Method of assembling a tissue heart valve

United States Patent m

Love et al.

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US005571174A [ii] Patent Number: 5,571,174 [45] Date of Patent: Nov. 5, 1996

[54] METHOD OF ASSEMBLING A TISSUE HEART VALVE

[75] Inventors: Charles S. Love, Camarillo; Jack W.

Love, Santa Barbara; John H. Calvin,

Carpenteria, all of Calif.

[73] Assignee: Autogenics, Glasgow, United Kingdom

[21] Appl. No.: 341,847

[22] Filed: Nov. 18, 1994

Related U.S. Application Data

[63] Continuation of Ser. No. 216,169, Mar. 22, 1994, abandoned, which is a continuation of Ser. No. 925,589, Aug. 3, 1992, Pat. No. 5,326,371, which is a division of Ser. No. 646,001, Jan. 24, 1991, Pat. No. 5,163,955.

[51] Int. CI.6 A61F 2/24

[52] U.S. CI 623/2

[58] Field of Search 623/2, 66, 900,

623/901; 137/515.7; 251/365

[56] References Cited

U.S. PATENT DOCUMENTS

A method for assembling a concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. A series of obturators may be used to size an annulus of the heart to be fitted. A precisely-configured cutting die is used to produce a precisely-cut tissue with a plurality of heart valve leaflets when the tissue is positioned between the first and second stents.

2 Claims, 25 Drawing Sheets

Reis, et al., "The flexible stent: A new concept in the fabrication of tissue heart valve prostheses", The Journal of Thoracic and Cardiovascular Surgery, Nov. 1971, vol. 62, No. 5, pp. 683-689; 693-695.

Yates, "A fascial frustum valve for aortic valve-replacement", Thorax, 1971, vol. 26, pp. 184-189. Brownlee, et al., "A fascia lata mitral valve based on the 'frustum' principle", Thorax, 1971, vol. 26, pp. 284-287. Bartek, et al., "Frame-mounted tissue heart valves: technique of construction", Thoraz, 1974, vol. 29, pp. 51-55. Ionescu, et al., "Replacement of heart valves with frame-mounted tissue grafts", Thorax, 1974, vol. 29, pp. 56-67. Black, et al., "A construction technique for minimizing valve leaflet fatigue failure in pericardial valves", Life Support Systems, Proceedings XI Annual Meeting ESAO, Alpbach-Innsbruck, Austria, Sep. 1984, vol. 2, Supp. 1.

Love, "An Alternate Method for Applying a DACRON Cover to a DELRIN Bioprosthetic heart Valve Stent", Proceedings of the Third Southern Biomedical Engineering Conference, Pergamon Press, 1984, pp 30-37.

Love, et al., "Degenerative calcification in tissue valves a metabolic/hemodynamic or immunologic problem?", Abstract published for the International Associate for Cardiac Biological Implants, Chicago, Apr. 5, 1987, p. 1.

Love, et al., "Experimental Evaluation of an Autogenous Tissue Heart Valve", Poster Presentation at the Fifth International Symposium Cardiac Bioprostheses, San Diego, Apr. 15, 1988.

Ruel, et al., "In Vitro Testing of Bioprostheses", Trans. Am. Soc. Artif. Intern. Organs, 1988, vol. XXXIV, pp. 1033-1039.

Love, et al., "The Autogenous Tissue Heart Valve: Experience with Pericardium", Pericardial Tissue as a Cardiac Valve Substitute, Proceedings of a Symposium, Thumberbach, Austria, Sep. 1988, pp. 31-40.

Matsuda, et al., "A Hand-Made Valved Conduit with High-Porosity Knitted Graft and Glutaraldehyde-Treated Autologous Pericardial Trileaflet Valve", Abstracts of the VH World Congress Artificial Organs, 1989, vol. 13, No. 4.

Khan, et al, "Doppler and Hemodynamic Characteristics of the Autogenics Bioprosthetic Valve":, p. 1.

Love et al., "Rapid Intraoperative Fabrication of an Autogenous Tissue Heart Valve: A New Technique", Proc. of the Third International Symposium on Cardiac Bioprosthesis, Yorke Medical Books, New York, 1986, pp. 691-698.