INJECTION OR INFUSION DEVICE COMPRISING AN IMPROVED RELEASE LINER

Abstract

An injection device configured for attachment to the skin of a patient using an adhesive layer includes a release liner covering the adhesive layer thereby preventing skin attachment. The release liner comprises a sheet of material where a first surface contacts the adhesive layer, and an aperture defining a passage for a film connected to a first sterile barrier film located within the injection device. An end of the film is connected to a second surface of the sheet of material that is opposite to the first surface, and the release liner is covered by a strengthening sheet connected to the second surface and covering the aperture and the end of the film.

Claims

1. An injection device configured for attachment to the skin of a patient using an adhesive layer, the injection device comprising a release liner covering the adhesive layer thereby preventing skin attachment, wherein the release liner comprises: a sheet of material with a first surface contacting the adhesive layer; a first aperture defining a passage for a film connected to a first sterile barrier film located within the injection device, wherein an end of the film is connected to a second surface of the sheet of material that is opposite to the first surface, and wherein the release liner is covered by a strengthening sheet connected to the second surface and covering the first aperture and the end of the film.

2. The injection device according to claim 1, wherein the release liner further comprises a second aperture for a hollow needle, wherein an end of the hollow needle is configured to be moved from a first position within the injection device to a second position outside the injection device, and wherein the second aperture is covered by a removable second sterile barrier film attached to the strengthening sheet.

3. The injection device according to claim 2, wherein the first sterile barrier film forms a removable sterile barrier within the injection device covering a passage on an inside of the injection device.

4. The injection device according to claim 3, wherein the passage on the inside of the injection device is a part of a sterile compartment enclosing a fluid path comprising a fluid path needle configured to be moved within the injection device through the passage into a septum of a cartridge, wherein the first sterile barrier film maintains the sterile compartment in a sterile condition when covering the passage.

5. The injection device according to claim 4, wherein the first sterile barrier film forms a removable sterile barrier within the injection device covering the septum of the cartridge and maintains a surface of the septum in a sterile condition.

6. The injection device according to claim 1, wherein the film connected to the first sterile barrier film is an integral part of the first sterile barrier film, or wherein the film connected to the first sterile barrier film is separate from and connected to the first sterile barrier film forming a pull tab for the first sterile barrier film.

7. The injection device according to claim 1, wherein the end of the film connected to the second surface of the sheet of material is adhesively connected or welded thereto.

8. The injection device according claim 4, wherein the strengthening sheet covers and connects to the end of the film of the first sterile barrier film covering the passage of the sterile compartment enclosing the fluid path and/or the strengthening sheet covers and connects to the end of the film of the first sterile barrier film covering the septum of the cartridge.

9. The injection device according to claim 4, wherein the strengthening sheet covers and connects to the removable second sterile barrier film and the end of the film of the first sterile barrier film covering the passage of the sterile compartment enclosing the fluid path.

10. The injection device according to claim 1, wherein two strengthening sheets are attached to the second surface of the sheet material of the release liner.

11. The injection device according to claim 4, wherein two strengthening sheets are attached to the second surface of the sheet material of the release liner, and wherein one of the two strengthening sheets covers and connects to the second sterile barrier film and the end of the film of the first sterile barrier film covering the passage for the sterile compartment enclosing the fluid path.

12. The injection device according to claim 1, wherein the release liner comprises a conductive layer covering and electrically shielding a sensor of the injection device.

13. The injection device according to claim 12, wherein the conductive layer comprises one or more of a silver ink layer or a carbon black layer.

14. The injection device according to claim 4, wherein the injection device comprises a housing enclosing the fluid path compartment, wherein the fluid path needle for penetrating the septum of the cartridge is connected by a tube to the hollow needle for penetrating the skin of a patient.

15. The injection device according to claim 14, wherein the housing comprises a cartridge holder for holding the cartridge, the cartridge comprising a fluid medicament sealed in a barrel by a moveable plunger and the septum covered by the removable first sterile barrier film.

16. The injection device according to claim 14, wherein the adhesive layer is connected to an outer surface of the housing.

17. The injection device according to claim 16, wherein the adhesive layer comprises a skin adhesive layer for adhesion to the skin, a circuit layer comprising an electrically conductive sensor, and an adhesive layer for adhesion to the outside surface of the housing.

