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US5797871: Ultrasonic cleaning of allograft bone

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Filing Information

Inventor(s) Wolfinbarger, Jr.; Lloyd ·
Assignee(s) LifeNet Research Foundation ·
Attorney/Agent(s) Jones & Volentine, L.L.P. ·
Primary Examiner Michael Buiz ·
Assistant Examiner Deborah Blyvers ·
Application Number US8646519
Filing date 05/07/1996
Issue date 08/25/1998
Predicted expiration date 08/19/2014
U.S. Classifications 604/49  · 128/898  ·
International Classifications A61M 3100  ·
Kind CodeA
International Classifications 128898 ·
Related U.S. Application DataBACKGROUND OF THE INVENTION
This application is a continuation-in-part of co-pending U.S. application Ser. No. 08/646,520 filed May 7, 1996 entitled "A Recirculation Method for Cleaning Essentially Intact Bone Grafts Using Pressure Medicated flow of Solvents and Bone Grafts Produced Thereby", and this application is a Continuation-in-Part of U.S. application Ser. No. 08/395,113 filed Feb. 27, 1995 now U.S. Pat. No. 5,556,379 which is a Continuation-in-Part of U.S. application Ser. No. 08/293,206 filed Aug. 19, 1994, now abandoned, all of which we incorporated by reference herein in their entirety.
25 Claims, No Drawings


Abstract

The present invention is directed to a method for cleaning cadaveric donor bone to produce bone grafts suitable for transplantation into a human, as well as the bone grafts produced thereby. The present method involves removing bone marrow potentially containing bacteria, virus or fungi, from the donor bone by sonicating the bone in a solvent containing one or more detergents to produce bone grafts essentially free from bone marrow, as well as bone grafts essentially free from any detectable bacterial, fungal, or viral contamination.

Independent Claims | See all claims (25)

  1. 1. A method for producing a bone graft suitable for transplantation into a human, comprising:sonicating said bone graft with a solvent comprising one or more detergents in an ultrasonic cleaner at a temperature from 37.degree. to 50.degree. C. and for a time period effective to produce a cleaned bone graft essentially free from bone marrow.
  2. 10. A method for producing a bone graft suitable for transplantation into a human, comprising:sonicating at a temperature from 37.degree. to 50.degree. C. said bone graft using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned bone graft, andwherein said first cleaned bone graft is essentially free from bone marrow.
  3. 22. A method for producing an essentially intact bone graft suitable for transplantation into a human, comprising:inducing a negative pressure mediated flow of a first solvent, said first solvent comprising one or more detergents, through an opening in a bone shaft of said essentially intact bone graft to produce a cleaned intact bone graft;sonicating said essentially intact bone graft in a container with said first solvent using an ultrasonic cleaner,wherein said inducing and said sonicating are carried out simultaneously for a time effective to produce a cleaned intact bone graft essentially free from bone marrow.
  4. 23. A method for producing an essentially intact bone graft suitable for transplantation into a human, comprising:sonicating said bone graft with a solvent comprising one or more detergents in an ultrasonic cleaner at a temperature and for a time period effective to produce a cleaned bone graft essentially free from bone marrow and,inducing a pressure mediated flow of said solvent through an opening in a bone shaft of said essentially intact bone graft wherein said pressure mediated flow is carried out for a period of time effective to produce a cleaned bone graft essentially free from bone marrow, andwherein said step of sonicating and said step of inducing are carried out simultaneously.
  5. 24. A method for producing a bone graft suitable for transplantation into a human, comprising:sonicating said bone graft using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned bone graft;sonicating said first cleaned bone graft using an ultrasonic cleaning device with a second solvent comprising one or more members selected form the group consisting of: an antibiotic, an antimycotic and an antiviral agent, to produce a second cleaned bone graft, andsonicating said second cleaned bone graft using an ultrasonic cleaning device with a third solvent comprising one or more decontaminating agents to produce a third cleaned bone graft, wherein said third cleaned bone graft is essentially free from bone marrow.
  6. 25.25. A method for producing a bone graft suitable for transplantation into a human, comprising:sonicating said bone graft using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned bone graft;agitating said first cleaned bone graft with a second solvent comprising one or more members selected from the group consisting of: an antibiotic, an antimycotic and an antiviral agent, to produce a second cleaned bone graft; andagitating said second cleaned bone graft with a third solvent comprising one or more decontaminating agents to produce a third cleaned bone graft, wherein said third cleaned bone graft is essentially free from bone marrow.

