WO2012076690A1

WO2012076690A1 - Closure device for infusion solution bags

Info

Publication number: WO2012076690A1
Application number: PCT/EP2011/072312
Authority: WO
Inventors: Ken POBERÉZNY; Shaun Phillips; Bruce Renfrew
Original assignee: Xellia Pharmaceutical Aps
Priority date: 2010-12-10
Filing date: 2011-12-09
Publication date: 2012-06-14

Abstract

An infusion bag closure device for sealing of a passage in an infusion bag is disclosed. The closure device comprises a first part and a second part, the first part comprises a first engagement part, a second engagement part, and at a first end a release arrangement, the second part comprises at a first end thereof an engagement part adapted to connect with the first engagement part of said first part to form a first connection and at a opposite second end an engagement part adapted to connect to the second engagement part of the first part to form a second connection. The connections are releasable connections and at least one of the connections is a snap connection and where the first part or the second part between the first and second engagement parts on a side adapted to face the other part comprises a planar surface.

Description

Closure device for infusion solution bags

The present invention relates to a device for supplying an infusion solution, especially the present invention relates to a closure device for a device for supplying an infusion solution comprising at least two compartments completely separated prior to use. Where at least one compartment comprises a sterile intravenous fluid and the at least one other compartment comprises a dose of a medicament.

BACKGROUND OF THE INVENTION

Flexible bags usually made out of plastic sheets and filled with a sterile intravenous liquid are well known and used for providing infusion solutions. A medicament can be provided dissolved in the liquid, but for many medicaments the stability of the medicament is aversively affected by the presence of liquids such as water which either results in very short shelf life or even makes it impossible to supply a medicament of acceptable quality dissolved in an intravenous liquid.

The prior art disclose different solutions for solving these problems. The possibility of providing an infusion bag comprising separate chambers comprising the liquid phase in one chamber and the medicament in another sealed compartment has been investigated. However, the previously provided structures have had drawbacks, as they have been demanding a number of additional handling steps to open the sealed chamber comprising the medicament; or sealing between the liquid chamber and the medicament chamber has been insufficient, resulting in leakage, especially of liquid from the liquid chamber into the medicament chamber, resulting in the same shelf life problems as discussed above.

EP0132632 describes a compartmented flexible solution container comprising a flexible bag with two compartments separated with a clamp member. The two inner surfaces of the clamp member intended for pressing against the outer surfaces of the bag are both made up of pads with a flat surface.

From DE20219137 a plastic bag clip is known. Each inside of the two legs forming the hinged clip is provided with a number of protruding ribs arranged so that the ribs overlap when the clip is closed. Thereby, when the clip is fastened on a plastic bag the bag is considerably deformed by the engagement of the protruding ribs.

W091/07205 discloses a medicament storing and mixing system comprising a plastic bag with two compartments separated by a closure. The closure comprises an external clamp provided over a releasable internal closure. The internal sides of the plastic bag are provided with protruding closure elements that interlock. Further the surfaces of the clamp, intended for being pressed against the external surfaces of the bag, in the area of the internal closure, each are provided with protruding ribs which when clamped over the bag forces the bag into a "W-form" on each side of the internal closure. This deformation of the two sheets of plastic forming the plastic bag courses considerable shear forces on the plastic material.

There is still a need for an improved solution for providing infusion bags

comprising at least one separate liquid proof medicament chamber. The device should allow for quick and effective opening of the passage between the

medicament chamber and the fluid/solvent chamber. The passage should be liquid proof also with respect to liquid films that may be present on the inner surface of the bag in the area around the passage. Further the device should allow for effective mixing of the medicament with the liquid phase upon opening of the passage between the infusion fluid and the medicament chamber. The closure device should further apply limited shear forces to the bag and limited deformation of the bag. Hereby the risk of damaging the integrity of the bag when placing the closure device is limited.

Preferably, for security reasons, it should not be possible to close the closure device after it has been opened. Any opening also for limited time or accidentally could result in possible mixing of the compounds within the compartments. Re-closing of the closure device would compromise the quality of the product.

