Implant

By designing a flexible deformable clamping set, the problem of insufficient adaptability of existing implant clamping pieces is solved, and adapting to different tissue thicknesses and shapes is achieved, reducing tissue damage and maintaining the smoothness of the shunt channel.

CN119488396APending Publication Date: 2025-02-21UNITED INNOMED (SHANGHAI) LTD
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Patent Information

Application Number
CN202311053444.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-08-18
Publication Date
2025-02-21

AI Technical Summary

Technical Problem

The clamping parts design of existing intracardiac or vascular implants is insufficient for adaptability, making it difficult to adjust adaptability according to the thickness or shape of the tissue, resulting in insufficient clamping fastness or tissue damage, and narrowing of the pore size of the shunt channel affects the shunt performance. .

Method used

An implant is designed including a body and at least one set of clamps. The clamping member set consists of a first clamping member and a second clamping member, both being spaced apart in the length direction of the body and being elastically deformable to be away from each other in the length direction of the body or shrink radially in the radial direction of the body to adapt to Different tissue thicknesses and shapes of the target site.

Benefits of technology

Through the elastic deformation of the clamp set, the implant can better adapt to the tissue morphology of the target site, reduce damage to the tissue, maintain the smoothness of the shunt channel, and improve the stability and functional performance of the implant.

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Abstract

An implant is provided for improving the physiological function of a target site and / or detecting a physiological metric of the target site. The implant includes a body and at least one set of clips. The main body is fixed to a target part and has a preset length; the clamping piece set comprises a first clamping piece and a second clamping piece, and the first clamping piece and the second clamping piece are distributed on the periphery of the main body at intervals in the length direction of the main body. Wherein the first clamping piece and the second clamping piece are configured to be capable of elastically deforming so as to be far away from each other in the length direction of the main body, and / or shrink in the radial direction of the main body.
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Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and in particular, to an implant. Background Art

[0002] Intracardiac or vascular implants can be used to improve the physiological function of the target site, or to monitor the physiological parameters of the target site, or to have both of the above functions. The implant needs to remain in the target site to work properly. For example, heart failure is a clinical syndrome caused by abnormal ventricular filling and ejection function. In order to prevent the left atrial pressure from increasing, a monitoring device can be implanted on the atrial septum to continuously monitor the left atrial pressure. When there is a continuous increase in pressure, a shunt device can also be implanted to shunt part of the blood in the left atrium to the right atrium, thereby reducing the left atrial pressure. A device with both monitoring and shunt functions can also be directly implanted to monitor and shunt at the same time.

[0003] In the prior art, a clamping component is used to clamp the tissue at the target site, so that the shunt or sensor is fixed on the tissue in the body, such as on the atrial septum. However, there are many shortcomings in the design of the existing clamping components. For example, the clamping components of the shunt with a mesh disc structure are disc-shaped and parallel to each other. The part where the disc is engaged with the tissue is difficult or impossible to achieve adaptive adjustment according to the thickness or shape of the tissue. This may cause problems such as insufficient clamping strength or damage to the tissue due to excessive clamping. At the same time, when the thickness of the clamped tissue is large or there are other tissues around it, the disc-type clamping component will produce a certain deformation and squeeze the shunt structure between the two clamping components, causing the aperture of the shunt channel to narrow, affecting the shunt performance. Summary of the invention

[0004] In view of this, the present disclosure provides an implant that can be applied to more target locations.

[0005] In a first aspect, an implant is provided for improving the physiological function of a target site and / or detecting the physiological index of a target site. The implant includes a main body and at least one clamping member group. The main body is used to be fixed to the target site, and the main body 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 at intervals on the periphery of the main body along the length direction of the main body; wherein the first clamping member and the second clamping member are configured to be elastically deformable to move away from each other in the length direction of the main body, and / or to contract in the radial direction of the main body.

[0006] In one possible implementation, the first clamping member and the second clamping member include a connecting section and a clamping section, one end of the connecting section is connected to the main body and the other end is connected to the clamping section, the first clamping member and the second clamping member each protrude as a whole from the outer circumferential surface of the main body, and the clamping section and / or the connecting section are configured to be deformable to move away from each other in the length direction of the main body, and / or to shrink in the radial direction of the main body.

[0007] In combination with the above possible implementations, in another possible implementation, the clamping segment and / or the connecting segment is deformed in the form of circumferential deflection and / or radial bending toward the main body to shrink in the radial direction of the main body.

[0008] In combination with the above possible implementation manner, in another possible implementation manner, a bending portion with a variable angle is included between the clamping segment and the connecting segment, so that the clamping segment can be compressed along the radial direction of the main body.

[0009] In combination with the above possible implementations, in another possible implementation, the clamping segment is configured such that at least a portion of the structure can change the angle with the connecting segment in the form of circumferential deflection and / or bending toward the main body, so that the clamping segment can be compressed radially along the main body.

[0010] In combination with the above possible implementation manner, in another possible implementation manner, the outermost end of the clamping section is a smooth structure.

