Drug fluid delivery device component with filling junction

Abstract

Drug fluid delivery device components and associated methods are provided. The delivery device component comprises: a wearable dispensing unit having a cannula in fluid communication with a reservoir for delivering a drug fluid from the reservoir via a tip of the cannula during use of the dispensing unit; and an engagement portion disposed at least partially around the cannula on the delivery side of the wearable dispensing unit and configured to receive an end portion of a drug filling device for filling the reservoir via the tip of the cannula. The delivery device component may include a removable support for the wearable dispensing unit, wherein at least a portion of the engagement portion is disposed on the removable support. A portion of the joint on the removable support provides a protective cover for the tip of the cannula.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 545,792, filed October 26, 2023, and U.S. Provisional Patent Application No. 63 / 650,541, filed May 22, 2024, which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to a drug delivery device for delivering drug fluids to humans or animals to treat or prevent disease, as well as associated delivery device components and methods of use. Background Technology

[0003] Drug fluids used to treat or prevent diseases in humans or animals typically need to be administered at regular intervals. Many different devices are known for drug fluid administration, including syringes, intravenous drips, cannulas, etc. Regular administration of drug fluids outside of a medical setting presents numerous challenges in ensuring safe and appropriate dosing.

[0004] One form of medication fluid that needs to be administered outside of a medical setting is insulin administration. Millions of people with diabetes worldwide rely on multiple daily injections (MDI) to manage their diabetes. Insulin pens are the most common method of insulin delivery globally. Currently, most insulin is delivered via standard insulin pens rather than by humans using alternative delivery methods such as smart insulin pens, insulin pumps, or automated insulin delivery systems.

[0005] People who use insulin pens often find it difficult to keep their blood sugar within the desired range throughout the night and may have to wake up multiple times each night to administer insulin, otherwise they risk both high and low blood sugar. The result is disrupted sleep and other problems, such as fatigue, anxiety, and grogginess upon waking in the short term, and more serious health risks in the long term.

[0006] Automated insulin delivery (AID) systems, such as insulin pumps with feedback from a continuous glucose monitor (CGM), can continuously control blood glucose levels, including overnight. These systems are expensive, can be highly invasive, and may require frequent infusion kit replacements. Many insulin pen users choose to rely solely on insulin pens or do not have access to insulin pumps.

[0007] Switching between daytime use of insulin pens or other non-pump delivery devices and short-term overnight use of insulin pumps is a current area of ​​development.

[0008] The foregoing discussion of the background of this invention is intended only to facilitate understanding of the invention. It should be understood that this discussion is not an admission or endorsement that any of the materials mentioned were part of common general knowledge in the art at the priority date of this application. Summary of the Invention

[0009] According to a first aspect of the present invention, a drug fluid delivery device component is provided, the drug fluid delivery device component comprising:

[0010] A wearable dispensing unit having a cannula in fluid communication with a reservoir for delivering drug fluid from the reservoir via the tip of the cannula during use of the dispensing unit; and

[0011] A junction is disposed at least partially around the sleeve on the delivery side of the wearable dispensing unit, and the junction is configured to receive the end portion of the drug filling device for filling the reservoir via the tip of the sleeve.

[0012] In one embodiment, the engagement may be configured to receive a standard-sized insulin pen tip, wherein the pen tip has a diameter in the range of 9.48 mm to 9.52 mm, as defined for receiving a dual-ended pen needle assembly. In another embodiment, the engagement may be configured to receive a vial top, wherein the top has a diameter in the range of 19.5 mm to 22 mm.

[0013] The delivery device component may include a removable support for a wearable dispensing unit, wherein at least a portion of an engagement is disposed on the removable support, and the portion of the engagement on the removable support provides a protective cap for the tip of the cannula. At least a portion of the engagement may be a receiving collar surrounding an opening disposed in the removable support, such that the protective cap surrounds the cannula. The engagement may be formed by a portion disposed on the removable support and a recess surrounding the cannula in the delivery side of the wearable dispensing unit. The depth of the recess may be the difference between a first length of cannula required to fill and a second length of cannula required for insertion into the body.

[0014] The delivery device components may include an attachment arrangement for securing a detachable support to a wearable dispensing unit. The attachment arrangement may be located at a joint and may be configured to have a latch that prevents the end portion of the drug filling device from releasing when inserted into the joint. The attachment arrangement may be configured to automatically release upon interaction with the drive unit when the drive unit is attached to the wearable dispensing unit.

[0015] The attachment arrangement of the removable support at the joint may include at least one elastic portion configured to press against and stabilize the drug filling device when it is inserted into the joint. Two opposing elastic portions may be present at the joint, and these portions may be configured together to grip the drug filling device, such that the removable support remains attached to the drug filling device when removed from the package.

[0016] The detachable support may include an engagement protrusion for engaging with a plunger of the wearable dispensing unit to provide restriction of the plunger's movement.

[0017] The wearable dispensing unit may include alignment protrusions configured to align with the drive unit when the drive unit is attached to the wearable dispensing unit.

[0018] The delivery device component may include an adhesive arrangement structure comprising a skin adhesive member disposed on the delivery side of the wearable dispensing unit, the skin adhesive member providing a skin adhesive surface configured to be exposed upon removal of the removable support. The skin adhesive member may include a skirt portion that is flexible relative to the wearable dispensing unit to provide flexible attachment to the user's skin. The skirt may be located within or extend from the dispensing unit's delivery side coverage area. The skin adhesive member may be located within the coverage area of ​​the wearable dispensing unit's delivery side on two opposite sides and may extend beyond the coverage area at one or both opposite ends.

[0019] The skin adhesive component may include a backing layer configured to cover a skin adhesive surface, and the backing layer may have at least one attachment portion for attachment to a removable support, and may be configured such that removal of the wearable dispensing unit from the removable support causes the backing layer to peel off from the skin adhesive surface. The backing layer may be a butterfly liner formed of two portions, each portion including an adhesive covering portion and an attachment portion, wherein one or both attachment portions are folded rearward over the adhesive covering portion. The removable support may include a liner anchoring member extending from a device-facing surface of the removable support, wherein the liner anchoring member is configured to engage the attachment portion of the backing layer. The device-facing surface of the removable support may have a recessed area for receiving the liner anchoring member. One or more attachment portions may include at least one slit configured for attachment to the anchoring member, wherein the slit is aligned with the removal direction of the backing layer.

[0020] The adhesive arrangement may include a device adhesive layer attached to the device-facing surface of the skin adhesive member, wherein the device adhesive layer is formed of a pressure-sensitive adhesive material and extends to the opposite side edge of the skin adhesive member. The skirt portion of the skin adhesive member may have an opposite side skirt located within the coverage area, and the device adhesive layer may extend to the side skirt. A removable support may be configured to apply pressure to the device adhesive layer in areas other than the side skirt to which the device adhesive layer extends. The dispensing unit may include side wings configured not to adhere to the device adhesive layer in the area of ​​the side skirt. The dispensing unit may include side wings configured to bend with the side skirt.

[0021] The wearable dispensing unit may include a plunger for movement within a reservoir, wherein the plunger has an interference fit with the inner surface of the reservoir, thereby eliminating the need for a sealing member. Alternatively, the wearable dispensing unit may include a plunger for movement within a reservoir, wherein the plunger has a full seal covering the front end of the plunger and formed of an elastomeric material. The full seal may conform to the shape of the front portion of the reservoir to reduce dead volume within the reservoir. The plunger may include a curved rear face for mating with the full seal to minimize clearance.

[0022] The delivery device component may include a surrounding package of the wearable dispensing unit, wherein a portion of the surrounding package provides a stable tray during filling of the wearable dispensing unit. The delivery device component may include a surrounding package of the wearable dispensing unit, wherein at least a portion of the surrounding package is integrated with a removable support.

[0023] The wearable dispensing unit may include a plunger-operating member for retracting the plunger of the wearable dispensing unit during bottle filling.

[0024] According to another aspect of the invention, a drug fluid delivery device is provided, comprising drug fluid delivery device components according to a first aspect and a reusable drive unit for connecting to a wearable dispensing unit for driving drug fluid delivery from a reservoir through a cannula. The drive unit may include opposite sides having depths for grasping by a person's fingers and thumb.

[0025] According to another aspect of the present invention, a method for using a drug fluid delivery device is provided, the method comprising:

[0026] A wearable dispensing unit is filled through the tip of a cannula, wherein the cannula is in fluid communication with a reservoir for delivering drug fluid from the reservoir via the tip of the cannula during use of the dispensing unit.

[0027] The method may include positioning a drug filling device in a junction on the delivery side of a wearable dispensing unit that at least partially surrounds a cannula, such that the cannula is inserted into the drug filling device.

[0028] In one embodiment, the drug filling device may be an insulin pen, and the method may include dispensing the drug from the insulin pen via a cannula to a reservoir.

[0029] In another embodiment, the drug filling device is a bottle, and the method may include retracting the plunger of the wearable dispensing unit to draw drug from the bottle through a cannula into a reservoir. The retraction of the plunger may be manually operated via the plunger. Alternatively, the retraction of the plunger may be automatically activated by attaching a drive unit to the wearable dispensing unit.

[0030] Where at least a portion of the joint can be disposed on a removable support for the wearable dispensing unit, the method may include attaching a drive unit to the wearable dispensing unit, thereby automatically releasing the removable support from the wearable dispensing unit. Automatic release of the removable support from the wearable dispensing unit may be caused by engaging the drive unit with an attachment arrangement structure to which the removable support is attached to the wearable dispensing unit. Releasing the removable support from the wearable dispensing unit may expose the adhesive surface on the delivery side of the wearable dispensing unit and the tip of the sleeve.

[0031] The method may include placing a wearable dispensing unit within a surrounding package, at least a portion of which provides support for the wearable dispensing unit during filling.

[0032] According to another aspect of the present invention, a detachable support member for a wearable drug delivery device is provided, the detachable support member comprising:

[0033] A protective base for use with a delivery device attached during encapsulation prior to use, the protective base comprising:

[0034] A central planar region, configured to correspond to a portion of the lower side of the delivery device corresponding to the area of ​​the device adhesive layer between the delivery device's dispensing unit and the skin adhesive layer, wherein the planar member applies pressure to the device adhesive material during encapsulation; and

[0035] An adhesive-protected removal arrangement is configured to expose the skin adhesive surface of the skin adhesive layer of the delivery device when the delivery device is removed from the removable support.

[0036] The adhesive-protected removal arrangement may include one or more anchoring members configured as attachment points to the backing of the skin adhesive surface of the delivery device, such that the backing is removed when the removable support is removed from the delivery device prior to use. Alternatively, the adhesive-protected removal arrangement may simply expose the adhesive surface when the removable support is removed.

