Source: http://www.google.com/patents/US7842097?dq=6272333
Timestamp: 2015-03-04 00:24:27
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Matched Legal Cases: ['Application No. 03808980', 'Application No. 03709281', 'Application No. 03709281', 'Application No. 03709281', 'Application No. 535466', 'Application No. 2003', 'Application No. 9', 'Application No. 9', 'Application No. 2', 'Application No. 03808980', 'Application No. 2006', 'Application No. 2003', 'Application No. 03808980']

Patent US7842097 - Porous, biodegradable, three-dimensionally fixed matrix having shape ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA porous three-dimensional tissue repair matrix is provided which is biodegradable. The matrix is preferably formed from mineralized collagen where the mineral comprises particulate calcium phosphate immobilized in the matrix....http://www.google.com/patents/US7842097?utm_source=gb-gplus-sharePatent US7842097 - Porous, biodegradable, three-dimensionally fixed matrix having shape retention; network of water insoluble biopolymer mineralized and bound with a cross-linked binder; promotes bone growthAdvanced Patent SearchPublication numberUS7842097 B2Publication typeGrantApplication numberUS 10/856,981Publication dateNov 30, 2010Filing dateMay 27, 2004Priority dateOct 16, 1995Fee statusPaidAlso published asCA2232986A1, CA2232986C, CA2476929A1, CA2476929C, CN1172724C, CN1204245A, CN1646070A, CN1646070B, DE69632829D1, DE69632829T2, EP0855884A1, EP0855884A4, EP0855884B1, EP1482872A1, EP1482872A4, EP1482872B1, US5776193, US6187047, US6764517, US20020183855, US20040220680, WO1997014376A1, WO2003071991A1Publication number10856981, 856981, US 7842097 B2, US 7842097B2, US-B2-7842097, US7842097 B2, US7842097B2InventorsRonald K. Yamamoto, Michael K. Kwan, Stephen D. PacettiOriginal AssigneeDepuy Spine, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (63), Non-Patent Citations (24), Referenced by (1), Classifications (50), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetPorous, biodegradable, three-dimensionally fixed matrix having shape retention; network of water insoluble biopolymer mineralized and bound with a cross-linked binder; promotes bone growth
US 7842097 B2Abstract
A porous three-dimensional tissue repair matrix is provided which is biodegradable. The matrix is preferably formed from mineralized collagen where the mineral comprises particulate calcium phosphate immobilized in the matrix.
This application is a divisional of prior application Ser. No. 10/086,225, filed Feb. 22, 2002, now U.S. Pat. No. 6,764,517, which claims priority to provisional application Ser. No. 60/005,523, filed Oct. 16, 1995. This is a continuation-in-part of application Ser. No. 09/782,794, filed Feb. 13, 2001, now U.S. Pat. No. 6,902,584, which is a continuation of application Ser. No. 09/110,726, filed Jul. 7, 1998, now U.S. Pat. No. 6,187,047; which is a divisional of application Ser. No. 08/633,554, filed Apr. 17, 1996, now U.S. Pat. No. 5,776,193, all of which are incorporated by reference herein.
The invention relates to materials useful for bone tissue repair.
A tissue repair matrix is provided which is porous, biodegradable, three-dimensionally fixed and has shape memory and maintains structural integrity and porosity after implant for a period sufficient to augment the tissue replacement process. The matrix comprises mineralized fibrillar insoluble collagen, collagen derivative or modified gelatin, bound with a binder. In one embodiment, the minerals comprise calcium phosphate immobilized within the matrix. The resulting product is lyophilized, cross-linked, dried and sterilized to form a porous matrix. The matrix may be used as a tissue repair material and/or a delivery vehicle for biologically active factor. The matrix may be implanted for bone regeneration and will retain its porosity and physical integrity for a period of greater than fourteen days after implant.
