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

• US 6,945,946 B2
• Filed: 05/17/2002
• Issued: 09/20/2005
• Est. Priority Date: 05/17/2002
• Status: Active Grant

• Current Assignee: John E. Rooney
• Original Assignee: John E. Rooney
• Inventors: Rooney, John E.
• Primary Examiner(s): Huson, Gregory L.
• Assistant Examiner(s): Pham, Huong Q.
• Application Number:
  US10/150,693
• Publication Number:
  US 20030216675A1
• Time in Patent Office: 1,222 Days
• Field of Search: 602/23, 602 27- 29, 602 5- 8, 128/882
• US Class Current: 602/27
• 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 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. A flexible, polyethylene hinge member hingedly attaches the anterior support shell to the L-shaped member and securing straps securely attach the anterior support shell in fixed, weight-bearing relation about the proximal, anterior portion of the user'"'"'s lower leg.

Claims

1. An orthotic combination for the treatment of diabetic plantar ulcers, the orthotic combination comprising:

at least one modified shoe, the modified shoe being custom-fitted for receiving an orthosis, 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,

a 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 lower 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 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; and

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.

2. The orthotic combination of claim 1 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

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

3. The orthotic combination of claim 2 wherein the plantar support platform is contoured to conform to the planter surface of a user'"'"'s foot, the plantar support platform comprising a first anterior segment to support the toes of the foot, a second anterior segment to support the metatarsal heads of the foot, an intermediate sole segment to support the arch of the foot, and a posterior segment to support the heel of the foot.

4. The orthotic combination of claim 3 wherein the L-shaped support member comprises molded polypropylene of about 3/16 inch thickness and the anterior support shell comprises molded polypropylene of about ⅛

inch thickness.

5. The orthotic combination of claim 4 wherein custom alignment wedges are used in combination with the orthosis.

6. An orthosis for the treatment of plantar ulcers, the orthosis 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 planter support platform further comprising an 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;

a rigid, 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;

a circumferential corrugated rib structure intermediate the posterior support shell height for increasing structural strength of the posterior support shell and for guiding placement of anterior 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;

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 I 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; and

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.

7. The orthosis of claim 6 wherein the hinge means is further defined by comprising a flexible polyethylene hinge member, the hinge member hingedly attaching the anterior support shell to the posterior support shell such that the proximal flared anterior shell brim and proximal flared posterior shelf bum 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.

8. The orthosis of claim 7 wherein the hinge member has 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.

9. The orthosis of claim 6 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.

10. The orthosis of claim 6 wherein the securing means is defined by further comprising at least one securing strap and the securing means receiving structure is further defined by comprising at least one securing strap receiving loop, the securing strap having an inner strap surface and an outer strap surface, the outer strap surface further comprising hook and loop fastening means, the securing strap having a posterior support shell attachment end and a securing strap feed end, the securing strap feed end being fed through the securing strap receiving loop for securing the anterior support shell in fixed, weight-bearing relation about the proximal portion of the user'"'"'s lower leg.

11. The orthosis of claim 6 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.

12. The orthosis of claim 6 wherein the L-shaped support member comprises molded polypropylene of about 3/16 inch thickness and the anterior support shell comprises molded polypropylene of about ⅛

inch thickness.

13. An orthosis for the treatment of diabetic plantar ulcers, 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 lower 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 horiztonal plane, the circumferential corrugated rib structure for increasing structural strength of the posterior support shell and for guiding placement of the anterior support shell; and

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.

14. The orthosis of claim 13 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.

15. The orthosis s of claim 13 wherein the plantar support platform is contoured to conform to the plantar surface of a user'"'"'s foot, the plantar support platform comprising a first anterior segment to support the toes of the foot, a second anterior segment to support the metatarsal heads of the foot, an intermediate sole segment to support the arch of the foot, and a posterior segment to support the heel of the foot.

16. The orthosis of claim 13 wherein the L-shaped support member comprises molded polypropylene of about 3/16 inch thickness and the anterior support shell comprises molded polypropylene of about ⅛

inch thickness.

17. The orthosis of claim 13 wherein custom alignment wedges are used in combination with the orthosis to provide stability therefor.