[0037] One or more anchoring members may be disposed in a recessed portion of the removable support. The removable support may include at least a portion of a joint configured to at least partially surround a sleeve extending from the delivery side of the wearable dispensing unit, and the joint configured to receive an end portion of a drug filling device for filling the dispensing unit via the tip of the sleeve.

[0038] According to another aspect of the present invention, an adhesive arrangement structure for a drug delivery device is provided, the adhesive arrangement structure comprising:

[0039] A skin adhesive component configured to form a flexible skirt extending from the lower side of the delivery device and having a skin adhesive surface;

[0040] A device adhesive layer, disposed on the upper surface of the skin adhesive member and used for attachment to the lower part of the delivery device; and

[0041] A backing that covers the skin adhesive surface and is configured for removal when the delivery device is released from the removable support.

[0042] The backing may have one or more anchoring openings for attachment to a removable support before removal. The anchoring openings may be slits formed during manufacturing that pass through the skin adhesive component and the backing.

[0043] The device adhesive layer can be a pressure-sensitive adhesive layer that extends to the opposite edge of the skin adhesive component, thereby avoiding the need for a separately die-cut pressure-sensitive adhesive layer.

[0044] According to another aspect of the present invention, a method for manufacturing an adhesive arrangement structure for a drug delivery device is provided, the method comprising:

[0045] Provide the skin adhesive component and remove the original backing from the adhesive surface of the skin adhesive component;

[0046] Attach the backing to the adhesive surface of the skin adhesive component;

[0047] A device adhesive layer is provided, having a width covering the skin adhesive component and a dimension smaller than the length of the skin adhesive component; the original backing is removed from the device adhesive layer; and the device adhesive layer is applied to the device-facing surface of the skin adhesive component; and

[0048] Cut to form a composite stack of skin adhesive components, backing and device adhesive layers.

[0049] The method may include cutting one or more anchoring openings through at least one end portion of the combined stack.

[0050] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings. Attached Figure Description

[0051] In the attached diagram:

[0052] Figure 1A and Figure 1B These are exploded top and exploded bottom perspective views of an example embodiment of a delivery device assembly including a delivery device component suitable for filling from a pen;

[0053] Figure 2A and Figure 2B These are top and bottom perspective views of an example embodiment of a packaged tray that holds components of the delivery device;

[0054] Figure 3A This is an exploded perspective view of an example embodiment of the delivery device components, including the dispensing unit and the detachable support.

[0055] Figure 3B This is a perspective view of an example embodiment of a delivery device including a dispensing unit and a driving unit;

[0056] Figures 4A to 4E These are various views of an example embodiment of the joint arrangement structure of the delivery device components, including the first attachment arrangement structure;

[0057] Figures 5A to 5G These are a series of perspective views of an example embodiment of a pen-filling delivery device component;

[0058] Figure 6 This is a flowchart illustrating a series of steps in an example implementation of a method using delivery device components;

[0059] Figure 7 This is an exploded perspective view of another example embodiment of a delivery device assembly including delivery device components suitable for filling from a bottle;

[0060] Figures 8A to 8D These are a series of perspective views of an example embodiment of a delivery device component for filling from a bottle;

[0061] Figure 9A and Figure 9B These are a series of perspective views of another example embodiment of the delivery device component for filling from a bottle;

[0062] Figure 10A and Figure 10B These are top and bottom perspective views of another embodiment of the delivery device component including the second attachment arrangement structure;

[0063] Figure 11 This is a top perspective view of another embodiment of the delivery device component including the third attachment arrangement structure;

[0064] Figure 12A and Figure 12B These are top and bottom perspective views of another embodiment of the delivery device component including the fifth attachment arrangement structure;

[0065] Figure 13 This is a top perspective view of another embodiment of the delivery device component including the fourth attachment arrangement structure;

[0066] Figure 14 This is a perspective lower view of an example embodiment of the delivery device, which shows an example of an adhesive arrangement structure;

[0067] Figures 15A to 15D These are exploded perspective and side views of an example embodiment of a delivery device component, which show another example of an adhesive arrangement structure;

[0068] Figures 16A to 16H This is a perspective view of another example embodiment of the adhesive arrangement structure and base support;

[0069] Figure 17A and Figure 17B This is a perspective view of another example embodiment of the base support member;

[0070] Figure 18A and Figure 18B These are various views of example embodiments of the delivery device components, showing the gripping arrangement structure.

[0071] Figure 19 It is a cross-section of an embodiment of a delivery device component including a plunger sealing arrangement structure; and

[0072] Figures 20A to 20D This is a perspective view of another example embodiment of the plunger and sealing arrangement structure of the delivery device components. Detailed Implementation

[0073] This disclosure describes a drug fluid delivery device for delivering a drug fluid into a human or animal body. In embodiments of this disclosure, the drug fluid is insulin, and an insulin delivery device is provided for transdermal or subcutaneous delivery of insulin. However, the delivery device is suitable for other forms of drug fluid that require periodic transdermal or subcutaneous administration.

[0074] An example wearable fluid drug delivery device comprises two main components: a dispensing unit, which includes a refillable reservoir for the drug fluid and a cannula for delivering the fluid to the body; and a drive unit, which includes a control unit for controlling the drive mechanism to deliver the drug fluid from the reservoir through the cannula. This wearable fluid drug delivery device may be referred to as a pump. When used for insulin delivery, this device is typically used in automated insulin delivery (AID) systems. Wearable fluid drug delivery devices come in various forms and can be designed to be worn for several days or shorter durations, such as only during fasting periods.

[0075] In some cases, wearable drug fluid delivery devices have a refillable reservoir. Typically, the reservoir has a filling port that provides access to the reservoir. This known filling port is located on the upper side of the device, opposite to the cannula outlet.

[0076] The described wearable drug fluid delivery device includes a cannula configured as an inlet for drug fluid to a reservoir and a delivery outlet. The cannula is positioned in a fixed location and configured to have a length suitable for filling and delivery. The cannula is suitable for filling from a drug filling device having a septum for receiving the cannula. An example of such a drug filling device is a vial having a septum for receiving a needle. Another example of such a drug filling device is a drug delivery pen (such as an insulin delivery pen) including an end with a septum designed to receive a removable, two-ended needle (e.g., as defined by ISO 11608-2).

[0077] A cannula is disposed in the described wearable drug fluid delivery device suitable for use as a filling needle. The cannula may be a steel cannula with a length of at least 5.5 mm to make it suitable for filling. In the described embodiment, a joint is provided at least partially around the cannula on the delivery side of the dispensing unit, wherein the joint is configured to receive an end portion of the drug filling device for filling the reservoir via the tip of the cannula. The joint may be configured to accommodate differences in the required length of the needle for filling and the shorter length of the needle for delivery to the user.

[0078] The following two main components of a wearable drug fluid delivery device can be integrated into a single device: a dispensing unit including a refillable reservoir and a cannula; and a drive unit including a control unit for controlling the drive mechanism to deliver drug fluid from the reservoir through the cannula. In other embodiments, the drive unit is detachable from the dispensing unit, allowing it to be reused multiple times with a replaceable dispensing unit. Such a dispensing unit can be configured to be filled from a drug filling device, regardless of whether it is detachable. The following description focuses on the dispensing unit provided as a replaceable component for a wearable drug fluid delivery device. However, it should be understood that the described joint can be adapted for use with a wearable drug fluid delivery device having an integrated, non-detachable dispensing unit. In particular, in some embodiments, the following support member, providing at least a portion of the joint, can be used with an integrated delivery device.

[0079] Reference Figure 1A and Figure 1B The diagram shows a top and bottom exploded perspective view of an example embodiment of a wearable drug delivery device assembly 101. The delivery device assembly 101 includes a drive unit 120 that can be attached to a dispensing unit 130 to form a combined wearable delivery device 100 for wearing on a user's body to deliver a drug fluid through the skin to the body. The dispensing unit 130 has a delivery side 133 supporting a skin adhesive member 180, which has a skin adhesive surface 182 for adhesion to the user's skin. The delivery device assembly 101 may also include a removable support 150 configured together with the dispensing unit 130 as a disposable delivery device component 110.

[0080] A single drive unit 120 can be reused together with a replacement dispensing unit 130. Therefore, the dispensing unit 130 can be disposed separately from the drive unit 120. The dispensing unit 130 includes a fillable reservoir 134 for the drug fluid and a plunger 135 for pushing fluid from the reservoir through a cannula 131 to deliver fluid to the user's body. The cannula 131 has a basal end located at the reservoir 134 and a cannula tip 132 inserted into the user's skin. The cannula 131 can be a steel cannula with an example size of 30G to 32G (G represents a specification).

[0081] The dispensing unit 130 may be configured as part of the delivery device component 110, which may be configured as a replacement component for the drug fluid delivery device 100. The delivery device component 110 includes a wearable dispensing unit 130 having a sleeve 131 in fluid communication with a reservoir 134 for delivering drug fluid from the reservoir 134 via a tip 132 of the sleeve 131 during use of the dispensing unit 130.

[0082] The delivery device component 110 includes a junction 140 disposed on the delivery side 133 of the dispensing unit 130, at least partially surrounding the sleeve 131. The junction 140 is configured to receive an end portion of a drug filling device for filling a reservoir via the tip 132 of the sleeve 131. In some embodiments, the junction 140 is configured to receive a standard-sized drug delivery pen tip. The standard size may be as specified in ISO 11608-2, which provides a standardized double-ended pen needle assembly and thus a corresponding pen receiving assembly. According to ISO 11609-2, the standard pen hub diameter is 9.48 mm to 9.52 mm. In other embodiments, the junction 140 is configured to receive a standard-sized vial top. The vial size is defined by ISO 8362-1 and may have a diameter of approximately 20 mm (approximately 19.5 mm to 22 mm) at the junction. A typical vial used for insulin is a 10 ml 6R clamp bottle.

[0083] The engagement portion 140 may be fully integrated into the dispensing unit 130 in the form of a recess 142 surrounding the sleeve 131. In another embodiment, the engagement portion 140 may be fully disposed on a removable support 150 that is configured together with the dispensing unit 130 as part of the delivery device component 110. In another embodiment, the engagement portion 140 may have a portion provided by the recess 142 in the dispensing unit 130 and a portion disposed on the removable support 150 that is configured together with the dispensing unit 130 as part of the delivery device component 110.

[0084] The removable support 150 may have a shape and size corresponding to the skin adhesive member 180 on the delivery side 133 of the dispensing unit 130. The removable support 150 can be detached from the dispensing unit 130 when it is ready to be attached to the user's body, thereby exposing the skin adhesive member 180.

[0085] In an alternative embodiment, the detachable support 150 may be smaller than the dispensing unit 130 and may take the form of a collar arrangement that provides at least a portion of the engagement 140 and protection for the sleeve 131 without having an extended base portion. As mentioned above, in embodiments of a wearable drug delivery device with an integrated dispensing unit and a drive unit, a detachable support 150 that can be removed from the delivery side of the device may be provided.

