumference of the two fixing rings 232 and the second groove 231b form a closed hole, which can be used for the fixed end 022a of the backguy to wrap around to change the extension direction, which not only limits the circumferential position of the backguy, but also the second fixing ring 232.
  • the pull wire can smoothly change the direction of extension.
  • the conversion member 231 having the second through hole 231a may also be used to cooperate with the second fixing ring 232 to change the extension direction of the pull wire, and the present invention is not limited thereto.
  • the conversion member 231 has a hole 233 opened along the axial direction of the delivery tube assembly 10, and the second limiting structure includes a plurality of The third through hole 234 opened radially of the member 231 and communicated with the hole 233; the transition structure includes the third through hole 234; the hole 233 and the third through hole 234 are used for the The extension direction is changed by passing the pull wire.
  • the hole 233 can be in various forms such as a through hole, a blind hole or a ring groove, and the pull wire can pass through the hole 233 and then pass through the third through hole 234 to change the extending direction. In the example shown in FIG.
  • the hole 233 is annular and opens towards the proximal end along the axial direction of the conversion member 231 , and the side wall of the third through hole 234 serves as a transition structure.
  • the intersection of the side wall of the third through hole 234 and the channel 233 is an arc surface to form a smooth transition.
  • the wire deploying part 1200 is disposed on the outer surface of the distal end of the inner tube 1100, and when the number of the wire deploying parts 1200 is more than two, More than two wire deployment parts 1200 are disposed on the inner tube 1100 at intervals in the axial direction.
  • a threading channel 1210 is formed on the thread deployment part 1200, and a part of the surface of the threading channel 1210 is formed as a smooth guide surface 1201, and the guide surface 1201 is used to guide the threading channel 1210 when the pull wire 20 passes through the threading channel 1210.
  • the pull wire 20 provides support force and deflects the extending direction of the pull wire 20 .
  • smooth means that there are no sharp edges on the guide surface 1201, that is, the guide surface 1201 is a continuous curved surface, or the guide surface 1201 includes a plurality of different surfaces, mostly A different surface can be a plane or a curved surface, and multiple different surfaces are connected with a smooth transition.
  • the guide surface 1201 includes a first sub-guiding surface 1201a, a second sub-guiding surface 1201b, and a first Three sub-guiding surfaces 1201c.
  • the axes of the first sub-guiding surface 1201a and the third sub-guiding surface 1201c are both straight lines, and the angle formed between them is 45°-135°.
  • the axis of the second sub-guiding surface 1201b is an arc, so that on a section parallel to the axial direction of the wire deployment component 1200, at least a part of the outline of the second sub-guiding surface 1201 is a curve.
  • the deflection angle can be at least 45° ⁇ Choose from a range of 135°.
  • an installation through hole 1220 is formed on the wire deployment part 1200 , and the wire deployment part 1200 is installed on the inner tube 1100 through the installation through hole 1220 .
  • the threading channel 1210 includes a threading hole (not marked in the figure), the threading hole includes a first hole segment 1211, the axis of the first hole segment 1211 is parallel to the axis of the installation through hole 1220, and, the Part of the hole wall of the first hole section 1211 can constitute the first sub-guiding surface 1201a.
  • the first sub-guiding surface 1201a is formed on the wire deployment part 1200 , and the wire deployment part 1200 is installed on the inner tube 1100 through the installation through hole 1220 .
  • the threading channel 1210 includes a threading hole (not marked in the figure), the threading hole includes a first hole segment 1211, the axis of the first hole segment 1211 is parallel to the axis of the installation through hole 1220, and, the Part of the hole wall of the first hole section 1211 can constitute the first sub
  • the threading hole may also include a second hole segment 1212 and a third hole segment 1213 .
  • the proximal end of the second hole section 1212 is connected to the distal end of the first hole section 1212, and part of the hole wall of the second hole section 1212 constitutes the second sub-guiding surface 1201b.
  • the proximal end of the third hole section 1213 is connected to the distal end of the second hole section 1212 , and part of the hole wall of the third hole section 1213 constitutes the third sub-guiding surface 1201c.
  • the surface roughness Ra of the guide surface 1201 should be as small as possible, so as to further reduce the distance between the pull wire 20 and the guide surface 1201 during the process of releasing or recovering the medical implant 2 . the resulting friction.
  • the surface roughness Ra of the guide surface 1201 may be less than or equal to 0.2.
  • the surface roughness Ra of the guide surface 1201 can be reduced by selecting materials, for example, the wire deployment component 1200 is made of relatively smooth materials such as polytetrafluoroethylene, ceramics, and glass, or , the wire deployment part 120 includes a base material and a lubricating coating, a channel for the pull wire 20 to pass is formed on the base material, and the lubricating coating is provided on a part of the surface of the channel to form the guide surface 1201 .
  • the wire deployment part 1200 may be a metal structural member, and the surface roughness Ra of the guide surface 1201 is reduced by grinding, polishing, etc. the surface of the threading channel 1210, where , the material of the wire deploying part 1200 includes but not limited to any one of titanium carbonitride, titanium nitride, stainless steel, and nickel titanium.
  • the number of the threading channel 1210 is set according to actual needs, and it may be one, or two, three, or more. As shown in Figures 16 to 18, when the number of the threading channels 1210 is more than two, preferably more than two threading channels 1210 are arranged at intervals around the installation through hole 1220 to reduce the wire deployment. The radial dimension of the component 1200 thereby reduces the radial dimension of the delivery system 1 .
  • outlets of a plurality of threading channels 1210 are located on the same circumference, or at least part of the outlets of the threading channels 1210 are located on different circumferences.
  • the wire deployment component 1200 has a streamlined shape, which includes a proximal segment 1200a and a distal segment 1200b axially connected, and the proximal segment The cross-sectional area of segment 1200a gradually increases in the direction from the proximal end to the distal end.
  • the advantage of doing this is that the bending performance of the delivery system 1 can be improved, which is beneficial for the delivery system 1 to pass through tortuous blood vessels, and at the same time, there is less interference with blood vessels and less damage to blood vessels.
  • the wire deployment part 1200 can be an integrated component or an assembled component, as long as the threading channel 1210 and the installation through hole 1220 can be formed on the wire deployment part 1200 .
  • the wire deploying part 1200 includes at least a wire deploying part body 1230 and a rotating part 1240 .
  • a first insertion hole is formed at the center of the wire deployment component body 1230 as at least a part of the installation through hole 1220 .
  • the thread deployment part body 1230 is also formed with a threading groove 1231 passing through the thread deployment part body 1230 in the axial direction.
  • the threading groove 1231 extends along the radial direction of the thread deployment part body 1230 , and open at the edge of the wire deploying part body 1230, the threading groove 1231 is a U-shaped groove or a fan-shaped groove.
  • the rotating member 1240 is rotatably connected to the groove wall of the threading groove 1231 , and encloses at least part of the groove wall of the threading groove 1231 to form the threading channel 1210 .
  • the rotating member 1240 has a circumferential surface, and a partial area of the circumferential surface constitutes the guide surface 1201 .
  • at least a partial area of the side of the circumferential surface away from the opening constitutes the guide surface 1201, that is, at least a partial area of the circumferential surface facing the installation through hole 1220 constitutes the guide surface 1201.
  • the extending direction of the distal end of the pull wire 20 can be deflected (as shown in FIG. 24 ). That is to say, in this embodiment, part of the surface of the rotating member 1240 is used as a support when the direction of the pull wire 20 is deflected, so that the friction force between the pull wire 20 and the wire deployment part 1200 is rolling friction. , to reduce the loss of control.
  • the wire deployment component body 1230 may have a smaller axial dimension.
  • the wire deployment component 1200 may further include a base 1250, and 1250 is connected to the proximal end surface of the fixing base body 1230, and the base 1250 is also provided with a second insertion hole corresponding to the first insertion hole, and the second insertion hole is in common with the first insertion hole.
  • the installation through hole 1220 is formed.
  • the base 1250 may also be provided with an introduction channel 1251 communicating with the threading channel, and the distal end of the pull wire 20 passes through the introduction channel 1251 and then passes through the threading channel 1210 .
  • the introduction channel 1251 can be set at the position of the base 1250 corresponding to the threading channel 1201 , which can be a hole (as shown in FIG. 22 and FIG. 23 ), such as a circular hole, a square hole, and the like. It should be noted that, in the embodiment of the present invention, there is no special limitation on the setting position of the introduction channel, as long as it can allow the distal end of the pull wire 20 to pass through and enter the threading channel 1210 . In addition, it is also preferable that the cross-sectional area of the base 1250 increases gradually from the proximal end to the distal end, so as to improve the bending performance of the delivery system 1 .
  • the base 1250 and the wire deployment component body 1230 can be integrally formed, or formed separately and then connected together.
  • the wire deployment member body 1230 may have a larger axial dimension, in this case, preferably, the cross section of the wire deployment member body 1230 increases gradually from the proximal end to the distal end.
  • the rotating member 1240 may be a rotating shaft, and the rotating shaft is mounted on the groove wall of the threading groove 1231 through a bearing.
  • an installation shaft (not shown) is formed on the opposite two groove walls of the threading groove 1231, and the rotating member 1240 is a certain pulley, and the fixed pulley is rotatably installed on the installation shaft.
  • the rotating member 1240 is preferably a metal structural member, and its material includes but not limited to any one of titanium carbonitride, titanium nitride, stainless steel, and nickel titanium.
  • a positioning groove 1241 is provided on the circumferential surface of the rotating member 1240, and the positioning groove 1241 extends one circle along the circumferential direction of the rotating member 1240, and part of the groove wall of the positioning groove 1241 (that is, the positioning The part of the groove 1241 facing the installation through hole) constitutes the guide surface 1201 .
  • the pull wire 20 is restricted in the positioning groove 1241 when passing through the threading passage 1210, so as to prevent the pull wire 20 from having a large movement range in the axial direction of the rotating member 1240 from causing damage to the medical device.
  • the positioning groove 1241 is arc-shaped.
  • the delivery system 1 provided by the embodiment of the present invention optimizes the structure of the wire deployment part 1200 to reduce the friction force of the pull wire 20 when passing through the threading channel 1210 on the wire deployment part 1200 , to reduce the problem of loss of control force when releasing or retrieving the medical implant 2, and then achieve improving the stable release or retrieving of the medical implant 2, reducing the release or retrieving of the medical implant 2 damage to human tissue.
  • the delivery system 1 releases or recovers the medical implant 2 it can also well overcome the problem of axial displacement of the medical implant 2, and improve the positioning accuracy.
  • the embodiment of the present invention has no special limitation on the number and setting positions of the wire deployment parts 1200 included in the delivery device, as long as the distal end of the pull wire 20 can be turned under the action of the guide surface 1201 and is compatible with the medical Implant 2 is connected.
  • the line deployment part 1200 is one (as shown in Figure 25, Figure 26, Figure 28 and Figure 29), two (as shown in Figure 27), and more (not shown in the figure), so
  • the wire deployment part 1200 can be arranged on the proximal side and/or the distal side of the medical implant 2 (as shown in Figure 25, Figure 26 and Figure 27), and the wire deployment part can also be arranged on the The inner side of the medical implant 2 (as shown in Figure 28 and Figure 29).
  • the conveyor includes at least one wire deployment part 1200 , and in the axial direction of the conveyor system 1 , any one of the wire deployment parts 1200
  • the distance between the wire deployment part 1200 and the medical implant 2 is greater than or equal to zero (as shown in FIG. 25 and FIG. 27 ), and when the medical implant 2 is in the crimped state, the wire deployment
  • the guide surface 1201 of the component 1200 deflects the extension direction of the pull wire 20 by a predetermined angle.
  • the guide surface 1201 deflects the extension direction of the pull wire 20 by 90° to 135° (that is, the part of the pull wire 20 between the wire deployment part 1200 and the medical implant 2 and the The angle ⁇ formed by the axes of the conveyors is 90°-135°).
  • the wire deployment part 1200 is arranged on the distal side of the medical implant 2, and the distance between the proximal end of the wire deployment part 1200 and the distal end of the medical implant is greater than or equal to 0 , and at the same time, the guide surface 1201 deflects the extension direction of the pull wire by 45° to 90° (that is, the part of the pull wire 20 between the wire deployment part 1200 and the medical implant 2 and the delivery
  • the angle ⁇ formed by the axis of the device is 45° ⁇ 90°).
  • the purpose of this setting is that when the medical implant 2 is compressed, there is no axial overlap between the medical implant 2 and the wire deployment part 1200, and the two do not contact, which can improve the overall medical performance.
  • the flexibility of the device so that the medical device can better adapt to tortuous blood vessels.
  • the medical implant 2 is arranged coaxially with the inner tube 1100 .
  • the part of the pull wire 20 between the wire deploying part 1200 and the medical implant 2 and the The included angle ⁇ formed by the axis of the inner tube 1100 will change accordingly.
  • the wire deploying part 1200 is arranged on the proximal side of the medical implant 2
  • the medical implant After the implant 2 is released, the angle of the included angle ⁇ decreases.
  • the wire deployment component 1200 is arranged on the distal side of the medical implant 2, after the medical implant 2 is released, The angle of the included angle ⁇ increases.
  • FIG. 10 and FIG. 11 show the assembly relationship between the pull wire and the conveying device. It should be understood that, in the example shown in FIG. 10 and FIG. 11 , only one pull wire in the pull wire set 02 is shown, but actually the pull wire set 02 may include multiple pull wires.
  • the pull wire forms a single coil loop
  • the fixed end 022a of the pull wire is wound into a loop and fixed on the first fixed ring 213, and then the pull wire passes through the first through hole 211a of the driver 211 and extends to the distal end , then pass through the second through hole 231a of the conversion piece 231, and stretch out from the far end of the conversion piece 231 to form a loop (the loop can form a pinned relationship with other backguys in the backguy set 02, or be directly used to drive stent), and then the pull wire passes through the second through hole 231a of the conversion part 231 again, extends to the proximal end, and then passes through the first through hole 211a of the driving part 211 again, and is connected with the pin-shaped part 221.
  • the example shown in Fig. 10 and Fig. 11 is only an example of the assembly relationship between the pull wire and the conveying device and is not limiting.
  • the delivery device includes more than two wire control assemblies 20 , and more than two wire fixing parts 21 of the wire control assemblies 20
  • the parts used to connect with the pull wire set 02 are staggered along the radial direction and/or circumferential direction of the delivery tube assembly 10 .
  • the wire-controlled valve prosthesis includes more than two pull-wire groups 02 arranged at intervals in the axial direction, and correspondingly, the delivery device includes more than two wire-controlled assemblies 20, and each wire-controlled assembly 20 corresponds to control A cable set 02.
  • the first limiting structures and/or fixing structures of the wire fixing parts 21 of more than two wire control assemblies 20 are coaxially arranged inside and outside around the inner tube 11 .
  • the first limiting structure and/or the fixing structure for controlling the wire fixing part 21 of the pull wire group 02 at the far end is located inside, and is used for controlling the first stop structure and/or fixing structure of the wire fixing part 21 of the pull wire group 02 at the proximal end.
  • a limiting structure and/or fixing structure is located on the outside.
  • the delivery device includes two wire control assemblies 20 , wherein the diameter of the driving member 211 of the wire control assembly 20 connected to the pull wire set 02 located at the proximal end is relatively large, The diameter of the drive element 211 of the wire control assembly 20 connected to the pull wire set 02 at the distal end is relatively small; the first through holes 211a of the two drive elements 211 are respectively arranged coaxially around the axis of the inner tube.
  • the two driving parts 211 are respectively connected to one puller tube 212 , so that the two driving parts 211 can be driven independently, so that the two wire fixing parts 21 can move independently of each other along the axial direction of the delivery tube assembly 10 .
  • the two wire control assemblies 20 can independently drive their corresponding pull wire groups 02 without mutual interference.
  • the wire fixing parts 21 of the two wire control assemblies 20 are fixed to each other, for example, the two driving parts 211 are connected to the same pull wire tube 212, at this time, the two pull wire groups 02 will be driven simultaneously to retract. Tight or loose.
  • the wire fixing parts 21 of the two wire control assemblies 20 are fixed to each other, not only can it be understood that the two wire control assemblies 20 have their own independent driving parts 211, as shown in Figure 14 and Figure 15, in some embodiments Among them, the two wire control assemblies 20 can also share the same driving part 211, which can also be understood as the driving parts 211 of the two wire control assemblies 20 are fused with each other and integrally formed. Further, the parts (such as the first through hole 211 a ) of the wire fixing parts 21 of more than two wire control assemblies 20 used to connect with the pull wire group are arranged in a staggered circumferential direction around the inner tube 11 to prevent the pull wires from intersecting and scratching each other.
  • the two pull wire groups 02 will be driven simultaneously to tighten or loosen.
  • the wire disengagement parts 22 of the two wire control assemblies 20 are not limited to be controlled simultaneously, but preferably can be driven independently.
  • only one dismantling wire 022 and multiple fixing wires 021 are set in each pull wire group 02, and correspondingly, only one wire disengagement part 22 can be set in each wire control assembly 20, and the structure of the conveying device is simple and easy to use
  • the backguys connected by the rest of the pins can be released. Simplified the steps of thread withdrawal operation.
