Stent delivery and release device and stent delivery and release system

Abstract

The present invention provides a stent delivery and release device for releasing a stent into a blood vessel, comprising: a guide head, a sheath core assembly, a sheath tube assembly, a control member, and a stent proximal release assembly, wherein the guide head is arranged at the distal end of the sheath core assembly, the stent proximal release assembly 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, and the stent proximal release assembly repeatedly tightens or releases the proximal end of the stent by controlling the axial length of the control member. The present invention solves the technical problem that the proximal or distal end of the stent is released before the release condition is met, resulting in inaccurate stent release position and ultimately stent release failure.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a stent delivery and release device and a stent delivery and release system. Background Art

[0002] Endovascular repair of thoracic and abdominal vascular disease is an effective treatment option that has gained tremendous popularity over the past decade. A covered stent is an implantable device consisting of a tubular surgical sheath and a self-expanding frame. The stent is released into the vessel segment requiring repair through the coordination of a delivery system. Placed within the vessel, the stent can occlude the aneurysm and reconstruct the blood flow pathway, preventing hemodynamic pressure from reaching the site of vascular lesions. Because true aneurysms, false aneurysms, and dissecting aneurysms are all caused by varying degrees of damage and lesions in the blood vessels, the inherent morphology of the vessels may be irregular, requiring a delivery system with good insertion performance.

[0003] The method for implanting an aortic stent is to compress the stent into a delivery and release device, then implant a guidewire through a minimally invasive incision in the femoral artery. The stent is then delivered to the lesion site of the aorta via a delivery system along the guidewire previously implanted in the human body. After being delivered to the exact lesion site with the assistance of imaging equipment, the stent is released and implanted into the lesion site. A common problem encountered by surgeons during the operation is that due to unstable instrument operation, complex vascular structure, narrow surgical field of view, etc., the proximal or distal end of the stent is released before the release conditions are met, resulting in inaccurate stent release position, a series of subsequent problems and uncertainties, and ultimately the failure of stent release. The delivery system needs to be able to accurately and easily introduce, accurately and safely release, and easily and easily withdraw. Summary of the Invention

[0004] 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 technical problem that the proximal end or distal end of the stent is released before the release conditions are met, resulting in inaccurate stent release position and ultimately leading to stent release failure.

[0005] The present invention provides a stent delivery and release device for releasing a stent into a blood vessel, comprising: a guide head, a sheath core assembly, a sheath tube assembly, a control component and a stent proximal end release component, wherein the guide head is arranged at the distal end of the sheath core assembly, the stent proximal end release component is arranged at the proximal end of the sheath core assembly, the sheath tube assembly is sleeved on the sheath core assembly, the control component is detachably connected to the guide head, and the stent proximal end release component repeatedly tightens or releases the proximal end of the stent by controlling the axial length of the control component.

[0006] Wherein, the control member is a flexible and slender structure, or a combination of a flexible and slender structure and a rigid and slender structure.

[0007] Wherein, the guide head includes a first main body and a first fixing member, the first fixing member is arranged at the proximal end of the first main body, and the first fixing member is detachably connected to the control member.

[0008] Wherein, the first fixing member is provided with a through hole, a barb, a slot or a combination thereof for fixing the control member.

[0009] Wherein, the control member is detachably connected to the proximal release assembly of the stent.

[0010] Among them, the proximal release assembly of the bracket includes a tail slider and a tail rotary rod, the tail rotary rod is sleeved on the proximal end of the sheath core assembly, the tail slider is sleeved on the tail rotary rod, and the tail rotary rod drives the tail slider to move along the extension direction of the sheath core assembly.

[0011] The tail slider includes a second main body and a second fixing member, and the second fixing member is arranged on the outside of the second main body for connection with the control member.

[0012] The tail end rotary rod comprises a main rod portion and a rotating portion connected to the main rod portion, and the tail slider is a hollow structure that moves along the threaded portion of the main rod portion.

[0013] The proximal end release assembly of the stent further comprises a tail end rotary cover and a release slider cover, wherein the tail end rotary cover is rotatably connected between the proximal end of the sheath assembly and the distal end of the release slider cover for releasing the control member.

[0014] Wherein, the second fixing member is arranged on the inner wall of the release slider cover for connection with the control member.