[0086] The portion of the engagement 140 disposed on the removable support 150 can provide a protective surrounding of the cannula tip 132 protruding from the delivery side 133 of the dispensing unit 130. The portion of the engagement 140 disposed on the removable support 150 may include a receiving collar 144 disposed on the removable support 150 surrounding an opening 145, positioned to surround the cannula 131 when the removable support 150 is attached to the dispensing unit 130. The opening 145 may be sized to receive the end of a medication filling device, including a diaphragm, such as the diaphragm end of an insulin pen or vial. The receiving collar 144 may extend as a single collar around the opening 145, or it may be a discontinuous collar formed by two or more portions sufficient to guide the end of the medication filling device to a position where the cannula 131 is inserted into the diaphragm of the medication filling device. Due to this configuration, the medication filling device can be received in the lower side of the removable support 150, i.e., the side opposite to the side supporting the dispensing unit 130.

[0087] In one embodiment, the engagement 140 is provided by a combination of a recess 142 surrounding the sleeve 131 in the delivery side 133 of the dispensing unit 130, an opening 145 extending from the removable support 150, and a collar 144. The depth of the recess 142 may be the difference between a first length of the sleeve 131 required for filling from the drug filling device and a second length of the sleeve 131 required for insertion into the user.

[0088] The delivery device component 110 may include an attachment arrangement 160 for securing the removable support 150 to the dispensing unit 130 during filling. The attachment arrangement 160 may take various forms as described below. Figure 1A and Figure 1B In one embodiment shown, the attachment arrangement 160 is disposed at the engagement 140 and configured to have latches 161, 162, the end portion of the drug filling device preventing the latches 161, 162 from releasing when inserted into the engagement 140. In this embodiment, the attachment arrangement 160 is configured to automatically release upon interaction with the drive unit 120 when the drive unit 120 is attached to the wearable dispensing unit 130. The attachment arrangement may also include an elastic portion shaped to conform to a portion of the engagement, as shown below. Figure 17A and Figure 17B As shown in the figure.

[0089] The removable support 150 may include an engagement protrusion 158 projecting from a device-facing surface 152. This engagement protrusion 158 engages with a plunger 135 of the dispensing unit 130 to provide restriction of movement of the plunger 135 when the removable support 150 is attached to the dispensing unit 130. This restriction of movement can provide a stop for the plunger 135 to limit its movement during filling and retain it within the reservoir 134. This prevents the plunger 135 from being ejected from the dispensing unit 130 when the reservoir 134 is fully filled. A corresponding opening 183 may be provided in the adhesive member 180 to allow the engagement protrusion 158 to extend through the adhesive member 180.

[0090] The dispensing unit 130 includes a fixed arrangement structure 128 corresponding to a fixed arrangement structure 129 of the drive unit 120 to hold the drive unit 120 in place before attaching the delivery device 100 to the user. The dispensing unit 130 may include an alignment protrusion 159 configured to align with the drive unit 120 when attached to the wearable dispensing unit. The alignment protrusion 159 provides axial alignment and tight dimensional fit with the wall of the drive unit 120 to axially constrain the reservoir 134 relative to the drive unit 120, allowing the drive unit 120 to precisely advance the plunger 135 during delivery. The alignment protrusion 159 aligns the reservoir 134 and the drive unit 120, resulting in accurate dose dispensing.

[0091] An adhesive arrangement structure for adhering a wearable delivery device 100 to a user's skin is described. The adhesive arrangement structure has the advantage of preventing the user from contacting the tip of the cannula during application and reducing overall processing complexity. The adhesive arrangement structure incorporates an improved process that facilitates manufacturing. A form of a removable support 150 for use in conjunction with the adhesive arrangement structure is also described. A form of a dispensing unit 130 for mating with the adhesive arrangement structure is also described. These aspects associated with the adhesive arrangement structure can be provided for drug delivery devices that do not include the joints and cannula filling aspects described herein. In other words, the adhesive arrangement structure can be configured with other known types of patch pumps or other drug delivery devices that attach to the user's skin.

[0092] A skin adhesive member 180 disposed on the delivery side 133 of the wearable dispensing unit 130 provides a skin adhesive surface 182. The skin adhesive member 180 may have an opening 181 corresponding to the engagement portion 140. The skin adhesive member 180 may include a skirt portion 195 that is flexible relative to the wearable dispensing unit 120 to provide flexible attachment to the user's skin. The skirt portion 195 may extend around the attachment island of the skin adhesive member 180 to the dispensing unit 120. Alternatively, the skirt portion 195 may extend from the dispensing unit 120 in the form of one or more flaps.

[0093] If a skirt portion 195 is provided, the skin adhesive member 180, including the skirt portion 195, can be located within the coverage area 139 of the dispensing unit 130. Alternatively, the skin adhesive member 180 can extend from the coverage area 139 of the dispensing unit 130 in at least one direction, as further described below with reference to FIG15.

[0094] The skin adhesive component 180 has a skin adhesive surface 182 that can be configured to be exposed when the removable support 150 is removed. The removable support 150 can provide a protective cover for the skin adhesive surface 182, allowing it to be exposed when the removable support 150 is removed. In another embodiment, the skin adhesive component 180 may have a backing disposed between the adhesive surface 182 and the removable support 150, and at least a portion of the backing can be attached to the removable support 150 such that removal of the removable support peels the backing from the adhesive surface 182. The following relates to... Figures 16A to 16D Further description of an example implementation. The arrangement structure that removes the backing can be applied to wearable devices that do not include the skirt portion.

[0095] The adhesive arrangement may include a device adhesive layer 196 attached to the device-facing surface 197 of the skin adhesive member 180. The device adhesive layer 196 may be formed of a pressure-sensitive adhesive material and may extend to the opposite side edges 184, 185 of the skin adhesive member 180. This has manufacturing advantages because it avoids the need for separately die-cutting the device adhesive layer 196. The following is about... Figure 17A Figure 17H ​​further illustrates the detachable support 150 and / or distribution unit 130 for adapting to adjustments of this arrangement.

[0096] Reference Figure 2A and Figure 2B The diagram shows a top perspective view and a bottom perspective view of an example embodiment of a package 170 for a delivery device component 110. The package 170 provides a sealed enclosure for the delivery device component 110.

[0097] A portion of the package 170 may provide a stable tray 171 for supporting the delivery device component 110 during filling of the wearable dispensing unit 130. The tray 171 provides stability during filling of the dispensing unit 130. The tray 171 also provides filling orientation by exposing the engagement portion 140 to the user. The tray 171 further protects the delivery device component 110 before and during filling; in particular, the moving portions of the dispensing unit 130 are protected. The tray 171 may include a plunger 135 for the dispensing unit 130 and a main recess 174 for a reservoir 134, wherein the recess 174 has a flat base such that the tray 171 rests securely on a surface. The tray 171 may also include a secondary recess 176 for receiving the dispensing unit 130 and a fixed arrangement structure 128 for attaching the dispensing unit 130 to the drive unit 120. In the illustrated embodiment, the fixed arrangement structure 128 is a protrusion located at one end of the dispensing unit 130, and the secondary recess 176 helps to provide additional support for the tray 171. The package 170 may include a removable cover for the tray 171, such as a blister pack cover.

[0098] Figure 2B An example of the delivery device component 110 is shown, as if the package 170 has just been opened by the user and is ready to be filled. The removable support 150 of the delivery device component 110 is exposed at the top in this orientation. The package tray 171 (e.g., in the user's hand or on a table) supports the delivery device component 110 while the medication filling device is inserted at the junction 140 for filling. The tray 171 protects the plunger 135 (e.g., from the user's fingers or other objects that might interfere with the plunger 135) as it slides backward due to the filling of the reservoir 134.

[0099] In another embodiment, the encapsulation of the delivery device component 110 is at least partially formed by the removable support 150, thereby minimizing waste material. In this way, the surrounding encapsulation is integrated with the removable support 150. This may include an attached cap portion and an adhesively attached sealing layer. The removable support 150 may be configured to have an additional cap portion for sealing the dispensing unit 130, wherein the cap portion has a snap-fit ​​lip surrounding the removable support 150. The additional cap may be shrink-wrapped to provide a sterile barrier for the dispensing unit 130 within it. The removable support 150 may have a sealing layer glued across the joint side of the removable support 150, which is peeled off before filling through the joint 140. After filling, the additional cap portion can be removed.

[0100] Figure 3AThis is an exploded perspective view of an example embodiment of a delivery device component 110, including a dispensing unit 130, a skin adhesive component 180, and a detachable support member 150. The delivery device component 110 may be disposed... Figure 2A and Figure 2B In the package 170. Figure 3A A joint 140 is shown, provided by the dispensing unit 130 and the removable support 150, passing through the adhesive member 180 and surrounding the sleeve 131.

[0101] Figure 3B This is a perspective view of an example embodiment of a wearable form of the delivery device 100, including a dispensing unit 130 and a drive unit 120. In this form, the removable support 150 has been removed before attachment to the user's body. The figure shows a skin adhesive member 180 ready to be attached to the user's body, with a skin adhesive surface 182 exposed and a sleeve 131 extending from an opening 181 in the adhesive member 180. The long sides 184, 185 of the adhesive member 180 may be located within the sides of the drive unit 120 and thus within the coverage area of ​​the delivery device 100. The ends 186, 187 of the adhesive member 180 may extend outward from the ends of the delivery device 100. In another embodiment, the long sides 184, 185 may match the coverage area of ​​the delivery device 100 or extend beyond the coverage area of ​​the delivery device 100 by a small distance (e.g., 1 mm or less). This maximizes the adhesive area to the skin and prevents the plastic portion from directly contacting the skin, while still not hindering the user's fingers and thumb from gripping the delivery device 100.

[0102] Figures 4A to 4E These are various views of an exemplary embodiment of the joint 140 of the delivery device component 110. In this exemplary embodiment, a first attachment arrangement structure 160 is shown and described. However, the joint 140 of this embodiment can be coupled with, as shown in reference... Figure 10A , Figure 10B , Figure 11 , Figure 12A , Figure 12B and Figure 13 Any of the attachment arrangement structures described herein may be used together. In this example embodiment, the dimensions of the joint 140 are suitable for filling by a drug filling device in the form of a pen delivery device. However, for other forms of filling devices, the equivalent joint 140 may be provided with a wider or narrower circumference.

[0103] Figure 4A and Figure 4BDetails of the joint 140 provided at the sleeve region of the dispensing unit 130 and at the removable support 150 are shown, wherein the removable support 150 engages with the dispensing unit 130 when the dispensing unit 130 is disposed in the package and during user filling.

