--- WO94/1~558 2131921 PCT~S93/~356 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 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 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
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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