PATCH INJECTION DEVICE WITH RELEASE LINER REMOVAL

Abstract

A patch injection device comprising a housing, an adhesive substrate having a first surface with a first surface area for skin attachment and a second surface which is opposite the first surface attaching partly to the housing and a removable release liner. The surface area of the second surface attaching to the housing is smaller than the first surface area and the excess area defines a skirt of the substrate at least partially surrounding the housing. The first surface of the substrate attaches to the removable release liner which fully covers the first surface area of the substrate. Furthermore a pull tab is provided being part of the release liner and located in a cut-out of the skirt of the substrate such that a peel force is transmittable from the release liner to the housing at the location where the cut-out reaches the housing.

Claims

1. A patch injection device, comprising: a housing; an adhesive substrate having a first surface with a first surface area for skin attachment and a second surface which is opposite the first surface for attaching partly to the housing; and a removable release liner, wherein a surface area of the second surface attaching to the housing is smaller than the first surface area and wherein an excess area defines a skirt of the substrate and at least partially surrounds the housing, and wherein the first surface of the substrate attaches to the removable release liner which fully covers the first surface area of the substrate, characterized by a pull tab that is part of the release liner and which is located in a cut-out of the skirt of the substrate, such that a peel force is transmittable from the release liner to the housing at a location where the cut-out reaches the housing.

2. The patch injection device according to claim 1, wherein the release liner partially extends beyond the adhesive substrate in an area of the cut-out, such that a surface area of the release liner is larger than the first surface area.

3. The patch injection device according to claim 2, wherein the adhesive substrate is flexible.

4. The patch injection device according to claim 3, wherein the pull tab is integrally formed with the release liner or the pull tab is a separate part attached to the release liner.

5. The patch injection device according to claim 4, wherein the pull tab comprises an opening.

6. The patch injection device according to claim 1, wherein the peel force is transmittable to the housing via the adhesive substrate at the location where the cut-out reaches the housing.

7. The patch injection device according to claim 6, wherein the cut-out is arc shaped.

8. The patch injection device according to claim 7, wherein the arc shaped cut-out of the skirt is adjacent or congruent to a contacting surface between the housing and the substrate.

9. The patch injection device according to claim 8, wherein the housing comprises at least one corner and the at least one corner is adjacent to the arc shaped cut-out of the skirt.

10. The patch injection device according to claim 9, wherein the adhesive substrate is partially stiffened in the skirt surrounding the housing.

11. The patch injection device according to claim 10, wherein the release liner is split into two separate parts each having a separate pull tab.

12. The patch injection device according to claim 11, wherein the adhesive substrate is a multilayered substrate comprising at least one supportive layer and at least two adhesive layers for attaching the housing to a part of the second surface and for attaching the removable release liner to the first surface.

13. The patch injection device according to claim 12, wherein the housing is an exterior housing comprising a top housing part and a bottom housing part, and wherein the adhesive substrate is attached to the bottom housing part.

14. The patch injection device according to claim 13, wherein the housing encloses a drive mechanism for expelling a medicament, a control unit for controlling medicament delivery and a fluid path comprising an injection needle for delivery of the medicament.

15. The patch injection device according to claim 14, wherein the housing houses a cartridge comprising a fluid medicament.

16. A patch injection device, comprising: a housing; an adhesive substrate having a first surface with a first surface area for skin attachment and a second surface, which is opposite the first surface for attaching partly to the housing; and a removable release liner, wherein a surface area of the second surface attaching to the housing is smaller than the first surface area and wherein an excess area defines a skirt of the substrate and at least partially surrounds the housing, and wherein the first surface of the substrate attaches to the removable release liner which fully covers the first surface area of the substrate, characterized by a pull tab that is a part of the release liner and which is located in a cut-out of the skirt of the substrate such that a peel force is transmittable from the release liner to the housing at a location where the cut-out reaches the housing, wherein the peel force is transmittable to the housing via the adhesive substrate at the location where the cut-out reaches the housing.

