WO2021129285A1

WO2021129285A1 - Stent delivery and release device and stent delivery and release system

Info

Publication number: WO2021129285A1
Application number: PCT/CN2020/131481
Authority: WO
Inventors: 李安伟; 王雷; 王永胜
Original assignee: 杭州唯强医疗科技有限公司
Priority date: 2019-12-23
Filing date: 2020-11-25
Publication date: 2021-07-01

Abstract

Disclosed are a stent delivery and release device (20) and a stent delivery and release system. The stent delivery and release device (20) is used for releasing a stent (10) in a blood vessel, and comprises: a guide head (201), a sheath core assembly (202), a sheath catheter assembly (203), a control member (205), and a stent proximal end release assembly (204); the guide head (201) is arranged at the distal end of the sheath core assembly (202); the stent proximal end release assembly (204) is arranged at the proximal end of the sheath core assembly (202); the sheath catheter assembly (203) is sleeved on the sheath core assembly (202); the control member (205) is detachably connected to the guide head (201); and the stent proximal end release assembly (204) repeatedly tightens or releases the proximal end of the stent (10) by controlling the axial length of the control member (205). The technical problem of the proximal end or distal end of the stent (10) being released when the stent (10) does not satisfy a release condition, which causes the release position of the stent (10) to be inaccurate, and ultimately leads to a release failure of the stent (10), is solved.

Description

Stent delivery and release device and stent delivery and release system

The present invention claims the priority of the prior applications of the application numbers 201911341841.8 and 201922337204.5 filed on December 23, 2019 named "Stent delivery release device and stent delivery release system", and the content of the foregoing prior application is incorporated herein by way of introduction. In this.

Technical field

The invention relates to the field of medical equipment, in particular to a stent delivery and release device and a stent delivery and release system.

Background technique

Endovascular repair of thoracic and abdominal vascular diseases is an effective treatment option that has gained tremendous popularity in the past decade. The stent graft is a transplantable device consisting of a tubular surgical graft sheath and a self-expanding frame. The vascular stent needs to be released in the vascular segment that needs to be repaired through the cooperation of the delivery system. The vascular stent is placed in the blood vessel, which can seal the aneurysm and rebuild the blood flow path, so that the hemodynamic pressure cannot reach the vascular lesion. Because whether it is a true aneurysm, a pseudoaneurysm or a dissecting aneurysm, different degrees of damage and disease have occurred in the blood vessel, and the shape of the blood vessel may be irregular, which requires a good delivery performance of the delivery system.

The implantation method of aortic vascular stent is to compress the stent into the delivery and release device, and then guide it by implanting a guide wire through a minimally invasive incision in the femoral artery, and then sending the stent through the delivery system along the guide wire that has been implanted in the body beforehand. The location of the lesion of the aorta is delivered to the exact location of the lesion with the assistance of the imaging device, and the stent is released and implanted to the location of the lesion. Common problems encountered by surgeons during the operation are due to unstable operation of the instrument, complex blood vessel structure, narrow surgical field of vision, etc. The proximal or distal end of the stent has been released before the release conditions are reached, resulting in the stent. The inaccuracy of the release position caused a series of subsequent problems and uncertainties, which eventually led to the failure of the stent release. The conveying system needs to be accurate and easy to introduce, accurate and safe release, and easy and easy to withdraw.

Summary of the invention

The purpose of the present invention is to provide a stent delivery and release device and a stent delivery and release system to solve the problem that the proximal or distal end of the stent has been released when the stent does not reach the release conditions, which causes the stent release position to be inaccurate. The technical problem that ultimately led to the failure of the stent release.

The present invention provides a stent delivery and release device for releasing a stent in a blood vessel, comprising: a guide head, a sheath core assembly, a sheath tube assembly, a control member, and a stent proximal release assembly. The guide head is arranged on the sheath core The distal end of the assembly, the proximal end release assembly of the stent is arranged at the proximal end of the sheath core assembly, the sheath tube assembly is sleeved on the sheath core assembly, the control member is detachably connected to the guide head, the The proximal end release assembly of the stent repeatedly tightens or releases the proximal end of the stent by controlling the axial length of the control member.

Wherein, the control member is a flexible slender structure, or a combination of a flexible slender structure and a rigid slender structure.

Wherein, the guide head includes a first main body portion and a first fixing member, the first fixing member is provided at the proximal end of the first main body portion, and the first fixing member and the control member are detachably connected .

Wherein, the first fixing member is provided with a through hole, a barb, a slot, or a combination thereof for fixing the control member.

Wherein, the control member is detachably connected to the proximal end release assembly of the stent.

Wherein, the stent proximal release assembly includes a tail slider and a tail end rotating rod, the tail end rotating rod is sleeved on the proximal end of the sheath core assembly, and the tail slider is sleeved on the tail end rotating rod. On the rod, the tail end rotating rod drives the tail slider to move along the extension direction of the sheath core assembly.

