Note: Descriptions are shown in the official language in which they were submitted.
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COLOSTOMY ALERT DEVICE AND METHOD
Field of the Invention
[0001] The present invention relates to a device and method
for a-lerting an individual to enable the individual to better
control fecal discharge and more particularly relates to an alert
device and method for colostomy patients.
Background of the Invention
[0002] Many patients, due to various medical conditions, have
undergone diversionary colostomy procedures. A colostomy is a
surgical creation of an artificial anus in the abdominal wall by
incising the colon and then extending it 'to the surface. The
stoma is the end of the small bowel extending through the
abdomen. Colostomies are often performed because of cancer or
benign, obstructive tumors or severe abdominal wounds. Many
colostomates establish a regular schedule with proper care,
colostomy irrigation and a proper pouching system.
[0003] However, even with proper surgery and post-surgical
care, colostomates may suffer incontinence and lack the control
over gas and feces that the normal rectal sphincter affords.
[0004] Accordingly, there exists a need for a device used by
colostomy patients alerting the patient to an impending episode
and also creating an obstacle or barrier to the passage of fecal
matter. Review of the existing published art indicates there are
various devices and methods for the detection, indication and
prevention of such incontinent episodes.
[0005] U.S. Patent No. 4,813,422 relates to a bowel control
probe apparatus and method for sensing and preventing incontinent
episodes. The probe comprises a catheter with an IP sensor tip
for sensing fecal mass in the rectum and a cuff which is inflated
with air to prevent passage of the fecal mass. The method of
sensing and preventing incontinent episodes includes inserting
the probe in the rectum, inflating the cuff, transmittion IR
light into the rectum, monitoring the reflective IR light and
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generating an alarm signal when a predetermined amount of
reflective IR is measured.
[0006] European Patent Application No. 88303054.6 also
discloses a probe insertable into the colon having a sensor
element at the tip and a light transmissive element. The sensor
reflects light transmitted in response to the presence of fecal
matter. The probe is preferably two-piece having a disposable
section for insertion, inflatable cuff is provided to block the
colon. Vent ports may be provided.
[0007] The preceding two patents relate to devices and methods
for monitoring fecal mass in the colon. The patent literature
also suggest other types of devices for use by colostomy
patients. U.S. Patent No. 4,351,322 relates to a.stoma-control
device and method including a support ring for surgical
implantation in the body beneath the abdominal wall extending
substantially around the stoma. The support is formed of a soft
material and tapers outwardly to a large supporting surface for
the bowel. A plug is,adapted to be received in the stoma within
the bowel for controlling the stoma. The plug includes an
inflatable balloon which, when inflated, presents an outwardly
tapered surface with a shape complimenting the tapered inner
surface of the support.
[0008] U.S. Patent No. 6,171,289 relates to a disposable
device for securing a colostomy bag to a stoma which has an
adhesive seal which is applied on the patient by means of a
contact face. A through passage communicates with the stoma. A
wetness detection device comprising at least two series of
electrodes for measuring conductivity are provided to trigger an
alarm when a predeteremined level of wetness is reached.
[0009] Thus, from the foregoing, it will be seen there are
various approaches to providing comfort to individuals having
bowel incontinence which includes use of optical wetness sensors.
In the case of colostomy patients, the existing art suggests
insertable devices including an inflatable element for blocking
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fecal matter. However, there nevertheless exists a need for a
colostomy alert device which is comfortable and which will
provide an obstacle to passage of fecal matter and which device
does not require surgical implantation. There also exists a need
for a device which will provide the user an indication of an
impending episode so that the patient may, by having advance
notification, take appropriate action to avoid any unpleasant and
embarras.sing incontinent episodes. In case of an ambulatory
patient, the individual may remove himself or herself to a
bathroom. In the case of a bedridden patient, the individual can
summon a medical attendant prior to elimination so the individual
may be assisted in reaching toilet facilities. Thus, elimination
can be controlled in a manner which avoids both embarrassment and
the soiling of clothing and bed linens.
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Summary of the Invention
[0010] The present invention provides an apparatus and method
for monitoring the presence of fecal mass in a stoma and
providing an alarm signal that will provide the user an
indication of an impending episode. Further, the device and
method of the present invention provides a physical barrier or
obstacle to the passage of fecal matter from the bowel.
[0011] The alert system comprises a hollow plug and a pliable
port or pad of preferably flexible, elastomeric material
adhesively attached about the stoma. The plug incorporates both
a hydrophobic and an odor eliminating filter. The plug has a
pair of electrical contacts which, when the plug is engaged in
the port, are connected to a sensor. The contacts also are
connected to a pair of contacts at the lower end of the plug.
When fecal matter enters the plug and bridges the lower contact,
a circuit is completed, activating the sensor to provide a
tactile or audible alert. An inflatable cuff about the tube
creates a barrier to passage of fecal matter. The plug may be
removed, irrigated or replaced as necessary. A pouch system may
be utilized without removing the slidable port so as to protect
the patient's skin.
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Brief Description of the Drawings
[0012] Figure 1 is an exploded view of the colostomy alert
device fo the.present invention;
[0013] Figure 2 is a top view of the colostomy alert device of
the_present invention;
[0014] Figure 3 is a persp.ective view of the plug;
[0015] Figure 4 is a cross-sectional view of the plug;
[0016] Figure 5 is a perspective view of a plug having an
adjustable opening; and
[0017] Figure 6a-6c is a plan view of interchangeable ends for
the plug.
