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USRE39587: Malleable paste for filling bone defects

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Filing Information

Inventor(s) Arthur A. Gertzman · Moon Hae Sunwoo ·
Assignee(s) Musculoskeletal Transplant Foundation ·
Attorney/Agent(s) John S. Hale · Gipple & Hale ·
Primary Examiner Carlos Azpuru ·
Assistant Examiner Casey Hagopian ·
Application Number US10843658
Filing date 05/12/2004
Issue date 04/24/2007
Predicted expiration date 05/12/2024
U.S. Classifications 424/423  · 424/426  ·
International Classifications A61F200  ·
Kind CodeE1
29 Claims, No Drawings


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.

Independent Claims | See all claims (29)

  1. 1. 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, chitosan and consisting of 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.
  2. 7. 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 106 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.
  3. 22. 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.
  4. 23. 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 2.0×106−3.0×106 Daltons.
  5. 24. 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 1.0×103 to 3.0×105 Daltons.
  6. 28. 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 1.0×106 Daltons, the bone powder content of the composition ranging from about 25% to about 30%.
  7. 29. 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.

References Cited

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Foreign Patent Documents

Document NumberAssigneesInventorsIssue/Pub Date
EP0522569United States Surgical CorporationJan 1993
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Other Publications

D. Cram and G. Hammond, The Carbohydrates II, pp. 43-55, 1974.
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Klokkevold et al., Osteogenesis Enhanced by Chitosan (Poly-N-Acetyl Glucosaminoglycan) In Vitro Periodontol (1996) 67:1170 1175.
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Sasaki, et al., Stimlulation of Osteroinduction in Bone Wound Healing by High-Molecular Hyaluronic Acid Bone, vol. 16 No. 1 (Jan. 1995).

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