Wherein, the tail slider includes a second main body and a second fixing member, and the second fixing member is provided on the outer side of the second main body for connection with the control member.

Wherein, the tail end rotating rod includes a main rod part and a rotating part connected with the main rod part, and the tail slider is a hollow structure to move along the main rod part in threaded cooperation.

Wherein, the proximal end release assembly of the stent further includes a tail end screw cap and a release slider cover, and the tail end screw cap is rotatably connected between the proximal end of the sheath assembly and the distal end of the release slider cover , Used to release the control member.

Wherein, the second fixing member is provided on the inner wall of the release slider cover for connection with the control member.

Wherein, the inner wall of the release slider cover is recessed with a sliding groove along the axial direction, the outer side of the tail slider is convex or the second fixing member is engaged with the sliding groove, and the tail slider is rotating and traveling. The sliding groove can be slid along the extending direction of the sliding groove to prevent the control member from being tangled and knotted during the traveling process.

Wherein, the proximal end release assembly of the stent further includes a sheath core fixing member arranged at the distal end of the tail slider to prevent the proximal end release assembly of the stent from driving the guide head when the stent is controlled to release the stent. Move at will.

Wherein, the sheath core assembly includes an inner sheath core, a Luer connector, a three-way valve and a three-way tube fixing member, the guide head is arranged at the distal end of the inner sheath core, and the sheath core fixing member is sleeved on the inner sheath core On the outer wall, the luer connector is connected to the tail of the inner sheath core, the inner sheath core is close to the luer connector end and a tee tube fixing part is arranged along the peripheral wall of the inner sheath core, and the tee tube fixing part is connected to the three-way valve through the tube body .

Wherein, the sheath tube assembly includes a multi-lumen tube, the multi-lumen tube is sleeved on the outer wall of the inner sheath core and communicates with the three-way tube fixing member, and the multi-lumen tube is provided with the control member There is a preset distance between the multi-lumen tube and the guide head to prevent entanglement and knotting during the traveling process of the control member.

The present invention provides a stent delivery and release system. The stent delivery and release system includes a stent and the above-mentioned stent delivery and release device, and the stent delivery and release device is used to control the radial contraction or expansion of the proximal end of the stent.

Wherein, the control member is a flexible elongated member, the second fixing member is provided with two channels, two ends of the control member respectively pass through the two channels, and one end of the control member is connected to the The guide head is fixed, and the other end is detachably fixed to the second fixing member.

Wherein, the control member is a flexible slender piece and a rigid slender piece, the guide head is provided with a fixed wire groove and a channel, and one end of the flexible slender piece is sleeved on the rigid slender piece. The distal end of the rigid elongated member is clamped in the fixing wire groove, the other end of the flexible elongated member passes through the channel and is fixed with the guide head, and the proximal end of the rigid elongated member can be It is disassembled and fixed to the guide head.

In summary, the proximal stent release component of the present application repeatedly tightens or releases the stent, that is, after the proximal stent release component can repeatedly retract and release the stent, the stent can be released to the exact location of the lesion, and the stent is successfully released. This technology solves the problem that the proximal or distal end of the stent is released when the stent does not reach the release conditions, causing the stent release position to be inaccurate, resulting in a series of subsequent problems and uncertainties, and ultimately leading to the failure of the stent release. problem.

Description of the drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

Figure 1 is a schematic diagram of the structure of the stent delivery and release system provided by the present invention.

Fig. 2 is a schematic structural diagram of the stent delivery and release device in Fig. 1.

Fig. 3 is an exploded structural diagram of the stent delivery and release device of Fig. 2.

FIG. 4 is a schematic diagram of part of the structure in FIG. 3.

FIG. 5 is a schematic cross-sectional structure diagram of a part of the structure in FIG. 4.

Fig. 6 is an enlarged schematic diagram of a structure of part M in Fig. 1.

Fig. 7 is an enlarged schematic diagram of another structure of part M in Fig. 1.

FIG. 8 is a schematic top view of the structure of part M in FIG. 1.

FIG. 9 is a schematic diagram of the structure of the guide head in FIG. 2.

Fig. 10 is a schematic diagram of the structure of the tail rotating rod in Fig. 2.

FIG. 11 is a schematic diagram of a structure of the tail slider in FIG. 2.

Fig. 12 is a schematic diagram of the structure of the tail release slider cover in Fig. 2.

Fig. 13 is a schematic diagram of the structure of the tail end fixing member in Fig. 2.

Fig. 14 is a schematic diagram of another structure of the tail slider in Fig. 2.

