CN117693375A

CN117693375A - Injection support pad

Info

Publication number: CN117693375A
Application number: CN202280048123.5A
Authority: CN
Inventors: S·斯特凡诺夫; N·阿里; D·斯科特; R·G·德米罗泽
Original assignee: Astor Medical
Current assignee: Astor Medical
Priority date: 2021-07-14
Filing date: 2022-06-30
Publication date: 2024-03-12

Abstract

The present disclosure relates generally to drug delivery devices (110) such as auto-injectors, and in particular to pads (100, 200, 300, 400, 500, 600, 700) for attaching drug delivery devices such as auto-injectors to injection sites.

Description

Injection support pad

Technical Field

The present disclosure relates generally to drug delivery devices, such as auto-injectors, and in particular to a pad for attaching a drug delivery device, such as an auto-injector, to an injection site.

Background

Many medical conditions require injection. Currently, there are many different injection devices, including pen injectors of various types, auto injectors and on-body devices. While many of these devices have achieved significant improvements in the management of many medical conditions, there are still various limitations in the current art. Especially patients requiring frequent injections and patients requiring injections of particularly viscous drugs. In view of these problems, the applicant has appreciated that various developments can be made to help improve drug delivery devices on the market today, as will be explained in more detail below.

Disclosure of Invention

It is an object of the present disclosure to provide a pad that solves or at least alleviates the problems of the prior art.

According to a first aspect of the present disclosure, a pad is provided that extends along an axis from a proximal end to a distal end. The proximal end is the end of the pad adjacent the injection site when the pad is in use. The pad comprises an attachment portion configured to receive a drug delivery device and a support structure at a proximal end of the attachment portion, the support structure being configured to abut the drug delivery device in use and the drug delivery device being arranged in the attachment portion. The support structure is configured to be pushed away from the attachment portion by a force exerted by the cap extension of the drug delivery device when transitioning from the retracted position to the extended position, such that the cap extension is allowed to move to the extended position in response to removal of the pad from the injection site when the drug delivery device is present in the attachment portion.

Embodiments of the present disclosure provide advantageous pads that attach at the injection site when in use. The pad has an attachment portion which, in use, locks the drug delivery device in place until the user disengages the drug delivery device. Desirably, the medicament delivery member (e.g. needle) is not exposed if the user removes the pad from the injection site before the medicament delivery device is disengaged from the attachment portion. To address this issue, embodiments of the present disclosure provide a means for ensuring that the cover extension transitions to the extended position to protect the needle in the event that the pad is removed from the injection site prior to disengagement of the drug delivery device from the attachment portion.

In the present disclosure, when the term "distal direction" is used, this means pointing away from the dose delivery site during use of the drug delivery device. When the term "distal portion/end" is used, this refers to the portion/end of the delivery device or the portion/end of a component thereof, which is located furthest away from the dose delivery site when the drug delivery device is in use. Accordingly, when the term "proximal direction" is used, this refers to the direction pointing to the dose delivery site during use of the drug delivery device. When the term "proximal portion/end" is used, this refers to the portion/end of the delivery device or the portion/end of a member thereof, which is located closest to the dose delivery site when the drug delivery device is used.

Furthermore, the terms "longitudinal", "longitudinally", "axially" or "axial" refer to a direction extending from a proximal end to a distal end, typically along the device or component thereof in the longest direction of extension of the device and/or component.

Similarly, the terms "transverse", "transverse" and "transversely" refer to directions substantially perpendicular to the longitudinal direction.

Furthermore, the terms "circumferential", "circumferentially" refer to a circumferential or circumferential direction relative to an axis, typically a central axis extending in the longest direction of extension of the device and/or component. Similarly, "radial" or "radially" refers to a direction extending radially relative to an axis, and "rotating", "rotating" and "rotationally" refer to rotation relative to an axis.

The same directional terminology has been used to describe other components, such as a pad, e.g., the proximal end of the pad is the portion of the pad closest to the dose delivery site (injection site), and the distal end of the pad is the portion of the pad furthest from the dose delivery site. In the figures, the longitudinal direction is the direction of the axis 102, and the respective circumferential direction 31 and radial direction 32 with respect to the axis 102 are also shown.

When the expression "at the injection site" or "at the dose delivery site" is used in this application, it generally refers to the point where the drug delivery device (e.g. needle) enters the patient and surrounding areas, e.g. the area of the attachment pad.

According to one embodiment, the support structure may be located at the proximal end of the pad adjacent the injection site when the pad is in use.

According to one embodiment, the support structure may be configured to allow the cover extension to penetrate the attachment portion to exceed the plane of the proximal end of the pad. Thus, the support structure is advantageously configured such that when converted to the extended position, the cover extension pushes the support structure and penetrates the pad.

According to one embodiment, the support structure may comprise at least one flexible arm attached to the pad, the at least one flexible arm configured to bend by a force from the cover extension. The flexible arms may be resiliently flexible, i.e. bend back towards the original position after use. When the pad is attached with the drug delivery device in the attachment portion at the injection site, the flexible arm is held in its original position by a reaction force provided by the body surface of the user at the injection site. Once the pad is removed, the at least one flexible arm is advantageously pushed in a proximal direction by a force from the transition of the cover extension to the extended position. In case the pad is removed from the injection site before the drug delivery device is detached from the attachment portion, the at least one flexible arm provides a relatively simple but reliable way to ensure that the cover extension is switched to the extended position, thereby protecting the needle.

