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CN118058799B - Double-net-disc deep venous thrombosis excision system capable of being released in segmented mode - Google Patents

Double-net-disc deep venous thrombosis excision system capable of being released in segmented mode Download PDF

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Publication number
CN118058799B
CN118058799B CN202410198470.7A CN202410198470A CN118058799B CN 118058799 B CN118058799 B CN 118058799B CN 202410198470 A CN202410198470 A CN 202410198470A CN 118058799 B CN118058799 B CN 118058799B
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Prior art keywords
rotary
catheter
net
bracket
conveying
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CN118058799A (en
Inventor
俞辉
文超逸
韩建超
彭大冬
山鹰
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Shanghai Rongmai Medical Technology Co ltd
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Shanghai Rongmai Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001Angioplasty, e.g. PCTA
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention provides a sectional release double-net-disc deep venous thrombosis excision system, which relates to the technical field of thromboembolism treatment, and comprises a bracket component, a rotary-cut component, a conveying component and a driving handle from a far end to a near end along the length direction, wherein the bracket component is arranged on the bracket component; the bracket component comprises a guide end head, a far-end net disk bracket, a bracket connecting piece, a vascular intervention catheter and a near-end net disk bracket; the rotary cutting assembly comprises a sleeve, a spiral coil and a cutter head, wherein the cutter head is arranged inside the sleeve; the conveying component is used for releasing the bracket component in a segmented way; the driving handle is used for providing rotary power for the rotary cutting assembly and is in transmission connection with the proximal end of the spiral coil. The sectional released double-net-disc bracket component has the advantages of remarkable thrombus capturing capacity, optimized excision effect, improved treatment safety and the like in the treatment of deep venous thrombosis of lower limbs, provides a doctor with a higher-level treatment option, and improves the success rate of treatment and the rehabilitation quality of patients.

Description

Double-net-disc deep venous thrombosis excision system capable of being released in segmented mode
Technical Field
The invention relates to the technical field of thromboembolic treatment, in particular to a sectional released double-net-disc deep venous thrombosis excision system.
Background
At present, the treatment of thrombus is performed by removing thrombus from the blood vessel using a variety of devices and procedures, which are referred to as mechanical thrombus removal (percutaneous mechanical thrombectomy, PMT) devices. The device is a set of instruments for removing the obstruction in the blood vessel, and adopts the modes of dissolving, crushing, sucking, stent or basket thrombus removing and the like to remove the obstruction such as thrombus, plaque and the like in the blood vessel so as to restore the blood circulation function.
However, when the thrombus is in tortuous position with a blood vessel or in non-acute thrombus, the existing thrombus aspiration catheter is easy to cause thrombus blockage, thrombus escape and the like.
The filter is placed in the inferior vena cava by adopting the inferior vena cava filter implantation method, so that the occurrence of acute pulmonary embolism can be prevented and reduced, the operation time is prolonged while the operation cost is increased, and the occurrence of the whole-course thrombosis of the vena cava filter and the inferior vena cava can be prevented for a long time.
In the process of sucking the thrombus suction catheter, the middle section of the catheter body and the opening at the distal end of the catheter are blocked frequently by massive thrombus, so that a doctor needs to withdraw the suction catheter for flushing for many times during operation and then send the suction catheter into a human body again for sucking, and the pain of a patient can be caused by the complicated operation to influence the treatment effect.
The AspirexTM mechanical thrombectomy system of BD company not only requires a host machine for system driving, but also brings operational inconvenience to doctors while being expensive. Secondly, aspirexTM mechanical thrombectomy systems themselves lack means to prevent venous thrombosis from escaping, and require purchase of their accessory pulmonary thrombosis protection system Capturex, which increases additional surgical costs and increases pain in patient surgery.
As with the AspirexTM mechanical thrombectomy system, a thrombectomy device disclosed in the invention of publication No. CN216317841U lacks means for preventing venous thrombectomy and fails to capture thrombens more effectively.
