Implant and implant system

Abstract

The utility model discloses an implant and an implant system, belongs to the technical field of interventional medical instruments, and aims to solve the problem that the existing implant is easy to fall off in the release process and after the release, the implant comprises a main body (1) and at least one pair of clamping pieces (2), each clamping piece (2) is provided with a near-end part close to the main body (1) and a far-end part far away from the main body (1), in the direction far away from the central axis of the main body, the width of the near-end part of at least one clamping piece (2) is gradually increased, and the width of the far-end part is gradually reduced. The clamping piece of the implant has a large clamping width after being completely released, the contact area of the clamping piece and the tissue is larger, the implant has good anti-falling performance after being semi-released and completely released, and the fixing capacity of the implant after being semi-released and released is improved.

Description

Technical Field

[0001] This utility model relates to the field of interventional medical device technology, specifically to an implant or an implant system. Background Technology

[0002] Heart failure is a clinical syndrome caused by abnormal ventricular filling and ejection function, specifically classified into three categories: heart failure with reduced ejection fraction, heart failure with mildly reduced ejection fraction, and heart failure with preserved ejection fraction. In patients with chronic heart failure with preserved or reduced ejection fraction, persistently elevated left atrial pressure is the main cause of pulmonary congestion, leading to hospitalization in 90% of heart failure patients. Creating an atrial shunt via a permanent implant diverts blood from the left atrium to the right atrium, achieving the desired goal of reducing left ventricular load and thus improving patients' clinical symptoms and quality of life. Wireless monitoring of left atrial pressure enables early detection and intervention, guiding medication adjustments to prevent heart failure deterioration, thereby optimizing heart failure management strategies, reducing heart failure readmission rates, and lowering patient mortality. The combined effect of both approaches, through early intervention and medication adjustment via left atrial pressure monitoring, prevents abnormally high left atrial pressure, thereby improving the safety of atrial shunt therapy.

[0003] In existing technologies, clamping components are often used to hold the left and right atrial walls, thereby fixing the shunt or sensor to the atrial septum. However, the design of existing clamping components still has many shortcomings. For example, a current shunt structure consists of a main body 1 and a clamping component 2, such as... Figure 1 As shown, an adjustable clamping member 2 is additionally provided on the main body 1 as a fixing structure. In order to facilitate the delivery of the implant to the target tissue, the clamping member 2 can only be flipped to the outer surface of the main body 1 at the connection point between the main body 1 and the clamping member 2 to compress the implant. The shape of this clamping arm itself is usually not changeable. Therefore, when the size of the clamping arm itself is too large, it will result in the implant being too large after compression. However, when the size of the clamping member 2 is small, the clamping area of ​​the clamping member 2 is small, making it difficult to achieve stable clamping, which makes the implant easy to fall off during and after release. Utility Model Content

[0004] To address the problem of existing implants easily falling off during and after release, this invention provides an implant and an implant system. The clamping member of the implant has a larger clamping width after full release, and the contact area between the clamping member and the tissue is larger. The implant has good anti-dislodgement performance after partial and full release, thus improving the fixation ability of the implant during partial and full release.

[0005] The technical solution adopted by this utility model embodiment to solve its technical problem is:

[0006] An implant is provided, the implant comprising a body and at least one pair of clamping members connected to the body; wherein the pair of clamping members comprises two clamping members spaced apart along the axial direction of the body, each clamping member having a proximal portion near the body and a distal portion away from the body, and the width of the proximal portion of at least one clamping member gradually increases and the width of the distal portion gradually decreases along a direction away from the central axis of the body.

[0007] In one possible implementation, multiple pairs of clamping members are arranged circumferentially spaced along the body, with the body, the proximal portion, and the distal portion connected in sequence.

[0008] In one possible implementation, each of the clamping members includes a first inner support segment, a first outer support segment, a second outer support segment, and a second inner support segment connected in sequence, wherein the proximal end of the first inner support segment and the proximal end of the second inner support segment are both connected to the main body; the proximal portion includes the first inner support segment and the second inner support segment, and the distal portion includes the first outer support segment and the second outer support segment.

[0009] In one possible implementation, each of the clamping elements is wound from the same metal wire; the clamping element is rotatable toward the side wall of the body to transition from a released state to a compressed state, or the clamping element is also rotatable toward the side wall of the body to transition from a compressed state to a released state.

[0010] In one possible implementation, the main body includes a support, the support and each of the clamping members being wound from the same metal wire; or, the main body includes a sensor and a connecting sleeve, the sensor being disposed in the connecting sleeve; each of the clamping members further includes a fixing portion, the fixing portion being connected to the proximal portion and connected to the sensor by clamping the connecting sleeve.

[0011] In one possible implementation, the implant further includes a monitoring element connected to the outer wall of the body, the body being a treatment element, the body being compressible from a released state toward the monitoring element to a compressed state, and the implant being able to be inserted into a delivery sheath when both the clamp and the body are in a compressed state.

[0012] In one possible implementation, the clamping member has a long axis and a short axis, the length of the long axis being greater than or equal to the length of the short axis, and the length of the long axis being greater than twice the diameter of the monitoring element; the length of the long axis and / or the short axis is 6 mm to 8 mm.

[0013] In one possible implementation, the clamping member has a major axis and a minor axis, and when the clamping member is in the released state, the distance between the minor axis and the proximal end of the clamping member is greater than half of the major axis; the distance between the minor axis and the proximal end of the clamping member is 3mm to 4mm.

[0014] In one possible implementation, the distance between the proximal end of the first inner support segment and the proximal end of the second inner support segment is 0 mm to 1 mm.

[0015] In one possible implementation, the distal ends of the first outer support segment and the distal ends of the second outer support segment are connected by a connecting structure, which is a loop structure or a knotted structure.

[0016] In one possible implementation, the implant further includes a radiopaque structure wound around the connecting structure; the corresponding connecting structures of the same pair of clamping members are parallel to each other.

[0017] In one possible implementation, the connecting structure is the knotted structure, located outside the distal end of the first outer support segment and the distal end of the second outer support segment; the connecting structure has a ring structure and the diameter of the connecting structure is between 1.5mm and 3.5mm.

