Cover structure for a drug delivery device
The cover structure for medication delivery devices addresses issues of unintentional needle exposure and user engagement by being axially movable with a locking mechanism, ensuring safe and effective medication delivery.
Patent Information
- Application Number
- JP2024524707
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-11-29
- Filing Date
- 2022-10-11
- Publication Date
- 2025-08-12
- Estimated Expiration
- 2042-10-11
AI Technical Summary
Current medication delivery devices face challenges with frequent injections, particularly for viscous medications, including unintentional exposure and damage to needles, and the need for user engagement to ensure proper delivery.
A cover structure for medication delivery devices that is axially movable between retracted and extended positions, featuring a locking mechanism with deflectable clips that require user interaction for activation, ensuring the needle is covered unless intentionally exposed.
The cover structure prevents unintentional needle exposure, forces user engagement for proper use, and ensures safe and effective medication delivery by maintaining the device in place during injection.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present disclosure relates generally to medication delivery devices, such as autoinjectors, and more particularly to a cover structure configured to surround a medication delivery member at the proximal end of the medication delivery device. [Background technology]
[0002] There are many medical conditions that require injections. Today, there are many different injection devices, including various types of pen injectors, autoinjectors, and on-body devices. While many of these devices have enabled significant improvements in the management of many medical conditions, various limitations of current technology still exist. Among these are the difficulties faced by patients who require frequent injections, and those who need to inject particularly viscous medications. In light of these issues, the applicant has recognized that various developments are possible to improve upon drug delivery devices currently on the market, as described in more detail below. Summary of the Invention [Problem to be solved by the invention]
[0003] It is an object of the present disclosure to provide a cover structure for a medication delivery device that solves or at least alleviates the problems of the prior art. [Means for solving the problem]
[0004] According to a first aspect of the present disclosure, a cover structure for a medication delivery device is provided. The cover structure is configured to surround a medication delivery member at a proximal end of the medication delivery device. The cover structure is axially movable along the medication delivery device between a retracted position in which the medication delivery member is exposed at the proximal end of the cover structure and an extended position in which the medication delivery member is covered by the cover structure. The cover structure includes a locking structure at the proximal end of the cover structure. The locking structure includes at least one deflectable clip having a distal end and a proximal end and an actuation surface configured to receive an actuation force. The at least one deflectable clip is positionable in a neutral position, where the at least one deflectable clip prevents the cover structure from moving axially from the extended position to the retracted position. Furthermore, the deflectable clip is positionable in a deflected position reachable by acting on the actuation surface, where the cover structure is allowed to move axially toward the retracted position. The deflectable clip is configured such that when an actuation force is applied to the actuation surface beginning at the proximal end and moving toward the distal end, the deflectable clip transitions from the neutral position to the deflected position.
[0005] The embodiments of the present disclosure provide a convenient cover structure that allows the medication delivery member to be exposed so that the medication delivery device can be activated only when at least one deflectable clip is pushed into a deflected state. In other words, it is possible to ensure that the medication delivery member, e.g., a needle, is not unintentionally exposed and thereby potentially damaged. Furthermore, the locking structure forces a user to take appropriate action to use the medication delivery device. For example, the locking structure may be releasable by a cooperating structure of the medication delivery auxiliary device that acts on the actuation surface, thereby forcing the user to use the medication delivery auxiliary device and advantageously ensuring that the medication is properly delivered to the user.
[0006] In this disclosure, when the term "distal direction" is used, it refers to the direction away from the volume delivery site during use of the drug delivery device. When the term "distal portion / end" is used, it refers to the portion / end of the delivery device, or a portion / end of a component thereof, which is located farthest from the volume delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the volume delivery site during use of the drug delivery device. When the term "proximal portion / end" is used, it refers to the portion / end of the delivery device, or a portion / end of a component thereof, which is located closest to the volume delivery site during use of the drug delivery device.
[0007] Additionally, the terms "longitudinal," "longitudinally," "axially," or "axially" refer to a direction extending from the proximal end to the distal end, typically along the device or its components, in the direction of the device's and / or component's greatest extension.
[0008] Similarly, the terms "lateral," "lateral," and "laterally" refer to a direction generally perpendicular to the longitudinal direction.
[0009] Additionally, the terms "circumferential," "circumferential," and "circumferentially" refer to the circumference or circumferential direction relative to an axis, typically a central axis extending in the longest direction of the device and / or component. Similarly, "radial" or "radially" refers to a direction extending radially relative to an axis, and "rotation," "rotationally," and "rotationally" refer to rotation relative to an axis.
