CN114099102A

CN114099102A - Support conveying system

Info

Publication number: CN114099102A
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
Current assignee: BEIJING TAIJIE WEIYE TECHNOLOGY CO LTD
Priority date: 2021-11-24
Filing date: 2021-11-24
Publication date: 2022-03-01

Abstract

The present disclosure relates to a stent delivery system, the stent delivery system comprising: a catheter and a delivery guidewire inside the catheter. The near end of the conveying guide wire is connected with an operating handle, and the far end of the conveying guide wire is connected with a hypotube and a braided tube. The far end of the braided tube is connected with the tip part to form a guide wire passage of the protective device. The connecting pipe is installed to the hypotube distal end, is equipped with joint portion on the connecting pipe, and joint portion one end is fixed on the connecting pipe, and the other end can slide on the connecting pipe along with the slider. The end part of the bracket is clamped with the clamping part of the connecting pipe, so that the bracket is fixed on the connecting pipe. The latch of the clamping part locks the bracket, thereby preventing premature ejection in the releasing process of the bracket and improving the success rate of the operation. The latch point end of joint portion is mellow and full, can release latch stress through the slip of slider when loading the support, and greatly reduced latch is to the damage of support, avoids the support of damage to cause the injury to the human body. The joint portion uses soft silk material, and double-thread structure and slider design make it not hinder conveying system's recovery.

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

The carotid artery is a large blood vessel that transports blood from the heart to the head, face, and neck, and is one of the main blood supply vessels of the brain, whereas carotid stenosis is the major risk factor and etiological basis for ischemic cerebrovascular disease, and 25% of ischemic stroke is associated with carotid stenosis or occlusion.

Carotid stenosis is a common disease, including congenital and acquired pathological changes, which seriously affects blood supply flow and causes insufficient blood and oxygen supply for the whole body. At present, the main therapeutic methods for Carotid stenosis include medical drug therapy, Carotid Endarterectomy (CEA), and Carotid stenting (CAS). In recent 20 years, with the aging of neuroimaging and neurointervention techniques, the improvement of intervention materials and the improvement of operator techniques, carotid artery stent implantation has become one of the main treatment methods for carotid artery stenosis due to the characteristics of safety, effectiveness, minimal invasion, remarkable treatment effect and the like.

At present, carotid stents are mainly classified into two types, one type is a braided stent, the other type is a laser engraving stent, compared with the braided stent, the laser engraving stent has better support performance on blood vessels, but the risk that the stent is prematurely ejected out of a conveying system exists when the release is close to the end due to high support performance, the prematurely ejected stent cannot completely cover a lesion part, and operation failure is easily caused.

Disclosure of Invention

In order to overcome the deficiencies of the prior art, the present disclosure aims to provide a stent delivery system to solve the above existing technical problems.

In order to achieve the above object, the present disclosure provides a stent delivery system including:

a conduit;

a delivery guidewire disposed within the catheter;

the hypotube is arranged in the catheter, and the near end of the hypotube is connected with the far end of the conveying guide wire;

the connecting pipe is arranged in the guide pipe, and the near end of the connecting pipe is connected with the hypotube;

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

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

In some aspects, the stent delivery system further comprises:

the braided tube is arranged in the hypotube, and the near end of the braided tube is connected with the far end of the conveying guide wire;

a tip portion provided at a distal end side of the connection tube, a proximal end of the tip portion being connected to a distal end of the braided tube.

In some aspects, the clamping portion includes a clamping tooth 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 a stainless steel wire, a platinum-tungsten alloy wire, a platinum-iridium alloy wire, a tungsten wire, or a polymer material wire.

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

the stent filaments at the end portions are more sparse than the stent filaments at the middle portion.

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

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

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

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

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

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

and the far end of the hypotube is provided with a second developing mark.

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

The disclosed embodiment provides a stent delivery system, including: the device comprises a catheter, a conveying guide wire and a hypotube, wherein the conveying guide wire and the hypotube are mutually connected and arranged in the catheter; the support of compressing cup joints on the connecting pipe, and the support silk at support tip is more sparse than the support silk at middle part, and the latch card of joint portion makes the support can not take place the endwise slip in the support tip sparse support silk. The bracket is locked by the latch of the clamping part, so that the bracket is prevented from being ejected out too early, and the success rate of the operation is improved; meanwhile, the tips of the clamping teeth of the clamping part are round, so that the damage of the clamping teeth to the bracket is greatly reduced, and the damage of the damaged bracket to a human body is avoided; the latch and the slider design of the double-wire structure can release the stress of the catheter to the clamping part when the conveying system is recovered, so that the catheter can be smoothly withdrawn into the sheath, and the blood vessel is not easily damaged.

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 view of the clamping portion according to the embodiment of the disclosure;

fig. 2b is a third schematic structural diagram of the fastening portion according to the embodiment of the disclosure;

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

fig. 3 is an axial schematic view of a clamping portion when the stent is delivered by the stent delivery system provided by the embodiment of the disclosure;

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

FIG. 5 is a schematic structural diagram illustrating a weaving pattern of a stent according to an embodiment of the present disclosure;

fig. 6 is a second schematic structural view illustrating a weaving manner of the stent according to the embodiment of the present disclosure;

fig. 7 is a third schematic structural view illustrating a weaving manner of the stent according to the embodiment of the present disclosure.

