A controlled release system

Abstract

The present application relates to a controlled release system, comprising an implant device and a delivery system. A plurality of first holes are provided in the proximal region of the implant device. The delivery system includes a plurality of traction rods and a plurality of release wires. The plurality of release wires, the plurality of traction rods, and the plurality of first holes correspond to each other in number and position. A second hole and a restraint are provided on each traction rod. The second hole is located at the distal end of the traction rod. The release wire passes through the restraint and the first hole or the second hole to realize the connection between the implant device and the delivery system. During the delivery process, the restraint can limit the movement of the release wire. When releasing the implant device, the release wire can be displaced relative to the traction rod. This system facilitates the timely repeated recovery of the implant device before disassembly; during the release process, the implant device can slowly expand from the sheath to the optimal shape, and the connection can be made detachable by retracting the release wire, having a controlled release function; the overall structure of this system is simple, the operation is convenient, and it is safe and reliable.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a controllable release system. Background Art

[0002] Minimally invasive transcatheter treatment of cardiovascular diseases has gradually become the main treatment method. Among them, for coronary artery stents, heart valves, occluders, large blood vessel stents, and other cardiovascular implant devices, the implant device needs to be delivered to the desired ideal position in the human body through a delivery device. The surgical operation process is generally to compress and deform the implant device and load it into the delivery catheter. By using the delivery catheter and / or the cooperation design of structures such as the inner push tube, the position of the implant device in the delivery catheter is kept relatively unchanged. Then, with the assistance of a guide wire or other imaging devices, the implant device is delivered to the target position through the delivery catheter, and then the implant device is released from the delivery catheter. Taking the self-expanding atrial septal shunt stent and the delivery device product as an example, during the withdrawal process of the delivery catheter, the position of the stent in the catheter is likely to change. Because the stent size is much larger than the delivery catheter size, the stent is prone to bounce, affecting the positioning of the stent, and thus resulting in an unsatisfactory surgical effect; during the release process, this product cannot achieve controllable release. Once the stent is partially released from the delivery catheter or completely released, the stent cannot be recycled into the delivery catheter again. Therefore, the position of the stent cannot be adjusted anymore, which requires high requirements for the operator and has a high risk of surgical failure.

[0003] Regarding using an atrial septal shunt device to reduce left atrial pressure, in 2011, Corvia medical company made certain improvements in the design of the shunt device. For example, in the patent US 9456812 B2, an atrial septostomy stent and a delivery system were proposed. Among them, the stent was formed by laser cutting, and was divided into two single-layer disks on the left and right. The right disk was flat, and the left disk bent to the right. The delivery system was not directly connected to the stent, but this design still had the following defects:

[0004] First, a retrievable rod and a proximal assembly (such as a coil) were provided on the stent. After the stent was placed at the target position on the atrial septum, since the retrievable rod could not be disassembled and withdrawn, the part of the stent connected to the delivery system needed to be placed in the atrium for a long time. The retrievable rod and the proximal assembly protruded on the atrial septum, not only occupying part of the atrial cavity space, but also affecting the hemodynamics in the atrium and causing a high risk of thrombus formation. In addition, it was difficult to fixedly connect the retrievable rod and the proximal assembly to the stent. As the blood flowed continuously in the atrial cavity, this part was prone to swing, resulting in a delay in the endothelialization rate of the stent.

[0005] Secondly, a proximal collecting piece is provided at the proximal end of the retrievable rod of the stent, and the proximal collecting piece has to be set in the exact center of the shunt hole. This means that after the stent is placed at the target position, it is very likely to affect the shunt effect and will also cause a great risk of thrombosis at that location.

[0006] In addition, a proximal end collecting piece is provided at the proximal end of the stent retractable rod, and a closed loop (coil) structure is connected to the proximal end collecting piece. The distal end of the grasping device adopts a hook or tab structure, which is used to insert into the hole of the implant device and connect or disassemble with the closed loop, so as to realize the deployment or withdrawal of the stent. This method has the following two problems:

[0007] First, the distal end of the release device uses a hook, which occupies space in the sheath when it is retracted, so the size of the sheath selected increases accordingly; in addition, affected by the operating space and hemodynamics, the hook and the ring are not easy to connect or detach in the in vivo environment;

[0008] Second, the retrieval device is not directly connected to the stent, but is connected through a ring connected to the distal restraint. This method is prone to uneven force transmission, and the device is prone to off-axis when the sheath is retracted. During the process of being loaded into the sheath and pushed to the target position, the thrust transmission cannot respond in time, and may even cause the operator to continue pushing the sheath handle outside the body, but the stent is slow to be pushed out from the distal end of the sheath. Summary of the invention

[0009] In view of this, the purpose of the present application is to provide a controllable release system with simple structure, convenient operation, safety and reliability.

[0010] The purpose of this application is achieved through the following technical solutions:

[0011] A controllable release system includes an implant device and a delivery system, wherein a plurality of first holes are provided in a proximal region of the implant device, and the delivery system includes a plurality of traction rods and a plurality of release wires, wherein the plurality of release wires, the plurality of traction rods and the plurality of first holes correspond to each other in number and position, and a second hole and a restraining member are provided on each traction rod, wherein the second hole is located at the distal end of the traction rod, and the restraining member is located at the proximal side of the second hole, and the first hole provided on the implant device and the second hole provided on the traction rod can be interlaced and matched with each other, and the release wire passes through the restraining member, the first hole or the second hole to realize the connection between the implant device and the delivery system, and during the delivery process, the restraining member can limit the movement of the release wire, and when the implant device is released, the release wire can be displaced relative to the traction rod.

[0012] The object of the present application can also be further achieved by the following technical solutions:

[0013] In one embodiment, a flexible section is provided in the proximal region of the implant device and / or the distal region of the traction rod. The flexible section provided in the proximal region of the implant device is called the first flexible section, and the first hole is provided in the proximal region of the first flexible section; the flexible section provided in the distal region of the traction rod is called the second flexible section, and the second hole is provided in the distal region of the second flexible section.

[0014] In a preferred embodiment, the first flexible section has a spring structure or a double-chamber structure to facilitate the insertion of the distal end of the release wire into the cavity of the spring structure or the double-chamber structure.

[0015] In a preferred embodiment, the first flexible section and / or the second flexible section has a hinge structure, a necking structure, an S-wave structure or a spring structure.

[0016] In a preferred embodiment, the first flexible section and / or the second flexible section is made of a material with shape memory function, or the first flexible section and / or the second flexible section is made of an elastic material.

[0017] In a preferred embodiment, a protrusion is provided on the first flexible section, and the protrusion is located on the distal side of the first hole to define the relative position between the implant device and the delivery system after they are connected.

[0018] In a preferred embodiment, the maximum dimension of the protrusion is not less than the minimum dimension of the second hole, and the distance between the protrusion and the first hole is 0.2 mm - 3 mm.

[0019] In a preferred embodiment, a protrusion is provided on the second flexible section, and the protrusion is located on the proximal side of the second hole to define the relative position between the implant device and the delivery system after they are connected.

[0020] In a preferred embodiment, the maximum dimension of the protrusion is not less than the minimum dimension of the first hole, and the distance between the protrusion and the second hole is 0.2 mm - 3 mm.

[0021] In one embodiment, the traction rod has a double-chamber or multi-chamber structure, and the release wire is placed in one of the cavities of the double-chamber or multi-chamber structure.

[0022] In one embodiment, the implant device is an elastic pore-forming stent that can be placed at the atrial septum, and the delivery system is used to deliver and controllably release the elastic pore-forming stent from outside the body to the atrial septum.

[0023] In a preferred embodiment, the elastic pore-forming stent is a three-dimensional corrugated and / or reticular structure formed by connecting multiple support rods to each other. The three-dimensional corrugated and / or reticular structure includes a left disk that fits against the atrial septal surface in the left atrium cavity, a right disk that fits against the atrial septal surface in the right atrium cavity, and a waist portion disposed between the left disk and the right disk and fixedly connecting the left disk and the right disk. A through-hole is provided in the waist portion, and 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 is in the shape of an "I". A first flexible section is provided in the circumferential region of the right disk, and the first pore is located at the distal end of the first flexible section.

[0024] In a preferred embodiment, the elastic pore-forming stent is formed by laser cutting and heat treatment shaping of a shape memory alloy tube.

[0025] In a preferred embodiment, the edge of the left disk encloses a circle, and the diameter of the circle ranges from 12 mm to 40 mm. The edge of the right disk encloses a circle, and the diameter of the circle ranges from 12 mm to 40 mm.

[0026] In a preferred embodiment, the diameter of the through-hole is 3 mm to 15 mm, and the axial height of the through-hole is 1 mm to 15 mm.

[0027] In a preferred embodiment, a series connection wire is provided at the edge of the left disk, the edge of the right disk, and / or the waist portion. The series connection wire passes through or winds around the support rods of the elastic pore-forming stent such that the edge of the left disk, the edge of the right disk, and / or the waist portion form a closed circle.

