Method and apparatus for the treatment of plantar ulcers and foot deformities

• US 20050240133A1
• Filed: 06/24/2005
• Published: 10/27/2005
• Est. Priority Date: 05/17/2002
• Status: Active Grant

• Current Assignee: John E. Rooney
• Original Assignee: John E. Rooney
• Inventors: Rooney, John E.
• Granted Patent: US 7,727,173 B2
• Time in Patent Office: Days
• US Class Current: 602/23
• CPC Class Codes: A61F 5/0111 for the feet or ankles

Abstract

A custom-made ankle/foot orthosis for the treatment of patients having plantar ulcers and foot deformities is disclosed, which comprises a rigid L-shaped support member and a rigid anterior support shell hingedly articulated to the L-shaped support member. The plantar portion of the L-shaped member further comprises at least one ulcer-protecting hollow spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar ulcer, thus allowing the user to transfer the user'"'"'s weight away from the plantar ulcer and facilitating plantar ulcer treatment. The anterior support shell is designed for lateral hinged attachment to the L-shaped member to take advantage of medial tibial flare structure for enhancing the weight-bearing properties of the disclosed orthosis. Leg securement structure attaches the anterior support shell to the L-shaped member in fixed, weight-bearing relation about the proximal, anterior portion of the user'"'"'s lower leg.

Claims

1. An orthosis for the treatment of diabetic plantar ulcers and foot deformities, the orthosis comprising:

a substantially rigid, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, continuously-formed, posterior support shell and a substantially horizontal, continuously-formed, plantar support platform, the posterior support shell having a posterior shell height and the plantar support platform having a platform length, the posterior support shell having an inner posterior shell surface and an outer posterior shell surface, the posterior support shell being sized and shaped to receive all posterior portions of a user'"'"'s lower leg and tarsal region, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the posterior support shell height terminating proximally in a proximal flared posterior shell brim, the posterior support shell height terminating distally in a tarsal support structure, the tarsal support structure comprising a medial tarsal support portion, a lateral tarsal support portion, and a heel support portion intermediate the medial tarsal support portion and lateral support portion, the medial tarsal support portion and the lateral tarsal support portion extending ventrally to a point intermediate the platform length, the proximal flared posterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of a user'"'"'s lower leg, the posterior support shell having a circumferential corrugated rib structure intermediate the posterior support shell height, the plantar support platform having a superior platform surface and an inferior platform surface, the plantar support platform further comprising at least one substantially rigid, integrally-formed, ulcer-protecting hollow, the hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior platform surface and the inferior hollow surface being continuous with the inferior platform surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s diabetic plantar ulcer, the superior hollow surface being spaced from the user'"'"'s diabetic plantar ulcer, the hollow for transferring a user'"'"'s weight away from the plantar ulcer thus facilitating plantar ulcer treatment;

a substantially rigid, anterior support shell for lateral hinged attachment to the posterior support shell, the anterior support shell having an inner anterior support shell surface and an outer anterior support shell surface, the anterior support shell for receiving the anterior, proximal portion of a user'"'"'s leg, the anterior support shell having a proximal flared anterior shell brim and a distal flared anterior shell rim, the proximal flared anterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of the user'"'"'s leg, the anterior support shell further comprising a plurality of securing strap receiving loops securely attached to the outer anterior support shell surface, a flexible polyethylene hinge member for hingedly attaching the anterior support shell to the posterior support shell, the hinge member having an inner hinge surface and an outer hinge surface, the hinge member having a posterior hinge portion and an anterior hinge portion, the outer hinge surface of the anterior hinge portion being securely fastened to the lateral most edge of the inner anterior support shell surface, the inner hinge surface of the posterior hinge portion being securely fastened to the lateral most edge of the outer posterior support shell surface, thus hingedly attaching the anterior support shell to the posterior support shell such that the proximal flared anterior shell brim and proximal flared posterior shell brim lie in substantially the same, substantially horizontal plane and such that the distal flared anterior shell brim and circumferential corrugated rib structure lie in substantially the same, substantially horizontal plane, the circumferential corrugated rib structure for increasing structural strength of the posterior support shell and for guiding placement of the anterior support shell;

a plurality of securing straps, the securing straps each having an inner strap surface and an outer strap surface, said inner and outer strap surfaces being sized and shaped and of sufficient length so as to be disposable in lapped engagement; and

connecting means joining the inner strap surface and the outer strap surface in secured manual detachable engagement, the securing straps each having a posterior shell attachment end fixedly attached to the anterior support shell for fixed weight bearing engagement about the anterior portions of the user'"'"'s lower leg.

2. The orthosis of claim 1 comprising a sole, the sole being adhesively attached to the inferior platform surface, the adhesively attached sole enabling the user to ambulate without a shoe.

3. The orthosis of claim 1 wherein the orthosis may be replaced by an alternative orthotic design as prescribed given a select biological development, the select biological development being selected from the group consisting of reduced edema and ulcer healing.

