ADJUSTABLE ANNULOPLASTY DEVICE

Abstract

An adjustable annuloplasty device (1) comprising a tube (2) having a basically annular shape or adopted to be brought into an annular shape. At least one portion, preferably three portions, of an outer wall (3) or the whole outer wall of the tube (2) is more rigid than opposite portion(s) of an inner wall (4) or the whole inner wall (4). The inner wall is arranged nearer to an inside (5) area defined by the annular shape than the outer wall (3). The inner wall (4) is adapted to be displaced inwardly at least along less rigid portion(s) of the circumference upon actuation by at least one actuation element (10) while the outer wall (4) remains basically constant.

Claims

1. An adjustable annuloplasty device (1) comprising: a tube (2) having a basically annular shape or adopted to be brought into an annular shape, wherein at least one portion of an outer wall (3) or the whole outer wall of the tube (2) is more rigid than opposite portion(s) of an inner wall (4) or the whole inner wall (4), the inner wall is arranged nearer to an inside (5) area defined by the annular shape than the outer wall (3), such that the inner wall (4) is adapted to be displaced inwardly at least along less rigid portion(s) of the circumference upon actuation by at least one actuation element (10) while the outer wall (4) remains basically constant.

2. The annuloplasty device (1) according to claim 1, wherein the tube (2) is in a straight, elongated shape adapted to be brought into an annular shape upon release of a delivery system.

3. The annuloplasty device (1) according to claim 1, wherein the inner wall (4) comprises at least one interruption (6), an outer wall portion(s) opposite the interruption(s) is continuous, and the inner wall (4) is able to be pivoted inwardly next to the interruptions (4) upon the activation.

4. The annuloplasty device (1) according to claim 3, wherein the tube (2) comprises larger cells (28) in the region of the interruptions (6) than in the other regions.

5. The annuloplasty device (1) according to claim 1, wherein the inner wall (4) is thinner than the outer wall (3).

6. The annuloplasty device (1) according to claim 1, wherein the tube (2) is basically formed as a mesh structure with cells (28), and the inner wall (4) has bigger mesh cells (28) than the outer wall (3).

7. The annuloplasty device (1) according to claim 1, wherein the outer wall (3) comprises a support ring.

8. The annuloplasty device (1) according to claim 1, wherein the tube (2) comprises and preferably is made of a memory shape material.

9. The annuloplasty device (1) according to claim 1, wherein the at least one actuation element (10) is integratable or integrated into the outer or inner wall (3, 4).

10. The annuloplasty device (1) according to claim 1, wherein three actuation elements (10) are integrated into the outer or inner wall (3, 4).

11. The annuloplasty device (1) according to claim 10, wherein two actuation elements (10a, b) are arranged at opposite lateral portions (30a, b) of the basically annular tube (2) and one actuation element (10c) is arranged at the posterior portion (31) of the basically annular tube 2.

12. The annuloplasty device (1) according to claim 1, wherein the device (1) is actuatable with an inflatable bladder.

13. The annuloplasty device (1) according to claim 1, wherein the at least one actuation element (10) comprises a stent (12).

14. The annuloplasty device (1) according to claim 1, wherein the at least one actuation element (10) is a mechanical actuator element.

15. A delivery system adapted to delivery an annuloplasty device according to claim 1.

16. The delivery device of claim 15 comprising a catheter for delivering of the annuloplasty device.

Description

[0075] Non-limiting embodiments of the invention are described, by way of example only, with respect to the accompanying drawings, in which:

[0076] FIG. 1: is a schematic view of an annuloplasty device;

[0077] FIG. 2: is a schematic view of a cross section of the annuloplasty device of FIG. 1;

[0078] FIG. 3: is a schematic view of an alternative annuloplasty device;

[0079] FIG. 4: is a schematic view of a unrolled tube of an annuloplasty device;

[0080] FIG. 5: is a schematic view of a part of an alternative tube in a linear shape;

[0081] FIG. 6: is a schematic view of the tube of FIG. 5 in an annular shape.

[0082] FIG. 1 shows a schematic view of an annuloplasty device 1. The annuloplasty device is arranged as an annular ring with an oval shape which is formed by a tube 2 with a D shaped or circular cross section. For a better understanding of the tube 2, the upper half of the tube 2 directed to the viewer is transparent. The tube 2 is made out of Nitinol. An outer wall 3 of the tube 2 is thicker than an inner wall 4 of the tube 2. Through this increased thickness of the outer wall 3 compared to the inner wall 4, the outer wall 3 is more rigid than the inner wall 4.

