Annuloplasty Devices

Abstract

The annuloplasty device includes a first support ring and a second support ring having a coiled configuration, the first support ring and the second support ring having a free end, the first support ring and the second support ring being arranged as a coil around a central axis and configured to be positioned on either side of the native heart valve leaflets of a heart valve, the first support ring and the second support ring having a free end, and a wire attached to a proximal connector at a proximal tip of a first end of one of the free ends. A method of retrieving the annuloplasty device from an implantation site in a heart valve is disclosed.

Description

[Technical field]

[0001] The present invention relates generally to the field of heart valve replacement and repair. More specifically, the present invention relates to annuloplasty devices for delivery and implantation in heart valves, and methods of retrieval of such annuloplasty devices. [Background technology]

[0002] Diseased mitral and tricuspid valves frequently require replacement or repair. The mitral and tricuspid valve leaflets, or their supporting chordae, may degenerate and weaken, or the annulus may dilate, causing valve leakage. Mitral and tricuspid valve replacement and repair is frequently performed with the aid of annuloplasty devices, such as annuloplasty rings, to reduce the diameter of the annulus or otherwise modify the shape of the annulus, or generally assist as a support structure during valve replacement or repair. Such annuloplasty devices are implanted in place by a variety of delivery devices.

[0003] A problem with the prior art devices is that the engagement mechanism between the annuloplasty device and the delivery device is less than optimal, and is not secure during the positioning phase or during possible repositioning to place the annuloplasty device in its final fixed position, which can make the procedure more complicated and time-consuming. This requires precise, i.e. time-consuming, navigation and manipulation in the previous devices to minimize the risk of suboptimal fixation of the annuloplasty device. During cardiac surgery, the heart is frequently stopped and blood perfusion is prevented, so there is a focus on reducing the time spent on valve replacement and repair. The above problems can have disastrous consequences for patients and the medical system, thus increasing the risk to the patient. A problem with the prior art devices that attempt to solve the above disadvantages is that the engagement mechanism between the annuloplasty device and the delivery device is more complicated. This can result in less cost-effectiveness and / or a bulkier profile for such devices, which can generally negatively impact the maneuverability of the annuloplasty device as well as making navigation overall more cumbersome when placing the annuloplasty device in its final position.

[0004] Thus, an improved annuloplasty device for delivery and implantation in heart valves would be advantageous, and would, among other things, allow for avoidance of many of the problems and compromises discussed above, enable a safer implantation procedure, reduce lengthy surgical procedures, and increase patient safety. Summary of the Invention

[0005] Accordingly, examples of the present invention preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or problems in the art, such as those identified above, singly or in any combination, by providing a device within the scope of the appended patents.

[0006] According to a first aspect, there is provided an annuloplasty device including first and second support rings having a coiled configuration, in which they are arranged as a coil around a central axis and configured to be positioned on either side of the native heart valve leaflets of a heart valve, the first and second support rings each having a free end, and a wire attached to a proximal connection at a proximal tip of a first end of one of the free ends.

[0007] According to a second aspect, there is provided a method of retrieving an annuloplasty device from an implantation site in a heart valve, the annuloplasty device including a wire attached to a proximal connection at a proximal tip of a free end thereof, the method comprising the steps of positioning the wire in a lumen of a delivery device, urging the delivery device over the wire towards the proximal tip, engaging the proximal tip with a distal portion of the delivery device, and retrieving at least a portion of the annuloplasty device through an opening in the distal portion and towards the lumen.

[0008] Further embodiments of the present invention are defined in the dependent claims, the features of the second and subsequent aspects of the present disclosure being as described above for the first aspect, optionally mutatis mutandis.

[0009] Some examples of the present disclosure provide more reliably implantable annuloplasty devices.

[0010] Some examples of the present disclosure provide annuloplasty devices that are easier to reposition during the implant procedure.

[0011] Some examples of the present disclosure reduce the time required to position and secure annuloplasty devices in a heart valve.

