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(12) United States Patent ao) Patent No.: us 6,228,044 Bi
Jensen et al. (45) Date of Patent: *May 8,2001
(54) METHODS AND APPARATUS FOR
TREATING PLANTAR ULCERATIONS
(75) Inventors: Jeffrey L. Jensen, Highlands Ranch;
Paul P. Burek, Aurora, both ol CO
(73) Assignee: Rose Biomedical Research, Denver,
( * ) Notice: This patent issued on a continued prosecution application filed under 37 CFR 1.53(d), and is subject to the twenty year patent term provisions of 35 U.S.C. 154(a)(2).
Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.
(21) Appl. No.: 09/225,822
(22) Filed: Jan. 5, 1999
(51) Int. C I. A61F 5/00
(52) U.S. CI 602/27; 602/23
(58) Field of Search 602/27, 13, 20,
602/60, 23; 128/847, 892, 882, DIG. 20;
5/648, 650, 651; 601/27, 33
The present invention provides methods and an apparatus for treating patients having ulcerations of the lower foot, including patients suffering from diabetic neuropathy. The brace generally includes a pair of rigid shells, a fastening system for joining the shells together to form a unified brace and a combination of bladders which engage the patient's leg and ankle to off-weight the plantar surface, prevent plantar flexing and minimize shearing forces to the plantar surface. The volume of the bladders may be adjusted by the addition or removal of a filler in order to maintain a uniform pressure between the bladders and the patient's leg. The filler contained in the bladders preferably does not undergo significant expansion or contraction in response to temperature or altitude changes. The brace also preferably includes a series of full-length bladders and a specially designed adjustable bladder located within the ankle and heel region of the brace to maximize off-weighting and to prevent the foot from moving downward toward the footbed of the brace. In addition to providing an effective means for off-weighting the plantar surface of a patient, the brace is reuseable, easy to apply and fully adjustable to accommodate changes in a patient's leg size.
Ulbrecht et al., "Controversies in Footwear . . .", pp. 441-451.
Fleischli et al., "Comparison of Strategies for Reducing ...", Journal of the American Podiatric Medical Association, vol. 87, No. 10, Oct. 1997, 466^172.
Scholl, William M. PhD., "Scholl Human Orthopedics and Engineering Labs", Version 1.2.
Shaw et al., "The Mechansim of Plantar Unloading in . . .", Foot & Ankle International, vol. 18, No. 12, Dec. 1997, pp. 809-817.
Armstrong et al., "Peak Foot Pressures Influence the . . .", Journal of rehabilitation Research and Development., vol. 35, No. 1, Jan. 1998, pp. 1-5.
Baumhauer et al., "A Comparison Study of Plantar Foot . . . ", Foot & Ankle International, vol. 18, No. 1, Jan. 1997, pp. 26-33.
Aircast, Inc., "Pneumatic Walker Diabetic System", Brochure produced by Aircast, Inc.
* cited by examiner