Mitral valve annuloplasty ring

• US 20030229395A1
• Filed: 03/28/2003
• Published: 12/11/2003
• Est. Priority Date: 06/16/1998
• Status: Abandoned Application

• Current Assignee: Respicardia, Inc. (Asahi Kasei Corporation)
• Original Assignee: Respicardia, Inc. (Asahi Kasei Corporation)
• Inventors: Cox, James L.
• Application Number:
  US10/401,907
• Publication Number:
  US 20030229395A1
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A mitral valve annuloplasty ring and method for implanting a mitral valve annuloplasty ring to treat mitral insufficiency by reestablishing the normal shape and contour of the mitral valve annulus. The annuloplasty ring is flexible and can be readily adjusted to different sizes and shapes. The method substantially eliminates scarring subsequent to the annuloplasty procedure to maintain flexibility of the ring and the annulus indefinitely.

Claims

1. An annuloplasty ring for repairing a valve in a patient'"'"'s heart, said annuloplasty ring comprising:

(a) a first section for implanting adjacent to the valve; and

(b) a second flexible section for implanting within a fat pad of an atrioventricular groove in the heart.

2. The annuloplasty ring of claim 1, wherein said second flexible section comprises a proximal end and a distal end and a means for joining the distal end to a needle.

3. The annuloplasty ring of claim 2, further comprising a needle having an attaching end with an outer diameter.

4. The annuloplasty ring of claim 3, wherein said means for joining the distal end to the needle comprising a frictional engagement.

5. The annuloplasty ring of claim 4, wherein said first section further comprises a first and second end, said first and second ends having an outer diameter;

said annuloplasty ring further comprising;

(a) a first means for joining the distal end of the second flexible section to the second end of the first section; and

(b) a second means for joining the proximal end of the second flexible section to the first end of the first section.

6. The annuloplasty ring of claim 5, wherein said first means for joining comprises a frictional engagement and said second means for joining comprises a frictional engagement.

7. The annuloplasty ring of claim 6, wherein said outer diameters of said first and second ends are approximately equal to said inner diameter of said hollow inner portion, and said frictional engagement of said first means for joining is between said inner diameter of said hollow inner portion at said distal end and said outer diameter of said second end, and said frictional engagement of said second means for joining is between said inner diameter of said hollow inner portion at said proximal end and said outer diameter of said first end.

8. The annuloplasty ring of claim 5, further comprising:

(a) an open configuration wherein said first section is attached to said second section by said second means for joining and said second end of said first section and said distal end of said second flexible section are unattached;

(b) a closed configuration wherein said first section is attached to said second section by said first and second means for joining, thereby forming a loop; and

(c) a surgical configuration wherein said first section is attached to said second section by said first means for joining and said second flexible section is attached to the needle by said means for joining said distal end of said second flexible section to said needle.

9. The annuloplasty ring of claim 4, wherein the distal end of the flexible section further comprises a hollow inner portion with an inner diameter approximately equal to the outer diameter of the attaching end of the needle and said frictional engagement is between said inner diameter and said outer diameter of the attaching end.

10. The annuloplasty ring of claim 1, wherein said first section is rigid with first and second ends being substantially straight, said first section further having a bow between the first and second ends.

11. The annuloplasty ring of claim 1, further comprising a means for sizing the ring.

12. A method for implanting an annuloplasty ring in a patient'"'"'s heart, comprising:

implanting a flexible section of the annuloplasty ring in the fat pad of the atrioventricular groove of the heart;

positioning a rigid section of the annuloplasty ring adjacent to the valve annulus; and

forming the annuloplasty ring into a closed loop.

13. The method of claim 12, wherein the annuloplasty ring includes a needle attached to the flexible section.

14. The method of claim 13, wherein the steps of implanting a substantial portion of the annuloplasty ring in the fat pad of the atrioventricular groove further comprises:

inserting the tip of the needle through the endocardium and the left atrial myocardial wall from the endocardial aspect at the right fibrous trigone;

passing the needle and a portion of the annuloplasty ring through the endocardium and the left atrial myocardial wall from the endocardial aspect, at the right fibrous trigone;

passing the needle and a portion of the annuloplasty ring in a posterior direction, external to and parallel to the mitral valve annulus; and

inserting the tip of the needle through left atrial myocardial wall from the epicardial aspect and back through the endocardium at the left fibrous trigone;

passing the needle and a portion the annuloplasty ring back through the left atrial myocardial wall from the epicardial aspect and back through the endocardium at the left fibrous trigone.

