External male catheter and applicator collar therefor

An external male urinary drainage catheter combined with a collar for facilitating proper fitting of the catheter upon a patient, and the method of using such a catheter/collar combination, are disclosed. The catheter includes a cylindrical section rolled to form a torus that is supported by the collar prior to catheter application, a tapered neck section that extends through the open-ended collar, and an inner sleeve portion that is held in a stretched condition by the collar to help insure placement of the sleeve in sealing engagement with the glans of a patient's penis during the initial stage of catheter application.

BACKGROUND 
The use of external catheters for male urinary drainage systems is well 
known, as disclosed in U.S. Pat. Nos. 4,378,018, 4,187,851, 3,863,638, 
3,835,857 and 4,475,910. Essentially, such a system comprises an elastic 
sheath adapted to fit over the user's penis, the sheath having an outlet 
at its distal end connected to a tube leading to a suitable collection 
receptacle. Since leakage resulting from fluid backflow between the penis 
and sheath is clearly undesirable, it has become a common practice to 
interpose a sealant pad between the sheath and the penile shaft as 
disclosed, for example, in U.S. Pat. No. 4,187,851 and in co-owned U.S. 
Pat. No. 4,378,018. 
While a sealant pad, when properly used, performs the dual functions of 
preventing leakage and retaining the catheter in place, difficulties have 
been reported in fitting such pads and catheters upon users exactly as 
intended. For example, a pad of the type depicted in U.S. Pat. No. 
4,187,851 takes the form of an adhesive strip intended to be wrapped about 
the penile shaft before the elastic catheter is unrolled into position 
over the penis. Performing such operations may be difficult or impossible 
by patients suffering from urinary incontinence since such patients often 
lack the motor control and/or mental acuity necessary for such 
manipulations. Nurses or other attendants may be unable to take the time 
necessary for properly wrapping and molding the sealant pads in place, and 
for then carefully fitting the sheaths over the pads to form leakproof 
seals. Should errors be made that might increase the possibilities of 
subsequent leakage, a nurse or attendant might nevertheless leave the 
improperly-applied pad and catheter in place because of time constraints 
or because of patient discomfort that might be associated with removing 
the improperly-applied pads and starting over. Moreover, problems 
resulting from improper application of an appliance might be more serious 
than occasional fluid leakage or mild patient discomfort. Thus, should an 
adhesive pad of the type shown in U.S. Pat. No. 4,187,851 be wrapped too 
tightly about the penile shaft, circulation might be impaired and tissue 
necrosis could result. 
External catheters are currently available that are internally coated with 
pressure-sensitive adhesive and therefore eliminate the need for using 
separate adhesive-coated sealant pads, as shown, for example, in U.S. Pat. 
No. 4,475,910. While such a construction avoids some of the more serious 
dangers associated with wrap-around sealant pads, the difficulties of 
application, and the problems of leakage resulting from improper 
application, persist and may even be more pronounced. Considerable care 
must be taken when unrolling an adhesive-coated sheath over the penis to 
make certain that the sheath is evenly applied without developing wrinkles 
and flow channels. All too frequently the adhesive-coated inner surfaces 
of such a sheath come into contact with each other during application of 
the catheter. Separation of the contacting surfaces, if possible at all, 
is difficult and time-consuming, with the result that corrective steps may 
not be taken and leakage of the catheter in later use is practically 
assured. 
Co-pending co-owned application Ser. No. 613,279, filed May 24, 1984, 
discloses an external male catheter having an inner sleeve designed to be 
stretched about the glans of the penis to prevent backflow and protect the 
delicate skin of the glans from injury caused by long-term contact with 
residual urine that may remain near the outlet end of the sheath when the 
catheter is used, especially by a patient confined to bed. A similar 
catheter with an inner sleeve is also disclosed in co-owned co-pending 
application Ser. No. 510,904, filed July 5, 1983. Such a catheter, whether 
held in place by adhesive coating or an adhesive pad, requires for proper 
operation that the inner sleeve be stretched into fluid-tight sealing 
contact with the glans before the proximal cylindrical portion of the 
catheter is adhesively secured to the penile shaft. 
