Patch-type injection device with improved release liner removal

Abstract

A patch-like injection device comprising a housing, an adhesive base having a first surface area with a first surface for skin attachment, and a second surface opposite the first surface partially attached to the housing, and a removable release liner. The surface area of the second surface attached to the housing is smaller than the first surface area, and the excess area defines a skirt of the base at least partially surrounding the housing. The first surface of the base is attached to a removable release liner covering the first surface area of the base entirely. Furthermore, a pull tab is provided which is part of the release liner and is located in a cut-out of the skirt of the base such that a peeling force can be transmitted from the release liner to the housing at the location where the cut-out reaches the housing.

Description

Technical Field

[0001] This invention relates to a patch injection device comprising a housing having an adhesive substrate attached thereto, the adhesive substrate being covered by a release liner. The adhesive substrate and the release liner are configured to improve the removal of the release liner from the patch injection device. Background Technology

[0002] Injection or infusion devices are frequently used for the subcutaneous delivery of fluid medications. Infusion devices, such as infusion pumps, are used for delivery based on a delivery profile that includes a base rate superimposed on a bolus injection of a drug such as insulin. Injection devices, such as injection pens, are used for single bolus injections based on a preset (fixed) dose or a variable dose.

[0003] Patch-type injection devices are supplied as patches that adhere to a patient's skin and are operable for delivery based on a delivery distribution or for bolus injection only. The dose is delivered from the reservoir via a fluid path terminating in a needle or cannula. The patch-type injection device adheres to the patient's skin using a base containing a skin adhesive. Prior to use, the skin adhesive is covered by a release liner, and the skin adhesive should allow for easy removal of the device after injection without tissue damage. Patch-type injectors can be designed for delivery of large bolus volumes (high-dose bolus injectors), including reservoirs with volumes greater than 1 mL (e.g., 5 mL or 10 mL). In this case, the weight of the patch-type injector may require an improved skin adhesion system.

[0004] Removing the release liner by the user is preferably accomplished by holding the device in one hand and peeling off the release liner with the other. Solutions requiring both hands (i.e., holding / peeling the base with one hand and holding / peeling the release liner with the other) may result in the device itself not being held by the user. This could cause the device to fall while peeling off the release liner, potentially damaging the device or wasting medication. This is detrimental to the patient's treatment and will also waste expensive medication.

[0005] The substrate used for skin adhesion is preferably a flexible substrate, which allows the substrate to adapt to the contours of different types of patients and can be used at different anatomical locations on the body where different shapes of injection devices are required (which (rigid) shells may not provide).

[0006] WO17219154 describes a patch-type injection device having a base for skin adhesion, wherein the surface area of ​​the base is equal to the bottom surface area of ​​the housing, and a release liner extends beyond the base to form a pull tab. The user can hold the device in one hand and grasp the extended area of ​​the release liner with their other hand for liner removal. The maximum size of the cartridge (or the weight of the device) may be limited by the skin adhesive used in combination with the restricted surface area of ​​the base that can be used for skin contact.

[0007] WO07122207 discloses a modular patch-type injection device with an adhesive base extending beyond the device housing. A release liner covers the adhesive, and no pull tab is provided for removing the release liner. Liner removal is cumbersome because both the base and the liner need to be held with both hands, leaving no hands free to hold the device housing.

[0008] WO19008562 illustrates an arrangement for a patch-type injection device using two separate pads, for example, requiring two hands to remove both pads simultaneously.

[0009] In EP2914314, a base comprising a skin adhesive forms a skirt surrounding the device. The base is flexible and includes individual reinforcements that are rigid enough to resist forces on the base caused by peeling of the cover (release liner).

[0010] The purpose of this invention is to provide an improved patch-type injection device with improved device operation, overcoming the disadvantages of the prior art in combining increased contact surface for skin adhesion with improved release liner removal.

[0011] This objective is achieved by the technical solution according to the present invention. The patch-type injection device includes an adhesive substrate for skin adhesion, and the adhesive substrate defines a skirt surrounding a housing of the patch-type injection device. The substrate includes a cutout, and a release liner extends beyond the cutout, allowing the release liner to be peeled off by the user while holding the device. The cutout extends to the housing of the device, such that the peeling force is directly transmitted to or directed to the housing.