[0015] Among them, the inner wall of the release slider cover is axially recessed with a sliding groove, the outer protrusion of the tail slider or the second fixing member is engaged with the sliding groove, and the tail slider can slide along the extension direction of the sliding groove during rotation to prevent the control member from being entangled and knotted during movement.

[0016] The proximal end release assembly of the stent further includes a sheath core fixing part, which is arranged at the distal end of the tail slider to prevent the proximal end release assembly of the stent from driving the guide head to move arbitrarily when controlling the release of the stent.

[0017] Among them, the sheath core assembly includes an inner sheath core, a Luer connector, a three-way valve and a three-way tube fixing part. 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 a three-way tube fixing part is arranged along the peripheral wall of the inner sheath core near the Luer connector end. The three-way tube fixing part is connected to the three-way valve through the tube body.

[0018] Among them, the sheath tube assembly includes a multi-lumen tube, which is sleeved on the outer wall of the inner sheath core and connected to the three-way tube fixing piece. The multi-lumen tube is provided with a channel for accommodating the control piece. There is a preset distance between the multi-lumen tube and the guide head to prevent the control piece from getting entangled and knotted during movement.

[0019] The present invention provides a stent delivery and release system, which includes a stent and the above-mentioned stent delivery and release device, and the stent delivery and release device is used to control the proximal radial contraction or expansion of the stent.

[0020] The control member is a flexible and slender member, the second fixing member is provided with two channels, the two ends of the control member pass through the two channels respectively, one end of the control member is fixed to the guide head, and the other end is detachably fixed to the second fixing member.

[0021] In which, the control member is a flexible slender member and a rigid slender member, the guide head is provided with a fixed wire groove and a channel, one end of the flexible slender member is sleeved on the distal end of the rigid slender member, the distal end of the rigid slender member is stuck in the fixed wire groove, the other end of the flexible slender member passes through the channel and is fixed to the guide head, and the proximal end of the rigid slender member is detachably fixed to the guide head.

[0022] To sum up, the proximal release component of the stent of the present application repeatedly tightens or releases the stent, that is, the proximal release component of the stent can repeatedly tighten and release the stent multiple times, and the stent can be released to the exact lesion position, and the stent is released successfully, thereby solving the technical problem that the proximal or distal end of the stent is released before the release conditions are met, resulting in inaccurate stent release position, a series of subsequent problems and uncertainties, and ultimately leading to stent release failure. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0024] Figure 1 It is a structural schematic diagram of the stent delivery and release system provided by the present invention.

[0025] Figure 2 yes Figure 1 Schematic diagram of the structure of the stent delivery and release device.

[0026] Figure 3 yes Figure 2 Schematic diagram of the exploded structure of the stent delivery and release device.

[0027] Figure 4 yes Figure 3 Schematic diagram of some structures in .

[0028] Figure 5 yes Figure 4 Schematic diagram of the cross-section of part of the structure.

[0029] Figure 6 yes Figure 1 A structural schematic diagram of an enlarged portion M in FIG.

[0030] Figure 7 yes Figure 1 Another structural schematic diagram of the enlarged M part.

[0031] Figure 8 yes Figure 1 Schematic diagram of the top view structure of the M part.

[0032] Figure 9 yes Figure 2 Schematic diagram of the structure of the guide head.

[0033] Figure 10 yes Figure 2 Schematic diagram of the structure of the tail rotating rod.

[0034] Figure 11 yes Figure 2 A structural diagram of the tail slider in .

[0035] Figure 12 yes Figure 2 Schematic diagram of the structure of the tail release slider cover.

[0036] Figure 13 yes Figure 2 Schematic diagram of the structure of the tail end fixing.

[0037] Figure 14 yes Figure 2 Another structural diagram of the tail slider in .

[0038] Figure 15 yes Figure 2 Schematic diagram of the structure of the release slider cover. DETAILED DESCRIPTION

[0039] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0040] It should be noted that, for stents, the end closer to the heart after implantation in a blood vessel is generally referred to as the "proximal end" of the stent, and the end farther from the heart after implantation in a blood vessel is referred to as the "distal end" of the stent. Based on this principle, the "proximal end" and "distal end" of any component of the stent are defined. For a delivery device, the end relatively closer to the operator is generally referred to as the "proximal end", and the end relatively farther from the operator is generally referred to as the "distal end". Based on this principle, the "proximal end" and "distal end" of any component of the delivery system are defined. "Axial" generally refers to the length direction of the stent when being delivered, and "radial" generally refers to the direction of the stent perpendicular to its "axial direction". Based on this principle, the "axial" and "radial" of any component of the stent graft are defined.

