Source: http://www.patentsencyclopedia.com/app/20100258568
Timestamp: 2017-11-20 10:34:42
Document Index: 718030515

Matched Legal Cases: ['arts 410', 'art 443', 'arts 444', 'arts 443', 'arts 444', 'art 473', 'arts 474', 'arts 473', 'arts 475', 'arts 474', 'arts 474', 'arts 474', 'art 517', 'art 610', 'art 671', 'art 810', 'arts 818', 'art 881', 'art 882', 'art 882', 'art 883', 'art 883', 'art 983', 'art 983', 'art 1010', 'art 1010', 'arts 1071', 'art 1081', 'art 1081', 'art 1112']

Assembly for Wetting a Medical Device - Patent application
Patent application title: Assembly for Wetting a Medical Device
Inventors: Jesper Mads Frederiksen (Vedbaek, DK) Anna Granath (Malmo, SE) Henrik Jeppesen (Holte, DK) Henrik Jeppesen (Holte, DK) Kim Becker (Hilleroed, DK) Lars Olav Schertiger (Fredensborg, DK) Klaus Sommer Ipsen (Vanloese, DK)
Patent application number: 20100258568
Assembly for Wetting a Medical Device - Patent application - is provided <?php require_once('/home/patents/php/mtc.config.php'); require_once('/home/patents/php/mtc.class.php'); $MTC = new MTC(); $MTC->init(); ?>
Inventors: Henrik Jeppesen Lars Olav Schertiger Jesper Mads Frederiksen Anna Granath Kim Becker Klaus Sommer Ipsen
An assembly for wetting a medical device is provided. The assembly comprises a compartment for a fluid medium and a package for the medical device. The compartment and the package are separate elements, which are joined together. An outlet from the compartment is movable so as to be able to connect to an entrance to the package and hereby establish communication for the fluid. This way the medical device may be wetted. The fluid medium may contain an anti-microbial agent such as hydrogen peroxide. The medical device may be a urinary catheter. A method for manufacturing such an assembly and a method of using it is also provided.
1. 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.
2. An assembly according to claim 1, wherein the medical device is a urinary catheter.
3. An assembly according to claim 1, wherein the medical device has a hydrophilic coating.
4. An assembly according to claim 1, where 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.
5. An assembly according to claim 1, where the outlet in a storage-position faces away from the entrance and in a use-position faces the entrance.
6. An assembly according to claim 1, where a movement of the outlet from the storage-position to the use-position follows a circular arc.
7. An assembly according to claim 1, where a movement of the outlet from the storage-position to the use-position is a transverse movement
8. An assembly according to claim 1, where the compartment comprises a rupturable pouch.
9. An assembly according to claim 1, where a joint between the package and the compartment comprises hinge means.
10. An assembly according to claim 1, where a joint between the package and the compartment comprises a detachable coupling.
11. An assembly according claim 1, where a joint between the package and the compartment comprises a pivoting plunger for applying pressure to the fluid in the compartment
12. An assembly according to claim 1, where the connection between the outlet and the entrance includes a friction-fit coupling.
13. An assembly according to claim 1 where the connection between the outlet and the entrance includes a snap-fit coupling.
14. An assembly according to claim 1 where the connection between the outlet and the entrance includes a spike-element and a rupturable membrane.
15. An assembly according to claim 1, where the outlet from the compartment comprises a cut-off double lumen tube having a fluid channel and an air channel and where the entrance to package is a weak point.
25. A method for manufacturing an assembly comprisingassembling a package including a medical device;providing the package with an entrance;sterilizing the package;producing a compartment including a fluid medium;providing the compartment with an outlet;sterilizing the compartment separately from the package;joining the package and the compartment to each other;
34. A method according to claim 25 wherein joining includes welding.
35. A method according to claim 25 wherein joining includes mechanically coupling the package and the compartment.
38. A method according to claims 25, wherein sterilization of at least the package or the compartment is done by radiation.
40. A method according to claim 25 and further including wetting the medical device comprising:a. moving the outlet from the compartment to a position so it may connect with the entrance to the package, andb. connecting the outlet and the entrance to each other so as to allow for fluid communication.
41. A method according to claim 40 further comprising the step of providing an air-flow out of the package.
42. A method according to claim 41 wherein the air-flow out of the package is provided by opening the package.
43. A method according to claim 41 wherein 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.
44. A method according to claim 41 wherein the air-flow out of the package is provided by an air-channel in the connection between the outlet and the entrance.
