U.S. patent number RE33,206 [Application Number 06/917,145] was granted by the patent office on 1990-05-01 for male condom catheter having adhesive on rolled portion.
This patent grant is currently assigned to Mentor Corporation. Invention is credited to James A. Conway, Peter R. Conway, Philip J. Conway.
United States Patent |
RE33,206 |
Conway , et al. |
May 1, 1990 |
Male condom catheter having adhesive on rolled portion
Abstract
A male urinal device (10) is disclosed. Device (10) includes a
laminated sheath (14) having an inner layer (26) of latex rubber
and outer layer (28) of silicone rubber. Adhesive (24) is stored
between the inner and outer layers (26, 28) when sheath (14) is
rolled. As sheath (14) is unrolled, adhesive (24) is released from
outer layer (28) and adheres to inner layer (26). Upon pressing
sheath (14) to a penis (12), a leak-free bond is created.
Inventors: |
Conway; James A. (Chatfield,
MN), Conway; Peter R. (Chatfield, MN), Conway; Philip
J. (Chatfield, MN) |
Assignee: |
Mentor Corporation (Goleta,
CA)
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Family
ID: |
26975929 |
Appl.
No.: |
06/917,145 |
Filed: |
October 9, 1986 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
307792 |
Oct 2, 1981 |
04475910 |
Oct 9, 1984 |
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Current U.S.
Class: |
604/349;
128/844 |
Current CPC
Class: |
A61F
5/453 (20130101) |
Current International
Class: |
A61F
5/453 (20060101); A61F 5/451 (20060101); A61E
005/44 () |
Field of
Search: |
;428/36,343,352 ;285/260
;138/109,285 ;604/347,349,350,351,352 ;128/760,DIG.21,137R,157 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"The Silicones as Tools in Biological Engineering", Braley, Med.
Electron. Biol. Engng., vol. 3 Pergamon Press, Great Britain, 1965
(pp. 127-136)..
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Primary Examiner: Kruter; J. L.
Attorney, Agent or Firm: Kinney & Lange
Claims
What is claimed is:
1. A male condom catheter designed to be connected to a urine
collection means and comprising a thin cylindrical sheath member of
resilient material rolled outwardly upon itself to form
consecutively larger rolls, said sheath member having an outer
surface and an inner surface designed to engage a penis when the
catheter is unrolled, and
the outer surface of the sheath member having prior to the rolling
thereof a layer of pressure sensitive adhesive over a substantial
portion thereof with a release layer between said adhesive and the
outer surface of the sheath member so that as the sheath member is
rolled up the pressure sensitive adhesive on the outer surface is
in direct contact with the inner surface of an adjacent roll so
that as the sheath member is unrolled the adhesive on the outer
surface is transferred to the porton of the inner surface in
engagement with the outer surface, without rolling the catheter
inside out, to cause the inner surface to adhere to the penis over
which the sheath is placed.
2. A device in accordance with claim 1 wherein said release layer
is a silicon rubber layer of material.
3. The male condom catheter of claim 1 in which the thin sheath
member has an integral conical portion of thicker material which is
designed to be connected to a urine collection means.
4. The male condom catheter of claim 1 in which the adhesive is
between the inner and outer surfaces of one or more consecutive
rolls so that the adhesive is covered by the inner surface when the
sheath is in rolled up condition. .[.5. The method of applying a
male condom catheter to a penis comprising:
forming a thin cylindrical sheath member of resilient material,
said sheath member having an outer surface and an inner surface
designed to engage a penis, and the outer surface of the sheath
member having a layer of pressure sensitive adhesive over a
substantial portion thereof with a release layer between said
adhesive and the outer surface of the sheath member;
rolling said sheath member outwardly upon itself to form
consecutively larger rolls so that the pressure sensitive adhesive
on the outer surface is in direct contact with the inner surface of
an adjacent roll;
unrolling the sheath member onto the penis so that the adhesive is
transferred to the portion of the inner surface which was in
engagement with the outer surface in the rolled up condition;
and
pressing said unrolled sheath member against the penis to cause the
adhesive to adhere to the penis to form a bond between the sheath
member
and the penis..]. .Iadd.6. A male condom catheter to be adhesively
secured to a penis and designed to be connected to a urine
collection means, said catheter comprising a thin, flexible
cylindrical member of resilient material rolled outwardly upon
itself to form a single roll with consecutively larger turns, the
outer surface of the cylindrical member having an adhesive release
layer thereon and said turns having a layer of pressure sensitive
adhesive therebetween in contact with the inner surface of the
cylindrical member and in contact with the release layer so that
upon said cylindrical member being unrolled onto a penis, the
adhesive releases from the adhesive release layer due to the
unrolling of the cylindrical member and adheres only to the inner
surface of the cylindrical member to cause the cylindrical member
to adhere to the penis.