  • the pull wire set 02 can be integrated into the conveying device, that is, the conveying device includes at least one pull wire set 02, and the pull wire set includes at least one pull wire. Please refer to the above for the specific structure and configuration of the pull wire group 02, and will not repeat them here.
  • the implant delivery device includes: a delivery tube assembly and at least one wire control assembly;
  • the wire control assembly includes: a wire fixing part and a wire detachment part;
  • the wire fixing part is used for The fixed ends of the stay wires in the stay wire group are connected;
  • the wire disengagement part is movably arranged along the axial direction of the delivery tube assembly, and the wire disengagement part is used to connect with the disengagement ends of the stay wires in the stay wire group;
  • the wire disengagement part satisfies a preset condition, the wire disengagement part is disengaged from the disengagement end of the pull wire.
  • the wire fixing part is connected to the fixed end of the pull wire
  • the wire detachment part is connected to the detachment end of the pull wire.

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Abstract

An implant conveying device, comprising a conveying pipe assembly (10) and at least one control-by-wire assembly (20). The control-by-wire assembly (20) comprises: a wire fixing component (21) and a wire release component (22), wherein the wire fixing component (21) is configured to be connected to a fixing end (022a) of a pull wire in a pull wire group (02); the wire release component (22) is movably arranged in an axial direction of the conveying pipe assembly (10), and the wire release component (22) is configured to be connected to a release end (022b) of the pull wire in the pull wire group (02); and when the wire release component (22) satisfies a preset condition, the wire release component (22) is separated from the release end (022b) of the pull wire. In this way, when the preset condition is satisfied, the wire release component (22) is separated from the release end (022b) of the pull wire, such that even if the release end (022b) of the pull wire forms a free end, the pull wire group (02) can be separated from a support (01). The release action of the pull wire group is simple, there are fewer friction strokes, and the effect on the stability of the support in a wire withdrawal process is small, such that the rate of a successful operation is increased, and the problems of an existing conveyor having a long wire withdrawal path and complex operation are solved.

Description

植入物的输送装置Implant delivery device 技术领域technical field
本发明涉及医疗器械技术领域,特别涉及一种植入物的输送装置。The invention relates to the technical field of medical devices, in particular to an implant delivery device.
背景技术Background technique
介入式瓣膜假体置入术是国际近年来研发的一种全新微创伤瓣膜置换技术,其原理是瓣膜假体被装载到输送系统内,通过经导管的方式输送到植入部位,如主动脉根部,瓣膜假体释放后被固定到主动脉瓣环处,替代功能退化的原生瓣膜,使病人心脏功能得到改善。这项技术,可以在不开胸、心脏不停跳的情况下治疗心脏瓣膜疾病,免去了以前外科开胸术、心脏停跳对病人造成的巨大创伤。Interventional valve prosthesis implantation is a new minimally invasive valve replacement technology developed internationally in recent years. Its principle is that the valve prosthesis is loaded into the delivery system and delivered to the implantation site through a catheter. At the root of the artery, the valve prosthesis is fixed to the aortic annulus after release, replacing the degraded original valve and improving the heart function of the patient. This technology can treat heart valve diseases without thoracotomy and heart beating, eliminating the huge trauma caused by previous surgical thoracotomy and cardiac arrest.
目前,瓣膜假体置入术主要有自膨胀式和球扩式两种机制,其各有利弊,其中球扩式瓣膜假体可以提供稳定的支撑力及释放过程中的稳定性,但是由于其支架材料的原因使其在释放后不能够被回收;自膨胀式瓣膜假体的优点在于可以纠错,在植入的过程中可以进行体内回收再次释放,但是由于自膨胀支架的性质,使其在释放过程中,形态不利于锚固。At present, there are mainly two mechanisms for valve prosthesis implantation: self-expanding and ball-expanding, each of which has advantages and disadvantages. Among them, the ball-expanding valve prosthesis can provide stable support and stability during release, but due to its The reason for the stent material is that it cannot be recovered after release; the advantage of the self-expanding valve prosthesis is that it can be corrected, and it can be recovered and released again during the implantation process, but due to the nature of the self-expanding stent, it cannot During release, the morphology is not conducive to anchoring.
目前出现一种基于自膨胀式瓣膜假体的线控技术,线控的目的在于在自膨胀式瓣膜假体的基础上增加线控,以实现类似球扩式的释放机制,提高植入过程中的稳定性,从而提高手术成功率。At present, there is a wire-controlled technology based on self-expanding valve prosthesis. The purpose of wire-control is to increase wire-control on the basis of self-expanding valve prosthesis, so as to realize a release mechanism similar to ball expansion, and improve the implantation process. stability, thereby improving the success rate of surgery.
在线控技术中,有两个因素直接影响手术的成功率:其一是撤线,即输送器将拉线从支架上撤离。因为在撤线过程中拉线与支架之间的摩擦导致拉线对支架始终产生一个作用力,而这种作用力很可能使支架产生位移,从而造成手术失败;其二是断线,即输送器端需提供一个断点,这是撤线的前提,断线的机制会影响输送器结构,增加了手术的复杂程度,影响了手术成功率。In the wire-controlled technology, there are two factors that directly affect the success rate of the operation: one is thread withdrawal, that is, the conveyor withdraws the pull wire from the stent. Because of the friction between the wire and the bracket during the withdrawal process, the wire always exerts a force on the bracket, and this force is likely to cause the bracket to shift, resulting in failure of the operation; It is necessary to provide a break point, which is the prerequisite for thread withdrawal. The mechanism of thread breakage will affect the structure of the conveyor, increase the complexity of the operation, and affect the success rate of the operation.
现有技术存在撤线路径长、操作复杂,导致瓣膜假体稳定性差、且手术难度高等问题。In the prior art, there are problems such as long thread withdrawal path and complicated operation, resulting in poor stability of valve prosthesis and high difficulty of operation.
发明内容Contents of the invention
本发明的目的在于提供一种植入物的输送装置,以解决现有输送器撤线路径长、操作复杂的问题。The object of the present invention is to provide an implant delivery device to solve the problems of long wire withdrawal path and complicated operation of the existing conveyor.
为解决上述技术问题,本发明提供一种植入物的输送装置,其包括:输送管组件及至少一个线控组件;所述线控组件包括:线固定部件及线脱离部件;In order to solve the above technical problems, the present invention provides an implant delivery device, which includes: a delivery tube assembly and at least one wire control assembly; the wire control assembly includes: a wire fixing part and a wire detachment part;
所述线固定部件用于与拉线组中的拉线的固定端连接;The wire fixing part is used to connect with the fixed end of the stay wire in the stay wire set;
所述线脱离部件沿所述输送管组件的轴向可移动地设置,所述线脱离部件用于与所述拉线组中的拉线的脱离端连接;当所述线脱离部件满足预设条件时,所述线脱离部件与所述拉线的脱离端脱离。The wire detachment part is movably arranged along the axial direction of the delivery tube assembly, and the wire detachment part is used to connect with the detachment end of the pull wire in the pull wire group; when the wire detachment part satisfies the preset condition , the wire disengagement part is disengaged from the disengagement end of the pull wire.
可选的,所述线固定部件沿所述输送管组件的轴向可移动地设置。Optionally, the wire fixing component is movably arranged along the axial direction of the delivery tube assembly.
可选的,所述线脱离部件位于所述线固定部件的近端,所述线脱离部件未满足预设条件时,所述线脱离部件与所述线固定部件同步地沿所述输送管组件的轴向移动。Optionally, the wire detachment part is located at the proximal end of the wire fixing part, and when the wire detachment part does not meet the preset condition, the wire detachment part and the wire fixing part synchronously move along the delivery tube assembly axial movement.
可选的,所述输送管组件包括内管,所述线固定部件可活动地套设于所述内管之外。Optionally, the delivery tube assembly includes an inner tube, and the wire fixing component is movably sleeved outside the inner tube.
可选的,所述预设条件包括所述线脱离部件机械性运动。Optionally, the preset condition includes mechanical movement of the wire breaking away component.
可选的,所述线脱离部件包括销形件,所述销形件具有开口,所述销形件用于供所述拉线的脱离端连接;所述预设条件包括:所述线脱离部件相对于所述拉线的脱离端移动,以使所述拉线的脱离端自所述开口中脱出。Optionally, the wire detachment part includes a pin-shaped part, the pin-shaped part has an opening, and the pin-shaped part is used for connecting the detachment end of the pull wire; the preset condition includes: the wire detachment part moving relative to the disengagement end of the pull wire, so that the disengagement end of the pull wire disengages from the opening.
可选的,所述输送装置还包括牵引件,所述牵引件的第一端与所述销形件连接,所述牵引件的第二端向近端延伸。Optionally, the delivery device further includes a traction member, the first end of the traction member is connected to the pin-shaped member, and the second end of the traction member extends proximally.
可选的,在所述拉线的脱离端与所述线脱离部件连接时,所述线脱离部件处于连接状态,此时所述线控组件与所述输送装置之远端的轴向距离不大于300mm。Optionally, when the disengagement end of the pull wire is connected to the wire disengagement part, the wire disengagement part is in a connected state, and the axial distance between the wire control assembly and the distal end of the delivery device is not greater than 300mm.
可选的,所述线固定部件包括驱动件,所述驱动件沿所述输送管组件的轴向可移动地设置;所述驱动件具有第一限位结构,所述第一限位结构用于限制所述拉线围绕所述输送管组件的周向位置。Optionally, the wire fixing part includes a driving part, and the driving part is movably arranged along the axial direction of the delivery tube assembly; the driving part has a first limiting structure, and the first limiting structure uses to limit the circumferential position of the pull wire around the delivery tube assembly.
可选的,所述第一限位结构包括多个沿所述驱动件的轴向贯通开设的第 一通孔,或者,所述第一限位结构包括多个沿所述驱动件的轴向开设于所述驱动件外周的第一凹槽;所述第一通孔或所述第一凹槽用于供所述拉线穿设。Optionally, the first limiting structure includes a plurality of first through holes opened along the axial direction of the driving member, or, the first limiting structure includes a plurality of holes along the axial direction of the driving member. A first groove opened on the outer periphery of the driving member; the first through hole or the first groove is used for passing the pull wire.
可选的,所述线固定部件还包括固定结构,所述固定结构用于与所述拉线的固定端连接。Optionally, the wire fixing part further includes a fixing structure, and the fixing structure is used for connecting with the fixing end of the pull wire.
可选的,不同的两个所述第一通孔用于供同一所述拉线依次穿过绕设,所述驱动件和其上的不同的两个所述第一通孔共同被配置为所述固定结构。Optionally, the two different first through holes are used for the same pull wire to pass through and wind in turn, and the driving member and the two different first through holes thereon are jointly configured as the the fixed structure.
可选的,所述固定结构包括:第一固定环,所述第一固定环用于供所述拉线的固定端绕设;Optionally, the fixing structure includes: a first fixing ring, the first fixing ring is used for wrapping around the fixing end of the pull wire;
所述第一固定环的径向内尺寸小于所述驱动件的径向外尺寸,所述第一固定环位用于与所述驱动件抵靠;或者The radially inner dimension of the first fixing ring is smaller than the radially outer dimension of the driving member, and the first fixing ring is used to abut against the driving member; or
所述第一固定环固定套设于所述驱动件的外周。The first fixing ring is fixedly sleeved on the outer periphery of the driving member.
可选的,所述线控组件还包括:线部署部件;所述输送管组件包括内管;Optionally, the wire control assembly further includes: a wire deployment component; the delivery tube assembly includes an inner tube;
所述线部署部件与所述内管固定连接;所述线部署部件用于供所述拉线沿所述输送管组件的径向汇合于其上后,将所述拉线的延伸方向改变为沿所述输送管组件的轴向延伸。The wire deploying part is fixedly connected with the inner tube; the wire deploying part is used for changing the extending direction of the pulling wire to along the radial direction of the delivery tube assembly after the pulling wire converges on it Axial extension of the delivery tube assembly described above.
可选的,所述线部署部件包括转换件,所述转换件具有第二限位结构,所述第二限位结构用于限制所述拉线围绕所述输送管组件的周向位置。Optionally, the wire deployment part includes a transition piece, the transition piece has a second limiting structure, and the second limiting structure is used to limit the circumferential position of the pull wire around the delivery tube assembly.
可选的,所述第二限位结构包括多个沿所述转换件的轴向贯通开设的第二通孔;或者,所述第二限位结构包括多个沿所述转换件的轴向开设于所述转换件外周的第二凹槽;所述第二通孔或所述第二凹槽用于供所述拉线穿设。Optionally, the second limiting structure includes a plurality of second through holes opened along the axial direction of the conversion member; or, the second limiting structure includes a plurality of holes along the axial direction of the conversion member. A second groove is provided on the outer periphery of the conversion member; the second through hole or the second groove is used for passing the pull wire.
可选的,所述线部署部件还包括过渡结构,所述过渡结构用于逐渐地改变所述拉线的延伸方向。Optionally, the wire deployment part further includes a transition structure, and the transition structure is used to gradually change the extension direction of the pull wire.
可选的,所述过渡结构包括:第二固定环;Optionally, the transition structure includes: a second fixing ring;
所述第二固定环相对于所述转换件固定设置,所述第二固定环用于供所述拉线绕设而改变延伸方向。The second fixing ring is fixedly arranged relative to the conversion element, and the second fixing ring is used for winding the pull wire to change the extending direction.
可选的,所述转换件具有沿所述输送管组件的轴向开设的孔道,所述第二限位结构包括多个沿所述转换件的径向开设并与所述孔道连通的第三通孔;所述过渡结构包括所述第三通孔;所述孔道与所述第三通孔用于供所述 拉线穿设而改变延伸方向。Optionally, the transition piece has a hole opened along the axial direction of the delivery tube assembly, and the second limiting structure includes a plurality of third holes opened along the radial direction of the transition piece and communicated with the hole. The through hole; the transition structure includes the third through hole; the tunnel and the third through hole are used for passing the pull wire to change the extending direction.
可选的,所述植入物的输送装置包括两个以上的所述线控组件,两个以上的所述线控组件的线固定部件中用于与拉线组连接的部分沿所述输送管组件的径向和/或周向相互错开。Optionally, the delivery device of the implant includes more than two wire control assemblies, and the wire fixing parts of the wire control assemblies of the two or more wire control assemblies are used to connect with the pull wire group along the delivery tube. The components are offset radially and/or circumferentially from one another.
可选的,两个以上的所述线控组件的所述线固定部件相互固定;或者,两个以上的所述线控组件的所述线固定部件沿所述输送管组件的轴向相互独立的移动。Optionally, the wire fixing parts of more than two wire control assemblies are fixed to each other; or, the wire fixing parts of more than two wire control assemblies are mutually independent along the axial direction of the delivery tube assembly of the mobile.
可选的,所述拉线组中包括多根所述拉线,所述线固定部件用于供多根所述拉线的固定端汇合连接。Optionally, the stay wire set includes a plurality of stay wires, and the wire fixing component is used for converging and connecting fixed ends of the plurality of stay wires.
可选的,所述输送装置还包括至少一个所述拉线组,所述拉线组包括至少一根拉线。Optionally, the conveying device further includes at least one pull wire set, and the pull wire set includes at least one pull wire.
综上所述,本发明提供的植入物的输送装置包括:输送管组件及至少一个线控组件;所述线控组件包括:线固定部件及线脱离部件;所述线固定部件用于与拉线组中的拉线的固定端连接;所述线脱离部件沿所述输送管组件的轴向可移动地设置,所述线脱离部件用于与所述拉线组中的拉线的脱离端连接;当所述线脱离部件满足预设条件时,所述线脱离部件与所述拉线的脱离端脱离。In summary, the implant delivery device provided by the present invention includes: a delivery tube assembly and at least one wire control assembly; the wire control assembly includes: a wire fixing part and a wire detachment part; the wire fixing part is used for The fixed ends of the stay wires in the stay wire group are connected; the wire disengagement part is movably arranged along the axial direction of the delivery tube assembly, and the wire disengagement part is used to connect with the disengagement ends of the stay wires in the stay wire group; When the wire disengagement part satisfies a preset condition, the wire disengagement part is disengaged from the disengagement end of the pull wire.
如此配置,线固定部件与拉线的固定端连接,线脱离部件与拉线的脱离端连接,在满足预设条件时,线脱离部件与拉线的脱离端脱离,如此即使得拉线的脱离端形成自由端,从而可使拉线组与支架分离。拉线组的脱离动作简单,摩擦行程少,撤线过程中对支架的稳定性影响小,提高手术成功率,克服了现有输送器撤线路径长、操作复杂的问题。In such a configuration, the wire fixing part is connected to the fixed end of the pull wire, and the wire detachment part is connected to the detachment end of the pull wire. , so that the pull wire group can be separated from the bracket. The detachment action of the pull wire group is simple, the friction stroke is small, the stability of the bracket is less affected during the wire withdrawal process, the success rate of the operation is improved, and the problems of long wire withdrawal path and complicated operation of the existing conveyor are overcome.
