Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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FECAL INCONTINENCE REMOTELY CONTROLLED VALVE AND METHOD
TECHNICAL FIELD
The present invention relates to a surgically implantable remotely
controllable valve for connection to the bowel canal rectum for controlling
the discharge
of fecal matter.
BACKGROUND ART
Bowel incontinence is the loss of bowel control, leading to an involuntary
passage of stool. This can range from occasionally leaking a small amount of
stool and
passing gas, to completely losing control of bowel movements. Surveys indicate
that
among people over age 65, experience bowel incontinence more often than men.
One to
three out of every 1,000 women report a loss of bowel control at least once
per month.
To hold stool and maintain continence, the rectum, anus, pelvic muscles, and
nervous
system must function normally. You must also have the physical and mental
ability to
recognize and respond to the urge to have a bowel movement.
Some of the causes are:
chronic constipation, causing the muscles of the anus and intestines to
stretch
and weaken, and leading to diarrhea and stool leakage;
chronic laxative use;
colectomy or bowel surgery;
decreased awareness of sensation of rectal fullness;
emotional problems;
gynecological, prostate, or rectal surgery;
injury to the anal muscles due to childbirth in women;
nerve or muscle damage from trauma, tumor, or radiation;
severe diarrhea that overwhelms the ability to control passage of stool;
severe hemorrhoids or rectal prolapse;
stress of unfamiliar environment.
Proper treatment can help most people, and can often eliminate the
problem. There are several ways to strengthen the anal and pelvic muscles and
promote
normal bowel function. Fecal impaction leads to a mass of stool that partially
blocks the
large intestine. Usually laxatives and enemas are of little help. A health
care provider
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may need to insert one or two fingers into the rectum and break the mass into
smaller
pieces that can pass more easily.
By adding fiber to your diet helps form normal stool.
Special fecal collection devices to contain the stool and protect the skin
from breakdown are known. These devices consist of a drainable pouch attached
to an
adhesive wafer. The wafer has a hole cut through the center, which fits over
the opening
of the anus.
Special care must be taken to maintain bowel control in people who have
a decreased ability to recognize the urge to defecate, or who have impaired
mobility that
prevents them from independently and safely using the toilet. Such people
require
assistance to use the toilet after meals, and promptly helped to the toilet if
they have the
urge to defecate.
Some patients may be treated with an artificial bowel sphincter. The
artificial sphincter consists of three parts: a cuff that fits around the
anus, a pressure-
regulating balloon, and a pump that inflates the cuff. See for example U.S
Patent Nos.
6,074,341 an 6,491,623 wherein the artificial sphincter is surgically
implanted around the
rectal sphincter. The cuff remains inflated to maintain continence. You have a
bowel
movement by deflating the cuff. The cuff will automatically re-inflate after a
time delay.
Several external devices are available for managing long-term diarrhea or
fecal incontinence. These devices have a drainable pouch attached to an
adhesive
wafer. This wafer has a hole cut through the center that fits over the anal
opening
(rectum). A fecal incontinence device may remain in place for 24 hours. It is
important to
remove the pouch if any stool leakage has occurred. Liquid stool is very
irritating to the
skin. If leakage occurs, the skin is cleaned and a new pouch is installed.
Such device is
applied to clean, dry skin.
A protective skin barrier (such as a paste) may be prescribed by a
healthcare provider. It is applied to the skin before attaching the device.
The buttocks is
spread apart, exposing the rectum, and the wafer and pouch is applied.
An enterostomal therapy nurse or skin care nurse is often requried to train
the care person.
Bowel incontinence also presents problems to nursing homes 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
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monitoring of patients is also necessary to prevent infections due to
prolonged contact
with fecal material on the skin surfaces.
The use of absorbent, disposable pads to protect the bed and the patient
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.
SUMMARY OF INVENTION
It is a feature of the present invention to provide a simple and remotely
controllable surgically implantable valve which is connected to the bowel
canal for
controlling the discharge of fecal matter and which substantially overcomes
the above-
mentioned disadvantages of the prior art.
Another feature of the present invention is to provide a surgically
implantable remotely controllable valve capable of being vibrated to dislodge
impacted
fecal matter.
Another feature of the present invention is to provide a surgically
implantable remotely controllable valve capable of generating alarms and
remotely
controllable to various operational modes.
Another feature of the present invention is to provide a surgically
implantable remotely controllable valve which results in economy in the
control of
patients equipped with such valves and wherein the valve is an intelligent
valve providing
data in association with a remote control device identifying the patient and
the activity of
the valve.
