IIIH
US006675048B2
(12) United States Patent ao) Patent No.: us 6,675,048 B2
McGraw et al. (45) Date of Patent: Jan. 6,2004
(54) ELECTRO-MEDICAL DEVICE FOR USE WITH BIOLOGICS
(75) Inventors: Michael B. McGraw, Vancouver, WA (US); William A. Rux, Hillsboro, OR (US); William J. Carroll, Sedro Woolley, WA (US); Richard M. Terrell, Vancouver, WA (US); Randy Alan Murphy, Vancouver, WA (US)
(73) Assignee: International Rehabilitative Sciences, Inc., Vancouver, WA (US)
( * ) Notice: Subject to any disclaimer, the term ol this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.
(21) Appl. No.: 09/905,159
(22) Filed: Jul. 16, 2001
(65) Prior Publication Data
US 2002/0016616 Al Feb. 7, 2002
Related U.S. Application Data
(63) Continuation-in-part ol application No. 09/679,557, filed on Oct. 6, 2000, which is a continuation-in-part ol application No. 09/566,081, filed on May 8, 2000.
(51) Int. C I. A61N 1/18
(52) U.S. CI 607/51; 607/3
(58) Field of Search 607/3, 50, 51,
607/66, 67, 75, 76
(56) References Cited
U.S. PATENT DOCUMENTS
3,783,880 A 1/1974 Kraus
3,893,462 A 7/1975 Manning
3,902,502 A 9/1975 Liss et al.
4,026,304 A 5/1977 Levy
4,033,336 A 7/1977 Murawski et al.
4,140,131 A 2/1979 Dutcher et al.
4,175,565 A 11/1979 Chiarenza et al.
4,177,819 A 12/1979 Kolsky et al.
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"Stimulation ol Bone Healing in new Fractures ol the Tibial Shalt Using Interferential Currents" by Fourie et al., Phys- iotherapy Research International, 2(4) pp. 255-268, 1997. "Bone Healing and Dynamic Interferential Current (DIC)— First Comparative Experimental Animal Study in Sheep" by Laabs et al., Langenbecks Archiv 1982. Inlerential Therapy To Promote Union ol Mandibular Frac- tures, J.M. Ganne et al., Australian and New Zealand Journal of Surgery, vol. 29, No. 1, Feb. 1979, pp. 81-83.
(List continued on next page.)
Primary Examiner—Scott M. Getzow
(74) Attorney, Agent, or Firm—Blank Rome LLP
(57) ABSTRACT
A multi-functional portable electro-medical device provides interferential current stimulation to promote bone growth. Two electrical signals are applied to a target area, each electrical signal being formed by a set of two electrode pads. A beat frequency is created at the location the signals intersect with each other. The beat frequency is the difference between the frequencies of the two signals and has an amplitude that is additive and greater than either signal alone. The depth of the interferential signal is increased by increasing the carrier frequency of the signals. The direction of the interferential signal shifts toward the signal having the lower amplitude. The electrical stimulation is used in combination with biologies to further increase bone growth. The target area is large enough to include multiple vertebral segments.
23 Claims, 58 Drawing Sheets
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Posterolateral Lumbar Intertransverse Process Spine Arthrodesis with Recombinant Human Bone Morphogenetic Protein 2/hyroxyapatite-tricalcium Phosphate after Laminectomy in the Nonhuman Primate, S.D. Boden et al., Spine, Jun. 15, 1999, vol. 24, No. 12; pp. 1179-1185 (abstract only).
CBER Mission/Vision 2004, Strategic Plan for 2004, Center For Biologies Evauation and Research, www.fda.gov/cber/ inside/mission.htm, last updated Nov. 5, 1999 (11 pages). The Bone Morphogenetic Protein Family and Osteogensis, J.M. Wozney, Genetics Institute, Inc., Cambridge, Mol. Reprod. Dev., Jun. 1992, vol. 32 No. 2, pp. 160-167 (Abstract Only).
1995 Volvo Award in Basic Sciences, The Use of an Osteoinductive Growth Factor for Lumbar Spinal Fusion, Part I: Biology of Spinal Fusion, S.D. Boden et al., Spine, vol. 20, No. 24, Dec. 15, 1995, pp. 2626-2632. Bone Morphogenetic Proteins in Human Bone Regeneration, E.H.J. Groneveled and E.H. Burger, European Journal of Endocrinology (2000), vol. 142, pp. 9-21. Cervical Interbody Fusion Cages. An Animal Model with and without Bone Morphogenetic Protein, T.A. Zdeblick et al, Spine, vol. 23, No. 7, Apr. 1998, pp. 758-765. CBER Tissue Action Plan, Center for Biologies Evaluation and Research, www.fda.gov/cber/tissue/purpose.htm last updated Feb. 4, 2000 (2 pages-p. 1 printed Aug. 2000). CBER Xenotransplanation Action Plan, Center for Biologies Evaluation and Research, www.fda.gov/cber/xap/xap.htm last updated Oct. 19, 2000 (4 pages). Inside CBER, Center For Biologies Evaluation and Research, www.fda.gov/cber/inside.htm last updated Oct. 16, 2000 (1 page).
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* cited by examiner
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