Patent Publication Number: US-2022218898-A1

Title: Wearable drug delivery device with removal element

Description:
RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 63/136,492, filed Jan. 12, 2021, the contents of which are incorporated herein by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     Embodiments of the present disclosure generally relate to drug delivery devices. More particularly, embodiments of the present disclosure relate to wearable drug delivery devices including a removal element. 
     BACKGROUND 
     A person may wear a medical device on his or her body for any of a variety of reasons, such as insulin injection, heart rate monitoring, or other reason. Many wearable medication delivery devices use an adhesive for attachment to the skin of the user. The trend is to use stronger, longer-wear adhesives, particularly for heavier wearable medication delivery devices. However, the adhesive may still be securely attached at the end of the required life of the wearable medication delivery device, thus resulting in irritation and skin damage when the medication delivery device is removed. A need therefore exists for improved techniques for removing wearable medical devices from users. 
     SUMMARY 
     This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. 
     In one approach of the disclosure, a device may include a device body coupled to an adhesive layer, and a removal element coupled to the adhesive layer. The removal element may include an end section proximate a perimeter of the adhesive layer, and a central section connected to the end section, wherein a force applied to the end section causes the central section to transition between a first configuration and a second configuration. 
     In another approach of the disclosure, a wearable drug delivery system may include a device body coupled to a pad, an adhesive layer coupled to the pad, and a removal element directly coupled to the adhesive layer. The removal element may include an end section proximate a perimeter of the adhesive layer for engagement by a user, and a central section connected to the end section, wherein a force applied to the end section causes the central section to transition from a first configuration to a second configuration. 
     In another approach of the disclosure, a method may include providing a device body coupled to an adhesive layer and coupling a removal element to the adhesive layer. The removal element may include an end section proximate a perimeter of the adhesive layer, and a central section connected to the end section. The method may further include receiving a force to the end section, wherein the force causes the central section to transition from a first configuration to a second configuration. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the drawings, like reference characters generally refer to the same parts throughout the different views. In the following description, various embodiments of the present disclosure are described with reference to the following drawings, in which: 
         FIG. 1  illustrates a perspective view of a device according to embodiments of the present disclosure; 
         FIG. 2  illustrates a top view of the device depicted in  FIG. 1  according to embodiments of the present disclosure; 
         FIG. 3A  illustrates a side view of the device depicted in  FIG. 1  according to embodiments of the present disclosure; 
         FIG. 3B  illustrates a side view of a device according to embodiments of the present disclosure; 
         FIG. 3C  illustrates a top view of a device according to embodiments of the present disclosure; 
         FIG. 3D  illustrates a side view of the device depicted in  FIG. 3C  according to embodiments of the present disclosure; 
         FIG. 3E  illustrates a top view of a device according to embodiments of the present disclosure; 
         FIG. 3F  illustrates a side view of the device depicted in  FIG. 3E  according to embodiments of the present disclosure; 
         FIGS. 4A-4B  illustrates bottom views of the device depicted in  FIG. 1  according to one embodiment of the present disclosure; 
         FIGS. 5A-5C  illustrates bottom views of the device depicted in  FIG. 1  according to various embodiments of the present disclosure; 
         FIG. 6A  illustrates a bottom view of another adhesive layer according to various embodiments of the present disclosure; 
         FIG. 6B  illustrates a cross-sectional view of a portion of the adhesive layer, taken along cutline B-B in  FIG. 6A , according to various embodiments of the present disclosure; 
         FIG. 7  illustrates a bottom view of a device according to various embodiments of the present disclosure; 
         FIG. 8  illustrates a method according to embodiments of the present disclosure. 
         FIGS. 9A-9C  illustrate bottom views of a device according to embodiments of the present disclosure; 
         FIGS. 10A-10E  illustrate bottom views of a device according to embodiments of the present disclosure; 
         FIG. 11A  illustrates a perspective view of a device according to embodiments of the present disclosure; 
         FIG. 11B  illustrates an end view of the device depicted in  FIG. 11A  according to embodiments of the present disclosure; 
         FIG. 11C  illustrates a top view of the device depicted in  FIG. 11A  according to embodiments of the present disclosure; 
         FIG. 12A  illustrates a perspective view of a device according to embodiments of the present disclosure; 
         FIG. 12B  illustrates an end view of the device depicted in  FIG. 12A  according to embodiments of the present disclosure; 
         FIG. 12C  illustrates a top view of the device depicted in  FIG. 12A  according to embodiments of the present disclosure; 
         FIG. 13  illustrates a top view of a device according to embodiments of the present disclosure; 
         FIG. 14A  illustrates a top view of a device according to embodiments of the present disclosure; 
         FIG. 14B  illustrates an end view of the device depicted in  FIG. 14A  according to embodiments of the present disclosure; 
     
    
    
     The drawings are not necessarily to scale. The drawings are merely representations, not intended to portray specific parameters of the disclosure. The drawings are intended to depict exemplary embodiments of the disclosure, and therefore are not be considered as limiting in scope. Furthermore, certain elements in some of the figures may be omitted, or illustrated not-to-scale, for illustrative clarity. Still furthermore, for clarity, some reference numbers may be omitted in certain drawings. 
     DETAILED DESCRIPTION 
     Systems, devices, and methods in accordance with the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, where one or more embodiments are shown. The systems, devices, and methods may be embodied in many different forms and are not to be construed as being limited to the embodiments set forth herein. Instead, these embodiments are provided so the disclosure will be thorough and complete, and will fully convey the scope of methods and devices to those skilled in the art. 
