ENSEMBLE CATHETER URINAIRE EXTERNE

AN EXTERNAL URINARY CATHETER ASSEMBLY

Abrégé français

L'invention concerne un ensemble cathéter urinaire externe, permettant de soulager un homme souffrant d'incontinence urinaire, qui comprend un élément intérieur (1), pouvant être placé, lorsqu'on l'utilise, sous le prépuce (6) du pénis et possédant à son extrémité distale un conduit de décharge (5) destiné à être relié à un tuyau, et un élément de maintien (8) extérieur qui lorsqu'on l'utilise coopère de manière circulaire avec la paroi extérieure dudit prépuce (6). Cet élément de maintien (8) extérieur est pourvu à son extrémité distale d'une ouverture (9) destinée au conduit de décharge (5) de l'élément intérieur (1). Des moyens de connexions (10) permettent de former une liaison étirable entre l'élément de maintien (8) extérieur, le conduit de décharge (5), et/ou l'élément intérieur, de façon à maintenir la coopération circonférentielle entre ledit élément de maintien (8) et la paroi extérieure du prépuce (6), dans des conditions de charge de tension agissant sur le conduit de décharge (5), par exemple du fait du poids du sac collecteur d'urine relié audit conduit de décharge (5).

Abrégé anglais

An external urinary catheter assembly for the relief of male urinary
incontinence comprises an inner member (1), which is arrangeable, in use,
under the foreskin (6) of a penis and has in its distal end a discharge
conduit (5) for connection with a hose, and an outer holder member (8) for
circumferential engagement, in use, with the external side of the foreskin
(6). The outer holder member (8) is formed in a distal end with an opening (9)
for the discharge conduit (5) of the inner member (1). Connection means (10)
is provided to form a stretchable link between the outer holder member (8) and
discharge conduit (5) and/or the inner member to maintain the circumferential
engagement of the outer holder member (8) with the external side of the
foreskin (6) under tensile load conditions acting on the discharge conduit
(5), e.g. from the weight of the urine collection bag connected with the
discharge conduit (5).

Revendications

15
CLAIMS
1. An external urinary catheter assembly for the
relief of male urinary incontinence comprising an in-
ner member (1,1',1'',1''',24), which is arrangeable,
in a position of use, under the foreskin (6) of a pe-
nis in surface contact with the corona thereof, a
discharge conduit (5,5',5'',5''',27) connected with
an opening (3) formed in a distal end section (2) of
the inner member (1, 1', 1'', 1''')) to be positioned
substantially opposite the urethral orifice in said
position of use to provide a sealed urine flow pas-
sage extending in a substantially axial direction to-
wards the exterior of the catheter assembly, and an
outer holder member (8,15,22,28,32-33,44) formed in a
distal end section with an opening (9,20) for said
discharge conduit (5, 5', 5'', 5''') and arrangeable, in
said position of use, in a substantially fixed axial
position with respect to the discharge conduit for
circumferential engagement with the external side of
the foreskin (6), characterized in that
a stretchable connection means (10,16,22a,30,37,54)
is provided between the discharge conduit (5,5',5'',
5''') and the outer holder member (8,15,22,28,32-
33,44) or the inner member (1''') to maintain the
outer holder member (8,15,22,28,32-33,44) in circum-
ferential engagement with the external side of the
foreskin in the position of use.
2. A urinary catheter assembly as claimed in
claim 1, characterized in that said dis-
tal end section (2) of the inner member
(1, 1', 1'', 1''') is formed with reinforcing means to
provide increased form stability.
3. A urinary catheter assembly as claimed in

16
claim 2, c h a r a c t e r i z e d in that said end
section (2) of the inner member (1, 1' , 1" , 1 "') forms
a shoulder portion providing a substantially flat end
face.
4. A urinary catheter member as claimed in claim
2,c h a r a c t e r i z e d in that the inner member
(24) and the discharge conduit (27) is formed as an
integral two-component member composed of a soft
elastic material and a reinforcement material added
to or forming the distal end section (26).
5. A urinary catheter assembly as claimed in
claim 2, 3 or 4, c h a r a c t e r i z e d in that
said inner member (24) is formed with a lining (25)
of a resilient skin-friendly material facing in said
position of use the corona of the penis.
6. A urinary catheter assembly as claimed in any
of the preceding claims, c h a r a c t e r i z e d
in that a layer (7,17,38,51) of a skin-friendly adhe-
sive is applied to an inner and/or outer engagement
surface of the inner member (1,1') and/or an inner
surface of the outer holder member (32-33,44).
7. A urinary catheter assembly as claimed in any
of the preceding claims, c h a r a c t e r i z e d
in that said connection means comprises a substan-
tially bellows-shaped member (10) having one end con-
nected with the outer holder member (e) at said dis-
tal end section and the other end arranged in said
position of use in a fixed position with respect to
the discharge conduit (5).
8. A urinary catheter assembly as claimed in any
of claims 1 to 6, c h a r a c t e r i z e d in that
the outer holder member (15,22) is formed as a
sheathing body of an elastic material and that said