The matrix is produced using a water-insoluble biodegradable biopolymer such as collagen, collagen derivative or modified gelatin. If gelatin is used, it will be modified to be insoluble in aqueous environments. The collagen may come from mineralized or unmineralized collagen sources, usually unmineralized collagen sources. Thus, the collagen may come from bone, tendons, skin, or the like, preferably Type I collagen which involves a combination of two strands of α2 and one α1 collagen chains. The collagen may be from a young source, e.g., calf, or a mature source, e.g., cow of two or more years. The source of the collagen may be any convenient animal source, mammalian or avian, and may include bovine, porcine, equine, chicken, turkey, or other domestic source of collagen. The insoluble collagenous tissue which is employed will normally be dispersed in a medium at an elevated pH, using at least about pH 8, more usually about pH 11-12. Commonly, sodium hydroxide is employed, although other hydroxides may be used, such as other alkali metal hydroxides or ammonium hydroxide.
Implanation in Bone
Implanation in Bone with Marrow or Autogenous Graft
Example III (Comparative Example)
Implantation in Soft Tissue Sites
The mineralized collagen matrix according to the invention was implanted into the subcutaneous tissue of 5 to 6 week old male Sprague Dawley rats and evaluated by histological methods after 4 and 8 weeks. After 4 weeks, the ingrowth of fibrous tissue into the ovoid mass of eosinophilic implant was observed. A moderate to marked chronic inflammatory response with a lymphocytic infiltrate was also observed. Peripherally, dense fibrous tissue and multinucleate giant cells were present. A moderate amount of mineralized collagen implant remained at this time point. At 8 weeks, implants of mineralized collagen showed fine and dense fibrous tissue and small void spaces. Moderate inflammation, primarily peripherally, with infiltrates of chronic inflammatory cells and scattered giant multinucleate cells was also observed. Three of six specimens showed small amounts of residual implant material, while the remaining three implant sites contained only traces of implant.
Residence Time of Implanated Mineralized Collage Matrix
The mineralized collagen matrix according to the invention was combined with autologous bone marrow and implanted into 1.5 cm segmental defects in the radius of New Zealand White rabbits. After 12 weeks, implant sites were evaluated histologically and showed residual mineralized collagen matrix present and in close apposition to the bony matrix.
Release of MP52
The mineralized collagen matrix according to the invention was hydrated with Morphogenic protein-52 (MP52) at a concentration of 0.1 mg MP52/cc matrix. The hydrated matrix was lyophilized. The lyophilized matrix was placed in PBS at 37� C. and the release of MP52 from the matrix was measured. At the following timepoints�15 min, 30 min, 1 hr and 18 hr, the cumulative release was 5%, 7%, 9% and 10% respectively. 90% of the loaded MP52 was recovered from the matrix after 18 hr.
The mineralized collagen matrix according to the invention was hydrated with vancomycin at a concentration of 10 mg of vancomycin/cc matrix. The hydrated matrix was lyophilized. The lyophilized matrix was placed in PBS at 37� C. and the release of vancomycin from the matrix was measured. At the following timepoints�6 hr, 24 hr, 51 hr, 73 hr and 97 hr, the cumulative release was 40%, 63%, 72%, 80% and 83% respectively.
