CN116492569A - Loader, conveying system and conveying method - Google Patents
Loader, conveying system and conveying method Download PDFInfo
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- CN116492569A CN116492569A CN202310456446.4A CN202310456446A CN116492569A CN 116492569 A CN116492569 A CN 116492569A CN 202310456446 A CN202310456446 A CN 202310456446A CN 116492569 A CN116492569 A CN 116492569A
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- 238000000034 method Methods 0.000 title claims abstract description 15
- 230000002439 hemostatic effect Effects 0.000 claims description 28
- 230000023597 hemostasis Effects 0.000 claims description 24
- 210000004204 blood vessel Anatomy 0.000 claims description 17
- 230000004323 axial length Effects 0.000 claims description 6
- 230000006835 compression Effects 0.000 claims description 5
- 238000007906 compression Methods 0.000 claims description 5
- 210000002615 epidermis Anatomy 0.000 claims description 4
- 230000000149 penetrating effect Effects 0.000 claims description 4
- 238000003780 insertion Methods 0.000 claims description 2
- 230000037431 insertion Effects 0.000 claims description 2
- 238000002716 delivery method Methods 0.000 claims 2
- 230000007704 transition Effects 0.000 description 11
- 239000008280 blood Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 230000003902 lesion Effects 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 229910000831 Steel Inorganic materials 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 239000010959 steel Substances 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 230000001746 atrial effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000002059 diagnostic imaging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0194—Tunnelling catheters
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Electrotherapy Devices (AREA)
Abstract
The invention belongs to the technical field of medical instruments, and particularly relates to a loader, a conveying system and a conveying method. Wherein, the loader includes a loading sheath, and the loader still includes: the sheath tip section is arranged at the distal end of the loading sheath, and the sheath tip section is of a hollow truncated cone-shaped structure with the outer diameter gradually reduced from the proximal end to the distal end. The mode of adding the sheath tip section at the distal end of the loading sheath can be matched with most of the conveying sheath on the market, so that the loading is smooth, the operation efficiency is greatly improved, the operation risk is reduced, and a more excellent operation mode is provided for patients.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a loader, a conveying system and a conveying method.
Background
Interventional therapy is a minimally invasive treatment performed by means of modern high-tech means. Under the guidance of medical imaging equipment, medical instruments, medicines and implantation instruments are conveyed to lesion sites through special catheters, guide wires and other precise medical instruments, so that diagnosis and local treatment of lesions in a human body are performed. The intervention operation has small trauma to human body, less invasiveness, quick recovery and good effect, and is a medical technology which is rapidly rising in recent years and widely popularized.
The interventional operation needs to establish a channel between a lesion part in a patient and an external operation end by means of an interventional diagnosis and treatment conveying sheath tube (such as a guide catheter, a conveying sheath tube, a guide sheath tube and the like), and further operation can be performed by means of a loader by firstly conveying medical instruments, medicines and implantation instruments into the corresponding conveying sheath tube, and finally the purpose of the lesion part can be achieved by using the surgical operation.
The loader mainly takes into account two points in function: firstly, the device can be matched with conveying sheath pipes with various structures, and is loaded smoothly; and secondly, the blood loss in the loading process is very small. However, the loader on the market is complex in structure, high in pertinence and not suitable for wide use.
For one of the following: at present, when medical instruments are conveyed by the loader on the market, the medical instruments are easy to be clamped, so that conveying failure is caused, springs are increased on part of the loader to assist the medical instruments, but the effect is very little.
For the second: the current foreign loader has the advantages that the technological level of the bracket is advanced, the pushing rod in the bracket and the steel sleeve on the medical instrument can be made to be very thin, so that the matched loading sheath can also be very thin, and when the pipeline is very small, the natural blood loss is very small (almost negligible). However, the domestic technology level generally cannot reach the foreign level, and a push rod with a very small pipe diameter and a medical instrument steel sleeve cannot be produced at all. So how to prevent excessive blood loss during loading is also a problem to be considered.
At present, medical instruments in China develop rapidly, and a conveying system is an indispensable item of each new development project. With the update iteration of medical instruments, a universally applicable conveying system needs to be designed, so that more efforts are put on the research and development of the medical instruments.