     Based on skin type, amount of hair, sebum secretion, etc., stronger tack adhesives are generally preferred for attaching medical devices to a skin of a wearer. Longer-wear medical device adhesives tend to build strength over the first few hours and/or first day of use, and then gradually degrade in strength over time. However, if a longer duration adhesive is employed with a shorter duration medical device, the adhesive will likely remain relatively strong at the time of medical device removal, thus causing irritation and/or skin damage to the wearer. For example, in the case of a 3-day patch pump, an adhesive designed for 10+ days of use may be employed due to the added mass and expected activity level of the user. At the end of the 3-day period, the patch pump may need to be removed despite the adhesive still being strong. One alternative is a less aggressive adhesive, which may be more prone to lose necessary strength before the end of the required life of the product. Embodiments herein combine stronger and longer-wear medical device adhesives with a removal device, which makes it easier to remove the medical device, resulting in less pain and irritation to the wearer. 
     In some embodiments, the removal element may be a cord, string, rope, or wire-like element that is secured to an adhesive surface along the bottom of the medication delivery device. When the wearable medication delivery device is secured to the wearer, one or more sections of the removal element may be exposed or exposable and thereby accessible to a user, such as for grabbing by the user&#39;s fingers or engaging with a tool, such as a paper clip or other element. To subsequently remove the wearable medication delivery device, the exposed section(s) of the removal element may be engaged (e.g., pulled), which causes the removal element to move along the adhesive surface, thus shearing a connection between the adhesive and the wearer&#39;s skin. 
       FIGS. 1-2  illustrate a wearable medication delivery system/device (hereinafter “device”)  100  according to non-limiting embodiments of the present disclosure. The device  100  may include a device body  102  coupleable to a wearer by an adhesive carrier or pad  104 , wherein the pad  104  may be coupled or attached to a bottom surface of a base  106  of the device body  102 . As will be described in greater detail herein, the pad  104  may include an adhesive layer attached to a bottom or underside thereof. The adhesive layer of the pad  104  can be used to attach the device body  102  to the skin of the wearer. Although not limited to any particular shape or size, the pad  104  can have a shape that is larger than the device body  102 . That is, an outer portion  108  of the pad  104  can extend beyond an outer perimeter or profile  110  of the base  106  of the device body  102 . Extending beyond the outer portion  108  of the pad  104  may be one or more removal elements  112 , which can be engaged by the wearer or other individual to aid with removal of the device  100 . As will be described in greater detail herein, the removal element(s)  112  may be secured to the device  100 , for example, between the adhesive layer of the pad  104  and the skin of the wearer. In various embodiments, the removal elements  112  may extend from a first end  116  and/or a second end  118  of the pad  104 . For example, the removal element  112  may include respective end sections  130 A- 130 B each configured as a loop with a central opening  133 . Embodiments herein are not limited in this context, however. 
     The device  100  can be any drug delivery device for providing any drug or medicine to a patient or user. In various embodiments, the device  100  may be a disposable drug delivery device intended for limited use. In various embodiments, the device  100  can be an insulin delivery device. The device  100  can be intended for use over a few days (e.g., approximately 3 days and/or approximately 80 hours), or for an extended length of time. In various embodiments, the device  100  can be an OmniPod® (Insulet Corporation, Acton, Mass.) insulin delivery device. 
     The device  100  may include a number of components to facilitate delivery of a medication to the user. Although not shown, the device  100  may include a reservoir for storing the medication, a needle or cannula for delivering the medication through the skin of the wearer, and a pump for transferring the medication from the reservoir, through the needle or cannula. The device  100  may also include a power source, such as a battery, for supplying power to the pump and/or other components of the device  100 . In some embodiments, the device  100  may also contain analog and/or digital circuitry for controlling the delivery of the medication. The circuitry may be implemented as a controller. The circuitry may include discrete, specialized logic and/or components, an application-specific integrated circuit, a microcontroller or processor that executes software instructions, firmware, or any combination thereof. In various embodiments, the control circuitry may be configured to cause the pump to deliver doses of the medication to the person at predetermined intervals. The size and/or timing of the doses may be programmed into the control circuitry using a wired or wireless link by the user or by a third party, such as a health care provider. 
     Instructions for determining the delivery of the medication to the user (e.g., the size and/or timing of any doses of the medication) may originate locally (e.g., based on determinations made by the device  100 ) or may originate remotely, which are then provided to the device  100 . Remote instructions may be provided to the device  100  over a wired or wireless link. The device  100  may execute any received instructions for the delivery of the medication to the user. In this way, under either scenario, the delivery of the medication to the user may be automated. 
     Turning now to  FIG. 3A , the device  100  according to embodiments of the present disclosure will be described in greater detail. As shown, an adhesive layer  120  may be coupled to a bottom surface  122  of the pad  104 . The adhesive layer  120  may generally have a same or similar shape as the pad  104 . As shown, the adhesive layer  120  may extend between the first end  116  and the second end  118  of the pad  104 . In other embodiments, the adhesive layer  120  may be sized and/or shaped differently from the pad  104 . The adhesive layer  120  may include an interior surface  126  opposite an exterior surface  128 , wherein the exterior surface  128  may be secured to the wearer&#39;s skin. 
     It will be appreciated that the design of the adhesive layer  120  can be selected as desired for a particular application. For example, adhesive formulations may be tailored based on wear time, strength required, initial tack, surface contact, activity level, environment, etc. The thickness of the adhesive layer  120  may be adjusted based on conformability, stability and residue left on body, etc. In some embodiments, the adhesive layer  120  can be made of any biocompatible material with biocompatible adhesive operable to hold the weight of the device  100  to the skin for a predetermined duration. 