17
connection means comprises an increased stretchabil-
ity of said distal end section (16,22a).
9. A urinary catheter assembly as claimed in any
of the preceding claims, c h a r a c t e r i z e d
in that the outer holder member (8,15,28), the inner
member (1,1',24) and the discharge conduit (5,5') are
connected with each other.
10. A urinary catheter assembly as claimed in
any of claims 1 to 8, c h a r a c t e r i z e d in
that the outer holder member (22,32-33,44) is sepa-
rate from the inner member (1" , 1" ') and the dis-
charge conduit (5 " , 5 "') and is maintained in the
position of use in said axially fixed position by a
retaining device (23,33,46) circumferentially engag-
ing the discharge conduit (5 " , 5"').
11. A urinary catheter assembly as claimed in
claim 10; c h a r a c t e r i z e d in that said re-
taining device (23,33,46) engages the discharge con-
duit (5 " , 5" ') by a relatively close frictional fit.
12. A urinary catheter assembly as claimed in
claim 10, c h a r a c t e r i z e d in that the dis-
charge conduit (5 ") is formed with a projecting
circumferential rib (23a) for securing said retaining
device (23) and thereby the outer holder member (22)
in an axially fixed position on the discharge con-
duit.
13. A urinary catheter assembly as claimed in
any of the preceding claims, c h a r a c t e r i -
z e d in that the outer holder member (15,22) is
formed as a rolled-up member which can be rolled-out
towards its position in use in engagement with the
external side of the foreskin.
14. A urinary catheter assembly as claimed in

18
any of claims 1 to 10, c h a r a c t e r i z e d in
that the outer holder member (8,22,28,32-33) com-
prises an elastic semi-rigid bowl-shaped device,
which is invertible between its position of use and
an inverted application position for application and
removal of the inner member (1, 1 " , 1 " ', 24) into and
from said position of use.
15. A urinary catheter assembly as claimed in
claims 9 and 14, c h a r a c t e r i z e d in that
said bowl-shaped device forms the outer holder member
(8, 28).
16. A urinary catheter assembly as claimed in
claim 15, c h a r a c t e r i z e d in that the outer
holder member (28) is formed with a proximal skirt-
like part connected with a ring member (31) to the
discharge conduit (27).
17. A urinary catheter assembly as claimed in
any of claims 10 to 12 and claim 14, c h a r a c t e
r i -z e d in that the outer holder member is com-
posed of a bowl-shaped part (32) and a generally tu-
bular retaining part (33) formed in one piece
therewith and surrounding the discharge conduit
(5 "') over a substantial part of the length thereof.
18. A urinary catheter assembly as claimed in
claim 17, c h a r a c t e r i z e d in that said
stretchable connection means (37) is provided between
said retaining part (33) and said bowl-shaped part
(32) in the form of a local wall thickness reduction.
19. A urinary catheter assembly as claimed in
claim 17 or 18, c h a r a c t e r i z e d in that a
major part of said bowl-shaped part (32) is made with
an increased wall thickness providing a relief-like
surface providing a number of petals (34) separated

