U.S. patent application number 14/975983 was filed with the patent office on 2016-04-14 for male external catheter with absorbent and adhesive.
The applicant listed for this patent is Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc.. Invention is credited to Anthony J. Conway, Richard D. Fryer.
Application Number | 20160100976 14/975983 |
Document ID | / |
Family ID | 36950883 |
Filed Date | 2016-04-14 |
United States Patent
Application |
20160100976 |
Kind Code |
A1 |
Conway; Anthony J. ; et
al. |
April 14, 2016 |
Male External Catheter with Absorbent and Adhesive
Abstract
The invention relates generally to external urinary catheters
for males. More specifically, the invention relates to an external
urinary catheter that includes an absorbent material to absorb
urinary discharge. The absorbent material can be located in either
a distal end of a tubular sheath, or in a receptacle that attached
to the distal end of the tubular sheath. The tubular sheath of the
external urinary catheter can include a tubular sheath of silicone
rubber, wherein the sheath has an inner surface and an outer
surface, and a layer of adhesive material directly and
non-releasably bonded to the inner surface.
Inventors: |
Conway; Anthony J.;
(Chatfield, MN) ; Fryer; Richard D.; (Chatfield,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Rochester Medical Corporation, a subsidiary of C.R. Bard,
Inc. |
Stewartville |
MN |
US |
|
|
Family ID: |
36950883 |
Appl. No.: |
14/975983 |
Filed: |
December 21, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14508450 |
Oct 7, 2014 |
9248058 |
|
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14975983 |
|
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|
11104388 |
Apr 12, 2005 |
8864730 |
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14508450 |
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Current U.S.
Class: |
604/374 ;
604/385.03 |
Current CPC
Class: |
A61F 5/4401 20130101;
A61F 2013/530343 20130101; A61F 2006/047 20130101; A61F 5/4407
20130101; A61F 2006/045 20130101; A61F 6/04 20130101; A61F 2006/044
20130101; A61F 13/471 20130101; A61F 5/453 20130101; A61F 5/443
20130101; A61F 6/02 20130101; A61F 2013/15146 20130101; A61F 13/82
20130101; A61F 5/451 20130101; A61F 5/4408 20130101 |
International
Class: |
A61F 5/44 20060101
A61F005/44; A61F 5/453 20060101 A61F005/453; A61F 5/443 20060101
A61F005/443 |
Claims
1. An external urinary catheter, comprising: a tubular sheath
including a closed distal end and an open proximal end; a layer of
adhesive material non-releasably bonded to a portion of an inner
surface of the tubular sheath; and an absorbent material positioned
distal to the layer of adhesive material, the absorbent material
being provided in a packet configured to be replaced and exchanged
without utilizing another tubular sheath.
2. The external urinary catheter according to claim 1, wherein the
packet comprises a semi-permeable coverstock containing and
surrounding the absorbent material.
3. The external urinary catheter according to claim 1, wherein the
inner surface is rolled onto an outer surface of the tubular sheath
in a storage configuration, the adhesive material releasably
contacting the outer surface.
4. The external urinary catheter according to claim 1, wherein the
absorbent material is isolated from an adjacent section of the
tubular sheath by a semi-permeable barrier.
5. The external urinary catheter according to claim 4, wherein the
semi-permeable barrier comprises a spunbound synthetic fiber
coverstock.
6. The external urinary catheter according to claim 1, wherein the
absorbent material is positioned in the closed distal end of the
tubular sheath.
7. The external urinary catheter according to claim 1, wherein the
tubular sheath is formed of silicone rubber.
8. The external urinary catheter according to claim 1, wherein the
distal end of the tubular sheath has an end dimension that is
different than a diameter of the proximal end.
9. The external urinary catheter according to claim 1, wherein the
distal end of the tubular sheath has an end dimension that is
greater than a diameter of the proximal end.
10. The external urinary catheter according to claim 1, wherein the
absorbent material is isolated from an adjacent section of the
tubular sheath by a semi-permeable barrier.
11. The external urinary catheter according to claim 10, wherein
the semi-permeable barrier comprises a spunbound synthetic fiber
coverstock.
12. The external urinary catheter according to claim 1, wherein the
absorbent material is positioned in the closed distal end of the
tubular sheath.
13. The external urinary catheter according to claim 1, wherein the
absorbent material includes cellulose fiber.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/508,450, filed Oct. 7, 2014, which is a
division of U.S. patent application Ser. No. 11/104,388, filed Apr.
12, 2005, now U.S. Pat. No. 8,864,730 B2 issued on Oct. 21, 2014,
which are incorporated by reference in its entirety into this
application.
TECHNICAL FIELD
[0002] The invention relates generally to external urinary
catheters for males. More specifically, the invention relates to an
external urinary catheter that includes an absorbent material to
absorb urinary discharge.
BACKGROUND
[0003] Urinary incontinence can be a serious problem for men. Many
incontinent men, particularly post prostatectomy patients, leak
only small amounts of urine between normal voiding. Generally, male
incontinence is handled through use of urine collection devices or
absorbent pads. Urine collection devices include what is commonly
called a "leg bag." A leg bag generally includes a tube and a large
collection bag sized to collect an amount of urine typically
discharged during voiding. The tube is retained near the urethra
and extends to a location where the large collection bag resides.
Often the large collection bag is strapped to the user's leg; hence
the term "leg bag."
[0004] Existing remedies, although suited for individuals who leak
a substantial volume of urine, are not well suited for an
incontinent male that leaks only small volumes of urine between
voiding. The existing devices are big, bulky, and uncomfortable.
Other existing devices occlude leakage of urine, and are also
uncomfortable. Some men will forego wearing such devices even
though they suffer from urinary incontinence. Such men, and others
using existing devices for the collection of only small amounts of
urine, would benefit from a smaller, less bulky and more
comfortable device that collects the small amounts of urine
discharged between normal voiding.
[0005] Therefore, a need remains for a device that collects small
amounts of urine leaked or discharged from incontinent males that
does not necessarily occlude the leakage of urine and is not highly
cumbersome to the user.