[0010] The same directional terms are used to describe other components such as pads, e.g., the proximal end of the pad is the portion of the pad closest to the volume delivery site (injection site), and the distal end of the pad is the portion of the pad furthest from the volume delivery site. In the figures, the longitudinal direction is along axis 102, and the corresponding circumferential 31 and radial 32 directions relative to axis 102 are also shown.
[0011] When the phrase "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 the surrounding area, e.g., the area where the pad is attached.
[0012] According to one embodiment, at least one deflectable clip may be configured to transition to the deflected state by acting on an actuation surface and cooperating with a circumferential structure of a mounting portion of the pad configured to receive a medication delivery device. Such a pad is attached to a user's injection site during use. The pad includes a mounting portion that, during use, can secure the medication delivery device in place until the user releases the engagement of the medication delivery device. Advantageously, when the medication delivery device is inserted into the mounting portion, the circumferential structure of the pad acts on the actuation surface, thereby transitioning the cover structure to the retracted position. The deflectable clip is particularly adapted to be deflected by the circumferential structure of the mounting portion. Therefore, it is recommended that users use pads that ensure proper delivery of medication, for example, pads that help the user maintain the medication delivery device in place at the injection site for a sufficient period of time.
[0013] According to one embodiment, the circumferential structure may be a cylindrical structure, and the locking structure is configured to fit inside the cylindrical structure. Because the cylindrical structure advantageously provides rotational symmetry, the circumferential orientation of the cover structure on the circumferential structure is of little or no importance in causing deflection of the clip.
[0014] According to one embodiment, the at least one clip may be in a neutral position and configured to abut a stop element of the medication delivery device when the cover structure is moved towards the retracted position, the stop element preferably being located distal to the at least one clip when the cover structure is in the extended position.
[0015] According to one embodiment, the stopping element may be part of the housing of the medication delivery device.
[0016] According to one embodiment, a distal end of the at least one clip may be configured to abut a stop element to prevent the cover structure from moving to the retracted position.
[0017] According to one embodiment, the deflectable clip may be configured such that when the deflectable clip is deflected laterally inward, the stop element is released, thereby allowing the cover structure to move toward the retracted position. Thus, the deflectable clip protrudes radially outward in the neutral position.
[0018] According to one embodiment, the locking structure may comprise at least two deflectable clips arranged symmetrically around the circumference of the cover structure.
[0019] According to one embodiment, each of the at least one deflectable clip may include a sloped surface extending from the proximal end to the distal end of the clip and may be configured to slide over a cylindrical structure of the mounting portion of the pad.
[0020] According to one embodiment, the at least one deflectable clip has a fixed proximal end and a free distal end, the free distal end being movable relative to the fixed end when the at least one deflectable clip transitions from a neutral position to a deflected position.
[0021] According to one embodiment, the at least one deflectable clip is fabricated into a cutout portion of the cover structure, providing a relatively simple method of providing the cover structure and clip as an integral, single structure.
[0022] According to one embodiment, when in the neutral position and the cover structure is in the extended position, the at least one deflectable clip is positioned proximally outside the housing of the medication delivery device.
[0023] There is further provided a medication delivery device comprising the cover structure of any of the embodiments disclosed herein.
[0024] According to a second aspect of the present disclosure, there is provided a pad extending along an axis from a proximal end to a distal end, the proximal end being the end of the pad adjacent an injection site when the pad is in use. The pad includes a mounting portion configured to receive a medication delivery device and a circumferential structure disposed on the mounting portion. The circumferential structure is configured to receive and compress a locking structure of a cover structure included in the medication delivery device when the medication delivery device is moved into a predetermined position on the mounting portion during use, whereby the locking structure moves from a neutral position that prevents axial movement of the cover structure toward a retracted position when the cover structure is in an extended position to a deflected position that allows axial movement of the cover structure toward the retracted position of the mounting portion.
[0025] This provides an advantageous pad including a circumferential structure that can cooperate with the locking structure of the cover structure, as described in the first aspect, to ensure that the medication delivery device is maintained in the proper position for medication delivery. Furthermore, the circumferential structure is specifically adapted to only allow activation of the locking structure when the medication delivery device is in place on the mounting portion, thereby encouraging the user to use the pad.
[0026] According to one embodiment, the proximal injection surface may include an adhesive for attaching the pad to the injection site.
[0027] This embodiment provides similar advantages to those described above with respect to the first embodiment.
