Note: Descriptions are shown in the official language in which they were submitted.
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An Assembly for Wetting a Medical Device
The invention relates to an assembly for wetting a medical device with a fluid
medium,
which fluid medium may include an antimicrobial agent. The assembly may be
used for
wetting a urinary catheter.
Background
Urinary catheters are widely used for intermittent catherization -
particularly in connection
with operative procedures, where the caregiver is performing the intermittent
catherization
and in connection with spinal cord injuries, where the user is left without
control of the
bladder. To reduce the risk of damage to the urethral wall, the catheters are
typically
coated with a coating imparting an extremely low friction on the surface of
the catheters.
This coating is normally activated by application of a fluid medium (e.g. tap
water or
sterilized water) to the coating - either in the production stage or just
prior to use. If the
coating is activated just prior to use, the fluid medium may be provided in a
separate
compartment with the medical device thus forming an assembly comprising a
package for
the medical device and a compartment for the fluid medium. Such assemblies are
shown
in e.g. W02006/092150. This patent application provides an assembly for
preparing a
medical device, in particular a urinary catheter, by releasing a fluid medium
onto the
device. The device is packed in a package, which contains the fluid medium
confined in a
compartment. DE10334372 provides a catheter system for urine withdrawal,
comprising a
tube for inserting into the human or animal body, which is provided with a
coating that can
be activated by means of liquid, and a compartment for containing the liquid
which
compartment contains a disinfectant dissolved in the liquid.
Some users of catheters experience Urinary Tract Infections (UTI) very often -
30%
experience more than 3 UTI's per year and 10% experience more than 6 UTI's per
year.
To reduce risk of infection the medical device as well as the fluid medium may
be
sterilized. For the fluid medium this is particularly the case if the fluid
medium is
prepacked with the medical device in an assembly. It may be beneficiary to be
able to
sterilize the medical device and the fluid medium separately and then attach
the closed
package containing the medical device and the closed compartment containing
the fluid
medium to each other following the sterilization process. This leaves a need
for a
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connection between the compartment containing the fluid medium and the package
containing the medical device.
However, there is a need to further reduce the risk of urinary tract
infections by applying
an anti-microbial composition just prior to catheterization.
Summary of the Invention
The invention concerns an assembly for wetting a medical device comprising a
compartment for a fluid medium and a package for the medical device. The
compartment
and the package are separate elements but are joined together such that an
outlet from
the compartment is movable from a position out of contact with an entrance to
the
package to a position in contact with the entrance. In the last position - the
use-position -
the fluid is able to flow from the compartment and into the package.
The moving of the outlet from the compartment may be done in several ways
including
displacing, pivoting or moving to another position.
The invention also concerns a method of manufacturing such an assembly and a
method
of using it to wet a catheter.
Detailed Description of the Invention
In a first aspect of the invention, the invention relates to an assembly for
wetting a medical
device comprising a compartment for a fluid medium and a package for
containing the
medical device, where the package and the compartment are separate elements
which
are joined together, where an outlet from the compartment is movable from a
storage-
position out of contact with an entrance to the package to a use-position in
contact with,
and connected to, the entrance to the package such that upon connection
communication
between the fluid in the compartment and the interior of the package is
established
through means for providing a flow of the fluid between the compartment and
the
package.
The outlet being out of contact with the entrance in the storage-position
prevents the fluid
medium from prematurely and accidentally entering into the package, e.g.
during
assembly, storage and prior to use. The user needs to actively move the outlet
into a
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position where it is in contact with the entrance and only when this is done,
the fluid can
be activated to flow into the package. This also leads to manufacturing
advantages as the
joint between the compartment and the package is different from the connection
providing
for the fluid contact. This means that this joint may be made without paying
regards to the
needs for providing fluid communication through the connection.
The compartment is a separate element from the package. These two separate
elements
may thus be produced, closed and sterilized separately. When the assembly is
assembled
the two elements are joined to each other - the compartment is not introduced
into the
package. This means that the assembly can be assembled without compromising
the
sterility of either part, or outside of a sterile-room. Thereby the risk of
introducing bacteria
into the package and thus into contact with the medical device is minimized.
Furthermore,
local distribution centers may be able to do individual assembles of e.g.
catheter-types
and sterilization fluids.
The fluid medium may be water or a saline-solution, e.g. physiological 0.9%
saline-
solution. In an embodiment it may include an anti-microbial such as hydrogen
peroxide.
Using hydrogen peroxide provides an anti-microbial effect to the medical
device, which
helps prevent infections.
Generally, the medical device contained in the package defines a longitudinal
direction of
the package.
By a movable outlet is meant an outlet, which in itself is movable as well as
an outlet
placed on a movable compartment.
In an embodiment the outlet is movable in the longitudinal direction of the
package and
the movement between the storage-position and the use-position is at least 1
cm, as
measured as the shortest possible distance traveled by the outlet between the
storage-
position and the use-position.
In another embodiment the outlet is movable such that it in a storage-position
faces away
from the entrance and in a use-position faces the entrance. The face of the
outlet is
generally perpendicular to the direction in which the fluid pours out. In this
embodiment
the outlet may be placed generally within the longitudinal direction of the
package or it
may be placed in a plane parallel to the longitudinal direction.
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The outlet may also be movable such that a movement of the outlet from the
storage-
position to the use-position follows a circular arc. The outlet following a
circular arc
corresponds to the outlet undertaking a pivoting motion or movement around a
centre of
the circle. This centre may e.g. be defined by a hinge-element. In such an
embodiment
the movement of the outlet may be as low as 2mm's defined as the shortest
possible
distance traveled by the outlet between the storage-position and the use-
position
Another embodiment relates to the outlet being movable such that a movement of
the
outlet from the storage-position to the use-position is a transverse movement.
By a
transverse movement is meant a movement in a plane perpendicular to the axis
defined
by the longitudinal direction of the package.
Often the outlet defines a circular plane. Yet another pattern of movement is
when the
circular outlet plane is moved along the axis defined by the longitudinal
direction of the
package while the plane is kept parallel to the axis defined by the
longitudinal direction of
the package.
All of these embodiments provide an increased security against the outlet
accidentally
connecting to the entrance of the package and hence wet the catheter
prematurely.
Common to all movement patterns is the separation of the movement patterns
from the
joint between the compartment and the package. Hereby a different movement
than the
movement of the outlet makes the joining of the compartment to the package.
Thus,
during manufacturing the risk of continuing the joining movement and thereby
of breaking
the seal of the compartment is minimized.
A storage-position is defined as a position where the outlet of the
compartment and the
entrance to the package is not connected to each other, but where the
compartment and
the package are joined together. It corresponds to the position in which the
assembly will
be stored following manufacturing and prior to use. A use-position is defined
as a position
where the outlet of the compartment and the entrance to the package is
connected to
each other, such that there may be fluid communication between the compartment
and
the interior of the package.
If the connection between the outlet and the entrance is rather small, then
the fluid in the
compartment may not be able to enter the package, as there is no interchange
between
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air in the package and the fluid in the compartment. Hence, means for
providing a flow of
fluid is provided. These means may include an air-channel provided anywhere in
the
compartment such that air will flow into the compartment and assist in forcing
the fluid out
of the compartment. The fluid may also be squeezed out of the compartment by
applying
5 an external force to the compartment. This implies that air may be
interchanged with the
fluid during the connection between the outlet and the entrance. The package
may also be
provided with an air-outlet for letting air of the package leave the package
as the fluid
enters. Otherwise the package may be opened to provide for an air-flow out of
the
package as the fluid enters the package. In an embodiment the connection
includes
means for interchanging air and fluid e.g. in form of a double-lumen tube
having a fluid-
channel and an air-channel. When the air-channel is small enough it will be
possible to
prevent fluid from flowing through the air-channel. Fluid will then flow
through the larger
fluid-channel and as the fluid flows in the air flows out through the smaller
air-channel.
The maximum size of the air-channel depends on the constitution of the
compartment that
is, how high a liquid column is formed in the compartment to provide pressure
to the
outlet. It also depends on which fluid is used and the surface tension of the
material used
for the double-lumen tube.
In an embodiment of the invention the medical device is a catheter and in a
related
embodiment it is a urinary catheter. In relation with urinary catheters,
sterilization is
important and typically urinary catheters need to be wetted prior to use.
These needs
make the abovementioned type of assembly particularly useful in connection
with urinary
catheters. An anti-microbial agent in the fluid medium may be particularly
interesting in
connection with urinary catheters as a fluid medium including an antimicrobial
agent may
help prevent urinary tract infections. Throughout the application the catheter
is described
as being placed with the distal end (the connector end) near the entrance to
the package.
However it may also be placed with the proximal end (the insertion end) near
the entrance
to the package.
The medical device may be provided with a hydrophilic coating. A hydrophilic
coating is
sensitive to moisture, as moisture will swell the coating - hence it is
advantageous to be
able to enclose the medical device in a closed package shortly after the
provision of the
hydrophilic coating. Separating the package for the medical device from the
compartment
for the fluid enables this early packaging.
