Tensioning applicator for attaching wearable medical device to skin surface and method thereof

Abstract

A tensioning applicator for attaching a wearable medical device to a tensioned skin surface and a method of using the same are described. A wearable medical device has a plurality of microneedles located on a first rotationally different section and a plurality of microneedles located on a second rotationally different section.

Description

BACKGROUND

[0001] The wearable medical device and / or fitness monitoring device industry is growing. People are becoming more interested in monitoring their health and sharing their health data remotely with a physician or emergency personnel. Many current devices that monitor parameters such as heart rate, blood pressure, oxygen saturation, etc. are in the form of wearable accessories, such as watches, bands, rings, chest bands, etc. However, not all parameters can be measured in this way, and these wearable devices are not sufficiently discreet. For example, continuous glucose monitoring via a device that adheres to the skin is becoming increasingly popular among diabetics, and even among people following a low-carb diet. However, the adhesive required to wear such devices often leads to skin damage and infection, especially in elderly users. Adhesives are also known to cause allergic reactions in some individuals, which can be severe enough to prevent some patients from using these devices.

[0002] What is needed is a way to secure a monitoring device to the skin without the need to use an adhesive. SUMMARY

[0003] In one embodiment, an applicator for attaching a wearable medical device to a skin surface is described. The applicator includes a loading actuator configured to counter-rotationally load first and second rotationally distinct sections of the wearable medical device; a retention system configured to retain the wearable medical device in the counter-rotationally loaded configuration; a skin tensioning system having a plurality of tensioning microneedles and a tensioning actuator configured to rotate the plurality of tensioning microneedles about an area within the applicator in which the wearable medical device is housed; and a mechanism for releasing the wearable medical device from the counter-rotationally loaded configuration.

[0004] In one embodiment, an applicator for attaching a wearable medical device to a skin surface is described. The applicator includes a loading actuator configured to counter-rotationally load first and second rotationally distinct sections of the wearable medical device; a retention system configured to retain the wearable medical device in the counter-rotationally loaded configuration; a skin tensioning system having a plurality of tensioning microneedles and a tensioning actuator configured to rotate the plurality of tensioning microneedles about an area within the applicator in which the wearable medical device is housed; and a mechanism for releasing the wearable medical device from the counter-rotationally loaded configuration.

[0005] In one embodiment, a method for attaching a wearable medical device to a tensed skin surface is described. The method includes providing an applicator described herein having a wearable medical device therein; and rotating first and second rotationally distinct sections of the wearable medical device such that the wearable medical device is in a counter-rotationally loaded configuration. The method further includes contacting the skin surface with the applicator; engaging a tensioning actuator such that a plurality of tensioning microneedles in contact with the skin surface rotate to create a tensed skin surface; and releasing the wearable medical device from the counter-rotationally loaded configuration such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the tensed skin surface.

[0006] In many embodiments, a method for attaching a wearable medical device to a tensed skin surface is described. The method includes providing an applicator described herein having a wearable medical device therein; contacting the skin surface with the applicator; and engaging a tensioning actuator such that a plurality of tensioning microneedles in contact with the skin surface rotate to create a tensed skin surface. The method further includes rotating a first rotationally distinct section of the wearable medical device and rotating a rotationally distinct section of the wearable medical device such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the tensed skin surface.

[0007] In one embodiment, a kit is described. The kit includes an applicator of the present disclosure and a set of instructions for attaching a wearable medical device to a skin surface. BRIEF DESCRIPTION OF DRAWINGS

[0008] The following detailed description of various embodiments of the present disclosure, made in connection with the drawings, can be more fully understood.

[0009] FIG. 1A is a bottom side view of the wearable medical device of

[0010] FIG. 1B is a top view of the wearable medical device of FIG. 1A

[0011] FIG. 2A is a top side view of the wearable medical device of the present disclosure.

[0012] FIG. 2B is a top view of the wearable medical device of FIG. 2A

[0013] is a bottom side view of the wearable medical device of the present disclosure. FIG. 3A

[0014] is a top view of the wearable medical device of FIG. 3B FIG. 2A ​​top view of a wearable medical device of

[0015] FIG. 4 side view and elevation angle measurement of a microneedle of the present disclosure are shown.

[0016] FIG. 5 top view and orientation angle measurement of a microneedle of the present disclosure are shown.

[0017] FIG. 6A top view of a wearable medical device with a mechanical actuator in an unloaded configuration.

[0018] FIG. 6B top view of a wearable medical device with a mechanical actuator in a loaded configuration.

[0019] FIG. 7A portion of an applicator of a wearable medical device with an insertion.

[0020] FIG. 7B portion of an applicator of a wearable medical device with an insertion. FIG. 7A

[0021] FIG. 8 applicator of the present disclosure with an example skin tensioning system and an inserted wearable medical device.

[0022] FIG. 9A example skin tensioning system for use in an applicator of the present disclosure.

[0023] FIG. 9B example tensioning actuator for use in a skin tensioning system.

[0024] FIG. 10 side view of an example applicator of the present disclosure.

[0025] FIG. 11 diagram of an applicator of the present disclosure tensioning a skin surface.

[0026] In the following description, reference is made to the accompanying drawings which form a part hereof. Various embodiments of the present disclosure are described exemplarily. It is to be understood that structural changes can be made without departing from the scope of the present disclosure. The drawings used are not necessarily to scale. Like numerals refer to like parts (e.g., 102, 202, 302, etc.; 110, 210, 310, etc.; etc.) throughout the several views. DETAILED DESCRIPTION

[0027] ​The present disclosure describes a wearable medical device that can be affixed to the skin via microneedles and an applicator for attaching the wearable medical device to the surface of the skin. The wearable medical device utilizes opposing forces between rotating sections to not only drive the microneedles into the skin, but also to affix the microneedles within the skin. Relative to similar devices that adhere to the skin via adhesive, the wearable medical device that is attached to the skin via microneedles is more resistant to accidental detachment and is worn for a longer period of time. Furthermore, the wearable medical device of the present disclosure is painlessly attached, painlessly worn, and does not cause skin damage or adverse reactions that often accompany adhesives. Additionally, the wearable medical device of the present disclosure allows for air flow underneath the device to prevent the growth of bacteria due to moisture accumulation and also allows for cleaning.

[0028] While the wearable medical device can include a permanent monitoring device thereon, the wearable medical device of the present disclosure is primarily intended to be used as a base for affixing a removable monitoring device thereto. The user can enjoy the flexibility of a modular system.

[0029] The applicator described herein performs tensioning of the surface of the skin to further increase the duration of wear. Attaching the wearable medical device into the tensioned surface of the skin allows for stronger anchoring of the microneedles as the surface of the skin relaxes.

[0030] Definitions

[0031] As used herein, the term“about” means ±10% of a given value. For example, about 10 means 9 to 11.

[0032] As used herein, the term“adhesive” as used herein refers to a polymeric composition that adheres two adherends together. Examples of adhesives are pressure sensitive adhesives and gel adhesives.

[0033] As used herein, the term“actuation guide” refers to a feature on or within a component of the applicator that is complementary to an applicator guide within the wearable medical device. In the manner of rotation within the applicator, the cooperation of the actuation guide and the applicator guide effectively rotates the first rotationally distinct section and / or the second rotationally distinct section within the wearable medical device.

[0034] As used herein, the term“applicator guide” or“application guide” refers to a feature on or within a component of the wearable medical device that is complementary to an actuation guide within the applicator. In the manner of rotation within the applicator, the cooperation of the applicator guide and the actuation guide effectively rotates the first rotationally distinct section and / or the second rotationally distinct section within the wearable medical device.

[0035] As used herein, the term “barb” describes a feature on a microneedle body that extends outward at an angle from the microneedle body. Barbed needles can be more difficult to remove from a skin surface than non-barbed needles. Also, barbed needles can prevent full penetration as compared to non-barbed needles. Barbed needles can increase attachment, thereby extending wear time. Barbed needles can also help achieve a desired gap between a wearable medical device and a skin surface.

