Bench wheel forming device

Abstract

An annuloplasty device is disclosed, the annuloplasty device comprising a first support ring and a second support ring having a coiled configuration, the first support ring and the second support ring being arranged as a coil about a central axis, the first support ring and the second support ring being configured to be positioned on either side of a native heart leaflet of a heart valve, the annuloplasty device comprising a stent disposed around at least a portion of the first support ring and / or the second support ring, the stent comprising a retention unit. Related methods of repairing a defective heart valve are also disclosed.

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, such as annuloplasty rings and annuloplasty helices, for placement in a heart valve annulus, and methods for repairing defective heart valves. [Background technology]

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

[0003] A problem with the annuloplasty implants of the prior art is to achieve the correct positioning in the heart valve and to fix the implant in the correct position. Suturing devices for annuloplasty implants have the drawback of making it difficult to suture in the correct position, thereby resulting in insufficient suture strength, and further resulting in a very time-consuming procedure that increases the risk for the patient. Furthermore, suturing devices are often not compact enough for catheter-based procedures. The use of clips to position annuloplasty implants also entails challenges, especially when implanting helical rings that are to be placed on both sides of the heart valve. Insufficient fixation of such implants causes traumatic effects, since the fixation structures must ensure the correct positioning of the device over time. Thus, a further problem with the prior art is also to achieve a reliable fixation in the annulus of the heart valve. Annuloplasty implants are meant to function for many years, and therefore it is very important to have long-term stability in this respect.

[0004] The above problems can have dire consequences for patients and the health care system: Patient risks are increased.

[0005] It would therefore be advantageous to have an improved annuloplasty implant or device, particularly one that would be able to avoid more of the problems and compromises mentioned above and ensure secure fixation of the annuloplasty device, particularly during the implantation stage, allowing for a less complicated procedure and improved patient safety as well as long term functionality. Related methods would also be advantageous. Summary of the Invention [Problem to be solved by 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, as mentioned above, singly or in any combination, by providing an apparatus according to the appended claims. [Means for solving the problem]

[0007] According to a first aspect, there is provided an annuloplasty device comprising a first support ring and a second support ring having a coiled configuration, the first support ring and the second support ring being arranged as a coil about a central axis, the first support ring and the second support ring being configured to be positioned on either side of a native heart valve leaflet of a heart valve, the annuloplasty device comprising a stent disposed around at least a portion of the first support ring and / or the second support ring, the stent comprising a retention unit.

[0008] According to a second aspect, there is provided a method of repairing a defective heart valve, the method comprising: positioning a first support ring of an annuloplasty device on a ventricular side of the heart valve, and a second support ring of the annuloplasty device on an atrial side of the heart valve such that the first support ring and the second support ring are arranged as a coil extending through a commissure of the heart valve, the first support ring and / or the second support ring comprising a stent disposed around at least a portion of the first support ring and / or the second support ring, the stent comprising a retention unit, and positioning the stent against valve tissue along said portion such that the retention unit is engaged within the tissue of the heart valve.

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

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

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

[0012] Some examples of the present disclosure provide for time-saving fixation of the annuloplasty to the target site.

[0013] Several examples of the present disclosure provide for ensuring the long-term function and position of an annuloplasty device.

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

[0015] Some examples of the present disclosure provide for more reliable implantation of annuloplasty devices in tight anatomical structures.

[0016] It should be emphasized that the term "comprises" / "comprising", as used in this specification, is taken to specify 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]

[0017] These and other aspects, features and advantages of which embodiments of the present invention are possible will become apparent and elucidated from the following description of embodiments of the invention, which proceeds with reference to the accompanying drawings.

[0018] [Figure 1] FIG. 2 is a schematic perspective view of an annuloplasty device having a stent disposed around at least a portion of a first support ring and a second support ring, according to an example of the present disclosure. [Diagram 2] 1 is a schematic diagram of a stent of an annuloplasty device according to one example of the present disclosure, the stent having multiple retention units. [Diagram 3] 1 is a more detailed schematic diagram of a portion of a stent of an annuloplasty device according to one example of the present disclosure. [Figure 4a] FIG. 1 is a detailed schematic diagram of a portion of a stent of an annuloplasty device according to one example of the present disclosure, with a retention unit of the stent in a retracted state. [Figure 4b] FIG. 2 is a detailed schematic diagram of a portion of a stent of an annuloplasty device according to one example of the present disclosure, with a retention unit of the stent in an expanded state. [Figure 4c] FIG. 2 is a schematic diagram of a portion of a stent of an annuloplasty device according to one example of the present disclosure, in a front view of a retention unit of the stent, the retention unit being in a retracted state. [Figure 4d] FIG. 1 is a detailed schematic diagram of a portion of a stent of an annuloplasty device according to one example of the present disclosure, with a retention unit of the stent in a retracted state. [Figure 4e] FIG. 2 is a detailed schematic diagram of a portion of a stent of an annuloplasty device according to one example of the present disclosure, with a retention unit of the stent in an expanded state. [Figure 5a] 1 is a cross-sectional schematic diagram of an annuloplasty device with a retention unit of a stent in an expanded state according to an example of the present disclosure. [Figure 5b] 13 is a cross-sectional schematic view of an annuloplasty device according to another example of the present disclosure, with a retention unit of a stent in an expanded state. [Figure 6] 1 is a side schematic view of an annuloplasty device having a first support ring and a second support ring separated by a transition region, according to an example of the present disclosure. [Figure 7a] FIG. 1 is a side schematic view of an annuloplasty device according to an example of the present disclosure, the annuloplasty device being positioned above and below the valve leaflets. [Figure 7b] 1 is a schematic top view of an annuloplasty device according to an example of the present disclosure. [Figure 8a] 1 is a schematic diagram of a stent of an annuloplasty device according to one example of the present disclosure, the stent being radially expanded. [Figure 8b] FIG. 2 is a schematic diagram of a stent of an annuloplasty device according to one example of the present disclosure, the stent being radially retracted. [Figure 9a] 1 is a schematic diagram of a stent of an annuloplasty device according to one example of the present disclosure, the stent being radially expanded. [Figure 9b] FIG. 2 is a schematic diagram of a stent of an annuloplasty device according to one example of the present disclosure, the stent being radially retracted. [Figure 10a] 1 is a schematic diagram of a stent of an annuloplasty device according to one example of the present disclosure, the stent having multiple retention units. [Figure 10b] 1 is a schematic diagram of a stent of an annuloplasty device according to another example of the present disclosure, the stent having multiple retention units. [Figure 10c] 1 is a schematic diagram of a stent of an annuloplasty device according to another example of the present disclosure, the stent having multiple retention units. [Figure 10d] 1 is a schematic diagram of a stent of an annuloplasty device according to another example of the present disclosure, the stent having multiple retention units. [Figure 11a] 1 is a flowchart of a method for repairing a defective heart valve according to an example of the present disclosure. [Figure 11b] 13 is another flowchart of a method for repairing a defective heart valve according to an example of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Next, specific embodiments of the present invention will be described with reference to the accompanying drawings. However, the present invention may be embodied in various forms and should not be construed as being limited to the embodiments described herein, but rather, these embodiments 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.