Detailed Description

The technical solution of the present disclosure is further described in detail by 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 present disclosure, and those skilled in the art can conceive of other similar schemes based on the concept of the present disclosure by combining and arranging specific features in the embodiments.

As discussed in this disclosure, the terms "distal" or "proximal" are used hereinafter in relation to a description of a position or orientation relative to a hand-held end of a treating physician or medical interventionalist. "distal" or "distal side" is a location that is distal to the direction of the physician or interventionalist's hand-held end, and is not limited to a particular end point, but may also be a location that is proximal to an end point. "proximal" or "proximal side" is a location near the direction of the physician or interventionalist hand-held end.

Fig. 1 is a schematic structural diagram 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; as shown in fig. 1 and 1a, the stent delivery system includes: the catheter comprises a catheter 1, a delivery guide wire 2, a hypotube 3, a connecting tube 4, a clamping part 5, a bracket 6, a braided tube 7, a tip part 8, a Y-shaped valve 9 and a handle 10.

The catheter 1 is a common medical catheter and is used for establishing a delivery passage 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, the far end of the conveying guide wire 2 is provided with a hypotube 3, the far end of the hypotube 3 is provided with a second developing mark 31, the hypotube 3 is arranged in the catheter 1, and the near end of the hypotube 3 is connected with the far end of the conveying guide wire 2; the far end of the hypotube 3 is provided with a connecting pipe 4, the connecting pipe 4 is arranged in the catheter 1, and the near end of the connecting pipe 4 is connected with the far end of the hypotube 3; the outer wall of the connecting pipe 4 is provided with a clamping part 5 for locking a bracket 6 to be conveyed; support 6 is netted open loop configuration, and when carrying, support 6 is compressed in pipe 1 and cup joints on connecting pipe 4, and the one end joint of support 6 is on joint portion 5, through joint portion 5 with support 6 joint on connecting pipe 4, prevents that support 6 from popping out too early in transportation process.

The hypotube 3 is also provided with a braided tube 7, 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 part 8, and the proximal end of the tip part 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 the operation. The tip portion 8 is made of silica gel, the hardness of the tip portion is 30-60A, and compared with other carotid artery stent products, the tip portion is smaller in hardness and can effectively reduce damage to blood vessels; the tip portion 8 is connected to the braided tube 7 to form a protector guide wire passage.

Fig. 2 is one of the structural schematic diagrams of the clamping portion provided in the embodiment of the present disclosure, and fig. 3 is an axial schematic diagram of the clamping portion when the stent is delivered by the stent delivery system provided in the embodiment of the present disclosure, as shown in fig. 2 and fig. 3, the clamping portion 5 is fixedly disposed at the proximal end of the connection tube 4, the clamping portion 5 includes a latch 51 and a slider 52, wherein the slider 52 is an annular structure, and is sleeved at the proximal end of the connection tube 4 and can slide along the connection tube 4; the latch 51 has a double-wire structure and is formed by bending a wire material, and the latch 51 can be made of a stainless steel wire, a platinum-tungsten alloy wire, a platinum-iridium alloy wire, a nickel-titanium alloy wire, a tungsten wire or other metal wires, or can be made of a high polymer material wire with 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 tube 4.

Fig. 2 a-2 c are schematic views of several other clamping portions with different structures according to the embodiment of the disclosure, which are easier to implement than the structure shown in fig. 2, but should be made of appropriate materials to ensure that the desired effect is achieved without damaging the blood vessel and the stent. The fixed near-end that sets up at connecting pipe 4 of joint portion 5 as shown in fig. 2a, joint portion 5 only contains latch 51, does not have the slider, and latch 51 is the double-filament structure, is formed by a silk material bending, and latch 51's both ends are all fixed on connecting pipe 4, thereby latch 51 can imbed support 6 and lock support 6 on connecting pipe 4.

As shown in fig. 2b, 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 without a slider, the latch 51 is of a monofilament structure, the distal end of the latch 51 is fixed to the connecting tube 4, the proximal end is not fixed, and a certain included angle exists between the latch 51 and the connecting tube 4, and the latch is in a barb shape and can clamp the bracket 6, so that the bracket 6 is locked on the connecting tube 4.

Furthermore, the engaging portion 5 shown in fig. 2c includes a plurality of loops of the teeth 51 of the monofilament structure, and the teeth 51 of each loop may be aligned with each other or may be staggered by a certain angle.

Fig. 4-7 are schematic structural views of a stent provided by an embodiment of the present disclosure, and 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, stent wires at the end portion 61 are more sparse than stent wires at the middle portion 62, so that when the stent 6 is compressed, a gap exists between stent wires at the end portion 61, which facilitates the clamping teeth 51 of the clamping portion 5 to be inserted so as to clamp the stent 6.