According to one embodiment, the support structure may comprise a proximal injection surface configured to be separated from the attachment portion by a force applied by the cap extension. The detachable support structure provides another advantageous configuration of the support structure. In one exemplary embodiment, the proximal injection surface may be hinged to the side structure of the pad. This provides for keeping the support structure connected to the pad after use and returning to its original position after use. The hinge may be, for example, a living hinge.

According to one embodiment, the proximal injection surface may comprise a clip configured to hold a support structure comprising the proximal injection surface in place prior to release by a force applied by the cap extension. This provides for ensuring that the proximal injection surface is in the correct position prior to use of the pad. Furthermore, the clip is advantageously configured to hold the proximal injection surface in place with a force adapted such that when the pad is removed from the injection site, the support structure is pushed by the cover extension against the force when the drug delivery device is attached in the attachment portion.

According to one embodiment, the proximal injection surface may be adjacent to the injection site when the pad is in use.

According to one embodiment, the proximal injection surface may extend across at least half of the area of the proximal end of the pad.

According to one embodiment, the support structure may comprise a set of clips configured to releasably lock the support structure to the attachment portion, wherein the set of clips is releasable by the cover extension upon insertion into the attachment portion. This is another advantageous construction of the support structure, which is provided with a clip locking the support structure to the attachment portion. Thus, the support structure may be released from the attachment portion. The clip is configured such that a force exerted on the clip by the housing of the drug delivery device when the housing of the drug delivery device is engaged in the attachment portion places the clip in a release position in which the support structure is releasable from the attachment portion.

In one example embodiment, the clip may include a flexible arm having a protrusion extending through a through hole of a wall of the attachment portion, wherein the protrusion is configured to be pushed out of the through hole by the cover extension, thereby releasing the support structure from the attachment portion. In one example embodiment, the flexible arms may be substantially parallel to the wall of the attachment portion.

According to one embodiment, the proximal injection surface may comprise an adhesive. An adhesive is used to attach the pad to the injection site.

According to a second aspect of the present disclosure, a pad is provided that extends along an axis from a proximal end to a distal end. The proximal end is the end of the pad adjacent the injection site when the pad is in use. The pad includes an attachment portion configured to releasably receive a drug delivery device. The attachment portion comprises a release mechanism that releases the drug delivery device from the pad when actuated, and a release arm configured to act on the release mechanism by transferring a force from the pad to the release mechanism caused by deformation of the pad when removed from the injection site when the pad is removed from the injection site.

This aspect provides similar advantages to those discussed above in relation to the first aspect.

According to one embodiment, the release arm may be attached to the pad surface at the distal end of the pad and extend to the distal surface of the release button of the release mechanism, wherein the release mechanism is actuated when the release arm acts on the distal surface of the release button. In one exemplary embodiment, the release arm is used to push the release button against a surface at the distal end of the pad, so the release arm pushes the release button in a proximal direction. The release arm may be hook-shaped to act on the distal surface of the release button. In one example, the release button may be attached to a surface at the distal end of the pad via a link arm.

According to one embodiment, the release arm may be attached to a removal tab of the pad, which is adapted to be pulled by a user to remove the pad from the injection site. Thus, when a user pulls on the removal tab for removing the pad from the injection site, the release arm is advantageously caused to actuate the release mechanism, thereby providing a timely transfer of the cover extension to the extended position.

According to one embodiment, a first end of the release arm may be attached to a proximal surface of a release button of the release mechanism and a second end of the release arm may be adapted to abut against a distal surface of the cushion, whereby when the cushion is removed from the injection site, the release arm flexes such that the second end moves in a direction towards the distal end of the cushion, whereby the release button is spatially shifted to cause actuation of the release mechanism.

According to one embodiment, the release arm may comprise a first arm part and a second arm part forming an acute angle therebetween, the first arm part comprising a first end and the second arm part comprising a second end, wherein the joint between the first arm part and the second arm part abuts against a stop edge of the pad to prevent the joint from moving towards the attachment part. Thereby, when the release arm is bent, the angle between the first arm portion and the second arm portion increases, thereby moving the release button away from the attachment portion, thereby actuating the release mechanism.

In one embodiment, the attachment portion may include a friction lock.

In general, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a/an/the element, device, component, means, etc" are to be interpreted openly as referring to at least one instance of the element, device, component, means, etc., unless explicitly stated otherwise.

