CN114099102B

CN114099102B - Support conveying system

Info

Publication number: CN114099102B
Application number: CN202111407705.1A
Authority: CN
Inventors: 张宏庆; 许永松; 穆磊; 程文杰; 范文吉; 武永昭; 刘海敏; 郭雷辰; 王孟静; 张婷
Original assignee: BEIJING TAIJIE WEIYE TECHNOLOGY CO LTD; Beijing Taijieweiye Technology Co ltd
Current assignee: BEIJING TAIJIE WEIYE TECHNOLOGY CO LTD; Beijing Taijieweiye Technology Co ltd
Priority date: 2021-11-24
Filing date: 2021-11-24
Publication date: 2025-07-08
Anticipated expiration: 2041-11-24
Also published as: CN114099102A

Abstract

The present disclosure relates to a stent delivery system, which comprises: a catheter and a delivery guide wire inside the catheter. The proximal end of the delivery guide wire is connected to an operating handle, and the distal end is connected to a hypotube and a braided tube. The distal end of the braided tube is connected to a tip portion to form a guide wire passage of a protective device. A connecting tube is installed at the distal end of the hypotube, and a clamping portion is installed on the connecting tube. One end of the clamping portion is fixed on the connecting tube, and the other end can slide on the connecting tube with a slider. The end of the stent is clamped with the clamping portion of the connecting tube to fix the stent on the connecting tube. The clamping teeth of the clamping portion lock the stent to prevent premature ejection during the release process of the stent, thereby improving the success rate of the operation. The clamping teeth of the clamping portion are rounded, and the clamping teeth stress can be released by sliding the slider when loading the stent, which greatly reduces the damage of the clamping teeth to the stent and avoids the damaged stent from causing harm to the human body. The clamping portion uses soft wire material, and the double wire structure and slider design make it not hinder the recovery of the delivery system.

Description

Support conveying system

Technical Field

The present disclosure relates to the field of medical devices, and more particularly to a stent delivery system.

Background

Carotid artery is a large vessel that carries blood from the heart to the head, face, neck, one of the main blood supply vessels of the brain, while carotid artery stenosis is the main risk factor and etiology basis for ischemic cerebrovascular disease, 25% of which is associated with carotid artery stenosis or occlusion.

Carotid stenosis is a common disease, including carotid stenosis caused by congenital and acquired lesions, which can severely affect blood supply flow and thus cause systemic insufficiency of blood and oxygen. At present, the treatment methods of carotid stenosis mainly include medical drug treatment, carotid endarterectomy (Carotid endarterectomy, CEA) and carotid stent implantation (Carotid angioplasty AND STENTING, CAS). In recent 20 years, along with the gradual maturity of neuroimaging and neurointerventional technologies, the improvement of interventional materials and the improvement of operator technologies, carotid stenting has become one of the main treatment methods of carotid stenosis due to the characteristics of safety, effectiveness, minimally invasive and remarkable curative effect.

At present, carotid stents are mainly of two types, one type is a woven stent, the other type is a laser engraved stent, and compared with the woven stent, the laser engraved stent has better support to blood vessels, but high support causes the risk that the stent can prematurely pop out of a conveying system when the release is close to the end, and the prematurely popped stent can not completely cover a lesion part, so that surgical failure is easy to cause.

Disclosure of Invention

In order to overcome the defects in the prior art, the disclosure aims to provide a stent conveying system so as to solve the technical problems.

To achieve the above object, the present disclosure provides a stent delivery system including:

A conduit;

A delivery guidewire disposed within the catheter;

A hypotube disposed within the catheter, a proximal end of the hypotube being connected to a distal end of the delivery guidewire;

the connecting pipe is arranged in the catheter, and the proximal end of the connecting pipe is connected with the hypotube;

the clamping part is at least partially fixedly arranged on the outer wall of the connecting pipe;

The bracket is sleeved on the connecting pipe, the proximal end of the bracket is clamped with the clamping part, and the bracket is configured to be separated from the clamping part after being pushed out of the catheter.