SUMMARY
[0006] The present disclosure relates to devices for management of
male urinary incontinence, particularly for collecting small
amounts of urine discharged between normal voiding. The present
disclosure further relates to methods associated with the devices,
including methods of use and manufacture. In one aspect of the
present disclosure, the devices include male external urinary
catheters that have an absorbent suitable for absorbing the small
amounts of urine discharged between normal voiding.
[0007] A variety of examples of desirable device features or
methods are set forth in part in the description that follows, and
in part will be apparent from the description, or may be learned by
practicing various aspects of the disclosure. The aspects of the
disclosure may relate to individual features as well as
combinations of features. It is to be understood that both the
foregoing general description and the following detailed
description are explanatory only, and are not restrictive of the
claimed invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is an enlarged cross sectional view of an external
urinary catheter of the present invention shown in a pre-use
orientation;
[0009] FIGS. 2 through 5 are cross sectional views of embodiments
of the invention that have absorbent material in a distal end of
the external urinary catheter;
[0010] FIGS. 6 through 8 are cross sectional views of embodiments
of the invention that have absorbent material in a reversibly
joined receptacle of the external urinary catheter;
[0011] FIGS. 9 and 10 are cross sectional views of embodiments of
the invention that also include a semi-permeable barrier;
[0012] FIG. 11 is a cross sectional view of an embodiment of the
invention that has the absorbent material adhered to an inner
surface of a tubular sheath;
[0013] FIG. 12 is a cross sectional view of an embodiment of the
invention that has the absorbent material adhered to the inner
surface of the receptacle;
[0014] FIG. 13 is a perspective view of the external urinary
catheter of FIG. 1 shown when the catheter is partially unrolled
onto a penis;
[0015] FIG. 14 is a perspective view of the external urinary
catheter of FIG. 13 shown when the catheter is fully unrolled onto
the penis;
[0016] FIG. 15 is a side view of a mandrel used to form the tubular
sheath of the external urinary catheter of the present
invention;
[0017] FIG. 16 is a partial cross-sectional view of the mandrel of
FIG. 15 shown when partially coated with a silicone coating;
[0018] FIG. 17 is a view similar to FIG. 16, but after the mandrel
is partially coated with an adhesive layer;
[0019] FIG. 18 is a view similar to FIG. 17, but after a portion of
the silicone coating and the adhesive layer on the mandrel have
been stripped away;
[0020] FIG. 19 is a view similar to FIG. 18, but after a first
overcoat layer of silicone rubber solution has been coated on the
mandrel over the adhesive layer and silicone coating remaining on
the mandrel;
[0021] FIG. 20 is a view similar to FIG. 19, but after an
application of a second overcoat layer of a silicone rubber
solution to a portion of the mandrel;
[0022] FIG. 21 is a view similar to FIG. 20, but after a step of
curing or vulcanizing the tubular sheath, and showing an upper
portion of the tubular sheath of the external urinary catheter
rolled up;
[0023] FIG. 22 is a schematic illustration of a mechanized system
used to coat the mandrels, as shown in FIGS. 15-21;
[0024] FIG. 23 is an enlarged cross-sectional view of the upper
portion of the external urinary catheter of FIG. 1 in the pre-use
orientation;
[0025] FIG. 24 is a top plan view of yet another embodiment of an
external urinary catheter of the present invention; and
[0026] FIG. 25 is a side view of a portion of the external urinary
catheter of FIG. 24.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0027] Reference will now be made in detail to various features of
the present disclosure that are illustrated in the accompanying
drawings. Wherever possible, the same reference numbers will be
used throughout the drawings to refer to the same or like
parts.
I. Structural Description, Generally
[0028] Referring to FIG. 1, one embodiment of an external urinary
catheter 100 is illustrated. The external urinary catheter 100
generally includes a tubular sheath 110, an adhesive layer 115, and
absorbent material 120.
[0029] Following manufacture and during pre-use storage, the
external urinary catheter 100 will generally have a pre-use
orientation, as shown in FIG. 1. In the pre-use orientation, an
upper portion 150 of the tubular sheath 110 is rolled up as shown.
The tubular sheath 110 of the catheter 100 has an inner surface 112
and an outer surface 114. When the upper portion 150 is rolled up
in the pre-use orientation, the inner surface 112 contacts the
outer surface 114 of the tubular sheath 110.
[0030] The adhesive layer 115 of the external urinary catheter 100
is provided on the inner surface 112 of the tubular sheath 110
during manufacture. Typically, the adhesive layer 115 includes a
biocompatible adhesive. A biocompatible adhesive is an adhesive
that can contact skin for extended periods without irritating or
damaging the skin. Typically, the adhesive layer 115 is
non-releasably bonded to a bonding region 152 of the inner surface
112, as will be discussed in greater detail hereinafter.
"Non-releasably bonded", "non-releasable adherence", or
"non-releasable contact" refers to contact that does not permit
easy separation of the adhesive layer 115 from the bonding region
152 of the tubular sheath 110.
[0031] When the external urinary catheter 100 is in a pre-use
orientation, the adhesive layer 115 is non-releasably bonded to the
bonding region 152 of the inner surface 112, and releasably bonded
to the outer surface 114 of the tubular sheath 110. "Releasably
bonded", "releasable adherence", or "releasable contact" refers to
contact that permits a relatively easy separation of the adhesive
layer 115 from the outer surface 114 of the tubular sheath 110. The
adhesive layer 115 releases and separates from the outer surface
114 of the tubular sheath 110 when the upper portion 150 of the
sheath 110 is unrolled, while the adhesive layer 115 remains
non-releasably adhered to the bonding region 152 of the tubular
sheath 110.
[0032] Still referring to FIG. 1, the absorbent material 120 of the
external urinary catheter generally functions to absorb leaked or
discharged urine. As will be described in greater detail
hereinafter, the absorbent material 120 can either be attached to
tubular sheath 110 or simply contained within the tubular sheath
110. In embodiments that simply contain the absorbent material 120,
it is contemplated that the absorbent material can be replaced or
exchanged by the user without utilizing a different tubular sheath
110.
