U.S. patent application number 13/714940 was filed with the patent office on 2013-06-27 for catheter assembly with resealable opening.
This patent application is currently assigned to DENTSPLY International Inc.. The applicant listed for this patent is DENTSPLY International Inc.. Invention is credited to Evelina GUSTAVSSON.
Application Number | 20130161208 13/714940 |
Document ID | / |
Family ID | 45463379 |
Filed Date | 2013-06-27 |
United States Patent
Application |
20130161208 |
Kind Code |
A1 |
GUSTAVSSON; Evelina |
June 27, 2013 |
CATHETER ASSEMBLY WITH RESEALABLE OPENING
Abstract
A medical device assembly is disclosed, comprising a medical
device, preferably having a hydrophilic surface coating, and a
package accommodating said medical device. The package if formed of
two sheets of foil material, a first foil of which has been deep
drawn into a trough shape, the package further comprising a
resealable opening arranged within the bounds of the second foil.
The medical device may e.g. be a urinary catheter.
Inventors: |
GUSTAVSSON; Evelina;
(Onsala, SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DENTSPLY International Inc.; |
York |
PA |
US |
|
|
Assignee: |
DENTSPLY International Inc.
York
PA
|
Family ID: |
45463379 |
Appl. No.: |
13/714940 |
Filed: |
December 14, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61580464 |
Dec 27, 2011 |
|
|
|
Current U.S.
Class: |
206/210 ;
206/364; 53/456 |
Current CPC
Class: |
A61M 2025/0046 20130101;
A61M 25/0045 20130101; A61M 25/0017 20130101; B65B 5/02 20130101;
B65D 75/00 20130101; A61M 25/002 20130101 |
Class at
Publication: |
206/210 ;
206/364; 53/456 |
International
Class: |
A61M 25/00 20060101
A61M025/00; B65B 5/02 20060101 B65B005/02 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 27, 2011 |
EP |
11195736.1 |
Claims
1. A medical device assembly comprising a medical device,
preferably having a hydrophilic surface coating, and a package
accommodating said medical device, wherein the package if formed of
two sheets of foil material, a first foil of which has been deep
drawn into a trough shape, the package further comprising a
resealable opening arranged within the bounds of the second
foil.
2. The medical device assembly of claim 1, wherein the two sheets
of foil material are joined along the edges of the foils.
3. The medical device assembly of claim 1, wherein the two sheets
of foil material are joined together by means of welding.
4. The medical device assembly of claim 1, wherein the medical
device is a catheter and the resealable opening is arranged at, and
preferably overlying, the part of the package housing the
non-insertable, rearward end of the catheter.
5. The medical device assembly of claim 1, wherein the medical
device is a catheter, and preferably a urinary catheter, and most
preferably a urinary catheter for intermittent use.
6. The medical device assembly of claim 1, wherein the resealable
opening in the second sheet comprises a perforation line extending
along a non-closed loop in one of said sheets, said perforation
line defining a flap opening, and a third sheet connected by means
of an adhesive over said flap opening, wherein said third sheet
with a margin covers the entire flap opening.
7. The medical device assembly of claim 6, wherein said adhesive is
adapted to maintain a sterile closure of the package before use,
and to be resealable after use.
8. The medical device assembly of claim 7, wherein said third sheet
further forms a tab not provided with adhesive, said tab providing
a grip portion for peel opening of the package.
9. The medical device assembly of claims 6, wherein the medical
device is a catheter, and the non-closed loop defining the flap
opening debouches towards the end of the package housing the
insertion end of the catheter.
10. The medical device assembly of claim 8, wherein the medical
device is a catheter, and the non-closed loop defining the flap
opening debouches towards the end of the package housing the
insertion end of the catheter.
11. The medical device assembly of claim 6, wherein the third sheet
covers the entire flap opening with a margin exceeding 2 mm.
12. The medical device assembly of claim 10, wherein the third
sheet covers the entire flap opening with a margin exceeding 2
mm.
13. The medical device assembly of claim 6, wherein the non-closed
loop has loop ends directed towards the interior of the non-closed
loop.
14. The medical device assembly of claim 12, wherein the non-closed
loop has loop ends directed towards the interior of the non-closed
loop.
