U.S. patent application number 13/331485 was filed with the patent office on 2012-06-28 for catheter assembly and a method and system for producing such an assembly.
This patent application is currently assigned to ASTRA TECH AB. Invention is credited to Evelina GUSTAVSSON, Jan UTAS.
Application Number | 20120165790 13/331485 |
Document ID | / |
Family ID | 43827810 |
Filed Date | 2012-06-28 |
United States Patent
Application |
20120165790 |
Kind Code |
A1 |
GUSTAVSSON; Evelina ; et
al. |
June 28, 2012 |
CATHETER ASSEMBLY AND A METHOD AND SYSTEM FOR PRODUCING SUCH AN
ASSEMBLY
Abstract
A catheter assembly is disclosed, comprising a catheter, such as
a urinary catheter, which at least a partly is provided with a
hydrophilic coating. The catheter assembly further comprises a
wetting fluid. The receptacle is in direct contact with the
hydrophilic coating of the catheter over essentially the entire
length of the part of the catheter being provided with the
hydrophilic coating. This may e.g. be achieved by using a shrink
wrap material. In order to accomplish adequate wetting, channels or
the like may be provided on the inner surface of the receptacle or
the outer surface of the catheter.
Inventors: |
GUSTAVSSON; Evelina;
(Ojersjo, SE) ; UTAS; Jan; (Kungsbacka,
SE) |
Assignee: |
ASTRA TECH AB
MOLNDAL
SE
|
Family ID: |
43827810 |
Appl. No.: |
13/331485 |
Filed: |
December 20, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61426052 |
Dec 22, 2010 |
|
|
|
Current U.S.
Class: |
604/544 ;
156/383; 156/86 |
Current CPC
Class: |
A61M 25/0111 20130101;
B65B 53/02 20130101; A61M 25/002 20130101; A61M 25/0017
20130101 |
Class at
Publication: |
604/544 ; 156/86;
156/383 |
International
Class: |
A61M 27/00 20060101
A61M027/00; B32B 37/06 20060101 B32B037/06 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 22, 2010 |
EP |
10196593.7 |
Claims
1. A catheter assembly comprising: a catheter, at least a part of
which is provided with a hydrophilic coating; a wetting fluid; and
a receptacle enclosing the wetting fluid and at least the part of
the catheter being provided with the hydrophilic coating; wherein
the receptacle is in direct contact with the hydrophilic coating of
the catheter over essentially the entire length of said part of the
catheter being provided with the hydrophilic coating.
2. The catheter assembly of claim 1, wherein the direct contact
between the hydrophilic coating and the receptacle occurs in a
number of contact points being distributed around the circumference
of the catheter, said contact points being discrete contact points
or contact points being continuously connected.
3. The catheter assembly of claim 2, wherein the contact points are
evenly distributed around the circumference of the catheter.
4. The catheter assembly of any one of the preceding claims,
wherein at least one of the inner surface of the receptacle facing
the hydrophilic coating and the outer surface of the hydrophilic
coating, facing the receptacle comprises a surface texture forming
channels between the receptacle and the hydrophilic coating, the
areas between the channels forming areas of direct contact between
the receptacle and the hydrophilic coating.
5. The catheter assembly of any one of the preceding claims,
wherein a substantial part of the hydrophilic coating is in direct
contact with the receptacle.
6. The catheter assembly of any one of the preceding claims,
wherein at least 20% of the area of the hydrophilic coating is in
direct contact with the receptacle, and preferably at least 30%,
and most preferably at least 50%.
7. The catheter assembly of any one of the preceding claims,
wherein the receptacle comprises a shrink-wrap film or package.
8. The catheter assembly of any one of the preceding claims,
wherein the receptacle is provided with areas or lines of weakness
for facilitating opening of the receptacle.
9. The catheter assembly of any one of the preceding claims,
wherein the wetting fluid is arranged separate from the hydrophilic
coating, said wetting fluid being releasable for wetting of the
hydrophilic coating before use.
10. The catheter assembly of any one of the claims 1-7, wherein the
wetting fluid is arranged in direct contact with the hydrophilic
coating, maintaining the hydrophilic in a wetted state.
11. The catheter assembly of any one of the preceding claims,
wherein the catheter is a urinary catheter.
