CN211834515U

CN211834515U - Controllable release system

Info

Publication number: CN211834515U
Application number: CN201922261026.2U
Authority: CN
Inventors: 董娟; 李彪; 胡晓明; 陈超; 李佳楠
Original assignee: Ningbo Diochange Medical Technology Co Ltd
Current assignee: Ningbo Diochange Medical Technology Co Ltd
Priority date: 2019-12-17
Filing date: 2019-12-17
Publication date: 2020-11-03
Anticipated expiration: 2029-12-17

Abstract

The utility model relates to a system of controllable release, including implanting apparatus and conveying system, the proximal end region of implanting apparatus is provided with a plurality of first holes, conveying system includes many traction bars and many release silk, many traction bars and a plurality of first hole are all the one-to-one in quantity and position, all be provided with second hole and constraint piece on every traction bar, the second hole is located the distal end of traction bar, the release silk passes constraint piece and first hole or second hole, realize implanting apparatus and conveying system's connection, in transportation process, the constraint piece can restrict the removal of release silk, when releasing the implantation apparatus, the release silk can be for the traction bar displacement. The system is convenient for timely and repeated recovery of the implantation instrument before the implantation instrument is disassembled; in the release process, the implantation instrument can slowly stretch from the sheath tube to the optimal shape, and the release wire can be withdrawn to realize detachable connection, so that the controllable release function is realized; the system has the advantages of simple overall structure, convenient operation, safety and reliability.

Description

Controllable release system

Technical Field

The application relates to the technical field of medical instruments, in particular to a controllable release system.

Background

Minimally invasive transcatheter treatment of cardiovascular diseases is becoming the main treatment means, wherein, for example, coronary stents, heart valves, occluders, great vessel stents and other cardiovascular implantation devices need to be delivered to the expected ideal position of human body by a delivery device. The operation process generally includes compressing and deforming the implant device to be received and loaded in a delivery catheter, utilizing the matching design of structures such as the delivery catheter and/or a push pipe positioned inside the delivery catheter and the like to keep the position of the implant device relatively unchanged in the delivery catheter, then delivering the implant device to a target position through the delivery catheter with the aid of a guide wire or other imaging equipment, and then releasing the implant device from the delivery catheter. In order to be self-expanding

For example, the interatrial septum shunt stent and the delivery device product, the position of the stent in the catheter is easy to change in the process of withdrawing the delivery catheter, and the stent is easy to jump because the size of the stent is far larger than that of the delivery catheter, so that the positioning of the stent is influenced, and further, the operation effect is not ideal; the product can not realize controllable release in the release process, once the stent is partially released from the delivery catheter or completely released, the stent can not be recycled and enters the delivery catheter, so that the position of the stent can not be adjusted, the requirement on an operator is high, and the risk of operation failure is high.

To use atrial septal shunt device to reduce left atrial pressure, 2011 Corvia medical company improves shunt device in design to a certain extent, for example, in patent US 9456812B 2, a atrial septal pore-creating stent and a delivery system are proposed, wherein, the stent is formed by laser cutting, and is divided into a left single-layer disk surface and a right single-layer disk surface, wherein the right disk surface is straight, and the left disk surface is bent to the right, and the delivery system is indirectly connected with the stent, but the design still has the following defects:

first, a recoverable rod and a near-end collecting piece (such as a coil) are arranged on a support, after the support is placed at a target position on an interatrial septum, the recoverable rod cannot be detached and withdrawn, so that a part of the support connected with a conveying system needs to be placed in an atrium for a long time, and the recoverable rod and the near-end collecting piece protrude out of the interatrial septum, not only occupies partial space of the cavity of the atrium, but also influences hemodynamics in the atrium, and can cause high risk of thrombosis.

Secondly, the proximal end of the retrievable rod of the stent is provided with a proximal collector, and the proximal collector has to be arranged at the exact center of the shunting hole, which results in that after the stent is placed at the target position, the shunting effect is influenced with a high probability, and a great risk of thrombosis is caused at the position.

In addition, a near end collecting piece is arranged at the near end of the stent recoverable rod, a closed loop (coil) structure is connected onto the near end collecting piece, and the far end of the grabbing device adopts a hook or protruding piece structure and is used for being inserted into a hole of the implanting device to be connected with or detached from the closed loop, so that the stent is unfolded or retracted; this approach has two problems:

firstly, the far end of the releasing device adopts a hook, and the structure occupies the space in the sheath tube when the sheath is retracted, so the size of the selected sheath is increased; in addition, due to the influence of the operation space and the hemodynamics, the hook and the lantern ring are not easy to connect and separate under the in-vivo environment;

second, collect device and support non-direct connection, but connect through the lantern ring of being connected with the restraint part of distal end, this mode easily causes the effort transmission uneven, and the device is off-axis easily appearing when receiving the sheath, and loading in the sheath intraductally and by the in-process of propelling movement to the target location, the transmission of thrust can not accomplish timely response, can lead to the operator to continue to push away the sheath pipe handle in vitro even, but the support is delayed not taking place from the condition that the distal end of sheath was pushed away.

Disclosure of Invention

In view of this, the present application aims to provide a controllable release system with simple structure, convenient operation, safety and reliability.

The purpose of the application is realized by the following technical scheme:

a controllable release system comprises an implantation instrument and a delivery system, wherein a plurality of first holes are formed in the proximal end area of the implantation instrument, the delivery system comprises a plurality of traction rods and a plurality of release wires, the traction rods and the first holes correspond to one another in number and position, a second hole and a binding piece are formed in each traction rod, the second hole is located at the distal end of each traction rod, the binding piece is located on the proximal end side of the second hole, the first holes formed in the implantation instrument and the second holes formed in the traction rods can be mutually inserted and matched with each other, the release wires penetrate through the binding pieces, the first holes or the second holes to achieve connection of the implantation instrument and the delivery system, and the binding pieces can limit movement of the release wires during delivery, the release wire is displaceable relative to the traction rod upon release of the implantation instrument.

The purpose of the application can be further realized by the following technical scheme:

in one embodiment, a flexible section is arranged at the proximal end region of the implantation instrument and/or the distal end region of the traction rod, the flexible section arranged at the proximal end region of the implantation instrument is called a first flexible section, and the first hole is arranged at the proximal end region of the first flexible section; the flexible section provided at the distal end area of the drawbar is referred to as a second flexible section, and the second hole is provided at the distal end area of the second flexible section.

In a preferred embodiment, the first flexible segment has a spring structure or a dual lumen structure to facilitate insertion of the distal end of the release wire into a lumen of the spring structure or the dual lumen structure.

In a preferred embodiment, the first flexible segment and/or the second flexible segment has a hinge structure, a necked structure, an S-wave structure or a spring structure.

In a preferred embodiment, the first flexible segment and/or the second flexible segment is made of a material having a shape memory function, or the first flexible segment and/or the second flexible segment is made of an elastic material.

In a preferred embodiment, a protrusion is provided on the first flexible segment distal to the first aperture to define the relative position of the implantation instrument and the delivery system after they are connected.

In a preferred embodiment, the maximum dimension of the protrusion is not smaller than the minimum dimension of the second hole, and the distance between the protrusion and the first hole is 0.2mm to 3 mm.

In a preferred embodiment, a protrusion is provided on the second flexible segment, the protrusion being located proximal to the second aperture to define a relative position between the implant device and the delivery system after connection.

In a preferred embodiment, the maximum dimension of the protrusion is not smaller than the minimum dimension of the first hole, and the distance between the protrusion and the second hole is 0.2mm to 3 mm.

In one embodiment, the tow bar is a bi-or multi-lumen structure, and the release wire is placed within a lumen of the bi-or multi-lumen structure.

In one embodiment, the implantation instrument is an elastic pore-creating scaffold capable of being placed at the interatrial septum, and the delivery system is used to deliver and controllably release the elastic pore-creating scaffold from outside the body to the interatrial septum.

In a preferred embodiment, the elastic pore-forming scaffold is a three-dimensional wavy and/or net-shaped structure formed by connecting a plurality of support rods, the three-dimensional wavy and/or net-shaped structure comprises a left disc fitted with an interatrial septum in a left atrial cavity, a right disc fitted with an interatrial septum in a right atrial cavity, and a waist part arranged between the left disc and the right disc and fixedly connected with the left disc and the right disc, wherein a through hole is arranged in the waist part, the through hole enables the left atrium and the right atrium to be in fluid communication, the longitudinal cross section of the elastic pore-forming scaffold is in an i shape, a first flexible section is arranged in the circumferential region of the right disc, and the first hole is located at the far end of the first flexible section.

In a preferred embodiment, the elastic pore-forming support is formed by laser cutting and heat treatment shaping of a shape memory alloy tube.

In a preferred embodiment, the edge of the left disk is rounded, the diameter of the circle is in the range of 12mm to 40mm, the edge of the right disk is rounded, the diameter of the circle is in the range of 12mm to 40 mm.

In a preferred embodiment, the diameter of the through hole is 3mm to 15mm, and the axial height of the through hole is 1mm to 15 mm.

