Prefabricated, sterile and disposable kits for the rapid assembly of a tissue heart valve

• US 5,653,749 A
• Filed: 06/02/1994
• Issued: 08/05/1997
• Est. Priority Date: 01/24/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Autogenics Co.
• Inventors: Love, Charles S., Calvin, John H.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/252,690
• Time in Patent Office: 1,160 Days
• Field of Search: 623/2, 623/66, 623/900, 623/901
• US Class Current: 128/898
• 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

This invention relates generally to a rapid assembly, concentric and flexible mating stent, tissue heart valve which can be assembled from prefabricated, sterile kits by a non-surgeon in the limited time available in an operating room. The kits provide the necessary tools and apparatus for harvesting the tissue and measuring the open annulus within the patient'"'"'s heart. In addition, the kits contain size-specific components to be used during the rapid manufacture of the tissue heart valve.

Claims

1. A pair of first and second pre-fabricated, sterile kits for use during open heart surgery to provide tools and apparatus for very rapidly manufacturing a prosthetic heart valve immediately following (a) harvesting of tissue from a patient, (b) opening of the patient'"'"'s chest cavity to expose the patient'"'"'s heart and (c) excising of a heart valve of the patient'"'"'s heart needing replacement, thereby leaving an open annulus within the heart, said first kit being a tissue harvesting and annulus sizing kit comprising a tray containing, for rapid availability, the following components for harvesting the tissue and quickly and accurately measuring said open annulus within the patient'"'"'s heart:

a tissue sizing template formed of a soft and flexible bio-compatible material for positioning directly upon the tissue to be harvested with said template being used as a guide to cut a piece of the patient'"'"'s tissue in the desired configuration;

a series of obturators of different size which the surgeon can selectively push into said open annulus to ascertain the size of the prosthetic heart valve to be constructed during the open heart procedure;

a first basin for holding a solution for rinsing said tissue;

said second kit being a size specific kit as determined by the annulus measured by using said first kit, said second kit comprising a tray containing, for rapid availability, the following components;

a cutting die for cutting out a portion of said harvested tissue along a perimeter sized to said measured annulus, said cutting die having a substantially continuous blade with a plurality of repeating curved segments, an inner and outer stent sized to said measured annulus, and an assembly mandrel for mounting said tissue between said inner and outer stents for permanently assembling a prosthetic heart valve sized to said measured annulus.

2. A pair of first and second pre-fabricated, sterile kits for use during open heart surgery to provide tools and apparatus for very rapidly manufacturing a prosthetic heart valve immediately following (a) harvesting of tissue from a patient, (b) opening of the patient'"'"'s chest cavity to expose the patient'"'"'s heart and (c) excising of the heart valve of the patient'"'"'s heart needing replacement, thereby leaving an open annulus within the heart, said first kit being a tissue harvesting and annulus sizing kit comprising a tray containing, for rapid availability, the following components for harvesting the tissue and quickly and accurately measuring said open annulus within the patient'"'"'s heart;

a tissue sized template formed of a soft and flexible bio-compatible material for positioning directly upon the tissue to be harvested with said template being used as a guide to cut a piece of the patient'"'"'s tissue in the desired configuration;

a series of obturators of different size which the surgeon can selectively push into said open annulus to ascertain the size of the prosthetic heart valve to be constructed during the open heart procedure;

said second kit being a size specific kit as determined by the annulus measured by using said first kit, said second kit comprising a tray containing, for rapid availability, the following components;

a cutting die for cutting out a portion of said harvested tissue along a perimeter sized to said measured annulus, said cutting die having a substantially continuous blade with a plurality of repeating curved segments, an inner and outer stent sized to said measured annulus, and an assembly mandrel for mounting said tissue between said inner and outer stents for permanently assembling a prosthetic heart valve sized to said measured annulus.

3. A pair of first and second pre-fabricated, sterile kits for use during open heart surgery to provide tools and apparatus for very rapidly manufacturing a prosthetic heart valve immediately following (a) harvesting of tissue from a patient, (b) opening of the patient'"'"'s chest cavity to expose the patient'"'"'s heart, and (c) excising of a heart valve of the patient'"'"'s heart needing replacement, thereby leaving an open annulus within the heart, said first kit being a tissue harvesting and annulus sizing kit comprising a tray containing, for rapid availability, the following components for harvesting the tissue and quickly and accurately measuring said open annulus within the patient'"'"'s heart:

a series of obturators of different size which the surgeon can selectively push into said open annulus to ascertain the size of the prosthetic heart valve to be constructed during the open heart procedure;

said second kit being a size specific kit as determined by the annulus measured by using said first kit, said second kit comprising a tray containing, for rapid availability, the following components;

a cutting die for cutting out a portion of said harvested tissue along a perimeter sized to said measured annulus, said cutting die having a substantially continuous blade with a plurality of repeating curved segments, an inner and outer stent sized to said measured annulus, and an assembly mandrel for mounting said tissue between said inner and outer stents for permanently assembling a prosthetic heart valve sized to said measured annulus.

4. A pre-fabricated, sterile kit for use during open heart surgery to provide tools and apparatus for very rapidly manufacturing a prosthetic heart valve immediately following (a) harvesting of tissue from a patient, (b) opening of the patient'"'"'s chest cavity to expose the patient'"'"'s heart, and (c) excising of a heart valve of the patient'"'"'s heart needing replacement, thereby leaving an open annulus within the heart, said kit comprising a tray containing, for rapid availability, the following components:

a cutting die for cutting out a portion of said harvested tissue along a perimeter sized to said open annulus, said cutting die having a substantially continuous blade with a plurality of repeating curved segments;

an inner and outer stent sized to said open annulus; and

an assembly mandrel for mounting said tissue between said inner and outer stents for permanently assembling a prosthetic heart valve sized to said open annulus.