Annulus repair device

Abstract

An annuloplasty device is disclosed that includes first and second support rings configured to be arranged axially in a first configuration in a coil-like manner, the first and second support rings configured to be arranged on opposite sides of the native heart valve leaflets of a heart valve, the first and second support rings axially spaced apart a first pitch distance in the first configuration, the first and second support rings configured to assume a contracted state having a second pitch distance that is shorter than the first pitch distance, and the first and second support rings configured to be transitionable between the first configuration and the contracted state for clamping the heart valve leaflets. A method for repairing a defective heart valve is also disclosed. [Selected figure] Figure 5b

Description

[Technical field]

[0001] The present invention relates generally to the field of heart valve repair. More particularly, the present invention relates to annuloplasty devices or implants, such as annuloplasty rings or annuloplasty helices, for placement in a heart valve annulus and methods of repairing defective heart valves. [Background technology]

[0002] Diseased mitral and tricuspid valves frequently require replacement and repair. The mitral and tricuspid leaflets or supporting chordae may degenerate and weaken, or the annulus may widen, leading to valve leakage. Mitral and tricuspid valve replacement and repair is frequently performed with the aid of an annuloplasty ring, which is used to reduce the diameter of the annulus or otherwise change the shape of the annulus, or generally assist as a support structure during the valve replacement or repair procedure. Annuloplasty rings are typically implanted around the annulus of the heart valve.

[0003] A problem with prior art annuloplasty implants is to achieve correct placement on the heart valve and fixation of the implant in the correct position. Suturing of devices for annuloplasty implants has the drawback of being difficult to suture in the correct position, which leads to insufficient suture strength and also increases the risk for the patient in very time-consuming procedures. Furthermore, suturing devices are often not compact enough for catheter-based procedures. The use of clips to position annuloplasty implants is also associated with challenges, especially when implanting spiral rings that are to be placed on either side of the heart valve. Insufficient fixation of such implants leads to traumatic effects, since the fixation structure must ensure the correct position of the device over time. Therefore, a further problem in the prior art is also to achieve reliable fixation to the annulus of the heart valve. Long-term stability is important in this respect, since annuloplasty implants are intended to function for many years.

[0004] The issues listed above increase patient risk with potentially dire consequences for patients and the healthcare system.

[0005] Thus, an improved annuloplasty implant would be advantageous, in particular making it possible to avoid many of the problems and compromises mentioned above, and inter alia ensuring secure fixation of the annuloplasty implant at the implant stage, improving patient safety as well as a less complicated procedure for long-term function. Related methods would also be advantageous. Summary of the Invention

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

[0007] According to a first aspect, there is provided an annuloplasty device comprising a first support ring and a second support ring configured to be arranged in a coil-like manner about an axial direction in a first configuration, the first support ring and the second support ring configured to be arranged on opposite sides of a native heart valve leaflet of a heart valve, the first support ring and the second support ring axially spaced apart a first pitch distance in the first configuration, the first support ring and the second support ring configured to adopt a contracted state having a second pitch distance in the axial direction that is shorter than the first pitch distance, and the first support ring and the second support ring configured to be transitionable between the first configuration and the contracted state for clamping the heart valve leaflet.

[0008] According to a second aspect, there is provided a method of repairing a defective heart valve, the method comprising: positioning first and second support rings of an annuloplasty device in a first configuration on opposing sides of native heart valve leaflets of the heart valve in a coil-like manner; activating a contracted state of the annuloplasty device to reduce a first pitch distance between the first and second support rings in the first configuration to a second pitch distance that is less than the first pitch distance, whereby the first and second support rings move towards each other and sandwich the native heart valve leaflets.

[0009] Further embodiments of the invention are defined in the dependent claims, the features of the second aspect of the disclosure being as described above with respect to the first aspect mutatis mutandis.

[0010] Some examples of the present disclosure provide for easy placement of annuloplasty implants at a heart valve.

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

[0012] Some examples of the present disclosure may allow for less time spent anchoring the annuloplasty to the target site.

[0013] Some examples of the present disclosure provide for ensuring long-term function and position of the annuloplasty implant.

[0014] Some examples of the present disclosure provide a reduced risk of damaging cardiac anatomical structures such as the valve annulus or leaflets.

[0015] Several examples of the present disclosure allow for easy guidance of an annuloplasty implant relative to the heart annulus.

[0016] Some examples of the present disclosure allow for more reliable implantation of annuloplasty implants into narrow anatomical structures.

[0017] Some examples of the present disclosure allow for avoidance of interference of the annuloplasty implant with the chordae of the valve leaflets.

