An implant device with a fishbone-shaped anchoring structure and its delivery system

Abstract

The present invention relates to the field of medical devices, and particularly to an implantable device with a fishbone-shaped anchoring structure and its delivery system. The implantable device at least includes a fixing part, and the fixing part includes a support body. The support body includes a plurality of elastic support rods and a plurality of anchoring structures. The support rod includes an inner side, an outer side, and a side wall. The plurality of anchoring structures are distributed in a fishbone shape on the side wall and / or the outer side of the support rod. When the implantable device is placed in a cavity, the ends of the anchoring structures and the outer side of the support rod can contact the inner surface of the cavity and form a non-piercing anchoring.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to an implant device with a fishbone-shaped anchoring structure and its delivery system. Background Art

[0002] Currently, in the field of cardiovascular medicine, atrial fibrillation is the most common persistent arrhythmia clinically. Atrial fibrillation can lead to rapid and chaotic arrhythmias, which in turn cause symptoms such as palpitations, chest tightness, dizziness, etc., resulting in a decrease in cardiac output and irregular and disordered blood flow in the vascular system. In severe cases, it can be fatal or disabling, seriously affecting people's health and quality of life. Therefore, preventing stroke is the fundamental goal of atrial fibrillation treatment. There are more than tens of millions of people with atrial fibrillation globally, and there are approximately 400,000 new cases every year. Among them, atrial fibrillation has a stroke risk of more than 50%. The quality of life of patients with atrial fibrillation is also greatly reduced, partly due to the fear of stroke and the anticoagulant drugs that must be taken long-term to prevent thrombosis. The left atrial appendage is connected to the left atrium and contracts or relaxes together with the left atrium during normal cardiac blood circulation. However, due to the complex cavity structure of the left atrial appendage, rich internal pectinate muscles, and deeper sulci in some positions, blood stagnates in it, making it extremely easy to form thrombi. In addition, when atrial fibrillation occurs, the uncoordinated electrical signals usually lead to disordered blood circulation in the left atrium, with some blood stagnating, and the atrium cannot contract or relax normally. As a result, the blood retained in the left atrial appendage is very likely to form thrombi at this time. Currently, clinically, the prevention of atrial fibrillation in the left atrial appendage mainly focuses on closing the left atrial appendage. Among them, the left atrial appendage occluder is a widely accepted treatment method at the present stage.

[0003] Patent CN207666637U provides a left atrial appendage occluder with strong adaptability. The left atrial appendage occluder includes a occluding disc, an anchoring part, and a connecting part connecting the occluding disc and the anchoring part; the left atrial appendage orifice is occluded by the occluding disc. Among them, the setting of the support disc frame and the flow-blocking membrane has a smaller contracted volume and is lighter compared to other metal-woven occluding discs. The flow-blocking membrane is used to block the blood from entering and leaving the left atrial appendage; especially the unique design of the sleeve, specifically, the sleeve is sleeved on the support ring outside the support disc frame. During the operation, the sleeve is filled with an elastic material. When the sleeve cooperates with the left atrial appendage orifice, due to the good elasticity and flexibility of the sleeve filled with the elastic material, it can adapt to the irregular shape of the left atrial appendage orifice and completely occlude the left atrial appendage orifice, solving the problem that the traditional occluding device cannot solve the problem of incomplete occlusion of the left atrial appendage orifice in different cases, and completely eliminating the hidden danger of thrombus formation in the left atrial appendage due to atrial fibrillation.

[0004] Patent CN210354812U provides an anchored left atrial appendage occluder, including an occluding member and a fixing member, wherein the occluding member includes a flat cage-shaped plug body formed by braided wires, the top of the plug body is formed by a transition of the braided wires to form a conical protrusion, the top fixing sleeve of the protrusion is provided with a top cover, the fixing member includes a connecting sleeve provided on the top cover, a plurality of inverted U-shaped support arms are provided on the top of the connecting sleeve, the fixing member also includes a connector connecting the ends of two adjacent support arms, the connector includes an upwardly inclined hook portion and two arc-shaped branches provided at the bottom of the hook portion, the top of the hook portion extends toward the connecting sleeve, and the support arm is provided with an anchor bar bent toward the occluding member. The fixing member can form a stable connection with the left atrial appendage through the dual effects of hooking and anchoring, which helps to improve the overall fixation of the occluder and has a stable and lasting occluding effect on the left atrial appendage, but the anchor bar of this design structure can easily scratch the inner wall of the left atrial appendage.

[0005] Patent CN108938037A provides a left atrial appendage occluder, including a stent and an anchoring member arranged on the stent, wherein the anchoring member includes a main body, a fixing member and a hook-shaped member, wherein the main body is respectively connected to the hook-shaped member and the stent, and the fixing member is arranged on the hook-shaped member and extends away from the main body. When the occluder is placed on an object to be occluded, the anchoring member is connected to the object to be occluded via the fixing member. The present invention can adapt to left atrial appendages of various shapes and will not hinder the occluder from being sheathed. The sheathing is convenient and it is not easy to scratch the sheath, which is conducive to repeated positioning and recovery. It is also convenient to fix and has high operating efficiency. However, the anchoring member can easily scratch the blood vessel wall.

[0006] Therefore, how to improve the anchoring effect of the left atrial appendage occluder while preventing it from puncturing the left atrial appendage wall, not hindering the occluder from entering the sheath, preventing it from scratching the sheath, and being able to repeatedly position and recover it, and improving operational efficiency during the operation has become a problem that needs to be solved urgently. Summary of the invention

[0007] In view of the above and others, an object of the present invention is to overcome the deficiencies of the prior art.

