U.S. patent number 3,577,982 [Application Number 04/799,748] was granted by the patent office on 1971-05-11 for equipment for delivering a liquid into a body stoma.
Invention is credited to Edwin La Par.
United States Patent |
3,577,982 |
La Par |
May 11, 1971 |
**Please see images for:
( Certificate of Correction ) ** |
EQUIPMENT FOR DELIVERING A LIQUID INTO A BODY STOMA
Abstract
Equipment for delivering a liquid such as a barium solution into
a body stoma such as the anus or the mouth of a colostomy, in which
equipment provision is made for retaining the equipment in the
desired position under the influence of reduced pressure or vacuum.
A vacuum chamber for this purpose preferably substantially
completely surrounds a catheter adapted to be inserted into the
stoma, the vacuum chamber being in spaced relation to the catheter
so as to cooperate with areas of the body surface spaced from the
stoma.
Inventors: |
La Par; Edwin (Andalusia,
PA) |
Family
ID: |
25176654 |
Appl.
No.: |
04/799,748 |
Filed: |
February 17, 1969 |
Current U.S.
Class: |
600/435; 604/278;
604/176 |
Current CPC
Class: |
A61F
5/442 (20130101); A61M 31/00 (20130101); A61M
3/0287 (20130101); A61M 1/90 (20210501); A61M
1/0058 (20130101) |
Current International
Class: |
A61F
5/442 (20060101); A61M 31/00 (20060101); A61M
3/00 (20060101); A61M 3/02 (20060101); A61m
003/00 (); A61m 025/02 () |
Field of
Search: |
;128/239--242,245,246,283,276,348--351,2 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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175,525 |
|
Mar 1917 |
|
CA |
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15,864 |
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Jul 1912 |
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FR |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
I claim:
1. Equipment for use in delivering a liquid into a body stoma,
comprising a cup adapted to engage the body surface surrounding the
stoma, a catheter extended through the cup and adapted to be
inserted into the stoma, the cup having an open edge in spaced
relation to the catheter, and vacuum means for retaining the
equipment in position when applied to a patient comprising an outer
wall cooperating with the cup to define an open-sided vacuum
chamber at least in large part surrounding said cup and with its
open side adapted to be presented toward the body, the vacuum
chamber having a vacuum passage therethrough adapted to be
connected to a vacuum producing means and thereby provide for
adherence of the equipment to the body by pressure reduction in the
vacuum chamber.
2. Equipment according to claim 1 in which the cup and the outer
wall are interconnected with the portion of the catheter extended
through the cup and in which the cup, vacuum chamber and said
portion of the catheter are formed of substantially rigid material
to provide for maintenance of the positional relationship of these
parts during use including pressure reduction in the vacuum
chamber.
3. Equipment as defined in claim 2 in which the rigid material of
which the cup, outer wall and interconnected portion of the
catheter are formed is radiolucent, the equipment further including
a radio-opaque marker associated with the catheter in a position
adapted to indicate the location of the stoma into which the
catheter is inserted.
4. Equipment according to claim 1 in which the cup and the outer
wall are relatively positioned to provide an annular open-sided
vacuum chamber surrounding the cup to provide for vacuum adherence
of the equipment at all sides of the cup.
5. Equipment according to claim 1 in which the edge of the cup is
shaped to fit the gluteal cleft surrounding the anus and in which
the catheter is adapted to be inserted into the intestine through
the anus, and further in which the outer wall is shaped to provide
a vacuum chamber having openings presented toward the buttocks at
opposite sides of the anus.
6. Equipment according to claim 1 in which the edge of the cup is
shaped to fit the abdominal wall surrounding one of the stomata of
a multiple stoma colostomy, and in which the cup and the outer wall
are relatively positioned to provide a vacuum chamber which is
eccentrically disposed with respect to the cup and thereby provide
the principal vacuum adherence of the equipment to the body surface
toward one side of the stoma into which the catheter is inserted in
an area offset from the other stoma of the colostomy.