[0018] It is emphasized that the term "comprises / comprising" when used in this specification is used to indicate the presence of stated features, integers, steps or components, but does not exclude the presence or addition of one or more other features, integers, steps, components or groups thereof. [Brief description of the drawings]

[0019] These and other aspects, as well as features and advantages of possible embodiments of the present invention will become apparent and become apparent from the following description of embodiments of the invention, which proceeds with reference to the accompanying drawings. [Figure 1a] FIG. 1a is a schematic illustration of an annuloplasty implant or device having first and second support rings in a first configuration and spaced apart a first axial pitch distance, according to one embodiment. [Figure 1b] FIG. 1b is a schematic diagram of an annuloplasty device having first and second support rings separated by a second axial pitch distance in a contracted state according to one embodiment. [Figure 2a] FIG. 2a is a schematic diagram of an annuloplasty device positioned on a heart valve in a first configuration, according to one embodiment. [Figure 2b] FIG. 2b is a schematic diagram of an annuloplasty device positioned on a heart valve in a contracted state, according to one embodiment. [Diagram 3] FIG. 3 is a schematic diagram of a side view of an annuloplasty device according to one embodiment. [Figure 4] FIG. 4 is a schematic diagram of a side view of an annuloplasty device according to one embodiment. [Figure 5a-b] 5a-b are schematic side views of an annuloplasty device with an internal channel according to one embodiment. [Figure 5c-f] 5c-f are detailed schematic side views of an annuloplasty device with an internal channel according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a schematic diagram of a side view of an annuloplasty device according to one embodiment. [Figure 7] FIG. 7 is a schematic diagram of a side view of an annuloplasty device according to one embodiment. [Figure 8] FIG. 8 is a schematic diagram of a side view of an annuloplasty device with an internal channel according to one embodiment. [Figure 9a-b] 9a-b are schematic side views of an annuloplasty device according to one embodiment. [Figure 10a-b] 10a-b are schematic cross-sectional views of an annuloplasty device according to one embodiment. [Figure 11a] FIG. 11a is a flow chart of a method for repairing a defective heart valve, according to one embodiment. [Figure 11b] FIG. 11b is another flow chart of a method for repairing a defective heart valve, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Description of the embodiments Hereinafter, specific embodiments of the present invention will 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 being limited to the embodiments described herein. Rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. In the drawings, like numbers refer to like elements.

[0021] The following description focuses on one embodiment of the present invention that is applicable to heart valve implants such as annuloplasty rings, however, it will be understood that the invention is not limited to such applications and may be applied to many other annuloplasty and heart valve implants, including, for example, replacement valves, and other medical implantable devices.

[0022] 1a-b are schematic illustrations of an annuloplasty device 100 or implant comprising a first support ring 101 and a second support ring 102 configured to be arranged like a coil around an axial direction 103 in a first configuration. The first support ring 101 and the second support ring 102 are configured to be arranged on opposite sides of the native heart valve leaflets 301 of a heart valve, as shown in FIG. 2a-b. As shown in FIG. 2a, the first support ring 101 can be arranged on the atrial side of the heart valve and the second support ring 102 can be arranged on the ventricular side. Thus, the first support ring 101 extends along the annulus of the heart valve. The first support ring 101 and the second support ring 102 are connected to form a coil-shaped or helical-shaped ring. The coil extends through the valve opening (dashed line) at its commissure 302, as shown diagrammatically in FIG. 2a. As shown in Figures 1a and 2a, in a first configuration, the first support ring 101 and the second support ring 102 are spaced apart in an axial direction 103 by a first pitch distance (p1). As shown in Figures 1b and 2b, the first support ring 101 and the second support ring 102 are configured to assume a contracted state having a second pitch distance (p2) in the axial direction 103 that is less than the first pitch distance (p1). The pitch distances (p1, p2) are the separation distances (i.e., gaps) between adjacent support rings 101, 102 in the axial direction 103. The first support ring 101 and the second support ring 102 are configured to be transitionable between the first configuration and a contracted state, thereby enabling them to clamp the heart valve leaflets 302. This facilitates reliable positioning of the first support ring 101 and the second support ring 102 on opposite sides of the heart valve as the first support ring 101 and the second support ring 102 are compressed towards each other in the contracted state, and at the same time, the first pitch distance (p1) can be selected to have sufficient separation to facilitate movement to opposite sides of the valve, so that the support rings 101, 102 can be easily positioned in the correct positions on opposite sides of the heart valve when in the first configuration.Thus, having a first support ring 101 and a second support ring 102 that are transitionable between a first configuration and a contracted state and configured to clamp the heart valve leaflets provides an easier implantation procedure while minimizing the risk of displacement from the valve annulus. Thus, the procedure can be performed in less time. Having the support rings 101, 102 compressed in a contracted state also provides for enhanced cell growth in the vicinity of the support rings 101, 102 and more rapid healing. Thus, the device 100 also improves the long-term outcome of the valve repair procedure as described.