[0104] In this embodiment, the engagement 140 is formed by a combination of a recess 142 in the dispensing unit 130 surrounding the sleeve 131, an opening 145 on the removable support 150, and a surrounding collar 144. The combination of the recess 142 with the opening 145 and the collar 144 constitutes a receiving cavity 146 suitable for a standard engagement of a medication-filled pen 190. Similarly, the dimensions can be adjusted to form a standard engagement for a vial or the like. Medication-filled pens, such as insulin pens, have a diaphragm designed for the needle according to standard ISO 11608-2.

[0105] exist Figure 4A and Figure 4B In the diagram, the cannula 131 is shown centered within the receiving cavity 146. The receiving cavity 146 is partially formed by a recess 142 in the delivery side of the dispensing unit 130, resulting in a length 193 of the cannula 131 within the receiving cavity 146 suitable for filling from a drug filling pen, while simultaneously reducing the exposed length 194 of the cannula 131 from the dispensing unit 130. The recess 142 reduces the exposed length 194 by decreasing the depth of the recess 142.

[0106] For drug delivery pens, the standard accessory requires a needle length of 4.7 mm to 7 mm to be inserted into the pen's diaphragm. This length is specified in ISO 11608-2 and refers to the amount by which the needle extends back into the pen's diaphragm, as measured from the needle hub surface at the end of the pen. Section 5.2.3 of ISO 11608-2 defines the barrel-end needle size l2 as 5.7 mm to 7 mm, where the possible needle hub joint h1 is 0 mm to 1 mm, thus giving a full range of 4.7 mm to 7 mm. Therefore, the cannula 131 needs to be of the same length to be inserted into the pen for use in filling the reservoir. The cannula 131 may have dimensions similar to the 4.7 mm to 7 mm needle of a drug-filling pen for insertion into the drug-filling pen.

[0107] The delivery cannula 131 may require a shorter length when inserted into the body compared to when inserted into the septum of the filling pen. For example, for the delivery device 100 intended for short-term use of less than 24 hours, an exposure length 194 of 3.5 mm to 4.5 mm extending from the base plane of the wearable delivery device 100 into the body may be suitable for most users. This exposure length 194 may be more specifically 3.8 mm to 4.2 mm, and preferably 4 mm. The injection tip length of insulin pen needles is typically in the range of 4 mm to 8 mm for insertion into the skin. In recent years, longer needles have been gradually phased out as shorter needles have proven to be less effective in causing pain and tissue damage.

[0108] The difference between the filling length 193 and the exposed length 194 of the sleeve 131 can be provided by the depth of the recess 142. For an exposed delivery length 194 of 3.5 mm to 4.5 mm, this difference, and therefore the depth of the recess 142, can be 0.2 mm to 3.5 mm. This range is obtained by subtracting the minimum delivery length of 3.5 mm from the maximum depth of the recess of 3.5 mm, i.e., the maximum filling length of 7 mm. The minimum depth of the recess is 0.2 mm, i.e., the minimum filling length 193 of 4.7 mm minus the maximum exposed delivery length 194 of 4.5 mm. As described in some embodiments herein, the minimum depth of the recess can be rounded to zero when the recess is not required. Embodiments without a recess can also be adapted for sleeves with longer delivery lengths, such as those required by some users, wherein the sleeve has sufficient length for insertion into the filling pen.

[0109] The engagement 140, having a receiving cavity 146, provides a dimensional fit. The drug filling device 190 is fitted to the engagement 140 for filling, and the engagement 140 receives the filling device and provides guidance and stability to the filling device when the sleeve 131 extends into the filling device to the appropriate depth controlled by the depth of the receiving cavity 146.

[0110] It may be necessary to inject the cannula 131 deeper into the body than into the pen used for filling. In this case, the engagement 140 may not include any recesses, and the removable support 150 may have an opening 145 and a surrounding collar 144, which includes spacer members to limit the pen filling depth of the engagement 140. For example, the dispensing unit 130 may have an 8 mm cannula exposed from its base plane for injection into the body, wherein the removable support 150 has spacer members spaced 2 mm apart from the dispensing unit 130, allowing only a 6 mm cannula 131 to be inserted into the filling pen.

[0111] Drug-filled pens, such as insulin pens, have an end or hub that supports a diaphragm according to standard ISO 11608-2. The end may include threads or other attachment arrangements to allow for secure attachment of a needle. The engagement portion 140 may include a corresponding attachment arrangement for securely receiving the filler pen. Alternatively, this is not necessary because the filling process does not require such fixation, and the engagement portion 140 may be sized to accommodate the attachment arrangement without engaging it.

[0112] Figure 4C The image shows the delivery device component 110 after filling, which has been flipped so that it rests on the removable support 150, wherein the drive unit 120 is mounted on the dispensing unit 130. The drive unit 120 is about to engage the fixed arrangement structure ( Figure 1A and Figure 1B (128, 129), and disconnect the attachment arrangement structure 160 between the distribution unit 130 and the detachable support 150.

[0113] The attachment arrangement 160 is formed by two opposing latching arms 161, 162, which extend inwardly from the collar 144 of the engagement 140. The latching arms 161, 162 are bent inward to provide a snap-fit ​​engagement 163 with the dispensing unit 130, such as... Figure 4D As shown in the figure.

[0114] The latching arms 161 and 162 have ramps 165 and 166, which are pushed downward and clamped together by a portion of the drive unit 120 when the drive unit 120 is attached to the dispensing unit 130. The downward force on the ramps 165 and 166 releases the snap-fit ​​engagements 163 and 164 from the dispensing unit 130 and also releases the removable support 150 from the dispensing unit 130. Figure 4E As shown in the figure.

[0115] When the drive unit 120 is installed, the ramp surfaces 165 and 166 engage with the lower part of the drive unit 120, causing the snap-fit ​​engagements 163 and 164 to rotate inward and disengage. Simultaneously, the distribution unit 130 engages the fixed arrangement structures 128 and 129 with the drive unit 120, such that when the drive unit 120 is lifted, the distribution unit 130 is released from the detachable support 150 and remains attached to the drive unit 120, thus forming the complete wearable assembly to be placed on the user's body.

[0116] The attachment arrangement 160 has the following additional benefits: when the filling device is located in the receiving cavity 146, the attachment arrangement 160 is supported by the filling device and the latch arms 161, 162 are prevented from bending and thus the snap-fit ​​engagements 163, 164 are prevented from disengaging, thereby preventing the disassembly of the removable support 150.

[0117] In this manner, when the drive unit 120 is attached to the distribution unit 130, the attachment arrangement structure 160 automatically releases the distribution unit 130 from the detachable support 150. To attach the drive unit 120 to the distribution unit 130, the user can slide the protruding end 129 of the fixing arrangement structure on the control unit 120 at an angle into the corresponding groove 128 at the end of the distribution unit 130. When the user presses down on the drive unit 120 to engage the snap-fit ​​fixing arrangements 128, 129 at the opposite ends of the drive unit 120 and the distribution unit 130, the lower part of the drive unit 120 is pushed downward against the ramp surfaces 165, 166 of the attachment arrangement structure 160. This downward force on the ramp surfaces 165, 166 causes the snap-fit ​​engagements 163, 164 to pivot inward and disengage from the distribution unit 130.

[0118] Figures 5A to 5G These are a series of perspective views of an example embodiment of a delivery device component filled from a drug filling pen 190. Figure 5A The encapsulation 170 is shown to be opened by removing the sterile barrier to leave the tray 171 stable on the support surface and revealing the joint 140 of the removable support 150. Figure 5B and Figure 5C The pen 190 is shown with its end portion 192 inserted into the receiving cavity 146 of the engagement 140.

[0119] When pen 190 is inserted into receiving cavity 146, the tip of sleeve 131 pierces diaphragm of pen 190, and medication can be dispensed by actuation of pen 190, thereby filling reservoir 134. In an alternative embodiment described below, instead of pen 190, the user can insert vial into suitably sized engagement and operate plunger 135 to fill reservoir 134.

[0120] Then, the delivery device component 110, in the form of a combination of the dispensing unit 130 and the removable support 150, is removed from the tray 171 and flipped over so that it sits on the support surface together with the removable support 150. The drive unit 120, as... Figure 5D Attached as shown, thus resulting in Figure 5EThe arrangement structure. Fixed arrangement structures 128 and 129 connect the drive unit 120 to the distribution unit 130, and the installation of the drive unit 120 causes the attachment arrangement structure 160 to disengage, so as to automatically disconnect the distribution unit 130 from the detachable support 150 in response to the attachment of the drive unit 120, such as... Figure 5F As shown in the figure.

[0121] The drive unit 120 and the dispensing unit 130 attached thereto and together forming the delivery device 100 are lifted away from the removable support 150, thereby exposing the adhesive surface and the sleeve.

[0122] The backing of the adhesive component 180 can be attached to the removable support 150 such that once the dispensing unit 130 is lifted away from the removable support 150, the backing automatically peels off, exposing the adhesive surface 182, and the delivery device 100 is ready for wear. The removable support 150 may have structural features for holding it in place during removal. The user's fingers grasp the drive unit 120 on the side, so the removable support 150 may have gripping features that allow it to be pulled open.

[0123] Delivery device 100 Figure 5G The device is shown to be placed on the user's body 105, wherein the cannula 131 pierces and penetrates through the skin until the adhesive is firmly secured to the skin surface. Manual insertion of the cannula 131 is described herein; however, an automatic or semi-automatic applicator can be used to hold and apply the delivery device 100 to assist in applying the force required to pierce and penetrate the skin. After wearing, the delivery device 100 is removed from the user's body, and the drive unit 120 is manually released from the dispensing unit 130 and discarded. The drive unit 120 is recharged for the next use.

[0124] Figure 6 This is a flowchart 200 illustrating a series of steps of an example embodiment of a method using delivery device component 110.

[0125] The method may provide a wearable dispensing unit 130 201 within a surrounding package 170. At least a portion of the surrounding package 170 may provide support for the wearable dispensing unit 130 during filling. The method may provide a wearable dispensing unit 130 201 attached to a removable support 150, the wearable dispensing unit 130 and the removable support 150 together providing a 202 engagement 140 for filling the reservoir 134 of the dispensing unit 130 via a sleeve 131 of the dispensing unit 120, the sleeve 131 also for delivering medication to the user.

[0126] The method can position the drug filling device 203 in a junction 140 provided on the delivery side 133 of the wearable dispensing unit 130, at least partially surrounding the sleeve 131, such that the sleeve 131 is inserted into the drug filling device.