[0018] In one possible implementation, the radius of the bend formed by the first outer support segment and the second outer support segment is 0.2 mm to 1 mm, the radius of the bend formed by the first inner support segment and the first outer support segment is 0.2 mm to 1 mm, and the radius of the bend formed by the second outer support segment and the second inner support segment is 0.2 mm to 1 mm.

[0019] In one possible implementation, the first inner support segment, the first outer support segment, the second outer support segment, and the second inner support segment are located in four different planes; and / or, the lengths of the first inner support segment, the first outer support segment, the second outer support segment, and the second inner support segment are all unequal.

[0020] In one possible implementation, in a pair of clamping members, the axial distance between the two clamping members gradually decreases along the central axis direction away from the body.

[0021] In one possible implementation, in a pair of clamping members, the two clamping members are a first clamping member and a second clamping member, respectively; the axial distance between the proximal portions of the first clamping member and the proximal portions of the second clamping member gradually decreases along a direction away from the central axis of the body; the plane containing the distal portions of the first clamping member and the plane containing the distal portions of the second clamping member are both perpendicular to the central axis of the body.

[0022] In one possible implementation, the main body has a cylindrical structure, and the number of clamping members is three pairs, with each clamping member having a quadrilateral structure.

[0023] In one possible implementation, in a pair of clamping members, the two clamping members correspond one-to-one along the axial direction of the body, the proximal end of the clamping member is connected to the body, the proximal ends of the two clamping members are circumferentially offset, and the distal ends of the two clamping members are axially coincident; when the clamping member is in the released state, the long axis of the clamping member is offset to one side of the body.

[0024] In one possible implementation, the clamping member is positioned along a predetermined direction from its proximal end to its distal end, with the major axis of the clamping member deviating from the diametrical direction of the body.

[0025] An embodiment of this utility model also provides an implant system, the implant system including a delivery sheath and the above-described implant, the delivery sheath having a container, the implant being able to be inserted into the container in a compressed state, and the clamping member having a long axis and a short axis in a released state, the size of the short axis being larger than the outer diameter of the container.

[0026] The clamping element of the implant has a large clamping width after full release, and the contact area between the clamping element and the tissue is larger. The implant has good anti-dislodgement performance after partial and full release, which improves the fixation ability of the implant after partial and full release. Attached Figure Description

[0027] The accompanying drawings, which form part of this application, are used to provide a further understanding of the present invention. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention.

[0028] Figure 1 This is a schematic diagram of implants in existing technology.

[0029] Figure 2 This is a three-dimensional schematic diagram of the implant in one embodiment of the present invention.

[0030] Figure 3This is a front view schematic diagram of the implant described in one embodiment of the present invention.

[0031] Figure 4 This is a schematic diagram of the clamping member of the implant being subjected to circumferential pressure in one embodiment of the present invention.

[0032] Figure 5 This is a schematic diagram of the radial pressure applied to the clamping member of the implant described in one embodiment of the present invention.

[0033] Figure 6 This is a three-dimensional schematic diagram showing the connection between the implant body and the monitoring element in another embodiment of the present invention.

[0034] Figure 7 This is a top view schematic diagram showing the connection between the main body of the implant and the monitoring element in another embodiment of the present invention.

[0035] Figure 8 This is a schematic diagram of the clamping member of the implant in a compressed state in another embodiment of the present invention.

[0036] Figure 9 This is a schematic diagram of the implant body in a compressed state in another embodiment of the present invention.

[0037] Figure 10 This is a schematic diagram of the clamping component in a semi-released state in the prior art.

[0038] Figure 11 This is a schematic diagram of the clamping member of the implant in a semi-released state in another embodiment of the present invention.

[0039] Figure 12 This is a schematic diagram of the main dimensions of the implant in another embodiment of the present invention.

[0040] Figure 13 This is a schematic diagram of different long axes of the clamping member of the implant in another embodiment of the present invention.

[0041] Figure 14 This is a schematic diagram of different short axes of the clamping member of the implant in another embodiment of the present invention.

[0042] Figure 15 This is a schematic diagram of the delivery sheath in another embodiment of the present invention.

[0043] Figure 16 This is a schematic diagram showing different distances between the short axis of the clamping member of the implant and the main body in another embodiment of the present invention.

[0044] Figure 17This is a schematic diagram of another embodiment of the present invention when the distance between the proximal end of the first inner support segment and the proximal end of the second inner support segment is large.

[0045] Figure 18 This is a schematic diagram showing the deflection of the clamping member when the distance between the proximal end of the first inner support segment and the proximal end of the second inner support segment is large in another embodiment of this utility model.

[0046] Figure 19 This is a schematic diagram showing the deflection of the clamping member when the distance between the proximal end of one inner support segment and the proximal end of the second inner support segment is small, according to another embodiment of the present invention.

[0047] Figure 20 This is a comparative schematic diagram of the clamping member of the implant in another embodiment of the present invention, which is a quadrilateral shape and a strip shape.

[0048] Figure 21 This is a schematic diagram of the connection structure of the implant in another embodiment of the present invention, located outside the distal end of the first external support segment and the distal end of the second external support segment, and the connection structure is a knotted structure.

[0049] Figure 22 This is a schematic diagram showing that, in another embodiment of the present invention, the connection structure of the implant is located inside the distal end of the first external support segment and the distal end of the second external support segment, and the connection structure is a loop structure.

[0050] Figure 23 This is a schematic diagram showing that, in another embodiment of the present invention, the connection structure of the implant is located inside the distal end of the first external support segment and the distal end of the second external support segment, and the connection structure is a loop structure.

[0051] Figure 24 This is a side view schematic diagram showing the structural interference between the first and second outer support sections and the outer tube 42 of the delivery sheath in another embodiment.

[0052] Figure 25 yes Figure 21 A schematic diagram of the first and second outer support sections subjected to radial compression.

[0053] Figure 26 This is a schematic diagram of the bending radius of the clamping member of the implant in another embodiment of the present invention.

[0054] Figure 27 This is a schematic diagram showing that the axial distance between the two clamping members in the implant gradually decreases in another embodiment of the present invention.