[0028] In a preferred embodiment, the material of the series connection wire includes PTFE wire, PET wire, UHMWPE wire made of polymer materials, and may also include cobalt-chromium alloy filaments, nickel-titanium alloy filaments, pure tantalum filaments, 316L filaments made of metal materials.

[0029] In a preferred embodiment, the wire diameter of the series connection wire is 0.02 mm to 1 mm.

[0030] In a preferred embodiment, a thin film is covered on the surface of the elastic pore-forming stent, and the material of the thin film includes polymer thin films such as PET, PTFE, and silica gel.

[0031] In a preferred embodiment, the polymer thin film is covered in the regions of the left disk and the right disk of the elastic pore-forming stent.

[0032] In a preferred embodiment, the polymer thin film completely covers and wraps the inner and outer surfaces of the elastic pore-forming scaffold, such that the entire elastic pore-forming scaffold has more excellent biocompatibility.

[0033] In one embodiment, the delivery system further includes a traction assembly piece, a traction handle, a release assembly piece and a release handle. The distal end of the traction assembly piece is fixedly connected to a plurality of the traction rods, the proximal end of the traction assembly piece is fixedly connected to the traction handle, the distal end of the release assembly piece is connected to a plurality of the release wires, the proximal end of the release assembly piece is fixedly connected to the release handle. The traction rods, the traction assembly piece and the traction handle form a traction assembly, the release wires, the release assembly piece and the release handle form a release assembly. The release assembly is located within the traction assembly, and the release assembly and the traction assembly are capable of relative movement.

[0034] In one embodiment, the distal end of the release wire abuts against the proximal side of the implanting instrument, or the distal end of the release wire passes through a first hole provided in the proximal region of the implanting instrument or the second hole provided on the traction rod and then extends proximally into the release assembly piece.

[0035] In one embodiment, the delivery system further includes a sheath assembly disposed outside the traction assembly. The sheath assembly includes a sheath and a sheath handle fixedly and sealingly connected to the proximal end of the sheath.

[0036] In a preferred embodiment, the delivery system further includes a loading sheath for receiving and pressing the connected implanting instrument, traction assembly and release assembly within the loading sheath. The loading sheath can be inserted into the sheath handle or the sheath.

[0037] In one embodiment, the binding member is a binding hole provided on and passing through the traction rod.

[0038] In a preferred embodiment, the number of the binding holes is even. Each release wire passes through the binding hole, the first hole and / or the second hole in an S shape in sequence from the proximal end to the distal end along its corresponding traction rod to achieve detachable connection between the implanting instrument and the delivery system.

[0039] In a preferred embodiment, on the same traction rod, the center distance between two adjacent binding holes is 1 mm - 20 mm.

[0040] In a preferred embodiment, on the same traction rod, the center distance between the second hole and the adjacent binding hole is 1 mm - 20 mm.

[0041] In one embodiment, the space defined by the plurality of traction rods and the second flexible section is conical, bowl-shaped or lantern-shaped.

[0042] In one embodiment, the release wire is a shape memory alloy wire, and the wire diameter of the release wire is 0.05 mm - 1 mm.

[0043] In one embodiment, the restraint member is a restraint tube having a hollow tubular structure. The restraint tube is sleeved outside the traction rod. The inner cavity of the restraint tube can accommodate at least one traction rod and one release wire at the same time, so that the release wire can pass through the inner cavity of the restraint tube and can slide in the cavity of the restraint tube.

[0044] In one embodiment, the restraint member is one or more restraint rings. The restraint rings are sleeved on the outer surface of the distal region of the traction rod. The restraint rings are fixedly connected to the release wire, so that when the release wire is retracted, the restraint rings and the release wire can slide along the traction rod under the action of the retraction force.

[0045] Compared with the prior art, the beneficial effects of the present application are mainly reflected in:

[0046] 1. The first hole provided on the implant device and the second hole provided on the traction rod in the present application can be inserted and matched with each other. The release wire sequentially passes through the restraint member, the first hole or the second hole in an S shape to realize the connection and assembly of the implant device and the delivery system. This connection method not only enables the implant device to be recycled in time before the implant device and the delivery system are disassembled, but also enables the implant device to be disassembled from the delivery system by retracting the release wire after the implant device is completely released. It also makes the series of processes of loading the implant device and the delivery system into the sheath tube after being crimped, pushing the sheath tube to the target position, and unfolding and connecting and disassembling at the target position slow and continuous, achieving controllable release. On the one hand, the second hole provided on the traction rod in the present application facilitates connection, and on the other hand, it can guide the release wire during disassembly, enabling the release wire to move along the traction rod, avoiding the release wire from knotting or winding, and realizing the controllability of the connection and disassembly of the implant device and the delivery system.

[0047] 2. The present application sets a restraining member on the traction rod, which can ensure the fit of each release wire with the corresponding traction rod, which brings the following benefits: a) When the implant device and the delivery system are in an assembled connection state, whether in the process of the implant device being pressed and gripped, loaded in the sheath of the delivery system, and pushed to the target position, or in the process of the implant device being gradually released from the sheath until it is fully stretched to the optimal shape, it is ensured that the release wires remain independent of each other to avoid multiple release wires from being knotted or entangled with each other, resulting in the inability to withdraw the release wires; b) During the surgical process of releasing the implant device, when the operator withdraws the release wire, the traction rod and the restraining member cooperate with each other to provide a guiding effect for the uniform transmission of the withdrawal force on the release wire, thereby ensuring that the distal ends of the multiple release wires can be smoothly and synchronously withdrawn from the first hole or the second hole, thereby realizing the controllable disassembly of the connection between the implant device and the delivery system, so that the implant device can be controllably released to the target position. Therefore, this design realizes the detachable connection and controllable release of the delivery system and the implant device, and the overall structure is simple, easy to operate, safe and reliable.

[0048] 3. The present application is provided with a flexible section, so that: a) it is convenient for the mating connection parts to be inserted and separated at a suitable angle, thereby realizing the controllable disassembly of the connection part of the implant device and the delivery system, and can effectively prevent the implant device from being detached from the delivery system and causing puncture of the surrounding tissues of the target position due to distal rebound; b) after the implant device is mated and connected with the delivery system, due to the certain deformation ability, the mating connection part has a certain compressibility. When the implant device is loaded in the sheath, the minimum inner diameter of the sheath used can be reduced, reducing damage to the patient's access route and expanding the scope of application of the product; secondly, this compressibility makes the size of the mating connection part and the inner cavity of the sheath more compact, so that there is no relative movement between the mating connection parts, which helps to enhance the soothingness, continuity and controllability of the implant device push and release process.

[0049] When the flexible segment is the first flexible segment, it also has the following advantages: a) when the implant device is placed on the target and released, the distal end of the flexible segment of the implant device is pulled and restrained by the traction rod and the release wire, so that the entire release process of the implant device is slow, continuous and controllable; b) after the implant device is completely released, the flexible segment can increase the contact area and fitting effect between the implant device and the target position (such as atrial septal tissue), which is beneficial to the formation of endothelialization on the surface of the implant device; c) effectively avoid the local stimulation reaction of the edge of the implant device to the tissue, and improve biocompatibility.

[0050] When the flexible section is the second flexible section, it also has the advantage of preventing the traction rod from excessively moving distally due to improper operation, thereby poking the target tissue and causing a local tissue reaction, or piercing the implanted device and affecting the effectiveness of the device.

[0051] 4. The present application is provided with a protrusion on the flexible section, which can define the relative position between the implant device and the delivery system after they are connected, so that when the implant device and the delivery system are assembled and placed in the sheath tube, during the process of being pushed and released from the sheath tube, it is ensured that the connected and mated parts do not undergo relative displacement in the axial direction, providing sufficient guarantee for controlled release.

[0052] 5. The release wire of the present application has good resilience or bending resistance. This design enables: a) effectively avoiding the phenomenon that the connected part of the implant device and the delivery system may be self-locked or jammed due to relative movement, resulting in the release wire being unable to be smoothly retracted from the first hole and / or the second hole, and thus the detachable connection and the controlled release function cannot be achieved; b) ensuring the accurate positioning of the implant device at the target position, avoiding the implant device of the prior art from moving backward as the delivery sheath tube is withdrawn, and thus enabling controlled release.

[0053] 6. The surface of the implant device of the present application is covered with a thin film, which has a physical isolation effect, so that when the distal end of the release wire is located at or passes through the near-end face side of the implant device, it will never touch the animal body or human tissue, ensuring sufficient safety during the controlled release process. Description of the Drawings

[0054] Figure 1 It is the state where the implant device is placed at the target position in the first embodiment, but the implant device and the delivery system are not disassembled.

[0055] Figures 2a - 2d It is a partial schematic view of the connected part between the implant device and the delivery system when the connection is not disassembled and released; Figure 2a 、 Figure 2b 、 Figure 2c and Figure 2d respectively show the connection structures of four different embodiments.

