Specification
A CATHETER ASSEMBLY COMPRISING A RECEPTACLE
ACCOMMODATING A CATHETER AND A WETTING FLUID POUCH
Technical field of the invention
The present invention relates to a catheter assembly comprising a
hydrophilic catheter, a wetting fluid pouch containing a wetting fluid for wetting
the catheter, and a receptacle for accommodation of the catheter and the
wetting fluid pouch. The invention further relates to a method for producing
such a catheter assembly.
Background
Catheters find their use in many different medical applications, such as
urinary catheters for bladder drainage. Catheters are normally pre-packed in
a receptacle by the manufacturer, in order to maintain the catheter in a clean
and preferably sterile condition.
For many types of catheters, such as urinary catheters, it is desirable
to have a slippery outer surface to facilitate insertion. For this reason
hydrophilic urinary catheters may have a hydrophilic outer surface coating
which should be wetted by a fluid such as water or saline for a certain time
period prior to insertion thereof into the urethra of a patient. In order to
facilitate the use and to improve cleanliness of the catheter, the assemblies
have in recent years developed to comprise a rupturable wetting fluid pouch
as well.
Thus, a typical catheter assembly of today may comprise a receptacle
with a cavity for accommodation of the catheter and the wetting fluid pouch.
However, as the wetting fluid pouch is loose it may fall out of the receptacle
as the receptacle is opened to expose the catheter. To alleviate this problem,
WO 01/52763 discloses a wetting fluid pouch affixed to a tear-off end of the
receptacle. Thus, after the catheter has been wetted, the tear-off end can be
torn off and removed from the receptacle along with the wetting fluid pouch
for disposal thereof. Whereas such an opening procedure may be
inconvenient for any user, the task becomes particularly demanding for users
being disabled, such as users with limited capability of moving their limbs.
A more convenient catheter assembly is known from WO03/092779
disclosing a catheter assembly comprising a catheter receptacle including a
compartment accommodating a wetting fluid. The compartment here forms an
integrated part of the receptacle, but is separated by a separation wall
including a point of weakness located between the wetting fluid compartment
and the cavity containing the catheter. Hereby, the wetting fluid may be
discharged into the cavity containing the catheter by compressing the wetting
fluid compartment. However, whereas this solution alleviates the above
discussed problems, the process of manufacturing a receptacle with an
integrated wetting fluid compartment tends to be rather complex.
Thus, there is generally a problem to provide a catheter assembly that
is easy to use, while also being easy and cost efficient to produce
Consequently, there is a need for an alternative catheter assembly that
alleviates the above-discussed problems.
Summary of the invention
It is therefore an object of the present invention to provide an
alternative catheter assembly, which overcomes or at least alleviates the
above-discussed problems of the prior art.
This object is achieved by means of the invention as defined in the
appended claims.
According to a first aspect of the invention there is provided a catheter
assembly comprising:
a catheter having on at least part of its surface a hydrophilic surface
layer intended to produce a low-friction surface character of the catheter by
treatment with a wetting fluid prior to use of the catheter;
a wetting fluid pouch comprising first and second layers of flexible
material joined by a seal to form a sealed closure accommodating the wetting
fluid;
a receptacle forming a cavity for accommodation of the catheter and
the wetting fluid pouch,
the wetting fluid pouch being openable by compression of the wetting
fluid pouch, thereby enabling the wetting fluid to be discharged into the
receptacle,
wherein at least one of the first and second layers of the wetting fluid
pouch extends beyond the seal of the sealed closure to form an attachment
area outside the sealed closure, wherein the wetting fluid pouch is attached to
an inner surface of the receptacle, the attachment being provided solely
between the receptacle and the attachment area.
The flexible material used for wetting fluid pouch is preferably a flexible
material wich provides a moisture barrier or low water vapour transmission.