15. The medical device assembly of claim 1, wherein the assembly
further comprises a wetting fluid for activation of said
hydrophilic surface coating, said wetting fluid being accommodated
by said package.
16. The medical device assembly of claim 15, wherein the wetting
fluid is arranged separately from said medical device in said
package, and preferably being arranged in a wetting fluid container
arranged within said package.
17. The medical device assembly of claim 1, further comprising a
fourth sheet arranged on the first sheet, on the side of said
package being opposed to the resealable opening, said fourth sheet
being connected by means of an adhesive to said first sheet, and
forming a tab not provided with adhesive, said tab providing a grip
portion for exposure of said adhesive to form a holding arrangement
for said package.
18. The medical device assembly of claim 1, wherein the first and
second sheets comprise laminated sheets, having a weldable inner
layer and a protective outer layer.
19. A method of producing a medical device assembly comprising the
steps: providing a medical device, preferably having a hydrophilic
surface coating or being formed of a hydrophilic material; and
accommodating the medical device in a package, said package
comprising: a first and a second sheets of foil material connected
around the edges, a first foil of which has been deep drawn into a
trough shape, the package further comprising a resealable opening
arranged within the bounds of the second foil.
Description
RELATED APPLICATIONS
[0001] This patent application claims the benefit of and priority
to EP Application Ser No. 11195736.1, filed on Dec. 27, 2011 and
U.S. Provisional Patent Application Ser. No. 61/580,464, filed on
Dec. 27, 2011, which are herein incorporated by reference for all
purposes.
TECHNICAL FIELD OF THE INVENTION
[0002] The present invention relates to a medical device assembly
comprising a medical device and a resealable package accommodating
the medical device. Specifically, the invention pertains to a
medical device having a hydrophilic surface coating, wherein the
assembly also includes a wetting fluid for activation of the
hydrophilic surface coating. The invention is particularly related
to catheters, and specifically to urinary catheters.
BACKGROUND OF THE INVENTION
[0003] The present invention relates to a medical device assembly,
and in particular for urinary hydrophilic catheters. Catheters are
commonly used for draining bodily fluids, e.g. from the bladder.
Urinary catheters are e.g. used by a large group of persons for
intermittent catheterization, which is a daily-life procedure,
taking place several times a day. Typically catheters for
intermittent catheterization are used by patients suffering from
urinary incontinence or by disabled individuals like para- or
tetraplegics. Using an intermittent catheter, the bladder may be
drained through a natural or artificial urinary canal. Many
catheters for intermittent catheterization are provided with a
hydrophilic coating or the like, providing a smooth and slippery
surface when wetted, for safe and comfortable insertion in the
urinary canal.
[0004] Many hydrophilic catheter assemblies include a supply of
wetting fluid, either in direct contact with the catheter or in a
separate compartment, for clean and convenient activation of the
hydrophilic surface before use.
[0005] However, there is still a need for improved packages for
such catheter assemblies. The package should preferably be
relatively simple and cost-efficient to produce. Further, the
package should be easy to open, even for users with reduced
dexterity. Still further, the package should enable adequate
wetting of the catheter, and handling of the package in a clean
manner. The package should also preferably be rather small, so that
it can easily be carried around by the user in his/her daily life.
It would also be highly advantageous if the package is resealable,
so that the catheter package could be re-closed after use, if it
cannot be immediately disposed of In particular, it would be
advantageous if the package would be resealable to enclose also a
wet product and/or a wetting fluid without any risk for
spillage.
[0006] Patent application US 2011/056852 by the same applicant
discloses a urinary catheter assembly having a resealable opening.
However, even though this catheter assembly is highly useable for
short catheters, for female users, re-insertion of longer
catheters, typically for male users, may be cumbersome and with the
risk of spillage and the like. Male catheters may be 40 cm long, or
even longer, and insertion of the tip portion through the
resealable opening without touching the insertable part of the
catheter is rather difficult, especially for users with reduced
dexterity. Further, closing of the resealable opening after
re-insertion of the catheter in a sufficiently sealed manner may
also be difficult with this known catheter assembly, and again,
especially for users with reduced dexterity. There is therefore a
need for a catheter assembly with resealable opening enabling
easier re-insertion of the catheter.
[0007] Many other types of medical devices face similar
problems.