[0023] As described further below, device 100 may include a shape memory material such that first and second rings 101, 102 assume a first configuration after being expelled from a delivery catheter (not shown). While disposed within the delivery catheter, device 100 may be elongated in an elongated shape. Alternatively, device 100 may be disposed in a coiled configuration when delivered to the target site, in which case device 100 may be implanted at the target site, for example, through an incision between ribs or by opening the chest. The present disclosure and associated advantages described for various embodiments apply to both such variations of device 100.

[0024] The annuloplasty device 100 may include fastening units 104, 104', 114 configured to couple the first support ring 101 with the second support ring 102 such that the first and second support rings 101, 102 are transitioned from a first configuration to a contracted state. FIG. 3 shows a schematic diagram of the fastening units 104, 104' configured to couple to compress the support rings 101, 102 toward each other. In one example, as shown diagrammatically in FIG. 3, the fastening units 104, 104' comprise an elongated extension 104 disposed on the first support ring 101 and a recess 104' disposed on the second support ring 102, or vice versa. The extension 104 couples with the recess 104' such that the support rings 101, 102 are transitioned to a contracted state with a reduced pitch distance (p2). The fastening units 104, 104' may be integrated into the first support ring 101 and / or the second support ring 102. This may provide a strong and secure fastening mechanism. The fastening units 104, 104' may also be formed from the same material as the first support ring 101 and / or the second support ring 102.

[0025] As shown diagrammatically in Fig. 4, the fastening unit may comprise a coil-shaped unit 114 configured to rotate relative to the first and second support rings 101, 102 and configured to overlap the first and second support rings 101, 102, such that as the coil-shaped unit 114 rotates, the coil-shaped unit 114 pushes the second support ring 102 towards the first support ring 101. Thus, the coil-shaped unit 114 is dimensioned such that the first and second support rings 101, 102 are intertwined within adjacent individual coils of the coil-shaped unit 114. When the coiled unit 114 is screwed into position over the first support ring 101, the distal-most coil of the coiled unit 114 eventually captures the second support ring 102, and the first ring 101 and the second ring 102 are forced towards each other, thereby decreasing the pitch distance (as shown diagrammatically by the arrows in FIG. 4). Efficient compression of the first ring 101 and the second ring 102 may be achieved in this manner.

[0026] The annuloplasty device 100 may include a stiffening unit 105, and at least a portion of the first support ring 101 and the second support ring 102 may include an internal channel 106 configured to receive the stiffening unit 105. FIG. 5a is a schematic diagram of the internal channel 106 extending along the first support ring 101 and the second support ring 102. In FIG. 5b, the stiffening unit 105 is inserted into the internal channel 106. In this manner, the stiffening unit 105 may be disposed as an internal coil within the internal channel 105. The pitch distance of adjacent coils of the stiffening unit 105 may be varied to affect the pitch distance of adjacent first support ring 101 and second support ring 102, and the stiffening unit 105 extends along adjacent first support ring 101 and second support ring 102. Thus, the stiffening unit 105 can apply a force to the first support ring 101 and the second support ring 102 to bring them into a contracted state (as shown diagrammatically by the oppositely pointing arrows in FIG. 5b). In this way, the stiffening unit 105 makes it easier to manipulate the pitch distance (p1, p2) between the first support ring 101 and the second support ring 102.

[0027] In one example, the first support ring 101 and the second support ring 102 can be transitioned from a first configuration to a contracted state by insertion of the stiffening unit 105 into the internal channel 106. That is, the stiffening unit 105 can have a relaxed heat-set shape, and the distance between adjacent coils of the stiffening unit 105 can correspond to a second pitch distance (p2). The first support ring 101 and the second support ring 102 can have a relaxed heat-set shape, and the distance between adjacent first support ring 101 and second support ring 102 can correspond to a first pitch distance (p1). The first support ring 101 and the second support ring 102 may be sufficiently flexible (i.e., more flexible than the stiffening unit 105) so that when the stiffening unit 105 is inserted into the internal channel 106, the first support ring 101 and the second support ring 102 may be caused to assume a second pitch distance (p2), i.e., to be in a contracted state.