The flexible material may e.g. comprise or consist of one or several of
aluminum, aluminium oxide, silicone oxide, metallocene polyvinylidene
chloride (PVdC) and poly(ethylene-vinylacetate) (EVA). For example, the
flexible material can be made as coextruded polyolefines with polyamides,
polyethylene terephtalate (PET), including barrier resins such as
polyvinylidene chloride (PVdC) or poly(ethylene-vinylacetate) (EVA). .
However, other materials exhibiting similar properties are also feasible.
The present invention is based on the understanding that provision of
an attachment area located outside of the seal of the wetting fluid pouch
enables a firm attachment between the wetting fluid pouch and the
receptacle. This prevents the wetting fluid pouch from falling out as the
receptacle is opened and the catheter is pulled out from the receptacle, even
if the wetting fluid pouch is located near the opening of the receptacle. As the
wetting fluid pouch remains attached to the receptacle and can be disposed
together with the receptacle, the opening procedure is facilitated, making the
catheter assembly feasible also for disabled users, such as users with limited
capability of moving their limbs. Furthermore, since the wetting fluid pouch
remains attached to the receptacle, the risk of spilling any wetting fluid that
remains in the wetting fluid pouch is reduced. Moreover, the wetting fluid
pouch does not obstruct removal of the catheter.
The attachment area of the wetting fluid pouch may be attached to the
inner surface of the receptacle by means of an adhesive, such as a medical
grade adhesive, or by means of welding. The weld may be a spot weld or an
elongated weld. The weld may be peelable or non-peelable. Since the
attachment is made solely between the inner surface of the receptacle and
the attachment area of the wetting fluid pouch, the risk of puncturing or
otherwise damaging the wetting fluid pouch when welding is virtually
eliminated. It also enables a cost efficient production of the catheter
assembly.
Moreover, by keeping the wetting fluid pouch in a fixed position, it may
be positioned to affect the receptacle as little as possible. This is
advantageous as holes in the receptacle could contaminate the product which
could be hazardous for the catheter user if it is not detected before use. The
wetting fluid may also be positioned so that optimal density distribution is
achieved when a plurality of catheter assemblies are arranged inside a
secondary package and sterilized by e.g. e-beam. For sterilization with ebeam,
even density distribution is to strive for in order to get a low dose ration
and ensuring the sterility of all catheter assemblies.
Preferably, only one of the first and second layers of the wetting fluid
pouch extends beyond the seal of the sealed closure to form a single layered
attachment area. Advantages with a single layered attachment area are
reduced consumption of material and a more pliable contact surface that can
easily be attached to the receptacle.
According to an embodiment, the wetting fluid pouch may be formed by
a single sheet of flexible material which is folded into the first and second
layers of flexible material. Preferably, the sheet is folded such that an edge of
the first layer of flexible material located opposite the fold and an edge of the
second layer of flexible material located opposite the fold may be displaced
relative each other, wherein the area between the edges forms the
attachment area. This may be achieved by displacing the fold from a centre of
the sheet of flexible material. This provides a convenient way of
manufacturing a wetting fluid pouch provided with an attachment area having
a single layer of flexible material.
According to another embodiment, the first and second layers of
flexible material may be two initially separate sheets of flexible material joined
by the seal to form the sealed closure. Preferably, the wetting fluid pouch may
have a side where an edge of the first layer of flexible material and the edge
of the second layer of flexible material are displaced relative each other,
wherein the area between the edges forms the attachment area.
The receptacle may be provided with opening means enabling opening
of the receptacle for removal of the catheter from said receptacle.
The opening means may comprise a peel-off joint. An advantage with a
peel-off joint is that it is relatively easy to open also for disabled users, such
as users with limited capability of moving their limbs. However, other
openings means may also be utilized, such as a tear-off end.
The wetting fluid pouch may be arranged adjacent the opening means.
This may be convenient as the receptacle may remain in the same position
throughout the opening procedure. For example, the receptacle may be held
such that the wetting fluid passes by gravity from the opened wetting fluid
pouch to the portion of the receptacle where the insertion end of the catheter
is located. The receptacle may then remain in that position as the receptacle
is opened to take out the catheter.