[0055] Figure 28This is a schematic diagram showing that, in another embodiment of the present invention, the clamping portions of the two clamping members in the implant are parallel to each other, away from the main body.

[0056] Figure 29 This is a schematic diagram showing that, in another embodiment of the present invention, any two edges of any single clamping member in the implant are not on the same horizontal plane.

[0057] Figure 30 This is a schematic diagram of a pair of clamping components of an implant in the prior art that are circumferentially offset.

[0058] Figure 31 This is a schematic diagram of an existing technology where the axial indirection between a pair of clamping components is too large.

[0059] Figure 32 This is a schematic diagram of a pair of clamping elements in the prior art with an excessively small axial distance.

[0060] Figure 33 This is a schematic diagram of a pair of clamping members of an implant in another embodiment of the present invention, wherein the proximal ends are circumferentially offset and the distal ends overlap.

[0061] Figure 34 This is a schematic diagram of the situation when the clamping device is long and narrow and is compressed by the tissue at the implantation site in the prior art.

[0062] Figure 35 This is a first schematic diagram of the clamping member of the implant in another embodiment of the present invention when it is compressed by the tissue at the implantation site.

[0063] Figure 36 This is a second schematic diagram of the clamping member of the implant in another embodiment of the present invention when it is compressed by the tissue at the implantation site.

[0064] The annotations in the attached figures are explained as follows:

[0065] 1. Main body; 2. Clamping component; 3. Monitoring element; 4. Delivery sheath; 5. Target tissue; 6. Atrial wall; 7. Tear opening;

[0066] 21. First inner support section; 22. First outer support section; 23. Second outer support section; 24. Second inner support section; 25. Connecting structure; 25a. Developing wire; 26. Fold; 27. First clamping member; 28. Second clamping member;

[0067] 41. Maximum outer diameter section; 42. Outer tube. Detailed Implementation

[0068] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0069] For ease of understanding and description, the embodiments of this utility model are described from the perspective of a reader or user. Here, radial direction refers to the diameter of the main body 1, axial direction refers to the direction of the central axis of the main body 1, circumferential direction refers to the direction surrounding the central axis of the main body 1, proximal end refers to the end of a component or element close to the main body 1, and distal end refers to the end of the component or element far from the main body 1. The dimensions and angles of each component or element can be determined or adjusted by those skilled in the art based on actual needs or a limited number of experiments.

[0070] like Figure 2 As shown, one embodiment of this utility model provides an implant for implantation into a target site within a biological body. The implant includes a main body 1 and two pairs of clamping members 2, which are connected to the main body 1. Each pair of clamping members 2 includes two clamping members 2 spaced apart along the axial direction of the main body 1. Each clamping member 2 has a proximal portion close to the main body 1 and a distal portion away from the main body 1, and the distal portion and the proximal portion are sequentially connected to the main body 1. Along the direction away from the central axis of the main body 1, the width of the proximal portion of each clamping member 2 gradually increases, and the width of the distal portion of each clamping member 2 gradually decreases.

[0071] It is understood that in other embodiments, only one of the clamping members 2 may conform to the above description, while the other clamping member may adopt a different design; this utility model does not limit this. Of course, when both clamping members conform to the above description, a better clamping effect and a better anti-drop function can be achieved.

[0072] As the width of the proximal portion of the clamping member 2 gradually increases, the clamping member 2 has a larger clamping width after full release, and the contact area between the clamping member 2 and the tissue is larger. The implant has good anti-dislodgement performance after partial and full release, which improves the fixation ability of the implant after partial and full release.

[0073] As a selectable and achievable technical solution, the main body 1 can be a hollow cylindrical structure or a solid columnar structure, and multiple pairs of clamping members 2 are evenly spaced along the circumference of the main body 1, with the main body 1, the proximal part and the distal part correspondingly connected.

[0074] As an optional and feasible technical solution, each clamping member 2 may also have an intermediate portion between its proximal and distal portions for connecting the proximal and distal portions. This utility model does not limit this.

[0075] like Figure 2 and Figure 3As shown, in this embodiment, the main body 1 includes a film and a metal support. The film covers the inner and / or outer surfaces of the metal support, and the metal support has a hollow cylindrical structure. Two pairs of clamping members 2 are evenly spaced along the circumference of the main body 1. In other embodiments, the main body 1 may also include a monitoring device, such as a pressure sensor; the number of clamping members 2 may be one pair or more than two pairs; the main body may also be a non-cylindrical structure.

[0076] Preferably, the clamping member 2 can have a quadrilateral structure, such as a rhombus, and the quadrilateral structure here also includes a generally quadrilateral structure. The clamping members 2 are arranged in pairs and perpendicularly connected to the body 1, with the two clamping members in the same pair being parallel to each other, so that when the clamping members 2 are in the released state, the two clamping members clamp the target tissue 5. In other embodiments, the clamping members 2 may also be non-perpendicularly connected to the body 1, or only the proximal portion may be perpendicularly connected to the body 1, or at least a portion of the corresponding distal portions in the same pair of clamping members 2 may be parallel to each other, as long as the projection of the clamping member onto a horizontal plane perpendicular to the central axis of the body 1 is a quadrilateral structure. That is, the quadrilateral structure described in the various embodiments includes not only planar quadrilateral structures but also spatial quadrilateral structures.

[0077] like Figure 4 As shown, the clamping member 2 comprises a first inner support section 21, a first outer support section 22, a second outer support section 23, and a second inner support section 24 connected in sequence. The proximal ends of both the first inner support section 21 and the second inner support section 24 are connected to the main body 1. When the proximal ends of the first inner support section 21 and the second inner support section 24 are not in contact and are separated by a certain preset range, the clamping member 2, although not having a standard quadrilateral structure, has a roughly quadrilateral structure. Along the diameter of the main body 1 and away from its central axis, the width of the proximal portion of each clamping member 2 gradually increases, and the width of the distal portion of each clamping member 2 gradually decreases.