附图说明Description of drawings
本领域的普通技术人员将会理解,提供的附图用于更好地理解本发明,而不对本发明的范围构成任何限定。其中:Those of ordinary skill in the art will understand that the provided drawings are for better understanding of the present invention, but do not constitute any limitation to the scope of the present invention. in:
图1是本发明实施例的线控瓣膜假体的一个示例的示意图;FIG. 1 is a schematic diagram of an example of a wire-controlled valve prosthesis according to an embodiment of the present invention;
图2是本发明实施例的线控瓣膜假体的另一个示例的示意图;2 is a schematic diagram of another example of a wire-controlled valve prosthesis according to an embodiment of the present invention;
图3是本发明实施例的植入物的输送装置与线控瓣膜假体装配后的示意图;Fig. 3 is a schematic diagram of the assembly of the implant delivery device and the wire-controlled valve prosthesis according to the embodiment of the present invention;
图4是本发明实施例的植入物的输送装置的示意图;4 is a schematic diagram of an implant delivery device according to an embodiment of the present invention;
图5是本发明实施例的输送管组件的示意图;5 is a schematic diagram of a delivery tube assembly according to an embodiment of the present invention;
图6a~图6c是本发明实施例的销形件的若干优选示例的示意图;Figures 6a to 6c are schematic diagrams of several preferred examples of the pin-shaped member of the embodiment of the present invention;
图7a~图7c是本发明实施例的线固定部件的若干优选示例的示意图;Figures 7a to 7c are schematic diagrams of several preferred examples of wire fixing components according to embodiments of the present invention;
图8a~图8d是本发明实施例的第一通孔和第二通孔的若干优选示例的示意图;8a to 8d are schematic diagrams of several preferred examples of the first through hole and the second through hole according to the embodiment of the present invention;
图9a、图9b是本发明实施例的线部署部件的若干优选示例的示意图;Fig. 9a and Fig. 9b are schematic diagrams of several preferred examples of wire deployment components according to the embodiment of the present invention;
图10是本发明实施例的拆离线与输送装置的装配示意图;Fig. 10 is a schematic diagram of assembly of a dismantling line and a conveying device according to an embodiment of the present invention;
图11是图10的A部放大图;Fig. 11 is an enlarged view of part A of Fig. 10;
图12是本发明实施例的输送装置的两个线控组件的一个优选示例的示意图;Fig. 12 is a schematic diagram of a preferred example of two wire control assemblies of the delivery device according to the embodiment of the present invention;
图13是图12的B部放大图;Fig. 13 is an enlarged view of part B of Fig. 12;
图14是本发明实施例的输送装置的两个线控组件的另一优选示例的示意图;Fig. 14 is a schematic diagram of another preferred example of two wire control assemblies of the delivery device according to the embodiment of the present invention;
图15是图14的C部放大图;Fig. 15 is an enlarged view of part C of Fig. 14;
图16是本发明根据一实施例所提供的输送装置的内管机构的结构示意图;图17是本发明根据一实施例所提供的输送装置的线部署部件的结构示意图;Fig. 16 is a schematic structural view of the inner tube mechanism of the delivery device according to an embodiment of the present invention; Fig. 17 is a schematic structural view of the wire deployment part of the delivery device according to an embodiment of the present invention;
图18是本发明根据一实施例所提供的输送系统的线部署部件的A-A剖视图;Fig. 18 is an A-A sectional view of the wire deployment part of the delivery system according to an embodiment of the present invention;
图19是本发明根据一实施例所提供的输送系统在装载医用植入物时,拉线与医用植入物的连接关系示意图,图示中拉线以辐射的形式与医用植入物连接;Fig. 19 is a schematic diagram of the connection relationship between the pull wire and the medical implant when the delivery system according to an embodiment of the present invention is loaded with the medical implant. In the illustration, the pull wire is connected to the medical implant in the form of radiation;
图20是本发明根据一实施例所提供的输送装置在装载医用植入物时,拉线与医用植入物的连接关系示意图,图示中,拉线在周向上环绕医用植入物;Fig. 20 is a schematic diagram of the connection relationship between the pull wire and the medical implant when the delivery device according to an embodiment of the present invention is loaded with the medical implant. In the illustration, the pull wire surrounds the medical implant in the circumferential direction;
图21是本发明根据另一实施例所提供的输送装置的线部署部件的结构示 意图,图示中的线部署部件不包括底座;Fig. 21 is a schematic structural view of the wire deployment part of the delivery device according to another embodiment of the present invention, the wire deployment part in the illustration does not include a base;
图22是本发明根据另一实施例所提供的输送装置的线部署部件的结构示意图,图示中的线部署部件包括底座;Fig. 22 is a schematic structural view of the wire deploying part of the delivery device according to another embodiment of the present invention, the wire deploying part in the illustration includes a base;
图23是本发明根据另一实施例所提供的输送系统的线部署部件的结构示意图,图23与图22的观察方位不同;Fig. 23 is a schematic structural view of the line deployment part of the delivery system according to another embodiment of the present invention, and the viewing directions of Fig. 23 and Fig. 22 are different;
图24是本发明根据另一实施例所提供的输送系统的拉线在穿过线部署部件上的孔道时其延伸方向发生偏转的示意图;Fig. 24 is a schematic diagram of deflection of the extension direction of the pull wire of the delivery system according to another embodiment of the present invention when passing through the hole on the wire deployment component;
图25是本发明根据一实施例所提供的医用装置的局部结构示意图,图中医用植入物处于压握状态,且医用装置包括一个线部署部件,该线部署部件设置于医用植入物的远端侧;Fig. 25 is a schematic diagram of a partial structure of a medical device according to an embodiment of the present invention. In the figure, the medical implant is in a crimped state, and the medical device includes a wire deploying part, which is arranged on the medical implant. distal side;
图26是图25所示的医用装置中,医用支架扩张时的示意图;Fig. 26 is a schematic diagram of the expansion of the medical stent in the medical device shown in Fig. 25;
图27是发明根据一实施例所提供的医用装置的局部结构示意图,图中医用植入物处于压握状态,且医用装置包括两个线部署部件,两个线部署部件分别设置于医用植入物的近端侧和远端侧;Fig. 27 is a schematic diagram of a partial structure of a medical device according to an embodiment of the invention. In the figure, the medical implant is in a crimped state, and the medical device includes two wire deployment parts, which are respectively arranged on the medical implant. the proximal and distal sides of the object;
图28是本发明根据一实施例所提供的医用装置的局部结构示意图,图中医用装置处于压握状态,且医用装置包括一个线部署部件,一个线部署部件设置于医用植入物的内部,且拉线位于线部署部件与医用植入物之间的部分与输送系统的轴线所形成的夹角为90°;Fig. 28 is a schematic diagram of a partial structure of a medical device according to an embodiment of the present invention. In the figure, the medical device is in a crimped state, and the medical device includes a wire deploying part, and a wire deploying part is arranged inside the medical implant. And the angle formed by the part of the pull wire between the wire deployment part and the medical implant and the axis of the delivery system is 90°;
图29是本发明根据实施例所提供的医用装置的局部结构示意图,图中医用装置处于压握状态,且医用装置包括一个线部署部件,一个线部署部件设置于医用植入物的内部,且拉线位于线部署部件与医用植入物之间的部分与输送系统的轴线所形成的夹角小于90°。Fig. 29 is a schematic diagram of a partial structure of a medical device according to an embodiment of the present invention. In the figure, the medical device is in a crimped state, and the medical device includes a wire deploying part, and a wire deploying part is arranged inside the medical implant, and The angle formed by the portion of the pull wire between the wire deployment member and the medical implant and the axis of the delivery system is less than 90°.
附图中:In the attached picture:
01-支架;02-拉线组;021-固定线;022-拆离线;022a-固定端;022b-脱离端;01-bracket; 02-pull wire group; 021-fixed wire; 022-detachment wire; 022a-fixed end; 022b-detachment end;
10-输送管组件;11-内管;12-外管;13-鞘管;14-锥形头;20-线控组件;21-线固定部件;211-驱动件;211a-第一通孔;211b-第一凹槽;212-拉线管;213-第一固定环;22-线脱离部件;221-销形件;222-牵引件;23-线部署部件; 231-转换件;231a-第二通孔;231b-第二凹槽;232-第二固定环;233-孔道;234-第三通孔。10-transport tube assembly; 11-inner tube; 12-outer tube; 13-sheath tube; 14-tapered head; 20-wire control component; ; 211b-the first groove; 212-guy wire tube; The second through hole; 231b-the second groove; 232-the second fixing ring; 233-the channel; 234-the third through hole.
1000-内管机构,1100-内管,1200-线部署部件,1200a-近端节段,1200b-第二节段,1210-穿线通道,1201-导向面,1201a-第一子导向面,1201b-第二子导向面,1201c-第三子导向面,1211-第一孔段,1212-第二孔段,1213-第三孔段,1220-安装通孔,1230-线部署部件本体,1231-穿线槽,1240-转动件,1241-定位槽,1250-底座,1251-导入通道,2000-外管,200-手柄,20-拉线,2-医用植入物。1000-inner tube mechanism, 1100-inner tube, 1200-wire deployment part, 1200a-proximal segment, 1200b-second segment, 1210-threading channel, 1201-guiding surface, 1201a-first sub-guiding surface, 1201b - second sub-guiding surface, 1201c - third sub-guiding surface, 1211 - first hole section, 1212 - second hole section, 1213 - third hole section, 1220 - installation through hole, 1230 - line deployment component body, 1231 -threading slot, 1240-rotating member, 1241-positioning slot, 1250-base, 1251-introduction channel, 2000-outer tube, 200-handle, 20-guy wire, 2-medical implant.
具体实施方式Detailed ways
为使本发明的目的、优点和特征更加清楚,以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且未按比例绘制,仅用以方便、明晰地辅助说明本发明实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in very simplified form and not drawn to scale, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention. In addition, the structures shown in the drawings are often a part of the actual structure. In particular, each drawing needs to display different emphases, and sometimes uses different scales.
如在本发明中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,术语“或”通常是以包括“和/或”的含义而进行使用的,术语“若干”通常是以包括“至少一个”的含义而进行使用的,术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的,此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征,术语“近端”通常是靠近操作者的一端,术语“远端”通常是靠近患者即靠近病灶的一端,“一端”与“另一端”以及“近端”与“远端”通常是指相对应的两部分,其不仅包括端点,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。此外,如在本发明中所使用的,一元件设置于另一元件,通常仅表示两元件之间存 在连接、耦合、配合或传动关系,且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动,而不能理解为指示或暗示两元件之间的空间位置关系,即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位,除非内容另外明确指出外。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is usually used in the sense of including "and/or", and the term "several" Usually, the term "at least one" is used in the meaning of "at least one", and the term "at least two" is usually used in the meaning of "two or more". In addition, the terms "first", "second "Two" and "third" are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, a feature defined as "first", "second", and "third" may explicitly or implicitly include one or at least two of these features, the term "proximal end" is usually the end close to the operator, the term The "distal end" is usually the end close to the patient, that is, the end close to the lesion. "One end" and "the other end" as well as "proximal end" and "distal end" usually refer to the corresponding two parts, which not only include the end point, the term "installation" , "connected" and "connected" should be understood in a broad sense. For example, it can be fixed connection, detachable connection, or integrated; it can be mechanical connection or electrical connection; it can be direct connection or through The intermediary is indirectly connected, which can be the internal communication of two elements or the interaction relationship between two elements. In addition, as used in the present invention, an element is arranged on another element, usually only means that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the relationship between the two elements can be direct or indirect through an intermediate element. connection, coupling, fit or transmission, but should not be understood as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content Also clearly point out. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
本发明的目的在于提供一种植入物的输送装置,以解决现有输送器撤线路径长、操作复杂的问题。The object of the present invention is to provide an implant delivery device to solve the problems of long wire withdrawal path and complicated operation of the existing conveyor.
以下参考附图进行描述。Description is made below with reference to the accompanying drawings.
请参考图1至图15,其中,图1是本发明实施例的线控瓣膜假体的一个示例的示意图;图2是本发明实施例的线控瓣膜假体的另一个示例的示意图;图3是本发明实施例的植入物的输送装置与线控瓣膜假体装配后的示意图;图4是本发明实施例的植入物的输送装置的示意图;图5是本发明实施例的输送管组件的示意图;图6a~图6c是本发明实施例的销形件的若干优选示例的示意图;图7a~图7c是本发明实施例的线固定部件的若干优选示例的示意图;图8a~图8d是本发明实施例的第一通孔和第二通孔的若干优选示例的示意图;图9a、图9b是本发明实施例的线部署部件的若干优选示例的示意图;图10是本发明实施例的拆离线与输送装置的装配示意图;图11是图10的A部放大图;图12是本发明实施例的输送装置的两个线控组件的一个优选示例的示意图;图13是图12的B部放大图;图14是本发明实施例的输送装置的两个线控组件的另一优选示例的示意图;图15是图14的C部放大图。Please refer to Fig. 1 to Fig. 15, wherein, Fig. 1 is the schematic diagram of an example of the wire-controlled valve prosthesis of the embodiment of the present invention; Fig. 2 is the schematic diagram of another example of the wire-controlled valve prosthesis of the embodiment of the present invention; Fig. 3 is a schematic diagram of the implant delivery device of the embodiment of the present invention assembled with the wire-controlled valve prosthesis; FIG. 4 is a schematic diagram of the implant delivery device of the embodiment of the present invention; FIG. 5 is a delivery device of the embodiment of the present invention A schematic diagram of a pipe assembly; Figures 6a to 6c are schematic diagrams of several preferred examples of pin-shaped parts in embodiments of the present invention; Figures 7a to 7c are schematic diagrams of several preferred examples of wire fixing components in embodiments of the present invention; Figures 8a to Fig. 8d is a schematic diagram of several preferred examples of the first through hole and the second through hole of the embodiment of the present invention; Fig. 9a and Fig. 9b are schematic diagrams of several preferred examples of the wire deployment part of the embodiment of the present invention; Figure 11 is an enlarged view of part A of Figure 10; Figure 12 is a schematic diagram of a preferred example of two wire control components of the delivery device according to the embodiment of the present invention; Figure 13 is a diagram 12 is an enlarged view of part B; FIG. 14 is a schematic diagram of another preferred example of two wire control assemblies of the delivery device according to an embodiment of the present invention; FIG. 15 is an enlarged view of part C of FIG. 14 .
图1和图2示出了一种植入物,具体为一种线控瓣膜假体,其包括:支架01及至少一个拉线组02,支架01优选为自膨式支架,其沿径向可扩张或收缩。拉线组02的一部分围绕支架01周向设置,通过驱动拉线组02,可以控制支架01的扩张或收缩。一个拉线组02包括至少一根拉线,在一些实施例中,拉线可根据功能的不同分为至少一根固定线021及至少一根拆离线022。固定线021可以理解为两端均为固定端022a的拉线,其两个固定端022a均与输送装置的线固定部件21连接,从而形成圈环。若存在两根以上的固定线021,则后一根固定线021穿过前一根固定线021的圈环,形成依次销接的关系; 拆离线022具有固定端022a和脱离端022b,固定端022a用于与输送装置的线固定部件21连接,脱离端022b则用于与输送装置的线脱离部件22连接。进而拆离线022穿过最后一根固定线021的圈环,对最后一根固定线021进行销接。如此配置,在线脱离部件22与脱离端022b脱离后,拆离线022相当于解除了对最后一根固定线021的销接,若干固定线021也依次解除销接关系,使得整个拉线组02与支架01相互脱离而完成撤线。在图1示出的示范例中,拆离线022形成单线圈环。如图2所示,在其它的一些实施例中,拆离线022形成双线圈环。在另一些实施例中,拉线均用于拆离而不区分固定线或拆离线,或者可认为所有的拉线均为拆离线022。在这些实施例中,每根拉线均具有固定端022a和脱离端022b,拉线的固定端022a与输送装置的线固定部件21连接,拉线的脱离端022b与输送装置的线脱离部件22连接。如此配置,在线脱离部件22与拉线的脱离端022b脱离后,拉线的脱离端022b即被放松,使得拉线组02与支架01相互脱离而完成撤线。Figure 1 and Figure 2 show an implant, specifically a wire-controlled valve prosthesis, which includes: a stent 01 and at least one puller group 02, the stent 01 is preferably a self-expandable stent, which can expand radially or shrink. A part of the pull wire group 02 is arranged around the stent 01 in a circumferential direction, and the expansion or contraction of the stent 01 can be controlled by driving the pull wire group 02 . A pull wire group 02 includes at least one pull wire. In some embodiments, the pull wire can be divided into at least one fixing wire 021 and at least one detachment wire 022 according to different functions. The fixed wire 021 can be understood as a pull wire with fixed ends 022a at both ends, and both fixed ends 022a are connected to the wire fixing part 21 of the conveying device, thereby forming a loop. If there are more than two fixed wires 021, the latter fixed wire 021 passes through the ring of the previous fixed wire 021 to form a relationship of pin connection in turn; 022a is used to connect with the wire fixing part 21 of the delivery device, and the disengagement end 022b is used to be connected with the wire release part 22 of the delivery device. Then dismantling line 022 passes through the loop of the last fixed line 021, and pins the last fixed line 021. In such a configuration, after the disengagement part 22 and the disengagement end 022b are disengaged, the detachment wire 022 is equivalent to releasing the pinning of the last fixing wire 021, and several fixing wires 021 are also releasing the pinning relationship in turn, so that the entire pull wire group 02 and the bracket 01 break away from each other to complete the line withdrawal. In the example shown in FIG. 1 , the detachment line 022 forms a single coil loop. As shown in FIG. 2, in some other embodiments, the detachment line 022 forms a double coil loop. In some other embodiments, the pull wires are all used for detachment without distinguishing between the fixed wire and the detachment wire, or all the pull wires can be considered as the detachment wire 022 . In these embodiments, each pull wire has a fixed end 022a connected to the wire fixing member 21 of the delivery device and a disengaged end 022b connected to the wire release member 22 of the delivery device. With such configuration, after the wire disengagement part 22 is disengaged from the disengagement end 022b of the wire, the disengagement end 022b of the wire is released, so that the wire group 02 and the bracket 01 are disengaged from each other to complete wire withdrawal.