The mineralized collagen matrix according to the invention can be easily hydrated by placing the matrix in fluid. The matrix maintains its integrity and shape after hydration. The hydrated matrix can be compressed and manually inserted through a narrow opening but returns to its original size and shape on rehydration. During the manipulation and compression the matrix maintains its integrity without any substantial loss of fibers.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS4294753Aug 4, 1980Oct 13, 1981The Regents Of The University Of CaliforniaBone morphogenetic protein processUS4434094Apr 12, 1983Feb 28, 1984Collagen CorporationPartially purified osteogenic factor and process for preparing same from demineralized boneUS4440750Feb 12, 1982Apr 3, 1984Collagen CorporationDemineralized bone and collagenUS4455256May 5, 1981Jun 19, 1984The Regents Of The University Of CaliforniaSolvent extraction, precipitationUS4563350Oct 24, 1984Jan 7, 1986Collagen CorporationHypoimmunogenic osteogenic factorUS4627982Feb 26, 1985Dec 9, 1986Collagen CorporationStimulating bone growth in mammalsUS4698326Dec 20, 1985Oct 6, 1987Regents Of The University Of MinnesotaComposition and method for osseous repairUS4780450Jul 28, 1987Oct 25, 1988The University Of Maryland At BaltimorePhysically stable composition and method of use thereof for osseous repairUS4789663Jul 5, 1985Dec 6, 1988Collagen CorporationMethods of bone repair using collagenUS4795467Apr 4, 1986Jan 3, 1989Collagen CorporationXenogeneic collagen/mineral preparations in bone repairUS4863732Dec 16, 1987Sep 5, 1989Collagen CorporationInjectable composition for inductive bone repairUS4888366Sep 25, 1987Dec 19, 1989Collagen CorporationImplantsUS4962091May 23, 1986Oct 9, 1990Syntex (U.S.A.) Inc.Controlled release of macromolecular polypeptidesUS5092883Dec 13, 1990Mar 3, 1992Eppley Barry LMethod for promoting soft connective tissue growth and repair in mammalsUS5133755Jun 21, 1990Jul 28, 1992Thm Biomedical, Inc.Method and apparatus for diodegradable, osteogenic, bone graft substitute deviceUS5208219Feb 14, 1991May 4, 1993Celtrix Pharmaceuticals Inc.Method for inducing bone growthUS5231169Feb 26, 1992Jul 27, 1993Norian CorporationMineralized collagenUS5236456Jan 17, 1991Aug 17, 1993Osteotech, Inc.Osteogenic composition and implant containing sameUS5264214Aug 14, 1992Nov 23, 1993Collagen CorporationComposition for bone repairUS5294446Jan 2, 1992Mar 15, 1994Southwest Research InstituteComposition and method of promoting hard tissue healingUS5306303Nov 19, 1991Apr 26, 1994The Medical College Of Wisconsin, Inc.Implanting a ceramic and leaving in place until new bone growth is inducedUS5306311Dec 17, 1991Apr 26, 1994Regen CorporationProsthetic articular cartilageUS5314474Apr 2, 1992May 24, 1994Thera Patent Gmbh & Co. Kg, Gesellschaft Fur Industrielle SchutzrechteBone replacement part made of glass ionomer cementUS5328955Jul 30, 1992Jul 12, 1994Collagen CorporationUsing a hydrophilic polyethyleneUS5338772Jun 22, 1992Aug 16, 1994Merck Patent Gesellschaft Mit Beschrankter HaftungImplant materialUS5366508Jul 7, 1992Nov 22, 1994Thm Biomedical, IncApparatus for biodegradable, osteogenic, bone graft substitute deviceUS5376636Mar 12, 1992Dec 27, 1994Creative Biomolecules, Inc.Method for promoting tissue repair and regeneration using PDGF and glucocorticoidsUS5393739Sep 15, 1993Feb 28, 1995Celtrix Pharmaceuticals, Inc.Use of bone morphogenetic protein in synergistic combination with TGF-β for bone repairUS5397770Feb 23, 1993Mar 14, 1995Levin; Robert H.Yeast-derived epidermal growth factor/urogastrone-like productsUS5413989May 3, 1993May 