ANNULOPLASTY DEVICE

Abstract

An annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration, wherein the device comprises a band which is expandable from a pre-set configuration, wherein the pre-set configuration of the band corresponds to the working configuration of the annulus.

Claims

1. An annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration, wherein the device comprises a band which is expandable and compressible from a pre-set configuration, wherein the pre-set configuration of the band corresponds to the working configuration of the annulus.

2. (canceled)

3. The annuloplasty device according to claim 1, wherein the band, in its compressed configuration, slidably fits through a lumen of a delivery catheter.

4. The annuloplasty device according to claim 3, wherein the dimensions of the band in the expanded configuration are equal or greater than the dimensions of the dysfunctional annulus.

5. The annuloplasty device according to claim 1, wherein the band in the pre-set configuration is substantially rigid.

6. The annuloplasty device according to claim 5, wherein the band in the pre-set configuration is substantially saddle-shaped.

7-10. (canceled)

11. The annuloplasty device according to claim 1, comprising: an anchoring means for anchoring the band to the annulus, the anchoring means is integrated with the band; and a means for automatically deploying the anchoring means.

12-14. (canceled)

15. The annuloplasty device according to claim 12, comprising a means for forcing the band into its pre-set configuration.

16. (canceled)

17. A method for repairing a heart valve annulus in a patient in need thereof, the method comprising implanting a annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration, wherein the device comprises a band which is expandable and compressible from a pre-set configuration, wherein the pre-set configuration of the band corresponds to the working configuration of the annulus, the heart valve annulus, implanting the device includes: compressing the band to deliver the device to the annulus through a delivery catheter; expanding the band to a circumference equal or greater than the circumference of the annulus; and releasing the band into the pre-set configuration.

18-20. (canceled)

21. The method according to claim 17, wherein the heart valve is the mitral valve, and the annulus is selected from a group of: the anterior annulus, the posterior annulus, the lateral commissure, and the medial commissure.

22. The method according to claim 17, wherein the heart valve is the tricuspid valve, and the annulus is selected from a group of: the anterior annulus, the posterior annulus, and the septal annulus.

23. An annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration, the device comprises: a support structure comprising a mouth, wherein the support structure is expandable from a pre-set configuration, wherein the pre-set configuration of the mouth corresponds to the working configuration of the annulus; and an anchoring means for anchoring the mouth to the annulus.

24. The annuloplasty device according to claim 23, wherein the support structure comprises an expandable mesh having a diamond-pattern.

25. The annuloplasty device according to claim 24, wherein the support structure is selected from among a substantially sinusoidal, crenelated and zigzag pattern.

26. The annuloplasty device according to claim 23, wherein the anchoring means extend from the mouth of the support structure.

27. (canceled)

28. The annuloplasty device according to claim 26, wherein the anchoring means extend inwards relative to the mouth of the support structure.

29. (canceled)

30. The device according to claim 28, wherein the device is configured to be implanted and the support structure is compressed to deliver the device to the heart valve annulus through a delivery sheath and the support structure is expanded to a circumference equal or greater than the circumference of the heart valve annulus and the support structure is released into the pre-set configuration.

31-32. (canceled)

33. The device according to claim 30, wherein the heart valve is the mitral valve, and the annulus is selected from a group of: the anterior annulus, the posterior annulus, the lateral commissure, and the medial commissure.

34. The device according to claim 30, wherein the heart valve is the tricuspid valve, and the annulus is the anterior annulus, the posterior annulus, and the septal annulus.

35. An annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration, the device comprising: a bridge structure having a first end and a second end; first means for anchoring the device to the annulus at the first end of the bridge structure; and second means for anchoring the device to the annulus at the first end of the bridge structure; wherein the device is expandable from a pre-set configuration, wherein the pre-set configuration of the device is configured to support the annulus in its working configuration.