.Iaddend. .Iadd.7. The catheter of claim 6 in which the adhesive
release layer and the adhesive extend over at least one turn of the
roll.
.Iaddend. .Iadd.8. The catheter of claim 6 in which there is a
bulbous surge chamber secured to the outlet side of the cylindrical
member. .Iaddend. .Iadd.9. The catheter of claim 6 in which the
adhesive release layer is formed of silicon rubber. .Iaddend.
Description
TECHNICAL FIELD
This invention relates to a male urinal device and, more
particularly, to an external male catheter for catching and
removing to a collection device unrestrained urine discharges.
BACKGROUND OF THE INVENTION
In connection with a male urinal device of the type using a urine
receptical worn on the body or near the body, it is common to use a
sheath of flexible material placed over the penis and connected to
the receptical with a tube or other form of flexible conduit. Some
devices customarily include a narrow tape wound relatively tightly
about the sheath to hold the sheath securely and prevent leakage.
Since urinal devices must be worn for long periods of time,
particularly in the case of paraplegics, wound tape exerts
continuous pressure on a penis and particularly on the urethral
passage which is located on the under side of the penis fairly
close to the surface. Constrictions and discomfort may result. It
is not uncommon for a tightly wound tape to cause swelling or even
gangrene. On the other hand, a loose tape can allow leakage of
urine and resultant irritation.
In U.S. Pat. No. 3,863,638, Rogers shows a liner pad between the
sheath and the penis to form a cushion and absorb some of the
pressure exerted by an externally wound tape. Often, however, the
pad is inadvertently not used by an attendant applying the device
to a patient or the pad is simply too wide or too narrow for a
particular penis. Additionally, Rogers indicates the use of
adhesive on both sides of the pad, thus eliminating the need for an
external tape.
In U.S. Pat. No. 4,187,851, .[.Houser.]. .Iadd.Hauser .Iaddend.also
eliminates an external tape by showing the use of an adhesive on
both the inner and outer surfaces of a pad. In this way, the pad
can be wound around a penis, and the sheath of the urinal device
rolled over the pad and held in place by the adhesive. Although the
devices of Rogers and .[.Houser.]. .Iadd.Hauser .Iaddend.eliminate
externally wound tape, they continue to present the problems which
result whenever a material is too tightly wound about a penis.
Broerman in U.S. Pat. No. 3,739,783 shows a urinal device to be
used without wound tape or pads. An adhesive is painted onto a
penis and a sheath impregnated with silicone rubber placed over the
adhesive. The method and device, however, are not satisfactory
since reliability continues to depend on an attendant's use of a
proper adhesive and proper application of the adhesive.
Hence, there continues to be a need for a safe, leak-free male
urinal device.
SUMMARY OF THE INVENTION
In one embodiment, a male urinal device in accordance with the
present invention includes a condom means for fitting about a
normal, flaccid penis. The condom means joins catheter means for
carrying urine to collection means. The condom means includes a
flexibly cylindrical member rolled outwardly upon itself forming
consecutively larger rolls. The member has adhesive between
consecutive rolls. The member includes outer means for releasing
the adhesive when the member is unrolled and inner base means for
providing an adhesive adhering surface when the member is unrolled.