15. The method of claim 14, wherein positioning the rigid n further comprises:

positioning the flexible section in a substantial parallel orientation with the posterior portion of the mitral valve annulus, by pulling the needle;

aligning the rigid section of the annuloplasty ring along an anterior portion of the mitral valve annulus; and

positioning the bow of the rigid section to conform with a contour of the mitral valve annulus adjacent the aortic valve root.

16. The method of claim 13, further comprising:

determining the appropriate size of the annuloplasty ring after implanting and positioning the ring and before forming the ring into a closed loop; and

cutting the annuloplasty ring to the appropriate size.

17. The method of claim 16, further comprising:

detaching the needle from the annuloplasty ring after implanting and positioning the ring and before determining the appropriate size.

18. The method of claim 16, wherein the step of forming the annuloplasty ring into a closed loop further comprises:

joining a second end of the rigid section to a distal end of the flexible section by inserting the second end of the rigid section into a hollow inner portion of the distal end of the flexible section.

19. The method of claim 12, further comprising:

suturing the annuloplasty ring to the valve annulus at the left and right fibrous trigones.

20. The method of claim 19, further comprising:

suturing the annuloplasty ring within the fat pad of the atrioventricular groove.

21. A kit for an annuloplasty ring comprising:

(a) a first section;

(b) a second flexible section having a proximal end and a distal end;

(c) a means for joining the distal end of the second flexible section to a needle.

22. The kit for an annuloplasty ring in claim 21, further comprising a needle having an attaching end with an outer diameter.

23. The kit for an annuloplasty ring in claim 22, wherein said means for joining the distal end to the needle comprising a frictional engagement.

24. The kit for an annuloplasty ring in claim 23, wherein said first section further comprises a first end and a second end, said first and second ends having an outer diameter, and

said annuloplasty ring further comprising:

(a) a first means for joining the distal end of the second flexible section to the second end of the first section; and

(b) a second means for joining the proximal end of the second flexible section to the first end of the first section.

25. The kit for an annuloplasty ring in claim 24, wherein said first means for joining comprises a frictional engagement and said second means for joining comprises a frictional engagement, said second flexible section includes a hollow inner portion at the distal and proximal ends, said hollow inner portion having an inner diameter approximately equal to the outer diameters of the first and second ends of the first section,

wherein said frictional engagement of said first means for joining is between said inner diameter of said hollow inner portion at said distal end and said outer diameter of said second end, and said frictional engagement of said second means for joining is between said inner diameter of said hollow inner portion at said proximal end and said outer diameter of said first end.

26. The kit for an annuloplasty ring of claim 23, wherein the distal end of the second flexible section further comprises a hollow inner portion with an inner diameter approximately equal to the outer diameter of the attaching end of the needle and said frictional engagement of said means for joining the distal end to a needle is between said inner diameter and said outer diameter of the attaching end.

27. The kit for an annuloplasty ring of claim 21, wherein said second flexible section further comprising a means for sizing the ring.

28. An annuloplasty ring for use in an annuloplasty surgical procedure to correct mitral insufficiency in a patient by restoring the mitral valve annulus to a normal shape and flexibility which is determined by the movement of the left ventricle, the mitral valve and the mitral valve annulus, wherein said annuloplasty ring comprises:

a first rigid section having a first end, a second end and a length, said first and second ends having an outer diameter;

a second flexible section having a distal end, a proximal end, a length, a means for sizing the ring, and at least one hollow inner portion with an exterior opening at the proximal and distal ends and an inner diameter;

a round-tip needle having a tip and an attaching end with an outer diameter;

a first means for joining the distal end of the second section to the second end of the first section;

a second means for joining the proximal end of the second section to the first end of the first section;

a third means for joining the distal end of the second section to the needle;

wherein said outer diameters of the first section and the outer diameter of the attaching end are approximately equal to the inner diameter of the hollow inner portion and said length of said second flexible section is greater than said length of said first rigid section;

said first means for joining comprising a frictional engagement between the inner diameter of the hollow inner portion at the distal end and the outer diameter of the second end;

said second means for joining comprising a frictional engagement between the inner diameter of the hollow inner portion at the proximal end and the outer diameter of the first end; and

said third means for joining comprising a frictional engagement between the inner diameter of the hollow inner portion at the distal end and the outer diameter of the attaching end of the needle;

said means for sizing the ring further comprising measurement indicia on the distal end of the second section;

said first rigid section is substantially straight and further comprises a bow positioned between the first and second ends;

the annuloplasty ring further comprising;

(1) an open configuration defined by said first section being joined to said second section by said second means for joining, wherein the exterior opening and hollow inner portion at the proximal end of the second section receive the first end of the first section therein, the first end and the proximal end are held together by said frictional engagement, and said second end and said distal end being unattached;