[0008] In conclusion there is still a need for an improved medical
device assembly of the above discussed general type.
SUMMARY OF THE INVENTION
[0009] It is therefore an object of the present invention to
provide a medical device assembly which at least alleviates the
above-discussed problems.
[0010] This object is obtained by means of a medical device
assembly and a method in accordance with the appended claims.
[0011] According to a first aspect of the invention, there is
provided a medical device assembly comprising a medical device, and
preferably a urinary catheter, and also preferably having a
hydrophilic surface coating, and a package accommodating said
medical device, wherein the package is formed of two sheets of foil
material, a first foil of which has been deep drawn into a trough
shape, the package further comprising a resealable opening arranged
within the bounds of the second foil.
[0012] In the context of the present application, "resealing"
relates to closure of a previously opened opening, wherein the
closure forms closure that at least to a large extent prevents
liquid from leaking out from the closure.
[0013] In the context of the present application, "deep drawn"
defines any process forming a permanent deformation of a plastic
material, such as vacuum forming and other types of thermoforming
by means of heating, and the like. In a preferred embodiment,
vacuum forming is used. In vacuum forming, the sheet is heated to a
forming temperature, stretched onto or into a single-surface mold,
and held against the mold by applying vacuum between the mold
surface and the sheet. The mold may e.g. be a cast or machined
aluminum mold, or a composite mold.
[0014] In the context of the present application, "trough" defines
a shape having a rim, thin or wide, encircling a lowered middle
section.
[0015] The rim is preferably provided with an essentially planar
edge portion, encircling the lowered middle section. The depth of
the lowered middle section is preferably sufficient to entirely
accommodate the height of the medical device and/or the height of a
wetting fluid container. Preferably, the depth is in the range
0.2-3 cm, and preferably in the range 0.5-2 cm, and most preferably
in the range 0.7-1.5 cm. It is further possible to have different
depths in different parts of the package. For example, a part
housing anon-insertable catheter end, and optionally a wetting
fluid container, may have a greater depth than a part housing an
insertable part of a catheter.
[0016] The second foil is preferably not deep-drawn. Instead, this
foil is preferably essentially planar, or only slightly curved.
[0017] This package is very well suited for use for catheters, and
in particular hydrophilic catheters, i.e. catheters being provided
with a hydrophilic surface coating or catheters being made of a
hydrophilic material. The package enables easy, clean and efficient
wetting and handling of the hydrophilic catheter, and also provides
sterile conditions for the entire wetting process. At the same time
the package is relatively simple and cost-efficient to produce. In
particular, the catheter assembly is well-suited for the type of
assemblies including a hydrophilic catheter and a wetting fluid
being accommodated by the package. The wetting fluid may e.g. be
arranged directly in contact with the hydrophilic surface of the
catheter, or in a separate compartment of the package or in a
separate container being housed by the package.
[0018] Since the resealable opening is arranged in a non-deep
drawn, and preferably essentially planar sheet, opening and
re-closing of the resealable opening is greatly facilitated. It has
been found by the present inventor that re-arranging a resealable
opening into a sealed and sufficiently closed condition is much
simpler on a planar or only slightly curved surface than on
surfaces curved in one or several directions. This is particularly
advantageous for users having reduced dexterity.
[0019] Further, during manufacturing, formation of the resealable
opening is also facilitated, enabling a more cost-efficient
production.
[0020] Still further, since the first sheet underlying the second
sheet with the resealable opening is deep drawn into a trough
shape, a spacing between the first and second sheets are formed and
continuously maintained. This spacing essentially corresponds to
the depth of the lowered middle section of the deep drawn trough.
Hereby, it is avoided that the catheter deforms the second sheet to
any significant degree. It is further ensured that there is a
spacing between the sheets also after withdrawal of the catheter
from the package. This greatly facilitates re-insertion of the
medical device, since re-insertion of the medical device hereby
does not necessitate separation of the sheets. Instead, the medical
device may simply be guided through the resealable opening into the
already available compartment formed between the sheets. This is
particularly advantagoues for use with relatively long medical
devices, such as long catheters, when manipulation of the tip
portion of the catheter by holding the rearward connector end is
complicated if it involves any other actions than simply guiding
the tip into a preformed compartment of sufficient dimensions.