[0056] Figure 3a It is a schematic view of the state where the implant device is placed at the target position in the first embodiment, but the connection with the delivery system is not disassembled when the restraint member is a restraint hole.

[0057] Figure 3b It is for Figure 3a the schematic view of the state after the connection between the implant device and the delivery system in

[0058] Figure 4a It is a schematic view of the implant device placed at the target position in the third embodiment, but the connection is not disassembled and released, where the distal end of the traction wire is placed at the near-end face of the implant device, and a' and b' in the figure are the states before the implant device and the delivery system are disassembled.

[0059] Figure 4bSchematic diagram of the disassembly and separation of the implant device and the delivery system in Embodiment 3. In the figure, a and b are the states after the disassembly of the implant device and the delivery system.

[0060] Figure 4c Schematic diagram of the implant device placed at the target position in Embodiment 3, but the connection is not disassembled and released. The distal end of the release wire is placed inside the traction assembly.

[0061] Figure 4d Schematic structural diagram when the restraint member is a restraint ring in Embodiment 3.

[0062] Figures 5a - 5h Schematic diagram of the process of placing the controllable release system in Embodiment 2 into the sheath tube and gradually releasing it. Among them, Figure 5a Schematic diagram of the state of the controllable release system in Embodiment 2 placed in the loading sheath; Figure 5b Schematic diagram of the state of the controllable release system in Embodiment 2 pushed to the distal end of the sheath tube through the loading sheath; Figure 5c Schematic diagram of the state when the sheath is pushed to the target position of the atrial septum, but the implant device is still placed inside the sheath; Figure 5d For Figure 5c On this basis, push the handle at the distal end of the traction assembly, and push the left disc of the implant device outside the sheath tube; Figure 5e For Figure 5d On this basis, withdraw the handle at the distal end of the sheath tube, and place the expanded left disc surface after release in the left atrial side area of the atrial septum and fit it to the target position; Figure 5f Schematic diagram of the state when further pushing the handle at the distal end of the traction assembly to push the entire implant device and the traction rod out of the sheath tube; Figure 5g For Figure 5f On this basis, further push the handle at the distal end of the traction assembly, so that the right disc of the implant device is placed in the right atrial side area of the atrial septum and fits it to the target position; Figure 5h Schematic diagram of the state when the release handle is withdrawn along the arrow direction in the figure, and the connection between the implant device and the delivery system can be detached.

[0063] Figure 6 Schematic plane expansion diagram of the integral structure of the traction rod and the traction assembly.

[0064] Figure 7a And Figure 7b Schematic structural diagram of the spatial shape defined by the traction rod and the traction assembly at the proximal end of the traction rod. Among them, Figure 7a Is bowl-shaped, Figure 7b Is conical.

[0065] Figure 8a And Figure 8b Schematic structural diagrams of the traction assembly and the release assembly in the natural state respectively.

[0066] Figure 9 Schematic diagram of an elastic pore-forming stent provided with a series connection line and forming a closed coil structure.

[0067] Figure 10 Schematic diagram of an elastic pore-forming stent with a film covering its surface. Detailed implementation manners

[0068] To make the objectives, technical solutions and advantages of the present application clearer and more understandable, the following examples are given with reference to the accompanying drawings to further elaborate on the present application in detail.

[0069] To more clearly describe the controllable release system provided by the present application, the terms "proximal end" and "distal end" are defined herein. The above terms are common terms in the field of medical devices. Specifically, the "proximal end" refers to the end closer to the operator during the surgical procedure, and the "distal end" refers to the end farther from the operator during the surgical procedure.

[0070] Example 1:

[0071] As Figure 1 shown, the controllable release system provided by the present invention includes an implant device 1 and a delivery system 2. A plurality of first holes 1111 are provided in the proximal region of the implant device 1. The delivery system 2 includes a plurality of traction rods 211 and a plurality of release wires 220. The plurality of release wires 220, the plurality of traction rods 211, and the plurality of first holes 1111 are in one-to-one correspondence in terms of quantity and position. A second hole 2111 and a restraint are provided on each traction rod 211. The second hole 2111 is located at the distal end of the traction rod 211, and the restraint is located on the proximal side of the second hole 2111. The first hole 1111 provided on the implant device 1 and the second hole 2111 provided on the traction rod 211 can be inserted and matched with each other. The release wire 220 passes through the restraint, the first hole 1111 or the second hole 2111 to realize the connection between the implant device 1 and the delivery system 2. During the delivery process, the restraint can limit the movement of the release wire 220. When the implant device 1 is released, the release wire 220 can be displaced relative to the traction rod 211.

[0072] In the present invention, restraints in various implementation manners can be provided on the proximal side of the second hole 2111 on the traction rod 211. In this embodiment, the restraint is a restraint hole 2100 provided on and penetrating through the traction rod 211. The restraint hole 2100 is set with appropriate size and shape. Preferably, the restraint hole 2100 can be circular, elliptical, rectangular, safety-pin-shaped, etc., so that the release wire 220 can smoothly pass through the restraint hole 2100. When the implant device 1 and the delivery system 2 are assembled and connected, the release wire 220 passes through the restraint hole 2100 on the corresponding traction rod 211 and is inserted into the first hole 1111, as Figure 2bAs shown; after the release wire 220 passes through the binding hole 2100, it can also be inserted into the second hole 2111, as Figure 2a shown. The design of adding the binding hole 2100 ensures the fitting of each release wire 220 with the corresponding traction rod 211, which brings many benefits, including: a) When the implant device 1 and the delivery system 2 are in an assembled connection state, whether the implant device 1 is compressed and held, loaded in the sheath 230 of the delivery system 2, and pushed to the target position, or when the implant device 1 is gradually released from the sheath 230 until it is fully extended to the optimal form, as Figure 1 shown, it ensures that all release wires 220 remain independent of each other, avoiding the possible knotting or entanglement of multiple release wires 220, which may cause the release wires 220 to be unable to be retracted; b) During the operation of releasing the implant device 1, when the operator withdraws the release wire 220, the traction rod 211 and the binding member cooperate with each other to provide a guiding function for the uniform transmission of the withdrawal force on the release wire 220, so as to ensure that the distal ends of multiple release wires 220 can be smoothly and synchronously withdrawn from the first hole 1111 or the second hole 2111, thereby realizing the controllable disassembly of the connection between the implant device 1 and the delivery system 2, enabling the implant device 1 to be controllably released to the target position. Therefore, this design realizes the detachable connection and controllable release of the implant device 1 and the delivery system 2, with a simple overall structure, convenient operation, and safety and reliability. As can be seen from the above, on the one hand, the second hole 2111 is provided on the traction rod 211 of the present invention to facilitate connection, and on the other hand, it can guide the release wire 220 during disassembly, so that the release wire 220 moves along the traction rod 211, avoiding knotting or entanglement of the release wire 220, and realizing the controllability of the connection and disassembly of the implant device 1 and the delivery system 2.

[0073] On each traction rod 211, one or more binding holes 2100 can be provided according to the maximum fitting requirement corresponding to the traction rod 211. The specific number of the binding holes 2100 and the hole pitch L2 between the binding holes 2100 (as well as the hole pitch L1 between the second hole 2111 and the adjacent binding hole 2100) can be specifically set according to the requirements for the rod length of the traction rod 211 in the specific use scenario. In particular, in order to ensure the effectiveness of force transmission, the hole pitch L2 of the binding holes 2100 located adjacent to each other should preferably be set to 1 mm - 20 mm. Similarly, the center distance L1 between the second hole 2111 and the adjacent binding hole 2100 can also be set to 1 mm - 20 mm. When the number of the binding holes 2100 is even, for example, 2, when the implanting device 1 and the delivery system 2 are assembled and connected, the release wire 220 is moved from the proximal end to the distal end and passes through all the binding holes 2100 on the corresponding traction rod 211 in an S shape in turn. Then, the distal end of the release wire 220 passes through the first hole 1111 located at the proximal end of the implanting device 1 or the second hole 2111 provided on the traction rod 211, and finally abuts against the proximal side of the implanting device 1 or extends proximally into the following release collecting member 221, and thus the connection and assembly of the implanting device 1 and the delivery system 2 can be easily achieved, such as Figure 3aAs shown. This connection method is a direct connection, rather than the indirect connection described in the background art. Unless the operator actively retracts and releases the wire 220, this assembly connection will not be disassembled. Therefore, during a series of surgical procedures before retracting and releasing the wire 220, the connection is safe and reliable, ensuring the smooth progress of the entire surgical procedure, including: pulling back the traction rod 211, the implanted device 1 that has been manufactured and fully deployed can be compressed and loaded into the sheath 230 of the delivery system 2 outside the body; then pushing the traction rod 211, the implanted device 1 can be pushed along the inner cavity track of the sheath 230 to the target position; then retracting the sheath 230, the implanted device 1 is unfolded from the distal end of the sheath 230. And precisely because this assembly connection has a high degree of safety and reliability, at any surgical moment before the connection is disassembled, including when the implanted device 1 is placed at the target position and fully deployed, it can be retracted back into the sheath 230 of the delivery system 2, thus realizing the function of timely repeated recovery. This timely repeated recoverability facilitates the operator to change the specifications of other implanted devices during the operation until the appropriate one is selected and the release state at the target position is optimal, thus ensuring that the operation has a sufficiently high effectiveness. In addition, this connection method enables the implanted device 1 and the delivery system 2 to be compressed and loaded into the sheath 230, pushed to the target position through the sheath 230, and unfolded and the connection disassembled at the target position in a slow and continuous series of processes, achieving controlled release. Also, because the first hole 1111 provided on the implanted device 1 and the second hole 2111 provided on the traction rod 211 can be inserted and matched with each other, after the implanted device 1 is fully unfolded from the sheath 230, the operator can retract the release wire 220 to complete the disassembly of the implanted device 1 and the delivery system 2, thus finally ensuring controlled release.

