Annuloplasty prosthesis with in vivo shape identification and related methods of use

• US 20070299514A1
• Filed: 05/31/2007
• Published: 12/27/2007
• Est. Priority Date: 06/02/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Galloway, Aubrey, Grossi, Eugene, Ryan, Timothy, Colvin, Stephen
• Granted Patent: US 8,197,538 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An annuloplasty prosthesis including a sheath, an arcuate stiffening element, and an imaging element. The arcuate stiffening element is disposed within the sheath and defines discrete, first and second ends separated by a lateral spacing. The imaging element is disposed within the sheath along the lateral spacing. With this configuration, following implant to the valve annulus, the imaging element provides a mechanism for non-invasively evaluating a shape of the valve annulus, for example, via radiographic, echogenic and/or other image enhancing visualization techniques. In some embodiments, the annuloplasty prosthesis provides a radiographic, echogenic and/or other image enhanced image of a near entirety of the valve annulus.

Claims

1. An annuloplasty prosthesis for repairing an atrial-ventricular valve having a valve annulus, the prosthesis comprising:

a sheath;

an arcuate stiffening element within the sheath, the stiffening element defining discrete first and second ends separated by a lateral spacing; and

an imaging element disposed within the sheath along the lateral spacing.

2. The annuloplasty prosthesis of claim 1, wherein the imaging element is a barium sulfate-impregnated strip.

3. The annuloplasty prosthesis of claim 1, wherein the imaging element is characterized as being more flexible than the stiffening element.

4. The annuloplasty prosthesis of claim 1, wherein the imaging element has a length that is at least 50% of a length defined by the lateral spacing.

5. The annuloplasty prosthesis of claim 1, wherein a first end of the imaging element is adjacent to, but spaced from, the first end of the stiffening element, and a second end of the imaging element is adjacent to, but spaced from, the second end of the stiffening element.

6. The annuloplasty prosthesis of claim 1, wherein the imaging element is rectangular.

7. The annuloplasty prosthesis of claim 1, wherein a width of the imaging element is greater than a diameter of the stiffening element.

8. The annuloplasty prosthesis of claim 1, wherein the stiffening element includes a metal wire such that following implantation to the valve annulus, the stiffening element facilitates at least one of radiographic, echogenic and image enhancing imaging of a first segment of the prosthesis and the imaging element facilitates at least one of radiographic, echogenic and image enhanced imaging of a second segment of the annuloplasty prosthesis.

9. The annuloplasty prosthesis of claim 8, wherein the first segment corresponds to a posterior aspect of a mitral valve annulus, and the second segment corresponds to an anterior aspect of the mitral valve annulus.

10. The annuloplasty prosthesis of claim 1, further comprising:

suture indicia formed on an exterior of the sheath in a segment of the annuloplasty prosthesis corresponding with the imaging element.

11. A method of implanting an annuloplasty prosthesis to an annulus of a heart valve of a patient, the method comprising:

providing an annuloplasty prosthesis comprising;

a sheath,

an arcuate stiffening element within the sheath, the stiffening element defining discrete first and second ends separated by a lateral spacing,

an imaging element disposed within the sheath along the lateral spacing;

implanting the annuloplasty prosthesis to the valve annulus;

generating an image of the annuloplasty prosthesis including an image of the imaging element by directing energy to the prosthesis and the valve annulus; and

evaluating a status of the valve based upon the image generated.

12. The method of claim 11, wherein the evaluated status relates to a flexibility of the valve annulus.

13. The method of claim 11, wherein the evaluated status relates to an orifice area of the valve annulus.

14. The method of claim 11, wherein the generated image further includes an image of the stiffening element.

15. The method of claim 14, wherein the evaluated status relates to a calculated orifice area of the valve annulus based upon the image of the imaging element and the image of the stiffening element.

16. The method of claim 11, wherein the valve is a mitral valve, and further wherein the annuloplasty prosthesis defines an anterior segment along the imaging element and a posterior segment along the stiffening element, and further wherein implanting the annuloplasty prosthesis includes:

securing the anterior segment of the annuloplasty prosthesis to an anterior aspect of the mitral valve annulus; and

securing the posterior segment of the annuloplasty prosthesis to a posterior aspect of the mitral valve annulus.

17. The method of claim 16, wherein the image generated of the imaging element is indicative of a flexibility of the anterior aspect of the mitral valve annulus.