External male urinary catheter with garment

An external male urinary catheter, generally in the form of a condom, molded to form accordion pleats running circumferentially of the sheath so as to enable the catheter to be telescopically folded, applied, and then expanded to connect to drainage tubing and further to a compressable collection receptacle in a manner that creates a negative pressure mechanism, the fixed flange of a supporting garment meshed with the corresponding flange of said catheter by a vulcanization process rendering the assembly virtually free of any constriction.

In my original application, Ser. No. 492,145 filed June 9, 1983, now U.S. 
Pat. No. 4,553,968, granted Nov. 19, 1985 and entitled "External Male 
Urinary Catheter With Garment", there is disclosed an exdwelling catheter 
supported by a garment of the men's brief type. The garment has right and 
left leg openings, side panels attached to a waistband, and a frontal 
opening positioned to register with the penis of the male wearer. Strands 
of the absorbent, porous garment and its cylindrical extension are meshed 
with the flange of a rubber external male urinary catheter by a 
vulcanization process. 
The effectiveness of the said invention is dependent upon the use of a full 
men's brief that provides a safe and comfortable support structure where, 
previously, constricting mechanisms such as adhesive tape, a hard rubber 
ring, or a tightly-fitting sponge member predisposed the patient to the 
complications of tissue necrosis, loss of function, obstruction to the 
flow of urine, urinary tract infection, pain, and general discomfort. 
While such a construction has been found quite satisfactory, there has 
appeared difficulty in the application of the one-piece garment/catheter 
assembly that cannot be rolled onto the penis as is a conventional condom. 
The overall object of the present invention is to provide a product which 
is constructed to be more efficiently and effectively applied and utilized 
by both health care professionals and laypersons. 
Accordingly, the catheter has been modified so that accordion pleats 
provide a mechanism whereby the catheter can be telescopically folded or 
compacted along its tubular axis, and then expanded to its functioning 
state. 
Another object of the present invention is to provide a garment comprised 
of a porous, absorbent, disposable material, with a partially padded back 
portion lined with a waterproof layer between the padding and the garment 
panel. As previously disclosed, the desirability of an absorbent, porous 
material is based on the need for absorption, ventilation, and evaporation 
of body fluids to preserve the integrity of the skin and to prevent rash, 
breakdown, and infection. The padding and waterproof lining are now added 
to the back of the garment for the management of fecal incontinence. While 
such an embodiment suggests a diaper product, the present invention 
encourages the flow and containment of urine away from the body, where its 
byproducts cannot damage the skin. 
A further object of this invention is to provide a collection receptacle or 
leg bag that enhances the gravitational flow of urine. The collection 
receptacle is attached to the polyethylene drainage tubing and then 
compressed with its valvular member in an open position. The valvular 
member is then closed with the collection receptacle still in a compressed 
state. This manner of attachment creates a negative pressure mechanism 
that directs the flow of urine downwards. 
Finally, an object of the present invention is to provide an external male 
urinary catheter assembly that a confused or uncooperative patient is less 
likely to remove by virtue of the more comfortable, more secure design.

