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USRE38522E1 Expired / Lapsed US ⏱️ 0.0 years remaining

Malleable paste for filling bone defects

Assignee: Musculoskeletal Transplant Foundation
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Filing: 2002-02-28
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Granted: 2004-05-25
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Expires: 2022-02-28
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Abstract

Abstract The invention is directed toward a malleable bone putty and a flowable gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone powder. The bone powder has a particle size ranging from about 100 to about 850 microns and is mixed in a high molecular weight hydrogel carrier, the hydrogel component of the carrier ranging from about 0.3 to 3.0% of the composition and having a molecular weight of about at least 10,000 Daltons. The composition contains about 25% to about 40% bone powder and can be additionally provided with BMP's and a sodium phosphate buffer.

Inventors

  • 👤 Arthur A. Gertzman
  • 👤 Moon Hae Sunwoo

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 01:59
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3604; A61L27/3608; A61K; A61K35/00; A61K35/12; A61K35/32; A61K38/00; A61K38/16; A61K38/17; A61K38/18; A61K38/1875; A61L24/00; A61L24/0005; A61L24/001; A61L24/0031; A61L27/3641; A61L27/3645; A61L27/365; A61L27/50; A61L27/52; C; C08; C08L; C08L5/00; C08L5/08; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/30004; A61F2002/30059; A61L2430/00; A61L2430/02