In a preferred embodiment, the edge of the left disc, the edge of the right disc and/or the waist portion are provided with series lines which pass through or wrap around the support bars of the elastic pore-forming scaffold so that the edge of the left disc, the edge of the right disc and/or the waist portion form a closed circle.

In a preferred embodiment, the material of the serial thread comprises PTFE thread, PET thread, UHMWPE thread made of high molecular material, and may also comprise cobalt-chromium alloy filament, nickel-titanium alloy filament, pure tantalum filament, 316L filament made of metal material.

In a preferred embodiment, the wire diameter of the series wire is 0.02mm to 1 mm.

In a preferred embodiment, a film is covered on the surface of the elastic pore-forming support, and the material of the film comprises a polymer film such as PET, PTFE, silica gel and the like.

In a preferred embodiment, the left disc and the right disc of the elastic pore-forming scaffold are covered with the polymer films.

In a preferred embodiment, the polymer film completely covers and wraps the inner surface and the outer surface of the elastic pore-forming scaffold, so that the whole elastic pore-forming scaffold has more excellent biocompatibility.

In one embodiment, the delivery system further comprises a traction assembly, a traction handle, a release assembly and a release handle, wherein the distal end of the traction assembly is fixedly connected with the plurality of traction rods, the proximal end of the traction assembly is fixedly connected with the traction handle, the distal end of the release assembly is connected with the plurality of release wires, the proximal end of the release assembly is fixedly connected with the release handle, the traction rods, the traction assembly and the traction handle form a traction assembly, the release wires, the release assembly and the release handle form a release assembly, the release assembly is located in the traction assembly, and the release assembly and the traction assembly can move relatively.

In one embodiment, the distal end of the release wire rests against the proximal end of the implantation instrument, or the distal end of the release wire extends proximally into the release catch after passing through a first hole provided in the proximal end region of the implantation instrument or through a second hole provided in the traction rod.

In one embodiment, the delivery system further comprises a sheath assembly disposed outside the pulling assembly, the sheath assembly comprising a sheath and a sheath handle sealingly and fixedly connected to a proximal end of the sheath.

In a preferred embodiment, the delivery system further comprises a loading sheath for reclamping the connected implantation instrument, distraction assembly and release assembly within the loading sheath, which can be inserted into the sheath handle or into the sheath.

In one embodiment, the tie down is a tie down hole provided on the tow bar and extending through the tow bar.

In a preferred embodiment, the number of the binding holes is even, and each release wire penetrates through the binding hole, the first hole and/or the second hole in an S-shape from the proximal end to the distal end along the corresponding traction rod in sequence to realize the detachable connection of the implantation instrument and the delivery system.

In a preferred embodiment, the center distance between two adjacent binding holes on the same traction rod is 1mm-20 mm.

In a preferred embodiment, the center distance between the second hole and the adjacent binding hole on the same traction rod is 1mm-20 mm.

In one embodiment, the space defined by the plurality of traction rods and the second flexible segment is conical, bowl-shaped or lantern-shaped.

In one embodiment, the release wire is a shape memory alloy wire having a wire diameter of 0.05mm to 1 mm.

In one embodiment, the tie-down is a tie-down tube having a hollow tubular structure, the tie-down tube being sleeved outside the drawbar, the lumen of the tie-down tube being capable of simultaneously receiving at least one drawbar and one release wire, such that the release wire is capable of passing through and sliding within the lumen of the tie-down tube.

In one embodiment, the tie down is one or more tie down rings fitted around the outer surface of the distal region of the tow bar, the tie down rings being fixedly connected to the release wire such that the release wire is withdrawn, the tie down rings and the release wire being slidable along the tow bar under the action of the withdrawal force.

Compared with the prior art, the beneficial effects of this application mainly appear:

1. according to the connecting mode, the implantation instrument can be timely and repeatedly recycled before the implantation instrument and the conveying system are not detached, and the implantation instrument can be detached from the conveying system by withdrawing the release wire after the implantation instrument is completely released; and the implantation instrument and the delivery system are pressed and held, loaded into the sheath, pushed to a target position through the sheath, unfolded at the target position, connected and detached, and a series of processes are slow and continuous, so that controllable release can be achieved. According to the application, the second holes are formed in the traction rod, so that connection is facilitated, the releasing wire can be guided when the traction rod is disassembled, the releasing wire can move along the traction rod, knotting or winding of the releasing wire is avoided, and connection and disassembly controllability of the implantation instrument and the conveying system is achieved.

2. This application sets up the constraint piece on the traction lever, and the constraint piece can guarantee every laminating nature of releasing silk and corresponding traction lever, and this benefit of bringing includes: a) when the implantation instrument and the delivery system are in an assembly connection state, no matter in the process that the implantation instrument is pressed and loaded in a sheath tube of the delivery system and pushed to a target position, or in the process that the implantation instrument is gradually released from the sheath tube until the implantation instrument is fully unfolded to an optimal form, the release wires are ensured to be mutually independent, and the situation that the release wires cannot be withdrawn due to the fact that a plurality of release wires are knotted or wound mutually is avoided; b) in the operation process of the instrument is implanted in the release, when the operator withdraws the release silk, the traction lever is mutually supported with the constraint piece, provide the guide effect for the even transmission of withdrawal force on the release silk, thereby guarantee that many release silk distal ends can be smoothly and in step the withdrawal out first hole or second hole, thereby realize the controllable dismantlement of being connected between implantation instrument and the conveying system, make the controllable release of implantation instrument to the target location, consequently this design realizes that conveying system and implantation instrument's connection detachability and release controllability, overall structure is simple, high durability and convenient operation, safety and reliability.

3. This application is provided with flexible section for: a) the insertion fit and the separation of the matched connecting part at a proper angle are facilitated, so that the controllable disassembly of the connecting part of the implantation instrument and the conveying system is realized, and the stabbing wound to the peripheral tissue of the target position due to the far-end rebound after the implantation instrument is connected and separated with the conveying system can be effectively prevented; b) after the implantation instrument is matched and connected with the conveying system, the matched and connected part has certain compressibility due to certain deformation capacity, and after the implantation instrument is loaded in the sheath, the minimum inner diameter of the sheath can be reduced, the damage to the patient to enter the way is reduced, and the application range of the product is expanded; secondly, the size matching of the matching connecting part and the inner cavity of the sheath tube is more compact due to the compressibility, so that the parts in matching connection do not move relatively, and the comfort, continuity and controllability of the pushing and releasing process of the implantation instrument are enhanced.

When the flexible section is the first flexible section, the following advantages are also provided: a) when the implantation instrument is placed in a target and then released, the distal end of the flexible section of the implantation instrument is pulled and bound by the traction rod and the release wire, so that the whole release process of the implantation instrument is slow, continuous and controllable; b) after the implantation instrument is completely released, the flexible section can increase the contact area and the fitting effect of the implantation instrument and a target position (such as atrial septal tissue), and is favorable for the formation of endothelialization on the surface of the implantation instrument; c) Effectively avoiding the local stimulation reaction of the edge of the implantation instrument to the tissue and improving the biocompatibility.

When the flexible section is the second flexible section, the device also has the advantage of avoiding the traction rod from excessively moving towards the far end due to improper operation, so that the traction rod pokes target tissues to cause local tissue reaction or pokes an implantation instrument to influence the effectiveness of the instrument.

4. The flexible section is provided with the protrusion, and the relative position between the implant instrument and the delivery system after the implant instrument and the delivery system are connected can be limited, so that the implant instrument and the delivery system are arranged in the sheath after being assembled, and the connection matching part is ensured not to generate relative displacement in the axial direction in the process of being pushed and released from the sheath, and sufficient guarantee is provided for controllable release.

5. The release wire of the present application has good resilience or bending resistance, and this design is such that: a) the connecting part of the implantation instrument and the conveying system is effectively prevented from self-locking or blocking due to relative movement, so that the release wire cannot be smoothly withdrawn from the first hole and/or the second hole, and further the connecting detachability and the controllable release function cannot be realized; b) The positioning accuracy of the implantation instrument at the target position is ensured, and the backward movement of the implantation instrument along with the backward movement of the conveying sheath in the prior art is avoided, so that the controllable release can be realized.

6. The utility model provides an implant apparatus surface covering has the film, and the film has the physical isolation effect for the distal end of releasing the silk is located or when implanting apparatus's near-end face one side, can not touch animal body or human tissue all the time, ensures that controllable release process has sufficient security.

Drawings

FIG. 1 shows the first embodiment with the insertion instrument in the target position but with the insertion instrument and delivery system not removed.

FIGS. 2a-2d are partial schematic views of the coupling portion of the insertion instrument to the delivery system when the coupling is not released for disassembly;

fig. 2a, 2b, 2c and 2d show the connection structure of four different embodiments, respectively.

FIG. 3a is a schematic view of the first embodiment with the constraint member being a constraint hole, the implantation instrument being positioned at the target site, but not being disconnected from the delivery system.

FIG. 3b is a schematic illustration of the delivery system of FIG. 3a with the insertion instrument removed from the delivery system.