[0012] Some examples of the present disclosure reduce the complexity of attaching and detaching an annuloplasty device to a delivery device.

[0013] Some disclosed examples improve the accuracy of positioning of annuloplasty devices at the annulus of a heart valve, thereby reducing the risk of complications.

[0014] Some examples of the present disclosure facilitate retrieval of the annuloplasty device after it has been positioned at the implantation site.

[0015] Some examples of the present disclosure reduce the risk of damage to heart valves during repair or replacement surgery.

[0016] Some examples of the present disclosure improve the maneuverability or steerability of annuloplasty devices.

[0017] It is emphasized that the term "comprises / comprising" as used in this specification is to be interpreted as specifying the presence of stated features, integers, steps, or components, but does not preclude the presence or addition of one or more other features, integers, steps, components, or groups thereof. [Brief description of the drawings]

[0018] These and other aspects, features and advantages of examples of the present invention will be apparent from and elucidated in the following description of the embodiments of the invention, taken in conjunction with the accompanying drawings. [Figure 1] 1 is a schematic side view of an annuloplasty device according to an example. [Diagram 2] 1 is a schematic side cross-sectional view of a detail of an annuloplasty device according to an example. [Figure 3a] 1 is a schematic side cross-sectional view of a detail of an annuloplasty device according to an example. [Figure 3b] 1 is a schematic diagram of a wire for connecting to an annuloplasty device according to an example of the present disclosure. [Figure 3c] 1 is a schematic diagram of a wire for connecting to an annuloplasty device according to an example of the present disclosure. [Figure 4a] 1 is a schematic side cross-sectional view of a detail of an annuloplasty device according to an example. [Figure 4b]1 is a schematic side cross-sectional view of a detail of an annuloplasty device according to an example. [Diagram 5] 1 is a schematic side cross-sectional view of a detail of an annuloplasty device according to an example. [Figure 6] 1 is a schematic side cross-sectional view of a detail of an annuloplasty device according to an example. [Figure 7] 1 is a schematic side cross-sectional view of a detail of an annuloplasty device according to an example. [Figure 8] FIG. 2 is a side schematic view of an annuloplasty device according to one example of the present disclosure, the annuloplasty device being positioned above and below the valve leaflets. [Figure 9a] FIG. 1 is a schematic diagram of an annuloplasty device positioned outside a delivery device. [Figure 9b] FIG. 1 is a schematic diagram of an annuloplasty device positioned inside a lumen of a delivery device. [Figure 10a] FIG. 1 is a schematic diagram of an annuloplasty device secured to tissue at an implantation site. [Figure 10b] 1 is a schematic diagram of an annuloplasty device being retrieved from an implantation site into the lumen of a delivery device. [Figure 11a] 1 is a flowchart of a method for retrieving an annuloplasty device from an implantation site in a heart valve, according to an example of the present disclosure. [Figure 11b] 1 is a flowchart of a method for retrieving an annuloplasty device from an implantation site in a heart valve, according to an example of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Specific examples of the present invention will be described with reference to the accompanying drawings. However, many of the present inventions may be embodied in various forms and should not be construed as being limited to the examples set forth herein. Rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the present invention. In the drawings, like numbers represent like elements.