Further, the wetting fluid pouch may be arranged between the catheter
and the opening means. As the wetting fluid pouch and the catheter in this
case are arranged tandemly (rather than overlying each other), the wetting
fluid pouch may be compressed without pressing the catheter against the
inner surface of the receptacle. This reduces the risk of holes or other
damage to the receptacle. Furthermore, as the wetting fluid pouch is arranged
next to the catheter, a lower dose ration can be used for sterilization of the
catheter assembly when irradiation, such as e-beam, is used.
According to alternative embodiment, the wetting fluid pouch may
overlie the catheter to achieve a more compact catheter assembly. In this
case, it is preferred that the attachment area of the wetting fluid pouch is
arranged to overly the catheter. Further, it is preferred that the sealed closure
accommodating the wetting fluid does not overly the catheter, but instead be
arranged transversely to the catheter. Hereby, the catheter assembly is still
very compact in length and width, and also becomes relatively thin, since it
only the thinnest part of the wetting fluid pouch overlies the catheter.
The attachment area which is attached to the receptacle may
preferably be arranged on only one side of the wetting fluid pouch. This has
the effect that the attachment between the wetting fluid pouch and the
receptacle forms a hinged connection. As a result, the wetting fluid pouch
does not obstruct the removal of the catheter from the receptacle as the
wetting fluid pouch may move about the attachment to give way for the
catheter.
The side of the wetting fluid pouch, where the attachment area is
attached to the receptacle, may preferably be essentially parallel to an axial
direction of the catheter. This further facilitates removal of the catheter from
the receptacle as the catheter may slide along the attachment of wetting fluid
pouch.
The attachment area may be provided at a side of the wetting fluid
pouch essentially parallel to an axial direction of the catheter. This may
facilitate removal of the catheter from the receptacle.
Furthermore, the attachment area may preferably be attached close to
a side edge of the receptacle. This further reduces obstruction during removal
of the catheter.
According to a second aspect of the invention there is provided a
method for producing a catheter assembly, comprising the steps of:
providing a receptacle;
providing a hydrophilic catheter;
arranging the catheter in a cavity of the receptacle;
providing a wetting fluid pouch comprising first and second layers of
flexible material joined by a seal to form a sealed closure for accommodation
of said wetting fluid, wherein at least one of said first and second layers
extends beyond the seal of the sealed closure to form an attachment area
outside the sealed closure for attaching said wetting fluid pouch to said
receptacle;
arranging the wetting fluid pouch containing the wetting fluid in the
cavity of the receptacle; and
attaching the attachment area of said wetting fluid pouch to an inner
surface of the receptacle.
This aspect of the invention provides similar advantages as discussed
above in relation to the first aspect.
These and other aspects of the invention will be apparent from and
elucidated with reference to the embodiments described hereinafter.
Brief description of the drawings
For exemplifying purposes, the invention will be described in closer
detail in the following with reference to embodiments thereof illustrated in the
attached drawings, wherein:
Fig. 1a-b schematically illustrates an embodiment of a catheter
assembly where the wetting fluid pouch and the catheter are tandemly
arranged;
Fig. 2a-b schematically illustrates an embodiment of a wetting fluid
pouch;
Fig. 3a-b schematically illustrates an embodiment of a catheter
assembly where the wetting fluid pouch overlie the catheter;
Fig. 4 schematically illustrates an alternative embodiment of a catheter
assembly; and
Fig. 5a-b schematically illustrates alternative embodiments of a wetting
fluid pouch.