51. A method according to claims 40 wherein the moving of an outlet comprises detaching the compartment followed by re-attaching it in a position where the outlet faces the entrance to the package.
53. A method according to claims 40 wherein the moving of an outlet comprises moving of a connecting device including the outlet from the compartment.
54. A method according to claim 53 wherein the moving is done in planes parallel to the longitudinal direction of the package.
[0001]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.
[0002]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. WO2006/092150. 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.
[0003]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.
[0004]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 connection between the compartment containing the fluid medium and the package containing the medical device.
[0005]However, there is a need to further reduce the risk of urinary tract infections by applying an anti-microbial composition just prior to catheterization.
[0006]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.
[0007]The moving of the outlet from the compartment may be done in several ways including displacing, pivoting or moving to another position.
[0008]The invention also concerns a method of manufacturing such an assembly and a method of using it to wet a catheter.
[0009]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.
[0010]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 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.
[0011]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.
[0012]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.
[0013]Generally, the medical device contained in the package defines a longitudinal direction of the package.
[0014]By a movable outlet is meant an outlet, which in itself is movable as well as an outlet placed on a movable compartment.
[0015]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.
[0016]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.
[0017]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 2 mm's defined as the shortest possible distance traveled by the outlet between the storage-position and the use-position
[0018]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.
[0019]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.
[0020]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.
[0021]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.
[0022]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.
[0023]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 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 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.
[0024]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.
[0025]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.
[0026]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.
[0027]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.
[0028]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.
[0029]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.
[0030]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-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.
[0031]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.
[0032]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.
[0033]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.
[0034]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 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.
[0035]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.
[0036]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.
[0037]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.
[0038]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.
[0039]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.
[0040]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.
[0041]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.
[0042]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.
[0043]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.
[0044]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.
[0045]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 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 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.
[0046]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 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.
[0047]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.
[0048]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.
[0049]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.
[0050]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.
[0051]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.
[0052]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 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.
[0053]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.
[0054]In another aspect the invention relates to a method for manufacturing an assembly comprising [0055]Assembling a package including a medical device [0056]Providing the package with an entrance to it [0057]Sterilizing the package [0058]Producing a compartment including the fluid medium [0059]Providing the compartment with an outlet from it [0060]Sterilizing the compartment separately from the package [0061]Joining the package and the compartment to each other
[0062]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.
[0063]In an embodiment the method concerns packing of a medical device, which is provided with a hydrophilic coating.
[0064]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--without demands for packing in controlled environment--shipping the package including the medical device to another location and here provide the fluid medium.
[0065]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.
[0066]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.
[0067]The package may be provided in similar ways.
[0068]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.
[0069]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.
[0070]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 the package ready-to-send, as it does not need time for evaporating following the sterilization process.
[0071]The compartment may also be sterilized by radiation, e.g. beta- or gamma-radiation or it may be sterilized by an autoclave treatment.
[0072]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 [0073]Moving an outlet from the compartment to a position so it may connect with an entrance to the package [0074]Connecting the outlet and the entrance to each other so as to allow for fluid communication
[0075]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.
[0076]The moving of the outlet may be as described above, e.g. transverse, along a circular arc etc.
[0077]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.
[0078]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.
[0079]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 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.
[0080]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 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.
[0081]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 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.
[0082]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.
[0083]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.
[0084]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.
[0085]FIGS. 1a-1c 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.
[0086]FIGS. 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.
[0087]FIGS. 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.
[0088]FIGS. 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.
[0089]FIGS. 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.
[0090]FIGS. 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.
[0091]FIGS. 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.
[0092]FIGS. 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.
[0093]FIGS. 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.
[0094]FIGS. 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.
[0095]FIG. 11 illustrates an embodiment of the connection between the outlet and the entrance in form of a double lumen tube.
[0096]FIGS. 1a-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. FIG. 1a illustrate the assembly 101 in a storage-position, FIG. 1b illustrate the assembly 110 in a use-position as the connection between the outlet and the entrance has been established and FIG. 1c illustrate the assembly 101 with an open package 110 and the catheter is ready to be removed.
[0097]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 FIG. 1c. 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.
[0098]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 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.
[0099]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.
[0100]In the embodiment of FIG. 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 FIGS. 1b and 1c 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.
[0101]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.