Other prior patents of general interest are Swedish Pat. No. 162302 and 
U.S. Pat. Nos. 4,022,213, 4,284,079, 3,405,714, 4,239,044, 3,353,538, 
3,511,241, 3,721,243, 3,631,857, 3,788,324, 3,339,551, 3,364,932, 
4,296,502, and 3,742,953. 
SUMMARY OF THE INVENTION 
This invention is directed to a catheter/applicator combination in which 
the external catheter is intended to be adhesively retained on the penis, 
preferably by a coating of pressure-sensitive adhesive applied to the 
inner surface of the catheter during its manufacture, and has an integral 
inner sleeve designed to be stretched over and sealingly engage the glans 
of the penis to protect the skin of the glans and provide an expandable 
space between the inner sleeve and the outer sheath to accommodate surges 
of fluid and prevent fluid backflow that might, if it were not for the 
inner sleeve, disrupt the adhesive connection between the catheter and the 
penile shaft. The applicator coacts with the catheter to facilitate proper 
orientation of the inner sleeve in relation to the glans at the time the 
catheter is fitted in place. Further aspects of the invention relate to 
the method for applying a catheter having an inner sleeve with the aid of 
an applicator that eliminates or greatly reduces the possibility that the 
catheter may accidentally be fitted improperly upon the patient. 
The external catheter used in this combination takes the form of a sheath 
of thin, stretchable elastic material having a generally cylindrical 
section merging at one end with a tapered neck section terminating in an 
outlet section of reduced diameter, and an inner sleeve having a proximal 
end merging with the distal end of the cylindrical section and an 
elongated tapered distal portion extending into the neck section and 
terminating in a distal opening spaced from the outlet section. Such a 
catheter is depicted and described in the aforementioned co-pending 
application Ser. No. 613,279, filed May 24, 1984. 
The applicator takes the form of a relatively rigid open-ended collar 
formed of polyethylene or other suitable plastic material. The collar is 
provided at one end with an external annular bead. At or near its opposite 
end, the collar is provided with a pair of diametrically-disposed recesses 
that are large enough to accommodate a user's fingers when the catheter is 
being fitted upon a patient. When the parts are combined, the catheter has 
its cylindrical section rolled to form a torus that extends about and is 
supported by the collar with the bead of the collar serving as retaining 
means. The neck and outlet sections of the catheter extend forwardly 
through the opening of the collar, and the inner sleeve extends from the 
torus over the collar's bead and then radially inwardly at the collar's 
proximal end. The radially inwardly extending portion of the inner sleeve 
is supported in stretched and generally planar condition along a plane 
normal to the central axis of the collar. 
The torus, formed of the rolled cylindrical section of the catheter, has an 
inner diameter smaller than the outside diameter of the bead; therefore, 
the bead retains the torus on the collar until an axial unrolling force is 
exerted on the torus of a magnitude sufficient to stretch or expand the 
torus outwardly and permit it to unroll over the bead. 
In use, the catheter/applicator combination is gripped by the fingers of 
one hand to direct the catheter's stretched inner sleeve against the glans 
of the penis. As the collar is advanced to receive the glans, the 
stretched sleeve portion wraps about the glans, conforming to its contour 
and sealingly engaging its surfaces. With the sleeve sealingly engaging 
the glans, the user simultaneously holds the collar and neck portion of 
the catheter stationary relative to the glans (such operation being 
greatly facilitated by the diametrically-disposed finger-receiving 
recesses formed in the collar) and then, using the fingers of the other 
hand, unrolls the torus over the bead of the collar and along the penile 
shaft. 
Other features, advantages, and objects of the invention will become 
apparent from the specification and drawings.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT 
The external male urinary drainage catheter which constitutes one element 
of the two-element combination of this invention incorporates the features 
disclosed in co-owned co-pending application Ser. No. 613,279, filed May 
24, 1984. Such an external catheter 10 is shown most clearly in unrolled 
condition in FIG. 4. It is formed of soft, highly elastic, natural or 
synthetic rubber. Natural latex is preferred but other elastomers having 
similar properties may be used. The catheter includes an elongated outer 
sheath 11 and an inner sleeve 12, the two being integral or permanently 
integrated as hereinafter described. 
