An ostomy prosthesis comprising a drainage tube securable at one end within an ostomy stoma deep to the fascia, and a skin-contacting plate to which the other tube end is secured. The prosthesis includes an ostomy bag having a mouth securable to the plate about the stoma. Closure means, operable from outside the bag, is provided to open and close the passageway defined by the drainage tube and plate to control the flow of bowel contents into the bag.

TECHNICAL FIELD 
This invention relates to the field of medical prosthetic devices and 
particularly to devices intended for use by ileostomy or colostomy 
patients. 
BACKGROUND ART 
Patients with surgical ostomy operations are routinely provided with 
externally worn ostomy bags. Such bags commonly have openings or mouths 
that are adhesively sealed to the skin of the patient about the ostomy 
stomas. Such bags must be periodically removed and emptied, of course. The 
adhesive seal between the mouth of the bag and the skin surrounding the 
stoma must be maintained airtight to prevent the escape of embarrassing 
odors. Often, the skin area surrounding the stoma to which the adhesive 
seal is applied becomes tender and painfully irritated, which irritations 
may be compounded by contact with bowel contents and may lead to serious 
infections. 
One solution to this problem is to eliminate the need for an adhesively 
sealed ostomy bag. My U.S. Pat. No. 4,381,765, for example, discloses a 
medical prosthesis that includes a drainage tube, the inner end of which 
is secured to the stoma of a patient deep to the fascia and the outer end 
portion of which is releasably sealed. It is yet desirable, however, to 
provide ostomy patients with appropriate bags to collect bowel contents, 
but means are needed to avoid the heretofore necessary adhesive seal 
between the mouth of the bag and the skin of a patient. 
DISCLOSURE OF THE INVENTION 
The ostomy prosthesis of the invention includes a drainage tube having an 
inner end portion that is insertable within the ostomy stoma of a patient, 
and an outer end portion. Securing means are carried by the inner end 
portion of the drainage tube to secure the latter to the stoma deep to the 
fascia. Plate means are provided to flatly abut the skin of a patient 
adjacent the stoma, and means are provided to connect the outer end 
portion of the drainage tube to the plate means. The plate means is 
provided with an orifice positioned to define, with the outer end portion 
of the drainage tube, a passageway for the evacuation of bowel contents. 
An ostomy bag is this embodiment is provided with a mouth, and sealing 
means are provided to seal the mouth of the bag to the plate means about 
the passageway to enable the bag to receive bowel contents issuing from 
the passageway. The prosthesis desirably includes manually operable 
closure means for releasably closing the passageway to prevent the escape 
of bowel contents. The bag in this embodiment has a flexible outer wall 
permitting manual manipulation of the manually operable closure means to 
open and close the passageway. In the manner thus described, the ostomy 
bag is sealingly secured to the ostomy opening, preventing the escape of 
bowel contents and odors, but yet is not adhered to the skin of the 
patient. Moreover, in the preferred embodiment, the flow of bowel contents 
into the bag can be regulated at will by the patient by manually opening 
and closing the passageway through the prosthesis.

BEST MODE FOR CARRYING OUT THE INVENTION 
Referring first to FIG. 1, the ileostomy device of the invention is 
designated generally as (10), and includes a drainage tube (12) and an 
ostomy bag (16). The inner end portion (12.1) of the drainage tube is 
inserted and maintained within the stoma of a patient, the drainage tube 
extending forwardly and outwardly from the stoma. 
In FIG. 1, "E" represents a patient's skin surrounding an ostomy stoma, "F" 
and "M", respectively, refer generally to layers of fat and muscle, and 
"L" refers to the abdominal fascia. The end portion of the bowel is 
depicted generally as "B", and, as shown in FIG. 1, the bowel extends 
forwardly and terminates at approximately the surface of the skin. In some 
instances, the bowel may protrude outwardly slightly of the skin surface. 