[0078] The proximal portion includes a first inner support segment 21 and a second inner support segment 24, and the distal portion includes a first outer support segment 22 and a second outer support segment 23. Alternatively, it can be understood that the first inner support segment 21 and the second inner support segment 24 are located in the proximal portion, and the first outer support segment 22 and the second outer support segment 23 are located in the distal portion. The width of the proximal portion of each clamp 2 can be understood as the distance between the first inner support segment 21 and the second inner support segment 24; the width of the distal portion can be understood as the distance between the first outer support segment 22 and the second outer support segment 23.

[0079] As an optional and achievable technical solution, when there is an intermediate part between the proximal and distal portions of the clamping member 2, the intermediate part may include two straight metal wires or metal wires with a certain curvature. One end of one metal wire is connected to the first inner support section 21, and the other end is connected to the first outer support section 22. One end of the other metal wire is connected to the second inner support section 24, and the other end is connected to the second outer support section 23.

[0080] The clamping member 2 can rotate toward the side wall of the main body 1 to switch from a released state to a compressed state, or the clamping member 2 can also rotate toward the side wall of the main body 1 to switch from a compressed state to a released state.

[0081] In this embodiment of the invention, the clamping member 2 is made of a single metal wire, that is, the first inner support section 21, the first outer support section 22, the second outer support section 23, and the second inner support section 24 are integrally formed from the same metal wire. Under compression, partial release, and release conditions, due to the geometric characteristics of the quadrilateral structure, the clamping member 2 can be stretched or compressed. Figure 4 As shown, the degree of freedom of the quadrilateral structure determines that the clamping member 2 can be compressed into an approximately straight rod structure during the compression process, thereby reducing the width of the clamping member, reducing the compression volume, facilitating the reduction of the delivery sheath size for implant delivery, and improving the safety of the delivery sheath during delivery; at the same time, it has better adaptive performance when encountering small implantation sites, for example, as Figure 5 As shown, when implanted in the atrial septum, if the implantation site is close to the atrial wall tissue, the clamp can deform under the interference of the atrial wall tissue, thereby increasing the width of the clamp and reducing the overall length of the clamp, thus preventing damage to the atrial wall tissue.

[0082] like Figures 6 to 9 As shown, as a selectable and achievable technical solution, the main body 1 has a hollow cylindrical structure. The implant also includes a monitoring element 3, which is connected to the outside of the main body 1. The main body 1 is a treatment element (such as a shunt device), and the number of clamping members 2 is three pairs. Combined with... Figure 15 When the implant is placed into the delivery sheath 4, the operator can squeeze the main body 1 from the released state to the monitoring element 3 to the compressed state, so that the main body 1 becomes a "C" shaped structure. When both the clamping member 2 and the main body 1 are in the compressed state, the implant can be loaded into the delivery sheath 4.

[0083] The monitoring element 3 can be connected to the outside of the main body 1 by means of bonding, welding or other methods. When the implant is compressed, the clamping member 2 first rotates towards the end of the main body 1 that is close to the clamping member 2. The clamping member 2 is stretched axially and converted to a compressed state. Then the main body 1 is squeezed towards the monitoring element 3, so that the main body 1 is compressed into a "C" shape and the main body 1 is also converted to a compressed state. At this time, the implant can be loaded into the delivery sheath 4.

[0084] like Figure 11 As shown, when the clamping member 2 is in a semi-released state (only one side of the clamping member in a pair is released, while the other side remains in the delivery sheath 4, and the main body 1 is still compressed), since the clamping member 2 in this embodiment has a quadrilateral structure, the three clamping members can firmly abut against the target tissue 5 without detaching from the target tissue 5. At the same time, the three pairs of clamping members are distributed in three directions, which will not affect the overall gripping performance of the implant.

[0085] Before implanting the implant into the target site, it is often necessary to artificially create a stoma in the target tissue 5. A small hole can be formed by puncturing the target tissue 5 with a puncture needle, and then the hole can be enlarged using an expansion device. In this case, the small hole often presents as a spindle-shaped tear 7 rather than a standard circular hole. In this embodiment, the expansion device is a delivery sheath. Specifically, before releasing the implant using the delivery sheath 4, the portion of the delivery sheath that carries the implant (which is also the maximum outer diameter portion 41 of the delivery system) first passes through the punctured small hole, thus forming a spindle-shaped tear 7. The size of this tear 7 will depend on the maximum outer diameter portion of the delivery sheath; that is, the minimum width H at the center of the tear 7 will be equal to the size of the maximum outer diameter portion 41 of the delivery sheath. In the prior art, the straight-bar type clamp 2 may exhibit issues such as… Figure 10 The morphology shown ultimately leads to the implant being completely or partially detached from the tear 7. To address this problem in the prior art, in this embodiment, under the same partial release condition, such as... Figure 11 As shown, since the clamping member of the implant has a quadrilateral structure, the clamping member 2 has a major axis b and a minor axis a. The minor axis a of the clamping member 2 is distributed in three different directions, and the implant can completely cross the tear 7, which significantly improves the fixation performance of the implant.

[0086] As a selectable and achievable technical solution, the length of the major axis b is greater than or equal to the length of the minor axis a, and the length of the major axis b is greater than twice the diameter of the monitoring element 3. Preferably, the length of the major axis b is 6mm to 8mm. In this embodiment, the major axis b refers to the distance between the distal end of the clamping member 2 and the proximal end of the clamping member 2. More specifically, the major axis b refers to the distance between a first specific point on the distal end of the clamping member 2 and a second specific point on the main body 1. The first specific point is the point on the clamping member 2 that is farthest from the central axis of the main body 1, that is, the first specific point can represent the position of the distal end. According to the extension lines of the first inner support segment 21 and the second inner support segment 24 towards the main body 1, the intersection of the two extension lines can be obtained. The line connecting this intersection point and the first specific point intersects the main body at the second specific point, that is, the second specific point can represent the position of the proximal end. The minor axis a refers to the distance between the proximal end of the first outer support segment 22 and the proximal end of the second outer support segment 23. The distal end of the clamping member 2 can also be understood as the connection end of the first outer support section 22 and the second outer support section 23; or, the distal end of the clamping member 2 can also be understood as the distal end of the distal portion; the proximal end of the clamping member 2 can also be understood as the end structure formed by the proximal end of the first inner support section 21 and the proximal end of the second inner support section 24 connected to the main body 1; or, the proximal end of the clamping member 2 can also be understood as the proximal end of the proximal portion of the clamping member 2.