19
by sectors (36) of a smaller wall thickness.
20. A urinary catheter assembly as claimed in
claims 17, 18 or 19, c h a r a c t e r i z e d in
that linear weakening zones (41) are provided at dia-
metrically opposite locations throughout the axial
length of said retaining part (33) and said bowl-
shaped part (32).
21. A urinary catheter assembly as claimed in
claim 20, c h a r a c t e r i z e d in that each of
said weakening zones (41) joins a recess (42) formed
in said retaining part (33) to provide a pair of
gripping flanges (43).
22. A urinary catheter assembly as claimed in
claim 17 or 18, c h a r a c t e r i z e d in that a
section line (48) is formed to extend through the ax-
ial length of said retaining part (46) and part of
the length of said bowl-shaped part (49) to allow
slight separation of adjoining edge regions, and that
a flap member (50) having an adhesive coating (51) on
its inner side is provided at the bowl-shaped part
(49) to secure the outer holder member (44) to the
foreskin by a plaster-like joint.
23. A urinary catheter assembly as claimed in
any of the preceding claims, c h a r a c t e r i -
z e d in that in a supply condition it comprises an
applicator member (14,21,39) arranged in connection
with the outer holder member (8,15,32-33) to assist
in positioning of the inner member (1,1',1 " ') in its
position of use.
24. A urinary catheter assembly as claimed in
any of claims 13 or 14 and claim 23, c h a r a c -
t e r i z e d in that the applicator member
(14,21,39) is a separate annular member retained by

20
the outer holder member (8,15,32-33) in its rolled-up
or inverted position.
25. A urinary catheter assembly as claimed in
claim 24, c h a r a c t e r i z e d in that the ap-
plicator member (39) has a substantially U-shaped
cross-section to provide an outer wall (39b) provid-
ing protection of an adhesive coating (38) on said
bowl- shaped device (32).
26. A urinary catheter assembly as claimed in
any of claims 1 to 14, c h a r a c t e r i z e d in
that the outer holder member (8,15,32-33) is formed
with a projecting flap or flange member (12,18,43)
serving as a grip for removal of the outer holder
member (8,15,32-33) from its position of use.
27. A urinary catheter assembly as claimed in
claim 26, c h a r a c t e r i z e d in that said
projecting flap member (12,18) joins a weakened tear-
apart zone (13, 19) extending through at least part of
the outer holder member (8,15).

Description

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
1
An external urinary catheter assembly.
The invention relates to an external urinary
catheter assembly for the relief of male urinary
incontinence comprising an inner member, which is
arrangeable, in a position of use, under the foreskin
of a penis in surface contact with the corona thereof,
a discharge conduit connected with an opening formed
in a distal end section of the inner member to be
positioned substantially opposite the urethral orifice
in said position of use to provide a sealed urine flow
passage extending in a substantially axial direction
towards the exterior of the catheter assembly, and an
outer holder member formed in a distal end section
with an opening for said discharge conduit and
arrangeable, in said position of use, in a
substantially fixed axial position with respect to the
discharge conduit for circumferential engagement with
the external side of the foreskin.
External male urinary catheter assemblies of this
kind have been suggested in the prior art in a number
of different designs.
Thus, from GB-A-2 075 847 an assembly is known
comprising a relatively short funnel-like uridom
device to be placed directly against the corona of the
penis to be kept in place under the foreskin. Around a
discharge conduit of the device an external sheathing
body is fastened in an inverted position to be brought
into engagement with the external side of the foreskin
after application of the uridom device to maintain the
assembly in place by means of the sandwich position of
the foreskin between the uridom device and the
external sheathing body.
In use the discharge conduit of the uridom device
is connected with a hose member, through which
discharged urine flows into a collection bag. After

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
2
repeated discharges the weight of the collection bag
becomes heavier and a tensile load is applied through
the hose member and the discharge conduct to the
uridom device positioned between the foreskin and the
corona. Due to the integral connection of the external
sheathing body with the uridom device the tensile load
is at least partly transferred also to the sheathing
body with the inherent risk that the whole assembly
may fall off from its position of use.
GB-A-2 126 483 discloses another design, in which
a more safe retainment of the assembly in the position
of use is implemented by use of a tubular urine
ducting device, e.g. of silicone rubber, arranged
outside the corona in extension thereof, so that a
rather severe extension of the foreskin is required to
keep the tubular device in place by arrangement of an
adhesive strip or strap member on the external side of
the foreskin. Evidently, the rather severe extension
of the foreskin required to keep the tubular device in
place causes considerable discomfort in use.
In EP-B-0 706 355 and 0 706 356 external urinary
catheter assemblies are disclosed in which a more safe
retainment in the position of use is obtained kith
considerably less discomfort to the user by means of a
short inner catheter member designed with improved
form stability in its distal end part around the
discharge conduit to be more safely kept in place
under the foreskin by a separate substantially bowl-
shaped outer holder member displaceably surrounding
the discharge conduit of the catheter member to be
movable between an application position, in which the
holder member is partly removed from the catheter
member and the position of use.
The use of a separate outer holder member is seen
by some users, however, as an inconvenience, as the

