Method and device for treatment of mitral insufficiency

• US 20040039443A1
• Filed: 12/24/2002
• Published: 02/26/2004
• Est. Priority Date: 06/30/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Seibold, Gerd, Solem, Jan Otto, Joergensen, Ib, Nielsen, Stevan, Quint, Bodo, Michlitsch, Kenneth J., Oepen, Randolf von, Eckert, Karl-Ludwig, Ha, Suk-Woo, Kimblad, Per-Ola
• Granted Patent: US 6,997,951 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

A device for treatment of mitral annulus dilation is disclosed, wherein the device comprises two states. In a first of these states the device is insertable into the coronary sinus and has a shape of the coronary sinus. When positioned in the coronary sinus, the device is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Claims

1. Apparatus for treating mitral annulus dilatation, the apparatus comprising:

a proximal stent section;

a distal anchor; and

means for drawing the distal anchor towards the proximal stent section.

2. The apparatus of claim 1 wherein the proximal stent further comprises a flange configured to abut the coronary ostium.

3. The apparatus of claim 1 wherein the distal anchor comprises a distal stent section.

4. The apparatus of claim 1 wherein the distal anchor comprises a Tee-shape adapted to be inserted into a region of a patient'"'"'s anatomy chosen from the group consisting of the left ventricular myocardium or the left ventricle.

5. The apparatus of claim 4 wherein the means for drawing comprises a wire, the apparatus further comprising a coil section disposed around the wire to redistribute a compressive load created by the wire.

6. The apparatus of claim 1 wherein the means for drawing comprises a central section connecting the proximal stent section to the distal anchor, the central section having a contracted state and a radially expanded state.

7. The apparatus of claim 6 wherein the means for drawing further comprises one or more biodegradable structures disposed on the central section.

8. The apparatus of claim 7 wherein the proximal stent section is configured to become biologically anchored to a vessel before the one or more biodegradable structures degrade.

9. The apparatus of claim 7 wherein the central section comprises a shape memory material.

10. The apparatus of claim 8 wherein the distal anchor comprises a distal stent section that is configured to become biologically anchored to a vessel before the one or more biodegradable structures degrade.

11. Apparatus for treating mitral annulus dilatation, the apparatus comprising:

a catheter having proximal and distal ends and a lumen extending therethrough;

a balloon affixed to the catheter, the balloon being in fluid communication with the lumen and having contracted and deployed states, wherein the balloon comprises a predetermined shape in the deployed state; and

a stent having contracted and deployed states, wherein the stent is plastically deformable by the balloon and substantially conforms to the predetermined shape of the balloon in the deployed state, wherein the stent is configured to apply a compressive load on the mitral valve annulus in the deployed state.

12. The apparatus of claim 11 wherein the balloon comprises a curved shape in the deployed state.

13. The apparatus of claim 12 wherein the balloon further comprises an anchor element disposed within the balloon and configured to maintain the shape of the balloon in the deployed state.

14. The apparatus of claim 13 wherein the anchor element comprises a radiopaque material.

15. Apparatus for treating mitral annulus dilatation, the apparatus comprising:

a proximal ball segment comprising a proximal ball having a lumen, a distal ball having a lumen, and a hollow rod extending therebetween;

a distal ball segment comprising a proximal ball having a lumen, a distal ball having a lumen, and a hollow rod extending therebetween; and

a connecting segment disposed therebetween, the connecting segment having a plurality of sockets, wherein the distal ball of the proximal ball segment and the proximal ball of the distal ball segment are configured to telescope and rotate relative to one another within the sockets.

16. The apparatus of claim 15 further comprising at least one interlocking segment coupled to the proximal and distal ball segments, the interlocking segment comprising a proximal section having a socket, a distal section having a ball and a lumen extending therethrough, and a hollow central section extending therebetween.

17. The apparatus of claim 15 further comprising a cinch wire having proximal and distal ends and a ball coupled to the distal end, wherein the cinch wire is configured to extend longitudinally through the lumens of the proximal and distal ball segments.

18. The apparatus of claim 15 further comprising a push rod configured to engage a proximal ball segment or interlocking segment.

19. The apparatus of claim 15 further comprising a cinch wire having a distal end configured to extend longitudinally through the lumens of the proximal and distal ball segments, wherein the distal end of the cinch wire loops around an exterior surface of the proximal and distal ball segments.

20. The apparatus of claim 19 further comprising at least one eyelet coupled to an exterior surface of the connecting segment, wherein the cinch wire is adapted to be disposed through the eyelet.