FIG. 15 is a schematic diagram of the structure of the release slider cover in FIG. 2.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

It should be noted that for stents, the end near the heart after implantation of the blood vessel is generally called the "proximal end" of the stent, and the end far away from the heart after the implantation of the blood vessel is called the "distal end" of the stent, and is defined according to this principle The "proximal" and "distal" of any part of the stent. For the conveyor, the end closer to the operator is generally referred to as the "proximal end", and the end relatively far away from the operator is referred to as the "distal end", and the "proximal end" and the "proximal end" of any part of the delivery system are defined according to this principle. "remote". "Axial" generally refers to the length direction of the stent when it is delivered, and "radial" generally refers to the direction perpendicular to the "axial direction" of the stent, and the "axial direction" of any component of the stent graft is defined according to this principle. "And "radial".

Please refer to Figure 1. The present invention provides a stent delivery and release system. The stent delivery and release system includes a stent 10 and a stent delivery release device 20. The stent delivery release device 20 is used to control the radial contraction or expansion of the proximal end of the stent 10 so as to release the stent 10 into the blood vessel, and the stent delivery release device 20 can be repeated The stent 10 is tightened or released to adjust the implantation position of the stent 10 to accurately release the stent 10 on the inner wall of the blood vessel cavity to realize the therapeutic function of the intraluminal stent 10. The stent delivery and release device 20 will be described in detail as follows.

2-5, the stent delivery and release device 20 includes a guide head 201, a sheath core assembly 202, a sheath tube assembly 203, and a stent proximal release assembly 204. The guide head 201 is provided at the distal end of the sheath core assembly 202, and the stent is near The end release assembly 204 is arranged at the proximal end of the sheath core assembly 202, the sheath assembly 203 is sleeved on the sheath core assembly 202, and the stent proximal release assembly 204 is used to repeatedly tighten or release the stent 10 so that the stent 10 can be accurately released In the treatment site within the blood vessel.

The stent proximal release component 204 of the present application repeatedly tightens or releases the stent 10, that is, after the stent proximal release component 204 retracts and releases the stent 10 many times, the stent 10 can be accurately released to the lesion position, ensuring that the stent 10 is successfully released, thereby It solves the problem that the proximal or distal end of the stent 10 has been released when the stent 10 does not reach the release conditions, which causes the release position of the stent 10 to be inaccurate, resulting in a series of subsequent problems and uncertainties, and finally leads to the stent 10 The technical problem of the release failure. In order to ensure good adhesion of the stent, the diameter of the stent after fully released should be greater than 10-15% of the diameter of the blood vessel. In the existing conventional stent design, if it is released at an inaccurate position and fully opened, the stent will be difficult to move , Cannot readjust the position.

As shown in Figure 1, the stent delivery and release device 20 further includes a control member 205, which is detachably connected to the guide head 201, and the control member 205 is detachably connected to the stent proximal release assembly 204, and the stent proximal release assembly 204 passes through The control member 205 repeatedly tightens or releases the bracket.

6-8, specifically, the proximal end of the stent 10 is provided with a connecting piece 101, the proximal end of the stent 10 is provided with a connecting piece 101 in the middle of each wave crest, and the connecting piece 101 is provided in the circumferential direction of the proximal end of the stent 10 At least one circle, the control member 205 passes through the connecting member 101, so that at least a part of the control member 205 surrounds the proximal end of the stent 10 to facilitate tightening or release of the proximal end of the stent 10. The connecting piece 101 may be a coil; the connecting piece 101 may be a through hole structure 101a on the bracket 10; the connecting piece 101 may be a separate structure, the connecting piece 101 is fixedly connected to the bracket 10, and each connecting piece 101 has a through hole structure 101a; the connecting piece 101 may be a flexible pull ring fixed on the bracket 10; or the connecting piece 101 may be a piece of wire rope fixed on the bracket 10 at a circumferential interval, and there is formed between the wire rope at a fixed interval and the bracket 10 The gap for the control member 205 to pass through; or the connecting member 101 is a connecting ring with a through-hole structure provided on the bracket. The connecting piece 101 is fixedly connected to the bracket by stitching, heat sealing or welding.

Therefore, in the present application, the control member 205 is detachably connected to the proximal end release assembly 204 and the guide head 201 of the stent, and at least a part surrounds the proximal end of the stent 10, so that after the stent 10 is released once, the stent delivery release device 20 will not interact with the stent. Disengaged, the stent delivery and release device 20 can retrieve the stent 10 through the control member 205 and then readjust the release position, and then the stent 10 can be tightened or released again, which solves the problem of adjusting the stent 10 when the release position of the stent 10 is inaccurate. Then release, so that the stent 10 can be released to an accurate position. In addition, the stent delivery and release device 20 of the present application can release the stent 10 step by step through the control member 205, so that the stent 10 can be accurately positioned and the assembly stability is high.

Referring to FIG. 9, the guide head 201 includes a first main body portion 2011 and a first fixing member 2012. The first fixing member 2012 is provided at the proximal end of the first main body portion 2011, and the first fixing member 2012 and the control member 205 are detachably connected . Specifically, the distal end of the first main body portion 2011 has a tapered structure, and the first fixing member 2012 may be an anchor barb, and the anchor barb is detachably connected to the control member 205.

