implants

Abstract

The implant comprises a main body (100) and at least one group of clamping members (200). The main body (100) is used to fix to a target site and has a predetermined length. The group of clamping members (200) includes a first clamping member (210) and a second clamping member (220), which are distributed around the outer circumference of the main body (100) at intervals along its axial direction. Of these, the first clamping member (210) and the second clamping member (220) are configured to be elastically deformable.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and more specifically, to implants.

Background Art

[0002] Intracardiac or vascular implants can be used to improve the physiological function of a target site or monitor physiological parameters of the target site, or have both of the above two functions. An implant cannot operate properly unless it is held in the target site. For example, heart failure is a clinical syndrome caused by abnormalities in ventricular filling and ejection functions. In order to prevent an increase in left atrial pressure, a monitoring device can be implanted in the atrial septum to continuously monitor the left atrial pressure. When a continuous pressure increase phenomenon appears, a shunt device can be further implanted to shunt a part of the blood in the left atrium to the right atrium to reduce the left atrial pressure. Furthermore, a device with both monitoring and shunting functions can be directly implanted to perform monitoring and shunting simultaneously.

[0003] In the prior art, a clamp member is used to clamp the tissue of the target site to fix a shunt or a sensor to the tissue in the body, such as the atrial septum. However, the existing designs of clamp members have many drawbacks. For example, the clamp member of a shunt with a mesh disk structure is disk-shaped and parallel to each other. The part that is engaged with the tissue of the disk is difficult or impossible to achieve an adaptive adjustment according to the thickness and shape of the tissue. This may cause problems such as insufficient firmness of clamping or excessive clamping that damages the tissue. At the same time, when the thickness of the clamped tissue is large or there are other tissues around, the disk-shaped clamp member will deform to a certain extent and press the shunt structure between the two clamp members, thereby narrowing the aperture of the shunt path and affecting the shunt performance.

Summary of the Invention

Problems to be Solved by the Invention

[0004] In view of this, the present invention provides an implant that can be applied to a wider range of target locations. [Means for solving the problem]

[0005] As a first aspect, the present invention provides an implant used for improving the physiological function of a target site and / or detecting physiological indicators of a target site. The implant comprises a main body and at least one group of clamping members. The main body is used for fixation to a target site and has a predetermined length, and the group of clamping members comprises a first clamping member and a second clamping member, which are distributed around the outer circumference of the main body at intervals along the axial direction of the main body, and which are configured to be elastically deformable so as to move away from each other in the axial direction of the main body and / or contract in the radial direction of the main body.

[0006] In one possible implementation, the first clamping member and / or the second clamping member include a connecting segment and a clamping segment, the connecting segment being connected at one end to the main body and at the other end to the clamping segment, each of the first and second clamping members as a whole protrudes from the outer circumferential surface of the main body, and the clamping segment and / or the connecting segment are configured to deform so as to move away from each other in the axial direction of the main body and / or contract in the radial direction of the main body.

[0007] In conjunction with the above possible implementations, in another possible implementation, the clamping segment and / or connecting segment deform in the form of deflection in the circumferential direction and / or bending toward the body in the radial direction, thereby contracting radially toward the body.

[0008] In conjunction with the above possible implementations, in another possible implementation, a curved portion with a variable angle is included between the clamping segment and the connecting segment, thereby allowing the clamping segment to be compressed along the radial direction of the main body.

[0009] In conjunction with the above possible implementations, in another possible implementation, the clamping segment is configured such that at least a portion of its structure can change the angle with respect to the connecting segment in the form of deflection and / or bending toward the body, thereby allowing the clamping segment to be compressed along the radial direction of the body.

[0010] In conjunction with the above possible implementations, in another possible implementation, the outermost end of the clamping segment has a smooth structure.

[0011] In conjunction with the above possible implementations, in another possible implementation, the clamping segment is made of a curved or wound elastic wire or elastic sheet, with the end of the elastic wire or elastic sheet located between the outermost end and the main body, or the clamping segment is made of a cut elastic sheet, with the end of the elastic sheet being arc-shaped.

[0012] In conjunction with the above possible implementations, in another possible implementation, if the clamping segment is formed by winding an elastic wire or elastic sheet, the ends of the elastic wire or elastic sheet are located inside the winding structure.

[0013] In conjunction with the above possible implementations, in another possible implementation, the outermost end of the clamping segment is made smooth by winding the entire or end of it around an elastic wire or elastic sheet.

[0014] In connection with the above possible implementations, in another possible implementation, the first and second clamping members are further curved in the circumferential direction so that they can be deflected circumferentially with respect to the main body by the action of an external force, and have a clamping angle with the main body, the clamping angle being less than 90°, and / or the first and second clamping members are deflected circumferentially with respect to the main body by the action of an external force because the circumferential width of the connecting segment is smaller than the width of the clamping segment and / or the curved portion.

[0015] In connection with the above possible implementations, in another possible implementation, the clamping segment includes a clamping portion, the clamping portion of the first clamping member and the clamping portion of the second clamping member having a minimum distance between them in the axial direction of the body, and / or the clamping portion of the first clamping member and the clamping portion of the second clamping member being parallel to each other.