[0008] According to an embodiment of the application in left atrial appendage occlusion surgery, the present invention can provide an implant device with a fishbone-shaped anchoring structure and a delivery system thereof for patients with structural heart disease who need interventional treatment, which can solve the problem of the occluder scratching the left atrial appendage wall and the sheath wall during the interventional treatment operation.

[0009] According to one aspect of the present invention, the implant device at least includes a fixing part, the fixing part includes a support body, the support body includes a plurality of elastic support rods and a plurality of anchoring structures, the support rods include an inner side, an outer side and a side wall, and the plurality of anchoring structures are distributed in a fishbone shape on the side wall and / or the outer side of the support rods; when the implant device is placed in a cavity, the ends of the anchoring structures and the outer sides of the support rods can contact the inner surface of the cavity and form a non-piercing anchoring.

[0010] In one embodiment, the implant device with a fishbone-shaped anchoring structure includes a patent ductus arteriosus occluder, a left atrial appendage occluder, an arterial / venous filter, and an embolectomy device.

[0011] In one embodiment, from the central axis of the fixing part from the inside to the outside, the side of the support rod close to the central axis is the inner side, and the side of the support rod far from the central axis is the outer side. Except for the inner side and the outer side, other parts are the side walls of the support rods.

[0012] In one embodiment, the anchoring structure cannot undergo elastic deformation relative to the support rod.

[0013] In one embodiment, in the state where the implant device is not loaded outside the body, during the process of pushing the implant device into the target position by the delivery system, after the implant device reaches the target position of the cavity, in any state during the whole process, the anchoring structure cannot undergo elastic deformation relative to the support rod.

[0014] In one embodiment, during the release process of the implant device, the support rod preferentially undergoes elastic deformation, and the anchoring structure cannot undergo elastic deformation relative to the support rod.

[0015] In one embodiment, non-piercing anchoring means that the area where the end of the anchoring structure pierces the cavity tissue is limited and the depth is very shallow, which increases the frictional resistance to a certain extent.

[0016] In one embodiment, the fixing part further includes a self-centering member, the support rods are radially distributed outward from the self-centering member and sequentially include a proximal connecting rod, an intermediate branch rod, and a distal circular rod. The distal circular rod is curved or at least a section is parallel to the central axis of the self-centering member in the general direction; wherein, the anchoring structure is distributed in a fishbone shape at least on the side wall of the distal circular rod, and the distance from the end of the anchoring structure to the edge of the side wall of the support rod does not exceed 1 mm; when the implant device is in any state, any one of the anchoring structures is on a plane, and this plane is tangent to the distal circular rod at the tangent point, and the tangent point is the connection point where the anchoring structure and the distal circular rod meet.

[0017] In one embodiment, the support body is formed by laser engraving and heat setting from the same shape memory alloy tube.

[0018] In one embodiment, the anchoring structures are distributed on two side walls of the distal looped rod. When the implantation device is in a natural unconstrained state, any one of the anchoring structures lies in a plane that is tangent to the side wall of the distal looped rod at the tangent point, which is the connection point where the anchoring structure and the distal looped rod meet, and the anchoring structures face radially outward.

[0019] In another embodiment, the anchoring structures are distributed on two side walls of the distal looped rod. When the implantation device is in a natural unconstrained state, any one of the anchoring structures lies in a plane that is tangent to the outer side of the distal looped rod at the tangent point, which is the connection point where the anchoring structure and the distal looped rod meet.

[0020] In one embodiment, the overall shape structure of the anchoring structures is one or a combination of more than one of the following: horn-shaped, two-pronged, three-pronged, four-pronged, five-pronged, wing-shaped; wherein, the curve length of each anchoring structure itself is [0.2 mm, 2 mm], and the spacing between adjacent anchoring structures along the support rod direction is [0.5 mm, 2 mm].

[0021] In one embodiment, the wall thickness of the shape memory alloy tube is [0.05 mm, 0.5 mm], and the outer diameter is [1 mm, 5 mm].

[0022] In a preferred embodiment, the wall thickness of the shape memory alloy tube is [0.15 mm, 0.3 mm], and the outer diameter is [2 mm, 4 mm].

[0023] In one embodiment, the distance from each anchoring structure to the support rod gradually widens from far to near.

[0024] In one embodiment, the implantation device and its delivery system include an isolation structure. Among them, when the implantation device is loaded in the delivery system, the isolation structure is at least partially located between the ends of all the anchoring structures and the inner wall of the delivery system; when the implantation device is placed at the target position in the cavity, the isolation structure is at least partially located inside the support rod or inside the ends of the anchoring structures.

[0025] In one embodiment, the distance from the end of the anchoring structure to the edge of the side wall of the distal looped rod is [0.2 mm, 0.5 mm].

[0026] In one embodiment, the isolation structure is arranged on the implantation device and is spaced apart and distributed at the ends of the anchoring structures, or is located between two adjacent anchoring structures, or is located inside the distal looped rod, or a combination of the three; wherein, the isolation structure includes one or more of a ball head, a bump, a cutting head, a small ball, a filling and thickening coating, as Figure 3e shown.

[0027] In one embodiment, flexible outer membranes are connected to the outside of the central member, the proximal connecting rod, and the intermediate branch rods, and a flexible inner membrane is connected to the inside of the distal looped rod. The inner membrane is the isolation structure. Among them, the outer membrane and the inner membrane can form an integral structure or a split connection structure.

[0028] In one embodiment, the split connection structure includes a partial connection structure. The partial connection structure adopts methods such as sewing and gluing. The microstructures, forming structures, and process manufacturing methods of the various parts of the split connection structure are different.