Further, this simplified re-insertion is highly advantageous for
users with reduced dexterity.
[0021] Preferably, the medical device is a hydrophilic urinary
catheter for intermittent use. However, even though the catheter
assembly is at present primarily intended for urinary hydrophilic
catheters, where the package also includes a wetting fluid, the
catheter assembly may also be used for other types of catheters.
For example, the catheter may be other types of catheters, such as
vein catheters and the like. Further, the catheter may be provided
with other types of lubricious coatings, such as gel lubricants and
the like, or being without any surface coating at all. Still
further, assemblies without a wetting fluid are also feasible.
Still further, the assembly of the present invention may also be
used for other types of medical devices than catheters.
[0022] The two sheets of foil material are preferably joined along
the edges of the foils, and preferably connected around the edges
by means of welding. Preferably, the first and second sheet
materials comprise laminated sheets, having a weldable inner layer
and a protective outer layer.
[0023] The resealable opening is preferably arranged at, and
preferably overlying, the part of the package housing the
non-insertable, rearward end of the medical device/catheter.
Hereby, the medical device/catheter may be withdrawn with the
connector end first, which enables a clean and convenient way of
handling the catheter without touching the insertable part directly
by hand.
[0024] Preferably, the resealable opening is arranged as a peel
opening. Most preferably, the resealable opening in the second
sheet may comprise a perforation line extending along a non-closed
loop in one of said sheets, said perforation line defining a flap
opening, and a third sheet connected by means of an adhesive over
said flap opening, wherein said third sheet with a margin covers
the entire flap opening. The third sheet further preferably forms a
tab not provided with adhesive, said tab providing a grip portion
for peel opening of the package.
[0025] By "perforation" is meant a diminished material thickness,
possibly extending over the entire thickness, providing a complete
cut-through. By means of "perforation line" is meant a line with
continous or discontinous perforations. Thus, in the context of the
present application, "perforation line" is used to indicate a line
forming a weakening, such as a total cut-through, a partial
cut-through, point perforations, or the like, forming a weakening
where a rupture will occur when a force is exerted on the
material.
[0026] Such a resealable opening is efficient and easy to use, and
also relatively simple to produce. The tab enables a very simple
peel-opening of the package. At the same time, the flap opening
provides an efficient way of removing the medical device, and also
for resealing of the package, once the medical device has been used
and been replaced in the package.
[0027] In production, one of the first and second sheets may be
provided with the non-closed loop perforation line, by means of
cutting or the like, and the third sheet material can thereafter be
adhered on top of it. Alternatively, the third sheet material can
be added first and the perforated line (or total cut) could be
formed afterwards.
[0028] The adhesive is preferably adapted to maintain a sterile
closure of the package before use, and to be resealable after
use.
[0029] The non-closed loop defining the flap opening preferably
debouches towards (i.e. faces) the end of the package housing the
insertion end of the medical device/catheter. Hereby, the tab is
arranged close to the end of the package, and the peeling occurs
downwards, towards the insertion end of the medical
device/catheter, which is efficient for avoiding spillage of the
wetting fluid within the package after activation, especially when
the medical device assembly is hanged, adhered or otherwise
arranged in a vertical direction during withdrawal from the package
and re-insertion into the package.
[0030] The third sheet preferably covers the entire flap opening
with a margin exceeding 2 mm, and preferably exceeding 5 mm.
Hereby, a sterile seal may be obtained before opening of the
package, and at the same time an adequate resealing capability may
be obtained.
[0031] The non-closed loop of the perforation line preferably forms
a tongue directed inwardly towards the non-closed opening of the
non-closed loop.
[0032] Further, the non-closed loop preferably has loop ends
directed towards the interior of the non-closed loop. Hereby, it is
efficiently avoided that the third material sheet is peeled off
completely.
[0033] The third sheet further preferably comprises a weakened area
forming a seal integrity mark. Hereby, it is ensured that the seal
has not been broken before use, ensuring full integrity of the
product. Preferably, the seal integrity mark is arranged between
the tab and the part of the third sheet overlying the perforation
line.
[0034] Preferably a wetting fluid is also included in the assembly.
The wetting fluid may be arranged in direct contact with the
hydrophilic surface of the medical device. However, preferably the
wetting fluid is arranged separately from said medical device
within the package. The separate arrangement of the wetting fluid
can be obtained by means of closed compartment within the package.