Therefore, there is a great need for a delivery system that can be universally adapted for use with push rods to release miniature medical instruments.
Disclosure of Invention
The invention aims at solving the technical problems of large blood loss during loading caused by the limitation of the prior loader and the limitation of the product technology level, and provides a loader, a conveying system and a conveying method.
The embodiment of the invention provides a loader, which comprises a loading sheath, wherein a hollow channel is arranged in the loading sheath, and the hollow channel penetrates through the loading sheath along the length direction of the loading sheath;
the distal end of the loading sheath tube is a sheath tube tip section, the sheath tube tip section is of a hollow truncated cone-shaped structure with the outer diameter gradually reduced from the proximal end to the distal end, and the length of the sheath tube tip section is larger than or equal to 15mm.
In one embodiment, the sheath tip segment has a length of greater than or equal to 20mm;
or the length of the sheath tip section is 15 mm-20 mm.
In one embodiment, the wall thickness of the tube body of the loading sheath tube is 0.5 mm-1.5 mm;
and/or the wall thickness at the distal end of the sheath tip section is 0.2 mm-0.5 mm;
and/or the outer diameter of the distal end of the sheath tip section is 2 mm-3.5 mm;
and/or the sheath tip section smoothly transitions from the proximal end to the distal end.
In one embodiment, the sheath tip segment is a sheath tip segment that is operably inserted into a delivery sheath, the sheath tip segment being a sheath tip segment that is adapted to abut a body of the delivery sheath;
and/or the distal outer diameter of the sheath tip section is not greater than the inner diameter of the body of the delivery sheath;
the sheath tip section has an outer diameter at the proximal end of the delivery sheath hub that is no greater than an inner diameter of the proximal end of the hub;
and/or the axial length of the sheath tip section is greater than the axial length of the delivery sheath interface;
and/or the inner diameters of the hollow channels are the same, and the inner diameters of the hollow channels are mutually matched with the outer diameters of the medical instruments after compression so that the medical instruments are loaded in the hollow channels after compression.
In an embodiment, the loader further comprises:
a first hemostatic valve is disposed at a proximal end of the loading sheath.
In one embodiment, the first hemostasis valve is in threaded or snap-fit connection with the proximal end of the loading sheath;
and/or the first hemostatic valve is a hemostatic valve with a locking function;
and/or, the first hemostatic valve is a T-shaped valve with an extension tube.
The invention also provides a conveying system, comprising:
the above-mentioned cartridge, said cartridge being adapted to be operatively inserted into the proximal end of the delivery sheath;
the pushing rod is a pushing rod which is connected with a medical instrument in an operable way by a far end, and the pushing rod is inserted into the loader in an operable way;
wherein the pushing rod is operable to compress the medical instrument into the loader or the pushing rod is operable to push the medical instrument out of the loader.
In one embodiment, the delivery system further comprises:
a second hemostatic valve disposed at a proximal end of the delivery sheath and adapted to lock and unlock the loading sheath of the loader.
In one embodiment, the second hemostasis valve is in threaded connection or clamping connection with the proximal section of the interface of the delivery sheath;
the second hemostasis valve is in threaded connection or clamping connection with the loading sheath;
and/or, the second hemostatic valve is a T-shaped valve with hemostatic function.
In one embodiment, the distal end of the push rod is threaded with the medical instrument.
The invention also provides a conveying method, which adopts the loader to carry out the following steps:
an inlet communicated with a blood vessel is manufactured at the human epidermis, the inlet is enlarged by using a dilator, a delivery sheath enters the blood vessel through the inlet, and a delivery channel is established in the blood vessel;
inserting the loader loaded with the medical instrument into the delivery sheath which is left in the human body and establishes a channel;
pushing a pushing rod connected with the proximal end of the medical instrument, enabling the medical instrument to enter the tube body of the conveying sheath tube, and continuing pushing the pushing rod until the medical instrument is released from the distal end of the conveying sheath tube and enters a blood vessel;
and separating the medical instrument from the pushing rod, and withdrawing the delivery sheath, the loader and the pushing rod from the human body.
