Annuloplasty device

Abstract

Disclosed is an annuloplasty device, comprising a first support ring and a second support ring forming a coiled structure, and corresponding first and second holding units. The first support ring transitions to the second support ring at a transition section, the transition section being adapted to be arranged at the commissure of a heart valve leaflet. The first support ring and the second support ring extend in respective first and second coil planes that are substantially perpendicular to the central axis. The transition section is at least partially bent along the central axis such that the first coil plane is separated from the second coil plane along the central axis by a certain distance at the transition section.

Description

Technical Field

[0001] The present invention generally relates to the field of cardiac valve repair. More specifically, the present invention relates to an annuloplasty device (such as an annuloplasty ring or helix) for positioning at a cardiac valve annulus and a method of repairing a defective cardiac valve. Background Art

[0002] Diseased mitral and tricuspid valves often need to be replaced or repaired. The mitral and tricuspid valve leaflets or supporting chordae tendineae may degenerate and weaken, or the annulus may dilate, which results in valve leakage. Replacement and repair of the mitral and tricuspid valves are often performed with the aid of an annuloplasty ring, which is used to reduce the diameter of the annulus, or otherwise alter the geometry of the annulus, or assist as a general support structure during valve replacement or repair procedures. Annuloplasty rings are typically implanted around the annulus of the cardiac valve.

[0003] Problems with prior art annuloplasty implants are achieving correct positioning at the cardiac valve and fixing the implant in the correct position. Suture devices for annuloplasty implants have the disadvantage of making it difficult to suture in the correct position, resulting in insufficient suture strength and also making the procedure very time-consuming, which increases the risk to the patient. In addition, suture devices are often not compact enough for catheter-based procedures. Using clips to position annuloplasty implants is also challenging, especially when implanting a helix ring that will be positioned on either side of the cardiac valve. Insufficient fixation of such implants can result in traumatic effects because the fixation structure must ensure that the device remains in the correct position over time. Thus, another problem in the prior art is achieving reliable fixation at the annulus of the cardiac valve. Annuloplasty implants are designed to function for several years and are thus critical for long-term stability in this regard.

[0004] The above problems can have dire consequences for patients and the healthcare system. The risk to the patient increases.

[0005] Therefore, an improved annuloplasty implant or device would be advantageous, particularly allowing avoidance of more of the above problems and compromises, and particularly allowing ensuring firm fixation of the annuloplasty device during the implantation phase, allowing long-term functioning in addition to a less complex procedure and increased patient safety. Related methods would also be advantageous. Summary of the Invention

[0006] Accordingly, examples of the present invention preferably seek to alleviate, mitigate or eliminate one or more deficiencies, drawbacks or problems in the art such as those identified above, alone or in any combination, by providing a device according to the appended patent claims.

[0007] According to a first aspect, there is provided an annuloplasty device, comprising: a first support ring and a second support ring forming a coiled structure, wherein the first support ring and the second support ring are arranged as coils around a central axis, wherein the first support ring and the second support ring are configured to be disposed on opposite sides of the native cardiac valve leaflets of a heart valve, the first support ring transitioning to the second support ring at a transition section, wherein the transition section is adapted to be disposed at the commissure of the cardiac valve leaflets, the first support ring and the second support ring extending in respective first and second coil planes substantially perpendicular to the central axis, the transition section being at least partially curved along the central axis such that the first coil plane is separated from the second coil plane by a distance (d1) along the central axis at the transition section.

[0008] According to a second aspect, there is provided a method of repairing a defective heart valve, comprising: positioning the second support ring of the annuloplasty device on the ventricular side of the heart valve; and positioning the first support ring of the annuloplasty device on the atrial side of the heart valve, the first support ring and the second support ring being arranged as coils around a central axis on opposite sides of the native cardiac valve leaflets of the heart valve. The first support ring and the second support ring are positioned such that the first support ring transitions to the second support ring at a transition section positioned at the commissure of the cardiac valve leaflets. The first support ring and the second support ring extend in respective first and second coil planes substantially perpendicular to the central axis. The transition section is at least partially curved along the central axis such that the first coil plane is separated from the second coil plane by a certain distance along the central axis at the transition section.

[0009] Further examples of the invention are defined in the dependent claims, wherein the features for the first aspect may be implemented for the second aspect and subsequent aspects and vice versa.

[0010] Some examples of the present disclosure provide for convenient positioning of the annuloplasty device at the heart valve.

[0011] Some examples of the present disclosure provide for convenient fixation of the annuloplasty device at the heart valve.

[0012] Some examples of the present disclosure provide for a shorter time for the annuloplasty device to be fixed to the target site.

[0013] Some examples of the present disclosure provide for the long-term effect and position of the fixed annuloplasty device.

[0014] Some examples of the present disclosure provide for a reduced risk of damaging the anatomical structure of the heart, such as the annulus or valve leaflets.

[0015] Some examples of the present disclosure provide for a more secure implantation of the annuloplasty device in a narrow anatomical structure.

[0016] Some examples of the present disclosure provide an annuloplasty device having improved adaptability to the anatomy of a heart valve.

[0017] Some examples of the present disclosure provide an annuloplasty device having increased retention at a heart valve.

[0018] It should be emphasized that when the term "comprising / including" is used in this specification, it is used to specify the presence of the recited features, integers, steps or components, but does not exclude the presence or addition of one or more other features, integers, steps, components and / or groups thereof. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] These and other aspects, features, and advantages achievable by embodiments of the present invention will be apparent and elucidated with reference to the following description of embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0020] Figure 1a A three-dimensional view schematically illustrates an annuloplasty device according to an example of the present disclosure, wherein the first support ring and the second support ring are in a relaxed first state;

[0021] Figure 1b A three-dimensional view schematically illustrates an annuloplasty device according to an example of the present disclosure, wherein the first support ring and the second support ring are in a displaced second state;

[0022] Figure 2a A side view schematically illustrates an annuloplasty device according to an example of the present disclosure, wherein the first support ring and the second support ring are in a relaxed first state;

[0023] Figure 2b A side view schematically illustrates an annuloplasty device according to an example of the present disclosure, wherein the first support ring and the second support ring are in a displaced second state;

[0024] Figure 3 A side view schematically illustrates an annuloplasty device according to an example of the present disclosure, wherein the annuloplasty device is positioned above and below the valve leaflets;

[0025] Figure 4 A side view schematically illustrates an annuloplasty device according to an example of the present disclosure, wherein the annuloplasty device is in an extended configuration;

[0026] Figures 5a to 5b A top view schematically illustrates an annuloplasty device according to an example of the present disclosure;

[0027] Figure 6 A three-dimensional view schematically illustrates an annuloplasty device according to an example of the present disclosure;

[0028] Figures 7a to 7b Schematically illustrates a cross-section of a first support ring or a second support ring of an annuloplasty device according to an example of the present disclosure, having an attached holding unit;

[0029] Figure 8 Is a flowchart of a method for repairing a defective heart valve according to an example of the present disclosure;

[0030] Figure 9 Schematically illustrates an annuloplasty device according to an example of the present disclosure in a top view;

[0031] Figure 10 In a top view and from Figure 9 Schematically illustrates an annuloplasty device according to an example of the present disclosure from the opposite side of the annuloplasty device in the view of;