However, in a preferred embodiment, the wetting fluid is arranged
in a wetting fluid container arranged within said package, such as
in a pouch, sachet or the like. In case the wetting fluid is
arranged separately, the container or compartment is openable into
the part of the package housing the medical device, in order to
enable release of the wetting fluid into contact with the
hydrophilic part of the medical device before use. Release of the
wetting fluid can be obtained by squeezing, bending or the like, as
is per se well known in the art.
[0035] The medical device assembly may further comprise a fourth
sheet arranged on the first sheet, on the side of said package
being opposed to the resealable opening, said fourth sheet being
connected by means of an adhesive to said first sheet, and forming
a tab not provided with adhesive, said tab providing a grip portion
for exposure of said adhesive to form a holding arrangement for
said package. By means of this fourth sheet material, the medical
device assembly may e.g. be attached to a sink, a wall or the like,
which enables very efficient and easy handling of the product, even
for user with reduced dexterity.
[0036] The package is preferably elongate, and preferably narrowly
surrounding the medical device and the optional wetting fluid
compartment. For example, the package may have an essentially
rectangular form in the forward section, and a larger and also
essentially rectangular form in the rearward section. Hereby, a
very cost-efficient and compact product is obtained.
[0037] According to a second aspect of the invention, there is
provided a method of producing a medical device assembly comprising
the steps: providing a medical device, preferably a hydrophilic
catheter, i.e. a catheter having a hydrophilic surface coating or
being made by a hydrophilic material; and accommodating the medical
device, and optionally also a wetting fluid, in a package, said
package comprising: a first and a second sheets of foil material
connected around the edges, a first of which has been deep drawn
into a trough shape, the package further comprising a resealable
opening arranged within the bounds of the second foil.
[0038] 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
[0039] 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:
[0040] FIG. 1 illustrates a perspective view of a medical device
assembly in accordance with an embodiment of the present invention;
and FIG. 2 illustrates an exploded view of the medical device
assembly in FIG. 1.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0041] In the following detailed description preferred embodiments
of the 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, e.g. the
length of the medical device, etc.
[0042] The medical device assembly can be used for many types of
medical devices. However, it is particularly suited for catheters.
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, hydrophilic urinary catheters, even though the
invention is not limited to this particular type of catheters, and
also not to catheters.
[0043] The catheter assembly as illustrated in FIGS. 1-2 comprises
a catheter 1 having a hydrophilic surface coating, a wetting fluid
for activation of said hydrophilic surface coating and a package 3
accommodating the catheter and the wetting fluid.
[0044] The catheter 1 may be any type of hydrophilic catheter, as
is per se well known in the art. Preferably, the catheter comprises
a flared rearward portion, forming a flared connector 11, and an
elongated shaft 12, connected to the flared connector 11, and in
the opposite end having a catheter insertion end 13.
[0045] An applicator 14, in the form of e.g. a tube, sleeve or
cuff, may be releasably attached to the connector 11, in order to
be release from the connector prior to insertion, and to aid in
manipulating the catheter during insertion without directly
contacting the catheter surface.
[0046] At least a part of the elongate shaft 12 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 shaft 12 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. Even though PVP is the
preferred hydrophilic material, other hydrophilic materials may be
used, such as hydrophilic polymers 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 coating may also comprise an
osmolality-increasing compound, as is e.g. taught in EP 0 217
771
[0047] The wetting fluid is preferably arranged separate from the
catheter, in a wetting fluid container 2, such as a pouch or a
sachet. The wetting fluid container is operable by means of e.g.
exerting a pressure to the container, whereby the wetting fluid is
released into the package, thereby wetting the hydrophilic surface
of the catheter. The wetting fluid is preferably a liquid, and most
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 flexible material used for wetting fluid pouch is
preferably a flexible material which provides a moisture barrier or
low water vapor transmission. The flexible material may e.g.
comprise or consist of one or several of aluminum, aluminum oxide,
silicone oxide, metallocene polyvinylidene chloride (PVdC) and
poly(ethylene-vinylalochol) (EVOH). For example, the flexible
material can be made as coextruded polyolefines with polyamides,
poly(ethylene terephthalate) (PET), including barrier resins such
as polyvinylidene chloride (PVdC) or poly(ethylene-vinylalochol)
(EVOH). However, other materials exhibiting similar properties are
also feasible.