In this fashion, the device may be stored with the adhesive
protected between consecutive rolls of the member and used by
unrolling the member onto a penis allowing the adhesive to release
from the outer releasing means and adhere to the base means and the
penis.
In a preferred embodiment, the male urinal device is in the form of
an external male catheter having a sheath or sleeve for fitment
about a normal, flaccid penis. The sleeve has an open end and an
end opposite which unitarily joins a bulbous surge chamber and a
catheter portion for connection to a tube leading to a collection
receptacle. The sleeve is comprised of an internal layer of latex
rubber with an external layer of an adhesive release agent. In a
pre-operational position, the sleeve is outwardly rolled upon
itself. A pressure-sensitive, medical adhesive is located between
consecutive rolls. When the sleeve is rolled onto a penis, the
adhesive adheres to the latex rubber layer and releases from the
release agent layer. In this way, the adhesive is sandwiched
between the latex rubber and the penis and upon applying a one time
appropriate amount of pressure to the sleeve and penis forms a
leak-free bond.
Thus, the method for installing the male external catheter onto a
penis includes the steps of unrolling the sleeve or condom portion
of the catheter onto the penis and pressing the unrolled condom
portion against the penis to form completely around the penis a
bond between the condom portion and the penis. As indicated the
adhesive is released from the outer surface of the condom portion
and adheres to the inner surface of the condom portion during the
unrolling step.
The present invention includes a method for making a male urinal
device. The method is comprised of dipping a male-type form of the
device into a liquid-state base material, curing the base material
adhering to the dipped form, applying a liquid-state release
material to the sheath portion of the cured base material, curing
the release material, applying a pressure-sensitive adhesive to a
cylindrical portion of the cured release material, and rolling from
an end of a form the sheath portion of the device.
The present device is particularly advantageous in that it
eliminates all need for a wound tape or pad about the penis.
Consequently, the medical risk of swelling and gangreen is
eliminated. Additionally, the present device eliminates the need
for an attendant to prepare the surface of the penis with a proper
adhesive. The present device provides a mechanism for storing a
proper adhesive in a pre-operational position and for automatically
transferring the adhesive to the required surface for making the
appropriate bond between the penis and the urinal device.
The device is easily installed on a penis by simply unrolling and
pressing. Additional steps of applying an adhesive or applying a
tape or a pad have been eliminated.
These and other advantages obtained by the use of the present
invention may be better understood by reference to the drawings
which form a further part hereof and to the accompanying
descriptive matter in which there is illustrated and described
preferred and other embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is perspective view of a urinal device being installed on a
penis in accordance with the present invention;
FIG. 2 is a cross-sectional view of a device in the pre-operational
position;
FIG. 3 is a perspective view of a device installed on a penis;
FIG. 4 is a flow diagram indicating the method for making the male
urinal device in accordance with this invention; and
FIG. 5 is a cross-sectional view of a portion of the device shown
in FIG. 2 on a larger scale and with the device partially unrolled
to show the transfer of the adhesive from the outer to the inner
surfaces of the catheter.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to the drawings wherein like reference numerals
designate identical or corresponding parts throughout the several
views, and more particularly to FIG. 1, a male urinal device in
accordance with the present invention is designated generally as
10. Device 10 is shown as an external catheter installed about a
male penis 12. Device 10 is comprised of a condom portion in the
form of a sheath or sleeve 14, merging with a conical portion 16 to
a constriction 18 before opening into a bulbous, surge chamber 20
which connects with a catheter or tube portion 22. Surge chamber 20
also serves as an anti-kink mechanism for tube 22 and a backflow
prevention device. Device 10 requires a sheath 14, but may, of
course, have more or less of the other indicated elements, and such
elements may assume various shapes or be arranged in an order other
than that illustrated.