[0032] Figure 11a Schematically illustrates details of an annuloplasty device according to an example of the present disclosure at Figure 10 Cross-section A-A in;

[0033] Figure 11b Schematically illustrates details of an annuloplasty device according to an example of the present disclosure at Figure 10 Cross-section B-B in;

[0034] Figure 11c In Figure 11a Schematically illustrates details of an annuloplasty device according to an example of the present disclosure in an enlarged view of the details of;

[0035] Figure 12 In Figure 10 Schematically illustrates an annuloplasty device according to an example of the present disclosure in a side view along the vertical direction Y;

[0036] Figure 13 Schematically illustrates details of an annuloplasty device according to an example of the present disclosure from Figure 12 The view in;

[0037] Figure 14 In Figure 10 Schematically illustrates an annuloplasty device according to an example of the present disclosure in a side view along the vertical direction Y and from the side opposite to Figure 12 ;

[0038] Figure 15 In Figure 10 Schematically illustrates an annuloplasty device according to an example of the present disclosure in a side view along the horizontal direction X;

[0039] Figure 16A three - dimensional view schematically illustrates an annuloplasty device according to an example of the present disclosure;

[0040] Figure 17a A top view schematically illustrates an annuloplasty device according to an example of the present disclosure;

[0041] Figure 17b A top view and from Figure 17a the opposite side of the annuloplasty device in the view of

[0042] Figure 18a schematically illustrates an annuloplasty device according to an example of the present disclosure at Figure 17a detail at cross - section A’ - A’ in

[0043] Figure 18b schematically illustrates an annuloplasty device according to an example of the present disclosure at Figure 17a detail at cross - section B’ - B’ in

[0044] Figure 19a In Figure 17a a side view along the vertical direction Y schematically illustrates an annuloplasty device according to an example of the present disclosure;

[0045] Figure 19b In Figure 17a a side view along the vertical direction Y and from the side opposite to Figure 19a schematically illustrates an annuloplasty device according to an example of the present disclosure;

[0046] Figures 20a to 20c A three - dimensional view schematically illustrates an annuloplasty device according to an example of the present disclosure; and

[0047] Figures 21a to 21d is a side view of the annuloplasty device in Figures 20a to 20c according to an example of the present disclosure. DETAILED DESCRIPTION

[0048] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terms used in the detailed description of the embodiments illustrated in the drawings are not intended to limit the present invention. In the drawings, like reference numerals refer to like elements.

[0049] The following description focuses on embodiments of the present invention that are applicable to cardiac valve implants, such as annuloplasty rings. However, it should be understood that the present invention is not limited to this application, but can be applied to many other annuloplasty implants and cardiac valve implants, including, for example, replacement valves and other medical implantable devices.

[0050] Figure 1a An example of an annuloplasty device 100 is schematically illustrated and includes: a first support ring 101 and a second support ring 102, which are adapted to be arranged in a coiled configuration around a central axis 103 as a coil (i.e., a helical shape), as Figure 1a illustrated. At least when in a relaxed state of the material of the annuloplasty device 100 (i.e., no external force acts on the device 100), the device 100 is arranged in a coiled configuration. The coiled-shaped device 100 has two free ends 116, 116'. The first support ring 101 and the second support ring 102 and the corresponding free ends 116, 116' are configured to be arranged on opposite sides of the native cardiac valve leaflets 301 of the cardiac valve, as for example Figure 3 illustrated in the side view. As Figure 3 shown, the first support ring 101 may be arranged on the atrial side of the cardiac valve, and the second support ring 102 may be arranged on the ventricular side (the second support ring 102 is also shown in dashed lines in the Figure 5a top view of -b, where the valve leaflets have been omitted). The second support ring 102 is illustrated in dashed lines and is arranged on the ventricular side of the cardiac valve in these examples, while the first support ring 101 is arranged on the atrial side of the cardiac valve (shown in solid lines). The first support ring 101 may thus extend along the annulus of the cardiac valve on the atrial side. The first support ring 101 and the second support ring 102 are connected to form a coiled or helical ring, as an integral continuous ring. As Figure 5a schematically illustrated in -b, the coil extends through the valve opening at its commissures 302, 302'. Thus, the first support ring 101 and the second support ring 102 may also assume a coiled configuration in the implanted state. As further explained below, the device 100 may include a shape memory material such that the device 100 resumes its coiled configuration after being delivered from a catheter (not shown) to the target site (after being temporarily restricted to the elongated configuration of the catheter). Figure 4FIG. 0 is a schematic view of the annuloplasty device 100 in this elongated, extended state. The annuloplasty device 100 (i.e., the annuloplasty implant 100) may comprise a shape memory material such as NiTiNol or another suitable biocompatible alloy that can be heat set into a defined shape during a heat treatment process (i.e., be in a defined relaxed shape without external forces), as described further below. The annuloplasty device 100 may engage tissue of the heart valve leaflets 301 between a first support ring 101 and a second support ring 102 (i.e., using a force acting parallel to the central axis 103).

[0051] The annuloplasty device 100 may optionally include retention units 104, 104', as schematically illustrated, for example, in Figure 1a -b, Figure 16 the perspective view of FIG. 2-4, Figure 12 FIG. Figure 14 FIG. Figure 19a -b of the side view, and Figure 7a FIG. Figure 11a -b and Figure 18a -b of the cross-sectional view (i.e., as viewed along the longitudinal 111 extending along the first ring 101 and the second ring 102). Figure 1a FIG. Figure 4 -b shows an example of a plurality of retention units 104, 104' arranged on the first support ring 101 and the second support ring 102. Figure 3 The example in FIG.

[0052] shows the device 100 in an elongated, extended configuration, for example, the device 100 arranged when constrained within a catheter. However, as described above, when released from the catheter, the device 100 assumes a coiled shape, and the retention units 104, 104' can then engage tissue on the atrial and ventricular sides of the heart valve, as Figure 12 FIG. Figure 16 FIG. Figure 19a FIG. Figure 20a -c, Figure 21a -d illustrate. The transition section 120 is adapted to be arranged at the commissures 302, 302' of the heart valve leaflets, for example, Figure 5bAt the exemplary commissure 302'. The first support ring 101 and the second support ring 102 extend in respective first coil planes 101' and second coil planes 102' that are substantially perpendicular to the central axis 103. The transition section 120 can be bent at least partially along the central axis 103 such that the first coil plane 101' is separated from the second coil plane 102' by a distance (d1) at the transition section 120 along the central axis 102 (i.e., along a direction parallel to the central axis). Such a transition section 120 with coil planes 101', 102' locally displaced by a distance (d1) and located at positions corresponding to the commissures 302, 302' provides an improved adaptation of the first support ring 101 and the second support ring 102 to the anatomy on opposite sides of the valve, especially when the heart is pulsating. The step-down in the coil planes 101', 102' at the transition section 120 due to the separation distance (d1), or the "S-shaped" or "Z-shaped" of the support rings 101, 102, provides a better engagement of the first support ring 101 and the second support ring 102 at the commissures 302, 302'. That is, the risk of the moving leaflets pulling on any of the support rings 101, 102 at the commissures 302, 302' is minimized because, due to the displacement (d1) (i.e., the increased pitch of the coils formed by the adjacent support rings 101, 102 or the rising local section 120), the first coil plane 101' of the first support ring 101 on the atrial side transitions to the second coil plane 102' of the second support ring 102 at a reduced distance at the transition section 120. This means that the first support ring 101 and the second support ring 102 can better conform to the two opposite sides of the valve near the commissures 302, 302'. Thereby, the annuloplasty device 100 can be fixed at the valve in a safer manner while minimizing the risk of dislodgment. The position of the transition section 120 can vary depending on the commissures 302, 302' and the first / second support rings 101, 102 extending through the leaflets. Thereby, the transition section 120 can have an increased slope or pitch relative to the central axis 103 compared to the rest of the first support ring 101 and the second support ring 102.