Fig. 4a is a schematic illustration of the third embodiment with the implantation instrument in the target position but with the connection released unremoved, wherein the distal end of the pull wire is disposed at the proximal end face of the implantation instrument, and a 'and b' are shown prior to removal of the implantation instrument and delivery system.

Fig. 4b is a schematic illustration of the third embodiment with the implantation instrument detached from the delivery system, wherein a and b are views after detachment of the implantation instrument and the delivery system.

FIG. 4c is a schematic view of the third embodiment with the insertion instrument in the target position but with the connection released unremoved, and with the distal end of the release wire positioned in the pull collection member.

Fig. 4d is a schematic structural view of the third embodiment in which the binding member is a binding ring.

FIGS. 5a-5h are schematic diagrams illustrating the process of placing the controlled release system in the sheath tube and gradually releasing the system according to the second embodiment, wherein FIG. 5a is a state of placing the controlled release system in the loading sheath according to the second embodiment; FIG. 5b illustrates the second embodiment in which the controllably releasable system is advanced through the loading sheath to the distal end of the sheath; FIG. 5c shows the sheath advanced to the interatrial septum target site, but with the implantation instrument still disposed within the sheath; FIG. 5d is a view of the handle at the distal end of the pushing and pulling assembly pushing the left disc of the implantation device out of the sheath, based on FIG. 5 c; FIG. 5e is the view based on FIG. 5d, wherein the handle at the distal end of the sheath is retracted, and the left disc surface which is unfolded after being released is placed in the left atrial side region of the interatrial septum and attached to the target position; FIG. 5f shows the distal end of the pull assembly being further advanced to push the entire implantation instrument and pull rod out of the sheath; FIG. 5g is the view of FIG. 5f, further pushing on the handle at the distal end of the pull collection member to position the right disc of the implantation instrument in the right atrial-lateral atrial region of the interatrial septum and in apposition to the target site; FIG. 5h illustrates the release handle retracted in the direction of the arrow, with the insertion instrument releasably coupled to the delivery system.

Fig. 6 is a schematic plan-view development of the tow bar and tow collection piece as a unitary structure.

Fig. 7a and 7b are schematic views showing the configuration of the space defined by the tow bar and the tow collection at the proximal end of the tow bar, where fig. 7a is bowl-shaped and fig. 7b is cone-shaped.

Fig. 8a and 8b are schematic structural views of the pulling assembly and the releasing assembly in a natural state, respectively.

FIG. 9 is a schematic view of an elastic pore-forming stent configured with series of wires and forming a closed coil structure.

FIG. 10 is a schematic view of an elastic pore-forming scaffold with a thin film covering the surface.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more apparent, the present application is further described in detail below by referring to the accompanying drawings and examples.

To more clearly describe the controlled release system provided herein, the terms "proximal" and "distal" are defined herein, which terms are conventional in the medical device art. Specifically, "proximal" refers to the end of the surgical procedure that is closer to the operator, and "distal" refers to the end of the surgical procedure that is further from the operator.

The first embodiment is as follows:

as shown in FIG. 1, the present application provides a controlled release system comprising an implantation instrument 1 and a delivery system 2. The proximal end region of the implantation instrument 1 is provided with a plurality of first holes 1111, the delivery system 2 comprises a plurality of traction rods 211 and a plurality of releasing wires 220, the plurality of traction rods 211 and the plurality of first holes 1111 correspond to each other in number and position one by one, each traction rod 211 is provided with a second hole 2111 and a binding piece 210, the second hole 2111 is positioned at the distal end of the traction rod 211, the binding piece 210 is positioned at the proximal end side of the second hole 2111, the first hole 1111 arranged on the implantation instrument 1 and the second hole 2111 arranged on the traction rod 211 can be mutually penetrated and matched, the releasing wires 220 penetrate through the binding piece 210, the first holes 1111 or the second holes 2111 to realize the connection of the implantation instrument 1 and the delivery system 2, the binding piece 210 can limit the movement of the releasing wires 220 during the delivery process, and the releasing wires 220 can be displaced relative to the traction rods 211 when the implantation instrument 1 is released.

The present application may be provided with various embodiments of the binding member 210 on the proximal side of the second hole 2111 on the drawbar 211, in this embodiment, the binding member 210 is a binding hole 2100 provided on the drawbar 211 and penetrating the drawbar 211, and the binding hole 2100 is provided with a suitable size and shape, and preferably, the binding hole 2100 may be a circular shape, an oval shape, a rectangular shape, a needle shape with a square-like shape, etc. so that the release wire 220 can smoothly pass through the binding hole 2100. When the implantation instrument 1 and the delivery system 2 are assembled, the release wire 220 is passed through the binding hole 2100 on the corresponding drawbar 211 and inserted into the first hole 1111, as shown in fig. 2 b; after passing through the binding aperture 2100, the release wire 220 may also be inserted into the second aperture 2111, as shown in FIG. 2 a. The design of the additional tie down holes 2100 ensures the conformability of each release wire 220 to the corresponding pull rod 211, which provides a number of benefits, including: a) when the implantation instrument 1 is in an assembled connection state with the delivery system 2, no matter during the process that the implantation instrument 1 is pressed, loaded in the sheath 230 of the delivery system 2 and pushed to a target position, or during the process that the implantation instrument 1 is gradually released from the sheath 230 until the implantation instrument 1 is sufficiently unfolded to an optimal form, as shown in fig. 1, all the release wires 220 are ensured to be mutually independent, so that the situation that the release wires 220 cannot be withdrawn due to the possibility of knotting or mutual winding of the plurality of release wires 220 is avoided; b) in the operation process of releasing the implantation instrument 1, when an operator withdraws the release wire 220, the draw bar 211 is matched with the binding piece 210 to provide a guiding function for the uniform transmission of withdrawing force on the release wire 220, thereby ensuring that the far ends of the release wires 220 can smoothly and synchronously withdraw from the first hole 1111 or the second hole 2111, realizing the controllable disassembly of the connection between the implantation instrument 1 and the conveying system 2, and leading the implantation instrument 1 to be controllably released to a target position, therefore, the design realizes the connection detachability and the release controllability of the implantation instrument 1 and the conveying system 2, and the whole structure is simple, the operation is convenient, and the operation is safe and reliable. As can be seen from the above, the second hole 2111 is provided on the drawbar 211 in the present application, which facilitates the connection, and guides the release wire 220 during the detachment, so that the release wire 220 moves along the drawbar 211, thereby preventing the release wire 220 from knotting or twisting, and realizing the controllability of the connection and detachment of the implantation instrument 1 and the delivery system 2.

One or more binding holes 2100 are arranged on each traction rod 211 according to the requirement of maximum fitting of the corresponding traction rod 211, the specific number of the binding holes 2100 and the hole spacing L2 between the binding holes 2100 (and the hole spacing L1 between the second hole 2111 and the adjacent binding hole 2100) can be specifically arranged according to the requirement of the traction rod 211 on the rod length in the specific application occasion, in particular, in order to ensure the effectiveness of force transmission, the hole spacing L2 between the binding holes 2100 at the adjacent positions is preferably set to be 1mm-20mm, and similarly, the center spacing L1 between the second hole 2111 and the adjacent binding hole 2100 can also be set to be 1mm-20 mm. When the number of the binding holes 2100 is even, for example, 2, when the implantation instrument 1 is assembled with the delivery system 2, the releasing wire 220 is passed through all the binding holes 2100 on the corresponding traction rod 211 from the proximal end to the distal end in an S-shape, and then the distal end of the releasing wire 220 is passed through the first hole 1111 at the proximal end of the implantation instrument 1 or the second hole 2111 provided on the traction rod 211, and finally abuts against the proximal side of the implantation instrument 1 or extends proximally into the release collection member 221 described below, so that the connection assembly of the implantation instrument 1 with the delivery system 2 can be easily achieved, as shown in fig. 3 a. This connection is a direct connection, not an indirect connection as described in the background art, and the assembled connection is not disassembled unless the operator actively withdraws the release wire 220, so that the connection is safe and reliable during the previous series of surgical operations of withdrawing the release wire 220, and the whole surgical process is ensured to be smooth, including: the traction rod 211 is pulled back, so that the produced and completely unfolded implantation instrument 1 can be pressed and loaded into the sheath 230 of the delivery system 2 in vitro; then, the traction rod 211 is pushed, so that the implantation instrument 1 can be pushed to a target position along the lumen track of the sheath 230; following withdrawal of sheath 230, insertion instrument 1 is deployed from the distal end of sheath 230. Just because of the high degree of safety and reliability of this assembled connection, it is possible to re-withdraw the insertion instrument into the sheath 230 of the delivery system 2 at any time of the operation before the connection is not disassembled, including when the insertion instrument 1 has been placed at the target site and fully deployed, thereby achieving the function of timely and repeated retrieval. This timely and repeated recyclability facilitates the operator to change the specifications of other implantation instruments during the procedure until the selection is proper and the release conditions at the target site are optimal, thus ensuring a sufficiently high effectiveness of the procedure. In addition, the connection mode enables the implantation instrument 1 and the delivery system 2 to be loaded into the sheath 230 in a pressing mode, pushed to the target position through the sheath 230, unfolded at the target position and connected and detached in a series of processes, and the controlled release is achieved. And because the first hole 1111 arranged on the implantation instrument 1 and the second hole 2111 arranged on the traction rod 211 can be mutually penetrated and matched, after the implantation instrument 1 is fully unfolded from the sheath tube 230, an operator can finish the disassembly of the implantation instrument 1 and the delivery system 2 by withdrawing the release wire 220, thereby finally ensuring the controllable release.