[0011] In combination with the above possible implementations, in another possible implementation, the clamping section is formed by bending or winding an elastic wire or an elastic sheet, and the end of the elastic wire or the elastic sheet is located between the outermost end and the main body; or, the clamping section is formed by cutting an elastic sheet, and the end of the elastic sheet is arc-shaped.

[0012] In combination with the above possible implementation manner, in another possible implementation manner, when the clamping section is formed by winding an elastic wire or an elastic sheet, the end of the elastic wire or the elastic sheet is located inside the winding structure.

[0013] In combination with the above possible implementation manner, in another possible implementation manner, the elastic wire or elastic sheet is wound as a whole or at the end so that the outermost end of the clamping section has a smooth structure.

[0014] In combination with the above possible implementations, in another possible implementation, the first clamping member and the second clamping member are also bent circumferentially so as to be able to deflect circumferentially relative to the main body under the action of external force, and / or the circumferential width of the connecting section of the first clamping member and the second clamping member is smaller than the width of the clamping section so that the first clamping member and the second clamping member can deflect circumferentially relative to the main body under the action of external force.

[0015] In combination with the above possible implementations, in another possible implementation, the clamping section 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 spacing between the first clamping member and the second clamping member in the length direction of the main body, and / or the clamping portion of the first clamping member and the clamping portion of the second clamping member are parallel to each other.

[0016] In combination with the above possible implementations, in another possible implementation, the clamping portion is an annular structure when viewed in the axial direction or radial direction of the main body.

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

[0018] In combination with the above possible implementation manner, in another possible implementation manner, the metal wires in the annular structure are wound in an interwoven manner.

[0019] In combination with the above possible implementation manner, in another possible implementation manner, there are multiple clamping member groups, and the axial relative positions of the clamping parts and the main body of at least two clamping member groups are different.

[0020] In combination with the above possible implementation manner, in another possible implementation manner, the first clamping member and the second clamping member have different shapes so that the clamping portion is biased at one end of the main body.

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

[0022] In combination with the above possible implementation manner, in another possible implementation manner, when the first clamping member and the second clamping member are partially staggered in the circumferential direction, their starting ends are staggered in the circumferential direction and their end ends overlap.

[0023] In combination with the above possible implementation manner, in another possible implementation manner, the clamping section includes a clamping portion, and the clamping portion is provided with an anti-slip protrusion or an anti-slip hole.

[0024] In combination with the above possible implementation manner, in another possible implementation manner, the outermost end is a circular ring structure, and the circular ring structure is provided with a developing material.

[0025] In combination with the above possible implementations, in another possible implementation, the main body includes a cylinder, the cylinder is formed by spirally winding an elastic curved segment of a metal material, and the first clamping member and the second clamping member are integrally formed with the cylinder.

[0026] In combination with the above possible implementations, in another possible implementation, the main body includes a cylinder of a diverter; or includes a sensor and a connecting piece, and the connecting piece is connected to the clamping piece group.

[0027] In the implant provided by the present disclosure, the clamping member can deform radially to adapt to different tissue thicknesses at the target site or deform circumferentially to adapt to different spatial structures at the target site, thereby reducing damage to the tissue at the target site. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings required for use in the embodiments are briefly introduced below.

[0029] It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and should not be viewed as limiting the scope.

[0030] It should also be understood that the same or similar reference numerals are used in the drawings to represent the same or similar elements.

[0031] It should also be understood that the drawings are merely schematic and that the sizes and proportions of elements in the drawings are not necessarily accurate.

[0032] Figure 1a It is a schematic diagram of the three-dimensional structure of an implant according to an embodiment of the present disclosure.

[0033] Figure 1b yes Figure 1a Side view of the implant.

[0034] Figure 2 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0035] Figure 3 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0036] Figure 4 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0037] Figure 5 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0038] Figure 6 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0039] Figure 7 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0040] Figure 8 is a schematic diagram of the implant when placed between the left atrium and the coronary sinus.

[0041] Fig. 9 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0042] Fig.10is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0043] Fig.11 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0044] Fig.12 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0045] Fig.13 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0046] Fig.14 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0047] Fig.15 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0048] Fig.16 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0049] Fig.17 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0050] Fig.18 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0051] Fig.19 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0052] Fig. 20 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0053] Fig.21 yes Fig. 20 Schematic diagram of the winding structure of the middle clamp.

[0054] Fig. 22 The figure is a schematic diagram of the winding structure of the clamping member in an optional implementation manner.

[0055] Fig.23 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0056] Fig.24 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.

[0057] Fig.25 is a schematic structural diagram of an implant according to another embodiment of the present disclosure. DETAILED DESCRIPTION

[0058] The following is an exemplary description of the embodiments of the present disclosure in conjunction with the accompanying drawings. It should be understood that the present disclosure can be implemented in a variety of ways and should not be construed as being limited to the embodiments described here. The embodiments described here are only for a more thorough and complete understanding of the present disclosure.