17. The patch injection device according to claim 16, wherein the cut-out of the skirt is arc shaped and the arc shaped cut-out is adjacent or congruent to a contacting surface between the housing and the substrate.

18. The patch injection device according to claim 17, wherein the adhesive substrate comprises a winglet that is not covered by the skin adhesive, whereas a remaining part on the first surface of the substrate is covered with the skin adhesive.

19. The patch injection device according to claim 18, wherein the housing comprises at least one corner and the at least one corner is adjacent to the arc shaped cut-out of the skirt.

20. The patch injection device according to claim 19, wherein the pull tab comprises an opening and the pull tab is integrally formed with the release liner or the pull tab is a separate part attached to the release liner.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] FIG. 1 depicts a bottom view for a prior art device according to WO17219154.

[0053] FIG. 2 depicts a top view of a patch injection device according to the present disclosure including a housing and an adhesive substrate with release liner.

[0054] FIG. 3 depicts a top view of a patch injection device including a housing and an adhesive substrate; The release liner has been removed from the adhesive substrate.

[0055] FIG. 4 depicts a cross section of the housing, the substrate and the release liner.

[0056] FIG. 5 presents detailed area “C” of FIG. 4 depicting a corner of the housing, the substrate, the cut-out and the release liner.

[0057] FIG. 6 depicts a top view of the substrate and release liner.

[0058] FIG. 7 depicts a detail for the layered substrate in a cross sectional view.

[0059] FIG. 8 demonstrates the removal of the release liner using one hand for the liner and the other hand for holding the housing.

[0060] FIG. 9 depicts a winglet on the patch injection device facilitating removal of the patch injection device from the skin.

DETAILED DESCRIPTION

Definitions

[0061] 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 includes a liquid, a solution, a gel or a fine suspension containing one or more medical active ingredients. A medicament can be a composition including 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 (for example 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.

[0062] The distal end or distal direction is defined by the direction of the needle configured to penetrate the skin of the patient. For a patch injection 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 proximal direction or end is opposite to the distal direction or end.

[0063] A patch injection device 1 according to the prior art (WO2017219154) is depicted in FIG. 1. The patch injection device 1 includes a housing 2 which may be attached to the skin of a patient using an adhesive substrate 5. Prior to use, the adhesive substrate 5 may be covered by a removable release liner 10 which extends laterally in one direction beyond the dimensions of the housing 2 forming a pull tab 12 including an opening or hole 14. The user can hold the device in one hand and grip the pull tab 12 with his other hand using the hole 14 as a pull ring to remove the release liner 10 in the direction indicated by the arrow. The user does not have to peel the release liner 10 directly from the substrate 5 as the adhesive substrate does not extend beyond the housing and can hold the device while removing the release liner and this may facilitate simplified device handling. For large dose patch injectors, the available surface area for skin attachment is, for this example, limited to the adhesive substrate 5 covering the bottom surface of a bottom housing part 4 and the weight of the device may call for stronger adhesives for skin attachment to prevent premature detachment of the device.

[0064] A patch injector 1 according to the present disclosure is presented in FIGS. 2 to 8. The adhesive substrate 5 may at least partially surround the housing 2 thereby establishing a skirt 11 thereby increasing the surface area available for skin attachment. The adhesive substrate has a first surface contacting the release liner 10 and a second surface contacting the housing 2, or may contact the bottom housing 4. The first surface facing the liner may be fully covered with a skin adhesive whereas the second surface facing the housing has no adhesive in the free standing area of the skirt. The skirt 11 includes a cut-out 13. Drawing the virtual contour for the substrate 5 would result in a rectangle with four rounded corners and the cut-out 13 is defined by an area of the substrate 5 that has been left out in the one corner. The removable release liner 10 may be attached to the substrate as depicted in FIG. 2 or has been removed as depicted in FIG. 3. The removable release liner 10 includes a pull tab 12 which extends from the housing 2 and the adhesive substrate. The pull tab 12 may have an opening or hole 14 such that the pull tab can be easily gripped by the user. In the embodiment presented in FIG. 2, the pull tab 12 is unitarily formed with the removable release liner 10. The pull tab 12 may also be available as a separate part that is attached or connected to the release liner 10. The release liner may include an arrow or sign indication the direction for removing the release liner. Such an arrow or indicator may be printed or embossed on both sides of the release liner in the area of the cut-out 13 of the substrate. Alternatively, the opening or hole itself 14 may have a different shape, for example an “arrow shape” indicating the direction for liner removal. The indicator on the release liner may start at the location where the cut-out 13 of the substrate is adjacent or proximate to the housing 2 or bottom housing 4.