In one embodiment, the pull rod 211 is a bi-or multi-lumen structure, and the release wire 220 is placed within a lumen of the bi-or multi-lumen structure.

The delivery system 2 may further comprise a pulling assembly 212, a pulling handle 214, a release assembly 221 and a release handle 224, wherein a distal end of the pulling assembly 212 is fixedly connected to the plurality of pulling rods 211, a proximal end of the pulling assembly 212 is fixedly connected to the pulling handle 214, a distal end of the release assembly 221 is connected to the plurality of release wires 220, and a proximal end of the release assembly 221 is fixedly connected to the release handle 224. As shown in fig. 8a, the drawbar 211, the drawbar union 212 and the drawbar handle 214 constitute a drawbar assembly 21; as shown in fig. 8b, the release wire 220, the release catch 221 and the release handle 224 form a release assembly, the release assembly 22 is located in the pulling assembly 21, and the release assembly 22 and the pulling assembly 21 can move relatively. The pulling-collecting member 212 is disposed at the proximal end of the plurality of pulling rods 211 for collecting and collecting the proximal ends of all the pulling rods 211, and finally the proximal ends of all the pulling rods 211 and the pulling-collecting member 212 are fixedly connected integrally, so as to ensure that the spatial positions of all the pulling rods 211 are kept unchanged, so that when the implantation instrument 1 and the delivery system 2 are in the assembled connection state, the pulling rods 211 and the corresponding releasing wire 220 are always kept independent from each other, no matter during the process that the implantation instrument 1 is pressed and loaded in the sheath tube 230 of the delivery system 2 or pushed to the target position in the sheath tube 230, as shown in fig. 5, or during each time when the implantation instrument 1 is gradually released from the sheath tube 230 or even fully expanded to the optimal configuration, as shown in fig. 1. The pulling collection member 212 is a hollow tubular structure, and the lumen inside the pulling collection member can accommodate all the releasing wires 220 and enable all the releasing wires 220 to smoothly slide in the lumen. In terms of manufacturing, the traction collection piece 212 and the traction rod 211 can be formed by integrally cutting and heat-treating a cobalt-chromium alloy tube or a nickel-titanium alloy tube material with a shape memory function, so that the processing and the manufacturing are convenient, and high coaxiality can be kept. The provision of a traction handle 214 at the proximal end of the traction funnel 212 facilitates the operator's manipulation of the traction handle 214 to control the pushing and retracting procedures of the implantation instrument 1 and the delivery system 2. The release collection 221 is disposed at the proximal end of the plurality of release wires 220 for gathering and collecting the proximal ends of all of the release wires 220, and ultimately, for connecting the proximal ends of all of the release wires 220 to the release collection 221. During release, when the operator pulls back on the release hub 221, all of the release wires 220 distal to the release hub 221 can be simultaneously withdrawn, thereby enabling detachment of the first aperture 1111 of the implantation instrument 1 from the second aperture 2111 of the delivery system 2, as shown in fig. 3 b. In one embodiment, the release collection 221 is a hollow tubular structure with an inner diameter that forms a transition fit with the gathered diameters of all the release wires 220 and an outer diameter that is smaller than the inner diameter dimension of the pull collection 212. The proximal ends of the plurality of release wires 220 are fixedly attached to the distal end of the release hub 221 by welding, adhesive, or mechanical engagement. In another embodiment, the same number of connection holes as the number of the release wires 220 are provided at the distal end of the release collection member 221, and a plurality of release wires 220 pass through the corresponding connection holes 2210 to connect the release wires 220 and the release collection member 221, from the manufacturing point of view, a number of nitinol wires with a certain length and good resilience are selected, each nitinol wire passes through every two adjacent connection holes 2210, and the wire extending from the connection holes 2210 forms the release wire 220, which can achieve the same effect and has the following advantages: a) the arrangement space of the connecting holes 2210 on the release collection piece 221 is saved, so that the outer diameter size of the release collection piece 221 is reduced; b) the releasing wires 220 can be close to the traction rods 211 as much as possible, the length of the releasing wires 220 is shortened, and the coaxiality between the releasing wires 220 and the traction rods 211 is improved as much as possible; c) the damage to materials and the risk of possible fracture and falling off caused by the traditional connecting process including welding, bonding or mechanical matching and other connecting modes are avoided.

When the present application is used in an interventional procedure, the wire diameter of the release wire 220 is selected to be 0.05mm to 1mm, the size of the selected wire diameter is smaller than the minimum size of the first hole 1111 and the second hole 2111, the number and the positions of the release wires 220 correspond to the plurality of traction rods 211 one by one, the release wire 220 should have non-flexibility, and the non-flexibility is defined as good resilience or bending resistance, but not flexibility, and the design has the following advantages: a) the phenomenon that the connecting parts of the implantation instrument 1 and the delivery system 2 are self-locked or jammed due to relative movement is effectively avoided, so that the release wire 220 cannot be smoothly withdrawn from the first hole 1111 and/or the second hole 2111, and further the connection detachability and controllable release function cannot be realized; b) the accurate positioning of the implantation instrument 1 at the target position is ensured, the implantation instrument 1 in the prior art is prevented from having no limit in the direction along the traction rod 211, and the implantation instrument 1 moves backwards along with the withdrawal of the delivery sheath 230, so that the controllable release is realized.

In the present application, a flexible section is provided in the proximal region of the implantation instrument 1 and/or in the distal region of the traction rod 211, the flexible section provided in the proximal region of the implantation instrument 1 is referred to as a first flexible section 1110, and a first hole 1111 is provided in the proximal region of the first flexible section 1110; the flexible segment provided at the distal end region of the drawbar 211 is referred to as a second flexible segment 2110, and a second hole 2111 is provided at the distal end region of the second flexible segment 2110.

In one embodiment, the second flexible section 2110 at the distal end of the drawbar 211 can be inserted from the outside to the inside into the first hole 1111 at the proximal edge of the implantation instrument 1, and the release wire 220 sequentially passes through the tie 210 and the second hole 2111, as shown in fig. 2a, to detachably connect the implantation instrument 1 to the delivery system 2; in another embodiment, the first flexible segment 1110 at the proximal end of the implantation instrument 1 can be inserted into the second hole 2111 at the distal end of the drawbar 211 from the outside to the inside, and the release wire 220 sequentially passes through the binding member 210 and the first hole 1111, so as to realize the controllable connection and the controllable disconnection of the implantation instrument 1 and the delivery system 2.

In this embodiment, a flexible segment is provided in the controlled release system, and the flexible segment comprises a first flexible segment 1110 and a second flexible segment 2110, which has the following advantages: a) the insertion fit and the separation of the matched connecting part at a proper angle are facilitated, so that the controllable disassembly of the connecting part of the implantation instrument 1 and the conveying system 2 is realized, and the puncture wound to the peripheral tissue of the target position due to the rebound of the far end after the implantation instrument 1 is connected and separated with the conveying system 2 can be effectively prevented; b) after the implantation instrument 1 is connected with the delivery system 2 in a matching way, as shown in fig. 3a, because the implantation instrument 1 has a certain deformation capacity, the part connected in a matching way has a certain compressibility, after the implantation instrument 1 is loaded in the sheath 230, the minimum inner diameter of the sheath 230 can be reduced, the damage to the patient entering the way can be reduced, and the application range of the product can be expanded; secondly, such compressibility enables the mating connection portion to be more compactly matched with the size of the inner cavity of the sheath 230, so that relative movement between the components of the mating connection portion does not occur, which helps to enhance the comfort, continuity and controllability of the pushing and releasing processes of the implantation instrument 1.

In addition, when the flexible segment is the first flexible segment 1110, the following advantages are also provided: a) when the implantation instrument 1 is released after being placed at a target position, the distal end of the flexible section 102 of the implantation instrument is pulled and bound by the traction rod 211 and the release wire 220, so that the whole release process of the implantation instrument 1 is slow, continuous and controllable; b) AS shown in fig. 3b, after the implantation device 1 is completely released, the flexible segment 102 can increase the contact area and the fitting effect of the implantation device 1 and the target location (for example, interatrial septum tissue, AS shown in fig. 3 b), which is beneficial to the formation of endothelialization on the surface of the implantation device 1; c) effectively avoiding the local stimulation reaction of the edge of the implantation instrument 1 to the tissue and improving the biocompatibility.