[0016] In conjunction with the above possible implementations, in another possible implementation, the clamping portion has an annular structure when viewed axially or radially from the main body.

[0017] In conjunction with the above possible implementations, in another possible implementation, the annular structure is formed by winding a metal wire.

[0018] In conjunction with the above possible implementations, in another possible implementation, in a ring structure, the metal wires are wound in a tangled manner.

[0019] In conjunction with the above possible implementations, in another possible implementation, there are multiple groups of clamping members, and the clamping portions of at least two groups of clamping members are in different axial relative positions with respect to the main body.

[0020] In conjunction with the above possible implementation methods, in another possible implementation method, the clamping portion is located predominantly at one end of the main body because the shapes of the first and second clamping members are different.

[0021] In conjunction with the above possible implementations, in another possible implementation, the first clamping member and the second clamping member are partially or completely offset in the circumferential direction.

[0022] In conjunction with the above possible implementations, in another possible implementation, if the first and second clamping members are partially offset in the circumferential direction, their starting ends are offset along the circumferential direction and their ends overlap.

[0023] In connection with the above possible implementation manners, in another possible implementation manner, the clamping segment includes a clamping portion provided with anti-slip protrusions or anti-slip holes.

[0024] In connection with the above possible implementation manners, in another possible implementation manner, the outermost end is an annular structure provided with a developing material.

[0025] In connection with the above possible implementation manners, in another possible implementation manner, the main body includes a cylindrical body formed by spirally winding an elastic curved segment of a metal material and integrally formed with the first clamping member and the second clamping member.

[0026] In connection with the above possible implementation manners, in another possible implementation manner, the main body includes a shunt cylindrical body, or includes a sensor and a connecting member connected to the clamping member group.

Advantages of the Invention

[0027] The implant according to the present invention can adapt to the thicknesses of different tissues at the target site by the clamping member deforming in the radial direction, or can adapt to different spatial structures at the target site by deforming in the circumferential direction, thereby reducing damage to the tissues at the target site. <000009b>

Brief Description of the Drawings

[0028] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required to be used in the embodiments are briefly introduced below.

[0029] It should be understood that the following drawings show only some embodiments of the present invention and should not be regarded as limiting the scope.

[0030] Furthermore, it should be understood that the same or similar reference numerals are used in the drawings to indicate the same or similar elements.

[0031] Furthermore, it should be understood that drawings are only schematic representations, and the sizes and proportions of elements in them are not necessarily precise.

[0032] [Figure 1a] This is a schematic diagram of the three-dimensional structure of an implant according to one embodiment of the present invention. [Figure 1b] This is a side view of the implant in Figure 1a. [Figure 2] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 3] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 4] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 5] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 6] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 7] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 8] This is a schematic diagram showing an implant placed between the left atrium and the coronary sinus. [Figure 9] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 10] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 11] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 12] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 13] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 14] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 15] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 16] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 17] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 18] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 19] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 20] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 21] This is a schematic diagram of the winding method of the clamping member shown in Figure 20. [Figure 22] This is a schematic diagram of the structure of a method for winding a clamping member in one selectable embodiment. [Figure 23] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 24] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Figure 25] This is a schematic diagram of the structure of an implant according to another embodiment of the present invention. [Modes for carrying out the invention]

[0033] Hereinafter, embodiments of the present invention will be described illustratively with reference to the drawings. There may be multiple ways in which the present invention can be realized, and it should not be interpreted as being limited to the embodiments described herein. Rather, it should be understood that the embodiments described herein are merely for the purpose of providing a clearer and more complete understanding of the present invention.

[0034] It should be understood that the terms "including" and their variations used in this invention are open inclusions, meaning "including, but not limited to." The term "based on" means "based at least partially," and the term "plural" means "two or more."

[0035] The terms "first" or "second," etc., are used in this invention to describe various elements, but it should be understood that these elements are not limited by these terms, and these terms are merely used to distinguish one element from another.

[0036] The present invention provides an implant used for improving the physiological function of a target site and / or detecting physiological indicators of a target site. The implant comprises a main body and at least one group of clamping members. The main body is used to fix to a target site and has a predetermined length. The group of clamping members comprises a first clamping member and a second clamping member, which are distributed around the outer circumference of the main body at intervals along the longitudinal direction (i.e., "axial direction") of the main body, and the group of clamping members is configured such that the first and second clamping members can change their spacing in the axial direction of the main body and / or contract in the radial direction of the main body by elastic deformation. If the thickness of the target site is greater than the distance between the first and second clamping members, the first and second clamping members can change their spacing in the axial direction of the main body and / or contract in the radial direction of the main body, thereby adapting themselves to the morphology of the tissue at the target site and reducing tissue damage.

[0037] Referring to Figures 1a and 1b, Figure 1a is a schematic diagram of the three-dimensional structure of an implant according to one embodiment of the present invention, and Figure 1b is a side view of the implant in Figure 1a.