The drainage tube (12) may be made of resilient silicone rubber or the 
like. Its inner end (12.1), as shown in FIG. 1, is received within the 
stoma of the patient deep to the fascia. A generally tubular length of 
thin-walled, resilient silicone rubber designated (13), overlays the inner 
portion (12.1) of the drainage tube. The ends of the thin-walled tubing 
length (13) are spaced from one another along the length of the drainage 
tube and are connected to the inner portion (12.1) of the drainage tube by 
means of relatively rigid annular bands (13.1) over which may be 
positioned wider silicone rubber supporting bands (13.2). As shown in FIG. 
1, the tubing section (13) can be inflated by means of water or other 
fluid inserted under pressure through inflation tube (12.3), the section 
(13) thereby forming an annular, generally doughnut-shaped balloon 
structure which dilates the bowel "B" deep to the fascia and thus secures 
the drainage tube against being pulled forwardly out of the stoma. By 
releasing the pressure of fluid through the inflation tube (12.3), of 
course, the balloon structure may be deflated and the device may be 
readily removed from the stoma. Details of a construction of a balloon 
structure (13) are disclosed in my U.S. Pat. No. 4,381,765, the relevant 
teachings of which are incorporated herein by reference. The inflation 
tube (12.3) passes from the balloon structure (13) outwardly of the stoma, 
and may terminate forwardly in a generally cylindrical plug that is 
received within the tube, as shown at (12.4), the plug having a pierced 
hole therethrough within which may be inserted a blunted hypodermic needle 
to facilitate inflation and deflation of the balloon structure. 
A plate (14), desirably generally circular, is provided with a central 
orifice (14.1) through which, in the embodiment of FIG. 1, the outer end 
(12.2) of the drainage tube passes. The outer drainage tube end (12.2) may 
have an outer, circumferential sawtooth structure as shown at (12.5) in 
FIG. 1 such that, as the plate (14) is pushed inwardly or rearwardly 
against the skin of a patient while concurrently pulling outwardly upon 
the drainage tube end (12.2), the plate orifice (14.1) will be captured 
behind one of the circumferential sawtooth ribs (12.5) to thus retain the 
tube in place. The inner surface (14.2) of the plate is shown in FIG. 1 as 
being in contact with the skin of a patient; it will be understood that 
gauze pads or other material may be employed between the plate (14) and 
the skin as desired so that the plate bears indirectly against the skin. 
The plate (14) is provided with an annular shoulder (14.3) which is spaced 
away from the inner surface (14.2) of the plate. The circumferential outer 
surface of the shoulder (14.3) may be grooved, as shown in FIG. 1, and the 
mouth of an ileostomy bag (16) may be sealingly secured to the grooved 
shoulder (14.3) by means of a cord or elastic bands (16.1) or the like. 
As shown in FIG. 1, the drainage tube (12) terminates forwardly in an 
annular rim (12.6) defining a plug seat. Plug means, shown generally at 
(18), is carried by the outer wall (16.2) of the bag and includes a plug 
(18.1) internally of the bag and sized to fit snugly within the rim (12.6) 
to thereby close the passageway defined by the drainage tube and the plate 
orifice. The tapered plug (18.1) is provided with a generally flat surface 
(18.2) facing the bag wall (16.2), and a separate, exterior handle portion 
(18.3) is provided similarly with a bag-facing surface (18.4). The handle 
portion may have a projection (18.5) that is received through a small 
aperture in the bag into a bore formed in the plug portion (18.1), all as 
shown in FIG. 1. The flat surfaces (18.2), (18.4) are carried on opposite 
surfaces of, and desirably are adhered to, the outer bag (16), thereby 
permitting the plug (18.1) to be manipulated through manual grasping of 
the handle portion (18.3). 
