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US007608113B2

(12) United States Patent ao) Patent No.: Us 7,608,113 B2

Boyer, II et al. (45) Date of Patent: Oct. 27,2009

(54) DEMINERALIZED BONE IMPLANTS

(75) Inventors: Michael L. Boyer, II, Paoli, PA (US);

David C. Paul, Phoenixville, PA (US);
Christopher M. Angelucci,

Schwenksville, PA (US)

(73) Assignee: Synthes USA, LLC, West Chester, PA (US)

( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 1068 days.

(21) Appl.No.: 10/718,804

(22) Filed: Nov. 24, 2003

(65) Prior Publication Data

US 2004/0107003 Al Jun. 3, 2004

Related U.S. Application Data

(63) Continuation of application No. 09/927,335, filed on Aug. 13, 2001, now Pat. No. 6,652,593.

(60) Provisional application No. 60/271,745, filed on Feb. 28, 2001.

(51) Int. CI.

A61F 2/28 (2006.01)

(52) U.S. CI 623/23.63

(58) Field of Classification Search None

See application file for complete search history.

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Selectively demineralized bone-derived implants are provided. In one embodiment, a bone sheet for implantation includes a demineralized field surrounding mineralized regions. In another embodiment, a bone defect filler includes a demineralized cancellous bone section in a first geometry. The first geometry is compressible and dryable to a second geometry smaller than the first geometry, and the second geometry is expandable and rehydratable to a third geometry larger than the second geometry.

30 Claims, 14 Drawing Sheets

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U.S. PATENT DOCUMENTS

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FOREIGN PATENT DOCUMENTS

OTHER PUBLICATIONS

Joseph Catanese III et al., "Heterogeneity of the mechanical properties of demineralized bone," Journal of Biomechanics, vol. 32, pp. 1365-1369, 1999.

Kai-Uwe Lewandrowski et al., "Mechanical Properties of Perforated and Partially Demineralized Bone Grafts," Clinical Orthopaedics and Related Research, No. 353, pp. 238-246, 1998. Kai-Uwe Lewandrowski et al., "Improved Osteoinduction of Cortical Bone Allografts: A Study of the Effects of Laser Perforation and Partial Demineralization," Journal of Orthopaedic Research, vol. 15, pp. 748-756, 1997.

Kai-Uwe Lewandrowski et al., "Kinetics of cortical bone demineralization: Controlled demineralization—a new method for modifying cortical bone allografts," Journal of Biomedical Materials Research, vol. 31, pp. 365-372, 1996.

Douglas W. Jackson et al., "Biologic Remodeling after Anterior Cruciate Ligament Reconstruction Using a Collagen Matrix Derived from Demineralized Bone," American Journal of Sports Medicine, vol. 24, pp. 405-414, 1996.

Kai-Uwe Lewandrowski et al., "Flexural Rigidity in Partially
Demineralized Diaphyseal Bone Grafts," Clinical Orthopaedics and
Related Research, No. 317, pp. 254-262, 1995.
J.J. Brozetal., "Material and Compositional Properties of Selectively
Demineralized Cortical Bone," J. Biomechanics, vol. 28, pp. 1357-
1368, 1995.

Howard S. An et al., "Comparison Between Allograft Plus
Demineralized Bone Matrix Versus Autograft in Anterior Cervical
Fusion. A Prospective Multicenter Study," SPINE, vol. 20, pp. 2211-
2216, 1995.

Norbert Kiibler et al., "Osteoinductive, Morphologic, and Biomechanical Properties of Autolyzed, Antigen-Extracted, Allogenic Human Bone," J. Oral Maxillofac. Surg., vol. 51, pp. 1346-1357, 1993.

S. M. Tuli et al., "The Osteoinductive Property of Decalcified Bone
Matrix. An Experimental Study," The Journal of Bone and Joint
Surgery, vol. 60-B, pp. 116-123, 1978.

Marshall R. Urist, "Surface-Decalcified Allogeneic Bone (SDAB)
Implants. A Preliminary Report of 10 Cases and 25 Comparable
Operations With Undecalcified Lyophilized Bone Implants.," Clini-
cal Orthopaedics and Related Research, No. 56, pp. 37-50, 1968.
Fred H. Albee, Bone Graft Surgery in Disease, Injury and Deformity,
D. Appleton-Century Company, Inc., New York, 1940, pp. 30,65-67,
114, 151, 155, 164, 212, 256-257, 270-273, 311-313.
Fred H. Albee, "Bone Surgery With Machine Tools," Scientific
American, Apr. 1936, pp. 178-181.

Fred H. Albee, Bone-Graft Surgery, W. B. Saunders Company, Philadelphia, Pennsylvania, 1915, pp. 90-92, 145, 165-166,171,368-369.

SU

1465040 Al

3/1989

* cited by examiner

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