[0038] In this embodiment, the implant is a flow divider comprising a main body 100 and a plurality of clamping member groups 200. The main body 100 is a cylindrical body of the flow divider, which is made of braided elastic wire, and a coating is laid on the inside and / or outside of the cylindrical body. Each clamping member group 200 includes a first clamping member 210 and a second clamping member 220, respectively. The first clamping member 210 and the second clamping member 220 in the same clamping member group are distributed in the axial direction of the main body 100, and there is a predetermined distance between them. The first clamping member 210 and the second clamping member 220 have a rod-like structure and are connected perpendicularly to the surface of the main body 100. In this embodiment, the first clamping member 210 and the second clamping member 220 are provided integrally with the elastic wire constituting the main body 100. In this embodiment, the first clamping members 210 in each group have the same axial position relative to the main body 100 and are uniformly distributed on the outer circumferential surface of the main body 100 with respect to the central axis. The second clamping members 220 in each group have the same axial position relative to the main body 100 and are uniformly distributed on the outer circumferential surface of the main body 100 with respect to the central axis. The multiple first clamping members 210 restrict one positional regulating structure in the axial direction of the main body 100, and the multiple second clamping members 220 restrict another positional regulating structure. When the main body 100 is inserted into the artificially created hole / foramen ovale in the atrial septum, the two positional regulating structures are distributed on both sides of the atrial septum and hold the main body 100 in the artificially created hole / foramen ovale by clamping the atrial septum. In Figure 1b, the dotted line a indicates the orientation of the atrial septum, which is parallel to the first clamping member 210 or the second clamping member 220, i.e., perpendicular to the main body 100.

[0039] The first clamping member 210 and the second clamping member 220 have a rod-like structure. Compared to a clamping structure with a disc-like structure, when the thickness of the atrial septum is greater than the distance between the first clamping member 210 and the second clamping member 220, the two can deform to move away from each other under pressure from the atrial septum, thereby adapting to the thickness of the tissue, and preventing the main body 100 from being pressed and deforming, which affects the size of the flow diversion path within the main body 100. In this way, the clamping member group 200 can reduce pressure on the tissue to some extent, thereby reducing tissue damage, while maintaining its inherent flow diversion capability.

[0040] Furthermore, the cylindrical body of the main body 100 is formed by spirally winding elastic curved segments made of metal. Specifically, the elastic curved segments are formed by extending them in an annular shape around the circumference from the starting position, then extending them spirally upwards for one or more turns, and then extending them in an annular shape around the circumference. The elastic curved segments are corrugated metal segments. Compared to structures that are woven or cut into a mesh, this cylindrical structure is not constrained by interference from other structures in the cylindrical body, increases the degree of freedom of the portion of the first clamping member 210 or the second clamping member 220 that is connected to the cylindrical body, and makes it easy to change the relative position of the first clamping member 210 or the second clamping member 220 with respect to the cylindrical body in response to external forces. Preferably, the first clamping member 210 and the second clamping member 220 are also wound with elastic curved segments. Specifically, the elastic curved segment extends radially outward from the surface of the cylindrical body, then folds back onto the surface of the cylindrical body to form the first clamping member 210 or the second clamping member 220. Compared to the case where the first clamping member 210 and the second clamping member 220 are fixed to the cylindrical body by processes such as welding or bonding, this method provides the first clamping member 210 and the second clamping member 220 with higher connection strength to the cylindrical body and ensures that the first clamping member 210 and the second clamping member 220 do not detach from the cylindrical body due to changes in position.

[0041] Of course, in other embodiments, the cylindrical body of the main body 100 may be constructed by weaving or cutting a mesh, and the first clamping member 210 and the second clamping member 220 may be fixed to the cylindrical body by processes such as welding or bonding, and the present invention is not limited thereto.

[0042] Referring to Figure 2, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention, the implant includes a main body 100 and a group of clamping members 200a. The group of clamping members 200a includes a first clamping member 210a and a second clamping member 220a. This embodiment differs from the previous embodiment in that the outer diameter of the implant can be reduced by the deformation of the first clamping member 210a and the second clamping member 220a along the radial direction of the main body 100, although other similarities with the previous embodiment will not be repeated here. Specifically, each of the first clamping member 210a and the second clamping member 220a protrudes from the outer circumferential surface of the main body 100 as a whole, and the two achieve radial contraction of the main body 100 by deforming by bending a part of their structure toward the main body 100 in the radial direction.

[0043] The first clamping member 210a includes a first connecting segment 211a, a first clamping segment 212a, a first clamping portion 213a, and a first curved portion 214a. One end of the first connecting segment 211a is connected to the main body 100, and the other end is connected to the first clamping segment 212a. Viewed radially, the two form an approximately inverted V-shape, and the connection point between the two is the first curved portion 214a. The end segment of the first clamping segment 212a extends outward approximately along the radial direction of the main body 100, forming the first clamping portion 213a. That is, in the process of extending outward along the radial direction, the first clamping member 210a exhibits a "low-high-low" configuration with respect to a horizontal reference. The horizontal reference may be the lower end surface of the main body 100. The second clamping member 220a includes a second connecting segment 221a, a second clamping segment 222a, a second clamping portion 223a, and a second curved portion 224a. Each part of the second clamping member 220a is symmetrical with respect to the first clamping member 210a in terms of plane, and the plane of symmetry is a cross-section passing through the axial center of the main body 100.