[0127] This method involves filling the wearable dispensing unit 130 204 through the tip 132 of the sleeve 131 by inserting the tip 132 into the diaphragm of the drug filling device. The sleeve 131 is in fluid communication with the reservoir 134 within the dispensing unit 130. The sleeve 131 is the same sleeve 131 used to deliver drug fluid from the reservoir 134 via the tip 132 of the sleeve 131 during use of the dispensing unit 130. Filling with the same sleeve used for dispensing the drug reduces any air in the sleeve and the reservoir, thereby reducing the need for prefilling. By filling the reservoir 134 with the delivery sleeve 131, the drug from the drug filling device fills the sleeve 131 itself, thus minimizing or eliminating air retention inside the sleeve 131 after filling. This simultaneously utilizes the drug prefilling sleeve 131 by means of the filling process and during the filling process.

[0128] When the medication filling device is a medication pen, the method includes using a pen ejection function to dispense medication from the pen 205 into a reservoir 134 via a cannula tip 132. When the medication filling device is a bottle, the method includes dispensing medication from the bottle 206 by retracting the plunger 135 of the wearable dispensing unit 130 to draw medication from the bottle via a cannula 131 into the reservoir 134. The retraction of the plunger can be done manually via the plunger or automatically by attaching a drive unit 120 to the wearable dispensing unit 130, as further described below.

[0129] This method allows the drive unit 207 to be attached to the wearable dispensing unit 130 to provide the delivery device 100. This can automatically release the removable support from the wearable dispensing unit 208. The automatic release of the removable support from the wearable dispensing unit can be caused by engaging the drive unit with the attachment arrangement structure that attaches the removable support to the wearable dispensing unit.

[0130] This method exposes the skin adhesive surface on the delivery side of the wearable dispensing unit 209 and the tip of the cannula. Releasing the removable support from the wearable dispensing unit exposes the skin adhesive surface. The method provides a delivery device 100 that is ready to be applied to a user's body, uses the adhesive surface to attach to the user's skin, and includes inserting the tip of the cannula into the user's skin.

[0131] Figure 7This is an exploded perspective view of another example embodiment of the delivery device assembly 301, which includes a joint 340 adapted for filling from a bottle. The delivery device assembly 301 may include a drive unit 320, a dispensing unit 330, an adhesive member 380, and a removable support member 350. The dispensing unit 330 and the removable support member 350 may together form the joint 340, which is sized to receive the top of the bottle such that the tip 332 of the sleeve 331 of the dispensing unit 330 is positioned to pierce the diaphragm of the bottle for retrieving the medication stored in the bottle.

[0132] The bottle can be a standard 10 ml bottle, such as those used for filling pumps or syringes. The bottle may have a rubber diaphragm at the top for piercing with a needle, or in this case, with the tip of a cannula. To accommodate the bottle rather than deliver the pen, a larger diameter opening in the engagement 340 is required, and the height and needle length are adjusted accordingly. Due to the different requirements for the needle length inserted into the bottle, the engagement 340 may be provided only on the removable support 350 in the form of an opening 345 and a surrounding collar 344, without a recess in the dispensing unit 330. In other embodiments, the recess 342 in the dispensing unit 330 may be provided around the cannula 331, eliminating the need for the removable support 350. Conversely, the recess 342 may not be provided in the dispensing unit 330.

[0133] Unlike a pen, a bottle does not have a dispensing mechanism; therefore, the plunger 335 of the dispensing unit 330 must withdraw the medication from the bottle. Typically, to maintain pressure within the bottle, the syringe plunger is first retracted to fill the syringe with air, and then a needle punctures the diaphragm of the bottle. The syringe plunger is advanced to dispense air into the bottle, thereby pressurizing the bottle, and then the syringe plunger retracts to withdraw the liquid. Optionally, the syringe plunger can be partially depressurized and retracted again to purge any remaining air from the syringe and into the bottle. This is the standard method for using bottles.

[0134] Two example methods are described for using a bottle as a filling device for dispensing unit 330. (Refer to...) Figures 8A to 8D Describe the first method, and refer to Figure 9A and Figure 9B Describe the second method.

[0135] Figures 8A to 8D These are a series of perspective views of an example embodiment of the delivery device component 410 filled from bottle 401.

[0136] In this example embodiment, the user manually actuates the plunger 435 of the dispensing unit 430 forward and backward. The plunger 435 may be manufactured large enough to be manipulated by hand by having an extension member 436. The extension member 436 may serve as a handle for operating the plunger 435 to fill the reservoir 434. The extension member 436 may be removed by breaking, releasing, loosening, or otherwise disassembling and discarding before the drive unit is attached to the dispensing unit 430.

[0137] Figure 8A and Figure 8B The illustration shows bottle 401 being inserted into joint 440 with extension member 436 and plunger 435 being pulled back. Figure 8C The diagram shows the extension member 436 and plunger 435 being pushed forward to expel air, and then the extension member 436 and plunger 435 being pulled backward to fill the reservoir 434 with the drug. Figure 8D It is shown that extension member 436 has been removed.

[0138] Figure 9A and Figure 9B Another example embodiment of the delivery device component 510 for filling from bottle 501 is shown. In this embodiment, drive unit 520 is used to operate plunger 535 to draw medication from bottle 501. Figure 9A A bottle 501 is shown inserted into the joint 540 of the removable support 550 and the dispensing unit 530, wherein the drive unit 520 is attached to the dispensing unit 530. The drive unit 520 can be attached to the dispensing unit 530 before the bottle 501 is inserted into the joint 540. In this embodiment, the removable support 550 does not automatically release when the drive unit 520 is attached to the dispensing unit 530.

[0139] Figure 9B A detailed view of the interior of the distribution unit 520 is shown, in which the reservoir 534 and plunger 535 are shown. Figure 9B The view also includes a plunger actuating member 536 of the drive unit 520 for retracting the plunger 535 to draw medication from the bottle 501. The plunger 535 includes a recess 537 for receiving the plunger actuating member 536 to allow the plunger actuating member 536 to operate the plunger 535 in both directions to retract the plunger 535 when filling the reservoir 534 through the cannula and to push the plunger 535 when delivering medication to the user through the cannula.

[0140] A user can attach the drive unit 520 and then mount the bottle 501 in the engagement 540. The drive unit 530 may have a controller that can control the plunger 535 to slide forward and backward to complete the filling of the reservoir 534 through the sleeve. The user can then wait until filling is complete, for example by monitoring the movement of the plunger 535, observing an indicator, or waiting for notifications in the associated application provided to the delivery device, before removing the removable support 550 from the delivery device and wearing the device.

[0141] exist Figure 9A and Figure 9B In this implementation, the following operations may be performed: The plunger 535 may be fully retracted during transport or after user preparation. The drive unit 520 may be snapped onto the dispensing unit 530 by the user. The bottle 501 may be mounted into the engagement 540 of the delivery device component 510, wherein the sleeve pierces the diaphragm of the bottle 501. The controller of the drive unit 520 may perform a return process to seat the plunger operating member 536 into the recess 537 of the plunger 535. The controller may fully advance the plunger 535, thereby expelling air from the reservoir 534 into the bottle 501. The controller may then retract the plunger 535 (partially or fully) to allow medication to be drawn from the bottle 501 into the reservoir 534. Optionally, the controller may again partially advance the plunger 535 to expel any remaining air bubbles. Optionally, the controller may again retract the plunger 535 to the final desired filling volume of the reservoir 534. The user may receive an indication that filling and prefilling are complete. The indication could be a stop movement, an indicator light, an application notification, etc. The user can then remove bottle 501 from the joint 540. The user can remove the removable support 550 to prepare the delivery device 500 for attachment to the user's skin and insertion of the cannula into the skin.

[0142] The controller may have a programming sequence that controls the plunger movement when the drive unit 520 is first attached to the dispensing unit 530 and then an indication is provided that the bottle 501 has been inserted into the engagement 540.

[0143] exist Figures 4A to 4E The first attachment arrangement 160 for attaching the removable support 150 to the dispensing unit 130 and for detaching the removable support 150 from the dispensing unit 130 is shown and described. Referring now to... Figure 10A , Figure 10B , Figure 11 , Figure 12A , Figure 12B and Figure 13 Describe alternative attachment arrangements. Any attachment arrangement in the attachment arrangement can be used with pen filler joint 140 or bottle filler joints 340, 440, 540.

[0144] Figure 10A and Figure 10B These are top and bottom perspective views of an example embodiment of the delivery device component 610 including the second attachment arrangement 660. In this arrangement, the attachment arrangement 660 may include manual levers 661, 662 for holding the dispensing unit 630. The manual levers 661, 662 include clamping portions 663, 664 that clamp the dispensing unit 630 and the removable support 650, wherein the levers 661, 662 extend on the removable support side. When the drive unit is mounted on the dispensing unit 620, the user can manually squeeze the manual levers 661, 662 to remove the clamping portions 663, 664 and release the dispensing unit 630 from the removable support 650.

[0145] Figure 11 This is a top perspective view of another embodiment of the delivery device component 710 including the third attachment arrangement structure 760. In this embodiment, similar clamping portions 763, 764 are arranged to clamp onto the opposite edges of the dispensing unit 730 and the removable support 750. In this embodiment, there is no lever for manual release, and when the drive unit is installed, the drive unit is pulled upward away from the removable support 750 to overcome the locking force of the clamping portions 763, 764.

[0146] Figure 12A and Figure 12B These are top and bottom perspective views of another embodiment of the delivery device component 810 including the fourth attachment arrangement 860. The attachment arrangement 860 includes similar clamping portions 863, 864 configured to clamp onto the opposing edges of the dispensing unit 820 and the removable support 840. In this embodiment, the clamping portions 863, 864 have ramps 865, 866 facing upwards relative to the dispensing unit 830, such that the drive unit 820 mounted on the dispensing unit 830 will press outwards against the ramps 865, 866, thereby releasing the clamping portions 863, 864. The clamping portions 863, 864 can remain attached to the removable support 850 released from the dispensing unit 830. In this way, the attachment arrangement 860 automatically disengages upon installation of the drive unit, but this is unrelated to the filling engagement as in the first attachment arrangement 160.

[0147] Figure 13This is a top perspective view of another embodiment of the delivery device component 910, including a fifth attachment arrangement structure 960 for attaching the dispensing unit 930 to the removable support 950. In this embodiment, instead of a latch, adhesive patches 961, 962 are provided on the corresponding facing surfaces of the dispensing unit 930 and the removable support 950. The adhesive patches 961, 962 may have sufficient fixation to allow for transport and handling, but this can then be overcome by the user pulling upwards on the attached drive unit.

[0148] Figure 14 This is a perspective lower view of an example embodiment of the delivery device 100, showing the adhesive arrangement of the adhesive member 180. This prepares the cannula 131 to be manually inserted into the user's skin to the desired depth before the adhesive surface 182 fully contacts the skin surface. The "skirt" 195 is an area of ​​the adhesive material that is not attached to the delivery device and is flexibly adhered to the skin to provide a stronger attachment. The skirt 195 may be located within the coverage area of ​​the delivery device or may extend beyond the coverage area of ​​the delivery device.