[0020] The following description focuses on embodiments of the invention that are applicable to heart valve implants, such as annuloplasty rings, however, it will be understood that the invention is not limited to this application and may be applied to many other annuloplasty and heart valve implants, including, for example, replacement valves, as well as other medical implantable devices.

[0021] Fig. 1 shows a schematic diagram of an example of an annuloplasty device 100 comprising a first support ring 101 and a second support ring 102, both of which are configured to be arranged as a coil in a coiled configuration around a central axis 103, i.e. in a helical shape, as shown in Fig. 1. The device 100 is arranged in a coiled configuration at least when the material forming the device 100 is in a relaxed state, i.e. when there are no external forces acting on the device 100. The coiled device 100 has two free ends 116, 116'. The first support ring 101 and the second support ring 102 and their respective free ends 116 and 116' are configured to be arranged on either side of the native heart leaflets 301 of a heart valve, as shown in the side view of Fig. 7a. As shown in FIG. 7a, the first support ring 101 may be arranged on the atrial side of the heart valve and the second support ring 102 on the ventricular side (the second support ring 102 is also shown in dashed lines in a top view of FIG. 7b, with the valve leaflets omitted). The second support ring 102 is shown in dashed lines and is arranged on the ventricular side of the heart valve in these examples, whereas the first support ring 101 is arranged on the atrial side of the heart valve (shown in solid lines in FIG. 7b). Thus, the first support ring 101 can extend along the annulus of the heart valve on the atrial side. The first support ring 101 and the second support ring 102 are connected to form a coil-shaped or ring-shaped ring as an integral continuous ring. The coil extends through the valve opening at the commissures 302, 302' of the valve. In the example of FIG. 7b, the coil extends through the commissures shown as 302', although it should be understood that in other examples, the annuloplasty device 100 may extend through the commissures shown as 302. Thus, the first support ring 101 and the second support ring 102 may assume a coiled configuration even when in an implanted state. As described further below, the device 100 may include a shape memory material such that the device 100 reassumes the coiled configuration after being delivered from a catheter (not shown) to the target site and then temporarily restrained in the elongated configuration of the catheter.The annuloplasty device 100, i.e., annuloplasty implant 100, may comprise a shape memory material such as NiTiNol or another suitable biocompatible alloy that may be heat set in a heat treatment procedure to a defined shape, i.e., a defined relaxed shape in the absence of an external acting force. The annuloplasty device 100 may clamp tissue of the valve leaflets 301 between the first support ring 101 and the second support ring 102, i.e., with a force acting parallel to the central axis 103.

