Incontinence device

An incontinence device comprising a generally tubular soft latex shape open at both ends. The upper end is smoothly curved and tapered inward to the opening with the latex of minimal thickness and coated on the outside adjacent the opening with a suitable adhesive for contact with the skin about the anal opening. The lower end is partially folded and clipped to permit the device to be affixed with an applicator specifically shaped for the purpose and inserted within the device. The shape and material of the device permits the device to fully stretch and shrink with the anal opening while remaining adhesively affixed to the skin.

BACKGROUND OF THE INVENTION 
The field of the invention pertains to medical appliances and, in 
particular, to devices that can be attached to the exterior skin of a 
person about or in an opening with the purpose of accepting and containing 
any solid or liquid material flowing from the opening. Such devices 
require a means of attachment that does not damage the skin but is 
reasonably secure. 
Lognion, U.S. Pat. No. 4,496,356, discloses an anal excretion collecting 
rectal catheter that is insertable beneath the sphincter muscles about the 
opening. The Lognion device comprises a collecting tube open at one end 
with a resilient ring that fits within the rectal opening. 
Wade, U.S. Pat. No. 2,564,773, discloses a therapeutic agent comprising a 
thimble and latex bag insertable into a bodily opening for the collection 
of fluids. The bag folds within the thimble before use and may be attached 
to the thimble with an adhesive. The thimble includes an opening for the 
admission of fluids and is directly insertable into the bodily opening. 
Wayne, U.S. Pat. No. 2,448,938 and Swiss Pat. No. 113 453 each disclose a 
sanitary protective appliance of similar structure to receive bodily 
fluids and semi-solids from infections and incisions. The appliances 
comprise soft thin rubber tubes of accordion like shape with an opening of 
relatively large diameter. On the inside surface adjacent the opening is 
an adhesive ring to enable the device to be adhesively attached to the 
skin about the body opening from which there is a discharge. 
Chen et al., U.S. Pat. No. 4,253,460 and Allen, Jr. et al., U.S. Pat. No. 
4,650,817 both disclose adhesives suitable for attaching appliances such 
as ostomy devices to the skin about a body opening. Such adhesives must be 
secure, reasonably fluid tight but nevertheless easy to remove without 
damage to the skin. 
U.S. Pat. No. 3,522,807 discloses an incontinence bag that has a pleated 
arrangement about the anus to expand and contract with the opening and 
closing of the anus. The overlapping leaves of the pleats do not provide 
for complete adhesive attachment to the skin thus permitting leakage and 
providing a difficult attachment. 
U.S. Pat. No. 4,445,898 discloses a foam backed skin barrier attachment and 
incontinence bag. The skin barrier is disclosed as soft, pliable, 
stretchable and contractable foam backed plastic 0.080 to 0.400 inches 
thick. Plastic backed by foam has limited stretchability if less than 25% 
which limits the expandability of the anal hole in the skin barrier to an 
amount less than needed for many patients. In such cases, the anus can not 
open sufficiently thereby causing severe pain or the adhesive fails and 
the bag detaches and leaks. 
Devices insertable within body openings have been found to cause permanent 
damage to the sphincter muscles after prolonged use. With a view toward 
overcoming and avoiding damage to the sphincter muscles of the anal 
opening but nevertheless providing a secure receptacle for body waste that 
does not damage the skin surrounding the anus, is sufficiently elastic (an 
elastic limit of about 200% or more) to accomodate the full opening of the 
anus and is easy to install the following described incontinence device 
has been developed. 
SUMMARY OF THE INVENTION 
The incontinence device comprises a generally tubular soft latex shape, 
tube or bag open at both ends but having a clip to retain the lower end 
partially folded up and closed. The upper end of the device is curved and 
tapered inward to the opening with the latex of minimal thickness, 
preferably 0.003 to 0.006 inches, and coated on the outside with a 
suitable adhesive for contact with the skin about the anal opening. The 
latex is purposefully made as thin as possible to enable the latex to 
offer little or no resistance to stretching with the skin as the anus is 
fully opened and closed by the sphincter muscles. Soft latex of the above 
thickness has a better than 400% elastic limit. 
A specifically shaped applicator is provided to enable a nurse or physician 
to easily apply the adhesive to the device and to conveniently and 
securely attach the adhesive and latex about the upper opening to the skin 
about the anus. The applicator fits within the tube and is removed through 
the lower end of the tube. The clipped lower end also permits the tube to 
be periodically opened to permit gases accumulated therein to be expelled, 
or fecal matter to be removed and the bag to remain on patient.

DESCRIPTION OF THE PREFERRED EMBODIMENTS 
Illustrated in FIGS. 1 and 2 is a generally tubular shape 20 formed of soft 
latex or a similar material that is liquid impermeable, very flexible and 
soft to the skin. The lower end 22 is open. As illustrated below the lower 
end may be closed by folding over and retaining with a plastic closure 
clip (not shown). The device is suitably about 18 inches long and 3 inches 
in diameter. With the exception of the upper end 24 a wall thickness of 
about 0.010 to 0.0020 inches is suitable. 
The upper end 24 includes an opening 26 of about one and one-quarter inches 
in diameter surrounded by an upper curved generally conical portion 28 
extending down to the tubular shape 20. The curved upper portion 28 is 
made specifically very thin for maximum elasticity and flexibility and 
adjacent the opening 26 is coated on the outside 27 just prior to use with 
an adhesive suitable for secure attachment to the skin. 
Since the human skin about the anal opening stretches and contracts a 
substantial amount with opening and closing of the anal sphincter muscles, 
the conical portion 28 must also stretch and contract with minimal 
resistance and maximum flexibility to prevent chafing of the skin and 
failure of the adhesive attachment. A thickness of 0.003 to 0.006 inches 
for soft latex has been found preferable with a two part adhesive 
comprising polyolmethylsiloxane in trichlorotriflouroethane. Thicknesses 
of about 0.015 inches for the latex adjacent the upper opening have been 
found too inflexible for satisfactory use although a thickness of less 
than 0.010 inches is serviceable. The thinned latex has been found far 
superior to plastics by providing elasticity on the order of 400%, or 
more. 
The inside of the device is preferably coated with a powder to prevent the 
sticking of stools to the inside of the latex tube. Cornstarch, baby 
powder or medical grade silicone lubricant are suitable materials. 
Illustrated in FIGS. 3 through 8 is an applicator comprising a handle 
portion 30 and shaped top 32. As shown the top 32 is generally saddle 
shaped with a depressed oval center 34. The saddle shape 32 is 
specifically to fit the skin and muscle structure about the human male or 
female anus. The saddle shape 32 is sized to fit within the conical 
portion 28 of the device. More particularly, the conical portion 28 is 
stretched over the applicator saddle shape 32 after insertion of the 
applicator from the open lower end 22 as shown in FIG. 9. 
As best shown in FIG. 10 the device 20 with the applicator held thereinside 
and the conical portion 28 stretched smoothly over the saddle shape 32 is 
coated with adhesive and applied about the anus 36. In place as shown in 
FIG. 11 the device may be lightly taped at 38 to the thigh and folded and 
clipped at 40.