[0149] The described delivery device 100 includes skirt protrusions 186, 187 extending at opposite ends of the delivery device 100. For a delivery device 100 intended for wear for less than 24 hours, the skirt does not need to be as robust as other long-term devices because it is exposed to fewer environmental factors (e.g., less physical activity, contact movement, and constant pushing throughout the day) and requires a shorter duration of adhesion. This means that the adhesive strength can be lower, and minor peeling at the edges is acceptable. The surface area of ​​the adhesive surface 182 can be reduced proportionally to the wear time of the delivery device 100, for example, less than 24 hours, 12 hours, or 8 hours. An "hourglass" skirt shape, having skirt protrusions wider than the middle portion of the delivery device 100, can also be used.

[0150] The skin adhesive surface 182 can be configured such that it does not extend beyond the coverage area of ​​the delivery device 100 on the opposite sides 184, 185, thereby providing space for the thumb and fingers to grasp the delivery device 100 without having to pinch the adhesive material above with the fingertips, and eliminating the possibility of accidentally folding the sides of the adhesive material down onto itself.

[0151] In an alternative embodiment, the opposite sides 184, 185 may extend to match the coverage area of ​​the delivery device 100, or may extend slightly beyond the coverage area of ​​the delivery device 100 (e.g., 1 mm or less). The opposite sides 184, 185 of the skin adhesive member 180 will still not affect the user's fingers and thumb gripping the sides of the delivery device 100. This maximizes the adhesive area to the skin and prevents the plastic portion of the delivery device 100 from directly contacting the skin during wear.

[0152] A skirt may be present on the side, but this skirt is completely recessed below the delivery device 100 in the gripping area. If the wearable delivery device adheres to the patch up to its edge, it will easily pull the patch off the skin because the patch adhesion is weak in tension. Instead, the delivery device 100 pulls the patch inward from the edge, creating a shear zone that is strong because the adhesive patch is very strong in shear.

[0153] Holding the exposed skirt protrusions 186 and 187 at the front and rear of the delivery device 100 maximizes overall adhesion to the skin. The exposed skirt protrusions 186 and 187 compensate for the recessed side portions of the adhesive in the gripping area. Since the long axis of the delivery device 100 is most likely to detach from the circular contours of the human body, the exposed skirt protrusions 186 and 187 secure the front and rear, protecting the most easily detachable areas of the wearable device. Furthermore, by extending the adhesive material within the exposed skirt protrusions 186 and 187, this provides users who require this additional adhesion with areas that can be held with the auxiliary adhesive, rather than having the entire delivery device adhered. Additionally, rubbing the adhesive patch against the skin is the optimal way to promote adhesion of the pressure-sensitive adhesive. The delivery device 100 is pressed down onto the adhesive patch beneath it, but the exposed areas of the skirt protrusions 186 and 187 can be manually rubbed against the skin by the user for maximum adhesion in these most critical areas.

[0154] Maximizing the adhesion strength along the long axis of the delivery device 100 helps ensure that the delivery device remains attached, and the entire adhesion perimeter is not required to maintain attachment. Even in the event of weak adhesion on the sides of the delivery device 100, the delivery device can still remain firmly attached as long as the front and rear are secure.

[0155] For shorter durations of wear of the delivery device, it is important that removal is easy, non-invasive, and causes minimal skin irritation and user annoyance. A small lip 188, a non-adhesive area, can be provided at the end of one of the exposed skirt protrusions 186, 187 to serve as a peeling protrusion for the user during removal. This keeps the accessible area of ​​the patch exposed outside the coverage area of ​​the wearable device, thus providing an easy-to-remove protrusion.

[0156] Figure 15A , Figure 15B and Figure 15C An example embodiment of the delivery device component 290 is shown, illustrating another example of an adhesive arrangement structure that can be used with any of the embodiments described or with other forms of wearable drug delivery devices. Figure 15A An exploded perspective view of a delivery device component 290 is shown, which includes an example embodiment of a dispensing unit 130 as previously described, an adhesive arrangement structure 280, and a removable support 250.

[0157] The adhesive arrangement structure 280 may include a skin adhesive member 281 attached to the delivery side of the dispensing unit 130 and having a skin adhesive surface 282 for attachment to a user's skin. The skin adhesive surface 282 is configured to be exposed when the removable support 250 is removed. The skin adhesive member 281 includes a skirt portion 295 that is flexible relative to the wearable dispensing unit 130 to provide flexible attachment to the user's skin.

[0158] A device adhesive layer 284, in the form of a region of double-sided pressure-sensitive adhesive (PSA) material, may be provided. This device adhesive layer 284 is adhered to a skin adhesive member 281 on a surface facing the dispensing unit 130, wherein the other side of the PSA portion is configured for adhesion to the dispensing unit 130 during device manufacturing. In this embodiment, the PSA portion has a width 285 and a length 286, wherein at least the width 285 is smaller than the width of the dispensing unit 130. In this way, the PSA portion 284 is located within the coverage area 139 of the dispensing unit 130. The reduced width 285 of the PSA portion allows the side portion of the adhesive surface 282 to form a skirt portion, which is flexible for adhesion to the user's skin while being protected beneath the dispensing unit 130. The area of ​​the skin adhesive member 281 surrounding the PSA portion forms a skirt with an upper surface that provides flexibility for attachment to the user's skin, and this upper surface has a protective surface for exposure during use. (See below for further details.) Figure 16A Alternative implementations of the PSA portion are described, wherein some PSA portions may extend into the skirt region.

[0159] The adhesive component 281 (and therefore the skirt) may be entirely within the coverage area 139 of the dispensing unit 130, or it may have one or more portions extending beyond the coverage area 139. For example, one or more end portions of the skin adhesive component 281 may extend from the coverage area 139 of the dispensing device, while side portions remain within the coverage area. The adhesive component 281 may have a lip 288 that provides a non-adhesive area at one end of the adhesive surface 282 to facilitate removal of the adhesive component 281 from the user's skin at the end of use.

[0160] The adhesive arrangement structure 280 of this embodiment may include a backing layer 270 configured to cover the adhesive surface 282 before being adhered to the user's skin. The backing layer 270 may have at least one attachment portion for attachment to the removable support 250 and is configured such that removal of the wearable dispensing unit 130 from the removable support 250 causes the backing layer 270 to peel off from the adhesive surface 281.

[0161] The dispensing unit 130 has a retaining sleeve protruding from the reservoir through the adhesive arrangement structure 280, which could pose a needle prick hazard if the user must manually reach underneath to peel off the adhesive backing layer 270. Therefore, the backing layer 270 is attached to the removable support 250 such that when the user lifts the dispensing unit 130 from the removable support 250 (e.g., when...),... Figure 15B , Figure 15C and Figure 15D As shown in the diagram, when the sleeve previously protected by the removable support 250 is exposed, the backing layer 270 automatically peels off without the user needing to place their fingers near the sleeve. This also reduces the overall processing complexity and the number of steps the user needs to perform.

[0162] exist Figures 15A to 15C In the illustrated embodiment, the backing layer 270 is a butterfly-shaped liner formed by two portions 272, 273, each portion including adhesive covering portions 274, 275 and attachment portions 276, 277, wherein the attachment portions 276, 277 are folded back over the adhesive covering portions 274, 275 and extend from the central region 283 of the adhesive surface 282. In one embodiment, each of the two portions 272, 273 of the butterfly liner can be folded back over itself such that the attachment portions 276, 277 are substantially the same size as the adhesive covering portions 274, 275. The two portions 272, 273 can overlap 278 at a line at the central region 283, and the folded portions 272, 273 can be adapted to overlap by angled folds.

[0163] exist Figure 15DIn the illustrated embodiment, the two portions 272A and 273A have different arrangements of attachment portions 276A and 277A, wherein one attachment portion 277A is folded back and the other attachment portion 276A is a flat extension. In other embodiments, the backing layer may be a single piece having attachment portions attached to a removable support. In one embodiment, a single liner in the form of a single butterfly wing may be present, having an adhesive cover portion covering the entire surface of the skin adhesive and attachment portions folded back over the adhesive cover portion.

[0164] Figures 15A to 15D The removable support 250 of one embodiment includes at least one lining anchoring member 251, 252 projecting from one or each end of the device-facing surface 253 of the removable support 250. The anchoring members 251, 252 may be hook or barb-shaped. The lining anchoring members 251, 252 are configured to engage with attachment portions 276, 277 of the backing layer. Figures 15A to 15C In one embodiment, a pair of anchoring members 251, 252 are present at each end portion of the removable support 250. In an alternative embodiment, the backing layer is a single component with folded extensions, which may provide a single anchoring member or a pair of anchoring members. Figure 15D In this embodiment, only one set of anchoring members 252A is required, and two attachment portions 276A and 277A are attached to the set of anchoring members 252A. The two attachment portions 276A and 277A are anchored to the removable support 250 at one or more anchoring members 252A.

[0165] The device-facing surface 253 of the removable support 250 may have one or more recessed areas 254 for accommodating the lining anchoring members 251, 252. Figures 15A to 15C In one embodiment, a recessed region 254 is provided at each end of the removable support 250, wherein the recessed region 254 has an inclined portion 256 that slopes at an angle from a central portion 257 toward a flat end portion 255 to form a bridge shape. The bridge shape provides the central portion 257 to abut against the dispensing unit 130 when the removable support 250 is attached, while providing space between the adhesive member 281 and the flat end portions 255 of the support anchoring members 251, 252, thereby allowing the attachment portions 276, 277 of the backing 270 to remain away from the adhesive covering portions 274, 275. Figure 15D The image shows two recesses 254; however, the anchoring member 251 and the associated recesses 254 can be replaced by an extension of the flat central portion 257 of the removable support member 250.

[0166] The attachment portions 276, 277, 276A, and 277A include at least one slit 266, 267 configured for attachment to anchoring members 251, 252. For ease of manufacture, the slits 266, 267 may be formed through all layers of the adhesive arrangement structure 280, including the skin adhesive member 280 and the backing 270. The slits 266, 267 may be aligned with the removal direction of the backing layer and / or with the direction in which the user peels the skin adhesive member 281 from their skin, such that the slits do not expand. In this example, the removal direction of the backing layer is the same as the direction of removal from the skin; however, this is not required. Slits 266, 267 are used because they remain closed within the skin adhesive member 281 and do not expand.

[0167] One limitation of patch die-cutting is that the same cutting pattern must penetrate all material layers; otherwise, a more expensive and specialized process is required. Therefore, thin slits 266 and 267 are cut through all layers at each end. The material can be sliced ​​using the die without material removal, thus minimizing any impact on the adhesion and aesthetics of the skin adhesive layer.