[0022] The annuloplasty device 100 further comprises stents 105, 105a, 105b, 105c disposed around at least a portion of the first support ring 101 and / or the second support ring 102. FIG. 1 illustrates an example in which three stents 105a, 105b, 105c are disposed around portions of the first support ring 101 and the second support ring 102. FIGS. 2-4 are further detailed views of the stent 105 configured to be disposed around at least a portion of the first support ring 101 and / or the second support ring 102. It should be understood that the annuloplasty device 100 can comprise a varying number of stents 105 depending on the particular implantation site of the annuloplasty device 100. Additionally, the ratio of the total length of the first support ring 101 and / or the second support ring 102 covered by the stent 105, 105a, 105b, 105c may vary depending on the placement of the annuloplasty device 100. Although this disclosure refers to the stent 105, it should be understood that any of the stents 105a, 105b, 105c illustrated in FIG. 1 may include the features described for the stent 105 in relation to FIGS. 2-10. The lattice or framework of the stent 105 may be formed by laser cutting a tubular material such as NiTinol or other biocompatible metal alloy, which is then pressed against the first support ring 101 and / or the second support ring 102. Thus, the stent 105 has a hollow interior to accommodate the first support ring 101 and / or the second support ring 102. The stent comprises a retaining unit 104, 104' as shown diagrammatically in Fig. 1 and in detailed views in Figs. 3-5 and 10. The retaining unit 104, 104' is shaped to pierce into the tissue of the heart valve. The retaining unit 104, 104' is fixed relative to the stent 105, which is fixed relative to the first support ring 101 and / or the second support ring 102, and the stent 105 is disposed on the first support ring 101 and / or the second support ring 102.Thus, once the stents 105a, 105b, 105c are positioned around at least a portion of the first support ring 101 and / or the second support ring 102, the annuloplasty device 100 can be anchored to the valve tissue with the retention units 104, 104'. Thus, the first support ring 101 and / or the second support ring 102 are provided with a robust anchoring mechanism by utilizing the stents 105, 105a, 105b, 105c as intermediate fixation structures for the retention units 104, 104', thereby eliminating the need to attach retention structures directly to the first support ring 101 and / or the second support ring 102. Thus, the stent 105 provides an increased reliability of the anchoring mechanism of the annuloplasty device 100, as it reduces the number of separate structures that need to be joined together, particularly in instances where the retention units 104, 104' are integrated with the stent 105 as described below. Thus, the long-term reliability of the annuloplasty device 100 may be improved. Thus, the manufacturing of the annuloplasty device 100 may also be easier since the number of separate elements is minimized. Thus, a more viable annuloplasty implant 100 is provided since manufacturing tolerances may be easier to adhere to and the overall complexity and associated costs may be reduced. With the annuloplasty device 100 having the stents 105, 105a, 105b, 105c and associated retention units 104, 104', a modular annuloplasty device 100 is also provided, in which the core structure of the first support ring 101 and the second support ring 102 may be provided with stents 105, 105a, 105b, 105c having retention units 104, 104' of various configurations and shapes depending on the specific application. Thus, the annuloplasty device 100 may be more easily tailored to a specific patient and anatomical situation, further enhancing patient safety.

[0023] As explained above, the retaining units 104, 104' may be formed from the material of the stent 105. Thus, the retaining units 104, 104' may be integral with the stent 105. The detailed view of FIG. 4c is a schematic example of how the retaining units 104 may be formed as part of the framework of the stent 105. Thus, the retaining units 104 may be cut as elongated structures with free ends 107 within the structural framework of the stent 105. In the example of FIG. 4c, the retaining units 104 are surrounded by the support elements 108 of the stent 105. The examples of FIGS. 2-4 show the support elements 108 arranged in a diamond pattern or closed cells 122, with the retaining units 104 extending into the voids of the individual diamonds or cells 122 at defined positions along the length of the stent 105. Thus, the stent 105 may comprise a plurality of support elements 108 forming a stent framework of closed cells 122, as further illustrated diagrammatically in the examples shown in FIGS. 4d-4e. A first support element 108a of the plurality of support elements 108 of the cell 122 may be movable as a retaining unit 104, 104' along a radial direction (R) perpendicular to the longitudinal direction (L) of the stent 105, as shown in Figs. 4d-4e. Thus, the retaining unit 104 shown in Figs. 4d-4e may be part of the support elements 108 forming the closed cell 122. Figs. 4d-4e show the retaining unit 104, i.e., the first support element 108a, disposed in a retracted state (p1) (Fig. 4d) and an expanded state (p2) (Fig. 4e), respectively. The retaining unit 104, or the first support element 108a, may be expanded in the radial direction (R) in the expanded state (p2) like an arch-like structure. Thus, the arch-like shape of the first support element 108a may be configured to exert pressure in the valve tissue and increase the retention force of the stent 105 in the valve annulus. The holding unit 104, or first support element 108a, may be folded into a wavy or otherwise curved or folded shape in the retracted state (p1), as illustrated in FIG. 4d.

[0024] It should be appreciated that the support elements 108 may be cut to form a variety of patterns. Forming the retention units 104, 104' as an integral part of the framework of the stent 105 results in a robust and strong retention unit 104, 104', minimizing the risk of the retention unit dislocating or deforming over time. Thus, providing an overall robust and reliable fixation mechanism for the annuloplasty device 100. As discussed above, manufacturing is also simplified as the number of separate elements of the annuloplasty device 100 that require assembly is minimized. The retention units 104, 104' may be cut to form a variety of shapes to optimize gripping force into tissue. The retention units 104, 104' may be formed by a variety of cutting techniques, such as laser cutting techniques.

[0025] The holding unit 104, 104' can be heat set to assume a defined bent shape, as shown diagrammatically in the example of FIG. 4b or FIG. 4e, which shows the expanded state (p2) of the holding unit 104. The expanded state (p2) can thus correspond to a relaxed state of the holding unit, in which the holding unit 104 is not acted upon by an external force. The holding unit 104 can be bent and heat treated during manufacture, such that the holding unit 104 assumes a defined shape in the expanded state (p2). The holding unit 104 can thus be biased towards the expanded state (p2) by attempting to reach the relaxed expanded state (p2).