[0074] In one embodiment, the traction rod 211 has a double - cavity or multi - cavity structure, and the release wire 220 is placed in one of the cavities of the double - cavity or multi - cavity structure.

[0075] The delivery system 2 may further include a traction collector 212, a traction handle 214, a release collector 221, and a release handle 224. The distal end of the traction collector 212 is fixedly connected to a plurality of the traction rods 211, the proximal end of the traction collector 212 is fixedly connected to the traction handle 214, the distal end of the release collector 221 is connected to a plurality of the release wires 220, and the proximal end of the release collector 221 is fixedly connected to the release handle 224. As Figure 8a shown, the traction rod 211, the traction collector 212, and the traction handle 214 form a traction assembly 21; as Figure 8bAs shown, the release wire 220, the release collection piece 221 and the release handle 224 constitute a release assembly, and the release assembly 22 is located in the traction assembly 21, and the release assembly 22 and the traction assembly 21 can move relative to each other. The traction collection piece 212 is arranged at the proximal end of multiple traction rods 211, and is used to gather and collect the proximal ends of all traction rods 211, and finally the proximal ends of all traction rods 211 are integrated and fixedly connected with the traction collection piece 212, ensuring that the spatial positions of all traction rods 211 relative to each other remain unchanged, so that when the implant device 1 and the conveying system 2 are in an assembled connection state, whether the implant device 1 is being gripped, loaded in the sheath 230 of the conveying system 2, or is being pushed to the target position in the sheath 230, as shown Figures 5a - 5h As shown, or in each moment of the implantation device 1 being gradually released from the sheath tube 230 and even fully stretched to the optimal shape, as shown in FIG. Figure 1 As shown, it is ensured that all traction rods 211 and corresponding release wires 220 remain independent of each other from beginning to end. The traction collection piece 212 is a hollow tubular structure, and the inner lumen can accommodate all release wires 220 and enable all release wires 220 to slide smoothly in the lumen. From the manufacturing aspect, the traction collection piece 212 and the traction rod 211 can be made of a cobalt-chromium alloy tube or a nickel-titanium alloy tube material with shape memory function through integral cutting and heat treatment, which is not only convenient for processing and manufacturing, but also can maintain high coaxiality. The traction handle 214 set at the proximal end of the traction collection piece 212 facilitates the operator to control the traction handle 214 to achieve the controllability of the push process and the withdrawal process of the implant device 1 and the conveying system 2. The release collection piece 221 is set at the proximal end of multiple release wires 220, and is used to gather and collect the proximal ends of all release wires 220, and finally realize the connection between the proximal ends of all release wires 220 and the release collection piece 221. During the release process, when the operator pulls back the release collection piece 221, all the release wires 220 at the distal end of the release collection piece 221 can be withdrawn synchronously, thereby achieving the detachability of the first hole 1111 of the implant device 1 and the second hole 2111 of the delivery system 2. Figure 3bAs shown. In one embodiment, the release assembly 221 is a hollow tubular structure, the inner diameter of which forms an interference fit with the diameter after all the release wires 220 are gathered, and the outer diameter of which is smaller than the inner diameter of the traction assembly 212. By means of welding, bonding or mechanical fitting, etc., a fixed connection between the proximal ends of the plurality of release wires 220 and the distal end of the release assembly 221 is achieved. In another embodiment, connection holes equal in number to the release wires 220 are provided at the distal end of the release assembly 221, and the plurality of release wires 220 pass through the corresponding connection holes 2210 to achieve the connection between the release wires 220 and the release assembly 221. From a manufacturing perspective, several nickel-titanium alloy wires of a certain length and with good resilience are selected. Each nickel-titanium alloy wire passes through every two adjacent connection holes 2210, and the wires extending out of the connection holes 2210 form the release wires 220. This structure can also achieve the same effect and has the following advantages: a) It is beneficial to save the layout space of the connection holes 2210 on the release assembly 221, thereby reducing the outer diameter of the release assembly 221; b) It can make the plurality of release wires 220 as close as possible to the plurality of traction rods 211, shorten the length of the release wires 220, and also improve the coaxiality between the release wires 220 and the traction rods 211 as much as possible; c) It avoids the damage to the material and the possible risks of fracture and detachment caused by traditional connection processes, including welding, bonding or mechanical fitting, etc.

[0076] When the present invention is used in an interventional operation, the wire diameter of the release wire 220 is selected to be 0.05 mm - 1 mm. The specifically selected wire diameter size should be smaller than the minimum size of the first hole 1111 and the second hole 2111. The number and positions of the release wires 220 correspond one by one to the plurality of traction rods 211. The release wires 220 should be non-flexible. The non-flexibility here is defined as good resilience or bending resistance, rather than flexibility. This design has the following advantages: a) It effectively avoids the phenomenon that the connection part between the implant device 1 and the delivery system 2 may move relatively and cause self-locking or jamming, resulting in the release wires 220 being unable to be smoothly withdrawn from the first hole 1111 and / or the second hole 2111, and thus the detachable connection and the controllable release function cannot be achieved; b) It ensures the accurate positioning of the implant device 1 at the target position and avoids the lack of limitation of the existing implant device 1 in the direction along the traction rod 211, so that the implant device 1 moves backward as the delivery sheath 230 is withdrawn, thereby achieving controllable release.

[0077] In the present invention, a flexible section is provided in the proximal region of the implant device 1 and / or the distal region of the traction rod 211. The flexible section provided in the proximal region of the implant device 1 is called the first flexible section 1110, and the first hole 1111 is provided in the proximal region of the first flexible section 1110; the flexible section provided in the distal region of the traction rod 211 is called the second flexible section 2110, and the second hole 2111 is provided in the distal region of the second flexible section 2110.

[0078] In one embodiment, the second flexible section 2110 at the distal end of the traction rod 211 can be inserted into the first hole 1111 at the proximal edge of the implant device 1 from the outside to the inside, and the release wire 220 sequentially passes through the restraint member and the second hole 2111, as shown in Fig. 2a, to achieve the detachable connection between the implant device 1 and the delivery system 2; in another embodiment, the first flexible section 1110 at the proximal end of the implant device 1 can be inserted into the second hole 2111 at the distal end of the traction rod 211 from the outside to the inside, and the release wire 220 sequentially passes through the restraint member and the first hole 1111 to achieve the controllable connection and detachable connection between the implant device 1 and the delivery system 2.

[0079] In the present embodiment, a flexible section is provided in the controllable release system, and the flexible section includes the first flexible section 1110 and the second flexible section 2110. The flexible section has the following advantages: a) facilitating the insertion and detachment of the mating connection part at a suitable angle, so as to achieve the controllable detachment of the connection part between the implant device 1 and the delivery system 2, and effectively preventing the surrounding tissue of the target position from being stabbed due to the distal end rebound after the connection between the implant device 1 and the delivery system 2 is detached; b) after the implant device 1 and the delivery system 2 are connected and mated, as Figure 3a shown, due to having a certain deformation ability, the mated connection part has a certain compressibility. When the implant device 1 is loaded in the sheath 230, the minimum inner diameter of the used sheath 230 can be reduced, the damage to the patient's access can be reduced, and the applicable range of the product can also be expanded; secondly, this compressibility makes the dimensional fit between the mated connection part and the inner cavity of the sheath 230 more compact, so that there is no relative movement between the mated connection components, which helps to enhance the smoothness, continuity and controllability of the pushing and releasing processes of the implant device 1.

[0080] In addition, when the flexible section is the first flexible section 1110, it also has the following advantages: a) during the release process of the implant device 1 after being placed at the target position, since the distal end of the flexible section 102 of the implant device is pulled and restrained by the traction rod 211 and the release wire 220, the entire release process of the implant device 1 is slow, continuous and thus controllable; b) as Figure 3b shown, after the implant device 1 is completely released, the flexible section 102 can increase the contact area between the implant device 1 and the target position (such as the atrial septum tissue, as Figure 3bThe contact area and fitting effect of the AS) shown are beneficial to the formation of endothelialization on the surface of the implant device 1; c) effectively avoid local irritation reactions of the tissue caused by the edges of the implant device 1, and improve biocompatibility.

