Dual-layer insole apparatuses for diabetic foot lesion prevention and related methods

Patent metadata

Field	Value
Publication number	US-11172731-B2
Application number	US-201716464443-A
Country	US
Kind code	B2
Filing date	Nov 28, 2017
Priority date	Nov 28, 2016
Publication date	Nov 16, 2021
Grant date	Nov 16, 2021

Abstract

Dual-layer insole apparatuses for diabetic foot lesion prevention and related methods are provided. Some insole apparatuses have a body defining a plurality of cavities configured to be coupled to a fluid source. The fluid source can deliver fluid to vary internal pressures of the cavities. The body further defines an insole-shaped structure.

First claim

The invention claimed is:

1. An insole apparatus to distribute pressure and sheer stresses on a foot due caused by mechanical loading due to walking or running comprising:
a body defining a plurality of cavities configured to be coupled to a fluid source such that the fluid source can deliver fluid to vary internal pressures of the cavities;
wherein the body defines an insole-shaped structure and the insole apparatus is configured to removably fit within a shoe; and
a processor configured to control the fluid source to:
(a) hold pressure in a first one or more of the cavities to be substantially constant;
(b) increase pressure of a second one or more of the cavities while the pressure in the first one or more of the cavities remains substantially constant;
(c) after a predetermined amount of time, decrease pressure of the second one or more of the cavities while the pressure in the first one or more of the cavities remains substantially constant; and
(d) increase pressure of a third one or more of the cavities while the pressure in the first one or more of the cavities remains substantially constant.

2. The insole apparatus of claim 1 , wherein the body is configured to be disposed under a patient's foot such that one or more of the cavities is disposed under a plantar surface of at least one portion of the patient's foot selected from the group consisting of: a metatarsal head, a hallux, and a calcaneus bone.

3. The insole apparatus of claim 1 , comprising a flexible substrate configured to be disposed over the cavities such that the flexible substrate matches the contours of the plurality of cavities.

4. The insole apparatus of claim 3 , where the flexible substrate includes a plurality of flexible substrate segments, each of which is configured to be disposed over a respective cavity.

5. The insole apparatus of claim 3 , wherein the body includes a plurality of protrusions extending toward the flexible substrate to define the cavities.

6. The insole apparatus of claim 5 , wherein each of the protrusions includes an elastomeric material configured to deform when the internal pressure of the respective cavity is varied.

7. The insole apparatus of claim 1 , comprising at least one sensor configured to capture data indicative of a pressure in one or more of the cavities.

8. The insole apparatus of claim 1 , wherein:
a first one or more of the cavities is in a first region of the body extending from a first side of the body to a second side of the body, wherein the first region is closer to a first end of the body than a second end of the body;
a second one or more of the cavities is in a second region of the body extending from the first region toward the first end and along the first side; and
a third one or more of the cavities are in a third region of the body extending from the first side to the second side at the second end.

9. The insole apparatus of claim 8 , wherein, when in use, the first region is configured to be disposed under a plantar surface of one or more metatarsal heads of a foot, the second region is configured to be disposed under a plantar surface of a hallux of a foot, and the third region is configured to be disposed under a plantar surface of a calcaneus bone of a foot.

10. The insole apparatus of claim 1 , comprising a second body defining a plurality of cavities configured to be coupled to the fluid source such that the fluid source can deliver fluid to vary internal pressures of the cavities, wherein, when in use, the second body is configured to be positioned above a dorsal surface of a foot.

11. The insole apparatus of claim 1 , wherein at least one cavity of the plurality of cavities includes a valve to atmosphere pressure, and the processor is further configured to open the value to bleed off pressure in the at least one cavity until a desired pressure is reached in the at least one cavity.

12. The insole apparatus of claim 1 , wherein the processor within the insole apparatus is further configured to:
fill the first one or more of the cavities with the fluid before the wearer puts on the shoe; and
fill the second one or more of the cavities with the fluid after the wearer puts on the shoe.

13. A method for actuating an insole apparatus having a body defining a plurality of cavities configured to be coupled to a fluid source such that the fluid source can deliver fluid to vary internal pressures of the cavities, wherein the body defines an insole-shaped structure and the insole apparatus is configured to removably fit within a shoe of a wearer and to distribute pressure and sheer stresses on a foot due caused by mechanical loading due to walking or running, the method comprising:
(1) while the wearer is walking or running, holding pressure in a first one or more of the cavities to be substantially constant;
(2) while the wearer is walking or running, increasing pressure of a second one of the cavities while the pressure in the first one or more of the cavities remains substantially constant;
(3) while the wearer is walking or running, after a first predetermined amount of time, decreasing pressure of the second one or more of the cavities while the pressure in the first one or more of the cavities remains substantially constant;
(4) while the wearer is walking or running, increasing pressure of a third one or more of the cavities while the pressure in the first one or more of the cavities remains substantially constant;
(5) while the wearer is walking or running, after a second predetermined amount of time, decreasing pressure of the third one or more of the cavities while the pressure in the first one or more of the cavities remains substantially constant; and
(6) while the wearer is walking or running, increasing pressure of a fourth one or more of the cavities, wherein insole apparatus is configured to removably fit within a shoe.

14. The method of claim 13 , wherein:
the second one or more of the cavities is aligned with a plantar surface of one or more metatarsal heads of a foot;
the third one or more of the cavities is aligned with the plantar surface of a hallux of the foot; and
the fourth one or more of the cavities is aligned with the plantar surface of a calcaneus bone of the foot.

15. The method of claim 13 , wherein steps (1)-(6) are controlled by a processor.

16. The method of claim 13 , comprising repeating steps (1)-(6).

17. The method of claim 13 , comprising simultaneously decreasing pressure of at least two of the first, second, and third one or more of the cavities while the pressure in the first one or more of the cavities remains substantially constant.

18. A method for actuating an insole apparatus having a body defining a plurality of cavities configured to be coupled to a fluid source such that the fluid source can deliver fluid to vary internal pressures of the cavities, wherein the body defines an insole-shaped structure and the insole apparatus is configured to removably fit within a shoe of a wearer and to distribute pressure and sheer stresses on a foot due caused by mechanical loading due to walking or running, the method comprising:
(1) while the wearer is walking or running, increasing a first, second, and third one of the cavities to a first pressure;
(2) while the wearer is walking or running, decreasing pressure of the second one of the cavities to a second pressure while maintaining the first and third one of the cavities at the first pressure;
(3) while the wearer is walking or running, after a first predetermined amount of time, increasing pressure of the second one o

Assignees

• Univ Texas
• The Univ Of North Texas Health Science Center At Fort Worth
• The Board of Regents of the Universsity of Texas Systems

Inventors

• Wijesundara Muthu B J
• Carrigan Wei
• Landrith Ryan
• Yavuz Metin

Classifications

• A43B3/34

  with electrical or electronic arrangements · CPC title

• A61F5/14 Primary

  Special medical insertions for shoes for flat-feet, club-feet or the like · CPC title

• A43B13/20

  Pneumatic soles {filled with a compressible fluid, e.g. air, gas (inflatable linings for skiboots A43B5/0407)} · CPC title

• A43B13/203

  provided with a pump or valve · CPC title

• A43B17/03

  filled with a gas, e.g. air · CPC title