- 31-10-2001 ~ DK000062!
CA 02390429 2002-05-07
3
displaceable arrangement of the holder member on the
discharge conduit of the inner catheter member may
easily cause complete separation of the holder member
from the catheter member during application of the
assembly. Whereas this problem may be avoided or at
least reduced by a friction fit between the outer
holder member and the discharge conduit, this would
make the axial displacement of the holder member with
respect to the discharge conduit required to bring
the holder member from the application position to
wards the position of use more difficult and cause
inconvenience, in particular to tetraplegics or other
users having reduced dexterity. For that reason a
one-piece assembly would be more attractive to many
users .
Moreover, a safe friction fit between the outer
holder member and the discharge conduit is needed to
maintain the holder member in a fixed axial relation-
ship with respect to the discharge conduit in the po-
sition of use and in practical applications of this
prior art assembly this requirement has resulted in a
tendency for the entire assembly to be detracted from
the position of use under tensile load conditions
acting on the discharge conduit, e.g. from the weight
of a filled or partly filled urine collection bag
connected through a hose with the discharge conduit,
It is therefore the object of the_present inven-
tion to provide a urinary catheter assembly of the
kind defined in which the drawbacks of the design of
prior art integrated solutions have been eliminated.
According to the invention an external male uri-
International Patent Application PCT/DK00/00629
ReF AMENDED SHEET

v
31-10-2001 DK00006~
CA 02390429 2002-05-07
4
nary catheter assembly of the kind defined is charac-
terized in that a stretchable connection means is
provided between the discharge conduit and the outer
holder member or the inner member to maintain the
outer holder member in circumferential engagement
with the external side of the foreskin in the posi-
tion of use.
Hy provision of said stretchable connection
means between the discharge conduit and the outer
holder member or the inner member the catheter assem
bly is kept safely in place even under tensile load
transferred from the collecting bag~through the con-
necting hose member to the discharge conduit, since a
certain movement or stretching of. the discharge con-
duit may be allowed without affecting the position of
the outer holder member in safe engagement with the
external side of the foreskin. In fact, a tensile
load acting on and causing slight stretching ox even
displacement of the inner member connected with the
discharge conduct may increase the holding effect of
the outer holder member.
Advantageous and preferred embodiments of the
urinary catheter assembly according to the invention
are stated in the dependent claims.
In the following the invention will be further
explained with reference to the schematical drawings
in which
figs. 1 and 2 are sectional views of a first em
bodiment of the catheter assembly in an application
position and a position of use, respectively,
fig. 3 is a perspective view of the outer holder
International Patent Application PCT/DK00/00629
Re: AMENDED SHEET

31-10-2001 DK000062
CA 02390429 2002-05-07
'J~~G1.
member in the embodiment in figs. 1 and 2, and
figs. 4 and 5 are sectional views of a second
embodiment in an application position and a position
of use, respectively,
fig. 6 is a sectional view of a third embodi-
ment,
fig. 7 a partly sectional view of a fourth
International Patent Application PCT/DK00/00629
ReF AMENDED SHEET

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
embodiment,
fig. 8 is a partly sectional view of a fifth
embodiment,
5 fig. 9 illustrates the embodiment in fig. 8 in
the position of use, and
fig. 10 is a side view of a sixth embodiment.
The catheter assembly shown in figs. 1 and 2
comprises an inner member 1 which in a distal end
section 2 is formed with an opening 3 which in a
position of use as shown in fig. 2 is opposite the
urethral orifice in the corona 4 of a penis. At the
opening 3 the distal end section 2 joins a discharge
conduit 5 by which the catheter may be connected e.g.
with a hose member, through which discharges of urine
from the catheter member 1 may flow into a collection
bag not illustrated. !'hereby a sealed urine flow
passage is provided to extend from the inner side of
the inner member 1 facing the urethral orifice in a
substantially axial direction towards the exterior of
the catheter assembly.
As shown in ficr. 2 the inner member ~ is formed
to be placed in use under the foreskin 6 of the penis
in contact with the corona 4 and the axial length of
the part of the inner member contacting the corona is
relatively short, e.g. between 5 and 35 mm, such that
in use the catheter member only covers the extreme
portion of the corona outside its largest diameter,
just below which the corona is connected with the
foreskin 6 through a sensitive skin band.
In the distal end section 2 around the discharge
conduit 5 the catheter 1 may be designed with
increased form stability so as to form a shoulder
portion having e.g. a substantially flat end face so
that in use the catheter member 1 maintains its outer