[0053] In one example, the length of the transition section 120 can approximately correspond to the offset distance 117 between the free ends 116, 116', as Figure 16 , Figure 17a , Figure 19a schematically illustrated. In one example, the transition section 120 can be arranged after the first support ring 101 forms substantially a complete ring, as Figure 20c illustrated.

[0054] The transition section 120 can be bent at least partially along the radial direction (R), where the radial direction (R) is perpendicular to the central axis 103, such that the transition section 120 is concave towards the radial direction (R). Figure 17a -b andFigure 20b Illustrated is an example of such a concave bend or “C - bend” of the transition section 120 towards the radial direction (R). This provides a further improvement in the engagement of the first support ring 101 and the second support ring 102 with the valve anatomy near the commissures 302, 302'. The risk of adverse force transmission or friction between the moving leaflets and any support ring 101, 102 at the commissures 302, 302' is minimized. The first support ring 101 and the second support ring 102 can extend as far as possible along the annulus while extending through the commissures 302, 302', with a minimal impact on valve movement, because the concave bend of the transition section 120 allows for adaptation to the anatomy where the commissures 302, 302' are closer to the central axis 103 than the annulus. Thus, the annuloplasty device 100 can be fixed at the valve in a further improved manner while minimizing the risk of long - term dislodgment.

[0055] As described above with respect to, for example Figure 12 , Figure 16 , Figure 17a - b, Figure 19a , Figure 20a - c, Figure 21a - d, the advantageous features of the transition section 120 provide an improved annuloplasty device 100 that has an improved anchoring into tissue and no displacement (d) as discussed below in the relaxed state ( Figure 1a - b). In the absence of displacement (d) in the relaxed state, the annuloplasty device 100 has a relaxed state corresponding to the figures in Figure 1b . In the case where the annuloplasty device 100 includes holding units 104, 104', the holding units 104, 104' are directed towards each other in the relaxed state and there is no displacement (d) as discussed below in the relaxed state. Thus, the transition section 120 as described throughout this disclosure provides a separate aspect of the present invention.

[0056] The first support ring 101 may include a first posterior arch 113 and a first front portion 114. The second support ring 101 may include a second posterior arch 113 and a second front portion 114. The first posterior arch 113 and the second posterior arch 113' may be adapted to conform to the posterior side of the heart valve, i.e., along the posterior leaflets, with an arcuate extension. The first front portion 114 and the second front portion 114' may each have a more straight extension or at least an extension that is less curved than the arcuate posterior sides 113, 113'. This is illustrated in, for example Figure 5b , Figure 9 , Figure 10 , Figure 16 , Figure 17a , Figure 20a - c. The first front portion 114 and the second front portion 114' can thus be adapted to conform to the anterior side of the heart valve, i.e., along the anterior leaflets.

[0057] At least a portion of the first front portion 114 and / or the second front portion 114' can be bent to form corresponding concave segments 123, 123' that are recessed toward the radial direction (R), where the radial direction (R) is perpendicular to the central axis 103, as, for example, Figure 17a and Figure 20c illustrated schematically. This provides a further improvement in the adaptability of the first support ring 101 and the second support ring 102 to the anatomy of the valve and its annulus. Since interference with the movement of the natural heart valve can be minimized, a more secure attachment of the annuloplasty device 100 and long-term reliability of the implantation are achieved.

[0058] The first front portion 114 can be displaced a certain distance (l1) along the radial direction (R) from the second front portion 114' such that at least a portion of the second front portion 114' extends at a greater radius (r) from the central axis 103 than the first front portion 114, as Figure 9 , Figure 11a , Figure 17a , Figure 18a , Figure 20c illustrated schematically. Thus, when the first support ring 101 is arranged on the atrial side and the second support ring 102 is arranged on the ventricular side, the second front portion 114' of the second support ring 102 will extend from the central axis 103 at a greater radius than the first front portion 114 of the first support ring 101. This is also illustrated in Figure 3 . The second support ring 102 having a greater radius on the ventricular side provides effective clamping of the valve tissue at the aortic-septal wall, thereby providing a more secure anchoring of the annuloplasty device 100.

[0059] As, for example, Figure 9 , Figure 11b , Figure 17a , Figure 18b , Figure 20c illustrated schematically, the first rear arch portion 113 can be displaced a distance (l2) along the radial direction (R) from the second rear arch portion 113'. The radial direction (R) is perpendicular to the central axis 103. The offset between the first rear arch portion 113 and the second rear arch portion 113' provides improved fixation of the annuloplasty device 100 on the reduced posterior annulus, thereby providing a more effective anchoring of the annuloplasty device 100. Thus, at least a portion of the first rear arch portion 113 can extend from the central axis 103 at a greater radius (R) than the second rear arch portion 113', as Figure 9 , Figure 11b , Figure 17a , Figure 18b , Figure 20c shown. Figure 11a -b, Figure 18aThe axis 103' in -b is parallel to the central axis 103. The first support ring 101, which has a greater radial extension along the posterior arch 113 on the atrial side compared to the posterior arch 113' of the second support ring 102 on the ventricular side, provides improved engagement with the perivalvular anatomy on the ventricular side, thereby providing a more secure anchoring of the annuloplasty device 100 and less interference with the native leaflets and chordae tendineae. In this case, the bending of the chordae tendineae can also be facilitated.

[0060] However, in another example, it should be understood that at least a portion of the second posterior arch 113' may extend from the central axis 103 with a greater radius (r) compared to the first posterior arch 113.

[0061] As regarding Figure 9 Figure 11, Figure 17, Figure 18, Figure 20c The advantageous features with the displacement distances (l1, l2) as described provide an improved annuloplasty device 100 with improved anchoring into the tissue and without the displacement (d) discussed below in the relaxed state ( Figure 1a -b). That is, in the case of no displacement (d) in the relaxed state, the annuloplasty device 100 has a relaxed state corresponding to the figure in Figure 1b . Thus, the displacement distances (l1, l2) also provide a separate aspect of the present invention.

