Vacuum tensioning applicator and method for attaching wearable medical devices to the skin surface

Abstract

A vacuum tensioning applicator and method of use are described for attaching a wearable medical device to a stretched skin surface, the wearable medical device having a plurality of microneedles on a first rotationally distinct segment and a plurality of microneedles on a second rotationally distinct segment.

Description

[Technical Field]

[0001] The industry for wearable medical devices and / or fitness monitoring devices is growing. People are becoming more interested in monitoring their own health and remotely sharing their health data with doctors or paramedics. Many of the current devices that monitor parameters such as heart rate, blood pressure, and oxygen saturation take the form of wearable jewelry, such as watches, bracelets, rings, and chest straps. However, not all parameters can be measured in this way, and these wearable devices are not inconspicuous. For example, continuous glucose monitoring via devices attached to the skin is gaining popularity among people with diabetes, and even among those on low-carbohydrate diets. However, the adhesives required to attach such devices often cause skin damage and infections, especially in elderly users. The adhesives are also known to cause allergic reactions in some individuals, which can be so severe that some patients are unable to use the device.

[0002] What is needed is a method to secure a monitoring device to the skin without requiring the use of adhesives. [Overview of the Initiative]

[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 load a first rotationally distinct segment and a second rotationally distinct segment of the wearable medical device in a counter-rotating manner; a holding system configured to hold the wearable medical device in a counter-rotating loaded configuration; a skin tensioning system having a chamber configured to surround an area within the applicator in which the wearable medical device is housed and to contact an area of ​​the skin surface; a mechanism for applying decompression to the area of ​​the skin surface; and a mechanism for releasing the wearable medical device from the counter-rotating loaded configuration.

[0004] In one embodiment, an applicator for attaching a wearable medical device to a skin surface is described. The applicator includes a drive actuator configured to rotate a first rotationally distinct segment within the wearable medical device and a second rotationally distinct segment in the opposite direction. The applicator further includes a skin tensioning system comprising a chamber configured to surround an area within the applicator in which the wearable medical device is housed and to contact an area of ​​the skin surface, and a mechanism for applying decompression to the area of ​​the skin surface.

[0005] In one embodiment, a method for attaching a wearable medical device to a stretched skin surface is described. The method includes providing an applicator, which is described herein and has a wearable medical device inside it, and rotating a first rotationally different segment of the wearable medical device and a second rotationally different segment so that the wearable medical device is configured to be reverse-rotatably loaded. The method further includes bringing the applicator into contact with the skin surface so that the chamber is in contact with the skin surface, engaging a mechanism for applying decompression to the skin surface to produce a stretched skin surface, and releasing the wearable medical device from the reverse-rotatably loaded configuration so that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the stretched skin surface.

[0006] In many embodiments, methods for attaching a wearable medical device to a stretched skin surface are described. The method includes providing an applicator, which has a wearable medical device inside, an applicator described herein, bringing the applicator into contact with the skin surface so that a chamber is in contact with the skin surface, and engaging a mechanism for applying decompression to the skin surface to produce a stretched skin surface. The method further includes rotating a first rotationally different segment and rotating a rotationally different segment so that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the stretched skin surface.

[0007] In one embodiment, a kit is described. The kit includes the applicator of the present disclosure and a set of instructions for attaching the wearable medical device to the skin surface. [Brief explanation of the drawing]