[0168] The butterfly-shaped folds of the extensions 276 and 277 of the backing layer 270 are pressed onto the anchoring members 251 and 252 of the removable support 250. Unlike circular cutouts that must be hooked onto plastic or held in place by a secondary heat-riveting process, the elongated slits can expand to surround the sides of the anchoring members 251 and 252, but maintain a tight grip once pressed. This also eliminates the need for secondary processes (latituding material laterally onto the latch, gluing, heat riveting, etc.) and is achieved with a simple top-down assembly motion, ideal for efficient automated assembly.

[0169] Slits 266, 267 and anchoring members 251, 252 can be positioned below the coverage area of ​​the wearable delivery device 100, such that the skin adhesive member 281 does not necessarily extend beyond the coverage area.

[0170] Reference Figures 16A to 16H Other example implementations of the additional aspects are described. Figure 16AThe image shows an adhesive arrangement structure 1280, which includes a device adhesive layer 1284 attached to the device-facing surface of a skin adhesive member 1281 and a backing 1270 protecting the skin adhesive surface of the skin adhesive member 1281. The device adhesive layer 1284 is formed of a pressure-sensitive adhesive (PSA) material and, in this embodiment, extends to opposite side edges 1285, 1286 of the skin adhesive member 1281. The width of the adhesive arrangement structure 1280 may be equal to or less than the width of the wearable delivery device. The skin adhesive member 1281 has a skirt portion 1220 with opposite side skirts 1221, 1222 located within a coverage area, and the device adhesive layer 1284 extends across the side skirts 1221, 1222.

[0171] Figure 16B An example embodiment of a removable support 1250 is shown, configured to apply pressure to areas of the device adhesive layer 1284 other than the areas to which the device adhesive layer extends, such as the side skirts 1221 and 1222. This configuration includes flat planar regions 1253 on which pressure is applied, wherein the flat planar regions 1253 have cut-off sides 1254 and 1255 corresponding to the side skirts 1221 and 1222, such that no pressure is applied in these areas.

[0172] The device adhesive layer 1284 facing the device should not be left to adhere to the user's skin, clothing, bedding, etc., therefore the device adhesive layer 1284 will need to be covered by the dispensing unit 1230 during attachment. The skin adhesive component 1281 should be firmly pressed down against the user's skin in any location including these sides, therefore the dispensing unit 2130 can extend downward to press the skin adhesive component 1281 against the user's skin.

[0173] Figures 16C to 16H Different embodiments of the distribution unit 1230, including flanks 1231 and 1232, are shown. Figures 16C to 16H Each of these shows a lower side view and a top view of the dispensing unit 1230. The side wings 1231, 1232 can be configured not to be adhered to the device adhesive layer 1284 in the areas of the side skirts 1221, 1222. Figures 16C to 16E Side wings 1231 and 1232 can be configured to bend with the side skirt (). Figures 16F to 16H ).

[0174] exist Figure 15AIn the illustrated embodiment, the "island" of the double-sided PSA serves to accommodate the adhesive layer 284 and is positioned in the middle of the skin adhesive member 281 for adhesion to the dispensing unit 130. The island is used such that the adhesive layer 284 does not adhere to the outer edge of the dispensing unit 130 to provide an unattached skirt 195 for good adhesion to the user's skin, allowing the adhesive to pull the skin with shear rather than stretch, as adhesive adhesion is stronger in shear and weaker in stretch.

[0175] There are manufacturing costs involved in die-cutting PSA parts individually into island-shaped sections and including the process of accurately placing them onto the patch. Placement tolerances can also vary (e.g., + / - 0.75 mm), so the design must be robust to this misalignment relative to the patch and reservoir, especially in cases with very small skirts on the sides as described. Figure 16A The alternative embodiment shown provides a continuous strip of double-sided PSA along the center of the skin adhesive member 1281 as the device adhesive layer 1284. This arrangement eliminates the need for separate die-cutting and placement processes and avoids placement tolerances on the sides.

[0176] To form side skirts 1221, 1222 that adhere well to the skin, the dispensing unit 1230 has side wings 1231, 1232 that do not adhere or adhere poorly to these side skirts 1221, 1222 of the device adhesive layer 1284 in these areas on the lower side of the dispensing unit 1230. Alternatively, the side wings 1231, 1232 do adhere to the side skirts 12215, 1222 of the device adhesive layer 1284, but bend with the device adhesive layer 1284.

[0177] Figures 16C to 16E Three example embodiments of the dispensing units 1230A, 1230B, and 1230C with side wings 1231 and 1232 are shown, with the side wings 1231 and 1232 having different methods to prevent strong adhesion.

[0178] exist Figure 16CIn the design, side wings 1231A and 1232A have cutouts 1233 to minimize adhesion to the device adhesive layer 1284. In Figures 17D and 17E, side wings 1231B, 1232B, 1231C, and 1232C are textured, for example, with small dots (Figure 17E) or ribs (Figure 17D), so that the device adhesive layer 1284 does not adhere well or only adheres to a small portion of its surface area, making it easy to peel off these areas. Preferably, the ribs (Figure 17D) are not connected to the central region 1234, so that when the device adhesive layer 1284 is peeled off from the ribs, the device adhesive layer 1284 does not continue to peel off into the central region 1234 where adhesion is desired.

[0179] Figures 16F to 16G Three examples of embodiments of the dispensing units 1230D, 1230E, and 1230F with side wings 1231 and 1232 are shown. The side wings 1231 and 1232 are flexible, such that even while the side wings 1231 and 1232 remain attached to the device adhesive layer 1284 and thus to the skin adhesive member 1281, they can be easily bent and used as part of a skirt. This can be achieved by making the material very thin and / or having slits to minimize its rigidity. Figure 16F The side wings 1231D and 1232D with cutout 1241 are shown. Figure 16G The side wings 1231E and 1232E with multiple winglets 1242 are shown. Figure 16H The side wings 1231F and 1232F with a single winglet 1243 are shown.

[0180] Combination Figures 16A to 16H In this embodiment, during manufacturing, the device adhesive layer 1284 can be firmly pressed against the dispensing unit 1230 in the central region to promote adhesion, while the skirt regions will not be pressed against the dispensing unit 1230. The removable support 1250 can be configured such that it will not press against the dispensing unit 1230 in the skirt regions after manufacturing assembly and during storage. The device adhesive layer 1230 can be formed of a pressure-sensitive PSA (pressure-sensitive adhesive) material, and thus adhesion can be reduced by not applying pressure to these side skirt regions.

[0181] A removable support for a wearable drug delivery device can be provided for a drug delivery device that adheres to a user's skin. The drug delivery device can be as described herein, or it can be another form of skin adhesive device. The removable support can take the form of a protective base for the delivery device attached during encapsulation prior to use. The removable support may include a central planar region configured to correspond to a portion of the underside of the delivery device that corresponds to the area of ​​the device adhesive layer between the dispensing unit of the delivery device and the skin adhesive layer, wherein the planar member applies pressure to the device adhesive material during encapsulation. The removable support may include an adhesive protection removal arrangement configured to expose the skin adhesive surface of the skin adhesive layer of the delivery device when the delivery device is removed from the removable support. This can be done by simply removing the removable support to expose the skin adhesive surface or by removing the adhesive liner from the skin adhesive surface. The central planar region may not extend across the entire width of the delivery device so that it does not apply pressure to the skirt region of the skin adhesive member, which may also have adhesive on its device-facing side.

[0182] An adhesive arrangement structure can be provided for a drug delivery device that adheres to a user's skin. The drug delivery device may be as described herein, or it may be another form of skin adhesive device. The adhesive arrangement structure includes: a skin adhesive member configured to form a flexible skirt extending from a lower side of the delivery device and having a skin adhesive surface; a device adhesive layer disposed on an upper surface of the skin adhesive member and for attachment to the lower side of the delivery device; and a backing covering the skin adhesive surface and configured for removal when the delivery device is released from a removable support.

[0183] A method for manufacturing an adhesive arrangement structure for a drug delivery device may include the following steps: A skin adhesive component may be provided, and an original backing may be removed from the adhesive surface of the skin adhesive component. The backing may be attached to the adhesive surface of the skin adhesive component. A device adhesive layer having a width covering the skin adhesive component and a dimension smaller than the length of the skin adhesive component may be provided. The original backing may be removed from the device adhesive layer, and the device adhesive layer may be applied to the device-facing surface of the skin adhesive component. Once such a stack is formed, the stack may be cut to form a combined stack of the skin adhesive component, backing, and device adhesive layer. The device adhesive layer extending to the width of the skin adhesive component eliminates the need for separately die-cutting the device adhesive layer.

[0184] One or more anchoring openings can be cut through at least one end portion of the combined stack. The anchoring openings can be cut into slits aligned with the removal direction of the backing and / or the direction of removal from the user's skin after use, to prevent the slits from opening. Slits are only used in the backing, but forming slits through the combined stack improves manufacturing efficiency.

[0185] The manufacturing method may include applying an adhesive arrangement structure to a dispensing unit by removing a second original backing from the device adhesive layer and applying the applied device adhesive layer to the underside of the dispensing unit. The method may include applying pressure from a removable support member attached to the dispensing unit during manufacturing and used for encapsulation, such that the adhesive arrangement structure is sandwiched between the dispensing unit and the removable support member. The removable support member may apply pressure only to a central region of the device adhesive layer that does not extend over the skirt portion.

[0186] Figure 17A and Figure 17B This is a view of another embodiment of the removable support 2150. In this embodiment, an attachment arrangement 2160 is provided at the junction 2140 between the drug filling device and the dispensing unit, the attachment arrangement 2160 including at least one elastic portion 2171, 2172. In addition to the latches 2161, 2162 described previously, at least one elastic portion 2171, 2172 is also provided. In the illustrated embodiment, there are opposing elastic portions 2171, 2172 between the latches 2161, 2162. The two opposing elastic portions 2171, 2172 are bent as part of a receiving collar 2144 for receiving the drug filling device.

[0187] The elastic portions 2171 and 2172 are configured to press against and stabilize the drug filling device when it is inserted into the joint 2140. Opposite elastic portions 2171 and 2172 provide slight tactile feedback when the drug filling device is installed into the joint and maintain stability of the drug filling device during filling. The opposite elastic portions 2171 and 2172 at the joint can be configured together to grip the drug filling device, such that the removable support 2150 remains attached to the drug filling device along with the dispensing unit and can be detached from the package. This adaptability of the attachment arrangement can be combined with any of the aforementioned embodiments of the removable support.

[0188] Figure 17A and Figure 17B Other variations of the removable support 2150 are also shown, which include a receiving collar 2144 disposed on the side 2151 of the removable support 2150 facing the distribution unit to provide a smooth, outward-facing side 2152.

[0189] Figure 18A and Figure 18B Is Figure 18A The delivery device component 110 and the delivery device 100 are shown in the figure. Figure 18B The view shown only illustrates the gripping arrangement of the delivery device 100. The drive unit 120 may have opposing side portions 124, 126 with depths for gripping by a person's fingers and thumb. The detachable support 150 may have a similar gripping side portion 154.