[0062] The first support ring 101 and the second support ring 102 may have a separation distance (d) and may move relative to each other along the central axis 103 such that the separation distance (d) is variable. In one example, the first support ring 101 and the second support ring 102 comprise an elastic shape - memory material and may move along the central axis 103 from a relaxed first state as illustrated in Figure 1a to a displaced second state as illustrated in Figure 1b . The first state may thus correspond to a defined heat - set shape of the material forming the first and second support rings. In the second state, the first and second rings are forced to move to a displaced position where the first and second rings shift their relative positions along the axis 103 ( Figure 1b ). Thus, there may be an elastic bias from the second state towards the first state. Thus, when displaced to the second state to clamp the leaflets from opposite sides, the first support ring 101 and the second support ring 102 strive to assume the first state. In Figure 1b , the first support ring 101 will strive to move towards the second support ring 102 and vice versa, because in Figure 1aIn the heat-set relaxed shape, the first support ring 101 and the second support ring 102 have opposite relative positions, where the first support ring 101 is below the second support ring 102. If the forces acting on the first support ring 101 and the second support ring 102 are removed, the latter will then move towards each other and pass by each other, such that the Figure 1a opposite relative positions in Figure 3 are presented. When the first ring 101 and the second ring 102 are arranged on opposite sides of the leaflet in the second state, the opposite arrangement of the first support ring 101 and the second support ring 102 having the relaxed shape as described above provides an increased compressive force on the valve tissue, as further seen in Figure 20a -c and Figure 21a -d is a schematic diagram of another example, where a section of the first support ring 101 and the second support ring 102 has an opposite position in the relaxed state, as illustrated by the opposite section 124 of the second support ring 102, so as to provide an increased compressive force along the front portions 114, 114'.

[0063] In one example, the first support ring 101 and the second support ring 102 have a relaxed first state, where the distance (d) between the first support ring 101 and the second support ring 102 is substantially zero.

[0064] Turning again to Figure 1a -b, if the first support ring 101 and the second support ring 102 include retaining units 104, 104', then in the first state, the first retaining unit 104 extends from the first support ring 101 in a direction away from the second support ring 102, as Figure 1a illustrated. Further, in the first state, the second retaining unit 104' extends from the second support ring 102 in a direction away from the first support ring 101, as Figure 1a illustrated. In the second state, the first retaining unit 104 extends from the first support ring 101 in a direction towards the second support ring 102, as Figure 1b shown. Further, in the second state, the second retaining unit 104' extends from the second support ring 102 in a direction towards the first support ring 101. The first retaining unit 104 and the second retaining unit 104' thus generate retaining forces on the opposite sides. The retaining units 104, 104' point towards the valve tissue between the first support ring 101 and the second support ring 102 from two opposite sides.

[0065] As described above, although asFigure 9 -19 An example of an illustrative annuloplasty device 100 shows retention units 104, 104' that extend in opposite directions away from each other to accommodate a change from a relaxed first state as illustrated to a displaced second state as illustrated. However, it should be understood that in the example of Figure 1a -19, the retention units 104, 104' can be arranged on the first support ring 101 and the second support ring 102 to extend towards each other. In the latter case, the positions of the first support ring 101 and the second support ring 102 should be reversed relative to the central axis 103. For example, in the relaxed state of the annuloplasty device 100, Figure 1b the first support ring 101 in the example of Figure 9 -19 would alternatively be placed on the right side of the second support ring 102, i.e., such that the position is displaced relative to the axis 103'. Figure 18b As described above, the first support ring 101 can be adapted to be arranged on the atrial side of the heart valve, and the second support ring 102 can be adapted to be arranged on the ventricular side of the heart valve, as illustrated in

[0066] -19. Figure 3 -14 shows an illustrative top view, where the second ring 102 is shown in dashed lines and the first ring 101 is shown in solid lines. In the example of Figure 5a -19, the transition point between the first ring 101 and the second ring 102 is at the commissure denoted as 302, while in the example of Figure 5a -19, the transition point between the first ring 101 and the second ring 102 is at the commissure denoted as 302'. Figure 5b -21 shows an example of an annuloplasty device 100 that can be arranged as illustrated in Figure 9 -21. Figure 5b -24.

[0067] Further with respect to the example of the annuloplasty device 100 including the retention units 104, 104', having retention units 104, 104' on both sides of the valve provides increased retention force and strength by which the annuloplasty device 100 is fixed at the valve. The retention units 104, 104' can thus engage tissue from the mentioned two sides, thereby generating a strong retention force in the radial direction (i.e., perpendicular to the axis 103). The first support 101 and the second support 102 clamp the tissue from both sides of the valve, causing the retention units 104, 104' to be forced into the tissue. The retention units 104, 104' can provide for shaping the annulus even with a reduced clamping force as desired, since the retention units 104, 104' can provide for fixing the shape of the annulus in the radial direction due to the retention force. This provides for a more reliable implantation at the heart valve both in the short term and in the long term.

[0068] The first holding unit 104 and the second holding unit 104' can extend along the axis 103 in opposite directions, as schematically illustrated, for example, Figure 1a and Figure 1b in. It is conceivable that the first holding unit 104 and the second holding unit 104' can extend at an angle with respect to the axis 103, and further, the aforementioned angle can vary along the length of the first support ring 101 and the second support ring 102 for different holding units 104, 104'. This angle can be varied such that the first holding unit 104 and the second holding unit 104' extend to firmly engage and penetrate into the tissue along the length of the first support ring 101 and the second support ring 102. The first holding unit 104 and the second holding unit 104' extending away from the first support ring 101 and the second support ring 102 should be interpreted as also including the variation of the above-mentioned angle. The angle at which the holding unit extends can be varied, as further described in the following examples.

[0069] In the first state, as described above, the first holding unit 104 and the second holding unit 104' can taper in a direction away from the first support ring 101 and the second support ring 102, as Figure 1a illustrated. Thus, when the first ring 101 and the second ring 102 are displaced relative to each other and introduced into the opposite sides of the heart valve leaflet in the shape seen in Figure 1b , the first holding unit 104 and the second holding unit 104' have reverse positions, where the tapered shape points towards the opposite support rings 101, 102 to engage the tissue clamped between the first support ring 101 and the second support ring 102 ( Figure 3 ).

[0070] The first holding unit 104 and the second holding unit 104' can be conical, as illustrated by the example in Figure 7b . This provides an effective penetration into the tissue while minimizing the amount of cutting, since the first holding unit 104 and the second holding unit 104' taper to a point. Thus, tissue damage can be minimized while providing a firm anchoring of the first support ring 101 and the second support ring 102. The first holding unit 104 and the second holding unit 104' can also be shaped as a frustum of a cone, as illustrated by the example in Figure 11c .

[0071] The holding units 104, 104' can be integrated with the first support ring 101 and / or the second support ring 102, as schematically illustrated, for example, in Figure 3 , Figure 4 , Figure 11a -c, Figure 18a -b. By integrating the holding units 104, 104' with the first ring 101 and / or the second ring 102, a stable, less complex and easier-to-implement fixing mechanism can be provided. As, for example,Figure 3 Exemplarily, a plurality of retention units 104, 104' may be provided on respective first support member 101 and second support member 102. Each individual retention unit 104, 104' may engage or penetrate the tissue at a short distance to minimize the amount of tissue damage. The sum of the retention forces and frictions generated by all the retention units 104, 104' may still provide a strong fixation into the tissue. Since each individual retention unit 104, 104' has a relatively small size, scar healing will be rapid. This provides a non-invasive yet still firm fixation of the annuloplasty device 100. Thus, the retention units 104, 104' may provide tissue fixation at multiple points across the annuloplasty device 100, resulting in a reduced force at each fixation point and eliminating the need for bulky suturing or knotting devices. There is also no risk of coronary artery occlusion or coronary sinus perforation. Thus, the annuloplasty device 100 provides operational simplicity and a more time-efficient procedure compared to suturing.