[0059] It should be understood that the term "including" and its variations used in the present disclosure are open inclusions, that is, "including but not limited to." The term "based on" means "at least in part based on", and the term "plurality" means "two or more".

[0060] It should be understood that although the terms “first” or “second” etc. are used in the present disclosure to describe various elements, these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

[0061] The present disclosure provides an implant for improving the physiological function of a target site and / or detecting the physiological index of a target site. The implant includes a main body and at least one clamping member group. The main body is used to be fixed to the target site, and the main body 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 on the periphery of the main body at intervals along the length direction of the main body; wherein the clamping member group is configured so that the first clamping member and the second clamping member can be elastically deformed to change the spacing in the length direction of the main body, and / or, contract in the radial direction of the main body. When the thickness of the target site is greater than the spacing between the first clamping member and the second clamping member, the first clamping member and the second clamping member can change the spacing in the length direction of the main body and / or contract in the radial direction of the main body to adapt to the morphology of the target site tissue, which can reduce damage to the tissue.

[0062] refer to Figure 1a and Figure 1b , Figure 1a is a schematic diagram of a three-dimensional structure of an implant according to an embodiment of the present disclosure, Figure 1b yes Figure 1a Side view of the implant.

[0063] In the present embodiment, the implant is a shunt device, comprising a main body 100 and a plurality of clamping member groups 200. The main body 100 is a barrel of the shunt device, and the barrel is formed by braiding elastic wire, and a coating is applied inside and / or outside the barrel. Each clamping member group 200 comprises 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 length direction of the main body 100, with a predetermined distance between the two. The first clamping member 210 and the second clamping member 220 are rod-shaped structures, which are vertically connected to the surface of the main body 100. In the present embodiment, the first clamping member 210 and the second clamping member 220 are arranged integrally with the elastic wire constituting the main body 100. In the present embodiment, the first clamping member 210 in each group has the same axial position relative to the main body 100, and is evenly distributed on the outer peripheral surface of the main body 100 around the central axis. The second clamping members 220 in each group have the same axial position relative to the main body 100 and are evenly distributed around the central axis on the outer circumference of the main body 100. The plurality of first clamping members 210 define a limiting structure in the axial direction of the main body 100, and the plurality of second clamping members 220 define another limiting structure. When the main body 100 is inserted into the stoma / foramen ovale of the atrial septum, the two limiting structures are distributed on both sides of the atrial septum to clamp the atrial septum, so that the main body 100 is kept in the stoma / foramen ovale. Figure 1b The middle dotted line a indicates the direction of the atrial septum, which is parallel to the first clamping member 210 or the second clamping member 220 , that is, perpendicular to the main body 100 .

[0064] The first clamping member 210 and the second clamping member 220 are rod-shaped structures. Compared with the clamping structure of the disc-shaped 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 be deformed and move away from each other under the pressure of the atrial septum, thereby adapting to the thickness of the tissue, and at the same time, the main body 100 will not be squeezed and deformed to affect the channel size of the shunt area in the main body 100. In this way, the clamping member group 200 can reduce the pressure on the tissue to a certain extent, thereby reducing the damage to the tissue, and can maintain the original shunt capacity.

[0065] Further, the cylinder of the main body 100 is formed by spirally winding an elastic curve segment of metal material. Specifically, the elastic curve segment extends one circle in a circular form in the circumferential direction from the starting position, then extends one circle or more circles in a spiral form, and then extends one circle in a circular form, thereby forming a cylinder, and the elastic curve segment is a wavy metal segment. Compared with a mesh weaving or cutting structure, this cylinder structure can make the first clamping member 210 or the second clamping member 220 connected to the cylinder have a higher degree of freedom, and will not be limited by the interference of other structures on the cylinder, so that the first clamping member 210 or the second clamping member 220 can change its relative position with the cylinder according to the external force received. Preferably, the first clamping member 210 and the second clamping member 220 are also wound by an elastic curve segment. Specifically, a part of the elastic curve segment extends radially outward from the surface of the cylinder and then folds back to the surface of the cylinder to form the first clamping member 210 or the second clamping member 220. Compared with the first clamping member 210 and the second clamping member 220 being fixed to the cylinder by welding, bonding and other processes, this method makes the first clamping member 210 and the second clamping member 220 have a higher connection strength with the cylinder, ensuring that the first clamping member 210 and the second clamping member 220 will not fall off from the cylinder due to changes in position.

[0066] Of course, in other embodiments, the cylinder of the main body 100 may also be a mesh woven or cut structure, and the first clamp 210 and the second clamp 220 may also be fixed to the cylinder by welding, bonding and other processes, and the present disclosure does not limit this.