[0026] Thus, the retention units 104, 104' can be elastically movable from a retracted state (p1) to an expanded state (p2). For example, when a delivery catheter (not shown) applies a compressive force on the stent 105 and associated retention unit 104, a force can be applied to the retention unit 104 such that the retention unit bends and assumes a retracted position or state (p1), as illustrated in FIG. 4a. When the annuloplasty device 100 is deployed from the delivery catheter, when the stent 105 is removed from the delivery catheter, the compressive force is removed and the elasticity of the retention unit 104 moves the retention unit toward the expanded state (p2). This provides an effective deployment of the retention units 104, 104' when the first support ring 101 and the second support ring 102 of the annuloplasty device 100 are removed from the delivery catheter. Thus, the retention units 104, 104' can expand and puncture into the valve tissue. The cross section of the annuloplasty device 100 may be minimized as the retention units 104, 104' may assume a retracted state (p1) when positioned inside the delivery catheter. The smaller cross section facilitates guiding the annuloplasty device 100 to a target site within the heart. The delivery catheter may also reduce wear and tear from the retention units 104, 104' as they may reduce friction between the tip 107 and the lumen of the delivery catheter when the retention units 104, 104' assume a retracted state (p1) within the delivery catheter. The reduced friction also facilitates moving the annuloplasty device 100 along the delivery catheter, requiring less force and providing greater control.

[0027] Thus, the retention units 104, 104' may be flexible to bend from the expanded state (p2) to the retracted state (p1). This also allows the retention units 104, 104' to bend to the retracted state (p1) upon retraction of the annuloplasty device 100 into the delivery catheter in case implantation is abandoned or repositioning is required. Thus, the annuloplasty device 100 can resume its compact cross-sectional profile.

[0028] In one example, the retention units 104, 104' can include a shape memory material that, when activated, transitions the retention units 104, 104' from the retracted state (p1) to the expanded state (p2). For example, the shape memory material can be temperature activated such that the retention units 104, 104' move toward the expanded state (p2) when heated to body temperature. This provides advantageous deployment of the retention units 104, 104' in some applications.

[0029] The retention units 104, 104' may be aligned essentially flush with the outer diameter (D) of the stent 105 in the retracted state (p1), as shown diagrammatically in Figure 4a or 4d. This provides a compact cross-sectional profile of the annuloplasty device 100, as well as reduced risk of high pressure and abrasion of the retention units 104, 104' against the lumen of the delivery catheter.

[0030] The stent 105 may be radially contractible along a radial direction (R) perpendicular to the longitudinal direction (L) of the stent 105 such that the stent 105 exerts a force (F) on the first support ring 101 and / or the second support ring 102. The radial direction (R) and the longitudinal direction (L) of the stent 105 are shown diagrammatically in FIG. 3. The example shown in FIG. 5a-5b is a cross-sectional view of the annuloplasty device 100, showing the stent 105 disposed around the first support ring 101 or the second support ring 102 and the retention unit 104 in an expanded state (p2). Thus, the stent 105 may be radially contractible towards the first support ring 101 and / or the second support ring 102, thereby exerting a force (F) on the first support ring 101 and / or the second support ring 102, as indicated by the arrow F in the illustration of FIG. 5a-5b. Thus, the stent 105 can assume a fixed position relative to the first support ring 101 and / or the second support ring 102 as the force (F) creates friction between the stent 105 and the first support ring 101 and / or the second support ring 102. Thus, the framework of the stent 105 can be cut to allow for radial (R) movement, i.e., the support elements 108 of the framework are allowed to move relative to each other, and thus the diameter (D) of the stent 105 is variable, as will be further explained with reference to Figures 8a-8b and 9a-9b. The stent 105 can be elastically expandable in the radial direction (R) such that the stent 105 can be expanded to a radially stretched state. The stent 105 can then attempt to reach a contracted relaxed state in which the inner diameter is smaller than the inner diameter in the radially stretched state. The inner diameter in the radially stretched state is d s (e.g., see FIG. 5a-FIG. 5b), and the outer diameter (d r) or more. Thus, the stent 105 may be disposed over the first support ring 101 and / or the second support ring 102 when in a radially stretched state. The stent 105 thus attempts to reach a contracted, relaxed state having a small inner diameter and exerts the aforementioned force (F) on the first support ring 101 and / or the second support ring 102 accordingly. This provides for easy fixing of the position of the stent 105 relative to the first support ring 101 and / or the second support ring 102. The example of FIG. 5a shows a cover 106 between the stent 105 and the first support ring 101 and / or the second support ring 102, as will be explained in more detail below. Thus, d r and d s The difference is even greater in this case.

[0031] The stent 105, in one example, can include a shape memory material. When the shape memory material is activated, it can cause the stent 105 to contract to a smaller diameter along the radial direction R to exert a force (F) on the first support ring 101 and / or the second support ring 102. For example, the shape memory material can be temperature activated such that the stent 105 attempts to assume a smaller inner diameter when heated to body temperature. This provides for an increased force (F) exerted on the first support ring 101 and / or the second support ring 102 to achieve a secure fixation of the stent 105 to the first support ring 101 and / or the second support ring 102.

[0032] 8a-8b and 9a-9b show an example of a radially contractible and expandable stent 105. The stent 105 can include a support element 108 configured to be contractible and expandable such that a predetermined length (L1) of the stent 105 is essentially maintained while an outer diameter (D1, D2) of the stent 105 is variable between an expanded diameter (D1) and a contracted diameter (D2). Thus, the overall length (L1) of the stent 105 can be fixed as the support element 108 undergoes movement and the diameter changes between D1 and D2. Although FIGS. 8a-8b and 9a-9b show a length L1 of a portion of the stent 105, it should be understood that this can correspond to the entire length, i.e., full length, of the stent 105 in the longitudinal direction (L). Thus, the stent 105 exhibits limited or no contraction in the longitudinal direction (L) as the diameter (D1, D2) changes. The stent 105 can be expanded to D1, positioned on the first support ring 101 and / or the second support ring 102, and then retracted to D2 to apply a radially inward force, thereby fixing the position of the stent on the first support ring 101 and / or the second support ring 102, with little or no variation in the length (L1) of the stent 105. This provides for easier and more accurate positioning of the stent 105 on the first support ring 101 and / or the second support ring 102. Thus, the position and coverage of the stent 105 over the first support ring 101 and / or the second support ring 102 can be predicted with improved accuracy, making it easier to tailor the stent 105 to different sizes of the first support ring 101 and the second support ring 102.

