Granted Patent B2

US 12,636,178 · App. 17/682,086 · Granted May 26, 2026

Inventor: Christopher J. Finley (Ridgefield, WA)

Assignee: ULCER SOLUTIONS, LLC

A61F5/0195A61F2005/0167A61F2005/0172

Abstract

Claims (29)

1 . A method of preventing plantar flexion comprising:

providing a lower extremity orthosis comprising;

a foot engagement portion configured to engage a foot of a patient, the foot engagement portion comprising opposing pliable sidewalls extending from a sole-supporting surface and defining a cavity configured to receive the foot without enclosing the foot, and an elastic member configured to span across an open top of the cavity to bias the opposing sidewalls toward one another when secured, the elastic member being selectively releasable from at least one of the opposing sidewalls; and

an elongated positioning member comprising a foot-underlying portion and a lower leg-underlying portion joined by a curved heel portion sized and shaped to avoid contacting a heel of the patient when the orthosis is worn, the foot-underlying portion being contained within or secured to the foot engagement portion to couple the elongated positioning member to the foot engagement portion,

wherein the lower leg-underlying portion is configured to selectively and removably couple the lower extremity orthosis to a heel offloading device external to the foot engagement portion via at least one of: (i) at least partial insertion of the lower leg-underlying portion into a slot or pocket of the heel offloading device; and (ii) engagement between a sleeve disposed around the lower leg-underlying portion and a releasable material on an outer surface of the heel offloading device,

wherein, when the lower extremity orthosis is coupled to the heel offloading device, the elongated positioning member positions the foot engagement portion to maintain a threshold angle with respect to a longitudinal axis of the heel offloading device that is less than 95°, thereby preventing or reducing plantar flexion of the foot while the heel offloading device is used and the lower extremity orthosis is applied to the foot, and

further wherein a space between the foot engagement portion and the lower leg-underlying portion remains open laterally and anteriorly such that, when the device is worn, the heel of the patient is externally visible and accessible for clinical care through the open cavity and lateral regions of the foot engagement portion; and

securing the lower extremity orthosis device to a lower extremity of the patient to offload the heel of the patient.

2 . The method of preventing plantar flexion of claim 1 further comprising removing at least one of the foot engagement portion and the lower leg engagement portion to expose the elongated positioning member.

3 . The method of preventing plantar flexion of claim 2 wherein the elongated positioning member further comprises one or more score lines operable to selectively shorten the length of the elongated positioning member further comprising the step of bending the elongated positioning member along a score line of the one or more score lines.

4 . The method of preventing plantar flexion of claim 3 further comprising securing the removed at least one of the foot engagement portion and the lower leg engagement portion to the elongated positioning member.

5 . A lower extremity orthosis device for a patient comprising:

a foot engagement portion configured to engage a foot of a patient, the foot engagement portion comprising opposing pliable sidewalls extending from a sole-supporting surface and defining a cavity configured to receive the foot without enclosing the foot, and an elastic member configured to span across an open top of the cavity to bias the opposing sidewalls toward one another when secured, the elastic member being selectively releasable from at least one of the opposing sidewalls; and

an elongated positioning member comprising a foot-underlying portion and a lower leg-underlying portion joined by a curved heel portion sized and shaped to avoid contacting a heel of the patient when the orthosis is worn, the foot-underlying portion being contained within or secured to the foot engagement portion to couple the elongated positioning member to the foot engagement portion,

wherein the lower leg-underlying portion is configured to selectively and removably couple the lower extremity orthosis to a heel offloading device external to the foot engagement portion via at least one of: (i) at least partial insertion of the lower leg-underlying portion into a slot or pocket of the heel offloading device; and (ii) engagement between a sleeve disposed around the lower leg-underlying portion and a releasable material on an outer surface of the heel offloading device,

wherein, when the lower extremity orthosis is coupled to the heel offloading device, the elongated positioning member positions the foot engagement portion to maintain a threshold angle with respect to a longitudinal axis of the heel offloading device that is less than 95°, thereby preventing or reducing plantar flexion of the foot while the heel offloading device is used and the lower extremity orthosis is applied to the foot, and

further wherein a space between the foot engagement portion and the lower leg-underlying portion remains open laterally and anteriorly such that, when the device is worn, the heel of the patient is externally visible and accessible for clinical care through the open cavity and lateral regions of the foot engagement portion.

6 . The lower extremity orthosis device of claim 5 wherein the foot-engagement surface is arranged at a non-parallel angle with respect to the lower leg engagement portion of the elongated positioning member, and wherein the non-parallel angle is less 110 degrees.

7 . The lower extremity orthosis device of claim 5 wherein the curved heel portion of the elongated positioning member maintains a threshold angle of the foot of the patient with respect to a longitudinal axis of the device.

8 . The lower extremity orthosis device of claim 5 wherein the foot engagement portion and the lower leg engagement portion are padded.

9 . The lower extremity orthosis device of claim 5 further comprising a sleeve operable to selectively and removably couple the lower extremity orthosis device to the lower leg engagement portion.

10 . The lower extremity orthosis device of claim 5 wherein the foot engagement portion and the lower leg engagement portion are removable.

11 . The lower extremity orthosis device of claim 5 wherein the lower leg engagement portion has a lower leg pocket operable to receive the second end of the elongated positioning member.

12 . The lower extremity orthosis device of claim 5 wherein the foot engagement portion has a foot engagement pocket operable to receive the first end of the elongated positioning member.

13 . The lower extremity orthosis device of claim 5 wherein the elongated positioning member further comprises one or more score lines operable to selectively shorten the length of the elongated positioning member.

14 . The lower extremity orthosis device of claim 5 wherein the lower extremity orthosis device is configurable to be sized for the patient.

15 . The lower extremity orthosis device of claim 5 wherein a floor of the device comprises at least three levels of thickness in relation to a base of the device.

16 . The lower extremity orthosis device of claim 5 wherein at least one of the elastic member and the cover include a hook and loop fastener.

17 . The lower extremity orthosis device of claim 5 wherein the foot engagement portion is releasably secured to the lower leg engagement portion.

Assignments (1)

Continuity (1)

References Cited (71)