Human cardiac valve placement with marine mammal ventricular outflow (aortic or pulmonary) valve

• US 6,165,216 A
• Filed: 07/12/1996
• Issued: 12/26/2000
• Est. Priority Date: 06/20/1995
• Status: Expired due to Fees

• Current Assignee: Efstathios Andreas Agathos
• Original Assignee: Efstathios Andreas Agathos
• Inventors: Agathos, Efstathios Andreas
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/678,196
• Time in Patent Office: 1,628 Days
• Field of Search: 623/2, 623/900, 623/66, 623/2.13, 623/2.42
• US Class Current: 623/2.13
• 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: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

The present invention provides a method of treating human cardiac valve dysfunction, by replacing the existing valve with a novel bioprosthesis of the present invention which comprises a marine mammal ventricular outflow (aortic or pulmonary) valve. The marine mammal ventricular outflow valve is treated by a fixative agent to sterilize, fix, increase the strength of the leaflets and lessen the antigenicity of the tissue valve. Following this step, the marine mammal ventricular outflow valve can either be stent-mounted or can be unstented. The stent-mounted marine mammal ventricular outflow valve can be used to replace a human aortic, mitral, or tricuspid valve, while the unstented marine mammal ventricular outflow valve can be used to replace a human aortic or pulmonary valve. Being a natural trileaflet valve, with symmetrical cusps and no muscle shelf within the leaflet, the marine mammal ventricular outflow valve presents superior hemodynamic advantages over the existing aortic porcine and bovine pericardial valves. The increase thickness of the leaflets result in a long-term durability, without the attendant disadvantages of re-replacing a bioprosthesis. Alternatively, a marine mammal trileaflet valve can be contructed from tissues such as pericardium and fascia lata.

Claims

1. A method of treating a human patient, comprising:

i. providing a marine mammal trileaflet valve, and

ii. surgically implanting said valve in said patient.

2. The method of claim 1, wherein said patient'"'"'s existing aortic valve is replaced with said marine mammal trileaflet valve.

3. The method of claim 1, wherein said patient'"'"'s existing pulmonary valve is replaced with said marine mammal trileaflet valve.

4. The method of claim 1, wherein said marine mammal valve is a fixed and sterilized stent-mounted trileaflet valve.

5. The method of claim 1, wherein said marine mammal valve is a fixed and sterilized whole excised unstented trileaflet valve.

6. The method of claim 1 wherein said marine mammal trileaflet valve is a ventricular outflow valve.

7. The method of claim 1, wherein said marine mammal trileaflet valve is a bioprothesis constructed from marine mammal tissues selected from the group consisting of pericardium or fascia lata.

8. The method of claim 1, wherein said marine mammal valve comprises a section of ascending aorta.

9. The method of claim 1, wherein said marine mammal valve comprises a section of pulmonary artery.

10. The method of claim 1, wherein said marine mammal valve has an inlet side and further comprises a flexible sewing skirt extending from said inlet side to facilitate suturing of the valve in said patient.

11. A method of treating valve dysfunction in a human patient, comprising:

i. providing a marine mammal ventricular outflow valve, and

ii. replacing an existing dysfunctional aortic, mitral, tricuspid or pulmonary valve in said patient with said ventricular outflow valve.

12. The method of claim 11, wherein said marine mammal valve is a fixed and sterilized stent-mounted valve.

13. The method of claim 11, wherein said marine mammal valve is a fixed and sterilized unstented valve.

14. The method of claim 11, wherein said marine mammal valve comprises a bioprothesis constructed from marine mammal tissues selected from the group consisting of pericardium or fascia lata.

15. The method of claim 11, wherein said marine mammal valve comprises a section of ascending aorta.

16. The method of claim 11, wherein said marine mammal valve comprises a section of pulmonary artery.

17. The method of claim 11, wherein said marine mammal valve has an inlet side and further comprises a flexible sewing skirt extending from said inlet side to facilitate suturing of the valve in said patient.

18. A composition, consisting of a fixed, marine mammal ventricular outflow valve having a sewing skirt.

19. The composition of claim 18, wherein said valve is a sterilized whole excised unstented valve.

20. The composition of claim 18, wherein said marine mammal is selected from the group consisting of seals, sea lions, dolphins, porpoises, and whales.

21. An excised, marine mammal valve having an inlet side and further comprising a flexible sewing skirt extending from said inlet side, said flexible skirt configured so as to facilitate suturing of the valve in a patient.

22. The excised, marine mammal valve of claim 21, further comprising a section of ascending aorta.

23. The excised, marine mammal valve of claim 21, further comprising a section of pulmonary artery.