Method of assembling a tissue heart valve

• US 5,571,174 A
• Filed: 11/18/1994
• Issued: 11/05/1996
• Est. Priority Date: 01/24/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Autogenics Co.
• Inventors: Love, Jack W., Love, Charles S., Calvin, John H.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/341,847
• Time in Patent Office: 718 Days
• Field of Search: 623/2, 623/66, 623/900, 623/901, 137/515.7, 251/365
• US Class Current: 29/890.12
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/91 Heart
• CPC Class Codes: Y10S 623/913 Heart
• CPC Class Codes: Y10S 623/918 Heart
• CPC Class Codes: Y10T 137/7857 Valve seat clamped between coupling elements
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

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.

Claims

1. A method of assembling a mating stent valve, comprising the steps of:

positioning a first stent on a mandrel;

indexing said first stent on said mandrel;

wrapping at least one piece of tissue around the first stent;

providing a second stent comprising a base portion and a top portion, each of which is normally in a closed position but which is capable of being expanded into an open position;

spreading the base portion and the top portion of the second stent into their respective open positions utilizing at least one spreading tool;

positioning the second stent, after said spreading step, over the first stent; and

removing the at least one spreading tool, thereby allowing the base and top portions of the second stent to move into their closed positions.

2. A method of assembling a mating stent valve, comprising the steps of:

positioning a first stent on a mandrel;

wrapping at least one piece of tissue around the first stent;

providing a second stent comprising a base portion and a top portion, each of which is normally in a closed position but which is capable of being expanded into an open position;

indexing said second stent to said mandrel;

spreading the base portion and the top portion of the second stent into their respective open positions utilizing at least one spreading tool;

positioning the second stent, after said spreading step, over the first stent; and

removing the at least one spreading tool, thereby allowing the base and top portions of the second stent to move into their closed positions.