[0029] In one embodiment, the microstructures, forming structures, and process manufacturing methods of the various parts of the integral structure are all the same.

[0030] In one embodiment, the anchoring structure can be located on the proximal connecting rod, or the intermediate branch rod, or the distal looped rod, or a combination of the three.

[0031] In one embodiment, the anchoring structure can face distally and / or proximally.

[0032] In one embodiment, the outer membrane and the inner membrane form an integral structure formed by the reverse interpenetration of the support body.

[0033] In one embodiment, the membrane is one or more of a silicone film, a polyurethane film, a polyester film, a polytetrafluoroethylene film, a polyethylene film, a polypropylene film, a polylactic acid film, a polycaprolactone film, and a polyvinyl alcohol film.

[0034] In a preferred embodiment, the membrane is fixed to the support body by sewing.

[0035] In one embodiment, a layer of membrane is provided inside the fixing part, which plays a blocking role to prevent the anchoring structures from rubbing against each other and self-locking and scratching the sheath wall. A layer of membrane is also provided outside the fixing part to block thrombus.

[0036] In one embodiment, a blocking part is provided at the proximal end of the fixing part. The blocking part has a three-dimensional structure and is used to block the opening area of the cavity.

[0037] In one embodiment, the isolation structure is arranged on the delivery system. The delivery system includes an outer sheath and a control handle. The isolation structure can be located between the outer sheath and the fixing part.

[0038] In one embodiment, the isolation structure includes a flexible wrapping film and a detachable connection structure. The wrapping film can at least cover the ends of all the anchoring structures. By operating the detachable connection structure, the wrapping film is disassembled, so that the fixing part is completely exposed from the wrapping film and radially expanded to a preset shape.

[0039] In one embodiment, the delivery system further includes a control wire. The isolation structure is a wrapping film, and a plurality of perforations are provided on the wrapping film. The plurality of perforations are spirally distributed. One end of the control wire is configured to pass through the plurality of perforations in sequence and then be detachably arranged. The other end of the control wire is connected to a control handle. After the fixing portion reaches the expected release position, the control handle is operated, and one end of the control wire is sequentially withdrawn from the plurality of perforations to gradually release the radial constraint on the wrapping film, so that the fixing portion is gradually radially expanded to a preset shape.

[0040] In one embodiment, the isolation structure is an isolation tube. The hardness of the inner surface of the isolation tube is not lower than the hardness of the end of the anchoring structure, or the surface roughness of the inner surface of the isolation tube is not higher than the surface roughness of the end of the anchoring structure; before the fixing portion is restored to the preset shape, the fixing portion and the isolation tube remain relatively stationary axially; after the fixing portion is restored to the preset shape, the outer sheath and the isolation tube are retracted simultaneously to complete the surgical procedure.

[0041] In one embodiment, as Figure 7a shown, the isolation structure is a second fixing portion that is part of the implanting instrument. The second fixing portion is located inside the fixing portion and has a support structure.

[0042] In one embodiment, as Figure 7b and Figure 7c shown, the fixing portion includes a reinforcing body. The reinforcing body includes a plurality of elastic reinforcing rods. At least a part of the reinforcing rods is in contact with the inner surface of the cavity; wherein the reinforcing rods diverge from the central member and / or the support rod and then are free outside the distal end of the support body. The reinforcing rods include an inner surface, an outer surface, and a side surface. The support body and the reinforcing body form a three-dimensional configuration.

[0043] In one embodiment, a buffer structure is provided at the end of the reinforcing rod. The buffer structure includes one or more of a circular ring, a spherical head, a bump, and a rod width tapering structure.

[0044] In one embodiment, from the central axis of the fixing portion from the inside to the outside, the side of the reinforcing rod close to the central axis is the inner surface, and the side of the reinforcing rod away from the central axis is the outer surface. Except for the inner surface and the outer surface, other parts are the side surfaces of the reinforcing rod.

[0045] In one embodiment, the reinforcing rod is provided with an anchoring structure or not provided with an anchoring structure.

[0046] In a preferred embodiment, as Figure 7b shown, the reinforcing rod is provided with a plurality of anchoring structures. The anchoring structures include fishbone spines and hook spines. The hook spines are J-shaped, and the free ends of the hook spines are away from the central axis direction of the fixing portion; the plurality of anchoring structures are distributed on the side surface and / or the outer surface of the reinforcing rod.

[0047] In one embodiment, the occluding portion is made of a material with elasticity and shape memory, and the occluding portion has a three-dimensional cage-like structure.

[0048] In one embodiment, a three-dimensional film is provided on the occluding portion.

[0049] Compared with the prior art, the advantages of the present invention are as follows:

[0050] 1. Taking the left atrial appendage occlusion as an example, currently in the left atrial appendage occlusion, problems such as insufficient anchoring effect of the anchoring structure and puncturing the left atrial appendage wall are likely to occur. At the same time, the anchoring structure will also hinder the introducer sheath of the occluder or even scrape the sheath tube, making it impossible to reposition and retrieve the occluder, thus affecting the surgical effect. Different from the prior art, in one embodiment of the present invention, several anchoring structures are distributed in a fishbone shape on the side wall and / or outside of the support rod; when the implanting device is placed in the cavity, the ends of the anchoring structures and the outside of the support rod can contact the inner surface of the cavity and form a non-piercing type of anchoring, which improves the safety and practicality while increasing the anchoring effect.

