U.S. patent number 3,802,418 [Application Number 05/218,925] was granted by the patent office on 1974-04-09 for colon catheter.
Invention is credited to Ralph S. Clayton.
United States Patent |
3,802,418 |
Clayton |
April 9, 1974 |
COLON CATHETER
Abstract
A colon catheter for removing and collecting waste colon
material through the anal canal. One end of a hollow tube is
inserted into the anal canal and held therein by an expandable
member and limiting elements outside of the anal opening against
the perineum. An enclosed bag attached to the end of the tube to
collect waste colon material may be made of plastic, may be clear
and may be covered by an opaque bag having a viewing window and
flaps to enclose the hollow tube after use. A side opening may be
provided for introducing an enema solution. The entire colon
catheter with the enclosed waste colon material is disposable as a
unit.
Inventors: |
Clayton; Ralph S. (El Paso,
TX) |
Family
ID: |
26813386 |
Appl.
No.: |
05/218,925 |
Filed: |
January 19, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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115610 |
Feb 16, 1971 |
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Current U.S.
Class: |
600/562; 604/918;
604/103.03 |
Current CPC
Class: |
A61M
25/1009 (20130101); A61F 2/0013 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61M 25/10 (20060101); A61b
010/00 () |
Field of
Search: |
;128/2F,283,246,286,344,129,239,247,349B,349BV,349R,348,350,351
;119/95 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Staff Meetings of the Mayo Clinic, September 2, 1936.
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Cohen; Lee S.
Attorney, Agent or Firm: Larson, Taylor & Hinds
Parent Case Text
RELATED APPLICATION
This application is a continuation-in-part of my earlier copending
application Ser. No. 115,610, filed Feb. 16, 1971, now abandoned.
Claims
I claim:
1. A catheter for removing waste material from the colon through
the anal opening comprising:
an elongated hollow tube having a first open end and a second open
end, and a lumen through the tube from the first open end to the
second open end being of circular cross-section having a diameter
of at least 10mm to facilitate the passage of solid waste colon
material from the first end thereof to the second end thereof,
a pair of limiting elements attached to the outside of the said
hollow tube between the first and second ends and extending
outwardly in opposite directions from each other generally
perpendicular to the axis of the tube to lie against the perinean
force and aft of the anal opening,
said tube including a first portion between the first open end and
the limiting elements which includes the first end and which is
insertable into the anal opening, and a second portion from the
limiting elements to the second open end, said first portion being
of sufficiently stiff material to withstand the inward closing
force of the anal sphincter muscles,
an annular expandable member fixed to and encircling the exterior
of the first portion of the tube from said first end to a point
along the exterior of the first portion of the tube and constructed
to be expanded outwardly to surround the exterior of the tube at
the said first end to seal off the anal canal such that waste
material can escape from the colon only into the first open end of
the hollow tube, and therethrough to the second open end, said
expandable member, when expanded extending outwardly from the first
open end transversely relative to the axis of the tube to assist in
guiding waste colon material into the said first open end, passage
means for delivering pressurized fluid to the annular member to
expand it after it is positioned in the anal canal,
the spacing along the exterior of the tube between the limiting
elements and the expandable member being such that after the first
portion of the tube has been inserted into the anal opening, the
anal canal is sealed between the limiting elements and the annular
expandable member to retain the first portion of the hollow tube in
place and seal the anal opening,
and means for connecting the second open end of the tube to an
enclosed container such that waste colon material can flow from the
colon through the first open end and through the lumen of the
hollow tube directly into the enclosed container.
2. A catheter according to claim 1, including a means for closing
off the hollow second end of the tube.
3. A catheter according to claim 2, said hollow tube being
sufficiently flexible such that the walls thereof can be manually,
elastically pinched towards each other to close the hollow tube,
and said closing means including a clamp to close the tube at the
second portion thereof.
4. A catheter according to claim 1, said first and second tube
portions being axially aligned to form one straight tube.
5. A catheter according to claim 4, said tube having an outside
diameter not greater than 35 mm.
6. A catheter according to claim 5, said tube having an inside
diameter of approximately 15 mm and an outside diameter of
approximately 19 mm.
7. A catheter according to claim 1, said limiting elements being a
pair of solid resilient bars extending approximately 2 cm to
opposite sides of the hollow tube.
