Cardiac valve annulus restraining device

• US 8,551,161 B2
• Filed: 04/24/2007
• Issued: 10/08/2013
• Est. Priority Date: 04/25/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Dolan, Mark
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US11/739,526
• Publication Number:
  US 20070250161A1
• Time in Patent Office: 2,359 Days
• Field of Search: None
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

A catheter based system for treating mitral valve regurgitation includes a reshaping device having a body and a plurality of movable anchoring barbs attached to the body of the device. The reshaping device can be made from a biocompatible material having suitable shape memory properties. The devices of the current invention can be self expandable, balloon expandable, or a combination self expandable and balloon expandable. One embodiment of the invention includes a method for attaching a reshaping device to the annulus of a mitral valve, moving the body of the device from a fully expanded configuration to a resting configuration, and thereby reshaping the mitral valve annulus.

Claims

1. A mitral valve reshaping device for treating mitral valve regurgitation at a mitral valve annulus having an initial mitral valve annulus diameter before treatment, the reshaping device comprising:

a serpentine ring having a distal end, a proximal end, and a plurality of anchoring barbs disposed on and extending from apexes at the distal end of the ring, the plurality of anchoring barbs being present only at the apexes at the distal end of the ring, the serpentine ring comprising a single annular ring having a plurality of struts joined together by apexes wherein the plurality of struts have a substantially equal length forming the serpentine ring with a single amplitude, the ring having a resting configuration with a resting configuration diameter less than the initial mitral valve annulus diameter; and

the ring further having an anterior side sized and shaped for alignment and placement on an anterior side of a mitral valve, and a posterior side for alignment and placement on a posterior side of a mitral valve;

wherein, in a compressed configuration, the reshaping device has the anchoring barbs aligned axially and parallel with a central longitudinal axis of the reshaping device;

in the resting configuration, the reshaping device has the anchoring barbs aligned radially outward from the central longitudinal axis and has the resting configuration diameter of the ring equal to a desired diameter of the mitral valve annulus after treatment, the desired diameter being smaller than the initial mitral valve annulus diameter before treatment; and

, in a deployment configuration, the reshaping device is elastically expandable from the resting configuration diameter to a deployment configuration diameter of the ring greater than or equal to the initial mitral valve annulus diameter before treatment.

2. The mitral valve reshaping device of claim 1, wherein there are no anchoring barbs on the anterior side of the ring.

3. The mitral valve reshaping device of claim 1, wherein the anchoring barbs are moveable between a restrained position in the compressed configuration and an insertion position in the resting configuration, and wherein the movement of the anchoring barbs is independent of any expansion of the ring.

4. The mitral valve reshaping device of claim 1, wherein the serpentine ring of the reshaping device comprises the plurality of struts, each strut having at least one rounded edge, such that the transverse cross-sectional shape of the strut does not have four right angle corners.

5. The mitral valve reshaping device of claim 1, wherein the mitral valve reshaping device comprises a shape memory material.

6. The mitral valve reshaping device of claim 5, wherein the mitral valve reshaping device is expandable from the compressed configuration to the resting configuration having a predetermined diameter that determines the diameter of the mitral valve annulus after treatment.

7. The mitral valve reshaping device of claim 6, wherein the mitral valve reshaping device is balloon-expandable to the deployment configuration having a diameter that is greater than the diameter of the reshaping device in the resting configuration.

8. The mitral valve reshaping device of claim 7, wherein when the expandable balloon is inflated, the mitral valve reshaping device radially expands into the deployment configuration, and the anchoring barbs engage the mitral valve annulus, and when the expandable balloon is deflated, the mitral valve reshaping device radially contracts to assume the resting configuration drawing the annulus to a predetermined diameter.

9. A system for treating mitral valve regurgitation at a mitral valve annulus having an initial mitral valve annulus diameter before treatment, the system comprising:

an elongated delivery catheter having a proximal end, a distal end, and a lumen;

an expandable balloon disposed on a distal portion of the catheter, the balloon being in fluid communication with the lumen;

an expandable mitral valve reshaping device comprising a serpentine ring body having a distal end, a proximal end, and a plurality of anchoring barbs disposed on and extending from apexes at the distal end of the body, the plurality of anchoring barbs being present only at the apexes at the distal end of the body, the serpentine ring body comprising a single annular ring having a plurality of struts joined together by apexes wherein the plurality of struts have a substantially equal length forming the serpentine ring with a single amplitude, the body having a resting configuration with a resting configuration diameter less than the initial mitral valve annulus diameter; and

the body of the reshaping device further comprises an anterior side sized and shaped for alignment and placement on an anterior side of a mitral valve, and a posterior side for alignment and placement on a posterior side of a mitral valve;

wherein, in a compressed configuration, the reshaping device has the anchoring barbs aligned axially and parallel with a central longitudinal axis of the reshaping device;

in the resting configuration, the reshaping device has the anchoring barbs aligned radially outward from the central longitudinal axis and has the resting configuration diameter of the body equal to a desired diameter of the mitral valve annulus after treatment, the desired diameter being smaller than the initial mitral valve annulus diameter before treatment; and

, in a deployment configuration, the reshaping device is elastically expandable from the resting configuration diameter to a deployment configuration diameter of the body greater than or equal to the initial mitral valve annulus diameter before treatment.

10. The system of claim 9, wherein the anchoring barbs on the anterior side of the body are shorter than the anchoring barbs on the posterior side.

11. The system of claim 9, wherein there are no anchoring barbs on the anterior side of the body.

12. The system of claim 9, wherein the anchoring barbs are moveable between a restrained position in the compressed configuration and an insertion position in the resting configuration, and wherein the movement of the anchoring barbs is independent of any expansion of the body.

13. The system of claim 9, wherein the serpentine ring body of the reshaping device comprises the plurality of struts, each strut having at least one rounded edge, such that the transverse cross-sectional shape of the strut does not have four right angle corners.

14. The system of claim 9, wherein the mitral valve reshaping device comprises a shape memory material.

15. The system of claim 14, wherein the mitral valve reshaping device is expandable from the compressed configuration to the resting configuration having a predetermined diameter that determines the diameter of the mitral valve annulus after treatment.

16. The system of claim 15, wherein the mitral valve reshaping body is balloon-expandable to the deployment configuration having a diameter that is greater than the diameter of the device in the resting configuration.

17. The system of claim 16, wherein when the expandable balloon is inflated, the mitral valve reshaping device radially expands into the deployment configuration, and the anchoring barbs engage the mitral valve annulus, and when the expandable balloon is deflated, the mitral valve reshaping device radially contracts to assume the resting configuration drawing the annulus to a predetermined diameter.