SUMMARY OF THE INVENTION

The present invention provides an infusion bag closure device for sealing of a passage in an infusion bag. The closure device comprises a first part and a second part, the first part comprises a first engagement part, a second engagement part, and at a first end a release arrangement, the second part comprises at a first end thereof a first engagement part adapted to connect with the first engagement part of said first part to form a first connection and at an opposite second end a second engagement part adapted to connect to the second engagement part of the first part to form a second connection, where the connections are releasable connections and at least one of the connections is a snap connection. The first part or the second part between the first and second engagement parts on a side adapted to face the other part comprises a planar surface. The planar surface provides for a flat arrangement of a part of the infusion bag between the two parts. When the closure device is closing a passage within an infusion bag the closure device will expose the part of the bag arranged within the closure device for no or very limited shear forces.

In one aspect of the present invention the first part or the second part between the first and second engagement parts on a side adapted to face the other part comprises at least one straight protruding rib with a V-shaped outer surface arranged to abut the planar surface of the other part when the first and the second part are connected. When the closure device is placed over a passage in the infusion bag, the bag will be in contact with the closure device at least in the areas of the V-shaped outer surface and the opposing planar surface. In one embodiment of the closure device, the planar surface is arranged on the first part and at least two straight ribs stretched out between the first and the second end are arranged on the surface of the second part. In one aspect of this embodiment, the second part comprises two outer ribs stretched out between the first and the second end and arranged at the opposite outer edges of the surface and at least one additional rib arranged between the two outer ribs. In another aspect the second part comprises two additional ribs stretched out between the first and the second end and arranged near the outer edges. In one embodiment all the ribs comprise V-shaped outer surfaces and the ribs are arranged with two ribs near each outer edge thereby forming a W-shaped outer surface at each edge.

In one aspect of the present invention the planar surface adapted for facing the other part is an outer protruding surface of two protruding rims arranged at opposite outer edges of the side facing the other part.

In yet another aspect the planar surface is arranged on the first part and the at least one V-shaped rib is arranged on the second part.

Further in another aspect the present invention a closure device wherein the release arrangement comprises a resiliently hinged arm comprising a release element adapted to engage with and release at least one of the snap connections. In one embodiment the release arrangement comprises a locking element adapted to lock the resiliently hinged arm to the rest of the first part. In this embodiment the release element is locked in a position after at least one of the snap connections has been released, and the release element can not easily be unlocked. Thereby it is also easily visible that the closure device has been released.

In a further aspect of the present invention the release element when the hinged arm is locked blocks the connection of the first or the second engagement parts. After release it is not possible to reconnect the first and the second part, without firstly unlocking the hinged arm which requires application of force thereto.

The present invention further provides an infusion solution device comprising a delivery opening, a first fluid compartment in fluid communication with said delivery opening, at least one separate medicament compartment and a removable closure device according to the present invention arranged for sealing a fluid communication opening between the first fluid compartment and the at least one separate medicament compartment.

In one aspect of the invention the at least one separate medicament compartment is arranged to comprise a dry, solid medicament.

In another aspect of the resent invention said fluid communication opening comprises a U-shaped channel and the closure device is arranged seal both legs of the U-shaped channel. In this aspect of the invention a triple barrier system is obtained with only one closure device. For the fluid to pass into the medicament compartment it has to first pass into the first leg of the U-shaped channel closed by the closure device, secondly pass through the U-shaped which could be empty or gas filled. Thirdly it has to pass out of the second leg of the U-shaped channel closed by the same closure device.

The present invention further provides a method for obtaining a liquid proof releasable sealing of two compartments of a flexible, plastic container that can be manually opened to allow fluid to pass between the two compartments, wherein the method comprises applying a closure device according to the present invention over an opening between the two compartments of the flexible, plastic container by placing the opening part of the flexible plastic container between the first and the second part closure device and connecting the first and the second engagement parts, respectively.