Claims Analysis

Total Claims: 36
Claim 1
Independent Claim 106 words
A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteogenic osteoinductive bone powder with a particle size ranging from about 100 to about 850 microns in a carrier, the bone powder ranging from about 25 to about 35% of the weight of the composition, the carrier is selected from the group consisting of sodium hyaluronate, and chitosan and N,O-carboxymethylchitosan in water solution having a high molecular weight ranging from five hundred thousand to three million Daltons and ranging from about 1.0% to about 3.0% by weight of the carrier solution.
Claim 2
Dependent Claim 106 words
A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteogenic osteoinductive bone powder with a particle size ranging from about 100 to about 850 microns in a carrier, the bone powder ranging from about 25 to about 35% of the weight of the composition, the carrier is selected from the group consisting of sodium hyaluronate, and chitosan and N,O-carboxymethylchitosan in water solution having a high molecular weight ranging from five hundred thousand to three million Daltons and ranging from about 1.0% to about 3.0% by weight of the carrier solution.
Claim 3
Dependent Claim 26 words
A malleable bone composition as claimed in claim 1 wherein said mixture includes bone morphogenic proteins in excess of the amount naturally occurring in allergenic bone.
Claim 4
Dependent Claim 19 words
A malleable bone composition as claimed in claim 1 including the addition of a calcium salt to the carrier.
Claim 5
Dependent Claim 28 words
A malleable bone composition as claimed in claim 1 wherein the balance of the carrier formulation contains a sodium phosphate buffer and having a pH of about 7.2.
Claim 6
Dependent Claim 18 words
A malleable bone composition as claimed in claim 1 wherein said bone powder is cortical allograft bone powder.
Claim 7
Dependent Claim 18 words
A malleable bone composition as claimed in claim 1 wherein said bone powder is corticocancellous allograft bone powder.
Claim 8
Dependent Claim 109 words
A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing mixture of demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 850 microns in a hyaluronic acid water carrier, the hyaluronic acid component ranging from above 1.0% to about 3% of the carrier solution and having a molecular weight of at least 10 6 Daltons and a viscosity ranging from 6,000 to about 275,000 cps, the bone content of the carrier ranging in weight from about 25% to about 35% total weight of the composition.
Claim 9
Dependent Claim 109 words
A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing mixture of demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 850 microns in a hyaluronic acid water carrier, the hyaluronic acid component ranging from above 1.0% to about 3% of the carrier solution and having a molecular weight of at least 10 6 Daltons and a viscosity ranging from 6,000 to about 275,000 cps, the bone content of the carrier ranging in weight from about 25% to about 35% total weight of the composition.
Claim 10
Dependent Claim 22 words
A malleable bone putty composition as claimed in claim 7 including the addition of a calcium salt to the hyaluronic acid carrier.
Claim 11
Dependent Claim 17 words
A malleable bone putty composition as claimed in claim 8 wherein said calcium salt is calcium chloride.
Claim 12
Dependent Claim 17 words
A malleable bone putty composition as claimed in claim 8 wherein said calcium salt is calcium sulfate.
Claim 13
Dependent Claim 17 words
A malleable bone putty composition as claimed in claim 8 wherein said calcium salt is calcium phosphate.
Claim 14
Dependent Claim 17 words
A malleable bone putty composition as claimed in claim 8 wherein said calcium salt is calcium hydroxyapatite.
Claim 15
Dependent Claim 29 words
A malleable bone putty composition as claimed in claim 7 wherein said carrier has a 2-3% hyaluronic acid concentration with the balance of the carrier formulation comprising saline water.
Claim 16
Dependent Claim 29 words
A malleable bone putty composition as claimed in claim 7 wherein said carrier has a 2-3% hyaluronic acid concentration with the balance of the carrier formulation comprising sterile water.
Claim 17
Dependent Claim 50 words
A malleable bone putty composition as claimed in claim 7 wherein said hydrogel carrier has a 2-3% hyaluronic acid concentration with the balance of the carrier formulation contains a sodium phosphate buffer with a pH of about 7.2, said buffer attracting calcium and concentrating same at the bone defect site.
Claim 18
Dependent Claim 25 words
A malleable bone putty composition as claimed in claim 7 wherein said carrier includes BMP in excess of the amount naturally occurring in allergenic bone.
Claim 19
Dependent Claim 19 words
A malleable bone putty composition as claimed in claim 7 wherein said bone powder is cortical allograft bone powder.
Claim 20
Dependent Claim 16 words
A malleable bone putty composition as claimed in claim 7 wherein said bone powder is corticocancellous.
Claim 21
Dependent Claim 34 words
A malleable bone putty composition as claimed in claim 7 including antimicrobial and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin.
Claim 22
Dependent Claim 12 words
A malleable bone putty composition as claimed in claim 7 including vitamins.
Claim 23
Dependent Claim 18 words
A malleable bone putty composition as claimed in claim 7 including enzymes such as collagenase, peptidases and oxidases.
Claim 24
Dependent Claim 96 words
A malleable bone putty composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 420 microns in a high molecular weight sodium hyaluronate and water carrier, the bone content of the composition ranging from about 30% to about 35% by weight and the high molecular weight sodium hyaluronate component ranges from about 2% to about 3% of the carrier and has a molecular weight greater than one million Daltons.
Claim 25
Dependent Claim 96 words
A malleable bone putty composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 420 microns in a high molecular weight sodium hyaluronate and water carrier, the bone content of the composition ranging from about 30% to about 35% by weight and the high molecular weight sodium hyaluronate component ranges from about 2% to about 3% of the carrier and has a molecular weight greater than one million Daltons.
Claim 26
Dependent Claim 79 words
A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 420 microns in a N,O-carboxymethylchitosan water carrier solution, the N,O-carboxymethylchitosan component ranging from about 1.0% to about 3% of the carrier weight and having a molecular weight ranging from 2.0×10 6 -3.0×10 6 Daltons.
Claim 27
Dependent Claim 79 words
A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 420 microns in a N,O-carboxymethylchitosan water carrier solution, the N,O-carboxymethylchitosan component ranging from about 1.0% to about 3% of the carrier weight and having a molecular weight ranging from 2.0×10 6 -3.0×10 6 Daltons.
Claim 28
Dependent Claim 95 words
A malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 850 microns in a high molecular weight chitosan water carrier solution with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component comprising about 3% of the carrier solution with the chitosan having a molecular weight ranging from about 1.0×10 3 to 3.0×10 5 Daltons.
Claim 29
Dependent Claim 95 words
A malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 850 microns in a high molecular weight chitosan water carrier solution with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component comprising about 3% of the carrier solution with the chitosan having a molecular weight ranging from about 1.0×10 3 to 3.0×10 5 Daltons.
Claim 30
Dependent Claim 23 words
A malleable bone putty composition as claimed in claim 24 wherein the carrier formulation includes a sodium phosphate buffer of about pH 7.2.
Claim 31
Dependent Claim 17 words
A malleable bone putty composition as claimed in claim 24 wherein said carrier solution includes saline water.
Claim 32
Dependent Claim 17 words
A malleable bone putty composition as claimed in claim 24 wherein said carrier solution includes sterile water.
Claim 33
Dependent Claim 90 words
A malleable bone gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 850 microns in a high molecular weight hyaluronic acid in water carrier with the hyaluronic acid component comprising about 1% of the carrier and having a molecular weight over 1.0×10 6 Daltons, the bone powder content of the compositions ranging from about 25% to about 30%.
Claim 34
Dependent Claim 90 words
A malleable bone gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 850 microns in a high molecular weight hyaluronic acid in water carrier with the hyaluronic acid component comprising about 1% of the carrier and having a molecular weight over 1.0×10 6 Daltons, the bone powder content of the compositions ranging from about 25% to about 30%.
Claim 35
Dependent Claim 99 words
A malleable bone gel composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 420 microns mixed in a high molecular weight hyaluronic acid water solution carrier with the hyaluronic acid component being present in the amount of about 1% of the carrier and having a viscosity of about 1,800 to 13,000 cps, the bone powder amount content of the composition ranging from about 25% to about 30% by weight.
Claim 36
Dependent Claim 99 words
A malleable bone gel composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 420 microns mixed in a high molecular weight hyaluronic acid water solution carrier with the hyaluronic acid component being present in the amount of about 1% of the carrier and having a viscosity of about 1,800 to 13,000 cps, the bone powder amount content of the composition ranging from about 25% to about 30% by weight.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2007-05-25 2007-11-24 2008-05-25 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2011-05-25 2011-11-24 2012-05-25 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2015-05-25 2015-11-24 2016-05-25 $7700.00 Window Closed / Lapsed

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