Note: Descriptions are shown in the official language in which they were submitted.
--- WO94/1~558 2131921 PCT~S93/~356
--1--
COLOSTOMY CLOSURE ~EVICE
This invention relates to a device for closing a
colostomy opening.
More particularly, the invention concerns an improved
colostomy closure device of the general type disclosed in my
United States Patent 4,809,871, issued March 7, 1989.
In a further and more particular respect the invention
relates to an improved colostomy closure device which relieves
the pressure of gas formed in the intestine.
In another aspect the invention pertains to such an
improved oolostomy clo5ure device which substantially
deodorizes gases ~ented from the intestine through the device.
In still another respect, the invention relates to a
colostomy closure device which sealingly engages the interior
of the open end of the intestine with improved reIiability,
but with reduced tendency to injure the mucosal intestinal
lining .
; In my issued United States Letters Patent 4,809,871,
issued Narch 7, 1989, I described a device for closing a
surgically constructed opening, such as a colostomy or
ileostomy opening, which could be easily and conveniently
implaced and removed by simple finger manipulation by the
-- WO94/15558 2 1 3 1 9 2 1 PCT~S9310035C
patient, without the assistance of skilled attendants. Such
a device has the potential to markedly reduce both the
physical inconvenience and embarrassment (which may even lead
to psychological impairment), caused by the necessi~y of
~earing an external colostomy bag or the like after a patient
is subjected to such surgical procedures.
Although the devices disclosed in my prior patent
functioned effectively for shorter periods of time, there was,
however, the need for further improvements to enhance the
long-term utility of the devices. Most importantly, my prior
device had to be removed periodically to vent gas which is
normally formed in the intestine. While continuous venting
was desirable, this had the potential for embarrassment of the
patient because of the odor of the effluent gas. Finally, the
integrity of the seal between the device and the interior of
the intestine required that considerable pre~sure be exerted
by the device against the mucosal inner lining of the
intestine. After extended use by the patient, such pressure
had the potential to cause irritation of the mucosa.
Accordingly, it is a principal object of the present
invention to provide an improved colostomy closure device.
Another object of the invention is to provide such an
~- improved device which continuously vents gas produced in the
intestine.
~ Wo~4/15558 2I31921 PCT~ 356
Yet another object of the invention is to provide a
vented closure device which substantially deodorizes the
vented gases.
~ Still another object of the invention is to provide an
improved colostomy closure device which has reduced tendency
to irritate the mucosal inner intestinal lining, while
maintaining an effective sealing engagement therewith.
These and other, further and more specific objects and
advantages of the invention will be apparent to those skilled
in the art from the following detailed description thereof,
taken in conjunction with the c~rawings, in which:
Fig. 1 is a perspective view of an improved colostomy
closure device con~tructed in accordance with the
principles of the present invention:
Fig. 2 is a cross-sectional view of the device of Fig.
1, taken along section line 2-2 thereof;
Fig. 2A is an enlarged sectional view of a portion of
the cap member of the device of Figs. 1-2;
2S Fig. 3 is a sectional view showing the device of Figs.
1-2, in
place in a colostomy opening, forming a removable
closure therefor;
.
WO94/lSS58 21319 21 PCT~S93/00356
-4-
Figs. 4-6 are sectional views, similar to Fig. 3, showing
the
sequence of steps for emplacement of the device to seal
a colostomy opening.
Briefly, my invention provides improvements in the
closure devices described in my above-identified patent for
temporarily sealing a colostomy opening which is ~ormed by
connection of an open end of the intestine with the periphery
of a surgical opening in the abdominal wall. Such devices
generally include a tubular elastic membrane, dimensioned to
-extend from the inner end thereof, through said surgical
opening to the outer end thereof outside the abdomen. A
deformable cap closes the inner end of the tubular membrane
lS and means are provided to radially tension the membrane to
sealingly engage with the periphery of the'surgical opening.
The deformable cap is shaped and dimensioned to be temporarily
deformed to pass through the surgical opening into the open
end of the intestine. The cap then autogenously reassumes an
undeformed shape which retains the cap within the intestine.
In accordance with the one embodiment of the present
invention, vent means are provided in the cap, which permits
passage of gas from the interior of the intestine, but which
retains liquids and solids therewithin.
~ WO ~115558 21 319 21 PCT~593/~3~
According to another embodiment of the present invention,
means are provided for deodorizing the gas vented through the
device.