[0036] As used herein, “center” refers to the point where two perpendicular planes intersect and each of the regions in the corresponding quadrants are equal. For example, the center of a microneedle base is the center of the region in contact with the corresponding rotationally distinct segment.

[0037] As used herein, the term “communicating member” refers to a substance that connects a first rotationally distinct segment and a second rotationally distinct segment, but the substance does not prevent independent rotation of the first rotationally distinct segment and the second rotationally distinct segment. As used herein, the term “tensioning communicating member” refers to an article that connects a first rotationally distinct segment and a second rotationally distinct segment, wherein the article deforms and stores potential energy when the first rotationally distinct segment and the second rotationally distinct segment are rotated, and the potential energy is converted to kinetic energy when the article is allowed to at least partially return to its original state. As used herein, “rolling communicating member” refers to a rotational article that is at least partially located between a first rotationally distinct segment and a second rotationally distinct segment, wherein the rotational article is accordingly rotated when the first rotationally distinct segment and the second rotationally distinct segment are rotated.

[0038] As used herein, the term “counter-rotationally” is used to describe the manner in which a first rotationally distinct segment and a second rotationally distinct segment rotate relative to each other. One segment rotates clockwise and the other segment rotates counterclockwise.

[0039] As used herein, “flexible” describes an article that can be stretched, bent, compressed, or otherwise twisted under the action of a force, but at least partially returns to an unstretched, unbent, uncompressed, or untwisted state when the force is removed.

[0040] As used herein, the term “microneedle” refers to a microstructured protrusion having a tip configured to penetrate the skin.

[0041] As used herein, “rotate” refers to moving about an axis of rotation by a degree.

[0042] As used herein, the phrase “rotationally distinct” describes a component that can rotate independently of another component. For example, two rotationally distinct components that are otherwise connected can be able to rotate in opposite directions to a degree.

[0043] BRIEF DESCRIPTION OF DRAWINGS

[0044] FIG. 1A is a bottom view of the wearable medical device 100 of the present disclosure, showing the first major surface of the base 102. The wearable medical device 100 includes a base 102 that includes a first rotationally distinct section 104 having a plurality of first microneedles 106 thereon and a second rotationally distinct section 108 having a plurality of second microneedles 110 thereon. The first and second rotationally distinct sections 104, 108 are shown in the shape of concentric cylindrical rings that are connected by a (tensioned) communication member 112 (shown here as a flexible rod or band). The communication member 112 is depicted as connecting the first and second rotationally distinct sections 104, 108 in a non-radial manner. During application, a loading actuator (not shown) causes the first rotationally distinct section 104 to rotate in a direction opposite the first microneedle 106 tips (shown here as clockwise) and the second rotationally distinct section 108 to rotate in a direction opposite the second microneedle 110 tips (shown here as counterclockwise), thereby contracting the communication member 112. The communication member 112 is stretched as the first and second rotationally distinct sections are rotated. Alternative arrangements in which the communication member 112 is otherwise flexed can be readily envisioned. Retention elements (not shown) hold the respective rotationally distinct sections 104 / 108 in the oppositely rotatingly loaded configuration. Upon contact with the skin, the retention elements (not shown) can disengage to release the wearable medical device 100, with the oppositely directed first and second microneedles 106 / 110 being driven into the skin surface by the (tensioned) communication member 112 at least partially returning to a relaxed state, respectively.

[0045] FIG. 1B is FIG. 1A is a top view of the wearable medical device 100 of the present disclosure, showing the second major surface of the base 102. The first and second rotationally distinct sections 104, 108 are shown in the shape of concentric cylindrical rings connected by the communication member 112.

[0046] FIG. 2Ais a top side view of the wearable medical device 200 of the present disclosure, showing the first major surface 202a and the second major surface 202b of the base 202. The wearable medical device 200 includes a base 202 that includes a first rotationally distinct section 204 having a plurality of first microneedles 206 thereon and a second rotationally distinct section 208 having a plurality of second microneedles 210 thereon. The first rotationally distinct section 204 and the second rotationally distinct section 208 are shown in the shape of concentric cylindrical rings that are in mechanical communication by a (rolling) communication member 212 (shown here as a rolling disc). During application, a drive actuator (not shown) causes the first rotationally distinct section 204 to rotate in a direction that aligns with the first microneedle 206 tips (shown here as clockwise) and the second rotationally distinct section 208 to rotate in a direction that aligns with the second microneedle 210 tips (shown here as counterclockwise), thereby causing the communication member 212 to roll. Upon contact with the skin, the drive actuator drives the first and second microneedles 206 / 210 into the skin surface.

[0047] FIG. 2B is FIG. 2A a top view of the wearable medical device 200, showing the second major surface of the base 202. The first rotationally distinct section 204 and the second rotationally distinct section 208 are shown in the shape of concentric cylindrical rings that are in mechanical communication by a (rolling) communication member 212.

[0048] FIG. 3Ais a bottom side view of a wearable medical device 300 showing a first major surface 302a and a second major surface 302b of a base 302. The wearable medical device 300 includes the base 302 comprising a first rotationally distinct section 304 with a plurality of first microneedles 306 thereon and a second rotationally distinct section 308 with a plurality of second microneedles 310 thereon. The first and second rotationally distinct sections 304 / 308 are shown in the shape of concentric cylindrical rings, and the respective microneedles 306 / 310 are each in flush rows. The wearable medical device 300 further includes a flexible film 311 in contact with the second major surface 302b. The flexible film 311 is adhered to the first and second rotationally distinct sections 304 / 308 and acts as a (tensioned) communication member 312 therebetween. During application, a loading actuator (not shown) rotates the first rotationally distinct section 304 in a direction opposite the first microneedle 306 tips (here shown counterclockwise) and the second rotationally distinct section 308 in a direction opposite the second microneedle 310 tips (here shown clockwise), thereby stretching the flexible film 311 / communication member 312 therebetween. A retention element (not shown) retains the respective rotationally distinct sections 304 / 308 in the oppositely rotatingly loaded configuration. Upon contact with the skin, a release element (not shown) can disengage to release the wearable medical device 300, with the opposite first and second microneedles 306 / 310 driven into the skin surface by the flexible film 311 / communication member 312 at least partially returning to a relaxed state.

[0049] FIG. 3B is FIG. 1AA top view of the wearable medical device 300 in FIG. 3 is shown with the second major surface of the base 302. A portion of the flexible membrane 311 / communicating member 312 can be observed between the in-laid backing 314 covering the first rotationally distinct segment (not shown) and the out-laid backing 316 covering the second rotationally distinct segment (not shown). The in-laid backing 314 is shown with in-applied guides 318 and the out-laid backing 316 is shown with out-applied guides 320. During application, a loading actuator (not shown) rotates the first rotationally distinct segment (not shown) in one direction (here shown as clockwise) by communicating with the in-laid backing 314 / in-applied guides 318 and rotates the second rotationally distinct segment (not shown) in the opposite direction (here shown as counter-clockwise) by communicating with the out-laid backing 316 / out-applied guides 320. In effect, the flexible membrane 311 / communicating member 312 is stretched or otherwise twisted. Retaining elements (not shown) hold the respective rotationally distinct segments in the oppositely rotatingly loaded configuration. Upon contact with the skin, the retaining elements (not shown) can disengage to release the wearable medical device 300 with the first microneedles and the second microneedles (not shown) driven into the skin surface by the flexible membrane 311 / communicating member 312 at least partially returning to a relaxed state.

[0050] FIG. 4 A side view of an example first microneedle 406 (or second microneedle) of the present disclosure is shown. The first microneedle 406 is shown with a microneedle base 422 in contact with the first rotationally distinct segment 404. The microneedle base 422 extends into a microneedle body 424 and terminates at a microneedle tip 426. The first microneedle 406 is shown at an elevation angle 428 (“θ EA ”). The elevation angle 428 is measured relative to a plane B passing through the center of the microneedle base 422 from a plane A parallel to the surface in which the first microneedle 406 is in contact with the first rotationally distinct segment 404 to the microneedle tip 426 (see plane C). — Plane A and plane B are perpendicular to each other, i.e., 90°.