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In an embodiment the compartment for the fluid medium is made of an injection-
molded
element. In this case useful materials are polyolefin's in general,
particularly PP (Poly-
Propylene), PE (Poly-Ethylene) and materials like ABS (Acrylonitrile-Butadiene-
Styrene),
PC (Poly-Carbonate), silicone and styrene-based materials. An injection-molded
element
provides for a relatively rigid element. This may be advantageous if the
compartment is to
be pushed or pivoted during handling of the assembly. Furthermore, in some
uses the
compartment need to be self-sustainable even when a slight pressure is applied
to it, e.g.
during storing or manufacturing. In these cases a rigid compartment may also
be
advantageous. Finally, the compartment may need to be at least partly
encircled by
another element or it may be placed atop another element - hence it need to be
self-
sustainable.
In another embodiment, the compartment is made as a foil-element. Such an
element
may be made of materials like aluminum, PETP (Poly-Ethylene-Tere-Phtalate),
LDPE
(Low-Density Poly-Ethylene), HDPE (High-Density Poly-Ethylene), PP (Poly-
Propylene),
PVC (Poly-Vinyl-Chloride), PA (Poly-Amide), PET (Amorphous Polyester) and
surface
treated paper. If the compartment is made as a foil-element, it will be easy
to pack and
store as it will only take up as much room as the amount of fluid demands. In
some
embodiments, the compartment needs to be able to be squeezed so as to get the
fluid out
of the compartment. In these embodiments foil-elements are also preferred.
The compartment may also be made as a foil-element on a frame of injection-
molded
elements or it may be made by two-component molding. In these cases
combinations of
the above materials are used.
For some embodiments, the compartment comprises a rupturable pouch. Such a
construction will be useful if the compartment is provided with an open outlet
covered by a
foil. In that case, the foil may be removed but the fluid will be contained
within the
compartment until pressure is applied to the rupturable pouch.
The package for the medical device may advantageously be made by extruding a
tubular
member. Then it just needs closing at the ends to make the final package.
Materials like
PVC, PU, silicone or a styrene-based material are suitable for this use.
Alternatively, the
package may be made by a foil, which is welded along the sides. For this
purpose,
materials like aluminum, PETP (Poly-Ethylene-Tere-Phtalate), LDPE (Low-Density
Poly-
Ethylene), HDPE (High-Density Poly-Ethylene), PP (Poly-Propylene), PVC (Poly-
Vinyl-
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Chloride), PA (Poly-Amide), PET (Amorphous Polyester) and surface treated
paper are
suitable. Yet another way of making the package may be by injection molding.
Materials
suitable for this comprise polyolefin's in general, particularly PP and
materials like ABS
(Acrylonitrile-Butadiene-Styrene), PC (Poly-Carbonate), silicone and styrene-
based
materials. Finally, it may be made by a 2-component molding including one
material for
making a part of the package and another one for making another part.
The above mentioned two-component molding of the package may be used to
protect the
entrance and act as a sealing, as the part of the package including the
entrance could be
made by a rather rigid material and then a more flexible material could be
used to cover
the remaining part of the medical device. If the entrance were in the form of
a socket, it
might be broken when subjected to pressure from the outside. Making the part
of the
package including the entrance of a rigid material may prevent such a breakage
of the
entrance. However, for packing purposes it may be advantageous that a part of
the
package is flexible, as this allows a closer packing of the assemblies next to
each other.
Another way of protecting the entrance to the package could be by making the
package in
two parts, which are subsequently put together. The rigid part could then be
injection-
molded and the more flexible part could be a foil welded to form the remaining
part of the
package.
The joint between the package and the compartment may be made as a fixed
attachment,
a detachable joint or it may comprise hinge means. A fixed attachment may be
manufactured very simple and easy as it may be in the form of welding, either
spot-
welding or continuous welding, gluing, a click-connection or sewing.
If the joint comprises hinge means they may be in the form a regular hinge pin
and hinge
flanges. This provides for a strong and durable hinge joint. The hinge means
may also
comprise a foil hinge, or a hinge being provided by making the material at the
hinge
thinner than the surrounding material. Finally, the hinge may be provided by a
click-
connection where one part comprises a groove and the other the hinge-pin. The
two parts
are snapped together and following that they are able to pivot with respect to
each other.
The joint may also comprise a joint providing for detaching the compartment
from the
package followed by attaching the compartment to the package in another
position. This
may be in the form of a threaded connection, a bayonet connection or by a push-
fit
coupling, e.g. a luer or snap fit connection. Such a joint may be particularly
useful for
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letting the fluid flow back into the compartment when the fluid has been used
to wet the
medical device. Due to the package being virtually depleted of fluid at the
time of opening,
the risk of spillage of the fluid is nearly eliminated.
In an embodiment the joint comprises a pivoting plunger for applying pressure
to the fluid
in the compartment. A pivoting plunger is very easy to use even for people
having poor
hand dexterity, as they are able to use the plunger as a lever to help them
provide
pressure to the fluid contained in the compartment and help the fluid evacuate
the
compartment. If the compartment comprises a pouch adapted for rupturing, the
pressure
applied by the plunger may relatively easily rupture it.
The outlet and the entrance are placed such that they are able to connect in a
use-
position. This means that the assembly has a position in which the outlet and
entrance are
aligned.
The connection between the outlet and the entrance may be in the form of a
friction-fit
coupling, e.g. a tapered spigot connected to a socket. This provides for a
secure
connection, where spillage through the connection is avoided due to the
tapered form of
the spigot and the socket. While the outlet and the entrance are connected
they will not be
likely to detach due to the friction-fit in the connection.
The connection between the outlet and the entrance may also be made in the
form of a
snap-fit coupling, e.g. a snap fastener. A snap-fit coupling provides for a
very good seal
between the outlet and the entrance. It also provides for a very quick and
reliable
connection between the outlet and the entrance.
In another embodiment the connection between the outlet and the entrance is in
the form
of a spike-element and a rupturable membrane, which has the effect of
providing a weak
point. The weak point at the entrance may be provided as a thinner part of
material or it
may be provided as another piece of material, which is more flexible than the
remaining
part of the package. By using such a spike-element it is very easy to make the
connection
between the outlet and the entrance. This leaves out the need for a complete
match
between the outlet and the entrance, as the size of the weak point provides
the spike-
element with a certain margin for penetration.
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In another embodiment, the outlet from the compartment comprises a double
lumen tube
having a fluid channel and an air channel. The entrance to package may be a
weak point.
The double lumen tube will function as spike-element, if one end is cut-off in
an angle,
thereby providing a beveled end. A user need only press the two parts (the
compartment
and the package) together at the area near the outlet and the entrance. Then
the fluid will
flow from the compartment to the interior of the package.
In yet another embodiment the entrance to the package comprises a cut-off
double lumen
tube having a fluid channel and an air channel and the outlet from the
compartment is a
weak point.
Another way of providing the connection between the outlet and the entrance is
to apply
magnets or adhesive to the outlet and entrance so as to get the two parts to
stick
together. When adhesive is used it need only be applied to either the outlet
or the
entrance.
Users using this type of assembly may have a poor dexterity in their hands. To
assist
holding an assembly like this during use, it may be provided with a gripping
member. Such
a gripping could be in the form of a hole, which in a foil compartment may be
punched
through the compartment and subsequently welded. If the compartment is blow-
molded or
injection-molded then the hole could be made as an integrated part of the
mold. The hole
need not be a part of the compartment but may be a part of the assembly as
such. In a
related embodiment, the gripping member could be in the form of an adhesive
pad or a
string attached to the assembly.
The assembly may in a storage-position be provided with a covering, which is
used to
cover the outlet and the entrance. This covering may comprise two covering
parts - one
for covering the outlet and one for covering the entrance. In a use-position,
these two
covering parts are removed. By covering the outlet and entrance with covering
parts in the
storage-position, the outlet and the entrance are kept completely sterile up
to the point just
prior to use. Thus, no bacteria will be transferred from the outlet to the
entrance and
further from the entrance into the package. Thereby the risk of contamination
of the
medical device contained in the package is minimized.
In an embodiment of the invention the assembly includes a joint comprising a
rail having
the compartment attached to it, such that the compartment may be slid along
the rail
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thereby connecting the outlet from the compartment to the entrance to the
package. The
sliding motion may be done in directions transverse to the longitudinal
direction of the
package and in directions parallel to the same longitudinal direction. A
sliding motion is
typically relatively easy to do even for people with poor hand dexterity, as
it only implies
5 applying of pressure in one direction or pulling in another direction. It is
also possible to
use an object - e.g. a handrail, a table or a washbasin - to provide the push
to the
compartment.
In another embodiment the assembly includes a joint comprising a containment
element
and a hinge-element such that the compartment in a storage-position is
contained in the
10 containment element and in a use-position is pivoted about the hinge-
element so as to
connect the outlet from the compartment to the entrance to the package. As
soon as the
compartment is pivoted out of the containment element, then the compartment
may be
pivoted by using a handrail or the like to provide the pivoting movement all
the way until
the outlet and the entrance are connected.
