Compliant dehydrated tissue for implantation and process of making the same
First Claim
1. A process for preparing a pliable soft tissue specimen, comprising the steps of:
- (1) treating natural soft tissue obtained from a donor with;
(a) liquid compositions of gradually increasing concentrations of a polar organic solvent or solvents, until the last of said liquid compositions contains at least approximately 25% by volume of said solvent, or mixture of solvents, the balance being water, the solvent being selected from a group consisting of aliphatic alcohols having 1 to 3 carbons and other water miscible polar organic solvents;
(b) thereafter with a second liquid composition of aqueous glycerol or of low molecular weight polyethylene glycol having a molecular weight less than approximately 1000 D, the glycerol or the low molecular weight polyethylene glycol, or mixtures thereof being in a concentration range of approximately 10 to 50% by volume, said second liquid composition also containing approximately 3-20% weight by volume of polyethylene glycol of a molecular weight in the range of 6,000 D to 15,000 D and approximately 2 to 75 units per milliliter heparin of a molecular weight greater than approximately 3 KD;
(2) thereafter briefly immersing the soft tissue in an aqueous heparin solution, and (3) thereafter freezing the tissue and lyophilizing the tissue to dryness.
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Abstract
A process for preparing pliable soft tissue specimen which are resistant to cracking and devoid of viable cells includes the steps of treating native soft tissue obtained from a donor by a gradually increasing gradient of aliphatic alcohol or other suitable water miscible polar organic solvent until the last alcohol (or other solvent) solution has at least 25% by volume of the organic liquid. Thereafter, the tissue specimen is treated with a solution containing glycerol or low molecular weight (<1000 D) polyethylene glycol, and polyethylene glycol of a molecular weight between approximately 6,000 to 15,000 D and heparin. Thereafter, the tissue specimen is briefly immersed in aqueous heparin solution, frozen and lyophilized. The tissue specimen is suitable for implantation as a homograft or xenograft, with or without rehydration.
489 Citations
17 Claims
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1. A process for preparing a pliable soft tissue specimen, comprising the steps of:
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(1) treating natural soft tissue obtained from a donor with;
(a) liquid compositions of gradually increasing concentrations of a polar organic solvent or solvents, until the last of said liquid compositions contains at least approximately 25% by volume of said solvent, or mixture of solvents, the balance being water, the solvent being selected from a group consisting of aliphatic alcohols having 1 to 3 carbons and other water miscible polar organic solvents;
(b) thereafter with a second liquid composition of aqueous glycerol or of low molecular weight polyethylene glycol having a molecular weight less than approximately 1000 D, the glycerol or the low molecular weight polyethylene glycol, or mixtures thereof being in a concentration range of approximately 10 to 50% by volume, said second liquid composition also containing approximately 3-20% weight by volume of polyethylene glycol of a molecular weight in the range of 6,000 D to 15,000 D and approximately 2 to 75 units per milliliter heparin of a molecular weight greater than approximately 3 KD;
(2) thereafter briefly immersing the soft tissue in an aqueous heparin solution, and (3) thereafter freezing the tissue and lyophilizing the tissue to dryness. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A process for preparing a pliable soft mammalian tissue specimen, for eventual implantation in a mammal to replace or augment native tissue, the process comprising the steps of:
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(1) treating natural soft mammalian tissue obtained from a donor with;
(a) liquid compositions of gradually increasing concentrations of an aliphatic alcohol or mixture of aliphatic alcohols having 1 to 3 carbon atoms, until the last of said liquid compositions contains at least approximately 25% by volume of said alcohol or mixture of alcohols, the balance being water;
(b) thereafter with a second liquid composition of aqueous glycerol containing the glycerol in a concentration range of approximately 10 to 50% by volume, said second liquid composition also containing approximately 3-20% weight by volume polyethylene glycol of a molecular weight in the range of 6,000 D to 15,000 D and approximately 2 to 75 units per milliliter heparin of a molecular weight greater than approximately 3 KD;
(2) thereafter briefly immersing the soft tissue in an aqueous heparin solution of approximately 20 to 500 units per milliliter concentration, and (3) thereafter freezing the tissue and lyophilizing the tissue to dryness. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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Specification