Method of fixing a physiologic mitral valve bioprosthesis

• US 5,931,868 A
• Filed: 11/12/1997
• Issued: 08/03/1999
• Est. Priority Date: 04/08/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gross, Jeffrey M.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/969,035
• Time in Patent Office: 629 Days
• Field of Search: 623/2, 623/900, 623/901, 623/66
• US Class Current: 128/898
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

A whole heart is collected shortly after the death of the animal. The left ventricle and left atrium of the animal heart is sectioned and exposed thereby exposing the mitral valve, the chordae tendineae and the papillary heads. The mitral valve is fixed in situ by fixing portions of the left ventricle and left atrium containing the mitral valve. The mitral valve is excised from the animal heart remnant to include a portion of the endocardium containing the papillary heads and the annulus. In the preferred embodiment of the invention, the excised mitral valve is further fixed to complete fixation of the papillary heads. Then, the excess myocardial tissue is trimmed away and the mitral valve is stored in fixing solution to await further processing.

Claims

1. A method for fixing a mitral valve in its natural geometry comprising the steps of:

(a) collecting a whole animal heart having myocardium, endocardium, a mitral valve having an annulus, chordae tendineae, papillary heads, left ventricle and left atrium shortly after the death of an animal;

(b) exposing, but not removing from the whole animal heart, the mitral valve, chordae tendineae and papillary heads of the animal heart such that major portions of the left ventricle and left atrium remain along with the exposed mitral valve, chordae tendineae, and papillary heads;

(c) fixing the entire result of step (b) to preserve the natural geometry of the mitral valve in situ with the major portions of the left ventricle and left atrium;

(d) excising tissue from the result of step (c), the excised tissue including the mitral valve, the annulus, and a portion of the endocardium containing the papillary heads, so that for each set of chordae tendineae and papillary head exposed in step (b), the entire chordae tendineae and substantially the entire corresponding papillary head are included in the excised tissue; and

(e) retaining the excised tissue while disposing the remainder of the fixed result of step (c).

2. The method of claim 1 in which the animal is porcine.

3. The method of claim 1 in which the animal is ovine.

4. The method of claim 1 in which the animal is bovine.

5. The method of claim 1 in which step (c) comprises a technique chosen from the group consisting of zero pressure, low pressure, and high pressure fixation.

6. The method of claim 5 in which step (c) comprises applying at least one fixative agent chosen from the group consisting of glutaraldehyde, carbodyamides, and epoxides.

7. The method of claim 1 further comprising the step of:

completing fixation of the papillary heads.

8. The method of claim 1 further comprising the step of:

trimming away excess myocardial tissue from the fixed result of step (d).

9. A method for fixing a mitral valve from a heart comprising the steps of:

(a) collecting a whole animal heart having myocardium, endocardium, a mitral valve having an annulus, chordae tendineae, papillary heads, left ventricle and left atrium shortly after the death of an animal;

(b) exposing, but not removnig from the whole animal heart, the mitral valve, chordae tendineae and papillary heads of the animal heart such that major portions of the left ventricle and left atrium remain along with the exposed mitral valve, chordae tendineae, papillary heads;

(c) fixing the entire result of step (b) to preserve the natural geometry of the mitral valve in situ with the major portions of the left ventricle and left atrium;

(d) excising the tissue from the result of step (c), the excised tissue including the mitral valve, the annulus, and a portion of the endocardium containing the papillary heads, so that for each set of chordae tendineae and papillary head exposed in step (b, the entire chordae tendineae and substantially the entire corresponding papillary head are included in the excised tissue;

(e) retaining the excised tissue while disposing the remainder of the fixed result of step (c);

(f) completing fixation of the papillary heads; and

,

(g) trimming away excess myocardial tissue from the fixed result of step (d).

10. A mitral valve fixed according to a method for fixing a mitral valve from a heart, the method comprising the steps of:

collecting a whole animal heart having myocardium, endocardium, a mitral valve, chordae tendineae, papillary heads, left ventricle and left atrium shortly after the death of an animal, the mitral valve having an annulus;

sectioning the left ventricle and left atrium of the animal heart thereby exposing the mitral valve, chordae tendineae and papillary heads of the animal heart, the resulting mitral valve, chordae tendineae, papillary heads and portions of the left ventricle and left atrium forming a heart remnant;

fixing the animal heart remnant including the mitral valve;

excising the mitral valve from the animal heart remnant to include the annulus, a portion of the endocardium containing the papillary heads so that for each set of chordae tendineae and papillary head, the entire chordae tendineae and substantially the entire corresponding papillary head is removed.

11. The valve of claim 10 wherein the animal heart is a porcine animal heart.

12. The valve of claim 10 wherein the animal heart is an ovine animal heart.

13. The valve of claim 10 wherein the animal heart is a bovine animal heart.

14. The valve of claim 10 wherein the step of fixing the animal heart remnant includes the step of fixing the animal heart remnant by a technique chosen from the group consisting of zero pressure, low pressure, or high pressure fixation.

15. The valve of claim 14 wherein the step of fixing the animal heart remnant by a technique chosen from the group consisting of zero pressure, low pressure, or high pressure fixation includes the step of applying fixative agents to the remnant, the fixative agents chosen from the group consisting of glutaraldehyde, carbodyamides, or epoxides.

16. The valve of claim 10 further comprising the step of:

fixing the animal heart remnant to complete fixation of the papillary heads.

17. The valve of claim 10 further comprising the step of:

trimming away excess myocardial tissue from the heart remnant.

18. The valve of claim 10 further comprising the step of:

trimming away excess myocardial tissue from the heart remnant.

19. A mitral valve fixed according to the method for fixing a mitral valve from a heart comprising the steps of:

collecting a whole animal heart having myocardium, endocardium, a mitral valve, chordae tendineae, papillary heads, left ventricle and left atrium shortly after the death of an animal, the mitral valve having an annulus;

sectioning the left ventricle and left atrium of the animal heart thereby exposing the mitral valve, chordae tendineae and papillary heads of the animal heart, the resulting mitral valve, chordae tendineae, papillary heads and portions of the left ventricle and left atrium forming a heart remnant;

fixing the animal heart remnant including the mitral valve;

excising the mitral valve from the animal heart remnant to include the annulus, a portion of the endocardium containing the papillary heads so that for each set of chordae tendineae and papillary head, the entire chordae tendineae and substantially the entire corresponding papillary head is removed;

fixing the animal heart remnant to complete fixation of the papillary heads;

trimming away excess myocardial tissue from the heart remnant.