Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
1998-12-07
2001-12-04
Brown, Michael A. (Department: 3733)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128S886000, C128SDIG008
Reexamination Certificate
active
06325066
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to training aids for training or retraining of bladder and/or anal sphincter muscles of the 20 million or more individuals in the United States who suffer from incontinence. More particularly, this invention utilizes a is disposable, inexpensive carbon impregnated sensor thread in a sensor strip that allows consideration of reusable cloth diapers and inserts which greatly reduces skin disorders and bladder infections while offering the advantage of cost reduction and conservation of space in landfills. In addition, the training aid may incorporate a modular system wherein a re-recordable voice module and receiver for receiving the voice module is adaptable for a variety of purposes.
BACKGROUND OF THE INVENTION
Incontinence is a urologic disorder that results in partial or full loss of control of anal and/or bladder sphincter muscles, reducing or eliminating control over fecal and urine flow, respectively. The American Foundation for Urological Disease (AFUD) reports that more than 50 million individuals suffer from traumatic urologic disorders, of which the National Association for Continence (NAFC) documents
20
million or so suffering from incontinence. Some of these individuals are in nursing homes or hospitals, while others are ambulatory to the point of leading normal lives with the exception of being affected by incontinence.
Incontinence sufferers are generally classified in three major groups; ambulatory adults, geriatric bedridden and juvenile. Specialized treatment is required for each group, with surgery being predominant for ambulatory adults and the geriatric, followed by medication, exercises of the muscles of the pelvic floor, biofeedback, electrical stimulation, and collagen injection. The associated cost of such treatments amounts to something on the order of about 13 billion dollars annually, with much of this cost being borne by Medicare. The National Association for Continence 1996 Spring report, Volume 14, #2 reports the following results after treatment:
2.6% report being cured
9.4% report having a worse condition
41.4% report slight to moderate to greatly improved conditions
46.6% report no change in condition.
From these treatment results, the Medicare burden is completely removed in only 2.6% of cases while 97.4% of these cases remain a financial burden. At the American Urological Association Allied authored by Jan O'Dea of Columbous Urology Inc. of Columbous, Ohio is quoted as stating “Our private urology practice has treated 21 men with continence after radical prostatectomy for localized prostate cancer. 20 of the 21 patients demonstrated improvement, with the majority reporting 75% to 100% satisfaction. 6 patients are totally pad free. Patients began treatment from 3 to 5 years after prostatectomy and had varying degrees of incontinence. Treatment for these patients consisted of a comprehensive approach using behavioral interventions and biofeedback assisted pelvic floor exercises.
Biofeedback is a scientific technique wherein an individual consciously controls a bodily function, such as heartbeat, blood pressure, or certain sphincter muscles, responsive to signals provided by instrumentation. Such instrumentation typically uses adhesive skin patches or straps incorporating electrical terminals that gather electrical information from skin of the patient, and which are manufactured by a number of manufacturers today. In addition, HUMED of Huntsville, Ala., has developed an affordable, portable application specific home/office biofeedback training system to serve an array of patient disorders including depression, incontinence, stress, and stroke. Success is repetitive dependent, necessitating a portable in-home unit.
Applicants system includes a portable computer similar to a laptop computer having a display, sensor package, CD ROM drive, and prerecorded memory voice modules. Accordingly, a patient visits a hospital, clinic, pain center, or other appropriate institution to be evaluated as to specific needs. Upon a determination that Applicants system is an appropriate treatment, the patient is provided the system along with a CD ROM and voice module containing information specific to his/her needs. After a predetermined period of time, the patient revisits the institution for evaluation of progress, at which point the patient may be given another CD ROM and voice module containing different instructions to further treatment. As such, one objective of the instant invention is to offer affordable training or retraining of the bladder and/or anal sphincter muscles that have been impaired by stroke, Alzheimer's disease, prostrate disorders, surgery, child birth, medication side effects, aids, behavioral disorders, learning disabilities and other conditions that necessitate training or retraining of muscles that control voiding of the bowel and bladder.
Aside from the ever present danger of skin and bladder infections, incontinence may rob the individual of self confidence, sleep, extended travel, the joy of physical activity, and often reduces an individual to a disabled condition. This sometimes occurs where an individual uses a gel-type incontinence garment or insert, which garments and inserts being designed to hold a greater quantity of liquid than a non-gel type garment or insert. As a result of the greater capacity of these gel-type devices, a user may become accustomed to the odor of urine, and in turn becoming unaware of the discomfort of others subjected to such odor. The ensuing embarrassment from this situation often drives an individual to become reclusive, in turn placing additional burdens on the state and federal governments, whereas with proper training or retraining of the bowel and bladder sphincter muscles, many of these conditions may be reduced or eliminated, allowing a disabled individual to resume a normal life. In addition, over 19 billion gel-type diapers, inserts and other incontinence garments are used annually, and occupy a significant proportion of landfill space. The materials in these diapers, inserts and disposable garments require something on the order of about 200 years to decompose. Applicants sensor strip may be constructed of readily decomposable materials, allowing use of non-disposable undergarments or diapers which may be washed. A number of incontinence alarms for ambulatory adults, geriatric bedridden and juveniles have been proposed but all are significantly different from Applicants bladder and bowel training system, and none have enjoyed any significant measure of success.
One reason for the lack of success of these prior art alarms may be that most disposable pads used for incontinence alarm systems are cumbersome to wear and difficult to connect. Another reason may be expense of the alarm and disposable pads, which may be considerable where each disposable pad is provided with leads that are connected to a sensor element in the pad, with terminals at the end of the leads for connection to the alarm. Yet another reason may be that many individuals with urinary incontinence tend to “dribble”, or constantly leak urine at the same rate as kidney production. In this instance, it is simply too expensive and time consuming to constantly change incontinence garments. As a result, these individuals often simply change their incontinence garments at set times during their waking hours. The problem with this is that the kidneys produce urine at varying rates, meaning that an incontinent individual may ignore a saturated incontinence garment too long, promoting skin rashes or ulceration of the skin. On the other hand, the incontinence garment may be changed before becoming sufficiently wetted to warrant changing, resulting in waste and the attendant cost.
Another problem is that in those devices wherein a sensor strip is used to sense a wet condition of an incontinence garment, such as in U.S. Pat. No. 5,226,928, issued to Johnson, the sensor strip is constructed of a non-variable length. As such, the strip must be long enough to insure adequate length for
Hughes Charles B.
Hughes Emory D.
Brown Michael A.
Clodfelter Mark
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