As thus described, it will be understood that the passage leading through 
the drainage tube can be closed and opened at will by a patient through 
the simple expedient of inserting and removing the plug (18.1) from the 
plug seat defined by the drainage tube rim (12.6). It will be noted that 
the mouth of the ileostomy bag (16) is not adhered to the skin "E" of the 
patient, and it will also be noted that the bag (16) remains sealed to the 
plate (14) and hence to the ostomy opening regardless of whether the 
passageway is open or closed. The unplugged passageway is substantially 
free of obstructions tending to interfere with the free passage of bowel 
contents. 
A modified embodiment of the invention is depicted in FIG. 2. In this 
Figure, the drainage tube is designated as (20) and the plate as (22). The 
inner end (not shown) of the drainage tube may be identical to that shown 
in FIG. 1. 
The plate (22) desirably is generally circular, and includes a generally 
flat inner surface (22.1) and a central orifice (22.2), the outer portion 
of which is tapered as shown at (22.3) to provide a plug seat. The plate 
includes a coaxially extending, generally tubular portion (22.4) that 
terminates rearwardly in a radially outwardly extending, beveled shoulder 
(22.5). In this embodiment, the drainage tube is cut to the desired length 
for each patient so that when the outer end portion (20.1) of the drainage 
tube is slipped over the tubing section (22.4) of the plate and held in 
place with external band (22.6) and the inner surface (22.1) of the plate 
is held in snug abutment against the skin (including covered skin) of the 
patient, the inner end portion of the drainage tube (20) is secured within 
the stoma in the manner shown in FIG. 1. Again, gauze or other spacing 
material may be placed between the plate and the skin as desired. In a 
manner similar to that depicted in FIG. 1, the plate (22) is provided with 
a forwardly extending, annular, grooved shoulder (22.7). 
An ileostomy bag is depicted in FIG. 2 generally as (24), and includes 
inner (toward the patient) and outer walls (24.1), (24.2). The mouth of 
the bag is shown generally as (24.3), and is formed in association with a 
disc (26) which is adhered or otherwise fixed to the surface of the inner 
wall (24.1), the disc having a central aperture (26.1) communicating with 
the interior of the bag. Extending from the disc coaxially with the 
aperture (26.1) is a short length of tubing (26.2) terminating in a 
radially inwardly protruding rim (26.3). The rim desirably is elastic, the 
orifice defined by the inner periphery of the rim being capable of 
elastically expanding so that the rim (24.5) may slip onto and be captured 
within the annular groove (22.7) of the plate (22) to thereby seal the bag 
to the plate. 
Plug means is depicted in FIG. 2 generally as (28) and may be formed in two 
sections, of which one is an outer or handle section (28.1) having a 
graspable, forwardly protruding portion (28.2) and a flange (28.3) in 
contact with and desirably bonded to the outer surface of the outer bag 
wall (24.2). The inner plug portion, designated (28.4), includes an 
inwardly tapering plug portion (28.5) and a flange (28.6) lying against, 
and preferably bonded to, the inner surface of the bag wall (24.2) in 
alignment with the flange (28.3). If desired, a small connecting rod as 
shown at (28.7) may be carried by the plug portion (28.1) and may extend 
rearwardly through a small hole formed in the bag wall and into a 
receptive bore (28.8) formed in plug portion (28.4). The bag walls (24.1), 
(24.2) are flexible, in the usual manner, and as a result the plug handle 
(28.2) may be grasped and manipulated as desired. 
With reference to the embodiment of FIG. 2, once the in-dwelling portion of 
the drainage tube and the plate (shown as the left-most element of FIG. 2) 
have been properly positioned with the plate lying snugly against the skin 
of the patient, a bag (24) may be rapidly and conveniently attached to the 
plate by simply stretching the elastic rim (26.3) over the annular 
shoulder (22.8) and into the groove (22.7). The plug (28) may then be 
moved into firm, sealing engagement within the plug seat (22.3) of the 
plate. At such time as it is desired to permit the flow of bowel contents 
through the drainage tube and into the bag, the patient merely grips the 
plug handle and pulls outwardly upon the plug (28) to open the passageway 
into the bag. The plug may then be simply replaced within the plug seat 
(22.3). Thus, the invention permits the bowel contents to be periodically 
emptied into an ostomy bag without removing the bag nor breaking the 
liquid and odor-proof seal between the bag and the stoma of the patient. 