In one embodiment, the medical instrument is loaded into the loader as follows:
penetrating a push rod into the loader from the proximal end of the loader, and penetrating the distal end of the push rod out of the distal end of the loader;
connecting the distal end of the pushing rod with the medical instrument;
the pushing rod is pulled back, so that the medical instrument is compressed and loaded in the loading sheath of the loader.
In an embodiment, when the medical instrument is in threaded connection with the pushing rod, a detaching handle is sleeved on the pushing rod, and the pushing rod is separated from the medical instrument by rotating the pushing rod through the detaching handle.
The invention has the positive progress effects that: the invention adopts the loader, the conveying system and the conveying method, and has the following advantages:
1. because the length of sheath pipe tip section is greater than 15mm in this application, reduced the probability that medical instrument was blocked, improved the practicality of loader.
2. The advantage of the standard component is utilized, and the hemostatic plug is combined with the existing product, so that hemostasis can be achieved effectively, and emptying is convenient.
3. In the operation process, when the hemostatic valve is matched with the delivery sheath pipe without the hemostatic valve, the standard part is arranged, so that the delivery sheath pipe has a locking function, and a more convenient, lower-cost and more efficient delivery mode is provided.
Drawings
FIG. 1 (a) is a perspective view of the loader of the present invention;
FIG. 1 (b) is a front view of FIG. 1 (a);
FIG. 2 (a) is a perspective view of the present invention with the cartridge attached to the delivery sheath;
fig. 2 (b) is a front view of fig. 2 (a);
FIG. 3 (a) is a schematic view of a prior art delivery sheath;
FIG. 3 (b) is a schematic view of a prior art configuration of a delivery sheath in a plugging scenario with a loading sheath and a delivery sheath not matching the loading sheath to release a medical instrument;
FIG. 3 (c) is a schematic view of a configuration of the loader of the present invention when connected to a delivery sheath;
FIG. 3 (d) is a schematic view of another embodiment of the present invention when the cartridge is coupled to a delivery sheath;
FIG. 4 (a) is a schematic illustration of a connection of a push rod to a medical instrument;
FIG. 4 (b) is an enlarged view of a portion of FIG. 4 (a);
FIG. 5 (a) is a front view of the delivery system of the present invention delivering a medical device;
FIG. 5 (b) is a partial cross-sectional view of FIG. 5 (a);
fig. 5 (c) is a partial enlarged view of fig. 5 (b);
FIG. 6 (a) is a perspective view of the medical device of the present invention after release from the delivery system;
FIG. 6 (b) is an enlarged view of a portion of FIG. 6 (a);
FIG. 6 (c) is a front view of the medical device of the present invention after release from the delivery system;
fig. 6 (d) is a partial enlarged view of fig. 6 (c).
Detailed Description
In order that the manner in which the invention is practiced, as well as the features and objects and functions thereof, will be readily understood and appreciated, the invention will be further described in connection with the accompanying drawings.
In the present invention, "distal", "proximal", "distal" and "proximal" are used as terms of orientation which are conventional in the art of interventional medical devices, wherein "distal" refers to an end or section of a loader or delivery system that is distal to an operator during a procedure, and "proximal" refers to an end or section of a loader or delivery system that is proximal to an operator during a procedure. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the loader or delivery system; "radial" refers to a direction perpendicular to the "axial" direction described above.
In the embodiments described below, the medical instrument 300 may be a medical instrument 300 such as an occluder, a vascular plug, a vascular stent, or an atrial shunt. The loader 100 in the embodiments described below is used to load the medical instrument 300 and transport the medical instrument 300 into a blood vessel or organ of a human body to diagnose a disease of the blood vessel or organ of the human body.
Referring to fig. 1 (a) and 1 (b), an embodiment of the present invention provides a loader 100, which includes a loading sheath 110, wherein the loading sheath 110 has a hollow channel therein, the hollow channel 140 penetrates through the loading sheath 110 along a length direction of the loading sheath, a medical instrument is loaded in the hollow channel, and a distal end of the loading sheath 110 is a sheath tip section 120.
The sheath tip 120 has a hollow truncated cone-shaped structure with an outer diameter gradually decreasing from the proximal end to the distal end, and in particular, in this embodiment, the length of the sheath tip 120 is greater than or equal to 15mm.