[0033] The support elements 108 can have different shapes configured to allow movement of the entire framework of the stent 105 primarily in the radial direction (R) with limited or no movement in the longitudinal direction (L). Figures 8a-8b show an example where the support elements 108 are curved in an S-shape. The S-shaped support elements 108 are stretched when a force is applied in the radial direction (R) so that the stent 105 assumes an expanded diameter (D1) in Figure 8a. When the external force is released, the S-shaped support elements 108 can contract again so that the stent 105 can assume a contracted diameter (D2) in Figure 8b. The length L1 of the stent 105 remains unchanged. It should be understood that the radial (R) movement is significantly greater than the longitudinal (L) movement, although some movement can occur that should have little effect on the length (L1) of the stent 105. The ratio of radial (R) movement to longitudinal (L) movement can be, for example, in the range of 5:1 to 10:1 for particularly advantageous and improved fixation of the stent 105 on the first support ring 101 and / or the second support ring 102. It is contemplated that the support element 108 can be curved into different shapes, such as a C-shape or a Z-shape, that allow for radial movement as discussed above.

[0034] 9a-9b show examples where the support elements 108 are curved in an arcuate shape. The arcuate support elements 108 or S-shaped support elements 108 may be arranged to form an essentially cylindrical shape of the stent 105. Thus, the support elements 108 may generally extend over the entire surface of such a cylindrical shape. The arcuate support elements 108 may be stretched upon application of a force in the radial direction (R) such that the stent 105 may assume an expanded diameter (D1) in FIG. 9a. When the external force is released, the arcuate support elements 108 may contract again such that the stent 105 may assume a contracted diameter (D2) in FIG. 9b. As mentioned above, the longitudinal (L) movement of the stent 105 is nonexistent or only slightly greater than the radial (R) movement.

[0035] As illustrated in Figures 8a-8b and 9a-9b, the support element 108 may comprise an elongated main frame 121 extending essentially along the longitudinal direction (L) of the stent 105. The elongated main frame 121 may define the aforementioned predetermined length (L1) of the stent 105. Thus, the elongated main frame 121 may assume an essentially fixed position in the longitudinal direction (L) when the outer diameter of the stent 105 changes between the expanded diameter (D1) and the contracted diameter (D2). This provides effective control over the length of the stent 105 in the longitudinal direction (L).

[0036] 10a-d show examples of stents 105 with different support elements 108 and retaining units 104. 10a-b show an example where the support elements 108 are S-shaped. The retaining units 104 may be shaped as expandable arcuate sections, as described above and as shown diagrammatically in 10a. Shown are the retracted state (p1) as well as the expanded state (p2) where the arcuate sections are shown in dashed lines. The retaining units 104 may be part of the support elements 108, as described in relation to 4d-e. As already mentioned, the support elements 108 may comprise an elongated main frame 121. In the latter case, the retaining units 104 may be part of the elongated main frame 121. 10b shows an example where the retaining units 104 may be shaped as expandable prong or hook-like structures. Shown are the retracted state (p1) as well as the expanded state (p2) where the prong or hook-like structures are shown in dashed lines. 10c-10d show further examples in which an arcuate (FIG. 10c) or hook-shaped (FIG. 10d) retaining unit 104 is arranged on an arcuate support element 108 of a stent 105. A retracted state (p1) as well as an expanded state (p2) are shown. The retaining unit 104 may be movable between the retracted state (p1) and the expanded state (p2) when the stent 105 has a contracted outer diameter (D2), e.g., when secured to the first support ring 101 and / or the second support ring 102 for anchoring the stent 105 in the valve tissue.

[0037] The annuloplasty device 100 may include a cover 106 disposed around at least a portion of the first support ring 101 and / or the second support ring 102. The cover 106 may be configured to promote endothelialization and cellular ingrowth onto the annuloplasty device 100. For example, the cover 106 may have a more porous surface than the surfaces of the first support ring 101 and the second support ring 102 that promotes cellular growth over the annuloplasty device 100. The cover 106 may include a woven fabric or polymeric fabric. The stent 105 may be disposed around at least a portion of the cover 106. The cover 106 may be disposed around the entire length of the first support ring 101 and the second support ring 102.

[0038] The stent 105 may exert a force on the cover 106 such that the cover 106 is sandwiched between the stent 105 and the first support ring 101 and / or the second support ring 102, as illustrated in the schematic diagram of FIG. 5a. Having the cover 106 sandwiched between the stent 105 and the first support ring 101 and / or the second support ring 102 may provide a secure fixation of the position of the cover 106 and the stent 105 relative to the first support ring 101 and / or the second support ring 102. Thus, the stent 105 may attempt to assume an inner diameter smaller than the outer diameter of the cover when the cover 106 is disposed around the first support ring 101 and / or the second support ring 102 such that a force (F) is exerted radially inwardly to sandwich the cover 106 against the outer surface of the first support ring 101 and / or the second support ring 102. If the stent 105 is formed from a temperature-activated shape memory material, the stent 105 can increase its force (F) radially inward as the stent 105 heats up to body temperature, which further increases the strength of the fixation of the stent 105 to the first support ring 101 and / or the second support ring 102.

