Papilloplasty band and sizing device

• US 20050197696A1
• Filed: 02/22/2005
• Published: 09/08/2005
• Est. Priority Date: 02/23/2004
• Status: Active Grant

• Current Assignee: The International Heart Institute of Montana Foundation
• Original Assignee: The International Heart Institute of Montana Foundation
• Inventors: Gomez Duran, Carlos Manuel
• Granted Patent: US 8,206,439 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

Unique semi-circular papillary muscle and annulus bands are described that are useful for modifying the alignment of papillary muscles, a mitral valve annulus and/or a tricuspid valve annulus. Methods to effect the alignment are also described and an unique sizing device that can be used for such alignment is described.

Claims

1. A cardiac prosthesis comprising:

a semi-circular band portion comprising a first end and a second end;

said first end including a first portion of a tether;

said second end including a second portion of said tether, wherein

said first and second portions of said tether are secured to each other, to provide an adjustable semi-circular band.

2. The cardiac prosthesis of claim 1, wherein said band is tubular.

3. The cardiac prosthesis of claim 1, wherein said band is a unitary rod.

4. The cardiac prosthesis of claim 1, wherein said band is formed from a biocompatible material selected from the group consisting of Dacron, teflon, a polyurethane, a nylon, a polyester, silastic, nitinol, nitinol mesh, titanium, titanium mesh, pericardium, pleura, peritoneum, duramater, tendons and arteries.

5. The cardiac prosthesis of claim 1, wherein said band has a cross section of between about 1.5 millimeters and about 6 millimeters.

6. The cardiac prosthesis of claim 1, wherein said flexible semi-circular band portion has a length of between about 50 millimeters to about 100 millimeters.

7. The cardiac prosthesis of claim 1, wherein said tether is a suture, a quick connect, a tourniquet, a hook and eye, a clasp, a threaded screw, a staple or a rachet.

8. The cardiac prosthesis of claim 2, further comprising a drawstring internally disposed within said tube.

9. A method to align the papillary muscles of a ventricle, comprising the steps of:

forming a passage about the papillary muscles of the ventricle through trabeculae;

inserting a cardiac prosthesis according to claim 1 through said passage; and

adjusting said cardiac prosthesis via said tether, such that said papillary muscles and chords are aligned relative to the valve of the heart.

10. The method of claim 9, further comprising the step of securing an annuloplasty prosthesis about an annulus of the heart'"'"'s valves.

11. The method of claim 10, further comprising the step of securing chords about said cardiac prosthesis to said annuloplasty prosthesis.

12. The method of claim 11, wherein the chords are inserted through tissue about each prosthesis.

13. The method of claim 11, wherein said chords are inserted through each prosthesis.

14. The method of claim 11, wherein the relationship between the lengths of the chords are adjusted such that the distance from the tips of the papillary muscles is equal to the intertrigonal distance of said heart.

25. A method to align the papillary muscles of the left ventricle, comprising the steps of:

forming a passage about the papillary muscles of the left ventricle through trabeculae;

inserting a cardiac prosthesis according to claim 1 through said passage;

measuring the distance between the trigones with a trigonal-papillary sizing device, said trigonal-papillary sizing device having a horizontal member and two vertical members of equal length attached to the distal ends of the horizontal member, said vertical members having the same length as the horizontal member, said horizontal member having a length equivalent to said intertrigonal distance; and

adjusting said cardiac prosthesis via said tether, such that said papillary muscles and ventricular chords are aligned relative to distance between the trigones.

26. The method of claim 25, further comprising the step of securing an annuloplasty prosthesis about the mitral valve annulus.

27. The method of claim 26, further comprising the step of securing chords about said cardiac prosthesis to said annuloplasty prosthesis.

28. The method of claim 27, wherein the chords are inserted through tissue about each prosthesis.

29. The method of claim 27, wherein said chords are inserted through each prosthesis.

30. The method of claim 27, wherein the relationship between the lengths of the chords are adjusted such that the distance from the tips of the papillary muscles is equal to the intertrigonal distance of said mitral valve.

15. A trigonal-papillary sizing device comprising:

a handle attached to a two forked prong;

said two forked prong having a proximal portion and two distal ends each having an equivalent length, wherein said proximal portion connects said two prongs, wherein said two distal prong ends are rounded and wherein the distance between said two prongs and said length of said two prongs are equal, said distances being equal to an intertrigonal distance.

16. The trigonal-papillary sizing device of claim 15, wherein said two prongs form a single planar unitary structure.

17. The trigonal-papillary sizing device of claim 16, wherein said single planar unitary structure curves out of the plane.

18. The trigonal-papillary sizing device of claim 15, wherein said apparatus is formed of a transparent material.

19. A packaged medical device, comprising:

a cardiac prosthesis comprising;

a semi-circular band portion comprising a first end and a second end;

said first end including a first portion of a tether;

said second end including a second portion of said tether, wherein

said first and second portions of said tether are secured to each other, to provide an adjustable semi-circular band; and

instructions to position said cardiac prosthesis about papillary muscles, the mitral valve annulus or the tricuspid annulus.

20. A packaged medical device, comprising:

a cardiac prosthesis comprising;

a semi-circular band portion comprising a first end and a second end;

said first end including a first portion of a tether;

said second end including a second portion of said tether, wherein

said first and second portions of said tether are secured to each other, to provide an adjustable semi-circular band;

an annuloplasty ring; and

instructions to position said cardiac prosthesis about papillary muscles.

21. A packaged medical device, comprising:

comprising;

a first and a second cardiac prosthesis each comprising;

a semi-circular band portion comprising a first end and a second end;

said first end including a first portion of a tether;

said second end including a second portion of said tether, wherein

said first and second portions of said tether are secured to each other, to provide an adjustable semi-circular band; and

instructions to position said cardiac prosthesis about papillary muscles, the mitral valve annulus or the tricuspid annulus.

22. A packaged medical device, comprising:

a cardiac prosthesis comprising;

a semi-circular band portion comprising a first end and a second end;

said first end including a first portion of a tether;

said second end including a second portion of said tether, wherein

said first and second portions of said tether are secured to each other, to provide an adjustable semi-circular band;

a trigonal-papillary sizing device; and

instructions to position said cardiac prosthesis about papillary muscles, based on the intertrigonal distance of the mitral valve measured with the sizing device.

23. A packaged medical device, comprising:

a cardiac prosthesis comprising;

a semi-circular band portion comprising a first end and a second end;

said first end including a first portion of a tether;

said second end including a second portion of said tether, wherein

said first and second portions of said tether are secured to each other, to provide an adjustable semi-circular band;

an annuloplasty ring;

a trigonal-papillary sizing device; and

instructions to position said cardiac prosthesis about papillary muscles, based on the intertrigonal distance of the mitral valve measured with the sizing device.

24. A packaged medical device, comprising:

comprising;

a first and a second cardiac prosthesis each comprising;

a semi-circular band portion comprising a first end and a second end;

said first end including a first portion of a tether;

said second end including a second portion of said tether, wherein

said first and second portions of said tether are secured to each other, to provide an adjustable semi-circular band;

a trigonal-papillary sizing device; and

instructions to position one of said cardiac prosthesis about papillary muscles, based on the intertrigonal distance of the mitral valve measured with the sizing device.