U.S. patent number 3,889,676 [Application Number 05/346,614] was granted by the patent office on 1975-06-17 for enemata administering device.
This patent grant is currently assigned to E-Z-EM Company Inc.. Invention is credited to Franklin R. Greene.
United States Patent |
3,889,676 |
Greene |
June 17, 1975 |
Enemata administering device
Abstract
An enemata administering device is disclosed which includes a
hollow stem with an exit port at one end, fluid inlet at the other
end, and expandable cylindrical sleeve of substantially constant
diameter sealed at its ends onto the exterior surface of the stem
near the exit ports and a conduit for inflating the sleeve. The
ends of the sleeve are spaced apart less than the length of the
sleeve and a reentrant section at an end of the sleeve is provided
to take up the excess sleeve material.
Inventors: |
Greene; Franklin R. (Flushing,
NY) |
Assignee: |
E-Z-EM Company Inc. (Westbury,
NY)
|
Family
ID: |
23360232 |
Appl.
No.: |
05/346,614 |
Filed: |
March 30, 1973 |
Current U.S.
Class: |
604/101.05;
D24/115; 604/912 |
Current CPC
Class: |
A61M
3/00 (20130101); A61M 3/0295 (20130101) |
Current International
Class: |
A61M
3/00 (20060101); A61M 3/02 (20060101); A61m
003/00 () |
Field of
Search: |
;128/246,245,349,351,348,2R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Yasko; J.
Attorney, Agent or Firm: Ryder, McAulay, Fields, Fisher
& Goldstein
Claims
What is claimed is:
1. An enemata administering device comprising: a hollow stem having
exit ports at a distal end thereof, an inlet at the proximal end
thereof for receiving a fluid, a smooth expandable resilient
cylindircal sleeve of substantially constant diameter and
substantially constant wall thickness mounted on the exterior
surface of said stem near said distal end of said stem, said sleeve
being hermetically sealed to said stem at both ends of said sleeve,
said sleeve having an unsealed section between said sealed ends,
said ends of said sleeve being sealed to said stem a distance apart
along said stem substantially less than the unsealed length of said
sleeve when said sleeve is deflated, only the proximal end of said
sleeve having a reentrant section to take up the resultant extra
length of sleeve material, only a portion of said reentrant section
being sealed to said stem, a substantial portion of said reentrant
section being free to expand away from said stem, said sleeve
conforming to said stem when deflated, and means for inflating said
sleeve.
2. The enemata administering device of claim 1 wherein said stem
has an aperture therethrough communicating with the interior
surface of said sleeve and wherein said means for inflating
comprises a conduit located inside said stem in communication with
the interior of said sleeve through said aperture.
3. An enemata administering device comprising: a hollow stem having
a forward end adapted to be inserted through the anal canal into a
patient's bowel, said forward end having exit ports therethrough,
the back end of said stem adapted for fluid communication with a
fluid source, a smooth expandable, resilient, single wall
cylindrical sleeve of substantially constant diameter and
substantially constant wall thickness mounted on the exterior
surface of said stem near said forward end at a position adapted to
being located within the patient's bowel when said device is in
use, said sleeve being hermetically sealed to said stem at both
ends of said sleeve, said sleeve having an unsealed section between
said sealed ends, said ends of said sleeve being sealed to said
stem a distance apart along said stem substantially less than the
unsealed length of said sleeve when said sleeve is deflated, only
the proximal end of said sleeve having a reentrant section to take
up the resultant extra length of sleeve material, only a portion of
said reentrant section being sealed to said stem, a substantial
portion of said reentrant section being free to expand away from
said stem, said sleeve conforming to said stem when deflated, a
conduit within said stem communicating at one end with the interior
of said sleeve and at the other end with a second fluid source to
permit selective inflation and deflation of said sleeve.