[0067] refer to Figure 2 , Figure 2 : is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. In this embodiment, the implant includes a main body 100 and a clamping member group 200a. The clamping member group 200a includes a first clamping member 210a and a second clamping member 220a. The other similarities between this embodiment and the previous embodiment are not repeated here. The difference from the previous embodiment is that the first clamping member 210a and the second clamping member 220a in this embodiment can be deformed along the radial direction of the main body 100, so that the outer diameter of the implant is reduced. Specifically, the first clamping member 210a and the second clamping member 220a each protrude from the outer peripheral surface of the main body 100 as a whole, and the two are bent and deformed radially toward the main body 100 through a partial structure, thereby achieving radial contraction in the main body 100.

[0068] The first clamping member 210a includes a first connecting section 211a, a first clamping section 212a, a first clamping portion 213a and a first bent portion 214a. One end of the first connecting section 211a is connected to the main body 100, and the other end is connected to the first clamping section 212a. When viewed from the radial direction, the two form a roughly inverted V-shaped structure, and the connection between the two is the first bent portion 214a. The terminal section of the first clamping section 212a extends outwardly roughly along the radial direction of the main body 100 to form the first clamping portion 213a. That is, in the process of extending radially outward, the first clamping member 210a presents a "low-high-low" shape relative to the horizontal reference. The horizontal reference can be the lower end surface of the main body 100. The second clamping member 220a includes a second connecting section 221a, a second clamping section 222a, a second clamping portion 223a and a second bent portion 224a. The various parts of the second clamping member 220 a are in a plane symmetrical relationship with the first clamping member 210 a , and the plane of symmetry is a cross section at the midpoint of the main body 100 .

[0069] Figure 2 The dotted line in the figure is the deformed shape of the first clamp 210 and the second clamp 220 when subjected to radial force. Due to the existence of the first curved portion 214a and the second curved portion 224a, the first clamp section 212a can be close to the first connecting section 211a, and the first connecting section 211a can be close to the main body 100; the second clamp section 222a can be close to the second connecting section 221a, and the second connecting section 221a can be close to the main body 100. In this way, it is equivalent to the first clamp 210a and the second clamp 220a being compressed in the radial direction, and the maximum diameter D' of the circumscribed circle of the outermost sides of the first clamp 210a and the second clamp 220a after compression is smaller than the maximum diameter D of the circumscribed circle before compression. In this way, when there are more tissues around the main body 100, the surrounding tissues can squeeze the first clamp 210a and the second clamp 220a to contract in the radial direction to reduce damage to the tissues.

[0070] refer to Figure 3 , Figure 31 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. In this embodiment, the implant includes a main body 100 and a clamping member group 200b. The clamping member group 200b includes a first clamping member 210b and a second clamping member 220b. The other similarities between this embodiment and the previous embodiment are not repeated here. Unlike the previous embodiment, the first clamping member 210b and the second clamping member 220b can not only deform along the radial direction of the main body 100, thereby reducing the outer diameter of the implant, but also can be axially away from each other 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. When viewed from the radial direction, the two are roughly S-shaped, and the connection between the two is the first curved portion 214b. The end section of the first clamping section 212b extends outwardly roughly along the radial direction of the main body 100 to form a first clamping portion 213b. In this way, when the first clamping member 210b extends outwardly in the radial direction, it presents a "low-high-low" shape relative to the horizontal reference, and presents a "near-far-near" shape relative to the vertical reference. This state is equivalent to that the first clamping section 212b does not extend further outward, but turns back and bends toward the main body 100. The horizontal reference can be the lower end surface of the main body 100. The vertical reference can be the center line of the main body 100. The various parts of the second clamping member 220b are in a plane symmetrical relationship with the first clamping member 210b, and the symmetry plane is the cross section at the midpoint of the main body 100. In this embodiment, the first curved portion 214b is a curved segment with a larger arc, so that the first clamping section 212b can have a larger spacing relative to the first connecting section 211b, and can also have a larger angle variation range. In this way, the first clamping section 212b can move radially toward the main body 100 and can also move axially (eg, Figure 3 When there is more tissue around the target part of the implant, the surrounding tissue can drive the first clamping member 210b and the second clamping member 220b to contract radially from both sides to avoid tissue damage; similarly, when the tissue at the target position is thick, the upper and lower clamping members can be driven to move away from each other in the axial direction to also avoid tissue damage.

[0071] The first clamping portion 213b is a portion of the free end of the first clamping member 210b, which has a certain length and is parallel to the end face of the main body 100. And 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 respectively the parts with the smallest spacing between the first clamping member 210b and the second clamping member 220b in the length direction of the main body 100, so the two are the main parts for forming clamping. In this way, after the first clamping section 212b moves away 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 form can form a larger clamping area, thereby forming a more stable clamping.

[0072] It can be understood that in other embodiments, the first clamping portion 213a located at the end section of the first clamping section 212a and the second clamping portion 223a located at the end of the second clamping section 222a may not be formed by extending radially outward from the main body 100, but extend toward the clamped tissue. When the first clamping member 210 and the second clamping member 220 are wound by elastic curved segments (for example, a U-shaped structure wound by 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 the ends thereof are smooth and will not damage the tissue. In other embodiments, the first clamping member 210 and the second clamping member 220 may also be sheet structures instead of being wound by elastic curved segments, and the ends thereof may be rounded to prevent damage to the tissue.

