U.S. patent number 3,581,732 [Application Number 04/790,946] was granted by the patent office on 1971-06-01 for stoma adapter.
This patent grant is currently assigned to Nancy J. Gates. Invention is credited to Gilbert G. Ruiz.
United States Patent |
3,581,732 |
Ruiz |
June 1, 1971 |
STOMA ADAPTER
Abstract
A device for conveying fluids, such as aqueous suspensions of
barium sulfate, into and out of a body opening such as a colostomy
opening, including conduit means, a radial flange integral with the
conduit means, pressure means for maintaining the flange in direct
contact with a stoma, base means for engaging the abdominal wall,
said base means being constructed to abut the abdominal wall
closely adjacent the stoma, body-encircling means for maintaining
the base means in place, said pressure means being fixed with
respect to said base means, whereby the body cavity is sealed at
the stoma and fluid communication between the cavity and the
exterior abdominal wall is prevented.
Inventors: |
Ruiz; Gilbert G. (Addison,
IL) |
Assignee: |
Gates; Nancy J. (Mt. Prospect,
IL)
|
Family
ID: |
25152200 |
Appl.
No.: |
04/790,946 |
Filed: |
January 14, 1969 |
Current U.S.
Class: |
600/435; 604/278;
604/179 |
Current CPC
Class: |
A61M
25/02 (20130101); A61F 5/445 (20130101); A61M
31/00 (20130101); A61M 2025/0246 (20130101); A61M
2025/028 (20130101) |
Current International
Class: |
A61F
5/445 (20060101); A61M 25/02 (20060101); A61M
31/00 (20060101); A61m 003/00 (); A61m
025/02 () |
Field of
Search: |
;128/283,2,1,224,229,239,241,242,245,246,348--351 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
I claim:
1. An apparatus for use in conjunction with a catheter having a
conduit to extend into a stoma in a person's body wall and having
an enlargement surrounding the conduit and being larger than the
stoma to contact the body wall with a portion of the conduit
extending outwardly from said enlargement, said apparatus
comprising:
a base having two ends and walls between said two ends, said walls
defining a truncated conical internal opening relatively large at
one end and relatively small at the other, said large end being of
a size to receive said enlargement, said base having an outward
peripheral flange at said one end of said walls of a configuration
to fit flat against said body wall about said stoma, said base
having an opening at said other end to receive said portion of the
conduit, whereby when said catheter is so positioned on said
person's body wall said base may be placed over the catheter with
the enlargement within the large end of the internal opening and
said portion extending through said end opening, said internal
opening being of a size that said base walls will, when said
catheter and base are so positioned, bear against the periphery of
said enlargement to hold said enlargement against said stoma, and
means for holding said base with its flange firmly against the
person's body and including a body-encircling band and a part in
contact with the exterior of the base.
2. An apparatus as set forth in claim 1, wherein the exterior of
said base defines a step of annular configuration between said ends
and substantially parallel to said ends, and said part comprises a
plate having an opening therein of a size to be received only over
the portion of said base between said step and said other end.
3. An apparatus as set forth in claim 2, wherein there are a
plurality of said steps with each step, commencing from said other
end, being a larger annulus from that of the preceding step,
whereby a plurality of said parts having openings therein of
different sizes, may be interchanged one at a time to engage a
respective sized step.
4. In the combination of a catheter and a device to hold it in
place wherein the catheter has a conduit to extend into a stoma in
a person's body wall and having an enlargement surrounding the
conduit and being larger than the stoma to contact the body wall
with a portion of the conduit extending outwardly from said
enlargement, the improvement wherein said device comprises:
a base having two ends and walls between said two ends, said walls
defining a truncated conical internal opening relatively large at
one end and relatively small at the other, said large end receiving
said enlargement, said base having an outward peripheral flange at
said one end of said walls of a configuration to fit flat against
said body wall about said stoma, said base having an opening at
said other end receiving said portion of the conduit, said internal
opening being of a size that said base walls will, when said
catheter and base are so positioned, bear against the periphery of
said enlargement to hold said enlargement against said stoma, and
means for holding said base with its flange firmly against the
person's body and including a body encircling band and a part in
contact with the exterior of the base.
5. In the combination as set forth in claim 4, wherein the
enlargement comprises a pneumatically expandable bulb.
6. In the combination as set forth in claim 5, wherein the exterior
of said base defines a step of annular configuration between said
ends and substantially parallel to said ends, and said part
comprises a plate having an opening therein of a size to be
received only over the portion of said base between said step and
said other end.
7. In the combination as set forth in claim 6, wherein there are a
plurality of said steps with each step commencing from said other
end, being a larger annulus from that of the preceding step,
whereby a plurality of said parts having openings therein of
different sizes may be interchanged one at a time to engage a
respective sized step.