[0072] The first support ring 101 and / or the second support ring 102 may be formed of a material having a circumferential wall 105 that encloses an internal channel 106 extending along the longitudinal axis 111 of the first support ring 101 and / or the second support ring 102. In the case where the annuloplasty device 100 includes the retention units 104, 104', the latter may extend through respective openings 107 in the circumferential wall 105, as schematically illustrated in Figure 7a -b and Figure 11a -c, Figure 18a as schematically illustrated in -b. Due to the support provided by the circumferential wall 105 at the openings 107, this provides a secure fixation of the retention units 104, 104' at the first support ring 101 and / or the second support ring 102.

[0073] The first retention unit 104 and the second retention unit 104' may extend through the internal channel 106, as schematically illustrated in Figure 7a -b. This provides a further improvement in the stability and strength of the fixation of the first retention unit 104 and the second retention unit 104'. The first retention unit 104 and the second retention unit 104' may be supported by the inner surface 109 of the internal channel 106 opposite the openings 107, as schematically illustrated in Figure 7a .

[0074] The first retaining unit 104 and the second retaining unit 104' may have respective attachment points 108 to an inner surface 109 of the inner channel 106 opposite the opening 107. Securing the first retaining unit 104 and the second retaining unit 104' to the inner surface 109 provides a particularly firm anchoring. The first retaining unit 104 and the second retaining unit 104' may be welded to the respective attachment points 108. The circumferential wall 105 may have a tubular shape surrounding the inner channel 106. In some applications, having a first support ring 101 and a second support ring 102 formed of a tubular material may provide a desired compressive force against tissue. In other examples, the first support ring 101 and / or the second support ring 102 may have a non-circular cross-section, as Figure 20a -c, Figure 21a -d schematically illustrated.

[0075] In an example where the annuloplasty device 100 includes retaining units 104, 104', the retaining units 104, 104' may be formed from the material of the circumferential wall 105. This may provide a particularly firm and robust retaining unit 104, 104' and an overall firm fixing mechanism for the annuloplasty device 100. The retaining unit 104 may be formed from the material of the first support member 101. Similarly, the retaining unit 104' may be formed from the material of the second support member 102. The retaining units 104, 104' may be cut and formed from the material of the circumferential wall 108. The first support member 101 and the second support member 102 may be integrated and formed from a single continuous material. Thus, the retaining units 104, 104' may also be formed from such material.

[0076] The retaining units 104, 104' may be cut to form various shapes for optimizing the clamping force into the tissue. The retaining units 104, 104' may be formed by different cutting techniques (such as milling or laser cutting techniques). It is also contemplated that the retaining units 104, 104' are fixed or integrated onto the respective support rings 101, 102 by other methods or by being formed from other materials.

[0077] The first front portion 114 may include a first plurality 104a of the first retaining units 104, and the second front portion 114' may include a smooth surface without the retaining unit 104', as Figure 18a schematically illustrated. This provides a firm anchoring into the tissue using the second front portion 114 on the atrial side while minimizing the risk of tissue damage along the first front portion 114 within the ventricle.

[0078] The first posterior arch 113 may include a second plurality 104p of the first retaining units 104, such as for example Figure 17a and Figure 18bis schematically illustrated in the relevant cross-section B'-B'. The second plurality 104p of first retaining units 104 may taper in a direction extending substantially parallel to the central axis 103. The second plurality 104p of first retaining units 104 on the first support ring 101 may thus extend substantially straight into the tissue along the posterior leaflet on the atrial side parallel to the central axis 103.

[0079] The second posterior arch 113' may also include a second plurality 104p' of second retaining units 104', such as, for example, Figure 17b and Figure 18b is schematically illustrated in the relevant cross-section B'-B'. The second plurality 104p' of second retaining units may taper in a direction extending substantially parallel to the central axis 103. That is, the retaining units 104p, 104p' on the first posterior arch 113 and the second posterior arch 113' may be substantially parallel to each other and parallel to the central axis 103. This provides a firm fixation to the valve anatomy.

[0080] Turning to Figure 11a -b and Figure 16 in the example, the first anterior portion 114 may include a first plurality 104a of first retaining units 104. The first plurality 104a of first retaining units may taper in a first direction 104A forming a first angle (v a ) with the central axis 103, as Figure 16 and Figure 11a is schematically illustrated in the relevant cross-section A-A. In one example, Figure 9 - 16 in the annuloplasty device 100 is in the aforementioned relaxed first state. That is, as seen in, for example, Figure 11a and Figure 16 the retaining units 104a, 104a' extend in a direction away from each other, while in the displaced second state, the first support ring 101 and the second support ring 102 will be displaced such that their relative positions are shifted, and the retaining units 104a, 104a' extend towards each other. However, in another example, as described above, the first support ring 101 and the second support ring 102 do not reverse in the relaxed state. The first plurality 104a of first retaining units 104 extending at an angle (v a ) with respect to the central axis 103 provides improved anchoring into the tissue at the anterior leaflet on the atrial side in some applications.

[0081] The first direction 104A may extend at least partially radially inwards towards the central axis 103, that is, as Figure 11aThe opposite direction (R) schematically indicated therein. The first plurality 104a of first holding units 104 can be clamped into the tissue at a radially inward angle, whereby in some procedures the risk of dislocation caused by the force acting radially inward on the first support ring 101 can be minimized.

[0082] The first posterior arch 113 can include a second plurality 104p of first holding units 104, as, for example, Figure 16 and Figure 11b illustrated schematically in the relevant cross-section B-B therein. The second plurality 104p of first holding units 104 can taper in a second direction 104P extending substantially parallel to the central axis 103. The second plurality 104p of first holding units 104 on the first support ring 101 can thus extend substantially straight into the tissue along the posterior leaflet on the atrial side parallel to the central axis 103. The combination of straight holding units 104p on the posterior arch 113 and angled holding units 104a on the anterior portion 114 provides effective but convenient anchoring into the tissue in some procedures and anatomies.

[0083] The second anterior portion 114' can include a first plurality 104a' of second holding units 104', as, for example, Figure 16 and Figure 11a illustrated schematically in the relevant cross-section A-A. The first plurality 104a' of second holding units can taper in a second direction 104A' forming a second angle (v a ') with the central axis 103. The second direction 104A' can extend at least partially radially outward toward the radial direction (R), as Figure 11a shown. The radial direction (R) is perpendicular to the central axis 103. The second support ring 102 will be disposed in the ventricle in the displaced second state, whereby the first plurality 104a' of second holding units 104' will extend into the tissue on the ventricular side along the anterior leaflet at a second, radially outward angle (v a '). This provides effective anchoring into the aortic septal wall in some procedures. In one example, the combination of holding units 104a on the anterior portion 114 of the first support ring 101 angled radially inward and holding units 104a' on the anterior portion 114' of the second support ring 101 angled radially outward provides effective anchoring and retention of the annuloplasty device 100 on opposite sides of the valve 100.

[0084] The second posterior arch 113' can also include a second plurality 104p' of second holding units 104', as, for example, Figure 16 and Figure 11bis schematically illustrated in cross-section B-B. The second plurality 104p' of second retention units may taper in a second direction 104P' that extends substantially parallel to the central axis 103. That is, the retention units 104p, 104p' on the first posterior arch 113 and the second posterior arch 113' may be substantially parallel to each other and parallel to the central axis 103.