8. A catheter according to claim 1, said pair of limiting elements
extending outwardly from a central part which surrounds the hollow
tube, said limiting elements being adjustable along the length of
the hollow tube.
9. A catheter according to claim 1, including an enclosed bag for
receiving and holding the waste colon material, and said connecting
means comprising a means connecting this bag onto the second end of
the hollow tube.
10. A catheter according to claim 9, said connecting means
including a stiff collar to which the opening of the bag is
connected, and means for snapping this collar into a fluid sealed
position on the second end of the tube.
11. A catheter according to claim 1, including a tubular insert
member having a first and second ends and a side opening into the
tubular insert intermediate of its ends, the first end of this
tubular insert connected in a fluid sealed manner to the second end
of the hollow tube, an enclosed bag connected to the second end of
this tubular insert in a fluid sealed manner, whereby waste colon
material flowing through the hollow tube flows through the tubular
insert and into the enclosed bag, and means for closing off this
tubular insert between the side opening and the second end thereof,
whereby the tubular insert can be closed off and an enema solution
introduced through the side opening and through the hollow tube
into the colon, and means for closing this side opening.
12. A catheter according to claim 1, said second portion being
formed at an angle relative to the first portion.
13. A catheter according to claim 12, said second portion being
turned approximately 90.degree. relative to the first portion and
constituting one of said limiting elements.
14. A catheter according to claim 12, including a one-way valve in
said hollow tube permitting material to flow only from the first
portion to and through the second portion of the hollow tube.
15. A catheter according to claim 1, wherein said hollow tube
further includes a side opening for receiving means to be
introduced into the colon passage, and means for selectively
opening or closing this first opening.
16. A catheter according to claim 15, wherein the side opening
includes a tube in communication with the interior of the first
portion of the hollow tube, and extending outwardly from the hollow
tube to form one of said limiting elements.
17. A system for facilitating removal and collection of waste colon
material from the human body comprising:
an elongated hollow tube having a first open end and a second open
end, and a lumen through the tube from the first open end to the
second open end being of circular cross-section having a diameter
of at least 10mm to facilitate the passage of solid waste colon
material from the first end thereof to the second end thereof,
a pair of limiting elements attached to the outside of the said
hollow tube between the first and second ends and extending
outwardly in opposite directions from each other generally
perpendicular to the axis of the tube to lie against the perinean
fore and aft of the anal opening,
said tube including a first portion between the first open end and
the limiting elements which includes the first end and which is
insertable into the anal opening, and a second portion from the
limiting elements to the second open end, said first portion being
of sufficiently stiff material to withstand the inward closing
force of the anal sphincter muscles,
an annular expandable member fixed to and encircling the exterior
of the first portion of the tube from said first end to a point
along the exterior of the first portion of the tube and constructed
to be expanded outwardly to surround the exterior of the tube at
the said first end to seal off the anal canal such that waste
material can escape from the colon only into the first open end of
the hollow tube, and therethrough to the second open end, said
expandable member, when expanded extending outwardly from the first
open end transversely relative to the axis of the tube to assist in
guiding waste colon material into the said first open end, passage
means for delivering pressurized fluid to the annular member to
expand it after it is positioned in the anal canal,
the spacing along the exterior of the tube between the limiting
elements and the expandable member being such that after the first
portion of the tube has been inserted into the anal opening, the
anal canal is sealed between the limiting elements and the annular
expandable member to retain the first portion of the hollow tube in
place and seal the anal opening,
and an enclosed container connected in a fluid sealed manner to the
second open end of the hollow tube to receive and hold waste colon
material discharging through the second open end of the hollow
tube.
18. The system of claim 17, said container being a plastic bag.
19. The system of claim 18, wherein the plastic bag is transparent,
and including an opaque bag covering this plastic bag.
20. The system of claim 19, including an opening in the opaque bag
to see therethrough to observe the plastic bag.
21. The system of claim 18, said opaque bag including a flap
extending out from the part thereof connected to the hollow tube,
said flap being sufficiently large to enclose the hollow tube, and
means for holding the flap about the hollow tube.
22. The system of claim 18, including a gas release valve in the
bag.
23. The system of claim 18, including means for attaching the bag
to a leg of the user.
24. The system of claim 18, including an insertion obturator
attached to the inside of the plastic bag.
25. The system of claim 18, including a stiff collar to which the
opening of the bag is connected, and means for snapping this collar
into a fluid sealed position onto the second end of the tube.