[0041] See also 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 and release device 20. The stent delivery and release device 20 is used to control the radial contraction or expansion of the proximal end of the stent 10, thereby releasing the stent 10 into the blood vessel. The stent delivery and release device 20 can repeatedly tighten or release the stent 10 to adjust its implantation position, accurately releasing the stent 10 onto the inner wall of the vascular lumen and achieving the therapeutic function of the intraluminal stent 10. The stent delivery and release device 20 will be described in detail below.

[0042] See also Figure 2-Figure 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 arranged at the distal end of the sheath core assembly 202, the stent proximal release assembly 204 is arranged at the proximal end of the sheath core assembly 202, the sheath tube 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 to the treatment site in the blood vessel.

[0043] The stent proximal release assembly 204 of the present application repeatedly tightens or releases the stent 10, that is, after the stent proximal release assembly 204 tightens and releases the stent 10 multiple times, the stent 10 can be accurately released to the lesion position, ensuring the successful release of the stent 10, thereby solving the technical problem that the proximal or distal end of the stent 10 is released before the release conditions are met, resulting in an inaccurate release position of the stent 10, a series of subsequent problems and uncertainties, and ultimately leading to the failure of the release of the stent 10. In order to ensure good wall adhesion, the diameter of the stent after full release should be greater than 10-15% of the blood vessel diameter. In existing conventional stent designs, if the stent is fully opened after being released at an inaccurate position, it will be difficult to move and unable to readjust its position.

[0044] like Figure 1 As shown, the stent delivery and release device 20 also includes a control member 205, which is detachably connected to the guide head 201 and the stent proximal release assembly 204. The stent proximal release assembly 204 repeatedly tightens or releases the stent through the control member 205.

[0045] See also Figure 6-Figure 8 Specifically, a connector 101 is provided at the proximal end of the stent 10. A connector 101 is provided at the middle of each crest of the proximal end of the stent 10, and the connector 101 is provided in at least one circumferential circle around the proximal end of the stent 10. The control member 205 passes through the connector 101, so that at least a portion of the control member 205 surrounds the proximal end of the stent 10, facilitating tightening or loosening of the proximal end of the stent 10. The connector 101 may be a coil; the connector 101 may be a through-hole structure 101a on the stent 10; the connector 101 may be a separate structure, fixedly connected to the stent 10, each connector 101 having a through-hole structure 101a; the connector 101 may be a flexible pull ring fixed to the stent 10; or the connector 101 may be a section of string fixed to the stent 10 at intervals along the circumference, with a gap formed between the string and the stent 10 for the control member 205 to pass through; or the connector 101 may be a connecting ring provided on the stent with a through-hole structure. The connector 101 is fixedly connected to the bracket by suturing, heat sealing or welding.

[0046] Thus, the present application is detachably connected to the proximal release assembly 204 and the guide head 201 of the stent through the control member 205, and at least a portion surrounds the proximal end of the stent 10, so that after the stent 10 is released once, the stent delivery and release device 20 will not be separated from the stent. The stent delivery and release device 20 can recycle the stent 10 and readjust the release position through the control member 205, and then can re-tighten or release the stent 10, solving the problem of adjusting and releasing the stent 10 when the release position of the stent 10 is inaccurate, so that the stent 10 can be released to the correct position. In addition, the stent delivery and release device 20 of the present application can release the stent 10 in steps through the control member 205, so that the stent 10 can be accurately positioned and the assembly stability is high.

[0047] See also Figure 9 The guide head 201 includes a first main body 2011 and a first fixing member 2012. The first fixing member 2012 is disposed at the proximal end of the first main body 2011 and is detachably connected to the control member 205. Specifically, the distal end of the first main body 2011 has a tapered structure, and the first fixing member 2012 can be an anchoring barb that is detachably connected to the control member 205.

[0048] Please continue reading Figure 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 tube fixing part 2024. The three-way tube fixing part 2024 is a hose fixedly connected to the three-way valve. 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. The inner sheath core 2021 is close to the Luer connector 2022 and a three-way tube fixing part 2024 is arranged along its peripheral wall. The three-way tube fixing part 2024 is connected to the three-way valve 2023 through the tube body.

