Wound healing foot wrap

Details Wound healing foot wrap Wound healing foot wrap

1998-10-08

2002-12-03

Weiss, John G. (Department: 3761)

Surgery: splint, brace, or bandage

Orthopedic bandage

Splint or brace

C602S023000, C602S030000, C601S150000

Reexamination Certificate

active

06488643

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to wound healing devices. More particularly, the invention relates to a therapeutic foot wrap for application of positive pressure to the first and fifth metatarsal head and heel regions of a patient suffering diabetic ulceration and/or like wounds.
BACKGROUND OF THE INVENTION
An ulcer is commonly defined as a lesion on the surface of the skin, or on a mucous surface, manifested through a superficial loss of tissue. Ulcers are usually accompanied by inflammation and often become chronic with the formation of fibrous scar tissue in the floor region. Chronic ulcers are difficult to heal; they almost always require medical intervention and, in many cases, lead to amputation of the limb upon which they occur.
In general, ulcers may be attributed to any of a variety of factors reducing superficial blood flow in the affected region. Leg (including the foot) ulcers, in particular, are attributable to congenital disorders, external injury, infections, metabolic disorders, inflammatory diseases, ischaemia, neoplastic disorders and, most commonly, arterial disease, neuropathic disorders and venous insufficiency. Neuropathic and ischaemic ulcers commonly manifest in association with diabetes and, for this reason, are often referred to as diabetic ulcers. Although certainly not exhaustive, the table entitled Common Etiology of Leg Ulcers, highlights the frequency at which patients are placed at risk for the formation of this potentially devastating disease.
Common Etiology of Leg Ulcers
Congenital:
Absence of valves, chromosomal disorders,
Klinefelter's syndrome, connective tissue
defects affecting collagen and elastic fibers,
arteriovenous aneurysms, prolidase deficiency.
External Injury:
Laceration, contact dermatitis, decubitus, inoc-
ulation (drug addiction), burns, cold, irradia-
tion.
Infections:
Viral, bacterial, fungal.
Metabolic Disorders:
Diabetes mellitus, colonic stasis from sugar/
fats.
Inflammatory Diseases:
Vasculitus, pyoderma gangrenosum, rheuma-
toid arthritis, panniculitus.
Ischaemia:
Peripheral vascular disease, embolus, sclero-
derma hypertension, sickle-cell anemia.
Neoplastic Disorders:
Skin neoplasms, leukemia.
Neuropathic Disorders:
Spina bifida, leprosy, diabetes mellitus, neoro-
pathy syringomyelia.
Venous Insufficiency:
Posture (prolonged standing, legs crossed, long
legs), abdominal pressure (tumor, pregnancy),
employment, physical activity (apathy, paraly-
sis, osteoarthritis), effort (weight lifting),
deep vein thrombosis (50% tibial fractures,
25% abdominal surgery, 25% myocardial
thrombosis, 50% strokes), blood stasis, hemo-
lytic anemias.
Perhaps as striking as the incidence of this disease, is the magnitude of the resources dedicated to the combat of its occurrence. It is estimated that leg ulcers cost the U.S. healthcare industry in excess of $1 billion annually in addition to being responsible for over 2 million annual missed workdays. Unfortunately, the price exacted by ulcers is not merely financial. Leg ulcers are painful and odorous open wounds, noted for their recurrence. Most tragic, diabetic ulcers alone are responsible for over 50,000 amputations per year. As alarming as are these consequences, however, the basic treatment regimen has remained largely unchanged for the last 200 years. In 1797, Thomas Baynton of Bristol, England introduced the use of strips of support bandages, applied from the base of the toes to just below the knee, and wetting of the ulcer from the outside. Standard of care treatment for ulcers affecting the foot has developed little beyond prevention oriented approaches. When management of the underlying disease condition fails to prevent ulcer formation, debridement and occlusive bandaging is about the only remaining option. As discussed in more detail herein, versions of these therapies remain the mainstay treatment to this day and, clearly, any improvement is of critical importance.
As noted above, the most common causes of leg ulcers are venous insufficiency, arterial disease, neuropathy, or a combination of these problems. Venous ulcers, in particular, are associated with abnormal function of the calf pump, the natural mechanism for return to the heart of venous blood from the lower leg. This condition, generally referred to as venous insufficiency or venous hypertension, may occur due to any of a variety of reasons, including damage to the valves, congenital abnormalities, arteriovenous fistulas, neuromuscular dysfunction, or a combination of these factors. Although venous ulcers tend to be in the gaiter area, usually situated over the medial and lateral malleoli, in severe cases the entire lower leg can be affected, resembling an inverted champagne bottle.
Diabetic and arterial ulcers, in particular, are associated with degenerative disease resulting in progressively narrowed vessel lumen which, in turn, causes obstructed blood flow. These types of ulcers are frequently found at sites of localized pressure or trauma. The diabetic patient (neuropathic ulcers), who may also suffer arterial disease, will often have impaired sensation in the foot area and will therefore likely be unaware of repeated trauma. This exacerbates ulceration in the traumatized or pressure-bearing areas, commonly the first and fifth metatarsal heads and over the heel.
Clinical modalities for prevention of venous ulcers generally focus on the return of venous blood from the lower extremities to the heart. Mechanical prophylaxes are widespread in the art of prevention and are often referred to as foot pumps or wraps, leg pumps or wraps and sequential compression devices, all of which function to prevent deep vein thrombosis (“DVT”), a common precursor to venous stasis ulcers. An exemplary foot pump is commercially available from Kinetic Concepts, Inc. of San Antonio, Tex. under the trademark “PLEXIPULSE.” An exemplary sequential compression device is described in U.S. Pat. No. 5,031,604 issued Jul. 16, 1991 to Dye (“Dye”).
As generally described in Dye, mechanical prophylaxes for DVT prevention are directed toward the improvement of venous return. To this end, devices like that of Dye are adapted to take advantage of the naturally occurring valvular structure of the veins to squeeze the blood from a patient's limb. For instance, the trademark “PLEXIPULSE” device is adapted to intermittently compress the patient's plantar venous plexus, promoting the return of blood from the patient's foot upward and through the calf region. Likewise, and as generally described at column 2, lines 33 et seq. of Dye, leg compression devices are usually adapted to squeeze the patient's leg first near the ankle and then sequentially upward toward the knee. This milking-type sequence may or may not be performed on a decreasing pressure gradient, but is always designed to move blood from the extremity toward the heart. It should be noted at this time that these types of devices are generally not appropriate for use in the intended function of the present invention as the described wraps tend to produce a shearing force in the region of the first and fifth metatarsal heads and over the heel.
Treatment of venous ulcers, on the other hand, is predominately centered about gradient compression, through bandaging, and leg elevation. Although it is not precisely known how or why they improve venous ulcer healing, compression therapies, specifically including compression bandaging techniques, are now the well-established mainstay for the treatment of venous stasis and other ulcers. In fact, it is generally undisputed that compression bandaging is the most efficacious method for wound healing, often resulting in overall improvement of the patient's quality of life.
Among the predominant theories for explaining the effects of compression bandaging, edema reduction and control for the improvement of venous hemodynamic abnormality concomitant prolonged venous hypertension from valvular incompetency or dysfunction stands out. It is thought that the reduction and control of edema improves capillary micr

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