4. An orthosis assembly for the treatment of diabetic plantar ulcers and foot deformities, the orthosis assembly comprising:

a substantially L-shaped lower leg support structure, the lower leg support structure comprising at least one substantially vertical, leg support portion and a substantially horizontal, foot support portion, the leg support portion being sized and shaped to receive a portion of a user'"'"'s lower leg, the foot support portion being sized and shaped to support a portion of a user'"'"'s foot, the leg support portion terminating proximally in an upper rim and terminating distally in a tarsal support structure, the tarsal support structure comprising a medial tarsal support portion and a lateral tarsal support portion, the medial tarsal support portion and the lateral tarsal support portion being cooperatively associated with the foot support portion, the upper rim being spatially located for fitted placement distal to the knee region of a user'"'"'s lower leg, the foot support portion having a superior surface, an inferior surface, and at least one rigid, off-loading, wound-protecting hollow, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment; and

leg securement means, the leg securement means being selectively encircled about the user'"'"'s lower leg for securing the leg support portion to the user'"'"'s lower leg.

5. The orthosis assembly of claim 4 comprising an anterior leg engagement portion, the leg support portion comprises a proximal flared posterior brim adjacent the upper rim and a circumferential rib structure intermediate the upper rim and the foot support portion, the anterior leg engagement portion comprising a proximal flared anterior brim and a distal flared anterior rim, the proximal flared anterior shell brim adjacent the upper rim, the anterior leg engagement portion being attached to the leg support portion such that the proximal flared anterior brim and proximal flared posterior brim lie in substantially the same plane and such that the distal flared anterior brim and circumferential rib structure lie in substantially the same plane, the proximal flared posterior brim and the circumferential rib structure for guiding placement of the anterior support shell.

6. The orthosis assembly of claim 4 wherein the leg support portion and the foot support portion are constructed by way of a lamination process, the lamination process utilizing a select resin, the select resin being selected from the group consisting of polyester resin and acrylic resin.

7. The orthosis assembly of claim 4 wherein the leg support portion comprises an inner leg support surface, leg support padding being attached to the inner leg support surface for alleviating skin irritation of the user'"'"'s lower leg and for maintaining total contact and foot support padding is attached to the plantar support platform.

8. The orthosis assembly of claim 7 wherein the padding is attached to at least one anterior portion of the leg support portion for relieving bony prominences at an anterior portion of the user'"'"'s lower leg.

9. The orthosis assembly of claim 7 wherein the foot support portion is contoured to conform to the plantar surface of the user'"'"'s foot, the foot support portion comprising a plurality of regions, the plurality of regions for supporting a plurality of foot regions of the user'"'"'s foot.

10. The orthosis assembly of claim 9 wherein the plurality of regions are selected from a region grouping, the region grouping comprising a first anterior segment for supporting the toe region of the user'"'"'s foot, a second anterior segment for supporting the metatarsal head region of the user'"'"'s foot, an intermediate sole segment for supporting the arch region of the user'"'"'s foot, and a posterior segment for supporting the heel region of the user'"'"'s foot.

11. The orthosis assembly of claim 10 wherein the region grouping comprises a partial foot filler prosthesis, the partial foot filler prosthesis for filling space adjacent the user'"'"'s foot, the user'"'"'s foot being amputated at a point intermediate the toe region and heel region.

12. The orthosis assembly of claim 8 wherein the leg securement means comprises at least one tie member, the tie member for binding the anterior portion of the leg support portion.

13. The orthosis assembly of claim 12 wherein the anterior portion of the leg support portion is removably attachable to the leg support portion.

14. The orthosis assembly of claim 7 wherein the lower leg support structure comprises select ankle support means, the select ankle support means being selected from the group consisting of ankle movement-enabling means and ankle movement-restricting means.

15. The orthosis assembly of claim 7 comprising select orthotic accessories, the select orthotic accessories being selected from the group consisting of at least one rigid upright assembly and at least one modified shoe, the modified shoe being custom-fitted for receiving the orthosis assembly, the rigid upright assembly being cooperatively associated with the leg support portion and the foot support portion for providing select support reinforcing means, the select support reinforcing means being selected from the group consisting of ankle movement-enhancing means and ankle movement-preventing means.

16. The orthosis assembly of claim 15 wherein custom alignment wedges are used in combination with the foot support portion and at least one modified shoe.

17. The orthosis assembly of claim 4 wherein the user may stand or walk while wearing the orthosis assembly.

18. An orthotic accessory assembly for the treatment of diabetic plantar ulcers, the orthotic accessory assembly comprising a foot support portion, the foot support portion being sized and shaped to support a portion of a user'"'"'s foot, the foot support portion having a superior support surface, an inferior support surface, and at least one off-loading, wound-protecting hollow, the wound-protecting hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior support surface and the inferior hollow surface being continuous with the inferior support surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment.

19. The orthotic accessory assembly of claim 18 comprising leg securement means, the leg securement means being cooperatively associated with the user'"'"'s lower leg for securing the foot support portion to the user'"'"'s lower leg.

20. The orthotic accessory assembly of claim 19 wherein the user may stand or walk while wearing the orthotic assembly.

21. The orthotic accessory assembly of claim 19 wherein the leg securement means comprises a leg support portion, the leg support portion being sized and shaped to receive a portion of a user'"'"'s lower leg, the leg support portion terminating proximally in an upper rim and terminating distally in a tarsal support structure, the tarsal support structure being cooperatively associated with the foot support portion, the upper rim being spatially located for fitted placement distal to the knee region of a user'"'"'s lower leg.