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

[0021] FIG. 1 illustrates a schematic example of an annuloplasty device (100) including a first support ring (101) and a second support ring (102), which are adapted to be arranged as a coil, i.e., in a helical or coiled configuration around a central axis (103), as shown in FIG. 1. The annuloplasty device (100) is arranged in a coiled configuration at least when the material that constitutes the annuloplasty device is in a relaxed state, i.e., when there is no external force acting on the annuloplasty device (100). The coiled annuloplasty device (100) has two free ends (104), (104'). The first support ring (101) and the second support ring (102) and each free end (104), (104') are configured to be arranged on either side of the native heart leaflets (301) of a heart valve, as illustrated in the side view of FIG. 8. As shown in FIG. 8, the first support ring (101) may be positioned around the annulus on the atrial side of the heart valve, and the second support ring (102) may be positioned on the ventricular side. When the first support ring (101) and the second support ring (102) are connected, a coil or helical ring is formed. The coil extends through the valve opening at its junction. Thus, the first support ring (101) and the second support ring (102) may assume a coiled configuration even in the implanted state. The annuloplasty device (100) may include a shape memory material, such that after delivery to a target site from a delivery device (401), such as the delivery catheter (401) shown diagrammatically in FIGS. 9a-9b, the annuloplasty device (100) resumes the coiled configuration after being temporarily retained in an expanded configuration inside such catheter (401). The annuloplasty device (100), i.e., the annuloplasty implant (100), may comprise a shape-memory material, such as Nitinol, or other suitable biocompatible alloy, that can be heat-set in a heat treatment procedure to a defined shape, i.e., a defined relaxed shape in the absence of external forces, such as a coiled configuration.

[0022] The annuloplasty device (100) includes a wire (106) attached to a proximal connection (107) at a proximal tip (105), (105') of a first end of one of the free ends (104), (104'). The wire (106) may be a suture, a wire, or other essentially flexible and elongated element sized to be placed and / or connected to a delivery device (401), as shown diagrammatically in Figures 9-10. Figures 1 and 2 show a schematic example in which the wire (106) is attached to the proximal tip (105) of the free end (104) of the first support ring (101). The examples shown in Figures 1-7 and 9-10 show the wire (106) attached to the first support ring (101). However, it should be understood that the wire (106) may be attached to the tip (105') of the free end (104') of the second support ring (102), although reference is made throughout this disclosure to the free end (104) and the proximal tip (105). The wire (106) attached to the proximal connection (107) at the proximal tip (105) should be interpreted as the wire (106) being rigidly fixed to the proximal tip (105), such that, in use, pulling the wire (106) towards a delivery device (401), such as a catheter (401), will retract the first and second support rings towards such catheter (401), thereby allowing the annuloplasty device (100) to be retrieved from such delivery catheter after having been previously deployed. Figure 9a shows the annuloplasty device (100) positioned outside of the delivery device (401), while Figure 9b is a schematic diagram showing the annuloplasty device (100) partially disposed within the lumen (402) of the delivery device (401), for example, when the pre-deployed annuloplasty device (100) has been pulled into the lumen (402) along the axial direction (112). Figure 10a is another schematic diagram showing the deployed annuloplasty device (100) secured to tissue (302) by retainers (117) extending from the first support ring (101) and / or the second support ring (102).In this example, the delivery device (401) is advantageously advanced towards the annuloplasty device (100) such that the distal portion (118) of the delivery device (401) engages the proximal tip (105) of the annuloplasty device (100) (FIG. 10a). By continuing to advance the delivery device (401), the distal portion (118) becomes fixed between the tissue (302) and the annuloplasty device (100) such that the retention portion (117) of the latter is lifted from its fixed position in FIG. 10a, i.e. moves along a radial direction (119) essentially perpendicular to the axial direction (112) as shown diagrammatically in FIG. 10b, while the annuloplasty device (100) is gradually withdrawn into the lumen (402) of the delivery device (401). The wire (106) effectively guides the delivery device (401) to the correct location so that the proximal tip (105) can be retrieved into the lumen (402). The proximal portion (118) may be formed with an at least partially curved or smooth shape, for example as shown diagrammatically in FIG. 10a. This facilitates fixation of the distal portion (118) while atraumatically engaging the tissue (302) and lifting the annuloplasty device (100) as described above. The method (200) is described in more detail below with respect to FIGS. 9-10.