[0033] General examples of suitable absorbent material include, but
are not limited to: cotton fiber, cellulose fiber, absorbent
polymers, hydrophilic absorbing power (powders having a chemical
structure that hold moisture either inter-molecularly or
intra-molecularly), synthetic fibers, and other types of material
that absorb urine.
[0034] More specific examples of cellulose fibers include wood
pulp, stabilized wood pulp, wood pulp with super absorbent, peat
moss board, tissue paper, or creped wadding. More specific examples
of synthetic fibers include nonwoven fibers of polypropylene,
polyester, nylon, polyethylene, and copolymers thereof. One example
of a suitable synthetic fiber is isotactic polypropylene.
[0035] More specific examples of absorbent polymers include
polypropylene, polyacrylates such as sodium polyacrylate, and
copolymers thereof. Absorbent polymers formed as a foam material
can also be used. Such foam materials can be formed from the water
actuation of polymers based on either toluene diisocyanate (TDI) or
methylene diphenyl diisocyanate (MDI), for example. Theses polymers
are commercially available under, for example, the trademarks
"HYPOL" (TDI) and "HYPOL PLUS" (MDI) from W.R. Grace & Co.,
Organic Chemicals Division (Lexington, Mass.). Polymer foams can
also be formed from polyurethanes or polyolefins.
[0036] The external urinary catheter 100 of the present disclosure
may include various volumes or amounts of the absorbent material
120. Generally speaking, the amount of absorbent material 120 used
can be described by an actual volume of the absorbent, or by the
volume of urine absorbed by the material. The amount of absorbent
material 120 included depends on the type of the absorbent material
and the level of urinary discharge for which the catheter 100 is
designed. For example, the amount of absorbent material 120 used
for men that have higher levels of urinary discharge will be
greater than the amount used for men that have lower levels of
urinary discharge.
[0037] In general, the absorbent material 120 functions to absorb
urine collected in the tubular sheath 110. In the embodiment shown
in FIG. 1, the absorbent material 120 is generally located in a
distal end 116 of the tubular sheath 110. There are a number of
different configurations of the tubular sheaths 110 in which
absorbent material 120 can be generally located in the distal end
116. Examples of such alternative embodiments are shown in FIGS.
2-5.
[0038] Referring now to FIGS. 2-5, the distal end 116 of each of
the tubular sheaths 110 has a different configuration. The
different configurations of FIGS. 2-5 are only exemplary
configurations; and other configurations are contemplated.
[0039] Referring specifically to FIG. 2, the distal end 116 of the
tubular sheath 110 has a generally square shape with a
cross-sectional dimension D1. The cross-sectional dimension D1 is
approximately equal to a diameter D2 of a main portion 154 of the
tubular sheath 110. In an alternative embodiment, the
cross-sectional dimension D1 can be larger or smaller than the
diameter D2 of the remainder of the tubular sheath 110.
[0040] In FIG. 3, the distal end 116 of the tubular sheath 110 has
a generally rounded shape with a maximum diameter D3. The maximum
diameter D3 is approximately the same as that of the main portion
154 of the tubular sheath 110. In FIG. 4, the distal end 116 has a
generally round shape with a maximum diameter D4. The maximum
diameter D4 is greater than that of the main portion 154 of the
tubular sheath 110.
[0041] In FIG. 5, the distal end 116 has a generally round shape
with a maximum diameter D5 that is also greater than the diameter
D2 of the main portion 154 of the tubular sheath 110. However, in
FIG. 5, the distal end 116 includes a necked portion 156 that
reduces in diameter prior to expanding to the maximum diameter D5.
In an alternative embodiment, the tubular sheath 110 can include a
necked portion that expands to a maximum diameter D5 that is less
than the diameter D2 of the main portion 154. It should also be
understood that any combinations of these and other distal end
constructions and shapes could be utilized. For example, the distal
end 116 can have a necked portion, and include a generally square
shape with a dimension greater than or less than the main portion
154 of the tubular sheath 110.
[0042] Referring now to FIGS. 6-8, in alternative embodiments, the
absorbent material 120 can be located in a receptacle 122 (e.g. a
pouch or cartridge). (See also FIG. 24.) Typically, the receptacle
122 is interconnected to the distal end 116 of the tubular sheath
110 by a joining assembly 124.
[0043] The receptacle 122 can be fashioned from a material that is
one or more of pliable, durable, collapsible, and inexpensive. For
example, the receptacle 122 can be pliable so that the catheter 100
is more malleable and comfortable for a user. The receptacle 122
can be durable to limit the possibility of the receptacle 122 being
pierced or ruptured. The receptacle 122 can be inexpensive so that
the receptacle 122 can be replaced whenever appropriate without
excessive cost. Examples of suitable materials that can be used to
manufacture the receptacle 122 include, for example, polyvinyl
chloride (PVC), polyurethane, block copolymers such as kraton, high
density polyethylene, low density polyethylene, and silicone
rubber. As can be understood, the receptacle 122 is in certain
embodiments waterproof (i.e., not permeable to water over the
length of time that the receptacle will remain in the user's
undergarment). The material can have a waterproof quality, or a
waterproofing material can be applied during the manufacture of the
receptacle 122.
[0044] Generally, the thickness of receptacle 122 (i.e., the
dimension that would be shown in a side view of FIG. 6-8) varies
depending on the type of material used, and the type and amount of
absorbent material 120 used. Typically, the thickness of receptacle
122, including the absorbent material 120, ranges from about 0.125
inches to about 1.50 inches; more typically between about 0.125
inches and 0.750 inches. Preferably, the thickness of the
receptacle 122 is sized to be comfortable and concealable.
[0045] The capacity of the receptacle 122 varies depending on the
level of urinary discharge for which the specific embodiment is
designed. Embodiments designed for higher levels of urinary
discharge will have receptacles 122 with a higher capacity, while
those designed for lower levels of urinary discharge will have
receptacles 122 with a lower capacity. The capacity of the
receptacles 122 can be smaller than a leg bag and suitable for
receiving discharge between voiding. Typically, the receptacle 122
has a capacity or volume V from about 25 mL to about 100 mL.