[0008] This application can be better understood by considering the following detailed description of various embodiments of the present disclosure in relation to the accompanying drawings. [Figure 1A] This is a diagram of the bottom side of the wearable medical device of this disclosure. [Figure 1B] Figure 1A is a top view of the wearable medical device. [Figure 2A] This is a diagram of the upper side of the wearable medical device of this disclosure. [Figure 2B] Figure 2A is a top view of the wearable medical device. [Figure 3A] This is a diagram of the bottom side of the wearable medical device of this disclosure. [Figure 3B] Figure 2A is a top view of the wearable medical device. [Figure 4] The side view and elevation angle measurement of the microneedle of this disclosure are shown. [Figure 5] The top view and orientation angle measurement of the microneedle of this disclosure are shown. [Figure 6A] This is a top view of an unloaded configuration of a wearable medical device having a mechanical actuator. [Figure 6B] This is a top view of a loaded configuration wearable medical device having a mechanical actuator. [Figure 7A] This is an applicator into which a wearable medical device has been inserted. [Figure 7B] Figure 7A shows the applicator in which the wearable medical device is loaded in reverse. [Figure 8] This is a diagram of the applicator of the present disclosure for applying tension to the skin surface. [Figure 9] This is a diagram of the applicator of the present disclosure for applying tension to the skin surface. [Figure 10] This is part of the applicator of the present disclosure, which has an exemplary skin tensioning system into which a wearable medical device is inserted. [Figure 11A] This is part of an exemplary skin tensioning system for use with the applicator of this disclosure. [Figure 11B] This is an exemplary tension-applying actuator for use in a skin tension-applying system. [Figure 12] Side view of a portion of an exemplary applicator of the present disclosure. [Figure 13] View of a portion of the applicator of the present disclosure that applies tension to the skin surface. [Figure 14] View of the applicator of the present disclosure that applies tension to the skin surface.

[0009] In the following description, reference is made to the accompanying drawings. Various embodiments in which the present disclosure may be implemented are provided by way of example. It should be understood that structural changes may be made without departing from the scope of the present disclosure. The drawings are not necessarily to scale. Like numbers used within the drawings refer to like components (e.g., 102, 202, 302, etc., 110, 210, 310, etc.).

Mode for Carrying Out the Invention

[0010] The present disclosure describes a wearable medical device that can be fixed to the skin via microneedles and an applicator for attaching the wearable medical device to the skin surface. The wearable medical device utilizes opposing forces between rotating segments not only to drive the microneedles into the skin but also to fix the microneedles within the skin. The wearable medical device attached to the skin via microneedles has much higher resistance to accidental removal and a longer wearing period compared to an equivalent device adhered to the skin via an adhesive. Further, the wearable medical device of the present disclosure is painless to attach, painless to wear, and does not cause skin damage or side effects that often occur with adhesives. In addition, the wearable medical device of the present disclosure allows for air flow under the device, preventing bacterial growth due to moisture accumulation and further allowing for washing.

[0011] A wearable medical device may include a permanent monitoring device thereon, but the wearable medical device of the present disclosure is mainly intended to function as a base plate for fixing a removable monitoring device thereto. A user may enjoy the versatility of a modular system.

[0012] The applicator described herein applies tension to the skin surface to further extend the wearing period. By attaching the wearable medical device to the stretched skin surface, it becomes possible to more firmly fix the microneedles when the skin surface relaxes.

[0013] Definitions As used herein, the term "about" means ±10 percent of a given value. For example, about 10 means 9 to 11.

[0014] As used herein, the term "adhesive" refers to a polymer composition that adheres two adherents together when used herein. Examples of adhesives are pressure-sensitive adhesives and gel adhesives.

[0015] As used herein, the term "actuation guide" refers to a feature on or within a component of an applicator that is complementary to an applicator guide within a wearable medical device. The mating of the actuation guide with the applicator guide by a rotating means within the applicator is effective to rotate a first rotationally different segment and / or a second rotationally different segment within the wearable medical device.

[0016] As used herein, the term "applicator guide" or "applying guide" refers to a feature on or within a component of a wearable medical device that is complementary to an actuation guide within the applicator. The mating of the applicator guide with the actuation guide by a rotating means within the applicator is effective to rotate a first rotationally different segment and / or a second rotationally different segment within the wearable medical device.