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
6
shape in the part which is engaged and retained by the
foreskin 6.
As illustrated this increased form stability may
be obtained in a simple manner by reinforcement
provided by an increased wall thickness in the distal
end 2.
The illustrated design of the inner catheter
member 1 is known per se from the above mentioned EP
patent publications and alternatively the increased
form stability may be obtained in any of the ways
disclosed in EP-B-0 706 355, the disclosure of which
is incorporated herein by reference
The inner member 1 may be made from any material
which is suitable for engagement with the sensitive
skin of the corona 4 in sealing contact therewith.
Suitable materials may comprise thermoplastic
elastomeric materials like SBS, SEBS or SIS compounds,
polyether, polyester, polyamide or polyurethane and
may also comprise thermoplastic materials such as
plastizised PVC or curable elastomeric materials like
latex, nitrite rubber, chloroprene rubber, SBS rubber,
isoprene rubber, silicone rubber or polyurethane.
To provide an improved sealing effect against the
corona 4 the inner side of the catheter member 1 may
be coated with a layer 7 of a skin-friendly adhesive
as used for medical articles intended to contact
sensitive skin tissue.
In the embodiment shown the discharge conduit 5
and the inner catheter member 1 are permanently
connected with a surrounding outer holder member 8
having an opening 9 for the discharge conduit 5 by
connecting means which according to the invention
forms a stretchable link. As shown in figs. 1 and 2
the connecting means may comprise a short bellows-
shaped member 10 having one end connected with the

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
7
discharge conduit 5 and the other end connected with
the outer holder member 8 at the edge of the opening
a
J.
In the embodiment in figs. 1 and 2 the outer
holder member 8 is formed as an invertible
substantially bowl-shaped member, which from the
inverted application position in fig. 1 may be brought
into the position of use by tilting around its
transition to the bellows member 10.
The holder member 8 may be made of any suitable
soft elastic, semi-rigid or rigid material such as
thermoplastic materials or curable elastomeric
materials as mentioned above for the inner member 1 or
it may alternatively be made in the form of a web of
textile material like gauze or non-textile material.
For improved engagement with the external side of the
foreskin the inner engagement surface of the outer
holder member 8 may be coated with a layer 11 of a
skin-friendly adhesive as mentioned above for the
inner member 1.
Such an adhesive layer may be dimensioned with
controlled adhesive properties and/or be applied in
various patterns as known in the art to control the
adhesive force.
By use of an adhesive layer the length of the
outer holder member in the position of use may be
reduced to cover only a part of the foreskin in order
to increase comfort in connection with removal of the
catheter assembly.
The provision of an adhesive is not compulsory,
however, and may be dispensed with, since a suffi-
cient holding force may be obtained by other means,
e.g. dimensioning of the outer holder member with a
length so as to cover, in the position of use the
entire external side of the foreskin surrounding the

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
8
corona.
As will be appreciated from fig. 2 the
stretchable link formed by the bellows-shaped member
will function to resist outwards displacement of_
5 the outer holder member 8 from its position of use in
engagement with the external side of the foreskin 6,
when tensile load conditions act as the discharge
conduit 2, e.g. from the weight of a collecting bag
through a connecting hose member.
10 Compared to the prior art designs disclosed it
the above-mentioned EP patent publications the holding
effect of the outer holder member is significantly
improved to provide incrased safety also under load
conditions resulting from physical activities of the
user.
In order to facilitate removal of the catheter
assembly after use the proximal end of the outer
holder member 8 is formed with a projecting flap 12,
which may serve as a grip which can be operated to
remove the outer holder member 8 by pulling back the
projecting flap 12 in a direction towards the inverted
position, from which the holder member was originall~;~
applicated .
This feature of the invention may be further
improved, if the outer holder member is formed as
shown in fig. 3 with a weakened tear-apart region or
zone 13 extending at least partly from the flap 12
towards the opening 9. By operation of the flap 12 the
outer holder member 8 will be torn apart for easy
removal of the catheter assembly.
As further illustrated in fig. 1 the inverted
application position of the outer holder member 8 may
be used for arrangement of an applicator member 14 of
a rigid or semi-rigid material inside the holder
member 8.