In the thrombus removing device disclosed by the invention with the publication number of CN113633344A, although venous thrombus can be prevented from escaping by the existence of a single net tray support, the flexibility of operation is lacking, and the number and the release state of the single net tray support are difficult to flexibly adjust according to the operation requirements for different blood vessel forms and pathological changes, so that personalized and customized treatment is difficult to realize.
Accordingly, there is a need for improvement in that the present invention provides a dual-mesh-disk deep vein thrombectomy system that is released in a segmented fashion.
Disclosure of Invention
Aiming at the defects existing in the prior art, the invention aims to provide a sectional-release double-net-disc deep venous thrombosis excision system, which comprises the following specific scheme:
a segmented released dual-mesh-disc deep vein thrombectomy system comprising, in a longitudinal direction from a distal end to a proximal end, a stent assembly, a rotational atherectomy assembly, a delivery assembly, a drive handle, wherein;
The stent component is a double radial net disk stent which is elastically expanded and coaxially arranged and comprises a guide end head, a far-end net disk stent, a stent connecting piece, a vascular interventional catheter and a near-end net disk stent;
The rotary cutting assembly is of a structure for cutting thrombus by adopting rotary power and comprises a sleeve, a spiral coil and a cutter head, wherein the cutter head is arranged in the sleeve, and the proximal end of the cutter head is fixedly connected with the distal end of the spiral coil;
The proximal end of the guiding end head is fixedly connected with the distal end of the distal end net disk bracket, the proximal end of the distal end net disk bracket is fixedly connected with the distal end of the bracket connecting piece, the proximal end of the bracket connecting piece is fixedly connected with the distal end of the sleeve, the proximal end of the sleeve is fixedly connected with the distal end of the vascular intervention catheter, the proximal end net disk bracket is coaxially fixed on the outer wall of the vascular intervention catheter close to the distal end, and the proximal end of the vascular intervention catheter is connected with the driving handle;
the conveying component is used for releasing the bracket component in a sectionalized way and can slide back and forth relative to the vascular interventional catheter;
the driving handle is used for providing rotary power for the rotary cutting assembly and is in transmission connection with the proximal end of the spiral coil.
Therefore, when the thrombus is cleared, after the guide wire is inserted into the blood vessel, the excision system is conveyed to the target position of the inferior vena cava in the blood vessel along the guide wire, at the moment, the distal net disc support and the proximal net disc support in the support assembly are both in a contracted state, and the rotary cutting assembly is in a closed state. After the guide end head passes through thrombus a certain distance, the guide end head slides from the far end to the near end through controlling the conveying component relative to the vascular interventional catheter until the far-end net disk support is released, the volume of the released far-end net disk support is enlarged, the thrombus is automatically unfolded and tightly attached to the vascular wall, and the thrombus can be captured and positioned, so that along with the thrombus escaping from venous blood flow, the thrombus is effectively captured in the space between net disks, the possibility of escaping is reduced, meanwhile, the rotary-cut component is in an exposed state, after the medicine which needs to be matched for use is injected, an operator drives the spiral coil to rotate through controlling the driving handle, and the cutter head is driven to rotate, so that the rotary-cut component can accurately control the transferring and cutting process of the thrombus, the thrombus is cut more thoroughly and efficiently, the risk of vascular obstruction is reduced to the greatest extent, and the treatment effect is improved.
In the process, after the distal net tray support is primarily released, the proximal net tray support can be released according to the operation requirement in a similar way, so that the method is suitable for different blood vessel morphologies and pathological changes, and personalized and customized treatment is realized.
Further, the conveying assembly comprises a conveying guide pipe, a rotary handle, a rotary positioning piece and a conveying shell;
a rotary positioning piece is arranged in the conveying shell near the proximal end, and the proximal end of the rotary positioning piece is in threaded connection with the distal end of the rotary positioning piece;
A conveying catheter is inserted into the conveying shell near the distal end, and the proximal end of the conveying catheter is fixedly connected with the distal end of the rotary grip;
the conveying catheter is coaxially sleeved outside the vascular intervention catheter, and a stent storage channel is formed between the conveying catheter and the vascular intervention catheter.
