US5746775A — Method of making calcification-resistant bioprost…

Claim 1

Independent Claim 107 words

A method of treating a biomaterial, the method comprising the steps of: (1) forming a liquid treatment solution consisting essentially of greater than 50% by volume of a water-soluble C1-C3 aliphatic alcohol in an aqueous buffer of a pH between 6.0 and 8.0; (2) exposing the biomaterial, wherein the biomaterial is a collagenous material derived from a mammalian species selected from the group consisting of bovine pericardium, porcine aortic heart valves, saphenous bypass grafts, aortic homografts, and dura mater, to the liquid treatment solution for a period of time sufficient to render the biomaterial resistant to calcification; and (3) rinsing the exposed biomaterial with a rinsing solution.

Claim 2

Independent Claim 107 words

A method of treating a biomaterial, the method comprising the steps of: (1) forming a liquid treatment solution consisting essentially of greater than 50% by volume of a water-soluble C1-C3 aliphatic alcohol in an aqueous buffer of a pH between 6.0 and 8.0; (2) exposing the biomaterial, wherein the biomaterial is a collagenous material derived from a mammalian species selected from the group consisting of bovine pericardium, porcine aortic heart valves, saphenous bypass grafts, aortic homografts, and dura mater, to the liquid treatment solution for a period of time sufficient to render the biomaterial resistant to calcification; and (3) rinsing the exposed biomaterial with a rinsing solution.

Claim 3

Dependent Claim 20 words

The method of claim 1 wherein the biomaterial rendered resistant to calcification is rendered resistant to in vivo pathologic calcification.

Claim 4

Dependent Claim 19 words

The method of claim 1 wherein said step of exposing comprises immersing the biomaterial in the liquid treatment solution.

Claim 5

Dependent Claim 26 words

The method of claim 3 wherein the alcohol is present in an amount of approximately between 60% and 80% by volume of the liquid treatment solution.

Claim 6

Dependent Claim 14 words

The method of claim 3 wherein the treatment solution further contains an anticalcification agent.

Claim 7

Dependent Claim 35 words

The method of claim 5 wherein the anticalcification agent is a multivalent metallic cation selected from the group consisting of a salt of Al +3 and Fe +3 which is soluble in the treatment solution.

Claim 8

Dependent Claim 22 words

The method of claim 6 wherein the anticalcification agent is AlCl 3 in a concentration range of from about 0.1M to 0.001M.

Claim 9

Dependent Claim 22 words

The method of claim 1 wherein the water-soluble aliphatic alcohol is selected from the group consisting of methanol, ethanol, propanol, and isopropanol.

Claim 10

Dependent Claim 12 words

The method of claim 8 wherein the water-soluble aliphatic alcohol is ethanol.

Claim 11

Dependent Claim 11 words

The method of claim 1 wherein the biomaterial has been cross-linked.

Claim 12

Dependent Claim 13 words

The method of claim 10 wherein the biomaterial has been crosslinked with glutaraldehyde.

Claim 13

Dependent Claim 22 words

The method of claim 1 wherein the time sufficient to render the biomaterial resistant to calcification is at least about 20 minutes.

Claim 14

Dependent Claim 23 words

The method of claim 12 wherein the time sufficient to render the biomaterial resistant to calcification is between about 24 to 96 hours.

Claim 15

Dependent Claim 22 words

The method of claim 1 wherein there is provided the further step of storing the treated biomaterial in a sterile, glutaraldehyde-free environment.

Claim 16

Dependent Claim 28 words

The method of claim 1 wherein there is provided the further step of storing the treated biomaterial in a storage solution of a lower aliphatic alcohol and glutaraldehyde.

Claim 17

Dependent Claim 30 words

The method of claim 15 wherein the storage solution is an aqueous solution containing approximately between 60% to 80% by volume of ethanol and approximately between 0.2% to 0.5% glutaraldehyde.

Claim 18

Dependent Claim 18 words

The method of claim 3 wherein the biomaterial is an aortic valve cusp and the alcohol is ethanol.

Claim 19

Dependent Claim 23 words

The method of claim 5 wherein the biomaterial is an aortic valve wall, and the anticalcification agent is an aluminum salt in ethanol.

Claim 20

Dependent Claim 17 words

The method of claim 1 wherein there is provided the further step of sterilizing the bioprosthetic tissue.

Claim 21

Dependent Claim 22 words

The method of claim 3 wherein the treatment solution is buffered to a pH in the range of between 7.0 and 7.6.

Claim 22

Dependent Claim 17 words

The method of claim 20 wherein the liquid treatment solution is buffered to a pH of 7.4.