[0085] The first anterior portion 114 and the second anterior portion 114' may include retention units 104, 104' that are arranged adjacent to the "triple-cone region" of the mitral valve and adjacent to the commissures 302, 302'. Clamping and fixation into the tissue at these regions provides a firm and secure anchoring of the annuloplasty device 100 to the heart valve. The retention units 104, 104' may be evenly spaced along at least a portion of the first anterior portion 114 and / or the second anterior portion 114', as Figure 16 and Figure 17a illustrated. This uniform distribution of fixation points provides reliable anchoring to the tissue, thereby minimizing the risk of local pressure peaks. However, it should be understood that the distance between the respective retention units 104, 104' may vary to optimize the anchoring of the annuloplasty device 100 to different anatomies. The first anterior portion 114 and / or the second anterior portion 114' may each have 5 to 6 retention units 104, 104'. The first posterior portion 113 and / or the second posterior portion 113' may each have 6 to 8 retention units 104, 104'. This may provide particularly effective fixation to the tissue while minimizing overall tissue penetration. However, it should be understood that the number of retention units 104, 104' may vary to optimize the anchoring of the annuloplasty device 100 to different anatomies and different-sized valves. In one example, the length of the retention units 104, 104' is in the range of 0.5 - 1.5 mm. In another example, the length of the retention units 104, 104' is in the range of 0.8 - 1.2 mm, such as 1.0 mm, which may provide particularly favorable fixation into the tissue while being easily deployable via a delivery catheter.

[0086] Regarding Figure 9 -19 described, the advantageous features of the retention units 104, 104' provide an improved annuloplasty device 100 that has convenient anchoring into the tissue and does not have the aforementioned displacement (d) even in the relaxed state. That is, in this case, the annuloplasty device 100 has a relaxed state corresponding to the figure in Figure 1b . That is, the retention units 104, 104' point in the direction of each other in the relaxed state. Thus, the shape and positioning of the retention units 104, 104' also provide separate aspects of the present invention.

[0087] As described above, the first support ring 101 may include a first posterior arch 113, and the second support ring includes a second posterior arch 113'. The first posterior arch 113 and the second posterior arch 113' may be adapted to conform to the posterior side of the heart valve. The first posterior arch 113 and the second posterior arch 113' may be separated by an intermediate front portion 114. Although the advantages of having the retaining units 104, 104' on the front portions 114, 114' have been described with reference to the examples of Figure 11a and Figure 16 , it is conceivable that the front portion 114 may include a smooth surface, as described in the example above with respect to 18. That is, the smooth surface may be without the retaining units 104, 104'. Figure 4 Additional examples are illustrated in, showing the rings 101, 102 in an expanded configuration. The retaining units 104, 104' may thus be arranged on the respective first posterior arch 113 and second posterior arch 113'. The first retaining unit 104 and the second retaining unit 104' may be arranged to have an offset distance 115 from the front portion 114 towards the respective first posterior arch 113 and second posterior arch 113'. Thus, the front portion 114 may include a smooth surface without the retaining units 104, 104'. That is, the first retaining unit 104 and the second retaining unit 104' may be arranged to have an offset distance 115 from the front portion 114 towards the respective first posterior arch 113 and second posterior arch 113'. The offset distance 114 may be varied to optimize the annuloplasty device 100 for a particular situation. The first support 101 may have a retaining unit 104 extending in a first direction, and the second support 102 may have a retaining unit 104' extending in the opposite direction.

[0088] The position of the first retaining unit 104 may be offset radially (perpendicular to the axis 103) with respect to the second retaining unit 104'. Thus, although both the first retaining unit 104 and the second retaining unit 104' may extend vertically, the risk of the first retaining unit 104 engaging the second retaining unit 104' is avoided, which otherwise could cause complete penetration of the valve tissue. This can be achieved by having support rings 101, 102 of different diameters and / or by arranging the first retaining unit 104 and the second retaining unit 104' to extend from opposite sides of the respective support rings 101, 102.

[0089] It should be understood that in one example, only the first support ring 101 or the second support ring 102 may include the retaining units 104, 104'. In additional examples, the annuloplasty device 100 does not include any retaining units 104, 104', as illustrated in Figure 20a -c, Figure 21a -d. In Figure 20a -c, Figure 21aIn the example of -d, due to the transition section 120, the curvature or position of the first support ring 101 and the second support ring 102 can be carefully adjusted to fit the anatomical structure, thereby providing a fixed position of the annuloplasty device 100 without the retention units 104, 104'.

[0090] In some examples, the first support ring 101 and / or the second support ring 102 may have a non-circular cross-section, as Figure 20a -c, Figure 21a -d schematically illustrated. The first support ring 101 and / or the second support ring 102 may be formed of solid material without an internal channel 106 that may have a non-circular cross-section. Having a non-circular shape provides an increased compressive force between the first ring 101 and the second ring 102 in the coiled configuration while maintaining a compact cross-sectional profile of the first ring 101 and the second ring 102. The dimensions of the sides of the cross-section may vary in order to provide optimized bending resistance of the support rings 101, 102. The cross-section may be substantially rectangular.

[0091] The cross-section may vary along the longitudinal direction 111 of the first support ring 101 and / or the second support ring 102. Changing the aforementioned dimensions of the sides (e.g., the sides of a rectangle) along the length of the first support ring 101 and the second support ring 102 (i.e., along the longitudinal direction 111) allows the flexibility of the rings 101, 102 to be changed along the longitudinal direction 111 and is customized to fit different anatomical positions around the annulus of the heart valve. This provides better adaptation to tissue movement, which may be greater in local segments of the annulus while other segments may have increased rigidity for a stronger clamping effect between the first support ring 101 and the second support ring 102. Thereby, a more secure and stable positioning of the device 100 can be provided and long-term function can be improved. The varying cross-section also provides optimized flexibility regarding the delivery and positioning phases of the annuloplasty device 100. For example, portions of the first support ring 101 and the second support ring 102 (such as commissural segments 113'b, 113'c) (see, for example Figure 20c ) that undergo the greatest bending motion when inserted into the delivery catheter may have a cross-section with increased flexibility, for example, by having a reduced area and / or reduced width in the direction in which the support rings 101, 102 bend.

[0092] Figure 20a -c, Figure 21a -d is a schematic diagram of another example of the annuloplasty device 100, which includes a transition section 120, providing the benefits as described above with respect to FIGS. 1-19.