In one aspect of the present invention the method comprises forming a gas filled pocket within the flexible, plastic container within the closure device. By forming at least one gas pocket the capillary forces acting on a liquid stored within one of the compartments is believed to be limited or reduced

The present invention provides a device for infusion solution comprising a delivery opening, a first fluid compartment in fluid communication with said delivery opening, at least one separate medicament compartment and a removable closure device arranged for sealing a fluid communication opening between the first fluid compartment and the at least one separate medicament compartment.

In one aspect the device the at least one separate medicament compartment is arranged to comprise a dry, solid medicament.

In one embodiment of the device according to the present invention said closure device is a clip comprising a first and a second part, the first part comprises at a first end thereof a first engagement part and at an opposite second end a handle and a protruding surface for snap engagement with said second part, the second part comprises at a first end thereof an engagement opening adapted to receive the first engagement part of said first part and at a opposite second end an opening adapted to receive the protruding surface of the first part for snap engagement.

The clip of the device according to the present invention may in one embodiment comprise a surface of the second part arranged for facing the first part is equipped with one or more straight ribs stretched out between the first and the second end.

Further the second part of the clip may comprise two outer ribs arranged at the opposite outer edges of the surface and at least one additional rib arranged between the two outer ribs. In one aspect the second part comprises two additional ribs evenly distributed in between the outer ribs.

In one embodiment of the device a surface of the first part arranged for facing the second part comprises protruding rims on the outer edges of the surface stretched out between the first and the second end. In one aspect the protruding rims have V- shaped outer surfaces.

In one aspect of the device according to the present invention the first end of the first part is adapted to be connected to the first end of the second part by a hinged connection.

The present invention further provides a closure device comprising a first and a second part, the first part comprises at a first end thereof a first engagement part and at an opposite second end a handle and a protruding surface for snap

engagement with said second part, the second part comprises at a first end thereof an engagement opening adapted to receive the first engagement part of said first part and at a opposite second end an opening adapted to receive the protruding surface of the first part for snap engagement.

In one aspect of the closure device a surface of the second part arranged for facing the first part is equipped with one or more straight ribs stretched out between the first and the second end. In one embodiment the second part comprises two outer ribs arranged at the opposite outer edges of the surface and at least one additional rib arranged between the two outer ribs. In a further embodiment the second part comprises two additional ribs evenly distributed in between the outer ribs.

In another aspect the closure device according to the present invention a surface of the first part arranged for facing the second part comprises protruding rims on the outer edges of the surface stretched out between the first and the second end. In one aspect the protruding rims have V-shaped outer surfaces.

In yet another aspect of the closure device the first end of the first part is adapted to be connected to the first end of the second part by a hinged connection.

The present invention also provides a method for obtaining a liquid proof sealing of a flexible, plastic container that can be manual opened to allow fluid to pass through, wherein the method comprising applying a closure device according to the present invention to an opening of the flexible, plastic container by placing an opening part of the flexible plastic container on the surface of the second part of the closure device and connecting the first end of first part of the closure device to the first end of the second part and moving the first part in a hinge like movement towards the second part until the protruding surface is snaps into the opening. In one embodiment the method comprises forming a gas filled pocket within the flexible, plastic container within the closure device.

In one embodiment of the present invention, the closure device provides a tight seal between a medicament compartment comprising a liquid and a medical

compartment comprising a dry medicament in spite of the capillary forces driving the liquid towards the compartment comprising the dry medicament during storage.

DESCRIPTION OF THE DRAWINGS

Figure la- lc show three embodiments of a device for infusion solution according to the present invention prior to the filling of the compartments.

Figure 2a-2c illustrates three embodiments of a device for infusion solution according to the present invention after the filling of the compartments.

Figure 3 an embodiment of a closure device according to the present invention.

Figure 4a - 4c illustrates the first part of a closure device.

Figure 5 illustrates the second part of a closure device.

Figure 6a shows a sketching of the cross section along the line A-A of the closure device according to figure 3.

Figure 6b shows a sketching of the cross section along the line B-B of the closure device according to figure lb when applied to a flexible bag.

Figure 7 illustrates a second embodiment of the closure device according to the present invention.

Figure 8 illustrates the second part of the closure device according to figure 7.

