ANNULOPLASTY DEVICE

Abstract

The invention relates to an annuloplasty device for use on a posterior annulus of a mitral valve, including at least a first and a second anchor unit, preferably a plurality of anchor units, that are deployable to the mitral valve by means of a vascular delivery device, such as a catheter, and positionable in a row along the annulus, including anchor means arranged on each of the first and second anchor units, wherein the first and second anchor units are interconnected by connection means defining a distance between the first and second anchor units, further including pulling means for reducing the distance between the first and second anchor units so as to pull the annulus together, wherein the anchor units are arranged to be rotatable to one another around a longitudinal axis extending along the row.

Claims

1-14. (canceled)

15. An annuloplasty device for use on a posterior annulus of a mitral valve, comprising: at least a first and a second anchor unit that are deployable to the mitral valve by means of a vascular delivery device and positionable in a row along the annulus, anchor means being arranged on each of the first and second anchor units; connection means interconnecting the first and second anchor units and defining a distance between the first and second anchor units; and pulling means for reducing the distance between the first and second anchor units so as to pull the annulus together; wherein the anchor units are arranged to be rotatable to one another around a longitudinal axis extending along the row.

16. The annuloplasty device of claim 15, wherein the vascular delivery device comprises a catheter.

17. The annuloplasty device of claim 15, wherein the anchor units are rotatable to one another around the longitudinal axis about 45-120 degrees.

18. The annuloplasty device of claim 17, wherein the anchor units are rotatable to one another around the longitudinal axis about 80-100 degrees.

19. The annuloplasty device of claim 15, wherein: the pulling means and the connection means are formed integrally with each other; and the connection means are at least one of formed as springs and made of a shape-memory alloy, preferably Nitinol.

20. The annuloplasty device of claim 19, wherein the connection means are made of Nitinol.

21. The annuloplasty device of claim 15, wherein the pulling means comprise at least one of electro magnets, electro-active polymers, a pneumatic means, a vacuum chamber, wires, and rigid wires

22. The annuloplasty device of claim 15, wherein the anchor means comprise at least one of needles, hooks, clips, staples, and rivets.

23. The annuloplasty device of claim 15, wherein the anchor means have a trident shape.

24. The annuloplasty device of claim 15, wherein a plurality of anchor means are arranged on each of the first and second anchor units.

25. The annuloplasty device of claim 15, wherein the anchor means are deployable from a first position, in which the anchor means are retracted for being arranged within the vascular delivery device, into a second position, in which the anchor means are deployed.

26. The annuloplasty device of claim 15, wherein the distal end of the annuloplasty device carries fixing means for fixing the distal end of the annuloplasty device to the annulus.

27. The annuloplasty device of claim 26, wherein the fixing means are formed by at least one of clamps and pliers.

28. The delivery device with the annuloplasty device according to claim 15 for delivering and deploying the annuloplasty device to the annulus of the mitral valve, comprising: at least one flexible tube, in which the annuloplasty device is housed prior to being delivered; a guiding wire for guiding the flexible tube to the annulus; and retracting means for retracting the flexible tube relative to the at least first and second anchor units of the annuloplasty device so as to successively release the anchor units from the flexible tube.

29. The delivery device of claim 28, wherein: a first and a second flexible tube are provided; and a first section of the annuloplasty device is housed in the first flexible tube and a second section of the annuloplasty device is housed in the second flexible tube prior to being delivered.

30. The delivery device of claim 28, wherein the wall of the tube, on its inner side, has a cross-sectional profile that provides a form-fit to a corresponding cross-sectional profile of the outer surface of the anchor units so as to prevent a rotation of the anchor units within the flexible tube.

31. The delivery device of claim 30, wherein: the tube comprises an axial extension of the inner cross-sectional profile which allows a rotation of the anchor units around the longitudinal axis about 45-120 degrees; and the cross sectional profile comprises a stopping surface for limiting the rotational movement of the anchor units.

32. The delivery device of claim 31, wherein the tube comprises the axial extension of the inner cross-sectional profile which allows the rotation of the anchor units around the longitudinal axis about 80-100 degrees

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In the following the present invention will be described by some exemplary embodiments:

[0043] FIG. 1a is a side view of an exemplary embodiment of the annuloplasty device according to the present invention;

[0044] FIG. 1b is a top view of the embodiment as depicted in FIG. 1a;

[0045] FIG. 2a-2c show a cross-sectional, a perspective and a side view of an exemplary embodiment of the delivery device according to the invention housing the annuloplasty device prior to being delivered to the heart tissue;

[0046] FIG. 3a-3c show a cross-sectional, a perspective and a side view of the delivery device with the first anchor unit of the annuloplasty device exiting the tube and prior to its rotation;

[0047] FIG. 4a-4c depict a cross-sectional, a perspective and a side view of the delivery device with the first anchor unit of the annuloplasty device in its position as in FIG. 4, but having been rotated; and

[0048] FIG. 1a-5d show views of the delivery device with the annuloplasty device in the different stages of implantation.

DETAILED DESCRIPTION

[0049] In FIG. 1 a and lb the exemplary embodiment of the annuloplasty device according to the invention is depicted with reference numeral 1. The annuloplasty device 1 comprises a first, a second, a third and a fourth anchor unit 2, 3, 4, 5, which are positioned in a row. Anchor units 2 and 3 are interconnected by spring means 6 and anchor units 4 and 5 are interconnected by spring means 7. The pair of anchor units 2, 3 is interconnected with the pair of anchor units 4, 5 via connection means 8. Each of the anchor units 2, 3, 4, 5 comprises anchor means 9, 10, 11, 12 having a trident shape, which are arranged on the end of the anchor units 2, 3, 4, 5 facing away from the springs 6, 7. The anchor units 2, 3, 4, 5 are able to rotate around their longitudinal axis according to arrow X.

