Methods and apparatus for treating plantar ulcerations

• US 6,682,497 B2
• Filed: 01/08/2001
• Issued: 01/27/2004
• Est. Priority Date: 01/05/1999
• Status: Expired due to Term

• Current Assignee: Rose Biomedical Development Corporation
• Original Assignee: Rose Biomedical Development Corporation
• Inventors: Jensen, Jeffrey L., Burek, Paul P.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): HWANG, VICTOR KENNY
• Application Number:
  US09/756,323
• Publication Number:
  US 20020095105A1
• Time in Patent Office: 1,114 Days
• Field of Search: 602/5, 602/13, 602/23, 602/27, 128/882, 128/892, 128/DIG.20, 564/8, 565/0, 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 brace for treating ulcerations on a plantar surface of a patient'"'"'s foot, comprising:

(a) 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 a foot of said patient, both shells including a vertical and horizontal section;

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 portion 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;

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 at least a majority of said foot;

(b) a first, second, and third bladder, said first bladder being positioned in said first shell, said second bladder being positioned in said second shell, and said third bladder being generally positioned in said ankle section, wherein at least one of said first, second, and third bladder contains a filler which undergoes minimal expansion and contraction as the temperature in said brace fluctuates, and further wherein the volume of at least one of said first, second and third bladder can be adjusted by the addition or removal of said filler to provide pressure between said at least one of said first, second and third bladder and said leg; and

(c) a fastening system which joins said first and second shell and immobilizes said first shell and said second shell around said leg to form said brace.

2. The brace of claim 1, 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.

3. The brace of claim 1, wherein said third bladder is sized to at least partially wrap around said ankle.

4. The brace of claim 3, 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 opposing sides of said ankle.

5. The brace of claim 1, wherein said third bladder extends beyond the ankle region of said first shell to cover a portion of an interior region of said horizontal section of said first shell where the underside of said patient'"'"'s heel is positioned.

6. The brace of claim 1, wherein the volume of said first bladder is adjustable and wherein the volume of said second bladder remains essentially constant.

7. The brace of claim 6, wherein the volume of said first and third bladder is adjustable.

8. The brace of claim 1, wherein said third bladder acts to immobilize said ankle and restricts the motion of said foot toward said horizontal section of said first shell.

9. The brace of claim 1, further including a layer of absorbent material attached to at least one of said first and second bladder and being positioned to contact the surface of said leg.

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

(a) a first and second 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 a foot of said patient, both shells including a vertical and horizontal section;

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 portion 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;

said vertical section of said second shell having sufficient longitudinal dimension to extend from a shin of said lower 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 at least a majority of said foot;

(b) a first, second, and third bladder, said first bladder being positioned in said first shell, said second bladder being positioned in said second shell, and said third bladder being generally positioned in said ankle section, wherein at least one of said first, second, and third bladder contains a filler which undergoes minimal expansion and contraction as the temperature in said brace fluctuates, and further wherein the volume of at least one of said first, second, and third bladder can be adjusted by the addition or removal of said filler to provide pressure between said at least one of said first, second, and third bladder and said leg; and

(c) a fastening system which joins said first and second shell and immobilizes said first shell and said second shell around said leg to form said brace.

11. The brace of claim 10, wherein said filler is selected from the group consisting of non-compressible silicon, injectible polyurethane foam, silicone and wax liquid composites, and compressible silicone liquid.

12. The brace of claim 10, 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.

13. The brace of claim 10, wherein said third bladder is sized to at least partially wrap around said ankle.

14. The brace of claim 13, 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.

15. The brace of claim 10, wherein the volume of said first bladder can be adjusted by the addition or removal of said filler and wherein the volume of said second bladder remains essentially constant.

16. The brace of claim 15, wherein the volume of said first and third bladder can be adjusted by the addition or removal of said filler.

17. The brace of claim 10, wherein said third bladder acts to immobilize said ankle and restricts the motion of said foot toward said horizontal section of said first shell.