In this embodiment, referring to fig. 2 (a) and 2 (b), the loader 100 is generally required to be used in combination with the delivery sheath 200 to deliver the medical instrument 300 into the human body. In use, the stoma is first created at the epidermis of the human body, the inlet is enlarged with a dilator, the delivery sheath 200 is passed through the inlet into the blood vessel, and a delivery channel is established within the blood vessel. The pushing rod 400 is connected with the medical instrument 300, and the pushing rod 400 penetrates into the loader 100 from the distal end of the loader 100 and then penetrates out from the proximal end of the loader 100. Pulling on the push rod 400 proximally, the medical instrument 300 is compressed and loaded into the loading sheath 110 of the loader 100. The loader 100 loaded with the medical instrument 300 is then inserted into the delivery sheath 200 that is left in the human body and establishes a passageway. Pushing the pushing rod 400 pushes the medical instrument 300 from the loading sheath 110 to the delivery sheath 200, and finally into the human body.
The inventor has found that manufacturers of the current commercial loaders 100 typically label their associated delivery sheath 200 on the commodity, and label the model because once the model is changed, the medical instrument 300 is easily stuck, resulting in a failed push. To address this problem, the current commercial loaders 100 typically add a spring at the proximal end to increase the pushing force, but with little success.
However, during the operation, the delivery sheath 200 is generally self-contained in a hospital, and thus if the model and manufacturer of the delivery sheath 200 are defined, the convenience of the hospital during the operation is greatly reduced.
The inventor's study found that the medical instrument 300 is easily stuck due to the fact that the conventional delivery sheath 200 includes the tube body 210 and the mouthpiece 220 from the distal end to the proximal end, as shown with reference to fig. 2 (a) and 3 (a). The tube 210 is detachably or fixedly connected with the interface 220. Interface 220 is generally divided into an interface near segment 221, an interface transition segment 222, and an interface far segment 223. The proximal interface section 221 may be connected to a hemostatic valve and the distal interface section 223 may be connected to the tube 210, with the distal interface section 223 having a tube diameter generally the same as or greater than the tube diameter of the tube 210. In order to be able to connect to standard hemostatic valves, the inner diameters of the proximal hub sections 221 of each company are uniform, the inner diameters of the distal hub transition sections 222 gradually increase from distal to proximal, the inner diameters of the distal hub sections 223 are adapted according to the size of the medical device 300 being delivered, and the lengths of the hub 220 of each delivery sheath 200 are substantially the same.
Many existing loading sheaths cannot be inserted into most delivery sheaths 200. Referring to fig. 3 (b), when the loading sheath 110 cannot be inserted into the distal interface section 223, the distal end of the loading sheath 110 will become lodged at the transition interface section 222. Because the inner diameter of the interface transition section 222 is large, i.e. the space is large enough, when the pushing rod 400 is pushed, the medical instrument 300 is released from the loading sheath 110, accumulated and blocked at the interface transition section 222, and the medical instrument 300 cannot move forward no matter how the pushing rod 400 is pushed, which directly causes the delivery failure of the medical instrument 300, and the problem is always a problem puzzled by the bracket delivery industry.
Since the medical instrument 300 needs to be loaded and transported in the hollow channel 140, the inner diameter of the hollow channel 140 is the same throughout, and the inner diameter of the hollow channel 140 is adapted to the compressed outer diameter of the medical instrument 300, so that the medical instrument 300 can be loaded in the hollow channel 140 after being compressed. That is, the inner diameter of the hollow channel 140 is slightly larger than the outer diameter of the medical instrument 300 after compression.
When the inner diameter of the hollow channel 140 within the sheath tip segment 120 is substantially uniform throughout the interior, the outer diameter values of the distal and proximal ends of the sheath tip segment 120 do not differ too much. Because the difference between the distal and proximal outer diameters of the sheath tip segment 120 is due primarily to the variation in the wall thickness of the sheath tip segment 120, the variation is not so great, which results in the impossibility of the difference between the proximal and distal outer diameters of the sheath tip segment 120 in this embodiment and the conventional loading sheath 110.