[0081] When the flexible section is the second flexible section 2111, it also has the advantages of avoiding excessive movement of the traction rod 211 towards the distal end due to improper operation, thereby stabbing the target tissue and causing local tissue reactions, or stabbing the implant device 1, which affects the effectiveness of the implant device 1.

[0082] In one embodiment, a protrusion 1112 is provided on the first flexible section 1110, and the protrusion 1112 is located on the distal side of the first hole 1111 to define the relative position between the implant device 1 and the delivery system 2 after they are connected, or a protrusion 2112 is provided on the second flexible section 2110, and the protrusion 2112 is located on the proximal side of the second hole 2111 to define the relative position between the implant device 1 and the delivery system 2 after they are connected. When the implant device 1 and the delivery system 2 are assembled and placed in the sheath 230, during the process of being pushed and released from the sheath 230, the protrusion can ensure that there is no relative displacement in the axial direction of the connection part, providing sufficient guarantee for controlled release. Preferably, the outer edge of the protrusion 1112 or 2112 should have a smooth transition without affecting sheath retraction, so that the implant device 1 can be smoothly compressed, held, and loaded into the sheath 230.

[0083] It is particularly worth noting that the first flexible section 1110 has both good resilience and a certain rigidity. The rigidity here is sufficient to enable the implant device 1 to be connected and cooperated with the delivery system 2 and loaded in the sheath 230. When the delivery system 2 is pushed to move the traction rod 211 towards the distal direction, the implant device 1 can also make timely mechanical responses and equivalent movements. Therefore, it is ensured that the implant device 1 can be pushed and introduced into the target position through the sheath 230; and the resilience here enables the implant device 1, especially the proximal region of the implant device 1 near the first hole 1111, to conformably fit to the surface of various anatomical morphological target tissues after the implant device 1 and the delivery system 2 are disassembled after connection and cooperation. Therefore, it is ensured that the implant device 1 has wide applicability.

[0084] In one embodiment, the first flexible section 1110 in the proximal region of the implant device 1 can adopt a necking structure or be locally heat-treated to make it flexible, and the rod width L8 is not greater than the minimum part size L3 of the second hole 2111 on the corresponding second flexible section 2110, so that the first flexible section 1110 can be inserted into the second hole 2111 from the outside to the inside, as Figure 2bAs shown. After insertion, the central axis of the first flexible section 1110 forms an angle of 1° - 80° with the central axis of the second flexible section 2110. The first hole 1111 at the distal end of the first flexible section 1110 of the implanting device is located within the space enclosed by the proximal end surface of the implanting device 1 and multiple traction rods 211. The wire diameter of the release wire 220 is not greater than the size of the smallest part of the first hole 1111, and it passes through all the restraint holes 2100 on the corresponding traction rod 211 in sequence along the corresponding traction rod 211 from the proximal end to the distal end in an S shape. Then, the distal end of the release wire 220 passes through the first hole 1111 located within the space enclosed by the proximal end surface of the implanting device 1 and multiple traction rods 211; finally, its distal end is placed on one side of the proximal end surface of the implanting device 1, or the distal end of the release wire 220 passes through the first hole 1111 provided in the proximal region of the implanting device 1 and extends proximally into the traction collecting member 212, thereby realizing the controllable release connection between the implanting device 1 and the delivery system 2. When the distal end of the release wire 220 is placed on one side of the proximal end surface of the implanting device 1, the stroke of retracting the release wire 220 is shortened, which is convenient for saving the time of the operator to retract the release wire 220; when the distal end of the release wire 220 passes through the first hole 1111 in the proximal region of the implanting device 1 and extends proximally into the traction collecting member 212, it can avoid the distal end of the release wire 220 touching the target tissue during the entire process of retracting the release wire 220, ensuring the safety of the release process.

[0085] The first flexible section 1110 in the proximal region of the implanting device 1 can also adopt a spring structure. The spring structure has the following advantages: a) The spring itself is a hollow structure, and its inner cavity can be set as the first hole 1111, so there is no need to set the first hole 1111 at the distal end of the first flexible section 1110; b) The distal end of the release wire 220 can be placed inside the first flexible section 1110, which not only enables each release wire 220 to have an independent channel, but also reduces the risk that the distal end of the release wire 220 scratches the proximal end surface of the implanting device 1 and causes poor corrosion resistance, and at the same time avoids the distal end of the release wire 220 stabbing the tissue in the target position (such as the right atrial surface of the atrial septum mentioned later) area and causing accidental injury; c) The longitudinal cross-sectional area of the spring structure is large, which can increase the imaging effect during the surgical operation.

[0086] In the first embodiment, as Figure 2c shown, the first flexible section 1110 in the proximal region of the implanting device 1 is an equal-diameter spring. The distal end of the spring passes through the first hole 1111 at the edge of the proximal end surface of the implanting device 1 and is fixedly connected to the first hole 1111, or the distal end of the spring is directly fixed to the edge of the proximal end surface of the implanting device 1. The inner cavity of the spring can at least accommodate the second flexible section 2110 at the distal end of the traction rod 211 and a release wire 220, so that the second flexible section 2110 can smoothly pass through the entire inside of the spring; after insertion, the second hole 2111 at the distal end of the second flexible section 2110 is located outside the inner cavity at the distal end of the spring.

[0087] In the second embodiment, as Figure 2d shown, the first flexible section 1110 in the proximal region of the implant device 1 is a series spring, and the series spring is composed of two equal-diameter springs with 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 implant device 1. The inner cavity of the spring at the proximal end of the first flexible section 1110 can at least accommodate the second flexible section 2110 at the distal end of the traction rod 211 and a release wire 220, so that the second flexible section 2110 and the release wire 220 can smoothly pass through the inside of the spring at the distal end of the first flexible section 1110; after insertion, the second hole 2111 at the distal end of the second flexible section 2110 is located in the region between the two series springs.

[0088] In the third embodiment, the first flexible section 1110 has a double-chamber structure, one chamber of which is used for fixedly connecting with the support rod 111 of the implant device 1, and the other chamber is used for accommodating the distal end of the release wire 220, which can also achieve the same effect as the first embodiment.

[0089] In the fourth embodiment, the first flexible section 1110 has a hinge structure and an S-wave structure. Compared with the above embodiments, these structural designs not only have better flexibility but also have better mechanical transmission, enabling timely mechanical responses such as axial tension and pressure, and are more conducive to the control of the pushing and releasing of the implant device 1 in the sheath 230.

[0090] In other embodiments, the first flexible section 1110 is made of a material with shape memory function, or the first flexible section 1110 is made of an elastic material, which facilitates the integral manufacturing and forming of the first flexible section 1110 and the implant device 1, avoiding the risk of connection failure caused by introducing other connections between the two. Of course, this is also beneficial for shortening the production cycle and mass production.

[0091] The second flexible section 2110 in the delivery system 2 can adopt the same or similar structural design as the first flexible section 1110 on the implant device 1. The setting of the second flexible section 2110 also has the advantage of avoiding the over-movement of the traction rod 211 towards the distal end due to improper operation, thereby poking the target tissue and causing local tissue reaction, or stabbing the implant device 1 and affecting the effectiveness of the device 1.

[0092] The space defined by the traction rod 211 and the second flexible section 2110 can be conical (as Figure 7b shown), bowl-shaped (as Figure 7aFor example, it may be spherical (as shown) or lantern-shaped (not shown), etc., further reducing the risk of the distal end of the delivery system 2 stabbing the target tissue. Of course, the traction rod 211 in the delivery system 2 should be selected to have good resilience to meet the requirements of various product access routes in the present invention. Especially when used in interventional surgery, the product access route is the body's own vascular system in an animal or human body, and the vascular system usually has a tortuous characteristic. This requires that the product, including the traction rod 211, should be designed to have good morphological adaptability and resilience.

[0093] During the operation, when the implant device 1 reaches the target position such as the atrial septum and fits with the target position, at this time, the doctor observes the shape and shunt volume of the implant device 1 through imaging means to determine the deployment shape and placement position of the implant device 1. If the effect is not ideal, before the cooperation connection is disassembled, the traction handle 214 can be retracted or the sheath 230 can be pushed forward, so that the implant device 1 that has been placed at the target position and fully deployed can be retracted back into the sheath 230 of the delivery system 2, thereby realizing the recovery of the implant device 1 and withdrawing it from the body. Then, depending on the situation, a different specification can be used or the operation can be ended. If the effect is ideal, keeping the position of the traction handle 212 unchanged, when the release handle 224 is slowly retracted proximally, the retraction force is evenly transmitted on the release wire 220 through the mutual cooperation of the traction rod 211 and the restraint member, so that the distal ends of the multiple release wires 220 can be smoothly and synchronously retracted out of the first hole 1111 or the second hole 2111. Since the implant device 1 and the traction rod 211 have good resilience and shape memory function, the first flexible section 1110 of the implant device 1 is synchronously disengaged 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 disengaged from the first hole 1111 at the distal end of the implant device 1, thus completing the controllable disassembly of the implant device 1 and the delivery system 2, and finally realizing the controllable release of the implant device 1.