[0087] like Figure 13 As shown, Figure 13 The dashed section represents the release condition when the major axis b of the clamping member 2 is less than twice the diameter d of the monitoring element 3, i.e., b < 2 × d. The solid line section represents the release condition when the major axis b of the clamping member is greater than twice the diameter d of the monitoring element 3, i.e., b > 2 × d. Obviously, when b < 2 × d, structural interference is likely to occur between the clamping member 2 and the monitoring element 3 during or after release. Therefore, preferably, b > 2 × d. Furthermore, according to anatomy, the minimum dimension of the atrial septum is 26 mm, thus the following constraint condition can be obtained: (2 × b + D) < 26 mm. Generally, the outer diameter D of the main body 1 is 5 mm to 8 mm, so the selectable range of b should be 6 mm to 10 mm. Considering that the puncture hole is not always centered on the atrial septum during implantation, preferably, the range of the major axis b is 6 mm to 8 mm to avoid damage to the atrial lateral wall by one side of the clamping member.

[0088] like Figure 12 and 14As shown, as an optional and achievable technical solution, the length range of the short axis a is 6mm to 8mm. When using the delivery sheath as a dilator to anteriorly dilate the puncture hole on the atrial septum, the minimum width of the fusiform portion of the fusiform tear is the outer diameter of the portion of the delivery sheath 4 that carries the implant. As shown by the dotted line in the figure, if the short axis a is much smaller than the size of the maximum outer diameter portion 41 of the delivery sheath, there is a risk of it falling off; when the long axis b of the clamp remains unchanged, as... Figure 14 As shown by the solid line, the length of the short axis a of the clamping member 2 is greater than the size of the maximum outer diameter portion 41 of the delivery sheath, significantly improving the implant's ability to prevent dislodgement. Generally, as... Figure 15 As shown, the diameter of the portion of the delivery sheath that carries the implant (i.e., the maximum outer diameter portion 41 of the delivery system) is 6mm to 8mm. Approximately, the minimum width H of the center of the fusiform tear can be equivalent to 6mm to 8mm. Therefore, the length of the short axis a of the clamp 2 should be as close as possible to or greater than 6mm, for example, the size range of the short axis a can be 6mm-8mm.

[0089] like Figure 16 As shown, when the implant is not fully released from the delivery system (i.e., in a semi-released state), preferably, the distance Ha between the short axis a and the proximal end (second specific point) of the clamp 2 is greater than half of the long axis b. In this embodiment, the distance Ha between the short axis a and the proximal end of the clamp 2 is also the vertical distance between the short axis a and the body 1. Figure 16 The dashed section shows the situation after release when the perpendicular distance between the minor axis a of the clamping member and the main body 1 is less than half of the major axis b, that is, Figure 16 The solid line shows the situation after release when the vertical distance between the short axis a of the clamping member and the main body 1 is greater than half of the long axis b, that is, Obviously, when When the widest part of the clamp 2 is closer to the tissue, the implant has better anti-dislodgement performance; therefore, preferably, When the clamping member 2 is in the released state, the distance Ha between the short shaft a and the proximal end of the clamping member 2 is at least 3 mm, for example, 4 mm.

[0090] like Figures 17 to 19 As shown, as a selectable and achievable technical solution, the distance l between the proximal end of the first inner support section 21 and the proximal end of the second inner support section 24 is 0 mm to 1 mm.

[0091] The distance between the proximal ends of the first inner support section 21 and the second inner support section 24 (which can be called the end spacing) can generally be adjusted according to the winding structure of the metal wire. Preferably, the distance between the proximal ends of the first inner support section 21 and the second inner support section 24 should be as small as possible, so that the structure of the clamping member 2 is more inclined to a standard quadrilateral rather than a pentagon, such as... Figure 17 As shown, when the distance l between the proximal end of the first inner support section 21 and the proximal end of the second inner support section 24 is too large, the clamping member 2 is closer to a pentagon. As shown by the dashed line, the clamping member 2 cannot fit completely close during compression, which ultimately leads to an increase in size after compression.

[0092] Furthermore, when the clamping member 2 needs to be spatially deflected, the end spacing determines the deflection performance of the clamping member 2. For example... Figure 18 As shown, for clamping member 2 with excessively large end spacing, when clamping member 2 needs to be twisted, clamping member 2 will... Figure 18 The structure shown by the dashed line is more difficult to compress into a smaller size. When the end spacing is small, such as... Figure 19 As shown, the clamp 2 is more easily pressed against the body 1 when deflection occurs, thus having greater degrees of freedom, being able to be squeezed into a smaller structure and adapt to a smaller anatomical space.

[0093] like Figure 20 As shown, it is obvious that, compared with implants having the same maximum unfolded outer diameter, the sum of the side lengths of the clamping member 2 with the quadrilateral structure is greater than that of the clamping member with the straight rod structure. Figure 20 (The dotted line part), while the clamping element 2 is made of metal wire, which has the property of being visible under X-rays. Therefore, the implant with the quadrilateral structure of the clamping element 2 has better imaging performance.

[0094] In addition, such as Figure 21 As shown, as an optional and feasible technical solution, the distal ends of the first outer support segment 22 and the distal ends of the second outer support segment 23 are connected by a connecting structure 25, which is a loop structure or a knotted structure. The connecting structure 25 has an overall ring structure.

[0095] The implant may also include an additional radiopaque structure, which may be made of a metal with better radiopaque properties than the main body 1, and is wound around the connection structure. For example, as Figure 21 As shown, a connecting structure 25 is formed by winding a metal wire at the distal end of the clamping member 2 to fix the developing structure (such as a developing ring or developing wire 25a, which is wound on the connecting structure 25).

[0096] Preferred, such as Figure 21 and 25As shown, the connecting structure 25 is the knotted structure. The connecting structure 25 is located outside the distal end of the first outer support section 22 and the distal end of the second outer support section 23. The connection points between the distal end of the first outer support section 22 and the distal end of the second outer support section 23 and the connecting structure 25 are both provided with bends 26.