[0039] The first support ring 101 can comprise a first posterior arcuate portion 113 and a first anterior portion 114. The second support ring 101 can comprise a second posterior arcuate portion 113' and a second anterior portion 114'. The first posterior arcuate portion 113 and the second posterior arcuate portion 113' can have an arcuate extension, configured to conform to the posterior aspect of the heart valve, i.e. along the posterior leaflet. The first anterior portion 114 and the second anterior portion 114' can each have a straighter extension, or at least an extension that is less curved than the arcuate posterior side 113, 113'. This is illustrated in FIG. 7b. Thus, the first anterior portion 114 and the second anterior portion 114' can be configured to conform to the anterior aspect of the heart valve, i.e. along the anterior leaflet. As mentioned, the first support ring 101 may be configured to be placed on the atrial side of the heart valve and the second support ring 102 may be configured to be placed on the ventricular side of the heart valve, as illustrated in Fig. 7a. Fig. 7b shows a schematic view from above, with the second ring 102 shown in dashed lines and the first ring 101 shown in solid lines. The transition point between the first ring 101 and the second ring 102 is at the commissure, which in the example of Fig. 7b is indicated as 302'.

[0040] The first anterior portion 114 may comprise an anterior stent 105c. The anterior stent 105c comprises a number of retention units 104 extending towards the second support ring 102, as shown diagrammatically in Fig. 1, the retention units being in an expanded state (p2). The second anterior portion 114' may comprise a smooth surface without retention units 104, as further shown in the example of Fig. 1. This provides a secure anchoring of the first anterior portion 114 in tissue on the atrial side, while at the same time minimizing the risk of tissue damage along the second anterior portion 114' in the ventricle.

[0041] The first posterior arcuate portion 113 may include a first posterior stent 105a. The first posterior stent 105a may include a first plurality of retention units 104 extending toward the second support ring 102, the retention units being in an expanded state (p2), as shown diagrammatically in FIG. 1 . The second posterior arcuate portion 113' may include a second posterior stent 105b. The second posterior stent 105b may include a second plurality of retention units 104' extending in a direction toward the first plurality of retention units 104. Thus, the first plurality of retention units 104 and the second plurality of retention units 104' may extend in opposite directions along the axial direction 103. Having retention units 104, 104' on both sides along the first posterior arcuate portion 113 and the second posterior arcuate portion 113' allows for increased retention and strength to secure the annuloplasty device 100 to the valve. The retaining units 104, 104' engage the tissue from both sides of the heart valve and generate a strong retaining force in the radial direction, i.e. perpendicular to the axial direction 103. The first support 101 and the second support 102 clamp the tissue from both sides of the valve so that the retaining units 104, 104' are pressed into the tissue. The retaining units 104, 104' can shape the annulus as desired even with a reduced clamping force, because the retaining units 104, 104' can fix the shape of the annulus in the radial direction due to said retaining force. This provides a more reliable implantation in the heart valve in both the short and long term.

[0042] Each individual retention unit 104, 104' can engage or pierce tissue at a short distance to minimize damage to the tissue. The sum of the retention forces and friction generated from all retention units 104, 104' still provides a strong fixation in the tissue. Because the dimensions of each individual retention unit 104, 104' are relatively small, scar healing is rapid. This provides an atraumatic yet secure fixation of the annuloplasty device 100. Thus, the retention units 104, 104' can provide tissue fixation at multiple points across the annuloplasty device 100, resulting in reduced forces per fixation point and eliminating the need for bulky suturing or knot forming devices. Additionally, there is no risk of coronary artery occlusion or coronary sinus perforation. Thus, the annuloplasty device 100 provides an easier procedure and a less time consuming procedure than suturing.

[0043] Positioning multiple separate stents 105a, 105b, 105c along the rear arcuate portion 113, 113' and the first anterior portion 114 further allows for displacement of the stents 105a, 105b, 105c from the intermediate portion 109 extending therebetween. The intermediate portion 109 shown in FIG. 1 has a larger radius of curvature than the rear arcuate portion 113, 113' and the anterior portion 114, 114'. Positioning the stents 105a, 105b, 105c at a distance from the intermediate portion 109 allows for greater flexibility along the intermediate portion 109 of the first and second support rings 101, 102 and easier bending along the intermediate portion.

[0044] The retention units 104, 104' may be evenly spaced along the stent 105, 105a, 105b, 105c, as illustrated in Figures 1 and 2. Such an even distribution of fixation points provides secure fixation to the tissue, minimizing the risk of localized pressure peaks. However, it should be understood that the distance between each of the retention units 104, 104' may be varied to optimize fixation of the annuloplasty device 100 to different anatomical structures. The first anterior portion 114 and / or the second anterior portion 114' may each have 5-6 retention units 104, 104'. The first posterior portion 113 and / or the second posterior portion 113' may each have 6-8 retention units 104, 104'. This may provide a particularly efficient fixation to the tissue while minimizing overall tissue penetration. However, it should be understood that the number of retention units 104, 104' may be varied to optimize 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 advantageous anchoring in tissue while being easy to deploy through a delivery catheter.