[0012] limited

[0013] The terms "medicine" or "pharmaceutical preparation" include any flowable medical formulation suitable for controlled administration via a device (e.g., a cannula or a needle), and include liquids, solutions, gels, or fine suspensions containing one or more medically active ingredients. A medicine can be a composition comprising a single active ingredient, or a premixed or co-formulated composition containing more than one active ingredient in a single container. Pharmaceutical preparations include pharmaceutical products, such as peptides (e.g., insulin, insulin-containing pharmaceutical products, GLP-1-containing pharmaceutical products, or derivatives or similar preparations), proteins and hormones, active ingredients derived from or harvested from biological sources, hormone- or gene-based active ingredients, nutritional preparations, enzymes, and other substances in both solid (suspension) and liquid forms, as well as polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies, or portions of antibodies, and suitable basic, auxiliary, and carrier substances.

[0014] The distal end or distal direction is defined by the orientation of the needle configured to penetrate the patient's skin. For patch-type injection devices, the distal end and distal direction face the needle configured to penetrate the patient's skin, 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.

[0015] In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude multiple. For example, "substrate," "pad," or "adhesive" does not exclude the fact that there may be two "pads," "substrates," or "adhesives" that functionally or structurally achieve the purpose of the "pad," "substrate," or "adhesive." Summary of the Invention

[0016] This invention relates to a patch-type injection device comprising a housing and an adhesive base having a first surface with a first surface area for attachment to skin, and a second surface at least partially attached to the housing opposite the first surface. The patch-type injection device includes a removable release liner. The surface area attached to the second surface of the housing is smaller than the first surface area, and the excess area defines a skirt at least partially surrounding the base of the housing. The first surface of the base is attached to the removable release liner that completely covers the first surface area of ​​the base. The patch-type injection device also includes a pull tab, preferably part of the release liner, located in a cut in the skirt of the base such that a peeling force can be transmitted from the release liner to the housing at the location where the cut reaches the housing. In other words, the skirt of the base surrounding the housing is interrupted at the location of the pull tab, and the base presents or includes a cut or recess with a width preferably at least equal to the width of the patient's thumb.

[0017] The skirt, at least partially surrounding the housing, extends the area of ​​the adhesive substrate beyond the housing area, and the excess area improves adhesion to the skin, allowing the use of a less strong skin adhesive and thus improving the desired removal of the device from the skin after use. Alternatively, a larger volume reservoir or cartridge (e.g., 5 mL or 10 mL) can be used, as the latter defines a significant portion of the device's weight, and the excess area prevents undesirable separation of the injection device before injection is complete. Alternatively, both an easily removable skin adhesive and a large-volume drug reservoir can be used in combination with the skirt surrounding the housing.

[0018] The removable release liner is formed as a sheet that at least completely covers a first surface area of ​​the adhesive substrate and prevents undesirable adhesion of the patch injection device before use. The pull tab is preferably formed as a sheet like the release liner and improves the removal of the release liner from the patch injection device. The pull tab is part of the release liner, or at least connected to the release liner in a manner that transfers the release force applied to the pull tab to the release liner, and may be reinforced by additional layers.

[0019] The position of the pull tab within the slit in the skirt ensures that the pull tab extends partially beyond the skirt and can be easily grasped by the user on both sides for pad removal. The slit in the skirt base ensures that the pull tab is unsupported and extends partially beyond the skirt or the housing of the device, thus leaving two surfaces of the sheet forming the pull tab available for the user to remove and release the pad.

[0020] The peeling force is transmitted from the release liner to the housing at the point where the cut reaches the housing. This means that the peeling force is locally and directly transmitted to the housing near the base cut, and not to the base or portions of the base that are not adjacent to the housing. The latter portion of the base (not adjacent to the housing) may be damaged, bent, or compliant, and the release of the release liner may require the user's hands to peel the base from the release liner and / or peel the release liner from the base. The peeling force is transmitted directly to the housing, which is held by the user in one hand while the user grasps the pull tab with their other hand. Mechanical stress is locally concentrated at the interface between the release liner and the first surface of the base (locally supported or supported by the rigid housing). This concentration of mechanical stress forms a starting point for controlled liner removal, allowing the release liner to be easily removed in one piece without tearing the liner (or base). The user can hold the device in one hand and the pull tab in the other. This contrasts with prior art devices where two pull tabs, each connected to a different portion of the release liner, must be held by the user with both hands, leaving no free hand for holding the device, which complicates operation or requires additional steps.

[0021] Alternatively, the patch injection device includes two cuts in the substrate, each cut reaching the housing.

[0022] The advantage of having two or more cuts in the substrate is that it allows for two differently oriented retaining devices for liner removal. Since the device is held by the user with one hand, the two cuts can be positioned to facilitate liner removal for either a left-handed or right-handed user. The liner release preferably extends partially beyond the adhesive substrate in the area of ​​the cut, such that the surface area of ​​the liner release is larger than the first surface area.