Please continue to refer to FIG. 4, the sheath core assembly 202 includes an inner sheath core 2021, a Luer connector 2022, a three-way valve 2023, and a three-way pipe fixing piece 2024. The three-way pipe fixing piece 2024 is a hose that is fixedly connected to the three-way valve 2023. The guide head 201 is arranged at the distal end of the inner sheath core 2021, the luer connector 2022 is connected to the tail of the inner sheath core 2021, and the inner sheath core 2021 is close to the luer connector 2022 and is provided with a three-way tube fixing member 2024 and a three-way tube fixing member 2024 along its peripheral wall. It communicates with the three-way valve 2023 through the pipe body.

The stent proximal release assembly 204 includes a sheath core fixing member 2041 that is sleeved on the outer wall of the inner sheath core 2021 to prevent the stent proximal release assembly 204 from driving the guide head 201 to move randomly when the stent is controlled to release the stent. Specifically, the sheath core fixing member 2041 includes two opposite through holes, and two ends of the control member 205 respectively pass through one through hole.

Please continue to refer to FIG. 3, the stent proximal release assembly 204 also includes a tail slide 2042. The tail slide 2042 is sleeved on the sheath core fixing member 2041 and the inner sheath core 2021. The tail slide 2042 is used to protect the inner sheath core 2021. At the same time, it plays a decorative role to prevent the inner sheath core 2021 from being exposed.

The proximal end release assembly 204 of the stent also includes an inner liner 2043 and a tail end fixing member 2044. The inner liner 2043 is sleeved on the tee fixing member 2024, and the proximal end of the inner liner 2043 is locked and fixed with the tail slide 2042. The fixing member 2044 is sleeved and fixed on the inner liner 2043.

The stent proximal release assembly 204 also includes a tail slider 2045 and a tail end rotating rod 2046. The tail end rotating rod 2046 is sleeved on the proximal end of the sheath core assembly 202, and the tail slider 2045 is sleeved on the tail end rotating rod 2046. The end rotating rod 2046 drives the tail slider 2045 to move along the extension direction of the sheath core assembly 202. In this application, the sheath core fixing member 2041 can be sleeved at any position of the distal end of the inner sheath core 2021 tail slider 2045 to fix the inner sheath core 2021 and prevent the tail slider 2045 from adjusting the axis of the control member 205 The guide head is driven to move freely when moving toward the length, thereby affecting the tightening and release of the proximal end of the stent. In a specific embodiment, the sheath core fixing member 2041 is provided between the distal end of the tail slider 2045 and the tee fixing member 2024. The tail end screw rod 2046 is sleeved on the proximal end of the inner sheath core 2021, the tail end screw rod 2046 is provided with an inner cavity, the proximal end of the inner sheath core 2021 is provided with a Luer connector 2022, and the Luer connector 2022 is provided on the tail end screw rod. In the inner cavity of 2046, the proximal end of the tail slide 2042 is also arranged in the inner cavity of the tail end rotating rod 2046. The tail end rotating rod 2046 moves along the axial movement and the circumferential rotation movement of the tail slide 2042.

Please refer to Figure 10-11, the tail end rotating rod 2046 includes a main rod part A and a rotating part B connected to the main rod part A, the tail slider 2045 is a hollow structure, and the tail slider 2045 is sleeved on the main rod A , The tail slider 2045 is threadedly connected with the main rod A, so that during the rotation of the rotating part B, the tail slider 2045 is matched with the thread of the main rod A, and the tail slider 2045 runs along the extension direction of the main rod A. To movement. Specifically, the main rod part A is externally threaded, and the tail slider 2045 is provided with internal threads, so that the tail slider 2045 is threaded with the main rod part A, and the tail screw rod is rotated. The tail screw rod drives the tail slider 2045 to rotate and make The tail slider 2045 moves axially. The outer diameter of the rotating part B is larger than the outer diameter of the main rod part A, so that the larger rotating part B facilitates the rotation, so that the tail slider 2045 can be driven to move more smoothly.

Please refer to FIG. 11, the tail slider 2045 includes a second main body C and a second fixing member D. The second fixing member D is provided on the outer side of the second main body C for connection with the control member 205. Specifically, the second fixing member D includes a fixing portion D1 and a winding portion D2, and the fixing portion D1 and the winding portion D2 are both provided on the outer wall of the second main body portion C, and are arranged opposite to each other. The fixing part D1 and the winding part D2 can be provided with round holes, and the winding part D2 is provided with two round holes. One end of the control member 205 is fixedly connected with the round hole of the fixing portion D1, and the other end of the control member 205 passes through the two round holes of the winding portion D2.

