Walking boot for diabetic and other patients

• US 20050172517A1
• Filed: 02/24/2005
• Published: 08/11/2005
• Est. Priority Date: 12/21/2000
• Status: Active Grant

• Current Assignee: Breg Incorporated (Breg Acquisition Corp.)
• Original Assignee: Medical Technology Incorporated
• Inventors: Bledsoe, Gary R., Bledsoe, Brett O.
• Granted Patent: US 7,418,755 B2
• Time in Patent Office: Days
• US Class Current: 36/110
• CPC Class Codes: A43B 7/141 having an anatomical or curved form
• CPC Class Codes: A43B 7/28 Adapting the inner sole or the side of the upper of the shoe to the sole of the foot

Abstract

An orthopedic walking boot promotes rapid healing of diabetic foot ulcerations by lowering the maximum peak pressure imposed upon the foot. The walker has a hard unyielding shell which is designed for walking. The shell closely and rigidly supports a mid-sole in a foot-shaped bed. The mid-sole has a foot-shaped cavity with rounded sides adapted to form resilient support for the heel, arch and sides of a foot in addition to the bottom of a foot. A conformable inner-sole is adapted to fit over the foot-shaped cavity in the mid-sole and be compressed in response to foot pressure between the sides and bottom of the foot and the sides and bottom of the foot-shaped cavity in the mid-sole thereby compensating for small differences between the shape of the foot and the shape of the cavity. Weight applied to the foot is transferred to the walking shell by contact between the sides of the foot, arch, and heel and the arch, heel and sides of the foot-shaped cavity as well as the bottom of the cavity thereby decreasing the peak or maximum unit pressure on the plantar surface of the foot. A breathable bootie which wraps the foot and lower leg in a protective “cocoon” is preferably secured to the upper surface of the insole thereby preventing foreign materials from entering the foot cavity.

Claims

1. An improved walking boot, comprising:

a walking shell having an inner and an outer surface, wherein the outer surface is a walking surface and the inner surface is a foot bed designed to receive and support a mid-sole;

one or more upright struts secured to said walking shell, said one or more upright struts adapted to secure said walking boot to a lower leg;

a premolded mid-sole having a lower outer surface mounted on said foot bed and an upper surface comprising a foot shaped cavity having a bottom surface with upwardly curving sides;

wherein said mid-sole is formed from material that will rebound from pressure and will not take a compression set;

an inner-sole having a foot receiving upper surface adapted to receive a foot and a bottom surface adapted to fit over said upper surface of said mid-sole, said inner-sole formed from a material that does not readily rebound from pressure and that will take a compression set in response to foot pressure, such that said inner-sole is adapted to mold itself closely to the loaded shape of the foot and tightly against said upwardly curving walls of said mid-sole; and

said foot shaped cavity having a width and depth such that in response to foot pressure the peripheral edges of said foot are loaded by said upwardly curving sides of said foot shaped cavity prior to said bottom of said foot shaped cavity loading the bottom of said foot;

2. The improved walking boot of claim 1, further comprising one or more upwardly turned edges on the walking shell, wherein spreading of said mid-sole in response to foot pressure is prevented by contact between said lower outer surface of said mid-sole and said one or more upwardly turned edges of said walking shell.

3. The improved walking boot of claim 1, further comprising:

a peripheral flange extending laterally substantially all around said foot receiving upper surface of said inner-sole;

a durable and resilient protective bootie adapted to extend around the lower leg and foot to restrict foreign objects from reaching the foot, said bootie having an open bottom secured to said peripheral flange of said inner-sole; and

wherein said one or more upright struts are secured to said bootie extending around the lower leg.

4. The improved walking boot of claim 1, wherein said inner-sole further comprises a skinned outer surface that prevents penetration by moisture or other liquids.

5. The improved walking boot of claim 1 wherein said mid-sole further comprises:

a lower density upper layer and a higher density lower layer;

said lower density upper layer composed of a material that will compress to accommodate the shape of said foot without taking a compression set;

said higher density lower layer composed of a material that will not significantly compress under foot pressure; and

wherein said mid-sole has a thickness and said lower density upper layer makes up about ⅔

of said thickness of said mid-sole and said higher density lower layer makes up about ⅓

of said thickness of said mid-sole.

6. The improved walking boot of claim 5 wherein said lower density upper layer has a Shore “

00”

hardness of about 50-55 and said higher density lower layer has a Shore “

A”

hardness of about 25-30.

7. The improved walking boot of claim 6, further comprising:

one or more upwardly turned edges on the walking shell, wherein spreading of said mid-sole in response to foot pressure is prevented by contact between said lower outer surface of said mid-sole and said one or more upwardly turned edges of said walking shell;

a peripheral flange extending laterally substantially all around said foot receiving upper surface of said inner-sole;

a skinned outer surface on said inner-sole that prevents penetration by moisture or other liquids;

a durable and resilient protective bootie adapted to extend around the lower leg and foot to restrict foreign objects from reaching the foot, said bootie having an open bottom secured to said peripheral flange of said inner-sole;

two upright struts extending vertically from said walking shell, said upright struts adapted to secure said walking boot to said protective bootie surrounding the lower leg; and

wherein said foot shaped cavity and said compression set inner-sole combine to maintain peak pressure on said foot below about 20.5 newtons per square centimeter.

8. The improved walking boot of claim 1 wherein each said one or more upright struts is connected to said walking shell by an adjustable joint that allows said one or more upright struts to adjustably pivot forward and backward relative to said walking shell.