[0023] Preferably, the release liner follows the outer contour of the adhesive substrate, except for the portion of the substrate where the cut is located. Therefore, the portion of the release liner within the cut in the substrate can form a pull tab. The release liner preferably follows a virtual contour of the substrate (as if there were no cut). For example, the substrate may have a rectangular shape in which one corner is left to form the cut. The release liner may have a complete rectangular shape including all four corners and thus extend from the substrate in the area of ​​the cut.

[0024] Patch injection molding preferably includes a flexible adhesive substrate. Flexibility is defined as non-rigid and conformable to non-flat or curved surfaces. The flexible material typically has a Young's modulus below 1 GPa, more preferably below 0.2 GPa, and most preferably below 0.1 GPa. Examples are paper sheets or film materials (less than 0.3 mm thick) made of polyester (such as PET), polyamide, or polyolefin materials.

[0025] The flexible base ensures that the base conforms to the contours of the patient's body once adhered. Optionally, only the skirt surrounding the shell is flexible and conforms to the shape of the patient's body. The flexibility of the base ensures good contact with the body and efficient use of the body adhesive, thus preventing the patch-type injection device from dislodging before the injection is complete. Alternatively, only the skirt area includes skin adhesive, and the first surface area opposite the second surface area contacting the shell does not have skin adhesive to avoid excessive perspiration during use. Alternatively, two different types of skin adhesive or two different bases can be used, one for the skirt and another for the central area.

[0026] The pull tab can be integrally formed with the release liner or the pull tab can be a separate part attached to the release liner.

[0027] The pull tab extends from the device, preferably from a cutout in the base for easy user access. The pull tab may be a separate part attached to the release liner, allowing it to extend from the device and even further beyond the (virtual) contour of the base. The pull tab may be made of a different material with higher tear strength, or it may have a textured surface, for example, to give the user a different tactile feel. Optionally, the pull tab, as a separate but attached part, may have different colors or be used to brand the product. Thus, a separate pull tab increases the versatility of the device. Optionally, the pull tab may be made of an elastomeric material, while the release liner may be made of thermoplastic sheet. The pull tab, as a separate part, may be formed as a sleeve; for example, the pull tab may be part of a needle cap sleeve.

[0028] For both integrally formed pull tabs and individual pull tabs, indicators such as arrows can be printed onto the pull tabs.

[0029] The pull tab preferably extends in a plane parallel to the first surface or parallel to the substrate. Alternatively, the pull tab extends in a plane angled relative to the first surface or even perpendicular to the first surface.

[0030] A patch-type injection device in which the pull tab includes a hole. When the pull tab is integrally formed with a release liner, the hole may be formed in the sheet of the release liner, or the hole may be in an extension of a separate portion forming the pull tab, such as a pull ring.

[0031] Independent of being formed integrally with the release liner or designed as a separate part, the holes in the pull tab have the advantage of allowing the pull tab to be easily grasped by the user to support liner removal. The holes can be circular or oval, or have different shapes, such as arrowhead shapes.

[0032] A patch-type injection device in which the peeling force of the release liner can be transmitted to the housing via the adhesive substrate at the location where the cut reaches the housing.

[0033] At the point where the cut reaches the housing, there is a boundary region where the housing and substrate terminate, while the release liner continues to extend laterally (or parallel to the bottom surface of the housing). Pulling the tab to peel off the release liner causes the load to transfer directly from the release liner to the housing via the substrate. Since the substrate is mechanically supported locally by the rigid housing or housing components, a flexible substrate is preferred as it will not bend or deflect locally. Therefore, bending and deformation of the substrate during liner removal are avoided by using the cut. Once the initial portion of the release liner has been removed from the substrate adjacent to the cut, further removal is straightforward because the peeling force will be evenly distributed and peeling begins from the defined starting point. This is particularly useful when combined with a flexible substrate.

[0034] The cut reaches the housing as defined by a portion of the cut just reaching (conforming to) the location where the second surface is attached to the housing or in the area of ​​the skirt or adjacent to that location within the second surface, such that there is an overlap between the second surface and the cut.

[0035] The cut in the skirt portion of the base is preferably arc-shaped. The cut in the base can have different shapes, such as arc-shaped, elliptical, or circular. The contour forming the shape is close to or adjacent to the shell. A release liner extending from the cut may have indicators printed thereon, such as arrows, to guide the user to the dispensing direction. Alternatively, the cut may be semi-circular, S-shaped, C-shaped, or have a straight edge. A straight cut can result in a triangular cut.