Therefore, the far-end net disk support and the near-end net disk support can be contracted in the support storage channel, when the far-end net disk support and the near-end net disk support are required to be released, the rotary handle is screwed to rotate relative to the rotary positioning piece, so that the conveying catheter is driven to gradually move from the far end to the near end, and in the process, the far-end net disk support is released to be exposed firstly, then the rotary cutting assembly is arranged, and then the near-end net disk support is arranged.
Further, at least three limit release clamping grooves are arranged on the outer wall of the rotary positioning piece.
Therefore, when the rotary handle moves to be matched with each limit release clamping groove, the state of the bracket component is different, and an operator can control the movement position of the rotary handle according to the requirement to flexibly release the number of the net disc brackets.
Further, an interface for accessing the syringe is formed on the rotary grip.
Thus, after the interface is connected to the syringe, a drug such as a contrast medium or physiological saline can be injected through the syringe.
Further, the driving handle comprises a driving shell, a gear cavity, a driving gear, a driven gear and a micro motor, wherein the gear cavity, the driving gear, the driven gear and the micro motor are arranged in the driving shell;
The output shaft of the miniature motor is in coaxial transmission connection with the driving gear, the driving gear is in meshed connection with the driven gear, and the driven gear is in coaxial transmission connection with the end part of the spiral coil.
Therefore, when the miniature motor works, the driving gear is driven to rotate, the driven gear meshed with the driving gear is driven to rotate, the spiral coil drives the cutter head to rotate, and the contacted thrombus is rotary-cut.
Further, a protective baffle is mounted on the side of the driven gear facing the distal end.
Thrombus after the rotary-cut subassembly excision has mobility, probably can get into the gear intracavity portion along vascular intervention pipe, from this, the setting of protective shield can prevent to beat on the driven gear with the thrombus of downflow owing to the gear rotation, reduces thrombus transport efficiency.
Further, the micro motor is connected with a battery pack through an electronic wire harness.
The battery pack thus provides an energy source for driving the operation of the micro-motor.
Further, the miniature motor is provided with a switch group;
The switch group comprises a safety switch and a button switch, wherein the safety switch is used for controlling the charge and discharge of the battery group, and the button switch is used for controlling the operation mode of inching operation and continuous operation.
Therefore, the safety switch and the button switch respectively perform different control actions, the miniature motor is assisted, the button switch can assist a doctor to rapidly and repeatedly perform thrombus rotary cutting according to the operation condition, and the thrombus rotary cutting device can also perform continuous rotary cutting aiming at a large number of thrombus.
Further, a guide wire twister is arranged on the upper side of the driving handle;
The drainage tube is installed to the downside of driving handle, and the drainage tube upper end is linked together with the gear chamber, and the lower extreme can be connected with the drainage bag.
Therefore, the guide wire twister can assist a doctor to control the guide wire, and the drainage tube can guide thrombus in the gear cavity to the drainage bag for collecting and transferring thrombus.
Compared with the prior art, the invention has the following beneficial effects:
(1) The excision system can effectively prevent deep venous thrombosis of lower limbs from escaping when receiving interventional therapy, remarkably improve the capture rate and the retention force of the thrombus, optimize the treatment of the thromboembolism and simultaneously adapt to various application requirements more flexibly.
(2) The excision system of the invention adopts the design of the modularized double-net-disc bracket, thereby reducing the operation cost and simultaneously reducing the pain of patients and the risks possibly caused by the subsequent operation requiring an additional venous filter.
(3) The coaxial arrangement and elastic expansion characteristics of the two mesh disc stents in the stent assembly can significantly improve the rate of thrombus capture and retention, optimizing the treatment of the thromboembolism to achieve more effective therapeutic results.
(4) The design of the contraction and release of the net disc support is realized by the cooperation of the support component and the conveying component, so that the shearing and tearing damage to the inner wall of a blood vessel when the thrombus is penetrated is reduced, and the complications and the blood vessel damage risk during operation are reduced, thereby obviously improving the treatment safety, and also allowing a doctor to flexibly release the net disc support according to the operation requirement so as to adapt to different blood vessel forms and pathological changes, and realizing personalized and customized treatment.