[0051] FIG. 5 A top view of the first rotationally distinct segment 504 (or second microneedle on the second rotationally distinct segment) of the present disclosure with a plurality of first microneedles 506 disposed thereon is shown. Each of the plurality of first microneedles 506 is independently disposed at an orientation angle 530 (“θ OA ”). The orientation angle 530 is measured relative to a radial plane D and a tangential plane E (i.e., the tangential plane E is tangent to the radial plane D, i.e., 90°). Plane F is parallel to plane E and is used for visual aid only. Each radial plane D passes through the center of the microneedle base 522 (see FIG. 4plane B, i.e., the radial plane D in the z-direction normal to plane B; tangential planes E and F in the x-direction). The first microneedle 506a aligned with the tangential planes E and F has an orientation angle 530, i.e., Θ OA = 0°. The first microneedle 506b angled toward the axis of rotation is characterized by an orientation angle 530, i.e., Θ OA < 0°, e.g., -10°. The first microneedle 506c angled away from the axis of rotation is characterized by an orientation angle 530, i.e., Θ OA > 0°, e.g., 10°. The description need not be limited to circular configurations.

[0052] FIG. 6A A top view (second major surface) of a wearable medical device 600 with a set of mechanical actuators 632a / 632b is shown, with the medical device shown in an unloaded configuration. The wearable medical device 600 includes a base 602 with a first rotationally distinct segment 604, a second rotationally distinct segment 608, and a communication member 612. A first mechanical actuator 632a is in communication with the first rotationally distinct segment 604, and a second mechanical actuator 632b is in communication with the second rotationally distinct segment 608. Upon squeezing the mechanical actuators 632a / 632b together, the first rotationally distinct segment 604 rotates counterclockwise, and the second rotationally distinct segment 608 rotates clockwise. The mechanical actuators 632a / 632b can be used to attach the wearable medical device to a skin surface or remove the wearable medical device from a skin surface.

[0053] FIG. 6B A top view of a wearable medical device 600 with a set of mechanical actuators 632a / 632b is shown, with the medical device shown in a loaded configuration. As compared to the unloaded configuration of FIG. 6A The communication member 612 is shown as stretched as compared to the unloaded configuration.

[0054] FIG. 7A A portion of an applicator 701 of an example insertion wearable medical device 700 in an unloaded configuration is shown. The applicator 701 does not include a skin tensioning system as described in the present disclosure. The applicator 701 is shown to illustrate aspects of the applicator related to loading the wearable medical device. The applicator 701 is shown to include a first segment actuation guide 703 within an inner wall 705 that cooperates with a first applicator guide 707 located on a first rotationally distinct segment 704. The applicator 701 is also shown to include a second segment actuation guide 709 within an outer wall 711 that cooperates with a second applicator guide 713 located on a second rotationally distinct segment 708.

[0055] FIG. 7B A portion of an example applicator 701 of a wearable medical device 700 is shown in a counter-rotatingly loaded configuration. The first rotationally distinct section 704 has been rotated clockwise, and the second rotationally distinct section 708 has been rotated counterclockwise. The applicator 701 holds the wearable medical device 700 in this counter-rotatingly loaded configuration (hold elements not shown) until the applicator 701 contacts a skin surface. Upon disengaging the hold elements (not shown), the wearable medical device 700 is released from the loaded configuration, and the plurality of microneedles on each section are driven into the skin surface.

[0056] FIG. 8 An applicator 801 of the present disclosure is shown with an example skin tensioning system 813 that surrounds an area in which a wearable medical device 800 is located. The applicator 801 is shown as including a skin tensioning system 813 that includes a first rotationally distinct tensioning section 815 having a plurality of first tensioning microneedles 817 thereon and a second rotationally distinct tensioning section 819 having a plurality of second tensioning microneedles 821 thereon. The first and second rotationally distinct tensioning sections 815, 819 are configured to operate in a similar manner as the wearable medical device 800, but without a communication member.

[0057] FIG. 9A An example skin tensioning system 913 for use in an applicator of the present disclosure is shown. The skin tensioning system 913 is shown as including a first rotationally distinct tensioning section 915 having a plurality of first tensioning microneedles 917 thereon and a second rotationally distinct tensioning section 919 having a plurality of second tensioning microneedles 921 thereon. The skin tensioning system 913 is further shown as including a tensioning actuator 923 configured to rotate the first and second rotationally distinct tensioning sections 915, 919.

[0058] FIG. 9B An applicator 901 of the present disclosure is shown without tensioning sections. FIG. 9A The tensioning actuator 923 includes a ring gear 925 configured to rotate a first rotationally distinct tensioning section (not shown), a sun gear 927 configured to rotate a second rotationally distinct tensioning section (not shown), and a plurality of planetary gears 929 located therebetween.

[0059] FIG. 10A side view of an applicator 1001 of the present disclosure is shown having an applicator housing 1031 and a torsion drive shaft 1033. The tensioning drive shaft 1033 is an element of the skin tensioning system and is configured to drive the tensioning actuator 1023. The applicator 1001 is further shown to include a plurality of first tensioning microneedles 1019 and a plurality of second tensioning microneedles 1021.

[0060] FIG. 11 is a diagram showing a cross-sectional view of an applicator 1101 of the present disclosure that tensions a skin surface SS. The applicator 1101 is pressed against the skin surface SS such that the applied force F A against the opposing force F O deforms the skin surface SS. The tensioning drive shaft 1033 is twisted to rotate a first rotationally distinct tensioning segment (not shown) having the first tensioning microneedles 1117 thereon and to rotate a second rotationally distinct tensioning segment (not shown) having the second tensioning microneedles 1121 thereon, thereby tensioning the region of the skin surface between the tensioning microneedles to form a tensioned skin surface TSS. The tensioned skin surface TSS remains in this tensioned state while the wearable medical device 1100 is released from the counter-rotatingly loaded configuration such that the first microneedles 1106 and the second microneedles 1110 are driven into the tensioned skin surface TSS.

[0061] Wearable medical device

[0062] In various embodiments, a wearable medical device is described. The wearable medical device can include a base having a first rotationally distinct segment and a second rotationally distinct segment. The second rotationally distinct segment can at least partially surround the first rotationally distinct segment. At least one communication member can communicate with the first rotationally distinct segment and the second rotationally distinct segment. The wearable medical device can also include a plurality of first microneedles located on the first rotationally distinct segment and a plurality of second microneedles located on the second rotationally distinct segment.

[0063] Further details and further features of the wearable medical device are described below. It should be understood that the details and features described below can be incorporated, either individually or in combination, unless otherwise stated.

[0064] Base

[0065] The base and all components within the base can be characterized by a first major surface and a second major surface. The first major surface is considered to be the skin contact surface, while the second major surface is opposite the first major surface and does not contact the skin when the wearable medical device is in use. Thus, all first microneedles and second microneedles described herein are located on the first major surface of the base.

[0066] In some embodiments, the base can further include one or more applicator guides for mating with an applicator, the applicator guides configured for rotating the first rotationally distinct segment and the second rotationally distinct segment. For example, the applicator guides can be in the form of one or more notches, protrusions, pins, pin holes, etc., where the applicator guides can complement actuation guides within an applicator. The applicator guides can be located on the second major surface, along the perimeter (minor surface), or a combination thereof.

[0067] In some embodiments, the base can further include one or more monitoring device securing features for attaching a monitoring device to the wearable medical device. Example monitoring device securing features can include a clip, a hook, a latch, a cradle, a threaded component for mating with a threaded monitoring device, an adhesive, or a combination thereof, etc. The monitoring device securing features can be located on the second major surface, along the perimeter (minor surface), or a combination thereof.

[0068] In some embodiments, the base can further include a first mechanical actuator in communication with the first rotationally distinct segment and a second mechanical actuator in communication with the second rotationally distinct segment. FIG. 6A and FIG. 6B Example mechanical actuation of a wearable medical device is shown without the use of an applicator as described herein. While FIG. 6A and FIG. 6B Reverse rotational loading of a wearable medical device (i.e., the mechanical actuators are pushed together) is demonstrated, but the opposite can also be envisioned. For example, a wearable medical device with rolling communication members (e.g., FIG. 2A ) can include mechanical actuators that can be used to drive the plurality of microneedles into a skin surface (i.e., the mechanical actuators are pushed apart).