[0028] According to a third aspect of the present disclosure, there is provided a cover structure for a medication delivery device, the cover structure being configured to surround a medication delivery member at a proximal end of the medication delivery device. The cover structure is movable in the axial direction of the medication delivery device between a retracted position in which the medication delivery member is exposed at the proximal end of the cover structure and an extended position in which the medication delivery member is covered by the cover structure. The cover structure includes a pad integrated with the cover structure, the pad extending along the axis from the proximal end to the distal end, the proximal end being the end of the pad adjacent to an injection site when the pad is in use.
[0029] Users of the medication delivery device are encouraged to use the pad to facilitate the act of injecting medication, and in particular to ensure that the medication delivery device remains in place at the injection site for a sufficient period of time. An embodiment of the third aspect of the present disclosure provides a cover structure with an integrated pad to ensure that the pad is employed when using the medication delivery device.
[0030] According to one embodiment, the proximal injection surface of the pad may include an adhesive.
[0031] According to one embodiment, the cover structure may include a release mechanism that, when actuated, releases the cover structure from the retracted position.
[0032] According to one embodiment, the release mechanism may be configured to lock onto a locking protrusion on the housing of the medication delivery device.
[0033] According to one embodiment, the cover structure may comprise a resilient tab adapted to apply a lateral force to the housing of the medication delivery device.
[0034] According to one embodiment, the pad and cover structure may be made in a single piece.
[0035] According to one embodiment, the cover structure may comprise a drug delivery member disposed at the proximal end of the pad and covered by a removable protective cap.
[0036] According to one embodiment, the medication delivery member may be configured to transition completely inside the cover structure once the removable protective cap is removed.
[0037] According to one embodiment, the cover structure may comprise a receiving portion configured to connect the medication delivery member to a medication container of the medication delivery device when the medication delivery device is attached to the cover structure.
[0038] This third aspect provides similar advantages to those discussed above with respect to the first and second aspects.
[0039] In general, all terms used in the claims should be interpreted according to their ordinary meaning in the art unless otherwise expressly defined herein. All references to "elements, apparatus, components, means, etc." should be interpreted broadly as referring to at least one example of an element, apparatus, component, means, etc., unless otherwise specified.
[0040] Specific embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]
[0041] [Figure 1] FIG. 1 is a perspective view of a pad and an autoinjector according to an embodiment of the present disclosure. [Figure 2] FIG. 2 is a side view of the pad and autoinjector in FIG. 1. [Figure 3A] 3 is a cross-sectional view of the auto-injector and pad of FIGS. 1 and 2 before the auto-injector engages the pad. FIG. [Figure 3B] 3 is a cross-sectional view of the autoinjector and pad of FIGS. 1 and 2 when the autoinjector is inserted into the mount of the pad. FIG. [Figure 3C] 3 is a cross-sectional view of the autoinjector and pad of FIGS. 1 and 2 when the autoinjector is inserted into the mount of the pad. FIG. [Figure 4A] 1 is a cross-sectional view of an autoinjector according to an embodiment. FIG. [Figure 4B] 1 is a cross-sectional view of an autoinjector according to an embodiment. FIG. [Figure 5A] 1 shows a cross-sectional view of a further possible embodiment of the present disclosure; [Figure 5B] 1 shows a cross-sectional view of a further possible embodiment of the present disclosure. [Figure 5C] 1 shows a cross-sectional view of a further possible embodiment of the present disclosure. [Figure 5D]1 shows a cross-sectional view of a further possible embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0042] The inventive concept will now be described in more detail with reference to the accompanying drawings, in which exemplary embodiments are shown. However, the inventive concept may 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 numbers refer to like elements throughout the description.
[0043] 1 and 2 show an example of a drug delivery device 110 and a pad 100 according to an embodiment of the present disclosure. The pad 100 extends along an axis 102 from a proximal end 104 to a distal end 106. The proximal end 104 is the end of the pad that is adjacent to an injection site when the pad is in use. The injection site is understood to be the drug delivery site.
[0044] The pad 100 includes a mounting portion 108 configured to receive a medication delivery device 110, such as an autoinjector or pen-type injector.
[0045] 1 and 2 extends from a proximal end 112 to a distal end 114 relative to the shaft 102. The drug delivery device 110 includes a housing 116, a window 118, a needle 120, and a cover structure 122 configured to cover the needle 120. The drug delivery device 110 also includes a mounting portion 124 configured to engage the mounting portion 108 of the pad 100.
