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US5697972A Expired / Lapsed US ⏱️ 0.0 years remaining

Bioprosthetic heart valves having high calcification resistance

Assignee: Korea Institute of Science and Technology
•
Filing: 1995-06-07
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Granted: 1997-12-16
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Expires: 2015-06-07
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Abstract

Abstract The specification describes an invention of calcification resistant bioprosthetic heart valves which can be used for a long term, and have good blood compatibility and in vivo stability, and have high calcification resistance. The bioprosthetic heart valves of the invention can be prepared by binding sulfonated polyethylene oxide (PEO) derivatives covalently to the tissue. The valves have an anionic effect equal to that of chondroitin sulfate, space filling effect, and blocking effect of the carboxyl group of collagen which has been known as one factor of the calcium deposition,. In particular, the present method has better advantages in view of calcification resistance than any other conventional methods, because it suppresses thrombosis and embolism and decreases incidence of infection.

Inventors

  • 👤 Young Ha Kim
  • 👤 Ki Dong Park
  • 👤 Dong Keun Han
  • 👤 Hack Joo Kim

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 05:44
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415; A61L; A61L27/00; A61L27/28; A61L27/34; A61L27/36; A61L27/3604; A61L27/3625; A61L27/3641; A61L27/3645; A61L27/3683; A61L27/3687; A61L27/50; A61L27/507; A61L2400/00; A61L2400/02; Y; Y10; Y10S; Y10S623/00; Y10S623/901; Y10S623/915; Y10S623/918