Generally speaking, if the receptacle 122 is designed for higher
levels of urinary discharge, the receptacle has a volume V of about
40 to 100 mL. If the receptacle 122 is designed for lower levels of
urinary discharge, the receptacle has a volume V of about 25 to 35
mL.
[0046] The shape of receptacle 122 can vary. Exemplary
configurations of the receptacle 122 are illustrated in FIGS. 6-8.
As shown, the receptacle 122 can have virtually any shape,
including a generally round shape (FIGS. 6 and 7) and a generally
square shape (FIG. 8).
[0047] Embodiments that include the receptacle 122 can be designed
so that receptacles of variable capacity can be used
interchangeably. This feature allows a user to vary the capacity of
the external urinary catheter 100 based on a personal level of
urinary discharge, which may or may not vary. For example, in one
embodiment, a kit may be provided to a user. The kit may include a
tubular sheath 110 along with an array of receptacles 122. Each
receptacle provided would include a different amount of absorbent
material contained within the receptacle. This would permit the
user to adjust the capacity of the external urinary catheter 100
according to the daily needs of the user.
[0048] In use, discharged urine flows from the sheath 110, through
the joining assembly 124, and into the receptacle 122. The joining
assembly 124 of the external urinary catheter 100 functions to
reversibly join the receptacle 122 to the distal end 116 of the
tubular sheath 110. What is meant by "reversibly join" is that the
receptacle 112 sealingly attaches to the tubular sheath 110, yet is
detachable or removable from the sheath without causing damage to
the sheath.
[0049] The joining assembly 124 is sized and constructed such that
the receptacle 122 is located a distance near the distal end 116 of
the tubular sheath 110, as opposed to a leg bag which is located a
distance away from the tubular sheath 110. Typically, the
receptacle 122 is located in relation to the tubular sheath 110
such that the entire catheter 100, including the receptacle 122, is
located at and within the pelvic region of the user. That is, the
tubular sheath 110, the joining assembly 124, and the receptacle
122 can all fit within a user's undergarment at the urinary area.
The user is thereby not encumbered with routing tubes through the
undergarment to locations away from the urinary area, such as is
required by conventional leg bags, for example. In the illustrated
embodiment, the receptacle 122 is located a distance D6 (e.g. FIG.
8) of about one inch to about three inches from the distal end 116
of the tubular sheath 110.
[0050] In the embodiment of FIG. 6, the joining assembly 124
includes a female connector 158 extending from the distal end 116
of the tubular sheath 110, and a male connector 160 extending from
the receptacle 122. In the embodiment of FIG. 7, the female
connector 158 of the joining assembly 124 extends from the
receptacle 122, and the male connector 160 extends from the distal
end 116 of the tubular sheath 110. In each embodiment, the male
connector 160 fits within the female connector 158 so that the
tubular sheath 110 is reversibly joined to the receptacle 122.
[0051] In another embodiment, the joining assembly 124 can include
a lock and unlock feature so that receptacle 122 is more securely
reversibly joined to tubular sheath 110. In yet another embodiment,
the joining assembly 124 functions like or includes a luer lock
type assembly. As shown in FIGS. 6-8, the size of joining assembly
124 can vary. For example, in FIG. 7, the joining assembly 124 is
larger than the joining assemblies shown in FIGS. 6 and 8. In an
embodiment, the joining assembly 124 is large enough so that urine
flow into the receptacle 122 is not restricted.
[0052] Referring now to FIGS. 24 and 25, another alternative
embodiment of the external urinary catheter 100 is illustrated.
Similar to some of the previous embodiments, the tubular sheath 110
of this embodiment is interconnected to the receptacle 122 via the
joining assembly 124.
[0053] As shown in FIG. 24, the distal end 116 of the tubular
sheath 110 defines an opening 166 that receives the joining
assembly 124. The joining assembly 124 provides fluid communication
between the tubular sheath 110 and the receptacle 122. The opening
166 is located in the tapering or necked portion 156 of the tubular
sheath.
[0054] The joining assembly 124 in the illustrated embodiment
includes a hollow fitting 130 and a tube member 140. In an
embodiment, each of the hollow fitting 130 and the tube member 140
of the joining assembly 124 is sized so that urine flow into the
receptacle 122 is not restricted.
[0055] The hollow fitting 130 has first and second ends 132, 134.
Each of the first and second ends 132, 134 is a male fitting end.
The first male fitting end 132 is sized and constructed for receipt
within the opening 166 formed in the distal end 116 of the tubular
sheath 110. In the illustrated embodiment, the first male fitting
end 132 includes ridges 138 that taper to ease insertion and
removal of the fitting 130 into and from the opening 166. Other
embodiments may include a first end 132 that continuously tapers
without ridges, or that has a straight fitting construction.
[0056] The second male fitting end 134 is received within a first
end 142 of the tube member 140. In the illustrated embodiment, the
second male fitting end 134 is secured within the first end 142 of
the tube member 140 by an adhesive or other securing material or
construction. In the illustrated embodiment, the second male
fitting end 134 is a straight fitting end. Other embodiments may
include a second end 134 that continuously tapers or includes
ridges.
[0057] A second end 144 of the tube member is positioned within an
opening 90 formed in the receptacle. In the illustrated embodiment,
the second end 144 of the tube member 140 is secured within the
opening 90 of the receptacle 122 by an adhesive or other securing
material or construction.
[0058] In the embodiment shown in FIGS. 24 and 25, the receptacle
122 is constructed from a material that is pliable and durable,
such as PVC, for example. In particular, first and second sheets or
plies 168, 170 of the material are joined together to form an
interior 172 for receipt of the absorbent material 120. In one
embodiment, the two plies may be sewn together along a seam 102, or
adhered together along the seam. The PVC receptacle 122 also has
sufficient pliability so that the catheter 100 is more malleable
and more comfortable for a user. In addition, the PVC receptacle
122 is durable to limit the possibility of the receptacle 122 being
pierced or ruptured. Further, the PVC receptacle has moisture
impermeable qualities that contain moisture absorbed by the
absorbent material 120 within the interior 172 of the receptacle
122 so that the exterior of the receptacle 122 remains dry.