Drawings

Specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of a pad and an auto-injector according to an embodiment of the present disclosure;

FIG. 2 is a side view of the pad and auto-injector of FIG. 1;

FIG. 3 is a perspective view of the pad of FIGS. 1 and 2;

FIG. 4 is a perspective view of the pad of FIGS. 1 and 2;

FIG. 5 is a perspective view of a pad and auto-injector with a cover extension in a retracted position according to an embodiment of the present disclosure;

FIG. 6 is a perspective view of the pad and auto-injector of FIG. 5 with the support structure pushed away from the attachment portion;

FIG. 7 is a perspective cut-away view of a pad according to an embodiment of the present disclosure;

FIG. 8A is a perspective cutaway view of a pad according to an embodiment of the present disclosure;

FIG. 8B is a perspective cross-sectional view of the pad of FIGS. 7 and 8A with the support structure pushed away from the attachment portion;

FIG. 9 is a perspective cut-away view of a pad according to an embodiment of the present disclosure;

FIG. 10 is a perspective cut-away view of the pad of FIG. 9;

FIG. 11 is a side view of the pad and auto-injector of FIG. 10;

FIG. 12 is a side view of the pad and auto-injector of FIG. 11 with the support structure pushed away from the attachment portion;

FIG. 13 is a perspective cross-sectional view of a portion of the pad and auto-injector of FIG. 12;

FIG. 14 is a distal perspective view of a pad according to an embodiment of the present disclosure;

FIG. 15 is a proximal perspective view of the pad of FIG. 14;

FIG. 16 is a perspective view of a pad according to an embodiment of the present disclosure;

FIG. 17 is a perspective cut-away view of the pad of FIG. 16;

fig. 18 is a side view of a pad according to an embodiment of the present disclosure.

FIG. 19 is a perspective view of a pad with strap according to an embodiment of the present disclosure, an

Fig. 20 and 21 illustrate a pad according to an embodiment of the present disclosure.

Fig. 22-25 illustrate a pad according to an embodiment of the present disclosure.

Detailed Description

The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. This inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided as examples so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like reference numerals refer to like elements throughout the specification.

Fig. 1 and 2 illustrate examples of a pad 100 according to embodiments of the present disclosure. Pad 100 extends along axis 102 from a proximal end 104 to a distal end 106. Proximal end 104 is the end of the pad adjacent the injection site when the pad is in use. The injection site is understood to be the site of drug delivery.

The pad 100 includes an attachment portion 108, the attachment portion 108 being configured to receive a drug delivery device 110, such as an auto injector or pen injector.

Drug delivery device 110 in fig. 1 and 2 extends from a proximal end 112 to a distal end 114 with respect to axis 102. Drug delivery device 110 includes housing 116, window 118, needle 120, and cover extension 122 configured to cover needle 120. The drug delivery device 110 further comprises an attachment portion 124, the attachment portion 124 being configured to engage with the attachment portion 108 of the pad 100.

The attachment portion 108 of the pad 100 is equipped with a locking mechanism 126 for releasably locking the drug delivery device 110 to the pad 100. The locking mechanism 126 may be configured in various ways, for example as a friction lock, wherein the movable arm 127 exerts a retaining force on the attachment portion 124 of the drug delivery device 110, or as a snap-fit lock, wherein a protrusion on the proximal end of the housing 116 of the drug delivery device 110 engages with a corresponding portion on the attachment portion 108 of the pad 100, thereby locking the drug delivery device 110 in place.

Further, the pad 100 optionally includes a release button 128, the release button 128 being configured such that actuation of the release button 128 releases the drug delivery device from the attachment portion 108.

Fig. 2 shows a drug delivery device 110 attached to a pad 100 at an attachment portion 108. A needle 120 extends from the proximal end 104 of the pad 100. In this state, the cover extension (sometimes referred to as a needle guard) is in a retracted position, exposing the needle 120. If the pad 100 is removed from the injection site with the drug delivery device 110 attached in the attachment portion 108, it is desirable that the needle 120 not remain in this exposed state.

To address the problem of exposed needles, the pad 100 is provided with a support structure that may be provided in a variety of configurations, which will now be described in more detail.

Turning now to fig. 3 and 4, two perspective views of the pad 100 are shown. The pad 100 includes a support structure 130 at the proximal end of the attachment portion 108. The support structure 130 is configured to rest against the drug delivery device in use, and the drug delivery device is arranged in the attachment portion 108. The support structure 130 provides a distal support surface in the attachment portion 108. The distal support surface faces in a distal direction and is located at the proximal end of the attachment portion 108.

Fig. 5 shows the pad 100 with the drug delivery device 110 attached to the pad 100 in the attachment portion 108, with the needle 120 extending outwardly at the proximal end 104 of the pad 100. In this state, the cover extension 122 is in the retracted position. Typically, the cap extension is biased toward its extended position protecting the needle 120, for example by a spring.

As shown in fig. 6, the support structure 130 is configured to be pushed away from the attachment portion 108 by a force exerted by the cover extension 122 of the drug delivery device 110 when transitioning from the retracted position to the extended position, such that the cover extension 122 is allowed to move to the extended position in response to removal of the pad 100 from the injection site when the drug delivery device 110 is present in the attachment portion 108.

When the pad is in use, the support structure 130 is located at the proximal end of the pad 100 adjacent the injection site. Further, the support structure 130 is configured to allow the cover extension 122 to penetrate the attachment portion 108 beyond the plane of the proximal end 104 of the pad 100. Thus, when the support structure 133 has been removed from the proximal end 104, the cover extension 122 reaches the proximal end of the pad 100.

In this embodiment, the support structure 130 is a plate-like structure that is generally parallel to the body 141 of the pad 100. The support structure 130 includes a proximal injection surface 132, the proximal injection surface 132 being configured to be separated from the attachment portion 108 by a force applied by the spring-biased cap extension 122. Proximal injection surface 132 is a surface that is attached to an injection site via, for example, an adhesive. Thus, when the pad is in use, the proximal injection surface 132 is adjacent to the injection site. Here, the proximal injection surface extends across substantially the entire proximal end 104 of the pad 100.