[0028] Due to the strength added by the stiffening unit 105 when disposed within the internal channel 106, the stiffening of the first and second support rings 101, 102 can be increased by inserting the stiffening unit 105 into the internal channel 106. That is, as the stiffness increases, the force required to exert on the first and second support rings 101, 102 at a certain distance apart can increase. The holding force exerted by the first and second rings 101, 102 against the valve tissue is thus increased, and the valve tissue disposed between the first and second support rings 101, 102 can be more strongly held. Thus, a more secure fixation can be provided. In one example, it is also conceivable that the stiffening of the first and second support rings 101, 102 can be increased by inserting the stiffening unit 105 without significantly affecting the distance between the first and second support rings 101, 102, i.e., the pitch distance. As discussed above, the increased retention force also provides sufficient fixation of the device 100 at the valve annulus. The stiffness can be variably changed by disposing the stiffening units 105 along various locations of the inner channel 106. In further examples, the stiffening units 105 can be disposed only on the first support ring 101, or only on the second support ring 102, or only on a portion of the first support ring 101, or only on a portion of the second support ring 102, or only on a portion of the first support ring 101 and a second portion of the second ring 102.

[0029] In one example, the stiffening unit 105 may include a shape memory material. Activation of the shape memory material may cause the first support ring 101 and the second support ring 102 to transition from a first configuration to a contracted state. Thus, when the stiffening unit 105 is placed in an interior position at 106, it may be actively manipulated to change its pitch distance, thereby affecting the pitch distances (p1, p2) of the first support ring 101 and the second support ring 102 as described above. The shape memory material may be configured to be activated according to an activation temperature. Thus, the temperature of the stiffening unit 105 may be altered to affect its shape change as described.

[0030] The annuloplasty device 100 may include at least a first stiffening unit 105 and a second stiffening unit 105'. The first and second stiffening units 105, 105' may be configured to be disposed simultaneously in the internal channel 106. This is illustrated in Figs. 5c-d, where the first stiffening unit 105 is introduced into the internal channel 106 (Fig. 5c) and the second stiffening unit 105' is introduced into the internal channel 106 (Fig. 5d). Although Figs. 5c-d show only a second of the first support ring 101 and / or second support ring 102, it should be understood that the first stiffening unit 105 and the second stiffening unit 105' may be introduced along any portion of the first support ring 101 and the second support ring 102, as explained above. The first stiffening unit 105 and the second stiffening unit 105' may be introduced sequentially or simultaneously. Although this example shows only two stiffening units 105, 105', it should be understood that any number of stiffening units can be introduced into the internal channel 106. As mentioned above, this results in a gradual and variable adjustment of the stiffness of the first support ring 101 and / or the second support ring 102 and / or a gradual and variable adjustment of the distance between the first support ring 101 and / or the second support ring 102, i.e. the pitch distance (p1, p2). Thus, the retention force of the first support ring 101 and the second support ring 102 can be carefully optimized during different steps of the fixation procedure and / or for different types of anatomical structures without the need to try different variations of the device 100. The mechanical features of the device 100 can also be optimized in-situ instead, for example by simultaneously observing the hemodynamics of the modified heart valve.

[0031] As illustrated in Figures 5e-f, the internal channel can include a first sublumen 106 and a second sublumen 106'. The first stiffening unit 105 can be configured to be disposed in the first sublumen 106 (Figure 5e), and the second stiffening unit 105' can be configured to be disposed in the second sublumen 106' (Figure 5f). The first stiffening unit 105 and the second stiffening unit 105' can be introduced sequentially or simultaneously. This provides advantageous optimization as described above. Furthermore, the insertion of the first stiffening unit 105 and the second stiffening unit 105' can be facilitated by providing dedicated sublumens 106, 106' for the first stiffening unit 105 and the second stiffening unit 105'. Although this example shows two sublumens 106, 106', any number of multiple sublumens can be arranged on the first support ring 101 and / or the second support ring 102, and respective stiffening units 105, 105' can be implemented for optimization to different applications.

[0032] The first reinforcement unit 105 can have a different stiffness than the second reinforcement unit 105'. This allows for easy variation of the stiffness of the first support ring 101 and / or the second support ring 102. In one example, the first reinforcement unit 105 can gradually increase the stiffness and / or decrease the pitch distance, a first distance, to initially position the device 100 accurately, and at the same time, by introducing the second reinforcement unit 105' (which can have an increased stiffness compared to the first reinforcement unit 105), the stiffness of the first support ring 101 and / or the second support ring 102 can be significantly increased and / or the pitch distance, a longer distance compared to the first distance, to finally fix the device 100 in place. In this way, a more secure and optimized fixation of the device 100 can be provided.