[0094] Embodiment Two:

[0095] On the basis of Embodiment One, as a special implementation case, the implant device 1 is an elastic pore-forming stent 11 that can be placed at the atrial septum, and the delivery system 2 is used to deliver and controllably release the elastic pore-forming stent 11 from outside the body to the atrial septum. Specifically, the elastic pore-forming stent 11 is formed by connecting multiple support rods 111 to form a three-dimensional wavy and / or reticulated structure. The three-dimensional wavy and / or reticulated structure includes a left disk that fits with the atrial septum surface in the left atrium cavity, a right disk that fits with the atrial septum surface in the right atrium cavity, and a waist portion that is disposed between the left disk and the right disk and fixedly connects the left disk and the right disk. A through hole is provided in the waist portion, and 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 the shape of an "I". A first flexible section 1110 is provided in the circumferential region of the right disk, and the first hole 1111 is located at the distal end of the first flexible section 1110.

[0096] In one embodiment, as Figure 9 shown, 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 both circularly enclosed. The diameter range of the left disk is 12 mm - 40 mm, and the diameter range of the right disk is 12 mm - 40 mm. The diameter of the through hole is 3 mm - 15 mm, and the axial height of the through hole is 1 mm - 15 mm.

[0097] The delivery system 2 at least includes multiple traction rods 211 corresponding one-to-one to the first holes 1111, a traction gathering member 212 fixedly connected to the proximal ends of all the traction rods, a traction handle 214 fixedly connected to the proximal end of the traction gathering member 212, multiple release wires 220 corresponding to the traction rods 211, a release gathering member 221 fixedly connected to the proximal ends of the release wires 220, and a release handle 224 fixedly connected to the proximal end of the release gathering member 221, as Figure 1 shown. As Figure 8a and Figure 8b shown, the traction rods 211, the traction gathering member 212, and the traction handle 214 form a traction assembly 21, while the release wires 220, the release gathering member 221, and the release handle 224 form a release assembly 22. The release assembly 22 is located within the traction assembly 21, and the release assembly 22 and the traction assembly 21 can move relative to each other. Preferably, the multiple traction rods 211 provided in the distal region of the traction assembly 21 should be 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 section 2110 is provided in the distal region of each traction rod 211, and a second hole 2111 is provided at the distal end of the second flexible section 2110. Preferably, the shapes of the second hole 2111 and the first hole 1111 are in the shape of a safety pin with smooth edges.

[0098] More preferably, the traction rods 211 are flat, and the number of rods is 3 - 20. The more rods there are, the better the roundness, but the number of rods should not be too many, otherwise it will cause the overall size of the delivery system 2 to be too large. Therefore, in the present invention, the number of traction rods 211 is preferably set to 6 - 12. The rod width L7 of the traction rods 211 is preferably set to 0.2 mm - 2 mm, the rod length is 5 - 100 mm, and the number of binding holes 2100 varies according to the length of the traction rods 211. Preferably, the hole spacing L2 between every two adjacent binding holes 2100 is 2 - 20 mm.

[0099] Preferably, the wire diameter L9 of the release wire 220 is 0.1-1 mm, and the wire diameter L9 is not greater than the minimum hole widths L10 or L3 of the first hole 1111 and the second hole 2111. The quantity and position correspond to those of the plurality of traction rods 211 one by one. The proximal ends of the plurality of release wires 220 are gathered into a bundle and placed in the release converging member 221, or the release wires 220 pass through the connection holes provided at the distal end of the release converging member 221 to realize the connection between the release wires 220 and the release converging member 221. In addition, the release wire 220 sequentially passes through all the binding holes 2100 on the corresponding traction rod 211 in an S shape from the proximal end to the distal end, and then passes through the first hole 1111 or the second hole 2111 within the space defined by the plurality of traction rods 211 and the right disk surface of the elastic pore-forming bracket 11, thereby realizing the detachable connection and controllable release between the elastic pore-forming bracket 11 and the delivery system 2.

[0100] To achieve this function, in one embodiment, the first flexible section 1110 at the distal end of the right disk edge of the elastic pore-forming bracket 11 adopts a necking structure or undergoes local heat treatment to make it flexible. A protrusion 1112 is provided on the first flexible section 1110. As Figure 2b shown, the protrusion 1112 is located on the distal side of the first hole 1111. The thickness dimension of the protrusion 1112 is not less than the hole length L3 of the second hole 2111. The distance between the protrusion 1112 and the first hole 1111 is 0.2 mm - 3 mm to effectively define the relative position between the implant device 1 and the delivery system 2 after connection. The rod width L8 of the first flexible section 1110 is smaller than the hole width L3 of the second hole so that the first flexible section 1110 can be inserted into the second hole 2111 from the outside to the inside. As Figure 1 shown. After insertion, in the 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°. The first hole 1111 at the distal end of the first flexible section 1110 is located within the space surrounded by the plurality of traction rods 211 and the right disk surface of the elastic pore-forming bracket 11. The wire diameter L9 of the release wire 220 is smaller than the width L10 of the first hole 1111, and it sequentially passes through all the binding holes 2100 on the corresponding traction rod 211 in an S shape along the corresponding traction rod 211 from the proximal end to the distal end. Then, the distal end of the release wire 220 passes through the first hole 1111 within the space surrounded by the plurality of traction rods 211 and the right disk surface of the elastic pore-forming bracket 11. Finally, its distal end is placed on one side of the right disk surface of the elastic pore-forming bracket 11, or the release wire 220 extends proximally into the traction converging member 212 within the area on one side of the right disk surface of the elastic pore-forming bracket 11, thereby realizing the detachable connection between the elastic pore-forming bracket 11 and the delivery system 2.

[0101] After the implant device 1 is cooperatively connected to the delivery system 2, due to the certain deformation ability of the flexible section 1110 and / or 2110, the cooperatively connected part has a certain compressibility. When the implant device 1 and the delivery system 2 are compressed and held and then loaded into the sheath 230, not only can the inner diameter of the used sheath 230 be reduced, reducing the damage to the patient's access, but also the cooperation between the cooperatively connected part and the inner cavity of the sheath 230 becomes more compact. As Figure 5a and 5b shown, during the process of placing the implant device 1 and the delivery system 2 into the sheath 230 and pushing them from the proximal end of the sheath 230 to the distal end of the sheath 230 and introducing them into the target position through the sheath 230, the protrusion 1112 located on the first flexible section 1110 and on the distal side of the first hole 1111 can play a limiting role to ensure that the axially opposite displacement does not occur between the cooperatively connected components.

[0102] After the sheath 230 is placed at the target position, as Figure 5c shown, slowly push the traction handle 214, and the distal end of the implant device 1 is slowly pushed out of the sheath 230 and gradually unfolds, as Figure 5d shown. Slowly withdraw the sheath handle 231 proximally, and slowly place the distal end of the deployed implant device 1 at the target position and fit it to the target tissue, as Figure 5e shown. Then, further slowly push the traction handle 231 distally, so that the entire implant device 1 and the distal end of the traction rod 211 are gradually pushed out of the sheath 230. During this process, due to the flexible section provided at the proximal edge of the implant device, the distal end of the flexible section is pulled and restricted by the traction rod 211 and the release wire 220, making the unfolding processes of the proximal end of the implant device 1 and the distal end of the traction rod 211 slow, continuous and controllable, as Figure 5f shown; further slowly push the traction handle 214 to push the entire traction rod 211 out of the sheath 230, so that the implant device 1 and the traction rod 211 are gradually fully unfolded, and the proximal end of the implant device 1 is placed at the target position and fits it to the target position, as Figure 5g shown. At this time, the doctor observes the shape and shunt volume of the implant device 1 through imaging means to determine the unfolded shape and placement position of the implant device 1. If the effect is not ideal, before the cooperative connection is disassembled, the traction handle 214 can be retracted or the sheath 230 can be pushed forward to re-withdraw the fully deployed implant device 1 that has been placed at the target position back into the sheath 230 of the delivery system 2, thereby realizing the recovery of the implant device 1 and withdrawing it from the body, and changing the specifications or ending the operation as appropriate. If the effects are all ideal, slowly retract the release handle 224 proximally, as Figure 5hAs shown, where a' and b' are the states of the implant device 1 and the delivery system 2 before disassembly, and a and b are the states after disassembly. The disassembly withdrawal force is evenly transmitted on the release wire 220 through the mutual cooperation of the traction rod 211 and the restraint member 210, so that the distal ends of the plurality of release wires 220 are smoothly and synchronously withdrawn from the second hole 2111, thereby realizing the controllable disassembly of the connection between the implant device 1 and the delivery system 2, and enabling the implant device 1 to be controllably released to the target position.