基于如上所述的线控瓣膜假体,可将拉线延伸向近端进行操控,这使得拉线相互之间易形成交叉、缠绕而影响操作。由此,请参考图3、图4和图5,本发明实施例提供一种植入物的输送装置,其包括:输送管组件10及至少一个线控组件20;所述线控组件20包括:线固定部件21及线脱离部件22;所述线固定部件21用于与拉线组02中的拉线的固定端022a连接;所述线脱离部件22沿所述输送管组件10的轴向(即内管11的轴向,详见下文关于内管11的说明)可移动地设置,所述线脱离部件22用于与所述拉线组02中的拉线的脱离端022b连接;当所述线脱离部件22满足预设条件时,所述线脱离部件22与所述拉线的脱离端022b脱离。Based on the above-mentioned wire-controlled valve prosthesis, the pull wires can be extended to the proximal end for manipulation, which makes it easy for the pull wires to form crossing and entanglement with each other and affect the operation. Therefore, referring to FIG. 3 , FIG. 4 and FIG. 5 , an embodiment of the present invention provides an implant delivery device, which includes: a delivery tube assembly 10 and at least one wire control assembly 20; the wire control assembly 20 includes: The wire fixing part 21 and the wire breaking part 22; the wire fixing part 21 is used to connect with the fixed end 022a of the pull wire in the pull wire group 02; The axial direction of the tube 11, see the description of the inner tube 11 below for details), and the wire disengagement part 22 is used to connect with the disengagement end 022b of the pull wire in the pull wire group 02; when the wire disengagement part 22, when the preset condition is met, the wire disengagement component 22 is disengaged from the disengagement end 022b of the pull wire.
线脱离部件22在预设条件时与拉线的脱离端022b脱离,这里的预设条件根据线脱离部件22的不同结构可以是不同的,例如在一些实施例中,线脱离部件22为机械脱离结构,则预设条件可以是线脱离部件22机械性运动,如线脱离部件22机械性地移动、扩张或解锁等;在另一些实施例中,线脱离部件22为电解脱结构,则预设条件可以是通电;在其它的一些实施例中,线脱离部件22为溶解结构,则预设条件可以是等待一定的时间等等。本领域技 术人员可根据线脱离部件22不同的结构来设置具体的预设条件。The wire disengagement part 22 disengages from the disengagement end 022b of the pull wire under preset conditions, and the preset conditions here may be different according to different structures of the wire disengagement part 22, for example, in some embodiments, the wire disengagement part 22 is a mechanical disengagement structure , then the preset condition can be that the wire detachment part 22 moves mechanically, such as the wire detachment part 22 mechanically moves, expands or unlocks, etc.; It may be energized; in some other embodiments, the wire detachment component 22 is a dissolving structure, and the preset condition may be waiting for a certain period of time and so on. Those skilled in the art can set specific preset conditions according to different structures of the wire breaking away part 22.
请参考图5,并结合图3和图4,输送管组件10包括内管11,内管11的内部可用于供导丝穿设,内管11的延伸方向即为其轴向,亦即整个输送管组件10的轴向。可以理解的,由于内管11可弯曲,因此其轴向也并非固定为一直线,而是跟随内管11的弯曲而弯曲。内管11的近端与手柄15连接,线控组件20的线固定部件21可活动地套设于所述内管11之外。进一步的,输送管组件10还包括外管12和鞘管13,外管12可活动地套设在线控组件20之外,鞘管13可活动地套设在外管12之外,植入物可被收纳于鞘管13内。可选的,内管11的远端设置有锥形头14,以便于输送装置穿行。对于输送管组件10的具体结构,本领域技术人员可根据现有技术进行理解和配置,本发明对此不作详述。Please refer to FIG. 5, and in combination with FIG. 3 and FIG. 4, the delivery tube assembly 10 includes an inner tube 11, and the inside of the inner tube 11 can be used for passing a guide wire. The extension direction of the inner tube 11 is its axial direction, that is, the entire The axial direction of the delivery tube assembly 10 . It can be understood that since the inner tube 11 is bendable, its axial direction is not fixed as a straight line, but bends following the bending of the inner tube 11 . The proximal end of the inner tube 11 is connected to the handle 15 , and the wire fixing part 21 of the wire control assembly 20 is movably sleeved outside the inner tube 11 . Further, the delivery tube assembly 10 also includes an outer tube 12 and a sheath tube 13, the outer tube 12 is movably sleeved outside the wire control assembly 20, the sheath tube 13 is movably sleeved outside the outer tube 12, and the implant can be It is accommodated in the sheath tube 13 . Optionally, the distal end of the inner tube 11 is provided with a tapered head 14 to facilitate the passage of the delivery device. As for the specific structure of the delivery tube assembly 10, those skilled in the art can understand and configure it according to the prior art, which is not described in detail in the present invention.
在一些实施例中,线固定部件21沿所述输送管组件10的轴向可移动地设置,拉线组02中包括多根拉线,所述线固定部件21用于供多根所述拉线的固定端022a汇合连接。线固定部件21汇集了拉线组02中多根拉线的固定端022a(可以理解的,若拉线包括固定线021和拆离线022,则线固定部件21汇集所有固定线021以及拆离线022的固定端022a),沿输送管组件10的轴向驱动线固定部件21即可控制拉线组02的收放。在其它的一些实施例中,线固定部件21沿所述输送管组件10的轴向固定设置,例如可将线固定部件21设置在近端的手柄处,通过直接驱动拉线的近端来实现控制拉线组02的收放。In some embodiments, the wire fixing part 21 is movably arranged along the axial direction of the delivery tube assembly 10, the pull wire group 02 includes a plurality of pull wires, and the wire fixing part 21 is used for fixing a plurality of the pull wires. Terminal 022a is confluently connected. The wire fixing part 21 brings together the fixed ends 022a of multiple stay wires in the pull wire group 02 (it can be understood that if the pull wires include the fixing wires 021 and the dismounting wires 022, then the wire fixing part 21 collects the fixed ends of all the fixing wires 021 and the dismounting wires 022 022a), driving the wire fixing component 21 along the axial direction of the delivery tube assembly 10 can control the retraction and retraction of the pull wire group 02 . In some other embodiments, the wire fixing part 21 is fixedly arranged along the axial direction of the delivery tube assembly 10, for example, the wire fixing part 21 can be arranged at the handle at the proximal end, and the control is realized by directly driving the proximal end of the pull wire. The retraction and release of the pull wire group 02.
较佳的,在所述拉线的脱离端022b与所述线脱离部件22连接时,所述线脱离部件22处于连接状态,此时所述线控组件20与所述输送装置之远端的轴向距离(应理解为线控组件20的最近端相对于输送装置之最远端的轴向距离)不大于300mm。线固定部件21和线脱离部件22相互靠近集成在输送管组件10的远端部分,简化了输送装置的线控结构。此外,拉线组02的收拉和脱离动作简单,摩擦行程少,撤线过程中对支架01的稳定性影响小,提高手术成功率,克服了现有输送器撤线路径长、操作复杂的问题。Preferably, when the detachment end 022b of the pull wire is connected to the wire detachment member 22, the wire detachment member 22 is in a connected state, and at this time the wire control assembly 20 is connected to the shaft at the distal end of the delivery device. The axial distance (should be understood as the axial distance between the proximal end of the wire control assembly 20 and the farthest end of the delivery device) is not greater than 300 mm. The wire fixing part 21 and the wire detaching part 22 are integrated in the distal part of the delivery tube assembly 10 close to each other, which simplifies the wire control structure of the delivery device. In addition, the retraction and detachment of the puller group 02 is simple, the friction stroke is less, and the stability of the bracket 01 is less affected during the withdrawal process, which improves the success rate of the operation and overcomes the problems of long withdrawal path and complicated operation of the existing conveyor .
请参考图6a~图6c,在一个示范例中,所述线脱离部件22为机械脱离结 构,其包括销形件221,所述销形件221具有开口;所述预设条件包括:所述线脱离部件22相对于所述拉线的脱离端022b移动,以使所述拉线的脱离端022b自所述开口中脱出。本实施例对销形件221的具体形态不作限制,图6a~图6c分别示出了螺旋形、L形以及勾形的销形件221,其共同的特点是具有开口而不闭合,在销形件221相对于脱离端022b朝向近端移动时,销形件221可受力而产生变形,使拉线的脱离端022b从销形件221上滑脱。在一个可替代的示范例中,销形件221呈螺旋形,其螺旋的周数在1~3之间。销形件221可由金属或非金属材料加工而成,可理解的,使销形件221产生变形的力应小于拉线的抗拉极限。Please refer to FIGS. 6a to 6c. In one example, the wire detachment member 22 is a mechanical detachment structure, which includes a pin-shaped member 221, and the pin-shaped member 221 has an opening; the preset condition includes: the The wire disengagement member 22 moves relative to the disengagement end 022b of the pull wire, so that the disengagement end 022b of the pull wire disengages from the opening. This embodiment does not limit the specific shape of the pin-shaped member 221. Figures 6a to 6c show spiral, L-shaped and hook-shaped pin-shaped members 221 respectively. Their common feature is that they have openings but not closures. When the shaped part 221 moves proximally relative to the disengagement end 022b, the pin-shaped part 221 can be deformed under force, so that the disengagement end 022b of the pull wire slips off from the pin-shaped part 221 . In an alternative example, the pin-shaped member 221 is in a spiral shape, and the number of turns of the spiral is between 1-3. The pin-shaped member 221 can be made of metal or non-metallic material, understandably, the force to deform the pin-shaped member 221 should be less than the tensile limit of the pull wire.
优选的,所述输送装置还包括牵引件222,所述牵引件222的一端与所述销形件221连接,所述牵引件222的另一端向近端延伸。牵引件222如可为牵引丝等,其向近端延伸后可与手柄连接,操作者通过近端处的手柄可以牵拉牵引件222,从而使销形件221朝向近端移动。需要说明的,若牵引件222为牵引丝等仅能受拉而无法传递推力的部件,则销形件221可被配置为朝向近端移动时与拉线脱离。当然在其它的一些实施例中,若采用导管作为牵引件222,则由于其可以传递推力,因此销形件221与拉线脱离的移动朝向可不受限制。为减小输送装置的尺寸,优选采用牵引丝等受拉部件作为牵引件222。Preferably, the delivery device further includes a traction member 222, one end of the traction member 222 is connected to the pin-shaped member 221, and the other end of the traction member 222 extends proximally. The traction member 222 can be a traction wire or the like, which can be connected to the handle after extending proximally, and the operator can pull the traction member 222 through the handle at the proximal end, thereby moving the pin-shaped member 221 toward the proximal end. It should be noted that if the traction member 222 is a component such as a traction wire that can only be pulled but cannot transmit thrust, the pin-shaped member 221 can be configured to disengage from the pull wire when moving toward the proximal end. Of course, in some other embodiments, if the guide tube is used as the traction member 222, since it can transmit thrust, the moving direction of the pin-shaped member 221 and the pulling wire can be unrestricted. In order to reduce the size of the conveying device, it is preferable to use a pulling member such as a pulling wire as the pulling member 222 .
进一步的,所述线脱离部件22位于所述线固定部件21的近端,所述线脱离部件22未满足预设条件时,所述线脱离部件22与所述线固定部件21同步地沿所述输送管组件10的轴向移动。未满足预设条件时,所有的拉线作用实质上是相同的,其均用于驱动控制支架01的收缩或扩张。因此,线脱离部件22与线固定部件21应被配置为同步地沿输送管组件10的轴向移动,以使各拉线同步地被收放。Further, the thread breaking part 22 is located at the proximal end of the thread fixing part 21, and when the thread breaking part 22 does not meet the preset condition, the thread breaking part 22 and the thread fixing part 21 synchronously move along the The axial movement of the delivery tube assembly 10 is described. When the preset condition is not met, all the pulling wires have substantially the same function, and they are all used to drive and control the contraction or expansion of the stent 01 . Therefore, the wire disengagement part 22 and the wire fixing part 21 should be configured to move synchronously along the axial direction of the delivery tube assembly 10, so that each pull wire is retracted synchronously.
请参考图7a至图7c,所述线固定部件21包括驱动件211,所述驱动件211沿所述输送管组件10的轴向可移动地设置;所述驱动件211具有第一限位结构,所述第一限位结构用于限制所述拉线围绕所述输送管组件10的周向位置。可选的,所述输送装置还包括拉线管212,驱动件211的近端与拉线管212连接,拉线管212向近端延伸并与手柄连接,操作者通过近端处的手柄可 以向近端拉或向远端推送拉线管212,从而带动驱动件211沿输送管组件10的轴向移动。驱动件211可设置于输送管组件10靠近远端的部分,驱动件211能够收集汇合拉线组02的各拉线,由此,拉线组02的各拉线均在整个输送装置的远端部位,驱动件211通过拉线管212进行操控,拉线组02的布线路径短,各拉线可同步地被收放,使得支架10的释放精度较高。进一步的,第一限位结构的设置,能够限制拉线组02的各拉线的周向位置,避免其相互之间产生交错和缠绕。Please refer to FIG. 7a to FIG. 7c, the wire fixing part 21 includes a driving member 211, and the driving member 211 is movably arranged along the axial direction of the delivery tube assembly 10; the driving member 211 has a first stop structure , the first limiting structure is used to limit the circumferential position of the pull wire around the delivery tube assembly 10 . Optionally, the delivery device also includes a pull-wire tube 212, the proximal end of the driver 211 is connected to the pull-wire tube 212, the pull-wire tube 212 extends to the proximal end and is connected to the handle, the operator can use the handle at the proximal end to Pull or push the pull wire tube 212 to the distal end, thereby driving the driving member 211 to move along the axial direction of the delivery tube assembly 10 . The driving part 211 can be arranged on the part near the distal end of the delivery tube assembly 10, and the driving part 211 can collect the pull wires of the converging pull wire group 02, thus, each pull wire of the pull wire group 02 is at the distal end of the entire delivery device, and the driving part 211 is controlled by the cable tube 212 , the wiring path of the cable group 02 is short, and each cable can be retracted synchronously, so that the release precision of the bracket 10 is high. Further, the setting of the first limiting structure can limit the circumferential position of each of the pull wires of the pull wire set 02, and avoid interlacing and entanglement among them.
优选的,所述第一限位结构包括多个沿所述驱动件211的轴向贯通开设的第一通孔211a(如图7a和图7b所示),或者,所述第一限位结构包括多个沿所述驱动件211的轴向开设于所述驱动件211外周的第一凹槽211b(如图7c所示);所述第一通孔211a或所述第一凹槽211b用于供所述拉线穿设。在图7a和图7b示出的示范例中,驱动件211为一个多腔管,其每个第一通孔211a可容纳一根或多根拉线通过。由此,第一通孔211a即限制了拉线的周向位置。本实施例对第一通孔211a和第一凹槽211b的截面形状、数量不作限定,图8a至图8d示范性地示出了若干优选的第一通孔211a的截面形状。需理解的,图8a至图8d仅为第一通孔211a的截面形状、数量的示例而非对第一通孔211a的截面形状、数量的限定。在图7c示出的示范例中,驱动件211为一个类似齿轮状的结构,其外周具有多个第一凹槽211b,每个第一通孔211a可容纳一根或多根拉线通过,其也能够限制拉线的周向位置。Preferably, the first limiting structure includes a plurality of first through holes 211a (as shown in FIG. It includes a plurality of first grooves 211b (as shown in FIG. 7c ) opened on the outer periphery of the driving member 211 along the axial direction of the driving member 211; the first through hole 211a or the first groove 211b is used For the said stay wire to pass through. In the example shown in Fig. 7a and Fig. 7b, the driving member 211 is a multi-lumen tube, each of the first through holes 211a can accommodate one or more pull wires to pass through. Thus, the first through hole 211a limits the circumferential position of the pull wire. In this embodiment, the cross-sectional shape and quantity of the first through hole 211a and the first groove 211b are not limited, and Fig. 8a to Fig. 8d exemplarily show several preferred cross-sectional shapes of the first through hole 211a. It should be understood that Fig. 8a to Fig. 8d are only examples of the cross-sectional shape and quantity of the first through holes 211a rather than limiting the cross-sectional shape and quantity of the first through holes 211a. In the example shown in FIG. 7c, the driving member 211 is a gear-like structure with a plurality of first grooves 211b on its outer periphery, and each first through hole 211a can accommodate one or more pull wires to pass through. It is also possible to limit the circumferential position of the pull wire.