(5) In conclusion, the sectional release double-net-disc support assembly has the advantages of remarkable thrombus capturing capacity, optimal excision effect, treatment safety improvement and the like in lower limb deep vein thrombus treatment, provides a doctor with a higher-level treatment option, and improves the treatment success rate and the recovery quality of patients.
Drawings
FIG. 1 is an overall schematic of an ablation system of the present invention;
FIG. 2 is a schematic view of the structure of FIG. 1 showing the interior of the drive handle;
FIG. 3 is a partial schematic view showing a specific construction of a bracket assembly;
FIG. 4 is a schematic cross-sectional view taken along line A-A in FIG. 3;
FIG. 5 is a partial schematic view showing a specific structure of the conveying housing;
FIG. 6 is a partial schematic diagram showing the position of the driving gear, driven gear;
FIG. 7 is a side view of FIG. 6;
FIG. 8 is a schematic diagram showing an unreleased state of the stent;
FIG. 9 is a schematic diagram showing a released state of the distal disc holder;
fig. 10 is a schematic diagram showing a completely released state of the stent.
Reference numerals: 1. a bracket assembly; 11. a guide tip; 12. a distal mesh disc holder; 13. a bracket connection; 14. a vascular interventional catheter; 15. a proximal mesh disc holder; 2. a rotary cutting assembly; 21. a sleeve; 22. a spiral coil; 23. a cutter head; 3. a transport assembly; 31. a delivery catheter; 32. rotating the grip; 321. an interface; 33. rotating the positioning piece; 331. a limit release clamping groove; 34. a transport housing; 341. an upper case; 343. a lower case; 4. a drive handle; 41. a drive housing; 42. a gear cavity; 43. a drive gear; 44. a driven gear; 45. a micro motor; 5. a protective baffle; 6. a battery pack; 7. a switch group; 71. a safety switch; 72. a push button switch; 8. a guidewire twister; 9. a drainage tube.
Detailed Description
The present invention will be described in further detail with reference to examples and drawings, but embodiments of the present invention are not limited thereto.
The invention provides a sectional release double-net-disc deep vein thrombosis excision system which is suitable for deep vein embolism thrombus removal, the key component of the excision system is a sectional release double-net-disc support, the support is provided with two specially designed net discs, the two net discs can be released freely in a sectional way, the free release double-net-disc support can enable the system to capture thrombus more effectively, and the sectional release function has higher flexibility on the thrombus excision process. The diameter of these mesh discs can be adjusted according to the size of the blood vessel, ensuring a complete fit to the patient's blood vessel.
Specifically, as shown in fig. 1, the excision system comprises a bracket assembly 1, a rotary cutting assembly 2, a conveying assembly 3 and a driving handle 4 from the far end to the near end along the length direction, and when the excision work is carried out, a doctor can adjust and control the bracket assembly 1 and the rotary cutting assembly 2 entering the blood vessel through controlling the driving handle 4 and the conveying assembly 3.
Wherein, with reference to fig. 3 and 4, the stent assembly 1 is a dual radial net disk stent which is elastically expanded and coaxially arranged, and comprises a guiding end head 11, a distal net disk stent 12, a stent connecting piece 13, a vascular intervention catheter 14 and a proximal net disk stent 15 in mechanical structure. Specifically, the guiding end 11 adopts a Tip end and adopts a polymer material with developability, and the whole body is conical, so that the thrombus can conveniently pass through and the possibility of thrombus escape is reduced; the distal net disk support 12 is a net disk support made of nickel titanium material and woven coaxially, and can be net disk-shaped, round and the like, without specific limitation, so that thrombus escape caused by venous blood flow is prevented, and the thrombus capturing rate and the holding force are remarkably improved; the bracket connecting piece 13 is a connecting piece which is formed by coaxially arranging and processing metal materials with certain hardness, so that unnecessary damage to the inner wall of a blood vessel caused by the following rotation of the net disk bracket is avoided; the vascular intervention catheter 14 is a catheter formed by coaxially arranging and processing high polymer materials with certain hardness; the proximal mesh disk support 15 is also a mesh disk support made of nickel-titanium material and woven coaxially, and may be in the shape of a mesh disk, a circle, or the like, without any particular limitation.