Figure 9 illustrates a device for infusion solution according to the present invention.

Figure 10 illustrates the device for infusion solution according to figure 9 after the closure device has been removed.

Figure 1 1 shows an end view of the second part of a second embodiment of the closure device.

Figure 12 shows the first part of a second embodiment of the closure device.

Figure 13 illustrates the first part and the second part of the second embodiment of the closure device Figure 14a and 14b illustrates an end view of the second embodiment of the closure device with out and with a part of the flexible bag.

Figure 15 is a top of the second embodiment of the closure device where the two parts are interconnected.

Figure 16 is a cross sectional view along B-B of the embodiment on figure 15.

Figure 17 is a cross sectional view along A- A of the embodiment of figure 15.

Figure 18 schematically illustrates a cross sectional view of a closure device when the closure device seals a passage.

Figure 19 illustrates the first part of the closure device in a locked position after the second part has been released there from.

PRINCIPAL DESCRIPTION OF THE INVENTION

The term "medicament" as applied here refers to any substance or combination of substances to be supplied to a subject in need thereof for treatment or prophylactic treatment of a medical condition. The term "medicament" also includes nutritional supplements.

The term "planar surface" as used here refers to straight, even and smooth surface. The planar surface may be a full planar surface or the surface may comprise planar areas as well as areas with other properties.

The term "snap lock", "snap connection" and "snap engagement" as used here refers to the securing of one element to another element by providing at least one gripping means on one of the elements and on the other element at least one griping area adapted for receiving and engaging with the gripping means. The snap lock or snap engagement may be configured releasable or non-releasable.

The term "engagement part" as used here refers to a part of the device which is constructed to connect and/or engage with another element, thereby forming connection such as a "snap connection".

The term "protruding rib with a V-shaped outer surface" as used here refers to a rib having a structure with a V-shaped cross section on the tip. The rib is arranged to be able to orthogonally abut a planar surface, whereby the contact area formed between the planar surface and the rib is a line. When two or more "ribs with a V-shaped outer surface" are arranged on one part arranged to face a planar surface, then a gas pocket in the infusion bag may be formed between the ribs. Such gas pockets will provide a liquid proof sealing in spite of capillary forces drawing the liquid through. The present invention may in one embodiment be utilized to supply any medicament applicable for separate storage and solution in an infusion solution. In one aspect of the invention the medicament is selected from dry powder anti-infectives selected from antibiotics, preferably dried antibiotics or more preferably freeze dried antibiotics.

In another aspect, the medicament is an anticancer or antifungal formulation in dry form.

Other embodiments could include all other compounds used for infusion or combinations thereof.

In yet another embodiment the medicament is provided in a fluid in one

compartment and infusion solution is provided in the other compartment.

In one aspect of the present invention the closure devices comprises two separate parts that are initially snapped together when closing the passage between to chambers. When the closure device is opened the two parts are disconnected and removed. This results in a full opening of the passage as no parts of the closure device remain in contact with the device for infusion.

Further, should the closure device be accidentally opened prior to the intended use of the device for infusion the parts will disconnect and the unintended opening will be obvious to the user who will register the premature opening and due to the possible reduction of quality of the medicament desist from use thereof. According to this aspect of the present invention the closure device provides an additional safety feature.

The present invention will now be described in further detail referring to the enclosed figures. Figure la, lb and lc respectively illustrates three embodiments of a device for infusion solution 1, 101 and 201 according to the present invention. The devices can be prepared by welding through heat or ultrasound or gluing two sheets of flexible plastic together, thereby forming a bag with openings for filling. Through holes may also be formed in the sheets for allowing a closure device to be placed over a selected passage or passages within the bag. Through holes for other purposes such as hanging the device on a stand may also be provided. The devices are illustrated in the state prior to filling. All the devices comprise a delivery opening 10 for delivering the infusion solution to an individual in need thereof. An infusion fluid compartment 2, 102, 202 can respectively be filled trough openings 4, 104 and 204. Further the devices/bags comprise medicament compartments 3, 3 ', 3 ", 103 and 203 these can respectively be filled with the intended medicament or medicaments through the openings 6, 6', 6", 106 and 206. The passage between the fluid compartments and the medicament compartments are sealed by closure devices 20, 120, 120' and 220 respectively. After filling of the different compartments the openings 4, 104, 204, 6, 6', 6", 106 and 206 are sealed by welding, or gluing of the two sheets together in the area around the openings. Figures 2a, 2b and 2c illustrate the closed bags after the filling openings have been sealed. The device according to figure 2a comprises three medicament chambers 3, 3 ' and 3 " that can be opened separately. If the same medicament is present in the compartments the dosage can be selected by opening one, two or three compartments, alternatively different medicaments can be combined immediately prior to administration by infusion.