26. The system according to claim 25, including a tubular insert
member having first and second ends and a side opening into the
tubular insert intermediate of its ends, the first end of this
tubular insert connected in a fluid sealed manner to the second end
of the hollow tube, an enclosed bag connected to the second end of
this tubular insert in a fluid sealed manner, whereby waste colon
material flowing through the hollow tube flows through the tubular
insert and into the enclosed bag, and means for closing off this
tubular insert between the side opening and the second end thereof,
whereby the tubular insert can be closed off and an enema solution
introduced through the side opening and through the hollow tube
into the colon, and means for closing this side opening.
Description
BACKGROUND OF THE INVENTION
This invention relates to medical apparatus, and in particular it
relates to a novel catheter for removing and collecting waste colon
material through the anal canal.
Present procedures for cleaning the colon passage have been the
same for literally hundreds of years. These include the use of
laxatives to stimulate expulsion of solids, liquids or gases,
enemas to soften and to stimulate expulsive activity by the colon
and finally, maneuvering the patient onto an open receptacle such
as a bed pan to collect materials expelled from the colon
passage.
These procedures are to say the least very inconvenient, even for
healthy persons. But for those not in a healthy state, there are
more serious medical and sanitary difficulties.
Sometimes a patient cannot hold the anal canal open at all because
of paralytic ileus which is the inability to complete the
neuro-muscular action required to open the anal sphincter muscles,
i.e. those muscles which control opening and closing of the anal
canal. This is not infrequent occurrence following surgery.
Inability to open the anal canal may occur at other times,
particularly in the case of old persons, children and unconscious
persons. Indeed, even healthy persons might involuntarily fight
releasing the colon contents to avoid making unpleasant sounds,
creating unpleasant odors or soiling the bed. In other cases,
patients are able to open the anal canal but cannol hold it open
long enough, sometimes one to three hours, to complete expulsion of
the colon contents.
Another problem is that some patients, while able to hold the anal
canal open are not capable of remaining in one position to expel
the colon contents for a long enough period of time. A bed pan is
extermely awkward and uncomfortable, and after a long period of
time, pressure pain can develop and one can become numb, hence
making expulsion that more difficult. In one known procedure for
removing gas and liquid contents of the colon passage, gravity is
used to facilitate movement of the material therethrough. In this
case it is necessary to move the patient between different
positions. But with the conventional bed pan, only one position is
possible, supine. Another disadvantage of the known bed pan or
toilet is that the erect position required to pass solid colon
contents may make is impossible to expel gases from the colon.
In addition to the above, there are serious sanitary and
cleanliness disadvantages to the conventional bed pan including
soiled linen and objectionable odors and sounds. Further, the need
to clean such soiled linens more frequently increases the
hospital's costs.
In addition to the above, current procedures do not permit an
opportunity for observing or testing the stool of the patient. At
present, observation is only possible with a patient's cooperation.
If the patient goes to the bathroom, disposes and flushes, there is
no chance for observation of the stool. For example, it may be
vital to know of blood loss in the stool. A patient could go to the
bathroom, expel the colon contents together with 2,000 cc. of
blood, flush and no one would know-- or be able to explain a sudden
loss in blood pressure. Also, current procedures including the bed
pan provide no opportunity for conducting certain laboratory tests
which require collection of the entire stool as it is not
practically possible to collect the entire stool with current
techniques.
In the past, catheters have been developed such as the Foley tube
for removing liquid materials from other parts of the body. Also,
catheters have been developed for introducing into the anal canal
liquids for enemas and the like. However, these known catheters are
not suitable for use for removing and collecting solid and gas
waste colon material through the anal canal. Thus, there exists a
need for a new and improved catheter and system for facilitating
removal and collection of waste colon material through the anal
canal.
SUMMARY OF THE INVENTION
It is a purpose of the present invention to provide a new and
improved catheter and system for removing and collecting waste
colon materials through the anal canal, which catheter and system
overcome the disadvantages of previously known procedures for
removing waste colon material through the anal canal.
This purpose of the present invention is achieved by providing a
new and improved colon catheter and a closed system in which the
catheter is sealed in the anal canal and wherein the colon material
passes through an enclosed passage to an enclosed receptacle.