[0017] As used herein, the term “barbed” describes a feature on the microneedle body that extends outward at an angle from the microneedle body. Barbed needles may be more difficult to remove from the skin surface than non-barbed needles. Similarly, barbed needles can prevent complete puncture compared to non-barbed needles. Barbed needles can increase adhesion, thereby extending the wear duration. Barbed needles can also help achieve a desired gap between the wearable medical device and the skin surface.

[0018] As used herein, “center” means the point where two perpendicular planes intersect and the areas of each of the four quadrants are equal. For example, the center of the microneedle base is the center of the region that contacts each of the rotationally different segments.

[0019] As used herein, the term “communicating member” refers to a material connecting a first rotationally distinct segment and a second rotationally distinct segment, the material not hindering the independent rotation of the first and second rotationally distinct segments. As used herein, the term “tension-imparting communicating member” refers to an article connecting a first rotationally distinct segment and a second rotationally distinct segment, in which potential energy is stored within the article, which deforms as the first and second rotationally distinct segments rotate, and is converted into kinetic energy when the article is able to return to its original state, at least partially. As used herein, “rolling communicating member” refers to a rotating article located at least partially between the first and second rotationally distinct segments, in which the rotating article rotates in accordance with the rotation of the first and second rotationally distinct segments.

[0020] As used herein, the term “counter-clockwise” is used to describe how a first rotationally distinct segment and a second rotationally distinct segment are rotated relative to each other. One segment is rotated clockwise, and the other segment is rotated counterclockwise.

[0021] As used herein, “flexible” means an article that can be stretched, bent, compressed, or otherwise twisted when subjected to force, but which returns to at least partially its non-stretched, bent, compressed, or twisted state when the force is removed.

[0022] As used herein, the term “microneedle” refers to a microstructure projection with a pointed tip that is configured to penetrate the skin.

[0023] As used herein, "rotation" means moving to some extent around an axis of rotation.

[0024] As used herein, the phrase “rotationally distinct” refers to a component that can be rotated independently of another component. For example, two otherwise connected rotationally distinct components can be rotated to some extent in opposite directions.

[0025] Description of the drawing Figure 1A is a bottom view of the wearable medical device 100 of the present disclosure, illustrating a first main surface of a base 102. The wearable medical device 100 includes a base 102, which has a first rotationally distinct segment 104 having a plurality of first microneedles 106 thereon, and a second rotationally distinct segment 108 having a plurality of second microneedles 110 thereon. The first rotationally distinct segment 104 and the second rotationally distinct segment 108 are shown in the shape of concentric cylindrical rings connected by a (tension-applying) communicating member 112 (shown here as a flexible rod or band). The communicating member 112 is shown connecting the first rotationally distinct segment 104 and the second rotationally distinct segment 108 in a non-radial direction. During application, a loading actuator (not shown) rotates the first rotationally distinct segment 104 in the opposite direction to the tip of the first microneedle 106 (shown here as clockwise) and the second rotationally distinct segment 108 in the opposite direction to the tip of the second microneedle 110 (shown here as counterclockwise), thereby contracting the connecting member 112. The connecting member 112 extends as the first and second rotationally distinct segments are rotated. Alternative configurations in which the connecting member 112 is bent in a different manner can also be easily envisioned. A retaining element (not shown) holds each rotationally distinct segment 104 / 108 in a configuration that is loaded in the opposite direction. Upon contact with the skin, the wearable medical device 100 can be released by disengaging a retaining element (not shown), at which point the first and second microneedles 106 / 110, which are oriented in opposite directions, are each driven into the skin surface by a communicating member 112 that returns to at least partially unextended (tension applied).

[0026] Figure 1B is a top view of the wearable medical device 100 of Figure 1A, illustrating the second main surface of the base 102. The first rotationally distinct segment 104 and the second rotationally distinct segment 108 are shown in the shape of a concentric cylindrical ring connected by a communicating member 112.