9. The improved walking boot of claim 1 comprising two upright struts extending vertically from said walking shell, wherein said lower leg can be secured between said struts in a slight forward angled position, thereby slightly dorsiflexing the ankle.

10. The improved walking boot of claim 1 comprising two upright struts extending vertically from said walking shell, wherein said lower leg can be secured between said struts in a slight backward angled position, thereby slightly plantarflexing the ankle.

11. The improved walking boot of claim 1 wherein said foot shaped cavity and said compression set inner-sole combine to maintain peak pressure on said foot below about 20.5 newtons per square centimeter.

12. An improved walking boot, comprising:

a walking shell having an inner and an outer surface, wherein the outer surface is a walking surface and the inner surface is a foot bed designed to receive and support a mid-sole;

one or more upright struts secured to said walking shell, said one or more upright struts adapted to secure said walking boot to a lower leg;

a premolded mid-sole having a lower outer surface mounted on said foot bed and an upper surface comprising a foot shaped cavity having a bottom surface with upwardly curving sides;

wherein said mid-sole is formed from a lower density upper layer and a higher density lower layer, said lower density upper layer composed of a material that will compress to accommodate the shape of said foot without taking a compression set and said higher density lower layer composed of a material that will not significantly compress under foot pressure;

an inner-sole having a foot receiving upper surface adapted to receive a foot and a bottom surface adapted to fit over said upper surface of said mid-sole, said inner-sole formed from a material that does not readily rebound from pressure and that will take a compression set in response to foot pressure, such that said inner-sole is adapted to mold itself closely to the loaded shape of the foot and tightly against said upwardly curving walls of said mid-sole; and

said foot shaped cavity having a width and depth such that in response to foot pressure the peripheral edges of said foot are loaded by said upwardly curving sides of said foot shaped cavity prior to said bottom of said foot shaped cavity loading the bottom of said foot.

13. The improved walking boot of claim 12, further comprising one or more upwardly turned edges on the walking shell, wherein spreading of said mid-sole in response to foot pressure is prevented by contact between said lower outer surface of said mid-sole and said one or more upwardly turned edges of said walking shell.

14. The improved walking boot of claim 12, further comprising:

a peripheral flange extending laterally substantially all around said foot receiving upper surface of said inner-sole;

a durable and resilient protective bootie adapted to extend around the lower leg and foot to restrict foreign objects from reaching the foot, said bootie having an open bottom secured to said peripheral flange of said inner-sole; and

wherein said one or more upright struts are secured to said bootie extending around the lower leg.

15. The improved walking boot of claim 12, wherein said inner-sole further comprises a skinned outer surface that prevents penetration by moisture or other liquids.

16. The improved walking boot of claim 12 wherein said lower density upper layer has a Shore “

00”

hardness of about 50-55 and said higher density lower layer has a Shore “

A”

hardness of about 25-30.

17. The improved walking boot of claim 12, wherein said foot shaped cavity and said compression set inner-sole combine to maintain peak pressure on said foot below about 20.5 newtons per square centimeter.

18. A method of supporting an injured foot, comprising:

providing a walking shell having inner and outer surfaces and one or more upright struts, wherein the outer surface is a walking surface and the inner surface is a foot bed designed to receive and support a mid-sole;

mounting a premolded mid-sole in the foot-bed, the mid-sole having a foot shaped cavity having a bottom surface with upwardly curving sides;

said mid-sole formed of a material having the characteristic of yielding without taking a compression set;

placing a self-molding inner-sole having a foot receiving upper surface and a bottom surface adapted to fit over the upper surface of the mid-sole in a manner that allows the inner-sole to conform itself closely to a foot and fit tightly against the upwardly curving walls of the mid-sole;

placing a foot on the foot receiving upper surface of the self-molding inner-sole over the foot receiving cavity in the mid-sole;

putting weight on the foot, thereby conforming and compressing the self-molding inner-sole closely against the loaded foot between the bottom and sides of the foot and the foot-shaped cavity;

said foot shaped cavity having a width and depth such that in response to foot pressure the peripheral edges of said foot are loaded by said upwardly curving sides of said foot shaped cavity prior to said bottom of said foot shaped cavity loading the bottom of said foot; and

securing a lower leg to said one or more upright struts after said inner-sole is compression molded.

19. The method of claim 18 further comprising the step of protecting the foot from hard foreign particles by surrounding the lower leg and foot with a durable and resilient soft protective bootie, said bootie having an open bottom that is secured to a flange around said foot receiving upper surface on said inner-sole.

20. The method of claim 18 further comprising the step of securing the ankle in slight dorsiflexion thereby further reducing the peak pressure on the hind foot.

21. The method of claim 20 wherein said slight dorsiflexion is created by angling said lower leg forward slightly before securing said lower leg to said one or more upright struts.

22. The method of claim 20 wherein said slight dorsiflexion is created by adjusting the angle of said one or more upright struts and said walking shell to angle said upright strut backward prior to securing said lower leg in alignment with said one or more upright struts.

23. The method of claim 18 further comprising the step of securing the ankle in slight plantarflexion, thereby further reducing the peak pressure on the fore foot.

24. The method of claim 23 wherein said slight plantarflexion is created by angling said lower leg backward slightly before securing said lower leg to said one or more upright struts.

25. The method of claim 23 wherein said slight plantarflexion is created by adjusting the angle of said one or more upright struts and said walking shell to angle said upright strut forward prior to securing said lower leg in alignment with said one or more upright struts.