[0023] The first (101) and second (102) support rings and their free ends (104), (104') extend generally along an axial direction (112). The proximal tip (105) of the free end (104) should be interpreted as part of the free end (104), such as the surface (115) of the free end (104) where the free end (104) terminates along the axial direction (112). The proximal connection (107) secures the wire (106) to the proximal tip (105). The attachment of the wire (106) to the proximal tip (105) ensures reliable retrieval of the first (101) and second (102) support rings and minimizes the cross-section of the annuloplasty device (100) in a direction perpendicular to the axial direction (112), i.e., in the radial direction (113). Manipulation of the wire (106) facilitates repositioning, resulting in more reliable implantation of the annuloplasty device (100). The position of the first and second support rings (101) and (102) in the heart valve may be altered, for example by pulling the wire (106), to optimize their respective ventricular and atrial positions. The wire (106) may also fully withdraw the first and second support rings (101) and (102) from the implantation site in case of complications, as described above. The minimized cross-section provided by the proximal connection at the proximal tip (105) allows for improved maneuverability and easier positioning of the first and second support rings (101) and (102) in the valve. The compact cross-section facilitates integration with existing delivery devices, and the procedure may be accomplished with fewer components and steps. In one aspect of the invention, there is provided an annuloplasty system including an annuloplasty device (100) as described with reference to Figures 1-10 and a delivery device (401) as described with reference to Figures 9-10.

[0024] The proximal connector (107) may include a lumen (108) sized to receive the distal tip (109) of the wire (106). FIG. 2 shows a schematic example in which the distal tip (109) of the wire (106) is disposed within the lumen (108) of the free end (104). FIGS. 4a-b are further schematic examples in which the proximal connector (107) includes a portion of the wire (106), such as the lumen (108) and its distal tip (109), and is disposed in the lumen (108). FIG. 4a shows an example in which the wire (106) is wound through the lumen (108). The length of the wire (106) that extends through the lumen (108) may vary, forming a fully wound configuration as illustrated in FIG. 4a, or extending a length through the lumen (108) that is essentially equivalent to the length of the lumen (108) itself, as illustrated in FIG. 4b. Arranging the lumen (108) to receive the wire (106), for example as illustrated in Figures 2 and 4a-b, facilitates attachment of the wire (106) to the free end (104) and its proximal tip (105). However, in other examples, it is contemplated that the wire (106) may be attached at other types of proximal connections (107). For example, the proximal connections (107) may include a material or element that secures the distal tip (109) of the wire (106) to the proximal tip (105) as illustrated diagrammatically in Figure 5, such as an adhesive material, or other material or element configured to secure the wire (106) while providing the aforementioned advantages, such as easy positioning and / or retrieval of the annuloplasty device (100) and providing a compact cross-section.

[0025] The first end (104) may be configured to be compressed to force the distal tip (109) of the wire (106) inside the lumen (108). Thus, in the example of FIG. 2, the first end (104) may be compressed radially inward, i.e., perpendicular to the axial direction (112), such that the inner wall of the lumen (108) is forced against the distal tip (109) of the wire (106). This effectively and securely secures the wire (106) inside the lumen (108) and to the first end (104). The first end (104) may be compressed during manufacturing of the annuloplasty device (100) to secure the wire (106). It is also contemplated that a user may secure the wire (106) to the first end (104), for example prior to a procedure, by inserting the distal tip (109) into the lumen (108) and subsequently compressing the first end (104), for example with an instrument configured to apply a radially inward compressive force on the first end (104). In one example, the lumen (108) shown in Figures 4a-b, which extends in a radial direction (113), may also be compressed to secure the wire (106) within the lumen (108). In another example, the distal tip (109) may be secured to the lumen (108) with an adhesive.

