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Method of preparing crosslinked biomaterial compositions for use in tissue augmentation

Assignee: Surgical Specialties US Corp
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Filing: 1994-08-08
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Granted: 1996-08-27
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Expires: 2014-08-08
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Abstract

Abstract The present invention discloses a novel method for preparing crosslinked biomaterial compositions for use in the augmentation of soft or hard tissue. In general, the method comprises mixing a biocompatible polymer, which is preferably collagen, with a sterile, dry crosslinking agent, which is preferably a synthetic hydrophilic polymer such as a functionally activated polyethylene glycol. Also provided are preferred processes for preparing sterile, dry crosslinking agents contained within syringes for use in the method of the invention. Methods for sterilization of the crosslinking agent include, but are not limited to, sterile filtration, aseptic processing, and e-beam or gamma irradiation. Methods for providing augmentation of soft or hard tissue using crosslinked biomaterial compositions prepared according to the method of the invention are also disclosed.

Inventors

  • 👤 Woonza M. Rhee
  • 👤 Richard A. Berg
  • 👤 Joel S. Rosenblatt
  • 👤 Jacqueline A. Tefft
  • 👤 Larry J. Braga
  • 👤 Thomas L. Smestad

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-26 13:26
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/12; A61L31/125; A61K; A61K47/00; A61K47/50; A61K47/51; A61K47/56; A61K47/59; A61K47/60; A61L15/00; A61L15/16; A61L15/22; A61L15/225; A61L24/00; A61L24/04; A61L24/08; A61L24/10; A61L24/102; A61L26/00; A61L26/0009; A61L26/0028; A61L26/0033; A61L27/00; A61L27/14; A61L27/18; A61L27/20; A61L27/22; A61L27/24; A61L27/26; A61L27/28; A61L27/34; A61L27/40; A61L27/44; A61L31/04; A61L31/041; A61L31/042; A61L31/043; A61L31/044; A61L31/08; A61L31/10; C; C08; C08H; C08H1/00; C08H1/06; C08L; C08L89/00; C08L89/04; C08L89/06; C09; C09J; C09J189/00; C09J189/04; C09J189/06; G; G02; G02B; G02B1/00; G02B1/04; G02B1/041; G02B1/043; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; A61F2/07; A61F2310/00; A61F2310/00005; A61F2310/00365; A61L2430/00; A61L2430/16; C08L2666/00; C08L2666/02