[0036] The preferred arcuate cut of the skirt is adjacent to or partially coincides with the contact surface between the housing and the base. Therefore, the edge of the surface area attached to the second surface of the housing is adjacent to the outline of the cut.

[0037] The housing of the patch injection device includes at least one corner, and the at least one corner is adjacent to an arcuate cutout in the skirt.

[0038] The corners of the shell are preferably rounded and located in a plane parallel to the base. Alternatively, the corners are located in a plane perpendicular to the base. As yet another alternative, the corners are rounded in both planes to form cup-shaped corners.

[0039] A patch-type injection device in which the release liner in contact with the substrate is divided into two separate parts, each with its own pull tab.

[0040] Optionally, the adhesive substrate is preferably partially reinforced in the skirt surrounding the housing. To further improve the removal of the release liner, especially in combination with a flexible substrate, further mechanical support can be provided to the substrate, preferably locally on the substrate adjacent to the cutout. Thus, a variable stiffness substrate can be achieved through localized application of reinforcements. These can be formed by ribs formed into the substrate or by additional sheets applied to the substrate. Alternatively, the substrate itself can be locally folded or structured to locally improve stiffness.

[0041] The adhesive substrate is preferably a multilayer substrate, comprising at least one support layer and at least two adhesive layers for attaching the housing to a portion of the second surface and for attaching the removable release liner to the first surface.

[0042] The support layer can be a woven or nonwoven (wool) material, for example, based on an organic material such as cotton. The support layer is preferably a flexible material. Open spaces in the woven material improve the penetration and adhesion of the adhesive layer and are beneficial for flexibility. Alternatively, multiple support layers are used, having an inner adhesive layer between the support layers and an outer adhesive layer for attachment to the release liner and the housing, respectively. The skin adhesive layer can be based on a biocompatible acrylic adhesive. The inner layer can be conductive or may have electrical contacts. For example, wires can be braided into the layer or a conductive ink pattern (e.g., carbon or silver) can be printed onto the layer. The conductive layer can be used as a sensor within the substrate, such as a capacitive sensor, a proximity sensor, or a temperature sensor.

[0043] The removable release liner can be made of a sheet of organic material such as paper, or of a polymeric material such as polyethylene terephthalate (PET) or an olefinic polymer (polypropylene or polyethylene) . The multilayer adhesive and / or release liner base may have one or more orifices, for example, allowing the insertion needle to move from the inside of the housing to the outside of the housing.

[0044] The base may have another cutout defined by the fact that the release liner does not extend from it for easy liner removal, but instead the release liner follows the contour of the cutout. This cutout serves a different purpose and is unrelated to the ease of liner removal, but may be beneficial during device assembly.

[0045] Therefore, multiple cuts can be envisioned, which facilitates liner removal (in combination with a release liner extending from the cut) and / or facilitates assembly.

[0046] The housing is an outer housing comprising a top housing portion and a bottom housing portion, and the adhesive substrate is preferably attached to the bottom housing portion.

[0047] Therefore, the second surface of the substrate is attached to the bottom shell portion, thereby forming the second surface region of the substrate (attached to the shell). The bottom shell portion and the top shell portion may be permanently attached to each other, or the top shell portion may be releasably connected to the bottom shell portion. The latter option may be advantageous for a semi-disposable device having a reusable portion (attached to or integral with the top shell portion) and a disposable bottom shell portion connected to the substrate and a release liner. A portion of the device is discarded after use, and another portion of the device can be reused for another drug injection or infusion. The corners of the shell are located at least in the bottom shell portion.

[0048] Optionally, the patch-type injection device may have features that facilitate removal of the device from the skin after application. Because the flexible skirt surrounding the housing is completely adhered to the skin, removal by the user may be difficult. The patch-type injection device may have features that promote device removal.

[0049] A patch-type injection device may include a non-adhesive region in a substrate to facilitate removal of the patch-type injection device after skin application. The non-adhesive region is part of a first surface of the substrate. Preferably, the non-adhesive region is surrounded by an adhesive for skin application, and optionally, there is a gradual transition from the adhesive region to the non-adhesive region.

[0050] The non-adhesive area is preferably located within the skirt of the substrate, forming a wing. The wing has the advantage of not adhering to the skin and being easily grasped for removal of the patch-type injection device from the skin. Optionally, when the release liner is attached to the first surface of the substrate, the non-adhesive area or wing is located adjacent to the pull tab of the release liner. The wing is preferably located at a corner of the patch-type injection device.