References Cited

U.S. Patent Documents

Document NumberAssigneesInventorsIssue/Pub Date
US4020183 Ortho Pharmaceutical Corporation Asculai et al. Apr 1977
US4169123 Moore-Perk Corporation Moore et al. Sep 1979
US4207689 Queen's University at Kingston Romera-Sierra et al. Jun 1980
US4258722 Ferris Manufacturing Corp. Sessions et al. Mar 1981
US4315919 SHANBROM EDWARD Shanbrom Feb 1982
US4366822 Applied Medical Devices, Inc. Altshuler Jan 1983
US4412985 SHANBROM EDWARD Shanbrom Nov 1983
US4456589 Genetic Laboratories, Inc. Holman et al. Jun 1984
US4526751 GARTNER WILLIAM J Gartner Jul 1985
US4553974 Mayo Foundation Dewajnee Nov 1985
US4637931 The United States of America as represented by the Secretary of the Army Schmitz Jan 1987
US4678470 American Hospital Supply Corporation Nashef et al. Jul 1987
US4695536 LINDSTROM RICHARD L Lindstrom et al. Sep 1987
US4801299 University Patents, Inc. Brendel et al. Jan 1989
US4891221 SHANBORM EDWARD Shanbrom Jan 1990
US4923677 Roy T. Witkin Simon et al. May 1990
US4946792 Osteotech, Inc. O'Leary Aug 1990
US4975526 Creative Biomolecules, Inc. Kuberasampath et al. Dec 1990
US4994030 Osteotech, Inc. Glowczewskie et al. Feb 1991
US5037437 University of Washington Matsen, III Aug 1991
US5041055 Freezing Machines, Inc. Roth Aug 1991
US5047030 DRAENERT KLAUS Draenert Sep 1991
US5095925 ELLEDGE DAVID M Elledge et al. Mar 1992
US5106626 International Genetic Engineering, Inc. Parsons et al. Apr 1992
US5118512 Osteotech, Inc. (a Delaware Corp.) O'Leary et al. Jun 1992
US5120656 Osteotech, Inc. O'Leary et al. Jun 1992
US5133756 Merck Patent Gesellschaft mit beschraenkter Haftung Bauer et al. Jul 1992
US5167961 Ed. Geistlich Sohne AG Fur Chemische Industrie Lussi et al. Dec 1992
US5186945 SHANBROM EDWARD Shanbrom Feb 1993
US5192282 DRAENERT KLAUS Draenert Mar 1993
US5333626 Cryolife, Inc. Morse et al. Aug 1994
US5454815 IMT Integral Medizintechnik Trading AG Geisser et al. Oct 1995
US5513662 Osteotech, Inc. Morse et al. May 1996

Foreign Patent Documents

Document NumberAssigneesInventorsIssue/Pub Date
SU952189KI NII ORTOPEDIIAug 1982
GB964545OLIN MATHIESONJul 1964
WO20WO9707389Feb 1997