Claims Analysis

Total Claims: 33
Claim 1
Independent Claim 33 words
A calcification resistant bioprosthetic heart valve prepared by binding an anionic hydrophilic polymer derivative of sulfonated polyethylene oxide covalently to tissue selected from the group consisting of porcine aortic valve and bovine pericardium.
Claim 2
Dependent Claim 33 words
A calcification resistant bioprosthetic heart valve prepared by binding an anionic hydrophilic polymer derivative of sulfonated polyethylene oxide covalently to tissue selected from the group consisting of porcine aortic valve and bovine pericardium.
Claim 3
Dependent Claim 48 words
The heart valve of claim 1, wherein the sulfonated polyethylene oxide is X--PEO--SO 3 , wherein X is an amine or aldehyde group and PEO is polyethylene oxide, and said sulfonated polyethylene oxide is selected from the group consisting of H 2 --N--PEO--SO 3 and OHC--PEO--SO 3 .
Claim 4
Dependent Claim 17 words
The heart valve of claim 1, wherein the PEO has a molecular weight of 100 to 20,000.
Claim 5
Dependent Claim 17 words
The heart valve of claim 1, wherein the PEO has a molecular weight of 200 to 10,000.
Claim 6
Dependent Claim 28 words
The heart valve of claim 2, wherein the H 2 N--PEO--SO 3 is prepared by sulfonating a terminal group of an amine terminated PEO with an alkyl sultone.
Claim 7
Dependent Claim 13 words
The heart valve of claim 5, wherein the alkyl sultone is propane sulfone.
Claim 8
Dependent Claim 25 words
The heart valve of claim 2, wherein the OHC--PEO--SO 3 is prepared by reacting an amine group of an amine-terminated sulfonated PEO with a dialdehyde.
Claim 9
Dependent Claim 11 words
The heart valve of claim 7, wherein the dialdehyde is glutaraldehyde.
Claim 10
Dependent Claim 32 words
The heart valve of claim 1, wherein the sulfonated PEO is added and bound to the tissue during oxidation with sodium metaperiodate, neutralization with ethylene glycol, or aldehyde activation with glutaraldehyde, thereof.
Claim 11
Dependent Claim 21 words
The heart valve of claim 1, wherein the sulfonated PEO is bound to the tissue by pre- or post-treatment of glutaraldehyde.
Claim 12
Dependent Claim 18 words
The heart valve of claim 1, wherein the sulfonated PEO is bound to the tissue using a carbodiimide.
Claim 13
Dependent Claim 12 words
The heart valve of claim 11, wherein the carbodiimide is 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide.
Claim 14
Dependent Claim 20 words
The heart valve of claim 12, wherein the carbodiimide is in aqueous solution having a pH of 3.0 to 5.0.
Claim 15
Dependent Claim 21 words
The heart valve of claim 1, wherein said heart valve is in glutaraldehyde for fixation, storage and aldehyde-activation of the tissue.
Claim 16
Dependent Claim 24 words
The heart valve of claim 1, wherein said heart valve is in a phosphate buffered saline solution as a buffer for stabilizing the tissue.
Claim 17
Dependent Claim 22 words
The heart valve of claim 11, wherein amine groups on the tissue are blocked with a blocking agent before using said carbodiimide.
Claim 18
Dependent Claim 14 words
The heart valve of claim 2, wherein said tissue is a porcine aortic valve.
Claim 19
Dependent Claim 13 words
The heart valve of claim 2, wherein said tissue is a bovine pericardium.
Claim 20
Independent Claim 36 words
A method for preparing calcification resistant bioprosthetic heart valves which comprises binding an anionic hydrophilic polymer derivative of sulfonated polyethylene oxide covalently to tissue selected from the group consisting of porcine aortic valve and bovine pericardium.
Claim 21
Independent Claim 36 words
A method for preparing calcification resistant bioprosthetic heart valves which comprises binding an anionic hydrophilic polymer derivative of sulfonated polyethylene oxide covalently to tissue selected from the group consisting of porcine aortic valve and bovine pericardium.
Claim 22
Dependent Claim 47 words
A method according to claim 19, wherein the sulfonated polyethylene oxide is X--PEO--SO 3 in which X is an amine or aldehyde group and PEO is polyethylene oxide, said sulfonated polyethylene oxide being selected from the group consisting of H 2 N--PEO--SO 3 and OHC--PEO--SO 3 .
Claim 23
Dependent Claim 17 words
A method according to claim 19, wherein the PEO has a molecular weight of 100 to 20,000.
Claim 24
Dependent Claim 17 words
A method according to claim 19, wherein the PEO has a molecular weight of 200 to 10,000.
Claim 25
Dependent Claim 38 words
A method according to claim 19, wherein said sulfonated polyethylene oxide is an amine-terminated sulfonated PEO of the formula H 2 N--PEO--SO 3 prepared by sulfonating one of two terminals of amine terminated PEO with an alkyl sulfone.
Claim 26
Dependent Claim 36 words
A method according to claim 19, wherein said sulfonated polyethylene oxide is an aldehyde-terminated sulfonated PEO of the general formula OHC--PEO--SO 3 prepared by reacting the amine group of the amine-terminated sulfonated PEO with a dialdehyde.
Claim 27
Dependent Claim 31 words
A method according to claim 19, wherein the sulfonated PEO is added and bound to the tissue during oxidation with sodium metaperiodate, neutralization with ethylene glycol, or aldehyde activation with glutaraldehyde.
Claim 28
Dependent Claim 18 words
The method according to claim 19, wherein the sulfonated PEO is bound to the tissue by glutaraldehyde treatment.
Claim 29
Dependent Claim 18 words
The method according to claim 19, wherein the sulfonated PEO is bound to the tissue using a carbodiimide.
Claim 30
Dependent Claim 25 words
The method according to claim 27, wherein said carbodiimide is 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide and said carbodiimide is in aqueous solution at a pH of 3.0 to 5.0.
Claim 31
Dependent Claim 25 words
The method according to claim 19, wherein said tissue is fixed and activated, and glutaraldehyde is used for the fixation and aldehyde-activation of the tissue.
Claim 32
Dependent Claim 21 words
The method according to claim 19, wherein a phosphate buffered saline solution is used as a buffer for stabilizing the tissue.
Claim 33
Dependent Claim 27 words
The method according to claim 26, wherein a blocking agent is used to block amine groups of the tissue prior to reacting the tissue with sulfonated PEO.

References Cited (Backward Citations)

US4838888A Cited
US4976733A Cited
US5182317A Cited
US5116361A Cited
US5216087A Cited
US5476516A Cited
US5507804A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2000-12-15 2001-06-16 2001-12-16 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2004-12-15 2005-06-16 2005-12-16 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2008-12-15 2009-06-16 2009-12-16 $7700.00 Window Closed / Lapsed

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