Special receptacle or package – For a tool – Body treatment
Reexamination Certificate
2000-09-08
2003-05-06
Gehman, Bryon P. (Department: 3629)
Special receptacle or package
For a tool
Body treatment
C206S589000, C417S476000, C418S045000
Reexamination Certificate
active
06557704
ABSTRACT:
FIELD OF THE INVENTION
This present invention relates generally to wound healing. More specifically, the present invention relates to an arrangement of components for a portable pump of the type for use with a gradient pressure compression bandage adapted for treating ulcers and the like in mammalian extremities, particularly venous stasis ulcers and edema.
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 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. Although certainly not exhaustive, the table entitled Common Etiology of Leg Ulcers highlights the frequency at which patient's 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,
inoculation (drug addiction), burns, cold,
irradiation.
Infections:
Viral, bacterial fungal.
Metabolic Disorders:
Diabetes mellitus, colonic stasis from sugar/fats.
Inflammatory
Vasculitus, pyoderma gangrenosum,
Diseases:
rheumatoid arthritis, panniculitus.
Ischaemia:
Peripheral vascular disease, embolus,
scleroderma hypertension, sickle-cell anemia.
Neoplastic Disorders:
Skin neoplasms, leukemia.
Neuropathic Disorders:
Spina bifida, leprosy, diabetes, mellitus,
neuropathy syringomyelia.
Venous Insufficiency:
Poster (prolonged standing, legs crossed, long
legs), abdominal pressure (tumor, pregnancy),
employment, physical activity (apathy,
paralysis, osteoarthritis), effort (weight lifting),
deep vein thrombosis (50% tibial fractures, 25%
abdominal surgery, 25% myocardial thrombosis,
50% strokes), blood stasis, hemolytic anemias.
Perhaps as striking as the incidence of this disease, is the magnitude of the resources dedicated to the combat of their 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. As discussed in more detail herein, versions of this therapy 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. While the exact pathologic relationship between venous insufficiency and venous ulcers remains largely unknown, distinct modalities for both prevention and treatment have nonetheless been developed.
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 area 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 exemplar 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 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.
Treatment for 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 of wound healing, often resulting in overall improvement of the patient's quality of life.
Among the predominant theories explaining the effects of compression bandaging, edema reduction and control stand out. It is thought that the reduction and control of edema improves capillary microcirculation, in turn resulting in the elimination of venous ulcers. Another popular theory holds that reactive hyperemia is responsible for the success of compression bandaging. According to this theory, the arrest and subsequent restoration of blood flow to the affected region, known as Bier's method, results in an ultimately increased presence of blood in the region. Regardless of the theory adopted, however, it is important to note that it is universally understood that a proper gradient must be established in order to obtain the benefits of compression bandaging. This gradient is generally accepted as being from about 35 to 45 mm Hg at the ankle and reducing to about 15 to 20 mm Hg at just below the knee. Often stated in the literature as a prerequisite to good bandaging technique, the maintenance of graduated compression is critical to effective treatment of ulcers. Failure to initially obtain, and thereafter maintain, the desired sub-bandage pressures is fatal to the treatment regimen.
The criticality of establishing and maintaining the desired sub-bandage pressure directly results in significant disadvantages, associated with the application of compression bandaging in general, and s
Gehman Bryon P.
KCI Licensing Inc.
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