[0051] The surface area of ​​the non-adhesive region is less than 50% of the first surface area, preferably less than 20% of the first surface area, more preferably less than 10% of the first surface area, and most preferably 5% of the first surface area.

[0052] Optionally, an indicator may be included on the surface of the skirt opposite the non-adhesive area or on the top surface of the wing. This indicator may have a texture for tactile touch and / or may have a visual indicator. A visual indicator, for example, is an arrow indicating the direction of removal of the patch-type injection device. Additionally and optionally, the indicator may have a text message. Thus, an indicator may be present on the release liner to facilitate liner removal, and an indicator may be present on the wing for removing the device from the skin. Optionally, the two indicators are adjacent to each other.

[0053] A patch-type injection device, wherein a housing surrounds a drive mechanism for dispensing a drug, a control unit for controlling drug delivery, and a fluid path including an injection needle for delivering the drug.

[0054] The drive mechanism may include an electric motor, or the mechanism may use a different power component such as a spring, or the mechanism may be hydraulically driven or driven by (gas) pressure. The mechanism may include a piston rod for advancing a plug in the reservoir toward the reservoir outlet. A gear mechanism may be positioned between the electric motor and the piston rod to convert the rotational movement of the electric motor into linear movement of the piston rod. The piston rod may be a segmented piston rod, with each segment connected by a membrane connector, allowing the piston rod to reversibly change from a linear configuration to a curved configuration. The control unit may be based on a mechanical system, such as using a motion connector, or more preferably, the control unit is an electronic control unit located on a printed circuit board and including integrated circuits and memory units or transmitter / receiver units. When using an electric motor and electronic control circuitry, the patch-type injection device includes a battery.

[0055] The fluid pathway may include a flexible tube connecting two insertion needles, one for insertion into the patient's skin and the other for insertion into a reservoir to establish a fluid connection between the reservoir and the skin insertion needle. The reservoir needle of the fluid pathway may be fixed within a housing and the reservoir may move within the housing to establish the fluid connection, or alternatively, the needle may move relative to the reservoir fixed to the housing. This so-called reservoir needle is moved by a reservoir needle insertion mechanism. The skin needle may be fixed to and extend from the housing and is covered by a movable needle sheath that moves relative to the housing for skin insertion. Alternatively, the skin needle is arranged within the housing and can move from a retracted position to an extended position outside the housing. This movement may be reversible or unidirectional. The skin needle insertion mechanism inserts the skin needle, and the needle insertion mechanism is preferably spring-biased. The skin needle insertion mechanism may also provide a force for needle retraction after medication has been delivered.

[0056] Furthermore, the housing of the patch-type injection device can accommodate a cartridge containing a fluid drug. The cartridge can be a flexible or rigid reservoir. Examples of rigid reservoirs include glass or polymer cartridges (e.g., made of COC). Flexible or rigid reservoirs can be closed by a puncturable diaphragm configured to be punctured by a reservoir needle. Alternatively, the reservoir is permanently connected to a fluid path. Rigid cartridges can be closed by a stopper or plunger, such that the fluid drug is surrounded between the stopper and the diaphragm. The cartridge can be present in devices with the advantage of pre-filling and devices ready for use (but may be limited to single use). Alternatively, the cartridge is inserted into the device just before use. The cartridge can be inserted via a gate mechanism that includes a cartridge holder or cap adapted to receive the cartridge. Optionally, the gate mechanism includes a cartridge needle for penetrating the diaphragm when the cartridge is inserted into the gate mechanism. As another option, the gate mechanism can include a latching mechanism that, once latched, mechanically or electrically unlocks from a dormant state to an active state (ready for use after filling). The advantage of inserting the tube just before use may be that finely prepared drugs can be mixed or reconstituted on the outside of the device just before use.

[0057] Semi-disposable patch-type injection devices include a disposable portion having a bottom housing section with an adhesive base, a release liner, and components that may come into contact with the fluid medication, such as a cartridge and a fluid path. The cartridge is inside the device and pre-filled, or the cartridge is pre-filled but inserted into the disposable portion before it adheres to the skin, or the cartridge is inside the device and empty (unfilled), and the user must fill the disposable portion of the device before use. Optionally, the disposable portion may include a battery power source to power the drive mechanism in a reusable portion.