The support 6 is a reticular open-loop structure, is formed by laser engraving and is made of nickel-titanium alloy. During manufacturing, a multi-section structural mode of sparse-dense-sparse is adopted, namely the number of the stent filaments at the two end parts 61 is small, and the number of the stent filaments at the middle part 62 is large, so that the end parts 61 are more sparse. The sparse end part 61 is convenient to be clamped with the clamping teeth 51 of the clamping part 5, so that the bracket 6 can be clamped on the connecting pipe 4, and premature ejection in the releasing process is prevented; the dense middle section 62 provides a higher metal coverage and improves the success rate of the surgery. The stent 6 is in the form of a plurality of ring-shaped structures which are connected by a connecting bridge. Specifically, the ring-shaped structures of the end portion 61 and the ring-shaped structures of the middle portion 62 are connected by a plurality of first connecting bridges 611, and the ring-shaped 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, the ring structure of the end portion 61 is formed by 24 wires, the ring structure of the middle portion 62 is formed by 36 wires, and the wires of the end portion 61 are longer than those of the middle portion 62, so as to manufacture a stent with two sparse ends and a dense middle.

The ring structures of the end portions 61 and the ring structures of the middle portion 62 are connected by 6 first connecting bridges 611, and every two ring structures of the middle portion 62 are connected by 6 second connecting bridges 621 or by 9 second connecting bridges 621. The second connecting bridges 621 among the plurality of annular structures of the middle portion 62 may be connected to each other in the axial direction to form a straight line, that is, the plurality of second connecting bridges 621 are linearly distributed in the axial direction, and this structure can reduce the stent shortening while ensuring the stent compliance; the second connecting bridges 621 between the multiple annular structures of the middle portion 62 may also be connected in an undulating manner, that is, the multiple second connecting bridges 621 are staggered in the axial direction, and the stent of such a structure can increase the flexibility of the stent.

When the stent 6 is loaded, as shown in fig. 2, the direction of the arrow in the figure is the loading direction of the stent 6, the stent 6 is compressed into a bundle shape, and is sleeved on the connecting tube 4 from the distal end to the proximal end, and when the stent 6 is sleeved on the clamping portion 5, the clamping teeth 51 are pressed by the stent 6 to contract inwards. At this time, the slide block 52 slides in the direction opposite to the inserting direction of the bracket 6, so as to avoid the latch 51 from being excessively extruded to damage the inner surface of the bracket 6; after the bracket 6 is loaded in place, the latch 51 and the slide block 52 are restored to the original state, and the latch 51 is clamped in the sparse mesh at the end part of the bracket 6, so that the bracket 6 is locked and fixed. A plurality of latch teeth 51 can be arranged on one circle of the slide block 52, and the specific number can be set according to requirements. The latch 51 of the double-wire structure can lock the bracket 6 more firmly, the tip end of the latch is smooth, and damage to the bracket 6 can be reduced. Meanwhile, when the stent delivery system is recycled, the design of the combination of the latch 51 and the slider 52 of the double wire structure more easily releases the stress contacting with the catheter 1, thereby being more easily withdrawn into the catheter 1.

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, support 6 can firmly be locked to the latch 51 of joint portion 5, and only when joint portion 5 released pipe 1, support 6 breaks away from with joint portion 5, and support 6 just can be released completely, and the problem that support 6 was too early popped out at the release in-process can effectively be avoided in this design. The latch 51 of the clamping part 5 is made of soft wire materials, the head part is smooth, the recovery of a stent conveying system is not influenced, and blood vessels cannot be punctured. When the release operation is carried out, the Y-shaped valve 9 is retracted while the handle 10 is fixed, 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 far end of the catheter 1, the stent 6 is automatically opened to be separated from the clamping part 5 and attached to the inner wall of a blood vessel, then the hypotube 3, the connecting pipe 4 and the tip part 8 are retracted into the catheter 1 through the retraction handle 10, and the whole stent delivery system is withdrawn out of the body along with the catheter 1.

The above-mentioned embodiments, objects, technical solutions and advantages of the present disclosure are described in further detail, it should be understood that the above-mentioned embodiments are merely illustrative of the present disclosure and are not intended to limit the scope of the present disclosure, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present disclosure should be included in the scope of the present disclosure.

Claims

1. A stent delivery system, comprising:

a conduit;

a delivery guidewire disposed within the catheter;

2. The stent delivery system of claim 1, further comprising:

3. The stent delivery system of claim 1, wherein the snap-in portion comprises a snap-in tooth and a slider;

4. The stent delivery system according to claim 3, wherein the latch is made of stainless steel wire, platinum-tungsten alloy wire, platinum-iridium alloy wire, tungsten wire or polymer material wire.

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

6. The stent delivery system of claim 5, wherein the stent is in a plurality of ring-like structures in a compressed state;

7. The stent delivery system according to claim 6, wherein the second connecting bridges between the plurality of ring structures of the middle portion are linearly arranged in the axial direction.

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

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

and the far end of the hypotube is provided with a second developing mark.

10. The stent delivery system of claim 2, wherein the proximal end of the tip portion is provided with a third visualization marker.