进一步的,所述线固定部件21还包括固定结构,所述固定结构用于与所述拉线的固定端022a连接。在图7a示出的示范例中,不同的两个所述第一通孔211a用于供同一所述拉线依次穿过绕设,所述驱动件211和其上的不同的两个所述第一通孔211a共同被配置为所述固定结构。优选的,同一拉线依次穿过相邻的两个第一通孔211a,即完成拉线与驱动件211的连接。可以理解的,在图7a所示出的示范例中,拉线优选形成如图2所示的双线圈环,即其固定端022a为两根线,使得拉线的固定端022a也可以分别穿过两个第一通孔211a。Further, the wire fixing part 21 also includes a fixing structure, and the fixing structure is used for connecting with the fixing end 022a of the pull wire. In the example shown in FIG. 7a, the different two first through holes 211a are used for the same pull wire to pass through and wind in sequence, and the driving member 211 and the different two first through holes thereon A through hole 211a is commonly configured as the fixing structure. Preferably, the same pull wire passes through two adjacent first through holes 211a in sequence, that is, the connection between the pull wire and the driving member 211 is completed. It can be understood that, in the exemplary example shown in FIG. 7a, the pull wire preferably forms a double-coil loop as shown in FIG. Two first through holes 211a.
在图7b和图7c示出的示范例中,所述固定结构包括:第一固定环213, 所述第一固定环213用于供所述拉线的固定端022a绕设,以使拉线与线固定部件21形成连接。需要说明的,这里的绕设,可以是双线绕过,也可以是单线自身形成圈环(如通过打结或焊接等方式成型)。In the example shown in FIG. 7b and FIG. 7c, the fixing structure includes: a first fixing ring 213, and the first fixing ring 213 is used for winding the fixing end 022a of the pull wire so that the pull wire and the wire The fixing part 21 forms the connection. It should be noted that the winding here may be a double wire winding, or a single wire itself forming a loop (such as forming by knotting or welding).
在一些实施例中,固定结构包括相对于驱动件211额外附设的第一固定环213,在图7b示出的示范例中,所述第一固定环213的径向内尺寸小于所述驱动件211的径向外尺寸,所述第一固定环213用于与所述驱动件211抵靠。需要说明的,第一固定环213的径向内尺寸是指第一固定环213沿径向的最小内尺寸。可选的,若第一固定环213的内周呈圆形,则第一固定环213的径向内尺寸即为其内径。若第一固定环213的内周呈多边形,则第一固定环213的径向内尺寸为其内接圆的直径。下述其它部件的径向内尺寸亦为同理。驱动件211的径向外尺寸是指驱动件211沿径向的最大外尺寸。可选的,若驱动件211的外周呈圆形,则驱动件211的径向外尺寸即为其外径。若驱动件211的外周呈多边形,则驱动件211的径向外尺寸为其外接圆的直径。下述其它部件的径向外尺寸亦为同理。In some embodiments, the fixing structure includes a first fixing ring 213 additionally attached to the driving member 211. In the example shown in FIG. 7b, the radial inner dimension of the first fixing ring 213 is smaller than that of the driving member 211 , the first fixing ring 213 is used to abut against the driving member 211 . It should be noted that the radial inner dimension of the first fixing ring 213 refers to the smallest inner dimension of the first fixing ring 213 along the radial direction. Optionally, if the inner circumference of the first fixing ring 213 is circular, the radial inner dimension of the first fixing ring 213 is its inner diameter. If the inner periphery of the first fixing ring 213 is polygonal, the radial inner dimension of the first fixing ring 213 is the diameter of its inscribed circle. The same applies to the radial inner dimensions of the other components described below. The radial outer dimension of the driving member 211 refers to the maximum outer dimension of the driving member 211 along the radial direction. Optionally, if the outer circumference of the driving member 211 is circular, the radial outer dimension of the driving member 211 is its outer diameter. If the outer circumference of the driving member 211 is polygonal, the radial outer dimension of the driving member 211 is the diameter of its circumscribed circle. The same applies to the radial outer dimensions of the other components described below.
在一个可选的实施例中,第一固定环213位于所述驱动件211的近端,拉线的固定端022a绕设于第一固定环213上后,穿过第一通孔211a朝向远端延伸,进而环绕于支架01。驱动件211在被朝向近端拉动时,第一固定环213被驱动件211带动而一同朝向近端移动,使得拉线被朝向近端拉动。驱动件211在被朝向远端推动时,支架01的自膨扩张驱动拉线朝向远端移动,带动第一固定环213朝向远端移动而继续抵靠于驱动件211上。需理解,本实施例并不限定将第一固定环213设置在驱动件211的近端,在其它的实施例中,第一固定环213与驱动件211的关系也可以是相反的,即将第一固定环213设置在驱动件211的远端,此时驱动件211在被朝向远端推动时,为收紧拉线驱使支架01收缩,而驱动件211在被朝向近端拉动时,为放松拉线,支架01扩张。In an optional embodiment, the first fixing ring 213 is located at the proximal end of the driving member 211, and after the fixing end 022a of the pull wire is wound around the first fixing ring 213, it passes through the first through hole 211a toward the distal end. Extend, and then surround the bracket 01. When the driving member 211 is pulled toward the proximal end, the first fixing ring 213 is driven by the driving member 211 to move toward the proximal end together, so that the pull wire is pulled toward the proximal end. When the driving member 211 is pushed toward the distal end, the self-expanding of the stent 01 drives the pull wire to move toward the distal end, and drives the first fixing ring 213 to move toward the distal end and continue to abut against the driving member 211 . It should be understood that this embodiment does not limit the arrangement of the first fixing ring 213 at the proximal end of the driving member 211. In other embodiments, the relationship between the first fixing ring 213 and the driving member 211 may also be reversed, that is, the second A fixing ring 213 is arranged on the distal end of the driving member 211. At this time, when the driving member 211 is pushed toward the distal end, the stent 01 is driven to shrink for tightening the stay wire, and when the driving member 211 is pulled toward the proximal end, it is for loosening the stay wire. , the stent 01 is expanded.
在图7c示出的示范例中,所述第一固定环213固定套设于所述驱动件211的外周。较佳的,驱动件211的第一限位结构包括多个沿驱动件211的轴向开设于驱动件211外周的第一凹槽211b。第一固定环213与驱动件211可通 过焊接、粘接、机械限位等方式相连接,第一固定环213的内周与第一凹槽211b形成了封闭的孔洞,其可供拉线的固定端022a绕设,其原理与图7b所示出的示范例类似,这里不再赘述。In the example shown in FIG. 7 c , the first fixing ring 213 is fixedly sleeved on the outer periphery of the driving member 211 . Preferably, the first limiting structure of the driving member 211 includes a plurality of first grooves 211b formed on the outer periphery of the driving member 211 along the axial direction of the driving member 211 . The first fixing ring 213 and the driving member 211 can be connected by means of welding, bonding, mechanical limit, etc., and the inner circumference of the first fixing ring 213 and the first groove 211b form a closed hole, which can be used for fixing the pull wire The terminal 022a is wound around, and its principle is similar to the example shown in FIG. 7b , which will not be repeated here.
优选的,所述线控组件20还包括:线部署部件23;所述线部署部件23与所述内管11固定连接;所述线部署部件23用于供所述拉线沿所述输送管组件10的径向汇合与其上后,将所述拉线的延伸方向改变为沿所述输送管组件10的轴向延伸。线部署部件23主要用于改变拉线的延伸方向。优选的,线部署部件23沿输送管组件10的轴向位置与支架01的装载位置相适配,更优选的,线部署部件23的远端与拉线环绕于支架01的位置相适配,以尽量减小线部署部件23与支架01之间的拉线相对于支架01径向的角度,优选使这部分拉线平行于支架01的径向。Preferably, the wire control assembly 20 further includes: a wire deployment part 23; the wire deployment part 23 is fixedly connected with the inner tube 11; After the radial direction of 10 merges with it, the extension direction of the pull wire is changed to extend along the axial direction of the delivery tube assembly 10 . The wire deployment part 23 is mainly used to change the extension direction of the pull wire. Preferably, the axial position of the wire deployment part 23 along the delivery tube assembly 10 is adapted to the loading position of the stent 01, more preferably, the distal end of the wire deployment part 23 is adapted to the position where the pull wire wraps around the stent 01, so as to Minimize the angle of the stay wires between the wire deployment part 23 and the bracket 01 relative to the radial direction of the bracket 01 as far as possible, and preferably make this part of the stay wires parallel to the radial direction of the bracket 01 .
可选的,所述线部署部件23包括转换件231,所述转换件231具有第二限位结构,所述第二限位结构用于限制所述拉线围绕所述输送管组件10的周向位置。第二限位结构的设置,能够限制拉线组02的各拉线的周向位置,避免其相互之间产生交错和缠绕。Optionally, the wire deployment part 23 includes a conversion piece 231, and the conversion piece 231 has a second limiting structure, and the second limiting structure is used to limit the circumferential direction of the pull wire around the delivery tube assembly 10. Location. The arrangement of the second limiting structure can limit the circumferential position of each of the pull wires of the pull wire set 02 to avoid interlacing and entanglement among them.
优选的,所述第二限位结构包括多个沿所述转换件231的轴向贯通开设的第二通孔231a;或者,所述第二限位结构包括多个沿所述转换件231的轴向开设于所述转换件231外周的第二凹槽231b;所述第二通孔231a或所述第二凹槽231b用于供所述拉线穿设。第二通孔231a和第二凹槽231b的结构和设置原理与驱动件211上的第一通孔211a和第一凹槽211b相似,本实施例对第二通孔231a和第二凹槽231b的截面形状不作限定,第二通孔231a如可为图8a至图8d所示。Preferably, the second limiting structure includes a plurality of second through holes 231a penetrating through the axial direction of the conversion member 231; or, the second limiting structure includes a plurality of holes 231a along the conversion member 231 The second groove 231b axially opened on the outer periphery of the conversion member 231; the second through hole 231a or the second groove 231b is used for passing the pull wire. The structure and setting principle of the second through hole 231a and the second groove 231b are similar to the first through hole 211a and the first groove 211b on the driving member 211. In this embodiment, the second through hole 231a and the second groove 231b The cross-sectional shape of is not limited, and the second through hole 231a may be as shown in FIG. 8a to FIG. 8d.
优选的,所述线部署部件23还包括过渡结构,所述过渡结构用于逐渐地改变所述拉线的延伸方向。需要说明的,这里逐渐地改变拉线的延伸方向是指,拉线在过渡结构处具有一定的转弯半径,而非呈尖锐地折角。可选的,逐渐地改变如可以圆弧形的圆滑改变,也可以是多个折线形成的多折改变。过渡结构的设置可以有效地减小拉线的磨损。Preferably, the wire deploying part 23 further includes a transition structure, and the transition structure is used to gradually change the extension direction of the pull wire. It should be noted that gradually changing the extension direction of the stay wire here means that the stay wire has a certain turning radius at the transition structure, rather than a sharp corner. Optionally, the gradual change may be, for example, a smooth change in the shape of an arc, or a multi-fold change formed by multiple fold lines. The arrangement of the transition structure can effectively reduce the abrasion of the stay wire.
请参考图9a,在一个可替代的示范例中,所述过渡结构包括:第二固定 环232;所述第二固定环232相对于所述转换件231固定设置,所述第二固定环232用于供所述拉线绕设而改变延伸方向。图9a示出的示范例中,转换件231外周具有沿轴向开设的第二凹槽231b,第二固定环232与转换件231可通过焊接、粘接、机械限位等方式相连接,第二固定环232的内周与第二凹槽231b形成了封闭的孔洞,其可供拉线的固定端022a绕设而改变延伸方向,既限制了拉线的周向位置,同时第二固定环232也作为过渡结构,使拉线圆滑地改变延伸方向。当然在其它的实施例中,也可以采用具有第二通孔231a的转换件231与第二固定环232配合来改变拉线的延伸方向,本发明对此不限。Please refer to FIG. 9a, in an alternative example, the transition structure includes: a second fixing ring 232; It is used for changing the extending direction of the pulling wires. In the example shown in Fig. 9a, the outer circumference of the conversion member 231 has a second groove 231b opened in the axial direction, and the second fixing ring 232 and the conversion member 231 can be connected by means of welding, bonding, mechanical limit, etc. The inner circumference of the two fixing rings 232 and the second groove 231b form a closed hole, which can be used for the fixed end 022a of the backguy to wrap around to change the extension direction, which not only limits the circumferential position of the backguy, but also the second fixing ring 232. As a transitional structure, the pull wire can smoothly change the direction of extension. Of course, in other embodiments, the conversion member 231 having the second through hole 231a may also be used to cooperate with the second fixing ring 232 to change the extension direction of the pull wire, and the present invention is not limited thereto.
请参考图9b,在另一个可替代的示范例中,所述转换件231具有沿所述输送管组件10的轴向开设的孔道233,所述第二限位结构包括多个沿所述转换件231的径向开设并与所述孔道233连通的第三通孔234;所述过渡结构包括所述第三通孔234;所述孔道233与所述第三通孔234用于供所述拉线穿设而改变延伸方向。孔道233如可为通孔、盲孔或环槽等各种形式,拉线可以通过孔道233进而穿过第三通孔234而改变延伸方向。在图9b示出的示范例中,孔道233呈环状,沿转换件231的轴向朝近端开放,第三通孔234的侧壁即作为过渡结构。优选的第三通孔234的侧壁与孔道233的交接处为圆弧面,以形成圆滑过渡。如此配置,转换件231的外周可不再设置额外的第二固定环232,减小了线部署部件23的径向外尺寸,减小了线部署部件23与植入物的接触高度,降低了对植入物压握时的干扰。Please refer to FIG. 9b. In another alternative example, the conversion member 231 has a hole 233 opened along the axial direction of the delivery tube assembly 10, and the second limiting structure includes a plurality of The third through hole 234 opened radially of the member 231 and communicated with the hole 233; the transition structure includes the third through hole 234; the hole 233 and the third through hole 234 are used for the The extension direction is changed by passing the pull wire. The hole 233 can be in various forms such as a through hole, a blind hole or a ring groove, and the pull wire can pass through the hole 233 and then pass through the third through hole 234 to change the extending direction. In the example shown in FIG. 9 b , the hole 233 is annular and opens towards the proximal end along the axial direction of the conversion member 231 , and the side wall of the third through hole 234 serves as a transition structure. Preferably, the intersection of the side wall of the third through hole 234 and the channel 233 is an arc surface to form a smooth transition. With such a configuration, the outer circumference of the conversion piece 231 can no longer be provided with an additional second fixing ring 232, which reduces the radial outer dimension of the wire deployment part 23, reduces the contact height between the wire deployment part 23 and the implant, and reduces the impact on the implant. Interference during implant crimping.
请参考图16,在另一个可替代的示范例中,所述线部署部件1200设置在所述内管1100的远端外表面上,当所述线部署部件1200的数量为两个以上时,两个以上的所述线部署部件1200沿轴向间隔地设置在所述内管1100上。所述线部署部件1200上形成有穿线通道1210,所述穿线通道1210的部分表面形成为平滑的导向面1201,所述导向面1201用于在所述拉线20穿过所述穿线通道1210时对所述拉线20提供支撑力,并使所述拉线20的延伸方向发生偏转。这里,“平滑”的含义是指所述导向面1201上没有尖锐的棱边,也就是说,所述导向面1201为一连续的曲面,或者所述导向面1201包括多个不 同的面,多个不同的面可以是平面也可以是曲面,且多个不同的面之间平滑过渡地连接。Please refer to FIG. 16 , in another alternative example, the wire deploying part 1200 is disposed on the outer surface of the distal end of the inner tube 1100, and when the number of the wire deploying parts 1200 is more than two, More than two wire deployment parts 1200 are disposed on the inner tube 1100 at intervals in the axial direction. A threading channel 1210 is formed on the thread deployment part 1200, and a part of the surface of the threading channel 1210 is formed as a smooth guide surface 1201, and the guide surface 1201 is used to guide the threading channel 1210 when the pull wire 20 passes through the threading channel 1210. The pull wire 20 provides support force and deflects the extending direction of the pull wire 20 . Here, "smooth" means that there are no sharp edges on the guide surface 1201, that is, the guide surface 1201 is a continuous curved surface, or the guide surface 1201 includes a plurality of different surfaces, mostly A different surface can be a plane or a curved surface, and multiple different surfaces are connected with a smooth transition.
以下对所述线部署部件1200的可选结构做详尽具体的介绍。The optional structure of the line deploying part 1200 will be described in detail below.