When the flexible section is the second flexible section 2111, the advantage of avoiding the traction rod 211 from excessively moving towards the distal end due to improper operation, so as to poke target tissue, cause local tissue reaction, or pierce the implantation instrument 1, and influence the effectiveness of the implantation instrument 1 is also provided.

In one embodiment, a protrusion 1112 is provided on the first flexible segment 1110, the protrusion 1112 being located on the distal side of the first hole 1111 to define the relative position between the implantation instrument 1 and the delivery system 2 after connection, or a protrusion 2112 is provided on the second flexible segment 2110, the protrusion 2112 being located on the proximal side of the second hole 2111 to define the relative position between the implantation instrument 1 and the delivery system 2 after connection. When the implantation instrument 1 and the delivery system 2 are assembled and placed in the sheath 230, pushed and released from the sheath 230, the protrusions ensure that the connection parts do not displace relative to each other in the axial direction, thereby providing sufficient security for controlled release. Preferably, the outer edge of the

protrusions

1112 or 2112 should be smooth and transition without affecting the retraction of the sheath, so that the implantation instrument 1 can be smoothly crimped and loaded into the sheath 230.

It should be particularly noted that the first flexible segment 1110 has both good resilience and a certain rigidity, where the rigidity is enough to make the implantation device 1 and the delivery system 2 cooperatively connected and loaded in the sheath 230, the push delivery system 2 moves the traction rod 211 towards the distal direction, and the implantation device 1 can also make a timely mechanical response and a corresponding movement, thereby ensuring that the implantation device 1 can be pushed and guided to the target position through the sheath 230; the resilience here enables the implant device 1, in particular the proximal region of the implant device 1 located in the vicinity of the first hole 1111, to conform to the target tissue surface in various anatomical configurations after the implant device 1 has been removed from the delivery system 2, thus ensuring a wide range of applicability of the implant device 1.

In one embodiment, the first flexible segment 1110 in the proximal region of the insertion instrument 1 may be necked down or partially heat treated to provide flexibility and a stem width L8 no greater than a minimum portion dimension L3 corresponding to the second aperture 2111 in the second flexible segment 2110 so that the first flexible segment 1110 may be inserted laterally inwardly into the second aperture 2111, as shown in FIG. 2 b. After insertion, the central axis of the first flexible segment 1110 and the central axis of the second flexible segment 2110 are in the range of 1 ° to 80 °, and the first hole 1111 at the distal end of the first flexible segment 1110 of the implantation device is located in the space defined by the plurality of traction rods 211 and the proximal end surface of the implantation device 1. The diameter of the release wire 220 is not larger than the size of the smallest portion of the first hole 1111, and it goes through all the binding holes 2100 of the corresponding drawbar 211 in an S-shape from the proximal end to the distal end along the corresponding drawbar 211. Then, the distal end of the release wire 220 passes through a first hole 1111 located in a space enclosed by the plurality of traction rods 211 and the proximal end surface of the implantation instrument 1; finally, its distal end is placed on the proximal face side of the implantation instrument 1, or the distal end of the release wire 220 extends proximally into the traction funnel 212 after passing through a first hole 1111 provided in the proximal region of the implantation instrument 1, so that a controlled release connection of the implantation instrument 1 to the delivery system 2 is achieved. When the distal end of the release wire 220 is placed on one side of the proximal end face of the implantation instrument 1, the stroke of retracting the release wire 220 is shortened, which is convenient for saving the time for an operator to retract the release wire 220; when the distal end of the release wire 220 extends proximally into the pull-in funnel 212 after passing through the first hole 1111 in the proximal region of the implantation instrument 1, the distal end of the release wire 220 is prevented from touching the target tissue throughout the retraction of the release wire 220, ensuring safety of the release procedure.

The first flexible section 1110 of the proximal region of the insertion instrument 1 can also be of a spring design, which has the following advantages: a) the spring is a hollow structure, and the inner cavity of the spring can be set as the first hole 1111, so that the first hole 1111 is not needed to be arranged at the far end of the first flexible section 1110; b) the distal end of the release wire 220 can be placed in the first flexible segment 1110, which not only allows independent passage of the release wires 220, but also reduces the risk of poor corrosion resistance caused by the distal end of the release wire 220 scratching the proximal surface of the implantation instrument 1, and simultaneously avoids accidental injury caused by the distal end of the release wire 220 pricking tissue in the region of the target site (e.g., the right atrial surface of the atrial septum mentioned later); c) the longitudinal cross-sectional area of the spring structure is large, and the developing effect can be improved in the operation process.

In a first embodiment, as shown in fig. 2c, the first flexible segment 1110 of the proximal end region of the implantation device 1 is a constant diameter spring, the distal end of which passes through a first hole 1111 at the edge of the proximal end face of the implantation device 1 and is fixedly connected with the first hole 1111, or the distal end of which is directly fixed to the edge of the proximal end face of the implantation device 1. The inner cavity of the spring can accommodate at least the second flexible section 2110 at the distal end of the drawbar 211 and a release wire 220, so that the second flexible section 2110 can smoothly pass through the whole spring interior; after insertion, second aperture 2111 at the distal end of second flexible segment 2110 is located outside the spring distal lumen.

In a second embodiment, as shown in fig. 2d, the first flexible segment 1110 of the proximal region of the implantation instrument 1 is a series spring, which series spring consists of two equal-diameter springs of different inner diameters. The spring at the distal end of the first flexible section 1110 is connected to the edge of the proximal end face of the implantation instrument 1, and the spring inner cavity at the proximal end of the first flexible section 1110 at least can accommodate the second flexible section 2110 at the distal end of the traction rod 211 and one release wire 220, so that the second flexible section 2110 and the release wire 220 can smoothly pass through the spring inside at the distal end of the first flexible section 1110; after insertion, second hole 2111 at the distal end of second flexible segment 2110 is located in the region between the two springs in series.

In the third embodiment, the first flexible segment 1110 has a dual lumen structure, wherein one lumen is used for fixedly connecting with the support rod 111 of the implantation device 1 and the other lumen is used for accommodating the distal end of the release wire 220, which can also achieve the same effect as the first embodiment.

In the fourth embodiment, the first flexible segment 1110 has a hinge structure and an S-wave structure, and compared with the above embodiments, these structural designs not only have better flexibility, but also have better mechanical transferability, so as to achieve timely mechanical responses such as axial tension and pressure, and further facilitate control of pushing and releasing of the implantation instrument 1 in the sheath 230.

In other embodiments, the first flexible segment 1110 is made of a material with a shape memory function, or the first flexible segment 1110 is made of a material with elasticity, which facilitates the integral manufacturing and molding of the first flexible segment 1110 and the implantation instrument 1, and avoids the risk of connection failure caused by introducing other connections therebetween, and of course, it is also beneficial to shorten the manufacturing period and mass production.

The second flexible segment 2110 in the delivery system 2 may be designed in the same or similar structure as the first flexible segment 1110 in the implantation instrument 1, and the second flexible segment 2110 also has the advantage of preventing the traction rod 211 from moving excessively to the far end due to improper operation, so as to poke the target tissue and cause local tissue reaction, or poke the implantation instrument 1 and affect the effectiveness of the instrument 1.

The space defined by the pull rod 211 and the second flexible segment 2110 may be tapered (as shown in fig. 7 b), bowl-shaped (as shown in fig. 7 a), or lantern-shaped (not shown), etc., further reducing the risk of the distal end of the delivery system 2 stabbing into the target tissue. Of course, the tow bar 211 of the delivery system 2 should be selected to have good resiliency to meet the requirements of the present application for various product access routes, particularly for use in interventional procedures where the product access route is the native vascular system of an animal or human body, which is often characterized by tortuosity, which requires that the product, including the tow bar 211, be designed to have good form adaptability and resiliency.

In the operation process, when the implantation instrument 1 reaches a target position such as an interatrial septum and is attached to the target position, a doctor observes the form and the flow distribution of the implantation instrument 1 through a contrast means so as to determine the unfolding form and the placement position of the implantation instrument 1. If the effect is not ideal, before the matching connection is not disassembled, the traction handle 214 can be retracted or the sheath 230 can be pushed forward, the implantation instrument 1 which is placed at the target position and is fully unfolded is retracted into the sheath 230 of the conveying system 2, so that the implantation instrument 1 is recovered and is withdrawn from the body, and the specification is changed or the operation is finished according to the condition. If the effect is desired, the position of the pulling handle 212 is kept unchanged, and when the releasing handle 224 is slowly withdrawn to the proximal end, the withdrawing force is uniformly transmitted on the releasing wires 220 through the mutual cooperation of the pulling rod 211 and the binding piece 210, so that the distal ends of the releasing wires 220 can be smoothly and synchronously withdrawn from the first holes 1111 or the second holes 2111. Due to the good resilience and shape memory of the implantation instrument 1 and the traction rod 211, the first flexible section 1110 of the implantation instrument 1 is synchronously separated from the second hole 2111 at the distal end of the traction rod 211, or the second flexible section 2110 at the distal end of the traction rod 211 is synchronously separated from the first hole 1111 at the distal end of the implantation instrument 1, so that the controllable detachment of the implantation instrument 1 and the delivery system 2 is completed, and the controllable release of the implantation instrument 1 is finally realized.