[0093] The second front portion 114' may include a reverse segment 124 that extends parallel to the first coil plane 101' and the second coil plane 102'. The reverse segment 124 and the second rear arch portion 113' extend on opposite sides of the first support ring 101 with respect to the direction of the central axis 103, as schematically illustrated, for example, in Figure 21d the side view of Figure 20b and the perspective view of Figure 20b . When the first support ring 101 and the second support ring 102 are arranged on opposite sides of the heart valve, raising a section of the second front portion 114' above the first support ring 101 (i.e., above the first front portion 114 as illustrated in Figure 20b ) provides an increased compressive force along the front portions 114, 114'. When the annuloplasty device 100 is positioned at the heart valve and the second support ring 102 is arranged on the atrial side, the reverse segment 124 will be pushed downward when forced to move to the appropriate position at the heart valve, i.e., in a direction opposite to the direction of the central axis 103 in Figure 20b . Thereby, the front portion 114' will also be placed on the atrial side of the heart valve. Having the reverse segment 124 in the relaxed state of the annuloplasty device 100 means that the second front portion 114' will tend towards the relaxed shape without external force, as illustrated in Figure 20b . The reverse segment of the second front portion 114' will thus tend to reach a position above the first front portion 114 with respect to the central axis 103 (as shown in

[0094] The first support ring 101 and the second support ring 102 have respective first free ends 116 and second free ends 116' that are configured to be arranged on opposite sides of the native heart valve leaflets, as described above. In one example, the reverse segment 124 transitions onto the free end 116' of the second support ring 102 at the front transition segment 125, as schematically illustrated in Figure 21d the side view of Figure 20b and the perspective view of Figure 20bIllustration. The second support ring 102 may include a free end 116', which is bent towards the free end 116 of the first support ring 101 in the plane of the coil planes 101', 102', as Figure 20a -b further illustrates. The second support ring 102 may thus be bent after the second front portion 114', i.e., adjacent to the commissural location. In one example, the front transition section 125 is arranged at the end towards the second front portion 114' in the direction along the free end 116', such that substantially the entire bent portion of the second support ring 102 after the second front portion 114' is arranged on the same side of the first support ring 101 as the second posterior arch portion 113' with respect to the direction of the central axis 103. This provides an improved fit to the surrounding anatomy of the annuloplasty device 100 in some examples.

[0095] The second front portion 114' may include a second front transition section 126, wherein the second support ring 102 is bent in the direction along the central axis 103 to form a gradually rising curve of the reverse section 124, as Figure 20b illustrated. The gradually descending curve of the reverse section 124 towards the free end 116' may thus be formed by the above-mentioned front transition section 125. Regarding Figure 20a -c, Figure 21a -d, the advantageous features of the reverse section 124 and the front transition sections 125, 126 provide an improved annuloplasty device 100 that also has a stronger hold in tissue without the above-mentioned transition section 120. The reverse section 124 thus also provides a separate aspect of the present invention.

[0096] In Figure 20a -c, Figure 21a -d examples, the lengths of the first support ring 101 and the second support ring 102 substantially form two complete rings. This provides an improved anchoring of the annuloplasty device 100 to the heart valve in some examples. In some cases, such as the offset distance 117 as described regarding Figure 6 may be advantageous.

[0097] The second posterior arch portion 113' may include a central posterior arch portion 113'a, and further a first commissural segment 113'b and a second commissural portion 113'c on either side of the central posterior arch portion 113'a, as Figure 20c and Figure 21c -d schematically illustrates. The first support ring 101 transitions to the first commissural segment 113'b on the transition section 120, and the second commissural segment 113'c is connected to the second front portion 114'. In one example, the separation distance (d2) between the first support ring 101 and the central posterior arch portion 113'a along the central axis 103 is less than the separation distances (d1, d3) between the first support ring 101 and either the first commissural segment 113'b or the second commissural segment 113'c.Figure 21c The side view is a schematic view showing a reduced distance (d2) between the first support ring 101 and the second support ring 102 compared to the distances (d1, d3) along either the first commissural segment 113'b or the second commissural segment 113'c. This provides improved compression between the first support ring 101 and the second support ring 102 along the central posterior arch 113'a. Thereby, fixation of the annuloplasty device 100 can be facilitated. At the same time, the larger separation distances (d1, d3) at the first commissural segment 113'b and the second commissural segment 113'c can provide a more reliable fit to the tissue at the cardiac valve commissure anatomy, for example, as described above with respect to having a separation distance (d1) at the transition segment 120.

[0098] In one example, the separation distance (d1) between the first commissural segment 113'b and the first support ring 101 is greater than the separation distance d3 between the second commissural segment 113'c and the first support ring 101. Figure 21c An example of such an increased separation distance (d1) is shown. Thus, as described above with respect to the transition segment 120, this provides an improved fit to the anatomy, where the first support ring 101 extends through the commissure and transitions to the second support ring 102 on the opposite side of the cardiac valve. In one example, the separation distances d2 and d3 can be substantially the same.

[0099] Regarding Figure 21b -c, Figure 21a The advantageous features of the relationship between the described separation distances (d1, d2, d3) -d provide an improved annuloplasty device 100 that also has a more secure anchoring into the tissue without the aforementioned reverse segment 124. Thereby, the separation distances (d1, d2, d3) also provide separate aspects of the present invention.

[0100] The first support ring 101 and the second support ring 102 can have respective free ends 116, 116', as Figure 6 illustrated. The free ends 116, 116' can be configured to be disposed on opposite sides of the native cardiac valve leaflets. The two free ends 116, 116' can be displaced from each other by a peripheral offset distance 117 that extends in the coil plane 118, as Figure 6is schematically illustrated. The coil plane 118 is substantially parallel to the annular perimeter 119 of the coil formed by the first support ring 101 and the second support ring 102, and perpendicular to the axis 103. Thus, when in the coiled configuration, the coil plane 118 corresponds to the plane spanned by the annular perimeter 119 of the device 100. The perimeter offset distance 117 between the two free ends 116, 116' thus extends substantially perpendicular to the central axis 103. This means that when the device 100 is positioned around the annulus of a heart valve in the implanted state, the two free ends 116, 116' will be separated along the plane of the valve. Having such an offset 117 (resulting in a reduced length of the first or second support ring 101, 102) in the plane of the valve may be advantageous in some anatomies where there is a risk of interfering with valve movement. In Figure 6 the example, the offset 117 extends along the anterior portion 114. In another example, such as Figure 16 and Figure 17a schematically illustrate, the length of the offset 117 is reduced and instead extends along a portion of the posterior arch 113. This further combines with having retention units 104, 104' on at least one of the anterior portions 114, 114' to provide enhanced anchoring strength to tissue when the tissue is clamped along the two anterior portions 114, 114' in some applications. In this example, the compressive force between the first ring and the second ring 101, 102 can also be applied to the "tri-cone" region of the valve adjacent to the commissures 302, 302'. In Figure 16 and Figure 17a the example, the total circumference of the first ring and the second ring 101, 102 can be approximately 710 degrees. In some examples, the offset 117 can be removed to make the first support ring 101 and the second support ring 102 have a complete 720-degree loop, for example, as illustrated in the examples of Figure 20a -c, Figure 21a -d.

[0101] The proximal connector element 121 can be fixed to the free end 116 of the first support ring 101. Figure 13 The example in shows a connector element 121 that includes an orifice for interlocking with a delivery catheter. Different types of connector elements can be provided at the free end 116. The distal end 116' of the second support ring 102 can be shaped with a blunt tip to reduce the risk of tissue damage, see Figure 12 .