Claims Analysis

Total Claims: 16
Claim 1
Independent Claim 95 words
A method of preparing a formed implant comprising a crosslinked biomaterial composition comprising the steps of: providing a device for extruding a biocompatible polymer and a device for extruding a sterile, dry crosslinking agent; mixing the biocompatible polymer and the crosslinking agent to initiate crosslinking between the biocompatible polymer and the crosslinking agent; extruding the biocompatible polymer and the crosslinking agent into a mold having a desired size and shape; and allowing the biocompatible polymer and the crosslinking agent to crosslink within the mold to produce a formed implant having a desired size and shape.
Claim 2
Independent Claim 95 words
A method of preparing a formed implant comprising a crosslinked biomaterial composition comprising the steps of: providing a device for extruding a biocompatible polymer and a device for extruding a sterile, dry crosslinking agent; mixing the biocompatible polymer and the crosslinking agent to initiate crosslinking between the biocompatible polymer and the crosslinking agent; extruding the biocompatible polymer and the crosslinking agent into a mold having a desired size and shape; and allowing the biocompatible polymer and the crosslinking agent to crosslink within the mold to produce a formed implant having a desired size and shape.
Claim 3
Dependent Claim 28 words
The method of claim 1, wherein the biocompatible polymer is selected from the group consisting of collagen, a collagen derivative, a glycosaminoglycan, a glycosaminoglycan derivative, and mixtures thereof.
Claim 4
Dependent Claim 12 words
The method of claim 2, wherein the collagen is atelopeptide fibrillar collagen.
Claim 5
Dependent Claim 34 words
The method of claim 2, wherein the glycosaminoglycan is selected from the group consisting of: hyaluronic acid, chondroitin sulfate A, chondroitin sulfate C, dermatan sulfate, keratan sulfate, keratosulfate, chitin, chitosan, heparin, and mixtures thereof.
Claim 6
Dependent Claim 34 words
The method of claim 1, wherein the crosslinking agent is a synthetic hydrophilic polymer containing a functional group capable of forming a covalent bond with a primary amino group on a biocompatible polymer molecule.
Claim 7
Dependent Claim 39 words
The method of claim 5, wherein synthetic hydrophilic polymer is a polyethylene glycol that has been chemically derivatized to contain a functional group capable of forming a covalent bond with a primary amino group on a biocompatible polymer molecule.
Claim 8
Dependent Claim 31 words
The method of claim 6, wherein the polyethylene glycol has been chemically derivatized to contain two functional groups capable of forming covalent bonds with primary amino groups on biocompatible polymer molecules.
Claim 9
Independent Claim 104 words
A method of providing a coating comprising a crosslinked biomaterial composition on a surface of a synthetic implant comprising the steps of: providing a device for extruding a biocompatible polymer and a device for extruding a sterile, dry crosslinking agent; mixing the biocompatible polymer and the crosslinking agent to initiate crosslinking between the biocompatible polymer and the crosslinking agent; extruding the biocompatible polymer and the crosslinking agent onto a surface of a synthetic implant; and allowing the biocompatible polymer and the crosslinking agent to crosslink on the surface of the synthetic implant to provide a crosslinked biomaterial coating on the surface of the implant.
Claim 10
Independent Claim 104 words
A method of providing a coating comprising a crosslinked biomaterial composition on a surface of a synthetic implant comprising the steps of: providing a device for extruding a biocompatible polymer and a device for extruding a sterile, dry crosslinking agent; mixing the biocompatible polymer and the crosslinking agent to initiate crosslinking between the biocompatible polymer and the crosslinking agent; extruding the biocompatible polymer and the crosslinking agent onto a surface of a synthetic implant; and allowing the biocompatible polymer and the crosslinking agent to crosslink on the surface of the synthetic implant to provide a crosslinked biomaterial coating on the surface of the implant.
Claim 11
Dependent Claim 28 words
The method of claim 8, wherein the biocompatible polymer is selected from the group consisting of collagen, a collagen derivative, a glycosaminoglycan, a glycosaminoglycan derivative, and mixtures thereof.
Claim 12
Dependent Claim 12 words
The method of claim 9, wherein the collagen is atelopeptide fibrillar collagen.
Claim 13
Dependent Claim 34 words
The method of claim 9, wherein the glycosaminoglycan is selected from the group consisting of: hyaluronic acid, chondroitin sulfate A, chondroitin sulfate C, dermatan sulfate, keratan sulfate, keratosulfate, chitin, chitosan, heparin, and mixtures thereof.
Claim 14
Dependent Claim 34 words
The method of claim 8, wherein the crosslinking agent is a synthetic hydrophilic polymer containing a functional group capable of forming a covalent bond with a primary amino group on a biocompatible polymer molecule.
Claim 15
Dependent Claim 40 words
The method of claim 12, wherein the synthetic hydrophilic polymer is a polyethylene glycol that has been chemically derivatized to contain a functional group capable of forming a covalent bond with a primary amino group on a biocompatible polymer molecule.
Claim 16
Dependent Claim 31 words
The method of claim 13, wherein the polyethylene glycol has been chemically derivatized to contain two functional groups capable of forming covalent bonds with primary amino groups on biocompatible polymer molecules.

References Cited (Backward Citations)

US5162430A Cited
US5292802A Cited
US5306500A Cited
US5328955A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1999-08-27 2000-02-26 2000-08-27 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2003-08-27 2004-02-26 2004-08-27 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2007-08-27 2008-02-26 2008-08-27 $7700.00 Window Closed / Lapsed

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