[0051] 2. Different from the prior art, in one embodiment of the present invention, the anchoring structure cannot undergo elastic deformation relative to the support rod. The anchoring structure is distributed in a fishbone shape at least on the side wall of the distal ring-shaped rod, and the distance from the end of the anchoring structure to the edge of the side wall of the support rod does not exceed 1 mm; the support body is formed by laser engraving and heat setting from the same shape memory alloy tube; when the implanting device is in any state, any one of the anchoring structures is on a plane, and this plane is tangent to the distal ring-shaped rod at the tangent point, and the tangent point is the connection point where the anchoring structure and the distal ring-shaped rod meet. The process is simple, which ensures that the anchoring structure as a whole has a certain curve radian. Coupled with the limited curve radian of the distal ring-shaped body, the distance from the end of the anchoring structure to the distal ring-shaped body is very short, so that the end of the anchoring structure only slightly protrudes on the distal ring-shaped body, thus realizing non-piercing type of anchoring while ensuring that the anchoring structure is fully anchored to the autologous tissue, strengthening the anchoring effect, increasing the frictional resistance and safety, reducing the risk of the left atrial appendage occluder falling off due to atrial fibrillation and other reasons, reducing the risk of the anchoring structure piercing the left atrial appendage wall, and enabling the left atrial appendage occluder to be repositioned and retrieved.

[0052] 3. Different from the prior art, in one embodiment of the present invention, the distance of each of the anchoring structures from the support rod gradually widens from far to near, which can realize non-piercing type of anchoring locally for the anchoring structure, increasing the probability of non-piercing type of anchoring. When the support body is formed by laser engraving and heat setting from the same shape memory alloy tube, the anti-fatigue fracture property during the support process is improved.

[0053] 4. Different from the prior art, in an embodiment of the present invention, when the implant device is loaded in the delivery system, the isolation structure is at least partially located between the ends of all the anchoring structures and the inner wall of the delivery system; when the implant device is placed at the target position in the cavity, the isolation structure is at least partially located inside the support rod or inside the ends of the anchoring structures; the distance from the end of the anchoring structure to the side wall edge of the distal looped rod is [0.2 mm, 0.5 mm]. The isolation structure plays an isolation role, thus preventing the implant device from scraping the sheath wall during the entry and exit process, and increasing the probability of non-piercing anchoring.

[0054] 5. Different from the prior art, in an embodiment of the present invention, the isolation structure is provided on the implant device and is distributed at intervals at the ends of the anchoring structures, or is located between two adjacent anchoring structures, or is located inside the distal looped rod, or a combination of the three; wherein, the isolation structure includes one or more of a ball head, a bump, a cutting head, a small ball, and a filling and thickening coating, which improves the safety and practicality while increasing the anchoring effect, thus preventing the implant device from scraping the sheath wall during the entry and exit process of the sheath tube.

[0055] 6. Different from the prior art, in an embodiment of the present invention, the outer coating film and the inner coating film can be an integral film or a split film. The inner coating film constitutes the isolation structure, and the outer coating film has a blocking effect on the anchoring structure. When the implant device enters and exits the sheath tube, it can prevent the implant device from getting stuck in the sheath tube due to the interlocking of the anchoring structures and avoid the anchoring structure from scraping the sheath wall at the same time.

[0056] 7. Different from the prior art, in an embodiment of the present invention, the isolation structure is provided on the delivery system and can be located between the outer sheath and the fixing part. When the isolation structure includes a flexible wrapping film and a detachable connection structure, the wrapping film can at least cover the ends of all the anchoring structures. By operating the detachable connection structure, the wrapping film is disassembled, so that the fixing part is completely exposed from the wrapping film and radially expands to a preset shape. The operation is simple, preventing the implant device from scraping the sheath wall.

[0057] 8. Different from the prior art, in an embodiment of the present invention, when the isolation structure is an isolation tube, the hardness of the inner surface of the isolation tube is not lower than the hardness of the ends of the anchoring structures, or the surface roughness of the inner surface of the isolation tube is not higher than the surface roughness of the ends of the anchoring structures. Before the fixing part is restored to the preset shape, the fixing part and the isolation tube remain relatively stationary axially; after the fixing part is restored to the preset shape, the outer sheath and the isolation tube are withdrawn simultaneously to complete the surgical process, which can ensure the smooth entry and exit of the implant device from the sheath tube and play an isolation role.

[0058] 9. Different from the prior art, in one embodiment of the present invention, the isolation structure is a second fixing part which is a part of the implant device. The second fixing part is located inside the fixing part and has the supporting body structure, which enhances the supporting effect and plays an isolation role at the same time, preventing the fixing part from scraping the inner wall of the sheath.

[0059] 10. Different from the prior art, the reinforcing rod in one embodiment of the present invention is formed by the self-centering piece and / or the supporting rod diverging from the far end of the supporting body and then being free, and the supporting body and the reinforcing body form a three-dimensional configuration, which increases the overall height of the fixing part while facilitating the enhancement of the stability, centration and flexibility of the fixing part, and improves the probability of the fixing part triggering anchoring. When the reinforcing rod is provided with an anchoring structure, the anchoring property of the fixing part is further improved.

[0060] 11. Different from the prior art, in one embodiment of the present invention, a buffer structure is provided at the end of the reinforcing rod. The buffer structure includes one or more of a circular ring, a ball head, a convex point, and a rod width tapering structure, which can prevent the sheath wall from being scratched or the inner wall of the cavity from being punctured. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figures 1a - 1e Schematic diagram of the state of an implant device with a fishbone-shaped anchoring structure in Embodiment 1 of the present invention.

[0062] Figures 2a - 2e Schematic diagram of different overall shapes of anchoring structures in one embodiment of the present invention.