22. The orthotic accessory assembly of claim 21 wherein the leg support portion and the foot support portion are constructed by way of a lamination process, the lamination process utilizing a select resin, the select resin being selected from the group consisting of polyester resin and acrylic resin.

23. The orthotic accessory assembly of claim 21 wherein the foot support portion is contoured to conform to the plantar surface of the user'"'"'s foot, the foot support portion comprising a plurality of regions, the plurality of regions for supporting a plurality of foot regions of the user'"'"'s foot.

24. The orthotic accessory assembly of claim 23 wherein the plurality of regions are selected from a region grouping, the region grouping comprising a first anterior segment for supporting the toe region of the user'"'"'s foot, a second anterior segment for supporting the metatarsal head region of the user'"'"'s foot, an intermediate sole segment for supporting the arch region of the user'"'"'s foot, and a posterior segment for supporting the heel region of the user'"'"'s foot.

25. The orthotic accessory assembly of claim 24 wherein the region grouping comprises a partial foot filler prosthesis, the partial foot filler prosthesis for filling space adjacent the user'"'"'s foot, the user'"'"'s foot being amputated at a point intermediate the toe region and heel region.

26. The orthotic accessory assembly of claim 19 wherein the lower leg support structure comprises select ankle support means, the select ankle support means being selected from the group consisting of ankle movement-enabling means and ankle movement-restricting means.

27. The orthotic accessory assembly of claim 19 comprising select orthotic accessories, the select orthotic accessories being selected from the group consisting of at least one rigid upright assembly and at least one modified shoe, the modified shoe being custom-fitted for receiving the foot support portion and the leg support portion, the rigid upright assembly being cooperatively associated with the leg support portion and the foot support portion for providing select support reinforcing means, the select support reinforcing means being selected from the group consisting of ankle movement-enhancing means and ankle movement-preventing means.

28. The orthotic accessory assembly of claim 27 wherein at least one layer of foam padding is spaced intermediate the modified shoe and the foot support portion.

29. The orthotic accessory assembly of claim 28 wherein the foot support portion is constructed from vacuum form molded polypropylene, the off-loading, wound-protecting hollow being molded into the polypropylene.

46. The orthotic accessory assembly of claim 18 in combination with a shoe, the shoe support portion being placed inside of said shoe, and a metal and calf leather corset attached to the shoe.

47. The orthotic accessory assembly of claim 46 wherein said foot support portion is either soft or rigid.

48. The orthotic accessory assembly of claim 46 wherein the foot support portion is truncated at a toe end and being sized and shaped to match size and shape of an amputee'"'"'s foot.

49. The orthotic accessory assembly of claim 47 wherein the foot support portion is truncated at a toe end to size and shape the foot support portion to correspond to the size and shape of an amputee'"'"'s foot, and a heel insert portion provided in said shoe for further support of a foot on said foot support portion.

50. The orthotic accessory assembly of claim 47 wherein a filler member is provided for engagement with an exposed end of an amputee'"'"'s foot when rested upon said foot support portion.

51. The orthotic accessory assembly of claim 18 wherein a curved ankle and calf support shell section is joined to said foot support portion as a one piece assemblage for fitted engagement about at least a portion of a leg, including a foot heel, ankle, and leg calf, curved opposing leg support shell section opposing said calf support section, hinges connecting the curved opposing leg support shell section to an upper end of said curved ankle and calf support section, and hook and loop fastening means detachably connecting the hinged curved ankle and calf support shell section and the curved opposing leg support shell section.

52. The orthotic accessory assembly of claim 18 in combination with a shoe, wherein a calf engaging member is vertically split and relatively flexible to enable split sections of said calf engaging member to be separated to allow a foot to be inserted through said calf engaging member into the shoe, hinges joining the calf engaging member to the shoe at the area of the ankle when a person'"'"'s foot has been inserted into the shoe.

30. A method of treating diabetic plantar ulcers, the method comprising the steps of:

forming a positive model, the positive model being of a user'"'"'s lower leg and ulcerated foot;

forming a clear plastic check socket from the positive model;

fitting the clear plastic check socket to the plantar surface of the user'"'"'s foot;

inspecting the plantar surface of the user'"'"'s foot through the clear plastic check socket fitting;

noting problematic portions of the clear plastic check socket in relation to the fitting;

correcting problematic portions of the positive model;

forming a custom-made orthosis for the treatment of diabetic plantar ulcers from the corrected positive model, the orthosis further comprising;

a rigid, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, posterior support shell and a substantially horizontal, plantar support platform, the posterior support shell having a posterior shell height and the plantar support platform having a platform length, the posterior support shell having an inner posterior shell surface and an outer posterior shell surface, the posterior support shell being sized and shaped to receive the posterior portion of a user'"'"'s lower leg and tarsal region, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the posterior support shell height terminating proximally in a proximal flared posterior shell brim, the posterior support shell height terminating distally in a tarsal support structure, the tarsal support structure comprising a medial tarsal support portion, a lateral tarsal support portion, and a heel support portion intermediate the medial tarsal support portion and lateral support portion, the medial tarsal support portion and the lateral tarsal support portion extending ventrally to a point intermediate the platform length, the proximal flared posterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of a user'"'"'s lower leg, the posterior support shell having a circumferential corrugated rib structure intermediate the posterior support shell height, the plantar support platform having a superior surface and an inferior surface, the plantar support platform further comprising at least one ulcer-protecting hollow, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s diabetic plantar ulcer, the hollow for transferring a user'"'"'s weight away from the plantar ulcer thus facilitating plantar ulcer treatment;