Next, the rotary cutting member 2 is configured to cut out thrombus by rotational force, and mechanically includes a sleeve 21, a spiral coil 22, and a cutter head 23. Specifically, the sleeve 21 is made of a polymer or metal material with certain hardness, and is provided with holes on one side or two sides, so that thrombus can be conveniently placed on the cutter head 23 with the spiral coil 22; the spiral coil 22 is a stainless steel/nickel titanium spring with certain rigidity, has a specific helix angle and a specific pitch, is more convenient for transferring thrombus, and in addition, the spiral coil 22 and the inner diameter of the vascular interventional catheter 14 have precise gap size design, so that the excised thrombus can be effectively transferred in the thrombus removal process, and the defects of large-block thrombus blocking and the like can be avoided; the cutter head 23 is made of a metal material having a certain hardness, and has an inner diameter slightly larger than the outer diameter of the spiral coil 22.
When the device is specifically connected, the proximal end of the guide end head 11 is fixedly connected with the distal end of the distal end net disk support 12, specifically, the Tip head end with the inner pipe is fixed with the distal end net disk support 12 in a hot melting mode; the proximal end of the distal net disk bracket 12 is fixedly connected with the distal end of the bracket connecting piece 13, specifically, the proximal end is fixed with the bracket connecting piece 13 by bonding and the like; the proximal end of the bracket connecting piece 13 is fixedly connected with the distal end of the sleeve 21, in particular to be in physical clamping connection; the sleeve 21 is internally provided with a cutter head 23, and the proximal end of the cutter head 23 is fixedly connected with the distal end of the spiral coil 22, in particular to welding, bonding and other modes; the proximal end of the sleeve 21 is fixedly connected with the distal end of the vascular access catheter 14, in particular by welding, bonding and the like; a proximal net disk bracket 15 is coaxially fixed on the outer wall of the vascular interventional catheter 14 close to the distal end, in particular by means of bonding and the like; the proximal end of the vascular access catheter 14 is connected to the drive handle 4, in particular by welding, adhesive or the like.
It should be noted that, in the stent assembly 1, the distance between the proximal end mesh disc stent 15 and the distal end mesh disc stent 12 is kept 20-50 mm, the specific size can be adjusted according to the deep vein positions of different lower limbs, the distal end mesh disc stent 12 can prevent thrombus from escaping due to venous blood flow, the thrombus capturing rate and the holding force are remarkably improved, and the proximal end mesh disc stent 15 can more effectively capture thrombus and prevent thrombus from escaping during operation.
With reference to fig. 1 and 5, next, the delivery assembly 3 is used to release the stent assembly 1 in sections, and is reciprocally slidable with respect to the vascular access catheter 14, and in mechanical configuration, the delivery assembly 3 includes a delivery catheter 31, a rotary grip 32, a rotary positioning member 33, and a delivery housing 34. Specifically, the delivery catheter 31 is a polymer catheter with an inner diameter slightly larger than the outer diameter of the vascular intervention catheter 14, the delivery catheter 31 is coaxially sleeved outside the vascular intervention catheter 14, and a stent storage channel is formed between the delivery catheter 31 and the vascular intervention catheter 14; the conveying shell 34 comprises an upper shell 341 and a lower shell 343 which can be spliced together, and is made of high polymer materials such as PC, ABS and the like; the rotary grip 32 is a female luer, the rotary positioning member 33 is a male luer, and both are in a luer shape, so that they are connected by screw threads.