18. An injection device configured for attachment to the skin of a patient using an adhesive layer, the injection device comprising a release liner covering the adhesive layer thereby preventing skin attachment, wherein the release liner comprises: a sheet of material with a first surface contacting the adhesive layer; an aperture defining a passage through which at least a first film passes; first sterile barrier film located within the injection device, wherein the at least first film is connected to the first sterile barrier film and an end of the at least first film is connected to a second surface of the sheet of material that is opposite to the first surface; and a second sterile barrier film that is connected to the second surface of the sheet of material or that is located within the injection device and connected to a second film, wherein when the second sterile barrier film is located within the injection device, an end of the second film extends through the passage of the aperture and is connected to the second surface of the sheet of material, and wherein the release liner is covered by at least a first strengthening sheet connected to the second surface, wherein the at least first strengthening sheet covers at least two of: the aperture, the end of the at least first film, the second sterile barrier film located on the external surface or the end of the second film.

19. The injection device according to claim 18, wherein the device comprises the second sterile barrier film located within the injection device, and wherein the first sterile barrier film and the second sterile barrier film form removable sterile barriers within the injection device covering a septum of the cartridge and a passage of a fluid compartment, respectively, to maintain a surface of the septum and the passage in a sterile condition.

20. The injection device according to claim 19, wherein a second strengthening sheet is attached to the second surface of the sheet material, and wherein the second strengthening sheet covers the other of the aperture, the end of the at least first film, or the end of the second film.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] While the invention has been described in detail in the drawings below and foregoing summary, such description is to be considered illustrative or exemplary and not restrictive. Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims.

[0037] FIG. 1: Cartridge closed by a septum with a crimp, the first sterile barrier film is connected to the crimp thereby covering the septum. The free end of the film is an integral part of the first barrier film.

[0038] FIG. 2: Cartridge closed by a septum with a crimp, the first sterile barrier film is connected to the crimp thereby covering the septum. The film is a separate film forming a pull tab and is connected to the first barrier film.

[0039] FIG. 3: Longitudinal section of an injection device illustrating the cartridge with a septum covered by a removable barrier film and a passage for a sterile compartment enclosing a needle that is covered by another removable barrier film. The ends of the films are connected to the outer surface of the release liner.

[0040] FIG. 4: Detailed view of the assembly of the cartridge and the fluid path unit of FIG. 3 when the release liner is removed.

[0041] FIG. 5: Injection device during assembly, the film connected to the second sterile barrier film covering the passage of the fluid path compartment passes through the apertures within the housing and the release liner and extends past an exterior of the device.

[0042] FIG. 6: Injection device during assembly, the end of the film illustrated in FIG. 5 is attached to the outside surface of the release liner at the exterior of the device.

[0043] FIG. 7: Injection device during assembly, the cartridge with a sterile barrier film covering the septum (FIGS. 1 and 2) has been inserted into the cartridge holder. The end of the film passes through the apertures in the housing and the release liner and extends past the exterior of the device.

[0044] FIG. 8: Injection device according to FIG. 7 during assembly, the end of the film covering the septum is attached to the outside surface of the release liner at the exterior of the device.

[0045] FIG. 9: Injection device whereby an additional strengthening sheet has been adhesively attached to the outside surface of the release liner thereby covering the ends of the sterile barrier films that are connected to the passage of the fluid path compartment and cartridge, respectively. Additionally, the strengthening sheet is attached to a third sterile barrier film covering the insertion needle.

[0046] FIG. 10: Injection device with two strengthening sheets of material attached to the outside surface of the release liner, a first strengthening sheet covers the end of the second sterile barrier film that covers the passage of the fluid path compartment and the third sterile barrier film covering the insertion needle. The second strengthening sheet covers both ends of the first and second sterile barrier films.

[0047] FIG. 11: Injection device with two strengthening sheets of material attached to the outside surface of the release liner, a first strengthening sheet covers both ends of the first and second sterile barrier film and a second strengthening sheet covers the third sterile barrier film.

DETAILED DESCRIPTION

[0048] The term medicament or medication includes any flowable medical formulation suitable for controlled administration through a means such as, for example, a cannula or a hollow needle and comprises a liquid, a solution, a gel or a fine suspension containing one or more medical active ingredients. A medicament can be a composition comprising a single active ingredient or a pre-mixed or co-formulated composition with more than one active ingredient present in a single container. Medication includes drugs such as peptides (e.g., insulin, insulin-containing drugs, GLP-1 containing drugs or derived or analogous preparations), proteins and hormones, active ingredients derived from or harvested by biological sources, active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances in both solid (suspended) or liquid form but also polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or parts of antibodies but also appropriate basic, auxiliary and carrier substances.