36. (canceled)

Description

[0069] The invention will be further described with reference to the drawings and figures, in which

[0070] FIG. 1 is a schematic representation of an annuloplasty device according to the present invention, in its pre-set configuration;

[0071] FIG. 1a is a schematic representation of the annuloplasty device of FIG. 1 in an expanded configuration;

[0072] FIG. 1b is a schematic representation of the annuloplasty device of FIG. 1 in a compressed configuration;

[0073] FIG. 1c is a schematic representation of the annuloplasty device of FIG. 1 illustrating anchoring means;

[0074] FIG. 2 is a schematic representation of an annuloplasty device according to the present invention, in its pre-set configuration;

[0075] FIG. 2a is a schematic representation of the annuloplasty device of FIG. 2 an expanded configuration;

[0076] FIG. 2b is a schematic representation of the annuloplasty device of FIG. 1 a compressed configuration;

[0077] FIG. 2c is a schematic representation of the annuloplasty device of FIG. 2 illustrating anchoring means;

[0078] FIG. 3 is a schematic representation of an annuloplasty device according to the present invention, in its pre-set configuration;

[0079] FIG. 3a is a schematic representation of the annuloplasty device of FIG. 3 a compressed configuration;

[0080] FIG. 4a is a schematic top representation of a working mitral valve;

[0081] FIG. 4b is a schematic representation of the three-dimensional shape of a working mitral valve;

[0082] FIG. 5 is a schematic top representation of a working tricuspid valve;

[0083] FIGS. 6a to 6h are schematic top representations of annuloplasty device shapes;

[0084] FIGS. 7a to 7c are schematic representations of an annuloplasty device according to the present invention, its delivery configuration, in its expanded configuration and in its pre-set configuration, respectively; and

[0085] FIGS. 8a and 8b shows an annuloplasty device according to the present invention which anchoring means extending inwards.

[0086] The embodiments described herein are provided as exemplary and non-limiting embodiments of the present invention.

[0087] With reference to FIG. 1, there is illustrated an annuloplasty device 1 for restoring a heart valve annulus A from a dysfunctional configuration to a working configuration, wherein the device 1 comprises a band 2 which is expandable from a pre-set configuration, wherein the pre-set configuration of the band 2 corresponds to a working configuration of the annulus A.

[0088] In the embodiment illustrated in FIG. 1, the annuloplasty device 1 comprises a closed band 2, which is tubular and formed of a mesh. The mesh structure is expandable as illustrated in FIG. 1a, and may be compressible as illustrated in FIG. 1b. The structure may have a pattern, such as a grid, diamond, serrated, crenelated, sinusoidal, spiral, helical and/or other patterns. Alternatively, the band 2 may be a solid band. The band 2 may comprise an elastic material or a shape-memory alloy, such as nitinol.

[0089] The band 2 is shown in an exemplary substantially oval pre-set configuration in FIG. 1, which corresponds to a working configuration of the annulus A. In FIG. 1a, the band 2 is illustrated in an expanded anchoring configuration, in which the dimensions of the band 2 can be expanded in directions d1 and/or d2 to reach the attachment sites of the annulus A. In FIG. 1b, the band 2 is illustrated in a compressed delivery configuration, in which the band 2 is compressed into a delivery catheter 3, so that the band 2 can be pushed along the inner lumen of the delivery catheter 3. In FIG. 1c, the band 2 comprises exemplary anchoring means 4, in the form of pegs. The anchoring means 4 are connected to the band 2, partially or completely along the band 2.

[0090] In the embodiment illustrated in FIG. 2, the annuloplasty device 1 comprises an open band 2, which is tubular and formed of a mesh. The band in FIG. 2 is shown in an exemplary curved pre-set configuration, which corresponds to a working configuration of the annulus A.

[0091] In FIG. 2a, the band 2 is illustrated in an expanded anchoring configuration, in which the dimensions of the band 2 can be expanded in directions d1. Upon release of the expanded band 2, the band 2 retracts into its pre-set configuration in direction d3.

[0092] In FIG. 2b, the band 2 is illustrated in a compressed delivery configuration, in which the band 2 is compressed into a delivery catheter 3, so that the band 2 can be pushed along the inner lumen of the delivery catheter 3. The band 2 may be compressed to that its radial dimension is decreased, or the band 2 may be folded upon itself to decrease its overall longitudinal dimension. In FIG. 2c, the band 2 comprises exemplary anchoring means 4, in the form of hooks. The anchoring means 4 are connected to the band 2, partially or completely along the band 2.