In some aspects, the stent delivery system further comprises:

a braided tube disposed within the hypotube, a proximal end of the braided tube being connected to a distal end of the delivery guidewire;

and the tip part is arranged on the distal end side of the connecting pipe, and the proximal end of the tip part is connected with the distal end of the braided pipe.

In some aspects, the clip includes a latch and a slider;

the sliding block is sleeved on the connecting pipe and can slide along the connecting pipe;

the end part of the latch is at least partially fixed on the sliding block, and the other end part of the latch is at least partially fixed on the connecting pipe.

In some embodiments, the latch is made of stainless steel wire, platinum tungsten alloy wire, platinum iridium alloy wire, tungsten wire or polymer material wire.

In some aspects, the stent comprises an end portion and a middle portion;

The end portion of the stent wire is thinner than the middle portion of the stent wire.

In some aspects, the scaffold is in a plurality of ring-like structures in a compressed state;

the annular structures at the end parts are connected with the annular structures at the middle part through a first connecting bridge;

The plurality of annular structures in the middle are connected through a second connecting bridge.

In some embodiments, the second connecting bridges between the plurality of annular structures of the middle portion are linearly distributed in the axial direction.

In some aspects, the second connecting bridges between the plurality of annular structures of the central portion are staggered in the axial direction.

In some aspects, the distal end of the catheter is provided with a first visualization mark;

the distal end of the hypotube is provided with a second visualization mark.

In some aspects, the proximal end of the tip portion is provided with a third development mark.

The embodiment of the disclosure provides a stent conveying system, which comprises a catheter, a conveying guide wire and a hypotube which are connected with each other and are arranged in the catheter, wherein the far end of the hypotube is connected with a connecting pipe, the near end of the connecting pipe is provided with a clamping part, the clamping part comprises clamping teeth and a sliding block, a compressed stent is sleeved on the connecting pipe, the stent wire at the end part of the stent is sparse compared with the stent wire at the middle part, and the clamping teeth of the clamping part are clamped in the sparse stent wire at the end part of the stent, so that the stent cannot axially slide. The clamping teeth of the clamping parts lock the bracket to prevent the bracket from being ejected out too early, so that the success rate of the operation is improved, meanwhile, the tip ends of the clamping teeth of the clamping parts are round, the damage of the clamping teeth to the bracket is greatly reduced, the damage of the damaged bracket to a human body is avoided, and the clamping teeth and the sliding block of the double-wire structure can release the stress of the guide pipe to the clamping parts when the conveying system is recovered, so that the guide pipe can be smoothly retracted into the sheath pipe, and the blood vessel is not easy to damage.

Drawings

Fig. 1 is a schematic structural view of a stent delivery system provided in an embodiment of the present disclosure;

FIG. 1a is an enlarged view of a portion of FIG. 1A;

Fig. 2 is a schematic structural diagram of a clamping portion according to an embodiment of the disclosure;

FIG. 2a is a second schematic structural diagram of a clamping portion according to an embodiment of the disclosure;

FIG. 2b is a third schematic structural view of the engaging portion according to the embodiment of the disclosure;

fig. 2c is a schematic structural diagram of a clamping portion according to an embodiment of the disclosure;

fig. 3 is an axial schematic view of a clamping portion of the stent delivery system according to the embodiment of the present disclosure when delivering a stent;

FIG. 4 is a schematic view of a stent in a compressed state provided by an embodiment of the present disclosure;

FIG. 5 is a schematic diagram of a braiding method of a stent according to an embodiment of the present disclosure;

FIG. 6 is a second schematic diagram of a braiding method of a stent according to an embodiment of the present disclosure;

fig. 7 is a third schematic structural view of a braiding method of a stent according to an embodiment of the present disclosure.

Detailed Description

The technical scheme of the present disclosure is described in further detail below through the accompanying drawings and examples.