[0063] Figures 3a - 3d It is a schematic diagram of a state in which an isolation structure of an embodiment of the present invention is an outer coating.

[0064] Figure 3e It is a schematic diagram of a state in which the isolation structure is a ball head in an embodiment of the present invention.

[0065] Figures 4a - 4j Schematic diagram of the process of releasing the implanted device in the left atrial appendage in Example 1 of the present invention.

[0066] Figure 5 A schematic diagram of the state in which the isolation structure in the second embodiment of the present invention is an isolation tube.

[0067] Figures 6a - 6d Schematic diagram of the process of releasing the implanted device in the left atrial appendage in Example 3 of the present invention.

[0068] Figure 7a It is a schematic diagram of a state in which the isolation structure is the second fixing portion in an embodiment of the present invention.

[0069] Figure 7b and Figure 7c It is a schematic diagram of a state in which a fixing portion includes a reinforcement body in an embodiment of the present invention.

[0070] The names of the parts referred to by the numbers in the drawings are as follows: 1 - implant device, 11 - fixing part, 111 - self - central part, 112 - proximal connecting part, 113 - intermediate branch rod, 114 - distal loop rod, 115 - second fixing part, 12 - occluding part, 13 - support body, 14 - support rod, 141 - outer side, 142 - inner side, 143 - side wall, 2 - anchoring structure, 3 - outer membrane, 31 - inner membrane, 4 - delivery outer sheath, 5 - control handle, 51 - steel cable, 52 - loader, 6 - isolation tube, 7 - wrapping film, 71 - ball head, 8 - control wire, 9 - reinforcing body, 91 - reinforcing rod. Detailed implementation manners

[0071] The present invention will be further described in detail below with reference to the drawings and embodiments.

[0072] In the present invention, the proximal end refers to the end close to the surgeon, and the distal end refers to the end far from the surgeon.

[0073] Embodiment 1:

[0074] In this embodiment, as Figures 1a - 1e shown, taking the intervention of the left atrial appendage to prevent thromboembolic diseases in patients with atrial fibrillation as an example, an implant device with a fish - bone - shaped anchoring structure and its delivery system, the implant device 1 includes a fixing part 11 and an occluding part 12. The occluding part 12 is a three - dimensional cage - like structure for occluding the opening area of the cavity. The occluding part 12 is made of a material with elasticity and shape memory. The fixing part includes a support body 13. The support body 13 includes a plurality of elastic support rods 14 and a plurality of anchoring structures 2. The support rod 14 includes an inner side 142, an outer side 141 and a side wall 143. A plurality of anchoring structures 2 are distributed in a fish - bone shape on the side wall 143 of the support rod 14; when the implant device 1 is placed in the cavity, the ends of the anchoring structures 2 and the outer side 141 of the support rod 14 can contact the inner surface of the cavity and form a non - piercing anchoring.

[0075] In this embodiment, the implant device with a fish - bone - shaped anchoring structure is a left atrial appendage occluder.

[0076] In this embodiment, the anchoring structure 2 cannot undergo elastic deformation relative to the support rod 14.

[0077] In this embodiment, from the central axis of the fixing part 11 from the inside to the outside, the side of the support rod 14 close to the central axis is the inner side 142, the side of the support rod 14 far from the central axis is the outer side 141. Except for the inner and outer sides, other parts are the side wall 143 of the support rod 14.

[0078] In this embodiment, when the implant device 1 is in an unloaded state outside the body, during the process of pushing the implant device 1 by the delivery system to introduce it into the target position, after the implant device 1 reaches the target position in the cavity, in any state during the whole process, the anchoring structure 2 cannot undergo elastic deformation relative to the support rod 14.

[0079] In this embodiment, during the release process of the implant device 1, the support rod 14 preferentially undergoes elastic deformation, and the anchoring structure 2 cannot undergo elastic deformation relative to the support rod 14.

[0080] In this embodiment, non-piercing anchoring means that the area where the end of the anchoring structure 2 pierces the cavity tissue is limited and the depth is very shallow, which increases the frictional resistance to a certain extent.

[0081] In this embodiment, as Figures 1a - 1e shown, the fixing part 11 further includes a self-centering member 111. The support rods 14 are radially distributed outward from the self-centering member 111 and sequentially include a proximal connecting rod 112, an intermediate branch rod 113, and a distal looped rod 114. The distal looped rod 114 is curved or at least has a section parallel to the central axis of the self-centering member 111 in the general direction. Among them, the anchoring structure 2 is distributed in a fishbone shape on at least both side walls 143 of the distal looped rod 114, and the distance from the end of the anchoring structure 2 to the edge of the side wall 143 of the support rod 14 does not exceed 1 mm.

[0082] In this embodiment, the support body 13 is formed by laser engraving and heat setting from the same shape memory alloy tube; when the implant device 1 is in any state, any one of the anchoring structures 2 is on a plane, and this plane is tangent to the distal looped rod 114 at the tangent point, and the tangent point is the connection point where the anchoring structure 2 and the distal looped rod 114 meet.

[0083] In this embodiment, the anchoring structure 2 is distributed in a fishbone shape on two side walls of the distal looped rod 114. When the implant device 1 is in any state, any one of the anchoring structures 2 is on a plane, and this plane is tangent to the outer side of the distal looped rod 114 at the tangent point, and the tangent point is the connection point where the anchoring structure 2 and the distal looped rod 114 meet.

[0084] In this embodiment, as Figures 2a - 2c shown, the overall shape structure of the anchoring structure 2 is in a horn shape; among them, the curve length of each anchoring structure 2 is [0.2 mm, 2 mm], and the distance between adjacent anchoring structures 2 along the direction of the support rod 14 is [0.5 mm, 2 mm].