[0049] The proximal stent release assembly 204 includes a sheath core retainer 2041, which is mounted on the outer wall of the inner sheath core 2021 to prevent the proximal stent release assembly 204 from causing the guide head 201 to move arbitrarily when controlling the stent release. Specifically, the sheath core retainer 2041 includes two opposing through-holes, one of which passes through each end of the control member 205.

[0050] Please continue reading Figure 3 The proximal release assembly 204 of the stent also includes a tail slide 2042, which is sleeved on the sheath core fixing piece 2041 and the inner sheath core 2021. The tail slide 2042 is used to protect the inner sheath core 2021 and also serves as a decoration to prevent the inner sheath core 2021 from being exposed.

[0051] The proximal release assembly 204 of the stent also includes an inner liner 2043 and a tail end fixing piece 2044 . The inner liner 2043 is sleeved on the three-way pipe fixing piece 2024 , and the proximal end of the inner liner 2043 is engaged and fixed with the tail slide 2042 . The tail end fixing piece 2044 is sleeved and fixed on the inner liner 2043 .

[0052] The stent proximal release assembly 204 also includes a tail slider 2045 and a tail rotary rod 2046. The tail rotary rod 2046 is mounted on the proximal end of the sheath core assembly 202, and the tail slider 2045 is mounted on the tail rotary rod 2046. The tail rotary rod 2046 drives the tail slider 2045 to move along the extension direction of the sheath core assembly 202. In the present application, the sheath core fixing member 2041 can be mounted at any position on the distal end of the tail slider 2045 of the inner sheath core 2021 to fix the inner sheath core 2021 and prevent the tail slider 2045 from driving the guide head to move arbitrarily when adjusting the axial length of the control member 205, thereby affecting the tightening and release of the proximal end of the stent. In a specific embodiment, the sheath core fixing member 2041 is located between the distal end of the tail slider 2045 and the three-way pipe fixing member 2024. The tail end rotating rod 2046 is sleeved on the proximal end of the inner sheath core 2021. The tail end rotating rod 2046 has an inner cavity. The proximal end of the inner sheath core 2021 is provided with a Luer connector 2022. The Luer connector 2022 is disposed in the inner cavity of the tail end rotating rod 2046. The proximal end of the tail slide 2042 is also disposed in the inner cavity of the tail end rotating rod 2046. The tail end rotating rod 2046 moves axially and rotates circumferentially along the tail slide 2042.

[0053] See also Figure 10-11 The tail end rotary rod 2046 includes a main rod portion A and a rotating portion B connected to the main rod portion A. The tail slider 2045 is a hollow structure. The tail slider 2045 is sleeved on the main rod portion A and is threadedly connected to the main rod portion A. Therefore, during the rotation of the rotating portion B, the tail slider 2045 moves circumferentially along the extension direction of the main rod portion A through the threaded engagement between the tail slider 2045 and the main rod portion A. Specifically, the main rod portion A is externally threaded, and the tail slider 2045 is internally threaded, so that the tail slider 2045 is threadedly connected to the main rod portion A. Rotating the tail rotary rod drives the tail slider 2045 to rotate and axially move the tail slider 2045. The outer diameter of the rotating portion B is larger than the outer diameter of the main rod portion A. Therefore, the larger rotating portion B is easier to rotate, thereby more smoothly driving the tail slider 2045 to move.

[0054] See also Figure 11The tail slider 2045 includes a second main body portion C and a second fixing member D. The second fixing member D is located on the outside of the second main body portion C and is connected to the control member 205. Specifically, the second fixing member D includes a fixing portion D1 and a winding portion D2. The fixing portion D1 and the winding portion D2 are both located on the outer wall of the second main body portion C and are arranged opposite each other. The fixing portion D1 and the winding portion D2 can be provided with circular holes, wherein the winding portion D2 is provided with two circular holes. One end of the control member 205 is fixedly connected to the circular hole of the fixing portion D1, and the other end of the control member 205 passes through the two circular holes of the winding portion D2.

[0055] The stent proximal release assembly 204 also includes a tail end rotary cover 2047 and a release slider cover 2048. The tail end rotary cover 2047 is rotatably connected between the proximal end of the sheath assembly 203 and the distal end of the release slider cover 2048, and is used to release the control member 205. Specifically, the release slider cover 2048 is mounted on the tail slide 2042, and the tail end rotary cover 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 passes through the winding portion D2 and is trapped between the tail end rotary cover 2047 and the release slider cover 2048. After the stent 10 is released, the tail end rotary cover 2047 is unscrewed, and the end of the control member 205 passing through the winding portion D2 is released and withdrawn, thereby retracting the release slider cover 2048 and driving the tail slider 2045 and the control member 205 away from the proximal end of the stent.