Detailed description of preferred embodiments
Fig 1 schematically illustrates a catheter assembly 100
according to an embodiment of the invention. The catheter assembly 100
comprises a wetting receptacle 10 1 or bag. The receptacle is preferably of a
flexible plastics material. The material may be transparent, but opaque or
semi-opaque materials may also be used. For example, the receptacle can be
made of polymer materials such as polyethen, polypropylene, polyamide, and
PET, or the receptacle can be made from a laminate of such polymer
materials and/or aluminum, aluminum oxide, or oriented polypropylene
(OPP). The receptacle has a downwardly extending elongate pocket 102 at
the forward end. The catheter assembly further comprises a hydrophilic
urinary catheter 103, with a connector 104 for connection to other devices,
such as a urine collection bag a drainage tube or the like. The catheter
receptacle 10 1 is adapted for accommodation of the catheter, and at least the
catheter tube is accommodated in the elongate pocket 102. Preferably, the
receptacle 10 1 encloses the whole length of the catheter. Preferably, the
receptacle comprises a narrow forward part 102 and a wider rearward part
113 . The narrow forward part 102 is adapted to accommodate at least a part
of the catheter, including the insertion end. It is possible to arrange essentially
the entire catheter in the narrow part 102. Alternatively, at least a part of the
catheter, including the outflow end (often referred to as connector end)
extends into the wider rearward part 113 . The catheter assembly also
comprises a wetting fluid pouch 105 containing a wetting fluid (not illustrated).
A more detailed view of the wetting fluid pouch is found in Fig. 2a-b. Referring
to Fig. 2a-b, the wetting fluid pouch is here formed by a rectangular sheet of
flexible material, such as an aluminum laminate, which sheet is folded along a
folding line 107 into first 106a and second 106b layers of flexible material.
The first and second layers of flexible material are joined by a seal so that the
first 106a and second 106b layers form a sealed closure 114 for
accommodation of the wetting fluid. Here the seal comprises three welds
108a-c. In this embodiment, the folding line 107 is parallel to, but displaced
from a centre line of the rectangular sheet, such that an edge 110 of the first
layer 106a of flexible material located opposite the fold 107 and an edge 111
of the second layer 106b of flexible material located opposite the fold 107, are
parallel but displaced relative each other, wherein the portion of the first layer
106a of flexible material that extends beyond the edge 111 of the second
layer 106b of material forms a single layered attachment area 112, or put
differently, the area between the two edges 110,1 11 forms the attachment
area 112. It is recognized that either side of the single layered attachment
area may be used to attach the wetting fluid pouch to the receptacle
Referring to Fig. 1, the wetting fluid pouch 105 is here arranged in a
part 113 of the receptacle extending rearwardly from the catheter 103, i.e.
behind the connector 104 of the catheter. It should be noted that the rearward
part 113 of the receptacle is in fluid communication with the forward part 102
housing the catheter 103.
Further, the wetting fluid pouch 105 is attached to the receptacle by at
least one weld 120 provided between the attachment area 112 of the wetting
fluid pouch and an inner surface of the receptacle. The weld 120 may extend
over an elongated area as illustrated in Fig. 1, or be a spot weld. It is also
possible to attach the attachment area to the receptacle with more than one
weld. Alternative ways of attaching the attachment area 112 of the pouch to
the inner surface of the receptacle may also be utilized, e.g. an adhesive,
such as medical grade adhesive, can be used. In this embodiment, the side of
the wetting fluid pouch where the attachment area 112 is arranged is
essentially parallel to the extension of the catheter 103. This side of the
wetting fluid pouch is here also the longer side of the pouch. It should be
noted, however, that the attachment of the wetting fluid pouch to the
receptacle preferably is provided solely between the attachment area and the
receptacle.
The wetting fluid pouch 105 is preferably adapted such that moderate
external pressure applied to the wetting fluid pouch will cause the sealed
closure to rupture. This can be achieved by allowing the welds to separate as
a result of the internal pressure induced when the wetting fluid pouch is
compressed. For example, one of the three welds 108-c (or a portion thereof)
can be made thinner than the other welds or have a point of weakness.
Preferably, the weld of the side of the wetting fluid pouch which is to be
arranged closest to the rearward end of the receptacle, i.e. the side to be
farthest away from the insertion end of the catheter, is made weaker than the
welds of the other sides. This will ensure that the wetting fluid will flow along
essentially the whole receptacle when released.