an anterior support shell for lateral hinged attachment to the posterior support shell, the anterior support shell having an inner anterior support shell surface and an outer anterior support shell surface, the anterior support shell for receiving the anterior, proximal portion of a user'"'"'s lower leg, the anterior support shell having a proximal flared anterior shell brim and a distal flared anterior shell brim, the proximal flared anterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of the user'"'"'s lower leg, the anterior support shell further comprising a plurality of securing strap receiving loops securely attached to the outer anterior support shell surface;

a flexible polyethylene hinge member for hingedly attaching the anterior support shell to the posterior support shell, the hinge member having an inner hinge surface and an outer hinge surface, the hinge member having a posterior hinge portion and an anterior hinge portion, the outer hinge surface of the anterior hinge portion being securely fastened to the lateral most edge of the inner anterior support shell surface, the inner hinge surface of the posterior hinge portion being securely fastened to the lateral most edge of the outer posterior support shell surface, thus hingedly attaching the anterior support shell to the posterior support shell such that the proximal flared anterior shell brim and proximal flared posterior shell brim lie in substantially the same plane and such that the distal flared anterior shell brim and circumferential corrugated rib structure lie in substantially the same plane, the circumferential corrugated rib structure for increasing structural strength of the posterior support shell and for guiding placement of the anterior support shell;

a plurality of securing straps, the securing straps each having an inner strap surface and an outer strap surface, the outer strap surface further comprising hook and loop fastening means, the securing straps each having a posterior support shell attachment end and a securing strap feed end, the securing strap feed ends each being fed through the securing strap receiving loops for securing the anterior support shell in fixed, weight-bearing relation about the proximal, anterior portion of the user'"'"'s lower leg;

donning the user'"'"'s lower leg and foot with the custom-made orthosis for the treatment of the user'"'"'s diabetic plantar ulcer; and

inserting the user'"'"'s orthotic-fitted foot into a modified shoe, the modified shoe for receiving the user'"'"'s orthotic-fitted foot.

31. The method of claim 30 wherein posterior support shell padding is attached to the inner posterior support shell surface for alleviating skin irritation of the posterior portion of a user'"'"'s lower leg and tarsal region and for maintaining total contact;

anterior support shell padding is attached to the inner anterior support shell surface for alleviating skin irritation of the anterior, proximal portion of a user'"'"'s lower leg and for maintaining total contact and for relieving bony prominences; and

plantar support platform padding is attached to the plantar support platform.

32. A method of treating plantar wounds, the method comprising the steps of:

forming a positive model, the positive model being of a user'"'"'s lower leg and foot, the foot having a wound;

forming a clear plastic check socket from the positive model;

fitting the clear plastic check socket to the plantar surface of the foot;

inspecting the plantar surface of the foot through the clear plastic check socket fitting;

noting problematic portions of the clear plastic check socket in relation to the fitting;

correcting problematic portions of the positive model;

forming a custom-made orthosis assembly for the treatment of plantar wounds from the corrected positive model, the orthosis further comprising;

a substantially L-shaped lower leg support structure and leg securement means, the lower leg support structure comprising at least one substantially vertical, leg support portion and a substantially horizontal, foot support portion, the leg support portion comprising an inner leg support surface, the leg support portion being sized and shaped to receive a portion of a user'"'"'s lower leg, the foot support portion being sized and shaped to support a portion of a user'"'"'s foot, the leg support portion terminating proximally in an upper rim and terminating distally in a tarsal support structure, the tarsal support structure comprising a medial tarsal support portion and a lateral tarsal support portion, the medial tarsal support portion and the lateral tarsal support portion being cooperatively associated with the foot support portion, the upper rim being spatially located for fitted placement distal to the knee region of a user'"'"'s lower leg, the foot support portion having a superior surface, an inferior surface, and at least one rigid, off-loading, wound-protecting hollow, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment, the leg securement means being selectively encircled about the user'"'"'s lower leg for securing the leg support portion to the user'"'"'s lower leg; and

donning the user'"'"'s lower leg and foot with the custom-made orthosis assembly for the treatment of the user'"'"'s plantar wound

33. The method of claim 32 wherein the method comprises an additional step after donning the user'"'"'s lower leg and foot with the custom-made orthosis assembly, the additional step being insertion of the user'"'"'s orthotic-fitted foot into a modified shoe, the modified shoe being adapted for receiving the user'"'"'s orthotic-fitted foot.