9, 1995Celtrix Pharmaceuticals, Inc.Bone morphogenic proteinsUS5425770Jul 30, 1993Jun 20, 1995Collagen CorporationCalcium phosphate/atelopeptide collagen compositions for bone repairUS5531794Sep 13, 1994Jul 2, 1996Asahi Kogaku Kogyo Kabushiki KaishaCeramic device providing an environment for the promotion and formation of new boneUS5532217Sep 7, 1995Jul 2, 1996Silver; Frederick H.Process for the mineralization of collagen fibers, product produced thereby and use thereof to repair boneUS5607474Sep 20, 1993Mar 4, 1997Board Of Regents, University Of Texas SystemMulti-phase bioerodible implant/carrier and method of manufacturing and using sameUS5645591May 29, 1990Jul 8, 1997Stryker CorporationForming bone in shape of inplanted deviceUS5683459Nov 21, 1994Nov 4, 1997Thm Biomedical, Inc.For facilitating the healing of structural tissue deficienciesUS5697980Jun 2, 1995Dec 16, 1997Mitsubishi Chem CorpArtificial filling and prosthetic materialUS5755792Jun 7, 1995May 26, 1998Thm Biomedical, Inc.Method and apparatus for biodegradable, osteogenic, bone graft substitute deviceUS5776193Apr 17, 1996Jul 7, 1998Orquest, Inc.Biodegradable bone replacement comprising network of mineralized biopolymer fibers and binderUS5876452May 30, 1995Mar 2, 1999Board Of Regents, University Of Texas SystemBiodegradable implantUS6013853Feb 15, 1994Jan 11, 2000The University Of Texas SystemA bioactive agent uniformly distributed in a biodegradable, at least 50%-porous polymer to supply a smooth continuous release the first two weeks of use; release profile promotes migration and differentiation of cells; bones; cartilageUS6118043Jun 7, 1995Sep 12, 2000Merck Patent Gesellschaft Mit Beschrankter HaftungBone replacement material with FGFUS6187047Jul 7, 1998Feb 13, 2001Orquest, Inc.Bone grafting matrixUS6764517Feb 22, 2002Jul 20, 2004Depuy Acromed, Inc.Tissue repair matrixUS6902584Feb 13, 2001Jun 7, 2005Depuy Spine, Inc.Bone grafting matrixEP0475077A2Aug 7, 1991Mar 18, 1992Synthes AG, ChurBone regeneration membraneEP0522569A1Jul 10, 1992Jan 13, 1993United States Surgical CorporationComposition for effecting bone repairGB1271763A Title not availableJP4275732B2 Title not availableJPH07236688A Title not availableWO1989004646A1Nov 14, 1988Jun 1, 1989Steven R JefferiesBone repair material and delayed drug deliveryWO1990001955A1Aug 16, 1989Mar 8, 1990Geistlich Soehne AgChemical compoundsWO1990010018A1Feb 22, 1990Sep 7, 1990Creative Biomolecules IncBone collagen matrix for implantsWO1991018558A1May 22, 1991Nov 30, 1991Creative Biomolecules IncSynthetic bone matrixWO1992020371A1May 7, 1992Nov 26, 1992Celtrix PharmaTargeted delivery of bone growth factorsWO1993004710A2Aug 19, 1992Mar 18, 1993Shaw Robert FMethods and compositions for the treatment and repair of defects or lesions in cartilage or boneWO1993005808A1Sep 9, 1992Apr 1, 1993David J BaylinkBone-growth-stimulating compositionWO1993005823A1Sep 9, 1992Apr 1, 1993David J BaylinkBone-growth-stimulating compositionWO1994000145A1Jun 30, 1993Jan 6, 1994Dow Chemical CoTargeted delivery of growth factors for bone regenerationWO1994001483A1Jul 1, 1993Jan 20, 1994Collagen CorpBiocompatible polymer conjugatesWO1994015653A1Jan 11, 1994Jul 21, 1994Genentech IncTgf-beta formulation for inducing bone growthWO1995008304A1Sep 20, 1994Mar 30, 1995Paul W BrownBone substitute composition comprising hydroxyapatite and a method of production thereforWO1997014376A1Oct 15, 1996Apr 24, 1997Orquest IncBone grafting matrixNon-Patent CitationsReference1Chinese Office Action from corresponding China Application No. 03808980.7 Issued Jun. 13, 2008.2Denki Kagaku Kogyo KK, Patent Abstracts