Outer sheath 11 includes an elongated cylindrical section 11a, a reduced 
drainage tube section 11b, and a tapered neck section 11c disposed 
therebetween. The wall thickness of the cylindrical section 11a is 
substantially less than that of the neck and drainage tube sections. For 
example, the cylindrical section may have a wall thickness within the 
general range of 0.006 to 0.010 inches and, in general, is too thin or 
limp to retain a cylindrical configuration without support. In contrast, 
the wall thicknesses of the drainage tube and neck sections might be 0.050 
inches or more and are generally great enough so that such sections will 
retain the configurations shown in the absence of distorting forces and 
will spring back into the illustrated shapes when distorting forces are 
removed. 
At its forward or distal end, neck section 11c is provided with a rounded 
taper leading to a reduced opening 13. In addition, the neck section is 
provided with a plurality of convolutions or annular enlargements 14. Two 
such convolutions of graduated size are depicted, their purpose being to 
permit greater stretchability, bending, and twisting of the drainage tube 
and neck sections when the device is in use, and to do so with less chance 
that kinking or obstruction of the lumen might occur. Also, such 
convolutions increase the fluid capacity at the distal end of the neck 
section and provide a reservoir for accommodating surges of fluid when the 
device is in use. 
Inner sleeve 12 has a proximal end portion 12a that merges smoothly with 
the distal end of the sheath's cylindrical body section 11a and an 
elongated distal end portion 12b disposed within the sheath's neck section 
11c. The distal end portion 12b tapers forwardly and inwardly, terminating 
in a reduced distal opening 15 that is spaced well behind (i.e., proximal 
to) opening 13. The setback also results in the provision of an annular 
and axially-elongated expansion space 16 between the outer surface of the 
sleeve's distal end portion 12b and the inner surface of neck section 11c. 
The wall thickness of the sleeve may be varied but, to insure 
conformability, good sealing properties, and wearer comfort, such 
thickness should approximate that of the relatively thin cylindrical body 
section 11a. Thus, both the cylindrical body section 11a and the inner 
sleeve 12b should appear as thin, limp, highly stretchable membranes, in 
contrast to the drainage tube and neck sections 11b and 11c with their 
shape-retaining properties. 
The adhesive means for adhesively securing the catheter to the penile shaft 
may take the form of a separate adhesive pad that is pre-applied before 
the catheter is fitted upon a wearer or, alternatively, as an adhesive 
coating along the inside surface of the catheter's cylindrical section 
11a. Both are fully disclosed in the aforementioned co-pending application 
Ser. No. 613,279, although only the latter version is depicted here in 
FIG. 4. Adhesive zone 17 is located within the cylindrical section 11a of 
the sheath behind inner sleeve 12. While the adhesive coating might 
conceivably extend the full length of the cylindrical section 11a, it is 
believed preferable to provide the adhesive zone in the form of a narrow 
but continuous band located within the distal portion of the sheath's 
cylindrical section 11a. The adhesive coating may be composed of any 
suitable medical-grade pressure-sensitive adhesive of a type well known in 
the art; a hypo-allergenic acrylic adhesive is believed to be particularly 
effective. 
The applicator takes the form of a short tube or collar 20 as shown most 
clearly in FIGS. 2 and 5-8. The short open-ended collar 20 is generally 
cylindrical in configuration although, as shown in the drawings, the 
preferred embodiment has a slight taper. The collar may be composed of any 
of a wide variety of relatively stiff or rigid plastic materials. A 
polyolefin such as high density polyethylene is believed particularly 
suitable, but other polymeric materials having similar properties would 
also be appropriate. Non-polymeric materials might also be used as, for 
example, cardboard. 
The collar is provided with a smoothly-rounded external enlargement or bead 
21 at its proximal end. At its opposite or distal end, the inner surface 
is beveled or radiused as shown at 22. A pair of enlarged recesses are 
formed in the cylindrical wall of the collar, such recesses being 
diametrically disposed and preferably of arcuate configuration. More 
specifically, when the collar is viewed in elevation, each recess has a 
generally semi-circular shape opening at the distal end of the collar. 