7. Equipment for use in rectally administering enemas comprising a
catheter for insertion into the intestine through the anus, and
mechanism for retaining the equipment in position as applied to a
patient including a vacuum device having walls shaped to fit the
gluteal cleft and defining a vacuum compartment with extended open
areas adapted to be presented toward the buttocks when the device
is positioned in the gluteal cleft and thereby provide for vacuum
adherence of the device to the buttocks the catheter being extended
through said device between said open areas and having a liquid
supply connection extended in a direction transverse to the
direction of extension of said open areas so that when the
equipment is applied the supply connection extends parallel to the
gluteal cleft.
8. Equipment as defined in claim 7 in which the vacuum device is
shaped at its outer side to have a valley adapted to parallel the
gluteal cleft when the device is applied to a patient, the liquid
supply connection lying in said valley.
9. Equipment for use in rectally administering enemas comprising a
catheter adapted for insertion into the intestine through the anus,
a cup having a cup wall sealed against the catheter and having a
free edge extended in spaced relation around the catheter, said
free edge being contoured in a manner generally conforming with the
topography of the gluteal cleft to provide for engagement with the
walls of the cleft in spaced relation to the anus, and vacuum means
for retaining the equipment in position when applied to a patient
comprising an outer wall extended in spaced relation around said
cup and cooperating with the cup to define a vacuum compartment
therebetween, said outer wall having a free edge spaced from the
free edge of the cup, the free edge of said wall also being
contoured in a manner generally conforming with the topography of
the gluteal cleft so as to engage the walls of the cleft in spaced
relation to the line of engagement of the free edge of the cup with
the walls of the gluteal cleft.
10. Equipment for use in rectally administering enemas comprising a
catheter adapted for insertion into the intestine through the anus,
a cup having a cup wall sealed against the catheter and having a
free edge extended in spaced relation around the catheter and
adapted to engage the walls of the gluteal cleft in spaced relation
to the anus, and vacuum means for retaining the equipment in
position when applied to a patient comprising an outer wall
extended in spaced relation around said cup and cooperating with
the cup to define a vacuum compartment therebetween, the outer wall
being shaped to define a vacuum compartment having areas or wings
extended at opposite sides of the catheter and adapted to overlie
the buttock areas at opposite sides of the gluteal cleft when the
equipment is applied, and the free edge of said outer wall being
contoured in a manner generally conforming with the topography of
the gluteal cleft and thereby provide a vacuum seal with said
buttock areas when the equipment is applied.
11. Equipment as defined in claim 10 in which said outer wall has a
vacuum passage therethrough adapted to be connected to a vacuum
producing means.
12. Equipment as defined in claim 10 in which said cup, outer wall
and the portion of the catheter adapted to be inserted into the
rectum are formed of substantially rigid material to provide for
maintenance of the positional relationship of these parts during
use including pressure reduction in the vacuum compartment.
13. Equipment as defined in claim 10 in which the catheter includes
a rigid portion of sufficient length to extend into the rectum, and
further including a flexible catheter tip adapted to extend from
the end of the rigid portion into the intestine.
Description
This invention relates to equipment for delivering liquids into
body stomata, and is especially adapted to the administration of
enemas, such as barium enemas, as used in radiological examination.
While various features of the invention are adapted for use in the
administration of barium enemas through the stoma of a colostomy,
the invention is especially adapted to the administration of such
enemas through the anus or rectum.
Although the muscle tone of the rectal sphincter in some patients
is adequate to retain the liquid of a barium enema during a
radiological examination, there are many patients in which this is
not true and, in addition, in the case of patients with
colostomies, there is no means present to retain liquids. Some
efforts have been made to meet these problems by the use of an
obturator associated with a catheter and adapted to be expanded
inside the stoma into which the catheter is inserted in order to
provide a means for preventing undesired loss of enema liquid. In
the case of barium enemas administered for radiological purposes,
such loss of the barium liquid is particularly disadvantageous, not
only because of the undesirable flow of the liquid onto the
adjacent surfaces of the body, but also because such loss results
in delivery to the surfaces of the body a radio-opaque material
which is at least confusing in the radiological examination and, in
many instances, even obliterates the very images sought to be
identified either in the fluoroscope or in the x-ray pictures being
taken.