[0056] See also Figure 5 、 Figure 12 and Figure 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 provided with a sliding groove E along the axial direction, and the outer protrusion of the tail slider 2045 or the second fixing member D is engaged with the sliding groove E. During the rotation process of the tail slider 2045, it can slide along the extension direction of the sliding groove E to prevent the tail slider 2045 from rotating circumferentially and causing the control member 205 to be entangled and knotted during the movement. In the present application, the sliding grooves E are arranged relative to each other and are respectively arranged corresponding to the fixing part D1 and the winding part D2, so that the fixing part D1 and the winding part D2 can both be accommodated in the sliding groove E, thereby allowing the fixing part D1 and the winding part D2 to move respectively in their respective sliding grooves E. One end of the control member 205 is fixed to the fixing part D1, and the other end of the gathering line passes through the winding part D2.

[0057] See also Figure 12 and Figure 13 The inner wall of the release slider cover 2048 is further provided with an axially recessed locking groove F, which is provided at the distal end of the release slider cover 2048 and has a groove depth greater than the sliding groove E; the tail end fixing piece 2044 includes a latch pin K disposed axially toward the release slider cover 2048, and the latch pin K is engaged and fixed in the locking groove F, so that the release slider cover 2048 is engaged and fixed with the tail end fixing piece 2044.

[0058] Please continue reading Figure 3 、 Figure 6-Figure 7 The sheath assembly 203 includes a multi-lumen tube 2031, which is sheathed over the outer wall of the inner sheath core 2021 and communicates with the three-way pipe fixture 2024. The multi-lumen tube 2031 has a channel for accommodating the control member 205. A predetermined distance exists between the multi-lumen tube 2031 and the guide head 201 to prevent the control member 205 from becoming entangled or knotted during its travel. Specifically, a predetermined distance exists between the multi-lumen tube 2031 and the guide head 201. The end of the multi-lumen tube 2031 near the guide head 201 is highly elastic, allowing the multi-lumen tube 2031 to bend along the blood vessel, facilitating the stent delivery and release device 20 to reach the lesion site via the guidewire. Two channels are axially arranged in the multi-lumen tube 2031, and the two channels are symmetrically arranged. The two ends of the control member 205 pass through the two channels respectively, and then pass through the two through holes respectively. Then, one end of the control member 205 is fixed to the fixing part D1, and the other end passes through the winding part D2 and passes through the pin and the engaging groove F to be exposed on the outer surface of the tail end fixing member 2044.

[0059] In the present application, an outer sheath 2132 is provided outside the multi-lumen tube 2031 , and a space is reserved between the outer sheath 2132 and the multi-lumen tube 2031 for accommodating the stent 10 in a compressed state.

[0060] The sheath tube assembly 203 also includes an outer sheath tube driver 2032 and a tooth block 2033. The outer sheath tube driver 2032 is fixed on the outer sheath tube 2132. Two stop blocks 2034 are protruding from the outer surface of the outer sheath tube driver 2032. There is a gap between the two stop blocks 2034. The tooth block 2033 is arranged in the gap. The tooth block 2033 moves axially to drive the outer sheath tube driver 2032 to move, and then drive the outer sheath tube 2132 to move.

[0061] Please continue reading Figure 6-Figure 8 The multi-lumen tube 2031 provides a space for accommodating the control member 205 to prevent the control member 205 from getting tangled with other components during movement. Specifically, the multi-lumen tube 2031 includes two through slots 2133, one of which is used to accommodate one end of the control member 205.

[0062] The sheath assembly 203 further includes a main slide 2035 and an end fixture 2036. The end fixture 2036 is sleeved on the distal end of the outer sheath 2132 and is spaced apart from the outer sheath driver 2032. The main slide 2035 is sleeved on the outer sheath 2132 and the outer sheath driver 2032, and a distance is provided between the distal end of the main slide 2035 and the end fixture 2036. The proximal end of the main slide 2035 is engaged with the tee fixture 2024. The main slide 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 above-mentioned liner 2043 of the present application is also sleeved on the proximal end of the main slide 2035.