(2) a surgical configuration defined by said first section being joined to said second section and said needle by said second and third means for joining, wherein said exterior opening and hollow inner portion at the proximal end of the second section receive the first end of said first section therein, the first end and proximal end are held together by said frictional engagement of said second means for joining and said distal end of said second section, and the exterior opening and hollow inner portion at the distal end of the second section receive the attaching end of the needle therein, the distal end and the attaching end are held together by said frictional engagement of the third means for joining; and

(3) a closed configuration defined by said first section being joined to said second section by said first and second means for joining, wherein the exterior opening and the hollow inner portion at the proximal end of said second section receive the first end of said first section therein, the proximal end and the first end are held by said frictional engagement of said second means for joining, and said exterior opening and the hollow inner portion at the distal end of the second section receive the second end of the first section therein, the distal end and the second end are held by said frictional engagement of said first means for joining;

wherein said first rigid section for implantation adjacent to an anterior portion of the mitral valve annulus and said second section for implantation in the fat pad of the atrioventricular groove.

29. A method for implanting an annuloplasty ring in a patient'"'"'s heart to correct mitral insufficiency in which the mitral valve annulus is restored to a normal shape and flexibility as determined by the movement of the left ventricle, the mitral valve and the mitral valve annulus, the steps comprising:

(1) providing an annuloplasty ring having an elongated flexible section attached at one end to a rigid section with a bow and attached at an opposite end to a round tipped-needle;

(2) inserting the tip of the needle through the endocardium and the left atrial myocardial wall of the heart from the endocardial aspect, at the right fibrous trigone;

(3) passing the needle and a portion of the annuloplasty ring through the endocardium and the left atrial myocardial wall of the heart from the endocardial aspect, at the right fibrous trigone;

(4) passing the needle and a portion of the annuloplasty ring in a posterior direction just external to and parallel to the mitral valve annulus;

(5) passing the needle and a portion of the annuloplasty ring around the outside of the mitral valve annulus in the fat pad of the atrioventricular groove in a clockwise direction to the left fibrous trigone;

(6) inserting the tip of the needle back through the left atrial myocardial wall and the endocardium from the epicardial aspect at the left fibrous trigone;

(7) passing the needle and a portion of the annuloplasty ring back through the left atrial myocardial wall from the epicardial aspect and back through the endocardium at the left fibrous trigone;

(8) positioning the flexible section substantially parallel to a posterior portion of the mitral valve annulus;

(9) aligning the rigid section along an anterior portion of the mitral valve annulus,

(10) positioning the bow of the rigid section conforms to a contour of the mitral valve annulus adjacent the aortic valve root and further positioning the flexible section around a posterior portion of the mitral vale annulus;

(11) detaching the needle from the flexible section;

(12) determining the appropriate size of the annuloplasty ring;

(13) cutting the flexible section of the annuloplasty to the appropriate size;

(14) closing the annuloplasty ring by affixing the distal end of the flexible section to the second end of the rigid section by inserting the rigid section into the inner hollow portion of the flexible section;

(15) suturing the annuloplasty ring to valve annulus which at the left and right fibrous trigones;

(16) suturing one point along the posterior section of the mitral valve annulus to the flexible section of the annuloplasty ring.

30. A kit for an annuloplasty ring to be used in an annuloplasty surgical procedure to correct mitral insufficiency in a patient by restoring the mitral valve annulus to a normal shape and flexibility which is determined by the movement of the left ventricle, the mitral valve and the mitral valve annulus, wherein said annuloplasty ring comprises:

a first rigid section having a first end, a second end, a length and an outer diameter;

a second flexible section having a distal end, a proximal end, a length, a means for sizing the ring, and at least one hollow inner portion with an exterior opening at the distal and proximal ends and an inner diameter;

a round-tip needle having a tip and an attaching end with an outer diameter;

a first means for joining the distal end of the second section to the second end of the first section;

a second means for joining the proximal end of the second section to the first end of the first section;

a third means for joining the distal end of the second section to the needle;

wherein said outer diameter of the first section and the outer diameter of the attaching end are approximately equal to the inner diameter of the hollow inner portion;

said first means for joining comprising a frictional engagement between the inner diameter of the hollow inner portion at the distal end and the outer diameter of the second end when the two ends are joined;

said second means for joining comprising a frictional engagement between the inner diameter of the hollow inner portion at the proximal end and the outer diameter of the first end when the two ends are joined; and

said third means for joining comprising a frictional engagement between the inner diameter of the hollow inner portion at the distal end and the outer diameter of the attaching end of the needle when the two ends are joined.