Surgery – Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
2003-02-28
2004-10-12
Winakue, Eric F. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
active
06802808
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a system for controlling episodes of bowel incontinence and also relates to a probe for detecting the presence of fecal mass in the rectum.
BACKGROUND OF THE INVENTION
Fecal incontinence is a disabling and distressing condition. Many patients have little or no control over bowel movements. This condition can be embarrassing resulting in curtailed activities and limited social involvement. In addition, bowel incontinence presents problems to nursing homes and caretakers as attending personnel are required to remove and replace soiled linens, blankets and gowns and are often required to bathe the patient after an episode. These tasks are unpleasant and also require substantial time and effort on the part of attending personnel. Increased monitoring of patients is also necessary to prevent infections due to prolonged contact with fecal material on the skin surfaces.
There are several approaches to the problem of bowel incontinence. A simple and commonly used technique is the use of absorbent, disposable pads to protect the bed and the patient. Use of pads may minimize the time required on the part of attending personnel after an episode but pads do not in any way serve to detect or prevent such episodes.
Many patients suffering from this condition may show a significant improvement of their symptoms either with conservative medical treatment or surgery. Various types of surgeries are performed to remedy this condition including sphincter repair, gracilopalsty, and gluteoplasty.
However, there are a considerable number of patients who have had surgical treatments that have failed. In some instances surgery is inappropriate due to the patient's poor general medical condition or as a result of a personal choice on the part of the patient.
One non-surgical approach to the problem of fecal incontinence is bio-feedback. The success rate for bio-feedback approaches to bowel incontinence is variable and may not be of significant long-term value to a patient with isolated deficiency in internal sphincter function.
Another non-surgical approach has been to provide devices that sense the presence of fecal material in the human colon. Such devices are designed to provide the patient and attendants sufficient time and warning so that the patient will be able to act to avoid an embarrassing or unpleasant episode.
Japanese Patent Publication 101569182 discloses a method and device for detecting fecal material. The purpose is to prevent incontinence of a patient confined to a bed by detecting the presence of fecal matter in the colon from the intensity difference of reflected light from the fecal material. The remote end section of a disposable probe is attached to a coupling member and is inserted into the colon by using a hypodermic syringe. When a sensor at the forward end of the probe comes into contact with fecal material, a tip formed as a flexible end cap and a flexible reflection strip composed of Mylar are deformed. Light is directed to the strip from a control unit through a fiberoptic cable and the intensity of the instant light and the reflected light are sampled and compared. When the signal variation is larger than the prescribed value, an audible or visual warning signal is provided to alert the patient and attendants.
Another bowel probe and method for controlling bowel incontinence is shown in U.S. Pat. No. 4,813,422. This patent discloses a bowel control apparatus and method for sensing and preventing incontinent episodes. The probe comprises a catheter with an infrared (IR) sensor tip for sensing fecal mass in the rectum and a cuff which is inflated to prevent passage of the fecal mass. The method of sensing and preventing incontinent episodes includes the steps of inserting the probe in the rectum, inflating the cuff, transmitting IR light into the rectum, monitoring the reflectance of IR light and generating an alarm signal when a predetermined amount of IR light is measured.
While devices, as described above have, to some extent, been successful in detecting a potential incontinent condition and generating an alarm, the use of optical or light reflecting systems in such an environment is not always reliable. Further, it has been found that use of inflatable cuffs without sensors to block discharge of fecal mass until the patient reaches a bathroom may have the potential, over prolonged time, to cause damage to the rectal tissue and restrict capillary blood flow.
It is therefore an object of the present invention to provide an improved apparatus and method for sensing the presence of fecal matter in the human colon.
It is another object of the present invention to provide an apparatus and method for detection of a potentially incontinent condition to a patient and to generate an alarm, either a local alarm or centralized alarm, to alert nursing or attending medical personnel to the condition.
It is a further object of the present invention to provide a system for detecting an incontinent condition and when detected will temporarily block the discharge of fecal matter in a manner to minimize injury or irritation to the rectal tissue even over prolonged periods of usage.
It is yet another object of the invention to provide a rectal probe which will stimulate rectal tissue and blood flow.
BRIEF SUMMARY OF THE INVENTION
Briefly, the present invention provides a catheter-like probe fabricated from a biochemically inert material which probe defines a lumen. The distal tip of the probe is configured for ease of insertion into the rectum and incorporates a pair of spaced-apart conductivity sensors which are connected to a monitoring system through electrical wires extending through the lumen or along the probe. The presence of fecal matter will complete a circuit between the conductivity sensors causing an electrical signal to be to monitoring equipment. The conductivity sensors may be spaced-apart, conductive rings or point contacts enclosed within an apertured sleeve which sleeve may be removed for cleaning. The signal will activate an alarm to alert attending medical personnel to an impending incontinent episode. The alarm device may be a pager device located at the patient which may also be capable of sending a remote signal to a centralized monitoring station.
The distal tip of the probe further incorporates flatus venting means which may be ports or vent holes in the distal end or, in the alternative, a portion of the probe may be a porous material which will allow gas to vent through the lumen. The lumen may incorporate a filter of charcoal or other odor eliminating material. An expandable, annular sealing sleeve extends about the probe and is located so that when it is inserted, the sealing sleeve is positioned in the area of the anus.
Located at an intermediate location between the distal and proximate ends of the probe is an inflatable cuff similar to that found on bladder-type catheters. The cuff is inflatable to block the rectum entrance preventing discharge of fecal matter from the colon until the patient reaches a bathroom. The bladder cuff may be connected to an air-pulsing system having an air pressure reservoir or plenum chamber connected to an air pump across a check valve. A valve is connected to the air supply reservoir. The cuff is inflated by air from the air supply reservoir to a predetermined volume as for example 20 cc of air. The valve will allow the cuff to slowly deflate over a period of time, as for example to 18 cc volume in one hour. The pump then activated to re-inflate the cuff to a predetermined volume. The pulsating or cyclic deflation and inflation of the cuff will stimulate rectal tissue preventing necrosis of rectal tissue and prevent unnecessary or undue restriction of capillary blood flow in the rectum.
In an alternate embodiment, which is a manual system, the inflatable cuff will deflate slowly over a period of time to provide tissue stimulation. The cuff is periodically re-inflated with air using a pump or syringe. Slow deflation occurs as the result of use of a material for the c
International Development Consultants, a Proprietorship of Wichi
Nelson Gregory J.
Venaiminov Nikita R.
Winakue Eric F.
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