Another advantage of the present invention is to provide a surgically
implantable remotely controllable valve which is easy to implant and easy to
use by the
patient or caretakers of the patient and wherein the valve body contains
actuation and
communication components packaged therein.
According to the above features, from a broad aspect, the present
invention provides a surgically implantable remotely controllable valve
connected to the
human bowel canal for controlling the discharge of fecal matter. The valve
comprises a
valve body having a pair of spaced-apart clamp arms defined by a stationary
base and a
displaceable arm having a clamping head aligned with the base. The stationary
base
has a concave surface to receive a portion of the bowel canal therein. The
displaceable
arm is secured to a remotely controlled solenoid contained in the body. A
power source
is provided in the body. A transceiver is in the body for receiving signals to
operate the
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arm and to generate signals including a malfunction alarm. Detector means
detects the
position of the arm. The clamping arm is operatable to an open mode, a closed
mode
and a vibration mode. The vibration mode causes vibrations transmitted to
fecal matter
in the bowel canal at least in the area of the clamp arms to vibrate the fecal
matter. A
remote control device operates the displaceable arm to a selected one of the
modes.
Monitoring circuit means communicates with the transceiver to identify a
wearer person
and associated status of the implant valve for effecting corrective action by
operation of
the remote control device.
The invention also includes the method of use.
BRIEF DESCRIPTION OF DRAWINGS
A preferred embodiment of the present invention will now be described
with reference to the accompanying drawings in which:
FIG. 1 is a side view of the implantable valve showing the valve
clamping head in an open position;
FIG. 2 is a side view similar to Figure 1 but showing the valve
clamping head in a semi-clamping position;
FIG. 3 is an end view showing the valve in a closed position;
FIG. 4 is a schematic view showing the valve implanted about the
urethra to control liquid discharge from the bladder;
FIG5 is a block diagram showing the communication system
associated with the surgically implantable valve to operate and monitor the
valve;
FIG. 6A is a fragmented view showing the construction of a probe
device for opening the clamp arms of the valve in a malfunction situation of
the valve;
and
FIG. 6B shows the operation of the probe device.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring now to the drawings and more particularly to Figures 1 to 3,
there is shown the construction of the surgically implantable and remotely
controllable
valve 10. The valve comprises a valve body 11 having an L-shaped transverse
configuration and housing a solenoid 12 secured to a displaceable clamping
head 13 by
a linkage 14. The clamping head 13 is displaced against a stationary base 15
which has
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a concave clamping surface 16 against which will rest a portion of the bowel
canal 17.
As shown in Figure 1 the bowel canal is filled with fecal matter 18.
The clamping head 13 is secured to an arm 19 which is sealingly
displaceable in a closable slot 20 formed in the body 11, as shown in Figure
3. The
clamping arm is operable from an open position or mode, as shown in Figure 1,
to a
closed position or close mode as shown in Figure 3. The solenoid 12 also
vibrates the
clamping head 13 from a midway position as shown in Figure 2 to its closed
position as
shown in Figure 3 whereby to impart vibration to the fecal matter 18 present
between the
clamp arms 13 and 15 to cause separation of the fecal matter in the bowel
canal 17 as
the clamping head descends upon the bowel canal 17, as better illustrated in
Figures 2
and 3. Accordingly, any impacted fecal matter 18 in that area and in the
surrounding
area will be loosened and dispersed prior to closure and in such a situation
would cause
some fecal matter to be expelled from the anal canal, as shown in Figure 3. It
is pointed
out that people with bowel incontinence usually wear a protective undergarment
such as
a diaper to isolate fecal matter expelled through the bowel canal. A pressure
cuff sensor
29' is implanted about the bowel canal 17 upstream of the vale and transmits
detection
signals.
Referring now to Figures 4 and 5, it is pointed out that the body 11 also
houses a transceiver device 25 including an antenna 26 capable of receiving
signals
from the remote control device 26 which is provided with colored lights 27,
27', 28 and
28' to indicate to an attendant person or nurse that the patient requires to
discharge fecal
matter or urine. Light 27 is a yellow light operated by the cuff sensor 29
when detecting
pressure indicating a need to place the patient on a toilet and operate the
valve 10 by
depressing switch button 9 to open the valve 10' in Figure 4, to release
urine. Once
urine is released, the cuff sensor 29 operates the green light 27' to indicate
that the
bladder has been evacuated and the valve is closed by switch 8. The same light
combination is also provided at the station module 31'. The light 28 is a red
light
indicating that the patient needs to be placed on a toilet to evacuate fecal
matter. The
cuff 29' (see figure 3) provides a signal to actuate light 28 directly to the
portable control
26 and for station receiver module 31' when the bowel canal 17 expands due to
the
presence of fecal matter. This is a signal to the attendant that the wearer
needs to go to
a toilet or be placed on a toilet, such as with Alzheimer patients, when the
valve can be
open for the release of fecal matter. The valve 10 is operated to an open
position by
switch 7 to evacuate the bowel. Light 28' is a green light indicating that the
bowel has
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been evacuated as detected by the pressure sensing cuff 29', and switch 6 is
operated to
close the valve 10.