As shown in Figures 2 to 3, the stent proximal release assembly 204 also includes a tail end screw cap 2047 and a release slider cover 2048. The tail end screw cap 2047 is rotatably connected to the proximal end of the sheath assembly 203 and the release slider cover 2048. Between the distal ends of the two to release the control member 205. Specifically, the release slider cover 2048 is sleeved on the tail slide 2042, and the tail end screw cap 2047 is connected between the proximal end of the tail end fixing member 2044 and the distal end of the release slider cover 2048. Specifically, one end of the control member 205 passing through the winding part D2 is clamped between the tail end screw cover 2047 and the release slider cover 2048. After the release of the bracket 10 is completed, the tail end screw cover 2047 is unscrewed, and the control member 205 passes through the winding part D2. One end of the line D2 is released and the release slider cover 2048 drives the tail slider 2045 and the control member 205 to withdraw from the proximal end of the stent.

Please refer to FIG. 5, FIG. 12 and FIG. 13, the second fixing member D is provided on the inner wall of the release slider cover 2048 for connection with the control member 205. Specifically, the inner wall of the release slider cover 2048 is recessed with a sliding groove E along the axial direction, and the outer side of the tail slider 2045 is convex or the second fixing member D is engaged with the sliding groove E, and the tail slider 2045 can slide along during rotation and travel. The groove E slides in the extending direction to prevent the tail slider 2045 from rotating in the circumferential direction, which may cause the control member 205 to be entangled and knotted during the traveling process. In the present application, the sliding grooves E are arranged oppositely, and are respectively arranged corresponding to the fixing portion D1 and the winding portion D2, so that the fixing portion D1 and the winding portion D2 can be received in the sliding groove E, so that the fixing portion D1 and the winding portion D2 can be received in the sliding groove E. The wire parts D2 move in the respective sliding grooves E, respectively. One end of the control member 205 is fixed to the fixing portion D1, and the other end of the gathering wire passes through the winding portion D2.

12 and 13, the inner wall of the release slider cover 2048 is also recessed in the axial direction with a locking groove F, the locking groove F is provided at the distal end of the release slider cover 2048, and the groove depth is greater than the sliding groove E; The end fixing member 2044 includes a pin K that faces the release slider cover 2048 and is arranged along the axial direction. The pin K is locked and fixed in the locking groove F so that the release slider cover 2048 and the end fixing member 2044 are locked and fixed.

Please continue to refer to Figures 3 and 6-7. The sheath assembly 203 includes a multi-lumen tube 2031. The multi-lumen tube 2031 is sleeved on the outer wall of the inner sheath core 2021 and communicates with the three-way tube fixing member 2024. The multi-lumen tube 2031 is provided with There is a channel for accommodating the control member 205, and a preset distance is provided between the multi-lumen tube 2031 and the guide head 201 to prevent the control member 205 from being entangled and knotted during travel. Specifically, there is a predetermined distance between the multi-lumen tube 2031 and the guide head 201, and the end of the multi-lumen tube 2031 close to the guide head 201 has good elasticity, so that the multi-lumen tube 2031 can bend along the blood vessel, which is beneficial to the stent delivery and release device 20 through The guide wire reaches the location of the lesion. The multi-lumen tube 2031 is provided with two channels along the axial direction, and the two channels are symmetrically arranged. After the two ends of the control member 205 pass through the two channels respectively, the two through holes are respectively passed through, and then one end of the control member 205 is fixed. In the fixing portion D1, the other end passes through the winding portion D2 and passes between the pin and the engaging groove F to be exposed on the outer surface of the tail end fixing member 2044.

In this application, the multi-lumen tube 2031 is sheathed with an outer sheath tube 2132, and a space is left between the outer sheath tube 2132 and the multi-lumen tube 2031 for accommodating the stent 10 in a compressed state.

As shown in Figures 3 to 5, the sheath assembly 203 also includes an outer sheath driver 2032 and a tooth block 2033. The outer sheath driver 2032 is sleeved and fixed on the outer sheath 2132. The outer surface of the outer sheath driver 2032 The upper protrusion is provided with two stoppers 2034. There is a gap between the two stoppers 2034. The tooth block 2033 is arranged in the gap. The tooth block 2033 moves in the axial direction to drive the outer sheath drive member 2032 to move, thereby driving the outer sheath The tube 2132 moves.

Please continue to refer to FIGS. 6-8. The multi-lumen tube 2031 provides a receiving space for the control member 205 to prevent the control member 205 from being entangled with other components during movement. Specifically, the multi-lumen tube 2031 includes two through slots 2133, and one through slot 2133 is used to receive one end of the control member 205 through.

As shown in Figure 3, the sheath assembly 203 also includes a main slide 2035 and an end fixing member 2036. The end fixing member 2036 is sleeved on the distal end of the outer sheath 2132 and has a distance from the outer sheath driving member 2032. , The main slide 2035 is sleeved on the outer sheath 2132 and the outer sheath driver 2032, and the distal end of the main slide 2035 and the end fixing member 2036 are spaced apart, and the proximal end of the main slide 2035 is engaged with three The through-pipe fixing member 2024, the main slideway 2035 includes an axial opening, and two stoppers 2034 extend from the axial opening and can slide along the extension direction of the axial opening. The aforementioned inner liner 2043 of the present application is also sleeved on the proximal end of the main slideway 2035.