Sheath 14 is cylindrical and has sufficient length to provide an
adequate cylindrical contact surface for adhesive 24 explained more
fully hereinafter. Sheath 14 is comprised of layers of material. An
inner layer 26 is a base material which unitarily connects with
conical portion 16, surge chamber 20 and catheter tube 22. Inner
layer 26 of sheath 14 has a relatively thin cross sectional
thickness as compared with the thickness of conical portions 16,
surge chamber 20 and tube 22. The latter, thicker elements must
generally retain their indicated shapes without being supported by
internal or external structure. Sheath 14 fits about a penis 12
and, consequently, assumes the shape of the penis.
An outer layer 28 is laminated or otherwise applied to inner layer
26. It is understood, of course, that intervening layers may exist,
but do not have particular significance with respect to the present
invention. Outer layer 28 also has a relatively thin cross section.
Outer layer 28 preferably extends the entire length of sheath
14.
With sheath 14 rolled in a pre-operational position, adhesive 24 is
located between the outer surface of outer layer 28 and the inner
surface of inner layer 26 of one or more consecutive rolls. The
inner layer 26 provides an inwardly facing surface to which
adhesive 24 readily adheres. The outer layer 28 provides a surface
facing outwardly from which adhesive 24 is readily released.
Inner layer 26 of sheath 14, conical portion 16, surge chamber 20
and tube 22 are formed from a latex rubber or other suitable base
material, such as a synthetic rubber. The outer layer 28 is a
silicone rubber or other suitable adhesive release material. Outer
layer 28 is preferably not porous since adhesive release is less
complete. The adhesive 24 is a medically approved,
pressure-sensitive adhesive suitable for creating a bond between
human skin and the base material. The adhesive bond must be
sufficiently strong and resistant to moisture to prevent urine
leakage therethrough, while not being so strong as to cause pain
when device 10 is removed from a penis.
As indicated in FIG. 4, urinal device 10 is made by using a
male-type form (not shown) having an outer contour similar to the
inner contour of a device 10. The form is dipped into a
liquid-state base material. When removed, the base material
adhering to the dipped form is cured in order to form inner layer
26 of sheath 14 as well as conical portion 16, surge chamber 20 and
tube 22. The form may be dipped and cured multiple times. The base
material portion of device 10 may be removed from the first form
and placed on a second form or not. Next, a liquid-state release
material, like silicone rubber, is applied to the sheath portion of
the cured base material. The release material is allowed to cure to
create outer layer 28 of sheath 14. Device. 10 again may or may not
be removed from one form and placed on another. The
pressure-sensitive adhesive 24 is then applied to a cylindrical
portion of the outer surface of outer layer 28. Sheath 14 is rolled
from its open end outwardly upon itself toward conical portion 16.
Device 10 is then easily stretched and removed from the male-type
form and is in its pre-operational position ready to be packaged or
used.
To use urinal device 10, conical portion 16 is brought into
proximity with the tip of a penis 12 as shown in FIG. 1. Sheath 14
is unrolled onto the penis. As unrolling occurs, as best shown in
FIG. 5, adhesive 24 is released from the release material of outer
layer 28 and adheres to the base material of inner layer 26. To
show this more clearly, the adhesive 24 is shown in dotted lines on
the portion of the outer surface 28 which has been unrolled to show
that the adhesive has been released from this outer surface. Hence,
when sheath 14 is completely unrolled, there is no adhesive along
outer layer 28. Rather, the adhesive is located on the inner
surface of inner layer 26. By pressing a cylindrical portion of the
extended sheath 14 against the penis, a bond between the sheath and
the penis is formed to hold device 10 safely in place in a
leak-free fashion, as shown in FIG. 3. At the end of device 10
opposite sheath 14, a delivery tube (not shown) is connected with
tube 22 to conduct urine to a containing receptacle (not
shown).
Device 10 is removed from a penis by reversing the hereinbefore
indicated steps.
Thus, the foregoing description has given numerous characteristics
and advantages of the present invention, together with details of
structure and function. It is to be understood, however, as
indicated a number of times hereinbefore, that the disclosure is
illustrative only. Consequently, any changes made, especially in
matters of shape, size and arrangement, to the full extent extended
by the general meaning of the terms in which the appended claims
are expressed, are within the principle of the invention.
* * * * *