在本发明的一实施例中,如图17及图18所示,所述导向面1201包括沿近端向远端依次平滑连接的第一子导向面1201a、第二子导向面1201b、以及第三子导向面1201c。其中,所述第一子导向面1201a和所述第三子导向面1201c的轴线均为直线,两者之间所形成的夹角的角度为45°~135°。所述第二子导向面1201b的轴线为弧线,从而在平行于所述线部署部件1200的轴向的截面上,所述第二子导向面1201的轮廓线的至少一部分为曲线。如此,当所述拉线20的远端穿过所述穿线通道1210时,在所述导向面1201的支撑下,所述拉线20在所述穿线通道1210的出口处(即所述第三子导向面1201c远离所述第二子导向面1201b的端部处)的延伸方向相对于所述拉线20在所述穿线通道1210的入口处的延伸方向来说,其偏转的角度至少可以在45°~135°范围内选择。In one embodiment of the present invention, as shown in Figure 17 and Figure 18, the guide surface 1201 includes a first sub-guiding surface 1201a, a second sub-guiding surface 1201b, and a first Three sub-guiding surfaces 1201c. Wherein, the axes of the first sub-guiding surface 1201a and the third sub-guiding surface 1201c are both straight lines, and the angle formed between them is 45°-135°. The axis of the second sub-guiding surface 1201b is an arc, so that on a section parallel to the axial direction of the wire deployment component 1200, at least a part of the outline of the second sub-guiding surface 1201 is a curve. In this way, when the distal end of the pull wire 20 passes through the threading channel 1210, under the support of the guide surface 1201, the pull wire 20 is at the exit of the threading channel 1210 (ie, the third sub-guiding The extension direction of the surface 1201c away from the end of the second sub-guiding surface 1201b) relative to the extension direction of the pull wire 20 at the entrance of the threading channel 1210, the deflection angle can be at least 45°~ Choose from a range of 135°.
可选地,所述线部署部件1200上还形成有一安装通孔1220,所述线部署部件1200通过所述安装通孔1220安装于所述内管1100上。所述穿线通道1210包括穿线孔(图中未标注),所述穿线孔包括第一孔段1211,所述第一孔段1211的轴线与所述安装通孔1220的轴线相平行,并且,所述第一孔段1211的部分孔壁可构成所述第一子导向面1201a,于本实施例中,所述第一孔段1211的远离所述安装通孔1220的一侧的孔壁构成所述第一子导向面1201a。Optionally, an installation through hole 1220 is formed on the wire deployment part 1200 , and the wire deployment part 1200 is installed on the inner tube 1100 through the installation through hole 1220 . The threading channel 1210 includes a threading hole (not marked in the figure), the threading hole includes a first hole segment 1211, the axis of the first hole segment 1211 is parallel to the axis of the installation through hole 1220, and, the Part of the hole wall of the first hole section 1211 can constitute the first sub-guiding surface 1201a. The first sub-guiding surface 1201a.
进一步地,所述穿线孔还可以包括第二孔段1212和第三孔段1213。其中,所述第二孔段1212的近端与所述第一孔段1212的远端连接,且所述第二孔段1212的部分孔壁构成所述第二子导向面1201b。所述第三孔段1213的近端与所述第二孔段1212的远端连接,且所述第三孔段1213的部分孔壁构成所述第三子导向面1201c。Further, the threading hole may also include a second hole segment 1212 and a third hole segment 1213 . Wherein, the proximal end of the second hole section 1212 is connected to the distal end of the first hole section 1212, and part of the hole wall of the second hole section 1212 constitutes the second sub-guiding surface 1201b. The proximal end of the third hole section 1213 is connected to the distal end of the second hole section 1212 , and part of the hole wall of the third hole section 1213 constitutes the third sub-guiding surface 1201c.
进一步地,所述导向面1201的表面粗糙度Ra应当尽可能地小,以在释放或回收所述医用植入物2的过程中,进一步减小所述拉线20与所述导向面1201之间产生的摩擦力。优选地,所述导向面1201的表面粗糙度Ra可以小 于或等于0.2。在一些实现方式中,可以通过材料的选择来减小所述导向面1201的表面粗糙度Ra,例如利用聚四氟乙烯、陶瓷、玻璃等较为光滑的材料来制造所述线部署部件1200,或者,所述线部署部件120包括基材和润滑涂层,所述基材上形成供所述拉线20穿过的通道,并在所述通道的部分表面上设置所述润滑涂层以形成所述导向面1201。在另一些实现方式中,所述线部署部件1200可以为金属结构件,并通过对所述穿线通道1210的表面进行打磨、抛光等处理以降低所述导向面1201的表面粗糙度Ra,在此,所述线部署部件1200的材料包括但不限于碳氮化钛、氮化钛、不锈钢、镍钛中的任意一种。Further, the surface roughness Ra of the guide surface 1201 should be as small as possible, so as to further reduce the distance between the pull wire 20 and the guide surface 1201 during the process of releasing or recovering the medical implant 2 . the resulting friction. Preferably, the surface roughness Ra of the guide surface 1201 may be less than or equal to 0.2. In some implementations, the surface roughness Ra of the guide surface 1201 can be reduced by selecting materials, for example, the wire deployment component 1200 is made of relatively smooth materials such as polytetrafluoroethylene, ceramics, and glass, or , the wire deployment part 120 includes a base material and a lubricating coating, a channel for the pull wire 20 to pass is formed on the base material, and the lubricating coating is provided on a part of the surface of the channel to form the guide surface 1201 . In other implementations, the wire deployment part 1200 may be a metal structural member, and the surface roughness Ra of the guide surface 1201 is reduced by grinding, polishing, etc. the surface of the threading channel 1210, where , the material of the wire deploying part 1200 includes but not limited to any one of titanium carbonitride, titanium nitride, stainless steel, and nickel titanium.
可选地,所述穿线通道1210的数量根据实际需要设置,其可以为一个,也可以为两个、三个、或者更多个。如图16至图18所示,当所述穿线通道1210的数量为两个以上时,优选两个以上的所述穿线通道1210环绕所述安装通孔1220间隔布置,以减小所述线部署部件1200的径向尺寸,进而减小所述输送系统1的径向尺寸。可选地,多个所述穿线通道1210的出口位于同一圆周上,或者至少部分所述穿线通道1210的出口位于不同的圆周上。Optionally, the number of the threading channel 1210 is set according to actual needs, and it may be one, or two, three, or more. As shown in Figures 16 to 18, when the number of the threading channels 1210 is more than two, preferably more than two threading channels 1210 are arranged at intervals around the installation through hole 1220 to reduce the wire deployment. The radial dimension of the component 1200 thereby reduces the radial dimension of the delivery system 1 . Optionally, outlets of a plurality of threading channels 1210 are located on the same circumference, or at least part of the outlets of the threading channels 1210 are located on different circumferences.
此外,本实施例中,如图16至图18所示,所述线部署部件1200具有流线型的外形,其包括轴向连接的近端节段1200a和远端节段1200b,所述近端节段1200a的横截面的面积沿近端向远端的方向逐渐增大。这样做的好处在于可以改善所述输送系统1的弯曲性能,有利于所述输送系统1穿过迂曲血管,同时与血管的干涉少,减少对血管的损伤。In addition, in this embodiment, as shown in FIGS. 16 to 18 , the wire deployment component 1200 has a streamlined shape, which includes a proximal segment 1200a and a distal segment 1200b axially connected, and the proximal segment The cross-sectional area of segment 1200a gradually increases in the direction from the proximal end to the distal end. The advantage of doing this is that the bending performance of the delivery system 1 can be improved, which is beneficial for the delivery system 1 to pass through tortuous blood vessels, and at the same time, there is less interference with blood vessels and less damage to blood vessels.
另外,本实施例中,所述线部署部件1200可以为一体式构件,也可以是拼装式构件,只要所述线部署部件1200上能够形成所述穿线通道1210及所述安装通孔1220即可。In addition, in this embodiment, the wire deployment part 1200 can be an integrated component or an assembled component, as long as the threading channel 1210 and the installation through hole 1220 can be formed on the wire deployment part 1200 .
请再参考图21,在本发明的另一实施例中,所述线部署部件1200至少包括线部署部件本体1230和转动件1240。所述线部署部件本体1230的中心位置形成有一第一插入孔,以作为所述安装通孔1220的至少一部分。所述线部署部件本体1230上还形成有沿在轴向上贯穿所述线部署部件本体1230的穿线槽1231,可选地,所述穿线槽1231沿所述线部署部件本体1230的径向延 伸,并在所述线部署部件本体1230的边缘处开口,所述穿线槽1231为U型槽或扇形槽。所述转动件1240可转动地连接于所述穿线槽1231的槽壁上,并与所述穿线槽1231的至少部分槽壁围合形成所述穿线通道1210。所述转动件1240具有圆周面,所述圆周面的部分区域构成所述导向面1201。通常,所述圆周面背离所述开口的一侧的至少部分区域构成所述导向面1201,也即所述圆周面的朝向所述安装通孔1220的一侧的至少部分区域构成所述导向面1201。当所述拉线20的远端穿过所述穿线通道1210,并抵靠在所述转动件1240上时,所述拉线20的远端的延伸方向能够发生偏转(如图24所示)。也就是说,本实施例中利用所述转动件1240的部分表面作为所述拉线20的进行方向偏转时的支撑,使得所述拉线20与所述线部署部件1200之间的摩擦力为滚动摩擦,达到减少控制力损失的目的。Please refer to FIG. 21 again. In another embodiment of the present invention, the wire deploying part 1200 includes at least a wire deploying part body 1230 and a rotating part 1240 . A first insertion hole is formed at the center of the wire deployment component body 1230 as at least a part of the installation through hole 1220 . The thread deployment part body 1230 is also formed with a threading groove 1231 passing through the thread deployment part body 1230 in the axial direction. Optionally, the threading groove 1231 extends along the radial direction of the thread deployment part body 1230 , and open at the edge of the wire deploying part body 1230, the threading groove 1231 is a U-shaped groove or a fan-shaped groove. The rotating member 1240 is rotatably connected to the groove wall of the threading groove 1231 , and encloses at least part of the groove wall of the threading groove 1231 to form the threading channel 1210 . The rotating member 1240 has a circumferential surface, and a partial area of the circumferential surface constitutes the guide surface 1201 . Usually, at least a partial area of the side of the circumferential surface away from the opening constitutes the guide surface 1201, that is, at least a partial area of the circumferential surface facing the installation through hole 1220 constitutes the guide surface 1201. When the distal end of the pull wire 20 passes through the threading channel 1210 and abuts against the rotating member 1240 , the extending direction of the distal end of the pull wire 20 can be deflected (as shown in FIG. 24 ). That is to say, in this embodiment, part of the surface of the rotating member 1240 is used as a support when the direction of the pull wire 20 is deflected, so that the friction force between the pull wire 20 and the wire deployment part 1200 is rolling friction. , to reduce the loss of control.
在一些实现方式中,所述线部署部件本体1230可具有较小的轴向尺寸,在此,如图22及图23所示,所述线部署部件1200还可以包括一底座1250,所述底座1250与所述固定座本体1230的近端端面连接,所述底座1250上还设有与所述第一插入孔对应的第二插入孔,所述第二插入孔与所述第一插入孔共同构成所述安装通孔1220。以及,所述底座1250上还可以设有与所述穿线通道相连通的导入通道1251,所述拉线20的远端穿过所述导入通道1251,再穿过所述穿线通道1210。所述导入通道1251可以设置于所述底座1250的对应于所述穿线通道1201的位置,其可以是孔(如图22及图23所示),例如圆形孔、方形孔等。需要说明的是,本发明实施例对所述导入通道的设置位置并没有特别限制,只要其能允许所述拉线20的远端穿过并进入所述穿线通道1210即可。此外,还优选所述底座1250的横截面积沿近端向远端的方向逐渐增大,以改善所述输送系统1的弯曲性能。可以理解,所述底座1250和所述线部署部件本体1230可以一体成型,也可以分体成型后再连接于一体。替代性地,所述线部署部件本体1230可具有较大的轴向尺寸,这种情况下,优选所述线部署部件本体1230的横截面沿近端向远端的方向逐渐增大。进一步地,本实施例中,所述转动件1240可以是一旋转轴,所述旋转轴通过轴承安装于所述穿线槽1231的槽壁上。或者,所述穿线槽1231的相对两个槽壁 上形成有安装轴(图中未示出),所述转动件1240为一定滑轮,所述定滑轮可转动地安装于所述安装轴上。以及,所述转动件1240优选为金属结构件,其材料包括但不限于碳氮化钛、氮化钛、不锈钢、镍钛中的任意一种。优选地,所述转动件1240的圆周面上设有定位槽1241,所述定位槽1241沿所述转动件1240的周向延伸一圈,所述定位槽1241的部分槽壁(即所述定位槽1241的朝向安装通孔的部分)构成所述导向面1201。所述拉线20在穿过所述穿线通道1210时被限制在所述定位槽1241中,避免所述拉线20因在所述转动件1240的轴向上具有较大的移动范围而对所述医用植入物2的释放或回收产生不利影响。进一步优选地,在所述转动件1240的纵截面上,所述定位槽1241的形状为弧形。本发明实施例所提供的输送系统1,通过对所述线部署部件1200的结构进行优化,以降低所述拉线20在穿过所述线部署部件1200上的所述穿线通道1210时的摩擦力,达到减小在释放或回收所述医用植入物2时的控制力损失的问题,进而达到改善所述医用植入物2的稳定释放或回收、减小医用植入物2在释放或回收时对人体组织的损伤的效果。不仅如此,所述输送系统1在释放或回收所述医用植入物2时,还能够很好地克服所述医用植入物2的轴向移位的问题,提高所述医用植入物2的定位准确性。In some implementations, the wire deployment component body 1230 may have a smaller axial dimension. Here, as shown in FIGS. 22 and 23 , the wire deployment component 1200 may further include a base 1250, and 1250 is connected to the proximal end surface of the fixing base body 1230, and the base 1250 is also provided with a second insertion hole corresponding to the first insertion hole, and the second insertion hole is in common with the first insertion hole. The installation through hole 1220 is formed. And, the base 1250 may also be provided with an introduction channel 1251 communicating with the threading channel, and the distal end of the pull wire 20 passes through the introduction channel 1251 and then passes through the threading channel 1210 . The introduction channel 1251 can be set at the position of the base 1250 corresponding to the threading channel 1201 , which can be a hole (as shown in FIG. 22 and FIG. 23 ), such as a circular hole, a square hole, and the like. It should be noted that, in the embodiment of the present invention, there is no special limitation on the setting position of the introduction channel, as long as it can allow the distal end of the pull wire 20 to pass through and enter the threading channel 1210 . In addition, it is also preferable that the cross-sectional area of the base 1250 increases gradually from the proximal end to the distal end, so as to improve the bending performance of the delivery system 1 . It can be understood that the base 1250 and the wire deployment component body 1230 can be integrally formed, or formed separately and then connected together. Alternatively, the wire deployment member body 1230 may have a larger axial dimension, in this case, preferably, the cross section of the wire deployment member body 1230 increases gradually from the proximal end to the distal end. Further, in this embodiment, the rotating member 1240 may be a rotating shaft, and the rotating shaft is mounted on the groove wall of the threading groove 1231 through a bearing. Or, an installation shaft (not shown) is formed on the opposite two groove walls of the threading groove 1231, and the rotating member 1240 is a certain pulley, and the fixed pulley is rotatably installed on the installation shaft. And, the rotating member 1240 is preferably a metal structural member, and its material includes but not limited to any one of titanium carbonitride, titanium nitride, stainless steel, and nickel titanium. Preferably, a positioning groove 1241 is provided on the circumferential surface of the rotating member 1240, and the positioning groove 1241 extends one circle along the circumferential direction of the rotating member 1240, and part of the groove wall of the positioning groove 1241 (that is, the positioning The part of the groove 1241 facing the installation through hole) constitutes the guide surface 1201 . The pull wire 20 is restricted in the positioning groove 1241 when passing through the threading passage 1210, so as to prevent the pull wire 20 from having a large movement range in the axial direction of the rotating member 1240 from causing damage to the medical device. The release or retrieval of the implant 2 has adverse effects. Further preferably, in the longitudinal section of the rotating member 1240, the positioning groove 1241 is arc-shaped. The delivery system 1 provided by the embodiment of the present invention optimizes the structure of the wire deployment part 1200 to reduce the friction force of the pull wire 20 when passing through the threading channel 1210 on the wire deployment part 1200 , to reduce the problem of loss of control force when releasing or retrieving the medical implant 2, and then achieve improving the stable release or retrieving of the medical implant 2, reducing the release or retrieving of the medical implant 2 damage to human tissue. Not only that, when the delivery system 1 releases or recovers the medical implant 2, it can also well overcome the problem of axial displacement of the medical implant 2, and improve the positioning accuracy.
本发明实施例对所述输送装置所包括的线部署部件1200的数量和设置位置没有特别限制,只要所述拉线20的远端能够在所述导向面1201的作用下转向,并与所述医用植入物2连接即可。例如,所述线部署部件1200为一个(如图25、图26、图28及图29所示)、两个(如图27所示)、以及更多个(图中未示出),所述线部署部件1200可以设置在所述医用植入物2的近端侧和/或远端侧(如图25、图26及图27所示),所述线部署部件也可以设在所述医用植入物2的内侧(如图28及图29所示)。The embodiment of the present invention has no special limitation on the number and setting positions of the wire deployment parts 1200 included in the delivery device, as long as the distal end of the pull wire 20 can be turned under the action of the guide surface 1201 and is compatible with the medical Implant 2 is connected. For example, the line deployment part 1200 is one (as shown in Figure 25, Figure 26, Figure 28 and Figure 29), two (as shown in Figure 27), and more (not shown in the figure), so The wire deployment part 1200 can be arranged on the proximal side and/or the distal side of the medical implant 2 (as shown in Figure 25, Figure 26 and Figure 27), and the wire deployment part can also be arranged on the The inner side of the medical implant 2 (as shown in Figure 28 and Figure 29).