In the present embodiment, however, referring to fig. 3 (c), 3 (d) and 5 (a), since the length of the sheath tip section 120 is greater than or equal to 15mm, the length of the sheath tip section 120 of the general loader 100 is generally less than 15mm, and thus the length of the sheath tip section 120 in the present embodiment is longer than the length of the sheath tip section 120 of the general loader 100. While the outer diameters of the distal and proximal ends of the sheath tip segment 120 are not significantly different from the common loading sheath 110, this allows the loading sheath 110 of this embodiment to be inserted deeper into the delivery sheath 200 than the common loading sheath 110. When inserted deeper, the distal exit of loading sheath 110 is enabled to avoid interface transition 222, thereby avoiding release of medical instrument 300 at interface transition 222.
Because the sheath tip 120 is inserted deeper, the cartridge 100 is able to accommodate smaller diameter delivery sheaths 200, allowing for a greater range of delivery sheath 200 options.
Of course, more preferably, the length of the sheath tip segment 120 may be 20mm or more, 17mm or more, or any number of the sheath tip segment 120 having a length of 15mm to 20mm, for example, 16mm, 17mm, 22mm, 25mm, or the like. As the sheath tip 120 is made longer, the sheath tip 120 can be inserted deeper into the delivery sheath 200, leaving the distal outlet of the loading sheath 110 farther away from the interface transition 222.
As shown in fig. 1 (a) to 3 (d), the loading sheath 110 includes a tube main body 150 and a sheath tip section 120 fixedly connected to the tube main body 150, and since the length of the sheath tip section 120 is lengthened, the tube main body 150 may not extend into the delivery sheath 200, and the wall thickness at the tube main body 150 may be made thicker, thereby enhancing the strength of the loading sheath 110 and facilitating the doctor's handling of the loading sheath 110. Preferably, the wall thickness of the tube body 150 of the loading sheath 110 is 0.5mm to 1.5mm.
Preferably, the wall thickness at the distal end of the sheath tip segment 120 is 0.2mm to 0.5mm, and when the wall thickness at the distal end of the sheath tip segment 120 is sufficiently small, the outer diameter at the distal end of the sheath tip segment 120 can be reduced as much as possible, allowing the sheath tip segment 120 to be inserted as deeply as possible.
More preferably, the outer diameter of the distal end of the sheath tip 120 is 2mm to 3.5mm, and when the outer diameter of the distal end of the sheath tip 120 reaches 2mm to 3.5mm, the outer diameter of the distal end of the sheath tip 120 is smaller than the inner diameter of the tube body 210 of the smallest delivery sheath 200 in the market, so that the loading sheath 110 in this embodiment can substantially match all of the delivery sheaths 200 in the market.
More preferably, as shown in fig. 3 (c), after the sheath tip segment 120 is inserted into the delivery sheath 200, the distal end of the sheath tip segment 120 can abut against the body 210 of the delivery sheath 200.
The distal end of the sheath tip 120 has an outer diameter that is no greater than the inner diameter of the body 210 of the delivery sheath 200, and the sheath tip 120 has an outer diameter at the proximal end of the hub 220 of the delivery sheath 200 that is no greater than the inner diameter of the proximal end of the hub 220, such that the distal end of the sheath tip 120 is capable of substantially abutting the body 210.
As shown in fig. 3 (c), when the distal end of the sheath tip segment 120 is smaller than the inner diameter of the tube body 210, the sheath tip segment 120 is inserted into the tube body 210. When the distal end of the sheath tip 120 is equal to the inner diameter of the tube 210, the distal end of the sheath tip 120 may abut against the distal end side of the tube 210 without being inserted into the tube 210, as shown in fig. 3 (b). When the tube diameter of the distal interface section 223 is the same as that of the tube body 210, as shown in fig. 3 (d), the distal end of the sheath tip section 120 abuts against the distal end side of the distal interface section 223, and the situation shown in fig. 3 (b) can be avoided.
Since the distal end of the loading sheath 110 has a very long sheath tip segment 120, the length of the sheath tip segment 120 can be almost greater than the length of the hub 220, and the distal end of the sheath tip segment 120 is made sufficiently thin, the inner diameter of the distal end of the sheath tip segment 120 is smaller than the inner diameter of the body 210 of most delivery sheaths 200 on the market, while the tube diameter of the proximal end of the sheath tip segment 120 is adapted to the tube diameter of the hub proximal segment 221. The sheath tip 120 tapers in cross-section from proximal to distal, with a rounded transition allowing easy insertion of the sheath tip 120 into the body 210.