The body 11 may also contain associated circuits such as a timer 30
which sends periodical signals to a remote monitoring circuit means herein a
monitoring
module 31 which includes a receiver 31' receiving the frequency signal 32 from
the
remote implant valve 10. This signal is sent to a frequency detector circuit
32 which
analyzes the frequency and identifies the wearer person having the implant
device and
feeds an ID signal to a monitor device 33. The monitor device is provided with
a display
screen which displays the identity (ID) of the wearer person and feeds signals
in a
patient file 34 contained within its memory to keep track of these signals and
corrective
action. This module 31 is accessible to a caretaker person such as a
responsible person
if the patient is at home or a nursing station, if in a hospital. The monitor
device is also
capable of generating a signal through a signal generator 35 providing a
visual and
audible alarm that a signal has been detected and corrective action is
required. It may
also be provided with lights 36 indicating certain conditions relating to the
patient of the
valve position. A timer circuit 37 is also associated with the monitor device
and capable
of timing the time of operation of the clamping head 13 from the time that the
ID signal
has been received by the monitor to the time that the clamping head has been
placed to
its open position to relieve the user person of the fecal matter collected
during a certain
lapsed period of time detected by the timer 30. The pressure sensing cuff 29'
may not
be required in such mode of operation. The monitor 33 is also provided with a
transmitting antenna 38 to communicate with a portable receiver device 39,
similar to the
remote control 26 which may be carried by a nurse or any attendant person away
from
the monitoring module 31.
Once the caretaker person receives a signal from the pressure sensing
cuffs, it will ask the person to sit on or displace the wearer person to a
toilet seat and
then the caretaker would activate the implanted valve through the remote
control device
26 to discharge excrement, as previously described.
As shown in Figure 4, the implantable remotely controllable valve 10' may
also be secured to the urethra 45 at a suitable location below the bladder 46
to discharge
fluids 47 from the bladder through the urethra 45. If the same patient is
provided with
two of these valves 10, then a valve 10' is connected to the urethra above the
valve and
generates different frequency signals to activate the light 27 to identify
that the bladder
needs to be evacuated.
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As shown in Figures 6A and 6B, in the event that the clamping head 13 of
the valve becomes stuck in a closed position, as shown in Figure 3, due to a
malfunction
of the solenoid or other reason, an alarm will be generated indicating that
the valve
clamping head does not operate. In such a situation, there is provided a probe
device,
as shown in Figures 6A and 6B, to open the valve. The probe device comprises a
plastic
tube 50 having a substantially rigid and deformable head 51 located in an
uppermost
region of the tube in an inner surface 54 thereof. By pushing the tube 50 into
the anal
canal 55, the head 51 opens the clamping head 13 of the valve by pushing it
outwardly
due to the force exerted by the head 51 and the tube 50 restoring the valve to
its open
position. The head 51 meanwhile has pushed air into the anal canal and fecal
matter 18.
A string or cord 52 secured to the head 51 and extending into the tube is then
pulled
outwardly in the direction of arrow 56, as shown in Figure 6B, to cause a
suction as
indicated by arrow 57 pulling on the fecal matter 18 as the tube is retracted
and causing
the fecal matter 18 to be sucked outwardly in the anal canal and assisting the
evacuation
of fecal matter. The valve is then operated again to determine if it is
properly operational
and this can be done by depressing all of the switch buttons on the remote
control 26.
As shown in Figures 1, 2 and 3, the valve body 11 is provided with position
detectors 60,
61 and 62 to provide signals indicative of the position of the clamping head
13.
It is pointed out that both the remote device 26 and the station monitor 33
can be adapted to also display the identity of the patient and/or its
location, such as the
room of a hospital or Senior Citizen Home.
It is within the ambit of the present invention to cover any obvious
modifications of the preferred embodiment described herein, provided such
modifications
fall within the scope of the appended claim.