Other Publications

Sattar et al., "Survival and Disinfectant Inactivation of the Human Immunoeficiency Virus: A Critical Review", RID 1991; 13 (May-Jun.), pp. 430-447.
Exact. excerpts from "Product Specification, Discription, Patent Application & Supporting Documentation", by EXOxEMIS, Inc., Feb. 1991.
Klebanoff et al., "Virucidal Activity of H202-generating Bacteria; Requirement for Peroxidase and Halide", Dept. of Medicine, University of Washington School of Medicine, Seattle Washington, Sep. 24, 1973.
"DMIN Asceptic Tissue Demineralization", a product brochure from Osteotech, Inc. 1993.
"Maximum Security for You and Your Parent", a product brochure regarding VIP Bone, from Cryolife, Inc., Feb. 12, 1992.
"The Virucidal Capacity of a Surfactant/Iodophor-Based Viral Inactivation Process for Bone Allografts", a report of studies designed and funded by Cryolife, Inc., undated.
Withrow et al., "Evaluation of the Antiretroviral Effect of various Methods of Sterilization/Preserving Cortiocancellous Bone", presented at the 36th Annual Meeting , Orthopaedic Research Society, Feb. 5-8, 1990, New Orleans, Louisianna, Transactions of the Orthopaedic Research Society, 16, 1990, pp. 226.
Garrison et al., "Comparison of Bacterial Contimation of Cadaveric Bone Allograft Collected Under Operation Room and Morgue Condition with and without the use of Decontaminating Process", presented at the Second Congress of the European Association of Tissue Bank, Athens, Greece, May 1993.
Morse, "A New Surfactant/Iodophor-Based Viral Inactivation Process (VIP) for Preparation of Bone Allografts", presented at the 16th Annual Meeting of the American Association of Tissue bank, San Diego, Aug. 1992.
"Improve Performance of Your Immunoassay Systems and Immunodiagnostics Kits", a product brochure by Medicine & Applied Sciences, Inc., undated.
"Viral Inactivation Agent for Blood Samples", an article referring to an Oct. 1990 issue of American Clinical Laboratory entitled an Antiviral Agent for General Use in Biological Samples.
Virginia Tissue Bank Procedure Manual, Section 5.9.4.5, Copyright registered on Aug. 6, 1986.
Buck et al., "Human Immunodeficiency Virus Cultured From Bone. Implications for Transplantation", Clinical Orthopaedics and Related Research, No. 251, 1990.
Navy Tissue Bank, Tissue Bank Coordinator Manual 10, "Procurement of Deep Tissues and Bones", p. 9. (undated).
Shutkin, "Homologous-Serum Hepatitis following the Use of Refrigerated Bone-Bank Bone", The Journal of Bone and Joint Surgery, vol. 16-1, No. 1, 1954.
Hyatt et al., "Bone Grafting. The Procurement, Storage, and Clinical Use of Bone Homografts", The American Academy of Orthopaedic Surgeons, Ann Arbor, U.S.A., 1957.
"Transmission of HIV through Bone Transplantation: Case Report and Public Health Recommendations", Morbidity and Mortality Weekly Report, vol. 37, No. 39, 1988.
Kakaiya et al., "Tissue Transplant-Transmitted Infections", Transfusion, vol. 31, No. 3, 1991.
Tomford et al., "A Study of the Clinical Incidence of Infections in the Use of Banked Allograft Bone", The Journal of Bone and Joint Surgery, vol. 63-A, No. 2, 1981.
Furlini et al., "Antibody Response to Human Immunodeficiency Virus after infected Bone Marrow Transplant", Eur. J. Clin, Microbiol. Infect. Dist., vol. 7, 1988.
Lord et al., "Infection in Bone Allografts. Incidence, Nature, and Treatment", The Journal of Bone and Joint Surgery, vol. 70-A, No. 3, 1988.
Bonfiglio et al., "The Immune Concept: Its Relation To Bone Transplantation", Annals New York Academy of Sciences, 1955.
Doppelt et al., "Operational and Finacial Aspects of A Hospital Bone Bank", The Journal of Bone Joint Surgery, vol. 63-A, No. 9, 1981.
Dirschi et al., "Topical Antibiotic Irrigation in the Prophylaxis of Operative Wound Infections in Orthopedic Surgery", Orthopedic Infection, vol. 22, No. 3, Jul. 1991.
Reynolds et al., "Clinical Evaluation of the Merthiolate Bone Bank and Homogenous Bone Grafts", The Journal of Bone and Joint Surgery, vol. 33-A, No. 4, 1951
"Med Clean Mark II", a product brochure by Advanced International Marketing for a unit which includes a pressurized stream of water for bone debridement. (undated).
U.S. Department of Health and Human Services/Public Health Service, "Transmission of HIV Through Bone Transplantation: Case Report and Public Health Recommendations," Morbidity and Morality Weekly Report, 37, 1988. pp. 597-599.
Mellonig, J. T. et al., "HIV Inactivation in a Bone Allograft", J. Periodontology, Dec. 1992, Vol. 63, pp. 979-983.

