Methods and apparatus for treating plantar ulcerations

• US 6,228,044 B1
• Filed: 01/05/1999
• Issued: 05/08/2001
• Est. Priority Date: 01/05/1999
• Status: Expired due to Term

• Current Assignee: Rose Biomedical Development Corporation
• Original Assignee: Rose Biomedical Research
• Inventors: Jensen, Jeffrey L., Burek, Paul P.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): POTHIER, DENISE M
• Application Number:
  US09/225,822
• Time in Patent Office: 854 Days
• Field of Search: 602/27, 602/13, 602/20, 602/60, 602/23, 128/847, 128/892, 128/882, 128/DIG. 20, 5/648, 5/650, 5/651, 601/27, 601/33
• US Class Current: 602/27
• CPC Class Codes: A61F 5/0111 for the feet or ankles
• CPC Class Codes: A61F 5/012 inflatable

Abstract

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.

Claims

1. A method for treating ulcerations on a plantar surface of a patient'"'"'s foot, comprising:

(a) inserting a patient'"'"'s leg between a first and second rigid shell, said first and second shell being generally L-shaped, having a generally semi-cylindrical cross-sectional configuration and being adapted for receiving a lower leg and foot of said patient;

(b) positioning a first adjustable bladder so that said adjustable bladder is sandwiched between said first shell and said leg;

wherein said positioning step involves arranging said first adjustable bladder between said first shell and said leg and arranging a non-adjustable bladder between said second shell and said leg;

(c) fastening said first and second shell together using a fastening system to form a unified brace; and

(d) adjusting the volume of said first adjustable bladder to engage said brace against said leg such that said plantar surface is off-weighted and shearing forces at said plantar surface and plantar flexing are significantly reduced.

2. A method for treating ulcerations on a plantar surface of a patient'"'"'s foot, comprising:

(a) positioning said patient'"'"'s leg in a first shell, said first shell being generally shaped and having a vertical and horizontal section adapted to receive a lower leg and foot of said patient;

said vertical section of said first shell having sufficient longitudinal dimension to extend from a calf of said leg to a location beneath a heel potion of said foot, thus including a calf section and an ankle section which are adapted to receive said calf and an ankle of said patient, respectively, and said horizontal section of said first shell extending outwardly from said vertical section of said first shell and having sufficient length to receive at least a majority of said foot;

(b) placing over the front of said individual'"'"'s leg a second shell, said second shell being generally L-shaped and having a vertical and horizontal section and being adapted to cover said lower leg and said foot;

said vertical section of said second shell having sufficient longitudinal dimension to extend from a shin of said leg to an instep of said leg, and said horizontal section of said second shell extending outwardly from said vertical section of said second shell and having sufficient length to cover a majority of said foot;

(c) fastening said first and second shells using a fastening system to form a unified brace; and

(d) adjusting the volume of at least one of a first and second bladder to create a desired pressure against said leg and to engage said brace against said leg such that said leg is essentially immobile within said brace and said plantar surface is off-weighted;

said at least one of a first and second bladder being disposed in said first and second shell, respectively, and said at least one of said first and second bladder containing a filler which undergoes minimal expansion and contraction as the temperature in said brace fluctuates so that said desired pressure against said leg is maintained to allow said ulcerations to heal.

3. The method of claim 2, wherein said filler is selected from the group consisting of non-compressible silicone, injectible polyurethane foam, silicone and wax liquid composites, and compressible silicone liquid.

4. The method of claim 2, further including a third bladder, said third bladder being generally positioned in said ankle section of said first shell.

5. The method of claim 2, wherein the volume of said first and third bladder is adjustable.

6. The method of claim 2, wherein said first bladder extends substantially the length of said vertical section of said first shell and said second bladder extends substantially the length of said vertical section of said second shell.

7. The method of claim 2, wherein said third bladder is sized to at least partially wrap around said ankle.

8. The method of claim 2, wherein said third bladder includes a central section which is adapted to be connected to said first shell and a first wing and a second wing on opposing sides of said central section, said first and second wing being sized to at least partially wrap around the sides of said ankle.

9. The method of claim 2, wherein the volume of said first bladder is adjustable and wherein the volume of said second bladder remains essentially constant.

10. The method of claim 2 further including a step of engaging a locking means, said locking means restricting the ability of said patient to operate said fastening system.

11. The method of claim 2, wherein:

(a) said first bladder extends substantially the length of said vertical section of said first shell and said second bladder extends substantially the length of said vertical section of said second shell;

(b) said third bladder is sized to at least partially wrap around said ankle;

(c) the volume of said first and third bladder is adjustable; and

(d) said first, second and third bladder contain said filler, said filler being selected from the group consisting of non-compressible silicone, injectible polyurethane foam, silicone and wax liquid composites and compressible silicone liquid.

12. A method for treating ulcerations on a plantar surface of a patient'"'"'s foot, comprising:

(a) inserting the patient'"'"'s leg between a first and second rigid shell, said first and second rigid shell being adapted for receiving a lower leg and a foot of the patient;

(b) positioning a first adjustable bladder so that said first adjustable bladder is sandwiched between said first shell and said leg;

(c) positioning a second bladder so that said second bladder is sandwiched between said second shell and said leg;

(d) fastening said first and second shell together using a fastening system to form a unified brace; and

(e) adjusting the volume of said first adjustable bladder by adding or removing a substantially incompressible filler to off-weight the patient'"'"'s foot to allow said ulcerations to heal.

13. The method of claim 12, wherein said adjusting stop utilizes a filler that undergoes minimal expansion and contraction as the temperature in said brace fluctuates.

14. The method of claim 12, wherein said adjusting step utilizes a filler selected from the group consisting of non-compressible silicon, indictible polyurethane foam, silicone and wax liquid composites, and compressible silicone liquid.

15. A method for treating ulcerations on a plantar surface of a patient'"'"'s foot, comprising:

(a) inserting the patients'"'"' leg between a first and second rigid shell, said first and second rigid shell being adapted for receiving a lower leg and a foot of the patient;

(b) positioning a first adjustable bladder so that said first adjustable bladder is sandwiched between said first shell and said leg;

(c) positioning a second bladder so that said second bladder is sandwiched between said second shell and said leg;

(d) fastening said first and second shell together using a fastening system to form a unified brace; and

(e) adjusting the volume of said first adjustable bladder by adding or removing a substantially incompressible filler to elevate at least a portion of the patient'"'"'s foot from an interior bottom surface of said brace to allow said ulcerations to heal.