In this embodiment, a support structure 130 including a proximal injection surface 132 is hinged to a side structure 134 of the pad 100. Thus, the pad 100 includes a hinge 136 that connects the planar support structure 130 to the body of the pad 100.

On the opposite side of hinge 136, support structure 130, including proximal injection surface 132, includes a clip 138, clip 138 configured to hold proximal injection surface 132 in place prior to release of the force applied by cap extension 122. The clip 138 is disposed on the distal side of the support structure and is configured to lock into a receiving slot 139 of a body 141 of the pad 100.

When the support structure 130 is released at the clip-slot connection, the support structure 130 rotates about an axis 140 parallel to the main plane 143 of the body 141 of the pad 100, as best shown in fig. 3, such that the attachment portion 108 forms a through-hole through which the cover extension 122 may extend.

The reaction force holds the support structure 130 in place as long as the pad 100 is attached to the injection site. However, if the pad 100 is removed from the injection site with the drug delivery device 110 locked in the attachment portion 108, no reaction force is applied, whereby the force from the cap extension releases the clamp 138 and the support structure 130 swings open at the hinge 136. Thus, the cover extension 122 transitions to a retracted state in which the needle 120 is covered.

Fig. 7 and 8A-8B illustrate an embodiment of a pad 300 that shares similar components as pad 100, except that the hinge is a living hinge 302. Similar to the function of the pad 100, when the cap extension 122 pushes the distal support surface 133 at the proximal end of the attachment portion 108, the living hinge 302 swings open and the support structure 130 including the proximal injection surface 132 folds away from the attachment portion 108, as best shown in fig. 8B. The living hinge 302 provides a support structure 130 including a proximal injection surface 132 to rotate across an axis 140, as also discussed with respect to fig. 3.

As best seen in fig. 8A-B, the proximal end 104 includes a collapsible support structure 130 and an unfolded portion 150, the unfolded portion 150 ensuring that the proximal end 104 can lie flat on the injection site. The proximal injection surface 132 of the support structure 130 here extends across at least half of the area of the proximal end 104 of the pad 300.

Fig. 9-13 illustrate another embodiment of the present disclosure. The pad shares similar components as the pad 100 shown in fig. 1-8. For example, pad 200 extends along axis 102 from proximal end 104 to distal end 106. Proximal end 104 is the end of the pad adjacent the injection site when the pad is in use. The injection site is understood to be the site of drug delivery.

Pad 200 includes an attachment portion 108, with attachment portion 108 configured to receive a drug delivery device 110, such as an auto injector or pen injector. Possible ones of the drug delivery device 110 and the attachment portion 108 are described above and will not be repeated here.

Pad 200 includes a support structure 230 according to an embodiment of the present disclosure. When the pad 200 is in use, the support structure 230 is located at the proximal end 104 of the pad 200 adjacent the injection site.

The support structure 230 is configured to abut the drug delivery device 110 in use, and the drug delivery device 110 is arranged in the attachment portion 108. The support structure 230 provides a distal support surface 233 in the attachment portion 108. Distal support surface 233 is directed distally toward pad 200.

Turning to fig. 10, a cross-sectional view of the pad 200 is shown, the support structure 230 including a set of clips 235 configured to releasably lock the support structure 230 to the attachment portion 108. When inserted into the attachment portion, the clip 235 is actuated to a releasable state by the drug delivery device 110. The clip 235, when engaged with the attachment portion 108, holds the support structure 230 in place to provide a distal support surface 233 at the proximal end of the attachment portion 108.

When the drug delivery device 110 is engaged in the attachment portion 108, the proximal end 112 of the drug delivery device 110 acts on the clips 235 such that they disengage from the attachment portion 108, releasing the support structure 230. However, the support structure 230 remains in place as long as a reaction force is provided from the injection site.

Fig. 11 shows the pad 200 with the drug delivery device 110 in place in the attachment portion 108, with the needle extending outwardly at the proximal end 104. Thus, the cover extension of the drug delivery device 110 is in the retracted position. The support structure 230 is configured to be pushed away from the attachment portion 108 by a force exerted by the cover extension 122 of the drug delivery device 110 when transitioning from the retracted position to the extended position, as shown in fig. 12 and 13, such that the cover extension 122 is allowed to move to the extended position in response to removal of the pad 200 from the injection site when the drug delivery device 110 is present in the attachment portion 108.

Turning again to fig. 10, the clamps 235 each include a flexible arm 237, the flexible arms 237 having a projection 239 extending radially through the through hole 241 of the wall 243 of the attachment portion 108. The protrusion 239 is configured to be radially pushed out of the through hole 241 by the drug delivery device 110, thereby releasing the support structure 230 from the attachment portion 108. The flexible arms (only one numbered) are substantially parallel to the wall 243 of the attachment portion 108.