Because the sheath tip 120 of the loading sheath 110 is long enough and smoothly transits, so that the loading sheath 110 can be easily inserted into the distal end 223 of the delivery sheath 200, the sheath tip 120 is matched with the inner diameter of the tube body 210, no extra gap exists, the tube body 210 and the loading sheath 110 can restrain the medical instrument 300, and the medical instrument 300 cannot be released in the tube body 210 and the loading sheath 110, so that the medical instrument 300 can be pushed to the target position by pushing the pushing rod 400.
Of course, in some embodiments, the axial length of the sheath tip segment 120 may be only greater than or equal to the sum of the axial lengths of the proximal interface segment 221 and the transition interface segment 222 of the interface 220.
In this embodiment, referring to fig. 1 (a) to 2 (b), the cartridge 100 further comprises a first hemostasis valve 130, the first hemostasis valve 130 being disposed at the proximal end of the loading sheath 110.
In order to solve the problem that the blood loss is very small in the loading process, no matter whether the delivery sheath 200 is provided with a hemostasis valve or not, the proximal end of the loading sheath 110 is provided with a hemostasis valve, namely a first hemostasis valve 130, and the loading sheath 110 can be stopped by the first hemostasis valve 130.
In this embodiment, the first hemostasis valve 130 is threaded or snap-fit with the proximal end of the loading sheath 110. To facilitate connection of the loading sheath 110 to the primary hemostasis valve 130, the proximal end of the device sheath 110 has a fitting 160, which fitting 160 is threaded or snapped into engagement with the primary hemostasis valve 130.
In this embodiment, the first hemostatic valve 130 is a hemostatic valve with a locking function.
In this embodiment, the first hemostatic valve 130 is a T-valve with an extension tube.
Referring to fig. 2 (a) and 2 (b), an embodiment of the present invention further provides a delivery system, including the loader 100 and the push rod 400 of the present invention, where the sheath tip 120 of the loader 100 is operably inserted into the delivery sheath 200. The distal end of the push rod 400 is operably connected to the medical instrument 300, and the push rod 400 is operably inserted into the cartridge 100. Wherein the push rod 400 is operable to compress the medical instrument 300 into the loader 100, or wherein the push rod 400 is operable to push the medical instrument 300 out of the loader 100.
In the present embodiment, when the tube diameter of the distal interface section 223 of the delivery sheath 200 is the same as the tube diameter of the tube body 210 and the outer diameter of the sheath tip section 120 is equal to the tube diameter of the tube body 210, the sheath tip section 120 is inserted into the delivery sheath 200 and abuts on the distal end side of the distal interface section 223.
When the tube diameter of the distal interface section 223 of the delivery sheath 200 is the same as the tube diameter of the tube body 210 and the outer diameter of the sheath tip section 120 is smaller than the tube diameter of the tube body 210, the sheath tip section 120 is inserted into the tube body 210.
When the diameter of the distal segment 223 is larger than the diameter of the tube body 210 and the outer diameter of the sheath tip segment 120 is equal to the diameter of the tube body 210, the sheath tip segment 120 is inserted into the delivery sheath 200 and abuts against the distal end side of the tube body 210.
When the tube diameter of the distal interface section 223 is greater than the tube diameter of the tube body 210 and the outer diameter of the sheath tip section 120 is less than the tube diameter of the tube body 210, the sheath tip section 120 is inserted into the tube body 210.
In this embodiment, the delivery system further comprises a second hemostasis valve 230, the second hemostasis valve 230 being disposed proximal to the delivery sheath, the second hemostasis valve 230 being operable to lock or unlock the loading sheath 110 of the loader 100. The second hemostasis valve 230 is not only capable of hemostasis the delivery sheath 2, but the second hemostasis valve 230 is also capable of securing the loading sheath 110 such that the loading sheath 110 can be secured relative to the delivery sheath 200.
In this embodiment, the second hemostasis valve 230 is threaded or snap-fit with the proximal interface section 221 of the delivery sheath 200.