Opening means 118 for opening the receptacle is here arranged
rearwardly from the catheter 103, i.e. behind the connector 104 of the
catheter, but on the other side of the wetting fluid pouch 105. The opening
means may comprise e.g. a peelable joint 118 connected to tabs 119a-b
extending from the edge for enabling opening of the receptacle by peeling the
tabs 119a-b apart, thereby separating the foil walls of the receptacle.
In order to prepare the catheter for catheterization, a compression
force is applied to the wetting fluid pouch 105 in such a way that the sealed
closure 114 is ruptured and wetting fluid is discharged into the receptacle.
This may be achieved without opening the receptacle, whereby the sterile
environment of the receptacle is still maintained during this step. The
receptacle may preferably be held vertically with the wetting fluid pouch
above the catheter, so that the wetting fluid is passed by gravity into the
elongate pocket 102 that accommodates the catheter 103. Preferably, the
wetting fluid pouch contains a sufficient amount of wetting fluid for the
insertable length of the catheter to be sufficiently wetted. After release of the
wetting fluid into the elongate pocket 102 the receptacle can be opened by
grabbing and peeling the tabs 119a-b to separate the foil walls at the end of
the receptacle. The receptacle is preferably arranged to allow a sufficient
degree of separation of the foil walls so that the catheter 103 can be easily
grabbed at the connector 104 and be pulled out of the receptacle.
Thus, the portion of the receptacle where the wetting fluid pouch is
arranged can be folded away by separating the foil walls all the way down to
the connector of the catheter. It should be noted that although this portion of
the receptacle is more or less turned inside out, the wetting fluid pouch will
remain affixed to the receptacle by the attachment weld 120. Thus, as the
catheter has been removed the receptacle 10 1 may be disposed along with
the wetting fluid pouch 105.
Fig.3 illustrates an alternative embodiment of a catheter assembly.
This embodiment resembles the embodiment discussed with reference to Fig.
1 and Fig. 2, but instead of having the catheter 103 and the wetting fluid
pouch 105 tandemly arranged, the wetting fluid pouch overlies the catheter,
enabling a more compact catheter assembly. In this embodiment, it may
suffice to separate the foil walls at the very end of the receptacle to provide
an opening that allows the catheter 103 to be grabbed at the connector 104.
The catheter may then be pulled out next to the wetting fluid pouch. Since the
wetting fluid pouch is attached along one side only, and since the attachment
side of the pouch is parallel to the axial direction of the catheter, the pouch
may move about the attachment to give way for the catheter as it is pulled out
of the catheter. As the wetting fluid pouch remains inside the receptacle
throughout the opening procedure, the risk of spilling any wetting fluid that
remains inside the wetting fluid pouch is reduced.
A production method of the wetting fluid pouch will now be described
with reference to Fig. 2 . In a production method of the wetting fluid pouch
105, the pouch may be formed by providing a rectangular sheet of flexible
material, such as an aluminum laminate; folding the sheet along a folding line
107 parallel to, but displaced from, the centre line of the sheet to a first 106a
and second 106b layers of flexible material; and providing a longitudinal
weld1 08b to join the two layers, wherein the weld is arranged along the edge
111 of the less wide layer 106b. This results in a tube of flexible material . The
tube is filled with wetting fluid (e.g. water or saline) and transversally welded
to form sealed closures 114 containing the wetting fluid. Cuts are made in the
transversal welding areas so that each sealed closure is separated from the
others to form a wetting fluid pouch. The single layer of material that remains
outside the longitudinal weld 108b forms an attachment area for attaching the
wetting fluid pouch to the receptacle.