34. A method of treating plantar wounds, the method comprising the steps of:

forming a positive model, the positive model being of a user'"'"'s lower leg and foot, the foot having a wound;

forming a custom-made orthosis assembly for the treatment of plantar wounds from the positive model, the orthosis assembly comprising;

a substantially L-shaped lower leg support structure and leg securement means, the lower leg support structure comprising at least one substantially vertical, leg support portion and a substantially horizontal, foot support portion, the leg support portion comprising an inner leg support surface, the leg support portion being sized and shaped to receive a portion of a user'"'"'s lower leg, the foot support portion being sized and shaped to support a portion of a user'"'"'s foot, the leg support portion terminating proximally in an upper rim and terminating distally in a tarsal support structure, the tarsal support structure comprising a medial tarsal support portion and a lateral tarsal support portion, the medial tarsal support portion and the lateral tarsal support portion being cooperatively associated with the foot support portion, the upper rim being spatially located for fitted placement distal to the knee region of a user'"'"'s lower leg, the foot support portion having a superior surface, an inferior surface, and at least one rigid, off-loading, wound-protecting hollow, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment, the leg securement means being selectively encircled about the user'"'"'s lower leg for securing the leg support portion to the user'"'"'s lower leg; and

donning the user'"'"'s lower leg and foot with the custom-made orthosis assembly for the treatment of the wound.

35. The method of claim 34 wherein the method comprises an additional step after donning the user'"'"'s lower leg and foot with the custom-made orthosis assembly, the additional step being insertion of the user'"'"'s orthotic-fitted foot into a modified shoe, the modified shoe being adapted for receiving the user'"'"'s orthotic-fitted foot.

36. A method of treating diabetic plantar ulcers, the method comprising the steps of:

forming a positive model, the positive model being of a user'"'"'s lower leg and ulcerated foot;

forming a clear plastic check socket from the positive model;

fitting the clear plastic check socket to the plantar surface of the user'"'"'s foot;

inspecting the plantar surface of the user'"'"'s foot through the clear plastic check socket fitting;

noting problematic portions of the clear plastic check socket in relation to the fitting;

crrecting problematic portions of the positive model;

forming a custom-made orthosis for the treatment of diabetic plantar ulcers from the corrected positive model, the orthosis further comprising;

a rigid, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, posterior support shell and a substantially horizontal, plantar support platform, the posterior support shell having a posterior shell height and the plantar support platform having a platform length, the posterior support shell having an inner posterior shell surface and an outer posterior shell surface, the posterior support shell being sized and shaped to receive the posterior portion of a user'"'"'s lower leg and tarsal region, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the posterior support shell height terminating proximally in a proximal flared posterior shell brim, the posterior support shell height terminating distally in a tarsal support structure, the tarsal support structure comprising a medial tarsal support portion, a lateral tarsal support portion, and a heel support portion intermediate the medial tarsal support portion and lateral support portion, the medial tarsal support portion and the lateral tarsal support portion extending ventrally to a point intermediate the platform length, the proximal flared posterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of a user'"'"'s lower leg, the posterior support shell having a circumferential corrugated rib structure intermediate the posterior support shell height, the plantar support platform having a superior surface and an inferior surface, the plantar support platform further comprising at least one ulcer-protecting hollow, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s diabetic plantar ulcer, the hollow for transferring a user'"'"'s weight away from the plantar ulcer thus facilitating plantar ulcer treatment,

an anterior support shell for lateral hinged attachment to the posterior support shell, the anterior support shell having an inner anterior support shell surface and an outer anterior support shell surface, the anterior support shell for receiving the anterior, proximal portion of a user'"'"'s lower leg, the anterior support shell having a proximal flared anterior shell brim and a distal flared anterior shell brim, the proximal flared anterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of the user'"'"'s lower leg, the anterior support shell further comprising a plurality of securing strap receiving loops securely attached to the outer anterior support shell surface,

a flexible polyethylene hinge member for hingedly attaching the anterior support shell to the posterior support shell, the hinge member having an inner hinge surface and an outer hinge surface, the hinge member having a posterior hinge portion and an anterior hinge portion, the outer hinge surface of the anterior hinge portion being securely fastened to the lateral most edge of the inner anterior support shell surface, the inner hinge surface of the posterior hinge portion being securely fastened to the lateral most edge of the outer posterior support shell surface, thus hingedly attaching the anterior support shell to the posterior support shell such that the proximal flared anterior shell brim and proximal flared posterior shell brim lie in substantially the same plane and such that the distal flared anterior shell brim and circumferential corrugated rib structure lie in substantially the same plane, the circumferential corrugated rib structure for increasing structural strength of the posterior support shell and for guiding placement of the anterior support shell;

a plurality of securing straps, the securing straps each having an inner strap surface and an outer strap surface, the outer strap surface further comprising hook and loop fastening means, the securing straps each having a posterior support shell attachment end and a securing strap feed end, the securing strap feed ends each being fed through the securing strap receiving loops for securing the anterior support shell in fixed, weight-bearing relation about the proximal, anterior portion of the user'"'"'s lower leg;

donning the user'"'"'s lower leg and foot with the custom-made orthosis for the treatment of the user'"'"'s diabetic plantar ulcer; and

inserting the user'"'"'s orthotic-fitted foot into a modified shoe, the modified shoe for receiving the user'"'"'s orthotic-fitted foot.

37. The method of claim 36 wherein posterior support shell padding is attached to the inner posterior support shell surface for alleviating skin irritation of the posterior portion of a user'"'"'s lower leg and tarsal region and for maintaining total contact;

anterior support shell padding is attached to the inner anterior support shell surface for alleviating skin irritation of the anterior, proximal portion of a user'"'"'s lower leg and for maintaining total contact and for relieving bony prominences; and

plantar support platform padding is attached to the plantar support platform.