8. In the combination as set forth in claim 4, wherein the exterior
of said base defines a step of annular configuration between said
ends and substantially parallel to said ends, and said part
comprises a plate having an opening therein of a size to be
received only over the portion of said base between said step and
said other end.
9. In the combination as set forth in claim 8, wherein there are a
plurality of said steps with each step commencing from said other
end, being a larger annulus from that of the preceding step,
whereby a plurality of said parts having openings therein of
different sizes may be interchanged one at a time to engage a
respective sized step.
Description
BACKGROUND OF THE INVENTION
In the radiographic examination of colostomies it is necessary to
transfer aqueous suspensions of barium sulfate through the body
opening (i.e. the stoma) in sufficient quantities to permit
observation of the structures involved during the examination.
Frequently the patient is required to change positions several
times during the course of the study. For example, at one point in
the radiographic study the patient may be required to lie on his
back, and at another point the patient may be required to lie on
one or the other side. Moreover, devices heretofore available for
inserting the barium sulfate suspensions into the involved organs
through a stoma would usually permit substantial leakage at the
stoma. Such leakage of the barium sulfate would generally be
sufficient to cause the barium sulfate suspension to collect or
drain around the stoma onto the body wall or into cloth packings.
Cloth packing would often be pressed against the stoma to minimize
such leakage or expulsion of the barium sulfate suspension. Shadows
resulting from such indiscriminate distribution of the barium
sulfate suspension against the outer body wall or into cloth
packings may have a tendency to obscure observation of details
involving internal organs in that area. Also, whenever the patient
is required to change position the tendency for the barium sulfate
suspension to leak from the stoma was increased.
Some of the devices heretofore provided for maintaining conduit
means such as tubes in body openings required the expansion of a
bulb or flange with the body to prevent the removal of the conduit
means from the body opening. Such devices are totally unsuitable
for use in connection with colostomies, ileostomies, and the like,
because of the danger of rupture of the wall of the organ
involved.
It is an object of this invention to provide a device for virtually
leakproof transfer of fluids such as aqueous barium sulfate
suspensions into the body through a stoma. It is a further object
to provide a device which is readily maintained in leakproof
condition during a radiographic examination, and especially during
a change in position by the patient. It is another object of this
invention to provide a device for the convenient, tidy and clean
transferring of fluid into and out of the body through a stoma,
which device is readily cleaned, sterilized, and simple to use.
SUMMARY OF THE INVENTION
In a device in accordance with this invention the conduit means has
a radial flange for sealingly engaging the outer portion of the
stoma the device includes means for pressing the flange against the
surfaces of the stoma. It also includes base means which abut the
abdominal wall closely adjacent the periphery of the stoma. The
means for pressing the flange against the stoma is fixed with
respect to the base means.
DESIGNATION OF THE FIGURES
FIG. 1 is a perspective view illustrating a preferred embodiment of
this invention;
FIG. 2 is a cross-sectional view taken approximately along the line
2-2 in FIG. 1;
FIG. 3 is a fragmentary perspective view of an end portion of a
catheter having integral therewith a flange near the end
thereof;
FIG. 4 is a cross-sectional view taken approximately along the
lines 2-2 of FIG. 1 illustrating the internal structure of an
alternative embodiment of this invention; and
FIG. 5 is a view of the base component as it faces the body.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Although the following disclosure offered for public dissemination,
in return for the grant of a patent, is detailed to ensure adequacy
and aid understanding, this is not intended to prejudice that
purpose of a patent which is to cover each new inventive concept
therein no matter how others may later disguise it by variations in
form or additions or further improvements. The claims at the end
hereof are intended as the chief aid toward this purpose; as it is
these that meet the requirement of pointing out the parts,
improvements, or combinations in which the inventive concepts are
found.
In accordance with this invention the interior 10 of a body organ,
such as the colon, is sealed with respect to fluid communication
with the skin 11 on the abdominal wall 12 by way of the opening 13
in stoma 15. The conduit means, generally 17, such as a Foley
catheter 19, or other catheter 19', has extending completely around
a portion of the circumference thereof an enlarged portion,
generally 22, which is sufficiently great in diameter to prevent
insertion of the enlarged portion, generally 22, into the interior
10 of the organ involved. A lower surface 25, 25' sealingly engages
stoma 15. An upper portion 26, 26' abuts against downwardly
directed surface 28 which maintains pressure on the enlarged
portion 22, which in turn causes pressure to be exerted at lower
surface 25, 25' against stoma 15.
An alternative construction of the conduit means 17 and more
particularly of the enlarged portions generally 22 will be
discussed in greater detail hereinafter.
Preferably the lowermost edge of base 32 includes a radially
extending flange 33 to increase the surface over which the
pressures are distributed, and to increase the stability of the
device when in position. While the flange 33 is shown as disposed
in a plane, it is to be understood that it can be shaped to closely
conform to the configuration of a particular region of the
abdominal wall, and can be sized to conform to the degree of
curvation of the particular patient's abdomen, e.g. for large or
small people. Flange 33 is preferably thin enough to be slightly
flexible, but thick enough to provide support.