[0102] Disclosed is a method 200 for repairing a defective heart valve. Method 200 is described in Figure 8 in connection with FIGS. 1-7 and Figure 9-21 is schematically illustrated. The order of the described steps should not be construed as restrictive, and it is contemplated that the order of the steps can vary according to a particular process. Method 200 includes: 201, positioning the second support ring 102 of the annuloplasty device 100 on the ventricular side of the heart valve. Method 200 further includes: 202, positioning the first support ring 101 of the annuloplasty device 100 on the atrial side of the heart valve. The first support ring 101 and the second support ring 102 are arranged as coils around the central axis 103 on opposite sides of the native heart valve leaflets of the heart valve. The first support ring 101 and the second support ring 102 are positioned such that the first support ring 101 transitions to the second support ring 102 on the transition section 120 located at the commissures 302, 302' of the heart valve leaflets. The first support ring 101 and the second support ring 102 extend in respective first coil planes 101' and second coil planes 102' that are substantially perpendicular to the central axis 103. The transition section 120 is at least partially curved along the central axis 103 such that the first coil plane 101' is separated from the second coil plane 102' by a distance (d1) along the central axis 103 at the transition section 120. Method 200 provides the benefits discussed above with respect to the annuloplasty device 100 and FIGS. 1-21. Due to the improved adaptability to the surrounding anatomy at the heart valve and the increased compressive force between the first support ring 101 and the second support ring 102, method 200 allows for convenient anchoring of the annuloplasty device 100 at the heart valve without the need to apply sutures, clips, or other external fastening devices.

[0103] The present invention has been described above with reference to specific embodiments. However, other embodiments than those described above are equally possible within the scope of the present invention. The different features and steps of the present invention can be combined in combinations different from those described. The scope of the present invention is limited only by the appended patent claims. More specifically, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary, and the actual parameters, dimensions, materials, and / or configurations will depend on the particular application in which the teachings of the present invention are used.

Claims

1. An annuloplasty device (100), comprising: A first support ring (101) and a second support ring (102), forming a coiled structure, wherein the first support ring and the second support ring are arranged as coils around a central axis (103), wherein the first support ring and the second support ring are configured to be arranged on opposite sides of the native cardiac valve leaflets (301) of the heart valve, wherein the first support ring transitions to the second support ring at a transition section (120), and wherein the transition section is adapted to be arranged at the commissures (302, 302') of the heart valve leaflets, wherein the first support ring and the second support ring extend in respective first coil planes (101') and second coil planes (102') that are substantially perpendicular to the central axis, and wherein the transition section is at least partially bent along the central axis such that the first coil plane is separated from the second coil plane by a distance (d1) along the central axis at the transition section, The first support ring includes a first posterior arch (113) and a first anterior portion (114), The second support ring includes a second posterior arch (113') and a second anterior portion (114'), The first posterior arch and the second posterior arch are adapted to conform to the posterior side of the heart valve, and the first anterior portion and the second anterior portion are adapted to conform to the anterior side of the heart valve, The second anterior portion (114') includes a reverse section (124) that extends parallel to the first coil plane and the second coil plane, wherein the reverse section and the second posterior arch (113') extend on opposite sides of the direction of the first support ring with respect to the central axis (103).

2. The annuloplasty device according to claim 1, wherein, The first support ring is adapted to be arranged on the atrial side of the heart valve, and the second support ring is adapted to be arranged on the ventricular side of the heart valve.

3. The annuloplasty device according to claim 1 or 2, wherein, The transition section is at least partially bent along a radial direction (R) that is perpendicular to the central axis (103) such that the transition section is concave towards the radial direction.

4. The annuloplasty device according to claim 1, wherein, At least a portion of the first anterior portion (114) and / or the second anterior portion (114') is bent to form respective concave sections (123, 123') that are concave towards a radial direction (R) perpendicular to the central axis (103).

5. The annuloplasty device according to claim 1 or 4, wherein, The first anterior portion (114) is displaced from the second anterior portion (114') by a distance (l1) along a radial direction (R) perpendicular to the central axis (103) such that at least a portion of the second anterior portion (114') extends from the central axis (103) at a greater radius (r) compared to the first anterior portion (114).

6. The annuloplasty device according to claim 1 or 2, wherein: The first posterior arch (113) is displaced from the second posterior arch (113') by a distance (l2) along a radial direction (R) perpendicular to the central axis (103).

7. The annuloplasty device according to claim 6, wherein, At least a portion of the first posterior arch (113) extends from the central axis (103) along the radial direction (R) at a greater radius (r) compared to the second posterior arch (113').

8. The annuloplasty device according to claim 1, wherein, The first support ring and the second support ring have respective first free ends (116) and second free ends (116') configured to be disposed on opposite sides of the native heart valve leaflet, and the reverse segment transitions to the free end of the second support ring on the front transition segment (125). Wherein, the front transition segment is at least partially curved along the central axis such that the direction of the free end (116') of the second support ring relative to the central axis (103) is disposed on the same side of the first support ring as the second posterior arch (113').

9. The annuloplasty device according to claim 1 or 2, wherein The second posterior arch (113') includes:[[]] A central posterior arch (113'a); and[[]] A first commissural segment (113'b) and a second commissural segment (113'c) on either side of the central posterior arch,[[]] Wherein, the first support ring transitions to the first commissural segment (113'b) on the transition segment, and the second commissural segment (113'c) is connected to the second front portion (114').[[]] Wherein, the separation distance (d2) along the central axis between the first support ring and the central posterior arch is less than the separation distance (d1, d3) between the first support ring and either of the first commissural segment and the second commissural segment.[[]] 10. The annuloplasty device according to claim 9, wherein, The separation distance (d1) between the first commissural segment (113'b) and the first support ring is greater than the separation distance (d3) between the second commissural segment (113'c) and the first support ring.[[]] 11. The annuloplasty device according to claim 1 or 2, wherein, The first support ring includes a first retaining unit (104), and the second support ring includes a second retaining unit (104'), wherein the first retaining unit and the second retaining unit extend axially in opposite directions.[[]] 12. The annuloplasty device according to claim 11, wherein the first support ring and the second support ring have a separation distance (d) and are movable relative to each other along the central axis to change the separation distance (d).[[]] Among them, The first support ring and the second support ring comprise an elastic shape memory material and are movable along the central axis from a relaxed first state to a displaced second state, whereby, in the first state:[[]] The first retaining unit extends from the first support ring in a direction away from the second support ring, and[[]] The second retaining unit extends from the second support ring in a direction away from the first support ring, and[[]] Wherein, in the second state:[[]] The first retaining unit extends from the first support ring in a direction towards the second support ring, and[[]] The second retaining unit extends from the second support ring in a direction towards the first support ring.[[]] Thereby, in use, when displaced to the second state to clamp the leaflet from the opposite sides, the first support ring and the second support ring tend to assume the first state, and the first retaining unit and the second retaining unit generate retaining forces on opposite sides.[[]] 13. The annuloplasty device according to claim 11, wherein, The first retaining unit and the second retaining unit are conical.[[]] 14. The annuloplasty device according to claim 1 or 2, wherein, The first support ring includes a first posterior arch (113) and a first front portion (114).[[]] Wherein, the first front portion (114) includes a first plurality of first holding units (104a), and Wherein, the second front portion (114') includes a smooth surface without holding units.

15. The annuloplasty device according to claim 14, wherein the first posterior arch portion (113) includes a second plurality of first holding units (104p), and the second plurality of first holding units (104p) taper in a direction substantially parallel to the central axis (103). Among them, The second posterior arch portion (113') includes a second plurality of second holding units (104p'), and the second plurality of second holding units (104p') taper in a direction substantially parallel to the central axis (103).

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