[0190] The overall shape of the wearable delivery device 100 can be smooth and rounded to avoid snagging, especially in the front and rear sections of the long axis where the delivery device 100 may most easily detach from the curved body parts. The drive unit 120 can completely cover the top and sides of the delivery unit, thus providing a smooth outer surface. Opposite side portions 124, 126 of the drive unit 120 can have vertical or concave areas capable of achieving stable gripping. Other designs may include ridges, lips, textures, or other features to improve grip strength and stability. The concave areas may be located only in the center of the sides used for gripping and are smoothed and rounded at corners to avoid snagging points or uncomfortable sharp corners.

[0191] The width-to-height ratio is important for holding the delivery device 100 stably. The delivery device 100 has a dispensing unit 130 located below the drive unit 120, so that in order to maximize the gripping height of the external controller, the side of the drive unit 120 can extend downward to the level of the skin, thereby surrounding the dispensing unit 130 below the drive unit 120.

[0192] The detachable support 150 lifts the drive unit 120 away from the support surface, providing space for fingers to naturally grasp the drive unit 120 with the pads of their fingers rather than their fingertips, thus allowing for a more secure grip.

[0193] Figure 19 This is a cross-section of an embodiment of a delivery device component in any of the aforementioned embodiments, including the plunger sealing arrangement. The dispensing unit 130 includes a plunger 135 for movement within a reservoir 134, wherein the plunger 135 has an interference fit 137 with the inner surface of the reservoir 134, thereby eliminating the need for an elastomeric sealing member such as an O-ring. The interference fit 137 is achieved by one or both of the material of the edge of the plunger 135 and the material of the inner surface of the reservoir 134, the materials being slightly compliant so that the components can be assembled together in a liquid-tight fit and slide together. The material can be polypropylene or polyethylene.

[0194] Figures 20A to 20DAnother embodiment of a plunger 2135 and sealing arrangement for interacting with a reservoir 2134 of a dispensing unit 2130 is shown. In this embodiment, the plunger 2135 includes a full seal 2136 covering the entire front end of the plunger 2135. The full seal 2136 has the advantage that it is easier to press the seal onto the front of the plunger manually or automatically than to carefully stretch and position an O-ring within a groove. The full seal 2136 has a front elastomeric surface that conforms to the front 2139 of the reservoir 2134, thereby leaving less dead volume during emptying and minimizing air in the reservoir 2134 after filling. The full seal 2136 can be a curved conical shape.

[0195] The full seal 2136 also isolates the plunger 2135 from drug contact, allowing for greater material and colorant options for the plunger to optimize cost, performance, and visibility without requiring drug compatibility. The plunger can be a color that contrasts with the reservoir, and can be transparent, making plunger movement and fill level visually apparent to the user. Figure 20D A plunger 2135 is shown that does not have a full seal 2136 but has a protrusion 2139 for holding the seal 2136 in place.

[0196] The plunger 2135 may have a rounded rear face 2137 that is rounded about the longitudinal axis 2138 of the plunger 2135. The full seal 2136 fits tightly into the reservoir opening, but the rear face 2137 of the plunger 2135 may have some lateral clearance. When the rear face is flat, the rotation of the plunger affects the advancement of the seal, which creates inconsistent clearance during pre-filling. By rounding the rear face 2137 so that all points on the rear face are equidistant from the seal, the clearance associated with lateral displacement of the plunger is eliminated. The goal is to allow the user to wear the device without having to manually pre-fill the ground with fluid to compensate for the clearance; therefore, it is important to make the clearance as small and consistent as possible.

[0197] The foregoing description has been presented for illustrative purposes; it is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Those skilled in the art will understand that many modifications and variations are possible in light of the foregoing disclosure. In particular, features shown in one embodiment may be used in combination with one or more features of other embodiments.

[0198] The language used in this specification has been chosen primarily for readability and instruction purposes, and may not have been chosen to depict or limit the subject matter of the invention. Therefore, the scope of the invention is intended not to be limited by this detailed description, but rather by any of the claims published based on the application of this invention. Thus, the disclosure of embodiments of the invention is intended to be illustrative and not to limit the scope of the invention.

[0199] Finally, unless the context otherwise requires, throughout the specification and appended claims, the word “comprising” or variations such as “including” or “comprising” shall be understood to mean including the stated whole or group of wholes, but not excluding any other whole or group of wholes.

Claims

1. A component of a drug fluid delivery device, comprising: A wearable dispensing unit having a sleeve in fluid communication with a reservoir for delivering drug fluid from the reservoir via the tip of the sleeve during use of the dispensing unit; as well as A junction, which is disposed at least partially around the cannula on the delivery side of the wearable dispensing unit, and configured to receive an end portion of a drug filling device for filling the reservoir via the tip of the cannula.

2. The delivery device component of claim 1, comprising a removable support for the wearable dispensing unit, wherein at least a portion of the engagement is disposed on the removable support, and the portion of the engagement on the removable support provides a protective cap for the tip of the sleeve.

3. The delivery device component according to claim 2, wherein, The at least portion of the joint is a receiving collar surrounding an opening provided in the removable support.

4. The delivery device component according to claim 2 or claim 3, wherein, The joint is formed by a portion disposed on the detachable support and a recess surrounding the sleeve in the delivery side of the wearable dispensing unit.

5. The delivery device component according to claim 4, wherein, The depth of the recess is the difference between the first length of the sleeve required for filling and the second length of the sleeve required for insertion into the body.

6. The delivery device component according to any one of claims 2 to 5, comprising an attachment arrangement for securing the detachable support to the wearable dispensing unit, wherein, The attachment arrangement is disposed at the joint and configured to have a latch, the end portion of the drug filling device preventing the latch from being released when inserted into the joint.

7. The delivery device component according to claim 6, wherein, The attachment arrangement is configured to automatically release itself through interaction with the drive unit when the drive unit is attached to the wearable distribution unit.

8. The delivery device component according to any one of claims 2 to 7, wherein, The detachable support includes an engagement protrusion for engaging with the plunger of the wearable dispensing unit to provide restriction of movement of the plunger.

9. A delivery device component according to any one of claims 2 to 8, comprising an adhesive arrangement structure including a skin adhesive member disposed on the delivery side of the wearable dispensing unit, the skin adhesive member providing a skin adhesive surface configured to be exposed when the removable support is removed.

10. The delivery device component according to claim 9, wherein, The skin adhesive component is located within the coverage area of ​​the delivery side of the wearable dispensing unit on two opposite sides, and extends beyond the coverage area at one or both opposite ends.

11. The delivery device component according to claim 9 or claim 10, wherein, The skin adhesive component includes a backing layer configured to cover the skin adhesive surface and having at least one attachment portion for attachment to the removable support, and configured such that removal of the wearable dispensing unit from the removable support causes the backing layer to peel off from the skin adhesive surface.

12. The delivery device component according to claim 11, wherein, The backing layer is a butterfly-shaped lining formed by two parts, each part including an adhesive covering part and an attachment part, wherein one or both of the attachment parts are folded back onto the adhesive covering part.

13. The delivery device component according to claim 11 or claim 12, wherein, The removable support includes a lining anchoring member extending from the device-facing surface of the removable support, the lining anchoring member being configured to engage the attachment portion of the backing layer, and wherein the device-facing surface of the removable support has a recessed area for receiving the lining anchoring member.

14. The delivery device component according to claim 12 or claim 13, wherein, The attachment portion includes at least one slit configured for attachment to the anchoring member, wherein the slit is aligned with the removal direction of the backing layer.

15. The delivery device component according to any one of claims 10 to 14, wherein, The adhesive arrangement includes a device adhesive layer attached to the device-facing surface of the skin adhesive member, wherein the device adhesive layer is formed of a pressure-sensitive adhesive material and extends to the opposite edge of the skin adhesive member.

16. The delivery device component according to claim 15, wherein, The skin adhesive component includes a skirt portion that is flexible relative to the wearable dispensing unit to provide flexible attachment to the user's skin, and the skirt portion has opposite side skirts located within the coverage area, and the device adhesive layer extends to the side skirts.

17. The delivery device component according to claim 16, wherein, The detachable support is configured to apply pressure to the area of ​​the device adhesive layer other than the area to which the device adhesive layer extends.

18. The delivery device component according to claim 16 or claim 17, wherein, The dispensing unit includes side wings configured not to adhere to the adhesive layer of the device in the area of ​​the side skirt.

19. The delivery device component according to claim 16 or claim 17, wherein, The distribution unit includes side wings configured to bend with the side skirt.

20. The delivery device component according to any one of claims 2 to 19, comprising a surrounding package of the wearable dispensing unit, wherein, At least a portion of the wraparound package is integrated with the removable support, and wherein a portion of the wraparound package provides a stable tray during filling of the wearable dispensing unit.

21. A drug fluid delivery device comprising a drug fluid delivery device component according to any one of claims 1 to 20 and a reusable drive unit for connection to the wearable dispensing unit for driving drug fluid from the reservoir through the cannula for delivery.

22. A method of using a drug fluid delivery device, comprising: A wearable dispensing unit is filled through the tip of a cannula, wherein the cannula is in fluid communication with a reservoir for delivering drug fluid from the reservoir via the tip of the cannula during use of the dispensing unit.

23. The method of claim 22, comprising: The drug filling device is positioned in a junction on the delivery side of the wearable dispensing unit, at least partially surrounding the cannula, such that the cannula is inserted into the drug filling device.

24. The method according to claim 22 or claim 23, wherein, The drug filling device is an insulin pen, and the method includes: The medication is dispensed from the insulin pen via the cannula into the reservoir.

25. The method according to claim 22 or claim 23, wherein, The drug filling device is a bottle, and the method includes: The plunger of the wearable dispensing unit is retracted to draw medication from the vial into the reservoir via the sleeve.

26. The method of claim 25, wherein, The plunger is retracted by automatically activating it by attaching the drive unit to the wearable delivery unit.

27. The method according to any one of claims 22 to 26, wherein, At least a portion of the joint is disposed on a detachable support for the wearable dispensing unit, the method comprising: The drive unit is attached to the wearable distribution unit, thereby automatically releasing the detachable support from the wearable distribution unit.

28. The method according to claim 27, wherein, The automatic release of the detachable support from the wearable distribution unit is caused by the engagement of the drive unit with the attachment arrangement structure that attaches the detachable support to the wearable distribution unit.

29. The method according to claim 27 or claim 28, wherein, Releasing the removable support from the wearable dispensing unit exposes the adhesive surface on the delivery side of the wearable dispensing unit and the tip of the sleeve.

30. The method according to any one of claims 22 to 29, comprising: The wearable dispensing unit is disposed within a surrounding package, at least a portion of which provides support for the wearable dispensing unit during filling.

Images