The assembly may also be made including a joint made as two couplings such
that in a
storage-position the compartment is placed with the outlet facing away from
the package
and in a use-position the compartment is placed with outlet connected to the
entrance of
the package. By two couplings is meant a situation where the compartment and
the
package each have two coupling-elements. This way a first coupling-element at
the
compartment is attached to a first coupling-element at the package in a
storage-position
and a second coupling-element at the compartment is attached to a second
coupling-
element at the package in a use-position. Another possibility is that the
package is
provided with only one coupling-element and the compartment is provided with
two
coupling-elements. In such an embodiment a first coupling-element at the
compartment is
attached to the coupling element at the package in a storage-position and a
second
coupling-element at the compartment is attached to the coupling element at the
package
in a use-position. Finally, the package may be provided with two coupling-
elements and
the compartment with one coupling-element. Then the coupling-element at the
compartment is attached to a first coupling-element at the package in a
storage-position
and to a second coupling-element at the package in a use-position. The
coupling-
elements may be any kind of detachable couplings e.g. threaded joints, snap
fit-coupling,
bayonet couplings, push-fit couplings etc.
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When the compartment is coupled to the package by such a detachable coupling,
the
coupling may also be used to provide access to the medical device following
the wetting
of the medical device. This leaves out the provision of other means to get
access to the
package to retrieve the medical device.
Other embodiments relate to assemblies including a joint comprising hinge-
means, where
the compartment and the package in a use-position are placed juxtaposed each
other.
The outlet and the entrance may be placed at the sides of the package and the
compartment facing each other in a use-position. The outlet from the
compartment and
the entrance to the package may also be placed in the longitudinal direction
of the
package such that they are facing each other. By juxtaposed is meant that the
compartment in a use-position is generally placed at one side of the package
containing
the medical device. This general embodiment comprises embodiments where the
compartment in a storage-position are placed either juxtaposed the package, in
a
longitudinal direction of the package or at an angle to the longitudinal
direction of the
package.
In a related embodiment the compartment and the package are placed end to end
in a
use-position and the outlet and the entrance are placed at the sides of the
package and
the compartment facing each other in a use-position. This means that the
compartment in
a use-position is placed generally at the same longitudinal direction as the
medical device
contained in the package. Again, this general embodiment comprises embodiments
where
the compartment in a storage-position are placed either juxtaposed the
package, in a
longitudinal direction of the package or an angle to the longitudinal
direction of the
package.
The hinge-means in the above-mentioned embodiments imply a pivoting motion. A
pivoting motion is easy to do for people with poor hand dexterity as they can
use a table
or other object to apply the necessary pivoting movement and hence need only
be able to
grab the assembly in a hand or between the hands. For some embodiments the
pivoting
movement is used to perform several actions in one movement - e.g. open to the
compartment and connect the outlet and entrance to each other.
Yet another embodiment relates to an assembly including a joint comprising
means for
providing a distance between the outlet of the compartment and the entrance to
the
package in a storage-position, which means are removed in a use-position. The
distance
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may be in any direction compared to the longitudinal direction of the package,
e.g.
lengthwise, parallel, transverse, at an angle. Such a distance-element may
serve several
purposes as it besides providing the necessary distance also may be used as
the sterile
covering of the outlet and the entrance.
The assembly may also include a joint comprising a connecting device including
the outlet
from the compartment. A connecting device may comprise a tube, a rod-like
member or
any other element suitable for providing fluid contact between the compartment
and the
package. Using a connecting device enables the fluid to enter the package
below the
connector. This leaves the connector without fluid and hence it is dry and
easy to hold.
Furthermore, fluid at the inside of the connector may get the urine to run at
the sides of
the connector instead of through the tube attached to the connector.
In another aspect the invention relates to a method for manufacturing an
assembly
comprising
- Assembling a package including a medical device
- Providing the package with an entrance to it
- Sterilizing the package
- Producing a compartment including the fluid medium
- Providing the compartment with an outlet from it
- Sterilizing the compartment separately from the package
- Joining the package and the compartment to each other
Separating the compartment for a fluid medium and the package for containing
the
medical device is advantageous when sterilization of the parts is considered.
Sterilization
of two smaller containers makes the dosage of the sterilization medium easy to
control, as
the volume of each container is rather limited.
In an embodiment the method concerns packing of a medical device, which is
provided
with a hydrophilic coating.
Separating the compartment and the package may also be advantageous due to the
need
to prevent medical devices having a hydrophilic coating from getting into
contact with any
fluid (e.g. moisture in the air) prior to packing. By separating the two
containers, it is
possible to produce and pack the medical device in one location and
subsequently -
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without demands for packing in controlled environment - shipping the package
including
the medical device to another location and here provide the fluid medium.
Furthermore, the joint is made without demands for providing for the fluid
communication
as this fluid communication is done through the outlet of the compartment and
the
entrance to the package. This means that the joint between the compartment and
package is easier to make than a joint providing for fluid communication would
be. If the
joint were to provide for the fluid communication then a too strong joining of
the
compartment to the package may lead to a rupture of the connection for the
fluid and
hence the catheter would be wetted prematurely. On the other hand, if the
joint were
made too weak the joint may not be able to hold the two parts together and
hence the
compartment may separate from the package.
As mentioned earlier, the compartment may be provided by injection molding
where the
opening is either closed by welding or squeezed together. Alternatively the
compartment
may be provided by foil-elements, where the foil-elements are welded along the
sides to
constitute the compartment. The compartment may also be provided by extruding
or blow-
molding an element, which subsequently is closed at the ends e.g. by welding.
In an
embodiment the compartment may be made as foil-element on a frame of injection-
molded elements. Then the frame may be made by injection-molding frame-
elements
using materials like PP or PE and a foil of PETP, Aluminum or LDPE may be
welded onto
the frame elements. In another embodiment the compartment may be made by two-
component-molding a more flexible part to a more rigid part. The more flexible
part may
then be used to provide sealing in a junction between the compartment and the
package.
The package may be provided in similar ways.
In an embodiment the joint is done by welding, e.g. spot-welding or continuous
welding.
Such a process is quick and easy to do for embodiments requiring a fixed
attachment
between the compartment and the package.
In another embodiment the joint is done by mechanical means, e.g. by attaching
a hinge-
element or welding a rail-element in the joint.
The sterilization of the package is done by Ethylene-Oxide. Alternatively it
may be
sterilized using radiation, e.g. beta- or gamma-radiation. Beta- and gamma-
radiation leave
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14
the package ready-to-send, as it does not need time for evaporating following
the
sterilization process.
The compartment may also be sterilized by radiation, e.g. beta- or gamma-
radiation or it
may be sterilized by an autoclave treatment.
In a third aspect the invention relates to a method for wetting a medical
device using an
assembly comprising a compartment and a package joined together, which method
comprises
- Moving an outlet from the compartment to a position so it may connect with
an entrance to the package
- Connecting the outlet and the entrance to each other so as to allow for
fluid
communication
Such a method provides a secure and efficient way of wetting a medical device.
As the
fluid stays in the compartment until the outlet of the compartment is
connected to the
entrance to the package this reduces the risk of or even prevents spillage of
the fluid.
The moving of the outlet may be as described above, e.g. transverse, along a
circular arc
etc.
In an embodiment the method further comprises the step of providing an air-
flow out of the
package. Providing an air-flow may help the fluid to flow between the
compartment and
the package.
The air-flow out of the package may be provided by opening the package. An
opening of
the package provides for a nearly unlimited transport of air out of the
package and hence
enables a very fast inflow of the fluid into the package.
In another embodiment the air-flow out of the package is provided through the
connection
between the outlet and the entrance and an air-channel in the compartment. In
a related
embodiment the connection may be provided by an air-channel. Some users find
it
beneficial to keep the package closed right until use. This prevents any
bacteria from the
environment to enter into the package. Furthermore, the catheter may be wetted
and
hence kept in a wetted condition. Another advantage may be that another person
may
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assist the user of the assembly in providing the wetting of the catheter while
the package
is still closed. Subsequently the user himself may open the package and use
the catheter.
The fluid may be forced out of the compartment by squeezing by hands a pouch
constituting the compartment. This is easy to do for people with poor hand
dexterity, as
5 they will be able to provide the pressure to the pouch by the hands, e.g. by
the heels of
the hands, and need not use a finger grip.
In another embodiment the fluid may be forced out of the compartment by
squeezing by a
plunger a pouch comprised in the compartment. In a related embodiment the
fluid may be
forced out of the compartment by squeezing by a hinge-flange a pouch comprised
in the
10 compartment. People with poor hand dexterity will also easily be able to do
this, as they
can use e.g. a leg, table or armrest to assist in applying the pressure to the
plunger. The
plunger will also function as a lever thereby minimizing the necessary force
to be applied
to it. As the fluid will only flow when the outlet and the entrance are
connected tilting of the
assembly during applying of the force will not cause spillage of the fluid.