[0044] The dotted lines in Figure 2 represent the configuration after the first clamping member 210 and the second clamping member 220 have been deformed by a radial force. Because of the presence of the first curved portion 214a and the second curved portion 224a, the first clamping segment 212a can approach the first connecting segment 211a, and the first connecting segment 211a can approach the main body 100. The second clamping segment 222a can approach the second connecting segment 221a, and the second connecting segment 221a can approach the main body 100. This corresponds to the first clamping member 210a and the second clamping member 220a being compressed along the radial direction, and the maximum diameter D' of the circumscribed circle where the outermost parts of the first clamping member 210a and the second clamping member 220a are located after compression is smaller than the maximum diameter D of the circumscribed circle before compression. In this way, when there is a lot of tissue around the main body 100, the surrounding tissue can press down on the first clamping member 210a and the second clamping member 220a so that they contract radially, thereby reducing damage to the tissue.

[0045] Referring to Figure 3, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention, the implant includes a main body 100 and a group of clamping members 200b. The group of clamping members 200b includes a first clamping member 210b and a second clamping member 220b. This embodiment differs from the previous embodiment in that, although other similarities with the previous embodiment will not be repeated here, the first clamping member 210b and the second clamping member 220b can deform along the radial direction of the main body 100 to reduce the outer diameter of the implant, and can also move away from each other in the axial direction to further avoid tissue damage. Specifically, the first clamping member 210b includes a first connecting segment 211b, a first clamping segment 212b, a first clamping portion 213b, and a first curved portion 214b. One end of the first connecting segment 211b is connected to the main body 100, and the other end is connected to the first clamping segment 212b. Viewed radially, the two members exhibit an approximately S-shape, and the connection point between them is the first curved portion 214b. The end segment of the first clamping segment 212b extends outward along approximately the radial direction of the main body 100, becoming the first clamping portion 213b. In this way, during the process of extending outward along the radial direction, the first clamping member 210b exhibits a "low-high-low" configuration with respect to the horizontal reference (a horizontal plane perpendicular to the axis between the first clamping member 210 and the second clamping member 220), and a "near-far-near" configuration with respect to the vertical reference (the axis of the main body 100). This state corresponds to the first clamping segment 212b not extending further outward, but rather being bent toward the main body 100. The horizontal reference may be the lower end surface of the main body 100. The vertical reference may be the centerline of the main body 100. Each portion of the second clamping member 220b is symmetrical with respect to the first clamping member 210b in plane, and the plane of symmetry is the cross-section at the midpoint of the main body 100. In this embodiment, since the first curved portion 214b is a curved segment with a large arc, the first clamping segment 212b can have a large gap between itself and the first connecting segment 211b, and can also have a larger range of angular change. In this way, the first clamping segment 212b can approach the main body 100 along the radial direction and can also move in the axial direction (shown by the dotted line structure in Figure 3).If there is a lot of tissue around the target site of the implant, the surrounding tissue can encourage the first clamping member 210b and the second clamping member 220b to contract radially from both sides, thereby avoiding tissue damage. Similarly, if the tissue at the target site is thick, the surrounding tissue can encourage the upper and lower clamping members to move away from each other axially, thus also avoiding tissue damage.

[0046] The first clamping portion 213b is the free end portion of the first clamping member 210b, has a fixed length, and is parallel to the end face of the main body 100. The first clamping portion 213b of the first clamping member 210b is parallel to the second clamping portion 223b of the second clamping member 220b. The first clamping portion 213b and the second clamping portion 223b are the parts where the axial distance between the first clamping member 210b and the second clamping member 220b on the main body 100 is minimized, and therefore they are the main parts that form the clamp. In this way, even if the first clamping segments 212b are separated from each other in the axial direction, the first clamping portion 213b and the second clamping portion 223b can still form surface / line contact with the tissue, and this configuration allows for the formation of a larger clamping area and a more robust clamp.

[0047] In other embodiments, the first clamping portion 213a located at the end segment of the first clamping segment 212a, and the second clamping portion 223a located at the end of the second clamping segment 222a, may not extend outward along the radial direction of the main body 100, but may extend toward the tissue to be clamped. If the first clamping member 210 and the second clamping member 220 are wound around elastic curved segments (for example, a U-shaped structure wound around metal wire), the relative positions of the first clamping portion 213a and the second clamping portion 223a can be flexibly adjusted according to the thickness of the tissue, and their ends are smooth and do not damage the tissue. In other embodiments, the first clamping member 210 and the second clamping member 220 may not be wound around elastic curved segments, but may be a flake structure, and their ends can be smoothed to prevent damage to the tissue.

[0048] Referring to Figure 4, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention. The implant in this embodiment has substantially the same structure as the implant in Figure 3, but differs in that the free ends of the first clamping member 210c and the second clamping member 220c have a wound structure, so the outermost 215c of the first clamping member 210c and the outermost 225c of the second clamping member 220c have a smooth structure, i.e., a smooth contour. The end 219c of the first clamping member 210c and the end 229c of the second clamping member 220c do not puncture the surrounding tissue and are located in the center of the wound structure (i.e., between the outermost part of the clamping member and the main body 100). In such a case, the clamping member may be a flat metal sheet with an unsmoothed end, or, as in the above embodiment, it may be a structure in which a single metal wire is wound, and has substantially a U-shape structure in plan view or bottom view.