[0085] In this embodiment, the wall thickness of the shape memory alloy tube is [0.15 mm, 0.3 mm], and the outer diameter is [2 mm, 4 mm].

[0086] In this embodiment, each anchoring structure 2 has a gradually widening structure from far to near with respect to the support rod 14.

[0087] In this embodiment, the implant device 1 and its delivery system include an isolation structure. When the implant device 1 is loaded in the delivery system, the isolation structure is at least partially located between the ends of all the anchoring structures 2 and the inner wall of the delivery system; when the implant device 1 is placed at the target position in the cavity, the isolation structure is at least partially located inside the support rod 14 or inside the ends of the anchoring structures 2; the distance from the end of the anchoring structure 2 to the side wall edge of the distal loop rod 114 is [0.2 mm, 0.5 mm].

[0088] In this embodiment, the isolation structure is provided on the implant device and is located inside the distal loop rod 114.

[0089] In this embodiment, as Figures 3a - 3e shown, flexible outer membranes 3 are connected to the outsides of the central member 111, the proximal connecting rod 112, and the intermediate branch rod 113, and a flexible inner membrane 31 is connected to the inside of the distal loop rod 114. The outer membrane 31 is the isolation structure; among them, the outer membrane 3 and the inner membrane 31 can form an integral structure.

[0090] In this embodiment, the microstructure, the forming structure, and the process manufacturing method of each part of the integral structure are all the same.

[0091] In this embodiment, the membrane is one or more of a silicone film, a polyurethane film, a polyester film, a polytetrafluoroethylene film, a polyethylene film, a polypropylene film, a polylactic acid film, a polycaprolactone film, and a polyvinyl alcohol film.

[0092] In this embodiment, the outer membrane 3 and the inner membrane 31 are an integral structure formed by the support body 13 being inserted in a reverse manner.

[0093] In this embodiment, the membrane is fixed to the support body by suture.

[0094] In this embodiment, the delivery system includes a delivery outer sheath 4, a control handle 5, a steel cable 51, and a loader 52.

[0095] In this embodiment, when the implant device 1 is in a natural unconstrained state, the ends of the anchoring structures 2 face the proximal end.

[0096] In this embodiment, a three-dimensional membrane is provided on the blocking portion 12.

[0097] The operation process steps in this embodiment during the operation are as follows (as Figures 4a - 4j shown):

[0098] (1)Perform standard percutaneous vascular puncture at the femoral vein, insert a stiff guide wire, and perform atrial septum puncture using an atrial septum puncture kit to establish a femoral vein access, and complete the subsequent operations of exchanging the stiff guide wire and establishing the delivery outer sheath 4 access;

[0099] (2)Operate the control handle 5 to push the delivery outer sheath 4 (including the delivery outer sheath core) retrograde along the stiff guide wire through the minimally invasive femoral vein opening into the left atrium, withdraw the delivery outer sheath core to the outside of the body, and retain the delivery outer sheath 4 to provide a channel;

[0100] (3)Insert a pigtail catheter along the stiff guide wire to make the pigtail catheter reach the left superior pulmonary vein, withdraw the stiff guide wire, pull out the delivery outer sheath 4 and the pigtail catheter as a whole from the left superior pulmonary vein, slightly adjust the position to make the front end of the pigtail catheter slide into the left atrial appendage, and push the delivery outer sheath 4 along the pigtail catheter to make the delivery outer sheath 4 reach the proximal position of the left atrial appendage;

[0101] (4)Withdraw the pigtail catheter, form a mating connection between the loader 52 loaded with the left atrial appendage occluder and the delivery outer sheath 4 outside the body, push the steel cable 51, so that the left atrial appendage occluder gradually enters the delivery outer sheath 4 under the push of the steel cable 51 and reaches the left atrial appendage until the fixing part 11 is pushed out of the delivery outer sheath 4, and the anchoring structure 2 on the fixing part 11 engages with the tissue in the left atrial appendage;

[0102] (5)Continue to operate the control handle 5 to move the delivery outer sheath 4 proximally, the occluding part 12 resumes its preset shape, and withdraw the delivery system to complete the surgical procedure.

[0103] Example Two:

[0104] The difference between the implant device with a fishbone-shaped anchoring structure and its delivery system provided in this example and those in Example One lies in:

[0105] In this example, the isolation structure is arranged on the delivery system. The delivery system also includes a delivery outer sheath 4, a control handle 5, and a steel cable 51. The isolation structure can be located between the delivery outer sheath 4 and the fixing part 11.

[0106] In this example, as Figure 5 shown, the isolation structure is an isolation tube 6.

[0107] In this example, the isolation structure is an isolation tube 6. The hardness of the inner surface of the isolation tube 6 is not lower than the hardness of the end of the anchoring structure, or the surface roughness of the inner surface of the isolation tube 6 is not higher than the surface roughness of the end of the anchoring structure; before the fixing part 11 resumes its preset shape, the fixing part 11 and the isolation tube 6 remain relatively stationary axially; after the fixing part 11 resumes its preset shape, the surgical procedure is completed by withdrawing the delivery outer sheath 4 and the isolation tube 6 simultaneously.