[0083] An actuation element 10 is arranged between the outer wall 3 and the inner wall 4. The actuation element 10 comprises an inflatable balloon 11. The balloon 11 is moveable around the circumference of the tube 2 (indicated with arrows). The balloon 11 is expandable with gas. The gas is provided by an actuator 20 over a transmission line 21. When inflated with gas, the balloon 11 expands and displaces the inner wall 4 inwardly towards an inside area 5 of the tube 2. Through the displacement of the inner wall 4, a valve annulus (not shown) to which the device 1 is applied is adjusted. Afterwards, the balloon 11 is deflated and moved to another place, where the balloon 11 may be inflated again. Due to the plastic deformation of the tube, the inwardly displaced wall remains in its expanded position. The inner wall 4 may therewith be displaced at multiple parts. The balloon 11 is inflated at the lateral parts 30a, b and at the posterior part 31 to displace the inner wall 4 and to adjust the valve annulus. The balloon 11 is then removed from the tube 2.

[0084] FIG. 2 shows a schematic crosssectional view through the tube 2 in the section AA shown in FIG. 1. The outer wall 3 of the tube 2 is thicker than the inner wall 4 of the tube 2. This provides a difference in rigidity and ensures that only the inner wall 4 is displaced upon activation with the actuation element (see FIG. 1).

[0085] FIG. 3 shows a schematic view of an alternative annuloplasty device 1. Three actuation elements 10a, b, c are arranged in the tube 2 between the inner wall 4 and the outer wall 3. Two actuation elements 10a, b are arranged at lateral portions 30a, b of the tube 2, one actuation element 10c is arranged at a posterior portion 30c of the tube 2. The three actuation elements 10 each comprise a stent 12. The stents 12 have a section integrally formed with the outer wall 3. The stents 12 are expandable with a balloon (not shown). The three stents 12 may be expanded with the same balloon or with a separate balloon each. The balloon is inflated via the actuator 20 and the transmission line 21. The stents 12 expand inwardly because of the part integrally formed with the outer wall 3 is more rigid than the rest of the stent 12. The stents therefore displace the inner wall 4 inwardly and adjust the valve annulus (not shown).

[0086] FIG. 4 shows a schematic view of an alternative and preferred embodiment of a tube 2 for forming the device 1. The tube 2 is formed as a tube of Nitinol by laser cutting. FIG. 4 shows a developed view of the tube 2. Alternatively the tube 2 might also be rolled out of a basically planar sheet of material. Instead of balloons, mechanical expansion elements are conceivable. The tube 2 comprises multiple horizontal struts 26 and multiple vertical struts 27. The struts 26, 27 are arranged such that the middle section 35 of the plate 25 comprises smaller cells 28 than neighbouring sections 36a, b. The outer sections 36 a, b, will form the inner wall 4 after folding the plate to a tube 2. The middle section 25 will form the outer wall 3. Because of the difference in dimensions of the cells 28 of the sections 35, 36, a difference in rigidity of the outer wall 3 and inner wall 4 will result after folding to a tube 2. The tube 2 thus substantially corresponds to a stent bent into an annular shape and having a more rigid outer wall 3 than an inner wall 4 directed to the centre of the annulus.

[0087] FIG. 5 shows a part of an alternative tube 2 according to the invention in a linear shape. The tube 2 is made of a superplastic titanium alloy and comprises the inner wall 4 and the outer wall 3. The inner wall 3 is interrupted in three portions 6 (only one is shown in FIG. 5), whereas the outer wall 3 is continuous opposite said interruptions. The tube 2 is formed with bigger cells 8 neighbouring the interruptions 6. The bigger cells 8 form 4 zig-zag structures, two on each side of the interruption 6. The zig-zags are pointing in the direction of the interruption 6. The rest of the tube 2 which connects the bigger cells is formed with two crossing wires arranged in a tubular manner. The inner wall 4 is displaceable in the region of the interruptions 6 with actuation elements, preferably with inflatable balloons (not shown).

[0088] FIG. 6 shows the tube 2 of FIG. 5 brought into an annular shape. The three interruptions 6a, b, c are arranged such that two interruptions 6a, b, are on lateral sides 30a, b, and one interruption 6c is on the posterior side 31. The tube 2 further comprises a fabric tissue 7 serving as an attachment component. The fabric tissue 7 is arranged circumferentially around the tube 2. The fabric tissue can be sutured to the mitral annulus therewith attaching the tube 2 to the annulus. In FIG. 6, the bigger cells 8 next to the interruptions 6 are bent inwardly, i.e. the zig-zag structures are pivoted inwardly around base portions of the zig-zag structures.