[0050] FIG. 2a shows a cross-sectional, FIG. 2b a perspective and FIG. 2c a side view of an exemplary embodiment of the flexible tube 13 of the delivery device according to the invention housing the annuloplasty device prior to being delivered to the heart tissue.

[0051] The parts, which correspond to the parts as already described with regard to FIG. 1a-1c, are designated with the same reference numerals.

[0052] In the depicted embodiment a first anchor unit 2 is shown prior to its delivery from the tube 13 of the delivery device. The anchor means 9 are fixed to the end of anchor unit 2 so as swivel around the axis 9b and are shown in their retracted position. The wall of the tube 13, on its inner side, has a cross-sectional profile that provides a form-fit to the corresponding cross-sectional profile of the outer surface of the anchor unit 2 comprising the anchor means 9 in their retracted position so as to prevent a rotation of anchor unit 2 as long as it is arranged within the flexible tube 13. In order to provide said form-fit, the tube 13 comprises two longitudinal grooves 29, in which a nose 30 of the anchor unit 2 is each guided.

[0053] Furthermore, the tube 13 comprises an extension 14, having a different inner cross-sectional profile than the tube 13 so as to allow for a rotation of the anchor unit 2 once it has left the tube 13. The extension 14 comprises a stopping surface 15, which limits the rotational movement of anchor unit 2 after its deployment (cf. FIG. 4a-4c).

[0054] FIG. 3a shows a cross-sectional, FIG. 3b a perspective and FIG. 3c a side view of the exemplary embodiment of the flexible tube 13 of the delivery device as depicted in FIG. 2a-2c with the first anchor unit 2 of the annuloplasty device having been moved out of the tube 13 and having been arranged in the extension 14 prior to rotation. As can be taken from FIG. 3a-3c the anchor means 9 have been deployed into their second, unretracted position by a swiveling movement around the axis 9b, which takes place immediately after the whole anchor means 9 has left the form-fit profile 16 of the tube 13.

[0055] FIG. 4a depicts a cross-sectional, FIG. 4b a perspective and FIG. 4c a side view of the delivery device with the first anchor unit 2 of the annuloplasty device according to FIG. 2, but with the anchor unit 2 having been rotated. The rotation is induced via the spring means 6, which develop their rotational power after anchor unit 2 is completely delivered outside of the form-fit part 16 of the tube 13. In their rotated position as shown in FIG. 4, the anchor means 9 get into engagement with the annulus thereby fixing the anchor unit 2 to the annulus.

[0056] FIG. 5a-5d depict views of the delivery device with the annuloplasty device in the different implanting stages of the annuloplasty device. As can be taken from FIG. 5a-5d the delivery device 17 comprises a first flexible tube 13 and a second flexible tube 18, a guiding wire 29, a plurality of pushing wires 30 and a catheter sleeve 19, in which the flexible tubes 13,18, the guiding wire 29 and the pushing wires 30 were housed prior to their delivery to the position shown in FIG. 5a.

[0057] In FIG. 5a the flexible tubes 13, 18 of the delivery device 17, a part of the guiding wire 29 and the pushing wires 30 were already released from the catheter sleeve 19, whereby in FIG. 5b the flexible tubes 13, 18 already resemble the anatomical shape of the annulus, which was achieved via moving ring 31, on which the pushing wires 30 are attached on their proximal end, from the position as depicted in FIG. 5a in its axial direction according to arrow X, to the position as depicted in FIG. 5b. The axial movement of the ring 31 induces the pushing wires 30 to push open in an angle of 90°.

[0058] At the distal ends of the annuloplasty devices 1 and 20 fixing means 27, 28 are attached, which serve for fixing the distal end of the annuloplasty devices 1 and 20 to the heart tissue (not shown), whereby said fixation takes place prior to the release of the first anchor units 2 and 21, respectively.

[0059] After the attachment of the fixing means 27, 28 the pusher wires 30 may be retracted from the implantation site via axially moving ring 31 in the direction of arrow Z (FIG. 5c).

[0060] Deployment of the anchor units 2, 3, 4, 5 of the annuloplasty device 1 and anchor units 21, 22, 23, 24 of the annuloplasty device 20 starts at the free ends 25, 26 of the tubes 13, 18.

[0061] FIG. 5c shows the anchor units 2, 3 and 21, 22, which have already successively been released from the tubes 13, 18, and which have already successively been rotated and are hence attached to the annulus (not shown).

[0062] FIG. 5d shows the anchor units 2, 3, 4, 5 and 21, 22, 23, 24, which have already been successively released from the tubes 13, 18, and which have already successively been rotated, whereby the anchor means 9, 10, 11, 12 on the anchor units 2, 3, 4, 5 were enabled to attach to the heart tissue (not shown).

[0063] Since the annuloplasty device as shown in FIG. 5a-5d just comprises 8 anchor units, namely anchor units 2, 3, 4, 5, 21, 22, 23, 24 FIG. 5d exhibits the full implantation state, whereby after said state is achieved tubes 13 and 18 can be removed from the implantation site via catheter sleeve 19 according to arrows Y.