12. A method for manufacturing a catheter assembly, comprising the
steps: providing a hydrophilic catheter; providing a wetting fluid;
arranging a receptacle around the wetting fluid and at least a part
of the catheter; and applying heat to the receptacle, thereby
making it shrink, whereby the receptacle, at least partly comes
into direct contact with the catheter.
13. A system for manufacturing a catheter assembly, comprising:
means for enclosing a wetting fluid and a hydrophilic catheter in a
receptacle; and means for applying heat to the receptacle, thereby
making it shrink, whereby the receptacle, at least partly comes
into direct contact with the catheter.
Description
TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates to a hydrophilic catheter
assembly including a wetting fluid, and a method and system for
manufacturing such an assembly. The present invention is
particularly related to hydrophilic urinary catheters.
BACKGROUND
[0002] Catheter assemblies for hydrophilic catheters, including a
wetting fluid for wetting and activation of the hydrophilic
catheter before use have been known for over a decade. In one type
of such products the wetting fluid is initially kept separate from
the hydrophilic surface, and released immediately prior to use,
thereby activating the hydrophilic surface. In another type of such
products, the wetting fluid is arranged in such a way that the
hydrophilic surface is maintained constantly wetted, and thereby
ready for immediate use.
[0003] The provision of the wetting fluid in the catheter assembly
entails many advantages. For example, there is no need to find a
water supply, and catheterization can constantly be performed in
any location and at any time. Further, the entire wetting process
can be performed under sterile conditions, without opening of the
package.
[0004] However, a drawback with such catheter assemblies is that
the products are relatively large and heavy and expensive to
produce. In order to ensure a proper wetting, a substantial amount
of wetting fluid is required, and in most products of this type,
the wetting fluid in itself forms a substantial part of the overall
weight of the product. Further, the provision of large volumes of
wetting fluid complicates the production, e.g. requiring larger
doses of radiation for sterilization, and also makes logistics more
complicated and expensive.
[0005] Consequently, there has for several years been a strive to
develop catheter assemblies of this type requiring more limited
amounts of wetting fluid. Such attempts are e.g. disclosed in EP 1
023 882, WO 2006/092150 and EP 2 106 821. However, these products
still require relatively large amounts of wetting fluid in order to
ensure adequate wetting, and the proposed products are relatively
complex, thereby increasing the manufacturing costs.
[0006] Further, there have been attempts to reduce the amount of
wetting fluid by proposing complex wetting procedures, where a
limited amount of wetting fluid is moved back and forth in order to
entail a proper wetting. Such solutions are e.g. disclosed in US
2005/0109648 and US 2004/0074794. However, these methods of wetting
are relatively complicated, making the wetting process tedious and
difficult to perform by e.g. disabled users. Further, there is a
significant risk that an inadequate wetting would occur from time
to time, which would be both painful and potentially harmful for
the user.
[0007] There is therefore still a need for a hydrophilic catheter
assembly ensuring an adequate wetting and which is less large and
heavy and/or less easier and less costly to produce and
distribute.
SUMMARY OF THE INVENTION
[0008] There is therefore an object of the present invention to
provide a catheter assembly and a method of manufacture that at
least partly overcome the above-discussed problems of the prior
art.
[0009] This object is achieved by means of a catheter assembly and
a method and system for manufacture according to the enclosed
claims.
[0010] According to a first aspect of the invention, there is
provided a catheter assembly comprising:
[0011] a catheter, at least a part of which is provided with a
hydrophilic coating;
[0012] a wetting fluid; and
[0013] a receptacle enclosing the wetting fluid and at least the
part of the catheter being provided with the hydrophilic
coating;
[0014] wherein the receptacle is in direct contact with the
hydrophilic coating of the catheter over essentially the entire
length of said part of the catheter being provided with the
hydrophilic coating.
[0015] The catheter assembly consequently provides a receptacle
which very narrowly encloses the part of the catheter being
provided with the hydrophilic coating. This results in a very lean
and light product, where a very limited amount of water is
sufficient to ensure an easy and highly effective wetting of the
entire hydrophilic surface.
[0016] This product can also be produced at a relatively low cost.