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
9
Such an annular applicator will be effective to
facilitate accurate positioning of the inner member 1
in contact with the corona during application of the
catheter assembly.
In the alternative embodiment shown in figs. 4
and 5 the inner member 1' is of the same design and
proportions as shown for the inner member 1 in figs. 1
and 2, whereas the outer holder member 15 is formed as
a soft flexible uridom-like member which in the
application position shown in fig. 4 assumes a rolled-
up condition surrounding the discharge conduit 5' of
the catheter member 1'.
The connecting means providing a stretchable link
between the outer holder member 15 and the discharge
conduit 5' is in this embodiment designed as a distal
end region 16 of the holder member 15 having reduced
wall thickness, but could also comprise a bellows
member as shown in figs. 1 and 2.
Typically, the holder member 15 will be made of
an elastomeric material such as a thermoplastic or
curable elastomer as mentioned above. Like in the
embodiment cf figs. 1 and 2 the inner engagement
surface of the holder member 15 may optionally be
coated with a layer 17 of a skin-friendly adhesive.
Also in this embodiment removal of the holder
member 15 after use may be facilitated by forming the
proximal end of the holder member 15 with a projecting
flap 18 serving as a grip and, like in the embodiment
in figs. 1 and 2, the holder member 15 may be formed
with a weakened tear-apart region or zone 19 extending
from the flap 18 at least partly towards the opening
20 for the discharge conduit 5'.
Moreover, the catheter assembly may comprise a
separate rigid or semi-rigid annular applicator member
21 of a design known per se arranged in contact with

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
holder member 15 in its rolled-up application
position.
In both of the illustrated embodiments the outer
holder member 8 or 15 may preferably be formed
5 integrally in one piece with the inner member 1 or 1'
and the discharge conduit 5 or 5', whereby manufacture
of the catheter assembly as a one-piece device may be
made simply by moulding. The holder member 8 or 15
may. however, also be connected with the inner member
10 and the discharge conduit by other conventional
methods such as welding, adhesive bonding etc.
In fig. 6 a modification of the embodiment in
figs. 4 and 5 is shown, in which the inner member 1 "
is of the same design as in the embodiments of figs. 1
- 2 and 4 - 5, whereas the outer holder member 22 is
formed as a separate member, not permanently connected
with the inner member and the discharge conduit. In
its distal end around an opening for the discharge
conduit 5 " the holder member 22 joins an annular
retaining member 23, which circumferentially engages
the discharge conduit 5 " to maintain the holder
member 22 in an axially fixed position with respect to
the discharge conduit 5 " in the position of use of
the catheter assembly.
The holder member 22 shown in fig. 6 may
otherwise be formed as a soft flexible sheathing body
of an elastic material as shown in figs . 4 and 5 and
be connected with the retaining member 23 by a distal
end section 22a of reduced wall thickness to provide a
stretchable link. Alternatively, a separate holder
member may be formed e.g. as a semi-rigid bowl-shaped
member connected with a retaining member by a bellows
member as shown in figs. 1 and 2
The retaining member 23, which may be made from
an elastomeric material, may be displaceably arranged

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
11
on the discharge conduit 5 " and engage it by a
relatively close frictional fit to secure the holder
member in the axially fixed position in the position
of use or the discharge conduit 5 " may be formed with
a projecting circumferential rib 23a which can be
passed by the retaining member 23 and secures the
axially fixed position of the retaining member and
thereby the holder member 22.
In the embodiment illustrated in fig. 7, the
inner member 24 is formed with a relatively flat
reinforced distal end section 26 in connection with
the discharge conduit 27. On the side intended to face
the corona of the penis in the position of use a
lining 25 of a resilient skin-friendly material joins
the formstable distal end section 26. The inner member
24 and the discharge conduit 27 may conveniently be
formed as an integral two-component member composed
of a soft elastic material such as any of the
materials mentioned in the foregoing and a
reinforcement material added to or forming the distal
end section 26 to provide formstability.
The outer holder member 28 may be formed as shown
with a proximal skirt-like part 29 of a semi-rigid
elastic material, which is connected with a rina
member 31 secured to the discharge conduit 27 by a
number of spaced strip-like connecting members 30
providing a stretchable link.
In the embodiment illustrated in figs. 8 and 9
and the modification thereof illustrated in fig. 11
the inner member 1 " ' is of the same general form as
shown in figs. 1-2 and 4-6. The outer holder member is
composed of an invertible, bowl-shaped part 32 of a
soft elastic, semi-rigid or rigid material, of the
same general form as the outer holder member shown in
figs. 1 and 2, and a generally tubular retaining part