     In one example, the adhesive layer  120  may provide ventilation and circulation between the adhesive layer  120  and the skin. In another example, the adhesive layer  120  is a continuous sheet of adhesive material. In yet another example, the adhesive layer  120  is a mesh sheet of adhesive material including perforations. In yet another example, the adhesive layer  120  is a continuous sheet of adhesive material with holes cut into the continuous sheet. The holes can align with features of the device body  102 , as desired. In yet another example, the adhesive layer  120  is a continuous sheet of adhesive material with holes cut into the continuous sheet, and mesh applied across the holes. In yet another example, the adhesive layer  120  and the pad  104  can be made of a transparent material to allow the condition of the skin around and below the device  100  to be monitored. In one example, the adhesive layer  120  may be constructed of a pressure sensitive acrylic-based adhesive with a woven or non-woven polyester backing. Alternatively, the adhesive layer  120  may be constructed from silicone, a synthetic rubber, hydrocolloid, or hydrogel. In yet another example, the adhesive layer  120  can be made of the same or different material as the pad  104 . In yet another example, the adhesive layer  120  can be made of a clear plastic film such as, for example, polyethylene. In yet another example, the adhesive layer  120  can be flexible and/or stretchable. 
     In various embodiments, the adhesive layer  120  can be stronger or weaker than the adhesive used on the bottom surface of the pad  104  (e.g., in terms of tensile stress required to remove the adhesive from a surface). Variable adhesive strengths of the adhesive layer  120  and the pad  104  may be desired by different users depending on user preferences (e.g., such as level of exercise, living in warmer climates, etc.). 
     As further shown, secured to the exterior surface  128  of the adhesive layer  120  may be the removal element  112 . In some embodiments, the removal element  112  may include end sections  130 A,  130 B extending beyond a perimeter  132  of the adhesive layer  120 , and a central section  134  connected to the end sections  130 A,  130 B. As shown, the central section  134  may correspond to a portion or portions of the removal element  112  positioned within a footprint defined by the perimeter  132  of the adhesive layer  120 . In some embodiments, the end sections  130 A,  130 B of the removal element  112  may be configured as loops, which extend away from the skin of the wearer, e.g., in the y-direction, to make it easier for the wearer or medical professional to engage, either manually or with the aid of a tool. In other embodiments, the end sections  130 A- 130 B of the removal element  112  may lay generally flat along the skin of the wearer. Although shown as generally being symmetrical, end section  130 A may be sized and/or configured differently than end section  130 B. 
     Although not shown, the exterior surface  128  of the adhesive layer  120  and the central section  134  of the removal element  112  may be covered with a release liner prior to use. For example, the release liner can protect the adhesive material and the removal element  112  along the exterior surface  128  of the adhesive layer  120  until installation/attachment of the device  100  to the skin of the wearer. 
     In an alternative embodiment, shown in  FIG. 3B , the removal element  112  may be sandwiched between the adhesive layer  120  and the pad  104 . That is, the central section  134  of the removal element  112  may be in direct physical contact with the interior surface  126  of the adhesive layer  120  and the bottom surface  122  of the pad  104 . During use, the removal element  112  may be engaged (e.g., pulled) manually, or with the aid of a tool, to break the attachment between the adhesive layer  120  and the pad  104 . The device body  102  and the pad  104  can then be removed from the wearer. With full access now provided, the wearer may then remove the adhesive layer  120 , for example, by rolling or tearing the adhesive layer  120  away from the skin of the wearer. 
     In some embodiments, as shown in  FIGS. 3C-3D , the end sections  130 A,  130 B of the removal element  112  may wrap around respective first and second ends  116 ,  118  of the pad  104 . As shown, the end sections  130 A,  130 B may extend along an outer surface  145  of the pad  104 . In some embodiments, the end sections  130 A,  130 B may be recessed within a groove (not shown) of the pad  104 , and can be detached from the outer surface  145  of the pad  104  for engaging/pulling by the user, e.g., at the end of the required life of the device  100 . Although non-limiting, the end sections  130 A,  130 B of the removal element  112  may be secured to the pad  104  by an adhesive. 
     In yet other embodiments, as shown in  FIGS. 3E-3F , the end sections  130 A,  130 B of the removal element  112  may be coupled to respective pull tabs  139 A,  139 B. The pull tabs  139 A,  139 B may be a portion of the pad  104  or an additional component secured to the outer surface  145  of the pad  104 , e.g., by an adhesive. The pull tabs  139 A,  139 B may have one or more edges or features engageable by the user. 
     Turning now to  FIGS. 4A-4B , a bottom view of the device  100  according to embodiments of the present disclosure will be described. As shown, the removal element  112  is arranged along the exterior surface  128  of the adhesive layer  120 . In this embodiment, the removal element  112  may be a continuous/closed loop of material, such as a metal, a polymer, or a nylon string. For example, the removal element may be a wire element laminated onto the exterior surface  128  of the adhesive layer  120 . Although not limited to any particular size or thickness, the wire element may maintain a small cross-sectional area/diameter commensurate with a thickness of the adhesive layer  120 , e.g., on the order of 0.001-0.002″ in diameter. The wire element may be stainless steel, which is inert, non-corrosive, high-strength, and typically does not pose allergy concerns when worn on body. Other materials for the removal element  112  may include nylon, polyethylene, and polyester. In some embodiments, the removal element  112  may include one or more flexible strands cabled or woven together. 