In the concrete connection, a rotary positioning piece 33 is installed in the conveying shell 34 near the proximal end, the proximal end of the rotary positioning piece 33 is in threaded connection with the distal end of the rotary positioning piece 33, a conveying catheter 31 is inserted in the conveying shell 34 near the distal end, and the proximal end of the conveying catheter 31 is fixedly connected with the distal end of the rotary handle 32.
Thus, the distal end tray support 12 and the proximal end tray support 15 can be retracted in the support storage channel, when the distal end tray support 12 and the proximal end tray support 15 need to be released, the rotating handle 32 is screwed to rotate relative to the rotating positioning member 33, so as to drive the conveying catheter 31 to gradually move from the distal end to the proximal end, and in the process, the distal end tray support 12 is released to be exposed firstly, then the rotary cutting assembly 2 is released, and then the proximal end tray support 15 is released.
It should be noted that, as shown in fig. 1, at least three limiting release slots 331 are provided on the outer wall of the rotary positioning member 33, and the distance between the limiting release slots 331 is set according to the distance between the distal end net tray support 12 and the proximal end net tray support 15, which is not particularly limited. When the rotary handle 32 moves to be matched with each limit release clamping groove 331, the state of the bracket component 1 is different, and an operator can control the movement position of the rotary handle 32 according to the requirement to flexibly release the number of the net disc brackets.
The rotary grip 32 has an interface 321 for accessing the syringe. After the interface 321 is connected to the syringe, a drug such as a contrast medium or physiological saline can be injected through the syringe.
Finally, drive handle 4 is used to provide rotational power to rotational atherectomy assembly 2, in driving connection with the proximal end of helical coil 22. In mechanical construction, with reference to fig. 1, 6 and 7, the drive handle 4 comprises a drive housing 41 and a gear chamber 42, a driving gear 43, a driven gear 44, a micro motor 45 inside the drive housing 41. Specifically, the driving housing 41 includes a left housing and a right housing which can be spliced together, and is made of a polymer material such as PC, ABS, etc. for fixing the components inside the driving handle 4; the gear cavity 42 is used for providing space for movement of the driving gear 43 and the driven gear 44, the driving gear 43 and the driven gear 44 are arranged in the gear cavity, and the driving gear 43 and the driven gear 44 are two gears with different sizes; the driving gear 43 is coaxially connected with the output shaft of the micro motor 45 in a transmission manner, the driving gear 43 is meshed with the driven gear 44, and the driven gear 44 is coaxially connected with the end part of the spiral coil 22 in a transmission manner.
Thus, when the micro-motor 45 is in operation, the output shaft may be operated according to 1:2,1:3, driving the driving gear 43 to rotate, driving the driven gear 44 meshed with the driving gear to rotate, driving the spiral coil 22 to rotate, driving the cutter head 23 to rotate by the spiral coil 22, and rotating the contacted thrombus.
The thrombus removed by the rotational atherectomy device 2 has fluidity, and may enter the gear cavity 42 along the vascular interventional catheter 14, for which, the driven gear 44 is provided with the protective baffle 5 on the side facing the distal end, and the protective baffle 5 is arranged to prevent thrombus flowing downward from being hit on the driven gear 44 due to rotation of the gear, thereby reducing thrombus transfer efficiency.
The micro motor 45 is connected to the battery 6 via an electric wire harness, and supplies power for driving the micro motor 45. The micro motor 45 is provided with a switch group 7, the switch group 7 comprises a safety switch 71 and a button switch 72, the safety switch 71 is used for controlling the charge and discharge of the battery group 6, and the button switch 72 is used for controlling the operation modes of inching operation and continuous operation.
The safety switch 71 and the button switch 72 respectively perform different control actions to assist the micro motor 45, and the button switch 72 can assist a doctor to rapidly and repeatedly perform thrombus rotary cutting according to operation conditions, and can also perform continuous rotary cutting for a large amount of thrombus.
The guide wire twister 8 is installed on the upper side of the driving handle 4, the doctor is assisted to control the guide wire, the drainage tube 9 is installed on the lower side of the driving handle 4, the upper end of the drainage tube 9 is communicated with the gear cavity 42, and the lower end of the drainage tube 9 can be connected with a drainage bag.
