BICUSPID FASCIA LATA VALVE

• US 3,739,402 A
• Filed: 10/15/1970
• Issued: 06/19/1973
• Est. Priority Date: 10/15/1970
• Status: Expired due to Term

• Current Assignee: Denton A. Cooley, Domingo S. Liotta, Paul Kahn
• Original Assignee: Denton A. Cooley, Domingo S. Liotta, Paul Kahn
• Inventors: Cooley, Denton A., Kahn, Paul, Liotta, Domingo S.
• Primary Examiner(s): Gaudet, Richard A.
• Assistant Examiner(s): Frinks, Ronald L.
• Application Number:
  US05/081,064
• Time in Patent Office: 978 Days
• Field of Search: 3/1,DIG.3 128/334R
• US Class Current: 623/2.16
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A graft-support for homograft and heterograft tissue valve implantation comprising a ring base, two struts extending from one side of the ring base and generally parallel to its axis, and a fabric layer covering the entire surface of the ring and struts. The fabric layer has a thickened portion at the apex of each strut, a second thickened portion along the top edge of the ring and a third thickened portion extending circumferentially of the ring. These thickened portions provide means for suturing the graft-support to the valve tissue and to the host heart, respectively. In one very advantageous embodiment, the ring is generally oblong in shape having a long diameter and a short diameter and the struts are disposed opposite to each other, one at each end of the oblong ring, i.e., at each end of the long diameter thereof or on a line parallel thereto. In effecting the transplantation, animal tissue, such as fascia lata derived from the patient, is wrapped around the upstanding struts and joined at the ends by suturing to form a closed ring of tissue, and forming also two cusps thereof supported by the struts. Each cusp is then sutured at its base to the covering at the top surface of the ring and along the sides of the struts, and a pledget of the fabric or suture is affixed around the top of the strut, the fabric thereover and the tissue to ensure coaptation of the cusps. The tissue, especially fascia lata from the patient, can also be extended to cover the side of the third thickened portion, or sewing ring, which is exposed to the ventricle so that, when the valve is emplaced, the entire ventricular surface is covered with autologous tissue. The device is then placed in the mitral valve position with struts extending into the ventricle and the host heart is sutured to the peripheral thickened flange, i.e., the third thickened portion.

Claims

1. A graft-support ring for a bicuspid valve for valve replacement in a damaged heart, including in combination a. a self-supporting shape-retaining frame comprising b. a rounded oblong ring having an upper face and a lower face and surrounding an oblong area having a major axis, c. a pair of prongs extending from one of said faces and generally perpendicular to said oblong area, and being disposed on a plane parallel to said major axis and perpendicular to said area, and d. a fabric covering compatible with body fluids contoured to said frame and completely enclosing it to provide a base for later suturing.

2. A graft-support ring as in claim 1 wherein said prongs extend from said ring approximately at the opposite ends of said major axis.

3. A graft-support ring as in claim 1 wherein said prongs are inclined outwardly at a small angle with respect to a line perpendicular to the plane of said area.

4. A graft-support ring for a bicuspid valve for use with autologous, homologous, or heterologous tissue, including in combination a. a self-supporting, shape-retaining frame comprising b. a generally oblong ring having an upper face, a lower face, and a long diameter with a center, c. a pair of struts extending from one of said faces and generally parallel to an axis through said center, and disposed on a plane parallel to said long diameter and perpendicular to the plane of said ring, d. each said strut having an apex remote from said ring, and e. a fabric covering compatible with body fluids contoured to said frame and completely enclosing it to provide a base for later suturing, f. said covering having a first thickened portion adjacent each said apex, a second thickened portion along the surface of said ring to each said apex, and a third thickened portion extending outwardly from said ring to form a sewing flange.

5. A graft-support ring as in claim 4 wherein said metal ring and struts are machined from one piece of titanium metal.

6. A graft-support ring as in claim 4 wherein said flange extends at an angle of from about 30* to about 60* to said central axis.

7. A graft-support ring as in claim 4 wherein said struts are inclined outwardly at a small angle with respect to the axis of the ring.

8. A graft-support ring as in claim 4 wherein one of said struts is disposed on said metal ring at each end of said long diameter.

9. A bicuspid fascia lata valve for insertion into a ventricle valve opening of a heart and providing ventricle-exposed surfaces, including in combination, a. a self-supporting, shape-retaining frame comprising b. a generally oblong metal ring having an upper face, a lower face, and a long diameter with a center, c. a pair of prongs extending from one of said faces generally parallel to an axis through said center, and disposed on a plane parallel to said center, and perpendicular to the plane of said ring, d. each of said prongs being disposed at each end of said plane and each said prong having an apex remote from said ring, e. a fabric covering compatible with body fluids contoured to and completely enclosing said frame to provide a base for suturing, f. said covering having a first thickened portion at each said apex, a second thickened portion along said prongs and said face, and a third thickened portion extending as a sewing flange from said ring, and g. fascia lata tissue covering said ventricle-exposed surfaces of said valve when inserted in said valve opening, and sutured to said fabric at said thickened portions.

10. A fascia lata valve as in claim 9 wherein said metal frame is machined from one piece of titanium.

11. A fascia lata valve as in claim 9 wherein said fascia lata is autologous tissue.

12. A fascia lata valve as in claim 9 wherein said struts are disposed on a plane parallel to and offset from said center line.