     As shown, the end section  130 A may extend beyond a first end  140  of the adhesive layer  120 , while the end section  130 B may extend beyond a second end  142  of the adhesive layer  120 . In the configuration of  FIG. 4A , the central section  134  of the removal element  112  may include a first path  141  including a first peak  144  extending towards a first side  150  of the adhesive layer  120 , and a second path  143  including a second peak  146  extending towards a second side  152  of the adhesive layer  120 . The first and second paths  141 ,  143  of the removal element  112  may be symmetrically or asymmetrically arranged about a lengthwise axis  147  in various embodiments. 
     When the device  100  is to be removed from the skin of the wearer, the removal element  112  may be engaged to cause the removal element  112  to transition from the first configuration shown in  FIG. 4A  to a second configuration shown in  FIG. 4B . In one embodiment, the end sections  130 A,  130 B may move laterally in opposite directions, e.g., along the lengthwise axis  147 , in response to a force ‘F’. As the end sections  130 A,  130 B move away from respective first and second ends  140 ,  142  of the adhesive layer  120 , the resultant pulling forces transmit force vectors on the first and second peaks  144 ,  146  of the central section  134 , thus causing the first and second peaks  144 ,  146  to move towards the lengthwise axis  147 , e.g., until relatively flat. As a result, the first and second paths  141 ,  143  of the removal element  112  shear an adhesive connection between the exterior surface  128  of the adhesive layer  120  and the skin of the wearer as the first and second paths  141 ,  143  move towards one another. The first and second paths  141 ,  143  may extend substantially parallel to one another when the end sections  130 A,  130 B are fully separated from one another. The first and second paths  141 ,  143  may also be substantially perpendicular with the lengthwise axis  147 , as shown. Once the removal element  112  is brought into the second configuration, end section  130 A or end section  130  may be pulled (e.g., in the z-direction and/or the y-direction) to further disrupt any remaining adhesive connection at an interface of the exterior surface  128  of the adhesive layer  120  and the skin of the wearer, resulting in easier removal of the device  100 . 
     Turning now to  FIGS. 5A-5B , a bottom view of the device  100  according to another embodiment of the present disclosure will be described. In the first configuration of  FIG. 5A , the first path  141  of the removal element  112  may include a first plurality of peaks  144 A and  144 B, and the second path  143  of the removal element  112  may include a second plurality of peaks  146 A and  146 B. The first path  141  may further define a first valley  161  between peaks  144 A and  144 B, and the second path  143  may define a second valley  162  between peaks  146 A and  146 B. As shown, the first plurality of peaks  144 A,  144 B extend towards the first side  150  of the adhesive layer  120 , while the first valley  161  extends towards the lengthwise axis  147 . Similarly, the second plurality of peaks  146 A,  146 B extend towards the second side  152  of the adhesive layer  120 , while the second valley  162  extends towards the lengthwise axis  147 . The first and second paths  141 ,  143  of the removal element  112  may be symmetrically or asymmetrically arranged about the lengthwise axis  147  in various embodiments. Furthermore, it will be appreciated that a greater or lesser number of peaks and valleys is possible in alternative embodiments. For example, additional peaks and valleys may be added to the first and/or second paths  141 ,  143  to maximize the number of force vectors present, which reduces the amount of force a user would need to exert on the end sections  130 A,  130 B to cause release of the adhesive layer  120 . 
     As further shown, each of the first plurality of peaks  144 A,  144 B may include a first base corner  164  and a second base corner  165 . Similarly, each of the second plurality of peaks  146 A,  146 B may include a first base corner  166  and a second base corner  167 . When the device  100  is to be removed from the skin of the wearer, the end sections  130 A,  130  of the removal element  112  may be engaged to cause the removal element  112  to begin transitioning from the first configuration shown in  FIG. 5A  to an intermediate configuration shown in  FIG. 5B . In the intermediate configuration, the end sections  130 A,  130 B may be pulled laterally in opposite directions, e.g., along the lengthwise axis  147 , which causes the first plurality of peaks  144 A,  144 B and the second plurality of peaks  146 A,  146 B to begin moving away from respective first and second sides  150 ,  152  and towards the lengthwise axis  147 . Meanwhile, the first base corner  164  and the second base corner  165  of the first path  141  may begin moving away from the lengthwise axis  147 , e.g., in directions shown by arrows  168  and  169 , respectively. Similarly, the first base corner  166  and the second base corner  167  of the second path  143  may also begin moving away from the lengthwise axis  147 , e.g., in directions shown by arrows  170  and  171 , respectively. As a result of the movement of the first plurality of peaks  144 A and  144 B and the second plurality of peaks  146 A and  146 B, respective valleys  161 ,  162  may become shallower. 
     As shown in  FIG. 5C , the end sections  130 A,  130 B may be fully separated from one another when the removal element  112  is in the second configuration. Movement of the first and second paths  141 ,  143  of the removal element  112  between first and second configurations will shear the adhesive connection between the exterior surface  128  of the adhesive layer  120  and the skin of the wearer as the first and second paths  141 ,  143  are brought substantially parallel to one another. Once the removal element  112  is brought into the second configuration, end section  130 A or end section  130  may be pulled (e.g., in the z-direction and/or the y-direction) to further disrupt any remaining adhesive connection at an interface of the exterior surface  128  of the adhesive layer  120  and the skin of the wearer, resulting in easier removal of the device  100 . 