In this embodiment, the second hemostasis valve 230 is threaded or snap-fit with the loading sheath 110.
In this embodiment, the second hemostatic valve 230 is a T-valve with hemostatic function.
Referring to fig. 4 (a) to 6 (d), an embodiment of the present invention further provides a conveying method, and the following steps are performed by using the conveying system of the present invention:
s1, an inlet communicated with a blood vessel is manufactured at the human epidermis, the inlet is enlarged by using a dilator, the delivery sheath 200 enters the blood vessel through the inlet, and a delivery channel is built in the blood vessel.
S2, the loader 100 with the medical instrument 300 mounted thereon is inserted into the delivery sheath 200 which is placed in the human body and has a channel established.
As shown in fig. 5 (a) to 5 (c), the loader 100 is inserted into the delivery sheath 200. Wherein, as shown in fig. 5 (c), the medical instrument 300 is compressively loaded in the cartridge 100, and the sheath tip section 120 of the cartridge 100 is inserted into the delivery sheath 200.
The loading of the medical instrument 300 into the loader 100 in this step may be performed before step S1, during step S1, or after step S1.
In the present embodiment, the process of loading the medical instrument 300 to the loader 100 is as follows:
the pushing rod 400 is inserted into the loader 100 from the distal end of the loader 100, the proximal end of the pushing rod 400 is inserted out from the proximal end of the loader 100 (when the proximal end of the loader 100 is provided with the first hemostatic valve 130, the pushing rod 400 is inserted out from the proximal end of the first hemostatic valve 130), and then the distal end of the pushing rod 400 is connected to the medical instrument 300, as shown in fig. 4 (a) and fig. 4 (b), which is a connection relationship between the pushing rod 400 and the medical instrument 300, and fig. 4 (a) does not include the loader 100. The pushing rod 400 and the medical instrument 300 can be detachably connected in a threaded manner, a hook connection or a clamping connection and the like.
Of course, in some embodiments, the push rod 400 may be threaded from the proximal end of the cartridge 100 and then threaded from the distal end of the cartridge 100.
Alternatively, the medical instrument 300 and the push rod 400 may be connected together and then inserted into the loader 100.
After the push rod 400 is connected to the medical instrument 300, the push rod 400 is pulled back so that the medical instrument 300 is compressed and loaded into the loading sheath 110 of the loader 100.
In the present embodiment, when the proximal end of the delivery sheath 200 is provided with the second hemostatic valve 230, the loading sheath 110 of the loader 100 is locked and fixed by the second hemostatic valve 230 after the loader 100 is inserted into the delivery sheath 200.
S3, pushing the pushing rod 400 connected with the proximal end of the medical instrument 300, enabling the medical instrument 300 to enter the tube body of the delivery sheath 200, and continuing pushing the pushing rod 400 until the medical instrument 300 is released from the distal end of the delivery sheath 200 and enters the blood vessel.
As shown in fig. 6 (a) to 6 (d), the medical instrument 300 is extended from the distal end of the delivery sheath 200 to an expanded state and is available for fixation at a target site of a blood vessel.
S4, separating the medical instrument 300 from the pushing rod 400, and withdrawing the delivery sheath 200, the loader 100 and the pushing rod 400 from the human body.
In this embodiment, when the medical instrument 300 and the push rod 400 are in threaded connection, the push rod 400 is rotated, and the push rod 400 is unhooked from the medical instrument 300.
In this embodiment, when the medical instrument 300 and the push rod 400 are in threaded connection, a release handle is sleeved on the push rod 400, and the push rod 400 is separated from the medical instrument 300 by rotating the push rod 400 through the release handle.
In this embodiment, when the push rod 400 is connected to the medical instrument 300 through a hook, the push rod and the medical instrument 300 can be separated by removing the hook.
The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (13)
1. A loader, characterized in that the loader comprises a loading sheath, wherein a hollow channel is arranged in the loading sheath, and the hollow channel penetrates through the loading sheath along the length direction of the loading sheath;
the distal end of the loading sheath tube is a sheath tube tip section, the sheath tube tip section is of a hollow truncated cone-shaped structure with the outer diameter gradually reduced from the proximal end to the distal end, and the length of the sheath tube tip section is larger than or equal to 15mm.