[0102]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 FIGS. 1a-1c, such that the upper part of the assembly corresponds to the top part of the compartment.
[0103]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.
[0104]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.
[0105]FIGS. 2a-2d illustrate an embodiment of the invention in which the assembly 201 comprises a package 210 including a catheter 230. FIGS. 2a and 2b show the assembly 210 in a storage-position in a front view and a side view respectively and FIG. 2d shows the assembly in a use-position. FIG. 2c shows an intermediate position for the compartment. The catheter 230 is the same as the catheter 130 of the embodiment in FIG. 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 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 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 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 FIG. 11. When the compartment 240 has been pivoted to the use-position and the connection between the outlet 247 and the entrance 220 has been established, then the foil 274 is removed and thereby access to the catheter 230 is established.
[0106]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.
[0107]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.
[0108]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.
[0109]FIGS. 3a-3b illustrate an embodiment in which the assembly 301 comprises a package 310 and a compartment 340 attached to the package. In FIG. 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 FIG. 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 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.
[0110]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 FIGS. 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 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 FIG. 3e.
[0111]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.
[0112]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.
[0113]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.
[0114]FIGS. 4a-4c illustrate an assembly 401 according to the invention including a package 410, a compartment 440, and a joint between the two 460. FIG. 4a illustrates the assembly in a storage position and FIG. 4b illustrates the assembly in a use-position. FIG. 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 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 FIG. 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.
[0115]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 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.
[0116]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.
[0117]FIGS. 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. FIG. 5a illustrates the assembly in a storage-position and FIG. 5c illustrates the assembly in a use-position. FIG. 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 FIG. 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 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 FIG. 11. The spike-element 524 constituted by the cut-off tube 521 will be able to penetrate the bottom of the compartment at the outlet.
[0118]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 the flexible material and the compartment are produced by two-component molding.
[0119]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 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.
[0120]The rail-element 580 consist of a generally U-shaped element 580 with one upper leg 581 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 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.
[0121]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. 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.
[0122]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.
[0123]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.
[0124]FIGS. 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. FIG. 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 FIG. 6b. FIG. 6c illustrates different steps between the storage-position and the use-position. The package is very similar to the package shown in FIG. 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 FIG. 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 in FIGS. 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 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.
[0125]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.
[0126]In FIGS. 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.
[0127]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 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.
[0128]Attachment in form of a welding 780 is made over a contact surface 781.
[0129]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.
[0130]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.
[0131]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.
[0132]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.
[0133]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.
[0134]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.
[0135]FIGS. 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. FIG. 8a illustrates a front-view of the assembly in a storage-position and FIG. 8c illustrates the assembly in a use-position. FIG. 8b illustrates an intermediate position between the storage- and the use-position. FIGS. 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 FIG. 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 FIG. 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.
[0136]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 receive the hinge pin 873. The distance-element 880 (shown in FIG. 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 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 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 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.
[0137]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 and hence enabling contact between the compartment and the package.
[0138]FIGS. 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. FIG. 9a illustrate the assembly in a storage-position, FIG. 9d illustrate the assembly in a use-position and FIGS. 9b and 9c illustrate intermediate positions therebetween. FIGS. 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 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 FIGS. 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 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.
[0139]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.
[0140]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 entrance. Then the fluid will run into the package and the air will flow back into the compartment.
[0141]FIGS. 10a-10f 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 FIGS. 4, 6 and 8. The same reference numbers are used for similar elements except for the prefix 10. FIG. 10a illustrates the assembly in a storage-position; FIG. 10c illustrate the assembly in a use-position and FIG. 10b an intermediate position therebetween. FIGS. 10d-10f 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 FIG. 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 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.
[0142]FIG. 11a 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.
[0143]FIGS. 11b and 11c 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.
[0144]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 FIGS. 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 FIGS. 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 FIGS. 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.
[0145]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 FIGS. 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 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 FIG. 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 FIGS. 5 and 6 may be provided with a package, which is entirely injection-molded.
[0146]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.
[0147]The hinge-element mentioned in FIGS. 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.
[0148]The outlet of the compartment is shown and illustrated as a penetrable 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.
[0149]Another solution could be to provide the entrance and the outlet with adhesive or magnets so they will stick together.
[0150]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.
[0151]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 produced by two-component molding or the parts may be glued or welded together.
[0152]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.
Patent applications by Kim Becker, Hilleroed DK
2012-04-19 Drinking vessel holder having a lifting device