     In some embodiments, as shown in  FIGS. 6A-6B , the removal element  112  may be fully or partially recessed within an embedded channel  175  of the adhesive layer  120 . For example, the embedded channel  175  may be a valley or indentation extending towards the pad (not shown) of the device  100 . The embedded channel  175  may be open, covered, or partially covered by one or more sections  176  of adhesive. In some embodiments, the sections  176  may include one or more weakened sections, e.g., perforations, which allow the removal element  112  to break therethrough when engaged. During use, the embedded channel  175  may prevent the removal element  112  from being in direct contact with the skin of the wearer until removal of the device  100  is desired. Similar to the approaches described above, the removal element  112  may move from a first configuration, in which the first and second paths  141 ,  143  are positioned within the embedded channel  175 , to a second configuration in which the first and second paths  141 ,  143  have exited the embedded channel  175  and move towards the lengthwise axis  147 , between an interface of the exterior surface  128  of the adhesive layer  120  and the skin of the wearer. In some embodiments, the embedded channel  175  may include a sloped surface  177  to allow the removal element  112  to exit the embedded channel  175  more easily. 
     Turning now to  FIG. 7 , a bottom view of a wearable drug delivery device (hereinafter “device”)  200  according to embodiments of the present disclosure will be described. The device  200  may be similar to the device  100  described herein. As such, only certain aspects of the device  200  will hereinafter be described for the sake of brevity. As shown, a removal element  212  is arranged along an exterior surface  228  of an adhesive layer  220 , wherein the adhesive layer  220  is attachable to a wearer&#39;s skin. In this embodiment, the removal element  212  may be a continuous/closed loop of material, such as a metal, a polymer, or a nylon string. For example, the removal element may be a wire element laminated onto the exterior surface  228  of the adhesive layer  120 . 
     As shown, the removal element  212  may include an end section  230 A extending beyond a first end  240  of the adhesive layer  220 , and an end section  230 B extending beyond a second end  242  of the adhesive layer  220 . In the configuration shown, a central section  234  of the removal element  212  may generally follow or extend along a perimeter  232  of the adhesive layer  220 . When the device  200  is to be removed from the skin of the wearer, end sections  230 A,  230 B of the removal element  212  may be engaged to cause the first and second paths  241 ,  243  to move centrally towards a lengthwise axis  247 . In one embodiment, the end sections  230 A,  230 B may move laterally in opposite directions, e.g., along the lengthwise axis  247 , in response to a pulling force. As the end sections  230 A,  230 B move away from respective first and second ends  240 ,  242  of the adhesive layer  220 , the resultant forces on corners  280 A,  280 B of the first path  241  and corners  281 A,  281 B of the second path  243  cause the removal element  212  to move towards the lengthwise axis  247 . As a result, the first and second paths  241 ,  243  of the removal element  212  shear an adhesive connection between the exterior surface  228  of the adhesive layer  220  and the skin of the wearer. 
       FIG. 8  illustrates a method  301  for removing a wearable drug delivery device in accordance with the embodiments described herein. At block  311 , the method  301  may include providing a device body coupled to an adhesive layer. In some embodiments, the adhesive layer may be attached to an underside of a pad, which may be coupled or attached to a bottom surface of a base of the device body. In some embodiments, the adhesive layer may be a pressure sensitive acrylic-based adhesive with a woven or non-woven backing. In some embodiments, the adhesive layer may be constructed from silicone, a synthetic rubber, hydrocolloid, and/or hydrogel. 
     At block  313 , the method  301  may include directly coupling a removal element to the adhesive layer, wherein the removal element includes an end section extending beyond a perimeter of the adhesive layer, and a central section connected to the end section. In some embodiments, the end section is configured as a loop extending from a first and/or second end of the adhesive layer. In some embodiments, the removal element is a continuous loop of material. In some embodiments, the removal element may be constructed from a metal, a polymer, or a nylon. In some embodiments, the removal element may be a flexible biocompatible material. In some embodiments, the removal element may include a first path including a first plurality of peaks, and a second path including a second plurality of peaks. 
     At block  315 , the method  301  may include receiving a force to the end section, wherein the force causes the central section to transition from a first configuration to a second configuration. Transitioning the central section from the first configuration to the second configuration may cause the adhesive layer to partially detach from a skin of a wearer. In some embodiments, the method  301  includes extending the central section towards the perimeter of the adhesive layer in the first configuration, and moving the central section towards a lengthwise axis of the adhesive layer in response to the force, wherein the force is applied in a direction extending away from the device body. In some embodiments, the method  301  may include orienting the central section parallel to the lengthwise axis in the second configuration. In some embodiments, the central section may be arranged in a series of peaks and valleys along the exterior surface of the adhesive layer when the central section is in the first configuration. 
     In some embodiments, the method  301  may include coupling the central section to the adhesive layer at a perforated connection. In some embodiments, the method  301  may include coupling a reinforcement member to the central section. In some embodiments, the method may include extending a main element of the removal element within a conduit coupled to the adhesive layer, and connecting a plurality of arm elements to the main element, wherein the plurality of arm elements extend through the conduit. In some embodiments, the method  301  may include coupling a detachment element to the plurality of arm elements, wherein the detachment element is positioned along an exterior surface of the adhesive layer, and wherein the detachment element is one of: a rigid rod coupled to each of the plurality of arm elements, and a loop coupled to each of the plurality of arm elements. In some embodiments, the method may include providing an adhesive along an exterior surface of each of the loops. 