The prior attempts to meet this problem by the use of an obturator
are subject to a number of disadvantages as is well known and which
will not be extensively reviewed, although it may be noted a major
disadvantage lies in the fact that an interior obturator is likely
to exert excessive internal pressure, sometimes sufficient to
damage or even rupture the intestinal wall.
In accordance with the present invention, the problems of
administering barium enemas are greatly diminished by the provision
of a special form of equipment adapted to form an external seal
against the surfaces of the body surrounding the stoma into which
the catheter is inserted, the seal being established under the
influence of reduced pressure or vacuum, thereby rendering the seal
effective without the necessity of employing an obturator in any
position and, moreover, without the necessity of employing straps
or other fastening devices such as body-encircling belts.
The invention also contemplates the employment of radiolucent
materials in the equipment, at least in the region where the
equipment is applied to the body of the patient, so that
radiological examination will not be hindered. It is also
contemplated according to the present invention to utilize a
radio-opaque marker associated with the equipment and preferably
positioned so as to mark the location of the stoma into which the
catheter is inserted, so that the radiologist is provided with a
guide or reference point for use in his analysis.
How the foregoing objects and advantages are attained will appear
more fully from the following description referring to the
accompanying drawings, in which:
FIG. 1 is a somewhat diagrammatic elevational view of one form of
equipment constructed according to the present invention, the
equipment here being shown in outline in position as it would be
applied to the rectum of a patient;
FIG. 2 is a sectional view on an enlarged scale, taken as indicated
by the section line 2-2 on FIG. 1;
FIG. 3 is a perspective view of the device shown in FIGS. 1 and
2;
FIG. 4 is a view of a modified form of device according to the
invention as it would be applied to the stoma of a colostomy;
FIG. 5 is an enlarged sectional view taken generally as indicated
by the section line 5-5 on FIG. 4; and
FIG. 6 is a perspective view of a third embodiment, which is also
adapted for use in administering an enema through the stoma of a
colostomy.
Turning first to the embodiment illustrated in FIGS. 1 to 3, it is
to be observed that the equipment there shown is especially adapted
for use in the administration of barium enemas through the rectum.
The equipment includes a catheter which is made up of several
pieces. Thus, the catheter includes a relatively flexible and soft
tip portion 7 formed, for example, of rubber having sufficient
rigidity to permit insertion through the anus and rectum into the
intestine, but of sufficient flexibility so that the catheter tip
will readily follow the contours of the intestine into which it is
inserted. This tip is provided with apertures as indicated at 7a,
preferably at several circumferentially and longitudinally spaced
points, to facilitate the free flow of the liquid being delivered
into the intestine. This tip portion is telescopically associated
with the intermediate portion of the catheter indicated at 8, the
portion 8 desirably having some rigidity and preferably formed of a
plastic or resinous material, for instance rigid polyvinyl chloride
resin, polymethyl methacrylate, or nylon. In all instances, it is
contemplated that both the rubber of the tip portion 7 and the
resin of the intermediate portion 8 shall be radiolucent, as, for
instance, by omission of any inorganic pigment which would cast any
appreciable shadow in the radiological examination.
The catheter portion 8 extends through a cup 9 and is preferably
sealed and rigidly connected with that cup. The free edge of the
cup is configured to fit the contours of the gluteal cleft in the
areas thereof surrounding the anus, so that when the catheter is
inserted into the intestine through the anus, the cup 9 forms a
compartment or chamber surrounding the region of the anus. This cup
is of relatively small dimension in the direction perpendicular to
the plane of the paper in FIG. 2, as can be seen from the
perspective view of FIG. 3, so that the cup has in effect two
laterally presented open areas of somewhat elongated shape. The
edge of each cup is provided with a sealing or cushion element or
bead 10, as appears in both FIGS. 2 and 3.