在一个优选的实施例中,如图25、图26及图27所示,所述输送器包括至少一个所述线部署部件1200,且在所述输送系统的1的轴向上,任一个所述线部署部件1200与所述医用植入物2之间的距离大于或等于零(如图25及图27所示),且当所述医用植入物2处于压握状态时,所述线部署部件1200的所述导向面1201使所述拉线20的延伸方向偏转预定角度。具体来说,当 所述线部署部件1200设置在所述医用植入物2的近端侧,且所述线部署部件1200的远端与所述医用植入物2的近端的距离大于或等于0,同时所述导向面1201使所述拉线20的延伸方向偏转90°~135°(即所述拉线20的位于所述线部署部件1200与所述医用植入物2之间的部分与所述输送器的轴线所形成的夹角α的角度为90°~135°)。和/或,所述线部署部件1200设置在所述医用植入物2的远端侧,且所述线部署部件1200的近端与所述医用植入物的远端的距离大于或等于0,同时所述导向面1201使所述拉线的延伸方向偏转45°~90°(即所述拉线20的位于所述线部署部件1200与所述医用植入物2之间的部分与所述输送器的轴线所形成的夹角α的角度为45°~90°)。这样设置的目的是,当所述医用植入物2被压缩时,所述医用植入物2与所述线部署部件1200之间在轴向上没有重合,两者不接触,可以改善整个医用装置的柔软度,从而所述医用装置能够更好地适应迂曲的血管。优选地,所述医用植入物2与所述内管1100同轴布置。In a preferred embodiment, as shown in FIG. 25 , FIG. 26 and FIG. 27 , the conveyor includes at least one wire deployment part 1200 , and in the axial direction of the conveyor system 1 , any one of the wire deployment parts 1200 The distance between the wire deployment part 1200 and the medical implant 2 is greater than or equal to zero (as shown in FIG. 25 and FIG. 27 ), and when the medical implant 2 is in the crimped state, the wire deployment The guide surface 1201 of the component 1200 deflects the extension direction of the pull wire 20 by a predetermined angle. Specifically, when the wire deployment part 1200 is arranged on the proximal side of the medical implant 2, and the distance between the distal end of the wire deployment part 1200 and the proximal end of the medical implant 2 is greater than or is equal to 0, and at the same time, the guide surface 1201 deflects the extension direction of the pull wire 20 by 90° to 135° (that is, the part of the pull wire 20 between the wire deployment part 1200 and the medical implant 2 and the The angle α formed by the axes of the conveyors is 90°-135°). And/or, the wire deployment part 1200 is arranged on the distal side of the medical implant 2, and the distance between the proximal end of the wire deployment part 1200 and the distal end of the medical implant is greater than or equal to 0 , and at the same time, the guide surface 1201 deflects the extension direction of the pull wire by 45° to 90° (that is, the part of the pull wire 20 between the wire deployment part 1200 and the medical implant 2 and the delivery The angle α formed by the axis of the device is 45°~90°). The purpose of this setting is that when the medical implant 2 is compressed, there is no axial overlap between the medical implant 2 and the wire deployment part 1200, and the two do not contact, which can improve the overall medical performance. The flexibility of the device, so that the medical device can better adapt to tortuous blood vessels. Preferably, the medical implant 2 is arranged coaxially with the inner tube 1100 .
此外,本领域技术人员可以理解,当所述医用植入物2被释放并径向扩张时,所述拉线20的位于所述线部署部件1200与所述医用植入物2之间的部分与所述内管1100的轴线所形成的夹角α的角度会相应发生改变,举例来说,当所述线部署部件1200设置于所述医用植入物2的近端侧时,所述医用植入物2被释放后,所述夹角α的角度减小,当所述线部署部件1200设置在所述医用植入物2的远端侧时,所述医用植入物2被释放后,所述夹角α的角度增大。In addition, those skilled in the art can understand that when the medical implant 2 is released and radially expanded, the part of the pull wire 20 between the wire deploying part 1200 and the medical implant 2 and the The included angle α formed by the axis of the inner tube 1100 will change accordingly. For example, when the wire deploying part 1200 is arranged on the proximal side of the medical implant 2, the medical implant After the implant 2 is released, the angle of the included angle α decreases. When the wire deployment component 1200 is arranged on the distal side of the medical implant 2, after the medical implant 2 is released, The angle of the included angle α increases.
请参考图10和图11,其示出了拉线与输送装置的装配关系。需理解,在图10和图11示出的示范例中,仅示意了拉线组02中的一根拉线,实际中拉线组02可包括多根拉线。在该示范例中,拉线形成一个单线圈环,拉线的固定端022a绕成一个圈环固定在第一固定环213上,进而拉线穿过驱动件211的第一通孔211a,向远端延伸,而后穿过转换件231的第二通孔231a,自转换件231的远端伸出形成圈环(该圈环如可与拉线组02中的其它拉线形成销接关系,或者直接用于驱动支架的收放),之后拉线再次穿过转换件231的第二通孔231a,向近端延伸,进而再次穿过驱动件211的第一通孔211a,与销 形件221连接。需理解的,图10和图11示出的示范例仅为拉线与输送装置的装配关系的一个示例而非限定。Please refer to FIG. 10 and FIG. 11 , which show the assembly relationship between the pull wire and the conveying device. It should be understood that, in the example shown in FIG. 10 and FIG. 11 , only one pull wire in the pull wire set 02 is shown, but actually the pull wire set 02 may include multiple pull wires. In this example, the pull wire forms a single coil loop, the fixed end 022a of the pull wire is wound into a loop and fixed on the first fixed ring 213, and then the pull wire passes through the first through hole 211a of the driver 211 and extends to the distal end , then pass through the second through hole 231a of the conversion piece 231, and stretch out from the far end of the conversion piece 231 to form a loop (the loop can form a pinned relationship with other backguys in the backguy set 02, or be directly used to drive stent), and then the pull wire passes through the second through hole 231a of the conversion part 231 again, extends to the proximal end, and then passes through the first through hole 211a of the driving part 211 again, and is connected with the pin-shaped part 221. It should be understood that the example shown in Fig. 10 and Fig. 11 is only an example of the assembly relationship between the pull wire and the conveying device and is not limiting.
请参考图12和图13,并结合图3,在一些实施例中,所述输送装置包括两个以上的所述线控组件20,两个以上的所述线控组件20的线固定部件21中用于与拉线组02连接的部分(如第一限位结构和固定结构等)沿所述输送管组件10的径向和/或周向相互错开。Please refer to FIG. 12 and FIG. 13 , in conjunction with FIG. 3 , in some embodiments, the delivery device includes more than two wire control assemblies 20 , and more than two wire fixing parts 21 of the wire control assemblies 20 The parts used to connect with the pull wire set 02 (such as the first limiting structure and the fixing structure, etc.) are staggered along the radial direction and/or circumferential direction of the delivery tube assembly 10 .
可选的,线控瓣膜假体包括两个以上沿轴向间隔排布的拉线组02,与其相适配的,输送装置包括两个以上的线控组件20,每个线控组件20对应控制一个拉线组02。Optionally, the wire-controlled valve prosthesis includes more than two pull-wire groups 02 arranged at intervals in the axial direction, and correspondingly, the delivery device includes more than two wire-controlled assemblies 20, and each wire-controlled assembly 20 corresponds to control A cable set 02.
在一些实施例中,两个以上的线控组件20的线固定部件21的第一限位结构和/或固定结构围绕内管11内外同轴排布。较佳的,用于控制较远端的拉线组02的线固定部件21的第一限位结构和/或固定结构位于内侧,用于控制较近端的拉线组02的线固定部件21的第一限位结构和/或固定结构位于外侧。In some embodiments, the first limiting structures and/or fixing structures of the wire fixing parts 21 of more than two wire control assemblies 20 are coaxially arranged inside and outside around the inner tube 11 . Preferably, the first limiting structure and/or the fixing structure for controlling the wire fixing part 21 of the pull wire group 02 at the far end is located inside, and is used for controlling the first stop structure and/or fixing structure of the wire fixing part 21 of the pull wire group 02 at the proximal end. A limiting structure and/or fixing structure is located on the outside.
以图3所示出的示范例为例,其包括两个拉线组02,分别位于其流入道与流出道处(即位于支架01的远近两端)。相对应的,如图12和图13所示,输送装置包括两个线控组件20,其中,与位于近端的拉线组02相连接的线控组件20的驱动件211的直径相对较大,与位于远端的拉线组02相连接的线控组件20的驱动件211的直径相对较小;两个驱动件211的第一通孔211a分别围绕内管的轴线内外同轴排布。进一步的,两个驱动件211分别与一个拉线管212连接,使得两个驱动件211能够被独立地驱动,使得两个线固定部件21沿所述输送管组件10的轴向相互独立的移动。如此配置,两个线控组件20分别可以独立地驱动各自对应的拉线组02,而不会相互产生干扰。当然在其它的一些实施例中,两个线控组件20的线固定部件21相互固定,例如两个驱动件211与同一个拉线管212连接,此时两个拉线组02将被同时驱动而收紧或放松。Taking the example shown in FIG. 3 as an example, it includes two pull wire groups 02 located at the inflow channel and the outflow channel respectively (that is, located at the far and near ends of the bracket 01 ). Correspondingly, as shown in FIG. 12 and FIG. 13 , the delivery device includes two wire control assemblies 20 , wherein the diameter of the driving member 211 of the wire control assembly 20 connected to the pull wire set 02 located at the proximal end is relatively large, The diameter of the drive element 211 of the wire control assembly 20 connected to the pull wire set 02 at the distal end is relatively small; the first through holes 211a of the two drive elements 211 are respectively arranged coaxially around the axis of the inner tube. Further, the two driving parts 211 are respectively connected to one puller tube 212 , so that the two driving parts 211 can be driven independently, so that the two wire fixing parts 21 can move independently of each other along the axial direction of the delivery tube assembly 10 . With such a configuration, the two wire control assemblies 20 can independently drive their corresponding pull wire groups 02 without mutual interference. Of course, in some other embodiments, the wire fixing parts 21 of the two wire control assemblies 20 are fixed to each other, for example, the two driving parts 211 are connected to the same pull wire tube 212, at this time, the two pull wire groups 02 will be driven simultaneously to retract. Tight or loose.
需理解的,两个线控组件20的线固定部件21相互固定,不仅可理解为两个线控组件20分别具有各自独立的驱动件211,如图14和图15所示,在一些实施例中,两个线控组件20还可以共用同一个驱动件211,也可以理解 为两个线控组件20的驱动件211相互融合一体成型。进一步的,两个以上的线控组件20的线固定部件21用于与拉线组连接的部分(如第一通孔211a)围绕内管11周向错开排布,以避免拉线相互交叉剐蹭。两个线控组件20的线固定部件21相互固定,则两个拉线组02将被同时驱动而收紧或放松。当然两个线控组件20的线脱离部件22可不限于被同时控制,而是优选可以分别独立地驱动。优选的,每一个拉线组02中仅设置一根拆离线022和多根固定线021,相对应的,每个线控组件20中可仅设置一个线脱离部件22,输送装置的结构简单,使用中在分离了一个拉线组02的拆离线022之后即可解除其余销接的拉线。简化了撤线操作的步骤。It should be understood that the wire fixing parts 21 of the two wire control assemblies 20 are fixed to each other, not only can it be understood that the two wire control assemblies 20 have their own independent driving parts 211, as shown in Figure 14 and Figure 15, in some embodiments Among them, the two wire control assemblies 20 can also share the same driving part 211, which can also be understood as the driving parts 211 of the two wire control assemblies 20 are fused with each other and integrally formed. Further, the parts (such as the first through hole 211 a ) of the wire fixing parts 21 of more than two wire control assemblies 20 used to connect with the pull wire group are arranged in a staggered circumferential direction around the inner tube 11 to prevent the pull wires from intersecting and scratching each other. When the wire fixing parts 21 of the two wire control assemblies 20 are fixed to each other, the two pull wire groups 02 will be driven simultaneously to tighten or loosen. Of course, the wire disengagement parts 22 of the two wire control assemblies 20 are not limited to be controlled simultaneously, but preferably can be driven independently. Preferably, only one dismantling wire 022 and multiple fixing wires 021 are set in each pull wire group 02, and correspondingly, only one wire disengagement part 22 can be set in each wire control assembly 20, and the structure of the conveying device is simple and easy to use After separating the dismantling line 022 of a backguy group 02, the backguys connected by the rest of the pins can be released. Simplified the steps of thread withdrawal operation.
可选的,在一些实施例中,可将拉线组02集成于输送装置中,即所述输送装置包括至少一个拉线组02,所述拉线组包括至少一根拉线。拉线组02的具体结构和配置请参考上文,此处不再赘述。Optionally, in some embodiments, the pull wire set 02 can be integrated into the conveying device, that is, the conveying device includes at least one pull wire set 02, and the pull wire set includes at least one pull wire. Please refer to the above for the specific structure and configuration of the pull wire group 02, and will not repeat them here.
综上所述,本发明提供的植入物的输送装置包括:输送管组件及至少一个线控组件;所述线控组件包括:线固定部件及线脱离部件;所述线固定部件用于与拉线组中的拉线的固定端连接;所述线脱离部件沿所述输送管组件的轴向可移动地设置,所述线脱离部件用于与所述拉线组中的拉线的脱离端连接;当所述线脱离部件满足预设条件时,所述线脱离部件与所述拉线的脱离端脱离。In summary, the implant delivery device provided by the present invention includes: a delivery tube assembly and at least one wire control assembly; the wire control assembly includes: a wire fixing part and a wire detachment part; the wire fixing part is used for The fixed ends of the stay wires in the stay wire group are connected; the wire disengagement part is movably arranged along the axial direction of the delivery tube assembly, and the wire disengagement part is used to connect with the disengagement ends of the stay wires in the stay wire group; When the wire disengagement part satisfies a preset condition, the wire disengagement part is disengaged from the disengagement end of the pull wire.
如此配置,线固定部件与拉线的固定端连接,线脱离部件与拉线的脱离端连接,在满足预设条件时,线脱离部件与拉线的脱离端脱离,如此即使得拉线的脱离端形成自由端,从而可使拉线组与支架分离。拉线组的脱离动作简单,摩擦行程少,撤线过程中对支架的稳定性影响小,提高手术成功率,克服了现有输送器撤线路径长、操作复杂的问题。In such a configuration, the wire fixing part is connected to the fixed end of the pull wire, and the wire detachment part is connected to the detachment end of the pull wire. , so that the pull wire group can be separated from the bracket. The detachment action of the pull wire group is simple, the friction stroke is small, the stability of the bracket is less affected during the wire withdrawal process, the success rate of the operation is improved, and the problems of long wire withdrawal path and complicated operation of the existing conveyor are overcome.
需要说明的,上述若干实施例之间可相互组合。上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosures shall fall within the protection scope of the claims.

Claims (35)

  1. 一种植入物的输送装置,其特征在于,包括:输送管组件及至少一个线控组件;所述线控组件包括:线固定部件及线脱离部件;An implant delivery device, characterized by comprising: a delivery tube assembly and at least one wire control assembly; the wire control assembly includes: a wire fixing part and a wire detaching part;
    所述线固定部件用于与拉线组中的拉线的固定端连接;The wire fixing part is used to connect with the fixed end of the stay wire in the stay wire set;
    所述线脱离部件沿所述输送管组件的轴向可移动地设置,所述线脱离部件用于与所述拉线组中的拉线的脱离端连接;当所述线脱离部件满足预设条件时,所述线脱离部件与所述拉线的脱离端脱离。The wire detachment part is movably arranged along the axial direction of the delivery tube assembly, and the wire detachment part is used to connect with the detachment end of the pull wire in the pull wire group; when the wire detachment part satisfies the preset condition , the wire disengagement part is disengaged from the disengagement end of the pull wire.
  2. 根据权利要求1所述的植入物的输送装置,其特征在于,所述线固定部件沿所述输送管组件的轴向可移动地设置。The implant delivery device according to claim 1, characterized in that, the wire fixing member is movably arranged along the axial direction of the delivery tube assembly.
  3. 根据权利要求2所述的植入物的输送装置,其特征在于,所述线脱离部件位于所述线固定部件的近端,所述线脱离部件未满足预设条件时,所述线脱离部件与所述线固定部件同步地沿所述输送管组件的轴向移动。The implant delivery device according to claim 2, characterized in that, the wire detachment part is located at the proximal end of the wire fixing part, and when the wire detachment part does not meet the preset condition, the wire detachment part Moves in the axial direction of the delivery tube assembly synchronously with the wire fixing member.
  4. 根据权利要求2所述的植入物的输送装置,其特征在于,所述输送管组件包括内管,所述线固定部件可活动地套设于所述内管之外。The implant delivery device according to claim 2, wherein the delivery tube assembly includes an inner tube, and the wire fixing component is movably sleeved outside the inner tube.
  5. 根据权利要求1所述的植入物的输送装置,其特征在于,所述预设条件包括所述线脱离部件机械性运动。The implant delivery device according to claim 1, wherein the preset condition includes mechanical movement of the wire breaking away component.