In the embodiment according to figure 2b the two closure devices 120 and 120' opens and/or closes passages leading into the same fluid compartment 103. when the closure devices are removed this design provides the additional feature that fluid can be allowed to flow trough the medicament compartment 103, which supports and eases the thorough and complete mixing and dissolving of the medicament in the infusion fluid.

Figure 3 shows one embodiment of a closure device according to the present invention. The closure device comprises a first part 21 and a second part 3 1. The first part comprises at a first end thereof a first engagement part 22. Further the first part comprises at a second end 23 thereof opposite the first end a handle 24.

Similarly the second part 31 comprises a first end 32 and a second end 33. The first end 32 is adjusted to receive the first end of the first part and contain it when the closure device or clip is closed. The second end 33 of the second part is adapted to receive the second end 23 of the first part by snap engagement when the closure device is closed and is adapted to release the first part when a user draws in the handle 24 in a direction away from the second part 3 1.

The figures 4a, 4b and 4c illustrate the first part of the closure device 21 in further detail. The surface of the first engagement part 22 may be structure to fit into an opening in the first end of the second part forming a hinge like connection. In one embodiment the first part 21 comprises protruding rims 25 and 25' on the surface 27 arrange to face the second part. The first part may further at the second end 23 thereof comprise a protruding element 26 arrange to face the second end of the second part and adjusted to snap into an opening in said second end of the second part.

Figure 5 shows a detailed view of a second part 31 of one embodiment of the closure device. At a first end 32 the first part comprises an engagement opening 39 for receiving and containing the first end of the first part when the closure device is closed. The second end 33 of the second part is adjusted for engagement with the second end of the first part. The second end 33 comprises in this embodiment an opening 36 for receiving the protruding element of the first part and retaining it, until it is actively removed. Further the second part 31 comprises ribs 35, 38, 38' and 35 ' arranged to face the first part when the device is closed. The ribs 35 and 35' are outer ribs along the edge of the surface stretched out between the first and the opposite second end. The ribs 38 and 38' are inner ribs. The second part of the closure device may comprise any number of ribs, only outer ribs or outer ribs and any number of inner ribs.

Figure 6a is a sketch of the cross section of the closure device illustrated on figure 3 along the line A-A. In the illustrated embodiment the protruding ends 28, 28' of the rims 25 and 25' of the first part 21 are V-shaped. The protruding ends 28, 28' are respectively arranged to abut with the protruding surfaces of the ribs 35 and 35' on the surface 37 of the second part 3 1. The protruding surfaces of the ribs 35 and 35' are planar surfaces.

Figure 6b shows a sketch of a similar cross section of a closure device, but this time when the closure device is in use and seals the passage between two compartments. Accordingly the cross section is along the line B-B of figure lb. The two sheets 50 and 51 pass between the first part 21 and the second part 31 of the closure device. In the areas where the rims 25, 25' respectively oppose the outer edges 35 and 35' pressure is applied when the closure device is closed and thereby the passage is closed. The structure of the closure device further results in the formation of a gas pocket 52 between the two sheets 50 and 51 within the structure of the closure device. In one aspect of the invention the gas pocket formed improves the sealing effect and secures that the sealing is liquid proof. The figure 6b also shows that the sheets 50 and 51 are kept generally flat within the closure device as the protruding surfaces of the ribs 35 and 35' are flat planar surfaces.