     Turning now to  FIGS. 9A-9C , a bottom view of a wearable drug delivery device (hereinafter “device”)  300  according to embodiments of the present disclosure will be described. The device  300  may be similar to the devices  100  and  200  described herein. As such, only certain aspects of the device  300  will hereinafter be described for the sake of brevity. As shown, a removal element  312  is arranged along an exterior surface  328  of an adhesive layer  320 , wherein the adhesive layer  320  is attachable to a wearer&#39;s skin. In some embodiments, the removal element  312  may be a portion or section of the adhesive layer  320 , wherein the removal element  312  is coupled to the adhesive layer  320  at a perforated interface or connection  337 . In various embodiments, the removal element  312  may be co-planar with the exterior surface  328  of the adhesive layer  320  or recessed into the adhesive layer  320 . As further shown, a central section  334  of the removal element  312  may include a reinforcement member  340  (e.g., flexible wire) extending along a length thereof. In some embodiments, the reinforcement member  340  may be embedded within a central section  334  of the removal element  312 , e.g., between multiple layers. 
     As shown, the removal element  312  may include end section  330 A opposite end section  330 B, wherein at least one of the end sections  330 A,  330 B may include a rigid or reinforced tip  333 , which may be a tab, loop, or other engageable feature. In an initial configuration, such as the configuration shown in  FIG. 9A , the reinforced tip  333  may be positioned within a perimeter  335  of the adhesive layer  320 . In other embodiments, all or a portion of the reinforced tip  333  may extend beyond/outside the perimeter  335 . As demonstrated, the removal element  312  may include a series of peaks and valleys in a folded or zig-zag arrangement. 
     During use, to remove the device  300  from the skin of the wearer, a force ‘F’ may be applied to the reinforced tip  333  of the removal element  312 , as shown in  FIG. 9A . Although non-limiting, the force may be applied parallel to a lengthwise axis ‘LA’ of the device  300 . The force may result in rotational shear, linear shear, and/or linear peeling along the removal element  312 , which causes the central section  334  to detach from the adhesive layer  320  at the perforated connection  337 . As the removal element  312  continues to unfold/expand, demonstrated in  FIGS. 9B-9C , the removal element  312  generally straightens and moves towards the lengthwise axis, shearing an adhesive connection between the adhesive layer  320  and the wearer&#39;s skin. 
     Although non-limiting, the removal element  312  may include an adhesive along an exterior surface  342  thereof. This adhesive may be relatively stronger or weaker than the adhesive of the adhesive layer  320 . In other embodiments, no adhesive is present along the exterior surface  342  of the removal element  312 . 
     Turning now to  FIGS. 10A-10E , a bottom view of a wearable drug delivery device (hereinafter “device”)  400  according to embodiments of the present disclosure will be described. The device  400  may be similar to the device  300  described herein. As such, only certain aspects of the device  400  will hereinafter be described for the sake of brevity. As shown, a removal element  412  is arranged in a serpentine pattern across an adhesive layer  420 , wherein the adhesive layer  420  is attachable to a wearer&#39;s skin. In some embodiments, the removal element  412  may be a portion or section of the adhesive layer  420 , and the removal element  412  may be coupled to a remainder of the adhesive layer  420  or to other sections of the removal element  412  at an interface  437 . Alternatively, the removal element  412  may make up the entire surface of adhesive layer  420 . In some embodiments, the interface  437  may be a slotted or perforated. Furthermore, the removal element  412  may be co-planar with an exterior surface  428  of the adhesive layer  420  or recessed into the adhesive layer  420 . As shown, a periphery of the removal element  412  may include a flexible release wire  440  (e.g., metal wire) extending along a serpentine length thereof. More specifically, in some embodiments, the release wire  440  may be positioned beneath/between the interface  437 . During removal, the release wire  440  may cut or break through the interface  437  when pulled. In some embodiments, the release wire  440  may include a release tab  448  at an end thereof. 
     As shown, the removal element  412  may include a central section  434  between opposite end sections  430 A and  430 B, wherein at least one of the end sections  430 A,  430 B may include a rigid or reinforced tip  433 , which may be a tab, loop, or other engageable feature. In an initial configuration, such as the configuration shown in  FIG. 10A , the release tab  448  and the reinforced tip  433  may be positioned within a perimeter  435  of the adhesive layer  420 . In other embodiments, all or a portion of the release tab  448  and/or the reinforced tip  433  may extend beyond/outside the perimeter  435 . As demonstrated, the removal element  412  and the release wire  440  may include a series of peaks and valleys in a folded, serpentine, or zig-zag arrangement, for example. 
     During use, to remove the device  400  from the skin of the wearer, a force ‘F’ may be applied first to the release tab  448  of the release wire  440 , as shown in  FIG. 10A . The release wire  440  may be pulled from the device  400 , cutting or breaking through the adhesive layer  420  at the interface  437  as the release wire  440  changes configuration. The release wire  440  may be entirely removed from the device  400 , as shown in  FIG. 10C , and a second force, ‘F2’ may be applied to the reinforced tip  433  of the removal element  412  to begin pulling the removal element  412  from the adhesive layer  420 . The second force may result in rotational shear, linear shear, and/or linear peeling along the removal element  412 , which causes the central section  434  to detach from the adhesive layer  420 , as demonstrated in  FIGS. 10D-10E . As the removal element  412  continues to unfold/expand, the removal element  412  generally straightens and moves towards a center of the device  400 , shearing an adhesive connection between the adhesive layer  420  and the wearer&#39;s skin. 
     Although non-limiting, the removal element  412  may include an adhesive along an exterior surface  442  thereof. This adhesive may be relatively stronger or weaker than the adhesive of the adhesive layer  420 . In other embodiments, no adhesive is present along the exterior surface  442  of the removal element  412 . 