[0049] The distal end or distal direction is defined by the direction of the needle configured to penetrate the skin of the patient. For an injection pen this may be the injection needle and the end of the pen holding the needle or being configured to hold the needle is the distal end. For an infusion device the distal end and the distal direction is towards the needle configured to penetrate the skin of the patient, which may be along the axis of the device or tilted or perpendicular to the axis of the device. The distal direction in an infusion device represents the direction in which the medicament flows towards the insertion needle. The proximal direction or end is opposite to the distal direction or end.

[0050] Turning to FIG. 1, a cartridge (9) is illustrated and comprises a barrel (1) or ampoule, for instance constructed of glass or from a polymeric material such as polypropylene or cyclo-olefinic polymer (or copolymer). The barrel (1) may be cylindrically shaped and have a narrowed neck (2) closed by a septum (27FIG. 4) that is connected to the cartridge (9) using a crimp (3). The crimp (3) defines an opening surrounding the septum (27). A first film (5), which may be a flexible film, has been removably attached to the crimp using a first sterile barrier film section (4). An end (6) of the first film (5) is not attached to the crimp and available for attachment to a release liner of the device or to a connector film, as will be discussed herein. FIG. 2 illustrates an alternative embodiment in which the end (6) of the first film is attached to a connector film (7) that is separate from the first film (5). The first film (5) has a U-shaped fold (8) and the connector film (7) is sandwiched between the first sterile barrier film (4) and the end (6) of the first film (5). The connector film (7) has been attached to the first film (5) using adequate attachment means such as gluing or welding. The connector film (7) includes a pull tab (10) for connecting to the release liner. The first barrier film (4) may be a porous film that enables gas sterilization such as gas plasma (hydrogen peroxide) or ethylene oxide sterilization (ETO) to sterilize the septum of the cartridge. Examples are non-woven porous polyethylene or polypropylene films or paper (cellulose) films that may be laminated or coated to enhance or control the adhesive properties.

[0051] FIG. 3 illustrates a longitudinal section of an injection device (16) showing an assembly of the cartridge (9) inserted into the injection device (16). The injection device (16) may be attached to the skin of the patient using a skin adhesive layer (21) which is covered by a release liner (20). FIG. 4 illustrates a detail view of when the first film (5) and a second film (11) have been removed together with the release liner (20). The function of the second film (11) will be discussed below. In FIG. 4, the cartridge (9) is illustrated with a moveable plunger (26) that can move towards the septum (27) for expelling the medicament. The external housing (17) encloses both the cartridge (9) and a compartment (13) for the fluid path enclosing a needle (14) that is aligned parallel to the longitudinal axis of the cartridge (9). The first and second films (5, 11) are positioned between the fluid path needle (14) and the cartridge (9). The cartridge is positioned within a cartridge holder (15) which, for this example, is part of the compartment (13) for the fluid path. The cartridge (9) is axially fixated in the housing (17) and biased towards the compartment (13) of the fluid path using a ratchet system (18, 19). A ratchet member (18) may be axially guided in the housing (17) after the cartridge (9) has been inserted such that ratchet teeth of the ratchet member (18) engage ratchet teeth of a counter ratchet member (19) axially fixed with respect to the housing (17). The ratchet member (18) engages a proximal rim of the barrel of the cartridge (9) thereby enabling axial fixation of the cartridge in the housing (17) and biasing the cartridge (9) towards the compartment (13) of the fluid path. Alternatively, and instead of the ratchet member, the cartridge is fixed using a ridge or fin on a cover (not shown) that may close the compartment (13) and during closing, the rib or fin may be elastically deformed on the proximal rim of the cartridge (9) thereby fixing the cartridge. The first film (5) is connected to the crimp (3) of the cartridge, which fixes a septum (27) to the neck (2). The first sterile barrier film (4) is an integral part of the first film (5) and is connected to the crimp (3) using a first member (22). The first member (22) may be for example a glue or a double-sided adhesive tape. Optionally the first member (22) is a resilient member such as an O-ring, which may be compressed once the cartridge (9) is fixed using the ratchet system (18, 19). The first sterile barrier film (4) may also be directly heat-welded onto a distal end surface of the crimp (3). The first sterile barrier film (4) is connected to the crimp (3) such that this connection can be released by applying a force to the end (6) of the first film to peel-off the first sterile barrier film (4) from the crimp (3).