Smaller sized products and less material makes it possible to use a
high speed production. Further, due to smaller size and lower
amount of wetting fluid, enhanced dose ratio properties can be
obtained when radiation sterilization is used. Still further, lower
weight and size result in smaller primary and secondary packages,
which makes the production easier and less costly, and also makes
the products easier and less costly to handle and store.
[0017] By means of the present invention, the amount of wetting
liquid required for appropriate wetting of the hydrophilic coating
may be reduced to only slightly more than the wetting fluid
contained in the hydrophilic coating when wetted. Consequently, a
substantial part of the wetting fluid, and preferably essentially
all the wetting fluid, is in this way used for its intended
purpose, viz. to be assimilated by the hydrophilic coating.
[0018] Preferably, the direct contact between the hydrophilic
coating and the receptacle occurs in a number of contact points
being distributed around the circumference of the catheter, said
contact points being discrete contact points or contact points
being continuously connected. By contact points being continuously
connected is in this context meant formation of one or several
continuous lines of contact, wherein each line forms a plurality or
even infinite number of contact points. Since the contact points
are distributed around the circumference of the catheter, a very
narrow spacing between the catheter and the receptacle is ensured.
Preferably, the contact points are evenly distributed around the
circumference of the catheter. Such even distribution can either be
obtained by discrete contact points being arranged with essentially
the same distance from each other, or by continuously connected
contact points or groups of closely arranged discrete points being
provided at essentially the same distance from each other.
[0019] It has surprisingly been found by the present inventor that
for many types of hydrophilic coatings, the wetting fluid will
distribute within the coating without the need for external
passageways.
[0020] However, in order to make the distribution of the wetting
fluid within the package faster and more efficient, it is preferred
to arrange passageways for the wetting fluid between the
hydrophilic coating and the receptacle. Preferably, at least one of
the inner surface of the receptacle facing the hydrophilic coating
and the outer surface of the hydrophilic coating, facing the
receptacle comprises a surface texture forming channels between the
receptacle and the hydrophilic coating, the areas between the
channels forming areas of direct contact between the receptacle and
the hydrophilic coating.
[0021] Preferably, a substantial part of the hydrophilic coating is
in direct contact with the receptacle. It is also preferred that at
least 20% of the area of the hydrophilic coating is in direct
contact with the receptacle, and even more preferably at least 30%,
and most preferably at least 50%.
[0022] The catheter assembly of any one of the preceding claims,
wherein the receptacle comprises a shrink-wrap film or package.
Hereby, the provision of the contact between the hydrophilic
coating and the receptacle becomes very easy to obtain. Packaging
can be made in a relatively large receptacle, which is subsequently
shrunk to a more compact state by the provision of heat. Such a
catheter assembly lends itself very well for a high speed automated
manufacturing process.
[0023] In order to facilitate opening of the package, for
withdrawal of the catheter before use, the receptacle is preferably
provided with areas or lines of weakness for facilitating opening
of the receptacle. Further, tabs for tearing may be provided to
further facilitate opening. Additionally or alternatively, other
opening means may be provided, such as peelable openings and the
like.
[0024] In one line of embodiments, the wetting fluid is arranged
separate from the hydrophilic coating, said wetting fluid being
releasable for wetting of the hydrophilic coating before use. For
example, the wetting fluid may be arranged in a separate
compartment formed in the receptacle, or in a separate wetting
fluid container arranged fully or partly within the bounds of the
receptacle. The release of the wetting fluid may be accomplished by
means of applying a pressure on the wetting fluid compartment.
Other actions for releasing of the wetting fluid may however also
be used, such as twisting, bending, pulling and the like.
[0025] In another line of embodiments, the wetting fluid is
arranged in direct contact with the hydrophilic coating,
maintaining the hydrophilic in a wetted state. Hereby, the
receptacle forms a compartment holding both the wetting fluid and
at least the part of the catheter being provided with the
hydrophilic coating. The wetting fluid may be provided in an amount
immediately wetting and activating the catheter. However, it is
also possible to provide the wetting fluid in an amount and form
which gradually wets and activates the hydrophilic coating during
an initial storage period.
[0026] The wetting fluid is preferably an aqueous liquid, such as
water or a an aqueous solution comprising an osmolality increasing
agent, such as saline. However, at least in embodiments where the
hydrophilic coating is maintained in a wetted state, it is also
possible to use a wetting fluid in gaseous form.