As shown in Figures 2 to 3, the sheath assembly 203 also includes a fixed handle 2037 and a button 2038. The fixed handle 2037 is provided outside the multi-lumen tube 2031 and the main slideway 2035, and the distal end of the fixed handle 2037 is clamped to the end. The fixing member 2036 and the main slide 2035 further include a button 2038 opening, the fixed handle 2037 includes an engaging opening, the button 2038 opening is arranged opposite to the engaging opening, and the button 2038 is engaged in the engaging opening and the button 2038 opening.

The sheath assembly 203 also includes a sliding handle 2039 and a sliding handle screw cover 2131. The sliding handle 2039 is sleeved outside the main slideway 2035. The sliding handle screw cover 2131 is rotatably connected to the distal end of the sliding handle 2039 and the proximal end of the fixed handle 2037. In between, the sliding handle 2039 and the fixed handle 2037 are locked and fixed by a button 2038.

The button 2038 includes a head G and a rod H connected to the head G. The rod H extends into the engaging opening and the opening of the button 2038. The head G is provided with a hook G1, and the inner wall of the sliding handle 2039 is provided with protrusions. , The hook G1 is engaged with the protrusion, so that the sliding handle 2039 and the fixed handle 2037 are engaged and fixed. Specifically, the inner wall of the distal end of the sliding handle 2039 is recessed with a ring-shaped protrusion, and the hook G1 penetrates the protrusion of the inner wall of the distal end of the sliding handle 2039 through the sliding handle rotating cover 2131 and is inverted.

When the stent needs to be released, the outer sheath 2132 is retracted to expose a part of the stent 10, press the button 2038, the button 2038 is separated from the sliding handle 2039, the sliding handle 2039 is threadedly connected with the tooth block 2033, and the tooth block can be driven by turning the sliding handle 2039 2033 rotates and moves the tooth block 2033 in the axial direction, thereby adjusting the movement of the outer sheath 2132. This is the slow movement of the outer sheath 2132 to release the proximal end of the stent in the compressed state, and then release the assembly through the proximal end of the stent 204 adjusts the release amount of the control member 205 to finely control the release of the proximal end of the stent to ensure the accuracy of the release position of the proximal end of the stent, and when the release of the proximal end of the stent is not accurate, the proximal end of the stent 10 can be recovered and then the release position can be readjusted After repeatedly tightening and releasing the proximal end of the stent, the proximal end of the stent 10 is finally released to an accurate position. When the proximal end of the stent is accurately released, the outer sheath 2132 continues to withdraw to expose all the stents. Press the button 2038, and the button 2038 separates from the sliding handle 2039. The surgeon can control the sliding handle 2039 and the sliding handle to rotate the cover 2131 along. The main slide 2035 moves to drive the tooth block 2033 and the outer sheath 2132 to move, instead of rotating the sliding handle 2039 assembly to move the tooth block 2033 and the outer sheath 2132, this movement method is faster, that is, the outer sheath 2132 Quick movement, convenient for quick release of the distal end of the stent after accurate release of the proximal end of the stent.

Therefore, the control member 205 of the present application passes through the multiple connecting members 101 in turn, the two ends of the control member 205 pass through different winding holes, and one of the thread ends passes through the passage of the multi-lumen tube 2031 and the passage of the sheath core fixing member 2041. The hole is fixed to the fixed part D1 of the tail slider 2045, and the other thread end passes through the other channel of the multi-lumen tube 2031 and the other through hole of the sheath core fixing member 2041, and then passes through the winding part D2 of the tail slider 2045 After passing through the two round holes in the opposite direction between the plug and the engaging groove F, they are exposed on the outer surface of the proximal end fixing member 2044. Therefore, when the tail end rotating rod 2046 rotates to drive the tail slider 2045 to move away from the guide head 201, the control member 205 shrinks and closes the proximal end of the bracket provided with the connecting piece 101 close to the guide head 201. When the tail end rotating rod 2046 rotates to drive When the tail slider 2045 moves close to the guide head 201, the control member 205 expands to expand the proximal end of the stent provided with the connecting member 101. In addition, the stent may not be provided with the connecting piece 101, and the control piece 205 directly passes through the wave crest at the proximal end of the stent in turn, and can also adjust the stent contraction and expansion. The control piece 205 may be thin wires and other flexible and tensile strength. Slender structure.

The control member 205 will be described as follows. The control member 205 is a flexible slender structure, or a combination of a flexible slender structure and a rigid slender structure. The material of the control member 205 includes, but is not limited to, polymer materials, fiber materials, metal materials, and the like. Optionally, the diameter of the flexible elongated member is in the range of 0.1-0.4 mm; the diameter of the rigid elongated member is in the range of 0.1-0.4 mm.