[0048] The wetting fluid may be any fluid that wets a hydrophilic
surface of the catheter.
[0049] Preferably, the wetting fluid container 2 is arranged close
to, and most preferably overlying, the connector end of the
catheter.
[0050] The package comprises a first sheet material 4 and a second
sheet material 5, connected around the edges to form an inner
cavity housing the catheter and the wetting fluid. The first and
second sheet materials are preferably connected around the edges by
means of welding, forming a welded edge joint 6. Preferably, the
first and second sheet materials comprise laminated sheets, having
a weldable inner layer and a protective outer layer.
[0051] The sheet materials are preferably of a flexible plastics
material. The material may be transparent, but opaque or
semi-opaque materials may also be used. For example, the sheets can
be made of polymer materials such as polyethene (PE), polypropylene
(PP), polyamide (PA), poly(ethylene terephthalate) (PET), oriented
polypropylene (OPP), oriented polyamide (OPA), etc. Also, the
receptacle can be made from a laminate of such polymer materials
and/or aluminum, aluminum oxide or other materials functioning as
barrier materials.
[0052] The first sheet material 4 is deep drawn into a trough
shape, thereby forming an upper rim 41, to be in contact with the
second sheet material 5, and a lower middle section, formed to
accommodate the catheter and the wetting fluid sachet. The rim is
preferably provided with an essentially planar edge 42 surrounding
the lowered middle section. The planar edge may have any
dimensions, such as being very thin or being relatively wide.
Further, the planar edge may have various dimensions around the
circumference. The second sheet material 5 is preferably
essentially planar, or only slightly curved.
[0053] The second sheet material 5 comprises a resealable opening
7. The resealable opening preferably comprises a perforation line
71 in the second sheet material, extending along a non-closed loop
defining a flap opening. The non-closed loop defining the flap
opening is preferably arranged over the connector end of the
catheter 1. Further, the non-closed loop preferably has an opening
72 debouching towards the end of the package housing the insertion
end of the catheter. At the end, the non-closed loop preferably
forms a tongue 73 directed inwardly towards the non-closed opening
of the non-closed loop. The loop ends, at the opening 72, are
preferably directed towards the interior of the non-closed
loop.
[0054] The non-closed loop generally forms a C- or U-shape.
[0055] The reseablable opening further preferably comprises a third
sheet material 74, arranged over the non-closed loop, and connected
to the second sheet material 5 by means of an adhesive. The third
sheet material is preferably arranged to cover the entire flap
opening with a margin, preferably exceeding 2 mm, and most
preferably exceeding 5 mm. An end of the third sheet material is
not adhered to the first sheet material, and forms a tab 75
providing a grip portion for peel opening of the package. The tab
is preferably arranged in the end directed towards the insertable
part of the catheter. Further, the tab may be provided with
gripping means to facilitate gripping of the tab. The gripping
means may e.g. be one or several of a surface coating, surface
roughening, corrugations, embossment, perforations or a larger
gripping opening, etc.
[0056] The adhesive is adapted to maintain a sterile closure of the
package before use, and to be resealable after use. The adhesive
preferably has a strength to withstand a pulling force in the range
of 3-10 N. The adhesive can e.g. be an acrylate emulsion, or an
acrylate based hot melt adhesive.
[0057] The third sheet material further preferably comprises a
weakened area forming a seal integrity mark. Hereby, it is ensured
that the seal has not been broken before use, ensuring full
integrity of the product. Preferably, the seal integrity mark is
arranged between the tab and the part of the third sheet material
overlying the perforation line. The weakened area preferably
comprises weakened or perforated lines arranged in a pattern, e.g.
as illustrated in the drawings, making part of the third sheet
material to remain adhered to the first sheet material during peel
off of the third sheet material.
[0058] The catheter assembly may further comprise a fourth sheet
material 8 arranged on the first sheet material, i.e. on the side
of the package being opposed to the third sheet material and the
resealable opening. The fourth sheet material is also connected by
means of an adhesive to the package, and forms a tab 81 not
provided with adhesive, said tab providing a grip portion for
exposure of said adhesive to form a holding arrangement for the
package. By means of this fourth sheet material, the catheter
assembly may e.g. be attached to a sink, a wall or the like, which
enables very efficient and easy handling of the product, even for
user with reduced dexterity.