This is particularly important when patients are first learning to wear a 
prosthesis of the type shown in FIG. 1 which, it will be understood, 
requires some bowel dilation. 
Referring now to FIG. 4, a drainage tube is there depicted as (30), its 
forward end (30.1) being firmly attached to a skin-contacting plate (32) 
in the manner described with reference to FIG. 1. The rearward end of the 
tube (30) (not shown) may be secured within the bowel deep to the fascia 
in the manner depicted in FIG. 1. The mouth of the ostomy bag (34) is 
attached to an annular groove formed in the periphery of the plate (32) by 
means of an elastic cord or string (34.1). 
In the embodiment of FIGS. 4-6, the outer end portion (30.1) of the 
drainage tube (30) is provided with a generally rectangular aperture 
(30.2) adjacent its end. A second tube (32), having an outer diameter 
approximately the same or very slightly smaller than the inner diameter of 
the tube (30), is inserted within the outer end of the tube (30) as shown 
in the drawing. The inner tube (32) similarly is provided with a generally 
rectangular aperture (32.1) adjacent its forward end and positioned so 
that as the inner tube (32) is moved axially within the tube (30), the two 
apertures may become aligned when the tube (32) is in its outermost 
position as shown in FIGS. 4 and 5. When the inner tube is moved to the 
left in FIG. 4, into the position shown in FIG. 6, the apertures (30.2), 
(32.1) are moved out of alignment, thereby sealing the drainage tube (30). 
A finger-like projection (32.2) extends radially outwardly from the inner 
tube (32) through the aperture (30.2) formed in the outer tube, the finger 
serving to restrain the amount of axial movement that is afforded the 
inner tube with respect to the outer tube. 
It will be noted in the embodiment of FIG. 4 that the wall (34) of the 
ostomy bag is not attached to the closure means defined by the structure 
of the respective inner and outer tubes (32), (30). Rather, the end of the 
tube (32) includes a plate depicted as (32.3), the periphery of which can 
readily be grasped by the fingers through the flexible bag wall (34) in 
order to push or pull the inner tube to the desired closure or drainage 
position. FIG. 5 shows the alignment of apertures (30.2), (32.1) when the 
tube (32) is in the position shown in FIG. 4, bowel contents being 
permitted to drain into the bag (34). When the closure means is moved to 
the position shown in FIG. 6, on the other hand, the respective tube 
apertures are out of alignment and the passageway leading through the 
drainage tube is thus closed. 
A presently preferred embodiment of the invention is illustrated in FIG. 7. 
In this embodiment, the drainage tube has a rearward end (not shown) that 
is provided with securing means such as that shown in FIG. 1 for securing 
the inner end of the drainage tube to the stoma of a patient deep to the 
fascia. A skin-contacting plate, designated (38) is attached to the 
forward end of the drainage tube. An annular groove (38.1) is formed in 
the plate coaxially with the central bore (38.2), the groove having a 
width approximately equal to the wall thickness of the end of the drainage 
tube (36). In this manner, the groove snugly receives and accommodates the 
everted end (38.3) of the drainage tube. The connection between the 
drainage tube and plate is formed by first passing the cut-to-length 
forward end of the drainage tube forwardly through the bore (38.2), then 
everting (that is, turning inside-out) the forward tube end (36.1) for a 
short distance, and then pulling the tube rearwardly again through the 
bore (38.2), the everted end (36.1) of the drainage tube being guided into 
the groove (38.1). The sharp-edged annular lip (38.3) formed between the 
bore (38.2) and the groove (38.1) of the plate thus seats between the 
opposing surfaces of the everted section of the tube and the adjacent 
tube. The connection thus formed has been found to be strong and 
creep-resistant. If desired, an adhesive may be used between the drainage 
tube end and lip (38.3) to more securely hold the tube in place. It will 
be noted that the forward rim (36.2) of the everted drainage tube end 
provides a smooth, circular opening readily receptive of a tapered plug 
when the drainage tube is to be closed. 