of Japan, JP 04282322A, Feb. 19, 1993, vol. 17, No. 086 (C-1028), Oct. 7, 1992.3European Examination Report dated Nov. 7, 2008 for related European Patent Application No. 03709281.4.4European Search Report from corresponding European Application No. 03709281.4 Issued Nov. 6, 2006.5European Search Report from corresponding European Application No. 03709281.4 Issued Sep. 11, 2007.6Examination Report dated Oct. 12, 2004, for related New Zealand Application No. 535466.7Final Rejection received Aug. 3, 2010 for Japanese Patent Application No. 2003-570739.8Inquiry from corresponding Japanese Application No. 9-515932 dated Apr. 30, 2008.9Japanese Official Action dated Oct. 27, 2008 for related Japanese Patent Application No. 9-515932.10Mayahara, H. et al., "In Vivo Stimulation of Endosteal Bone formation by Basic Fibroblast Growth Factor In Rats", Growth Factors, vol. 9, 1993, pp. 73-80.11Office Action dated Dec. 29, 2009 for Canadian Patent Application No. 2,476,929.12Office Action dated May 22, 2009 for Chinese Patent Application No. 03808980.7.13Office Action dated Oct. 15, 2009 for Japanese Patent Application No. 2006-272877.14Office Action dated Sep. 28, 2009 for Japanese Patent Application No. 2003-570739.15Reddi, et al., "Introduction and Maintenance of New Bone Formation by Growth and Differentiation Factors", Annales Chirurgiae et Gynacologiae, vol. 77, pp. 189-192, 1998.16Shanbhag et al., "Macrophage/particle interactions: effect of size, composition and surface area", J Biomed Mater Res., Jan. 1994, 28(1): 81-90.17Taiho, Yuukuhin Kogyo KK, Patent Abstracts of Japan, JP 02 000213A; Mar. 8, 1990, vol. 014, No. 123 (C-0698),Jan. 5, 1990.18Third Office Action dated Jan. 23, 2009 for related Chinese Patent Application No. 03808980.7.19U.S. Appl. No. 09/782,794, Yamamoto et al.20Urist, Marshall; Bone: Formation by autoinduction:, Science 12, vol. 150, No. 3698, pp. 893-899, Nov. 1965.21Wang, JS, Aspenburg P., "Basic Fibroblast Growth Factor Increases", Allograft Incorporation; Acta Orthopaedica Scandinavica, vol. 65, No. 1, Feb. 1994, pp. 27-31.22Wang, JS, et al., "Basic Fibroblast Growth Factor Enhances bone-graft incorporation: Does and time Dependence in Rats", , Journal of Orthopaedic Research, US, The Journal of Bone and Joint Surgery, Inc., vol. 14, No. 2, Mar. 1996, pp. 316-323.23Wiltfant, et al., "Ectopic Bone Formation with the help of Growth Factor bFGF", Journal of Cranio-Maxxillofacial Surgery, vol. 24, No. 5, pp. 300-304, Oct. 1996.24Wozney, "Bone Morphogenetic Proteins" Progress in Growth Factor Research, vol. 1, pp. 267-280, 1989.Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8337879Apr 15, 2011Dec 25, 2012Orthocon, Inc.Absorbable implants and methods for their use in hemostasis and in the treatment of osseous defectsClassifications U.S. Classification623/23.51, 623/23.75, 623/23.61, 623/16.11, 424/423International ClassificationA61F2/00, A61L24/00, A61F2/28, A61L27/54, A61L27/26, A61L27/46, A61F2/02, A61P19/00, A61L27/00, A61F2/30, A61L27/56Cooperative ClassificationA61F2002/2835, A61F2310/00365, A61L24/0036, A61L27/26, A61F2002/2817, A61L24/0084, A61L2300/414, A61L2430/02, A61F2/28, A61L27/56, A61F2002/30092, A61L27/46, A61F2210/0004, A61L2300/406, A61F2310/00383, A61L2300/64, A61L24/0042, A61F2002/30199, A61F2310/00293, A61L2300/602, A61F2230/0063, A61L27/54, A61F2002/30677, A61F2002/30062, A61F2210/0014, A61L2300/30European ClassificationA61L24/00H8, A61F2/28, A61L27/54, A61L24/00R4E, A61L27/26, A61L27/46, A61L24/00H9, A61L27/56Legal EventsDateCodeEventDescriptionApr 30, 2014FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services