[0073] refer to Figure 4 , Figure 4 FIG. 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. The implant in this embodiment has the same Figure 3 The implants in the present invention have basically the same structure, except that the free ends of the first clamp 210c and the second clamp 220c are of a winding structure, so that the outermost side 215c of the first clamp 210c and the outermost side 225c of the second clamp 220c are of a rounded structure, i.e., have a rounded contour. The end 219c of the first clamp 210c and the end 229c of the second clamp 220c are located at the center of the winding structure (i.e., between the outermost side of the clamp and the main body 100), and will not pierce the surrounding tissue. In this case, the clamp can be a flat metal sheet whose end is not rounded; or it can be combined with the above embodiment, and be a structure wound by a metal wire, and have a roughly U-shaped structure when viewed from above or above.

[0074] refer to Figure 5 and Figure 6 , in which two implants with different clamps are shown. Figure 51 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. The implant includes a main body 100 and a clamping member group 200d, and the clamping member group 200d includes a first clamping member 210d and a second clamping member 220d. The first clamping member 210d includes a first connecting section 211d and a first clamping section 212d. For the same parts as the above-mentioned embodiment, no further description is given here. The difference is that the first clamping section 212d is a winding structure as a whole. The first clamping section 212d in the first clamping member 210d is wound outwardly in the axial direction, that is, wound upward in the figure. In addition, the free end is a winding structure, so that the outermost side 215d of the first clamping member 210d is a smooth structure, that is, it has a smooth contour. The end 219d of the first clamping member 210d is located at the center of the winding structure (that is, between the outermost side of the clamping member and the main body 100), and will not stab the surrounding tissue. The second clamping member 220d is in a plane symmetrical relationship with the first clamping member 210d, and the symmetry plane is a cross section at the midpoint of the main body 100.

[0075] When the clamp has at least one curved portion in both the axial direction and the radial direction, the clamp can provide a certain elasticity in these two directions, which is suitable for adjusting the overall radial size of the implant and the spacing between the two upper and lower clamps according to the implantation environment. The first clamping section 212d and the entire first clamp 210d are a winding structure, which is equivalent to a curved portion in any direction. The more the number of windings, the less the degree of radial deformation of the winding portion. Therefore, the ideal radial size adjustment capability and the ideal shape after deformation can be achieved by adjusting the number of windings.

[0076] In some optional embodiments, the number of turns of the clamping section of the implant clamp is greater, such as more than Figure 5 The first clamping section 212d in the embodiment has one or more more circles.

[0077] Figure 6 FIG. 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. Figure 5 The clamping sections of the implant in the embodiment of the present invention have opposite winding directions, that is, the clamping sections of the first clamping member 210e and the second clamping member 220e are both wound inwardly, that is, wound toward each other.

[0078] refer to Figure 7 and Figure 8 , Figure 7 is a schematic structural diagram of an implant according to another embodiment of the present disclosure, Figure 8It 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' are in different axial relative positions with the main body 100. That is, the two clamps in the same clamping member group have different shapes, and the shapes of the clamps in different clamping member groups are also different. The first clamping part and the second clamping part in the clamping member group 200f are offset to one end of the main body 100, and the first clamping part and the second clamping part in the clamping member group 200f' are offset to the other end of the main body 100. The direction of the clamping space defined by the multiple clamping member groups (the dotted line shown in the figure) is non-orthogonal to the main body 100. In this way, when the implant is installed to the target site, a certain deflection angle can be achieved. For example, it can be implanted between the left atrium and the coronary sinus. The space near the coronary sinus is smaller. The deflected installation method allows one end of the main body 100 to be tilted in the coronary sinus, reducing the occupied space.

[0079] refer to Fig. 9 , Fig. 9 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. The implant includes a main body 100, a first clamping member group 200g and a second clamping member group 200g'. The first clamping member and the second clamping member in the same clamping member group have different shapes, so that the first clamping portion and the second clamping portion are offset at one end of the main body. The first clamping member group 200g and the second clamping member group 200g' have the same structure, and both are evenly distributed in the circumference of the main body 100. This method is also suitable for implanting Fig. 9 Shown between the left atrium and the coronary sinus.

[0080] refer to Fig.10 , Fig.10 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. The implant includes a main body 100, a first clamping member group 200h and a second clamping member group 200h'. In this embodiment, the distance between the two clamping members in the first clamping member group 200h and the second clamping member group 200h' is relatively large, which can adapt to thicker tissues at the implantation site, such as double-layer blood vessels (arterial and venous blood vessel walls) in arteriovenous fistula surgery.

