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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.