Each recess has an axial dimension approximately half the length of the 
collar, and the length of the collar itself is less than the collar's 
diameter and substantially less than the length of the neck section 11c of 
the catheter. 
The catheter and collar are supplied to a user with the catheter mounted 
upon the collar as shown in FIGS. 1, 3, 5, and 8. The cylinrical section 
11a of the catheter is rolled upon itself to form a torus 25. Collar 20 is 
dimensioned so that its outer diameter, exclusive of bead 21, is 
approximately the same, or only slightly greater, than the inside diameter 
of torus 25. Bead 21 therefore has an outside diameter significantly 
larger than the inside diameter of the torus, with the result that the 
bead serves as retention means to hold the torus in place until a 
sufficient axial unrolling force is exerted on the torus to cause it to 
stretch or expand outwardly to clear the bead. 
The neck section 11c extends from torus 25 inwardly about bead 21 and then 
forwardly or distally through the opening of collar 20. The convoluted 
portion 14 is fully exposed beyond the collar's distal end, as is outlet 
section 11b of the catheter. 
Of particular importance is the fact that the inner sleeve 12 is supported 
in stretched or tensioned condition at the proximal end of collar 20. The 
sleeve extends from the torus 25 about bead 21 and then radially inwardly 
along a plane normal to the axis of the collar (FIGS. 3, 5, 8). Except for 
its central opening 15, the inner sleeve therefore appears as a membrane 
stretched across the proximal end of the collar. Bead 21 therefore 
performs the dual functions of preventing torus 25 from unrolling and, by 
reason of such restraint, maintaining the inner sleeve in the stretched 
and generally planar condition shown. 
It will be noted from FIG. 8 that the adhesive layer or zone 17 is located 
far enough from the merger of the inner sleeve 12 and neck section 11c 
that the outermost surfaces of the torus are free of adhesive coating. 
Thus, there is no risk that the adhesive 17 might adhere to the inner 
surfaces of an envelope or package (not shown) in which the assembly will 
be marketed and stored. Although the cylindrical section of the catheter 
is coiled into torus shape, the adhesive does not adhere to the outer 
surface (when unrolled) of the cylindrical section 11a because of a 
release coating or layer of silicone rubber or other suitable release 
material, or because of a removal release strip or layer, all as well 
known in the art for the purposes of preventing unintended adherence 
between pressure-sensitive adhesives and adjacent surfaces. 
FIGS. 1 and 6-7 illustrate the method of applying the external catheter to 
a patient. The user first grips the exposed distal portion of the collar 
and directs the stretched membrane-like inner sleeve 12 into contact with 
the glans (FIG. 6). Because the inner sleeve is in stretched condition, it 
may be applied evenly and uniformly to the glans. Once the glans is fully 
received within the opening of collar 20 and sleeve portion 12 is fully 
stretched over the glans in firm sealing contact with it, the user grips 
the neck section 11c and holds it firmly against the glans as shown most 
clearly in FIG. 1. Such operation is greatly facilitated by the enlarged 
recesses 23 which serve as finger openings for gripping the catheter's 
neck section 11c and the glans G, and for also immobilizing or holding the 
collar as, with the fingers of the other hand, the user urges torus 25 
rearwardly over bead 21 (FIG. 7). As the torus unrolls, the adhesive layer 
17 is brought into contact with the shaft S of the penis behind the corona 
of the glans, such adhesive contact thereby securing the external catheter 
in operative position with the inner sleeve 12 stretched over the glans as 
shown in FIG. 7. The torus is unrolled the length of the penile shaft, as 
indicated by broken lines in FIG. 7, collar 20 is removed and discarded, 
and the outlet section 11b of the catheter is connected to a suitable 
drainage tube (not shown). 
While in the foregoing we have disclosed an embodiment of the invention in 
considerable detail for purposes of illustration, it will be understood by 
those skilled in the art that many of these details may be varied without 
departing from the spirit and scope of the invention.