US6509145B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Process for reducing mineralization of tissue used in transplantation
Assignee: Medtronic Inc
•
Filing: 1999-09-30
•
Granted: 2003-01-21
•
Expires: 2019-09-30
Abstract
Abstract A method of making a tissue-derived implantable medical device that includes contacting the tissue with a composition comprising at least one oxidizing agent prior to implantation of the medical device.
Inventors
- 👤 Mark W. Torrianni
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 00:43
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3687; A61L27/3604; A61L27/3625; A61L27/3641; A61L27/3645; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61L2400/00; A61L2400/02
Claims Analysis
Total Claims: 60
Claim 1
Independent Claim
118 words
A method of making a tissue-derived, implantable vascular bioprosthesis, the method comprising: excising tissue from an animal, the excised tissue selected form the group consisting of porcine aortic toot tissue, bovine aortic root tissue, porcine pericardium, bovine pericardium, bovine veins, porcine veins, bovine arteries, and porcine arteries; and removing cell debris from the excised tissue by a method which comprises: contacting the excised tissue with a composition comprising at least on oxidizing agent prior to significant degradation of the excised tissue; and rinsing the oxidizing agent-contacted tissue to remove at least a portion of the oxidizing agent, wherein the oxidizing agent is selected from the group of sodium hypochlorite, performic acid, periodic acid, peracetic acid, and combinations thereof.
Claim 2
Independent Claim
118 words
A method of making a tissue-derived, implantable vascular bioprosthesis, the method comprising: excising tissue from an animal, the excised tissue selected form the group consisting of porcine aortic toot tissue, bovine aortic root tissue, porcine pericardium, bovine pericardium, bovine veins, porcine veins, bovine arteries, and porcine arteries; and removing cell debris from the excised tissue by a method which comprises: contacting the excised tissue with a composition comprising at least on oxidizing agent prior to significant degradation of the excised tissue; and rinsing the oxidizing agent-contacted tissue to remove at least a portion of the oxidizing agent, wherein the oxidizing agent is selected from the group of sodium hypochlorite, performic acid, periodic acid, peracetic acid, and combinations thereof.
Claim 3
Dependent Claim
21 words
The method of claim 1 wherein the sodium hypochlorite is in a concentration of about 2 mM to about 20 mM.
Claim 4
Dependent Claim
19 words
The method of claim 1 wherein the composition comprising an oxidizing agent further comprises at least one chelating agent.
Claim 5
Dependent Claim
27 words
The method of claim 3 wherein the chelating agent is selected from the group of ethylenediaminetetraacetic acid, ethylenebis(oxyethylenenitrilo)tetraacetic acid (EGTA), citric acid, salts thereof, and combinations thereof.
Claim 6
Dependent Claim
21 words
The method of claim 1 wherein the composition comprising at least one oxidizing agent further comprises at least one buffering agent.
Claim 7
Dependent Claim
18 words
The method of claim 5 wherein the buffering agent has a pKa of about 7.0 to about 7.5.
Claim 8
Dependent Claim
13 words
The method of claim 5 wherein the buffering agent is an organic buffer.
Claim 9
Dependent Claim
24 words
The method of claim 7 wherein the buffering agent is selected from the group of HEPES, TES, BES, MOPS, PIPES, MES, and combinations thereof.
Claim 10
Dependent Claim
27 words
The method of claim 1 wherein contacting the tissue with a composition comprising at least one oxidizing agent is carried out for at least about 24 hours.
Claim 11
Dependent Claim
17 words
The method of claim 1 wherein the rinsing step includes contacting the tissue with a detergent composition.
Claim 12
Dependent Claim
15 words
The method of claim 10 wherein the detergent composition comprises at least one reducing agent.
Claim 13
Dependent Claim
17 words
The method of claim 10 wherein the detergent composition comprises an ionic detergent or a nonionic detergent.
Claim 14
Dependent Claim
25 words
The method of claim 10 wherein contacting the tissue with the detergent composition is carried out at a temperature of at least about 30° C.
Claim 15
Dependent Claim
22 words
The method of claim 10 wherein contacting the tissue with the detergent composition comprises sonicating the tissue while immersed in the composition.
Claim 16
Dependent Claim
24 words
The method of claim 10 wherein contacting the tissue with a detergent composition comprises contacting it with a first and a second detergent composition.
Claim 17
Dependent Claim
23 words
The method of claim 15 wherein the first detergent composition comprises an ionic detergent and the second detergent composition comprises a nonionic detergent.