As seen in FIGS. 1, 2 and 3, the device in this embodiment also
includes a structure generally indicated at 11 interconnected with
the cup and catheter and having sidewalls 12 with a sealing bead 13
at the free edges thereof. The walls 12 are shaped to conform with
and fit into the gluteal cleft in the region surrounding the cup 9,
the sealing bead 13 being adapted to engage and form a seal with
the buttocks at opposite sides of the gluteal cleft in the manner
clearly indicated in FIGS. 1 and 2.
As will be apparent from the drawings, the device of FIGS. 1, 2 and
3 is also preferably made of relatively large dimension in the
direction across the gluteal cleft, but of relatively small
dimension in the direction or plane normal to the large dimension.
Indeed, as appears in both FIGS. 1 and 3, the overall shape of this
device somewhat resembles a butterfly shape having enlarged areas
extended to overlie the buttocks and having a narrow intermediate
area in the central region of the device adjacent to the catheter.
By this shaping of the device, a substantial vacuum chamber area is
provided overlying each of the buttocks at opposite sides of the
gluteal cleft, while at the same time the dimension of the vacuum
chamber or compartment is minimized in the region overlying the
perineum, so as to avoid encroachment upon the genital region.
Since it is contemplated that the equipment be retained in its
desired position by pressure reduction or vacuum, some appreciable
surface area of the body is desirably engaged by the device, and
the shape of the device as just described provides this appreciable
surface area engagement, and thus introduces a positional stability
tending to avoid undesired shifting of the device or catheter with
respect to the anus.
From FIGS. 2 and 3 it will further be seen that the outer wall 14
of the device of FIGS. 1, 2 and 3 is provided with a central valley
through which the catheter projects, and from which the rigid
plastic part of the catheter 8 projects downwardly as indicated at
8a. A flexible rubber tube 15 is associated with the portion 8a and
extended to any desired source of the enema liquid, such as the
enema can 16 shown in FIG. 1, the flow being controlled by any
suitable valve such as indicated at 17.
By arranging the portions of the catheter 8 and 8a in the manner
just described, especially the nesting of those portions in the
valley of the outer wall 14, when the device is applied to a
patient upon an examination table, the catheter connection is
protected within the valley of the wall 14, so that for the most
part the only contact of the device with the table will be high
points of the wall 14. This is desirable not only for the
protection of the equipment but also for the comfort of the
patient.
Pressure reduction in the vacuum chamber is effected by any
suitable vacuum pump or system such as indicated diagrammatically
at 18 in FIG. 1 which is connected with a trap or receiver 19
which, in turn, is connected by means of the tube 20 extended to
penetrate one of the walls 12 defining the vacuum chamber. Just
inside of the wall 12, the vacuum tube 20 communicates with the
vacuum space through apertures in a shield 21 indicated in dot-dash
lines in FIG. 2. A device of this kind is shown in section in FIG.
5 which illustrates another embodiment of the equipment of the
invention in which this same type of shield is utilized, as will
further appear. The purpose of this device is to shield the inlet
to the vacuum tube 20 so that in the event of contact with a fold
of skin, the vacuum system will still operate to provide the
desired pressure reduction within the vacuum compartment and thus
provide for adherence of the equipment to the body surfaces
surrounding the stoma into which the catheter is inserted.
The cup 9 and the various walls of the surrounding vacuum chamber,
including the walls 12 and 14 are desirably formed of radiolucent
material and these wall parts are also desirably substantially
rigid. Appropriate materials for this purpose have been mentioned
above in connection with the portion 8 of the catheter, and the
wall elements just referred to may be made of those same materials.