[0058] The reusable portion preferably includes a drive mechanism, a control unit, and an electric motor. The disposable portion and the reusable portion can be releasably mechanically connected to each other via a snap-fit ​​connection, a bayonet connection, or a threaded connection. Alternatively, the disposable portion and the reusable portion can be connected by a third part, a clip, or an assembly component. An electrical connection between the two portions may be present alongside the mechanical connection, and the electrical connection may be separate from or integrated with the mechanical connection. Attached Figure Description

[0059] The subject matter of the invention will be explained in more detail below with reference to preferred exemplary embodiments shown in the accompanying drawings, which illustrate:

[0060] Figure 1 According to the prior art apparatus of WO17219154,

[0061] Figure 2 A patch-type injection device comprising a housing, an adhesive substrate, and a release liner.

[0062] Figure 3: A patch-type injection device with a housing and adhesive substrate; the release liner has been removed.

[0063] Figure 4 Cross-sections of the shell, base, and release liner.

[0064] Figure 5 : Shows details of the corners, base, cutouts, and release liner of the housing.

[0065] Figure 6 Top view of the base and release liner.

[0066] Figure 7 : Detailed layered substrate,

[0067] Figure 8 Use one hand to remove the release liner while holding the housing with the other hand.

[0068] Figure 9 : Small wings on a patch-type injection device used for skin removal. Detailed Implementation

[0069] According to the prior art (WO17219154), the patch injection device 1 is in Figure 1 As shown in the diagram, the patch-type injection device 1 includes a housing 2 that can be attached to a patient's skin using an adhesive base 5. The adhesive base 5 is covered by a removable release liner 10 that extends laterally beyond the dimensions of the housing 2, forming a pull tab 12 including a hole 14. The user can hold the device in one hand and grasp the pull tab 12 in the hole 14 with their other hand 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 base 5 and can hold the device while removing the release liner, thus improving device operation. For high-dose patch injectors, in this example, the usable surface area for skin attachment is limited to the bottom surface of the bottom housing portion 4, and the weight of the device may require a stronger adhesive for skin attachment to prevent premature separation of the device.

[0070] According to the patch syringe 1 of the present invention, Figures 2 to 8 As shown in the diagram. An adhesive base 5 at least partially surrounds the housing 2, forming a skirt 11. The adhesive base has a first surface that contacts the release liner 10 and a second surface that contacts the housing 2 (more preferably the bottom housing 4). The first surface facing the liner is preferably completely covered with skin adhesive, while the second surface facing the housing has no adhesive in the unsupported area of ​​the skirt. The skirt 11 includes at least one cutout 13. Drawing a virtual outline for the base 5 will result in a rectangular shape with four rounded corners, and the cutout 13 is defined by an area of ​​the base 5 omitted in one corner. The removable release liner 10 is attached to the base ( Figure 2 ) or has been removed Figure 3 The removable release liner 10 includes a pull tab 12 extending from the housing 2 and the adhesive substrate. The pull tab 12 may have a hole 14, allowing it to be easily grasped by a user. In the current example, the pull tab 12 is integrally formed with the removable release liner 10; alternatively, the pull tab 12 is a separate portion attached to or connected to the release liner. Optionally, the release liner may have an arrow or symbol indicating the direction for removing the release liner. This arrow or indicator may be printed or embossed on both sides of the release liner, preferably in the area of ​​the cutout 13 for the substrate. Alternatively, the hole 14 may have a different shape, such as an "arrow shape" indicating the direction for liner removal. The indicator on the release liner preferably begins at a location adjacent to or near the cutout 13 of the substrate where the housing 2 or the bottom housing 4 is located.

[0071] Optionally, the base 5 and the release liner 10 have a second cut 37 in the skirt 11. In this case, the release liner 10 follows the contour of the base 5 and does not form a pull tab. The second cut is useful during device assembly, for example, for lateral insertion of a sterile barrier or a separator foil for battery terminals, or for providing passage to a sterilizing agent such as ETO. The second cut 37 is therefore referred to as a component cut and, independently of the cut 13 described above, facilitates the removal of the release liner prior to use.

[0072] Optionally, there may be multiple cutouts 13 that can be used to facilitate the removal of the release pads, which may be combined with multiple release pads.

[0073] Patch-type injection device 1 ( Figure 2 It may further include an actuation button 33 and / or an optical indicator 34 (e.g., an LED indicator) and / or a cover 35 for closing the cartridge (retainer) present within the housing. The cover 35 is preferably a removable cover and may have an observation window 36 for observing the cartridge present in the patch-type injection device.