In a production method of the catheter assembly 100, the receptacle
10 1 is manufactured, and the catheter 103 and the wetting fluid pouch 105
are arranged inside the receptacle 10 1. An attachment area 112 of the
wetting fluid pouch is attached to an inner surface of the receptacle. Then, the
assembly 100 may be sterilized. Sterilization of the catheter may be achieved
by irradiation by an e-beam in which case the fluid in the wetting fluid pouch
could be sterilized when assembled, at the same time as the rest of the
components of the assembly. Since the wetting fluid pouch is kept in a fixed
position, it may preferably be positioned for optimal density distribution. When
sterilized with e-beam, even density distribution is to strive for in order to get a
low dose ration and ensuring the sterility of the catheter assembly.
Furthermore, the wetting fluid pouch may preferably be positioned so
that it will have as little affect as possible on the receptacle. For example, it is
preferred to arrange the wetting fluid pouch so that the outer sides of the
wetting fluid pouch do not lie in direct contact with the inner sides of the
receptacle, but arranged at a certain distance from said inner sides. This is
advantageous as holes in the receptacle could contaminate the product which
could be hazardous for the catheter user if it is not detected before use. To
the same end, the wetting fluid pouch is preferably made free from sharp
corners, especially at parts distant from the attachment area, e.g. by provision
of rounded corners.
Fig. 4 illustrates another embodiment of the catheter assembly. This
embodiment resembles the embodiment discussed with reference to Fig. 1
and 2, but is provided with additional opening means offering alternative ways
to remove the catheter from the receptacle. The additional opening means
are here in the form of tear lines 115 arranged at the elongate pocket 102 of
the receptacle. The tear lines are connected to one or several gripping
handles 116, such as a pulling tab.
Fig. 5a illustrates another embodiment of a wetting fluid pouch. This
embodiment resembles the embodiment discussed above with reference to
Fig. 2, but two corners of the wetting fluid pouch are rounded, which corners
are located on a side of the wetting fluid pouch opposite to the side with the
attachment area 112. This may further facilitate the removal of the catheter
from the receptacle. As discussed above, rounded corners also reduces the
risk of damaging the receptacle. Still further, the pressure and stress obtained
with rounded corners is less concentrated compared to sharp corners,
thereby minimizing the risk of leakage at the corners.
Fig. 5b illustrates yet another embodiment of a wetting fluid pouch.
Here the first 106a and second 106b layers of flexible material are two initially
separate rectangular sheets of flexible material joint by a seal to form the
sealed closure 114. The two sheets have the same width, but the first sheet
106a is longer than the second sheet 106b. The sheets are arranged on top
of each other edge to edge, except for one side (here the upper side) where
the edge of the first sheet and the edge of the second sheet are displaced
relative each other. The area 112 between the edges forms the attachment
area. In this embodiment, the seal comprises four welds 108a-d provided
along the edge of the smaller sheet. Similarly, a wetting fluid pouch with a first
attachment area on a first side, and a second attachment area on a second
side (opposite the first side), can be achieved by displacing two sheets having
the same size relative each other.
Specific embodiments of the invention have now been described.
However, several alternatives are possible, as would be apparent for
someone skilled in the art. For example, although the wetting fluid pouch in
the described embodiments has been arranged close to the connector of the
catheter, the pouch may also be arranged close to the insertion end of the
catheter, or in any other suitable location in the assembly. It is also possible
to have a wetting fluid pouch with an attachment area along more than one
side of the wetting fluid pouch, and attaching the wetting fluid pouch to the
receptacle using one or more of these attachment areas.
Such and other obvious modifications must be considered to be within
the scope of the present invention, as it is defined by the appended claims. It
should be noted that the above-mentioned embodiments illustrate rather than
limit the invention, and that those skilled in the art will be able to design many
alternative embodiments without departing from the scope of the appended
claims. In the claims, any reference signs placed between parentheses shall
not be construed as limiting to the claim. The word "comprising" does not
exclude the presence of other elements or steps than those listed in the
claim. The word "a" or "an" preceding an element does not exclude the
presence of a plurality of such elements. Further, a single unit may perform
the functions of several means recited in the claims.