[0046] The mounting portion 108 of the pad 100 includes a locking mechanism 126 for releasably locking the medication delivery device 110 to the pad 100. The locking mechanism 126 may be configured in various ways, for example, as a friction lock in which a movable arm 127 applies a retaining force to the mounting portion 124 of the medication delivery device 110, or as a snap-fit lock in which a protrusion on the proximal end of the housing 116 of the medication delivery device 110 engages with a corresponding portion of the mounting portion 108 of the pad 100 to lock the medication delivery device 110 in place.
[0047] Additionally, the pad 100 optionally includes a release button 128 configured to release the medication delivery device from the mounting portion 108 upon actuation of the release button 128 .
[0048] 2 shows the medication delivery device 110 attached to the pad 100 at the attachment portion 108. The needle 120 extends from the proximal end 104 of the pad 100. In this state, a cover structure, sometimes referred to as a needle guard, is in a retracted position, thereby exposing the needle 120. When the medication delivery device 110 is not attached to the attachment portion 108, the needle 120 is desirably not maintained in such an exposed state. Furthermore, when using the medication delivery device 110 to deliver medication to an injection site, the pad 100 is desirably used, and therefore the user is desirably encouraged or even forced to use the pad 100 to ensure proper and safe delivery of the medication.
[0049] To address the above issues, the cover structure 122 is provided with a locking structure, which will now be described in more detail.
[0050] Reference is now made to Figures 3A-3C, each of which illustrates a cross-sectional view of the covering structure 122 of the drug delivery device 110. The covering structure 122 is configured to surround the drug delivery member 120 at the proximal end 112 of the drug delivery device 110. The general operation of the covering structure is that it is axially movable along the axis 102 of the drug delivery device 110, as better seen in Figure 1, between a retracted position in which the drug delivery member 120 is exposed at the proximal end 112 of the covering structure 122, and an extended position in which the drug delivery member 120 is covered by the covering structure 122. In the extended position of the covering structure 122, the drug delivery member 120 is covered in a manner that prevents it from causing unnecessary injury. In the extended position, the covering structure 122 is located proximal to the drug delivery member 120.
[0051] Cover structure 122 includes a locking structure 130 at proximal end 112 of the cover structure. Locking structure 130 includes at least one deflectable clip 132 having a distal end 136 and a proximal end 138, and an actuation surface 134 configured to receive an actuation force. At least one deflectable clip 132 is positionable in a neutral position in which at least one deflectable clip 132 prevents axial movement of cover structure 122 from the extended position to the retracted position, as shown in FIG. 3A where clip 132 abuts stop element 140.
[0052] Additionally, the deflectable clip 132 is positionable in a deflected position, as shown in Figures 3B-3C, that is achievable upon actuation surface 134, where cover structure 122 is permitted to move axially toward the retracted position shown in Figure 3C. Clip 132 is configured such that when an actuation force is applied to actuation surface 134 starting from proximal end 138 and moving toward distal end 136, clip 132 transitions from the neutral position to the deflected position. The sliding force is preferably applied to the actuation surface starting from proximal end 138 and sliding toward distal end 136.
[0053] In the neutral position, the actuating surface 134 of the deflectable clip 132 gradually reaches radially further from the proximal cylindrical portion 140 of the cover structure 122 on the distal end 136 of the clip compared to the proximal end 138 of the clip 132. In the neutral position, the actuating surface 134 is inclined relative to the longitudinal axis 102 of the medication delivery device 110.
[0054] 3A, the proximal end 112 of the medication delivery device 110 is shown just prior to insertion into the mounting portion 108 of the pad 100. The needle 120 is covered by or contained within a cover structure 122, which is here in an extended position. The cover extension 122 is slidable within the housing 116 in the longitudinal direction of the medication delivery device 110, such that it can move between an extended position and a retracted position. The cover structure 122 may be spring biased toward the extended position.
[0055] The cover structure 122 is generally cylindrical with a hollow interior space for accommodating the needle 120. Additionally, the clip 132 provides a tapered shape to a portion of the cover structure 122, with the wider portion of the tapered shape being at a distal end 136 of the clip 132.
[0056] At the proximal-most end of the cover structure 122 is a cylindrical portion 140 that facilitates a precise fit of the cover structure 122 onto the mounting portion 108 of the pad 100. The cylindrical portion 140 is located proximally relative to the clip 132.
[0057] In this neutral position of the clip 132, the clip 132 abuts against a stop element 142 of the medication delivery device 110 to prevent the cover structure 122 from moving toward the retracted position. In this particular embodiment, it is a distal end 136 of at least one clip 132 that is configured to abut against the stop element 142. Furthermore, the deflectable clip 132 is positioned proximally outside the housing 116 of the medication delivery device 110.