[0049] Referring to Figures 5 and 6, two types of implants having different clamping members are shown. Figure 5 is a schematic diagram of the structure of an implant according to another embodiment of the present invention. The implant includes a main body 100 and a group of clamping members 200d, the group of clamping members 200d including a first clamping member 210d and a second clamping member 220d. The first clamping member 210d includes a first connecting segment 211d and a first clamping segment 212d. Parts that are the same as in the above embodiment will not be repeated here. The difference is that the first clamping segment 212d as a whole has a wound structure. In the first clamping member 210d, the first clamping segment 212d is wound outward in the axial direction, i.e., upward in the figure. Also, because the free end has a wound structure, the outermost part 215d of the first clamping member 210d has a smooth structure, i.e., a smooth contour. The end portion 219d of the first clamping member 210d does not puncture the surrounding tissue and is located at the center of the winding structure (i.e., between the outermost part of the clamping member and the main body 100). The second clamping member 220d is symmetrical to the first clamping member 210d in terms of plane, and the plane of symmetry is a cross-section passing through the central part of the axial direction of the main body 100.

[0050] If the clamping member has at least one curved portion in both the axial and radial directions, it can provide a certain degree of elasticity in these two directions, making it suitable for adjusting the overall radial dimensions of the implant and the distance between the two upper and lower clamping members according to the implantation environment. The first clamping segment 212d in the first clamping member 210d is a wound structure as a whole, which corresponds to a curved portion in any direction. The more turns there are, the smaller the degree to which the wound portion can be deformed radially, so by adjusting the number of turns, it is possible to achieve ideal radial dimensional adjustment capability and an ideal shape after deformation.

[0051] In some selectable embodiments, the number of turns of the clamping segment of the implant clamping member may be greater, for example, one or several more turns than the first clamping segment 212d in Figure 5.

[0052] Figure 6 is a schematic diagram of the structure of an implant according to another embodiment of the present invention. Compared to the implant in Figure 5, the winding direction of its clamping segments is reversed; that is, the clamping segments of the first clamping member 210e and the second clamping member 220e are both wound inward, i.e., wound toward each other.

[0053] Referring to Figures 7 and 8, Figure 7 is a schematic diagram of the structure of an implant according to another embodiment of the present invention, and Figure 8 is a schematic diagram of the implant when it is implanted between the left atrium and the coronary sinus. The implant includes a main body 100 and a first clamping member group 200f and a second clamping member group 200f'. The first clamping member group 200f and the second clamping member group 200f' have different axial relative positions with respect to the main body 100. That is, the shapes of two clamping members in the same clamping member group are different, and the shapes of clamping members in different clamping member groups are also different. The first and second clamping parts in clamping member group 200f are located eccentrically at one end of the main body 100, and the first and second clamping parts in clamping member group 200f' are located eccentrically at the other end of the main body 100. The orientation of the clamping space limited by the multiple clamping member groups (dotted lines shown in the figures) is non-orthogonal to the main body 100. In this way, when attaching the implant to the target site, a certain deflection angle can be achieved. For example, the implant may be embedded between the left atrium and the coronary sinus, where the space closer to the coronary sinus is small. This deflection attachment method allows one end of the main body 100 to be positioned diagonally in the coronary sinus, reducing the occupied space.

[0054] Referring to Figure 9, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention, the implant includes a main body 100, a first clamping member group 200g, and a second clamping member group 200g'. Because the shapes of the first and second clamping members within the same clamping member group are different, the first and second clamping portions are concentrated at one end of the main body. The structures of the first clamping member group 200g and the second clamping member group 200g' are the same, and they are uniformly distributed in the circumferential direction of the main body 100. This method is also suitable for implantation between the left atrium and the coronary sinus, as shown in Figure 9.

[0055] Referring to Figure 10, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention, the implant includes a main body 100, a first clamping member group 200h, and a second clamping member group 200h'. In this embodiment, the spacing between the two clamping members in the first clamping member group 200h and the second clamping member group 200h' is large, making it suitable for implantation in thick tissues, such as in the two layers of blood vessels (arterial and venous vessel walls) in arteriovenous fistula surgery.

[0056] Referring to Figures 11 to 14, implants having different numbers of clamping member groups are shown. The implant shown in Figure 11 has two clamping member groups, which are distributed at 180-degree intervals in the circumferential direction of the main body 100. The implant shown in Figure 12 has three clamping member groups, which are distributed at 120-degree intervals in the circumferential direction of the main body 100. The implants shown in Figures 13 and 14 have four clamping member groups, which are distributed at 90-degree intervals in the circumferential direction of the main body 100. Figures 11 to 14 are all plan views, i.e., structural diagrams viewed from the axial direction of the main body 100. In the above embodiments, since the two clamping members of each clamping member group are in the same position in the circumferential direction of the main body 100, two clamping members in the same clamping member group overlap in the plan view.

[0057] In the embodiments shown in Figures 11 to 14, the clamping member may be a U-shaped structure formed by bending an elastic wire, with its end being arc-shaped. The clamping member may also be a U-shaped structure formed by cutting a metal sheet. Furthermore, when viewed from the radial direction of the main body 100, the clamping member may have the structure shown in Figures 2 to 7.

