Annuloplasty and suture rings

• US 5,306,296 A
• Filed: 08/21/1992
• Issued: 04/26/1994
• Est. Priority Date: 08/21/1992
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wright, John T. M., Elliott, Donald P.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/933,339
• Time in Patent Office: 613 Days
• Field of Search: 623/2, 623/1, 623/900, 623/11, 623/12
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

Adjustable, flexible suture 2ings, mitral and tricuspid annuloplasty 2ings having internal drawstrings that emerge from the 2ings on the annular faces so that the drawstring knots are out of the bloodstream, the drawstrings being contained in clearly marked channels, the mitral 2ing having a curved semi-flexible stiffener member in the anteri/r segment to maintain intertrigonal distance during implantati/n are disclosed.

Claims

1. An annuloplasty ring comprising an annulus shaped and sized for insertion in a human heart comprised of multi-layers of braided tube. wherein each layer forms a wall, said annulus formed from a single length of tubular braid that is invaginated to form a double walled tube having first and second ends and inner and outer walls, a roll over fold formed at one end thereof, and two cut ends formed at the other end thereof, said inner and outer walls of the tube being sealed together at said two cut ends forming a seal line, said tube being rolled so that said seal line lies substantially centrally in the inner wall of the tube, said tube set to form a "V" cross-section configuration to form an eight walled flexible contractile member.

2. The ring of claim 1, wherein said seal line is a heat seal line.

3. The ring of claim 2 tube being heat set to form "V" cross-section configuration to form an eight walled flexible contractile member.

4. The ring of claim 1 tube being heat set to form a "V" cross-section configuration to form an eight walled flexible contractile member.

5. The ring of claim 4 constructed and configured to be a tricuspid annuloplasty ring.

6. The ring of claim 1 ring having an inner annular periphery and an outer annular periphery constructed and adapted for being sutured to the human heart tissue and, lying between said peripheries, a first face constructed and configured to lie, when in use, against the annulus defined by the tissue surrounding a human heart valve, and a second face opposite the first face, said ring comprising at least one pair of drawstrings exiting the first face approximate the inner annular periphery for ring lying against the tissue annulus and being spaced from the outer annular periphery.

7. The ring of claim 1 wherein the annulus comprises an anterior segment and a right and left posterior segments further comprises:

a stiffener wire extending substantially throughout the anterior segment, the stiffener wire having first and second ends, said ends being configured to form loops on the respective ends thereof;

a first string having ends which extend outwardly through the tube walls at first and second points respectively, the first and second points being spaced, respectively, from the first and second ends of the wire, extending inside the tube a point adjacent an end of the wire, at which point the string extends outwardly through the wall of the tube, thence around the tube, thence inwardly through the walls proximate the said end of the wire, thence through the loop in said end of the wire, thence outwardly through the walls, thence around the first string outside the tube, thence inwardly through the walls and over the first string, forming a knot to secure said end of the wire to the tube and to the first string to the first end of the wire, and thence into the tube and along the tube; and

a second string extending from outside the annulus proximate a third point, through the tube away from the first end of the wire toward the second point, outwardly through the tube wall and inwardly through the tube wall proximate a fourth point to secure the second string approximate said fourth point, along the inside of the tube to proximate a fifth point, and thence through the tube wall, a first end of the second string extending out of the tube wall proximate the third point, the second end of the second string extending out of the tube wall proximate the fifth point.

8. The ring of claim 7 wherein the third point is adjacent the first point and the fifth point is adjacent the second point, wherein the second string form a knot at the fourth point, and wherein the first ends of the respective strings comprise a first pair of drawstrings for permitting contraction of the annulus between the first end of the wire and the first point and between the first point and the third point, respectively and the second ends of the respective strings comprise a second pair of drawstrings for permitting contraction of the annulus between the second end of the wire and the second point and between the second point and the third point, respectively.

9. The ring of claim 7 wherein the wire is polished on all surfaces, the second ends thereof are radiused and wherein the loops are formed without denting the wire in the portions thereof that lie adjacent the ends of the wire.

10. The ring of claim 7 further comprising a second knot formed by the string proximate the second end of the wire, said second knot being a mirror image of the first knot.

11. The ring of claim 1 wherein the annulus comprises an anterior segment and right and left posterior segments, and having a first face constructed and configured to lie, when in use, against the annulus defined by the tissue surrounding a human heart valve, and a second face opposite the first face, a first portion constructed and configured to form a curved member that encompasses substantially the whole of the anterior segment of the human valve annulus, a second portion constructed and configured to form a flexible, contractible member that encompasses substantially the whole of the right and left posterior segments of the human mitral valve annulus and means in the ring for selectively contracting, independently of one another, either the right posterior segment or the left posterior segment, or both posterior segments and a second portion being so constructed and configured and connected respectively at first and second ends thereof to first and second ends, respectively, of the first portion, the first portion being relatively substantially more rigid that the second portion, the first and second ends of the second portion being so constructed and configured as to permit hinging movement of the second portion relative to the first portion adjacent the ends of the first portion to permit the ring to conform to the human mitral valve annulus.

12. The annuloplasty ring of claim 1 wherein the annulus comprises an anterior segment and a right and left posterior segments, said ring having a first face constructed and configured to lie, when in use, against the annulus defined by the tissue surrounding a human heart valve, and a second face opposite the first face, and further comprising:

a first portion constructed and configured to form a curved member that encompasses substantially the whole of the anterior segment of the human valve annulus;

a second portion constructed and configured to form a flexible, contractible member that encompasses substantially the whole of the right and left posterior segments of the human mitral valve annulus;

the first and second portions together constructed and configured such that the first and second portions, respectively, lie generally in first and second planes; and

means in the ring for selectively contracting, independently of one another, the right posterior segment proximate one end of the curved member, the right posterior segment distal front the said one end of the curved member, the left posterior segment proximate the other end of the curved member, or the left posterior segment distal from the said one end of the curved member.

13. The mitral annuloplasty ring of claims 12 wherein the second portion that is adapted to lie adjacent the left posterior segment is contractible by means of a first pair of drawstrings and the second portion that is adapted to lie adjacent the right posterior segment is contractible by means of a second pair of drawstrings.

14. The annuloplasty ring of claim 12 wherein drawstrings exit the first face of the ring that is constructed and configured to lie against the tissue annulus.

15. The annuloplasty ring of claim 1 wherein the annulus comprises an anterior segment and a right and left posterior segments, said ring having a first face constructed and configured to lie, when in use, against the annulus defined by the tissue surrounding a human heart valve, and a second face opposite the first face, and further comprising:

a first portion constructed and configured to form a curved member that encompasses substantially the whole of the anterior segment of the human valve annulus; and

a second portion constructed and configured to form a flexible, contractible member that encompasses substantially the whole of the right and left posterior segments of the human mitral valve annulus, and

at least one pair of drawstrings in the second portion, said portion being contractible by means of said drawstrings, said drawstrings exiting the first face of the ring intended to lie against the tissue annulus.