38. The method of claim 37 wherein the L-shaped support member is comprised of molded polypropylene of about 3/16 inch thickness and the anterior support shell is comprised of drape molded polyethylene of about 3/16 inch thickness.

39. The method of claim 37 wherein the L-shaped support member and the anterior support shell are constructed by way of a lamination process, the lamination process utilizing a select resin, the select resin being selected from the group consisting of a polyester resin and an acrylic resin.

40. A method of treating plantar ulcers, the method comprising the steps of:

forming a positive model, the positive model being of a user'"'"'s lower leg and ulcerated foot;

forming a custom-made orthosis for the treatment of plantar ulcers from the positive model, the orthosis further comprising;

a rigid, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, posterior support shell and a substantially horizontal, plantar support platform, the posterior support shell having a posterior shell height and the plantar support platform having a platform length, the posterior support shell having an inner posterior shell surface and an outer posterior shell surface, the posterior support shell having a first posterior shell edge and a second posterior shell edge opposite the first posterior shell edge, the posterior support shell being sized and shaped to receive the posterior portion of a user'"'"'s lower leg and tarsal region, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the posterior support shell height terminating proximally in a proximal flared posterior shell brim, the posterior support shell height terminating distally in a tarsal support structure, the tarsal support structure comprising a medial tarsal support portion, a lateral tarsal support portion, and a heel support portion intermediate the medial tarsal support portion and lateral support portion, the medial tarsal support portion and the lateral tarsal support portion extending ventrally to a point intermediate the platform length, the proximal flared posterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of a user'"'"'s lower leg, the plantar support platform having a superior surface and an inferior surface, the plantar support platform further comprising at least one ulcer-protecting hollow, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar ulcer, the hollow for transferring a user'"'"'s weight away from the plantar ulcer thus facilitating plantar ulcer treatment;

an anterior support shell for hinged attachment to the posterior support shell, the anterior support shell having an inner anterior support shell surface and an outer anterior support shell surface, the anterior support shell having a first anterior shell edge and a second anterior shell edge opposite the first anterior shell edge, the anterior support shell for receiving the anterior, proximal portion of a user'"'"'s lower leg, the anterior support shell having a proximal flared anterior shell brim and a distal flared anterior shell brim, the proximal flared anterior shell brim being spatially located for fitted placement in distal adjacency to the fibular head of the user'"'"'s lower leg, the anterior support shell further comprising at least one securing means receiving structure securely attached to the outer anterior support shell surface;

hinge means for hingedly attaching the anterior support shell to the posterior support shell, the hinge means having a posterior hinge portion and an anterior hinge portion, the anterior hinge portion being securely fastened to the first anterior shell edge, the posterior hinge portion being securely fastened to the first posterior shell edge, thus hingedly attaching the anterior support shell to the posterior support shell;

securing means for operatively engaging the securing means receiving structure, thus securing the anterior support shell in fixed, weight-bearing relation about the proximal, anterior portion of a user'"'"'s leg; and

donning the user'"'"'s lower leg and foot with the custom-made orthosis for the treatment of the user'"'"'s plantar ulcer.

41. The method of claim 40 wherein the hinge means is further defined by comprising a flexible polyethylene hinge member, the hinge member having an anterior hinge portion and a posterior hinge portion, the hinge member having an inner hinge surface and an outer hinge surface, the outer hinge surface of the anterior hinge portion being securely fastened to the inner anterior support shell surface, the inner hinge surface of the posterior hinge portion being securely fastened to the outer posterior support shell surface, the hinge member thus hingedly attaching the anterior support shell to the posterior support shell such that the proximal flared anterior shell brim and proximal flared posterior shell brim lie in substantially the same plane and such that the distal flared anterior shell rim and circumferential corrugated rib structure lie in substantially the same plane, the circumferential corrugated rib structure for increasing structural strength of the posterior support shell and for guiding placement of the anterior support shell.

42. The method of claim 40 wherein the first anterior shell edge is the lateral most edge of the anterior support shell;

the second anterior shell edge is the medial most edge of the anterior support shell;

the first posterior shell edge is the lateral most edge of the posterior support shell; and

the second posterior shell edge is the medial most edge of the posterior support shell.

43. The method of claim 40 wherein posterior support shell padding is attached to the inner posterior support shell surface for alleviating skin irritation of the posterior portion of a user'"'"'s lower leg and tarsal region and for maintaining total contact;

anterior support shell padding is attached to the inner anterior support shell surface for alleviating skin irritation of the anterior, proximal portion of a user'"'"'s lower leg and for maintaining total contact and for relieving bony prominences; and

plantar support platform padding is attached to the plantar support platform.

44. The method of claim 40 wherein the L-shaped support member is comprised of molded polypropylene of about 3/16 inch thickness and the anterior support shell is comprised of drape molded polyethylene of about 3/16 inch thickness.

45. The method of claim 40 wherein the L-shaped support member and the anterior support shell is comprised of molded polypropylene of about 3/16 inch thickness and the anterior are constructed by way of a lamination process, the lamination process utilizing a select resin, the select resin being selected from the group consisting of a polyester resin and an acrylic resin.