In a specific embodiment, the control member 205 is a flexible elongated member, the second fixing member D is provided with two channels, two ends of the control member 205 pass through the two channels respectively, and one end of the control member 205 passes through The other end of the first fixing member 2012 is detachably fixed to the second fixing member D. After the stent is released, one end of the control member 205 is detached from the second fixing member D and pulled out of the channel, and finally withdrawn from the body together with the stent delivery and release device 20 .

Please refer to FIGS. 7 and 13-14. In another specific embodiment, the control member 205 is a flexible elongated member and a rigid elongated member, and the first fixing member 2012 is provided with a fixed wire groove N With a channel, one end of the flexible elongated member is sleeved at the distal end of the rigid elongated member, the distal end of the rigid elongated member is clamped in the fixing wire groove N, and the other end of the flexible elongated member passes through the channel and is fixed to the first fixing member 2012. The proximal end of the rigid elongated member is detachably fixed to the first fixing member 2012. After the stent is released, the rigid elongated member is removed to release the flexible thin member, and finally the control member 205 and the stent delivery and release device 20 are withdrawn from the body. The difference between this embodiment and the previous embodiment is that the control member 205 is a flexible elongated member and a rigid elongated member, and the first fixing member 2012 is a through hole and a fixed wire groove. The distal end of the rigid elongated member is clamped in the fixing wire groove, and the distal end of the flexible elongated member is sleeved in the middle part of the fixing wire groove of the rigid elongated member. As shown in Figures 13-14, the second fixing member D is a winding part D2 provided on the outer wall of the tail slider 2045 and a fixing hole provided on the inner wall of the release slider cover 2048. The proximal end of the flexible elongated member passes through The hole is connected with the winding part D2 of the tail slider 2045, the proximal end of the rigid elongated piece penetrates the fixing hole inside the release slider cover 2048, and the fixing hole is provided with two threaded holes to fix the rigid elongated piece by connecting with screws When the inner wall of the slider cover 2048 is released, the stability of the rigid elongated member is ensured when the flexible elongated member is pulled to control the release of the proximal end of the stent. The delivery and release sequence of the stent in this embodiment is the same as that in the previous embodiment. The improvement is that in this embodiment, the path of the flexible elongated member withdrawn from the control member 205 is halved and the time is halved, which reduces the process of adjusting the stent release by the flexible control member 205. The risk of entanglement in the middle knot reduces the length of the operation and improves the efficiency and safety.

The following describes the delivery and release of the stent by the stent delivery and release device 20 roughly in the following order:

The stent is retracted to the position of the guide head 201, and the outer sheath 2132 is close to the guide head 201. At this time, the control member 205 is detachably connected to the guide head 201, and one end of the flexible elongated piece sequentially passes through the other end of the connecting piece 101 at the proximal end of the stent It is fixed to the winding part D2 of the tail slider 2045, and the rigid elongated member is fixed to the fixing hole inside the release slider cover 2048. And the tail slider 2045 is at the proximal end of the tail end rotating rod 2046 so that the control member 205 is in a tight state;

The stent delivery and release device 20 guides the stent through the delivery system to the diseased location of the aorta along the guide wire implanted in the human body, drives the outer sheath driver 2032 to move the outer sheath 2132 away from the guide head 201, and moves the proximal end of the stent Expose, adjust the stent proximal release assembly 204 to release the stent proximal end. When the stent release position is inaccurate, the adjustment control member 205 shrinks to retract the stent to the first fixing member 2012 of the guide head 201, and then fine-tune the stent delivery release device 20 , Align the stent with the lesion position again, and then release the proximal end of the stent.

When the proximal release position of the stent is accurate, hold the proximal end fixing member 2044 firmly, unscrew the tail end screw cap 2047, and then slowly move the release slider cap 2048 axially away from the guide head 201 by at least 100mm, As a result, the tail slider 2045, the tail end rotating rod 2046, and the control member 205 are withdrawn from the outside of the multi-lumen tube 2031 into the multi-lumen tube 2031 together.

When the control member 205 enters the multi-lumen tube 2031, press the button 2038 while quickly moving the sliding handle 2039 to move the outer sheath 2132 and release the distal end of the stent; after the release is completed, the stent delivery and release device 20 is withdrawn from the human body.

Therefore, the release of the stent by the stent delivery and release device 20 realizes a multi-stage release mode that releases the proximal end first and then releases the distal end. In addition, the proximal release assembly can retract and release the stent multiple times, thereby ensuring that the stent is properly released. Releasing to the appropriate lesion position ensures the therapeutic effect of the stent and avoids a series of problems caused by the deviation of the stent release position.