[0027] Figure 2A is a top view of the wearable medical device 200 of the present disclosure, illustrating the first main surface 202a and the second main surface 202b of the base 202. The wearable medical device 200 includes the base 202, which has a first rotationally distinct segment 204 having a plurality of first microneedles 206 thereon, and a second rotationally distinct segment 208 having a plurality of second microneedles 210 thereon. The first rotationally distinct segment 204 and the second rotationally distinct segment 208 are shown in the shape of concentric cylindrical rings mechanically connected by a (rolling) communicating member 212 (referred to here as a rolling disk). During application, a drive actuator (not shown) rotates the first rotationally distinct segment 204 in a direction aligned with the tip of the first microneedle 206 (shown here as clockwise) and the second rotationally distinct segment 208 in a direction aligned with the tip of the second microneedle 210 (shown here as counterclockwise), thereby causing the communicating member 212 to roll. Upon contact with the skin, the drive actuator drives the first and second microneedles 206 / 210 into the skin surface.

[0028] Figure 2B is a top view of the wearable medical device 200 of Figure 2A, illustrating the second main surface of the base 202. The first rotationally distinct segment 204 and the second rotationally distinct segment 208 are shown in the shape of a concentric cylindrical ring mechanically connected by a (rolling) communicating member 212.

[0029] Figure 3A is a bottom view of the wearable medical device 300, illustrating the first main surface 302a and the second main surface 302b of the base 302. The wearable medical device 300 includes the base 302, which has a first rotationally distinct segment 304 having a plurality of first microneedles 306 thereon, and a second rotationally distinct segment 308 having a plurality of second microneedles 310 thereon. The first rotationally distinct segment 304 and the second rotationally distinct segment 308 are shown in the shape of concentric cylindrical rings, with each microneedle 306 / 310 arranged in three rows. The wearable medical device 300 further includes a flexible membrane 311 in contact with the second main surface 302b. The flexible membrane 311 is bonded to the first rotationally distinct segment 304 and the second rotationally distinct segment 308, acting as a (tension-applying) communicating member 312 between them. During application, a loading actuator (not shown) rotates the first rotationally distinct segment 304 in the opposite direction to the tip of the first microneedle 306 (shown here as counterclockwise) and the second rotationally distinct segment 308 in the opposite direction to the tip of the second microneedle 310 (shown here as clockwise), thereby stretching the flexible membrane 311 / communicating member 312 between them. A retaining element (not shown) holds each rotationally distinct segment 304 / 308 in the reverse-rotating loaded configuration. Upon contact with the skin, a retaining element (not shown) may be disengaged, releasing the wearable medical device 300, at which point the opposing first and second microneedles 306 / 310 are driven into the skin surface by the flexible membrane 311 / communicating member 312, which returns to at least partially unextended state.

[0030] Figure 3B is a top view of the wearable medical device 300 of Figure 1A, illustrating the second main surface of the base 302. A portion of the flexible membrane 311 / communicating member 312 can be seen between an inner backing material 314 covering a first rotationally distinct segment (not shown) and an outer backing material 316 covering a second rotationally distinct segment (not shown). The inner backing material 314 is shown to have an inner applicating guide 318, and the outer backing material 316 is shown to have an outer applicating guide 320. During application, a loading actuator (not shown) rotates the first rotationally distinct segment (not shown) in one direction (shown here clockwise) by communication with the inner backing material 314 / inner applicating guide 318, and rotates the second rotationally distinct segment (not shown) in the opposite direction (shown here counterclockwise) by communication with the outer backing material 316 / outer applicating guide 320. In practice, the flexible membrane 311 / communicating member 312 is stretched or otherwise twisted. A retaining element (not shown) holds each rotationally different segment in a configuration that is loaded in the opposite direction. Upon contact with skin, the retaining element (not shown) may disengage, releasing the wearable medical device 300, at which point the first and second microneedles (not shown) are driven into the skin surface by the flexible membrane 311 / communicating member 312, which returns to at least partially unstretched.