CLAIMS
1. A catheter assembly comprising:
a catheter having on at least part of its surface a hydrophilic surface
layer intended to produce a low-friction surface character of the catheter by
treatment with a wetting fluid prior to use of the catheter;
a wetting fluid pouch comprising first and second layers of flexible
material joined by a seal to form a sealed closure accommodating said
wetting fluid;
a receptacle forming a cavity for accommodation of said catheter and
said wetting fluid pouch,
said wetting fluid pouch being openable by compression of said wetting
fluid pouch, thereby enabling the wetting fluid to be discharged into the
receptacle,
wherein at least one of said first and second layers of said wetting fluid
pouch extends beyond the seal of the sealed closure to form an attachment
area outside the sealed closure, wherein said wetting fluid pouch is attached
to an inner surface of said receptacle, said attachment being provided solely
between the receptacle and said attachment area.
2 . A catheter assembly according to claim 1, wherein only one of said
first and second layers of said wetting fluid pouch extends beyond the seal of
the sealed closure to form a single layered attachment area.
3 . A catheter assembly according to claim 1 or 2, wherein the wetting
fluid pouch is formed by a single sheet of flexible material which is folded into
said first and second layers of flexible material.
4 . A catheter assembly according to claim 3, wherein an edge of the
first layer of flexible material located opposite the fold and an edge of the
second layer of flexible material located opposite the fold are displaced
relative each other, wherein the area between the edges forms said
attachment area.
5 . A catheter assembly according to claim 1 or 2, wherein the first and
second layers of flexible material are two initially separate sheets of flexible
material joined by said seal to form the sealed closure.
6 . A catheter assembly according to claim 5, wherein the wetting fluid
pouch has a side where an edge of the first layer of flexible material and the
edge of the second layer of flexible material are displaced relative each other,
wherein the area between the edges forms the attachment area.
7 . A catheter assembly according to any one of the preceding claims,
wherein the receptacle is provided with opening means enabling opening of
said receptacle for removal of the catheter from said receptacle.
8 . A catheter assembly according to claim 7, wherein the opening
means comprises a peel-off joint.
9 . A catheter assembly according to claim 7 or 8, wherein said wetting
fluid pouch is arranged adjacent said opening means.
10 . A catheter assembly according to any one of claims 7 to 9, wherein
said wetting fluid pouch is arranged between said catheter and said opening
means.
11. A catheter assembly according to any one of claims 1 to 9, wherein
said wetting fluid pouch overlies said catheter, and preferably overlies the
catheter with the at least one of said first and second layers of said wetting
fluid pouch extending beyond the seal of the sealed closure to form the
attachment area outside the sealed closure.
12 . A catheter assembly according to any one of the preceding claims,
wherein the attachment area which is attached to the receptacle is arranged
on only one side of the wetting fluid pouch.
13 . A catheter assembly according to claim 12, wherein the side of the
wetting fluid pouch where the attachment area is attached to the receptacle,
is essentially parallel to an axial direction of the catheter.
14 . A catheter assembly according to any one of the preceding claims,
wherein said attachment area is welded to the inner surface of the receptacle.
15 . A catheter assembly according to any one of the preceding claims,
wherein said attachment area is attached to the inner surface of the
receptacle by an adhesive.
16 . A catheter assembly according to any one of the preceding claims,
wherein said attachment area is attached close to a side edge of the
receptacle.
17 . A method for producing a catheter assembly, comprising the steps
of:
providing a receptacle;
providing a hydrophilic catheter;
arranging the catheter in a cavity of the receptacle;
providing a wetting fluid pouch comprising first and second layers of
flexible material joined by a seal to form a sealed closure for accommodation
of said wetting fluid, wherein at least one of said first and second layers
extends beyond the seal of the sealed closure to form an attachment area
outside the sealed closure for attaching said wetting fluid pouch to said
receptacle;
arranging the wetting fluid pouch containing the wetting fluid in the
cavity of the receptacle; and
attaching the attachment area of said wetting fluid pouch to an inner
surface of the receptacle.