[0027] According to another aspect of the invention, there is
provided a method for manufacturing a catheter assembly, comprising
the steps:
[0028] providing a hydrophilic catheter;
[0029] providing a wetting fluid;
[0030] arranging a receptacle around the wetting fluid and at least
a part of the catheter; and
[0031] applying heat to the receptacle, thereby making it shrink,
whereby the receptacle, at least partly comes into direct contact
with the catheter.
[0032] With this aspect of the invention, similar advantages as
discussed above in relation to the first aspect are obtainable.
Further, the specific embodiments discussed in relation to the
first aspect are also combinable with this second aspect of the
invention.
[0033] According to still another aspect of the invention, there is
provided a system for manufacturing a catheter assembly,
comprising:
[0034] means for enclosing a wetting fluid and a hydrophilic
catheter in a receptacle; and
[0035] means for applying heat to the receptacle, thereby making it
shrink, whereby the receptacle, at least partly comes into direct
contact with the catheter.
[0036] With this aspect of the invention, similar advantages as
discussed above in relation to the first aspect are obtainable.
Further, the specific embodiments discussed in relation to the
first aspect are also combinable with this second aspect of the
invention.
[0037] 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
[0038] 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:
[0039] FIG. 1a and FIG. 1b are side views showing a catheter
assembly according to a first embodiment of the present invention,
wherein FIG. 1a illustrates a catheter assembly in an intermediate
production step, and FIG. 1b illustrates the catheter assembly in a
final configuration.
[0040] FIGS. 2a-2d show cross-sections of various embodiments of
catheter assemblies according to the present invention.
[0041] FIGS. 3a and 3b show another cross-section of an embodiment
of a catheter according to the invention, and a side-view of a cut
out part of the same catheter assembly, respectively.
[0042] FIGS. 4a and 4b show another cross-section of an embodiment
of a catheter according to the invention, and a side-view of a cut
out part of the same catheter assembly, respectively.
[0043] FIG. 5 shows a side view of another embodiment of a catheter
assembly according to the invention.
[0044] FIG. 6 shows a side view of another embodiment of a catheter
assembly according to the invention.
[0045] FIG. 7 shows a side view of still another embodiment of a
catheter assembly according to the present invention.
[0046] FIG. 8 shows a side view of a cut out part of a catheter
assembly according to another embodiment of the present
invention.
[0047] FIG. 9 shows a side view of still another embodiment of a
catheter assembly according to the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0048] In the following detailed description, preferred embodiments
of the present invention will be described. However, it is to be
understood that features of the different embodiments are
exchangeable between the embodiments and may be combined in
different ways, unless anything else is specifically indicated. It
may also be noted that, for the sake of clarity, the dimensions of
certain components illustrated in the drawings may differ from the
corresponding dimensions in real-life implementations of the
invention, for instance the dimension of the hydrophilic coating is
exaggerated. Even though in the following description, numerous
specific details are set forth to provide a more thorough
understanding of the present invention, it will be apparent to one
skilled in the art that the present invention may be practiced
without these specific details. In other instances, well known
constructions or functions are not described in detail, so as not
to obscure the present invention.
[0049] The catheters may be used for many different purposes, and
for insertion into various types of body-cavities. However, the
following discussion is in particular concerned with the preferred
field of use, urinary catheters, even though the invention is not
limited to this particular type of catheters.
[0050] With reference to FIGS. 1a and 1b, the catheter assembly
comprises a hydrophilic catheter 1, i.e. a catheter which is at
least partly provided with a hydrophilic coating. The hydrophilic
coating may e.g. be polyvinyl pyrrolidone (PVP), but many other
types of hydrophilic coatings are known in the art, and may be used
in the context of the present invention. It is also feasible to use
a catheter entirely formed of a hydrophilic material, thereby
making the hydrophilic coating to be an integrally formed outer
surface area of said catheter. The hydrophilic coating provides a
low-friction character to the catheter when wetted, thereby
facilitating insertion of the catheter into the urethra, and
reducing the risk of pain etc.