[0081] refer to Figures 11 to 14 , which shows implants with different numbers of clamp groups. Fig.11 The implant shown in FIG. 1 has two sets of clamps, which are spaced 180 degrees apart in the circumferential direction of the body 100 . Fig.12 The implant shown has three clip sets that are spaced 120 degrees apart around the body 100 circumference. Fig.13 and Fig.14 The implant shown has four clip sets that are spaced 90 degrees apart around the circumference of the body 100 . Figures 11 to 14They are all top views, that is, structural views viewed along the axial direction of the main body 100. In the above embodiments, the two clamps of each clamp group are at the same position in the circumferential direction of the main body 100, so the two clamps in the same clamp group overlap in the top view.

[0082] Figures 11 to 14 In the embodiment shown, the clamping member can be a U-shaped structure formed by bending an elastic wire, and the end of the clamping member is in an arc shape. The clamping member can also be a U-shaped structure cut from a metal sheet. Furthermore, when viewed from the radial direction of the main body 100, the clamping member can also be Figures 2 to 7 The structure of the clamp shown in .

[0083] Fig.14 The implant shown in Fig.13 The implant structure shown in the figure is basically the same, except that the clamping member is also provided with an anti-skid structure. For example, the end (clamping portion) of the first clamping member 210 is provided with a plurality of anti-skid protrusions 201 and anti-skid holes 202, both of which can enhance the static friction between the clamping member and the tissue, so that the implant is more firmly fixed to the target site. In some optional embodiments, only the anti-skid protrusions 201 or the anti-skid holes 202 may be provided.

[0084] refer to Fig.15 , Fig.15 FIG. 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. The implant includes a main body 100 and four clamping member groups. Fig.14 The structure of the clamping member in the embodiment is similar, except that the structure of the end of the clamping member in this embodiment is different. Taking the first clamping member 210 as an example, its main body is formed by bending elastic wire, and a ring 216 is provided at the end, and the ring 216 is also wrapped with a developing material 217. The ring 216 can prevent the end of the clamping member from piercing the tissue. The developing material can provide image reference information to the doctor during the implantation process.

[0085] refer to Fig.16 and Fig.17 , which shows a top view of the clamping members in the same clamping member group when the circumferential positions are different. Fig.16 The implant shown includes three clamping member groups, and the first clamping member 210 and the second clamping member 220 in the same group are completely staggered in the circumferential direction, that is, the two do not overlap at all when viewed from the axial direction. In this embodiment, the first clamping member 210 and the second clamping member 220 are radially arranged along the main body 100. The circumferential spacing angle of the first clamping member 210 and the second clamping member 220 is 60 degrees. Fig.17In the implant shown, the first clamping member 210 and the second clamping member 220 in the same group are partially staggered in the circumferential direction, that is, the two have partially overlapped structures when viewed from the axial direction. Specifically, the starting ends of the two are staggered in the circumferential direction, while the ends have partially overlapped structures. The first clamping member 210 and the second clamping member 220 are partially or completely staggered in the circumferential direction, which can increase the projected area, improve the fixation effect, and reduce damage to tissues.

[0086] Figures 18 to 23 Some implants having circumferentially deflectable clamps are shown.

[0087] refer to Fig.18 , Fig.18 It is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure, and the viewing direction is axial. In this embodiment, the implant includes a main body 100 and six clamping member groups evenly distributed on the circumferential surface of the main body 100. Taking the first clamping member 210i as an example, it can be a structure formed by bending an elastic wire. The first clamping member 210i extends radially outward, and the rear half is bent circumferentially, so that it forms a deflection in the circumferential direction of the main body 100. In this way, when the implant is installed to the target site, if there are more tissues around the target site, the surrounding tissues can squeeze the first clamping member 210i to make it move closer to the surface of the main body 100 (as shown by the dotted line in the figure), and the clamping member retracts toward the center, thereby reducing its diameter. This can reduce damage to surrounding tissues. When observed radially from the main body 100, the first clamping member 210i can also be Figures 2 to 7 In this way, the clamping member can simultaneously achieve radial contraction in the form of circumferential deflection and radial bending toward the main body. In some optional embodiments, when viewed axially from the main body 100, the end of the first clamping member 210i can also be a winding structure, so that a smooth structure can be formed on its outermost side to prevent puncturing tissue.

[0088] refer to Fig.19 , Fig.19 FIG. 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. Fig. 20In the implant structure shown in the figure, in this embodiment, each clamping member as a whole has a certain angle of deflection relative to the main body 100 in the circumferential direction. Specifically, when observed from the axial direction of the main body 100, the first clamping member 210j is a teardrop-shaped structure formed by bending a metal wire or a curved long sheet-like structure formed by cutting a metal sheet. The front half of the first clamping member 210j (the part connected to the main body 100) is the connecting section, and the rear half (the part on the free end side) is the clamping section. The circumferential width of the connecting section of the first clamping member 210j is less than the circumferential width of the clamping section. That is, when observed from the axial direction, the width of the connecting section is less than the width of the clamping section. Specifically, when viewed from the axial direction downward, the first clamping member 210j is a shape with a gradual width, and the base of the first clamping member 210j (i.e., the starting end of the connecting section, starting from the end of the surface of the main body 100, connected to the main body 100) is relatively small in width, and the width gradually increases during the extension process to the end, so that the width of the end is the largest. In the original state, the first clamping member 210j has a certain angle with the diameter of the main body passing through its base, and the angle is less than 90°. In this way, when the first clamping member 210j is implanted in the target part, if there is a lot of surrounding tissue, the surrounding tissue can easily drive the first clamping member 210j to rotate around the base, so that it moves closer to the surface of the main body 100. In this way, the first clamping member 210j retracts toward the center, thereby reducing its diameter. In addition, the base of the first clamping member 210j is smaller in width and weaker in strength than the end, so adaptive deflection can occur more easily.