[0026] As illustrated diagrammatically in Figures 3a to 3c and 4b, the distal tip (109) of the wire (106) may include an enlarged portion (110). The presence of the enlarged portion (110) at the distal tip (109) facilitates secure fixation of the wire (106) to the free end (104). The enlarged portion (110) has an enlarged cross section in the radial direction (113), i.e., a wider cross section compared to the cross section of the entire wire (106). The enlarged portion (110) may have various shapes, such as a cylindrical shape as illustrated diagrammatically in Figures 3a and 4b, a spherical shape as illustrated diagrammatically in Figure 3b, or a hook shape as illustrated in Figure 3c. Thus, the enlarged portion (110) may include at least a partially spherical or hook-shaped portion. As illustrated in Figures 3a to 3c and 4b, the enlarged portion (110) may be arranged such that the wire (106) terminates at the enlarged portion (110). This allows for a compact arrangement for fastening the wire (106) to the free end (104) and makes efficient use of the available space, i.e., there is no need to accommodate an excess of the wire (106) beyond the enlarged portion (110) in the free end (104) in either the axial direction (112) or the radial direction (113). The enlarged portion (110) may be sized such that it does not extend beyond the free end (104) of the first support ring (101) and / or the second support ring (102) in the radial direction (113). As shown diagrammatically in Figure 3a, the enlarged portion (110) may be sized to be accommodated within the lumen (108) of the free end (104), for example. In this example, as illustrated in Figure 3a, the enlarged portion (110) may be sized to lock against a narrowing (111) in the lumen (108). After placement of the enlarged portion (110) in the lumen (108) to create such a narrowing (111), the free end (104) may be radially compressed (113). Figure 4b shows another example where the lumen (108) has a narrowing (111) relative to the enlarged portion (110), such that the enlarged portion (110) cannot be pulled through the narrowing (111). This further facilitates secure fixation of the wire (106) to the free end (104).The enlarged portion (110) may be sized so as not to extend radially (113) beyond the free end (104) in the example of FIG. 4b. This provides a compact fixation of the wire (106). It reduces the risk of interfering with the surrounding tissue and facilitates delivery of the annuloplasty device (100) through the delivery device (401). The enlarged portion (110) may be a separate element attached to the distal tip (109) by a press-fit connection to the distal tip (109), such as by pinching or pressing the enlarged portion (110) onto the distal tip (109). The enlarged portion (110) may be attached to the distal tip (109) by an adhesive. The enlarged portion (110) may be formed solely from an adhesive or other polymeric material. For example, an adhesive or polymeric material configured to be molded and then cured may be applied to the distal tip (109) and molded to form the expansion (110), which is subsequently cured in a curing step. The expansion (110) may be formed from the material of the wire (109) to provide an integrated expansion (110) without attaching a separate element or material. Thus, the distal tip (109) of the wire (109) may be formed into the expansion (110). Thus, the diameter of the distal tip (109) of the wire (106) may be larger compared to the remainder of the wire (106). The diameter of the distal tip (109) may be increased during the manufacture of the wire (106). The diameter of the distal tip (109) may be increased by forming a knot in the wire (109) or by folding the wire (106) at the distal tip (109). The overlapping lines in such folds can be secured in place by application of adhesive.

[0027] As illustrated in Figures 2 and 3a, the lumen (108) may extend along the axial direction (112) of the first free end (104). This effectively fixes the wire (106) to the free end (104) as described above, since the retention force may be applied to a length of the wire (106) that is easily adjustable and optimizable. That is, the retention force may be increased by lengthening the distal tip (109) that extends inside the lumen (108), which may then be compressed as described above to be fixed inside the distal tip (109). This allows the wire (106) to be securely fixed to the free end (104) without affecting the cross-sectional dimension, i.e., the radial dimension (113), of the annuloplasty device (100). Furthermore, an external fixation element may not be required, which may otherwise cause adverse effects on the surrounding tissue, such as tissue friction or increase the risk of thrombus formation.

[0028] The lumen (108) may be coaxially aligned with the first end (104) along the axial direction (112), which optimizes the structural integrity of the free end (104) with the stronger support ring (101). However, it is contemplated that in some instances the wire (106) may be secured to the lumen (108) that is offset from the center of the free end (104) in the radial direction (113).

[0029] The lumen (108) may include a perforated opening at the proximal tip (105). Thus, the lumen (108) may be formed in the otherwise solid support rings (101), (102). A perforated opening should be construed as any feature by which an opening is cut into the free end (104). Thus, the distal tip (109) of the wire (106) may be inserted and secured into the opening or lumen as described above. In other examples, the first support ring (101) and / or the second support ring (102) may be formed from a tubular material, in which case the distal tip (109) of the wire (106) may be inserted and secured without the need for an additional manufacturing step of cutting an opening into the free end (104).