Example two:

on the basis of the first embodiment, as a specific example, the implantation device 1 is an elastic pore-creating stent 11 that can be placed at the interatrial septum, and the delivery system 2 is used for delivering and controllably releasing the elastic pore-creating stent 11 from the outside of the body to the interatrial septum. Specifically, the elastic pore-forming stent 11 is formed by connecting a plurality of support rods 111 with each other to form a three-dimensional wavy and/or net-shaped structure, the three-dimensional wavy and/or net-shaped structure comprises a left disc fitted with the interatrial septum in the left atrium cavity, a right disc fitted with the interatrial septum in the right atrium cavity, and a waist portion arranged between the left disc and the right disc and fixedly connected with the left disc and the right disc, a through hole is formed in the waist portion, the through hole enables the left atrium and the right atrium to be in fluid communication, the longitudinal cross section of the elastic pore-forming stent 11 is in an i shape, a first flexible section 1110 is arranged in the circumferential region of the right disc, and the first hole 1111 is located at the far end of the first flexible.

In one embodiment, as shown in FIG. 9, the elastic pore-forming stent 11 is formed by laser cutting and heat treatment shaping of a shape memory alloy tube. The edges of the left disk and the right disk are encircled into a circle, the diameter range of the left disk is 12mm-40mm, and the diameter range of the right disk is 12mm-40 mm. The diameter of the through hole is 3mm-15mm, and the axial height of the through hole is 1mm-15 mm.

The delivery system 2 comprises at least a plurality of pull rods 211 corresponding to the first holes 1111 one by one, a pull collection member 212 fixedly connected to the proximal ends of all the pull rods, a pull handle 214 fixedly connected to the proximal end of the pull collection member 212, a plurality of release wires 220 corresponding to the pull rods 211, a release collection member 221 fixedly connected to the proximal end of the release wires 220, and a release handle 224 fixedly connected to the proximal end of the release collection member 221, as shown in fig. 1. As shown in fig. 8a and 8b, the drawbar 211, the drawbar union 212 and the drawbar handle 214 constitute the drawbar assembly 21, while the release wire 220, the release union 221 and the release handle 224 constitute the release assembly 22, the release assembly 22 being located within the drawbar assembly 21, and the release assembly 22 and the drawbar assembly 21 being capable of relative movement. Preferably, the plurality of traction rods 211 disposed at the distal end region of the traction assembly 21 are circumferentially rotationally symmetric about the central axis of the traction assembly 21 and diverge distally, the axis of each traction rod 211 is coplanar with the central axis of the traction assembly 21, a second flexible segment 2110 is disposed at the distal end region of each traction rod 211, and a second hole 2111 is disposed at the distal end of the second flexible segment 2110. Preferably, the second hole 2111 and the first hole 1111 have a shape of a paperclip with smooth edges.

More preferably, the pulling rods 211 are flat, the number of the rods is 3-20, the larger the number of the rods is, the better the roundness is, but the number of the rods is not too large, otherwise, the overall size of the conveying system 2 is too large, and therefore, the number of the pulling rods 211 is preferably 6-12 in the present application. The width L7 of the drawbar 211 is preferably set to 0.2mm-2mm, the length of the drawbar is preferably 5-100mm, the number of the binding holes 2100 is different according to the length of the drawbar 211, and preferably, the hole interval L2 between every two adjacent binding holes 2100 is 2-20 mm.

Preferably, the wire diameter L9 of the release wire 220 is 0.1-1mm, the wire diameter L9 is not greater than the minimum hole width L10 or L3 of the first hole 1111 and the second hole 2111, and the number and positions correspond to the plurality of traction rods 211 one by one; the proximal ends of the release wires 220 are gathered together and placed in the release collection member 221, or the release wires 220 pass through a connecting hole formed in the distal end of the release collection member 221, so that the release wires 220 are connected with the release collection member 221. In addition, the releasing wire 220 sequentially passes through all the binding holes 2100 on the corresponding draw bar 211 from the near end to the far end in an S shape, and then passes through the first hole 1111 or the second hole 2111 in a space defined by the draw bar 211 and the right disc surface of the elastic pore-forming bracket 11, so that the detachable connection and the controllable release of the elastic pore-forming bracket 11 and the conveying system 2 are realized.

To accomplish this, in one embodiment, the first flexible segment 1110 distal to the right disk edge of the resilient pore-forming stent 11 is necked down or partially heat treated to impart flexibility. A protrusion 1112 is provided on the first flexible segment 1110, as shown in FIG. 2b, the protrusion 1112 is located at the distal side of the first hole 1111, the protrusion 1112 has a thickness dimension no less than the hole length L3 of the second hole 2111, and the distance between the protrusion 1112 and the first hole 1111 is 0.2mm-3mm, so as to effectively define the relative position between the implantation instrument 1 and the delivery system 2 after the connection. The stem width L8 of the first flexible segment 1110 is less than the hole width L3 of the second hole so that the first flexible segment 1110 can be inserted into the second hole 2111 from the lateral side to the medial side. After insertion, in a natural state, the central axis of the first flexible section 1110 and the central axis of the second flexible section 2110 form an angle of 1-80 °, and the first hole 1111 at the distal end of the first flexible section 1110 is located in a space surrounded by the plurality of traction rods 211 and the right disk surface of the elastic pore-forming support 11. The wire diameter L9 of the release wire 220 is smaller than the width L10 of the first hole 1111 and passes through all the binding holes 2100 of the corresponding drawbar 211 in an S-shape from the proximal end to the distal end along the corresponding drawbar 211. Then, the far end of the releasing wire 220 passes through a first hole 1111 in a space enclosed by the plurality of traction rods 211 and the right disc surface of the elastic pore-forming bracket 11; finally, the distal end of the elastic pore-creating support 11 is placed on the right disc side, or the release wire 220 extends proximally in the region of the right disc side of the elastic pore-creating support 11 into the traction gathering member 212, so that the elastic pore-creating support 11 is detachably connected with the conveying system 2.

After the implantation instrument 1 is connected with the delivery system 2 in a matching way, as the flexible sections 1110 and/or 2110 have certain deformation capacity, the parts connected in a matching way have certain compressibility, and after the implantation instrument 1 and the delivery system 2 are loaded in the sheath 230 after being pressed and held, the internal diameter of the sheath 230 can be reduced, the damage to the patient entering the way can be reduced, and the matching between the matching connection parts and the inner cavity of the sheath 230 is more compact. As shown in fig. 5a and 5b, during the process that the implantation instrument 1 and the delivery system 2 are placed in the sheath 230 and pushed from the proximal end of the sheath 230 to the distal end of the sheath 230, and guided to the target position through the sheath 230, the protrusion 1112 on the first flexible segment 1110 and on the distal side of the first hole 1111 can play a role of limiting, and ensure that the components of the mating connection are not displaced relatively in the axial direction.

After sheath 230 is positioned at the target location, traction handle 214 is slowly advanced as shown in fig. 5c, and the distal end of the implantation instrument 1 is slowly advanced out of sheath 230 and gradually extended as shown in fig. 5 d. The sheath handle 231 is slowly withdrawn proximally to slowly place the distal end of the deployed insertion device 1 at the target site and into engagement with the target tissue, as shown in fig. 5 e. Then, the traction handle 231 is further slowly pushed to the far end, so that the whole implantation instrument 1 and the far end of the traction rod 211 are gradually pushed out of the sheath 230, in the process, as the edge of the near end of the implantation instrument is provided with the flexible section, the far end of the flexible section is pulled and bound by the traction rod 211 and the release wire 220, the expansion processes of the near end of the implantation instrument 1 and the far end of the traction rod 211 are both slowly, continuously and controllably, as shown in fig. 5 f; the pulling handle 214 is further slowly pushed to push the whole pulling rod 211 out of the sheath 230, so that the implantation instrument 1 and the pulling rod 211 are gradually and completely unfolded, and the proximal end of the implantation instrument 1 is arranged at the target position and is jointed with the target position, as shown in fig. 5 g. At this time, the doctor observes the form and the flow rate of the implantation instrument 1 by an imaging means to determine the deployed form and the placement position of the implantation instrument 1. If the effect is not ideal, before the matching connection is not disassembled, the traction handle 214 can be retracted or the sheath 230 can be pushed forwards, the implantation instrument 1 which is placed at the target position and is fully unfolded is retracted into the sheath 230 of the delivery system 2, so that the implantation instrument 1 is recovered and is withdrawn from the body, and the specification is changed or the operation is finished according to the situation. If desired, the release handle 224 is slowly withdrawn proximally, as shown in fig. 5h, where a 'and b' are before the insertion device 1 and delivery system 2 are removed and a and b are after the insertion device 1 and delivery system 2 are removed. The disassembly withdrawing force is uniformly transmitted on the releasing wires 220 through the mutual matching of the traction rod 211 and the binding piece 210, so that the distal ends of the releasing wires 220 are smoothly and synchronously withdrawn out of the second holes 2111, the controllable disassembly of the connection between the implantation instrument 1 and the delivery system 2 is realized, and the implantation instrument 1 is controllably released to a target position.