[0097] like Figure 22 and Figure 21 As shown, compared to a loop structure, when the connecting structure 25 located on the outside of the clamping member 2 is a knotted structure, it can better fix the developing structure. For example... Figure 22 and Figure 23 As shown, when the implant needs to be retrieved, because the connecting structure is not planar, when the connecting structure is located inside the first outer support section 22 and the second outer support section 23 in an uncompressed state, the end of the outer tube 42 of the delivery sheath is prone to getting stuck between the connecting structure and the first outer support section 22 (and / or the second outer support section 23) during the retrieval process, ultimately leading to retrieval failure. Figure 24 As shown.

[0098] Therefore, preferably, such as Figure 21 As shown, the knotted structure, when not compressed, should be located outside the first outer support section 22 and the second outer support section 23. Figure 25 As shown, when the implantation space is too small, the distal end of the clamp 2 can be radially squeezed inward when it encounters tissue. Figure 5 In contrast, since the distal end of the clamping member 2 is rounded, the part in contact with the tissue is smoother and less likely to cause damage to the tissue. Furthermore, there is a bend 26 at the connection between the knotted structure and the first outer support section 22 and the second outer support section 23 on both sides of the circumference. Therefore, the first outer support section 22 and the second outer support section 23 on both sides of the knotted part have a higher degree of freedom.

[0099] like Figure 5 As shown, when the clamping member 2 is subjected to radial compression, the first outer support section 22 and the second outer support section 23 are at most compressed into an approximate crossbar structure, while the clamping member 2 with the knotted structure can still be compressed inward to a size similar to... Figure 25 The concave shape is shown. Preferably, the connecting structure 25, the distal portion, and the proximal portion are all made of the same metal wire. In one optional and feasible technical solution, the main body 1 includes a support made of wound metal wire, and the support and the clamping member 2 are made of the same metal wire; in another optional and feasible technical solution, the main body 1 includes a sensor and a connecting sleeve, the sensor is disposed in the connecting sleeve, and the clamping member 2 also includes a fixing portion, the fixing portion is connected to the proximal portion, and is connected to the sensor by clamping the connecting sleeve.

[0100] It is understood that when the clamping member 2 includes the connecting structure 25, the first specific point on the long axis b of the clamping member 2 (the point farthest from the central axis of the main body 1) is located on the connecting structure 25. The diameter of the connecting structure 25 is between 1.5mm and 3.5mm, preferably 2.5mm, to provide sufficient space for the development structure to provide sufficient development function, while providing sufficient movement space for the first outer support section 22 and the second outer support section 23.

[0101] like Figure 26 As shown, as a selectable and achievable technical solution, the lengths of the first inner support segment 21 and the second inner support segment 24 are the same, the lengths of the first outer support segment 22 and the second outer support segment 23 are the same, and the clamping member 2 has a rhomboid structure. The bending radius r1 formed by the first outer support segment 22 and the second outer support segment 23 can be 0.2mm to 1mm, the bending radius r2 formed by the first inner support segment 21 and the first outer support segment 22 can be 0.2mm to 1mm, and the bending radius r3 formed by the second outer support segment 23 and the second inner support segment 24 can be 0.2mm to 1mm. When the bending radius is too small, the clamping member 2 is prone to sharp structures, leading to tissue damage; while when the bending radius is too large, the side arms of the clamping member 2 are difficult to compress to a completely fitted state. Therefore, preferably, the bending radius can be 0.2mm to 1mm.

[0102] Furthermore, the radii r1 and r2 of the bending segment can be the same or different, the radii r2 and r3 of the bending segment can be the same or different, and the radii r1 and r3 of the bending segment can be the same or different.

[0103] like Figure 27 As shown, based on the above-mentioned improved scheme, as an optional and achievable technical solution, the spatial shape of the clamping members can be adjusted, i.e., the mating height h of the two clamping members 2 can be reduced, where h is less than the distance between the proximal ends of the two clamping members 2, to accommodate more anatomical shapes. When the tissue thickness is greater than h, each pair of clamping members 2 can move away from each other from their adjacent distal ends with the proximal end as the axis, becoming as follows: Figure 27 The shape shown by the dashed line further enhances the ability to prevent implantation from falling off.

[0104] Specifically, in a pair of clamping members 2, the two clamping members 2 are a first clamping member 27 and a second clamping member 28, respectively. The proximal and distal portions of the first clamping member 27 are located in the same plane, and the proximal and distal portions of the second clamping member 28 are also located in the same plane. The axial distance between the two clamping members 2 gradually decreases along the direction away from the central axis of the main body 1.

[0105] like Figure 28 As shown, in another implementation, based on the above scheme, the spatial shape of the clamping member 2 is further adjusted. The connecting part of the clamping member 2 near the main body 1 is twisted axially, and the clamping part of the clamping member 2 away from the main body 1 is made parallel, so that the clamping part changes from point contact to line contact, thereby increasing the clamping area. Compared with the previous scheme, the contact area between the clamping member 2 and the tissue in this scheme is larger, further reducing damage to the tissue.

[0106] Specifically, in a pair of clamping members 2, the two clamping members 2 are a first clamping member 27 and a second clamping member 28, respectively. The proximal and distal portions of the first clamping member 27 are not in the same plane, and the proximal and distal portions of the second clamping member 28 are not in the same plane. Along the direction away from the central axis of the body 1, the axial distance between the proximal portions of the first clamping member 27 and the second clamping member 28 gradually decreases; the plane containing the distal portions of the first clamping member 27 and the second clamping member 28 are both perpendicular to the central axis of the body 1. In other embodiments, the proximal portions of the first clamping member 27 and the second clamping member 28 may also be located within a spatial curved surface to have stronger deformation capability and adapt to more target tissues 5 with different thicknesses.

[0107] like Figure 29 As shown, further adjustments are made to the spatial morphology of the clamping element 2 based on the above scheme. Any pair of clamping elements 2 can be centrally symmetrical, axially symmetrical, or neither centrally symmetrical nor axially symmetrical. When a pair of clamping elements 2 is not axially symmetrical, and when the clamped tissue is not perpendicular to the implant body, the clamping force on the tissue can be reduced, thereby avoiding damage to the tissue.