4. An enemata administering device comprising a hollow stem having
a forward end adapted to be inserted through the anal canal into a
patient's bowel, said forward end having exit ports therethrough,
the back end of said stem adapted for fluid communication with a
fluid source, an expandable, resilient, single wall cylindrical
sleeve of substantially constant diameter and substantially
constant wall thickness mounted on the exterior surface of said
stem near said forward end at a position adapted to being located
within the patient's bowel when said device is in use, both ends of
said sleeve being hermetically sealed to said stem a distance apart
along said stem substantially less than the length of said sleeve
when said sleeve is deflated, said sleeve having a reentrant
section adjacent to one end of said sleeve to take up the resultant
excess sleeve material, only a portion of said reentrant section
being sealed to said stem, a substantial portion of said reentrant
section being free to expand away from said stem, said sleeve lying
flat on said stem when deflated, a conduit within said stem
communicating at one end with the interior of said sleeve and at
the other end with a second fluid source to permit selective
inflation and deflation of said sleeve, said reentrant section of
said sleeve being only at the end of said sleeve furthest from the
forward end of said stem during insertion of the device into the
patient's anal canal and at the end of said stem closest to the
forward end of said stem during retraction of the device from the
patient's anal canal.
Description
BACKGROUND OF THE INVENTION
This invention relates to devices for giving enemata and, more
particularly, to a device which precludes accidental expulsion of
an enemata apparatus and the enema fluid.
Enamata devices are used to permit the controlled rectal injection
of a fluid for many purposes including purgation, medicinal and
diagonistic such as through the use of X-rays. As one example,
frequently an enema is given to place a barium solution in the
colon during X-ray examination.
Many enemata devices presently exist and are being used for these
purposes. It is well known to place an inflatable baloon like
sleeve adjacent the distal end (clyster tip) of the apparatus in
order to control and preclude premature expulsion of the apparatus
itself and the injected fluid. In order to limit the extent of
penetration into the anal canal by the enemata apparatus and still
obtain sufficient inflation of the inflatable sleeve to accomplish
its intended purpose, sleeves of the type having an accordian
structure are commonly used. Such a sleeve is illustrated in U.S.
Pat. No. 3,459,175.
In order to insert an enemata device using the accordian like
sleeve it is necessary for the administrator to wrap or fold the
sleeve about the hollow tube of the enemata apparatus to facilitate
insertion of the apparatus into the anal canal. After the apparatus
is inserted and the sleeve inflated, the administrator pulls back
on the apparatus in order to be sure that the inflated sleeve abuts
the anal sphincter mucles in order to obturate the anal canal. It
is also standard practice for a conduit employed to inflate the
sleeve to be located on the exterior of the hollow tube and,
consequently, also be inserted through the anal canal. The bulk of
the folded accordian sleeve and the flexible conduit has been found
to be discomforting to the patient. Obviously, it is preferred to
reduce the size of the enemata apparatus as much as possible
without sacrificing the effectiveness of the apparatus, including
the effectiveness of the expulsion control means.
It is also preferable to have a disposable enemata apparatus.
However, in order for the device to be disposable it is essential
that it be produced at minimal expense thereby requiring minimal
material and labor in its production.
Accordingly, it is an objective of this invention to provide an
improved enemata administering device which can be manufactured
easily and inexpensively, which has less bulk than existing devices
and which can be inserted into the patient with less patient
discomfort than existing devices.
It is a further objective of this invention to provide an improved
enemata administering device which may be inserted and placed in
operative position by the administrator easily and with minimal
manipulation and which may be inserted into the anal canal a
minimal distance.
BRIEF DESCRIPTION OF THE INVENTION
Briefly described, this invention in one form comprises an improved
enemata administering device formed of a hollow stem having exit
ports at the clyster tip or distal end thereof and a fluid inlet at
the proximal end of the stem. A cylindrical, expandable resilient
sleeve is mounted on the exterior of the stem immediately adjacent
the clyster tip. The sleeve is formed with one end thereof having a
reentrant section. Only a portion of the reentrant section, namely
a small section immediately adjacent the inner most end of the
reentrant section is hermetically sealed to the exterior surface of
the stem. The other end of the sleeve also is hermetically sealed
to the stem.
A conduit is provided to permit controlled inflation of the sleeve.