[0058] The implant shown in Figure 14 has a structure that is almost the same as the implant shown in Figure 13, but differs in that the clamping member is further provided with an anti-slip structure. For example, the end (clamping portion) of the first clamping member 210 is provided with a plurality of anti-slip protrusions 201 and anti-slip holes 202. Both of these increase the static frictional force between the clamping member and the tissue, allowing the implant to be fixed more firmly to the target site. In some selectable embodiments, only the anti-slip protrusions 201 or only the anti-slip holes 202 may be provided.

[0059] Referring to Figure 15, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention, the implant includes a main body 100 and four clamping member groups. The clamping members in the clamping member groups are similar in structure to the clamping members in Figure 14, but differ in the structure of the ends of the clamping members in this embodiment. Taking the first clamping member 210 as an example, its main body is made of a bent elastic wire, and it is provided with a ring 216 at its end, around which developing material 217 is further wrapped. The ring 216 prevents the end of the clamping member from puncturing tissue. The developing material can provide the physician with image reference information during the implantation process.

[0060] Refer to Figures 16 and 17, which show plan views when the circumferential positions of clamping members within the same group of clamping members are different. The implant shown in Figure 16 includes three groups of clamping members, where the first clamping member 210 and the second clamping member 220 within the same group are completely offset in the circumferential direction, that is, when viewed from the axial direction, the two do not overlap at all. In this embodiment, the first clamping member 210 and the second clamping member 220 are arranged radially along the radial direction of the main body 100. The circumferential spacing angle between the first clamping member 210 and the second clamping member 220 is 60 degrees. In the implant shown in Figure 17, the first clamping member 210 and the second clamping member 220 within the same group are partially offset in the circumferential direction, that is, when viewed from the axial direction, the two have some structural overlap. Preferably, the starting ends of the two are offset in the circumferential direction, and the ends have some structural overlap. By partially or completely offsetting the first clamping member 210 and the second clamping member 220 in the circumferential direction, the projected area can be increased, the fixation effect can be improved, and damage to tissue can be reduced.

[0061] Figures 18 to 23 show several implants having a clamping member that can be deflected in the circumferential direction.

[0062] Referring to Figure 18, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention, the viewing direction is axial. In this embodiment, the implant includes a main body 100 and a group of six clamping members uniformly distributed on the circumferential surface of the main body 100. Taking the first clamping member 210i as an example, it may be a structure in which an elastic wire is bent. The first clamping member 210i extends outward along the radial direction, and its rear portion is curved in the circumferential direction, thereby forming a deflection in the circumferential direction of the main body 100. In this way, when the implant is attached to a target site, if there is a lot of tissue around the target site, the surrounding tissue can press the first clamping member 210i closer to the surface of the main body 100 (as shown by the dotted line in the figure), and the clamping member shrinks toward the center, reducing its diameter. In this way, damage to the surrounding tissue can be reduced. Viewed from the radial direction of the main body 100, the first clamping member 210i may be a curved or wound structure as shown in Figures 2 to 7. In this way, the clamping member can simultaneously achieve radial contraction in two forms: deflection in the circumferential direction and bending toward the main body in the radial direction. In some selectable embodiments, when viewed from the axial direction of the main body 100, the end of the first clamping member 210i may have a coiled structure, thereby forming a smooth structure on its outermost surface and preventing tissue puncture.

[0063] Referring to Figure 19, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention. Compared to the implant structure shown in Figure 20, in this embodiment, each clamping member as a whole is deflected at a certain angle in the circumferential direction relative to the main body 100. Specifically, viewed from the axial direction of the main body 100, the first clamping member 210j is a teardrop-shaped structure made of a curved metal wire, or a curved elongated piece-shaped structure made of a cut metal sheet. The front half of the first clamping member 210j (the part connected to the main body 100) is a connecting segment, and the rear half (the part on the free end side) is a clamping segment. The circumferential width of the connecting segment of the first clamping member 210j is smaller than the circumferential width of the clamping segment and / or the curved part. That is, viewed from the axial direction, the width of the connecting segment is smaller than the width of the clamping segment. Specifically, in an axial view, the first clamping member 210j has a shape in which its width gradually changes, with a smaller width at the base (i.e., the starting end of the connecting segment, the end that starts from the surface of the main body 100, and the end that connects to the main body 100), and a gradually increasing width as it extends toward the end, with the end being the widest. Preferably, in its original state, the first clamping member 210j has a constant clamping angle with respect to the diameter of the main body passing through its base, and this clamping angle is less than 90°. In this way, when the first clamping member 210j is embedded in the target site, if there is a lot of surrounding tissue, it becomes easier to encourage the first clamping member 210j to rotate around its base and approach the surface of the main body 100. In this way, the first clamping member 210j shrinks toward the center, and its diameter decreases. Furthermore, because the base of the first clamping member 210j is narrower and has less strength than the end, adaptive deflection can occur more easily.