[0103] In another embodiment, the second flexible section 2110 at the distal end of the traction rod 211 adopts a necking structure to make it flexible, and forms an angle of 1° - 80° with the corresponding first flexible section 1110. A protrusion 2112 is provided on the second flexible section 2110, as Figure 6 shown. The protrusion 2112 is located on the proximal side of the second hole 2111. The width dimension L12 of the protrusion is not less than the hole width L10 of the first hole 1111. The distance L11 between the protrusion 2112 and the second hole 1111 is 0.2 mm - 3 mm to define the relative position between the implant device 1 and the delivery system 2 after they are connected.

[0104] The rod width L5 of the second flexible section 2110 is not greater than the hole width L10 of the corresponding first hole 1111, so that the second flexible section 2110 can be inserted into the first hole 1111 from the outside to the inside, as Figure 2bAs shown. After insertion, the central axis of the first flexible section 1110 forms an angle of 1° - 80° with the central axis of the second flexible section 2110. The second hole 2111 at the distal end of the second flexible section 2110 is located within the space enclosed by the proximal end faces of multiple traction rods 211 and the elastic pore-forming bracket 11. The wire diameter of the release wire 220 is not greater than the size of the smallest part of the second hole 2111, and it passes through all the binding holes 2100 on the corresponding traction rod 211 in an S shape along the corresponding traction rod 211 from the proximal end to the distal end. Then, the distal end of the release wire 220 passes through the second hole 2111 located within the space enclosed by the multiple traction rods 211 and the right disk surface of the elastic pore-forming bracket 11. Finally, its distal end is placed on the proximal side of the right disk surface of the elastic pore-forming bracket 11, or the release wire 220 extends proximally into the traction assembly 212 within the proximal region of the right disk surface of the elastic pore-forming bracket 11, thereby realizing the detachable connection between the elastic pore-forming bracket 11 and the delivery system 2. In this embodiment, the requirements for the rod width of the first flexible section 1110 of the elastic pore-forming bracket and the aperture size of the first hole 1111 are lower, that is: the rod width of the first flexible section 1110 of the elastic pore-forming bracket and the aperture size of the first hole 1111 are relatively relaxed, making the edge design of the proximal end face of the elastic pore-forming bracket 11 more rounded. This design has two advantages, including: a) reducing the risk of the elastic pore-forming bracket 11 stimulating the target position tissue (such as the right atrial tissue of the atrial septum) and even causing physical damage; b) reducing the risk of thrombus formation at the right disk edge of the elastic pore-forming bracket 11.

[0105] As an embodiment, on the surface of the elastic pore-forming bracket 11, at least the left disk and right disk regions are covered with a biocompatible film 13, and the film 13 wraps at least all the support rods in the entire left disk and right disk regions, such as Figure 10 as shown. The film 13 should preferably be made of a biocompatible material, and the material can include polymer materials such as PET, PTFE, and silicone. The setting of the film 13 has the following advantages: a) The surface of the film 13 is smooth and has a low friction coefficient, which is convenient for repeatedly pushing and retrieving the elastic pore-forming bracket 11 from the sheath 230 during the operation, and is extremely beneficial to the introducibility and controllable release of the elastic pore-forming bracket 11 through the sheath 230; b) Preventing the possible precipitation of nickel ions when the support rods 111 of the elastic pore-forming bracket 11 are made of nitinol, ensuring the biological safety of the elastic pore-forming bracket 11; c) Promoting the endothelialization of the left disk and right disk of the elastic pore-forming bracket 11, enabling the left disk and right disk to grow into one with the surface of the target tissue as quickly as possible, and ensuring the firmness of the elastic pore-forming bracket 11 fitting with the target tissue at the atrial septum; d) The film 13 has a physical isolation effect, so that when the distal end of the release wire 220 is located on or passes through the proximal end face side of the implanting instrument 1, the distal end of the release wire 220 will never touch the animal or human tissue, ensuring sufficient safety during the release process.

[0106] In another embodiment, the inner surface and the outer surface of the elastic pore-forming stent 11 are completely coated with a thin film 13, so that the entire elastic pore-forming stent 11 has better biocompatibility.

[0107] In one embodiment, a series wire 12 is provided at the edge of the left disk, the edge of the right disk and / or the waist of the elastic pore-forming stent 11. The series wire 12 will pass through or wind around the support rod 111 of the elastic pore-forming stent 11 so 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 provided along the circumferential direction at the edge of the mesh structure of the elastic pore-forming stent 11. As Figure 9 and Figure 10 shown, a series wire 12 passing through all the connection holes 1112 is provided on the elastic pore-forming stent 11. The wire diameter of the series wire 12 is 0.02 mm - 1 mm. The series wire 12 can sequentially pass through the connection holes 1112 along the circumferential direction and pass through the corresponding first holes 1111 on each support rod 111, and finally form a closed-loop coil 12. This closed-loop coil 12 is beneficial to the fitting of the polymer thin film 13 to the surface of the stent 11, and at the same time avoids the influence on the fitting between the thin film 13 at the edge of the stent 11 and the elastic pore-forming stent 11 due to the multiple sheathing of the implant device 1, ensuring the multiple repeated retrievability of the implant device 1. To facilitate the realization of the above functions, the material of the series wire 12 used may include PTFE wire, PET wire, UHMWPE wire made of polymer materials, so that the series wire 12 has good flexibility, and may also include cobalt-chromium alloy filaments, nickel-titanium alloy filaments, pure tantalum filaments, 316L filaments made of metal materials. This not only makes the series wire 12 have a certain shape memory property, improves the roundness of the left and right disks of the elastic pore-forming stent 11, but also makes the elastic pore-forming stent 11 have a certain imaging effect, facilitating the operator to observe and control the position and shape of the elastic pore-forming stent 11 in time during the operation by using imaging equipment, and the detection during postoperative follow-up.

[0108] Preferably, the thin film 13 completely covers and wraps the inner surface and the outer surface of the entire elastic pore-forming stent 11, including all the support rods 111, all the first holes 1111, the series wire 12 and all the first flexible sections 1110, so that the entire elastic pore-forming stent 11 has better biocompatibility.

[0109] Embodiment Three:

[0110] Based on Embodiment One, the difference between Embodiment Three and Embodiment One is that the restraint member is not the restraint hole 2100 provided on the traction rod 211, but a restraint tube 2101 or a restraint ring 2102 provided on the traction rod 211.

[0111] In one embodiment, as Figures 4a - 4c shown, the binding member is a binding tube 2101 with a hollow tubular structure. The binding tube 2101 is sleeved outside the traction rod 211. The binding tube 2101 preferably selects high molecular tubes such as FEP, PTFE, PE, POE, PET, and silica gel. 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 adhesion between the release wire 220 and the traction rod 211, enabling the release wire 220 to smoothly pass through the inner cavity of the binding tube 2101 and slide in the cavity of the binding tube 2101; at the same time, it avoids opening holes in the traction rod 211, increases the anti-deformation ability of the traction rod 211 to a certain extent, and can provide a guiding effect for the withdrawal of the release wire 220, thereby ensuring the effectiveness of the disassembly between the connection part of the implant device 1 and the delivery system 2.

[0112] The release wire 220 is located inside the traction rod 211, and its wire diameter is not greater than the hole width of the first hole 1111 and the second hole 2111. The distal end of the release wire 220 extends along the corresponding traction rod 211 from the proximal end to the distal end and passes through the entire binding tube 2101. Then, the distal end of the release wire 220 abuts against the proximal side of the implant device 1, as Figure 4a shown, where a' and b' are the states before the disassembly of the implant device 1 and the delivery system 2, Figure 4b and a and b shown in Figure 4c are the states after the disassembly of the implant device 1 and the delivery system 2, or the distal end of the release wire 220 passes through the first hole 1111 provided in the proximal region of the implant device 1 and then extends proximally into the release collecting member 212, as Figure 4c shown, thereby realizing the controllable release connection between the implant device 1 and the delivery system 2.

[0113] In another embodiment, as Figure 4d shown, the binding member is one or more binding rings 2102. The binding rings 2102 are sleeved on the outer surface of the distal region of the traction rod 211. In a preferred embodiment, the binding rings 2102 are arranged in the middle region of the traction rod 213 and are fixedly connected to the traction rod 211, and the inner cavity facilitates the smooth sliding of the release wire 220. In another preferred embodiment, the binding rings 2102 are located in the middle of the release wire 220 in the distal region, and the binding rings 2102 are fixedly connected to the release wire 220. The inner cavity of the binding ring 216 can accommodate the traction rod 211, so that when the release wire 220 is withdrawn, the binding rings 2102 and the release wire 220 can slide along the traction rod 211 under the action of the withdrawal force. The binding rings 2102 preferably select thin-walled metal tubes, and of course, high molecular materials such as FEP, PTFE, POE, PET, and silica gel can also be selected.