The conduit is located inside the hollow stem and projects through
an aperture in the stem so that it communicates with the interior
of the sleeve. The other end of the conduit projects through an
aperture at the proximal end of the stem so that it may be
connected to a source of fluid, such as an air syringe. Application
of pressure to the interior surface of the sleeve causes the sleeve
to be inflated thereby providing the desired expulsion control
structure.
BRIEF DESCRIPTION OF THE DRAWINGS
The above objectives and attendant advantages may be better
understood from the detailed description below together with the
attached drawings in which:
FIG. 1 is a perspective illustration of an enemata administering
device formed in accordance with one embodiment of this
invention.
FIG. 2 is a sectional view taken along line 2--2 of FIG. 1.
FIG. 3 is a sectional view of a portion of the device of FIG. 1
showing a sleeve expanded.
FIG. 4 is a sectional view of an enemata administering device
formed in accordance with a second embodiment of this
invention.
DETAILED DESCRIPTION OF THE INVENTION
In FIGS. 1-3 there is illustrated an improved enemata administering
device 10 formed in accordance with a first embodiment of this
invention. The device includes a smooth, flexible, plastic tubular
enema stem 12 having a distal end clyster tip portion 14 of
conventional shape, such as a tapered bulbular shape. The clyster
tip 14 is provided with a primary exit orifice 16 at the extreme
distal end thereof and a plurality of secondary exit ports 18
through the sides thereof. The remainder of the enema stem 12 is
cylindrical and terminates at the proximal end 20 into which may be
inserted or, alternatively, onto which may be formed a bayonette
type connector 22 adapted to receive a flexible tube 24 from a
fluid supply such as an enema fluid container (not shown). The
enema stem 12 is formed of a suitable plastic material such as
polyvinylchloride which may be easily molded or extruded into the
desired shape.
An expandable resilient sleeve 30, preferably made of latex, is
mounted on the exterior of the enema stem 12. The sleeve 30, prior
to mounting on the stem 12, is of cylindrical shape having a thin
single wall. When mounted on the stem 12 both ends 32, 36 of the
sleeve 30 are hermetically sealed to the stem at a distance spaced
from each other less than the total length of the sleeve. For
example, with a 2 inch long sleeve 30 about a one-sixteenth inch
section at the extreme ends 32, 36 of the sleeve are sealed to the
stem, spaced apart 11/2 inches. The sleeve 30 is then folded over
at one end, namely the end thereof remote from the clyster tip 14
to form a reentrant section 34. As a result, only a portion (about
one-sixteenth inch) of the reentrant section 34 (which is about
one-fourth inch long) is hermetically sealed to the stem 12, that
portion being the end 32 of the sleeve which also forms the
innermost end of the reentrant section 34. Thus, in this example,
about three-sixteenths inch of the reentrant section 34 is
available to be inflated with the rest of the sleeve 30 to increase
the ultimate diameter of the inflated sleeve 30.
An aperture 38 is provided through the stem 12 to receive a
flexible conduit 40 which is located within the interior of the
stem 12. The front end of the conduit 40, which also may be made of
polyvinylchloride, is sealed to the conduit wall defining the
aperture 38 so that it communicates with the interior of the sleeve
30 while the back end of the conduit 40 passes through a second
aperture 42 formed near the proximal end 20 of the stem 12 and is
adapted to removably receive a fluid source such as an air syringe
44.
In operation, the clyster tip 14 of the stem 12 is inserted into
the patient's bowel through the anal canal a distance sufficient to
clear the reentrant section 34 of the inflatable sleeve 30 beyond
the anal sphincter muscles. Because the reentrant portion 34 of the
sleeve 30 is at the back end of the sleeve 30, the forward end or
end which is first inserted through the anal canal is only a single
layer thick and lies flat and smooth upon the enema stem 12 thereby
minimizing the risk of the forward end 36 of the sleeve 30 forming
an obstructive discomforting abutment or tending to be pulled free
from the stem 12 during insertion of the stem through the anal
canal. After the enemata administering device 10 is inserted the
sleeve 30 is inflated by pumping air through the conduit 40 into
the interior of the sleeve 30. As the sleeve 30 expands the
reentrant section 34 unfolds to enlarge the ultimate diameter of
the inflated sleeve 30 beyond what would be the case with a sleeve
having the same length but without the reentrant section. Of
course, the reentrant portion will only lift off the stem 12 up to
the point 32 where the sleeve 30 is hermetically sealed to the stem
12 (see FIG. 3).