[0093] In the preferred embodiment illustrated in FIG. 3, the annuloplasty device 1 comprises a substantially saddle-shaped band 2. The shape of the band 2 in its pre-set configuration corresponds to and restores the annulus A to its working configuration. The band 2 may be expanded (not shown) in any direction owing to the material and/or the structure of the band 2, as described hereinabove. In the expanded configuration, the band 2 reaches and anchors to the attachment sites of the degenerated or dilated annulus A. Upon release of the band 2 from its expanded configuration, the band 2 reverts into its pre-set configuration, thereby reshaping the annulus A to its working configuration.

[0094] FIGS. 6a to 6h are top views of exemplary pre-set working configurations for the annuloplasty device 1. The device 1 is preferably three-dimensionally shaped to correspond to the three-dimensional shape of a working annulus and/or to restore a dysfunctional annulus to a working configuration. The device 1 may have a closed shape (as shown in FIGS. 61 to 6c) to surround the valve. Alternatively, the device 1 may have an opened shape (as shown in FIGS. 6d to 6h) to partially surround and restore the valve.

[0095] FIGS. 7a to 7c are provided to illustrate additional or alternative features of the annuloplasty device as described hereinabove. An annuloplasty device 20 is provided with a support structure 21 comprising a distal mouth 22, wherein the support structure 21 is expandable from a pre-set configuration (FIG. 7b), wherein the pre-set configuration of the mouth 22 corresponds to a working configuration of the annulus; and means 23 for anchoring the mouth to the annulus.

[0096] In FIG. 7a, the annuloplasty device 20 is illustrated in its delivery configuration, folded so as to fit in a delivery catheter 3. In this embodiment, the annuloplasty device 20 is its folded configuration has smaller outer dimensions than those of the pre-set configuration.

[0097] In FIG. 7b, the annuloplasty device 20 is illustrated in its expanded configuration. During the implantation process, the support structure 21 is expanded (by means of a delivery device—not shown), so that the dimensions of the mouth 22 are greater than those of the annulus and greater than those of the mouth 22 in the pre-set configuration.

[0098] Once suitably positioned, the device 20 is released so that the anchoring means 23 (in the present embodiment comprising barbs) grab and anchor to or into the tissue surrounding the annulus. The mouth 22 reverts to its pre-set configuration as shown in FIG. 7c, so that the annulus is reverted to a working configuration.

[0099] In FIGS. 7a to 7c, the anchoring means 23 extend longitudinally from the support structure 21. However, the anchoring means 23 may extend inwardly relative to the mouth and/or support structure as shown in FIGS. 8a and 8b. This inward angle has the advantage of improving the grabbing of and anchoring to the patient's tissues.

[0100] In situ, the support structure 21 may extend away from the annulus or may be located partially or completely through the annulus.

[0101] A method for repairing a heart valve will now be outlined, using device 1 from FIG. 3.

[0102] The device 1 is detachably connected to a delivery device (not shown). For example, the distal detachment may be controlled proximally. Within the context of the present invention, “proximal” side refers to the side closest to the medical practitioner and outside the patient; “distal” refers to the side closest to the target annulus.

[0103] The device 3 is compressed (for example as illustrated in FIG. 3a) to fit into the inner lumen of a delivery catheter 3. The band 2 in its compressed configuration is compressed so as to decrease its radial dimension and slidably fit in the delivery catheter 3. The device 1 is pushed by the delivery device along the length of the catheter 3. The distal end of the catheter 3 is positioned adjacent the pathologically degenerated annulus A.

[0104] As the device 1 exits the delivery catheter 3, the device 1 naturally reverts to its pre-set configuration. The device 1 is positioned so that its contours corresponds to the general contours of the annulus (as shown in FIG. 3).

[0105] For a better understanding of the present invention, reference is made to FIGS. 4a, 4b and 5, illustrating the anatomy of the mitral valve 5 and the tricuspid valve 6.

[0106] The mitral valve 5 comprises an anterior leaflet 7, a posterior leaflet 8, a lateral leaflet 9 and a medial leaflet 10. The tricuspid valve 6 comprises an anterior leaflet 11, a posterior leaflet 12 and a septal leaflet 13.

[0107] The mitral valve 5 and tricuspid valve 6 do not have a planar configuration, but are curved and saddle-shaped. FIGS. 4a and 5 show the relatively high areas H and the relatively low areas L. The device 1 according to the present invention preferably does not have a substantially planar configuration. Instead, the device 1 is curved, and preferably saddle-shaped, so as to follow the natural configuration of the annulus A.