15 The moving of an outlet may comprise sliding of the compartment, pivoting
the
compartment, displacing of the compartment or detaching the compartment
followed by
re-attaching it in a position where the outlet faces the entrance to the
package. As
mentioned earlier sliding, pivoting or displacing is movements, which are easy
to do for
people with poor hand dexterity, as they do not need to able to use a finger
grip to do
these motions. Furthermore, all of the motions may be done by using a leg,
table, armrest
etc. to assist in doing the movement of the compartment. The detaching and re-
attaching
lead to a completely closed assembly including the fluid, which following the
wetting may
then be poured back into the compartment such that there is no fluid in the
package as
the catheter is to be removed.
The method of wetting the medical device may further comprise the step of
removing an
element placed between the compartment and the package prior to the moving of
an
outlet. This will in an easy way visualize whether the assembly has been
activated or not.
In an embodiment the moving of an outlet comprises moving of a connecting
device
including the outlet from the compartment, and in a related embodiment the
moving is
done in planes parallel to the longitudinal direction of the package.
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16
Brief Description of the Drawing
Figures 1 a-1 c illustrate an embodiment of the invention, in which the
compartment is slid
across a rail to establish the connection between the outlet of the
compartment and the
entrance to the package.
Figures 2a-2d illustrate an embodiment of the invention, in which the
compartment is
hingedly attached to the assembly such that the hinge initially is placed
below the
compartment in a storage-position and in a use-position is placed above the
compartment.
Figures 3a-3e illustrate an embodiment of the invention, in which the
compartment is
detachably attached to the package such that the outlet faces away from the
entrance and
then subsequently moved such that the outlet faces the entrance of the
package.
Figures 4a-4c illustrate an embodiment of the invention in which the
compartment is
hingedly attached to the assembly and where the outlet is placed at a side of
the
compartment.
Figures 5a-5c illustrate an embodiment of the invention, in which the
compartment is
attached at a rail and a slide initially prevents the movement of the
compartment along the
rail.
Figures 6a-6c illustrate an embodiment of the invention in which the
compartment is
hingedly attached to the assembly such that the hinge initially in the storage-
position is
placed above the compartment and in a use-position is placed below the
compartment.
Figures 7a-7c illustrate an embodiment of the invention in which the
compartment is fixed
to the package and the communication between the fluid of the compartment and
the
package is established by a movable outlet of the compartment.
Figures 8a-8g illustrate an embodiment of the invention in which the
compartment and the
package are hingedly joined and a foil-element provides the initial distance
between the
outlet and the entrance.
Figures 9a-9g illustrate an embodiment of the invention in which the
compartment
comprises a pouch-element and the compartment and the package are hinged to
each
other.
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17
Figures 10a-10f illustrate an embodiment of the invention in which the
compartment and
the package are hingedly joined and the compartment is pivoted approx. 180
degrees
prior to connecting the outlet and the entrance.
Figure 11 illustrates an embodiment of the connection between the outlet and
the
entrance in form of a double lumen tube.
Detailed Description of the Drawing
Figures la-1c illustrate an assembly 101 according to the invention, which
assembly
includes a package 110, a compartment 140 and a joint between the two 160.
Figure 1 a
illustrate the assembly 101 in a storage-position, figure 1 b illustrate the
assembly 110 in a
use-position as the connection between the outlet and the entrance has been
established
and figure 1 c illustrate the assembly 101 with an open package 110 and the
catheter is
ready to be removed.
The package is provided with two sidewalls 111, 112, a proximal end wall 113
and a distal
end wall 114. The proximal end is defined as the insertion end of the medical
device
contained in the package and the distal end is defined as the opposite end.
Additionally
the package has a front wall 115 and a back wall 116, which are shown more
clearly in
figure 1 c. The package further includes package-opening means 117, which may
be in the
form of notches, tearing lines etc. The package-opening means 117 could be
placed
anywhere at the package 110. In this embodiment the package-opening means is
placed
in the distal end of the package and is in form of a tab 118. Furthermore, the
package
comprises an entrance into the package as indicated at 120. In this embodiment
the
entrance 120 is placed in the distal end wall 114. The entrance may be in the
form of e.g.
a tube, a channel in the joint or in the package or a foil sleeve.
The package is used to hold a medical device - in this embodiment a urinary
catheter 130
having a proximal end 131 and a distal end 132 and an essentially tubular
element 133
stretching therebetween. The proximal end includes a tip 134 having eyelets
135 for
leading the urine into the catheter. The distal end includes a connector 136,
which is
flared in the distal connecting end as illustrated at 137. The connector
comprises ribs 138
at the proximal end where it is attached to the tubular element 133. These
ribs serve a
production purpose, as they provide for cooling when the catheter is injection-
molded. The
catheter further includes a hydrophilic coating 139, which covers the
insertable length of
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18
the catheter. For a male catheter the insertable length is 250-300 mm and for
a female
catheter the insertable length is between 60-130 mm. The insertable length
corresponds
to the length of the tubular element except for the distal 5 cm's.
The compartment 140 is in this embodiment an injection-molded rigid element
having
sidewalls 141-144 and end walls 145, 146. One of the end walls is in this
embodiment
provided with an outlet 147, which is in the form of a ring-shaped element.
The
compartment is further provided with an air-inlet 148, which initially is
covered with a foil
149 for allowing the fluid 150 in the compartment to enter into the package.
In the embodiment of figure 1 the joint 160 between the compartment 140 and
the
package 110 is made as a plate 161 acting as a rail. The dimensions of the
rail may be
adapted to the bottom of the compartment 140. The plate 161 has a border 162
on all four
sides of the plate so as to keep the compartment 140 within the plate 161. The
plate 161
has a hole 163, which is aligned with the entrance to the package 120. In a
direction
parallel to the bottom of the compartment the plate 161 has a larger dimension
D than the
corresponding dimension of the compartment d. This means that the compartment
140
has one position, a storage-position, on the plate 161, in which the outlet
147 of the
compartment is out of contact with the hole 163 in the plate and thereby out
of contact
with the entrance 120 to the package, and another position, a use-position, in
which the
outlet 147 of the compartment is in contact with the hole 163 in the plate and
thereby in
contact with the entrance 120 to the package. Thus, in the storage-position
there is no
connection between the outlet 147 and the entrance 120 while in the use-
position the
connection is established. As shown in figures 1 b and 1 c the fluid 150 is
entering into the
package 110. The hole 163 of the plate is in this embodiment initially covered
with a foil
covering 164 so as to prevent contamination of the hole 163 prior to use.
Besides being a rigid injection-molded element, the compartment may also be an
element
having a rigid lower part (near the rail). Non-limiting examples may be a box
part
extending only partly up the sides and the remaining part being made of a foil
material, a
frame placed in the lower part of an element of foil material or a foil
material including a
rod-element acting as a pushing element. The only limitation is that it should
be able to be
pushed or pulled along the rail and hence the part of the compartment
connected to the
rail should include a rigid element - at least in the pushing or pulling
direction. If the
compartment is made including a rigid element and otherwise a foil it would
take up less
room, than if the compartment were made entirely of a rigid element.
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Furthermore, the outlet is illustrated as a ring-shaped element. However, it
may also be a
cylindrical element, which in a storage-position is pushed up into the
compartment and
when the compartment is pushed along the rail the cylindrical element would
eventually
fall into the hole of the rail so as to establish the connection between the
outlet of the
compartment and the rail element. Such an element would have an upper end
attached to
the bottom of the compartment. In this case upper means the direction
indicated in figures
1 a-1 c, such that the upper part of the assembly corresponds to the top part
of the
compartment.
The rail-element is illustrated as a plate but it may also be a frame element
in which case
the outlet of the compartment is covered by other means so as to prevent the
fluid from
pouring out too early and keep the outlet sterile. These other means may be a
foil
covering, which is removed or perforated prior to use.
The materials of the plate and the compartment are adapted to each other so as
to
provide low friction between the two elements. Most of the plastics materials
will be so
smooth so that the friction between the elements is low enough. Alternatively
the elements
may be polished or they may be provided with a lubricant to provide the low
friction.
Figures 2a-2d illustrate an embodiment of the invention in which the assembly
201
comprises a package 210 including a catheter 230. Figures 2a and 2b show the
assembly
210 in a storage-position in a front view and a side view respectively and
figure 2d shows
the assembly in a use-position. Figure 2c shows an intermediate position for
the
compartment. The catheter 230 is the same as the catheter 130 of the
embodiment in
figure 1 and will not be described further. The assembly 201 also comprises a
compartment 240 enclosing the fluid and a joint 260 including a containment
element 270
for the compartment and a hinge element 280. The package 210 of this
embodiment
includes two sidewalls 211, 212, a proximal end wall 213 and a distal end 214
of the foil.