[0052] The fluid path compartment (13) includes a passage (25) which allows the fluid path needle (14) to move through the passage (25). The passage (25) is covered by a second film (11) and the second barrier film (11a) which is an integral part of the second film (11) is attached to a wall of the fluid path compartment (13) and covering the passage (25), thereby preventing contamination of the fluid path comprising the needle (14). The second barrier film (11a) may be a porous film that enables gas sterilization such as gas plasma (hydrogen peroxide) or ethylene oxide sterilization (ETO) to sterilize the fluid path. The second sterile barrier film (11a) may be connected to the fluid path compartment (13) using a second member (23). The second member (23) may be for example glue or a double-sided adhesive tape. The second member (23) may optionally be a resilient member such as an O-ring which may be compressed once the cartridge (9) is fixed using the ratchet system (18, 19). The second sterile barrier film (11a) may also be directly heat welded onto the wall of the compartment (13) comprising the passage (25). The second sterile barrier film (11a) may be connected to the compartment (13) such that this connection can be released by applying a force to the end (12) of the second film (11) to peel-off the second sterile barrier film (11a) from the compartment (13) such that the passage (25) is free for the fluid path needle (14) to move therethrough.

[0053] The first and second films (5, 11) are guided through an aperture (24) in the cartridge holder (15) such that the ends of the first and second films (6, 12) can be guided through an aperture (28) in the release liner (20).

[0054] The ends of the films (6, 12) are connected to the outer surface of the release liner (20) such that the first and second films (5, 11) are removed from the crimp (3) respectively passage (25) upon removal of the release liner (20) from the skin adhesive layer (21), see FIG. 4. Optionally, a gap that may exist between the septum (27) and the wall of the fluid path compartment (13) after removing the first and second films (5, 11) may be closed due to the resilience of the connecting members (22, 23) and/or due to the ratchet system (18, 19) which immediately closes the gap. A disadvantage of the assembly illustrated in FIGS. 3 and 4 is that the aperture (28) in the release liner (20) acts as a stress concentrator such that the release liner can easily tear leading to partial removal of the release liner (20). As a consequence, the device cannot be properly attached to the skin of the patient.

[0055] An embodiment according to the present invention is illustrated in FIGS. 5 to 9. A bottom view of the injection device (16) is illustrated, e.g., shown upside down, with the release liner (20) covering the skin adhesive layer (21). The release liner (20) includes a cut-out (29) acting as a handle to facilitate the removal of the release liner (20). The release liner (20) includes an aperture (28), which is C-shaped extending inwardly from the side or edge of the release liner (20) to facilitate the insertion of the second film (11) from the side using the end (12) of the second film (11). The outside surface of the release liner (20), i.e., the surface that is not contacting the skin adhesive, comprises a second adhesive spot (31) which may be a double sided adhesive tape. The end of the second film (12) is attached to the outside surface of the release liner (20) using the second adhesive spot (31), see FIG. 6. Alternatively, the second adhesive spot (31) is present at the end (12) of the second film (11). Other attachment means for the end (12) of the second film (11) are, for example, heat welding or ultrasonic welding. In addition, the surfaces that contact to each other may be roughened, etched, blasted, heat treated or plasma treated to enhance the adhesive connection therebetween. Once the end of the second film (12) has been attached to the release liner (20), the cartridge (9) may be inserted into a side of the cartridge holder (15), see FIG. 7. The end (6) of the first film (5) or the pull tab (10) of the connector film (7) may be guided into the C-shaped aperture (28) during cartridge insertion, and the first and second films (5,11) may be arranged parallel to another and contact each other. The end of the first film (6) or the pull tab (7) is attached to the release liner using a first adhesive spot (30), see FIG. 8. The options presented above for attaching the second film (11) to the second adhesive spot (31) equally apply to attachment of the first film (5) to the first adhesive sport (30).

[0056] The sequence presented in FIGS. 5 to 8 may also be reversed, i.e., the cartridge (9) may be inserted and the first film (5) is attached to the release liner (20) followed by attaching the second film (11) to the release liner.

[0057] The release liner (20) comprises a second aperture (32) that surrounds a third sterile barrier film (33), FIG. 8. The third sterile barrier film (33) is removably connected to the housing (17) of the injection device or to the housing of the fluid path compartment (13). The third sterile barrier film (33) covers a passage in the housing that is available for a hollow, skin piercing needle to move from a first position in the injection device to a second position outside the injection device for penetrating the skin of the patient. The hollow, skin piercing needle may move between the first and second positions perpendicular to a plane of the release liner (20). The third sterile barrier film (33) may be constructed from the same material as the first and second sterile barrier films (4,11a) and allows for gaseous sterilization techniques. The release liner (20) may not be directly connected to the third sterile barrier film (33) but the release liner (20) may surround the third sterile barrier film (33).