[0045] The first support ring 101 can transition to the second support ring 102 via a transition section 120 as shown in FIG. 6. The stent 105 has been omitted from FIG. 6 for a clearer illustration. The transition section 120 is configured to be placed at the commissures 302, 302' of the heart valve leaflets, for example at the commissures 302', as shown in FIG. 7b. The first support ring 101 and the second support ring 102 extend in a first coil plane 101' and a second coil plane 102', respectively, that are essentially perpendicular to the central axis 103. existsThe transition region 120 can be at least partially bent 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 102 (i.e., along a direction parallel to the central axis) at the transition region 120. Having such a transition 120 where the coil planes 101', 102' are locally displaced by the distance (d1) and in a position corresponding to the location of the commissures 302, 302' improves the adaptation of the first and second support rings 101, 102 to the anatomical structures on either side of the valve, particularly when the heart is beating. This allows the retention units 104, 104' of the stents 105, 105a, 105b, 105c to effectively pierce into tissue as the first and second support rings 101, 102 adapt to the anatomical structures.

[0046] Furthermore, having a drop or "S" or "Z" shape of the coil planes 101', 102' in the transition region 120 due to the separation distance (d1) provides a better joint 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 either of the support rings 101, 102 at the commissures 302, 302' is minimized, since 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 shorter distance in the transition region 120 due to the displacement (d1). This means that the first support ring 101 and the second support ring 102 can better fit on both sides of the valve close to the commissures 302, 302'. Thus, the annuloplasty device 100 may be secured to the valve in a more secure manner while minimizing the risk of dislocation. The location of the transition portion 120 may be altered depending on which commissure 302, 302', first support ring 101 / second support ring 102 extends through the valve leaflet. Thus, the transition portion 120 may have an increased inclination or pitch relative to the central axis 103 compared to the remainder of the first support ring 101 and second support ring 102.

[0047] The transition section 120 may be at least partially curved along a radial direction (r) of the coiled configuration of the first and second support rings 101, 102, which is perpendicular to the central axis 103, such that the transition section 120 is concave toward the radial direction (r). Such a concave bend or "C-curve" of the transition section 120 toward the radial direction (R) may further improve the attachment of the first and second support rings 101, 102 to the valve anatomy proximate the commissures 302, 302'. The risk of adverse force transmission or friction between the moving leaflets and either of the support rings 101, 102 at the commissures 302, 302' is minimized. The concave bend of the transition section 120 allows the commissures 302, 302' to conform to anatomy that is located closer to the central axis 103 than the annulus, so that the first support ring 101 and the second support ring 102 can extend as far along the annulus as possible while extending through the commissures 302, 302' with minimal impact on valve motion. Thus, the annuloplasty device 100 can be secured to the valve in a further improved manner while minimizing the risk of long-term displacement.

[0048] The first support ring 101 and the second support ring 102 may have free ends 116 and 116', respectively, as shown in FIG. 1. The free ends 116, 116' may be configured to be positioned on either side of the native heart valve leaflets. The two free ends 116, 116' may be displaced from each other by a peripheral offset distance that extends in the coil plane. The coil plane is substantially parallel to the annular circumference of the coil formed by the first support ring 101 and the second support ring 102 and perpendicular to the axial direction 103. The coil plane thus corresponds to the plane spanned by the annular circumference of the device 100 when in the coiled configuration. The peripheral offset distance 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 implanted around the annulus of the heart valve, the two free ends 116, 116' are separated along the plane of the valve. Such an offset 117 in the plane of the valve reduces the length of the first support ring 101 or the second support ring 102, which may be advantageous in some anatomical structures where there may be a risk of the first support ring 101 or the second support ring 102 interfering with valve motion.

[0049] A method 200 for repairing a defective heart valve is disclosed. The method 200 is illustrated diagrammatically in FIG. 11a in conjunction with FIGS. 1-10. The order in which the steps are described should not be construed as limiting, and it is contemplated that the order of the steps may be varied depending on the particular procedure. The method 200 includes positioning 201 a first support ring 101 of an annuloplasty device 100 on the ventricular side of the heart valve, and positioning 202 a second support ring 102 of the annuloplasty device on the atrial side of the heart valve. The first support ring and the second support ring are thus arranged as a coil extending through the commissures 302, 302' of the heart valve. The first support ring 101 and / or the second support ring 102 comprise a stent 105, 105a, 105b, 105c disposed around at least a portion of the first support ring 101 and / or the second support ring 102. The stent comprises a retention unit 104, 104'. The method 200 includes positioning 203 the stent 105 against valve tissue along the aforementioned portions of the first support ring 101 and / or the second support ring 102 such that the retention units 104, 104' are engaged 204 into the tissue of the heart valve. The method 200 provides advantageous advantages as discussed above with respect to the annuloplasty device 100 and Figures 1-10. The method 200 allows for easy anchoring of the annuloplasty device 100 to the heart valve due to the robust and reliable anchoring mechanism provided by the stent 105, 105a, 105b, 105c and the retention units 104, 104' secured thereto.

[0050] Another method 200 is shown diagrammatically in Fig. 11b. The method 200 may include placing 2031 an anterior stent 105c on the atrial side along a first anterior portion 114 of the first support ring 101, and placing 2032 a first posterior stent 105a on the atrial side along a first posterior arcuate portion 113 of the first support ring 101. The method 200 may further include placing 2033 a second posterior stent 105b on the ventricular side along a second posterior arcuate portion 113' of the second support ring 102.

[0051] The method 200 may further include engaging 2041 the retention unit 104 of the anterior stent 105c into the atrial valve tissue and engaging 2042 the retention unit 104 of the first posterior stent 105a and the retention unit 104' of the second posterior stent 105b with the atrial and ventricular valve tissues, respectively, to anchor the annuloplasty device 100 to the heart valve. Thus, as further described above with reference to Figures 1-10, a secure fixation of the annuloplasty device on both sides of the heart valve leaflets is provided.