In another embodiment, the second flexible section 2110 of the distal end of the pull rod 211 is necked down to provide flexibility between 1 ° and 80 ° relative to the first flexible section 1110. A protrusion 2112 is provided on second flexible segment 2110, and as shown in FIG. 6, protrusion 2112 is located proximal to second aperture 2111, with a protrusion width dimension L12 no less than the aperture width L10 of first aperture 1111, and a distance L11 between protrusion 2112 and second aperture 1111 is between 0.2mm and 3mm to define the relative position of the insertion instrument 1 and delivery system 2 when coupled thereto.

Second flexible segment 2110 has a stem width L5 that is no greater than the hole width L10 corresponding to first hole 1111 so that second flexible segment 2110 can be inserted into first hole 1111 from the outside to the inside, as shown in FIG. 2 b. After insertion, the central axis of the first flexible segment 1110 and the central axis of the second flexible segment 2110 form an angle of 1-80 °, and the second hole 2111 at the distal end of the second flexible segment 2110 is located in a space defined by the plurality of traction rods 211 and the proximal end face of the elastic hole-forming bracket 11. The release wire 220 has a wire diameter no greater than the smallest dimension of the second aperture 2111 and extends proximally and distally along the corresponding drawbar 211 and is S-shaped to pass through all of the tie-down apertures 2100 in the corresponding drawbar 211. Then, the far end of the releasing wire 220 passes through a second hole 2111 in a space surrounded by the plurality of traction rods 211 and the right disc surface of the elastic pore-forming bracket 11; finally, the distal end of the release wire is placed at one side of the proximal end of the right disc surface of the elastic pore-forming support 11, or the release wire 220 extends proximally into the traction gathering piece 212 in the proximal region of the right disc surface of the elastic pore-forming support 11, so that the elastic pore-forming support 11 is detachably connected with the conveying system 2. In this embodiment, the requirements for the shaft width of the first flexible segment 1110 of the elastic pore-forming stent and the pore size of the first pores 1111 are lower, namely: the wide and the pore size of first hole 1111 of the pole of the first flexible section 1110 of elasticity pore-creating support has been relaxed relatively for the edge design of the end face is more mellow and more moist near elasticity pore-creating support 11, and this design has two aspects advantages, include: a) the risk that the elastic pore-forming bracket 11 stimulates the tissue at the target position (such as the right atrial tissue at the interatrial septum) and even causes physical damage is reduced; b) the risk of thrombus formation at the right disc edge of the elastic pore-forming stent 11 is reduced.

As an embodiment, on the surface of the elastic pore-creating support 11, at least the left disc and the right disc area are covered with a biocompatible film 13, the film 13 at least wraps all the support rods of the whole left disc and right disc area, as shown in fig. 10, the film 13 should preferably be made of a biocompatible material, the material may include a polymer material such as PET, PTFE, silica gel, etc., and the film 13 has the following advantages: a) the film 13 has smooth surface and low friction coefficient, is convenient to repeatedly push and recover from the sheath 230 to the sheath 230 for many times in the operation process, and is extremely favorable for the introduction and controllable release of the elastic pore-forming stent 11 through the sheath 230; b) when the supporting rod 111 of the elastic pore-forming bracket 11 is made of nickel titanium material, the toxicity, sensitization and teratogenicity caused by the possible precipitation of nickel ions are prevented, and the biological safety of the elastic pore-forming bracket 11 is ensured; c) promoting the endothelialization of the left disc and the right disc of the elastic pore-forming bracket 11, so that the left disc and the right disc can grow into a whole with the surface of the target tissue as fast as possible, and ensuring the firmness of the fit of the elastic pore-forming bracket 11 with the target tissue at the interatrial septum; d) the membrane 13 has a physical barrier function, so that when the distal end of the release wire 220 is located at or passes the proximal end face side of the implantation device 1, the distal end of the release wire 220 will not touch the animal or human tissue at all times, ensuring sufficient safety during the release process.

In another embodiment, both the inner and outer surfaces of the elastic pore-forming scaffold 11 are completely covered with the thin film 13, so that the entire elastic pore-forming scaffold 11 has more excellent biocompatibility.

In one embodiment, the elastic pore-forming stent 11 is provided with a series of lines 12 at the edge of the left disk, the edge of the right disk and/or the waist, and the series of lines 12 will pass through or wrap around the support rods 111 of the elastic pore-forming stent 11 such that the edge of the left disk, the edge of the right disk and/or the waist form a closed circle. Preferably, a plurality of connection holes 1112 are arranged on the edge of the net-shaped structure of the elastic pore-creating support 11 along the circumferential direction, as shown in fig. 9 and 10, a serial line 12 passing through all the connection holes 1112 is arranged on the elastic pore-creating support 11, the line diameter of the serial line 12 is 0.02mm to 1mm, the serial line 12 can sequentially pass through the connection holes 1112 along the circumferential direction and pass through the corresponding first holes 1111 of each support rod 111, and finally a closed loop coil 12 is formed, the closed loop coil 12 is beneficial to the adhesion of the polymer film 13 and the surface of the support 11, and simultaneously, the influence of the repeated sheathing of the implantation instrument 1 on the adhesion of the edge film 13 of the support 11 and the elastic pore-creating support 11 is avoided, and the repeated recoverability of the implantation instrument 1 is ensured. In order to realize the above functions, the used material of the serial line 12 may include PTFE, PET, UHMWPE made of high molecular material, so that the serial line 12 has good flexibility, or may include cobalt-chromium alloy, nickel-titanium alloy, pure tantalum, 316L made of metal material, so that the serial line 12 has certain shape memory, which improves the roundness of the left and right discs of the elastic pore-forming stent 11, and the elastic pore-forming stent 11 has certain developing effect, thereby facilitating the operator to observe and control the position and shape of the elastic pore-forming stent 11 in time in the operation by using an imaging device, and the detection of the postoperative follow-up.

Preferably, the film 13 completely covers and wraps the entire inner and outer surfaces of the elastic pore-forming stent 11, including all the support rods 111, all the first holes 1111, the serial line 12, and all the first flexible segments 1110, so that the entire elastic pore-forming stent 11 has more excellent biocompatibility.

Example three:

based on the first embodiment, the third embodiment is different from the first embodiment in that the tie 210 is not a tie hole 2100 provided on the drawbar 211, but a tie tube 2101 or a tie ring 2102 is provided on the drawbar 211.

In one embodiment, as shown in fig. 4a to 4c, the binding member 210 is a binding tube 2101 having a hollow tubular structure, the binding tube 2101 is sleeved outside the traction rod 211, the binding tube 2101 is preferably made of polymer tube such as FEP, PTFE, PE, POE, PET, silicone, etc., and its inner cavity can accommodate at least one traction rod 211 and one release wire 220 at the same time, which not only enhances the fit between the release wire 220 and the traction rod 211, but also enables the release wire 220 to smoothly pass through the inner cavity of the binding tube 2101 and slide in the inner cavity of the binding tube 2101; meanwhile, the draw bar 211 is prevented from being provided with a hole, the anti-deformation capacity of the draw bar 211 is increased to a certain degree, and a guiding effect can be provided for the retraction of the release wire 220, so that the effectiveness of the detachment between the connection parts of the implantation instrument 1 and the delivery system 2 is ensured.

The release wire 220 is positioned inside the pull rod 211 and has a wire diameter no greater than the hole width of the first hole 1111 and the second hole 2111. The distal end of the release wire 220 extends through the entire cinch tube 2101 from the proximal end to the distal end along the corresponding pull rod 211. The distal end of the release wire 220 then lies against the proximal end of the implantation instrument 1, as shown in fig. 4a, with a 'and b' in a state before the implantation instrument 1 and the delivery system 2 are detached, and a and b in a state after the implantation instrument 1 and the delivery system 2 are detached, as shown in fig. 4b, or the distal end of the release wire 220 extends proximally into the release funnel 212 after passing through a first bore 1111 provided in the proximal region of the implantation instrument 1, as shown in fig. 4c, so that a controlled release connection of the implantation instrument 1 to the delivery system 2 is achieved.

In another embodiment, as shown in fig. 4d, the tie down 210 is one or more tie down rings 2102, the tie down rings 2102 being sleeved over an outer surface of the distal region of the drawbar 211. In a preferred embodiment, a cinch ring 2102 is disposed in a central region of the pull rod 213 and is fixedly coupled to the pull rod 211, the lumen facilitating smooth sliding movement of the release wire 220. In another preferred embodiment, the binding ring 2102 is located in the middle of the release wire 220 at the distal region, the binding ring 2102 is fixedly connected with the release wire 220, and the lumen of the binding ring 216 can accommodate the drawbar 211, so that the binding ring 2102 and the release wire 220 can slide along the drawbar 211 under the action of the draw back force when the release wire 220 is drawn back. The binding ring 2102 is preferably a thin-walled metal tube, but may also be made of polymer materials such as FEP, PTFE, POE, PET, silica gel, and the like.