The present disclosure is described in detail below with reference to specific embodiments, but it should be understood that the following embodiments are not intended to limit the disclosure, and those skilled in the art can think of permutation and combination of specific features of the embodiments to form other similar schemes based on the concepts of the present disclosure.

As discussed in this disclosure, the term "distal" or "proximal" is used below in relation to the description of the position or orientation of the handpiece relative to the treating physician or medical intervention physician. The "distal" or "distal side" is a position away from the direction of the hand of the physician or interventional physician, and is not limited to a particular endpoint, but may be a position proximal to the endpoint. "proximal" or "proximal side" is a position that is proximal to the direction of the physician or interventional physician's hand.

Fig. 1 is a schematic structural view of a stent delivery system according to an embodiment of the present disclosure, fig. 1a is a partial enlarged view of a portion a in fig. 1, and as shown in fig. 1 and 1a, the stent delivery system includes a catheter 1, a delivery guidewire 2, a hypotube 3, a connection tube 4, a clamping portion 5, a stent 6, a braided tube 7, a tip portion 8, a Y-valve 9, and a handle 10.

The catheter 1 is a commonly used medical catheter for establishing a delivery path of a stent delivery system, a Y-shaped valve 9 is connected to the proximal end of the catheter 1, and a first developing mark 11 is arranged at the distal end of the catheter 1.

The conveying guide wire 2 for conveying operation is arranged in the catheter 1, a hypotube 3 is arranged at the distal end of the conveying guide wire 2, a second developing mark 31 is arranged at the distal end of the hypotube 3, the hypotube 3 is arranged in the catheter 1, the proximal end of the hypotube 3 is connected with the distal end of the conveying guide wire 2, a connecting pipe 4 is arranged at the distal end of the hypotube 3, the connecting pipe 4 is arranged in the catheter 1, the proximal end of the connecting pipe 4 is connected with the distal end of the hypotube 3, a clamping part 5 is arranged on the outer wall of the connecting pipe 4 and used for locking a support 6 to be conveyed, the support 6 is of a net-shaped open-loop structure, the support 6 is compressed in the catheter 1 and sleeved on the connecting pipe 4 during conveying, one end of the support 6 is clamped on the clamping part 5, the support 6 is clamped on the connecting pipe 4 through the clamping part 5, and premature ejection of the support 6 during conveying is prevented.

A braided tube 7 is further arranged in the hypotube 3, the proximal end of the braided tube 7 is connected with the distal end of the delivery guide wire 2, the distal end of the braided tube 7 is connected with a tip end 8, and the proximal end of the tip end 8 is provided with a third developing mark 81 which can be used for observing and positioning the distal end of the stent 6 in an operation. The tip 8 is made of silica gel, has the hardness of 30-60A, is smaller than that of other carotid artery stent products, and can effectively reduce the damage to blood vessels, and the tip 8 is connected with the braided tube 7 to form a guide wire passage of the protective device.

Fig. 2 is a schematic structural view of a clamping portion provided in an embodiment of the present disclosure, fig. 3 is an axial schematic view of the clamping portion when a stent is conveyed by a stent conveying system provided in an embodiment of the present disclosure, as shown in fig. 2 and fig. 3, the clamping portion 5 is fixedly disposed at a proximal end of a connecting tube 4, and the clamping portion 5 includes a latch 51 and a slider 52, wherein the slider 52 is in a ring structure and is sleeved at the proximal end of the connecting tube 4 to slide along the connecting tube 4, the latch 51 is in a double-wire structure and is formed by bending a wire, and the latch 51 may be made of a metal wire such as a stainless steel wire, a platinum-tungsten alloy wire, a platinum-iridium alloy wire, a nickel-titanium alloy wire or a tungsten wire, or a polymer wire with a certain strength and flexibility. The proximal end of the latch 51 is fixed to the slider 52, and is slidable with the slider 52, and the distal end of the latch 51 is fixed to the connection pipe 4.

