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US6093530A Expired / Lapsed US ⏱️ 0.0 years remaining

Non-calcific biomaterial by glutaraldehyde followed by oxidative fixation

Assignee: Corcym SRL
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Filing: 1998-02-06
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Granted: 2000-07-25
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Expires: 2018-02-06
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Abstract

Abstract This invention relates to tanning biomaterial to obtain calcification resistant biomaterial with good mechanical properties for bioprosthetic applications. The biomaterial of the invention is obtained by tanning tissue by any method except by oxidation, and then at a later time tanning the tissue by any of the oxidative fixation methods. The process was shown to provide beneficial results with the most frequently used fixation process, which involves fixating tissue with glutaraldehyde. Tissue fixated with glutaraldehyde and then by oxidative fixation has a lower calcification potential than does glutaraldehyde-only tanned tissue and has mechanical properties more similar to glutaraldehyde tanned tissue than to oxidative stabilized tissue. In particular, a process is described where tissue is fixed with glutaraldehyde followed by photoxidation.

Inventors

  • 👤 Brian K. McIlroy
  • 👤 Mark A. Moore
  • 👤 Richard E. Phillips

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-24 09:34
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3691; A61L27/3604; A61L27/3641; A61L27/3687; A61L2400/00; A61L2400/02

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 45 words
The process of producing calcification retardant biomaterial suitable for use in a bioprosthesis, said biomaterial comprising a biological tissue, said process comprising: (1) fixating biomaterial by a glutaraldehyde fixation process; and (2) subsequently fixating the biomaterial by an oxidative process which comprises a photooxidation process.
Claim 2
Dependent Claim 45 words
The process of producing calcification retardant biomaterial suitable for use in a bioprosthesis, said biomaterial comprising a biological tissue, said process comprising: (1) fixating biomaterial by a glutaraldehyde fixation process; and (2) subsequently fixating the biomaterial by an oxidative process which comprises a photooxidation process.
Claim 3
Dependent Claim 19 words
The process of claim 1 wherein the fixation process comprises exposing the biomaterial to glutaraldehyde in buffered saline solution.
Claim 4
Dependent Claim 89 words
The process of claim 1 wherein the fixation process comprises exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 10 to 100° C., followed by exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 15° to 30° C., followed by exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 30° to 44° C.
Claim 5
Dependent Claim 58 words
The process of claim 1 wherein the fixation process comprises exposing the biomaterial to glutaraldehyde in buffered saline solution, and then at a later time the photooxidation process comprises exposing the biomaterial to a solution containing a photosensitive dye, and then exposing the biomaterial in the solution to light in quantities sufficient to cause crosslinking of the tissue.
Claim 6
Dependent Claim 73 words
The process of claim 1 wherein the fixation process comprises exposing the biomaterial to glutaraldehyde in buffered saline solution, and the photooxidation process comprises exposing the biomaterial to a solution comprising dissolved oxygen and one or more of a compound selected from methylene blue, methylene green, rose bengal, riboflavin, proflavin, fluorescein, rosin, and pyridoxal-5-phosphate, and then exposing the biomaterial in the solution to light in quantities sufficient to cause crosslinking of the biomaterial.
Claim 7
Dependent Claim 143 words
The process of claim 1 wherein the fixation process comprises exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 1° to 10° C., followed by exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 15° to 30° C., followed by exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 30° to 44° C., and the photooxidation process comprises exposing the biomaterial to a solution comprising dissolved oxygen and one or more of a compound selected from methylene blue, methylene green, rose bengal, riboflavin, proflavin, fluorescein, rosin, and pyridoxal-5-phosphate, and then exposing the tissue in the solution to light in quantities sufficient to cause crosslinking of the tissue.
Claim 8
Dependent Claim 54 words
The process of claim 1 wherein the fixation process comprises exposing the biomaterial to glutaraldehyde in buffered saline solution, and the photooxidation process comprises exposing the biomaterial to a solution comprising dissolved oxygen and riboflavin, and then exposing the biomaterial in the solution to light in quantities sufficient to cause crosslinking of the biomaterial.
Claim 9
Dependent Claim 124 words
The process of claim 1 wherein the fixation process comprises exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 1° to 10° C., followed by exposing the tissue to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 15° to 30° C., followed by exposing the biomaterial to glutaraldehyde in phosphate buffered saline solution for about 12 to 36 hours at a temperature from about 30° to 44° C., and the photooxidation process comprises exposing the biomaterial to a solution comprising dissolved oxygen and riboflavin, and then exposing the biomaterial in the solution to light in quantities sufficient to cause crosslinking of the tissue.
Claim 10
Dependent Claim 17 words
The process of claim 1, wherein said calcification retardant biomaterial is stable following implantation in a host.
Claim 11
Dependent Claim 13 words
The process of claim 1, wherein said biological tissue is a heart tissue.

References Cited (Backward Citations)

US4838888A Cited
US5147514A Cited
US5332475A Cited
US5476516A Cited
US5447536A Cited
US5697972A Cited
US5645587A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2003-07-25 2004-01-24 2004-07-25 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2007-07-25 2008-01-24 2008-07-25 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2011-07-25 2012-01-24 2012-07-25 $7700.00 Window Closed / Lapsed

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