[0063] The sheath assembly 203 also includes a fixed handle 2037 and a button 2038. The fixed handle 2037 is arranged outside the multi-lumen tube 2031 and the main slide 2035, and the distal end of the fixed handle 2037 is clamped to the end fixing piece 2036. The main slide 2035 also includes a button 2038 opening. The fixed handle 2037 includes a clamping opening. The button 2038 opening is arranged opposite to the clamping opening, and the button 2038 is clamped in the clamping opening and the button 2038 opening.

[0064] The sheath assembly 203 also includes a sliding handle 2039 and a sliding handle rotary cover 2131. The sliding handle 2039 is mounted outside the main slide 2035. The sliding handle rotary cover 2131 is rotatably connected between the distal end of the sliding handle 2039 and the proximal end of the fixed handle 2037. The sliding handle 2039 and the fixed handle 2037 are fixed by engaging with the button 2038.

[0065] The button 2038 includes a head G and a rod H connected to the head G. The rod H extends into the engagement opening and the button 2038 opening. The head G is provided with a hook G1. The inner wall of the sliding handle 2039 is provided with a protrusion. The hook G1 engages with the protrusion to secure the sliding handle 2039 to the fixed handle 2037. Specifically, the distal inner wall of the sliding handle 2039 is recessed with an annular protrusion. The hook G1 passes through the sliding handle screw cap 2131 and is invertedly engaged with the protrusion on the distal inner wall of the sliding handle 2039.

[0066] When the bracket needs to be released, the outer sheath 2132 retreats to expose a portion of the bracket 10, and the button 2038 is pressed. The button 2038 is separated from the sliding handle 2039, and the sliding handle 2039 is threadedly connected to the tooth block 2033. Rotating the sliding handle 2039 can drive the tooth block 2033 to rotate and move the tooth block 2033 axially, 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 bracket in the compressed state, and then adjust the release amount of the control part 205 through the proximal end release component 204 of the bracket to finely control the release of the proximal end of the bracket to ensure the accuracy of the proximal end release position of the bracket. If the release is inaccurate once, the proximal end of the bracket 10 can be recovered and the release position can be readjusted. After repeatedly tightening and releasing the proximal end of the bracket, the proximal end of the bracket 10 is finally released to the accurate position. When the proximal end of the stent is accurately released, the outer sheath 2132 continues to retreat to expose all the stents, and the button 2038 is pressed. The button 2038 is separated from the sliding handle 2039. The surgeon can control the sliding handle 2039 and the sliding handle screw cap 2131 to move along the main slide 2035 to drive the tooth block 2033 and the outer sheath 2132 to move, instead of moving the tooth block 2033 and the outer sheath 2132 by rotating the sliding handle 2039 assembly. This movement method is faster, that is, the rapid movement of the outer sheath 2132, which facilitates the rapid release of the distal end of the stent after the proximal end of the stent is accurately released.

[0067] Thus, the control member 205 of the present application sequentially passes through the plurality of connectors 101, and the two ends of the control member 205 pass through different winding holes. One of the wire ends passes through the channel of the multi-lumen tube 2031 and the through hole of the sheath-core fixing member 2041, and is fixed to the fixing portion D1 of the tail slider 2045. The other wire end passes through another channel of the multi-lumen tube 2031 and another through hole of the sheath-core fixing member 2041, and then passes through two circular holes of the winding portion D2 of the tail slider 2045, and then passes in the opposite direction between the latch and the engaging groove F to be exposed on the outer surface of the proximal tail end fixing member 2044. Therefore, when the tail end rotary rod 2046 rotates to drive the tail slider 2045 away from the guide head 201, the control member 205 contracts and retracts the proximal end of the stent provided with the connector 101 toward the guide head 201. When the tail end rotary rod 2046 rotates to drive the tail slider 2045 toward the guide head 201, the control member 205 extends and expands the proximal end of the stent provided with the connector 101. In addition, the stent may not be provided with the connector 101, and the control member 205 may directly pass through the crest of the proximal end of the stent in sequence, and can also adjust the contraction and expansion of the stent. The control member 205 may be a thin wire or other slender structure with good flexibility and tensile strength.

[0068] The control member 205 is described below. The control member 205 is a flexible, elongated structure, or a combination of a flexible and rigid elongated structure. Materials for the control member 205 include, but are not limited to, polymer materials, fiber materials, and metal materials. Optionally, the diameter of the flexible elongated member ranges from 0.1 to 0.4 mm; the diameter of the rigid elongated member ranges from 0.1 to 0.4 mm.