[0059] As shown in FIGS. 24 and 25, the receptacle 122 generally
has a width W, a height H, and a thickness T, although the
disclosed principles can be applied in a variety of sizes and
applications. The width W of the receptacle 122 can be, for
example, between 1.5 and 5.0 inches or between about 2.0 and 3.0
inches. The height H of the receptacle 122 can be, for example,
between 2.0 inches and 6.0 inches or between about 3.0 and 4.0
inches. The thickness T of the receptacle 122 is generally between
0.125 inches and 1.50 inches, depending upon the type of absorbent
material 120 used. In an embodiment, the thickness T is between
about 0.5 and 1.0 inches. Further, the distance D6 (see FIG. 6)
between the receptacle 122 and the distal end 116 of the tubular
sheath 110 when assembled (not shown) can be between 2.0 inches and
6.0 inches; e.g., between about 3.5 and 4.5 inches.
[0060] Each of the width W, the height H, the thickness T, and the
distance D6 are sized and dimensioned such that the receptacle 122
conveniently fits within the undergarment of the user. That is, the
receptacle 122 is sized so that the entire catheter 100 fits within
the user's underwear, and does not required that the receptacle be
attached or located at a location away from the pelvic area of the
user. Accordingly, the PVC material of the receptacle 122 is also
chosen to be comfortable against the user's skin. For example, the
exterior of the receptacle 122 can be flocked with cotton or
synthetic flocking, or embossed. As previously discussed, the shape
of receptacle 122 can vary. In the embodiment of FIGS. 24 and 25,
the receptacle 122 has a rectangular configuration, although any
shape that comfortably fits an average-sized male can be used.
[0061] At the same time, the receptacle 122 is sized to provide a
urine absorbing capacity depending on the level of urinary
discharge between normal voiding. As previously described in
relation to the other embodiments, the capacity of the receptacle
122 of FIG. 24 can be smaller than a leg bag and suitable for
receiving discharge between voiding. The width W, height H, and
thickness T of the receptacle 122 defines a volume associated with
the receptacle 122. The capacity of the receptacle 122 is a
function of the volume and the type of absorbent material 120 used.
In an embodiment, the volume of the receptacle 122 is between 1.0
cubic inch and 5.0 cubic inches. In one embodiment, the absorbent
material 120 is cellulose fiber. In providing cellulose fiber
absorbent material in the volume of between about 3.0 and 4.0 cubic
inches, the receptacle 122 has a capacity to contain between about
45 and 60 mL of urine. Because the receptacle 122 is sized to fit
within the user's pelvic region, (i.e., within the user's
undergarment) the capacity of the receptacle 122 is typically no
more than about 100.0 mL.
[0062] Similar to the previous embodiments, the embodiment of FIG.
24 is designed so that the receptacle 122 can be interchanged. This
feature allows a user to vary the capacity of the external urinary
catheter 100 based on a personal level of urinary discharge, which
may or may not vary. For example, a user may interchange a first
receptacle with a second receptacle having a different amount of
absorbent material or a different type of absorbent material to
adjust the capacity of the external urinary catheter 100.
[0063] The receptacle 122 is also interchangeable so that a user
can replace a filled or used receptacle with a new receptacle as
needed. For example, during use of the catheter 100 embodiment of
FIG. 24, urine discharged into the sheath 110 flows through the
joining assembly 124 and into the receptacle 122. When the
receptacle 122 has filled, the user detaches the filled receptacle
by removing the first end 132 of the fitting 130 from the opening
166 in the tubular sheath 110. The tubular sheath 110 remains in
position on the penis. A new receptacle is then attached to the
distal end 116 of the tubular sheath.
[0064] The joining assembly 124 of the external urinary catheter
100 functions to reversibly join the receptacle 122 to the distal
end 116 of the tubular sheath 110. In the embodiment of FIG. 24,
the joining assembly 124 attaches and detaches from the tubular
sheath 110 (i.e., the joining assembly 124 is removed or detached
along with the receptacle 122). In an alternative embodiment, the
catheter 100 can be constructed such that the receptacle 122
attaches and detaches from the joining assembly 124 (i.e., only the
receptacle 122 is removed or detached).
[0065] The receptacle 122 can also be disposable. The user may
simply throw away the receptacle when the receptacle has been
filled. In alternative embodiments, the receptacle 122 may be
recycled. That is, the receptacle can be configured to provide
access to the absorbent material 120 so that used absorbent
material can be removed and replaced with new material, and the
receptacle 122 reused.
[0066] Various alternative embodiments including other features can
be practiced in accord with the principles disclosed. For example,
the external urinary catheter 100 may include more than one type of
absorbent material 120. For instance, a synthetic fiber such as
polypropylene, polyester, nylon, polyethylene, or copolymers
thereof can be spunbound to create a coverstock for another
absorbent. A coverstock functions to provide a semi-permeable
membrane or barrier that allows moisture to pass through that
barrier so that the moisture is absorbed by another absorbent
material enclosed within the barrier. Use of a coverstock provides
a number of advantages, including keeping the skin of the user more
dry, and retaining the absorbent material 102 in a particular
location, such as a distal end 116 of the tubular sheath 110.
Suitable examples of synthetic fibers that can be spunbound to form
coverstock include polyester and polypropylene.
[0067] Referring now to the external urinary catheters 100 of FIGS.
9 and 10, two embodiments of a coverstock or semi-permeable barrier
126 are illustrated. In the embodiment of FIG. 9, the
semi-permeable barrier 126 is located adjacent to the distal end
116 of the tubular sheath 110. In the embodiment of FIG. 10, the
semi-permeable barrier 126 is in the joining assembly 124.
[0068] The semi-permeable barrier 126 functions to allow urine to
pass into the absorbent material 120, but does not allow the
absorbent material 120 to migrate through to the main portion 154
of the tubular sheath 110. Alternatively, or in addition, the
semi-permeable barrier 126 can function to allow urine to pass
through into the volume V containing the absorbent material 120,
but does not allow urine to pass out of the volume V. In an
embodiment in which the absorbent material 120 is completely
contained or surrounded by the barrier 126, the barrier 126 and the
absorbent material 120 can be replaced or exchanged by the user
without utilizing another tubular sheath 110. For example, as shown
in FIGS. 13 and 14, the barrier 126 and absorbent material 120 can
be provided in the form of a packet 118. The packet 118 can be
replaced and exchanged without utilizing another tubular sheath
110. It is to be understood that the semi-permeable barrier can be
incorporated into any of the embodiments shown, and in combination
with any other features described.