[0051] The hydrophilic coating is arranged on at least part of the
substrate forming the catheter shaft. The hydrophilic polymer
coating may comprise material selected from polyvinyl compounds,
polysaccharides, polyurethanes, polyacrylates or copolymers of
vinyl compounds and acrylates or anhydrides, especially
polyethyleneoxide, polyvinyl-pyrrolidone, heparin, dextran, xanthan
gum, polyvinyl alcohol, hydroxy propyl cellulose, methyl cellulose,
copolymer of vinylpyrrolidone and hydroxy ethylmethyl acrylate or
copolymer of polymethylvinyl ether and maleinic acid anyhydride.
The preferred hydrophilic polymer is polyvinylpyrrolidone.
[0052] The hydrophilic coating preferably forms a polyurea network,
whereby said polyurea network forms a covalent bond to said active
hydrogen groups in the substrate. Alternatively, the hydrophilic
coating may form an ester bond or an epoxy bond to said active
hydrogen groups in the substrate.
[0053] The coating may also comprise an osmolality-increasing
compound, as is e.g. taught in EP 0 217 771.
[0054] The elongate shaft/tube of the catheter is made of a
substrate material. The substrates may be made from any polymer
material, which are well-known in the technical field and to which
the said hydrophilic polymers adhere, such as polyurethanes, latex
rubbers, other rubbers, polyvinylchloride, other vinyl polymers,
polyesters, polyether block amid, polypropene, polyethen polyamide
and styren-ethen/buten-styren co-polymer and polyacrylates.
However, preferably the substrate is made of a polymer blend
comprising a polyolefin and a composition having molecules with
active hydrogen groups, and preferably a composition having
molecules with active hydrogen groups. The polyolefin can comprise
at least one polymer selected from the group: polyethene,
polypropene, and styrene block copolymer. The composition having
molecules with active hydrogen groups can be a polymer having
active hydrogen groups bound to the polymer via nitrogen, such as
polyamide or polyurethane.
[0055] The catheter typically comprises a flared rearward portion,
i.e. a connector end 11, connected to an elongate shaft 12, wherein
at least part of the elongate shaft is an insertable part, provided
with said hydrophilic coating on the outer surface. The connector
end may function as a connector of the catheter, being connectable
to other devices, such as a urine collection bag, a drainage tube
or the like. The forward end of the elongate shaft forms a rounded
tip portion 13, and an internal lumen extends from the tip portion,
through the elongate shaft to the connector end. However, this is
only an example of a catheter to be used in the context of the
present invention. Many other catheter types may be used in this
context as well, such as catheters having an integrally formed
funnel shaped connector end, or even without a connector. Further,
the tip portion may have many different configurations, as is per
se well known in the art. Further, several lumens may be provided
in the catheter, and it is also feasible to use external channels
instead of an internal lumen.
[0056] At least a part of the elongate tube forms an insertable
length to be inserted through a body opening of the user, such as
the urethra in case of a urinary catheter. By insertable length is
normally, in the context of a hydrophilic catheter, meant that
length of the elongate tube which is coated with a hydrophilic
material, for example PVP, and which is insertable into the urethra
of the patient. Typically, this will be 50-140 mm for a female
patient and 200-350 mm for a male patient.
[0057] The catheter is arranged in a receptacle 2, together with a
wetting fluid 3.
[0058] The wetting fluid may either be arranged in a separate
container, which is openable before use of the catheter, for
wetting of the hydrophilic coating or in direct contact with the
hydrophilic coating. In case the wetting fluid is arranged
separately from the insertable part of the catheter, the separation
wall or joint could e.g. be a breakable or peelable membrane wall,
but alternative embodiments are naturally feasible, such as various
types of detachable or openable caps or closings. For example, the
wetting fluid container may be a sachet or a pouch containing the
wetting fluid, and which is openable by application of a pressure
on the sachet/pouch. However, other ways of enabling opening of the
wetting fluid container are feasible, such as application of a
pulling force, twisting, bending, etc. Preferably the wetting fluid
may be discharged without breaking or rupturing the receptacle,
even though this may not be necessary, depending on the intended
use, etc.
[0059] The wetting fluid is preferably an aqueous liquid, such as
water or saline. Such wetting fluid containers and wetting fluids
are per se well known in the art. The wetting fluid container can
e.g. be made of sheet material comprising aluminium, or any other
material having a moisture vapour transmission rate (MVTR)
comparable to that of aluminium.