[0069] In a specific embodiment, the control member 205 is a flexible and slender member, and the second fixing member D is provided with two channels. The two ends of the control member 205 pass through the two channels respectively. One end of the control member 205 passes through the first fixing member 2012, and the other end 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.

[0070] See also Figure 7 、 Figure 13-14 In another specific embodiment, the control member 205 is a flexible slender member and a rigid slender member, and the first fixing member 2012 is provided with a fixed wire groove N and a channel. One end of the flexible slender member is sleeved on the distal end of the rigid slender member, and the distal end of the rigid slender member is stuck in the fixed wire groove N. The other end of the flexible slender member passes through the channel and is fixed to the first fixing member 2012. The proximal end of the rigid slender member is detachably fixed to the first fixing member 2012. After the stent is released, the rigid slender member is pulled out to release the flexible member, and finally the control member 205 is withdrawn from the body together with the stent delivery and release device 20. The difference between this embodiment and the previous embodiment is that the control member 205 is a flexible slender member and a rigid slender member, and the first fixing member 2012 is a through hole and a fixed wire groove. The distal end of the rigid slender member is stuck in the fixed wire groove, and the distal end of the flexible slender member is sleeved on the middle part of the fixed wire groove of the rigid slender member. As Figures 13 and 14 As shown, the second fixing member D comprises a winding portion 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 slender member passes through the through hole and is connected to the winding portion D2 of the tail slider 2045. The proximal end of the rigid slender member passes through the fixing hole on the inner side of the release slider cover 2048. The fixing hole is provided with two threaded holes, which are connected with screws to fix the rigid slender member to the inner wall of the release slider cover 2048, ensuring the stability of the rigid slender member when the flexible slender 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 of the previous embodiment. The improvement is that the path and time of withdrawing the flexible slender member of the control member 205 in this embodiment are halved, reducing the risk of the flexible control member 205 becoming tangled during the adjustment of the stent release, shortening the operation time, and improving efficiency and safety.

[0071] The following describes how the stent delivery and release device 20 delivers and releases the stent in roughly the following order:

[0072] The stent is retracted to the position of the guide head 201, with the outer sheath 2132 close to the guide head 201. The control member 205 is now detachably connected to the guide head 201. One end of the flexible elongated member passes through the connector 101 at the proximal end of the stent, and the other end is fixed to the winding portion D2 of the tail slider 2045. The rigid elongated member is fixed to the fixing hole inside the release slider cover 2048. The tail slider 2045 is positioned proximal to the tail end rotary rod 2046, placing the control member 205 in a taut state.

[0073] The stent delivery and release device 20 guides the stent along the guide wire implanted in advance in the human body to deliver the stent to the diseased position of the aorta through the delivery system, drives the outer sheath drive 2032 to move the outer sheath 2132 away from the guide head 201, exposes the proximal end of the stent, adjusts the proximal end release component 204 of the stent to release the proximal end of the stent, and when the stent release position is inaccurate, adjusts the control component 205 to contract and retract the stent to the first fixing component 2012 of the guide head 201, and then fine-tunes the stent delivery and release device 20 to realign the stent with the diseased position, and then releases the proximal end of the stent.

[0074] When the proximal release position of the stent is accurate, hold the proximal tail end fixing piece 2044 tightly to keep it stationary, unscrew the tail end rotary cover 2047, and then slowly move the release slider cover 2048 axially away from the guide head 201 for at least 100 mm, thereby driving the tail slider 2045, the tail end rotary rod 2046, and the control piece 205 to be withdrawn from outside the multi-lumen tube 2031 into the multi-lumen tube 2031.

[0075] After the control member 205 enters the multi-lumen tube 2031, the button 2038 is pressed and the sliding handle 2039 is quickly moved to move the outer sheath 2132 to 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.

[0076] Therefore, the stent delivery and release device 20 realizes a multi-stage release method for the stent, which releases the proximal end first and then the distal end. In addition, the proximal release component can retract and release the stent multiple times, thereby ensuring that the stent is properly released to the appropriate lesion location, ensuring the therapeutic effect of the stent, and avoiding a series of problems caused by deviation in the stent release position.