[0108] In another implementation, in a pair of clamping members 2, the two clamping members 2 are a first clamping member 27 and a second clamping member 28; the first inner support segment 21 and the second inner support segment 24 of the first clamping member 27 are located in a first plane, and the first outer support segment 22 and the second outer support segment 23 of the first clamping member 27 are located in a second plane; the first inner support segment 21 and the second inner support segment 24 of the second clamping member 28 are located in a third plane, and the first outer support segment 22 and the second outer support segment 23 of the second clamping member 28 are located in a fourth plane. The first plane, the second plane, the third plane, and the fourth plane are not parallel to each other.

[0109] like Figure 30 As shown in the figure, the dashed line represents the clamping member 2 located on one side of the target tissue 5, and the solid line represents the clamping member 2 located on the other side of the target tissue 5. When the two clamping members 2 in a pair are completely offset circumferentially, if the preset clamping distance is too large, the following will occur: Figure 31In some cases, the clamping element 2 cannot fit well with the tissue, causing circumferential deflection of the implant; conversely, when the preset clamping distance is too small, [further issues may occur]. Figure 32 In such cases, clamp 2 squeezes the tissue into a wavy shape, further increasing the damage to the tissue.

[0110] Therefore, to avoid the above situation, it is preferable to set the distal portion of the clamping member 2 as an overlapping structure. By clamping the tissue with the distal portion of the clamping member, the circumferential stability of the implant is ensured to a certain extent, and damage to the tissue is also reduced. For example, as... Figure 33 As shown, in a pair of clamping members 2, the two clamping members 2 correspond one-to-one along the axial direction of the main body 1. The proximal part of the clamping member 2 is connected to the main body 1. The proximal ends of the two clamping members 2 are circumferentially offset, and the distal parts of the two clamping members 2 are axially coincident. Figure 33 The solid line in the middle represents the first clamping element. Figure 33 The dashed line represents the second clamping element. Each first clamping element and its adjacent second clamping element form a clamping element group. By adjusting the relative position of the proximal ends of the clamping elements 2, the proximal ends of each pair of clamping elements can be misaligned while the clamping portions (which can be the distal portions and / or connecting structures) coincide. This ensures that the long axis of each individual clamping element does not pass through the center of the main body, further enhancing the torsional and clamping capabilities of the clamping elements.

[0111] In existing technology, once the implant is fully released, the straight-bar type clamp 2, lacking a bent portion, is difficult to deflect. Figure 34 As shown, when the space at the implantation site is too small, the two clamping arms of the straight-bar type clamp 2 are of equal length and parallel, making it difficult for the clamp 2 to be twisted to either side as shown. Figure 34 The shape shown by the dashed line indicates that the distal end is prone to causing tissue damage.

[0112] As a viable and feasible technical solution, to avoid damage to tissues from the distal end, during implant fabrication, the clamping member 2 is pre-shaped to be offset circumferentially to one side of the main body 1. The main body 1 has a cylindrical structure, and the setting direction of the clamping member 2 does not pass through the central axis of the main body 1. The setting direction is from the proximal end to the distal end of the clamping member 2. When the clamping member 2 is in the released state, its long axis is offset to one side of the main body 1. Due to the quadrilateral structure of the clamping member 2, the inner support section, outer support section, and two outer support sections of the clamping member 2 all form bent sections, making the clamping member 2 more prone to twisting. This twisting occurs through compression on one side and stretching on the other side. Figure 35 The shape shown by the dashed line reduces damage to the tissue. At this time, the lengths of the first inner support segment 21, the first outer support segment 22, the second outer support segment 23 and the second inner support segment 24 can be different, as long as a quadrilateral structure can be formed and it is offset relative to the long axis of the main body 1.

[0113] Specifically, such as Figure 36 As shown, when the clamping structure contacts the tissue of the atrial wall 6, because the long axis of the clamping member is pre-deflected in a certain direction, when the implantation site is too small, the compressive force of the tissue will be pre-loaded in the direction of the clamping member's deflection, i.e., the part indicated by the arrow in the figure, further causing the clamping member to deflect, ultimately becoming... Figure 36 The shape shown by the dashed line.

[0114] In other embodiments, the body 1 may also have a non-cylindrical structure, with the long axis of the clamping member 2 offset to one side of the body 1, and the extension line of the long axis of the clamping member 2 toward the body 1 not passing through the central axis of the body 1.

[0115] As an optional and feasible technical solution, the main body 1 and the clamping member 2 are integrally wound from at least one metal wire, or the main body 1 and the clamping member 2 can be connected by a sleeve or the like, and the main body 1 may include a monitoring element 3.

[0116] Based on all the above solutions, the first clamping member 27 and the second clamping member 28 of each pair of clamping members 2 can be exactly the same or completely different in shape. The twisting method of the clamping members and the adjustment of parameters can be combined in pairs, and the implant can have a single pair of clamping members or multiple pairs. Preferably, the implant contains three pairs of clamping members 2, which have good anti-dislodgement performance and increase the size of the implant after compression as little as possible.

[0117] The implants disclosed in all the above schemes can be implanted not only in the interatrial septum, but also in other target tissues in the human body, such as the tissue between the left atrium and the coronary sinus.

[0118] Another embodiment of this utility model provides an implant system, which includes a delivery sheath 4 and any of the implants described in the above embodiments. The delivery sheath 4 has a container, which is the part of the delivery sheath that carries the implant (and is also the part with the largest outer diameter 41 of the delivery system). The implant can be inserted into the container in a compressed state. In the released or partially released state of the implant, the minor axis a of the clamp 2 is larger than the outer diameter of the container. More specifically, the delivery sheath 4 includes an inner tube and an outer tube. The outer tube includes the container, which is the part with the largest outer diameter on the outer tube. The implant is connected to the inner tube and correspondingly disposed in the container.

[0119] The above description is merely a specific embodiment of this utility model and should not be construed as limiting the scope of its implementation. Therefore, any substitution of equivalent components or equivalent changes and modifications made within the scope of protection of this utility model should still fall within its coverage. Furthermore, the technical features, technical solutions, and embodiments of this utility model can be freely combined and used.