[0074] The cross-section of the patch injection device is Figure 4 Presented in Figure 4A cylinder 27 containing a fluid drug 28 situated between a movable piston 31 and a puncturable diaphragm 30 is shown. Optionally, the drug is a solid drug, such as a lyophilized product reconstituted prior to use. A drive mechanism 24, including a transmission system and a piston rod 32, is configured to advance the piston 31 in the cylinder toward an outlet 29 closed by the diaphragm 30. The housing 2 also houses a fluid path 25 including at least one injection needle 26. The at least one injection needle 26 is preferably connected to a conduit for delivering fluid from the cylinder toward the outlet of the fluid path. The fluid path 25 may include two injection needles, one for puncturing the diaphragm 30 (needle 26 in the illustrated example) and the other for puncturing the patient's skin. Preferably, one needle is aligned with the longitudinal axis of the cylinder 27, while the other needle is oriented perpendicularly to it. A needle insertion mechanism, not shown, is configured to move the needle 26 from a retracted position (…). Figure 4 (As shown in the diagram) is moved to the insertion position, thereby piercing the diaphragm. The needle insertion mechanism can simultaneously move the tip of the second needle from the retracted position inside the housing through the orifice 40 in the housing and the base to the position outside the housing.

[0075] From Figure 4 The details of the cross section are presented in Figure 5 middle, Figure 5 The interface between the corner 20 of the bottom housing 4, the adhesive base 5, and the release liner 10 is shown. The housing section 17 includes a substantially flat bottom surface, which is part of the contact surface 19 between the housing and the base. The base 5 is also shown as a partial section 16 (shaded) due to the presence of the cut 13, while the portion of the base 5 outside the section plane is indicated by the unshaded line. The cut 13 reaches or is adjacent to the housing, and this is indicated as location 15. Preferably, the indicator arrow on the release liner 10 begins at location 15.

[0076] Top view of base 5 and release liner 10 Figure 6 Presented in Figure 6 A first surface region 8 of the base 5 of the contact release pad 10 and a second surface region 9 for contacting the housing are shown. An excess region or skirt 11 surrounds the housing having a cutout 13 and a second cutout 37. The cutout 13 is formed as an arc 18, and the arc 18 comes close to or adjacent to the second surface region 9 intended for securing the housing to the base, presented as position 15. A pull tab 12 extends from the cutout 13. The base may further include at least one sensor region 38 and / or at least one electrical contact or wiring 39. The sensor may be a proximity sensor or a contact sensor, which may be a mechanical sensor or an electrical sensor, such as a capacitive sensor. Additionally, the base has an orifice 40 for a skin insertion needle.

[0077] The layered substrate 5 includes at least one adhesive layer 22 for contacting the housing, at least one support layer 21, and at least one skin adhesive layer 23. The support layer is positioned between the skin adhesive layer and the adhesive layer for contacting the housing. Figure 7 Alternatively, the substrate is based on multiple double-sided adhesive tapes, each tape having a support layer and two adhesive layers suitable for a specific purpose, such as an inner adhesive layer for mechanical support or an outer adhesive layer for contacting the housing or releasing the gasket.

[0078] The skirt 11 may be locally mechanically supported by the base itself (e.g., a corrugated or folded base structure), or the skirt may be locally reinforced by adding ribs or membranes to the surface (preferably to the second surface facing the shell).

[0079] Release pad removal in Figure 8 Presented in the image. The user holds the housing 2 of the patch injection device 1 in one hand and can hold the pull tab 12 with the other hand. The patch injection device includes a skirt 11 surrounding a base 5 of the housing, and the pull tab 12 is formed as an extension of the release pad 10. A cutout 13 in the base 5, together with the pull tab 12, ensures that the pull tab can be grasped by the user from both sides. By pulling the pull tab in the direction indicated by the arrow, a mechanical load is directed to a position 15 near the cutout adjacent to the housing. When the base 5 is attached to the bottom housing, the housing (more specifically, the bottom housing portion) provides mechanical support to the flexible base 5. As a result, the peeling force of the release pad from the base is directed to the housing via the base at the position near the cutout adjacent to the housing. As a result, the release pad will first begin to peel from the base where the base is mechanically supported, and not in the skirt area where it is not mechanically supported by the housing. The starting point for pad removal will be position 15, and pad removal will proceed to other areas supported by the housing, as well as non-mechanically supported areas in the flexible skirt. This design allows for easy removal of the release liner while retaining the casing containing the (expensive) drug.

[0080] Optionally, the patch-type injection device may have features that facilitate removal of the device from the skin after application. As an example, the adhesive base 5 includes small wings 41 as part of the skirt 11. Figure 9 The area on the wing facing the release liner is not covered by skin adhesive before the liner is removed, while the rest of the base (on the first surface) is covered with skin adhesive. In this example, the wing 41 is located next to the pull tab 12. After the liner is removed, the first surface of the base, except for the wing, adheres to the skin. Therefore, once the medication has been injected, the wing can be easily grasped by the user to remove the device from the skin. The top surface of the wing facing the user may include indicators, such as dot 42 ( Figure 9 Alternatively, dots can be imprinted into or printed onto the substrate to increase roughness, allowing the load to be easily transferred from the user's fingers to the substrate.