1 In yet another embodiment of the present invention, the
cap member is provided with at least two spaced, radially
extending annular sealinq flanges, which are shaped and
dimensioned to flexibly bear outwardly against and sealingly
engage the inner surface of the intestine when the cap is
undeformed.
Turning now to the drawings, in which like reference
:` characters identify the same elements in the several views,
Figs. 1-2 depict a colostomy closure device constructed in
accordance with the presently preferred eabodiment of the
invention, consisting of a cap--e~ber,. generally identified
by reference character ll, a deformable tensioning ring 12 and
a generally tubular elastic membrane 13 extending between the
cap ll and the tensioning ring 12. As seen more clearly in
20 fig. 2A, the central portion of the~cap ll is formed to
provide an upstanding cylindrical boss 14 and a plurality of
d annels 15 co unicating between the underside of the cap ll
~- -and the cylindrical recess formed by the boss 14. A filter
disk 16, made of material which is porous to gas but will not
~ : 25 permit passage of liquids or solids is carried in the bottom
;~ portion of the cylindrical recess formed by the boss 14. A
~: variety of materials will perform this function, ranging from
;~ fabrics to paper materials. In the presently preferred
',
- W094/15558 2 1 3 1 9 2 I PCT~S93/~356
-6-
embodiment of the invention I use a fabric material formed of
expanded Teflon which is commercially available under the
trademark Goretex. Alternatively, I ~se a membrane made of
microporous acrylic polymer on nylon which renders it
~hydrophobic, and which is commercially available under the
trademark Versapel. A layer 17 of odor absorbent or
deodorizing material is carried in the recess formed by the
boss 14 on top of the filter disk 16. In the presently
preferred embodiment of the invention I employ a disk of
activated charcoal. The filter and deodorizer disks can be
press fit into the cylindrical recess formed by the boss 14
or may be adhesively secured therein.
The outer periphery of the cap ll is provided with a
plurality of spaced, radially extending annular sealing
flanges 18 formed integrally with the cap ll. These flanges
18 are dimensioned to bear outwardly against and sealingly
engage the inner surface l9 of the intestine 21 when the cap
Il is undeformed, as shown more clearly in Fig. 3. This
multiple flange structure is somewhat more flexible in the
radial direction than the sinqle flange structure shown in my
issued '871 patent, and yet can form a oomewhat more effective
seal against the interior of the intestinal wall while
actually exerting a lower radially outwardly directed
pressure. The net effect is to increase the reliability of
the seal, while reducing the tendency of the device to
irritate the mucosal intestinal lining over extended periods
of use.
r 0 94/15558 2 1 3 1 9 2 I PCT~S93/0035C
.
Fig. 3 depicts a typical colostomy opening 22, formed in
the abdominal wall 23. The abdominal wall 23 consists of
layers of skin 24, subcutaneous tissue 25, fascia 26, muscle
27 and peritoneum 28. In the colostomy operation, the bowel
1 wall 21 is sutured to the periphery of the opening 22 in the
abdominal wall 23. Upon healing, the open end of the bowel
21 terminates just at the surface of the skin 24~
The cap 11 (shown undeformed) causes slight deformation
29 of the bowel wall 21 just under the abdominal wall 23, to
retain the cap 11 within the open end of the intestine 22..
The walls 13 of the elastic tubular membrane are radially
tensioned by the annular ring 12 in the direction of the
arrows A to cause the lower portions 13A of the membrane 13
to sealingly engage the inner surface of the colostomy opening
22.
Figs. 4, 5 and 6 depict the steps in the placement of the
device if Figs. 1-2, to form a colostomy closure as shown in
Fig. 3. As depicted, the device of Figs. 1-2 is first
positioned above the opening 22 with the finger 31 pressing
downwardly on the deformable cap }1. The cap 11 is then
deformed as shown in Fig. 5 by pressing downwardly to push it
through the colostomy opening 22. Once the cap 11 is below
the abdominal wall 23, it autogenously reassumes its normal
shape (see Fig. 6). Upon removal of the finger 31, the
annular ring 12 reassumes its normal shape by movement in the
directions of the arrows A to radially tension the elastic
1~ .
W094115558 2 1 3 1 9 2 1 PCT~S93/~35C
-8-
tubular membrane 13 and draw it into sealing engagement with
the periphery of the colostomy opening 22.
Having described my invention in such terms as to enable
those skilled in the art to understand and practice it and
1 having ident~fied the presently preferred embodiments thereof,
I CLAIM:
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