Rapid assembly, concentric mating stent, tissue heart valve with enhanced clamping and tissue alignment

• US 5,326,371 A
• Filed: 08/03/1992
• Issued: 07/05/1994
• 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): Green, Randall L.
• Assistant Examiner(s): WILLSE, DAVID H
• Application Number:
  US07/925,589
• Time in Patent Office: 701 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 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. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Claims

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

utilizing a tissue template to cut out at least one roughly-dimensioned piece of tissue;

successively utilizing obturators to size an annulus of a heart to be fitted;

utilizing a precisely-configured cutting die to cut the roughly-dimensioned tissue into precisely-cut tissue having a size appropriate for the annulus to be fitted;

said precisely-configured die being configured with a plurality of ferrules;

utilizing said ferrules to cut a plurality of holes in said precisely-cut tissue; and

situating the precisely-cut tissue between first and second stents, one of said first and second stents being configured with a plurality of tissue alignment members extending from a surface thereon registering said holes with corresponding ones of said tissue alignment members.

2. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of one of said first and second stents;

providing a tissue cutting die matched in size and shape to said first and second stents;

configuring said tissue cutting die with a plurality of ferrules;

cutting at least one piece of tissue from a larger piece of tissue utilizing said tissue cutting die while cutting a plurality of holes in said at least one piece of tissue utilizing said ferrules;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place.

3. The method of very rapidly assembling a heart valve during open heart surgery, comprising the steps of:

positioning a tissue sizing template formed of a soft and flexible bio-compatible material directly upon the tissue to be harvested;

using said template as a guide to cut a piece of the patient'"'"'s tissue into a roughly-dimensioned piece of tissue;

successively utilizing a series of obturators of different sizes by selectively pushing the obturator into the open annulus of the heart to select the obturator corresponding to the size of the prosthetic heart valve to be constructed during the open heart procedure;

positioning a precisely configured cutting die corresponding in size to said selected obturator proximate to said cut piece of said patient'"'"'s tissue and, before said tissue is mounted around a stent, utilizing said die to cut said roughly-dimensioned piece of tissue into a precisely-cut tissue having a size appropriate for said measured annulus so that said tissue may be mounted between said first and second stents without any additional cutting or trimming;

situating the precisely-cut tissue between first and second stents; and

positioning the stents together to securely clamp the tissue therebetween.

4. The method of assembling a heart valve during open heart surgery which is sized to the open annulus remaining after the patient'"'"'s heart valve has been excised, comprising the steps of:

providing a first prefabricated, sterile and disposable tissue harvesting and preparing and annulus sizing kit which is not size-specific to said open annulus and which does not contain an assembled valve, said kit comprising a universal handle;

a tissue sizing template having an opening for receiving said universal handle, said template being formed of a soft and flexible bio-compatible material;

a series of obturators of different size, each obturator having an opening for removably receiving said universal handle;

a first basin for tissue cleaning;

a second basin for holding a fixative solution; and

a third basin for valve assembly;

attaching said universal handle to said tissue sizing template;

using said universal handle to position said tissue sizing template directly upon the patient'"'"'s tissue to be harvested;

using said template as a guide to cut a piece of the patient'"'"'s tissue into a roughly-dimensioned piece of tissue;

cleaning and removing any fatty deposits from said piece of tissue in said first basin;

treating said tissue by brief immersion in a fixative solution in said second basin;

removing said universal handle from said tissue sizing template and selectively attaching said handle to said obturators;

using said handle to push the connected obturator into said open annulus;

selecting the obturator corresponding to the size of said open annulus;

selecting a second, prefabricated, sterile and disposable kit corresponding to the obturator selected from said first kit, said second kit comprising a tray containing, for rapid availability, the following components;

a precisely configured cutting die, an inner and an outer stent, and an assembly mandrel, each of said components corresponding in size to said selected obturator;

positioning said cutting die adjacent said roughly-dimensioned piece of tissue and, before said tissue is mounted around one of said stents, utilizing said cutting die to cut said tissue into a precisely cut piece of tissue;

mounting said tissue around said inner stent in said third basin; and

utilizing said mandrel to locate said second stent to permanently situate said tissue between said inner and outer stents and form said heart valve without any tissue cutting or trimming steps after said tissue is removed from said cutting die.