With specific reference to the drawings, an embodiment of the present 
invention is generally designated by reference numeral 10. The basic 
features of this invention, as illustrated in FIG. 1, include a supporting 
garment 12 attached to catheter 30 which is further connected to 
collection receptacle 46 by polyethylene drainage tubing 48. 
Still with reference to FIG. 1, garment 12, comprised of porous, absorbent, 
disposable material has elasticized right and left leg openings 18 and 20, 
respectively, and an elasticized waistband 16 at the top, to which are 
attached right and left panels 22 and 24, respectively. It is understood 
that flexibility within the overall design of the present invention is 
maintained to enable adjustment or accommodation to the patient's waist 
size. Applicant has found that the standard diameter of an ordinary 
condom, i.e., 40-45 mm, is consistent with the objections of the present 
invention as stated and further set forth below. 
FIG. 2 shows a frontal opening 28 in garment 12 positioned to register with 
the penis of the male user. Frontal opening 28 has an inside diameter 
adapted to encircle the penis without causing structural or functional 
constriction. Fixed flange 26 circumscribes frontal opening 28 and 
represents treated elastomeric material such that the elastomeric material 
is meshed with strands of garment 12 by appropriate industrial processes, 
e.g., vulcanization, heat setting or the like. The meshing is desirable to 
eliminate the excess bulk associated with previous devices and, at the 
same time, produce a lighter weight but still effective means of support. 
Fixed flange 26 which, in turn, is supported by garment 13, then, creates 
an anchoring mechanism for catheter 30 in lieu of the above-mentioned 
constricting mechanisms. 
Catheter 30, generally in the form of a condom, is also made of treated 
elastomeric material rendering catheter 30 a moderately thin, flexible, 
resilient yet durable tubular sheath capable of being molded so as to 
provide accordion pleats 42 that run circumferentially of the sheath. The 
body of catheter 30 is formed by alternating inner and outer diameters 32 
and 34, respectively. 
The diameter of the internal cavity of of the catheter at its proximal end, 
as determined by the inner diameter 32 and as referred to in FIG. 3, 
corresponds to that of frontal opening 28. The proximal end of catheter 30 
extends to form flange 38 which is attached to fixed flange 26 by adhesive 
40 or by appropriate industrial processes so as to provide a continuous 
interlock that adds firmness to the support structure. 
The above-described accordion pleats enable catheter 30, now united with 
garment 12, to be telescopically folded, as illustrated in FIG. 4, and 
thereby more easily applied onto the penis. Previously, the one-piece 
garment/catheter assembly proved to be problematic in its application 
where the patient was confronted with a dangling, loose catheter member 
that could not be rolled onto the penis as is a conventional condom. 
The distal portion of catheter 30 gradually reduces ln internal diameter, 
as shown in FIGS. 2 and 4, so that the inner diameter of pleats may be 
snugly engaged by the tip of the penis without constricting the flow of 
urine therethrough. The catheter is molded with a converging end portion 
36 to end in cylindrical tubular member 44. Aperture 45 of tubular member 
44, as shown in FIG. 2, has a slightly larger diameter than that of 
polyethylene drainage tubing 48. Drainage tubing 48 can therefore be 
fitted into aperture 45 and thus makes possible fluid communication 
between catheter 30 and collection receptacle 46 at its inlet 50. The 
outlet 54 of the receptacle 46 is connected to a valve 55. 
Collection receptacle 46, now connected to polyethylene drainage tubing 48, 
is essentially a polyethylene bag which is normally expanded but is 
capable of being compressed as illustrated in broken lines in FIG. 5. 
Valvular member 55 is left open as enough pressure is applied to bring 
together the sides of collection receptacle 46. Valve 55 is then closed. 
The tendency of the receptacle to expand to its normal shape creates a 
negative pressure mechanism akin to a siphon. Urine is drawn away from the 
body as long as collection receptacle 46 remains at a level below the 
urinary bladder. Urine collected in the receptacle is eliminated through 
tubular outlet member 54 and valve 55. 
Polyethylene drainage tubing 48 should be taped to the patient's thigh to 
prevent pull on the device and consequent pain and discomfort. Collection 
receptacle 46 has means to be attached by strap 56 to the ambulatory 
wearer at his calf or to the bedside of the bedridden patient. 
While the above description contains many specifities, these should not be 
construed as limitations on the scope of the invention, but, rather, as an 
exemplification of one preferred embodiment thereof. For example, the 
material of the garment may not necessarily be disposable after one-time 
use. In that case, the garment along with the catheter would be 
conveniently laundered and reused. Or, the garment may be composed of 
washable and reusable fabric with the catheter being detachable and 
disposable after one-time use. Here, adhesive would be reapplied onto both 
flanges. Accordingly, the scope of the invention should be determined not 
by the embodiment illustrated, but by the appended claims and their legal 
equivalents.