[0108] The device 1 is positioned adjacent the annulus A so that the device 1 is above the area of the annulus to be reshaped. This area may be the whole perimeter of the annulus A, or one or more portions of the annulus A. For example, a saddle-shaped device 1 may be used to reshape the whole annulus, or an open band device 1 may be used to reshape e.g. the posterior leaflet 8, 12 only.

[0109] From this position, and using the delivery device, the device 1 is expanded from its pre-set configuration so that the anchoring means 4 reach the attachment sites of the degenerated annulus. The attachment sites are preferably such that the configuration they outline has greater dimensions than those of the pre-set configuration of the device 1. Therefore, in order to grasp and anchor to the attachment sites of the annulus A, the device 1 is expanded.

[0110] Once the device 1 is suitably expanded, the anchoring means 4 are anchored to the attachment sites of the annulus A. The device 1 may be sutured to the attachment sites. However, it is preferred to avoid such an intricate and irreversible procedure by providing the device 1 with anchoring means. The anchoring means 4 may be hooks or pegs or other means which may be pushed into the tissue of the annulus A.

[0111] In an embodiment, the anchoring means 4 are pressed into the tissue of the annulus A upon release of the annuloplasty device 1, owing to the device 1 reverting to its pre-set configuration. Alternatively or additionally, the delivery device may be used to press on the anchoring means 4, and/or the arms may be used to manipulate and/or rotate the band 2 so that the anchoring means 4 (for example hooks) grasp and secure to the annulus A.

[0112] It is also envisaged that the annuloplasty device 1 is anchored to the “back” of the annulus, for example on the ventricular side of the annulus. In this embodiment, the delivery sheath 3 is pushed through the annulus, until the distal end of the sheath 3 is positioned beyond the annulus. The device 1 is pushed forward, and deploys upon exiting the delivery sheath 3. The device 1 is expanded beyond its pre-set configuration and suitably positioned to catch the annulus. The device 1 is anchored to the back of the annulus and released into its pre-set configuration.

[0113] It may be advantageous to provide structural support to the back of the annulus, if the back of the annulus is better defined, has better tissue integrity and provides more suitable anchoring sites. In addition, the anchoring step may be improved by using the pulling (in the proximal to distal direction) the annuloplasty device 1 to provide greater anchoring force.

[0114] A problem arising from conventional annuloplasty rings is that their implantation is difficult to reverse. In other words, the rings cannot be easily removed and repositioned in the event of an unsuccessful implantation. In the present invention, anchoring means 4 secured to the annulus by pressure from the annuloplasty device 1 (owing to its pre-configuration) may be used, so that should the device 1 require repositioning, the expansion of the device 1 would release the anchoring means 4. The device 1 can be repositioned with minimal trauma to the annulus A.

[0115] Although the present invention has been described within the context of heart valves and in particular of annuloplasty procedures, it is envisaged that it could have other advantageous implementations involving the reshaping of an anatomical structure.

[0116] The present invention is particularly beneficial in the context of transcatheter procedures and/or in the cardiovascular field. For example, in transcatheter procedures, access points are formed through tissues and/or blood vessels. The device may be used to restore blood vessels to their working configuration by partially or completely closing the access point(s) so as to minimise or prevent blood flow to the outside of the blood vessels.

[0117] The present invention may be used in the context of an atrial septal defect (ASD), which is a hole in the atrial septum. The ASD may be congenital, or may be the desired result of a medical procedure intended to relieve the pressure between the two atrial chambers of the heart. The device may be used to partially or completely close the hole so as to minimise or prevent blood flow between the atrial chambers.

[0118] Thus, the present invention provides an annuloplasty device for preventing further deterioration of the annulus', for improving or restoring the annulus' function and/or for palliative support. The device is simple and standardisable. The development and implantation of the device in patients becomes less resource-intensive when compared to conventional devices. The present annuloplasty device can be delivered and implanted using a transcatheter method, which is minimally invasive. The device is easily secured to a dysfunctional annulus in order to restore it to a healthy working configuration. This requires minimal manipulation, positioning and adjustment in situ. The medical practitioners require less extensive training as would be required to implant conventional annuloplasty devices. Importantly, the annuloplasty device according to the present invention restore the shape, in particular the three-dimensional shape, of the annulus instead of simply reducing the opening of the valve.