Claim 18
Dependent Claim
19 words
The method of claim 16 wherein the first and/or the second detergent compositions comprise at least one reducing agent.
Claim 19
Dependent Claim
15 words
The method of claim 1 further comprising treating the rinsed tissue with a fixative composition.
Claim 20
Dependent Claim
21 words
The method of claim 18 wherein treating the tissue with a fixative composition comprises using a glutaraldehyde- or a carbodiimide-based process.
Claim 21
Dependent Claim
16 words
The method of claim 19 wherein the fixative composition further comprises at least one buffering agent.
Claim 22
Independent Claim
125 words
A method for making a tissue-derived implantable medical device from freshly excised tissue of an animal, the method comprising: excising fresh tissue from an animal, the tissue selected from the group consisting porcine aortic root tissue, bovine aortic root tissue, porcine pericardium, bovine pericardium, bovine veins, porcine veins, bovine arteries, and porcine arteries; contacting the freshly excised tissue with a composition comprising at least one oxidizing agent prior to significant degradation of the excised tissue, wherein the oxidizing agent is selected from the group of sodium hypochlorite, performic acid, periodic acid, peracetic acid, and combinations thereof; rinsing the oxidizing agent-contacted tissue to remove at least a portion of the oxidizing agent; and contacting the rinsed tissue with a composition comprising at least one reducing agent.
Claim 23
Independent Claim
125 words
A method for making a tissue-derived implantable medical device from freshly excised tissue of an animal, the method comprising: excising fresh tissue from an animal, the tissue selected from the group consisting porcine aortic root tissue, bovine aortic root tissue, porcine pericardium, bovine pericardium, bovine veins, porcine veins, bovine arteries, and porcine arteries; contacting the freshly excised tissue with a composition comprising at least one oxidizing agent prior to significant degradation of the excised tissue, wherein the oxidizing agent is selected from the group of sodium hypochlorite, performic acid, periodic acid, peracetic acid, and combinations thereof; rinsing the oxidizing agent-contacted tissue to remove at least a portion of the oxidizing agent; and contacting the rinsed tissue with a composition comprising at least one reducing agent.
Claim 24
Dependent Claim
21 words
The method of claim 21 wherein the sodium hypochlorite is in a concentration of about 2 mM to about 20 mM.
Claim 25
Dependent Claim
19 words
The method of claim 21 wherein the composition comprising an oxidizing agent further comprises at least one chelating agent.
Claim 26
Dependent Claim
27 words
The method of claim 23 wherein the chelating agent is selected from the group of ethylenediaminetetraacetic acid, ethylenebis(oxyethyleneitrilo)tetraacetic acid (EGTA), citric acid, salts thereof, and combinations thereof.
Claim 27
Dependent Claim
21 words
The method of claim 21 wherein the composition comprising at least one oxidizing agent further comprises at least one buffering agent.
Claim 28
Dependent Claim
18 words
The method of claim 25 wherein the buffering agent has a pKa of about 7.0 to about 7.5.
Claim 29
Dependent Claim
13 words
The method of claim 25 wherein the buffering agent is an organic buffer.
Claim 30
Dependent Claim
24 words
The method of claim 27 wherein the buffering agent is selected from the group of HEPES, TES, BES, MOPS, PIPES, MES, and combinations thereof.
Claim 31
Dependent Claim
27 words
The method of claim 21 wherein contacting the tissue with a composition comprising at least one oxidizing agent is carried out for at least about 24 hours.
Claim 32
Dependent Claim
16 words
The method of claim 21 also comprising contacting the reducing agent-contacted tissue with a detergent composition.
Claim 33
Dependent Claim
17 words
The method of claim 30 wherein the detergent composition comprises an ionic detergent or a nonionic detergent.
Claim 34
Dependent Claim
25 words
The method of claim 30 wherein contacting the tissue with the detergent composition is carried out at a temperature of at least about 30° C.
Claim 35
Dependent Claim
22 words
The method of claim 30 wherein contacting the tissue with the detergent composition comprises sonicating the tissue while immersed in the composition.
Claim 36
Dependent Claim
24 words
The method of claim 30 wherein contacting the tissue with a detergent composition comprises contacting it with a first and a second detergent composition.
Claim 37
Dependent Claim
23 words
The method of claim 34 wherein the first detergent composition comprises an ionic detergent and the second detergent composition comprises a nonionic detergent.
Claim 38
Dependent Claim
16 words
The method of claim 21 further comprising treating the reducing agent contacted-tissue with a fixative composition.