The plate (38) may be provided with a suitable internal channel as shown at 
(38.4) through which the outer portion of an inflation tube (39) may pass, 
the inflation tube thus being continuously accessible to the wearer. 
Adhered coaxially to the forward surface (38.5) of the plate (38) is an 
attachment flange (40.1) of an annular attachment plate (40), the latter 
having a short, tubular section (40.2) terminating forwardly in an 
outwardly turned rim (40.3). If desired, the tubular section (40.2) and 
rim (40.3) may be formed integrally on the forward face (38.5) of the 
plate (38). 
An ostomy bag is shown generally as (42), and comprises inner and outer 
walls (42.1), (42.2) joined at their peripheries as by heat sealing to 
form an edge seal (42.3). An ostomy bag such as that shown at (42) is 
commonly provided with a circular opening (42.4) of sufficient diameter as 
to spacedly encircle the stoma of a patient; the openings may commonly 
range up to four or five centimeters in diameter. Adhered to the exterior 
surface (42.5) of the inner bag wall (42.1) about the opening (42.4) is an 
annular mounting flange (44.1) of a second annular attachment plate (44). 
This plate has a rearwardly (toward the patient) extending bore (44.2) 
within which is snugly received the tubular section (40.2) of the 
attachment plate (40). The annular plate (44) includes an annular shoulder 
(44.3) within which the rim (40.3) of the attachment plate (40) is 
received. The male and female annular attachment plates (40), (44) are 
sufficiently resilient as to enable them to be connected as shown in FIG. 
7, the seal therebetween being substantially air-tight and hence 
odorproof. 
Adhered to the inner surface (42.6) of the outer bag wall (42.2) is a plug 
(46) having a tapered, rearwardly extending nose (46.1) sized to be 
received snugly within the tubular rim (36.2) at the forward end of the 
drainage tube (36). The wall (42.2) is sufficiently flexible as to enable 
a user to grasp the outwardly extending shoulder (46.2) of the plug 
through the wall so that the plug nose can be maneuvered into and out of 
plugging engagement with the drainage tube rim (36.2). 
The tubular section (40.2) typifies annular fastening means for fastening 
to the plate (38) a mating second annular fastening means (44) carried by 
the bag about its opening (42.4), and it will be noted that the annular 
fastening means (40.2) is carried forwardly (away from the patient) by the 
plate and is spaced forwardly from the rearward, skin-contacting surface 
(38.6) of the plate, thereby permitting the bag to be spaced outwardly 
slightly from the patient's skin. Of importance, of course, is the fact 
that no adhesive is required to hold the prosthesis of the invention to 
the skin of a patient; particularly, the ostomy bag is devoid of 
skin-contacting adhesive. 
The drainage tubes described herein desirably are of silicone rubber or 
other biologically compatible material, and preferably are at least 
slightly flexible to permit them to be drawn through the ordinarily snugly 
fitting central orifice of the mounting plates. The latter, in turn, 
desirably are of a rigid material, desirably a plastic such as 
polycarbonate or the like. The plugs and the other closure structure 
adhered to or carried by the ostomy bag preferably are of silicone rubber. 
The ostomy bags are commonly made of flexible plastic material such as 
polyethylene or polypropylene. The bag materials desirably are 
substantially inert to the bowel contents, and the bag walls are 
sufficiently flexible as to enable the operation of the closure means as 
described above and also for the purpose of being able to conform 
comfortably to the body of the wearer. 
While a preferred embodiment of the present invention has been described, 
it should be understood that various changes, adaptations and 
modifications may be made therein without departing from the spirit of the 
invention and the scope of the appended claims.