The lowermost surface 31, 31' of base 32 abuts skin 11 in close
proximity to the outer circumference of stoma 15. Thus the
configuration of the opening 34 in base 32 at lowermost surface 31
is substantially circular. Skin 11 at surface 31, 31' is
illustrated as being slightly depressed to signify the slight
pressure exerted upon skin 11 by surface 31, 31'. Body encircling
means generally 35 (which includes a body-encircling belt 36,
preferably made of an elastic material and base-engaging means 38)
maintains base 32 in position at stoma 15.
While the base-engaging means 38 is shown in the attached drawings
to engage base 32 at a height approximately halfway up the height
of the base 32, i.e. at the height indicated by the letter "H" in
FIG. 2, it is not essential that the base-engaging means be at that
particular height. While the base-engaging means may be fixed to
base 32 closely adjacent the skin when the device of this invention
is used in connection with stomata in the upper abdominal regions,
it is preferred that the base-engaging means 38 be constructed to
engage base 32 at a substantial distance above the abdominal wall
12 when the device of this invention is used in connection with a
stoma in the lower abdominal region. The base-engaging means 38
which is illustrated is a flat piece having three openings. Two
openings 39 receive the belt 36 and a larger central opening 39'
fits over base 32 to securely fit thereon at a particular height
above the skin. A smaller opening 39' causes higher engagement with
a conical exterior. Thus it is not essential that steps 37 be
provided to limit height of the base-engaging means 38, since
availability of a number of different sized articles 38 will
provide such flexibility in adjustment.
While the body-encircling means, generally 35, are shown to be
relatively narrow for the purpose of clarity of illustration, it is
preferred that the body-encircling means 35 be relatively wide,
e.g. 3 inches or wider, and that they be relatively resilient, or
elastic.
As illustrated in FIG. 2, a preferred embodiment of this invention
utilizes a commonly available Foley-type catheter 19. The base 32
illustrated in FIG. 2 consists of a cup or conelike structure open
at both ends and is readily cleaned and sterilized. The catheter
illustrated in FIG. 2 is intended to suggest the use of a wide
variety of similar catheters having a bulb 40 which can be
pneumatically expanded and which completely surrounds the conduit
portion 41 of catheter 19. A large variety of these catheters are
available, i.e. in different materials such as plastic, rubber,
etc., and in different sizes of conduit portion 41 and bulb 40.
While a relatively short (e.g. 1 to 11/2 inches) terminal portion
44, 44' beyond the enlarged portion 22 of catheter 19, 19' as
illustrated in the accompanying drawings, the length of this
portion may optionally be substantially longer. For example, when
the device of this invention is intended for use in the
radiographic examination of the signoidostomy, terminal portion 44,
44' is preferably about 4 inches long.
I have found that under actual hospital use conditions the device
described above provides substantially leakproof transferring means
for conveying aqueous barium sulfate solutions into and out of a
body opening, such as a colostomy or ileostomy opening. Moreover, I
have observed that the device in accordance with this invention
permits the patient to change positions during the course of the
study without causing substantial leakage or loss of the barium
sulfate solution from the stoma.
It will be appreciated that the use of the device in accordance
with this invention provides limited sealing pressure between the
lower surface of the enlarged portion of the conveying means, such
as the catheter, and the stoma, and yet permits excessive or
possibly harmful pressures to be distributed against the abdominal
wall. Moreover, the relatively close fitting of the base with the
outer circumference of the stoma provides a degree of stability
with respect to the relative positions of the catheter flange and
the stoma.
Since not all stomata are of the same diameter, it is desirable and
preferable to have available a set of different sized devices of
this invention. It is preferable to use a device having an opening
34 which fits closely around stoma 15. Alternatively, if the
opening 34 is somewhat oversized, I prefer to place a spongelike
material or packing 46 around the stoma within opening 34. This not
only assists in the stabilization, but in the event of a trace of
inadvertent leakage, the liquid is diffused over a larger area,
diminishing the likelihood that there will be interference with the
radiographic examination. The quantity of such leakage, which is
sometimes observed in using the device of this invention, is so low
that no interference with the radiographic study has been reported.
The spongelike packing 46 may be in the form of a thin doughnut,
and may, of course, be disposable.
The relatively large diameter of the base means and also the wide
diameter of the optional portion 26' provides stability with
respect to the perpendicular orientation of the device with respect
to the abdominal wall. This is an important factor in preventing
inadvertent leakage. As indicated above it is preferred that the
body-encircling means be relatively wide and in such embodiments
the vertical stability of the device is even further enhanced, in
spite of the movements which a patient is often required to make
during the course of radiographic studies.
* * * * *