Claim 39
Dependent Claim
21 words
The method of claim 36 wherein treating the tissue with a fixative composition comprises using a glutaraldehyde- or a carbodiimide-based process.
Claim 40
Dependent Claim
16 words
The method of claim 37 wherein the fixative composition further comprises at least one buffering agent.
Claim 41
Independent Claim
99 words
A method of making a tissue-derived heart valve bioprosthesis, the method comprising: excising heart valve tissue from an animal, the excised tissue including valvular leaflets and supporting structure; and removing cell debris from the excised tissue by a method which comprises: contacting the excised tissue with a composition comprising at least one oxidizing agent prior to significant degradation of the excised tissue; and rinsing the oxidizing agent-contacted tissue to remove at least a portion of the oxidizing agent, wherein the oxidizing agent is selected from the group of sodium hypochlorite, performic acid, periodic acid, peracetic acid, and combinations thereof.
Claim 42
Independent Claim
99 words
A method of making a tissue-derived heart valve bioprosthesis, the method comprising: excising heart valve tissue from an animal, the excised tissue including valvular leaflets and supporting structure; and removing cell debris from the excised tissue by a method which comprises: contacting the excised tissue with a composition comprising at least one oxidizing agent prior to significant degradation of the excised tissue; and rinsing the oxidizing agent-contacted tissue to remove at least a portion of the oxidizing agent, wherein the oxidizing agent is selected from the group of sodium hypochlorite, performic acid, periodic acid, peracetic acid, and combinations thereof.
Claim 43
Dependent Claim
21 words
The method of claim 39 wherein the sodium hypochlorite is in a concentration of about 2 mM to about 20 mM.
Claim 44
Dependent Claim
19 words
The method of claim 39 wherein the composition comprising an oxidizing agent further comprises at least one chelating agent.
Claim 45
Dependent Claim
27 words
The method of claim 41 wherein the chelating agent is selected from the group of ethylenediaminetetraacetic acid, ethylenebis(oxyethylenenitrilo)tetraacetic acid (EGTA), citric acid, salts thereof, and combinations thereof.
Claim 46
Dependent Claim
21 words
The method of claim 39 wherein the composition comprising at least one oxidizing agent further comprises at least one buffering agent.
Claim 47
Dependent Claim
18 words
The method of claim 43 wherein the buffering agent has a pKa of about 7.0 to about 7.5.
Claim 48
Dependent Claim
13 words
The method of claim 43 wherein the buffering agent is an organic buffer.
Claim 49
Dependent Claim
24 words
The method of claim 45 wherein the buffering agent is selected from the group of HEPES, TES, BES, MOPS, PIPES, MES, and combinations thereof.
Claim 50
Dependent Claim
27 words
The method of claim 39 wherein contacting the tissue with a composition comprising at least one oxidizing agent is carried out for at least about 24 hours.
Claim 51
Dependent Claim
16 words
The method of claim 39 also comprising contacting the oxidizing agent-contacted tissue with a detergent composition.
Claim 52
Dependent Claim
17 words
The method of claim 48 wherein the detergent composition comprises an ionic detergent or a nonionic detergent.
Claim 53
Dependent Claim
25 words
The method of claim 48 wherein contacting the tissue with the detergent composition is carried out at a temperature of at least about 30° C.
Claim 54
Dependent Claim
22 words
The method of claim 48 wherein contacting the tissue with the detergent composition comprises sonicating the tissue while immersed in the composition.
Claim 55
Dependent Claim
24 words
The method of claim 48 wherein contacting the tissue with a detergent composition comprises contacting it with a first and a second detergent composition.
Claim 56
Dependent Claim
23 words
The method of claim 52 wherein the first detergent composition comprises an ionic detergent and the second detergent composition comprises a nonionic detergent.
Claim 57
Dependent Claim
20 words
The method of claim 39 further comprising contacting the rinsed tissue with a composition comprising at least one reducing agent.
Claim 58
Dependent Claim
16 words
The method of claim 54 further comprising treating the reducing agent contacted-tissue with a fixative composition.
Claim 59
Dependent Claim
21 words
The method of claim 55 wherein treating the tissue with a fixative composition comprises using a glutaraldehyde- or a carbodiimide-based process.
Claim 60
Dependent Claim
16 words
The method of claim 56 wherein the fixative composition further comprises at least one buffering agent.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2006-01-20 | 2006-07-22 | 2007-01-21 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2010-01-20 | 2010-07-22 | 2011-01-21 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2014-01-20 | 2014-07-22 | 2015-01-21 | $7700.00 | Window Closed / Lapsed |