     Turning now to  FIGS. 11A-11C , a removal system  501  of a wearable drug delivery device (hereinafter “device”)  500  according to embodiments of the present disclosure will be described. Although only a portion of the device  500  is shown for clarity, the device  500  may include any or all of the features of devices  100 ,  200 ,  300 , and/or  400  described herein. As shown, the removal system  501  includes a removal element  512  arranged along both an exterior surface  528  and an interior surface  526  of an adhesive layer  520 , wherein the adhesive layer  520  secures the device  500  to a wearer&#39;s skin. The removal element  512  may include a main element  550  extending within a conduit  552 , and a plurality of arm elements  554  extending from the main element  550 . Although shown as coupled to the interior surface  526  of the adhesive layer  520 , the conduit  552  may be coupled to the exterior surface  528  or embedded within the adhesive layer  520  in other embodiments. 
     As shown, the main element  550  may extend along a lengthwise axis ‘LA’ of the device  500 , while the arm elements  554  may extend transverse to the main element  550 . The arm elements  554  may connect with the main element  550  through openings  558  of the conduit  552 . In this embodiment, the main element  550  and the arm elements  554  may be a flexible or semi-rigid wire or string material. Furthermore, the arm elements  554  may pass through the adhesive layer  520  for connection with one or more detachment elements  560 . As best demonstrated in  FIG. 11B , the detachment elements  560  are positioned along the exterior surface  528  of the adhesive layer  520 . The detachment elements  560  may be a rigid rod or tube positioned adjacent a perimeter  535  of the adhesive layer  520 . In various embodiments, the detachment elements  560  may be non-adhesive or include an adhesive surface. 
     In some embodiments, the removal element  512  may include a rigid or reinforced tip  533 , which may be a tab, loop, or other engageable feature. In an initial configuration, the tip  533  may be positioned within the perimeter  535  of the adhesive layer  520 . In other embodiments, all or a portion of the tip  533  may extend beyond/outside the perimeter  535 . Furthermore, although shown as positioned above the interior surface  526 , the tip  533  may be positioned along the exterior surface  528  or between the interior and exterior surfaces  526 ,  528  in other embodiments. 
     During use, to remove the device  500  from the skin of the wearer, a force may be applied to the tip  533  of the removal element  512 . Although non-limiting, the force may be applied along, or parallel to, the lengthwise axis of the device  500 . The force may cause the main element  550  to move towards a first end  540  of the adhesive layer  520  and the arm elements  554  to move towards the conduit  552 . The arm elements  554  in turn pull the detachment elements  560  towards the conduit  552 , resulting in rotational shear, linear shear, and/or linear peeling between the adhesive layer  520  and the wearer&#39;s skin. In some embodiments, the detachment elements  560  may crumple the adhesive layer  520  as the detachment elements  560  are brought towards the lengthwise axis. Furthermore, a height difference (e.g., along the y-direction) between the conduit  552  and the detachment elements  560  is increased as the tip  533  is pulled, resulting in an increased upward (e.g., along the y-direction) force, which causes peeling and folding of the adhesive layer  520 . 
     Turning now to  FIGS. 12A-12C , a removal system  601  of a wearable drug delivery device (hereinafter “device”)  600  according to embodiments of the present disclosure will be described. Although only a portion of the device  600  is shown for clarity, the device  600  may include any or all of the features of the devices described herein. As shown, the removal system  601  includes a removal element  612  arranged along both an exterior surface  628  and an interior surface  626  of an adhesive layer  620 , wherein the adhesive layer  620  is securable to a wearer&#39;s skin. The removal element  612  may include a main element  650  extending within a conduit  652 , and a plurality of arm elements  654  extending from the main element  650 . Although shown as coupled to the interior surface  626  of the adhesive layer  620 , the conduit  652  may be coupled to the exterior surface  628  or embedded within the adhesive layer  620  in other embodiments. 
     As shown, the main element  650  may extend along a lengthwise axis ‘LA’ of the device  600 , while the arm elements  654  may extend transverse to the main element  650 . The arm elements  654  may connect with the main element  650  through openings  658  of the conduit  652 . In this embodiment, the main element  650  and the arm elements  654  may be a flexible or semi-rigid wire or string material. Furthermore, the arm elements  654  may pass through the adhesive layer  620  for connection with one or more detachment elements  660 . As best demonstrated in  FIG. 12B , the detachment elements  660  are positioned along the exterior surface  628  of the adhesive layer  620 . The detachment elements  660  may be flat discs, as shown, or an additional wire length configured as a loop or other shape. Embodiments herein are not limited in this context. 
     During use, to remove the device  600  from the skin of the wearer, a force may be applied, along the lengthwise axis, to a tip  633  of the removal element  612 . The force may cause the main element  650  to move towards a first end  640  of the adhesive layer  620  and the arm elements  654  to move towards the conduit  652 . The arm elements  654  in turn pull the detachment elements  660  towards the conduit, resulting in rotational shear, linear shear, and/or linear peeling between the adhesive layer  620  and the wearer&#39;s skin. In some embodiments, the detachment elements  660  may crumple the adhesive layer  620  as the detachment elements  660  are brought towards the lengthwise axis. 