Referenced By

Document NumberAssigneeInventorsIssue/Pub Date
AU770935 REGENERATION TECH INC MILLS C RANDAL et al. Mar 2004
FR2866237 BIOBANK BARDONNET RAPHAEL Aug 2005
US6143033 Synthes (USA) David C. Paul et al. Nov 2000
US6258125 Synthes (U.S.A.) David C. Paul et al. Jul 2001
US5977432 Life Net Research Foundation Wolfinbarger, Jr.; Lloyd et al. Nov 1999
EP1929862 Musculoskeletal Transplant Foundation The designation of the inventor has not yet been filed Jun 2008
EP1128849 Regeneration Technologies, Inc. MILLS, C., Randal et al. Feb 2007
EP1779868 --
US6652583 Rhode Island Hospital Richard A. Hopkins et al. Nov 2003
US6579318 Ortho Development Corporation Peter Pal Varga et al. Jun 2003
USRE38614 Synthes (U.S.A.) David C. Paul et al. Oct 2004
US6379385 Tutogen Medical GmbH Rolf-Dieter Kalas et al. Apr 2002
US6511509 LifeNet Louis Ford et al. Jan 2003
US6734018 Lifenet Lloyd Wolfinbarger, Jr. et al. May 2004
US6652818 Regeneration Technologies, Inc. C. Randal Mills et al. Nov 2003
USD501555 Ortho Development Corporation Peter Pal Varga et al. Feb 2005
US7585461 Osteotech, Inc. Lawrence A. Shimp et al. Sep 2009
US6554863 Synthes David C. Paul et al. Apr 2003
US6592624 DePuy AcroMed, Inc. Robert D. Fraser et al. Jul 2003
USD494274 Ortho Development Corporation Peter Pal Varga et al. Aug 2004
US6689087 Cybersonics, Inc. Dharmendra Pal et al. Feb 2004
USD493225 Ortho Development Corporation Peter Pal Varga et al. Jul 2004
US6482584 Regeneration Technologies, Inc. C. Randal Mills et al. Nov 2002
US6613278 Regeneration Technologies, Inc. C. Randal Mills et al. Sep 2003
US7300465 Synthes (U.S.A.) David C. Paul et al. Nov 2007
US7387612 Cybersonics, Inc. Dharmendra Pal et al. Jun 2008
US6520993 DePuy Acromed, Inc. Stephen B. James et al. Feb 2003
US6986788 Synthes (U.S.A.) David C. Paul et al. Jan 2006
US6627230 Centerpulse Biologics Inc. James J. Benedict et al. Sep 2003
US6852127 Ortho Development Corporation Peter Pal Varga et al. Feb 2005
US7063726 LifeNet Katrina Crouch et al. Jun 2006
US7902270 Catherine Cadorel Jean-Pierre Cougoulic Mar 2011
US7648676 RTI Biologics, Inc. C. Randal Mills et al. Jan 2010
US7726319 Osteotech, Inc. Todd M. Boyce Jun 2010
US8043377 Osprey Biomedical, Inc. Richard D. Guyer et al. Oct 2011
US8158379 Allosource Chad Ronholdt Apr 2012
US8409623 --
US8454603 --
US8563232 --
US8669043 --

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