[0060] Further, the wetting fluid container may be arranged close
to the distal part of the catheter, close to the proximal part of
the catheter, or in any other suitable location in the
assembly.
[0061] In the use situation, the user opens the wetting fluid
container, preferably without opening the receptacle, so that the
wetting fluid comes into contact with the hydrophilic coating. When
the hydrophilic coating is adequately wetted, the catheter is
removed from the receptacle and inserted into the urethra.
[0062] It is also possible to provide the wetting fluid in direct
contact with the hydrophilic coating. Such an embodiment is
illustrated in FIG. 7. Hereby, the hydrophilic coating remains
constantly wetted during storage, and the catheter is consequently
ready for immediate use.
[0063] The wetting fluid is preferably an aqueous liquid, such as
sterile water, saline or the like.
[0064] In the final configuration, the receptacle is in direct
contact with the hydrophilic coating of the catheter over
essentially the entire length of the part of the catheter being
provided with the hydrophilic coating, as is shown in FIG. 1b. This
provides a very narrow pocket housing the catheter, thereby
providing a very lean product, and also significantly reducing the
amount of wetting liquid required for appropriate wetting of the
hydrophilic coating.
[0065] For easy manufacturing, it is preferred to use a receptacle
comprising a material which is shrinkable by application of e.g.
heat. Such shrink wrap packages can e.g. be made of a material
comprising or consisting of polyolefin. Preferably, the material
comprises at least two films, which are either crosslinked, or non
crosslinked. However, other materials are also feasible, including
PVC and several other compositions. The material can be of a
variety of thicknesses, clarities, strengths and shrink ratios. For
example, a shrink film of PVC may have a thickness in the range
75-100 gauge (0.75-1.00 mm) and a shrink film of polyolefin may
have a thickness in the range 60-75 gauge (0.60-0.75 mm) Both PVC
and polyolefin shrink films have excellent clarity and gloss, as
well as 40% shrink factor.
[0066] Hereby, the receptacle provides a first state, in which the
internal volume is relatively large, thereby enabling easy
insertion of the catheter and the wetting fluid in the receptacle.
This is illustrated in FIG. 1a. Thereafter, and preferably after
closing the receptacle, the package is shrunk, e.g. by application
of heat to the package, thereby reducing the package to the final
state, as is illustrated in FIG. 1b.
[0067] Depending on e.g. the type of hydrophilic coating used and
the thickness of the hydrophilic coating, a wetting fluid will
migrate and distribute adequately within the hydrophilic coating
itself. If this is the case, it is possible to provide a receptacle
which is in direct contact with the hydrophilic coating over
essentially the entire hydrophilic coating. This provides the
narrowest receptacle possible, and consequently enables the use of
a very low amount of wetting fluid.
[0068] However, for some types of hydrophilic coating, the
migration of the wetting fluid within the coating may not be
sufficient to ensure proper activation of the entire hydrophilic
coating, or at least such proper activation may take too long
time.
[0069] To ensure adequate wetting in a limited period of time, it
is preferred to provide the direct contact between the hydrophilic
coating and the receptacle in a number of contact points being
distributed around the circumference of the catheter, wherein the
contact points are discrete contact points or contact points being
continuously connected. Since the contact points are distributed
around the circumference of the catheter, a very narrow spacing
between the catheter and the receptacle is still ensured.
Preferably, the contact points are evenly distributed around the
circumference of the catheter. Such even distribution can either be
obtained by discrete contact points being arranged with essentially
the same distance from each other, or by continuously connected
contact points or groups of closely arranged discrete points being
provided at essentially the same distance from each other.
[0070] A number of embodiments illustrating such distributed
contact points will now be discussed.
[0071] According to one embodiment, as illustrated in FIG. 2a, the
receptacle is provided with a number of evenly separated and
inwardly facing ribs 21. These ribs forms protrusions protruding
inwardly from the receptacle surface, and will consequently forming
the contacts between the receptacle and the hydrophilic coating of
the catheter. Between the ribs 21, channels 22 are formed, which
efficiently distributes the wetting fluid over essentially the
entire surface of the hydrophilic coating.