The distal end is attached to the injection-molded containment element 270,
which
includes the distal part of the catheter and the entrance 220 to the package
210. The
containment element 270 is a generally box-shaped element having two sidewalls
271, a
front wall 272 and a back wall 273. The back wall is initially covered with a
foil 274. The
containment element 270 also comprises two generally cylindrical cut-outs, an
upper cut-
out 275 and a lower cut-out 276. The upper cut-out 275 contains the
compartment 240 in
the storage-position during storage of the assembly 201. The lower cut-out 276
contains
the compartment 240 in the use-position when the catheter is to be wetted. The
assembly
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is further provided with a hinge element 280 for moving the compartment 240
from the
storage position in the upper cut-out 275 to the use-position in the lower cut-
out 276. The
hinge-element is made as a regular pivoting hinge having a hinge pin 281 and
two hinge-
flanges 282. The compartment consists of a generally cylindrical element 241
having a
5 curved sidewall 242 extending all the way around the element 241, a front
wall 243 and a
back wall 244. In the part of the compartment 240 facing away from the
catheter 230 in
the storage-position, the compartment 240 is provided with an outlet 247. In
this
embodiment the outlet 247 is in the form of a membrane. When the compartment
240 is
pivoted to the use-position, the outlet 247 is brought into contact with the
entrance 220 to
10 the package 210. The entrance 220 is in this embodiment in form of a sharp
double lumen
tube 221 where the largest lumen will act as fluid outlet and the smallest
lumen will act as
air inlet to the compartment in order to provide a good liquid flow out of the
compartment.
The double lumen tube 221 is shown in more detail in figure 11. When the
compartment
240 has been pivoted to the use-position and the connection between the outlet
247 and
15 the entrance 220 has been established, then the foil 274 is removed and
thereby access
to the catheter 230 is established.
The distance between the hinge-pin 281 and the outlet 247 of the compartment
corresponds to the distance between the hinge-pin and the entrance 220 to the
package.
This enables the outlet 247 to connect to the entrance 220.
20 The outlet from the compartment need not be placed in the periphery of the
element. It
may be placed in the wall facing away from the foil covering. In this case the
containment
element need only have one cut-out to contain the compartment in the storage-
position. In
the use-position the compartment may be attached to the side of the
containment element
and the outlet from the compartment may be connected to an entrance also
placed at the
side of the containment element.
The foil covering the back wall may not cover the compartment or the lower cut-
out in
which case it is only used as a cover for the catheter package.
Figures 3a-3b illustrate an embodiment in which the assembly 301 comprises a
package
310 and a compartment 340 attached to the package. In figure 3a, the assembly
301 is
shown in a position where the compartment 340 has just been removed, that is a
position
close in time to the storage position. In figure 3b the same assembly 310 is
shown a little
later as the compartment 340 is about to be attached to the package 310 so as
to bring
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the assembly 301 in a use-position. The joint 360 between the package and the
compartment is in this embodiment in the form of a threaded joint so the
compartment 340
is screwed on and off the package 310. The package 310 consists of a
cylindrical
injection-molded container 311 having a proximal end 312 and a distal end 313
and a
curved sidewall 314 extending therebetween. The proximal end 312 is provided
with a
cylindrical indentation 315 having an internal screw thread 316. The ring-
shaped area 317
surrounding the indentation 315 is generally flat. The distal end 313 is
provided with a
hollow cylindrical protrusion 318 having an external screw thread 319
surrounded by a
generally flat ring-shaped area 320. The entrance 321 to the package is
provided in the
distal end of the cylindrical protrusion 318. Initially the entrance 321 is
provided with a
covering foil 322 so as to protect it prior to use. The compartment 340 is in
this
embodiment in the form of an injection-molded generally cylindrical container
341 having
two ends 342 and 343. The cylindrical container 341 comprises a cylindrical
protrusion
344 at one end 342 having an external screw thread 345 matching the internal
screw
thread 316. The cylindrical protrusion 344 comprises an air-inlet 346, which
in the use-
position establishes contact between the air and the interior of the
compartment 340. In
the other end 343 an outlet in form of a cylindrical indentation 347 is
provided. This
indentation has an internal screw thread 348 and a membrane 349 provided at
the end of
the screw thread 348. The connection between the outlet 347 and the entrance
321 is
provided, as the external screw thread 319 is higher than the internal screw
thread 348.
As the two parts are joined the end of the external screw thread 319 will
penetrate the
membrane 349 placed at top of the internal screw thread 348 and thus cause the
fluid
medium to flow. Furthermore, the cylindrical protrusion comprises a foil
covering 350. In a
storage-position the compartment 340 is attached to the package by a joint
between the
two screw threads 343 and 316. The foil-covering 350 covers the outlet 347
from the
compartment 340. In a use-position, the compartment 340 is unscrewed from the
package, the foil-covering 350 is removed and then the compartment is
connected to the
package at the entrance 321. The external screw thread will cut the membrane
349 and
the air-inlet 346 will help the fluid exit the compartment 340 and enter into
the package
310 to wet the catheter 330. The package is subsequently opened by breaking
the
package at a tearing-line 324.
The package 310a may be made with only one screw thread fitting 319a placed at
the
distal 313a or the proximal end of the package, as illustrated in figures 3c-
3e. In this case
the compartment 340a may be made with a screw thread fitting 345a placed in
both ends.
In such an embodiment the compartment 340a may in a storage-position be placed
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22
upside-down at the package, such that the outlet 347a of the compartment is
facing away
from the package. When the assembly is to be used the compartment 340a is
removed
from the package, turned upside down and attached to the package in the use-
position,
such that the outlet 347a from the compartment faces the entrance to the
package. In this
embodiment the outlet of the compartment is preferably covered with a
protection foil
350a prior to use. This is removed before the compartment is attached to the
package in
the use-position. The outlet 347a is provided with a spike element 348a, which
penetrates
a membrane 349a attached at the entrance 320a, such as it is illustrated in
figure 3e.
The joint between the compartment and the package may also be in the form of a
bayonet
coupling or a snap-fit coupling or any other mechanical attaching means.
The end of the compartment may be provided with a handle so it will be easier
to turn
even for people with poor hand dexterity. The end of the compartment may also
be
provided with a groove for placing a pen or other object, which may then be
used as a
handle.
In a related embodiment the catheter may be placed upside down into the
package such
that the compartment in a use-position is attached near the tip of the
catheter. Then the
package may be provided with a cap attached by any conventional mechanical or
adhesive attachment means e.g. screw thread, bayonet coupling or gluing, in
the end near
the connector of the catheter. Following wetting of the catheter the assembly
including the
compartment and the package is turned upside-down such that the excess wetting
fluid
flows back into the compartment. Then the package is opened by removing the
cap and
the catheter is pulled out.
Figures 4a-4c illustrate an assembly 401 according to the invention including
a package
410, a compartment 440, and a joint between the two 460. Figure 4a illustrates
the
assembly in a storage position and figure 4b illustrates the assembly in a use-
position.
Figure 4c illustrates the assembly in different positions from the storage-
position to the
use-position. Elements similar to the other embodiments are referenced to with
the same
numbers except for the prefix being 4 in this embodiment. The package
comprises two
parts a proximal end 410a of foil, e.g. HDPE, PP or aluminum, and a distal end
410b of an
injection-molded material, e.g. PP. The two parts 410a and 410b are attached
by e.g.
adhesive, heat welding or high frequency welding. The proximal end 410a
comprises two
sidewalls 411, 412, a proximal end 413 and a tapered distal end 414. The
distal end 410b
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has a proximal end wall 415 and an inclined distal end wall 416 and two
sidewalls, one
facing the compartment 417 and one facing away from the compartment 418. The
catheter 430 corresponds to the catheter 130 of the embodiment shown in figure
1. In this
embodiment the compartment 440 comprises an element 441, which has two
sidewalls
442 making out the top and bottom of the element. The sidewalls 442 are formed
as
segments of a circle - approx. 150 degrees - having a curved part 443 and two
straight
parts 444, 445. The sidewalls are connected with a curved wall 446 connecting
the two
curved parts 443 of the sidewalls 442. The sidewalls are furthermore connected
with a
straight generally rectangular wall 446a, which connects the two straight
parts 444 with
each other. An outlet 447 is formed in the rectangular wall 446a near the
periphery of the
cylindrical element 441. In this embodiment the outlet 447 is a cutting
element in form of a
sloped or cut-off spigot. The compartment includes a rupturable pouch 449,
which when
the outlet is open will be able to hold the fluid inside the compartment. Upon
application of
a pressure to the pouch 449, the pouch will burst and the fluid will be able
to exit the
compartment.