[0108] The operation process steps in this embodiment during the operation are as follows:

[0109] (1)Perform standard percutaneous vascular puncture at the femoral vein, insert a stiff guide wire, and perform atrial septum puncture with an atrial septum puncture kit to establish a femoral vein access, and complete the subsequent operations of stiff guide wire exchange and establishment of the delivery outer sheath 4 passage;

[0110] (2)Operate the control handle 5, and push the delivery outer sheath 4 (including the delivery outer sheath core) retrogradely along the stiff guide wire through the minimally invasive femoral vein opening and push it into the left atrium along the stiff guide wire. Withdraw the delivery outer sheath core 41 to the outside of the body, and retain the delivery outer sheath 4 to provide a passage;

[0111] (3)Insert a pigtail catheter along the stiff guide wire to make the pigtail catheter reach the left superior pulmonary vein. Withdraw the stiff guide wire, pull out the delivery outer sheath 4 and the pigtail catheter as a whole from the left superior pulmonary vein, slightly adjust the position to make the front end of the pigtail catheter slide into the left atrial appendage, and push the delivery outer sheath 4 along the pigtail catheter to make the delivery outer sheath 4 reach the proximal position of the left atrial appendage;

[0112] (4)Withdraw the pigtail catheter, form a mating connection between the loader 52 loaded with the left atrial appendage occluder and the delivery outer sheath 4 outside the body. Operate the control handle 5 and push the steel cable 51 to make the isolation tube 6 and the left atrial appendage occluder gradually enter the delivery outer sheath 4 from the loader 52 at the same time and reach the left atrial appendage. Continue to push the steel cable 51 until the fixing part 11 is pushed out of the isolation tube 6, and the anchoring structure 2 on the fixing part 11 engages with the tissue in the left atrial appendage;

[0113] (5)Continue to operate the control handle 5 to move the delivery outer sheath 4 and the isolation tube 6 proximally at the same time, the occluding part 12 resumes its preset shape, and withdraw the delivery system to complete the operation process.

[0114] Embodiment Three:

[0115] The differences between the implant device with a fishbone-shaped anchoring structure and its delivery system provided in this embodiment and those in Embodiment Two are as follows:

[0116] In this embodiment, the isolation structure includes a flexible wrapping film 7 and a detachable connection structure. The wrapping film 7 can at least cover the ends of all the anchoring structures 2. Operate the detachable connection structure, and the wrapping film 7 is disassembled so that the fixing part 11 is completely exposed from the wrapping film 7 and radially expands to a preset shape.

[0117] In this embodiment, as Figure 6aAs shown, the delivery system further includes a control wire 8, the isolation structure is a wrapping film 7, and a plurality of perforations are provided on the wrapping film 7. The plurality of perforations are spirally distributed. One end of the control wire 8 is configured to pass through the plurality of perforations in sequence and then be detachably arranged. The other end of the control wire 8 is connected to the control handle 5. After the fixing portion 11 reaches the expected release position, the control handle 5 is operated, and one end of the control wire 8 is gradually withdrawn from the plurality of perforations to gradually release the radial constraint on the wrapping film 7, so that the fixing portion 11 is gradually radially expanded to a preset shape.

[0118] The operation process steps in the operation of this embodiment are as follows (as Figures 6a - 6d shown):

[0119] (1) Perform a standard percutaneous vascular puncture at the femoral vein, insert a stiff guide wire, and perform an atrial septum puncture with an atrial septum puncture kit to establish a femoral vein access, and complete the subsequent operations of exchanging the stiff guide wire and establishing the access of the delivery outer sheath 4;

[0120] (2) Operate the control handle 5 to push the delivery outer sheath 4 (including the delivery outer sheath core) retrogradely along the stiff guide wire through the minimally invasive femoral vein opening and push it into the left atrium along the stiff guide wire. Withdraw the delivery outer sheath core to the outside of the body, and retain the delivery outer sheath 4 to provide a channel;

[0121] (3) Insert a pigtail catheter along the stiff guide wire so that the pigtail catheter reaches the left superior pulmonary vein. Withdraw the stiff guide wire, pull out the delivery outer sheath 4 and the pigtail catheter as a whole from the left superior pulmonary vein, slightly adjust the position, and slide the front end of the pigtail catheter into the left atrial appendage. Push the delivery outer sheath 4 along the pigtail catheter so that the delivery outer sheath 4 reaches the proximal position of the left atrial appendage;

[0122] (4) Withdraw the pigtail catheter, form a mating connection between the loader 52 equipped with the left atrial appendage occluder and the delivery outer sheath 4 outside the body. Operate the control handle 5 and push the steel cable 51 so that the flexible wrapping film 7 and the left atrial appendage occluder gradually enter the delivery outer sheath 4 from the loader 52 at the same time and reach the left atrial appendage. Continue to push the steel cable 51 until the fixing portion 11 is pushed out of the delivery outer sheath 4. Operate the control wire 8 to gradually withdraw one end of the control wire 8 from the plurality of perforations to gradually release the radial constraint on the wrapping film 7. The fixing portion 11 preferentially resumes to the preset shape, and the anchoring structure 2 engages with the tissue in the left atrial appendage;

[0123] (5) Operate the control handle 5 to move the delivery outer sheath 4 proximally while continuing to operate the control wire to gradually release the radial constraint on the wrapping film. The occluding portion 12 resumes to the preset shape, and the delivery system is withdrawn to complete the surgical procedure.

[0124] The above content is only the preferred embodiment of the present invention. For those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manner and application scope. The content of this specification should not be construed as a limitation to the present invention.