[0065] The substrate 5 and the release liner 10 may have a second cut-out 37 in skirt 11. The release liner 10 follows the contours of the substrate 5 and no pull tab is formed. The second cut-out may facilitate improved assembly of the device, for example for sideways insertion of sterile barriers or isolation foils for battery terminals or for providing access to sterilization agents such as ETO. The second cut-out 37 is therefore referred to as an assembly cut-out and may be independent from the above mentioned cut-out 13 promoting release liner removal prior to use.

[0066] There may be a plurality of cut-outs 13 available for promoting release liner removal.

[0067] The patch injection device 1 in FIG. 2 may further include an actuation button 33 and/or an optical indicator 34 (for example a LED indicator) and/or a cover 35 for closing a cartridge holder or covering a cartridge present within the housing. The cover 35 may be a removable cover and may have a viewing window 36 for viewing the cartridge present in the patch injection device.

[0068] A cross section of the patch injection device is depicted in FIG. 4 with the cartridge 27 containing a fluid medicament 28 present between a moveable piston 31 and a pierceable septum 30. The medicament may be a solid medicament, for example a lyophilisate that may be reconstituted prior to use. A drive mechanism 24 including drive train and a piston rod 32 is configured to advance the piston 31 in the cartridge towards an outlet 29 which is closed by the septum 30. The housing 2 furthermore houses a fluid path 25 including at least one hollow injection needle 26. The at least one injection needle 26 may be connected to a tubing for fluid delivery from the cartridge towards an outlet of the fluid path. The fluid path 25 may include two hollow injection needles, one for piercing the septum 30 and the other one for piercing the skin of the patient. One needle may be aligned with the longitudinal axis of the cartridge 27 and the other needle may be oriented perpendicular thereto. A needle insertion mechanism may be configured to move the needle 26 from a retracted position (depicted in FIG. 4) to an inserted position piercing the septum. The needle insertion mechanism may simultaneously move a tip of the second needle from a retracted position inside the housing through an aperture 40 in the housing and substrate to a position exterior to or outside the housing for penetrating the skin of a patient.

[0069] A detailed view for the cross section of FIG. 4 is depicted in FIG. 5 presenting the interface between a corner 20 of the bottom housing 4, the adhesive substrate 5 and the release liner 10. The cross section 17 of the housing includes a substantially flat bottom surface being part of the contacting surface 19 between the housing and the substrate. Due to the presence of the cut-out 13, the substrate 5 is also depicted having a local cross section 16 (hatched) whereas the part of the substrate 5 that is out of the cross section plane is indicated as non-hatched. The cut-out 13 reaches or is adjacent to the housing indicated as location 15. The indication arrows on the release liner 10 may start at location 15.

[0070] A top view of the substrate 5 and the release liner 10 is depicted in FIG. 6, showing the first surface area 8 of the substrate 5 contacting the release liner 10 and the second surface area 9 for contacting the housing. The excess area or skirt 11 is configured to surround the housing having the cut-out 13 and a second cut-out 37. The cut-out 13 is formed as an arc 18 and the arc 18 comes close to or is adjacent to the second surface area 9 intended for fixation of the housing to the substrate, presented in FIG. 6 as the location 15. The pull tab 12 extends from the cut-out 13. The substrate may further include at least one sensor area 38 and/or at least one electrical contact or wiring 39. The sensor may be a proximity or contact sensor which may be a mechanical sensor or an electrical sensor, for example a capacitive sensor. Furthermore, the substrate 5 may have the aperture 40 for the skin insertion needle.