5. The method of assembling a heart valve during open heart surgery which is sized to the open annulus remaining after the patient'"'"'s heart valve has been excised, comprising the steps of:

providing a first prefabricated, sterile and disposable tissue harvesting and preparing and annulus sizing kit which is not size-specific to said open annulus and which does not contain an assembled valve, said kit comprising a tissue sizing template, a series of obturators of different size, a first basin for tissue cleaning;

a second basin for holding a fixative solution; and

a third basin for valve assembly;

using said template as a guide to cut a piece of the patient'"'"'s tissue into a roughly-dimensioned piece of tissue;

cleaning and removing any fatty deposits from said piece of tissue in said first basin;

treating said tissue by brief immersion in a fixative solution in said second basin;

selectively pushing said obturators into said open annulus;

selecting the obturator corresponding to the size of said open annulus;

selecting a second, prefabricated, sterile and disposable kit corresponding to the obturator selected from said first kit, said second kit comprising a tray containing, for rapid availability, the following components;

a precisely configured cutting die, a first and a second stent, and an assembly mandrel, each of said components corresponding in size to said selected obturator;

positioning said cutting die adjacent said roughly-dimensioned piece of tissue and, before said tissue is mounted around one of said stents, utilizing said cutting die to cut said tissue into a precisely cut piece of tissue;

mounting said tissue around said first stent in said third basin;

utilizing said mandrel to locate said second stent to permanently situate said tissue between said inner and outer stents and form said heart valve without any tissue cutting or trimming steps after said tissue is removed from said cutting die.

6. The method of assembling a heart valve during open heart surgery which is sized to the open annulus remaining after the patient'"'"'s heart valve has been excised, comprising the steps of:

providing a first prefabricated, sterile and disposable tissue harvesting and preparing and annulus sizing kit which is not size-specific to said open annulus and which does not contain an assembled valve, said kit comprising a tissue sizing template and a series of obturators of different size;

using said template as a guide to cut a piece of the patient'"'"'s tissue into a roughly-dimensioned piece of tissue;

selectively pushing said obturators into said open annulus;

selecting the obturator corresponding to the size of said open annulus;

selecting a second, prefabricated, sterile and disposable kit corresponding to the obturator selected from said first kit, said second kit comprising a tray containing, for rapid availability, the following components;

a precisely configured cutting die, a first and a second stent, and an assembly mandrel, each of said components corresponding in size to said selected obturator;

positioning said cutting die adjacent said roughly-dimensioned piece of tissue and, before said tissue is mounted around one of said stents, utilizing said die to cut said tissue into a precisely cut piece of tissue;

mounting said tissue around said first stent;

utilizing said mandrel to locate said second stent to permanently situate said tissue between said inner and outer stents and form said heart valve without any tissue cutting or trimming steps after said tissue is removed from said cutting die.

7. The method of assembling a heart valve during open heart surgery which is sized to the open annulus remaining after the patient'"'"'s heart valve has been excised, comprising the steps of:

providing a first prefabricated, sterile and disposable tissue harvesting and preparing and annulus sizing kit which is not size-specific to said open annulus and which does not contain an assembled valve, said kit including a series of obturators of different size;

cutting a piece of tissue into a roughly-dimensioned piece of tissue;

selectively pushing said obturators into said open annulus;

selecting the obturator corresponding to the size of said open annulus;

selecting a second, prefabricated, sterile and disposable kit corresponding to the obturator selected from said first kit, said second kit comprising a tray containing, for rapid availability, the following components;

a precisely configured cutting die, a first and a second stent, and an assembly mandrel, each of said components corresponding in size to said selected obturator;

positioning said cutting die adjacent said roughly-dimensioned piece of tissue and, before said tissue is mounted around one of said stents, utilizing said die to cut said tissue into a precisely cut piece of tissue;

mounting said tissue around said first stent; and

utilizing said mandrel to locate said second stent to permanently situate said tissue between said inner and outer stents and form said heart valve without any tissue cutting or trimming steps after said tissue is removed from said cutting die.

8. The method of assembling a heart valve during open heart surgery, comprising the steps of:

positioning a tissue sizing template formed of a soft and flexible bio-compatible material directly upon the tissue to be harvested;

using said template as a guide to cut a piece of the patient'"'"'s tissue into a roughly-dimensioned piece of tissue;

cleaning and removing any fatty deposits from said piece of tissue in a first basin;

treating said tissue by brief immersion in a fixative solution in a second basin;

rinsing said piece of tissue in a third basin;

successively utilizing a series of obturators of different sized by selectively pushing the obturator into said open annulus to select the obturator corresponding to the size of the prosthetic heart valve to be constructed during the open heart procedure;

positioning a precisely configured cutting die corresponding in size to said selected obturator proximate to said cut piece of said patient'"'"'s tissue and, before said tissue is mounted around a stent, utilizing said die to cut said roughly-dimensioned piece of tissue into a precisely-cut tissue having a size appropriate for said measured annulus so that said tissue may be mounted between said first and second stents without any additional cutting or trimming;

mounting said tissue around said inner stent in a fourth basin; and

locating said second stent to permanently situate said precisely-cut tissue between said first and second stents and securely clamp the tissue therebetween.