Fig. 13 is a perspective cross-section of the pad 200 when the cover extension 122 has pushed the released support structure 230 away from the attachment portion 108. In this position, the support structure 230 is configured to allow the cover extension 122 to penetrate the attachment portion 108 to exceed the plane of the proximal end 104 of the pad 200. The support structure 230 includes the proximal injection surface 132 and is configured to be separated from the attachment portion 108 by a force applied by the spring-biased cap extension 122. Proximal injection surface 132 is a surface that is attached to an injection site via, for example, an adhesive. Thus, when the pad is in use, the proximal injection surface 132 is adjacent to the injection site. Here, the proximal injection surface 132 extends only across a portion of the entire proximal end 104 of the pad 100.

In the initial state, as shown in fig. 11, the housing 116 pushes the projection 239, see fig. 10 or 13, so that the flexible arms 237 are elastically radially pushed out from the corresponding through holes 241. The projection includes an inclined surface 244, the inclined surface 244 being adapted for sliding the housing 116 against such that the projection 239 is forced radially outwardly from the engaged position in the through hole 241.

Fig. 14 and 15 illustrate a pad 400 according to another embodiment. The pad 400 includes similar components to the embodiments described with reference to the previous figures and is numbered identically and will not be repeated here. However, the pad 400 includes a support structure 430 that is different from the support structures of other embodiments. The support structure 430 is provided in the form of a flexible arm 431 attached to the pad 400. The flexible arm 431 provides a distal support surface 433 for the drug delivery device when engaged in the attachment portion 108. The flexible arm 431 is configured to be pushed away from the attachment portion 108 by a force exerted by a cover extension of the drug delivery device when transitioning from the retracted position to the extended position such that the cover extension is allowed to move to the extended position in response to removal of the pad 400 from the injection site when the drug delivery device is present in the attachment portion 108. In other words, the at least one flexible arm 431 is configured to bend by a force from the cover extension. The flexible arm 431 is configured such that when the pad 400 is removed from the injection site, the force from the spring-biased cap extension is sufficient to flex the flexible arm so that the cap extension can penetrate the attachment portion in the proximal direction beyond the plane of the proximal end of the pad 400.

In this particular embodiment shown in fig. 14 and 15, the flexible arms 431 each include a U-shaped structure 435 and a link arm 436, the link arm 436 connecting the U-shaped structure 435 with the attachment portion 108 at the proximal end 104.

Fig. 16-18 show pads 500 and 600 according to the second aspect. In this second aspect, the pads 500, 600 extend along the axis 102 from the proximal end 104 to the distal end 106. The proximal end 104 is the end of the pad 500, 600 adjacent the injection site when the pad 500, 600 is in use.

The pad 500, 600 includes an attachment portion 108, the attachment portion 108 being configured to releasably receive a drug delivery device. The attachment portion comprises a release mechanism 501, 601 which, when actuated, releases the drug delivery device from the pad 500, 600.

The pads 500, 600 include release arms 502, 602, respectively, the release arms 502, 602 being configured to act on the release mechanisms 501, 601 when the pads 500, 600 are removed from the injection site by transferring forces from the pads to the release mechanisms caused by deformation of the pads upon removal from the injection site.

The attachment portion 108 of the pad 500, 600 is provided with a locking mechanism 126 for releasably locking the drug delivery device 110 to the pad 100. The locking mechanism 126 comprises a movable arm 127 exerting a holding force on the attachment portion 124 of the drug delivery device 110, see e.g. fig. 2-3. This may be a friction lock.

Turning now to the pad 500 shown in fig. 16 and 17, wherein fig. 16 is a perspective view of the pad 500 and fig. 17 is a cross-sectional view of the pad 500.

In this embodiment, release arm 502 is attached to pad surface 504 at distal end 106 of pad 500. The release arm 502 extends distally of the release button 128 of the release mechanism 126 in a distal direction. The release arm 502 is attached to a removal tab 506 of the pad 500, the removal tab 506 being adapted to be pulled by a user to remove the pad 500 from the injection site. When the pad 500 is deformed by a user pulling on the tab 506, the release arm 502 acts on the distal surface 508 of the release button 128, causing the release mechanism 126 to be actuated.

In this embodiment, release button 128 is attached to a surface at distal end 106 of pad 500 via link arm 514.

In use, and when the user pulls the removal tab 506, the hook-shaped release arm 502 reaches the release button 128 and pushes the release button 128 in a proximal direction as indicated by arrow 510 toward the surface at the distal end 106 of the pad 500. The movable arm 127 is then pulled in a radial direction of the attachment portion 108 where the drug delivery device is arranged, see e.g. fig. 3, thereby reducing the force exerted by the movable arm 127 on the drug delivery device, thereby releasing the drug delivery device from the attachment portion 108.

Another pad similar to the pad in fig. 16 and 17 is shown in fig. 22-25. In this example, the release arm 502 is again used to actuate the release mechanism 126 in the same manner as described for the pad in fig. 16 and 17, but the release arm 502 acts on the lever 509 instead of directly on the release button 128. In particular, as shown in fig. 25, a lever 509 is attached to the release mechanism 126, including (optionally) to the release button 128. An optional ridge is provided on the distal surface of release button 128; this facilitates gripping. An optional ridge is provided on the proximal surface of the removal tab 506; this facilitates gripping. The ridge may alternatively be provided elsewhere, such as on the distal surface of the removal tab 506. An optional cover 511 is also visible; the cover 511 may protect the adhesive layer on the proximal end of the pad and is typically removed by the user prior to use of the pad.