2. The cartridge of claim 1, wherein the sheath tip segment has a length of greater than or equal to 20mm;
or the length of the sheath tip section is 15 mm-20 mm.
3. The cartridge of claim 1, wherein the tube body wall thickness of the loading sheath is 0.5mm to 1.5mm;
and/or the wall thickness at the distal end of the sheath tip section is 0.2 mm-0.5 mm;
and/or the outer diameter of the distal end of the sheath tip section is 2 mm-3.5 mm;
and/or the sheath tip section smoothly transits from the proximal end to the distal end.
4. The cartridge of claim 1, wherein the sheath tip segment is a sheath tip segment for operable insertion into a delivery sheath, the sheath tip segment being a sheath tip segment for abutment with a body of the delivery sheath;
and/or the distal outer diameter of the sheath tip section is not greater than the inner diameter of the body of the delivery sheath;
the sheath tip section has an outer diameter at the proximal end of the delivery sheath hub that is no greater than an inner diameter of the proximal end of the hub;
and/or the axial length of the sheath tip section is greater than the axial length of the delivery sheath interface;
and/or the inner diameters of the hollow channels are the same, and the inner diameters of the hollow channels are mutually matched with the outer diameters of the medical instruments after compression so that the medical instruments are loaded in the hollow channels after compression.
5. The cartridge of claim 1, wherein the cartridge further comprises:
a first hemostatic valve is disposed at a proximal end of the loading sheath.
6. The loader of claim 5, wherein said first hemostasis valve is threaded or snap-fit with the proximal end of said loading sheath;
and/or the first hemostatic valve is a hemostatic valve with a locking function;
and/or, the first hemostatic valve is a T-shaped valve with an extension tube.
7. A delivery system, comprising:
the cartridge of any one of claims 1 to 6, being a cartridge employing a proximal end operably inserted into a delivery sheath;
the pushing rod is a pushing rod which is connected with a medical instrument in an operable way by a far end, and the pushing rod is inserted into the loader in an operable way;
wherein the pushing rod is operable to compress the medical instrument into the loader or the pushing rod is operable to push the medical instrument out of the loader.
8. The delivery system of claim 7, wherein the delivery system further comprises:
a second hemostatic valve disposed at a proximal end of the delivery sheath and adapted to lock and unlock the loading sheath of the loader.
9. The delivery system of claim 8, wherein the second hemostasis valve is threaded or snap-fit with the proximal segment of the delivery sheath;
the second hemostasis valve is in threaded connection or clamping connection with the loading sheath;
and/or, the second hemostatic valve is a T-shaped valve with hemostatic function.
10. The delivery system of claim 7, wherein a distal end of the push rod is threadably coupled to the medical instrument.
11. A conveying method, characterized in that the following steps are performed using the loader according to any one of claims 1 to 6:
an inlet communicated with a blood vessel is manufactured at the human epidermis, the inlet is enlarged by using a dilator, a delivery sheath enters the blood vessel through the inlet, and a delivery channel is established in the blood vessel;
inserting the loader loaded with the medical instrument into the delivery sheath which is left in the human body and establishes a channel;
pushing a pushing rod connected with the proximal end of the medical instrument, enabling the medical instrument to enter the tube body of the conveying sheath tube, and continuing pushing the pushing rod until the medical instrument is released from the distal end of the conveying sheath tube and enters a blood vessel;
and separating the medical instrument from the pushing rod, and withdrawing the delivery sheath, the loader and the pushing rod from the human body.
12. The delivery method according to claim 11, wherein the medical instrument is loaded into the loader as follows:
penetrating a push rod into the loader from the distal end of the loader, and penetrating the distal end of the push rod out from the proximal end of the loader;
connecting the distal end of the pushing rod with the medical instrument;
the pushing rod is pulled back, so that the medical instrument is compressed and loaded in the loading sheath of the loader.
13. The delivery method of claim 11, wherein when the medical instrument is in threaded connection with the pushing rod, a detaching handle is sleeved on the pushing rod, and the pushing rod is separated from the medical instrument by rotating the pushing rod through the detaching handle.
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