The beads or sealing elements 10 and 13 are also desirably formed
of radiolucent material, and for the purpose of these beads a
sponge type of rubber is suitable. The sponge rubber of the sealing
elements 10 and 13 is also desirably formed with an impervious
surface layer so that the sponge rubber material will not soak up
any barium liquid in the sealing area, as this would render those
sealing elements radio-opaque and undesirably cast shadows in the
radiological examination. In the application of the device to a
patient it is contemplated that these beads be wiped with vaseline
or other similar material adapted to produce a tight seal when the
pressure is reduced in the vacuum compartment.
Attention is called to the fact that the cup 9 provides a seal
against the body surfaces in spaced relation to the catheter and
the anus in which the catheter is inserted, so that there is a
small compartment thus formed surrounding the anus, into which any
liquid leakage will be received and will be isolated from the
surrounding vacuum chamber. In this way flow of the barium liquid
over any extensive area surrounding the anus is prevented, and in
addition the vacuum system is protected as against entrance of such
liquid. In any event, even if some liquids were to enter the vacuum
tube 20, they would be received in the trap 19 and thus would not
enter the vacuum producing system 18.
Since all of the parts of the equipment immediately associated with
the patient are contemplated to be formed of radiolucent material,
those parts will not appear or cast any appreciable shadow in the
radiological examination. However, it is desirable to provide a
marker formed of radio-opaque material, so that the radiologist is
assisted in locating the positional relationship of the equipment
and the anus. For this purpose it is contemplated to use a marker
such as indicated at 22 in the form of a ring of material applied
to the catheter just outside the anus. This may be formed of or
include lead, barium or an iodide compound.
Turning now to the embodiment of FIGS. 4 and 5, it is noted that
the device is here adapted to the administration of an enema
through the stoma of a colostomy formed in the abdominal wall. This
device comprises a cup 23 having its edge provided with a resilient
sealing bead 24 positioned to engage the abdominal wall around and
in spaced relation to a stoma of a colostomy.
As in the first embodiment, the catheter is here also made up of
several parts, including the rigid part 25 which extends through
the cup 23 and to which a soft and relatively flexible tip 26 is
telescopically connected. In this instance, as will be seen from
FIG. 5, the rigid part of the catheter 25 terminates just outside
of the stoma, instead of extending into the intestine, as in the
first embodiment. Termination of the rigid part of the catheter
just outside of the anus can also be utilized in the first
embodiment, and in addition in the embodiment of FIG. 5 it is
possible to employ an arrangement in which the rigid part of the
catheter extends into the stoma of the colostomy. Where it is
desired to utilize the insertion of the catheter for the purpose of
aiding in establishing and maintaining the position of the
equipment, the extension of the rigid part of the catheter into the
stoma, whether it be the anus or the stoma of a colostomy, may be
resorted to for this purpose.
In the embodiment of FIGS. 4 and 5 the device also includes a
structure having a wall 27 cooperating with the cup 23 in
establishing a vacuum chamber or compartment at least in large part
surrounding the cup. The edge of this wall 27 as shown in FIG. 5 is
provided with a sealing bead 28 and the vacuum compartment may be
subjected to the reduced pressure by means of the tube 29 extended
through the vacuum chamber wall 27 and terminating in the shield
element 30 provided with several apertures adapted to avoid
blocking of the vacuum connection in the event of unintentional
contact with some body surface or skin fold, as above described
with reference to shield 21 of the first embodiment. The tube 29
may be connected through the trap 19 with the vacuum system 18, as
in the first embodiment.
The cup 23 and the wall 27, as well as the intermediate portion of
the catheter 25 are all contemplated to be made of radiolucent
material of substantially rigid type, for example materials of the
kinds referred to above. A radio-opaque marker 31 is also desirably
provided on the catheter just outside of the stoma.
A flexible enema tube 32 may be telescopically associated with the
catheter portion 25, and this tube may be fed from a source such as
indicated at 16 through a valve 17, as in the first embodiment.