Turning now to fig. 18, a pad 600 is shown. In this embodiment, the first end 604 of the release arm 602 is attached to a proximal surface 606 of the release button 128. The second end 608 of the release arm 602 is adapted to abut a distal surface 610 of the pad 600. In this manner, when the pad 600 is removed from the injection site, the release arm 602 flexes such that the second end 608 moves in a proximal direction toward the distal end 106 of the pad 600, which causes the release button 128 to spatially transfer to cause actuation of the release mechanism 601.

The release arm 602 is adapted to be flexible and biased and held in place in the proximal direction, i.e., when the pad 600 is attached to a user, the release mechanism 126 is actuated without the reaction force provided by the injection site. When the pad 600 is removed, the release arm 602 flexes open and causes a pulling action on the release button 128 in a radial direction, such that the movable arm 127 releases the drug delivery device from the attachment portion 108.

In this particular embodiment, the release arm 602 includes a first arm portion 611 and a second arm portion 612, with the first arm portion 611 and the second arm portion 612 forming an acute angle therebetween. The first arm portion 611 includes a first end 604 and the second arm portion 612 includes a second end 608. The joint between the first arm portion and the second arm portion abuts a stop edge 614 of the bolster 600 to prevent the joint from moving toward the attachment portion 108. As the release arm 602 flexes, the angle between the first arm portion 611 and the second arm portion 612 increases, whereby the second arm portion moves along the curved path indicated by arrow 620, thereby moving the release button 128 away from the attachment portion 108, thereby actuating the release mechanism 601. Thus, the bending motion of the release arm 601 is a relative motion between the first arm portion 611 and the second arm portion 612.

The release button 128 of the pad 600 is not attached to the pad distal surface 610 as is the case with the pad 500. The release button 128 of the pad 600 is connected only to the movable arm 127 and the release arm 602 that extend into the attachment portion 108. This advantageously enables an effective pulling action of the release button by the release arm 602 when the pad 602 is removed from the injection site.

Fig. 19 discloses a pad 700 configured to be attached to an injection site via a strap 702 instead of an adhesive. Strap 702 may be attached to pad 700 via attachment points 704, or strap 702 may be glued or co-molded directly with pad 700. Strap 702 may be adjusted with a locking clip. In a possible embodiment, velcro strips may be used to lock the pad 700 to the body.

Fig. 20 and 21 show another pad 800. The pad includes a proximal portion 811 and a distal portion 813. The proximal portion 811 includes a proximal injection surface 832, shown separately in fig. 20, and is located proximal of the proximal portion 811. As with other examples herein, proximal injection surface 832 is a surface that is attached to an injection site via, for example, an adhesive. Thus, when the pad is in use, proximal injection surface 832 is adjacent to the injection site. Proximal injection surface 832 may be an adhesive layer only at the proximal side of proximal portion 811 and may include a removable cap 833 that protects the adhesive layer prior to use. Optionally, proximal injection surface 832 includes an aperture 839; this may allow the needle to pass through the hole (rather than alternatively piercing the adhesive layer). Similarly, optional hole 841 in proximal injection surface 832 may allow a needle to pass through the hole (rather than alternatively piercing proximal injection surface 832).

Distal portion 813 includes an attachment portion 808. The attachment portion 808 may receive a drug delivery device, such as an auto-injector or pen injector, as shown in fig. 21 with an auto-injector. In fig. 21, a portion of an auto-injector can be seen, including a housing 116, a syringe 117 including a needle 120, a syringe carrier 119, a cap extension 122 (needle shield), and a cap extension spring 123 of the auto-injector.

Attachment portion 808 includes an optional tubular section 809. The tubular section may help align the drug delivery device during insertion of the pad 800.

The frusto-conical design of the pad (and the protruding placement of the button, in this example, the button includes optional ribs to improve the grip of the button 828) is designed such that when attempting to remove the drug delivery device and pad from the injection site after injection, the user will naturally grasp the button, releasing the distal portion 813 from the proximal portion 811, which can help ensure proper use of the device and pad even if the user does not follow the instructions strictly.

The proximal portion 811 is releasably attached to the distal portion 813. The distal portion 813 includes a release button 828, the release button 828 including a flexible arm including an outwardly extending hook 837 extending away from the axis from the flexible arm. The proximal portion 811 includes a corresponding recess 835 with an outwardly extending hook 837 extending into the recess 835 (see fig. 21). Two release buttons and two corresponding recesses are provided, but alternatively one release button and one corresponding recess may be provided.

The proximal portion 811 includes a support structure 830, in this example, the support structure 830 is a surface that extends perpendicular to the longitudinal axis; the support structure 830 is configured to abut against the drug delivery device when in use (when the drug delivery device is arranged in the attachment portion). This may hold the cover extension in the retracted position, as shown in fig. 21.