According to the present invention, there is provided a colon
catheter in the form of a hollow tube, the interior lumen of which
is of sufficiently large cross-section and short enough for the
passage of solid waste colon materials. At one end of the tube
there is provided an expandable balloon element which is expanded
after this first end of the tube has been placed into the anal
canal past the anal sphincter muscles. The tube is held in place by
cooperation between the expandable tube and positionable against
the perineum. A means would normally be provided for closing off
the tube between these limiting elements and the second or free end
of the tube. Means are provided for attaching an enclosed
receptacle to this second end of the tube to receive the colon
material. In a simple arrangement, the receptacle which is
preferably a plastic bag is simply clamped onto the end of the
tube. In another arrangement, the bag may be attached to a stiff
collar which may be formed as a snap ring to be snapped onto the
end of the tube.
Means may also be provided for introducing an enema solution in the
colon. In one arrangement, this may include an insert to be placed
between the end of the tube and the bag, this insert including a
side opening. In another arrangement, a side opening may be formed
as a part of the tube itself. In either case, means would be
provided for closing off this side opening.
In accordance with another feature of the invention, the bag, which
would normally be of clear plastic, may be covered by an opaque bag
having a viewing window for viewing the contents of the plastic
bag. The arrangement may also include flaps for enclosing the main
tube after use, an obturator formed within the plastic bag, means
for tying the bag onto the leg of the user, a gas release bleed
valve formed in the bag to relieve collected gases, and/or clamps
for closing off the main tube (or the tubular insert) by simply
pinching the same as one would pinch a hose. In this case, however,
the tube, while being sufficiently resilient and elastic to permit
such pinching must be sufficiently stiff to maintain its shape in
the anal canal opposing the inward force of the anal sphincter
muscles. Such materials are known.
The present invention overcomes the numerous disadvantages of prior
techniques in a most effective manner. First, as a solution to the
cases in which patients either could not hold the anal canal open
at all or could not hold it open for a sufficient length of time,
the present invention is held in position such that it holds the
anal sphincter muscles apart to open the anal canal without efforts
by the patient. Thus, for those suffering from paralytic ileus, it
provides for the first time an arrangement for permitting such
persons to maintain the anal canal open to pass waste colon
material. The colon catheter may be held in place as long as needed
and the patient may assume any position. Thus, for those who in the
past had to experience the significant discomfort of sitting for
any length of time on a bed pan, they may now relax with the colon
catheter inserted and assume any position comfortable for them
including lying on their stomach. For a patient with a large
collection of gases in the intestines, he may now lie on his
stomach which is the best position to permit the escape of such
gases through the anal canal.
To overcome the cleanliness and sanitary problems, with the present
invention, colon material moves directly into an enclosed
disposable plastic bag. Thus, objectionable noises, odors and
soiling of the bed are eliminated. With the invention, the colon
catheter itself, after being removed from the patient, may be
totally enclosed whereby the entire unit including the bag with its
contents and the used colon catheter can be enclosed and disposed
of as a unit in a clean substantially odorless manner. Also
important is the savings in material and labor costs associated
with changing soiled bed linens.
The present invention also provides a medical advance in that it
provides an opportunity for observation and testing of the stool.
For patients who might not have been limited to a bed pan, this now
provides an opportunity to assure collection and observation of all
contents of the stool. Also, for conducting certain tests which
require the total stool content, such total content is now
available and it is in a condition susceptible for handling and
testing.
Thus, it is an object of this invention to provide a new and
improved catheter for removing and collecting colon material.
It is another object of this invention to provide a new and
improved system for removing and collecting colon material.
It is another object of this invention to provide a disposable
system for easily removing colon material.
It is another object of this invention to provide an arrangement
for expelling the colon contents, which arrangement overcomes the
disadvantages associated with previous techniques.
It is another object of this invention to provide an arrangement
for removing the colon contents which assuees an opportunity to
observe and/or test the stool.
It is another object of this invention to provide a new and
improved catheter for removing waste colon material including a
catheter inserted into the anal canal and a bag associated
therewith for collecting the waste colon materials.
It is another object of this invention to provide an arrangement
for removing and collecting waste colon material which eliminates
the inconveniences and discomforts associated with previously used
procedures.
It is another object of this invention to provide a colon catheter
having a main hollow tube, the lumen of which is sufficiently short
and of sufficiently large cross-section for removal of waste colon
material and including an expandable member at one end, limiting
elements positionable against the perineum for holding the catheter
in place, and means at the free end for connecting this catheter to
an enclosed container for collecting the colon material.