Fig. 2 a-2 c are schematic views of several other different structures of the clamping portion according to the embodiments of the present disclosure, which are easier to implement than the structure shown in fig. 2, but are made of materials properly, so as to ensure the desired effect without damaging the blood vessel and the stent. As shown in fig. 2a, the clamping portion 5 is fixedly disposed at the proximal end of the connecting tube 4, the clamping portion 5 only includes a latch 51, no sliding block is provided, the latch 51 is of a double-wire structure and is formed by bending a wire, two ends of the latch 51 are both fixed on the connecting tube 4, and the latch 51 can be embedded into the bracket 6 to lock the bracket 6 on the connecting tube 4.

As shown in fig. 2b, the clamping portion 5 is fixedly arranged at the proximal end of the connecting pipe 4, the clamping portion 5 only comprises a latch 51, no sliding block is arranged, the latch 51 is of a monofilament structure, the distal end of the latch 51 is fixed on the connecting pipe 4, the proximal end is not fixed, a certain included angle exists between the latch 51 and the connecting pipe 4, and the latch is in a barb shape, so that the bracket 6 can be clamped and locked on the connecting pipe 4.

Further, the clamping portion 5 shown in fig. 2c includes a plurality of turns of the teeth 51 of the monofilament structure, and the teeth 51 of each turn may be aligned with each other or may be offset by a certain angle.

Fig. 4-7 are schematic structural views of a stent according to an embodiment of the present disclosure, as shown in fig. 4-7, the stent 6 includes an end portion 61 and a middle portion 62, wherein, in order to enable the stent 6 to be clamped with the clamping portion 5, the stent wire of the end portion 61 is thinner than the stent wire of the middle portion 62, so that a gap exists between the stent wires of the end portion 61 when the stent 6 is compressed, so that the latch 51 of the clamping portion 5 can be embedded to clamp the stent 6.

The bracket 6 is of a net-shaped open-loop structure and is formed by laser engraving, and the bracket is made of nickel-titanium alloy. During manufacturing, a multi-section structure mode of 'sparse-dense-sparse' is adopted, namely, the number of stent wires of the two end parts 61 is small, the number of stent wires of the middle part 62 is large, and the end parts 61 are sparse. The sparse end portion 61 is convenient to clamp with the clamping teeth 51 of the clamping portion 5, so that the support 6 can be clamped on the connecting pipe 4 to prevent premature ejection in the releasing process, and the dense middle portion 62 can provide high metal coverage rate to improve the success rate of the operation. The bracket 6 presents a plurality of ring structures, and the ring structures are connected through connecting bridges. Specifically, the annular structures of the end portion 61 and the annular structures of the middle portion 62 are connected by a plurality of first connecting bridges 611, and the annular structures of the middle portion 62 are connected by a plurality of second connecting bridges 621.

In some preferred embodiments, as shown in fig. 5-7, 24 wires are used for the wires of the ring structure of the end portion 61, 36 wires are used for the ring structure of the middle portion 62, and the wires of the end portion 61 are longer than the wires of the middle portion 62, so that a stent with sparse ends and dense middle is manufactured.

The annular structures of the end portion 61 and the annular structures of the middle portion 62 are connected through 6 first connecting bridges 611, and each two annular structures of the middle portion 62 can be connected through 6 second connecting bridges 621, and also can be connected through 9 second connecting bridges 621. The second connection bridges 621 between the plurality of annular structures of the middle part 62 may be connected with each other in the axial direction to form a straight line, that is, the plurality of second connection bridges 621 are linearly distributed in the axial direction, which can reduce the shrinkage of the stent while ensuring the flexibility of the stent, and the second connection bridges 621 between the plurality of annular structures of the middle part 62 may also be connected in a wave-like manner, that is, the plurality of second connection bridges 621 are staggered in the axial direction, which can increase the flexibility of the stent.