During use of the pad 800, the pad is typically first attached to the injection site. The drug delivery device will be inserted into the pad and typically activated by insertion into the pad (e.g. by retracting the cover extension to the position shown in fig. 21) and/or by e.g. a user pressing a button. The drug delivery device may be held in place (in the position shown in fig. 21) relative to the pad by, for example, a friction fit or a snap fit. This may allow the drug delivery device to remain in the position shown in fig. 21 (and thus in a position where injection may occur) without the user having to hold the drug delivery device in place at the injection site. Once the injection is completed, the user squeezes the two buttons 828 toward one another releasing the hooks 837 from the recesses 835, thereby separating the proximal portion 811 from the distal portion 813. Thus, distal portion 813 may be removed from the injection site with the drug delivery device, leaving proximal portion 811 attached to the injection site (the proximal portion may then be removed from the injection site). Separating proximal portion 811 from distal portion 813 allows cover extension 122 to extend from its retracted position (because proximal portion 811 no longer limits proximal movement of cover extension 122), thereby covering the needle. In this example, release of the hook 837 from the recess 835 will normally positively urge the distal portion 813 away from the proximal portion 811 due to the cap extension.

The pads disclosed herein may be made of a transparent material. Further, the side wall of the attachment portion may include an opening that forms a window proximate the base of the attachment portion adjacent the pad surface. Prior to use, the instructions may tell the patient to see if the cap extension is fully depressed while using the auto-injector. With the window and/or transparent material, the patient is able to check the status of the cover extension when using the auto injector in conjunction with the injection support pad.

The pads disclosed herein may include embedded electronics that include different units.

A sensor unit that can identify injection events such as insertion of the auto-injector into the attachment portion, start of injection, and end of injection.

A memory unit configured to store recorded data during an injection.

A connection unit configured to send the stored data directly to a smart device or the network.

And a processing unit configured to control the entire system and process the data before transmitting the data.

A user interface unit configured to provide feedback to the patient, such as status LEDs, tactile and/or audio feedback.

When an auto-injector is placed into the injection port, a sensor inside the support pad may be configured to recognize the event and provide feedback to the patient via a tactile/visual or audio element.

When the injection is completed, the sensor may be configured to identify the event and again provide feedback to the patient. Furthermore, the collected data is stored in the memory unit and may be transmitted to the smart device/network via the connection unit after the injection event is completed.

The sensor may be one or a combination of the following: mechanical switches, hall effect sensors, and accelerometers.

Mechanical switches, hall effect sensors, and/or accelerometers may be used to detect insertion of the auto-injector into the injection port.

An accelerometer may be used to detect an injection event.

Possible wireless communication methods include bluetooth and cellular networks.

Bluetooth connections typically require the smart device to transfer stored data to the network and often require a pairing action between the support pad and the smart device before the support pad can be used. However, bluetooth may provide a cheaper alternative and it generally requires less space on a PCB (printed circuit board).

The cellular network is used without any pairing procedure, it can be used as a plug-and-play device, and does not require pre-set-up. However, it may be more expensive and generally requires more space on the PCB.

Either (or both) of these techniques may be used, depending on the requirements of the product.

Such a processing unit may comprise a logic circuit or a control unit comprising a microprocessor, a microcontroller, a programmable digital signal processor and/or another programmable device. The processing circuits may also or alternatively each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the processing circuitry includes a programmable device such as the microprocessor, microcontroller, or programmable digital signal processor described above, the processor may also include computer executable code that controls the operation of the programmable device.

The inventive concept was described above mainly with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Some features are summarized in the following clauses.

1. A pad (100, 200, 300, 400) extending along an axis (102) from a proximal end (104) to a distal end (106), wherein the proximal end is an end of the pad adjacent an injection site when the pad is in use, the pad comprising:

An attachment portion (108), the attachment portion (108) being configured to receive a drug delivery device (110), an

A support structure (130, 230, 430) at the proximal end of the attachment portion, the support structure being configured to abut the drug delivery device in use, and the drug delivery device being arranged in the attachment portion,

the support structure is configured to be pushed away from the attachment portion by a force exerted by a cap extension (122) of the drug delivery device when transitioning from a retracted position to an extended position such that the cap extension is allowed to move to the extended position in response to the pad being removed from the injection site when the drug delivery device is present in the attachment portion.

2. The pad of claim 1, wherein the support structure is located at a proximal end of the pad adjacent the injection site when the pad is in use.

3. The pad of any one of claims 1 and 2, wherein the support structure is configured to allow the cover extension to penetrate the attachment portion to exceed a plane (143) of the proximal end of the pad.

4. The pad of any of the preceding claims, wherein the support structure comprises at least one flexible arm (237) attached to the pad, the at least one flexible arm configured to bend by a force from the cover extension.

5. The pad of any one of claims 1 and 2, wherein the support structure comprises a proximal injection surface (132) configured to be separated from the attachment portion by a force applied by the cap extension.

6. The pad of claim 5, wherein the proximal injection surface is hinged to a side structure (134) of the pad.

7. The pad of claim 6, wherein the hinge is a living hinge (302).

8. The pad of any of claims 6 and 7, wherein the proximal injection surface comprises a clip (138), the clip (138) configured to hold the proximal injection surface in place prior to release by a force applied by the cap extension.

9. The pad of any one of claims 5-8, wherein the proximal injection surface is adjacent to the injection site when the pad is in use.

10. The pad of any one of claims 5-9, wherein the proximal injection surface extends across at least half of the area of the proximal end of the pad.

11. The pad of claim 5, wherein the support structure comprises a set of clips (236) configured to releasably lock the support structure to the attachment portion, wherein the set of clips are releasable by the cover extension when the cover extension is inserted into the attachment portion.