In a clip according to the present invention the plastic sheets forming the bag are not subjected to excessive shear forces.

Figure 7 shows an alternative embodiment of the closure device 20 according to the present invention. In this embodiment the closure device comprises a series of first parts 21 arranged for closing a series of parallel medicament compartments as illustrated on figures l a and lb. The closure device further comprises a second part 13 1 with an engagement part at a first end 32 thereof for containing the first end of a first part 21, and a second end comprising a second engagement part 33 for receiving a second end of a third first part 21. The second part 131 further comprises elements 132 and 133 for engagement with the first end of one first part and the second end of a different first part.

Figure 8 shows additional details of the second part 13 1, including inner and outer ribs 138, 138' and 135, 135 ' and an opening 136 for receiving and retaining the protruding element 26 of the first element.

Although the illustrated embodiment comprises three first parts also embodiments comprising two, four or any other number of first parts can be envisaged. Figure 9 and 10 illustrates another embodiment of the present invention. The illustrated device for infusion 301 comprises two compartments 302 and 303 connected by a U-shaped channel 307. On figure 9 the connection is closed by a closure device 320 arranged to close the connection twice by covering both legs of the U-shaped channel 307 with one closure device. The closure device is arranged to grip over the channel from each side of the infusion device, the visible side and the back side. As visible on figure 10 the infusion device comprises two openings 308, one on each side of the U-shaped channel allowing for the two parts of the closure device to engage directly with each other through the openings.

The illustrated closure device 320 is a second embodiment of the closure device. However it should be understood that this second embodiment of the closure device is not limited to use with the illustrated embodiment of the device for infusion but can be employed with any type of device for infusion comprising at least to connected compartments initially kept separated by a closure device, such as the device embodiments illustrated on figures la- lc and 2a-2c.

Figure 1 1 illustrates an end view of a second part 331 of the second embodiment of a closure device 320 according to the present invention. Visible is a first end 332 comprising a first resiliently connected protruding engagement member 339. The first protruding engagement member 339 is arranged on a first side of the second part adapted to the face the first part of the closure device when the device is closed. The first protruding engagement member 339 is adapted to releasable connect the second part to the first part through an opening 308 in an infusion device. Also visible are two protruding ribs 335, 335' on the rim of the second part on the side facing the first part. The end surface of each of the protruding ribs 335. 335' comprises two V-shaped edges 360, 361 and 360', 36 respectively. The V- shape edges are arranged to face the first part of the closure device and be in contact with the outer surface of the passage in the infusion device or bag when arranged to close of the passage between two compartments.

Figure 12 illustrates the first part 321 of the second embodiment of the closure device. The visible surface 327 of the first part comprises a planar surface area intended for facing the infusion bag and the second part of the closure device. The planar surface provides for the closing of the closure device without implying considerable shear forces to the plastic sheets forming the passage to be closed. The sheets are not as in the prior art bend around overlapping ribs and providing the sheets with a number of successive 90 degree turns is avoided.

On figure 13 the first part 321 and the second part 331 are illustrated correctly positioned above each other. Closing the device is obtainable by lowering the first part, normally after a part of a passage has been provided in-between the two parts. The first part comprises first and second openings 345 and 346 adapted to receive and releasable connect the second part to the first part; see both figure 12 and 13. The first end 332 of the second part comprising the protruding engagement member 339 is directed into the first opening 345, whereas a second end 333 comprising a resiliently connected protruding engagement member 336 is directed into opening 346. The first part further comprises a resiliently hinged locking member 324 comprising a partly flexible leg with an outer end comprising a protruding locking element 340 adapted to fit into a recess 341 arrange on a side surface of the first part. Further locking member comprises a release element 342 protruding from the locking member towards the first opening. The locking member 324 provides two functions, firstly when the locking element is biased at the hinged connection against the rest of the first part the release element 342 enters into the cavity provided by the opening 345 through an additional opening 345a. The release element pushes against the resiliently connected engagement member 339. The member is forced away from the engaged position it is thereby released from engagement with the first part. When the releasable connection is released at the first end also the second end 333 is released as no spring force between the two ends 332 and 333 is present any longer.