[0071] A detail of the layered substrate 5 is depicted in FIG. 7. The layered substrate 5 includes at least one adhesive layer 22 for contacting the housing and at least one supportive layer 21 and at least one skin adhesive layer 23. The supportive layer 21 may be positioned between the skin adhesive layer 23 and the adhesive layer for contacting the housing 22.The substrate may constructed from a plurality of double sided adhesive tapes, each having a supportive layer and two adhesive layers adapted to the specific purpose, e.g. either an internal adhesive layer for mechanical support or an external adhesive layer for contacting the housing or the release liner.

[0072] The skirt 11 may be locally mechanically supported by the substrate itself (for example by a rippled, or folded substrate structure) or the skirt may be locally stiffened by adding ribs or films onto the second surface facing the housing.

[0073] The removal of the release liner is depicted in FIG. 8. The user holds the housing 2 of the patch injection device 1 in one hand and may grip the pull tab 12 with his other hand. The patch injection device includes the skirt 11 of the substrate 5 surrounding the housing and the pull tab 12 is formed as an extension of the release liner 10. The cut-out 13 of the substrate 5 together with the pull tab 12 ensures that the pull tab can be gripped on both sides by the user. By pulling the pull tab in the direction indicated by the arrow, the mechanical load is directed to location 15 were the cut-out is adjacent to the housing. The housing or the bottom housing part may provide mechanical support to the flexible substrate 5 as the substrate 5 is attached to the bottom housing. The peel-off force releasing the liner from the substrate may be directed to the housing via the substrate at the location were the cut-out is adjacent to the housing. The release liner may first start to peel from the substrate where the substrate is mechanically supported and avoiding the skirt area which is not mechanically supported by the housing. The intended starting point for the liner removal may be location 15 and the liner removal will subsequently progress to the other areas, mechanically supported by the housing and finally to the non-mechanically supported areas in the flexible skirt. With this configuration, an easy removal of the release liner may be envisaged while holding the housing containing the medicament.

[0074] The patch injection device may have a feature to facilitate the removal of the device from the skin after skin attachment as depicted in FIG. 9. The adhesive substrate 5 may include a winglet 41 that may be part of the skirt 11 and the area on the winglet facing the release liner before liner removal is not covered by a skin adhesive whereas the remaining part on the first surface of the substrate is covered with a skin adhesive. The winglet 41 may be located next to the pull-tab 12. After liner removal, the first surface of the substrate attaches to the skin except for the winglet. The winglet may be easily grasped by the user for removal of the device from the skin once the medication has been injected. The top surface of the winglet facing the user may comprise an indicator, for example dots 42.The dots may be embossed into the substrate or printed onto the substrate to increase the roughness such that the load can be easily transferred from the user’s fingers to the substrate.

[0075] In the claims, the word “including” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. For example “substrate”, “liner” or “adhesive” does not exclude the fact that there may be two “liners”, “substrates” or “adhesives” that functionally or structurally fulfill the purpose of “a liner” or “a substrate” or “an adhesive”.

TABLE-US-00001 LIST OF REFERENCE SIGNS 1 Patch injection device 20 Corner housing 2 Housing 21 Supportive layer 3 Top housing 22 Adhesive layer to housing 4 Bottom housing 23 Skin adhesive 5 Adhesive substrate 24 Drive mechanism 6 First surface 25 Fluid path 7 Second surface 26 Injection needle 8 First surface area 27 Cartridge 9 Second surface area 28 Fluid medicament 10 Removable release liner 29 Outlet 11 Skirt 30 Septum 12 Pull tab 31 Piston 13 Cut-out 32 Piston rod 14 Opening or Hole 33 Actuation button 15 Location where cut-out reaches housing 34 Optical indicator 16 Cross section substrate 35 Cover 17 Cross section housing 36 Viewing window 18 Arc 37 Second cut-out 19 Contacting surface housing- substrate 38 Sensor area 39 Electrical contacts / wiring 40 Aperture 41 Winglet 42 Dots