[0058] When clip 132 is deflected radially inward, as indicated by arrow 144, the clip is deflected laterally inward to a position laterally closer to longitudinal axis 102 than stop element 142, whereby cover structure 122 is no longer prevented by stop element 140 from moving longitudinally toward the retracted position, as described in more detail herein.
[0059] The pad 100 includes a mounting portion 108 configured to receive a medication delivery device 110. More specifically, in use, the cover structure 122 is inserted into the mounting portion 108 while being guided by the cylindrical portion 140. The proximal end 112 of the housing 116, which includes the stop element 140, also fits inside the mounting portion.
[0060] A circumferential structure 146 is disposed on the mounting portion 108. Referring to FIG. 3B , when the medication delivery device 110 is inserted into the mounting portion 108, the at least one deflectable clip 132 transitions to a deflected state by cooperating with the circumferential structure 146 of the mounting portion 108. As a result, the circumferential structure 146 acts on the actuating surface 134 to deflect the clip 132, as indicated by arrow 150. In this exemplary embodiment, the actuating surface 134 faces radially outward in the lateral direction. In other words, the circumferential structure 146 acts radially toward the longitudinal axis 102 of the medication delivery device 110. The circumferential structure 146 slides over the actuating surface 134 from the proximal end 138 toward the distal end 136.
[0061] Thus, the circumferential structure 146 is configured to receive and press the clip 132 of the locking structure 130 of the cover structure 122 when the medication delivery device 110 is moved into position on the mounting portion 108. In this embodiment, the circumferential structure 146 is a cylindrical structure, and the locking structure is configured to fit inside the cylindrical structure.
[0062] As described above, as a result, the locking structure moves from a neutral position that prevents axial movement of the cover structure 122 toward the retracted position when the cover structure 122 is in the extended position to a biased position that allows axial movement of the cover structure 122 toward the retracted position of the mounting portion.
[0063] In Figure 3B, the cover structure 122 is still in the extended position and the clip 132 is in the deflected position. When the cover structure 122 is pressed toward the proximal support portion 148 of the attachment portion 108 adjacent the injection site during use of the pad 100 and medication delivery device 110, the cover extension 122 is permitted to move longitudinally toward the extended position shown in Figure 3C. The stop element 142 moves into a space laterally outward of the circumferential structure 146. The movable arm 127 of the locking mechanism 126 now applies a retaining force to the attachment portion 124 of the medication delivery device 110.
[0064] The clip is preferably resilient so that the clip 132 springs back to a neutral position once released by the stop element 142.
[0065] The locking structure 130 preferably comprises at least two deflectable clips 132 symmetrically positioned around the circumference of the cover structure 122 .
[0066] To facilitate deflection of the clips 132, each clip 132 includes a ramp 152 extending from the proximal end 138 to the distal end 136 and configured to slide over the cylindrical structure of the pad's mounting portion. The ramp 138 may be the entire actuation surface 134, or the actuation surface 134 may include the ramp 152.
[0067] The proximal end 138 of the clip is now the fixed end about which the clip can rotate as indicated by the arrow, and the distal end 136 is thus the free end that is movable relative to the fixed end as the at least one deflectable clip 132 transitions from the neutral position to the deflected position.
[0068] One way to realize the clips 132 is to make them into cutouts in the cover structure, so that the clips 132 and the cover structure 122 are made as one integral part by cutting the material of the cover structure 122 to form the clips. The cutouts may be made, for example, in a U-shape.
[0069] 4A-4B show a further embodiment of the present disclosure relating to a cover structure 222 for a drug delivery device 110. Similar to the first embodiment, the cover structure 222 is configured to surround the drug delivery member 120 at the proximal end 112 of the drug delivery device 110.
[0070] Furthermore, in this embodiment, the cover structure 222 is also movable in the axial direction of the drug delivery device 210 between a contracted position shown in FIG. 4B, in which the drug delivery member 120 is exposed at the proximal end 112 of the cover structure, and an extended position shown in FIG. 4A, in which the drug delivery member 120 is covered by the cover structure 222.
[0071] The cover structure 222 includes a pad 200 integral with the cover structure 222. Similar to the pad 100 described in connection with the previous figures, the pad 200 extends along an axis 102 from a proximal end 104 to a distal end 106, with the proximal end 104 being the end of the pad 200 adjacent the injection site when the pad is in use.
[0072] The cover structure 222 is a cylindrical structure having a hollow interior space for accommodating the drug delivery member 120. Thus, the cover structure 222 may have a tubular body.