[0114] Example 4:

[0115] Based on Embodiment 2, the difference between Embodiment 4 and Embodiment 2 is that the delivery system 2 further includes a sheath assembly disposed outside the traction assembly 21. The sheath assembly at least includes a sheath 230 and a sheath handle 231 that is hermetically and fixedly connected to the proximal end of the sheath 230. When the implant device 1 is connected to the traction assembly 21 and the release assembly 22, by pulling back the traction assembly 21, both the traction rod 211 of the traction assembly 21 and the implant device 1 undergo elastic deformation and can be retracted and loaded into the sheath 230. After the implant device 1 is placed at the target position of the atrial septum, by pulling back the release assembly 22, the release wire 220 is withdrawn from the first hole 1111 or the second hole 2111 located in the space surrounded by the multiple traction rods 211 and the proximal end face of the implant device 1, so that the traction assembly 21 is disengaged from the implant device 1, thereby realizing the controllable release of the implant device 1 and the delivery system 2.

[0116] In another embodiment, as Figure 5a shown, the delivery system 2 further includes a loading sheath 232. The outer diameter of the loading sheath 232 is not greater than the inner cavity dimensions of the sheath handle 231 and the sheath 230. It is used to preload the assembled implant device 1, traction assembly 21, and release assembly 22 into the inner cavity of the loading sheath 232 after being compressed and held outside the body, and then smoothly introduce them into the inner cavity of the sheath 230 through the preloading sheath 232, so as to avoid possible damage to the device and unsmooth pushing caused by the friction between the distal part of the implant device 1 and the sealing ring in the sheath handle 231 during the pushing process. During the operation, the loading sheath 232 can be inserted into the sheath handle 231 or directly inserted into the proximal end of the inner cavity of the sheath 230. Preferably, the preloading sheath 232 and the proximal end of the sheath handle 231 are detachably connected by means of threaded cooperation, snap fit, plug-in member cooperation, etc., so that the operator can push the compressed implant device 1, together with the traction assembly 21 and the release assembly 22, into the sheath 230 through the preloading sheath 232. By further pushing the traction assembly 21, the implant device 1 can be finally introduced into the distal end of the sheath 230 located in the target position area along the inner cavity of the sheath 230. In this embodiment, the preloading sheath 232 is directly connected to the sheath handle 231, which builds a passage for the pushing of the implant device 1 and the delivery system 2, and avoids possible damage to the device and unsmooth pushing caused by the friction between the distal part of the implant device 1 and the sealing ring in the sheath handle 231 during the pushing process.

[0117] Finally, it should be noted that the above are only preferred embodiments of the present invention and are not used to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A controllable release system, comprising an implant device (1) and a delivery system (2), characterized in that, a plurality of first holes (1111) are provided in the proximal region of the implant device (1), the delivery system (2) comprises a plurality of traction rods (211) and a plurality of release wires (220), the plurality of release 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, a second hole (2111) and a restraint are provided on each traction rod (211), the second hole (2111) is located at the distal end of the traction rod (211), the restraint is located on the proximal side of the second hole (2111), the first hole (1111) provided on the implant device (1) and the second hole (2111) provided on the traction rod (211) can be inserted and matched with each other, the release wire (220) passes through the restraint and the first hole (1111) or the restraint and the second hole (2111) to realize the connection between the implant device (1) and the delivery system (2), during the delivery process, the restraint can limit the movement of the release wire (220), when releasing the implant device (1), the release wire (220) can displace relative to the traction rod (211); a flexible section is provided in the proximal region of the implant device (1) and / or the distal region of the traction rod (211), the restraint is one or more restraint rings (2102), and the restraint ring (2102) is sleeved on the outer surface of the distal region of the traction rod (211); or, the restraint is a restraint hole (2100) provided on the traction rod (211) and penetrating the traction rod (211); or, the restraint is a restraint tube (2101) having a hollow tubular structure, and the restraint tube (2101) is sleeved on the traction rod (211).

2. The controllable release system according to claim 1, characterized in that, the flexible section provided in the proximal region of the implant device (1) is called a first flexible section (1110), and the first hole (1111) is provided in the proximal region of the first flexible section (1110); the flexible section provided in the distal region of the traction rod (211) is called a second flexible section (2110), and the second hole (2111) is provided in the distal region of the second flexible section (2110).

3. The controllable release system according to claim 2, characterized in that, the first flexible section (1110) has a spring structure or a double-chamber structure to facilitate the distal end of the release wire (220) to be inserted into the cavity of the spring structure or the double-chamber structure.

4. The controllable release system according to claim 2, characterized in that, The first flexible section (1110) or the second flexible section (2110) has a hinge structure, a necking structure, an S-wave structure, a spring structure, or the first flexible section (1110) or the second flexible section (2110) is made of a material with shape memory function, or the first flexible section (1110) or the second flexible section (2110) is made of an elastic material.

5. The controllable release system according to claim 2, wherein, a protrusion (1112) is provided on the first flexible section (1110), and the protrusion (1112) is located on the distal side of the first hole (1111) to define the relative position between the implant device (1) and the delivery system (2) after they are connected, or a protrusion (2112) is provided on the second flexible section (2110), and the protrusion (2112) is located on the proximal side of the second hole (2111) to define the relative position between the implant device (1) and the delivery system (2) after they are connected.

6. The controllable release system according to claim 1, wherein, the number of the binding holes (2100) is even, and each release wire (220) sequentially passes through the binding holes (2100), the first hole (1111) and / or the second hole (2111) in an S shape along its corresponding traction rod (211) from the proximal end to the distal end to achieve the detachable connection between the implant device (1) and the delivery system (2).

7. The controllable release system according to claim 1, wherein, the inner cavity of the binding tube (2101) can accommodate at least one traction rod (211) and one release wire (220) at the same time, so that the release wire (220) can pass through the inner cavity of the binding tube (2101) and can slide in the cavity of the binding tube (2101).

8. The controllable release system according to claim 1, wherein, the binding ring (2102) is fixedly connected to the release wire (220), so that when the release wire (220) is retracted, the binding ring (2102) and the release wire (220) can slide along the traction rod (211) under the action of the retraction force.

9. The controllable release system according to claim 1, wherein, The implant device (1) is an elastic pore-forming stent (11) that can be placed at the atrial septum. The elastic pore-forming stent (11) is a three-dimensional wave-shaped and / or reticular structure formed by connecting multiple support rods (111). The three-dimensional wave-shaped and / or reticular structure includes a left disk that fits against the atrial septum surface in the left atrium cavity, a right disk that fits against the atrial septum surface in the right atrium cavity, and a waist portion disposed between the left disk and the right disk and fixedly connecting the left disk and the right disk. A through hole is provided in the waist portion, and the through hole enables fluid communication between the left atrium and the right atrium. The longitudinal cross-section of the elastic pore-forming stent (11) is in the shape of an "I". A first flexible section (1110) is provided in the circumferential region of the right disk, and the first hole (1111) is located at the distal end of the first flexible section (1110).

10. The controllable release system according to claim 9, wherein, a series connection wire (12) is provided at the edge of the left disk, the edge of the right disk, and / or the waist of the elastic pore-forming stent (11). The series connection wire (12) passes through or winds around the support rods (111) of the elastic pore-forming stent (11) such that the edges of the left disk, the edges of the right disk, and / or the waist form a closed circle; a thin film (13) is covered on the surface of the elastic pore-forming stent (11).

11. The controllable release system according to claim 1, wherein, the delivery system (2) further includes a traction collecting member (212), a traction handle (214), a release collecting member (221), and a release handle (224). The distal end of the traction collecting member (212) is fixedly connected to multiple traction rods (211), the proximal end of the traction collecting member (212) is fixedly connected to the traction handle (214), the distal end of the release collecting member (221) is connected to multiple release wires (220), the proximal end of the release collecting member (221) is fixedly connected to the release handle (224). The traction rods (211), the traction collecting member (212), and the traction handle (214) form a traction assembly (21), the release wires (220), the release collecting member (221), and the release handle (224) form a release assembly (22). The release assembly (22) is located within the traction assembly (21), and the release assembly (22) and the traction assembly (21) can move relative to each other.

12. The controllable release system according to claim 11, wherein, the distal end of the release wire (220) abuts against the proximal side of the implant device (1), or the distal end of the release wire (220) passes through the first hole (1111) provided in the proximal region of the implant device (1) or the second hole (2111) provided on the traction rod (211) and then extends proximally into the release collecting member (221).

13. The controllable release system according to claim 11, wherein, The conveying system (2) further includes a sheath assembly disposed outside the traction assembly (21), and the sheath assembly includes a sheath (230) and a sheath handle (231) sealingly and fixedly connected to the proximal end of the sheath (230).

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