[0089] refer to Fig. 20 and 21 , Fig. 20 is a schematic structural diagram of an implant according to another embodiment of the present disclosure, Fig.21 yes Fig. 20 Schematic diagram of the winding structure of the clamping member. In this embodiment, when observed from the axial direction of the main body 100, the first clamping member 210k is a teardrop-shaped structure formed by bending a metal wire or a curved strip structure formed by cutting a metal sheet. The base of the first clamping member 210k (starting from the end of the surface of the main body 100 and connected to the main body 100) is relatively small in width and the end is relatively large in width. The first clamping member 210k is bent in the circumferential direction so that it will be subjected to a larger circumferential force component when squeezed by the surrounding tissue, which is convenient for it to retract adaptively. In this embodiment, the end of the first clamping member 210k is a circular ring structure, which can enhance the clamping performance of the first clamping member 210k on the tissue, and the developing material can also be wound on the circular ring structure. Preferably, the circular ring structure is integrally formed with other parts of the first clamping member 210k, and all are wound by the same metal wire. Among them, the metal wire extends unidirectionally in the axial direction of the circular ring structure during the winding process, that is, the adjacent parts of the metal wire in the circular ring structure will not be intertwined with each other. Fig.21 The winding method of the middle clamp is only for illustration, and its specific details are not limited to those shown in the figure.

[0090] Fig. 22 is a schematic diagram of the winding structure of the clamping member in an optional embodiment. Fig.21 The winding method of the clamping member shown in the figure is such that the metal wires are intertwined during the winding process, that is, the metal wires extend back and forth in the axial direction of the annular structure during the winding process, and adjacent parts of the metal wires in the annular structure are intertwined. This method is conducive to the winding of the developing material and can enhance the developing effect.

[0091] refer to Fig.23 , Fig.23 : is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. In this embodiment, when viewed from the axial direction of the main body 100, the shape of the first clamping member 2101 is a U-shape as a whole, consisting of two rod segments and a ring with a diameter greater than the distance between the two rod ends, and the ring is located at the free end of the first clamping member 2101. The first clamping member 2101 extends radially along the main body 100 and has a certain angle with the diameter passing through the base of the first clamping member 2101. The end of the first clamping member 2101 is a ring structure, which can be wound with a developing material.

[0092] refer to Fig.24 , Fig.24 FIG. 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. Fig.19 The implant structures shown are basically the same, except that the first clamping member 210m is not deflected or deformed in the circumferential direction of the main body 100, but is arranged in a standard central radial pattern. The base width of the first clamping member 210m is small and the strength is relatively weak, so if the surrounding tissue is squeezed during the implantation process, the main body 100 can be manually rotated to deflect the first clamping member 210m relative to the main body 100.

[0093] Figures 18 to 24 The first clamping member is used as an example. It can be understood that the second clamping member can have the same shape as the first clamping member 210j when viewed in the axial direction, or can have a different shape from the second clamping member 210j, such as reverse deflection. When the first clamping member and the second clamping member are deflected, the radial size of the entire implant will be reduced, thereby avoiding damage to tissues.

[0094] Figures 18 to 24 The implant shown has a clamp that can be deflected in the circumferential direction. When the clamp as a whole deflects in the circumferential direction, the distance between the outermost end of the clamp and the center line of the main body 100 is also reduced, which is equivalent to achieving radial contraction in the form of circumferential deflection. In some optional embodiments, the rear half of the clamp can also be bent in the circumferential direction relative to the front half to form a partial circumferential deflection, thereby achieving radial contraction. Fig.18The first clamping member 210i is shaped as a broken line in the axial direction, and the rear half of the broken line can be bent relative to the front half, thereby forming a local circumferential deflection.

[0095] refer to Fig.25 , Fig.25 1 is a schematic diagram of the structure of an implant according to another embodiment of the present disclosure. In this embodiment, the implant is a sensing device, and the main body 100 includes a sensor 300 and a connector. The connector is, for example, a heat shrink tube, and the sensor 300 is fixed in the connector. One end of the clamp is disposed between the connector and the sensor, and the two are coaxially connected by a heat shrink process. The sensor is held at the target site by the connector and the clamp.