[0077] The above disclosure is only a preferred embodiment of the present invention, and it is certainly not intended to limit the scope of the present invention. A person skilled in the art can understand that all or part of the processes of the above embodiment and equivalent changes made in accordance with the claims of the present invention are still within the scope of the invention.

Claims

1. A stent delivery and release device for releasing a stent into a blood vessel, characterized in that: include: A guide head, a sheath core assembly, a sheath tube assembly, a control member and a stent proximal end release assembly, wherein the guide head is arranged at the distal end of the sheath core assembly, the stent proximal end release assembly 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 a flexible and slender structure, or a combination of a flexible and slender structure and a rigid and slender structure, the control member is detachably connected to the guide head, and the stent proximal end release assembly repeatedly tightens or releases the proximal end of the stent by controlling the axial length of the control member; the stent proximal end release assembly includes a tail slider and a tail end rotary rod, the tail slider includes a second main body and a second fixing member, the second fixing member is arranged on the outside of the second main body for connection with the control member, and the tail end rotary rod is sleeved on the sheath core assembly. At the proximal end of the component, the tail slider is sleeved on the tail end rotary rod, and when the tail end rotary rod rotates to drive the tail slider to move away from the guide head, the control member contracts, and when the tail end rotary rod rotates to drive the tail slider to move closer to the guide head, the control member extends; the proximal end release component of the bracket also includes a tail end rotary cover and a release slider cover, and the tail end rotary cover is rotatably connected between the proximal end of the sheath tube component and the distal end of the release slider cover to release the control member; the inner wall of the release slider cover is axially recessed with a sliding groove, and the outer side protrusion of the tail slider or the second fixing member is engaged with the sliding groove, and the tail slider can slide along the extension direction of the sliding groove during its rotation to prevent the control member from being entangled and knotted during its movement.

2. The stent delivery and release device according to claim 1, characterized in that: The guide head includes a first main body and a first fixing member. The first fixing member is arranged at the proximal end of the first main body, and the first fixing member is detachably connected to the control member.

3. The stent delivery and release device according to claim 2, characterized in that: The first fixing member is provided with a through hole, a barb, a slot or a combination thereof for fixing the control member.

4. The stent delivery and release device according to claim 1, characterized in that: The control component is detachably connected to the proximal end release assembly of the stent.

5. The stent delivery and release device according to claim 1, characterized in that: The tail end rotary rod includes a main rod portion and a rotating portion connected to the main rod portion, and the tail slider is a hollow structure that moves along the threaded portion of the main rod portion.

6. The stent delivery and release device according to claim 1 is characterized in that the stent proximal release component also includes a sheath core fixing part, and the sheath core fixing part is arranged at the distal end of the tail slider to prevent the stent proximal release component from driving the guide head to move arbitrarily when controlling the release of the stent.

7. The stent delivery and release device according to claim 6 is characterized in that the sheath core assembly includes an inner sheath core, a Luer connector, a three-way valve and a three-way tube fixing part, 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 a three-way tube fixing part is arranged along the peripheral wall of the inner sheath core near the Luer connector end, and the three-way tube fixing part is connected to the three-way valve through the tube body.

8. The stent delivery and release device according to claim 7 is characterized in that the sheath assembly includes a multi-lumen tube, which is sleeved on the outer wall of the inner sheath core and 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 movement.

9. A stent delivery and release system, characterized in that the stent delivery and release system includes a stent, and a stent delivery and release device as described in any one of claims 1 to 8, wherein the stent delivery and release device is used to control the radial contraction or expansion of the proximal end of the stent; the control member is a flexible slender member, and the guide head is provided with two channels; the two ends of the flexible slender member respectively pass through the two channels and the proximal end of the stent, one end of the flexible slender member is fixed to the second fixing member, and the other end is detachably connected to the second fixing member.

10. A stent delivery and release system, characterized in that the stent delivery and release system comprises a stent, and a stent delivery and release device as described in any one of claims 1 to 8, wherein the stent delivery and release device is used to control the radial contraction or expansion of the proximal end of the stent; the control member is a flexible slender member and a rigid slender member, and the guide head is provided with a fixed wire groove and a channel; the proximal end of the rigid slender member is fixed by the second fixing member, and when the distal end of the rigid slender member abuts against the groove wall of the fixed wire groove, one end of the flexible slender member is fixed in the fixed wire groove by the rigid slender member, and the other end passes through the channel and the proximal end of the stent and is fixed to the second fixing member.

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