[0069] Another alternative embodiment including another feature
that can be practiced in accord with the principles disclosed is
illustrated in FIG. 11. In this embodiment the absorbent material
120 of the external urinary catheter 100 is adhered to the inner
surface 112 of the tubular sheath 110. Adhering the absorbent
material 120 to the inner surface 112 prevents the absorbent
material 120 from migrating within the tubular sheath 110. Methods
of adhering the absorbent material 120 to the inner surface 112 of
the tubular sheath 110 vary depending on the composition of the
absorbent material 120. The absorbent material 120 can also be
adhered to the inner surface of the receptacle 122, as shown in
FIG. 12. It is to be understood that adhering the material to an
inner surface can be incorporated into any of the embodiments
shown, and in combination with any other features described.
II. Method of Use
[0070] The external urinary catheter 100 is typically worn by users
that discharge relatively small amounts of urine between normal
voiding, as compared to users that discharge an amount that
necessitates a leg bag. Referring to FIGS. 13 and 14, in use, a
user, or perhaps a health care professional, engages a tip 31 of a
penis 30 with the external urinary catheter 100 in the pre-use
orientation (shown in FIG. 1). In particular, the distal end 116 of
the tubular sheath 110 is applied to the tip 31 of the penis 30.
The upper portion 150 of the tubular sheath 110 is then unrolled
using moderate force to press the rolled up portion of the upper
portion 150 in a direction away from the tip 31 of the penis 30.
This can generally be accomplished by pressing on the rolled upper
portion 150 with one's thumb and forefinger (not shown).
[0071] As the upper portion 150 unrolls, the adhesive layer 115
releases from the outer surface 114 of the tubular sheath 110. In
an embodiment, the releasability characteristics are such that the
upper portion 150 is relatively easy to unroll onto the penis 30.
As the adhesive layer 115 comes into contact with an outer surface
32 of the penis 30, the adhesive layer 15 adheres to the outer
surface 32. This secures the external urinary catheter 100 to the
penis 30. In an embodiment, the adhesive layer 115 seals the
tubular sheath 110 to the penis 30 such that leakage above the area
where the adhesive layer 115 contacts the outer surface 32 of the
penis 30 is prevented. The external urinary catheter 100 secures to
the user only at the location where the adhesive layer 115 contacts
the outer surface 32 of the penis. No other belts, straps,
garments, or coupling/attaching devices are necessary. The catheter
100 of the present invention thereby provides a more comfortable
solution to incontinence, and is not highly cumbersome or bulky for
the user.
[0072] The external urinary catheter 100 can be removed from the
penis 30 by pulling the upper portion 150 of the tubular sheath 110
away from the penis 30 and down over the outer surface 114. Removal
can be accomplished in any manner that accommodates the comfort of
the patient. It will be appreciated that one appropriate method of
removing the catheter 100 is to roll the upper portion 150 up again
so that the catheter 100 returns to generally the same orientation
as that shown in FIG. 1. When removing the catheter 100, the
adhesive layer 115 releases the outer surface of the penis 30, and
the catheter 100 can be removed from the penis 30 with relative
ease.
[0073] Generally speaking, the external urinary catheter 100 can be
worn for variable amounts of time depending on the user, the
capacity for which the device is designed, and the amount of
urinary discharge the user is experiencing. For example, the
external urinary catheter 100 can be worn for certain defined
periods of time, until the catheter begins to feel uncomfortable,
until the absorbent has reached an absorbance capacity, or until
the user removes the catheter to void.
[0074] Depending on the specific absorbent material 120 utilized,
the catheter 100 may exhibit altered characteristics when the
material has absorbed an amount of urine. Examples of such altered
characteristics include an increase in the weight of the catheter
100 and a change in the flexibility of the portion of the catheter
100 that contains the absorbent material 120. In certain
embodiments, the absorbent material can change color to indicate
that material is saturated with urine. Changes such as these and
others can also be used by the wearer to determine when the
catheter 100 should be removed and/or replaced.
[0075] In addition, in embodiments having a detachable receptacle
122 (e.g., FIG. 24), the tubular sheath 110 can be worn throughout
the day, not only between voiding. In particular, the receptacle
122 can be detached when the user needs to void. The user can then
void through the open end 166 of the tubular sheath 110, and then
reattach the receptacle 122 or reattach a replacement receptacle to
the same tubular sheath 110.
III. Method of Manufacturing
[0076] As described herein below, the tubular sheath 110 can be
made by combining two or more layers of a silicone rubber solution
or of separate silicone rubber solutions. Once the silicone rubber
solutions are dried and cured in a vulcanizing process, the
respective silicone rubber solution coatings combine to form a
single unitary tubular sheath without separate layers. It will be
appreciated that any silicone rubber solution used to form silicone
rubber products of one type or another may be used to form the
silicone rubber sheath of the present invention. The vulcanizing
process may be either a heat process, a catalyzed process employing
a catalyzing agent or agents, a combination of the two, or any
other suitable vulcanizing process known in the art.
[0077] Referring now to FIGS. 15-22, a suitable method of making an
external urinary catheter 100 of the present invention includes a
series of steps designed to coat a mandrel 20. The mandrel 20 has a
generally cylindrical shape, which may narrow or taper at a lower
end 22 (FIG. 15). In one embodiment, the lower end 22 of mandrel 20
may include a larger diameter than that of the remaining mandrel
20. The mandrel 20 having a larger lower end diameter may be
utilized to form a bulbous portion 162 at the distal end 116 of the
tubular sheath 110, such as shown in FIG. 4. Alternatively, the
lower end 22 of mandrel 20 may be configured to provide the
embodiments shown in FIGS. 2, 3, and 5. In certain embodiments,
either the external surfaces 164 of the mandrel 20 are coated with
Teflon.RTM., or the mandrel 20 is made of Teflon.RTM.. A tip (not
shown) for forming male or female connectors 158, 160 (FIGS. 6 and
7) of the joining assembly 124 can be coupled to the lower end 22
of the mandrel 20.
