Dynamic annulus heart valve and reconstruction ring

• US 4,339,831 A
• Filed: 03/27/1981
• Issued: 07/20/1982
• Est. Priority Date: 03/27/1981
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Johnson, Keith M.
• Primary Examiner(s): FRINKS, RONALD
• Application Number:
  US06/248,624
• Time in Patent Office: 480 Days
• Field of Search: 3/1.5, 3/1, 137/512.1, 137/512.15, 137/854, 137/852
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: F16K 15/1402 having an integral flexible member cooperating with a plurality of seating surfaces
• CPC Class Codes: F16K 15/148 the closure elements being fixed in their centre
• CPC Class Codes: Y10T 137/784 Integral resilient member forms plural valves
• CPC Class Codes: Y10T 137/789 Central mount

Abstract

A synthetic leaflet aortic and mitral heart valve for use in replacement of diseased natural heart valves having a flexible, curved framework, a flexible membrane attached to the framework and fixation means for attaching the valve to the tissue annulus. The framework consists of at least three curved flexible valve struts, each joined together at one end to a common central point of the valve and extending in the same direction radially at equal angles so that the free ends are unattached and at a distance from one another. The free ends are provided with sewing pads for artificial attachment of each free end separately to the natural tissue annulus or to an artificial annulus reconstruction ring which itself is sutured to the tissue annulus to restore its symmetry. The membrane is formed of a thin, common flexible synthetic material which is hemispherically shaped to fit over, and be attached to the framework to provide at least three partial hemispheric segments extending between adjacent frame struts in such a manner that the free edge of each segment can contact the tissue annulus when the valve is closed. Upon forward flow of the blood, the valve segments collapse inward against one another and allow blood to pass between the tissue annulus and the collapsed membrane segments.

Claims

1. A prosthetic heart valve comprising:

a. a flexible frame means comprising a plurality of arcuate frame struts, means for commonly joining together one end of each frame strut and for extending the valve struts radially and in a common direction from the point of joinder so that the free ends of said valve struts terminate at points spaced from one another and radially from said common point and each of said valve struts curves approximately 90°

from said point of joinder to said free end thereof;

b. a plurality of valve leaflets formed of thin, flexible, impermeable sheet material, each leaflet having three edges and a hemispheric segment shape, with first and second edges conforming to the hemispheric segment shape defined by two adjacent valve struts extending from said point of joinder to the free ends thereof and the third edge having a length sufficient to extend between the free ends of said two adjacent valve struts in an arc measured radially from said point of joinder;

c. means for attaching the first and second edges of each of said valve leaflets along the length of adjacent ones of said valve struts from said point of joinder to adjacent free ends thereof, leaving the third edge extending between free ends of said valve struts; and

d. fixation means coupled to said free ends of said valve struts for providing points of attachment of said valve to cardiac tissue;

whereby said valve leaflets are adapted to bellow out and effect closure of the third edge of each of said leaflets against body tissue in a first direction of blood flow and to collapse inward against one another in a second direction of blood flow to thus block or allow blood flow in said first and second directions.

2. The heart valve of claim 1 wherein said plurality of frame struts comprises three valve struts and said commonly joining means equiangularly joins said valve struts for providing a generally circular configuration of said valve, when viewed axially, capable of use as an aortic replacement valve.

3. The heart valve of claim 1 wherein said plurality of frame struts comprises three valve struts, one of said valve struts being shorter in length than the other two valve struts, and said commonly joining means joins said one valve strut and said other two struts at a first and second vertical angle and commonly joins said other two valve struts at a third angle greater than said first and second angles for providing a generally oblong configuration of said valve, when viewed axially, capable of use as a mitral replacement valve.

4. The heart valve of claim 1 wherein said valve leaflets are formed of a single membrane shaped into a curved surface conforming to the shape of said open framework and wherein said free edges constitute segments of a single free edge of said membrane extending between adjacent free ends of said valve struts.