[0069] In some embodiments, with or without an applicator as described herein, the mechanical actuators can be used to apply and / or remove the wearable medical device to / from a skin surface. While the mechanical actuators are not necessary for the use of an applicator as described herein, the applicator can be configured to actuate the mechanical actuators. In other words, any such mechanical actuators can be considered “applicator guides” as used herein when combined with an applicator.

[0070] In some embodiments, the base can further include a flexible film adhered to or otherwise connected to the second major surface and extending at least from the first rotationally distinct segment to the second rotationally distinct segment such that the first rotationally distinct segment can be in communication with the second rotationally distinct segment (i.e., a communication member). In some embodiments, the flexible film can span the entire second major surface of the base. In some embodiments, the flexible film can extend beyond the perimeter of the base. A base having a flexible film extending beyond the perimeter of the base can further include an adhesive thereon that can be used as an auxiliary skin attachment modality.

[0071] In some embodiments, the flexible film can be composed of a material such as a woven (e.g., cotton, rayon, polyvinyl chloride, polyethylene, or polyurethane), latex, or the like. In some embodiments, the flexible film can be breathable and water resistant.

[0072] In some embodiments, the flexible film can further include an adhesive on one or more surfaces. In some embodiments, a suitable adhesive can be composed of an acrylate, a methacrylate, an epoxy diacrylate, or the like. The adhesive can be located on a surface that, when applied, contacts the skin surface and thus serves as an auxiliary means of securing the wearable medical device to the skin. The adhesive can be located on a surface that, when applied, is opposite the skin surface and can serve as a means of attaching the placement backing and / or the monitoring device (i.e., monitoring device securing feature). In some embodiments, the flexible film can be in the form of a double-sided tape.

[0073] In many embodiments, the flexible film can be light transmissive. In many embodiments, the flexible film can be composed of a material that is easily punctured (e.g., by a needle). In other embodiments, the flexible film can include regions devoid of material for passage of a needle (e.g., extending from a mounted glucose monitor device), light (e.g., emitted from a mounted oximeter device), electrode, or some other skin contacting or penetrating probe.

[0074] In many embodiments, the base can further include a flexible film as described herein and one or more placement backings. The one or more placement backings can be reversibly or irreversibly adhered to the flexible film with an adhesive or can otherwise be sewn thereto. The placement backings can include application guides configured to cooperate with loading actuators within the applicator. In some embodiments, the placement backings can include an inner placement backing configured to rotate the first rotationally distinct segment (e.g., by inner application guides) and an outer placement backing at least partially surrounding the inner placement backing configured to rotate the second rotationally distinct segment (e.g., by outer application guides).

[0075] Rotating different sections

[0076] In many embodiments, the first rotationally distinct segment and the second rotationally distinct segment can be arranged such that they share a common axis of rotation. While separate axes of rotation are conceivable and are intended to be encompassed by the scope of the present disclosure, a shared axis of rotation is the simplest and most elegant construction.

[0077] In many embodiments, the first rotationally distinct segment and the second rotationally distinct segment are configured for rotation in opposite directions (i.e., clockwise and counterclockwise relative to one another), wherein the rotation induces a stress within a communication member in communication with each segment. The stress can be in the form of tension, compression, torsion, bending, winding, twisting, rotation, etc. The applicator or other applicator device of the present disclosure can be configured to fix the first rotationally distinct segment and the second rotationally distinct segment in a state of rotation and to bear the potential energy within the stress communication member. The kinetic energy provided by the release of the stress within the communication member is effective to cause the rotationally distinct segments to remove rotation such that the microneedles on the segments can be driven into the skin under some force.

[0078] The first rotationally distinct segment and the second rotationally distinct segment can independently have any size and shape, so long as either segment does not impede the rotation of the other segment. Example shapes include a full cylinder or half cylinder, an elliptical cylinder, a conical frustum, a rectangle, a square, a truncated cone, etc.; the shape can be solid or annular (i.e., ring-shaped). An annular shape of the first rotationally distinct segment can allow light from a mounted monitoring device to pass through, or other physical contact between the skin surface and a mounted monitoring device. In some embodiments, the first rotationally distinct segment and the second rotationally distinct segment can each be a cylindrical ring (i.e., a washer) and arranged in a concentric manner. In other embodiments, the first rotationally distinct segment can be a solid cylinder and the second rotationally distinct segment can be a cylindrical ring arranged in a concentric manner. Some shapes can be more suitable for different applications, e.g., to accommodate different areas of the body, to accommodate different shapes of monitoring devices, etc.

[0079] In many embodiments, the first rotationally distinct segment and the second rotationally distinct segment are arranged such that at least one major surface of each of the segments is flush with one another. In embodiments where the first rotationally distinct segment and the second rotationally distinct segment do not include at least one major surface of each of the segments that are flush with one another, the wearable medical device will require the first microneedles and the second microneedles to be unequal in length so that each set of microneedles can contact the skin.

[0080] In some embodiments, the first and second rotationally distinct segments can each independently be characterized by a maximum length and a maximum width of about 5 mm to about 75 mm. For example, the maximum length and / or maximum width can be selected from a value (in mm) in a range of about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75, or between any of the foregoing values (e.g., between about 25 and about 40, etc.).

[0081] In some embodiments, the first and second rotationally distinct segments can each independently be characterized by an average thickness of about 1 mm to about 10 mm. For example, the average thickness can be selected from a value (in mm) in a range of about 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10, or between any of the foregoing values (e.g., between about 3 and about 8, etc.).

[0082] In many embodiments, the first and second rotationally distinct segments can each include at least 10 microneedles thereon. In some embodiments, the first and second rotationally distinct segments can each independently include 10 to 500 microneedles thereon. For example, the first and second rotationally distinct segments can each independently include a number of microneedles in a range of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, or 500, or between any of the foregoing values (e.g., between about 50 and about 100, etc.). The number of needles in each rotationally distinct segment can be selected according to various factors, such as the intended device placement, skin type, activity level of the user, intended wear time, etc.

[0083] In some embodiments, the first rotationally distinct segment can include one or more first applicator guides configured to cooperate with one or more actuator guides within an applicator described herein. The one or more first applicator guides can be located on an inner circumference (minor surface) of the first rotationally distinct segment. In some embodiments, the second rotationally distinct segment can include one or more second applicator guides configured to cooperate with one or more actuator guides within an applicator described herein. The one or more second applicator guides can be located on an outer circumference (minor surface) of the second rotationally distinct segment. In some embodiments, the first and second applicator guides can independently be in the form of notches, protrusions, pins, pin holes, etc.

[0084] In some embodiments, the first rotationally distinct segment and the second rotationally distinct segment can be composed of a material selected from a metal, a plastic, or a combination thereof.

[0085] In some embodiments, the wearable medical device can have only two rotationally distinct segments. In other embodiments, the wearable medical device can have more than two rotationally distinct segments, where any additional rotationally distinct segments can be characterized in a similar manner as any of the rotationally distinct segments described herein.

[0086] Communicating member

[0087] In some embodiments, the communication member can be a tension communication member selected from a flexible rod or band, a spring, a flexible membrane (as described above), a combination thereof, or the like. In other embodiments, the communication member can be a rolling communication member, such as a rolling disk.

[0088] In some embodiments, the communication member can be in the form of a flexible rod, a flexible band, or a spring.

[0089] In many embodiments, the communication member can at least partially connect the first rotationally distinct segment and the second rotationally distinct segment via a minor surface (e.g., an inner wall or an outer wall of a rotationally distinct segment shaped as a ring). In some embodiments, the communication member can at least partially connect the first rotationally distinct segment and the second rotationally distinct segment via a major surface (e.g., a second major surface opposite a first major surface having microneedles).