[0081] Reference Symbol List

[0082] 1. Patch-type injection device

[0083] 2. Shell

[0084] 3. Top shell

[0085] 4. Bottom shell

[0086] 5. Adhesive substrate

[0087] 6 First Surface

[0088] 7 Second Surface

[0089] 8 First surface region

[0090] 9 Second surface region

[0091] 10 Removable release pads

[0092] 11. Skirt

[0093] 12 Film Pulling

[0094] 13 Incisions

[0095] 14 holes

[0096] 15. The cut reaches the location of the shell.

[0097] 16 Section Base

[0098] 17-section shell

[0099] 18 arcs

[0100] 19 Contact Surface Housing-Base

[0101] 20 Corner housing

[0102] 21 Support layer

[0103] 22 Adhesive layer to the shell

[0104] 23 Skin adhesives

[0105] 24 Drive mechanism

[0106] 25. Fluid Path

[0107] 26 Injection needles

[0108] 27 tubes

[0109] 28. Fluid Drugs

[0110] 29 Exports

[0111] 30 Diaphragm

[0112] 31 Piston

[0113] 32 Piston Rod

[0114] 33 Actuation button

[0115] 34 Optical Indicators

[0116] 35 lids

[0117] 36 Observation Window

[0118] 37 Second incision

[0119] 38 Sensor Area

[0120] 39 electrical contacts / wiring

[0121] 40-hole opening

[0122] 41 Little Wing

[0123] 42 points.

Claims

1. A patch-type injection device, comprising: case, An adhesive substrate having a first surface with a first surface area for skin adhesion and a second surface that is partially attached to the housing opposite the first surface. Removable release liner The surface area attached to the second surface of the housing is smaller than the first surface area, and the excess area defines a skirt that at least partially surrounds the base of the housing. Furthermore, the first surface of the substrate is attached to a removable release liner that completely covers the first surface area of ​​the substrate. The feature is that a pull tab, which is part of the release liner and is located in a cut in the skirt of the base, the cut being adjacent to or partially coincident with the second surface that brings the housing into contact with the base, and wherein the housing includes at least one corner and the at least one corner is adjacent to the cut in the skirt, such that a peeling force can be transmitted from the release liner to the housing at the location where the cut reaches the housing.

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

3. The patch-type injection device according to claim 2, wherein, The release liner extends partially beyond the adhesive substrate in the region of the cut, such that the surface area of ​​the release liner is larger than the first surface area.

4. The patch-type injection device according to claim 1, claim 2, or claim 3, wherein, The adhesive substrate is flexible.

5. The patch-type injection device according to any one of the preceding claims, wherein, The pull tab is integrally formed with the release liner, or the pull tab is a separate part attached to the release liner.

6. The patch-type injection device according to any one of the preceding claims, wherein, The pull tab includes a hole.

7. The patch-type injection device according to any one of the preceding claims, wherein, The peeling force can be transmitted to the housing via the adhesive substrate at the location where the cut reaches the housing.

8. The patch-type injection device according to any one of the preceding claims, wherein, The cut in the skirt is arc-shaped.

9. The patch-type injection device according to any one of the preceding claims, wherein, The release liner is divided into two separate parts, each with its own pull tab.

10. The patch-type injection device according to any one of the preceding claims, wherein, The adhesive substrate is partially reinforced.

11. The patch-type injection device according to claim 10, wherein, The adhesive substrate is partially reinforced in the skirt surrounding the housing.

12. The patch-type injection device according to any one of the preceding claims, wherein, The adhesive substrate is a multilayer substrate, which includes at least one support layer and at least two adhesive layers for attaching the housing to a portion of the second surface and for attaching the removable release liner to the first surface.

13. The patch-type injection device according to any one of the preceding claims, wherein, The housing is an outer housing comprising a top housing portion and a bottom housing portion, wherein the adhesive substrate is attached to the bottom housing portion.

14. The patch-type injection device according to any one of the preceding claims, wherein, The housing encloses a drive mechanism for discharging the drug, a control unit for controlling drug delivery, and a fluid path including an injection needle for delivering the drug.

15. The patch-type injection device according to claim 14, wherein, The housing contains a cylinder containing a fluid drug.

Images