Other objects and other advantages of the invention will become
apparent from the detailed description to follow, together with the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
There follows a detailed description of a preferred embodiment of
the invention to be read together with the accompanying
drawings.
FIG. 1 is a cross-sectional view of the colon catheter in place in
the anal canal.
FIG. 2 shows an element of FIG. 1 taken along line 2--2 of FIG.
1.
FIG. 3 is a perspective view of the colon catheter of FIG. 1
removed from the anal canal.
FIG. 4 is a cross-sectional view of a receptacle to be used in
conjunction with the colon catheter of FIGS. 1-3.
FIG. 5 is a cross-sectional view of a tubular insert which may be
used in conjunction with the catheter and the receptacle of FIGS.
1-4.
FIG. 6 illustrates an obturator which may be used for inserting the
colon catheter of FIGS. 1-3.
FIG. 7 is a perspective view showing another embodiment of the
invention.
FIG. 8 is a sectional view taken along line 8-8 of FIG. 7.
FIG. 9 is a sectional vew through the embodiment of FIGS. 7 and 8
showing the device in use.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings, like elements are represented by
like numerals throughout the several views.
FIG. 1 illustrates the colon catheter 10 in place in an anal canal
20. Anal sphincter muscles 21 are also shown. The catheter includes
a main hollow tube 11 having a lumen 12 extending therethrough from
a first opening 13 to a second opening 14. This main tube must be
sufficiently stiff to retain its shape in place in the anal canal
in opposition to the force of the sphincter muscles 21 tending to
close the anal canal. At the same time, it must be sufficiently
resilient such that is can be closed by a clamp 22 which simply
pinches the tube like one would pinch a hose. Such materials are
known. At the end of the tube 11 adjacent the first opening 13,
there is provided an annular balloon 15 of suitable elastic
material such as Latex. This balloon may be a separate anulus
attached by a suitable adhesive to the outer wall of the tube 11 in
which case it would include a separate external tube 16 for
delivering air and removing air from the balloon 15. Alternatively,
the tube 16 can be formed into the wall of the tube 11.
As is evident in FIG. 1, the balloon 15 holds the end of the tube
11 adjacent the balloon 15 in the colon passage to seal the same.
Intermediate its length, this tube has formed on the outside
thereof limiting elements in the form of bars 17 and 18. In this
embodiment, these limiting elements are formed as a separate piece
as shown in FIG. 2, which piece is slid over the outside of the
tube 11 onto a set of concentric circular ridges 19. In using the
device, after the balloon 15 has been expanded in place, the member
with limiting elements 17 and 18 formed thereon is slid up the tube
until it presses tightly against the perineum such that the balloon
15 seals the anal canal and the catheter is secured firmly in place
to prevent leakage or accidental removal thereof. The ridges 19 are
of sufficient height such that the member with limiting elements 17
and 18 will not slide down the tube in use.
Although the specific dimensions of the catheter will vary, to
accommodate the average adult, the outside diameter of this tube 11
should be 19 millimeters although it may be as great as 35
millimeters for special uses. The inside diameter should be about
15 millimaters in order to accommodate the colon waste material. It
may be somewhat smaller but should be no less then 10 millimeters.
Thus, an optimum catheter would have an inside diameter of 15
millimeters, a thickness of 2 millimeters, and an outside diameter
of 19 millimeters. Preferably, the length of the tube 11 is as
short as possible. A minimum length is believed to be 5 centimeters
and an optimum length would be 7 centimeters comprising
approximately 5 centimeters between the limiting elements 17 and 18
and the first opening 13, and approximately 2 centimeters between
the limiting elements and the second opening 14. The limiting
elements themselves may be between 1 to 3 centimeters in length and
an optimum would be approximately 2 centimeters.
FIG. 3 illustrates the catheter of FIGS. 1 and 2 removed from the
patient. Although ideally the balloon 15, in the relaxed condition,
would be drawn tightly about the tube 11, this is difficult to
obtain in practice and not really necessary. It is equally
practical to make the balloon 15 of a construction which droops as
shown in solid lines 15 in FIG. 3 in the relaxed condition. The
balloon can still be held very closely to the tube 11 during
insertion of the device into the anal canal. The expanded position
of balloon 15 is shown in dotted lines in FIG. 3. Also, in FIG. 3
the member with limiting bars 17 and 18 has been moved downwardly
slightly to expose a few ridges 19 and a clamp 22 is shown pinching
the section of the tube 11 between the limiting elements and the
second opening 14.