[0072] Alternatively, as is illustrated in FIG. 2b, the ribs 21'
may be formed by provision of smoothly rounded channels 22'.
[0073] Additionally or alternatively, it is also feasible to
provide channels in the hydrophilic coating. Such an embodiment is
illustrated in FIG. 2c, where channels 15 are formed in the
hydrophilic coating 14.
[0074] Additionally or alternatively, it is also feasible to
provide separate extension members 4 within the receptacle, said
extension members forming a distance between the hydrophilic
coating and the receptacle. Such an embodiment is illustrated in
FIG. 2d. The extension members can e.g. be rods or the like of a
preferably flexible material.
[0075] Instead of evenly distributed contact points, it is also
feasible to provide only one or a few channels for distributing the
wetting fluid in the lengthwise direction. Such a channel 15'' may
be formed in the hydrophilic coating, as is illustrated in FIGS. 3a
and 3b. Additionally or alternatively, the channel 22'' may be
formed in the receptacle, as is illustrated in FIGS. 4a and 4b.
[0076] The contact points may form channels extending primarily in
the lengthwise direction, as is illustrated in FIGS. 1a and 1b.
Alternatively, the channels may extend helically around the
catheter, as is illustrated in FIGS. 3b and 4b. However, other
extension configurations of the channels are also feasible.
[0077] In the embodiment illustrated in FIG. 1b, the wetting fluid
container is arranged above the connector end of the catheter, i.e.
opposite the insertion end. However, it is also possible to arrange
the wetting fluid container above the insertion end, i.e. opposite
the connector end. Such an embodiment is illustrated in FIG. 5.
[0078] Further, in order to reduce the amount of wetting fluid
necessary to adequately wet the hydrophilic coating of the
catheter, it is not necessary to make the entire receptacle narrow.
The same effect is achievable as long as the part of the receptacle
housing the insertable part of the catheter is made sufficiently
narrow. Consequently, other parts of the receptacle may be still be
relatively large. For example, it is possible to provide a
receptacle having an enlarged portion housing the wetting fluid
container. Such an enlarged part of the receptacle may e.g. be use
for collecting the drained urine, i.e. forming a urine collection
bag. Such an embodiment is illustrated in FIG. 6.
[0079] Production of the catheter assembly illustrated in FIG. 6 is
still relatively simple. For example, only the forward part of the
receptacle, i.e. the part housing the insertable part of the
catheter, may be shrunk, e.g. by applying heat selectively only on
this part of the receptacle. Additionally or alternatively it is
possible to use a thicker material, or even a different type of
material, in the different parts of the receptacle.
[0080] The contact points may be arranged as continuous lines.
However, it is also possible to use contact points formed as
separated lines, comprising groups of contact points. However,
according to another embodiment, it is also possible to use
discrete contact points being evenly distributed over internal
surface of the receptacle. Such an embodiment is illustrated in
FIG. 8. Hereby, a multitude of channels, each being in contact with
each other, are formed.
[0081] In order to facilitate opening of the package, for
withdrawal of the catheter before use, the receptacle is preferably
provided with areas or lines of weakness for facilitating opening
of the receptacle. Further, tabs for tearing may be provided to
further facilitate opening.
[0082] Additionally or alternatively, other opening means may be
provided, such as peelable openings and the like.
[0083] In FIGS. 1B, 5, 7 and 9, peel openings are indicated in both
the top and bottom end of the receptacle. However, alternatively,
openings may be provided only on one of said side. The openings may
also be tear openings, and if tear openings are used, the openings
may also be provided at a distance from the ends.
[0084] In all the above-discussed embodiments having a wetting
fluid container, it is also possible to provide the wetting fluid
container with rounded edges, in order to reduce the strain on the
receptacle. Such an embodiment is illustrated in FIG. 9. Further,
it is possible to arrange the catheter with its insertion end or
the discharge end (connector end) partly overlapping the wetting
fluid container. Such an embodiment is also illustrated in FIG.
9.
[0085] A system for manufacturing a catheter assembly of the
above-discussed type preferably comprises means for enclosing a
wetting fluid and a hydrophilic catheter in a receptacle and means
for applying heat to the receptacle, thereby making it shrink,
whereby the receptacle, at least partly comes into direct contact
with the catheter.
[0086] 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.
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