[0090] In some embodiments, the wearable medical device can include one or more communication members in the form of a flexible rod or band extending from an outer wall of a first rotationally distinct segment shaped as a ring and an inner wall of a second rotationally distinct segment shaped as a ring. In some embodiments, the flexible rod or band can extend radially (i.e., parallel to a radius) between the first rotationally distinct segment and the second rotationally distinct segment. In other embodiments, the flexible rod or band can extend non-radially (e.g., at an angle relative to a radial plane) between the first rotationally distinct segment and the second rotationally distinct segment. The non-radial arrangement can be measured according to one end of the communication member on a radial plane and the other end of the communication member measured at an angle (°) of about 1° to 45° (e.g., 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, 25, 28, 30, 32, 35, 38, 40, 42, or 45 degrees or a range between any of the foregoing values (e.g., between about 20 and about 40)) relative to the radial plane. The flexible rod or band in a non-radial arrangement can be positioned in one of two orientations (i.e., / and \), and depending on the direction of rotation of the rotationally distinct segments, the flexible rod or band can be stretched or bent.

[0091] In some embodiments, the type of communication member and the number of communication members present in the wearable medical device of the present disclosure can be selected according to the desired kinetic energy for driving the rotation of the different segments. For example, the wearable medical device can be customized for the type of skin surface to which the device is to be applied, which can require more or less force to adequately or safely install the wearable medical device into the skin surface.

[0092] In some embodiments, the wearable medical device can include 1 to 20 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 18, or 20 or a value ranging between any of the foregoing values (e.g., between 2 and 6, etc.)) communication members. In some embodiments, each of the communication members is the same type. In other embodiments, a mix of communication members can be present within the wearable medical device.

[0093] Microneedle

[0094] In many embodiments, the first microneedles and the second microneedles can be arranged in a circular or semi-circular array extending around the axis of rotation, regardless of the shape of the first rotationally distinct segment and the second rotationally distinct segment. In many embodiments, the plurality of first microneedles can be arranged in one or more rows along the first rotationally distinct segment. Likewise, the plurality of second microneedles can be arranged in one or more rows in a circular path along the second rotationally distinct segment. In some embodiments, the rows can be flush with adjacent rows or can be staggered. In some embodiments, each of the plurality of first microneedles and second microneedles can be arranged in 1 to 5 rows, e.g., 1, 2, 3, 4, or 5 rows, e.g., 2 to 3 rows.

[0095] In some embodiments, the plurality of first microneedles and second microneedles can be arranged in rows, and each microneedle can be independently separated from one another by a distance of about 1 mm to about 10 mm. For example, any of the microneedles can be separated by a distance of about 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 or a value ranging between any of the foregoing values (e.g., between about 4 and about 6, etc.) in mm.

[0096] In embodiments having more than one row, the rows can be independently separated by a distance of about 5 mm to about 10 mm. For example, the rows can be independently separated by a distance of about 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 or a value ranging between any of the foregoing values (e.g., between about 6 and about 8, etc.) in mm.

[0097] In some embodiments, each of the first microneedles and the second microneedles can independently be characterized by an elevation angle of from about 40° to about 80° relative to a plane to which the microneedle is attached (i.e., the respective rotationally distinct segment). For example, the first microneedles and the second microneedles can independently be characterized by an elevation angle of about 40, 42, 45, 48, 50, 52, 55, 58, 60, 62, 65, 68, 70, 72, 75, 78, or 80, or a value within a range between any of the foregoing values (e.g., between about 45 and about 50, etc.) (°). For reference, a microneedle that is perpendicular to a parallel plane that passes through the respective rotationally distinct segment is characterized by an elevation angle of 90°. Elevation angles that are not within the above-mentioned range are still within the scope of the present disclosure; however, it is believed that the above-mentioned range can provide benefits to the user in terms of pain reduction, skin health maintenance, and longer wear times. Obviously, depending on the point of reference, any elevation angle can be measured as an acute or an obtuse angle. Thus, the above-mentioned elevation angles can be considered as their obtuse angle counterparts (i.e., from about 140° to about 100°, respectively, and all angles therebetween). The elevation angle is measured from a parallel plane that passes through the respective rotationally distinct segment to the center of the microneedle tip relative to a plane that is perpendicular to the parallel plane and passes through the center of the microneedle base.

[0098] In many embodiments, each of the first microneedles can be characterized by the same elevation angle. In other embodiments, at least a portion of the first microneedles can be characterized by one elevation angle, and at least another portion of the first microneedles can be characterized by another elevation angle. In some cases, a mix of elevation angles can be beneficial for tailoring the wearable medical device to the intended area of the body on which the wearable medical device is to be worn. In many embodiments, each of the second microneedles can be characterized by the same elevation angle. Likewise, in other embodiments, at least a portion of the second microneedles can be characterized by one elevation angle, and at least another portion of the second microneedles can be characterized by another elevation angle. In some embodiments, each of the first microneedles and the second microneedles can be characterized by the same elevation angle, or some portion of the first microneedles or the second microneedles can be characterized by a different elevation angle.

[0099] In embodiments having at least a portion of first microneedles characterized by an elevation angle other than 90°, these elevation angle first microneedles must all point in the same rotational direction (i.e., all tips face clockwise or counterclockwise). Likewise, in embodiments having at least a portion of second microneedles characterized by an elevation angle other than 90°, these elevation angle second microneedles must all point in the same rotational direction. Further, in embodiments having both first and second microneedles characterized by an elevation angle other than 90°, the elevation angle first microneedles can be in opposite rotational directions relative to the elevation angle second microneedles. In other words, each first microneedle characterized by an elevation angle other than 90° (e.g., 40° to 80°) can be oriented such that the first microneedle tip faces in one rotational direction, and each second microneedle characterized by an elevation angle other than 90° (e.g., 40° to 80°) can be oriented such that the second microneedle tip faces in a rotational direction opposite the rotational direction of the first microneedle tip. When referring to opposite rotational directions, an implied shared rotational axis is suggested.

[0100] In some embodiments, each of the first and second microneedles characterized by an elevation angle other than 90° can be independently arranged to be at an orientation angle of about -25° to about 0° (aligned with the tangent) or about 0° (aligned with the tangent) to about 25° relative to a tangent of the rotational vector (i.e., the rotation of the respective rotationally distinct segment). Negative orientation angle values indicate that the needle points toward the rotational axis, while positive orientation angle values indicate that the needle points away from the rotational axis. For example, any given microneedle can be characterized by an orientation angle of a value (°) in a range of about -25, -22, -20, -18, -15, -12, -10, -8, -5, -2, 0, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25, or any of the foregoing values on either side of 0 (e.g., between about -15 and about -8, between about 5 and about 12, etc.). In many embodiments, each of the first and second microneedles can be arranged such that the entire needle body is aligned tangentially to the rotational vector (i.e., an orientation angle of 0°) relative to the rotation of the respective rotationally distinct segment. The orientation angle is measured from a tangential plane passing through the center of the microneedle base to the center of the microneedle tip. In other words, a microneedle parallel to the tangent of the rotational vector is characterized by an orientation angle of 0°. Further, for reference, a microneedle characterized by an orientation angle of 90° would be perpendicular to the rotational vector and would not be capable of piercing the skin surface at all during operation of the wearable medical device.

[0101] In some embodiments, each of the first microneedle and the second microneedle can independently be characterized by a length of about 0.2 mm to about 3.0 mm. For example, each of the first microneedle and the second microneedle can independently be characterized by a length of about 0.2, 0.5, 0.8, 1.0, 1.2, 1.5, 1.8, 2.0, 2.2, 2.5, 2.8, or 3.0 or a range between any of the foregoing values (e.g., between about 0.5 and about 0.8, etc.) in mm. The length of the needle can be selected as needed for the application. For example, shorter needles can be more comfortable for elderly users or for areas of the skin that can be thinner.