It is a feature of the present invention that means are provided
for collecting the waste colon material passing through the tube 11
and through the opening 14. Although a bag may simply be attached
to the end of the tube 11, in a preferred arrangement the end of
the tube is provided with an annular ring 23 adapted to receive a
receptacle as shown in FIG. 4.
Referring now to FIG. 4, this receptacle may be a suitable plastic
bag such as a polyethylene bag or the like 30 attached by a
suitable adhesive at 31 to a stiff annular collar 32 having an
inwardly projecting annular flange 33, the entire element 32 being
of a resilient material such that the flange 33 will snap over the
annular lip 23, thus acting as a snap ring and sealing against the
tube 11 in a fluid tight manner. It is preferable that the bag 30
be transparent so that the stool can be observed. However, for
aesthetics it is preferable to cover the bag. In the preferred
embodiment, an opaque covering such as a paper bag 36 encloses the
plastic bag 30 and is attached by a suitable adhesive 37 to the
outside of the stiff collar 32. A clear window 38 may be provided
for viewing the contents of the bag 30 through the opaque covering
36. Strings 40 may be attached to the bag 36 for tying the same to
a leg of the user.
It is contemplated that the entire system including the catheter
and the bag will be disposable. To facilitate such disposability,
there may be provided a flap 39 attached. to the outside of the
stiff collar 32 by a suitable adhesive. In the present embodiment,
this collar 39 is shown as an extension of the paper bag 36. After
use, and with the tube 11 in place with its flange 23 within the
flange 33 of collar 32, the entire flip 39 can be drawn up and
around the catheter 10 and closed by any suitable means such as
strings 41 attached to the outside of flap 39.
The bag 30 may also include a gas bleed valve 42 which may be
similar to a conventional football valve for releasing gases from
the bag 30. The bag may also include an obturator 43 attached at 44
to the interior of the bag 30 for a purpose to be explained in
greater detail below.
FIG. 5 illustrates an insert which may be provided between the
flanges 23 and 33 for introducing an enema solution or the like to
the colon. In this case, the insert member 60 would be formed of a
stiff material like the stiff collar 32. It includes a first
opening 61 and a second opening 63. A flange 62 is provided to
encircle the lip 23 in the same manner as flange 33, and the lip 67
is adapted to be encircled by the flange 33 in the same manner as
lip 23. The insert includes a side passage 64 with a suitable
removable cover 65. A clamp 66 similar to clamp 22 may be provided
for closing off this insert between the side opening 64 and the
second opening 63 so that when the insert is in place one may close
off the insert 60 by clamp 66 thus permitting the enema solution to
be delivered directly through the opening 64 and into the colon
passage, after which the clamp 66 would be removed, permitting the
waste material to move through the tube 11, the insert 60, and the
stiff collar and into the bag 30.
The device as shown in FIGS. 1 through 5 would operate as follows.
Firstly, the expandable member 15 would be relaxed as shown in FIG.
3 and the elements 17 and 18 would be positioned low relative to
the ridges 19 as shown in FIG. 3. The tube would be opened (not
closed by the clamp 22) and an obturator would be placed through
the tube 11 projecting through the opening 13 for facilitating
introduction of the device into the anal canal. If it is desired to
insert the tube 11 without the bag 30 attached thereto, a separate
conventional obturator 50 (FIG. 6) would be used having the usual
rounded head 51 and an elongated rod 52. After the end 13 and the
balloon 15 have been placed into the anal canal beyond the
sphincter muscles 21, the obturator would be removed, the balloon
15 expanded by introducing air through tube 16 and then the
limiting elements 17 and 18 would be pushed up against the perineum
to tightly hold the catheter in place. A conventional fixed volume
safety cuff may be used for introducing air through the tube 16,
thus carefully controlling the volume of the introduced air.
The device could also be inserted with the bag 30 already attached
to the tube 11, either with or without the insert member 60. In
this case, the balloon 15 and the elements 17 and 18 would be as
previously described. However, in this case one would grasp for the
rod portion 45 and the base portion 44 of the obturator within the
bag 30 by handling the same through the bags 36 and 30. The rod
portion 45 would be at least as long as the tube 11. The obturator
head 43 which is also rounded like the obturator head 51 would be
pushed through the lumen with the head 43 projecting at the opening
13. In this manner, the tube would be inserted after which the
obturator 43 would be withdrawn. It would then simply remain in the
bag 30 and would be disposed of along with the remainder of the
apparatus after use. This provides the additional advantage of
having a disposible readily available single use obturator for each
application.