[0033] The first support ring 101 and the second support ring 102 can include a magnetizing portion 107 including a material configured to be magnetized or a magnetic material, such that a magnetic force from the magnetizing portion 107 acting on the first support ring 101 and the second support ring 102 can transition the first support ring 101 and the second support ring 102 from the first configuration to the contracted state. Thus, the magnetizing portion 107 can include a material configured to be magnetized, for example, by applying energy, such as electromagnetic energy, to the magnetizing portion 107 to affect the degree of magnetization of the magnetizing portion 107. For example, the magnetizing portion 107 can be positioned in contact with at least a portion of the first support ring 101 and the second support ring 102 such that the first support ring 101 and the second support ring 102 adopt the first configuration without being magnetized. Energy can then be applied to exert a magnetic attraction on the first support ring 101 and the second support ring 102 (as shown diagrammatically by the arrows in FIG. 6 ) to magnetize the magnetized portion 107 for transition to a contracted state. The portion of the magnetized portion 107 that is placed in contact with the first support ring 101 can have a different magnetic polarity compared to the portion of the magnetized portion 107 that is placed on the second support ring 102, thereby creating an attractive force between the two. The first support ring 101 and the second support ring 102 can be at least partially formed from a material that includes the magnetized portion 107. Alternatively, or in addition, the first support ring 101 and the second support ring 102 can be configured to receive the magnetized elements 108, 108′, 113, as described further below. Having the magnetized portion 107 facilitates transition of the first support ring 101 and the second support ring 102 to a contracted state for secure fixation to the heart valve.

[0034] The annuloplasty device 100 can include magnetization elements 108, 108', 113 that include a material configured to be magnetized and / or a magnetic material. That is, the magnetization elements 108, 108', 113 can be magnetized by applying energy, such as electromagnetic energy, at a desired time, such as when placed in contact with at least a portion of the first support ring 101 and the second support ring 102. The magnetization elements 108 can also include magnetic material that is already magnetically polarized before being placed in contact with the first support ring 101 and the second support ring 102. Thus, at least a portion of the first support ring 101 and the second support ring 102 can include a receiver 109 configured to receive and secure the magnetization elements 108, 108', 113. In this manner, when the magnetized elements 108, 108', 113 are placed in the receiver 109, the first support ring 101 and the second support ring 102 are configured to transition from the first configuration to the contracted state by the magnetic forces from the magnetized elements 108, 108', 113 acting on the first support ring 101 and the second support ring 102. As will be explained, the magnetic forces may be achieved by applying energy to activate the polarization of the magnetized elements 108, 108', 113 or by placing already polarized magnetized elements 108, 108', 113 in the receiver 109. Figures 7 and 8 are schematic examples of magnetic elements 108, 108', 113 placed in such a receiver 109. In FIG. 7, magnetized elements 108, 108' are disposed on two portions of the first support ring 101 and the second support ring 102 and have opposite magnetic polarizations, whereby, when a magnetic field is present, an attractive magnetic force pushes the first ring 101 and the second ring 102 towards each other into a contracted state.

[0035] 8 is a schematic diagram in which the receiver 109 may comprise an internal channel 106 disposed in the first support ring 101 and the second support ring 102. The internal channel 106 may be configured to receive a magnetizing element 113 such that the magnetizing element 113 is disposed in the internal channel 106 and the first support ring 101 and the second support ring 102 are configured to transition from a first configuration to a contracted state due to a magnetic force from the magnetizing element 113 acting on the first support ring 101 and the second support ring 102.

[0036] The magnetized elements 108, 108', 113 can be configured to be removably connected to the first and second support rings 101, 102. Thus, once the first and second support rings 101, 102 are compressed by magnetic forces into a contracted state, for example when the surrounding tissue has sufficiently grown and healed, the magnetized elements 108, 108', 113 can be removed, which may be advantageous, for example, for cardiac MRI examinations.

[0037] The annuloplasty device 100 may include a biodegradable restraining unit 110. At least a portion of the first support ring 101 and the second support ring 102 may be configured to engage with the restraining unit 110 to maintain the first pitch distance (p1) apart. The first support ring 101 and the second support ring 102 may be configured to assume a contracted state that separates the first support ring 101 and the second support ring 102 at a second pitch distance (p2) when the restraining unit 110 biodegrades. Thus, the first support ring 101 and the second support ring 102 may be configured to have a relaxed heat-set shape that corresponds to the contracted state at the second pitch distance (p2). In this case, the restraining unit 110 may be configured to apply a force to the first support ring 101 and the second support ring 102 to separate them and assume the first configuration at the first pitch distance (p1), as shown diagrammatically in FIG. 9a. As shown diagrammatically in FIG. 9b, when the restraining unit 110 is partially or completely degraded, its structural integrity is not sufficient to separate the first support ring 101 and the second support ring 102, resulting in a contracted state. Thus, an effective transition between the first configuration and the contracted state can be provided. This also facilitates positioning of the device 100 on both sides of the valve, as it provides for avoidance of undesirable friction with tissue or entanglement with portions of the anatomical structure due to the first pitch distance (p1). Although the restraining unit 110 has been described as being biodegradable, it is contemplated that it may be removed or weakened by other mechanisms.