[0073] The cover structure 222 is disposed coaxially with the outer cylindrical wall 206 of the mounting portion 208 of the pad 200 and extends proximally from the distal end 106 of the pad. The cover structure 222 is located inside the outer cylindrical wall 206 of the mounting portion 208 and has a smaller diameter than the outer cylindrical wall 206.
[0074] Furthermore, the cover structure 222 is fixedly attached to the pad 200, for example, at the attachment portion 208. Here, the cover structure 222 extends to the proximal end 104 of the pad 200.
[0075] In Figure 4A, the cover structure 222 is in an extended position in which the needle 120 is covered. As the drug delivery device is moved proximally toward the injection site, the cover structure 222 moves longitudinally, exposing the needle 120 to the proximal side 104 of the pad (see Figure 4B). In this retracted position, the housing 216 of the drug delivery device 210 has moved into the space between the cover structure 222 and the outer cylindrical wall 206 of the mounting portion 208. In other words, in this retracted position, the housing 216, the cover structure 222, and the outer cylindrical wall 206 are coaxially oriented relative to one another.
[0076] The pad 200 and the cover structure 222 are preferably made in a single piece. For example, the pad 200 with the attachment portion 208 may be molded with the cover structure 222. The cover structure 222 is part of the medication delivery device 110.
[0077] The proximal injection surface 202 of the pad preferably comprises an adhesive and is in contact with the injection site when the drug delivery device 210 is in use.
[0078] Here, the cover structure 222, including the integrated pad 200 and mounting portion 208, further includes a locking mechanism 126 that, when actuated, releases the cover structure 222 from the retracted position.
[0079] The locking mechanism 126 may be configured in various ways, such as, for example, as a friction lock in which the movable arm 127 applies a retaining force to the housing 216 of the medication delivery device 210, or as a snap-fit lock in which a protrusion on the proximal end of the housing 216 of the medication delivery device 210 engages with a corresponding portion of the mounting portion 208 of the pad 200 to lock the cover structure 222 in a retracted position.
[0080] Additionally, pad 100 optionally includes a release button 128 configured such that actuation of release button 128 releases housing 216, and thus cover structure 222, from the retracted position.
[0081] Housing 216 includes a locking projection 220 at the proximal end 112 of the housing. Projection 220 extends laterally away from longitudinal axis 102 and engages a proximal shoulder 228 on release mechanism movable arm 127. When the release button is pressed, shoulder 228 moves away from housing 216, releasing projection 220.
[0082] Furthermore, to improve locking of the housing 216 and thereby maintain the cover structure 122 in the retracted position, in the space between the cover structure 222 and the outer wall 206, a set of elastic tabs 230 attached to the cover structure are adapted to apply a lateral force to the housing 216 of the medication delivery device.
[0083] 5A-5D show cross-sectional views of one possible embodiment of the present disclosure in which a drug delivery device 110 has a drug container 304, eg, a cartridge, in its body 306, and a pad 100 includes a needle 120 as the drug delivery member.
[0084] The pad 100 includes a mounting portion 208, as described in connection with other embodiments herein. However, in this embodiment, the mounting portion itself, and more specifically the cylindrical wall 206, functions as the cover structure. However, the cover structure is not initially part of the medication delivery device, but once in use, as described below, the body of the medication delivery device 110 is attached to a needle assembly 308 housed in the mounting portion 208.
[0085] The needle 120 is disposed in a through-hole in a tubular needle hub 310. The needle 120 extends beyond the proximal end 104 of the pad 100 and is covered by a removable protective cap 302.
[0086] 5B shows that once the removable protective cap 302 is removed, the needle 120 is fully transferred inside the cover structure 322. Transfer of the needle can be achieved in a variety of ways. In one possible embodiment, as the cap 302 rotates, the needle hub 310 also rotates due to the structural engagement therebetween.
[0087] For example, the distal engagement member 311 of the hub 310 is a threaded member designed to interact with threads 314 in the central passage of the retaining member 312. The threads 316 between the cap 302 and the retaining member 312 have a different pitch direction than the threads 314 between the hub 310 and the retaining member 312. Thus, when the cap 302 is rotated proximally to remove it from the retaining member 312, the rotation of the hub 310 moves the hub 310 distally into the retaining member 312. It should be understood that this pivoting needle isolation guard is provided by way of example only, and that there may be other possible ways to achieve movement of the needle into the mounting portion 208.