For convenience, the portion of the tube 11 between the limiting
elements and the first opening 13 may be referred to conveniently
as the first portion and the portion of tube 11 between the
limiting elements and the second opening 14 may be referred to as
the second portion.
FIGS. 7 through 9 illustrate another embodiment of the invention.
In this embodiment the catheter 110 includes a first portion 112
and a second portion 113 defining a lumen between a first opening
130 and a second opening 137. The inside and outside diameters and
the length of the catheter 110 between the opening 130 and 137
would be the same as described above with respect to the
embodiments of FIGS. 1 through 5. The catheter tube 111 in this
case may be of the same material as the catheter tube 11, thus
permitting the same to be closed by a suitable clamp 22, or in the
alternative, since valves are shown in this embodiment, the tube
111 may be of a somewhat stiffer material.
In this embodiment, there is shown a side tube 131 having a cap 132
formed as an integral part of the tube 111. Suitable flap valves
140 and 141 are provided across the second portion 113 and the side
opening 131, respectively. In this embodiment, a limiting bar 121
extends to the side of the first portion 112 opposite from the side
opening 131. Hence, in this case the bar 121 and the side opening
tube 131 constitute the limiting means.
In this embodiment, there is provided a suitable expandable member
115 similar to the expandable member 15 except that in this
embodiment, there is illustrated the arrangement wherein the tube
116 is formed in the walls of tube 111, opening into the member 115
at opening 118. This enclosed tube 116 enters the atmosphere at
opening 117, at which it would be connected to a suitable supply
tube.
This embodiment shows a suitable resilient ring 139 for holding a
plastic bag 138 onto the end of the tube 111 and a suitable ring
133 for holding a hose or the like onto the end of tube 131 for
receiving an enema solution or the like.
The embodiment of FIGS. 7 through 9 may be modified as follows.
First, the bar 121 could be eliminated and the second portion 113
turned 90.degree. relative to the first portion 112 whereby it
could itself serve as one limiting means. In some cases the side
tube 131 is not necessary and hence it can be constructed as a
solid bar, thus still serving as the other limiting means. Also,
the second portion 113 can be shortened considerably, such that it
extends from the turn approximately 1 to 3 centimeters to its
second opening 137.
When the hollow tube 131 is used, the one-way valve 140 should be
resilient enough to permit the passage thereof of colon material
but stiff enough to prevent gases and liquids from returning
therethrough into the colon. Also, the valve 140 should be
sufficiently resilient so that an insertion obturator initially
extending all the way from the opening 130 to the opening 137 can
be pulled out through the valve 140 and out through the opening 137
after the catheter has been inserted.
The embodiments of FIGS. 7 through 9, with or without the described
modifications, would operate in substantially the same manner as
described above with respect to the embodiment of FIGS. 1 through
6. In this case, one would use the obturator used in FIG. 6,
inserting the rod portion 52 down through the opening 130 and then
through the opening 137 with the rounded head portion 51 protruding
through the opening 130. In this case, and with the expandable
member 115 relaxed, the first portion 112 would be inserted through
the anal canal 20. In this case, movement would be limited through
engagement of the elements 131 and 121 and/or 113 against the
perineum, after which the member 115 would be expended to seal the
anal canal and retain the catheter in place. The plastic bag 138
would then be connected and held in place by a suitable elastic
ring 139. If desired, the embodiment of FIGS. 7 through 9 can be
used to introduce an enema solution as follows. The operator would
remove the cap 132 and place a cover over the opening 137 and then
introduce through the tube 131 a suitable enema solution. After the
appropriate amount had passed through the flap valve 141 and
through the portion 112 into the colon, the cap 132 would be
replaced after which the cap would be removed from opening 137 and
the bag attached as described above, after which removal of waste
material from the colon passage would commence in the usual
manner.
Although the invention has been described above in considerable
detail with respect to preferred embodiments thereof, it will be
apparent that the invention is capable of numerous modifications
and variations apparent to those skilled in the art without
departing from the spirit and scope of the invention.
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