53. An orthosis assembly for the treatment of plantar wounds, the orthosis assembly comprising:

a rigid, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, posterior support shell and a substantially horizontal, plantar support platform, the plantar support platform having a platform length, the posterior support shell having a first posterior shell edge and a second posterior shell edge opposite the first posterior shell edge, the posterior support shell being sized and shaped to receive the posterior portion of a user'"'"'s lower leg, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the plantar support platform having a superior platform surface, an inferior platform surface, and at least one rigid, off-loading, wound-protecting hollow, the wound-protecting hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior platform surface and the inferior hollow surface being continuous with the inferior platform surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment; and

first and second securing straps, each securing strap comprising an inner strap surface, an outer strap surface, a shell attachment end, and strap engagement end, the shell attachment ends being fixedly secured to the first and second posterior shell edges, the inner strap surface of the first securing strap comprising first strap fastening means and the outer strap surface of the second securing strap comprising second strap fastening means, the first and second strap fastening means being cooperatively associated and fastenable about the user'"'"'s lower leg for securing the posterior support shell to the user'"'"'s lower leg.

54. The orthosis assembly of claim 53 wherein a clear check socket fitting is required prior to contructing the orthosis assembly.

55. The orthosis assembly of claim 53 wherein the first and second strap fastening means are defined by hook and loop fastening means.

56. The orthosis assembly of claim 53 wherein the platform length is abbreviated for supporting a user'"'"'s partially amputated foot.

57. The orthosis assembly of claim 56 comprising a partial foot filler prosthesis, the partial foot filler prosthesis for filling space adjacent the user'"'"'s foot.

58. The orthosis assembly of claim 53 comprising support fastening means, the posterior support shell being separable from the plantar support platform, the support fastening means fastening the posterior support shell to the plantar support platform.

59. An orthosis assembly for the treatment of plantar wounds, the orthosis assembly comprising:

a rigid, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, posterior support shell and a substantially horizontal, plantar support platform, the plantar support platform having a platform length, the posterior support shell having a first posterior shell edge, a second posterior shell edge opposite the first posterior shell edge, and at least one strap-securing loop, the strap-securing loop being fixedly attached to a select shell edge, the select shell edge being selected from the group consisting of the first and second posterior shell edges, the posterior support shell being sized and shaped to receive the posterior portion of a user'"'"'s lower leg, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the plantar support platform having a superior platform surface, an inferior platform surface, and at least one rigid, off-loading, wound-protecting hollow, the wound-protecting hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior platform surface and the inferior hollow surface being continuous with the inferior platform surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment; and

at least one securing strap, the securing strap comprising an inner strap surface, an outer strap surface, a shell attachment end, and a feed end, the shell attachment end being fixedly secured a select shell edge, the select shell edge being selected from the group consisting of the first and second posterior shell edges, the outer strap surface comprising strap fastening means, the feed end being fed through the strap-securing loop about the user'"'"'s lower leg for securing the posterior support shell to the user'"'"'s lower leg.

60. The orthosis assembly of claim 59 wherein a clear check socket fitting is required prior to contructing the orthosis assembly.

61. The orthosis assembly of claim 59 wherein the strap fastening means are defined by hook and loop fastening means.

62. The orthosis assembly of claim 59 wherein the platform length is abbreviated for supporting a user'"'"'s partially amputated foot.

63. The orthosis assembly of claim 62 comprising a partial foot filler prosthesis, the partial foot filler prosthesis for filling space adjacent the user'"'"'s foot.

64. The orthosis assembly of claim 59 comprising support fastening means, the posterior support shell being separable from the plantar support platform, the support fastening means fastening the posterior support shell to the plantar support platform.

65. An orthosis assembly for the treatment of plantar wounds, the orthosis assembly comprising:

a rigid, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, posterior support shell and a substantially horizontal, plantar support platform, the plantar support platform having a platform length, the posterior support shell having a first posterior shell edge, a second posterior shell edge, and at least one strap-securing loop, the strap-securing loop being fixedly attached to a select shell edge, the select shell edge being selected from the group consisting of the first and second posterior shell edges, the posterior support shell being sized and shaped to receive the posterior portion of a user'"'"'s lower leg, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the plantar support platform having a superior platform surface, an inferior platform surface, and at least one rigid, off-loading, wound-protecting hollow, the wound-protecting hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior platform surface and the inferior hollow surface being continuous with the inferior platform surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment;

a rigid, anterior support shell for strapped attachment to the posterior support shell, the anterior support shell having an inner anterior support shell surface, an outer anterior support shell surface, and a plurality of strap-receiving loops securely attached to the outer anterior support shell surface, the anterior support shell for receiving the anterior, proximal portion of a user'"'"'s lower leg; and

at least two securing straps, the securing straps each comprising an inner strap surface, an outer strap surface, a shell attachment end, and a feed end, the shell attachment ends being fixedly secured a select shell edge, the select shell edge being selected from the group consisting of the first and second posterior shell edges, the outer strap surfaces comprising strap fastening means, the feed ends being fed through the strap-securing loops, the anterior support shell being secured to the proximal, anterior portion of the user'"'"'s lower leg in fixed, weight-bearing relation.