[0038] The restraining unit 110 may be configured to be attached to an exterior 111 of the first support ring 101 and the second support ring 102, as shown diagrammatically in Figure 10a. Alternatively, or in addition, the restraining unit may be configured to be disposed within the interior 112 of the first and second support rings 101, 102, as shown generally in Figure 10b. In either case, the restraining unit 110, once disassembled, provides the above-mentioned compression of the first and second support rings 101, 102.

[0039] The first support ring 101 and / or the second support ring 102 may include a shape memory material. In this case, activation of the shape memory material transitions the first support ring 101 and the second support ring 102 from the first configuration to a contracted state, shortening the pitch distance (p2). The shape memory material may be configured to assume the contracted state in response to an activation temperature. It is contemplated that the device 100 may be maintained at a prescribed temperature while disposed within a delivery catheter (not shown). Thereafter, when the device 100 is exposed to warm tissue and ejected from the delivery catheter, an activation temperature is reached, thereby compressing the first support ring 101 and the second support ring 102 toward each other.

[0040] The first support ring 101 and / or the second support ring 102 may comprise a shape memory material, such as NiTiNol or another suitable biocompatible alloy that can be heat set to a prescribed shape by a heat treatment procedure. The shape memory material may comprise a material having multiple phases, thereby allowing the shape of the support rings 101, 102 to be actively changed, as described above. A shape memory material may be considered as any material that can change to a desired shape upon interaction with an external source, such as an energy source providing heat and / or electromagnetic energy that can be transferred to the device 100 and change its shape. It is also contemplated that the shape of the device 100 may be influenced by direct mechanical manipulation of the curvature of the first support ring 101 and / or the second support ring 102, for example, by transferring a force or torque to the device 100 via a delivery device. Through the various shape affecting procedures mentioned, the device 100 can assume an elongated delivery configuration for advancement within a catheter, an initial shape or first configuration when disposed in a coiled configuration along the valve annulus, and also an activated state, such as the contracted state described above, for increased fixation strength at the heart valve annulus.

[0041] The support rings 101, 102 can be formed from solid rods or other solid elongated structures having various cross sections, such as circular, elliptical, diamond, triangular, rectangular, etc. The support rings 101, 102 can also be formed from hollow tubes or other hollow structures having the above cross sections. The support rings 101, 102 may be formed from sandwiched laminated materials, including several layers of different materials, or different layers of the same material. The support rings 101, 102 can be formed from stents or stent-like structures, and / or braided materials. The support rings 101, 102 can be formed from braids of different materials woven together, or from braids of the same material. As mentioned above, the support rings 101, 102 can also be formed from NiTinol, or another suitable biocompatible material. The surfaces of the first support ring 101 and the second support ring 102 may be provided with other materials and / or may be treated with different materials and / or may be configured to increase the material's resistance to fracture when repeatedly bent.

[0042] The first support ring 101 and the second support ring 102 can have an elongated delivery configuration for advancement within a catheter and a contracted implantation shape as described above.

[0043] A method 200 for repairing a defective heart valve is disclosed. The method 200 is shown in FIG. 11a in conjunction with FIG. 2a-b. The order in which the steps are described should not be construed as limiting, and it is understood that the order of the steps can be varied depending on the particular procedure. The method 200 includes a positioning step 201 for positioning the first support ring 101 and the second support ring 102 of the annuloplasty device 100 in a first configuration as coils on opposite sides of the native heart leaflets of the heart valve, and an activation step 202 for activating a contracted state of the annuloplasty device to reduce a first pitch distance (p1) between the first support ring 101 and the second support ring 102 in the first configuration to a second pitch distance (p2) that is shorter than the first pitch distance (p1), thereby causing the first support ring 101 and the second support ring 102 to move towards each other and pinch the native heart leaflets 301. Thus, the method 200 provides advantageous advantages as described above with respect to the annuloplasty device 100 and Figures 1-10. In this manner, easier and more reliable positioning of the device 100 in the heart valve is achieved.