[0064] Referring to Figures 20 and 21, Figure 20 is a schematic diagram of the structure of an implant according to another embodiment of the present invention, and Figure 21 is a schematic diagram of the structure of the winding method of the clamping member in Figure 20. In this embodiment, when viewed from the axial direction of the main body 100, the first clamping member 210k is a teardrop-shaped structure made of a curved metal wire, or a curved elongated structure made of a cut metal sheet. The width of the base of the first clamping member 210k (the end that starts from the surface of the main body 100 and is connected to the main body 100) is small, and the width of the end is large. Since the first clamping member 210k is curved along the circumferential direction, when pressed by the surrounding tissue it receives a larger circumferential force component and becomes more easily adaptively compressed. In this embodiment, the end of the first clamping member 210k is an annular structure, and this annular structure can enhance the clamping performance of the first clamping member 210k against the tissue, and developing material may be wound around the annular structure. Preferably, the annular structure and the other parts of the first clamping member 210k are integrally molded and wound together with the same metal wire. During the winding process, the metal wire is stretched in one direction along the axial direction of the annular structure, that is, adjacent portions of the metal wire in the annular structure do not intertwine with each other. The winding method of the clamping member in Figure 21 is only schematic, and its specific details are not limited to those schematically shown in the drawing.

[0065] Figure 22 is a schematic diagram of the structure of the clamping member winding method in a selectable embodiment. Compared to the clamping member winding method shown in Figure 21, the metal wire may become entangled during the winding process; that is, the metal wire reciprocates and stretches in the axial direction of the annular structure during the winding process, and entanglement exists between adjacent portions of the metal wire within the annular structure. Such a method is advantageous for winding the developing material and can enhance the contrast effect.

[0066] Referring to Figure 23, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention, in this embodiment, when viewed from the axial direction of the main body 100, the shape of the first clamping member 210l is U-shaped overall and consists of two rod-shaped segments and one ring whose diameter is greater than the distance between the two rod-shaped segments, with the ring located at the free end of the first clamping member 210l. The first clamping member 210l extends radially along the radial direction of the main body 100 and has a constant angle with respect to the diameter passing through the base of the first clamping member 210l. The end of the first clamping member 210l is an annular structure and may have developing material wrapped around it.

[0067] Referring to Figure 24, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention. The implant in this embodiment is substantially the same as the implant structure shown in Figure 19, but differs in that the first clamping members 210m are not deflected or deformed in the circumferential direction of the main body 100, but are arranged in a standard central radial pattern. The base of the first clamping members 210m is narrow and relatively weak in strength, so if it is pressed by surrounding tissue during the implantation process, the main body 100 can be artificially rotated to deflect the first clamping members 210m relative to the main body 100.

[0068] Figures 18 to 24 all show the first clamping member schematically, but it can be understood that the second clamping member may have the same shape as the first clamping member 210j when viewed from the axial direction, or it may have a different shape from the second clamping member 210j, for example, a shape that deflects in the opposite direction. After the first and second clamping members are deflected, the overall radial dimension of the implant is reduced, thereby avoiding tissue damage.

[0069] The implants shown in Figures 18 to 24 have a clamping member that can be deflected in the circumferential direction. The clamping member as a whole is deflected in the circumferential direction, and the distance between the outermost / outermost end of the clamping member and the center line of the main body 100 is also reduced. This corresponds to achieving radial contraction by deflecting in the circumferential direction. In some selectable embodiments, the rear half of the clamping member may be bent in the circumferential direction relative to the front half, thereby forming local circumferential deflection and achieving radial contraction. As shown in Figure 18, the first clamping member 210i has a broken line shape in an axial view, and the rear half of the broken line is bendable relative to the front half, thereby forming local circumferential deflection.

[0070] Referring to Figure 25, which is a schematic diagram of the structure of an implant according to another embodiment of the present invention. In this embodiment, the implant is a detection device, and the main body 100 includes a sensor 300 and a connecting member. The connecting member is, for example, a heat shrink tube, the sensor 300 is fixed within the connecting member, and one end of a clamping member is provided between the connecting member and the sensor and is coaxially connected by a heat shrink process. The sensor is held at the target site via the connecting member and the clamping member.

[0071] Figures 1b to 11 mainly illustrate the morphological design of the implant from a radial perspective, and Figures 12 to 24 mainly illustrate the morphological design of the implant from an axial perspective. However, since any design configuration from a radial perspective and any design configuration from an axial perspective can be combined, one or more of the above embodiments can be combined to form a new embodiment. In the drawings, the main body 100 is shown as cylindrical as an example, but those skilled in the art will understand that the main body 100 may be other cylindrical structures, such as a frustoconical shape, and the present invention is not limited thereto.

[0072] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes, substitutions, or combinations that a person skilled in the art could easily conceive of within the scope disclosed herein should be included within the scope of protection of the present invention. Accordingly, the scope of protection of the present invention should be in accordance with the appended claims.

Claims

1. It includes a main body and at least one group of clamping members, The main body is used to fix to the target area and has a predetermined length. The clamping member group includes a first clamping member and a second clamping member, and the first clamping member and the second clamping member are distributed around the outer circumference of the main body at intervals along the axial direction of the main body. The first clamping member and the second clamping member are configured to be elastically deformable. An implant characterized by the following features.