66. The orthosis assembly of claim 65 wherein a clear check socket fitting is required prior to contructing the orthosis assembly.

67. The orthosis assembly of claim 65 wherein the strap fastening means are defined by hook and loop fastening means.

68. The orthosis assembly of claim 65 wherein the platform length is abbreviated for supporting a user'"'"'s partially amputated foot.

69. The orthosis assembly of claim 68 comprising a partial foot filler prosthesis, the partial foot filler prosthesis for filling space adjacent the user'"'"'s foot.

70. The orthosis assembly of claim 65 comprising support fastening means, the posterior support shell being separable from the plantar support platform, the support fastening means fastening the posterior support shell to the plantar support platform.

71. An orthosis assembly for the treatment of plantar wounds, the orthosis assembly comprising:

a pliable, substantially L-shaped support member, the L-shaped support member comprising a substantially vertical, leg support portion and a substantially horizontal, foot support portion, the leg support portion having first and second leg portion edges, the leg support portion being sized and shaped to receive a user'"'"'s lower leg, the foot support portion comprising first and second foot support edges, the foot support portion being sized and shaped to support a user'"'"'s foot, the foot support portion having a superior insert-receiving surface and an inferior ground-engaging surface;

and at least one rigid plantar support member cooperatively received by the foot support portion at the superior insert-receiving surface, the plantar support member comprising a superior support surface, an inferior support surface, and a off-loading, wound-protecting hollow, the wound-protecting hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior insert-receiving surface and the inferior hollow surface being continuous with the inferior ground-engaging surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment; and

at least one tie member, the tie member being cooperatively associated with the first and second leg portion edges and the first and second foot support edges for securing the L-shaped support member and the plantar support member to the user'"'"'s lower leg and foot.

72. The orthosis assembly of claim 71 wherein a clear check socket fitting is required prior to contructing the orthosis assembly.

73. The orthosis assembly of claim 71 wherein the first and second leg portion edges and the first and second foot portion edges are located anteriorly.

74. An orthosis assembly for the treatment of plantar wounds, the orthosis assembly comprising:

at least one modified shoe, the modified shoe being custom-fitted for receiving an orthotic insert, the modified shoe comprising an inner insert-receiving surface and an outer upright-receiving surface, the orthotic insert comprising a superior support surface, an inferior support surface, and a off-loading, wound-protecting hollow, the wound-protecting hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior support surface and the inferior hollow surface being continuous with the inferior support surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment; and

a leg support assembly, the leg support assembly comprising rigid medial and lateral upright members and a leg support portion, the leg support portion comprising a proximal end, a distal end, and first and second leg portion edges, the leg support portion being sized and shaped to receive a portion of a user'"'"'s lower leg, the upright members extending proximally from the outer upright-receiving surface to points adjacent the proximal end; and

at least one flexible select securing member, the flexible select securing member being cooperatively associated with the first and second leg portion edges for securing the leg support portion to the user'"'"'s lower leg.

75. The orthosis assembly of claim 74 wherein a clear check socket fitting is required prior to contructing the orthosis assembly.

76. The orthosis assembly of claim 74 wherein the select securing member is selected from the group consisting of at least one tie member and at least one securing strap.

77. The orthosis assembly of claim 76 wherein each securing strap comprises a fastening means surface, hook and loop fastening means, a support attachment end, and a strap engagement end, the support attachment end being fixedly secured to the leg support portion, the hook and loop fastening means being fixedly attached to the fastening means surface, the hook and loop fastening means for securing the leg support portion to the user'"'"'s lower leg.

78. The orthosis assembly of claim 74 wherein the upright members are articulated adjacent the outer upright-receiving surface.

79. An orthosis assembly for the treatment of plantar wounds, the orthosis assembly comprising:

a leg support assembly, the leg support assembly comprising rigid medial and lateral upright members, each upright member comprising a proximal end and a distal end, the leg support portion being sized and shaped to receive medial and lateral portions of a user'"'"'s lower leg;

a plantar support platform, the plantar support platform being attached to the leg support assembly, the plantar support platform being sized and shaped to support the plantar portion of a user'"'"'s foot, the plantar support platform comprising a superior platform surface, an inferior platform surface, and at least one rigid, off-loading, wound-protecting hollow, the wound-protecting hollow having a superior hollow surface and an inferior hollow surface, the superior hollow surface being continuous with the superior platform surface and the inferior hollow surface being continuous with the inferior platform surface, the hollow being spatially located for fitted placement in inferior adjacency to a user'"'"'s plantar wound, the hollow for transferring a user'"'"'s weight away from the plantar wound thus facilitating plantar wound treatment; and

a proximal securing strap and a distal securing strap, the securing straps each comprising a fastening means surface and strap fastening means, the strap fastening means being fixedly attached to the fastening means surface, the strap fastening means for securing the leg support assembly about the user'"'"'s lower leg.

80. The orthosis assembly of claim 79 wherein a clear check socket fitting is required prior to contructing the orthosis assembly.

81. The orthosis assembly of claim 79 wherein the medial and lateral upright members are articulatably attached to the plantar support platform.

82. The orthosis assembly of claim 79 wherein the leg support portion is sized and shaped to receive a distal portion of a user'"'"'s lower leg.