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
12
33 formed in one piece with the bowl-shaped part 32
and surrounding the discharge conduit 5 " ' over a
substantial part of the length thereof. Like the
retaining member in figure 6 the tubular retainina
part 33 may be displaceably arranged on the discharge
conduit 5 " ' and engage it by a relatively close
frictional fit. Alternatively, the tubular retaining
part 33 may be connected with the discharge conduit
5 " ' by a relatively weak adhesive joint, e.g.
localized in one or more dots.
As best seen in fig. 9 the tubular retaining part
33 and the major part of the adjoining bowl-shaped
part 32 is made with an increased wall thickness
providing a relief-like surface providing a number of
petals 34 towards the free edge 35 of the bowl-shaped
part 32, whereas sectors 36 of the bowl shaped part 32
between the petals 34 has a smaller wall thickness. In
the embodiment in figs. 8 and 9 a local wall thickness
reduction at the transition between the retaining part
33 and the bowl-shaped part 32 provides a stretchable
elastic link 37 having somewhat the same character and
function as a film-hinge, whereby the bowl-shaped part
32 may be brought from the inverted position shown in
fig. 8 to the position of use illustrated in fig. 9 by
snap action.
The flower-like design of the bowl-shaped part 32
with petals 34 has appeared to provide by itself a
very good holding effect against the foreskin, which
may be further improved by application of adhesive
coatings 38 to a part of the side of each petal 34,
which in the position of use will engage the foreskin.
In the modification in fig. 11, in which the
tubular retaining part 33 is connected with the
discharge conduit 5 " ' by an adhesive dot 52, a
stretchable link is alternatively formed between the

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
13
interconnected retaining part and discharge conduit
at the joint 52 and the distal end section 53 of the
inner member 1 " ' by means of a wall part 54 of
reduced thickness causing the wall part 54 to collapse
S by the inversion of the bowl-shaped member 32 towards
the position of use, in which the bowl-shaped member
32 is very safely held against the external side of
the foreskin due to the combination of the squeezing
effect of the flower-like design and the adhesive
coatings 38.
As shown in figs. 8 and 11 inversion of the bowl-
shaped part 32 to the position of use may be assisted
by use of an annular applicator member 39 of generally
U-shaped cross-section with a relatively short inner
wall part 39a and a longer outer wall part 39b.
Thereby, the inversion may be performed by a
relatively modest pressure on the applicator 39 in the
direction of arrow 40.
As further seen from figs. 8 and 11 this
applicator design also provides a protection of the
adhesive coatings 38, which in the inverted position
in fig. 8 are facing outwards.
Removal of the outer holder member illustrated in
fis. 8, 9 and 11 may be facilitated by means of linear
weakening zones 41 provided at diametrically opposite
locations throughout the axial length of the tubular
retaining part 33 and the bowl-shaped part 32, each
such weakening zone joining the bottom of a recess 42
formed from the free end of the tubular retaining
member 33 to provide a pair of gripping flanges 43. By
gripping of these flanges 43 the entire outer holder
member will be broken at least along one of the
weakening zones 41 and may easily be removed from
engagement with the foreskin.
In the embodiment illustrated in fig. 10 the

CA 02390429 2002-05-07
WO 01/35877 PCT/DK00/00629
14
outer holder member 44 is of the same general
geometrical shape as shown in figs. 8 and 9, but is
made of a less rigid, elastic material with uniform
relative small wall thickness. From the bottom of one
of a pair of recesses 45 formed in the tubular
retaining part 46 to provide gripping flanges 47 a
section line 48 extending through the axial length of
the retaining part 46 and part of the axial length of
the bowl-shaped part 49 allows slight separation of
l0 the adjoining edge regions. At the free end of the
bowl-shaped part 49 a flap member 50 is provided on
the inner side with an adhesive coating 51 to secure
the bowl-shaped part 49 in engagement with the
foreskin in the position of use by an adhesive joint.
20
30

Dessin représentatif