[0044] 11b shows a further flow chart of a method 200 of repairing a defective heart valve. The order in which the steps of the method 200 are shown should not be construed as limiting, and it is understood that the order in which the steps of the method 200 are performed may be varied. The method 200 may include a coupling step 203 in which the first support ring 101 is coupled to the second support ring 102 with fastening units 104, 104', 114, whereby the first support ring 101 and the second support ring 102 are moved from the first configuration to a contracted state.

[0045] The fastening unit may comprise a coil-shaped unit 114. The method 200 may comprise a rotating step 204 of rotating the coil-shaped unit 114 relative to the first support ring 101 and the second support ring 102, whereby as the coil-shaped unit 114 rotates, the coil-shaped unit 114 pushes the second support ring 102 towards the first support ring 101.

[0046] The method 200 may include an insertion step 205 of inserting a stiffening unit 105 into an internal channel 106 disposed in at least a portion of the first support ring 101 and the second support ring 102 to transition the first support ring 101 and the second support ring 102 from the first configuration to a contracted state.

[0047] The stiffening unit 105 may include a shape memory material. The method 200 may include an activation step 206 of activating the shape memory material to transition the first support ring 101 and the second support ring 102 from the first configuration to a contracted state.

[0048] The method 200 may comprise an inserting step 2051 of inserting a first stiffening unit 105 into the internal channel 106, 106' to increase the stiffness of the first and / or second support ring 101, 102. The internal channel may be a single channel or may include multiple sublumens 106, 106' as illustrated in Figs. 5c-f. The method 200 may further comprise an inserting step 2052 of inserting a second stiffening unit 105' into the internal channel 106, 106' to further increase the stiffness of the first support ring 101 and / or the second support ring 102, as described above in relation to Figs. 5c-f. In this way, the stiffness and associated holding force between the first support ring 101 and the second support ring 102 may be gradually changed by the insertion of the first stiffening unit 105 and the second stiffening unit 105'.

[0049] The method 200 may include an inserting step 2051' of inserting the first stiffening unit 105 into the internal channel 106, 106' to reduce the pitch distance between the first support ring 101 and / or the second support ring 102, e.g., to a first distance. The method 200 may further include an inserting step 2052' of inserting the second stiffening unit 105' into the internal channel 106, 106' to further reduce the pitch distance between the first support ring 101 and / or the second support ring 102, e.g., to a second distance. In this way, the distance between the first support ring 101 and the second support ring 102 may be gradually changed by the insertion of the first stiffening unit 105 and the second stiffening unit 105', and the holding force between the first support ring 101 and the second support ring 102 may be changed. This provides advantageous benefits as further explained with respect to Figures 5c-f.

[0050] The first support ring 101 and the second support ring 102 may comprise a magnetizing portion 107 comprising a material configured to be magnetized or a magnetic material. The method 200 may include a transitioning step 207 of transitioning the first support ring 101 and the second support ring 102 from the first configuration to a contracted state by an application step 208 of applying a magnetic force from the magnetizing portion 107 to act on the first support ring 101 and the second support ring 102.

[0051] The method 200 may include an inserting step 209 of inserting the magnetizing element 113 into the internal channel 106 disposed in at least a portion of the first support ring 101 and the second support ring 102. The method 200 may further include a transitioning step 210 of transitioning the first support ring 101 and the second support ring 102 from the first configuration to a contracted state by an applying step 211 of applying a magnetic force from the magnetizing element 113 to act on the first support ring 101 and the second support ring 102.

[0052] The first support ring 101 and / or the second support ring 102 may comprise a shape memory material. The method 200 may include an activation step 212 of activating the shape memory material to transition the first support ring 101 and the second support ring 102 from the first configuration to a contracted state.

[0053] The method 200 may include an activation step 213 of activating the shape memory material in response to setting the temperature of the first support ring 101 and / or the second support ring 102 to an activation temperature.

[0054] The present invention has been described above with reference to certain embodiments. However, other embodiments than those described above are equally possible within the scope of the present invention. Different features and steps of the present invention may be combined in other combinations than those described. The scope of the invention is limited only by the appended claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and shapes described herein are meant to be exemplary, and that the actual parameters, dimensions, materials, and / or shapes will depend on the particular application or uses for 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), the first support ring (101) and the second support ring (102) are configured to be arranged like a coil in a first configuration about an axial direction (103); the first support ring and the second support ring are configured to be positioned on opposite sides of a native heart valve leaflet (301) of a heart valve; the first support ring and the second support ring are spaced apart in the axial direction by a first pitch distance (p1) in the first configuration; the first support ring and the second support ring are configured to assume a contracted state having a second pitch distance (p2) in the axial direction that is shorter than the first pitch distance; the first support ring and the second support ring have an elongated delivery configuration for advancement through a catheter and an implanted configuration in the contracted state; the first support ring and the second support ring are configured to be transitionable between the first configuration and the contracted state to reduce a gap between the first support ring and the second support ring and to clamp the heart valve leaflets; the first support ring and / or the second support ring comprise a shape memory material, and activation of the shape memory material transitions the first support ring and the second support ring from the first configuration to the contracted state; the shape memory material is configured to adopt the contracted state in response to an activation temperature; The annuloplasty device includes a removable restraining unit (110), wherein at least a portion of the first support ring and the second support ring are configured to engage with the removable restraining unit to maintain the first pitch distance apart and to assume the contracted state when the removable restraining unit is removed.