[0102] In some embodiments, each of the first microneedle and the second microneedle can independently be characterized by a diameter of about 1 pm to about 25 pm. For example, each of the first microneedle and the second microneedle can independently be characterized by a diameter of about 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25 or a range between any of the foregoing values (e.g., between about 8 and about 12, etc.) in pm. In some embodiments, any of the microneedles described herein can have a uniform diameter or a non-uniform diameter within the ranges described above. A non-uniform diameter can be characterized by a decreasing diameter along the microneedle body toward the tip. For example, a non-uniform diameter can decrease in diameter along the microneedle body toward the tip at a rate of about 5% to 25% (e.g., 5%, 8%, 10%, 12%, 15%, 18%, 20%, 22%, or 25%, or a range between any of the foregoing values (e.g., between 10% to about 15%, etc.)). A non-uniform diameter can also include regions within the microneedle body where the diameter can be larger, or isolated regions where the diameter can be larger. Such regions of larger diameter can be in the form of barbs. Microneedles having barbs can be used to better anchor the microneedle within the skin surface. Regions of larger diameter can also prevent the entire microneedle from penetrating the skin, effectively leaving a region between the skin surface and the base to allow air flow therebetween and prevent moisture accumulation and / or bacterial growth. In some embodiments, at least a portion of the first microneedle and / or the second microneedle can be characterized by a non-uniform diameter.

[0103] In many embodiments, it is desirable to leave a space between the skin surface and the wearable medical device such that airflow can prevent moisture buildup and bacterial growth. One way to accomplish this is to select microneedles that have a certain length and / or a certain diameter. In other words, the microneedles can only insert a certain percentage of the way into the skin. For example, the microneedles can insert 25% to 75% of the length of the skin, such as 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75% of the length, or a value within a range between any of the foregoing values. In some embodiments, the wearable medical device can have a gap thickness of about 0.15 mm to about 1 mm (e.g., 0.15 mm, 0.2 mm, 0.25 mm, 0.3 mm, 0.35 mm, 0.4 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.60 mm, 0.65 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm, or 1 mm or a value within a range between any of the foregoing values) above the skin surface.

[0104] In some embodiments, any of the microneedles described herein can also include a microneedle base. The microneedle base can be any shape, but it is typically at least 25% larger than the diameter of the microneedle. The microneedle base can provide stability, but also serves to prevent the microneedle from inserting 100% into the skin surface, thereby leaving the desired gap between the skin surface and the wearable medical device. In some embodiments, the microneedle base can be the shape of a truncated or tapered-truncated cone.

[0105] In many embodiments, any of the microneedles described herein can be constructed from plastic, metal, absorbable material, or a combination thereof. Suitable plastics include polyolefin materials, polyesters, polyurethanes, and the like. Suitable metals include stainless steel, titanium, and nitinol (nickel / titanium alloy), and the like. Absorbable materials include those used to form absorbable sutures, such as polyglycolide (e.g., DEXON®), poly(glycolide / lactide) random copolymer (e.g., VICRYL®), and the like. TM TM

[0106] In some embodiments, any of the microneedles described herein can be coated with one or more electrically conductive substances such that the wearable medical device can function as a dry electrode.

[0107] In some embodiments, any of the microneedles described herein can be solid or hollow. Hollow microneedles can allow passage of a therapeutic agent.

[0108] In some embodiments, each of the first microneedles and the second microneedles can be the same. In other embodiments, any of the first microneedles or any of the second microneedles can differ from one another in one or more of the aspects described above.​​

[0109] Applicator

[0110] In many embodiments, an applicator for attaching a wearable medical device of the present disclosure to a skin surface is described. The applicator can include a loading actuator configured to counter-rotationally load a first rotationally distinct section and a second rotationally distinct section of the wearable medical device, a retention system configured to retain the wearable medical device in the counter-rotationally loaded configuration, a skin tensioning system having a plurality of tensioning needles and a tensioning actuator configured to rotate the plurality of tensioning needles about an area of the wearable medical device contained within the applicator, and a mechanism for releasing the wearable medical device from the counter-rotationally loaded configuration. For example, an applicator having a loading actuator can be suitable for use with a wearable medical device described herein having a tensioning communication member.

[0111] In many embodiments, an applicator for attaching a wearable medical device of the present disclosure to a skin surface is described. The applicator can include a driving actuator configured to rotationally drive a first rotationally distinct section and a second rotationally distinct section within the wearable medical device in a counter-rotational manner, and a skin tensioning system having a plurality of tensioning needles and a tensioning actuator configured to rotate the plurality of tensioning needles about an area of the wearable medical device contained within the applicator. For example, an applicator having a driving actuator can be suitable for use with a wearable medical device described herein having a rolling communication member.

[0112] In some embodiments, features of the described applicators can be strictly mechanically driven. In other embodiments, features of the applicators can be at least partially electrically driven.

[0113] While the applicators described herein relate to assisting in the attachment of wearable medical devices of the present disclosure, the applicators can be used to attach wearable medical devices that can be outside the described scope, so long as the wearable medical devices include a first rotationally distinct section, a second rotationally distinct section, and a plurality of microneedles.

[0114] In some embodiments, the described applicators can also be configured to remove a wearable medical device from a skin surface. To remove a wearable medical device, the applicator can be brought into contact with the wearable medical device, and the loading actuator engaged to effectively rotate the first rotationally distinct section and the second rotationally distinct section such that the first microneedles and the second microneedles are removed from the skin surface.

[0115] Further details of the applicators are described below.

[0116] Loading actuator

[0117] In some embodiments, the loading actuator can include any combination of mechanical components for effecting rotation of the first rotationally distinct segment and the second rotationally distinct segment. For example, the loading actuator can include one or more of a spring, a gear, a piston, a pump, etc. In some embodiments, the loading actuator can include a planetary gear system having a ring gear, a sun gear, and one or more planetary gears. For example, the ring gear can be effective to rotate the second rotationally distinct segment of the wearable medical device, and the sun gear can be effective to rotate the first rotationally distinct segment. In other words, the rotationally distinct segments of the wearable medical device can have gear teeth that are complementary to the respective gears. In some embodiments, the applicator can include a mechanism for engaging the loading actuator. For example, the mechanism can include a twist applicator, a retracting plunger, etc.

[0118] In some embodiments, the loading actuator can be tuned to a particular tensioned communication member or a particular number of communication members. For example, the loading actuator can be configured to load the wearable medical device in reverse rotation with a selected degree of rotation such that the communication members are fully or incompletely relaxed once the wearable medical device is attached to the skin surface. Incompletely relaxed communication members once the wearable medical device is attached to the skin surface can be used to further secure the wearable medical device into the skin surface because the remaining tension will continuously pull the opposing microneedles into the skin. However, excessive residual tension in the communication members can cause injury when in the skin surface. Conversely, the communication members can be over-extended upon application. In other words, the communication members that have relaxed beyond the original configuration can in fact be re-tensioned. Over-extended communication members can ultimately act to pull the microneedles out of the skin surface due to the force favoring return to their original configuration when the wearable medical device is attached to the skin surface, reducing wear time.

[0119] Driving actuator

[0120] In some embodiments, the driving actuator can include any combination of mechanical components for effecting rotation of the first rotationally distinct segment and the second rotationally distinct segment. For example, the driving actuator can include one or more of a spring, a gear (e.g., a planetary gear system), a piston, a pump, etc. In some embodiments, the applicator can include a mechanism for engaging the driving actuator. For example, the mechanism can include a twist applicator, a retracting plunger, etc.

[0121] Retention system

[0122] In some embodiments, the retention system can include any combination of mechanical components for retaining the first rotationally distinct segment and the second rotationally distinct segment of the wearable medical device in a counter-rotationally loaded configuration. In some embodiments, the retention system can include retention elements, such as pins, latches, cradles, and the like.

[0123] In some embodiments, the retention system can also include a docking platform for retaining the wearable medical device within the applicator. In some embodiments, the docking platform can extend beyond the perimeter of the applicator. For example, upon tensioning the skin surface, it can not be desirable for multiple microneedles of the wearable medical device to come into contact with the skin surface while under tension. Thus, the docking platform can be configured for retracting the wearable medical device away from the skin surface prior to tensioning of the skin surface and / or extending the wearable medical device toward the skin surface after tensioning of the skin surface.

