Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2000-10-23
2002-08-06
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C128SDIG008
Reexamination Certificate
active
06428467
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices and methods, and more particularly to devices and methods for evaluating and treating urinary and fecal incontinence by using proprioceptive neuromuscular facilitation and sensation, as well as devices and methods to facilitate urinary drainage and pelvic organ support.
BACKGROUND OF THE INVENTION
Urinary incontinence is believed to affect 15% to 30% of noninstitutionalized persons over the age of 60, and more then 50% of elderly persons (over the age of 60) who reside in nursing homes.
The presently available modes of treatment for urinary incontinence fall into four general categories, namely: i) management apparatus, ii) behavioral, iii) pharmacologic, and iv) surgical.
i. Management Apparatus for Incontinence
The management apparatus modes of treatment generally comprise absorbent and/or catheter structures worn by a user to retain any urinary and/or fecal incontinence. In their simplest forms, such devices comprise diaper-like structures which must be periodically changed by the user. Although such management apparatus has proven generally effective in masking the results of incontinence, they are uncomfortable to wear, difficult to change, and oftentimes fail during use thereby embarrassing the user.
ii. Behavioral Treatment for Incontinence
The use of behavioral training as a treatment for urinary and/or fecal incontinence can involve numerous behavioral techniques including; bladder re-training (e.g., voiding on a timed schedule), and/or the performance of exercises (e.g., Kegel exercises) to strengthen and retrain a group of muscles collectively known as the “pelvic floor muscles.” As an adjunct to these behavioral training techniques, various intravaginal and/or intra-anal devices may be utilized to facilitate the performance of such pelvic muscle training exercises. Such intravaginal and/or intra-anal devices have included simple weighted apparatus such as pessaries or intravaginal cones. Exemplary of such prior art pessaries are the pessaries manufactured by Milex Wester Company, 639 North Fairfax, Los Angeles, Calif. 90036; while an example of such weighted cone device is the “FEMINA” cone manufactured by Dacomed Corporation, 1701 East 79th Street, Minneapolis, Minn., 55425. Other types of prior art devices include pneumatic-type devices and electromyographic (EMC) transducers or sensors which are insertable into or placed just outside of the vagina and/or anus to obtain EMG data indicative of baseline pelvic floor muscle tone and/or contraction(s) of the pelvic floor muscles during the performance of specific muscle contraction exercises. Such EMG data may be usable for diagnostic purposes as well as for monitoring the performance and/or effect of muscle training exercises. Some EMG devices have included means for providing visual or auditory feedback to assist the patient in the performance of pelvic floor muscle exercises (e.g., Myoexorciser III, available from Verimed 1401 East Broward Boulevard, Suite 200, Fort Lauderdale, Fla. 33301 and the PRS 8900 Office System made by Incare Medical Products, Libertyville, Ill. 60048.
Additionally, the prior art has included at least one transvaginal electrical stimulation device which is operative to deliver periodic or timed electrical stimulation to the pelvic floor muscles and nerves. Such electrical stimulation causes involuntary contraction of the pelvic floor muscles and may serve as an adjunct to the performance of volitional exercise and/or other behavioral training techniques (e.g., Microgyn II Stimulation Device, InCare Medical Products, Division of Hollister Incorporated, 2000 Hollister Drive, LibertyVille, Ill., 60048 and also the Innova Feminine Incontinence Treatment System available from EMPI, Inc., 1275 Grey Fox Road, St. Paul, Minn. 55112).
Although some of or all of the above-described devices and systems for exercise and/or training of the pelvic floor muscles may be effective in the treatment of urinary incontinence, there remains a need for the development of improved devices and systems which are capable of strengthening and training the pelvic floor muscles in minimal time, with minimal assistance from physicians or other health care professionals as well as a system which serves to remind a user to perform muscle exercises and to provide proprioceptive input to assist the user in exercising and strengthening desired muscles.
iii. Pharmacologic Treatment for Incontinence
The prior art pharmacologic treatment of urinary incontinence typically involves the long term administration of drugs. Such pharmacologic treatment may result in drug-related side effects. Also, the efficacy of such pharmacologic treatment is frequently limited and largely dependant upon the patient's ability or willingness to comply with the prescribed drug dosage schedule.
iv. Surgical Treatment for Incontinence
The prior art surgical modes of treatment of urinary incontinence typically involve the performance of one or more major surgeries procedures under anesthesia. These major surgical procedures can be associated with significant risks and may sometime result in post-surgical failure, infections, or other complications. Also, these surgical procedures typically result in significant expense to the patient and/or the patient's third party insurer.
As such, there exists a substantial need in the art for an incontinence treatment system and methodology which reduces or eliminates the need for prior art management apparatus and/or surgical treatments, reduces the use of long-term drug administration, accentuates muscle strengthening and training while reminding a patient to conduct muscle strengthening exercise, as well as provide a proprioceptive input to assist the patient in contracting the appropriate muscles and/or muscle groups necessary for the effective treatment of incontinence.
Additionally, in connect therewith, there is a need in the art to facilitate the drainage of urine from the bladder of a patient. In this regard, systems to collect urine for quantitative and qualitative analysis and facilitate bladder drainage, which typically comprise an indwelling rubber catheter disposed within the urethra of the patient, such as a Foley catheter, suffer from the draw back of being difficult and uncomfortable to utilize and further, are less than optimal to collect urine, particularly with respect from female patients. Additionally, it is well recognized that long-term use of indwelling catheters is a significant source of bacteriuria and UTI (urinary tract infection). Indeed, there are reported cases of sepsis and death from severe UTI caused by such indwelling catheters.
A condition further related to incontinence is prolapse, i.e., the slipping down of an organ or part from its normal position, of the uterus, bladder (cystocele), vagina, and/or rectum (rectocele). With respect to prolapse of the uterus, such condition occurs when the uterus falls into the vagina due to stretching and laxity of its supporting structures. Cystocele/rectocele are conditions where the bladder/rectum herniate into, and at times out, of the vagina.
Typically, pessary devices are utilized to provide the necessary pelvic support for the various aforementioned conditions. Such pessary devices, which are well-known to those skilled in the art, can take the form of ring pessaries, folding pessaries, such as the Hodge folding pessary or Risser folding pessary, cube pessaries, and gellhorn pessaries, all of which are designed to be inserted within the anatomical passageway that is the subject of the prolapse and remain resident therein to provide the necessary structural support.
While such pessary devices are generally effective in providing the necessary structural support to thus maintain the organ or part of the body affected by the prolapse in its normal position, such pessary devices currently in use suffer from numerous drawbacks. Specifically, such devices are ill-suited to remain firmly anchored within the anatomical passageway within which the same
Lacyk John P.
Stetina Brunda Garred & Brucker
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