[0078] In an embodiment, depicted in FIG. 22, a series of mandrels
20 are attached to a pallet 23 so that numerous external urinary
catheters 100 can be mass-produced. This can be accomplished by
coating each of the mandrels 20 in a series of coating steps. The
coating steps include dipping each of the mandrels 20, e.g., in
unison, in a series of dip tanks 80a-e that are raised up to a
precise level calculated to accomplish a specific task. It will be
appreciated that a series (not shown) of pallets can also be
employed so that a continuous mechanized production operation can
be developed to mass-produce catheters 100. The pallet 23 or a
series of pallets (not shown) are advanced by a mechanized
advancing system 88. It will be appreciated that any known
mechanization system for advancing the pallet 23 or pallets can be
used.
[0079] Referring now to FIGS. 16 and 22, in one method of
manufacture, a first portion 24 of the mandrel 20 is coated with a
silicone coating 40. The first portion 24 of the mandrel 20 is
defined as the area of the mandrel between dashed lines A and B
illustrated in FIG. 16. To create the silicone coating 40, the
pallet 23 of mandrels 20 is dipped into a first dip tank 80a
containing a fluid silicone release agent 81, e.g., a
polydimethylsiloxane fluid (Dow Corning 360 Medical Fluid from Dow
Corning, Inc., Midland, Mich. 48360) having a viscosity of 12,500
centistokes, diluted about 1:25 in hexamethyldisiloxane. The fluid
silicone release agent 81 forms the silicone coating 40. In order
to ensure that the first portion 24 (FIGS. 16-18) of the mandrel 20
is completely coated with the silicone coating 40, the pallet 23 to
which the mandrels 20 are attached is centered over the first dip
tank 80a and the dip tank 80a is raised a calculated distance, as
shown. The distance is calculated such that the mandrel 20 is
submersed within the release agent 81 to a designated level
corresponding to the dashed line A. At the designated level, the
entire first portion 24 of mandrel 20 is submersed. After the first
portion 24 is fully submersed, the first dip tank 80a is lowered
and the silicone coating 40 is permitted to dry (FIG. 16).
[0080] Referring now to FIGS. 17 and 22, the pallet 23 is then
advanced to a second dip tank 80b containing adhesive material or
fluid 82. The adhesive material 82 bonds to unvulcanized silicone
rubber during a vulcanizing process. The adhesive material 82 can
include a suitable polymeric adhesive, such as a suitable copolymer
of acrylic acid esters with vinylacetate, or cross linking pressure
sensitive adhesive, for instance. One example of an adhesive that
can be used is Gelva MAS 788 manufacture by Solutia Inc. (St. Louis
Mo.). The second dip tank 80b is raised a distance (not shown)
calculated to dip the mandrel 20 into the adhesive fluid 84 in the
second dip tank 80b so that the entire first portion 24 of the
mandrel 20 between the lines designated A and B is coated by the
adhesive fluid 82. As shown in FIG. 17, the adhesive fluid 82 forms
the adhesive layer 115, which is disposed over the silicone coating
40. The second dip tank 80b is then lowered, and the adhesive layer
115 allowed to dry for a period of time.
[0081] Referring now to FIGS. 18 and 22, the pallet 23 is then
advanced to a third dip tank 80c containing a solvent 83, e.g.,
trichloroethane (trichlor 1,1,1) or xylene. The solvent 83 strips
or removes the adhesive layer 115 and the silicone coating 40 from
the mandrel 20. In this step, the dip tank 80c is raised a distance
(not shown) calculated to dip the mandrel 20 into the solvent 83 up
to the line on the mandrel 20 designated B so that the adhesive
layer 115 and the silicone fluid coating 40 which coat a second
portion 26 of the mandrel 20 is stripped. The second portion 26 of
the mandrel 20 is defined as the area of the mandrel below the line
designated B, and proximate the lower end 22 of the mandrel 20. In
some methods, the tank 80c may be lowered and raised several times
to provide a rapid stripping action. The pallet 23 can also be
advanced to a new dip tank (not shown) having a second solvent (not
shown) to further assist in stripping the second portion 26 of the
mandrel 20. In some embodiments, a vibrator (not shown) is
connected to the pallet 23 or the mandrel 20 to vibrate the mandrel
20 and speed the removal of the adhesive coating 115. In other
embodiments, an ultrasonic cleaning system (not shown) is
incorporated into the dip tank 80c.
[0082] In some methods, a further step can be added at this point
in the manufacturing process. This step involves shaping the lower
end 22 of mandrel 20 by selectively coating the lower end 22 with
an agent that buildups the lower end 22. Shaping the lower end 22
of the mandrel 20 provides the shaped distal end 116 configurations
of the catheter 100 previously disclosed. The agent can be the same
or similar to that of the mandrel release agent 81 utilized
previously.
[0083] In continuing the manufacture of the catheter 100, the
mandrel 20 is advanced on the pallet 23 to a fourth dip tank 80d
containing an unvulcanized silicone rubber solution 84 which can be
a disiloxane solvent, e.g., a hexamethyldisiloxane solvent. The
disiloxane solvent is suitable because the disiloxane solvent does
not destroy the integrity of the adhesive layer 1715 that remains
on the first portion 24 of the mandrel 20. When the mandrel 20 is
dipped into the silicone rubber solution 84 in the fourth dip tank
80d, the silicone rubber solution 84 coats the mandrel 20 and
overcoats the silicone coating 40 and the adhesive layer 115. This
overcoating forms a first overcoat layer 46 as shown in FIG. 19. If
the shaping step was performed, the first overcoat layer 46 will
have a shaped region, such as an enlarged region that eventually
becomes the distal end 116 of the tubular sheath 110. The fourth
dip tank 80d is then lowered, and the overcoat layer 46 is allowed
to dry for a period of time.