2. The implant is used to improve the physiological function of a target site and / or to detect physiological indicators of the target site, and the first clamping member and the second clamping member are configured to be able to contract in the radial direction of the main body and / or move away from each other in the axial direction of the main body by elastic deformation. The implant according to feature 1.

3. The first clamping member includes a connecting segment and a clamping segment, and / or the second clamping member includes a connecting segment and a clamping segment, wherein one end of the connecting segment is connected to the main body and the other end is connected to the clamping segment, and each of the first clamping member and the second clamping member as a whole protrudes from the outer circumferential surface of the main body. The implant according to feature 1 or 2.

4. The connecting segments are configured such that they can be deformed to move away from each other in the axial direction of the main body. The implant according to feature 3.

5. The clamping segment is configured to be able to contract in the radial direction of the main body by deformation. The implant according to feature 3 or 4.

6. The connecting segment is configured to be contractible in the radial direction of the main body by deformation. The implant according to any one of claims 3 to 5.

7. The clamping segments are configured to deform so that they can move away from each other in the axial direction of the main body. The implant according to any one of claims 3 to 6.

8. The clamping segment deforms in the form of deflection in the circumferential direction and contracts in the radial direction of the main body. The implant according to feature 5.

9. The clamping segment deforms by bending toward the main body in the radial direction, and contracts radially toward the main body. The implant according to feature 5.

10. The connecting segment deforms in the form of deflection in the circumferential direction and contracts in the radial direction of the main body. The implant according to feature 6.

11. The connecting segment deforms by bending toward the main body in the radial direction, and contracts radially toward the main body. The implant according to feature 6.

12. Between the clamping segment and the connecting segment, there is a curved portion whose angle can be changed so that the clamping segment can be compressed along the radial direction of the main body. The implant according to any one of claims 3 to 10.

13. The clamping segment is configured such that at least a portion of its structure can change the angle between it and the connecting segment in the form of deflection in the circumferential direction and / or bending toward the main body, so that the clamping segment can be compressed along the radial direction of the main body. The implant according to any one of claims 3 to 10.

14. The outermost end of the clamping segment has a smooth structure. The implant according to any one of claims 1 to 13.

15. The clamping segment is formed by bending or winding an elastic wire or elastic sheet, and the end of the elastic wire or elastic sheet is located between the outermost end and the main body. The implant according to feature 14.

16. The clamping segment is made by cutting an elastic sheet, and the end of the elastic sheet is arc-shaped. The implant according to feature 14.

17. If the clamping segment is formed by winding an elastic wire or elastic sheet, the end of the elastic wire or elastic sheet is located inside the winding structure. The implant according to claim 15 or 16, characterized by the features described above.

18. The elastic wire or elastic sheet is wound either entirely or at its ends such that the outermost end of the clamping segment has a smooth structure. The implant according to feature 17.

19. The first clamping member and the second clamping member are further curved in the circumferential direction so as to be deflectable in the circumferential direction relative to the main body by the action of an external force, and the first clamping member and the second clamping member have a clamping angle with the main body, the clamping angle being less than 90°. The implant according to any one of claims 1 to 18.

20. The first clamping member and the second clamping member are such that they can be deflected in the circumferential direction relative to the main body by the action of an external force, the circumferential width of the connecting segment is smaller than the width of the clamping segment and / or the curved portion. The implant according to any one of claims 1 to 19.

21. The outermost end is a ring-shaped structure on which developing material is provided. The implant according to any one of claims 14 to 20.

22. The clamping segment includes a clamping portion, and the clamping portion of the first clamping member and the clamping portion of the second clamping member have a minimum distance between them in the axial direction of the main body. The implant according to any one of claims 3 to 13.

23. The clamping portion of the first clamping member and the clamping portion of the second clamping member are parallel to each other. The implant according to any one of claims 3 to 13.

24. In an axial or radial view of the main body, the clamping portion has an annular structure. The implant according to feature 22 or 23.

25. The aforementioned annular structure is formed by winding a metal wire, The implant according to feature 24.

26. In the aforementioned annular structure, the metal wire is wound in an entangled manner. The implant according to feature 25.

27. The number of the clamping member groups is multiple, and the clamping portions of at least two of the clamping member groups are in different axial relative positions with respect to the main body. The implant according to feature 22 or 23.

28. The first clamping member and the second clamping member have different shapes such that the clamping portion is unevenly distributed at one end of the main body. The implant according to feature 22 or 23.

29. The first clamping member and the second clamping member are partially or completely offset in the circumferential direction. The implant according to any one of claims 1 to 13.

30. The first clamping member and the second clamping member are partially offset in the circumferential direction, with their starting ends offset along the circumferential direction and their ends overlapping. The implant according to feature 29.

31. The clamping segment includes a clamping portion provided with anti-slip protrusions or anti-slip holes. The implant according to any one of claims 3 to 13.

32. The main body includes a cylindrical body, the cylindrical body is formed by spirally winding elastic curved segments of a metal material, and is integrally molded with the first clamping member and the second clamping member. The implant according to any one of claims 1 to 31.

33. The main body includes the cylindrical body of the flow divider, The implant according to any one of claims 1 to 31.

34. The main body includes a sensor and a connecting member connected to the clamping member group. The implant according to any one of claims 1 to 31.

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