In further considering the arrangement of FIGS. 4 and 5 it is first
noted that as surgically constructed, colostomies are frequently
"double barreled" and frequently have two stomata positioned in the
abdominal wall relatively close to each other. Such a colostomy is
illustrated in FIG. 5, the two portions of the intestine being
indicated at 33 and 34. The stoma communicating with the left side
of the colon communicates with the rectum, and this portion of the
colon is indicated at 33 in FIG. 5. The stoma associated with the
right side of the colon, which is indicated at 34 in FIG. 5, is the
portion which communicates with the upper colon and small
intestine. Where a barium enema is desired for radiological
examination of the lower part of the colon, such examination is
ordinarily effected by way of a barium enema introduced in
retrograde fashion through the rectum, so that the stoma of the
portion of the colon indicated at 33 ordinarily is not used as the
entrance point for the barium solution. For this reason, in FIG. 5,
the equipment is shown as being associated with the stoma of the
portion 34 of the intestine, which cannot be reached through the
rectum.
Because the two stomata of such a typical colostomy are ordinarily
positioned relatively close to each other in the abdominal wall,
the device as shown in FIG. 5 is constructed so that the vacuum
compartment is eccentrically positioned with relation to the
catheter and with relation to the stoma into which the catheter is
inserted. By arranging the vacuum compartment in this way, it is
possible to apply the equipment to the desired stoma without
overlapping the stoma of the other portion of the colon, which
would be undesirable from many standpoints including the fact that
this would destroy the vacuum action by which adherence of the
equipment to the abdominal wall is intended to be secured.
As in the first embodiment, the cup 23 provides a small chamber
surrounding the stoma and isolating that area from the vacuum
chamber. The arrangement of FIGS. 4 and 5 also provides a
substantial area over which the vacuum is effective, thereby
providing a secure adherence and stability of the equipment during
use.
In the embodiment shown in FIG. 6 the parts are essentially the
same as those described above with reference to FIGS. 4 and 5 and
are therefore given similar reference numerals but each one further
including the letter a. The difference between the embodiment of
FIG. 6 and the embodiment of 4 and 5 is that the wall structure 27a
defining the outside of the vacuum compartment is concentrically
arranged with respect to the catheter 25a and the cup 23a, instead
of eccentrically as in FIGS. 4 and 5. This variant is suitable for
use in connection with any colostomy where only a single stoma is
provided or where the stomata of a "double barreled" "colostomy are
sufficiently separated to accommodate application of the equipment
to one stoma without overlapping the second stoma.
The embodiment of FIG. 6 may also be adapted for use with one stoma
of a double barreled colostomy where the two stomata are close
together, by providing a blocking element or obturator bridging the
space between the wall 27a and the cup 23a at one side of the
device. With such an arrangement the entire device would be
rotationally positioned so that the blocking element or obturator
would overlie the second stoma and thus shield it from the action
of the reduced pressure provided in the vacuum chamber.
With all the embodiments illustrated and described, it is
contemplated that at least certain of the parts be so formed as to
be disposable, for instance the flexible rubber catheter tip. While
the entire device might be disposable, this would not be necessary
and the principal portion of the device, especially when formed of
certain materials such as polymethyl methacrylate, nylon or rigid
polyvinyl chloride can readily be sterilized by known techniques,
after removal of the catheter tip and the enema liquid supply and
vacuum tubes.
Devices of the kind disclosed may readily be made in graduated
sizes adapted for use not only with adult patients but also with
pediatric patients. This may be of special importance in connection
with the embodiment of FIGS. 1 to 3 wherein it is desired to have
the device fit the topography of the gluteal cleft.
In accordance with the foregoing, provision is made for a secure
and simple application and attachment of equipment of the kind here
involved, without resort to any body-encircling devices, and
without resort to any obturators. The administration of barium
enemas and also the administration of liquids for other purposes
into body stomata is simplified and rendered more reliable.
* * * * *