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Detailed Description of the Invention
[0018] The exploded view of Figure 1 shows the components of
the alert device. The device includes a flexible, elastomeric pad
12 having a central aperture 16. The pad 12 is adhered to the
patient by an adhesive ring 18, having a central aperture in
registry with the aperture 16 of the pad 12. The central aperture
16 received a plug 14. The plug 14 is formed by a lumen 72 having
a top end 74 and bottom end 76. An absorbent sleeve 90 encircles
the plug 14 to absorb any moisture. The sleeve is made of gauze
or any other suitable material and may be removed and replaced as
necessary.
[0019] The circuit board may have a replacement indicator. The
replacement indicator counts elapsed time that the device has been
used or the number of times the plug has been removed and
replaced. Once a threshold limit of either of these measures has
been reached, the circuit board will send a signal to an indicator
for alerting the user to the fact that the entire device needs to
be replaced. The periodic replacement of the device insures that
the device will not fail due to a dead battery.
[0020] With reference to Figure 2, the detail of the pad 12 can
be seen. The pad has a central raised area, affording greater
depth to the aperture 16. The sidewall of the aperture 16 houses
conductive rings 20, 22. Each conductive ring is connected to a
conductor 24, 26 leading from the central aperture to a location
30 on the edge of the pad. Attached to the terminal end of the
conductors 24, 26 is circuit board 32. The circuit board may be
permanently affixed to the pad or may be connected by suitable
connectors 34 to the conductors 24, 26 to be maintained in place.
The circuit board 32 contains a power source 36, such as a
battery, an alarm 38 and a signaler 40, such as an LED. In
addition to the circuit board 32, the pad can be provided with a
transmitter 44 for sending a signal to a remote location such as
medical attendants at a nearby nurses station. In place of or in
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addition to the signaler 40, the pad may include a tactile alarm,
such as a vibrator 60. The vibrator 60 would derive its power
from the battery 36 or may be provided with its own power source.
[0021] The structure of the plug 14 is best seen with reference
to Figures 3 and 4. In Figure 3, located below the top end 74 are
two conductive rings 80, 82 encircling the outer surface of the
plug. When the plug is inserted into the central aperture of the
pad, the top ring 80 makes contact with the upper ring 20. In a
like manner, the lower ring 82 makes contact with the lower ring
22. The ring conductors could be other shapes such as strips or
points, but the rings make alignment of the conductors easier.
Also, about the outer surface of the plug is an inflatable cuff
120. When the plug is inserted into the stoma, the cuff can be
inflated to help maintain the plug in place.
[0022] Figure 4 shows the internal structure of the plug 14.
Near the bottom end 76 of the plug, first and second conductors
100, 102 encircle the inner surface of the plug. Each lower
conductive ring 100, 102 is electrically connected to an upper
conductive ring 80, 82 by a conductor 92, 94. As depicted, lower
conductive ring 102 is connected to upper conductive ring 80 by a
first conductor 92 whereas lower conductive ring 100 is
electrically connected to upper conductive ring 82 by a second
conductor 94. Which lower ring is connected to which upper ring
is not important as long as one of the upper rings is connected to
one of the lower rings. Located at the top of the plug is a
hydrophilic filter 84 and a charcoal filter 86. Combined, the
filters allow the venting of gas to avoid bloating.
[0023] The bottom of the plug 14 may be open as shown in Figure
4, or may be provided with an adjustable or exchangeable closure.
This allows the opening to be adjusted depending on the
consistency of the patient's stool. Figure 5 shows an adjustable
opening for the bottom of the plug. The closure can be formed
integrally with the plug or as a separate closure, attaching to
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the plug in any suitable manner, such a mating threads. The
bottom surface is provided with a semi-circular opening 77. A
semicircular closure 78 is rotatably secured to the closure. By
rotating closure 78, the amount of the sernicircular opening 77
exposed can be adjusted.
[0024] Figure 6a-6c disclose exchangeable closures which may
be attached to the bottom of the plug 14. The structure shown
depicts Figure 6a with a single small opening. Figure 6b is
shown with two small openings, whereas Figure 6c has two larger
openings. These three configurations are intended for a soft
stool, medium stool and hard stool, respectively. Instead of
being attachable, the plug may be formed with a bottom wall
having the structure seen in Figure 6a-6c. If integral, the plug
having the appropriate sized openings is selected.
(0025] With the structure of the device being described, the
operation may now be explained.
[0026] An absorbable sleeve 90 is fit about the plug 14. The
plug 14 is then inserted into the central aperture 16. The plug
may be frictionally fit or may have mating connectors to ensure
the secure fit between the plug 14 and pad 12. When properly
inserted, two electrical branches are created. In the embodiment
shown, the first branch consists of the conductor 24, conductive
ring 20, conductive ring 80, conductor 92 and conductor ring 102.
The second branch consists of conductor 26, conductive ring 22,
conductive ring 82, conductor 94 and conductive ring 100. When
fecal matter passing through the intestines enters the hollow
portion of the plug, and comes into physical contact with the
lower conductive rings100, 102, the two electrical branches just
described complete a circuit. The completion of the circuit
causes the circuit board 32 to activate alarm 38, which may be
an Led 40. In addition, transmitter 44 can be used to cause a
signal to be transmitted to a remote location, such as a nurses
station. Also, vibrator 60 may be activated to provide the
patient with a tactile warning. The alarm provides notice to the
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patient that a possible episode is eminent. The patient may then
proceed to a bathroom to remove and empty the plug. After
cleaning of the plug, the plug may be repositioned in the pad.
The charcoal filter and ophobic filter allow gas to pass through
the plug to eliminate bloating and provide comfort to the
patient.
[0027] The device and method of the present invention provides
incontinence that is controlled over intestinal gas and fecal
matter, providing the user advance notice of a episode. The low
profile of the device, when properly positioned, is virtually
undetectable by others.
[0028] While the invention has been described with reference
to a preferred embodiment, variations and modifications would be
apparent to one of ordinary skill in the art. The invention
encompasses such variations and modifications.