In summary, in connection with the inventive ablation system, the procedure for clearing thrombus is as follows:
guidewire penetration: advancing the guidewire to a point proximal to the thromboembolism by a Seldinger technique;
contrast measurement size: performing inferior vena cava radiography while measuring the dimensions (including diameter and length) of the lower limb deep vein thromboembolic site;
and (3) instrument placement: delivering a distal portion of the deep vein thrombectomy system along the guidewire to a target inferior vena cava position, wherein the ablation system is in the stent unreleased state of fig. 8, and securing the guidewire via the guidewire twister 8, reducing the amount of skill to manipulate the guidewire securing;
and (3) stent release: after passing through thrombus by 2-3mm, the rotary handle 32 is pulled back to the second limit release clamping groove 331, at this time, the excision system is in a distal disc support release state in the support figure 9, after the delivery catheter 31 connected with the rotary handle 32 is pulled back for the same stroke synchronously, the distal net disc support 12 is released, and the sleeve 21 of the rotary cutting assembly 2 is completely exposed in the pulling back process;
Thrombus removal: the appropriate amount of the mixture of physiological saline and contrast medium is injected from the interface 321 under the rotary grip 32 using a loop-handle syringe, the safety switch 71 is turned on, the push button switch 72 is lightly pressed to turn on the click rotary cutting mode, and the cutting system is retracted while slowly rotating the handle left and right. The released distal disc stent prevents peripheral thrombus from escaping, and simultaneously, the thrombus capture auxiliary rotary-cut assembly 2 is used for placing the thrombus into the sleeve 21 and cutting the thrombus by the cutter head 23 rotating at a high speed.
It should be noted that, if a large amount of thrombus is encountered, the button switch 72 may be pressed, and the clicking sound system is heard to enter the continuous rotary cutting mode. After a large amount of thrombus is observed through contrast medium contrast, after the distal disc stent is initially released, the rotary handle 32 can be selectively pulled back from the second limit release clamping groove 331 to the proximal third limit release clamping groove 331, at this time, the excision system is in the complete release state of the stent in fig. 10, and the proximal net disc stent 15 of the mechanical thrombus excision system is released, so that better thrombus capturing capability is provided;
And (3) carrying out bracket loading: the push button 72 is turned off to slowly push the rotary handle 32 of the proximal third limit release catch 331 to the distal first limit release catch 331, sequentially retract the proximal disc holder and the distal disc holder into the holder storage channel in the delivery catheter 31, and collect the remaining thrombus on the holder back into the delivery catheter 31.
And (3) finishing rotary cutting of thrombus: the tested instrument is withdrawn from the body.
The released distal net disk support 12 is enlarged in volume, thrombus can be captured and positioned, the possibility of escape is reduced, the rotary-cut assembly 2 can accurately control the transfer and excision processes of the thrombus, the excision of the thrombus is more thorough and efficient, the risk of vascular obstruction is reduced to the greatest extent, and the treatment effect is improved.
In the above process, after the distal net tray support 12 is primarily released, the proximal net tray support 15 can be released according to the operation requirement in a similar way, so as to adapt to different blood vessel morphologies and pathological changes, and realize personalized and customized treatment.
The above description is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above examples, and all technical solutions belonging to the concept of the present invention belong to the protection scope of the present invention. It should be noted that modifications and adaptations to the present invention may occur to one skilled in the art without departing from the principles of the present invention and are intended to be within the scope of the present invention.