Claims

1. An implant device with a fishbone-shaped anchoring structure, characterized in that: the implant device at least includes a fixing part, the fixing part includes a support body, the support body includes a plurality of elastic support rods and a plurality of anchoring structures, the support rod includes an inner side, an outer side and a side wall, and a plurality of the anchoring structures are distributed in a fishbone shape on the side wall of the support rod; when the implant device is placed in a cavity, the end of the anchoring structure and the outer side of the support rod can contact the inner surface of the cavity, and the area where the end of the anchoring structure pierces the cavity tissue is limited and the depth is very shallow, which increases the frictional resistance to a certain extent; the anchoring structure cannot undergo elastic deformation relative to the support rod; and the fixing part further includes a self-centering member, the support rods are radially distributed outward from the self-centering member and sequentially include a proximal connecting rod, an intermediate branch rod, and a distal circular rod, the distal circular rod is curved, or at least a section is parallel to the central axis of the self-centering member in the general direction; wherein, the anchoring structure is distributed in a fishbone shape at least on the side wall of the distal circular rod, and the distance from the end of the anchoring structure to the edge of the side wall of the support rod does not exceed 1 mm; when the implant device is in any state, any one of the anchoring structures is on a plane, and the plane where the anchoring structure is located is tangent to the distal circular rod at the tangent point, and the tangent point is the connection point where the anchoring structure and the distal circular rod meet; each anchoring structure shows a gradually widening structure from far to near the support rod.

2. The implant device with a fishbone-shaped anchoring structure according to claim 1, characterized in that: the support body is formed by laser engraving and heat setting from the same shape memory alloy tube; the anchoring structures are distributed on two side walls of the distal circular rod, and the overall shape structure of the anchoring structure is one or a combination of more of a horn type, a two-pronged type, a three-pronged type, a four-pronged type, a five-pronged type, and a wing type; wherein, the curve length of each anchoring structure itself is [0.2 mm, 2 mm], and the distance between adjacent anchoring structures along the direction of the support rod is [0.5 mm, 2 mm].

3. The implant device with a fishbone-shaped anchoring structure according to claim 1, characterized in that: the implant device includes an isolation structure; wherein when the implant device is loaded in a delivery system, the isolation structure is at least partially located between the ends of all the anchoring structures and the inner wall of the delivery system; when the implant device is placed at the target position of the cavity, the isolation structure is at least partially located inside the inner side of the support rod or inside the inner side of the ends of the anchoring structures; the distance from the end of the anchoring structure to the edge of the side wall of the distal circular rod is [0.2 mm, 0.5 mm].

4. The implant device with a fishbone-shaped anchoring structure according to claim 3, characterized in that: The isolation structure is disposed on the implant device, and is spaced and distributed at the end of the anchoring structure, or is located between two adjacent anchoring structures, or is located inside the distal looped rod, or a combination of the three; wherein, the isolation structure includes one or more of a ball head, a bump, a cutting head, a small ball, and a filled and thickened coating.

5. An implant device with a fishbone-shaped anchoring structure according to claim 3, wherein: Flexible outer membranes are connected to the outer sides of the self-central member, the proximal connecting rod, and the intermediate branch rod, and a flexible inner membrane is connected to the inner side of the distal looped rod, and the inner membrane is the isolation structure; wherein, the outer membrane and the inner membrane can form an integral structure or a split connection structure.

6. An implant device with a fishbone-shaped anchoring structure according to claim 5, wherein: The outer membrane and the inner membrane form the integral structure formed by reverse interpenetration through the support body.

7. An implant device with a fishbone-shaped anchoring structure according to claim 3, wherein: The isolation structure is disposed on the delivery system, the delivery system includes an outer sheath and a control handle, and the isolation structure can be located between the outer sheath and the fixing part.

8. An implant device with a fishbone-shaped anchoring structure according to claim 7, wherein: The isolation structure includes a flexible wrapping film and a detachable connection structure, the wrapping film can at least cover the ends of all the anchoring structures, and by operating the detachable connection structure, the wrapping film is disassembled so that the fixing part is completely exposed from the wrapping film and radially expands to a preset shape.

9. An implant device with a fishbone-shaped anchoring structure according to claim 7, wherein: The isolation structure is an isolation tube, the hardness of the inner surface of the isolation tube is not lower than the hardness of the end of the anchoring structure, or the surface roughness of the inner surface of the isolation tube is not higher than the surface roughness of the end of the anchoring structure; before the fixing part is restored to the preset shape, the fixing part and the isolation tube remain relatively stationary axially; after the fixing part is restored to the preset shape, the outer sheath and the isolation tube are retracted simultaneously to complete the surgical procedure.

10. An implant device with a fishbone-shaped anchoring structure according to claim 3, wherein: The isolation structure is a second fixing part of a part of the implant device, and the second fixing part is located inside the fixing part and has the support body structure.

11. An implant device with a fishbone-shaped anchoring structure according to claim 1, wherein: The fixing part includes a reinforcing body, the reinforcing body includes a plurality of elastic reinforcing rods, and at least a part of the reinforcing rods is in contact with the inner surface of the cavity; wherein the reinforcing rods diverge from the self-central member and / or the support rod outside the distal end of the support body and then are free, the reinforcing rods include an inner surface, an outer surface, and a side surface, and the support body and the reinforcing body form a three-dimensional configuration.

12. An implant device with a fishbone-shaped anchoring structure according to claim 11, characterized in that: a buffer structure is provided at the end of the reinforcing rod, and the buffer structure includes one or more of an annular ring, a spherical head, a convex point, and a rod width tapering structure; and, a plurality of anchoring structures are provided on the reinforcing rod, and the anchoring structures of the reinforcing rod include fishbones and hook spines, the hook spines are J-shaped, and the free ends of the hook spines are away from the central axis direction of the fixing part; a plurality of the anchoring structures are distributed on the side surface of the reinforcing rod.

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