[0124] Skin tensioning system

[0125] In many embodiments, the tensioning actuator is configured for rotating the multiple tensioning microneedles about an area of the wearable medical device that is housed within the applicator (e.g., a retention system, such as a docking platform). In some embodiments, the tensioning actuator can include a planetary gear transmission system for rotating the multiple microneedles about the retention system.

[0126] In many embodiments, the multiple tensioning microneedles can be present as a first multiple tensioning microneedles and a second multiple tensioning microneedles. In some embodiments, the first multiple tensioning microneedles can be located on a first rotationally distinct tensioning segment, and the second multiple tensioning microneedles can be located on a second rotationally distinct tensioning segment, where the second rotationally distinct tensioning segment at least partially surrounds the first rotationally distinct tensioning segment. The first rotationally distinct tensioning segment and the second rotationally distinct tensioning segment can be configured for rotating in opposite directions about an axis of rotation (i.e., in a counter-rotational manner). In many embodiments, the first rotationally distinct tensioning segment and the second rotationally distinct tensioning segment each take the shape of a cylindrical ring and are arranged in a concentric manner.

[0127] In embodiments having a first rotationally distinct tensioning segment and a second rotationally distinct tensioning segment, the tensioning actuator can include a planetary gear transmission system having a ring gear, a sun gear, and one or more planet gears. For example, the ring gear can be effective for rotating the second rotationally distinct tensioning segment, and the sun gear can be effective for rotating the first rotationally distinct tensioning segment. In other words, the rotationally distinct tensioning segments can have gear teeth that are complementary to the respective gears.

[0128] In some embodiments, the plurality of tensioning microneedles can each be independently characterized by an elevation angle of about 40° to about 80° relative to a plane to which the microneedle is attached (e.g., about 40° to about 80° relative to the respective rotationally distinct tensioning segment). For example, at least a portion of the plurality of tensioning microneedles can be independently characterized by an elevation angle of about 40, 42, 45, 48, 50, 52, 55, 58, 60, 62, 65, 68, 70, 72, 75, 78, or 80, or a range of values (°) between any of the foregoing values (e.g., between about 45 and about 50, etc.). Elevation angles that are not within the above- described range (e.g., 90°) are still within the scope of the present disclosure, but can not be sufficient to tension the skin surface. Measuring the elevation angle of a tensioning microneedle is the same as measuring the elevation angle of a microneedle on a wearable medical device described above. In embodiments having a first plurality of tensioning microneedles and a second plurality of tensioning microneedles on respective rotationally distinct tensioning segments, wherein at least a portion of the first plurality of tensioning microneedles and the second plurality of tensioning microneedles are characterized by an elevation angle (e.g., 40° to 80°), the plurality of first tensioning needles can be oriented such that the first tensioning microneedle tips face in one rotational direction, and the plurality of second tensioning microneedles can be oriented such that the second microneedle tips face in a rotational direction that is opposite the rotational direction of the first tensioning microneedle tips.

[0129] In some embodiments, each of the first and second tensioning microneedles, which are characterized by an elevation angle that is not equal to 90°, can be independently arranged to be at an orientation angle of about -25° to about 0° (aligned with the tangent) or about 0° (aligned with the tangent) to about 25° relative to a tangent of a rotation vector (i.e., with respect to the rotation of the respective rotationally distinct tensioning segment). Negative orientation angle values indicate that the needle is pointing toward the rotation axis, while positive orientation angle values indicate that the needle is pointing away from the rotation axis. For example, any given tensioning microneedle can be characterized by an orientation angle of about -25, -22, -20, -18, -15, -12, -10, -8, -5, -2, 0, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25, or a range of values (°) between any of the foregoing values on either side of 0 (e.g., between about -15 and about -8, between about 5 and about 12, etc.). In many embodiments, each of the first and second tensioning microneedles can be arranged such that the entire needle body is aligned tangentially with respect to the rotation of the respective rotationally distinct tensioning segment (i.e., an orientation angle of 0°). The orientation angle is measured from a tangential plane that passes through the center of the microneedle base to the center of the microneedle tip, as described above with respect to microneedles on a wearable medical device.

[0130] In some embodiments, each of the first and second tensioned microneedles can independently be characterized by a length of about 0.5 mm to about 3.5 mm. For example, each of the first and second microneedles can independently be characterized by a length in a range of values (in mm) of about 0.5, 0.8, 1.0, 1.2, 1.5, 1.8, 2.0, 2.2, 2.5, 2.8, 3.0, or 3.5, or between any of the foregoing values (e.g., between about 0.5 and about 0.8, etc.). The length of the needle can be selected as needed for the application. For example, shorter needles can be more comfortable for elderly users or for areas of the skin that can be thinner. In many embodiments, the length of the tensioned microneedle can be selected to be longer than the microneedles of the wearable medical device. Alternatively, where the applicator has a means of extending the wearable medical device beyond the perimeter of the applicator (e.g., an extendable docking platform), the length of the tensioned microneedle can be selected to be equal to or shorter than the microneedles of the wearable medical device.

[0131] In some embodiments, each of the first and second tensioned microneedles can independently be characterized by a diameter of about 1 pm to about 25 pm. For example, each of the first and second tensioned microneedles can independently be characterized by a diameter in a range of values (in pm) of about 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25, or between any of the foregoing values (e.g., between about 8 and about 12, etc.). In some embodiments, any of the tensioned microneedles described herein can have a uniform diameter or a non-uniform diameter within the ranges described above.

[0132] In some embodiments, the plurality of tensioned microneedles can be arranged in circular or semi-circular rows extending around a rotation axis. For example, the plurality of tensioned microneedles can be arranged in 1 to 5 rows.

[0133] In some embodiments, the plurality of tensioned microneedles can be composed of metal, plastic, rubber, silicone, or a combination thereof.

[0134] In many embodiments, the plurality of tensioned microneedles can be driven into the skin surface prior to rotation. In other embodiments, the plurality of tensioned microneedles can operate by friction (e.g., by blunt rubber microneedles) without piercing the skin surface.

[0135] Release mechanism

[0136] In some embodiments, the mechanism for releasing the wearable medical device from the reverse-rotationally loaded configuration can include any combination of mechanical components for disengaging the retaining element. The mechanism can include a button, a compression plunger, a switch, etc. Upon disengaging the retaining element, the potential energy stored within the loaded communication member can drive the wearable medical device back to its original state, or at least partially to a relaxed state.

[0137] Additional features

[0138] In some embodiments, the described applicator can further include a docking platform for holding the wearable medical device within the applicator. In some embodiments, the docking platform can extend beyond the perimeter of the applicator. For example, upon tensioning the skin surface, it can be undesirable for multiple microneedles of the wearable medical device to come into contact with the skin surface while under tension. Thus, the docking platform can be configured for retracting the wearable medical device away from the skin surface prior to tensioning the skin surface and / or extending the wearable medical device toward the skin surface after tensioning the skin surface.

[0139] In some embodiments, the described applicator can further include an actuation guide configured to cooperate with the applicator guide on the first rotationally distinct segment and the second rotationally distinct segment. Alternatively, the applicator can include a docking platform for holding the wearable medical device within the applicator, and an actuation guide configured to cooperate with the applicator guide on the docking platform. In some embodiments, the actuation guide can be a track within a stationary wall of the applicator. The track within the stationary wall of the applicator can be angled to accommodate rotation of the first rotationally distinct segment and / or the second rotationally distinct segment (see, e.g., FIGS. 1 1 A and 1 1 B). FIG. 7A and FIG. 7B ). The actuation guide can assist independent rotation of the first rotationally distinct segment and the second rotationally distinct segment, and thus can have any configuration. For example, the actuation guide can include a track, a pin, a gear, a friction-inducing component, etc.

[0140] Application method

[0141] In many embodiments, a method for attaching a wearable medical device (e.g., a wearable medical device of the present disclosure having a tensioning communication member) to a skin surface is described. The method can include providing an applicator having a wearable medical device therein as described herein; and rotating a first rotationally distinct segment and rotating a second rotationally distinct segment such that the wearable medical device is in a counter-rotationally loaded configuration. The method can also include contacting the skin surface with the applicator; engaging a tensioning actuator such that a plurality of tensioning microneedles in contact with the skin surface rotate to create a tensioned skin surface; and releasing the wearable medical device from the counter-rotationally loaded configuration such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the tensioned skin surface.