Claims (7)

1. A segmented released double-mesh-disc deep vein thrombectomy system comprising, in length from distal to proximal ends, a stent assembly (1), a rotary cutting assembly (2), a delivery assembly (3), a drive handle (4), wherein;
the support component (1) is an elastically-expanded and coaxially-arranged double-radial net disk support, and comprises a guide end head (11), a far-end net disk support (12), a support connecting piece (13), a vascular intervention catheter (14) and a near-end net disk support (15);
The rotary cutting assembly (2) is of a structure for cutting thrombus by adopting rotary power and comprises a sleeve (21), a spiral coil (22) and a cutter head (23), wherein the cutter head (23) is arranged in the sleeve (21), and the proximal end of the cutter head (23) is fixedly connected with the distal end of the spiral coil (22);
The proximal end of the guiding end head (11) is fixedly connected with the distal end of the distal net disk bracket (12), the proximal end of the distal net disk bracket (12) is fixedly connected with the distal end of the bracket connecting piece (13), the proximal end of the bracket connecting piece (13) is fixedly connected with the distal end of the sleeve (21), the proximal end of the sleeve (21) is fixedly connected with the distal end of the vascular intervention catheter (14), the proximal net disk bracket (15) is coaxially fixed on the outer wall of the vascular intervention catheter (14) close to the distal end, and the proximal end of the vascular intervention catheter (14) is connected with the driving handle (4);
The conveying component (3) is used for releasing the bracket component (1) in a sectionalized way and can slide back and forth relative to the vascular interventional catheter (14);
the driving handle (4) is used for providing rotary power for the rotary cutting assembly (2) and is in transmission connection with the proximal end of the spiral coil (22);
Wherein, the conveying component (3) comprises a conveying conduit (31), a rotary handle (32), a rotary positioning piece (33) and a conveying shell (34);
A rotary positioning piece (33) is arranged in the conveying shell (34) near the proximal end, the proximal end of the rotary positioning piece (33) is in threaded connection with the distal end of the rotary positioning piece (33) relatively, and at least three limit release clamping grooves (331) are formed in the outer wall of the rotary positioning piece (33);
A conveying catheter (31) is inserted into the conveying shell (34) near the distal end, and the proximal end of the conveying catheter (31) is fixedly connected with the distal end of the rotary handle (32);
The conveying catheter (31) is coaxially sleeved outside the vascular intervention catheter (14), and a stent storage channel is formed between the conveying catheter and the vascular intervention catheter (14).
2. The segmented released dual-mesh deep vein thrombectomy system of claim 1, wherein the swivel grip (32) has an interface (321) formed thereon for accessing a syringe.
3. The segmented released double-mesh-disk deep vein thrombectomy system according to claim 1, wherein the driving handle (4) comprises a driving housing (41) and a gear cavity (42), a driving gear (43), a driven gear (44) and a micro motor (45) inside the driving housing (41), wherein the driving gear (43) and the driven gear (44) are installed inside the gear cavity (42);
an output shaft of the micro motor (45) is coaxially connected with the driving gear (43) in a transmission way, the driving gear (43) is meshed with the driven gear (44), and the driven gear (44) is coaxially connected with the end part of the spiral coil (22) in a transmission way.
4. A segmented released double-mesh deep vein thrombectomy system according to claim 3, wherein the side of the driven gear (44) facing distally is fitted with a guard shield (5).
5. A segmented released double-mesh-disc deep vein thrombectomy system according to claim 3, wherein the micro-motor (45) is connected to a battery pack (6) by means of an electronic harness.
6. The segmented released double-mesh-disc deep vein thrombectomy system according to claim 5, wherein the micro-motor (45) is provided with a switch set (7);
The switch group (7) comprises a safety switch (71) and a button switch (72), wherein the safety switch (71) is used for controlling the charge and discharge of the battery group (6), and the button switch (72) is used for controlling the operation modes of inching operation and continuous operation.
7. A segmented released double-mesh-disc deep vein thrombectomy system according to claim 3, wherein a guide wire twister (8) is mounted on the upper side of the drive handle (4);
a drainage tube (9) is arranged at the lower side of the driving handle (4), the upper end of the drainage tube (9) is communicated with the gear cavity (42), and the lower end of the drainage tube can be connected with a drainage bag.
CN202410198470.7A 2024-02-22 2024-02-22 Double-net-disc deep venous thrombosis excision system capable of being released in segmented mode Active CN118058799B (en)

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CN104739486A (en) * 2015-03-12 2015-07-01 湖南瑞康通科技发展有限公司 Thrombus cutting system
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