The joint 460 between the package 410 and the compartment 440 is in this
embodiment
made as a pivotable connection 470 and a covering element 480. The pivotable
connection has a plunger 471, in the form of another part of a cylindrical
element having a
diameter d, which is slightly less than the diameter D of the half cylinder
441. The plunger
471 has two sidewalls 472 formed as segments of a circle - approx. 120 degrees
- having
a curved part 473 and two straight parts 474 and 475, which each of them
largely
corresponds to the radius r of the circle. As described in connection with the
element 441,
the plunger 471 has a curved wall 476 connecting the two curved parts 473 of
the
sidewalls 472. Furthermore, the sidewalls are connected with a generally
rectangular wall
477 on the side of the plunger 471 facing the compartment 440. This
rectangular wall 477
connects the two straight parts 475. The straight parts 474 need not be
connected with a
wall. Where the straight parts 474 meets the periphery of the circle two pins
478 extends
out from the periphery in a direction corresponding to the straight parts 474
and extending
away from the center of the circle. The two elements 441 and 471 are pivotable
around
the same hinge-element 461, which in this embodiment is formed as a hinge pin.
When
the assembly is to be used, the covering element 480 is removed by pulling at
a ring-
element 481 and the two elements 441 and 471 are pivoted in the same direction
by
pushing or pulling at the pins 478. The element 441 constituting the
compartment 440 will
be able to pivot until the wall 446 of the compartment is in brought into
contact with the
sidewall of the package 417 and the outlet 447 is connected to the entrance
420, thereby
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24
establishing the communication for the fluid medium. In this embodiment the
entrance is in
the form of membrane 421 which the cutting element 448 is able to penetrate
upon
application of a moderate force. When the compartment 440 is in this position
the plunger
471 will be able to continue the pivoting movement and enter into the
compartment 440.
Upon application of further pivoting movement the plunger 471 will eventually
apply a
pressure to the rupturable pouch 449, which is high enough to cause it to
rupture. Then
the fluid will exit the compartment through the outlet 447 and enter into the
package
through the entrance 420.
The pivoting movement and force applied to the compartment may also be
provided by a
hinge having two hinge flanges. In this case the compartment may be in the
form of a
squeezable box-like element. Then one of the hinge flanges is used to cover
the top of the
package and the other covers the top wall of the compartment. The flanges may
be made
as plate elements, which are rigid such that they may be subjected to an
applied pressure
without noticeable bending. When the catheter is to be used the hinge flange
covering the
package is pivoted around the hinge joint to a position where it is placed
atop the other
hinge flange. This may provide for opening of the package. By further pushing
atop the
two hinge flanges the compartment is brought into contact with the package.
Even further
pushing on the hinge flanges will cause the rupturable pouch included in the
compartment
to burst and then the fluid from the compartment will enter into the package
to wet the
catheter. The hinge flanges are described as rigid elements however the
material
properties are of less importance as long as the flanges are able to transfer
the applied
pressure from the hinge flanges to the compartment.
Figures 5a-5c illustrate an assembly 501 according to the invention in which
the package
510 and the compartment 540 are connected by a joint 560 comprising two
elements a
rod-element 570 and a rail-element 580. Figure 5a illustrates the assembly in
a storage-
position and figure 5c illustrates the assembly in a use-position. Figure 5b
illustrates an
intermediate position. The package is very similar to the package of the
embodiments
earlier described and the elements similar to the other embodiments are
referenced to
with the same numbers except for the prefix being 5 in this embodiment - e.g.
the
sidewalls of the package are numbered 511 and 512. The catheter 530
corresponds to the
catheter 130 of the embodiment shown in figure 1. The distal part 517 of the
package is
made of a rather rigid injection molded element 518, which in its cross-
section largely
corresponds to the cross-section of the compartment 540. Like described with
one of the
earlier embodiments, the entrance 520 to package is made as a sharp double
lumen tube
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521 where the largest lumen will act as fluid outlet and the smallest lumen
will act as air
inlet to the compartment in order to provide a good liquid flow out of the
compartment. The
double lumen tube 521 is shown in more detail in figure 11. The spike-element
524
constituted by the cut-off tube 521 will be able to penetrate the bottom of
the compartment
5 at the outlet.
The compartment 540 is made of an injection-molded element 541 having
sidewalls 542
and a top wall 543 and a bottom wall 544. The bottom wall may have a membrane
545
acting as an outlet 546 for the fluid in the compartment. This membrane 545 is
in this
embodiment provided by a more flexible material than the rest of the
compartment, where
10 the flexible material and the compartment are produced by two-component
molding.
The rod-element 570 consists of a generally straight rod having an upper end
571 and a
lower end 572. The rod-element is used to connect the compartment 540 to the
package
510 so as to prevent two from disengaging completely. The lower end of the rod-
element
is fixed to a point 519 in the package. The upper end 571 of the rod-element
is movable in
15 the compartment 540. The length of the rod-element may be such that the
upper end 571
may be used to penetrate a membrane covering the air-inlet 547 to compartment.
The
surface of the rod-element 573 is preferably made such as to provide a
generally low
friction.
The rail-element 580 consist of a generally U-shaped element 580 with one
upper leg 581
20 covering at least a part of the top wall 543 and another lower leg 582
covering a part of
the bottom wall 544 of the compartment 540. Thereby the lower leg extends
between the
compartment and the package. The rail-element 580 is made of a material (e.g.
PP)
having a smooth surface so as to provide low friction between the rail-element
and the
compartment. When the assembly is to be used the rail-element 580 is slid to
the side
25 such that the lower leg 582 extending between the compartment 540 and the
package
510 is disengaged and hence the compartment 540 is able to move to a position
in
intimate contact with the package 510. In this position the connection between
the outlet
546 of the compartment and the entrance 520 to the package is established
thereby
providing the communication for the fluid medium.
The compartment and the package may alternatively be made as elements having
rigid
frame elements in combination with foil elements. The elements may be shaped
as boxes
having corner element of rigid injection-molded elements and sidewalls of foil-
elements.
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They may also be shaped as angular elements having more than 4 sides.
Additionally,
they may be shaped as cylindrical elements having a rigid ring-element at the
top and the
bottom and rigid string-elements extending therebetween. In that case foil
elements may
be attached to the ring elements so as to constitute the top and bottom sides
as well as
the sidewalls.
The rail-element may also be provided as a block with a pulling ring placed
between the
compartment and the package. In use the block may be removed by pulling the
ring and
hence enabling contact between the compartment and the package.
The rod-element may be cylindrical. However, it may also be angular in cross-
section. If
the rod-element is e.g. triangular or quadrangular the compartment will be
prevented from
rotating with respect to the package as the two parts will be maintained in
the same
general configuration with respect to each other. The rod-element is shown as
being
placed within the package and the compartment. However, it may also be placed
on the
outside. This would have the advantage that sealing around the rod-element may
be
omitted.
Figures 6a-6c illustrate an embodiment where the assembly 601 comprises a
compartment 640 which in a storage-position is placed next to or juxtaposed
the package
610. Figure 6a illustrates the storage-position of the assembly. In use-
position the
compartment 640 is pivoted 180 degrees and placed upside-down on top of the
package
610, as illustrated in figure 6b. Figure 6c illustrates different steps
between the storage-
position and the use-position. The package is very similar to the package
shown in figure
4. The same reference-numbers is used for the same parts except for the prefix
6. The
distal end wall 616 of the injection-molded part 610b is not tapered in this
embodiment but
extends generally transverse to the length direction of the package 610. The
distal end
wall 616 includes the entrance 620 to the package. Like described earlier, the
entrance
620 is made as a sharp double lumen tube 621, where the cut-off tube will
provide a
spike-element 624. The double lumen tube 621 is shown in more detail in figure
11. The
package is further divided along an opening line 617 at an oblique angle
compared to the
distal end wall. The opening line 617 may be provided by two parts meeting at
the
opening line and they may further be sealed by a gasket. An example is shown i
figures 8
and 10. The compartment 640 is a generally box-like element having a top wall
641 and a
bottom wall 642, where top and bottom are defined as distal and proximal in a
storage-
position. Between the top and bottom wall extends 4 sidewalls 643-646. An
outlet 647 is
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placed in the top wall 641. The outlet 647 is made as a thinner part of the
compartment,
such that it may easily be penetrated by the spike-element 624 at the entrance
620. The
joint 660 between the compartment and the package comprises a covering 670 and
a
hinge-element 680. The covering 670 comprises a cover part 671, which in
storage-
position covers the distal wall 616 of the package (the distal part) and the
top wall 641 of
the compartment. The covering 670 further comprises a finger-tab 672 for
pulling at the
covering 670. The covering 670 is attached to the sidewalls 645 and 618
furthest from
each other of the compartment and the package respectively. The hinge-element
680
comprises a hinge pin onto which the top wall 641 of the compartment and the
distal wall
616 of the package are attached. When the assembly is to be used the user
grips the
finger-tab 672 to release the covering from the distal end wall 616 and the
top wall 641,
but the covering is not released from the two sidewalls 645 and 618. The user
then pulls
the finger-tab 672 to the side to pivot the compartment 640 to a position atop
the package
610. This leaves the entrance 620 and the outlet 647 in an end-to-end
position. Upon
connection of the outlet 647 to the entrance 620 the fluid will enter into the
package 610..