[0142] In many embodiments, a method for attaching a wearable medical device (e.g., a wearable medical device of the present disclosure having a rolling communication member) to a skin surface is described. The method can include providing an applicator having a wearable medical device therein as described herein; contacting the skin surface with the applicator; and engaging a tensioning actuator such that a plurality of tensioning microneedles in contact with the skin surface rotate to create a tensioned skin surface. The method can also include rotating a first rotationally distinct segment and rotating a rotationally distinct segment such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the tensioned skin surface.

[0143] In some embodiments, any of the methods described herein can further include selecting a degree of rotation for rotating the first rotationally distinct segment and for rotating the second rotationally distinct segment, whether it is for loading a wearable medical device (e.g., having a tensioning communication member) or driving a wearable medical device (e.g., having a rolling communication member).

[0144] In some embodiments, any of the methods described herein for attaching a wearable medical device can further include attaching a monitoring device to the wearable medical device.

[0145] In some embodiments, any of the methods described herein for attaching a wearable medical device to a skin surface can further include applying a supplemental securing article to the wearable medical device or the wearable medical device having a monitoring device thereon. The supplemental securing article can be a bandage, a protective covering (e.g., waterproof / sweatproof), etc. In some embodiments, the supplemental securing article can include a backing and a skin-compatible adhesive.

[0146] In some embodiments, a method for removing a wearable medical device from a skin surface is described. The method can comprise engaging a mechanical actuator on the wearable medical device such that the wearable medical device is in a counter-rotationally loaded configuration; and lifting the wearable medical device from the skin surface.

[0147] In some embodiments, a method for removing a wearable medical device from a skin surface is described. The method can comprise contacting an applicator to a wearable medical device on a skin surface; engaging a loading actuator within the applicator such that the wearable medical device is in a counter-rotationally loaded configuration; and lifting the wearable medical device from the skin surface.

[0148] Monitoring method

[0149] In many embodiments, a method for monitoring a biological signal is described. The method can comprise detecting the biological signal with a monitoring device secured to a wearable medical device of the present disclosure attached to a skin surface.

[0150] In some embodiments, the biological signal can be selected from an electrical signal, a chemical signal, a light emission signal, or a combination thereof.

[0151] The method can further comprise attaching the wearable medical device to the skin surface.

[0152] The method can further comprise securing the monitoring device to the wearable medical device attached to the skin surface.

[0153] Kit

[0154] In many embodiments, a kit is described. The kit can comprise an applicator of the present disclosure and a set of instructions for attaching a wearable medical device to a skin surface.

[0155] In some embodiments, the kit can further comprise one or more wearable medical devices of the present disclosure.

[0156] In some embodiments, the kit can further comprise one or more monitoring devices.

[0157] In some embodiments, the kit can further comprise one or more supplemental securing articles.

Claims

1. An applicator for attaching a wearable medical device to a skin surface, the applicator comprising: a loading actuator configured to counter-rotationally load a first rotationally distinct section and a second rotationally distinct section within a wearable medical device, a retention system configured to retain the wearable medical device in a counter-rotationally loaded configuration; a skin tensioning system comprising: a plurality of tensioning microneedles, and a tensioning actuator configured to rotate the plurality of tensioning microneedles about an area within the applicator in which the wearable medical device is housed; and a mechanism for releasing the wearable medical device from the counter-rotationally loaded configuration, the wearable medical device comprising: a base comprising: a first rotationally distinct section, a second rotationally distinct section at least partially surrounded by the first rotationally distinct section, a plurality of first microneedles located on the first rotationally distinct section, and a plurality of second microneedles located on the second rotationally distinct section; and at least one communication member in communication with the first rotationally distinct section and the second rotationally distinct section.

2. An applicator for attaching a wearable medical device to a skin surface, the applicator comprising: a driving actuator configured to rotationally drive a first rotationally distinct section and a second rotationally distinct section within a wearable medical device in an opposite rotational manner; and a skin tensioning system comprising: a plurality of tensioning microneedles, and a tensioning actuator configured to rotate the plurality of tensioning microneedles about an area within the applicator in which the wearable medical device is housed, the wearable medical device comprising: a base comprising: a first rotationally distinct section, a second rotationally distinct section at least partially surrounded by the first rotationally distinct section, a plurality of first microneedles located on the first rotationally distinct section, and a plurality of second microneedles located on the second rotationally distinct section; and at least one communication member in communication with the first rotationally distinct section and the second rotationally distinct section.

3. The applicator of any one of claims 1-2, further comprising a first rotationally distinct tensioning section and a second rotationally distinct tensioning section at least partially surrounding the first rotationally distinct tensioning section, the plurality of tensioning microneedles comprising a plurality of first tensioning microneedles and a plurality of second tensioning microneedles, the plurality of first tensioning microneedles being located on the first rotationally distinct tensioning section and the plurality of second tensioning microneedles being located on the second rotationally distinct tensioning section.

4. The applicator of claim 3, wherein the first rotationally distinct tensioning section and the second rotationally distinct tensioning section each take the shape of a cylindrical ring and are arranged in a concentric manner.

5. The applicator of any one of claims 3-4, wherein the first plurality of tensioned microneedles and the second plurality of tensioned microneedles are each independently characterized by an elevation angle of about 40° to about 80°, and each first tensioned microneedle of the first plurality of tensioned microneedles is oriented such that a rotational direction in which a first microneedle tip faces is opposite a rotational direction in which a second microneedle tip of each second tensioned microneedle of the second plurality of tensioned microneedles faces.

6. The applicator of any one of claims 3-5, wherein the tensioning actuator is configured to rotate the first rotationally distinct tensioning segment having a first plurality of tensioned microneedles thereon, and is configured to rotate the second rotationally distinct tensioning segment having a second plurality of tensioned microneedles thereon, wherein the first rotationally distinct tensioning segment and the second rotationally distinct tensioning segment are rotated in counter-rotating fashion.

7. The applicator of any one of claims 1-2, wherein at least a portion of the plurality of tensioned microneedles is independently characterized by an elevation angle of about 40° to about 80°.

8. The applicator of any one of claims 1-7, wherein at least a portion of the plurality of tensioned microneedles is independently characterized by an elevation angle of about 40° to 80°, and is independently arranged at an orientation angle of -25° to 25°.

9. The applicator of any one of claims 1-8, wherein the first plurality of microneedles and the second plurality of microneedles are each independently characterized by a length of about 0.5 mm to about 3.5 mm.

10. The applicator of any one of claims 1-9, wherein each tensioned microneedle of the plurality of tensioned microneedles is independently characterized by a diameter of about 1 pm to about 25 pm.

11. A method of attaching a wearable medical device to a tensioned skin surface, the method comprising: providing the applicator of any one of claims 1-10 having the wearable medical device therein; rotating a first rotationally distinct segment and rotating a second rotationally distinct segment such that the wearable medical device is in a counter-rotating loaded configuration; contacting the skin surface with the applicator; engaging the tensioning actuator such that the plurality of tensioned microneedles in contact with the skin surface rotate to create a tensioned skin surface; and releasing the wearable medical device from the counter-rotating loaded configuration such that a first plurality of microneedles and a second plurality of microneedles of the wearable medical device are driven into the tensioned skin surface.

12. A method of attaching a wearable medical device to a tensioned skin surface, the method comprising: providing the applicator of any one of claims 1-10 having the wearable medical device therein; contacting the skin surface with the applicator; engaging the tensioning actuator such that the plurality of tensioned microneedles in contact with the skin surface rotate to create a tensioned skin surface; and rotating a second rotationally distinct section such that the plurality of first microneedles and the plurality of second microneedles of the wearable medical device are driven into the tensed skin surface.

13. A kit comprising: an applicator according to any one of claims 1 to 10; and instructions for attaching a wearable medical device to a skin surface.

14. The kit of claim 13, further comprising one or more wearable medical devices.

15. The kit of any one of claims 13 to 14, further comprising a monitoring device.

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