5. The heart valve of claim 4 wherein said valve struts and said valve leaflets are formed of a common biocompatible and non-thrombogenic material and said attaching means comprises the molecular bond of said membrane material to said valve strut material.

6. The heart valve of claim 5 wherein said material is expanded polytetrafluoroethylene sheet material and said membrane and framework is formed of bonded layers of said sheet material.

7. The heart valve of claim 1 wherein said material is expanded polytetrafluoroethylene sheet material and said membrane and framework is formed of bonded layers of said sheet material.

8. The heart valve of claim 4 wherein said material is expanded polytetrafluoroethylene sheet material and said membrane and framework is formed of bonded layers of said sheet material.

9. The heart valve of claim 1 further comprising:

an annular reconstruction ring meant for implantation in the position of the excised natural heart valve and for reconstructing an annular surface suitable for attachment of a heart valve formed of a ring-shaped body of relaxed and pliant silicone rubber with an elastic fabric sleeve surrounding said body through which said ring means may be sutured in place around the excised valve annulus.

10. A prosthetic heart valve for permanent implantation in the heart valve annulus comprising:

a. expansible valve frame means further comprising a plurality of flexible, curved valve struts and means for joining one end of each valve strut together to form a curved, open framework, the other free ends of said valve struts extending in a common direction with respect to the other and spaced from one another;

b. a like plurality of valve leaflets made of thin, flexible, impermeable sheet material, each leaflet formed to fit between adjacent ones of said valve struts and having a free edge extending in an arc between the respective free ends of said valve struts;

c. means for attaching said leaflets from the joined end to the free end of adjacent ones of said valve struts to form a fluid tight covering over said framework; and

d. support means for attaching the free ends of said valve struts to the tissue annulus, whereby said leaflets may bellow out and contact the tissue annulus during closure of said valve and may collapse inwardly against one another during opening of said valve.

11. The heart valve of claim 10 wherein said plurality of frame struts comprises three valve struts, one of said valve struts being shorter in length than the other two valve struts and said commonly joining means joins said one valve strut and said other two struts at a first and second vertical angle and commonly joins said other two valve struts at a third angle greater than said first and second angles for providing a generally oblong configuration of said valve, when viewed axially, capable of use as a mitral replacement valve.

12. The heart valve of claim 10 wherein said plurality of frame struts comprises three valve struts, and said commonly joining means equiangularly joins said valve struts for providing a generally circular configuration of said valve, when viewed axially, capable of use as an aortic replacement valve.

13. The heart valve of claim 10 wherein said valve leaflets are formed of a single membrane shaped into a curved surface conforming to the shape of said open framework and wherein said free edges constitute segments of a single free edge of said membrane extending between adjacent free ends of said valve struts.

14. The heart valve of claim 13 wherein said valve struts and said membrane are formed of a common biocompatible and non-thrombogenic material and said attaching means comprises molecular bond of said membrane material to said valve strut material.

15. The heart valve of claim 14 wherein said material is expanded polytetrafluoroethylene sheet material and said membrane and framework is formed of bonded layers of said sheet material.

16. The heart valve of claim 10 wherein said valve struts and said membrane are formed of a common biocompatible and non-thrombogenic material and said attaching means comprises molecular bond of said membrane material to said valve strut material.

17. The heart valve of claim 16 wherein said material is expanded polytetrafluoroethylene sheet material and said membrane and framework is formed of bonded layers of said sheet material.

18. The heart valve of claim 17 wherein said plurality of frame struts comprises three valve struts and said commonly joining means equiangularly joins said valve struts for providing a generally circular configuration of said valve, when viewed axially, capable of use as an aortic replacement valve.

19. The heart valve of claim 17 wherein said plurality of frame struts comprises three valve struts and one of said valve struts being shorter in length than the other two valve struts and said commonly joining means joins said one valve strut and said other two struts at a first and second vertical angle and commonly joins said other two valve struts at a third angle greater than said first and second angles for providing a generally oblong configuration of said valve, when viewed axially, capable of use as a mitral replacement valve.