The above-disclosed are only the preferred embodiments of the present invention. Of course, the scope of rights of the present invention cannot be limited by this. Those of ordinary skill in the art can understand all or part of the procedures for implementing the above-mentioned embodiments and make them in accordance with the claims of the present invention. The equivalent changes of is still within the scope of the invention.

Claims

A stent delivery and release device for releasing a stent in a blood vessel, characterized by comprising: a guide head, a sheath core assembly, a sheath tube assembly, a control member, and a stent proximal release assembly. The guide head is arranged on the sheath The distal end of the core assembly, the proximal end release assembly of the stent is arranged at the proximal end of the sheath core assembly, the sheath tube assembly is sleeved on the sheath core assembly, the control member is detachably connected with the guide head, so The proximal end release assembly of the stent repeatedly tightens or releases the proximal end of the stent by controlling the axial length of the control member.
The stent delivery and release device according to claim 1, wherein the control member is a flexible slender structure, or a combination of a flexible slender structure and a rigid slender structure.
The stent delivery and release device according to claim 1, wherein the guide head comprises a first main body and a first fixing member, the first fixing member is provided at a proximal end of the first main body, and The first fixing part is detachably connected to the control part.
The stent delivery and release device according to claim 3, wherein the first fixing member is provided with a through hole, a barb, a slot or a combination thereof for fixing the control member.
The stent delivery and release device according to claim 1, wherein the control member is detachably connected to the proximal release assembly of the stent.
The stent delivery and release device according to claim 5, wherein the proximal end release assembly of the stent comprises a tail slider and a tail end rotating rod, and the tail end rotating rod is sleeved on the proximal end of the sheath core assembly The tail slider is sleeved on the tail end rotating rod, and the tail end rotating rod drives the tail slider to move along the extension direction of the sheath core assembly.
The stent delivery and release device according to claim 6, wherein the tail slider includes a second main body and a second fixing member, and the second fixing member is provided on the outside of the second main body. The control member is connected.
The stent delivery and release device according to claim 7, wherein the tail end rotating rod includes a main rod part and a rotating part connected with the main rod part, and the tail slider is a hollow structure along the main rod. The rod thread cooperates with movement.
The stent delivery and release device according to claim 7, wherein the proximal end release assembly of the stent further comprises a tail end screw cap and a release slider cover, and the tail end screw cap is rotatably connected to the sheath assembly. Between the proximal end and the distal end of the release slider cover, it is used to release the control member.
The stent delivery and release device according to claim 9, wherein the second fixing member is provided on the inner wall of the release slider cover for connection with the control member.
The stent delivery and release device according to claim 10, wherein the inner wall of the release slider cover is recessed with a sliding groove along the axial direction, and the outer side of the tail slider is convex or the second fixing member is engaged with The sliding groove can slide along the extending direction of the sliding groove during the rotation and travel of the tail slider, so as to prevent the control member from being entangled and knotted during the travel.
The stent delivery and release device according to claim 7, wherein the proximal end release assembly of the stent further comprises a sheath core fixing member which is provided at the distal end of the tail slider to prevent the stent The proximal release component drives the guide head to move freely when the stent is controlled to release.
The stent delivery and release device according to claim 12, wherein the sheath core assembly comprises an inner sheath core, a Luer connector, a three-way valve and a three-way tube fixing member, and the guide head is arranged at the distal end of the inner sheath core. The sheath core fixing part is sleeved on the outer wall of the inner sheath core, the luer connector is connected to the tail of the inner sheath core, and the inner sheath core is close to the luer connector end and a tee fixing part is arranged along its peripheral wall. The through-pipe fixing part communicates with the three-way valve through the pipe body.
The stent delivery and release device according to claim 13, wherein the sheath tube assembly comprises a multi-lumen tube, the multi-lumen tube is sleeved on the outer wall of the inner sheath core and is connected to the three-way tube fixing member The multi-lumen tube is provided with a channel for accommodating the control member, and there is a preset distance between the multi-lumen tube and the guide head to prevent the control member from being entangled and knotted during the traveling process.
A stent delivery and release system, wherein the stent delivery and release system comprises a stent, and the stent delivery and release device according to any one of claims 7-14, and the stent delivery and release device is used to control the stent The proximal end of the control member is radially contracted or expanded, the control member is a flexible elongated member, the second fixing member is provided with two channels, and the two ends of the control member respectively pass through the two channels, so One end of the control member is fixed to the guide head, and the other end is detachably fixed to the second fixing member.
A stent delivery and release system, wherein the stent delivery and release system comprises a stent, and the stent delivery and release device according to any one of claims 7-14, and the control member is a flexible elongated piece and A rigid elongated member, the guide head is provided with a fixed wire groove and a channel, one end of the flexible elongated member is sleeved at the distal end of the rigid elongated member, and the distal end of the rigid elongated member is clamped in In the fixing wire groove, the other end of the flexible elongated member passes through the channel and is fixed to the guide head, and the proximal end of the rigid elongated member is detachably fixed to the guide head.