At the same time the protruding locking member 340 will have entered into the recess 341. The locking member and the recess are configured to be structural opposites so that the protruding element is snapped into the recess and locked in place. The release element 342 is thereby retained within the cavity inside the openings 345 and 345a and the protruding engagement member 339 can not be reintroduced trough opening 345 as it is blocked by the release member 342. This is illustrated in further detail on figure 19 where the second part has been released and removed and the blocking of the opening 345 by the release member 342 is shown. Also illustrated is the snap locking of the locking element 340 in the recess 341.

The Figures 14a and 14b are provided to illustrate how the part of the bag forming the passage is arranged within the closure device. On figure 14a only an end view of the closed closure device is shown whereas on figure 14b the closure device is closing of a passage. A part of the front side 50 of the bag is present and position in contact with the planar surface 327 of the first part. An opposite part of the backside of bag faces the second part and is in contact with the v-shaped edges 360, 361 and 360', 36 on the end surface of each of the protruding ribs 335. 335' . The planar surface 327 effectively limits the deformation of the bag and the sheer forces that the material of the bag experiences.

As will be discussed later it is believed that gas pockets are formed within the bag in the area between the v-shaped edges and possibly also between the edges 361 and 361 ' . Figures 15, 16 and 17 illustrates the closed closure device 321 seen from the front, and as cross sections along the lines B-B and A-A respectively. From the front the only visible parts of the second part 331 of the closure device are the protruding engagement members 336 and 339. These have been entered into the openings 246 and 345 respectively. On the cross sectional view on figure 16 it is shown have these protruding elements gripping around and retained by internal surfaces 349 and 348 respectively. The end elements 333 and 332 protrude out of the openings 345 and 346 on the backside. When the locking member 324 is forced towards the end 332 of the second part the outer end 347 of the release element 342 is brought in contact with the protruding engagement member 339. Due to the resilient construction of the end part 332 the engagement member is forced sideways away from the internal surface 348. When the engagement element looses contact with the internal surface the whole end part of the second part is released from the opening 345. This also releases the tension that has kept the other end part 333 locked into opening 346 and therefore the whole second part is released from the first part. The locking member when being moved from a open to a closed position accordingly transfers spring tension to the second part and as this energy is released instantly when the protruding element 339 looses its grip the second part preferably springs out and removes it self from the second part and the bag. This feature secures a full opening of the passage between the two chambers in the bag as the two parts of the closure device are fully removed from the bag.

Figure 17 shows a cross section of the closure device along the line A-A.

Figure 18 is a sketch of the cross section of the closure device when it is placed over a passage formed between two plastic sheets 50 and 51. The sheet 51 rests flat on the surface 327 of the first part. The second sheet 50 partly follows the contour of the second part. On the figure a gas pocket 370 between the sheets is formed in the area between the W-formed edges 360' and 36 and the surface 327. A gas pocket 371 is also formed in the area between the ribs 335', and 335 and the surface 327. On the figure a gas pocket 372 is also formed between the sheets in the area between the W-formed edges 360 and 361 and the surface 327. A further gas pocket 373 is illustrated on the figure. This gas pocket 373 could be placed the U-shape passage illustrated on figures 9 and 10 where one closure device closes the entrance into both legs of the U-shaped passage. This is a sketch, and the gas pockets between the edges 360', 361 ' and 360, 361 respectively are increased in size, to make them more visible. Also a person skilled in the art will understand that the formation of at least one of these gas pockets 370, 371 , 372 and 373 will provide a barrier to liquid penetration due to capillary forces.

Without being bound by this theory it is believed that the structural features of the closure device provides formation of gas pockets within the passage between the compartments, and that it is the presence of this gas pocket that secures the liquid proof sealing. The gas pockets are believed to hinder capillary forces, that otherwise could draw liquid from the infusion fluid compartment and into the medicament compartment.

Unless the closure device is connected to the bag under vacuum gas will be present and gas may be enough to secure the presence of the gas pockets.