Claim 23

Dependent Claim 23 words

The method of claim 4 wherein the alcohol is present in an amount of approximately 80% by volume of the liquid treatment solution.

Claim 24

Independent Claim 97 words

A method of making calcification-resistant biomaterial for use in the interior of a human or animal, the method comprising the steps of: a) subjecting glutaraldehyde pre-treated bioprosthetic tissue, wherein the bioprosthetic tissue is a collagenous material derived from a mammalian species selected from the group consisting of bovine pericardium, porcine aortic heart valves, saphenous bypass grafts, aortic homografts, and dura mater, to an aqueous, treatment solution of at least about 50% by volume of a water-soluble C1-C3 aliphatic alcohol for a period of time between about 20 minutes and 96 hours; and b) rinsing the bioprosthetic tissue.

Claim 25

Independent Claim 97 words

A method of making calcification-resistant biomaterial for use in the interior of a human or animal, the method comprising the steps of: a) subjecting glutaraldehyde pre-treated bioprosthetic tissue, wherein the bioprosthetic tissue is a collagenous material derived from a mammalian species selected from the group consisting of bovine pericardium, porcine aortic heart valves, saphenous bypass grafts, aortic homografts, and dura mater, to an aqueous, treatment solution of at least about 50% by volume of a water-soluble C1-C3 aliphatic alcohol for a period of time between about 20 minutes and 96 hours; and b) rinsing the bioprosthetic tissue.

Claim 26

Dependent Claim 35 words

The method of claim 23 wherein there is provided the further step of: c) storing the bioprosthetic tissue in a sterile, buffered solution of approximately between 0.2% to 0.5% glutaraldehyde and at least 60% ethanol.

Claim 27

Dependent Claim 10 words

The method of claim 23 wherein the alcohol is ethanol.

Claim 28

Dependent Claim 34 words

The method of claim 23 wherein the solution further contains an anticalcification agent which is a multivalent metallic cation selected from the group consisting of a salt of A1 +3 and Fe +3 .

Claim 29

Dependent Claim 15 words

The method of claim 26 wherein the anticalcification agent is an aluminum salt in ethanol.

Claim 30

Dependent Claim 25 words

The method of claim 23 wherein the alcohol is present in an amount of approximately between 60% and 80% by volume of the treatment solution.

Claim 31

Dependent Claim 23 words

The method of claim 28 wherein the alcohol is present in an amount of approximately 80% by volume of the liquid treatment solution.

Claim 32

Independent Claim 133 words

A method of treating a biomaterial, the method comprising the steps of: (1) forming a liquid treatment solution consisting essentially of a water-soluble C1-C3 aliphatic alcohol in an amount of greater than about 40% by volume and a further organic solvent, wherein the combined amount of the alcohol and organic solvent is greater than about 50% by volume, in an aqueous buffer at pH between about 6.0 and 8.0; (2) exposing the biomaterial, wherein the biomaterial is a collagenous material derived from a mammalian species selected from the group consisting of bovine pericardium, porcine aortic heart valves, saphenous bypass grafts, aortic homografts, and dura mater, to the liquid treatment solution for a period of time sufficient to render the biomaterial resistant to calcification; and (3) rinsing the exposed biomaterial in a rinsing solution.

Claim 33

Independent Claim 133 words

A method of treating a biomaterial, the method comprising the steps of: (1) forming a liquid treatment solution consisting essentially of a water-soluble C1-C3 aliphatic alcohol in an amount of greater than about 40% by volume and a further organic solvent, wherein the combined amount of the alcohol and organic solvent is greater than about 50% by volume, in an aqueous buffer at pH between about 6.0 and 8.0; (2) exposing the biomaterial, wherein the biomaterial is a collagenous material derived from a mammalian species selected from the group consisting of bovine pericardium, porcine aortic heart valves, saphenous bypass grafts, aortic homografts, and dura mater, to the liquid treatment solution for a period of time sufficient to render the biomaterial resistant to calcification; and (3) rinsing the exposed biomaterial in a rinsing solution.

Claim 34

Dependent Claim 17 words

The method of claim 30 wherein the treatment solution includes about 40% alcohol and 40% organic solvent.

Claim 35

Dependent Claim 13 words

A biomaterial produced by the process of claims 1 or 23 or 30.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2001-05-04	2001-11-03	2002-05-05	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2005-05-04	2005-11-03	2006-05-05	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2009-05-04	2009-11-03	2010-05-05	$7700.00	Window Closed / Lapsed

Method of making calcification-resistant bioprosthetic tissue

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