After the fluid has left the compartment 640 and entered through the outlet
647 and the
entrance 620 the top of the package is pivoted further and the package is torn
apart at the
opening-line 617. This opens the package 610 and the catheter 630 may be
removed
from the package.
The covering may be made of foil. It may also be made by a thin injection-
molded or
extruded plate. The covering may also be removed entirely from the assembly
and the
compartment may then be pivoted by using a hand or other means.
In figures 7a-7c an embodiment of the invention is illustrated - showing an
assembly 701
according to the invention. The assembly comprises a package 710 for a
catheter 730, a
compartment for the fluid medium 740 and a joint between the two 760. In this
embodiment the joint 760 comprises a connecting device 770 and an attachment
780
between the package 710 and the compartment 740.
The package is provided with two sidewalls 711, 712, a proximal end wall 713
and a distal
end wall 714. The package further includes package-opening means 715, which in
this
embodiment includes a finger-tab 716, provided with a ring-element 717, which
make it
easy to grip. Furthermore, the package comprises an entrance into the package
as
indicated at 720. The compartment 740 has two sidewalls, 741, 742 and two end
walls
743, 744. Furthermore, the compartment is provided with an air-inlet 745
placed at top of
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the compartment, so that prior to being used it is covered by the connecting
device 770.
The connecting device 770 is in this embodiment attached to the compartment
along a
tear-line 746. A tube-element 771 having an inlet 772 and an outlet 773
constitutes the
connecting device 770 in this embodiment. The inlet 772 communicates with an
exit 747
of the fluid medium compartment 740 such that the outlet of the compartment in
this
embodiment corresponds to the outlet 773 of the connecting device. In use-
position, the
outlet 773 connects to an entrance 720 of the package 710. Prior to connection
the outlet
773 may be provided with a plug 774 made as a closure of the tube provided
with a
tearing line 775. The plug is torn off prior to use. The length of the
connecting device is at
least as long as the shortest length along a straight line between the exit
747 of the
compartment and the entrance 720 to the package.
Attachment in form of a welding 780 is made over a contact surface 781.
The connecting device is shown as a tube however other types of connecting
devices may
be used. The connecting device may be integrated with the compartment or it
may be a
separate component to be attached to the socket on the compartment. The
connecting
device may also be in the form of a rather rigid rod-like element having a cam
surface
near the exit of the compartment so as to be able to pivot in a plane parallel
to the length
direction of the catheter. The cam surface may also act as closure for the
fluid until the
outlet is in contact with the entrance to the catheter.
The joint between the compartment and the package may be made as described
above
by welding, gluing, sewing etc. It may also be made as a hinge having one or
more hinge
joints over the contact surface or a continuous hinge over the entire contact
surface, e.g. a
foil hinge.
Instead of making the plug as a closure of the tube, it may be made as a
separate
element in the same material as the tube or in another material.
A foil may be used to cover the tube or the entire compartment prior to use.
This prevents
contamination of the tube prior to insertion of this into the catheter
package.
If the compartment is made as a foil-element like a pouch, the air-inlet may
be omitted, as
it would be possible to squeeze the pouch by hands and then get the fluid out
of the
compartment.
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The length of the connecting device is minimized if the attachment is made as
a hinge.
This way the inlet to the connecting device will have a short distance to the
entrance to
the package.
Figures 8a- 8g illustrate an assembly 801 according to the invention in which
the
compartment 840 in a storage-position is placed in the generally longitudinal
direction of
the package 810. Figure 8a illustrates a front-view of the assembly in a
storage-position
and figure 8c illustrates the assembly in a use-position. Figure 8b
illustrates an
intermediate position between the storage- and the use-position. Figures 8e-8g
illustrate
three different side-views of the assembly in a storage-position - as seen
from the two
sides and from the front. The compartment and the package are assembled at a
joint 860
comprising a hinge-element 870 and a distance-element 880. The package is very
similar
to the package shown in figure 6. The same reference-numbers is used for the
same parts
except for the prefix 8. The distal end wall 816 of the injection-molded part
810b extends
generally transverse to the length direction of the package 810. The distal
end wall 816
includes the entrance 820 to the package.. Like described earlier, the
entrance 820 is
made as a sharp double lumen tube 821, where the cut-off tube will provide a
spike-
element 824. The double lumen tube 821 provides a channel extending through
the distal
part of the package 810b. As shown in the sectional view at figure 8b, the
tube 821
comprises an air-channel 822 and a fluid channel 823. The distal part of the
package
810b is slightly larger in cross-section than the compartment 840 and is
further provided
with a border or upstanding wall 816a from the distal end wall 816. The
package is further
divided along an opening line 817 at an oblique angle compared to the distal
end wall.
The opening line 817 is made as two parts of the package split along the line.
A sectional
view of the front wall 818 is shown in which the two parts 818a and 818b is
shown. The
two parts are sealed by a gasket 819, which may be made of rubber. The
compartment
840 is a generally box-like element having a top wall 841 and a bottom wall
842, where
top and bottom are defined as distal and proximal in a storage-position. The
top wall 841
is generally parallel to the distal end wall of the package and the bottom
wall 842 is not
parallel to the top wall 841 of the compartment 840. The bottom wall 842
includes the
outlet 847 from the compartment, which may be in form of a rupturable membrane
848..
The joint 860 between the compartment 840 and the package 810 comprises a
hinge-
element as indicated at 870 and a distance-element 880. The hinge-element
comprises
two hinge-flanges 871 and 872. One of the hinge flanges 871 terminates in a
hinge pin
873 and the other terminates in a socket 874, which by snapping or clicking is
able to
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receive the hinge pin 873. The distance-element 880 (shown in figure 8d) is in
this
embodiment a piece of foil of e.g. PE or PP comprising two covering parts, an
upper part
881 for covering the outlet 847, and a lower part 882 for covering the
entrance 820 prior to
use. The upper part 882 is further attached to the side of the compartment
facing the
5 pulling direction. The distance element 880 further comprises a pulling part
883 extending
between the upper and lower covering parts and which pulling part 883
terminates in a
ring-element 884 so as to provide for easy pulling. The assembly further
comprises a snap
catch in form a hook-element 885 placed at the bottom wall 842 of the
compartment 840
and a cooperating catch-element 886 placed at the package. As the distance-
element 880
10 is removed from the area between the compartment and the package, the
compartment
840 will pivot around the hinge-element 870. Then the outlet 847 will be able
to connect to
the entrance 820, and the spike-element 824 will rupture the membrane 848, so
as to
provide communication for the fluid. At the same time the hook-element 885
will connect
to the catch element 886, thereby attaching the compartment to the package.
Further
15 pulling at the ring-element 884 will cause the opening line 817 to open at
the division in
the distal part of the package - e.g. the sidewalls 818a and 818b - and hence
access to
the now wetted catheter 830 is provided.
The distance-element may also be provided as a block with a pulling ring
placed between
the compartment and the package. In use the block may be removed by pulling
the ring
20 and hence enabling contact between the compartment and the package.
Figures 9a-9g illustrate an assembly 901 according to the invention in which
the
compartment 940 and the package 910 are hinged together and the outlet 947
from the
compartment is placed on the side of the compartment, which in use-position
faces the
entrance 920 to the package. Figure 9a illustrate the assembly in a storage-
position,
25 figure 9d illustrate the assembly in a use-position and figures 9b and 9c
illustrate
intermediate positions therebetween. Figures 9e-9g illustrate side-views of
the assembly.
The joint 960 between the compartment 940 and the package 910 comprises a
hinge-
element 970 and a covering element 980. The package 910 has sidewalls 911, and
912
and end walls of which only the distal 914 can be seen in the figures. The
package 910 is
30 further provided with an air-outlet 915 which in a storage-position may be
covered by a foil
916. The joint 960 has a generally U-shape in cross-section, where the package
leg 961 is
attached to the package by welding and the compartment leg 962 likewise is
welded to
the compartment. As illustrated in figure 9f and 9g, the joint has a generally
planar extent
in the direction transverse the hinge. The compartment 940 consists of a foil
pouch 941
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having a backside 942, which is attached to the compartment leg 962 of the
joint 960. The
frontside of the compartment 943 is provided with an outlet 947 in form of a
rupturable
membrane 948. The leg 961 of the joint attached to the package further has
border walls
963 for providing an enclosure for the pouch as the pouch 941 is ruptured. The
leg 962 of
the joint attached to the compartment also comprises border walls 964 -
however, only in
the lower portion of the leg 962. The border walls 964 are attached to the leg
962 at two
extensions 965 and 966 of the leg. The entrance 920 to the package is placed
between
the border walls 963 and consists of an element 921 comprising a spike-element
924.The
hinge-element 970 is made as a part having a material thickness, which allows
it to bend.
The covering element 980 comprises two foil coverings, one outlet cover 981
covering the
outlet 947 from the compartment and one entrance cover 982 covering the
entrance 920
to the package. Between the two foil coverings a pulling part 983 is placed.