2. 2. The annuloplasty device of claim 1, comprising a fastening unit (104, 104', 114) configured to couple the first support ring with the second support ring such that the first support ring and the second support ring are transitioned from the first configuration to the contracted state.

3. The annuloplasty device of claim 2 , wherein the fastening unit is integrated into the first support ring and / or the second support ring.

4. 3. The annuloplasty device of claim 2, The fastening unit comprises a coil-shaped unit (114), The coil-shaped unit is configured to be rotated relative to the first support ring and the second support ring such that the first support ring and the second support ring overlap, whereby upon said rotation, the coil-shaped unit pushes the second support ring towards the first support ring.

5. 5. An annuloplasty device according to any one of claims 1 to 4, comprising a stiffening unit (105, 105'), wherein at least a portion of the first support ring and the second support ring comprises an internal channel (106) configured to receive the stiffening unit.

6. 6. The annuloplasty device of claim 5, wherein insertion of the stiffening unit into the internal channel transitions the first and second support rings from the first configuration to the contracted state.

7. 6. The annuloplasty device of claim 5, wherein the stiffening unit comprises a shape memory material, and activation of the shape memory material transitions the first support ring and the second support ring from the first configuration to the contracted state.

8. 8. An annuloplasty device according to any one of claims 5 to 7, comprising at least a first stiffening unit (105) and a second stiffening unit (105'), the first stiffening unit and the second stiffening unit being configured to be simultaneously positioned in the inner channel.

9. 9. The annuloplasty device of claim 8, wherein the internal channel comprises a first sublumen (106) and a second sublumen (106'), the first stiffening unit configured to be disposed in the first sublumen and the second stiffening unit configured to be disposed in the second sublumen.

10. 10. The annuloplasty device of claim 8 or 9, wherein the first stiffening unit has a different stiffness than the second stiffening unit.

11. 11. The annuloplasty device according to claim 1, wherein the first support ring and the second support ring are provided with a magnetized portion (107), The magnetization portion includes a material configured to be magnetized or a magnetic material, whereby a magnetic force from the magnetization portion acting on the first support ring and the second support ring transitions the first support ring and the second support ring from the first configuration to the contracted state.

12. The annuloplasty device according to any one of claims 1 to 11, a magnetizing element (108, 108', 113) comprising a material adapted to be magnetized and / or a magnetic material, An annuloplasty device, wherein at least a portion of the first support ring and the second support ring have a receiving portion (109) configured to receive and secure the magnetization element, whereby when the magnetization element is placed in the receiving portion, the first support ring and the second support ring are configured to transition from the first configuration to the contracted state by magnetic forces from the magnetization element acting on the first support ring and the second support ring.

13. 13. The annuloplasty device of claim 12, the receiver comprises an internal channel (106) disposed in the first support ring and the second support ring; The annuloplasty device, wherein the internal channel is configured to receive the magnetized element (113), such that when the magnetized element is disposed in the internal channel, the first support ring and the second support ring are transitioned from the first configuration to the contracted state by magnetic forces from the magnetized element acting on the first support ring and the second support ring.

14. 14. The annuloplasty device of claim 12 or 13, wherein the magnetizing element is configured to be removably connected to the first support ring and the second support ring.

15. 15. An annuloplasty device as described in any one of claims 1 to 14, comprising a biodegradable restraining unit (110), wherein at least a portion of the first support ring and the second support ring are configured to engage with the restraining unit to maintain the separation at the first pitch distance and assume the contracted state when the restraining unit biodegrades.

16. 16. An annuloplasty device as claimed in claim 14 or claim 15, wherein the inhibition unit is configured to be attached to the exterior (111) or disposed on the interior (112) of the first support ring and the second support ring.

17. 10. The annuloplasty device of claim 1, wherein the first support ring and the second support ring are configured to be maintained at a defined temperature while disposed within a catheter; The annuloplasty device, wherein the first support ring and the second support ring are configured to be ejected from the catheter, thereby reaching the activation temperature and causing the first support ring and the second support ring to be compressed toward each other.

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