When the bracket 6 is loaded, as shown in fig. 2, the arrow direction in the drawing is the loading direction of the bracket 6, the bracket 6 is compressed into a bundle shape, the bracket 6 is sleeved on the connecting pipe 4 from the distal end to the proximal end, and when the bracket 6 is sleeved on the clamping part 5, the clamping teeth 51 are extruded by the bracket 6 to shrink inwards. At this time, the sliding block 52 slides in the direction opposite to the sleeving direction of the bracket 6, so that the latch 51 is prevented from being excessively extruded to damage the inner surface of the bracket 6, and after the bracket 6 is loaded in place, the latch 51 and the sliding block 52 are restored, and the latch 51 is clamped into the sparse mesh at the end part of the bracket 6, so that the bracket 6 is locked and fixed. A plurality of latches 51 may be provided on one circumference of the slider 52, and the specific number may be set as needed. The latch 51 of the double wire structure can lock the bracket 6 more firmly, the tip of the latch is round, and damage to the bracket 6 can be reduced. At the same time, the combined design of the latch 51 and slider 52 of the double wire structure more easily relieves the stress in contact with the catheter 1 and thus more easily withdraws into the catheter 1 when the stent delivery system is retrieved.

When the carriage 6 is conveyed, it is determined that the carriage 6 is conveyed to the optimum position by observing the first development mark 11, the second development mark 31, and the third development mark 81.

When releasing support 6, latch 51 of joint portion 5 can firmly lock support 6, and only when joint portion 5 released pipe 1, support 6 and joint portion 5 break away from, and support 6 can be released completely, and this design can effectively avoid support 6 too early problem that pops out in the release process. The latch 51 of the clamping part 5 is made of soft wires, the head is round, the recovery of the stent conveying system is not affected, and the blood vessel is not stabbed. When the release operation is carried out, the handle 10 is fixed, the Y-shaped valve 9 is retracted, the Y-shaped valve 9 drives the catheter 1 to retract, the stent 6 is gradually exposed, after the stent 6 and the clamping part 5 are completely exposed out of the distal end of the catheter 1, the stent 6 is automatically opened to be separated from the clamping part 5 and stuck on the inner wall of a blood vessel, and then the hypotube 3, the connecting pipe 4 and the tip part 8 are retracted into the catheter 1 through the retracting handle 10, so that the whole stent conveying system is withdrawn from the body along with the catheter 1.

While the foregoing embodiments have been described in some detail for purposes of clarity of understanding, it will be understood that the above description is by way of example only and is not intended to limit the scope of the disclosure, and that any modifications, equivalents, improvements, etc. that fall within the spirit and principles of the disclosure are intended to be included within the scope of the disclosure.

Claims

1. A stent delivery system, the stent delivery system comprising:

A conduit;

A delivery guidewire disposed within the catheter;

the clamping part is fixedly arranged on the outer wall of the connecting pipe at least in part and comprises clamping teeth and a sliding block;

the end part of the latch is at least partially fixed on the sliding block, and the other end part of the latch is at least partially fixed on the connecting pipe;

The bracket is of a net-shaped open-loop structure and is engraved by laser, the bracket is sleeved on the connecting pipe, a near-end mesh of the bracket is clamped with the clamping teeth of the clamping part, and the bracket is configured to be separated from the clamping part after being pushed out of the catheter;

2. The stent delivery system of claim 1, wherein the latch is made of stainless steel wire, platinum tungsten alloy wire, platinum iridium alloy wire, tungsten wire, or polymer wire.

3. The stent delivery system of claim 1, wherein the stent comprises an end portion and a middle portion;

4. The stent delivery system of claim 3, wherein the stent is in a plurality of ring-like configurations in a compressed state;

5. The stent delivery system of claim 4, wherein the second connecting bridges between the plurality of ring structures of the central portion are linearly distributed in the axial direction.

6. The stent delivery system of claim 4, wherein the second connecting bridges between the plurality of ring structures of the central portion are staggered in the axial direction.

7. The stent delivery system of claim 1, wherein a distal end of the catheter is provided with a first visualization mark;

the distal end of the hypotube is provided with a second visualization mark.

8. The stent delivery system of claim 1, wherein a proximal end of the tip portion is provided with a third visualization mark.