12. The pad of claim 11, wherein the clip comprises a flexible arm (237), the flexible arm (237) having a protrusion (239) extending through a through hole (241) of a wall (243) of the attachment portion, wherein the protrusion is configured to be pushed out of the through hole by the cover extension, thereby releasing the support structure from the attachment portion.

13. The pad of claim 12, wherein the flexible arms are substantially parallel to a wall of the attachment portion.

14. The pad of any one of claims 5-13, wherein the proximal injection surface comprises an adhesive.

15. A pad (500, 600) extending along an axis from a proximal end to a distal end, wherein the proximal end is an end of the pad adjacent an injection site when the pad is in use, the pad comprising:

an attachment portion configured to releasably receive a drug delivery device, wherein the attachment portion comprises a release mechanism (501, 601) that releases the drug delivery device from the pad when actuated, and

a release arm (502, 602) configured to act on the release mechanism when the pad is removed from the injection site by transmitting a force from the pad to the release mechanism caused by deformation of the pad when removed from the injection site.

16. The pad of claim 15, wherein the release arm is attached to a pad surface (504) at a distal end of the pad and extends to a distal surface (508) of a release button (128) of the release mechanism, wherein the release mechanism is actuated when the release arm acts on the distal surface of the release button.

17. The pad of claim 16, wherein the release arm is to push the release button toward a surface of the distal end of the pad, or wherein the release arm is to push a lever of the release mechanism toward a surface of the distal end of the pad.

18. The pad of any of claims 16 and 17, wherein the release arm is hooked to act on a distal surface of the release button.

19. The pad of any of claims 16-18, wherein the release button is attached to the surface (504) at a distal end of the pad via a link arm (514).

20. The pad of any of claims 16-19, wherein the release arm is attached to a removal tab (506) of the pad, the removal tab (506) being adapted to be pulled by the user to remove the pad from the injection site.

21. The pad of claim 20, wherein the deformation of the pad upon removal from the injection site is a deformation of the removal tab (506).

22. The pad of claim 15, wherein a first end (602) of the release arm is attached to a proximal surface (606) of a release button of the release mechanism and a second end (608) of the release arm is adapted to abut against a distal surface (610) of the pad, whereby when the pad is removed from the injection site, the release arm flexes such that the second end moves in a direction towards the distal end of the pad, whereby the release button is spatially shifted to cause actuation of the release mechanism.

23. The pad of claim 22, wherein the release arm comprises a first arm portion (611) and a second arm portion (612) forming an acute angle therebetween, the first arm portion comprising the first end and the second arm portion comprising the second end, wherein a joint between the first arm portion and the second arm portion abuts a stop edge (614) of the pad to prevent movement of the joint toward the attachment portion, whereby, when the release arm is flexed, the angle between the first arm portion and the second arm portion increases to move the release button away from the attachment portion to actuate the release mechanism.

24. The pad of any of claims 16-23, wherein the attachment portion comprises a friction lock.

25. A pad (800) extending along an axis (102) from a proximal end (104) to a distal end (106), wherein the proximal end is an end of the pad adjacent an injection site when the pad is in use, the pad comprising:

a distal portion (813) comprising an attachment portion configured to receive a drug delivery device, and

a proximal portion (811) located at a proximal end of the distal portion, the proximal portion (811) being configured to abut against the drug delivery device in use, and the drug delivery device being arranged in the attachment portion,

the proximal portion (811) is configured to be removed from the distal portion (813) by movement of a button (828) of the distal portion (813).

26. The pad (800) of claim 25, wherein the button (828) comprises a flexible arm comprising an outwardly extending hook (837) extending from the flexible arm away from the axis, and wherein the proximal portion (813) comprises a recess (835), the hook (837) extending into the recess (835).

Claims

3. The pad of any of claims 1 and 2, wherein the support structure is configured to allow the cover extension to penetrate the attachment portion to exceed a plane (143) of the proximal end of the pad.

4. Pad according to any of the preceding claims, wherein the support structure comprises at least one flexible arm (237) attached to the pad, the at least one flexible arm being configured to bend by a force from the cover extension.

5. The pad of any one of claims 1 and 2, wherein the support structure comprises a proximal injection surface (132) configured to be separated from the attachment portion by a force applied by the cover extension.

7. The cushion of claim 6, wherein the hinge is a living hinge (302).

9. The pad of any one of claims 5 to 8, wherein the proximal injection surface is adjacent to the injection site when the pad is in use.

10. A pad (500, 600) extending along an axis from a proximal end to a distal end, wherein the proximal end is an end of the pad adjacent an injection site when the pad is in use, the pad comprising:

11. The pad of claim 10, wherein the release arm is attached to a pad surface (504) at the distal end of the pad and extends to a distal surface (508) of a release button (128) of the release mechanism, wherein the release mechanism is actuated when the release arm acts on the distal surface of the release button.

12. The pad of claim 11, wherein the release arm is to push the release button toward a surface of the distal end of the pad.

13. The pad of any of claims 11 and 12, wherein the release arm is hooked to act on a distal surface of the release button.

14. Pad according to any of claims 11-13, wherein the release button is attached to the surface (504) at the distal end of the pad via a link arm (514).

15. The pad of any of claims 11-14, wherein the release arm is attached to a removal tab (506) of the pad, the removal tab (506) being adapted to be pulled by the user to remove the pad from the injection site.