[0058] A strengthening sheet (40) is attached to the release liner (20) to cover at least the end (6) of the first film (5), the end (12) of the second film (11), the third sterile film (33) and the aperture (28) of the release liner (FIG. 9). The strengthening sheet (40) may be adhesively attached to the surface of the release liner and the surfaces of the first and second films (5, 11) and the third sterile barrier film (33). The strengthening sheet (40) may be constructed from a polymeric material, a sheet of paper or from a woven or non-woven textile material. Examples for the polymeric sheet materials are: polyethylene terephthalate, polybutylene terephthalate, polyester foils, captam foils or polyolefin films such as high density polyethylene (HDPE) or polypropylene (PP) films. The strengthening sheet (40) strengthens the assembly of both sheets (20, 40), thereby preventing mechanical damage to the release liner (20) as the removal of the first and second films (5,11) from the inside of the housing (thereby releasing the connections between the first and second films (5,11) from the septum (3), aperture (25), respectively) may lead to stress concentrations around the aperture (28) in the release liner (20).

[0059] A second embodiment is presented in FIG. 10, the second embodiment differs from the first embodiment in that the strengthening sheet (40) covers the third sterile barrier film (33), the second film (11) and the aperture (28) in the release liner. Thus the second film (11) with the second sterile barrier film (11a) connected to the compartment (13) enclosing the fluid path and the third barrier film (33) are first adhesively connected to the strengthening sheet (40) which may be followed by insertion of the cartridge (9) having the first film (5) connected thereto. The end of the first film (6) or the pull tab (10) may be attached to the release liner (20) after application of the strengthening sheet (40). A second strengthening sheet (41) may be finally applied to the first film (5) to strengthen the connection between the first film (5) and the release liner (20). The second strengthening sheet (41) may partially overlap with the strengthening sheet (40) as illustrated in FIG. 10.

[0060] A third embodiment is illustrated in FIG. 11. The strengthening sheet (40) is applied to the first and second films (5, 11) and covers the aperture (28). The second strengthening sheet (41) covers and adhesively connects to the third sterile barrier film (33).

[0061] Alternative embodiments can be easily derived based on the three embodiments described above. For example it can be envisioned that only the second film (11) is used in the device, maintaining the fluid path compartment (13) in a sterile condition whereas no first film (5) is used that covers the septum of the cartridge. Thus only the second film (11) and the third sterile barrier film (33) are covered by the strengthening sheet (40). Alternatively, only a first film (5) is used and no second film (11).

[0062] In yet another alternative, guide pulleys may be used within the device to guide the first film (5) and/or the second film (11) such that the forces required to remove the first and second barrier films (4, 11a) are reduced to facilitate the release liner (20) removal. Such a guide pulley system may be combined with the application of a strengthening sheet (40) to the release liner.

[0063] In yet another alternative, the injection device comprises a cartridge without a first sterile barrier film, whereas the fluid path compartment (13) is provided with a second film (11). The second film may be removed when the release liner is removed, but optionally the second film (11) is not removed and the fluid path needle (14) pierces the second sterile barrier film (11a) before piercing the septum of the cartridge upon device activation.

[0064] In yet another alternative, only a first film (5) is provided covering the septum of the cartridge whereas no second film (11) is applied to the housing of the fluid path compartment (13). The first film (5) may be removed upon removal of the release liner (20), but alternatively the needle may pierce through the first film (5) and the septum (27) when the first film is not removed.

[0065] In the claims, the word comprising does not exclude other elements or steps, and the indefinite article a or an does not exclude a plurality. For example a first film does not exclude the fact that there may be two films that functionally or structurally fulfill the purpose of a first film. The mere fact that certain elements or steps are recited in distinct claims shall not preclude the existence of further meaningful combinations of these elements or steps.

TABLE-US-00001 PART ANNOTATION 1 Barrel 19 Ratchet counter member on housing 2 Neck 20 Release liner 3 Crimp 21 Skin adhesive 4 First sterile barrier 22 First member film 5 First film 23 Second member 6 End of first film 24 Aperture cartridge holder 7 Connector film 25 Passage fluid path compartment 8 U-shaped fold 26 Plunger 9 Cartridge 27 Septum 10 Pull tab 28 Aperture release liner 11 Second film 29 Cut out release liner 11a Second sterile barrier 30 First adhesive spot film 12 End of second film 31 Second adhesive spot 13 Compartment, housing of 32 Second aperture release fluid path liner 14 Needle, fluid path needle 33 Third sterile barrier film 15 Cartridge holder 40 Strengthening sheet 16 Injection device 41 Second strengthening sheet 17 External housing 18, 19 Ratchet system 18 Ratchet member