     Although non-limiting, the detachment elements  660  may include an adhesive along an exterior surface  642  ( FIG. 12B ) thereof. This adhesive may be relatively stronger or weaker than the adhesive of the adhesive layer  620 . In other embodiments, no adhesive is present along the exterior surface  642  of the detachment elements  660 . In yet other embodiments, an adhesive of the adhesive layer  620  within an interior of each detachment element  660  may be stronger than the adhesive of the remainder of the adhesive layer  620 . When the removal element  612  is pulled, the detachment elements  660  separate the wearer&#39;s skin from the stronger portions of the adhesive, making the remaining parts easier to peel. 
     Turning now to  FIG. 13 , a removal system  701  of a wearable drug delivery device (hereinafter “device”)  700  according to embodiments of the present disclosure will be described. Although only a portion of the device  700  is shown for clarity, the device  700  may include any or all of the features of the devices described herein. As shown, the removal system  701  includes a removal element  712  coupled to an adhesive layer  720 , wherein the adhesive layer  720  is securable to a wearer&#39;s skin. The removal element  712  may include a main element  750  extending within a conduit  752 , and a plurality of arm elements  754  extending from the main element  750 . In other embodiments no conduit  752  is present. 
     As shown, the main element  750  may extend along a lengthwise axis ‘LA’ of the device  700 , while the arm elements  754  may extend transverse to the main element  750 . The arm elements  754  may connect with the main element  750  through openings of the conduit  672 . In this embodiment, the main element  750  and the arm elements  754  may be a flexible or semi-rigid wire or string material. 
     As further shown, the arm elements  754  may be coupled to a plurality of removal portions  760  of the adhesive layer  720 . For example, the arm elements  754  may be embedded within the removal portions  760 . In various embodiments, the removal portions  760  may be co-planar with the exterior surface of the adhesive layer  720 , or the removal portions  760  may be recessed into the adhesive layer  720 . The removal portions  760  may be connected to the adhesive layer  720  at a perforated interface or connection  737 . 
     During use, to remove the device  700  from the skin of the wearer, a force may be applied, along the lengthwise axis, to a tip  733  of the removal element  712 . The force may cause the main element  750  to move towards a first end  740  of the adhesive layer  720 , and the arm elements  754  to move towards the conduit  752 . The arm elements  754  in turn pull the removal portions  760  towards the conduit, resulting in rotational shear, linear shear, and/or linear peeling between the removal portions  760  and the wearer&#39;s skin. 
     Although non-limiting, the removal portions  760  may include an adhesive along an exterior surface in contact with the wearer&#39;s skin. This adhesive may be relatively stronger or weaker than the adhesive of the adhesive layer  720 . In other embodiments, no adhesive is present along the exterior surface of the removal portions  760 . 
     Turning now to  FIGS. 14A-14B , a removal system  801  of a wearable drug delivery device (hereinafter “device”)  800  according to embodiments of the present disclosure will be described. Although only a portion of the device  800  is shown for clarity, the device  800  may include any or all of the features of the devices described herein. In this embodiment, the removal system  801  includes a removal element  812  coupled to an adhesive layer  820 , the removal element  812  including a main element  850  extending within a conduit  852 . A plurality of rigid arm elements  854  may extend laterally from the main element  850 . As shown, the arm elements  854  may connect with one or more detachment elements  860 . Although non-limiting, the detachment elements  860  may be a rigid rod or tube positioned adjacent a perimeter  835  of the adhesive layer  820 . 
     As shown, the adhesive layer  820  may include a plurality of cutouts  870  to encourage shearing between the adhesive layer  820  and a wearer&#39;s skin during removal. The cutouts  870  may be openings through the adhesive layer  820 , or they may be areas of the adhesive layer  820  without any adhesive along an exterior surface  828 . In some embodiments, a pulling force on a tip  833  of the main element  850  causes the detachment elements  860  to stretch the adhesive layer  820  over the arm elements  854  extending from the conduit  852 , as demonstrated in  FIG. 14B . Stretching of the adhesive layer  820  weakens the overall bond strength between the adhesive and skin, making it easier to remove the device  800 . The adhesive layer  820  with cutouts  870  may be incorporated into any of the devices or embodiments described herein. 
     As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. Furthermore, references to “one embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments also incorporating the recited features. 
     The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Accordingly, the terms “including,” “comprising,” or “having” and variations thereof are open-ended expressions and can be used interchangeably herein. 
     All directional references (e.g., proximal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, etc.) are only used for identification purposes to aid the reader&#39;s understanding of the present disclosure. The directional references do not create limitations, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer two elements are directly connected and in fixed relation to each other. 
     Still furthermore, although the illustrative method  301  is described above as a series of acts or events, the present disclosure is not limited by the illustrated ordering of such acts or events unless specifically stated. For example, some acts may occur in different orders and/or concurrently with other acts or events apart from those illustrated and/or described herein, in accordance with the disclosure. In addition, not all illustrated acts or events may be necessary to implement a methodology in accordance with the present disclosure. Furthermore, the method  301  may be implemented in association with the formation and/or processing of structures illustrated and described herein as well as in association with other structures not illustrated. 
     The present disclosure is not to be limited in scope by the specific embodiments described herein. Indeed, other various embodiments of and modifications to the present disclosure, in addition to those described herein, will be apparent to those of ordinary skill in the art from the foregoing description and accompanying drawings. Thus, such other embodiments and modifications are intended to fall within the scope of the present disclosure. Furthermore, the present disclosure has been described herein in the context of a particular implementation in a particular environment for a particular purpose. Those of ordinary skill in the art will recognize the usefulness is not limited thereto and the present disclosure may be beneficially implemented in any number of environments for any number of purposes. Thus, the claims set forth below are to be construed in view of the full breadth and spirit of the present disclosure as described herein.