[0088] The retaining member 312 includes a tubular receptacle 318 configured to receive the needle 120 and connect it to the drug container 304 of the drug delivery device 110 when attached to the cylindrical wall 206, which is a cover structure 322. As shown in Figure 5C, the body 306 of the drug delivery device is pushed into the retaining member 312, as indicated by arrow 320, causing the needle 120 to protrude from the proximal end 104 of the pad 100. The cover structure 322 is therefore in a retracted position.
[0089] 5D shows the drug delivery device 110 after use, with the needle covered by the cover structure 322, now in the extended position. After use, the user can remove the drug delivery device 110 using the locking mechanism 126 and dispose of the drug delivery device 110 and pad 300.
[0090] The pads described herein may be made from a transparent material. Additionally, the sidewall of the mount may include an opening that forms a window near the base of the mount adjacent the pad surface. Prior to use, the patient is instructed to ensure that the cover extension is fully depressed when using the autoinjector. This window allows the patient to inspect the condition of the cover extension when using the autoinjector in combination with the injection support pad.
[0091] The pads disclosed herein may also include embedded electronics that include different units.
[0092] A sensor unit capable of recognizing injection events such as insertion of the autoinjector into the attachment, the start of an injection, and the completion of an injection.
[0093] A memory unit configured to store data recorded during the injection.
[0094] A connectivity unit configured to transmit stored data directly to a smart device or network.
[0095] A processing unit configured to control the entire system and process data before sending it out.
[0096] A user interface unit configured to provide feedback to the patient, such as a status LED, tactile, and / or audio feedback.
[0097] When the autoinjector is placed on the mount, a sensor inside the support pad is configured to recognize the event and provide feedback to the patient via tactile / visual or audio elements.
[0098] Once the injection is complete, the sensor is configured to recognize the event and again provide feedback to the patient. Additionally, the collected data may be stored in the memory unit and transmitted to a smart device / network via the connectivity unit after the injection event is complete.
[0099] The sensor may be one or a combination of a mechanical switch, a Hall effect sensor, and an acceleration sensor.
[0100] A mechanical switch, a Hall effect sensor, or an acceleration sensor can be used to detect the insertion of the autoinjector into the injection port.
[0101] The acceleration sensor can be used to detect an injection event.
[0102] Possible wireless communication methods include Bluetooth and cellular networks.
[0103] Bluetooth connectivity requires the smart device to transmit stored data to the network and requires a pairing operation between the Support Pad and smart device before the Support Pad can be used, but it is a cheaper alternative and requires less space on the pc board.
[0104] Cellular networks do not require a pairing process and can be used as a plug-and-play device with no prior setup required, but they are more expensive and require more space on the printed circuit board.
[0105] Depending on the product requirements, either of these two techniques can be used.
[0106] Such a processing unit may comprise a logic circuit or control unit including a microprocessor, a microcontroller, a programmable digital signal processor, or another programmable device. The processing circuit may also or instead include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor, respectively. Where the processing circuit includes a programmable device such as the microprocessor, microcontroller, or programmable digital signal processor mentioned above, the processor may further include computer-executable code for controlling the operation of the programmable device.
[0107] The inventive concept has been described above primarily with reference to certain examples. However, as will be readily apparent to those skilled in the art, other embodiments besides those disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.
[0108] Some aspects are described in the following appendix.
[0109] 1. A cover structure (222, 322) for a drug delivery device (210), the cover structure configured to surround a drug delivery member (120) at a proximal end (112) of the drug delivery device; the covering structure is movable axially in the medication delivery device between a retracted position in which the medication delivery member is exposed at a proximal end of the covering structure and an extended position in which the medication delivery member is covered by the covering structure; The cover structure is A pad (200) integrated with a cover structure, the pad extending along an axis (102) from a proximal end (104) to a distal end (106), the proximal end being the end of the pad adjacent an injection site when the pad is in use. A cover structure (222, 322).
[0110] 2. The cover structure of claim 1, wherein the proximal injection surface (202) of the pad comprises an adhesive.
[0111] 3. The cover structure according to claim 1 or 2, comprising a locking mechanism (126) that, when activated, releases the cover structure from the retracted position.
[0112] 4. A cover structure as described in appended claim 3, wherein the locking mechanism (126) is configured to engage with a locking protrusion (220) of the housing of the medication delivery device.
[0113] 5. A cover structure according to any one of claims 1 to 4, comprising a resilient tab (230) adapted to apply a lateral force to the housing (216) of the medication delivery device.
[0114] 6. The cover structure according to any one of claims 1 to 5, wherein the pad and the cover structure are made from a single part.
[0115] 7. The cover structure according to any one of claims 1 to 5, wherein the cover structure is part of a drug delivery device.