[0059] In order to ensure that the fourth sheet materials are not
removed completely during peeling, perforated lines (not shown) may
be arranged on one or preferably both of the sides. The perforated
lines preferably extend from the outer side of the fourth sheet
material, about in the center of the sheet material, towards the
interior of the sheet in a direction away from the pulling tab. The
tear line preferably ends in a hook or the like towards the side of
the sheet, but not extending entirely to the side of the sheet.
[0060] Alternatively, the fourth sheet may comprise two separate
sheets: An inner sheet 8, which is connected to the first sheet by
means of e.g. adhesive 81, and an outer sheet 9, which is connected
to the inner sheet. The connection between the inner and outer
sheet may also be provided by means of adhesive 91. The adhesive
may be provided on either the outer surface of the inner sheet or
the inner surface of the outer sheet, or preferably on both. A tab
93 is provided in the outer sheet to allow for simple separation of
the inner and outer sheets. In an area 92 opposite the tab 93, the
connection between the inner and outer sheets is made stronger,
e.g. by using a stronger adhesive. Hereby, separation of the two
sheets, which is initiated by pulling the tab 93, is stopped at
this area 92, and the exposed areas with adhesive on the inner
and/or outer sheets may be used to attach the package to any
suitable surface or object.
[0061] The third and fourth sheet materials may e.g. be of
polypropene (polypropylene), polyester or polyethene
(polyethylene).
[0062] In a preferred embodiment, the package is elongate, and
preferably has an essentially rectangular forward part, in the form
of an elongate pocket, and an enlarged rearward part. The enlarged
reraward part may be rectangular or of other shapes, such as having
rounded corners, etc. The enlarged rearward part is preferably
dimensioned to accommodate the catheter connector and the wetting
fluid container. The elongate pocket is preferably dimensioned to
accommodate, and narrowly surround, the insertable part of the
catheter. Hereby, a very compact product is obtained.
[0063] In use, the wetting fluid container is opened, for
activation of the hydrophilic surface of the catheter. After
sufficient wetting, the tab of the fourth sheet may be peeled, so
that the catheter assembly can be connected to a sink or the like.
The tab of the third sheet is peeled open, and the catheter is
removed and used. Thereafter, the catheter may be re-inserted, and
the package can then be closed, and stored for later disposal.
[0064] A method of manufacturing the above-discussed catheter
assembly preferably comprises the following steps of producing the
package, performed in any order: providing a first and second sheet
material; deep drawing the first sheet into the appropriate trough
shape; providing a resealable opening, e.g. by the sub-steps of:
providing the non-closed loop perforated line in the second sheet
material by cutting the material; providing third sheet materials;
optionally, providing the perforated lines in the third sheet
material; adhering the third sheet material to the first sheet
material; connecting the first and second sheet material to each
other along the edges, e.g. by means of welding; optionally,
providing a hanging means, e.g. in the form of an adhesive, which
may include the sub-steps: providing one or two sheet(s) of a
fourth sheet material; optionally, providing the perforated lines
in the fourth sheet material; and adhering the fourth sheet
material to the first sheet material.
[0065] In addition, the catheters and the wetting fluid container
is provided and arranged within the package before the package is
finally closed, and sterilization of the product is provided by
means of e.g. radiation.
[0066] The third and fourth sheet material may be provided on large
sheets, arranged on a layer of adhesive, and with the perforation
lines pre-arranged before assembly.
[0067] 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 in the described embodiments has been arranged
separated from the catheter, in a wetting fluid container, it is
also possible to arrange the wetting fluid in direct contact with
the catheter, thereby always maintaining a ready-to-use state.
Further, if a wetting fluid container is used, it is possible to
arrange this container close to the connector end of the catheter,
close to the insertion end of the catheter, or at any other
location within the receptacle. Still further, resealable openings
may be provided in other forms than in the above-indicated
preferred embodiment. Further, a package without the fourth sheet
is feasible, and other sheets may also be used. Further, other
shapes for the various perforation lines are feasible. 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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