Gas pockets can also be obtained by applying a gas stream or a gas pressure to the bag or device for infusion during placing and/or closing the closure device. Thereby gas pockets are formed between the rims of the first part of the closure device (see 52 in Figure 6b and 371 in figure 18) and/or between the V-shaped edges (see 370 and 372 in figure 18). A further gas pocket can also be present externally to the closure device (see 373 in Figure 18).

The closure device may be applied to a passage within the device for infusion in a step separated in time from the filling of the device for infusion. The gas can be selected from any type of sterile gas. Preferably a gas is selected that will not react with the medicament or the infusion fluid.

The dosage provided in each device can be freely selected and adapted to the intended individual to be treated. Each device may comprise one or several doses of the medicament and one or more of the doses may be dissolved in the infusion liquid simultaneously.

A person skilled in the art will recognize that the present invention may be modified in different ways without leaving the main principals of the invention. All such modifications fall within the scope of the present invention as defined by the claims.

Claims

1. An infusion bag closure device for sealing of a passage in an infusion bag, where the closure device comprises a first part and a second part, the first part comprises a first engagement part, a second engagement part, and at a first end a release arrangement, the second part comprises at a first end thereof a first engagement part adapted to connect with the first engagement part of said first part to form a first connection and at an opposite second end a second engagement part adapted to connect to the second engagement part of the first part to form a second connection, where the connections are releasable connections and at least one of the connections is a snap connection and where the first part or the second part between the first and second engagement parts on a side adapted to face the other part comprises a planar surface.

2. Closure device according to claim 1, wherein the first part or the second part between the first and second engagement parts on a side adapted to face the other part comprises at least one straight protruding rib with a V-shaped outer surface arranged to abut the planar surface of the other part when the first and the second part are connected.

3. Closure device according to claim 2, wherein the planar surface is arranged on the first part and at least two straight ribs stretched out between the first and the second end are arranged on the surface of the second part.

4. Closure device according to claim 3, wherein the second part comprises two outer ribs stretched out between the first and the second end and arranged at the opposite outer edges of the surface and at least one additional rib arranged between the two outer ribs.

5. Closure device according to claim 3, wherein the second part comprises two additional ribs stretched out between the first and the second end and arranged near the outer edges.

6. Closure device according to anyone of the claims 1-5, wherein the planar surface adapted for facing the other part is an outer protruding surface of two protruding rims arranged at opposite outer edges of the side facing the other part.

7. Closure device according to anyone of the claims 2-5, wherein the planar surface is arranged on the first part and the at least one V-shaped rib is arranged on the second part.

8. Closure device according to anyone of the preceding claims, wherein the release arrangement comprises a resiliently hinged arm comprising a release element adapted to engage with and release at least one of the snap connections

9. Closure device according to claim 8, wherein the release arrangement

comprises a locking element adapted to lock the resiliently hinged arm to the rest of the first part.

10. Closure device according to claim 9, wherein the release element when the hinged arm is locked blocks the connection of the first or the second engagement parts.

1 1. Infusion solution device comprising a delivery opening, a first fluid

compartment in fluid communication with said delivery opening, at least one separate medicament compartment and a removable closure device according to claim 1- 10 arranged for sealing a fluid communication opening between the first fluid compartment and the at least one separate medicament compartment.

12. Device according to claim 1 1, where the at least one separate medicament compartment is arranged to comprise a dry, solid medicament.

13. Device according to claim 1 1 or 12, where said fluid communication opening has a u-shaped channel and the closure device is arranged seal both legs of the channel.

14. Method for obtaining a liquid proof releasable sealing of two compartments of a flexible, plastic container that can be manual opened to allow fluid to pass between the two compartments, wherein the method comprises applying a closure device according to any one of the claims 1-10 over an opening between the two compartments of the flexible, plastic container by placing the opening part of the flexible plastic container between the first and the second part closure device and connecting the first and the second engagement parts, respectively.

15. Method according to claim 14, wherein the method comprises forming a gas filled pocket within the flexible, plastic container within the closure device.