[0116] 8. A cover structure (322) according to any one of claims 1 to 6, comprising a drug delivery member disposed at the proximal end of the pad and covered by a removable protective cap (302).
[0117] 9. The cover structure of claim 8, wherein the drug delivery member is configured to transition completely inside the cover structure once the removable protective cap is removed.
[0118] 10. A cover structure according to claim 8 or 9, comprising a receiving portion (318) configured to connect the drug delivery member to the drug container (304) of the drug delivery device when the drug delivery device is attached to the cover structure.
[0119] 11. A cover structure according to any one of claims 8 to 10, wherein the main body (306) of the drug delivery device including the drug container is inserted into the cover structure during use. [Explanation of symbols]
[0120] 31 circumferential direction, 32 radial direction, 100 pad, 102 shaft, 104 proximal end, 106 distal end, 108 mounting portion, 110 drug delivery device, 112 proximal end, 114 distal end, 116 housing, 118 window, 120 needle, 122 cover structure, 124 mounting portion, 126 locking mechanism, 127 movable arm, 128 release button, 130 locking structure, 132 deflectable clip, 134 actuation surface, 136 distal end, 138 proximal end, 140 proximal cylindrical portion, 142 stop element, 144 arrow, 146 circumferential structure, 148 proximal support portion, 150 arrow, 152 inclined surface, 200 pad, 202 proximal injection surface, 206 outer cylindrical wall, 208 Mounting portion, 210, drug delivery device, 216, housing, 220, protrusion, 222, cover structure, 228, proximal end shoulder, 230, elastic tab, 300, pad, 302, protective cap, 304, drug container, 306, body, 308, needle assembly, 310, needle hub, 311, distal engaging member, 312, retaining member, 314, thread, 316, thread, 318, tubular receiver, 320, arrow, 322, cover structure
Claims
1. A cover structure (122) for a drug delivery device (110), comprising: the cover structure is configured to surround a drug delivery member, which is a needle, at the proximal end (112) of the drug delivery device; the covering structure is movable axially in the medication delivery device between a contracted position in which the medication delivery member (120) is exposed at a proximal end of the covering structure and an extended position in which the medication delivery member (120) is covered by the covering structure; the cover structure includes a locking structure (130) at the proximal end of the cover structure; the locking structure comprises at least one deflectable clip having a distal end (136) and a proximal end (138), and an actuation surface (134) configured to receive an actuation force and sloping outwardly from the proximal to the distal side; at least one of the deflectable clips is positionable in a neutral position, wherein in the neutral position, the at least one deflectable clip prevents the cover structure from moving axially from the extended position to the retracted position; the deflectable clip is further positionable in a deflected position accessible upon acting on the actuation surface, wherein in the deflected position the cover structure is permitted to move axially toward the retracted position; the deflectable clip is configured such that when an actuation force is applied to the actuation surface starting from the proximal end (138) and moving toward the distal end (136), the deflectable clip transitions from the neutral position to the deflected position.
2. The cover structure of claim 1, wherein at least one of the clips (132) is configured to abut against a stop element (142) of the medication delivery device when the cover structure is in the neutral position and moves toward the contracted position.
3. The cover structure of claim 2 , wherein the stop element is part of a housing (116) of the medication delivery device.
4. 4. The cover structure of claim 2 or 3, wherein the distal end (136) of at least one of the clips is configured to abut the stop element.
5. 5. The cover structure of claim 1, wherein the deflectable clip is configured such that when the deflectable clip is deflected laterally inward, a stop element is released, thereby allowing the cover structure to move toward the retracted position.
6. The cover structure of claim 1 , comprising at least two of the deflectable clips arranged symmetrically around the circumference of the cover structure.
7. 7. The cover structure of claim 1, wherein each of the at least one deflectable clips includes a sloped surface (152) extending from a proximal end to a distal end.
8. 8. The cover structure of claim 1, wherein at least one of the deflectable clips has a fixed proximal end (138) and a free distal end (136), the free distal end being movable relative to the fixed proximal end when the at least one deflectable clip moves from the neutral position to the deflected position.
9. The cover structure of claim 1 , wherein at least one of the deflectable clips is made in a cutout in the cover structure.
10. A cover structure as described in any one of claims 1 to 9, wherein when in the neutral position and the cover structure is in the extended position, at least one of the deflectable clips is positioned proximal to the outside of the housing (116) of the medication delivery device.
11. A drug delivery device having a cover structure described in any one of claims 1 to 10.
Citation Information
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