Mitral heart valve replacements

• US 5,415,667 A
• Filed: 12/29/1992
• Issued: 05/16/1995
• Est. Priority Date: 06/07/1990
• Status: Expired due to Term

• Current Assignee: Glycar II, L.P.
• Original Assignee: Robert W.M. Frater
• Inventors: Frater, Robert W. M.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BURKE, ELIZABETH
• Application Number:
  US07/965,419
• Time in Patent Office: 868 Days
• Field of Search: 623/1-3, 623/900, 623/2
• US Class Current: 623/2.11
• 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: A61F 2/2457 Chordae tendineae prostheses

Abstract

A mitral heart valve replacement of essentially flexible bioincorporable material comprising a generally D-shaped (30) sewing ring having an opening (31) with at least one long straight side portion (32), an anterior cusp (33) hinged contiguously from that straight side portion (32) a posterior cusp (34) hinged contiguously from a shorter side portion (35) of the opening (31) opposite the anterior cusp (33), and two lateral cusps (36A & 36B) hinged contiguously one from each of the remaining side portions of the opening (31) extending between adjacent ends of the side portions (35) from which the anterior (33) and posterior cusps (34) are hinged, together with chordae of bioincorporable material extending from edge portions of the cusps for connection to the papillary muscles in the cavity of the ventricle when the sewing ring is sutured to the atrio-ventricular junction of the host or patient heart.

Claims

1. A mitral heart valve replacement of essentially flexible bioincorporable material comprising a generally D-shaped sewing ring having an opening defined by a perimeter including at least one long straight side portion thereof, an anterior cusp hinged contiguously from said straight side portion;

a posterior cusp hinged contiguously from a shorter side portion of said opening perimeter opposite said anterior cusp, and two lateral cusps respectively hinged contiguously one from each of two lateral side portions of said opening perimeter extending between adjacent ends of the lateral side portions from which said anterior and posterior cusps are hinged, chordae of bioincorporable material extending from edge portions of said cusps for connection to papillary muscles in a ventricle cavity when the sewing ring is sutured to an atrio-ventricular junction of a host or patient heart, wherein aggregate surface area of said cusps exceeds an area circumscribed by the sewing ring so that when the valve is caused to open, by said papillary muscles pulling the chordae, said cusps simply deflect away from each other, and when said papillary muscles allow the valve to close, the edge portions of the cusps meet within said ventricle cavity of the patient heart.

2. A mitral heart valve replacement as in claim 1, wherein the anterior cusp is contiguous with one-third of said perimeter of the sewing ring opening and has a generally semicircular edge portion to enable it to project deeply into said ventricle cavity, and the posterior and lateral cusps also have generally semicircular edge portions.

3. A mitral heart valve replacement as claimed in claim 1 or claim 2, wherein the sewing ring opening is D-shaped, and is matched by a correspondingly larger D-shaped external profile to suit said atrio-ventricular junction in a patient heart.

4. A mitral heart valve replacement as in claim 1 or claim 2, wherein the sewing ring opening is trapezium-shaped, to provide interrelated longer and shorter parallel straight side portions from which are hinged the anterior and posterior cusps respectively, and two non-parallel side portions from which are hinged the lateral cusps, while the sewing ring has a D-shaped external profile to suit the atrio-ventricular junction in a patient heart.

5. A mitral heart valve replacement as in any one of claims 1 or 2, wherein the sewing ring is formed by a combination of integral flange portions of the anterior, posterior and lateral cusps stitched to a flat basic ring element cut from the bioincorporable material.

6. A mitral heart valve replacement as in claim 5, wherein the flange portions of the cusps are interposed between the basic ring element and a similar flat reinforcing or stiffening element of biocompatible material.

7. A mitral heart valve replacement as in claim 5, wherein the posterior cusp and the lateral cusps and respective integral flange portions thereof are formed from a flat strip of the bioincorporable material, with spacer portions between adjacently located cusp portions, which spacer portions are partially segmented so that said integral flange portion can conform to an arcuate portion of a D-shaped opening, and to bring said adjacently located cusp portions into contiguous disposition with each other.

8. A mitral heart valve replacement as in claim 1 or 2, wherein the chordae are formed integral with the cusps and are provided with integral attachment portions at ends remote from the cusps for suturing to the papillary muscles.

9. A mitral heart valve replacement as in claim 8, wherein the cusps, chordae and attachment portions are provided with non-elastic reinforcing strands running from the cusps to the attachment portions.

10. A mitral heart valve replacement as in claim 9, wherein similar strands also run from side to side of the cusps adjacent their free edges or across the middle.

11. A mitral heart valve replacement as in, claim 1 or 2, wherein the bioincorporable material is biological material, so as to allow the host to cover the valve with living self-repairing fibrous tissue and on this a growth of new endothelium presenting a surface to the blood that does not clot.

12. A mitral heart valve replacement as in claim 1 or 2, wherein the valve is made of a non-biological material that allows the host to provide a cover of fibrous tissue and endothelium leaving the implanted material completely covered by natural host tissue.

13. A mitral heart valve replacement as in, claim 1 or 2, wherein the sewing ring is provided with a central marker line, to indicate inner and outer stitching zones for different ranges of heart size.

14. A mitral heart valve replacement as in claim 13 wherein the marker line is a broken line, formed by an interwoven suture.

15. A mitral heart valve replacement as in, claim 1 or 2, wherein the chordae are separate chords attached by sewing to the edge portions of the cusps and to attachment portions adapted to be eventually sewn to the papillary muscles.

16. A mitral heart valve replacement as in claim 15, wherein said attachment portions of said lateral cusps are secured to adjacently located attachment portions of the anterior and posterior cusps.

17. A mitral heart valve replacement as in claim 16, wherein a rigid holder is temporarily secured to the sewing ring and has a generally U-shaped bar extending between the chordae of the anterior and posterior cusps as far as the attachment portions, so as to prevent collapsing of the valve, particularly during placement in the patient heart.

18. A mitral heart valve replacement as in claim 17, wherein the holder is provided with notches or slots for location of sutures through the sewing ring.

19. A mitral heart valve replacement as in claim 17, wherein the holder has a detachable handle used during placement of the valve in the patient heart.

20. A combined sizing and suture placement guiding device comprising an elongate handle carrying an arcuate sizing member having a circumferential shallow groove for fitting within a corresponding part of a remnant of an excised natural valve of a patient heart at an atrioventricular junction, with notches or slots, one adjacent each end of said sizing member and one intermediate thereof, for indicating positions for placement of sutures to be passed also through corresponding positions on a sewing ring of a replacement valve and with a depth gauge depending from the sizing member for contact with papillary muscles to indicate the positions of placement sutures in papillary muscles for securing attachment portions of connective chordae.

21. A combined sizing and suture placement guiding device as in claim 20 wherein the depth gauge is a generally U-shaped bar having a rectilinear base portion to lie across the papillary muscles.

22. A combined sizing suture and suture placement guiding device as in claim 20 or claim 21 provided with said handle is arranged for assisting placement of the device in the patient heart and removal therefrom.