[0084] Referring now to FIGS. 20 and 22, the pallet 23 is then
advanced to a fifth dip tank 80e containing an additional silicone
rubber solution 88. The additional silicone rubber solution 88 can
have a greater concentration of silicone rubber than the first
overcoat layer 46. The solvent may also be varied. The dip tank 80e
is raised and the mandrel 20 is dipped into the dip tank 80e to a
level just below the line designated B so as to add an additional
thickness proximate the lower end 22 of the mandrel 20. This forms
a final overcoat layer 48 over the first overcoat layer 46. The dip
tank 80e is then lowered and the final overcoat layer 48 is allowed
to air dry so that the solvent in the silicone rubber overcoat
layer 46 evaporates. It will be appreciated that additional dip
tanks may be provided for additional dipping steps.
[0085] In one embodiment, the first overcoat layer 46 has a
generally uniform thickness throughout the construction of the
sheath 110. The thickness is typically between about 0.002 and
0.010 inches; e.g., between about 0.003 and 0.008 inches. The final
overcoat layer 48 provides additional thickness in the proximal
region 116 of the sheath 110. The thickness at the distal end 116
is between 0.020 to 0.080 inches; e.g., between about 0.030 to
0.060 inches.
[0086] In an embodiment of the method, the final overcoat layer 48
is vulcanized or cured in an oven (not shown) at an elevated
temperature, e.g., about 205.degree. F. It will be appreciated that
the temperature is maintained at a level below the boiling point of
the solvents of the silicone rubber solutions to prevent the
formation of bubbles in the silicone rubber caused by evaporation
or the boiling off of the solvents. Furthermore, it will also be
appreciated that other silicone rubber systems that are catalyzed
without heat may also be used to provide a vulcanizing system
resulting in a vulcanized silicone rubber elastomeric construction
50.
[0087] Once the silicone rubber has been vulcanized, the tubular
sheath 110 is formed. The tubular sheath 110 is permitted to cool.
When cooled, the upper portion 150 of the tubular sheath is rolled
from a top 25 of the mandrel 20 (FIG. 21) so that the inner surface
112 (FIG. 23) of the tubular sheath 110 rolls up onto the outer
surface 114 of the tubular sheath. In the process of rolling the
tubular sheath 110, the adhesive layer 115, which has now been
integrally bonded with the silicone rubber during the vulcanizing
process, comes into contact with the outer surface 114 of the
tubular sheath 110.
[0088] Referring to FIG. 23, when the catheter 100 is fully rolled
up into its pre-use orientation (as shown in FIG. 1), the catheter
100 includes the single tubular sheath 110 (FIG. 1) having a
unitary construction made of silicone rubber with an adhesive layer
115 integrally bonded to the tubular sheath 110. The adhesive layer
115 is interposed between the inner surface 112 and the outer
surface 114 of the sheath 110. The adhesive layer 115 is integrally
bonded to the inner surface 112 as a result of cross-linking
between constituents in the adhesive layer 115 and constituents in
the unvulcanized silicone rubber of the overcoat layer 46 during
the vulcanizing process. The adhesive layer 115 will not, however,
irreversibly adhere or bond to any of the vulcanized silicone
rubber surfaces with which the adhesive contacts after the
vulcanizing process. The adhesive layer 115 does contact the outer
surface 114, but any adherence to the outer surface 114 is limited
to releasable adherence.
[0089] In particular, when the upper portion 150 of the tubular
sheath is rolled up, trace amounts of the silicone coating 40
adhere to the adhesive layer 115, and the remaining portion of the
silicone coating 40 stays on the mandrel 20. The trace amounts of
silicone coating 40 that adhere to the adhesive strip are absorbed
by the outer surface 114 of the tubular sheath 110 when the coating
40 comes into contact with the outer surface 114.
[0090] It is to be appreciated that it is important that the trace
amounts of silicone fluid adhering to the adhesive layer 115 are
absorbed by the outer surface 114, because if not absorbed, the
coating 40 could interfere with the adherence of the adhesive layer
115 with the penis 30. It will also be appreciated that the
silicone coating 40 is just one of many mandrel release agents
which can be used to coat the mandrel 20. Other agents that prevent
making removal of the adhesive layer 115 from the mandrel 20 overly
difficult can also be used.
[0091] The adhesive layer 115 is selected for its ability to bond
with the silicone rubber during the vulcanized process and for its
lack of adherence when the layer 115 comes into contact with
vulcanized silicone rubber after the vulcanizing process. It will
be appreciated that any biocompatible adhesive which will
cross-link with silicone rubber during the vulcanizing process will
be a suitable adhesive so long as the biocompatible adhesive will
releasably adhere to new silicone rubber surfaces with which the
biocompatible adhesive comes into contact after the adhesive is
bonded to the inner surface of a silicone rubber sheath during the
vulcanizing process.
[0092] Inclusion of the absorbent material 120 occurs after the
above formation of the tubular sheath 110. The specific method of
providing or including the absorbent material 120 depends on the
specific type of the absorbent material 120 used, and the specific
arrangement. For example, in the embodiments having the absorbent
material 120 located in the distal end 116 of the sheath 110, the
absorbent material 12 is typically placed at or adjacent to an
enclosed tip 53 (FIG. 21) of the sheath 110. For instance, if the
absorbent material 120 is hydrophilic powder, the material can
simply be introduced into the tubular sheath 110, and directed
towards the enclosed tip 53 at the distal end 116 of the sheath
110. If the hydrophilic powder is to be adhered to the inner
surface 112 of the tubular sheath 110, a suitable adhesive, such as
Gelva Mas 788, for example, can be applied to the desired portion
of the tubular sheath 110 adjacent the enclosed tip 53 before the
powder is introduced into the tubular sheath 110.
[0093] In the embodiments having the absorbent material 120 located
in the receptacle 122, the enclosed tip 53 of the tubular sheath
110 is removed to provide the opening 166 (FIG. 24) at the distal
end 116. The absorbent material 12 is disposed in the receptacle
122, and the receptacle is interconnected to the opening 166 at the
distal end 116 via the joining assembly 124.
[0094] The above specification provides a complete description of
the invention. Since many embodiments of the invention can be made
without departing from the spirit and scope of the invention,
certain aspects of the invention reside in the claims hereinafter
appended.
* * * * *