A conventional clamp 46 may then be closed upon the conduit 40 to
retain the air within the expanded sleeve 30. The inflated
ballooned sleeve 30 now serves to block or preclude the enemata
administering device 10 from being accidentally or prematurely
expelled from the bowel. Furthermore, it also precludes flow of
fluid from the bowel. The enemata administering device 10 is now
ready to be used for the purpose for which it is inserted. A fluid,
such as a barium sulphate suspension, may now be pumped into the
bowel for X-ray observance. The barium suspension, or other
suitable fluid, is pumped through the tube 24 and the hollow stem
12 out through the exit ports 16, 18 into the bowel.
Upon completion of the administration of the enema, the air is
removed from the inflated sleeve 30 by opening the clamp 46.
Because of the direction of the pressure applied by the anal
sphincter muscles on the inflated balloon sleeve 30, as the sleeve
deflates it tends to ride up toward the clyster tip 14 forming a
reentrant portion at the front end of the sleeve thereby forming a
single layer, smooth back end 32 of the sleeve 30. The back end 32
is the end whch is first exposed to the anal canal as the enemata
administering device 10 is withdrawn through the anal canal thereby
again minimizing discomforting abutment of the sleeve during
removal of the device 10 through the anal canal.
FIG. 4 illustrates an enemata administering device 50 formed in
accordance with a second embodiment of this invention. In addition
to the sleeve 30 in the form described above in the first
embodiment and illustrated in FIGS. 1-3, an additional inflatable
sleeve 52 is mounted on the stem 12 and spaced from the back end of
the sleeve 30. The second or additional sleeve 52 may have the form
of the first sleeve 30 or, alternatively, in a preferred form of
this invention, the second sleeve 52 is provided with the
conventional accordian shaped form wherein the conduit 54 used for
inflating the second sleeve 52 is mounted on the exterior of the
stem 12 and communicated with the interior of the sleeve 52.
The purpose for the second sleeve 52 is that once the enemata
administering device 50 is inserted through the anal canal into the
bowel, the first sleeve 30 is located inside the bowel while the
second sleeve 52 is located outside the patient and, when inflated,
tends to pull the internal inflated sleeve 30 against the anus to
help seal the anal canal. Because the second sleeve 52 remains
outside the patient, there is no need to have the conduit 54 which
is used for inflating the sleeve 52 located internally within the
hollow stem 12 since the conduit will not be inserted into the
patient and therefore will provide no discomfort to the
patient.
It can be seen that the enemata administering device of this
invention provides a device which is easy and inexpensive to
manufacture since it requires less material than that previously
used in the accordian shaped inflatable sleeve. More importantly,
there is less bulk located on the exterior surface of the enema
stem thereby making it easier and less discomforting to insert this
improved enemata administering device into the patient. There is no
need for the administrator to fold and hold the inflatable sleeve
during insertion of the device 10 into the patient as was formerly
done with the accordian type inflatable sleeve.
When using the known fluted or similar inflatable balloon, the
standard procedure is to insert the device a distance great enough
to clear the folded back balloon, inflate and then pull back to
seat the inflated balloon against the sphincter. This procedure is
simplified and made less uncomfortable through the use of this
invention. Because of the simple, smooth fold at the reentrant
portion 34, the balloon 30 when inflated will pull the reentrant
portion free of the sphincter. Thus the device 10 or 50 can be
inserted no further than necessary to seat the inflated balloon
30.
By locating the conduit 40 for inflating the sleeve within the stem
12 there is a further reduction in the bulk inserted through the
anal canal and, concommitently, a further reduction in
discomfort.
By virtue of the construction of the device of this invention, the
reentrant portion of the sleeve 30 is always on the end of the
sleeve opposite to the portion of the device first moving through
the anal canal. Therefore, there is less chance of the sleeve
abutting against the anal canal and less discomfort to the
patient.
* * * * *