[0030] As shown in the example of Figures 4a-4b, the lumen (108) may extend along a radial direction (113) perpendicular to the axial direction (112). Thus, the wire (106) may be effectively secured to the free end (104) by radially inserting (113) into the lumen (108), which may be particularly advantageous in some applications. Securement may be achieved as described above, for example, by compressing or forcing the lumen (108) against the wire (106) and / or by having an enlarged diameter portion (111) and / or by other securing mechanisms, such as adhesives.

[0031] The proximal connector (107) may include a protrusion (114) extending from the proximal tip (105) in the axial direction (112) of the first end (104). As shown generally in FIGS. 4a-4b, the lumen (108) may extend through the protrusion (114). Having the protrusion (114) from the proximal tip (105) to which the wire (106) is secured facilitates securing the wire (106) to the free end (104). The protrusion (114) may be formed from the material forming the first support ring (101) and / or the second support ring (102), or may include other biocompatible materials such as stainless steel or nitinol. The protrusion (114) may be integral with the free end (104). The projection (114) may be a separate element secured to the free end (104) or may be formed as an integral extension of the free end (104), i.e., as a continuous piece of material.

[0032] As shown diagrammatically in FIG. 6, the protrusions (114) may have a width (w1) in the radial direction (113) that is smaller than the width (w2) of the proximal tip (105) in the radial direction (113). This reduces the cross section in the radial direction (113). This is because, when the wire (106) is folded, as shown, for example, in FIG. 6 or 4b, the space above and / or below the protrusions (114) in the radial direction (113) can accommodate at least a portion of the wire (106). This may provide a more compact annuloplasty device (100). The shorter extension of the wire (106) in the radial direction (113) also minimizes the risk of too high friction between the wire (106) and the surrounding delivery catheter. This facilitates delivery and / or retrieval of the annuloplasty device (100).

[0033] The proximal connection portion (107) may be at least partially disposed on a surface (115) of the proximal tip (105). As shown diagrammatically in FIG. 7, the surface (115) has a normal direction (116). The surface (115) may be angled such that a vector component of the normal direction (116) is parallel to the axial direction (112) of the first end (104). In the example of FIG. 7, the normal direction (116) of the surface (115) is essentially parallel to the axial direction (112). That is, the aforementioned vector component is therefore equal to the normal direction (116). However, it is contemplated that the normal direction (116) of the surface (115) may have a non-zero angle, i.e., an acute angle, with respect to the axial direction (112) such that at least a vector component of the normal direction (116) is parallel to the axial direction (112). Having a proximal connection (107) at such surface (115) of the proximal tip (105) maintains a minimized cross section in the radial direction (113). That is, attaching the wire (106) to such surface (115) or proximal connection (107) limits the cross-sectional width compared to when a wire such as a suture is attached to other parts of the first support ring (101) and / or second support ring (102), such that the suture extends from the surface of the first support ring (101) and / or second support ring (102) itself, i.e., anywhere between the free ends (104') and (104). In comparison, the proximal attachment to the surface (115) as described above does not increase the width of the annuloplasty device (100) in the radial direction (113), or at least limits any contribution to the width in the radial direction (113). This further provides for a compact annuloplasty device (100) that is easier to manipulate to the target location.