[0096] Figures 1b to 11 The radial perspective of the implant is mainly introduced. Figures 12 to 24 The morphological design of the implant from the axial perspective is mainly introduced. It can be understood that any radial perspective design scheme can be combined with any axial perspective design scheme, so one or more of the above embodiments can be combined into a new embodiment. Although the main body 100 is cylindrical as an example in the drawings, it can be understood by those skilled in the art that the main body 100 can also be other cylindrical structures, such as a truncated cone, and the present invention does not limit this.

[0097] The above is only a specific implementation of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any changes, substitutions and combinations that can be easily thought of by any technician familiar with the technical field within the technical scope disclosed in the present disclosure should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims

1. An implant for improving the physiological function of a target site and / or detecting the physiological index of a target site, characterized in that: include: A main body, used for fixing to the target site, the main body having a predetermined length; as well as At least one clamping member group, the clamping member group includes a first clamping member and a second clamping member, the first clamping member and the second clamping member are distributed at intervals on the periphery of the main body along the length direction of the main body; The first clamping member and the second clamping member are configured to be elastically deformable to move away from each other in the length direction of the main body, and / or to contract in the radial direction of the main body.

2. The implant according to claim 1, characterized in that The first clamping member and the second clamping member include a connecting section and a clamping section, one end of the connecting section is connected to the main body and the other end is connected to the clamping section, the first clamping member and the second clamping member each protrude as a whole from the outer circumferential surface of the main body, and the clamping section and / or the connecting section are configured to be deformable to move away from each other in the length direction of the main body, and / or to shrink in the radial direction of the main body.

3. The implant according to claim 2, characterized in that The clamping section and / or the connecting section are deformed in the form of circumferential deflection and / or radial bending toward the main body to contract in the radial direction of the main body.

4. The implant according to claim 2, characterized in that A bending portion with a variable angle is included between the clamping segment and the connecting segment, so that the clamping segment can be compressed along the radial direction of the main body.

5. The implant according to claim 4, characterized in that The clamping section is configured such that at least a portion of the structure can change the angle between the clamping section and the connecting section in the form of circumferential deflection and / or bending toward the main body, so that the clamping section can be compressed in the radial direction of the main body.

6. The implant according to any one of claims 1 to 5, characterized in that The outermost end of the clamping section is a smooth structure.

7. The implant according to claim 6, characterized in that The clamping section is formed by bending or winding an elastic wire or an elastic sheet, and the end of the elastic wire or the elastic sheet is located between the outermost end and the main body; or, the clamping section is formed by cutting an elastic sheet, and the end of the elastic sheet is arc-shaped.

8. The implant according to claim 7, characterized in that When the clamping section is formed by winding an elastic wire or an elastic sheet, the end of the elastic wire or the elastic sheet is located inside the winding structure.

9. The implant according to claim 8, characterized in that The elastic wire or elastic sheet is wound as a whole or at the ends so that the outermost end of the clamping section has a smooth structure.

10. The implant according to any one of claims 1 to 5, characterized in that The first clamping member and the second clamping member are also bent in the circumferential direction so as to be able to deflect circumferentially relative to the main body under the action of external force, and / or the circumferential width of the connecting section of the first clamping member and the second clamping member is smaller than the width of the clamping section so that the first clamping member and the second clamping member can deflect circumferentially relative to the main body under the action of external force.

11. The implant according to any one of claims 1 to 5, characterized in that: The clamping section 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 spacing between the first clamping member and the second clamping member in the length direction of the main body, and / or the clamping portion of the first clamping member and the clamping portion of the second clamping member are parallel to each other.

12. The implant according to claim 11, characterized in that The clamping portion is an annular structure when viewed in the axial direction or radial direction of the main body.

13. The implant according to claim 12, characterized in that The annular structure is formed by winding a metal wire.

14. The implant according to claim 13, characterized in that The metal wires in the annular structure are wound in an interwoven manner.

15. The implant according to claim 11, characterized in that There are multiple clamping member groups, and the clamping parts of at least two of the clamping member groups have different axial relative positions with the main body.

16. The implant according to claim 11, characterized in that The first clamping member and the second clamping member have different shapes so that the clamping portion is biased at one end of the main body.

17. The implant according to any one of claims 1 to 5, characterized in that The first clamping member and the second clamping member are partially or completely staggered in the circumferential direction.

18. The implant according to claim 17, characterized in that When the first clamping member and the second clamping member are partially staggered in the circumferential direction, the starting ends of the two are staggered in the circumferential direction and the end ends overlap.

19. The implant according to any one of claims 1 to 5, characterized in that The clamping section comprises a clamping portion, and the clamping portion is provided with an anti-slip protrusion or an anti-slip hole.

20. The implant according to claim 6, characterized in that The outermost end is a circular ring structure, and the circular ring structure is provided with a developing material.

21. The implant according to claim 1, characterized in that The main body comprises a cylinder, which is formed by spirally winding an elastic curved segment of a metal material, and the first clamping member and the second clamping member are integrally formed with the cylinder.

22. The implant according to claim 1, characterized in that The subject includes: the body of a diverter; or A sensor and a connecting piece, wherein the connecting piece is connected to the clamping piece group.