This pulling
part 983 is connected to a finger tab 984 via a distance-element 985. The
distance-
element 985 is a rigid element connected to the leg 961 at a hinge 986
provided by a
thinning of the material. The other end of the distance-element 985 is
attached to the leg
962 in a groove provided between the main part of the leg and the extension
965. The
distance-element 985 keeps the outlet 947 and the entrance 920 apart in the
storage-
position. When the assembly is to be used the distance-element 985 and the
foil
coverings 981, 982 are removed by pulling at the finger tab 984. Then the
outlet 947 is
connected to the entrance 920 and the air-outlet covering 916 is removed. By
applying a
pressure to the outside of the legs 961, 962 the pouch 941 is squeezed and the
fluid is
pressed into the package 910.
The joint may also be attached to the compartment and the package by gluing.
In a
storage-position the compartment may be pivoted 360 degrees compared to the
use-
position such that the pouch faces towards the package and the outlet of the
compartment
faces outward. In this embodiment the covering element may be in the form of
one or two
foils covering the entrance to the package and the outlet. These foils are
removed prior to
use. After removing the foils the compartment are pivoted at the hinge-element
such that
the pouch faces away from the package and the outlet faces the entrance of the
package.
Instead of providing an air-outlet from the package, the fluid may also be
entered into the
package by packing the medical device at a reduced pressure (vacuum). Then as
the
outlet connects to the entrance, the fluid will be sucked into the package.
Another
possibility is to provide a double lumen tube as connector between the outlet
and the
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entrance. Then the fluid will run into the package and the air will flow back
into the
compartment.
Figures 10a-1 Of illustrates an assembly 1001 according to the invention in
which the
package 1010 comprises a proximal part 1010a of foil and a distal part 1010b
welded to it,
quite similar to the embodiment of figures 4, 6 and 8. The same reference
numbers are
used for similar elements except for the prefix 10. Figure 1 Oa illustrates
the assembly in a
storage-position; figure 1 Oc illustrate the assembly in a use-position and
figure 1 Ob an
intermediate position therebetween. Figures 1 Od-1 Of illustrate side-views of
the assembly.
The compartment 1040 is joined to the package 1010 at a joint 1060 comprising
a hinge-
element 1070 and a covering foil 1080. Like the packages described earlier,
this package
1010 has sidewalls 1011, 1012 and a proximal and a distal side end wall of
which only the
distal end wall 1014 may be seen in the figures. The distal end wall 1014 is
curved at two
opposite sides and terminates in a gasket 1015. The distal end of the package
is further
provided with border walls 1016 which helps steer the compartment 1040 into
place as
explained later. The compartment 1040 comprises two sidewalls 1041, 1042
connected by
an upper wall 1043 and a lower wall 1044 both of which are curved. The
compartment
further has a front wall 1045 and a back wall 1046. The outlet 1047 of the
compartment is
placed near the top of one of the sidewalls 1041. The outlet 1047 is in this
embodiment in
form of a rupturable membrane 1048. The compartment 1040 further comprises an
intermediate wall 1049 dividing the compartment in a fluid chamber 1040a and a
chamber
1040b for receiving the distal end of the catheter 1030 comprised in the
package. The
distal end wall 1014, the gasket 1015 and the lower wall 1044 of the
compartment
constitute an opening line 1017 like the opening line of figure 8. The hinge-
element 1070
is made by two parts 1071, 1072, which are snapped or clicked together. One of
the
elements comprises the hinge pin 1073 and the other comprises a receiving
socket 1074.
The entrance 1020 comprises a double lumen tube 1021 as described in
connection with
the earlier embodiments. The double lumen tube 1021 has an air-channel 1022
and a fluid
channel 1023. In use the fluid flows in through the fluid channel 1023 and the
air flows the
opposite way through the air-channel 1022. The covering element 1080 comprises
a
cover part 1081 and a finger tab 1082 terminating in a pulling ring 1083. The
cover part
1081 covers one of the sidewalls 1041 of the compartment in a storage-
position. When
the assembly is to be used, the user pulls upwards and outwards in the
covering element
using the pulling ring 1083 and the finger tab 1082. This way the membrane
1048 at the
outlet 1047 is exposed. By pulling further outwards and then downwards at the
pulling ring
1083, the compartment is pivoted around the hinge-element to a position where
the outlet
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1047 connects to the entrance 1020. The spike-element 1024 at the double lumen
tube
1021 at the entrance 1020 penetrates the membrane 1048 at the outlet 1047 and
the fluid
of the compartment is able to enter into the package.
Figure 11 a illustrates the double lumen tube 1101 having a narrow air-channel
1102 and a
larger fluid channel 1103. The tube element 1101 has a cut-off end 1104, which
due to the
tapered cut is able to act as spike-element. The other end 1105 extends
transversely to
the longitudinal direction of the channels. The tube element 1101 has a curved
surface
1106 extending between the two ends though in the figure a part of it is cut-
away so as to
reveal the air-channel.
Figures 11 b and 11 c illustrate two different views of the tube 1101 placed
inside a
compartment 1107 comprising a fluid chamber 1108 and a pocket 1109 for holding
the
tube-element 1101. The pocket will assist in maintaining the tube in the
desired position
prior to use. The compartment has a front wall 1110 and a back wall 1111. The
tube is
placed at a bendable part 1112, which is able to tip such that the tube may be
penetrated
through the wall 1110 of the compartment. The tube may be a double-lumen tube
but it
may also be a single-lumen tube. Even though it is illustrated as a tube it
may also have
other shapes, e.g. angular.
Even though the compartment and the package are illustrated as having a
particular
shape, they may in related embodiments have other shapes. E.g. the compartment
of
figures 1, 4, 5 and 6 may be cylindrical or oval in shape even though the
compartments
are shown as box-like elements. Likewise the compartments of figures 2 and 3
may have
a box-like shape. Some of these shapes may be easier to handle for people with
poor
hand dexterity, e.g. an egg-shaped compartment may be easier to apply a
pushing force
to or an angular compartment may be easier to turn. The package of figures 1,
2, 4, 5, 6
and 7 may be formed entirely as an injection-molded cylindrical element. A
cylindrical
package may take up less space, as the waste of room surrounding the connector
of the
catheter will be minimized.
The package is in some embodiments shown as an injection-molded element, in
other as
a foil-element and finally as a combination. In related embodiments the
package may be
made of other materials than shown. E.g. in figures 1, 2, 4 and 7 the package
may be
formed as an injection-molded element or a combination of a rigid injection-
molded
material and a foil-element. It may also be formed in the form of an extruded
tube. In that
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case the package is connected to the compartment by welding. Alternatively the
package
may be connected to the compartment by gluing, e.g. by a UV-curing adhesive.
In the
embodiment shown in figure 3, the package may be provided as a partly
injection-molded
element and a partly foil-element, such that the part including the coupling
is made by a
rigid material. The embodiments shown in figure 5 and 6 may be provided with a
package,
which is entirely injection-molded.
The package-opening means may be provided differently from what is illustrated
in the
figures. In the embodiments including foil-packages, the package-opening means
may be
in the form of peelable joints notches, tearing lines etc. The package-opening
means
could be placed anywhere at the package. If the package is made of rather
rigid material
instead of foil material, the package may further comprise a bellow-shaped
part so as to
enable a pushing out the catheter of the package. Then the bellows may be
pushed
together and the connector may be exposed so as to enable a grip on it.
The hinge-element mentioned in figures 2, 4, 6 and 8 is in most embodiments
shown as a
regular hinge-element having a pin-element. However, the hinge-element may
also be
made as foil-hinge or a hinge formed by reducing the thickness of the material
and
thereby providing a hinge.
The outlet of the compartment is shown and illustrated as a penetratable
element.
However, it may also be in the form of an element, which can be coupled to a
matching
element on the entrance to the package. Such an element may be a spigot
matching a
socket at the entrance or a snap-fit coupling, e.g. a snap-fastener or a luer-
lock coupling.
Furthermore, the entrance to the package may be made as a penetrable element,
which is
able to penetrate the pouch in the compartment. The penetrable element and the
outlet
from the pouch may be covered with foils prior to use.
Another solution could be to provide the entrance and the outlet with adhesive
or magnets
so they will stick together.
In some embodiment the compartment may be provided with an air-inlet or the
package
may be provided with an air-outlet. If the air-inlet to the compartment or the
air-outlet from
the package is not provided through the connection, the air-inlet or- outlet
may be
provided by a hole initially covered by a breakable closure device in form of
a pin.
Alternatively the air-inlet or -outlet hole may be covered by a foil.
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The membrane constituting the outlet from the compartment or the entrance to
package
may be provided as a thinner material of the same material as the compartment.
The
membrane may also be provided by a material different from the rest of the
compartment.
In that case membrane and the package or the compartment respectively may be
5 produced by two-component molding or the parts may be glued or welded
together.
The entrance to the package may be formed as a cross or star shaped sharp rod
with
holes around it so the liquid will run on the outside surface of the rod and
into some holes
in package. Another solution could be a cone-shaped element having cutting
holes in it,
like an element known as a lemon squeezer.