Example four:

based on the second embodiment, the fourth embodiment is different from the second embodiment in that the conveying system 2 further includes a sheath assembly disposed outside the pulling assembly 21. The sheath tube assembly at least comprises a sheath tube 230 and a sheath tube handle 231 which is fixedly connected with the proximal end of the sheath tube 230 in a sealing way, when the implantation instrument 1 is connected with the traction assembly 21 and the release assembly 22, the traction assembly 21 is pulled back, and the traction rod 211 of the traction assembly 21 and the implantation instrument 1 are elastically deformed and can be retracted into the sheath tube 230; after the implantation instrument 1 is positioned at the interatrial septum target site, the release assembly 22 is retracted and the release wire 220 is withdrawn from the first bore 1111 or the second bore 2111 in the space defined by the plurality of pull rods 211 and the proximal end surface of the implantation instrument 1, thereby disengaging the pull assembly 21 from the implantation instrument 1 and allowing controlled release of the implantation instrument 1 from the delivery system 2.

In another embodiment, as shown in fig. 5a, the delivery system 2 further comprises a loading sheath 232, the outer diameter of the loading sheath 232 is not larger than the inner cavity size of the sheath handle 231 and the sheath 230, and the loading sheath 232 is used for pre-loading the assembled implantation instrument 1, the traction assembly 21 and the release assembly 22 into the inner cavity of the loading sheath 232 after being pressed and held outside the body, and is smoothly guided into the inner cavity of the sheath 230 through the pre-loading sheath 232, so as to avoid the possible damage of the instrument and the poor pushing caused by the friction between the distal end part of the implantation instrument 1 and the sealing ring in the sheath handle 231 during the pushing process. During the operation, the loading sheath 232 may be inserted into the sheath handle 231 or directly inserted into the proximal end of the lumen of the sheath 230, and preferably, the pre-loading sheath 232 and the proximal end of the sheath handle 231 are detachably connected through a screw fit, a snap fit, a plug fit, or the like, so that the operator can push the gripped implantation device 1, together with the pulling assembly 21 and the releasing assembly 22, into the sheath 230 after pre-loading the sheath 232, and further push the pulling assembly 21, so as to finally guide the implantation device 1 to the distal end of the sheath 230 located in the target site area along the lumen of the sheath 230. In this embodiment, the pre-assembled sheath 232 is directly connected to the sheath handle 231, which creates a channel for pushing the implanting device 1 and the delivery system 2, and avoids device damage and unsmooth pushing caused by friction between the distal end portion of the implanting device 1 and the sealing ring in the sheath handle 231 during pushing.

Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present application, and are not intended to limit the present application, and any modifications, equivalents, improvements, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. A system for controlled release, comprising an implantation instrument (1) and a delivery system (2), characterized in that the proximal end region of the implantation instrument (1) is provided with a plurality of first holes (1111), the delivery system (2) comprises a plurality of tow bars (211) and a plurality of release wires (220), the plurality of tow bars (211) and the plurality of first holes (1111) all correspond one-to-one in number and position, each tow bar (211) is provided with a second hole (2111) and a tie (210), the second hole (2111) is located at the distal end of the tow bar (211), the tie (210) is located at the proximal side of the second hole (2111), the first hole (1111) provided on the implantation instrument (1) and the second hole (2111) provided on the tow bar (211) can be mutually interpenetrated and fitted, the release wire (220) passes through the tie (210), the first hole (1111) or the second hole (2111) to achieve connection of the implantation instrument (1) and the delivery system (2), the tie (210) can limit the movement of the release wire (220) during delivery, and the release wire (220) can be displaced relative to the traction rod (211) when the implantation instrument (1) is released.

2. A system for controlled release according to claim 1, characterized in that a flexible segment is provided at a proximal region of the implantation instrument (1) and/or at a distal region of the drawbar (211), the flexible segment provided at the proximal region of the implantation instrument (1) being referred to as first flexible segment (1110), the first hole (1111) being provided at a proximal region of the first flexible segment (1110); the flexible section provided at the distal end region of the drawbar (211) is referred to as a second flexible section (2110), and the second hole (2111) is provided at the distal end region of the second flexible section (2110).

3. The system of claim 2, wherein the first flexible segment (1110) has a spring structure or a dual lumen structure to facilitate insertion of the distal end of the release wire (220) into a lumen of the spring structure or the dual lumen structure.

4. The system of claim 2, wherein the first flexible segment (1110) or the second flexible segment (2110) has a hinge structure, a necked down structure, an S-wave structure, a spring structure, or the first flexible segment (1110) or the second flexible segment (2110) is made of a material having a shape memory function, or the first flexible segment (1110) or the second flexible segment (2110) is made of an elastic material.

5. A system for controlled release according to claim 2, characterized in that a protrusion (1112) is provided on the first flexible segment (1110), the protrusion (1112) being located on the distal side of the first hole (1111) to define the relative position between the implantation instrument (1) and the delivery system (2) after connection, or a protrusion (2112) is provided on the second flexible segment (2110), the protrusion (2112) being located on the proximal side of the second hole (2111) to define the relative position between the implantation instrument (1) and the delivery system (2) after connection.

6. The system of claim 1, wherein the tie down (210) is a tie down hole (2100) disposed on the drawbar (211) and extending through the drawbar (211).

7. A system for controlled release according to claim 6, characterized in that the number of the tie-down holes (2100) is even and each release wire (220) passes through the tie-down hole (2100), the first hole (1111) and/or the second hole (2111) in an S-shape in sequence from the proximal end to the distal end along the corresponding drawbar (211) to enable detachable connection of the implantation instrument (1) to the delivery system (2).

8. A system for controlled release according to claim 1, characterized in that the tethering member (210) is a tethering tube (2101) with a hollow tubular structure, the tethering tube (2101) is sleeved outside the traction rod (211), the lumen of the tethering tube (2101) can accommodate at least one traction rod (211) and one release wire (220) simultaneously, such that the release wire (220) can pass through the lumen of the tethering tube (2101) and can slide within the lumen of the tethering tube (2101).

9. A system for controlled release according to claim 1, wherein the tie down (210) is one or more tie down rings (2102), the tie down rings (2102) being fitted around the outer surface of the distal end region of the drawbar (211), the tie down rings (2102) being fixedly connected to the release wire (220) such that upon withdrawal of the release wire (220), the tie down rings (2102) and the release wire (220) are slidable along the drawbar (211) under the action of the withdrawal force.

10. The controlled release system according to claim 1, wherein the implantation device (1) is an elastic foramen-making stent (11) capable of being placed at the interatrial septum, the elastic foramen-making stent (11) is a three-dimensional wavy and/or net-like structure formed by connecting a plurality of support rods (111) with each other, the three-dimensional wavy and/or net-like structure comprises a left disc fitting with the interatrial septum surface in the left atrial chamber, a right disc fitting with the interatrial septum surface in the right atrial chamber, and a waist portion disposed between and fixedly connecting the left disc and the right disc, a through hole is disposed in the waist portion, the through hole enables fluid communication between the left atrium and the right atrium, the elastic foramen-making stent (11) has an I-shaped longitudinal cross section, a first flexible segment (1110) is disposed in a circumferential region of the right disc, the first aperture (1111) is located at a distal end of the first flexible segment (1110).

11. The controlled release system according to claim 10, characterized in that at the edges of the left disc, the edges of the right disc and/or the waist of the elastic pore-creating support (11) there are provided series lines (12), which series lines (12) pass through or wrap around the support bars (111) of the elastic pore-creating support (11) such that the edges of the left disc, the edges of the right disc and/or the waist form a closed circle; the surface of the elastic pore-forming bracket (11) is covered with a film (13).

12. The system for controlled release according to claim 1, wherein the delivery system (2) further comprises a pulling hub (212), a pulling handle (214), a release hub (221), and a release handle (224), wherein a distal end of the pulling hub (212) is fixedly connected to the plurality of pulling rods (211), a proximal end of the pulling hub (212) is fixedly connected to the pulling handle (214), a distal end of the release hub (221) is connected to the plurality of release wires (220), a proximal end of the release hub (221) is fixedly connected to the release handle (224), the pulling rods (211), the pulling hub (212), and the pulling handle (214) constitute a pulling assembly (21), and the release wires (220), the release hub (221), and the release handle (224) constitute a release assembly (22), the release assembly (22) is located within the pulling assembly (21), the release assembly (22) and the pulling assembly (21) being relatively movable.

13. The system of controlled release according to claim 12, characterized in that the distal end of the release wire (220) abuts against the proximal side of the implantation instrument (1), or that the distal end of the release wire (220) extends proximally into the release catch (221) through the first hole (1111) provided in the proximal region of the implantation instrument (1) or the second hole (2111) provided on the drawbar (211).

14. The system of claim 12, wherein the delivery system (2) further comprises a sheath assembly disposed outside the tractor assembly (21), the sheath assembly comprising a sheath (230) and a sheath handle (231) sealingly and fixedly coupled to a proximal end of the sheath (230).