[0052] The method 200 may include positioning the first support ring 101 and the second support ring 102 on the atrial and ventricular sides of the heart valve, respectively, by removing 2021 the first support ring and the second support ring from a delivery catheter (not shown), where the retention units 104, 104' move from a retracted state (p1) to an expanded state (p2) as the first support ring 101 and the second support ring 102 are removed from the delivery catheter.

[0053] The retaining units 104, 104' can be aligned essentially flush with the outer diameter (D) of the stents 105, 105a, 105b, 105c in the retracted state (p1) when the first support ring 101 and the second support ring 102 move along the lumen in the case of a delivery catheter.

[0054] The present invention has been described above with reference to specific embodiments. However, embodiments other than those described above are equally possible within the scope of the present invention. Different features and steps of the present invention can be combined in combinations other than those described. The scope of the present invention is limited only by the appended claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application or applications in which the teachings of the present invention are used.

Claims

1. 1. An annuloplasty device (100), comprising: A first support ring (101) and a second support ring (102) having a coiled configuration, the first support ring (101) and the second support ring (102) being arranged as a coil about a central axis (103). Equipped with the first support ring and the second support ring are configured to be positioned on either side of a native heart valve leaflet (301) of a heart valve; The annuloplasty device (100) includes a stent (105, 105a, 105b, 105c) disposed around at least a portion of the first support ring and / or the second support ring. Equipped with An annuloplasty device (100), wherein said stent comprises a retention unit (104, 104').

2. The annuloplasty device of claim 1 , wherein the retention unit is integral with the stent by being formed from the material of the stent.

3. The holding unit includes a shape-memory material, and when the shape-memory material is activated, the holding unit is moved to a retracted state (p １ ) to the expanded state (p ２ 3. The annuloplasty device of claim 1 or 2, wherein the annulus is transitioned to a first transition state.

4. The holding unit is in a retreated state (p １ ) to the expanded state (p ２ 4. The annuloplasty device according to claim 1, wherein the annuloplasty device is elastically movable relative to the annulus.

5. The holding unit is in the expanded state (p ２ ) to the retreated state (p １ 5. The annuloplasty device of claim 4, wherein the annuloplasty device is flexible so as to bend in a direction perpendicular to the annulus.

6. The annuloplasty device of claim 5 , wherein the retention unit is aligned essentially flush with an outer diameter (D) of the stent in the retracted state.

7. 7. The annuloplasty device of claim 1, wherein the stent comprises a plurality of support elements (108) forming a stent framework consisting of closed cells (122), and a first support element (108a) of the plurality of support elements of a cell (122) is movable as a retention unit (104, 104') along a radial direction (R) perpendicular to the longitudinal direction (L) of the stent.

8. The annuloplasty device of any one of claims 1 to 7, wherein the stent is radially contractible along a radial direction (R) perpendicular to the longitudinal direction (L) of the stent such that the stent exerts a force (F) on the first support ring and / or the second support ring.

9. 9. The annuloplasty device of claim 8, wherein the stent comprises a shape memory material that, when activated, causes the stent to contract to a smaller diameter along a radial direction (R) to apply the force to the first support ring and / or the second support ring.

10. The outer diameter of the stent (D １ , D ２ ) is the expansion diameter (D １ ) and shrinkage diameter (D ２ ) while the predetermined length of the stent (L １ 10. The annuloplasty device of claim 1, further comprising a support element (108) configured to be contractible and expandable such that the annulus of ...

11. The support element comprises an elongated main frame (121) that extends essentially along the longitudinal direction (L) of the stent, the elongated main frame being adapted to extend along the predetermined length (L) of the stent. １ ) the elongate main frame defines a diameter (D １ ) and the contracted diameter (D ２ 11. The annuloplasty device of claim 10, wherein the annuloplasty device assumes an essentially fixed position in the longitudinal direction (L) when changing between said longitudinal direction (L) and said annulus plasty device.

12. a cover (106) disposed around at least a portion of the first support ring and / or the second support ring; The annuloplasty device of any one of claims 1 to 11, wherein the stent is disposed around at least a portion of the cover.

13. The annuloplasty device of claim 12 , wherein the stent exerts a force on the covering such that the covering is sandwiched between the stent and the first support ring and / or the second support ring.

14. the first support ring comprises a first rearward arcuate portion (113) and a first forward portion (114); the second support ring comprises a second rearward arcuate portion (113') and a second forward portion (114'); the first posterior arcuate portion and the second posterior arcuate portion are configured to conform to a posterior aspect of the heart valve, and the first anterior portion and the second anterior portion are configured to conform to an anterior aspect of the heart valve; said first anterior portion (114) comprising an anterior stent (105c), said anterior stent comprising a plurality of retention units; The annuloplasty device according to any one of claims 1 to 13, wherein the second front portion (114') comprises a smooth surface without a retaining unit.

15. the first posterior arcuate portion (113) comprises a first posterior stent (105a) comprising a first plurality of retention units; The annuloplasty device of claim 14, wherein the second posterior arcuate portion (113') comprises a second posterior stent (105b) having a second plurality of retention units extending in a direction toward the first plurality of retention units.

16. the first support ring transitions to the second support ring via a transition portion (120), the transition portion being configured to be disposed at a commissure (302, 302') of the heart valve leaflets; the first and second support rings extend in a first coil plane (101') and a second coil plane (102'), respectively, that are essentially perpendicular to the central axis; The transition portion is such that the first coil plane is a distance (d １ 16. The annuloplasty device of claim 1, wherein the annuloplasty device is at least partially curved along the central axis such that the annulus is spaced apart by a distance of 1 mm.

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