[0034] Figure 11a, in conjunction with Figures 9-10, shows a flow chart of a method (200) of retrieving an annuloplasty device (100) from an implantation site of a heart valve. The annuloplasty device (100) includes a wire (106) attached to a proximal connection (107) at a proximal tip (105), (105') of the free end (104), (104') of the annuloplasty device (100), as described above. The method (200) includes positioning (201) the wire (106) in a lumen (402) of a delivery device (401) and urging (202) the delivery device (401) over the wire (106) in the direction of the proximal tip (105), (105'). The method (200) includes engaging (203) the proximal tip (105), (105') with the distal portion (118) of the delivery device (401) and retrieving (204) at least a portion of the annuloplasty device (100), i.e., the first support ring (101) and / or the second support ring (102), through the opening (403) of the distal portion (118) and into the lumen (402) (FIGS. 9b and 10b). As elucidated above, the wire (106) effectively guides the delivery device (401) to a precise location such that the proximal tip (105) is retrieved into the lumen (402). Thus, the procedure can be accomplished in a short time, facilitating both partial retrieval for repositioning and complete retrieval and removal of the annuloplasty device (100) from the implantation site.

[0035] 11b shows another flow chart of a method (200) of retrieving an annuloplasty device (100) from an implantation site of a heart valve, in conjunction with FIGS. 9-10. The method (200) may include wedging (203') the distal portion (118) between the tissue (302) at the implantation site and the annuloplasty device (100), whereby the retainer (117), which in this example is fixed to the annuloplasty device (100), is lifted from its fixed position in the tissue (FIG. 10a) and moved in a radial direction (119 (FIG. 10b)) essentially perpendicular to the axial direction (112) along which the annuloplasty device (100) extends in an elongated shape. Thus, the retainer (117) may be lifted from its fixed position such that the delivery device (401) is gradually pushed over the annuloplasty device (100). As such, the method (200) may include retrieving (204') the annuloplasty device (100) and its retention portion (117) into the lumen (402). The wire (106) effectively guides the delivery device (401) to the correct location such that the proximal tip (105) is retrieved into the lumen (402) after which the retention portion (117) disengages from the tissue, thereby effectively and easily retrieving the annuloplasty device (100), which is secured to the tissue by the retention portion (117).

[0036] 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. The various features and steps of the present invention may be combined in other combinations than those described above. The scope of the present invention is limited only by the appended claims. More generally, all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and those skilled in the art will readily appreciate that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application in which the teachings of the present invention are used.

Claims

1. a first support ring (101) and a second support ring (102) having a coiled configuration, in which they are arranged as a coil around a central axis (103) and are configured to be positioned on either side of the native heart valve leaflets (301) of the heart valve, the first support ring (101) and the second support ring (102) each having a free end (104, 104'); a line attached to a proximal connector (107) at a proximal tip (105, 105') of a first end of one of said free ends; 1. An annuloplasty device (100) comprising: the proximal connection portion includes a lumen (108) sized to receive the distal tip (109) of the wire; The first end is configured to be compressed to compress the distal tip of the wire within the lumen.

2. The annuloplasty device of claim 1 , wherein the distal tip of the wire includes an enlarged diameter portion (110).

3. 3. The annuloplasty device of claim 2, wherein the enlarged portion is sized to be fixed against the narrowing of the lumen (111).

4. The annuloplasty device of claim 2 or 3, wherein the enlarged portion includes an at least partially spherical portion or a hooked portion.

5. The annuloplasty device of claim 1 , wherein the lumen extends along an axial direction of the first end.

6. The annuloplasty device of claim 5 , wherein the lumen is coaxially aligned with the first end along the axial direction.

7. The annuloplasty device of claim 5 or 6, wherein the lumen comprises a perforated opening at the proximal tip (105, 105').

8. The annuloplasty device of claim 1 , wherein the lumen extends along a radial direction (113) perpendicular to an axial direction (112) of the first end.

9. 9. The annuloplasty device of claim 8, wherein the proximal connection portion includes a protrusion (114) extending from the proximal tip portion (105, 105') in the axial direction (112) of the first end, the lumen extending through the protrusion.

10. The protrusion has a width (w ２ The radial width (w １ 10. The annuloplasty device of claim 9, further comprising:

11. 11. The annuloplasty device of claim 1, wherein the proximal connection portion is at least partially disposed on a surface (115) of the proximal tip portion (105, 105'), the surface having a normal direction (116), the surface being angled such that a vector component of the normal direction is parallel to an axial direction (112) of the first end.

Images