  6. 根据权利要求5所述的植入物的输送装置,其特征在于,所述线脱离部件包括销形件,所述销形件具有开口,所述销形件用于供所述拉线的脱离端连接;所述预设条件包括:所述线脱离部件相对于所述拉线的脱离端移动,以使所述拉线的脱离端自所述开口中脱出。The implant delivery device according to claim 5, wherein the wire disengagement member comprises a pin-shaped member having an opening for receiving the disengagement end of the pull wire. connection; the predetermined condition includes: the wire disengagement member moves relative to the disengagement end of the pull wire, so that the disengagement end of the pull wire disengages from the opening.
  7. 根据权利要求6所述的植入物的输送装置,其特征在于,所述输送装置还包括牵引件,所述牵引件的第一端与所述销形件连接,所述牵引件的第二端向近端延伸。The implant delivery device according to claim 6, characterized in that, the delivery device further comprises a traction member, the first end of the traction member is connected to the pin-shaped member, and the second end of the traction member The end extends proximally.
  8. 根据权利要求1所述的植入物的输送装置,其特征在于,在所述拉线的脱离端与所述线脱离部件连接时,所述线脱离部件处于连接状态,此时所述线控组件与所述输送装置之远端的轴向距离不大于300mm。The implant delivery device according to claim 1, characterized in that, when the detachment end of the pull wire is connected to the wire detachment part, the wire detachment part is in a connected state, and at this time the wire control assembly The axial distance from the distal end of the delivery device is no greater than 300mm.
  9. 根据权利要求1所述的植入物的输送装置,其特征在于,所述线固定 部件包括驱动件,所述驱动件沿所述输送管组件的轴向可移动地设置;所述驱动件具有第一限位结构,所述第一限位结构用于限制所述拉线围绕所述输送管组件的周向位置。The implant delivery device according to claim 1, characterized in that, the wire fixing part comprises a driving part, and the driving part is movably arranged along the axial direction of the delivery tube assembly; the driving part has A first limiting structure, the first limiting structure is used to limit the circumferential position of the pull wire around the delivery tube assembly.
  10. 根据权利要求9所述的植入物的输送装置,其特征在于,所述第一限位结构包括多个沿所述驱动件的轴向贯通开设的第一通孔,或者,所述第一限位结构包括多个沿所述驱动件的轴向开设于所述驱动件外周的第一凹槽;所述第一通孔或所述第一凹槽用于供所述拉线穿设。The implant delivery device according to claim 9, characterized in that, the first limiting structure includes a plurality of first through holes opened through the axial direction of the driving member, or, the first The limiting structure includes a plurality of first grooves opened on the outer periphery of the driving member along the axial direction of the driving member; the first through hole or the first groove is used for passing the pull wire.
  11. 根据权利要求10所述的植入物的输送装置,其特征在于,所述线固定部件还包括固定结构,所述固定结构用于与所述拉线的固定端连接。The implant delivery device according to claim 10, wherein the wire fixing part further comprises a fixing structure, and the fixing structure is used to be connected with the fixing end of the pulling wire.
  12. 根据权利要求11所述的植入物的输送装置,其特征在于,不同的两个所述第一通孔用于供同一所述拉线依次穿过绕设,所述驱动件和其上的不同的两个所述第一通孔共同被配置为所述固定结构。The implant delivery device according to claim 11, characterized in that, the two different first through holes are used for the same pull wire to pass through and wind in turn, and the driving member is different from the one on it. The two first through holes are jointly configured as the fixing structure.
  13. 根据权利要求11所述的植入物的输送装置,其特征在于,所述固定结构包括:第一固定环,所述第一固定环用于供所述拉线的固定端绕设;The implant delivery device according to claim 11, wherein the fixing structure comprises: a first fixing ring, the first fixing ring is used for wrapping around the fixing end of the pull wire;
    所述第一固定环的径向内尺寸小于所述驱动件的径向外尺寸,所述第一固定环位用于与所述驱动件抵靠;或者The radially inner dimension of the first fixing ring is smaller than the radially outer dimension of the driving member, and the first fixing ring is used to abut against the driving member; or
    所述第一固定环固定套设于所述驱动件的外周。The first fixing ring is fixedly sleeved on the outer periphery of the driving member.
  14. 根据权利要求1所述的植入物的输送装置,其特征在于,所述线控组件还包括:线部署部件;所述输送管组件包括内管;The implant delivery device according to claim 1, wherein the wire control assembly further comprises: a wire deployment component; the delivery tube assembly includes an inner tube;
    所述线部署部件与所述内管固定连接;所述线部署部件用于供所述拉线沿所述输送管组件的径向汇合于其上后,将所述拉线的延伸方向改变为沿所述输送管组件的轴向延伸。The wire deploying part is fixedly connected with the inner tube; the wire deploying part is used for changing the extending direction of the pulling wire to along the radial direction of the delivery tube assembly after the pulling wire converges on it Axial extension of the delivery tube assembly described above.
  15. 根据权利要求14所述的植入物的输送装置,其特征在于,所述线部署部件包括转换件,所述转换件具有第二限位结构,所述第二限位结构用于限制所述拉线围绕所述输送管组件的周向位置。The implant delivery device according to claim 14, characterized in that, the wire deployment part comprises a transition piece, the transition piece has a second limiting structure, and the second limiting structure is used to limit the A pull wire surrounds a circumferential location of the delivery tube assembly.
  16. 根据权利要求15所述的植入物的输送装置,其特征在于,所述第二限位结构包括多个沿所述转换件的轴向贯通开设的第二通孔;或者,所述第二限位结构包括多个沿所述转换件的轴向开设于所述转换件外周的第二凹 槽;所述第二通孔或所述第二凹槽用于供所述拉线穿设。The implant delivery device according to claim 15, characterized in that, the second limiting structure includes a plurality of second through holes opened through the axial direction of the conversion member; or, the second The limiting structure includes a plurality of second grooves opened on the outer periphery of the conversion member along the axial direction of the conversion member; the second through hole or the second groove is used for passing the pull wire.
  17. 根据权利要求15所述的植入物的输送装置,其特征在于,所述线部署部件还包括过渡结构,所述过渡结构用于逐渐地改变所述拉线的延伸方向。The implant delivery device according to claim 15, wherein the wire deployment part further comprises a transition structure, and the transition structure is used to gradually change the extension direction of the pull wire.
  18. 根据权利要求17所述的植入物的输送装置,其特征在于,所述过渡结构包括:第二固定环;The implant delivery device according to claim 17, wherein the transition structure comprises: a second fixing ring;
    所述第二固定环相对于所述转换件固定设置,所述第二固定环用于供所述拉线绕设而改变延伸方向。The second fixing ring is fixedly arranged relative to the conversion element, and the second fixing ring is used for winding the pull wire to change the extending direction.
  19. 根据权利要求17所述的植入物的输送装置,其特征在于,所述转换件具有沿所述输送管组件的轴向开设的孔道,所述第二限位结构包括多个沿所述转换件的径向开设并与所述孔道连通的第三通孔;所述过渡结构包括所述第三通孔;所述孔道与所述第三通孔用于供所述拉线穿设而改变延伸方向。The implant delivery device according to claim 17, wherein the conversion member has a hole opened along the axial direction of the delivery tube assembly, and the second limiting structure includes a plurality of holes along the conversion direction. The third through hole opened in the radial direction of the member and communicated with the channel; the transition structure includes the third through hole; the channel and the third through hole are used to pass through the pull wire to change the extension direction.
  20. 根据权利要求14所述的植入物的输送装置,其特征在于,所述线部署部件上形成有穿线通道,所述穿线通道的部分表面形成为平滑的导向面,所述导向面用于在拉线穿过所述穿线通道时支撑所述拉线,并使所述拉线的延伸方向发生偏转。The implant delivery device according to claim 14, wherein a threading channel is formed on the wire deployment part, and a part of the surface of the threading channel is formed as a smooth guide surface, and the guide surface is used for The pull wire is supported when the pull wire passes through the threading channel, and the extending direction of the pull wire is deflected.
  21. 根据权利要求20所述的植入物的输送装置,其特征在于,所述导向面包括沿近端向远端依次平滑地连接的第一子导向面、第二子导向面和第三子导向面,其中,所述第一子导向面和所述第三子导向面的轴线均为直线,所述第一子导向面的轴线与所述第三子导向面的轴线所形成的夹角的角度为45°~135°,所述第二子导向面的轴线为弧线。The implant delivery device according to claim 20, wherein the guide surface comprises a first sub-guidance surface, a second sub-guidance surface and a third sub-guidance surface which are sequentially and smoothly connected from the proximal end to the distal end. surface, wherein the axes of the first sub-guiding surface and the third sub-guiding surface are straight lines, and the angle formed by the axis of the first sub-guiding surface and the axis of the third sub-guiding surface is The angle is 45°-135°, and the axis of the second sub-guiding surface is an arc.
  22. 根据权利要求21所述的植入物的输送装置,其特征在于,所述穿线通道包括穿线孔,所述穿线孔包括第一孔段,所述第一孔段的部分孔壁构成所述第一子导向面。The implant delivery device according to claim 21, characterized in that, the threading channel includes a threading hole, and the threading hole includes a first hole segment, and part of the hole wall of the first hole segment constitutes the second hole wall. A sub-guiding surface.
  23. 根据权利要求22所述的植入物的输送装置,其特征在于,所述穿线孔还包括第二孔段和第三孔段;所述第二孔段的近端与所述第一孔段的远端连通,所述第二孔段的部分孔壁构成所述第二子导向面,所述第三孔段的近 端与所述第二孔段的远端连通,所述第三孔段的部分孔壁构成所述第三子导向面。The implant delivery device according to claim 22, wherein the threading hole further comprises a second hole segment and a third hole segment; the proximal end of the second hole segment is connected to the first hole segment The distal end of the second hole segment communicates with the second sub-guiding surface, the proximal end of the third hole segment communicates with the distal end of the second hole segment, and the third hole segment Part of the hole wall of the segment constitutes said third sub-guiding surface.
  24. 根据权利要求21所述的植入物的输送装置,其特征在于,所述线部署部件包括轴向连接的近端部分和远端部分,所述近端部分的横截面的面积沿近端向远端的方向逐渐增大。The implant delivery device according to claim 21, wherein the wire deployment member comprises a proximal portion and a distal portion axially connected, and the cross-sectional area of the proximal portion is along the proximal direction. The direction of the distal end gradually increases.
  25. 根据权利要求20所述的植入物的输送装置,其特征在于,所述线部署部件包括线部署部件本体和转动件,所述线部署部件本体上形成有沿其轴向贯通延伸的穿线槽,所述转动件可转动地连接于所述穿线槽的槽壁上,并与所述穿线槽的至少部分槽壁围合成所述穿线通道;所述转动件具有圆周面,且所述圆周面的一部分区域构成所述导向面。The implant delivery device according to claim 20, characterized in that, the wire deploying part comprises a wire deploying part body and a rotating part, and the wire deploying part body is formed with a threading groove extending through and extending along its axial direction. , the rotating member is rotatably connected to the groove wall of the threading groove, and forms the threading channel with at least part of the groove wall of the threading groove; the rotating member has a circumferential surface, and the circumferential surface A part of the area constitutes the guide surface.
  26. 根据权利要求25所述的植入物的输送装置,其特征在于,所述穿线槽沿所述线部署部件本体的径向延伸,并在所述线部署部件本体的边缘处开口,所述转动件的所述圆周面背离所述开口的一侧的至少部分区域形成所述导向面。The implant delivery device according to claim 25, characterized in that, the threading groove extends radially along the body of the wire deployment part and opens at the edge of the body of the wire deployment part, and the rotating At least a partial area of the side of the circumferential surface of the member facing away from the opening forms the guide surface.
  27. 根据权利要求25所述的植入物的输送装置,其特征在于,所述转动件的圆周面上形成有沿所述转动件的周向延伸一圈的定位槽,所述定位槽的部分槽壁构成所述导向面。The implant delivery device according to claim 25, wherein a positioning groove extending one circle along the circumferential direction of the rotating member is formed on the peripheral surface of the rotating member, and a part of the positioning groove is A wall forms the guide surface.
  28. 根据权利要求27所述的植入物的输送装置,其特征在于,在所述转动件的纵截面上,所述定位槽为弧形。The implant delivery device according to claim 27, characterized in that, on the longitudinal section of the rotating member, the positioning groove is arc-shaped.
  29. 根据权利要求25所述的植入物的输送装置,其特征在于,所述线部署部件还包括底座,所述底座连接于所述线部署部件本体的近端端面上,所述底座上设有与所述穿线通道相贯通的导入通道,且所述底座的横截面的面积沿近端向远端的方向逐渐增大。The implant delivery device according to claim 25, wherein the wire deployment part further comprises a base, the base is connected to the proximal end surface of the wire deployment part body, and the base is provided with An introduction channel connected with the threading channel, and the cross-sectional area of the base gradually increases from the proximal end to the distal end.
  30. 根据权利要求20-29中任一项所述的植入物的输送装置,其特征在于,所述线部署部件上还设有安装通孔,以使所述线部署部件能够套装至目标管体上;所述穿线通道的数量为至少一个,当所述穿线通道的数量为多个时,多个所述穿线通道环绕所述安装通孔间隔地布置。The implant delivery device according to any one of claims 20-29, characterized in that, the wire deployment part is further provided with an installation through hole, so that the wire deployment part can be fitted into the target tube body Above; the number of the threading channel is at least one, and when the number of the threading channel is multiple, a plurality of the threading channels are arranged at intervals around the installation through hole.
  31. 根据权利要求20-29中任一项所述的植入物的输送装置,其特征在于, 所述导向面的表面粗糙度Ra小于或等于0.2。The implant delivery device according to any one of claims 20-29, characterized in that, the surface roughness Ra of the guide surface is less than or equal to 0.2.
  32. 根据权利要求1所述的植入物的输送装置,其特征在于,所述植入物的输送装置包括两个以上的所述线控组件,两个以上的所述线控组件的线固定部件中用于与拉线组连接的部分沿所述输送管组件的径向和/或周向相互错开。The implant delivery device according to claim 1, characterized in that, the implant delivery device comprises more than two wire control assemblies, and more than two wire fixing parts of the wire control assemblies The parts used for connecting with the puller group are staggered with each other along the radial direction and/or circumferential direction of the delivery tube assembly.
  33. 根据权利要求32所述的植入物的输送装置,其特征在于,两个以上的所述线控组件的所述线固定部件相互固定;或者,两个以上的所述线控组件的所述线固定部件沿所述输送管组件的轴向相互独立的移动。The implant delivery device according to claim 32, characterized in that, the wire fixing parts of more than two wire control assemblies are fixed to each other; or, the wire fixing parts of more than two wire control assemblies The wire fixing members move independently of each other along the axial direction of the delivery tube assembly.
  34. 根据权利要求1所述的植入物的输送装置,其特征在于,所述拉线组中包括多根所述拉线,所述线固定部件用于供多根所述拉线的固定端汇合连接。The implant delivery device according to claim 1, characterized in that, the pulling wire group includes a plurality of the pulling wires, and the wire fixing part is used for converging and connecting fixed ends of the plurality of pulling wires.
  35. 根据权利要求1所述的植入物的输送装置,其特征在于,所述输送装置还包括至少一个所述拉线组,所述拉线组包括至少一根拉线。The implant delivery device according to claim 1, characterized in that the delivery device further comprises at least one puller wire set, and the puller wire set includes at least one puller wire.
PCT/CN2022/119267 2021-10-12 2022-09-16 Implant conveying device WO2023061148A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202111187574.0 2021-10-12
CN202111187574.0A CN115957045A (en) 2021-10-12 2021-10-12 Implant delivery device
CN202111302111.4A CN116059023A (en) 2021-11-04 2021-11-04 Fixed head, conveying system, inner tube mechanism, catheter assembly and medical device of conveying system
CN202111302111.4 2021-11-04

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070287883A1 (en) * 2006-06-07 2007-12-13 Lilip Lau Apparatus and method for pulling a cardiac harness onto a heart
CN105188612A (en) * 2013-05-20 2015-12-23 爱德华兹生命科学公司 Prosthetic heart valve delivery apparatus
CN110198686A (en) * 2016-11-18 2019-09-03 科菲瓣膜技术有限公司 Cardiac valve delivery device and system
CN110678148A (en) * 2017-04-18 2020-01-10 图尔弗股份有限公司 Delivery system with tether for prosthetic heart valve device and associated methods
WO2020198101A1 (en) * 2019-03-27 2020-10-01 Edwards Lifesciences Corporation Delivery apparatus for a prosthetic valve

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070287883A1 (en) * 2006-06-07 2007-12-13 Lilip Lau Apparatus and method for pulling a cardiac harness onto a heart
CN105188612A (en) * 2013-05-20 2015-12-23 爱德华兹生命科学公司 Prosthetic heart valve delivery apparatus
CN110198686A (en) * 2016-11-18 2019-09-03 科菲瓣膜技术有限公司 Cardiac valve delivery device and system
CN110678148A (en) * 2017-04-18 2020-01-10 图尔弗股份有限公司 Delivery system with tether for prosthetic heart valve device and associated methods
WO2020198101A1 (en) * 2019-03-27 2020-10-01 Edwards Lifesciences Corporation Delivery apparatus for a prosthetic valve

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