Claims

1. An implant, characterized in that, The implant includes: Main body (1), and At least one pair of clamping members (2) are connected to the main body (1); The at least one pair of clamping members (2) includes two clamping members (2) arranged axially spaced along the body (1); each clamping member (2) has a proximal portion close to the body (1) and a distal portion away from the body (1), and along a direction away from the central axis of the body (1), the width of the proximal portion of at least one clamping member (2) gradually increases and the width of the distal portion gradually decreases.

2. The implant according to claim 1, characterized in that, Multiple pairs of clamping members (2) are arranged at circumferential intervals along the body (1), and the body (1), the proximal portion and the distal portion are connected in sequence.

3. The implant according to claim 1, characterized in that, Each of the clamping members (2) includes a first inner support section (21), a first outer support section (22), a second outer support section (23), and a second inner support section (24) connected in sequence. The proximal end of the first inner support section (21) and the proximal end of the second inner support section (24) are both connected to the main body (1). The proximal portion includes the first inner support section (21) and the second inner support section (24), and the distal portion includes the first outer support section (22) and the second outer support section (23).

4. The implant according to claim 3, characterized in that, Each of the clamping members (2) is made of the same metal wire; the clamping member (2) can rotate toward the side wall of the main body (1) to switch from the released state to the compressed state, or the clamping member (2) can also rotate toward the side wall of the main body (1) to switch from the compressed state to the released state.

5. The implant according to claim 3, characterized in that, The main body (1) includes a bracket, and the bracket and each of the clamping members (2) are made of the same metal wire; or, the main body (1) includes a sensor and a connecting sleeve, and the sensor is disposed in the connecting sleeve; each of the clamping members (2) also includes a fixing part, the fixing part is connected to the proximal part, and is connected to the sensor by clamping the connecting sleeve.

6. The implant according to claim 3, characterized in that, The implant also includes a monitoring element (3) connected to the outer side wall of the body (1). The body (1) is a treatment element. The body (1) can be squeezed from a released state to a compressed state towards the monitoring element (3). When both the clamping member (2) and the body (1) are in a compressed state, the implant can be inserted into the delivery sheath (4).

7. The implant according to claim 6, characterized in that, The clamping member (2) has a long axis and a short axis, the length of the long axis is greater than or equal to the length of the short axis, and the length of the long axis is greater than twice the diameter of the monitoring element (3); the length of the long axis and / or the short axis is 6mm to 8mm.

8. The implant according to claim 3, characterized in that, The clamping member (2) has a long axis and a short axis. When the clamping member (2) is in the released state, the distance between the short axis and the proximal end of the clamping member (2) is greater than half of the long axis; the distance between the short axis and the proximal end of the clamping member (2) is 3mm to 4mm.

9. The implant according to claim 3, characterized in that, The distance between the proximal end of the first inner support section (21) and the proximal end of the second inner support section (24) is 0 mm to 1 mm.

10. The implant according to any one of claims 3-9, characterized in that, The distal end of the first outer support section (22) and the distal end of the second outer support section (23) are connected by a connecting structure (25), which is a loop structure or a knot structure.

11. The implant according to claim 10, characterized in that, The implant also includes a radiopaque structure, which is wound around the connecting structure (25); the corresponding connecting structures (25) of the same pair of clamping members (2) are parallel to each other.

12. The implant according to claim 10, characterized in that, The connecting structure (25) is the knotted structure, and the connecting structure (25) is located outside the distal end of the first outer support section (22) and the distal end of the second outer support section (23); the connecting structure (25) has a ring structure and the diameter of the connecting structure (25) is 1.5mm-3.5mm.

13. The implant according to claim 3, characterized in that, The bending radius formed by the first outer support segment (22) and the second outer support segment (23) is 0.2mm to 1mm, the bending radius formed by the first inner support segment (21) and the first outer support segment (22) is 0.2mm to 1mm, and the bending radius formed by the second outer support segment (23) and the second inner support segment (24) is 0.2mm to 1mm.

14. The implant according to claim 3, characterized in that, The first inner support segment (21), the first outer support segment (22), the second outer support segment (23), and the second inner support segment (24) are located in four different planes; and / or, the lengths of the first inner support segment (21), the first outer support segment (22), the second outer support segment (23), and the second inner support segment (24) are all unequal.

15. The implant according to any one of claims 1-9, characterized in that, In a pair of clamping members (2), the axial distance between the two clamping members (2) gradually decreases along the central axis direction away from the main body (1).

16. The implant according to any one of claims 1-9, characterized in that, In a pair of clamping members (2), the two clamping members (2) are a first clamping member (27) and a second clamping member (28); Along the direction away from the central axis of the main body (1), the axial distance between the proximal portion of the first clamping member (27) and the proximal portion of the second clamping member (28) gradually decreases; The plane containing the distal portion of the first clamping member (27) and the plane containing the distal portion of the second clamping member (28) are both perpendicular to the central axis of the main body (1).

17. The implant according to any one of claims 1-9, characterized in that, The main body (1) has a cylindrical structure, and the number of clamping members is three pairs, with each clamping member having a quadrilateral structure.

18. The implant according to any one of claims 1-9, characterized in that, In a pair of clamping members (2), the two clamping members (2) correspond one-to-one along the axial direction of the main body (1), the proximal end of the clamping member (2) is connected to the main body (1), the proximal ends of the two clamping members (2) are circumferentially offset, and the distal ends of the two clamping members (2) are axially coincident. When the clamping member (2) is in the released state, the long axis of the clamping member (2) is offset to one side of the main body (1).

19. The implant according to any one of claims 1-9, characterized in that, Along a set direction, the set direction being from the proximal end of the clamping member (2) to the distal end of the clamping member (2), the major axis of the clamping member (2) being offset from the diametrical direction of the body (1).

20. An implant system, characterized in that, The implant system includes a delivery sheath (4) and an implant as described in any one of claims 1-19, the delivery sheath (4) having a container into which the implant can be inserted in a compressed state, and the clamping member (2) having a major axis and a minor axis in a released state, the minor axis being larger than the outer diameter of the container.

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