[0031] Figure 4 shows a side view of an exemplary first microneedle 406 (or second microneedle) of the present disclosure. The first microneedle 406 is shown having a microneedle base 422 that is in contact with a first rotationally distinct segment 404. The microneedle base 422 extends to a microneedle body 424 and terminates at a microneedle tip 426. The first microneedle 406 is at an elevation angle 428 (θ EAThe angle of elevation 428 is measured from a plane A parallel to the surface on which the first microneedle 406 contacts the first rotationally distinct segment 404, to a plane B passing through the center of the microneedle base 422 from the microneedle tip 426 (see plane C), where planes A and B are perpendicular to each other, i.e., 90°.

[0032] Figure 5 shows a top view of a first rotationally distinct segment 504 (or a second rotationally distinct segment on which a second microneedle is arranged) of the present disclosure, on which a plurality of first microneedles 506 are arranged. Each of the plurality of first microneedles 506 is independently oriented at an orientation angle 530 (θ OA The first microneedles 506a aligned with tangent planes E and F have an orientation angle 530 of 0°, i.e., θ. OA = 0°. The first microneedle 506b, angled toward the axis of rotation, has an orientation angle 530 that is less than 0° to a certain degree of measurable extent, i.e., θ OA Characterized by <0°, for example, -10°. The first microneedle 506c, angled away from the axis of rotation, has an orientation angle 530 greater than 0° to a certain degree of measurable extent, i.e., θ OA Characterized by angles >0°, for example, 10°. The explanation does not need to be limited to circular structures.

[0033] Figure 6A shows a top view (second main view) of a wearable medical device 600 having a pair of mechanical actuators 632a / 632b, the medical device being shown in an unloaded configuration. The wearable medical device 600 includes a base 602, which has a first rotationally distinct segment 604, a second rotationally distinct segment 608, and a communicating member 612. The first mechanical actuator 632a communicates with the first rotationally distinct segment 604, and the second mechanical actuator 632b communicates with the second rotationally distinct segment 608. When the mechanical actuators 632a / 632b are grasped together, the first rotationally distinct segment 604 rotates counterclockwise and the second rotationally distinct segment 608 rotates clockwise. Mechanical actuators 632a / 632b may be used to attach a wearable medical device to the skin surface or to remove a wearable medical device from the skin surface.

[0034] Figure 6B shows a top view of a wearable medical device 600 having a pair of mechanical actuators 632a / 632b, the medical device shown in a loaded configuration. The communicating member 612 is shown extended compared to the unloaded configuration in Figure 6A.

[0035] Figure 7A shows an exemplary applicator 701 into which an unloaded wearable medical device 700 is inserted. Applicator 701 does not include a skin tensioning system as described herein. Applicator 701 is illustrated to illustrate an applicator aspect related to loading a wearable medical device. Applicator 701 is shown to include a first segment actuation guide 703 in an inner wall 705, which mates with a first applicator guide 707 located on a first rotationally distinct segment 704. Applicator 701 is further shown to include a second segment actuation guide 709 in an outer wall 711, which mates with a second applicator guide 713 located on a second rotationally distinct segment 708.

[0036] Figure 7B shows an exemplary applicator 701 in which the wearable medical device 700 is in a reverse-rotationally loaded configuration. The first rotationally distinct segment 704 is rotated clockwise, and the second rotationally distinct segment 708 is rotated counterclockwise. The applicator 701 holds the wearable medical device 700 in this reverse-rotationally loaded configuration until the applicator 701 makes contact with the skin surface (retaining elements are not shown). When the retaining elements (not shown) are disengaged, the wearable medical device 700 is released from the loaded configuration, and multiple microneedles on each segment are injected into the skin surface.

[0037] Figure 8 shows a cross-sectional view of the applicator 801 of the present disclosure, in which the skin tensioning system 813 has a chamber 835 located outside the applicator body 837, and the applicator 801 is used to apply tension to the skin surface SS to produce a stretched skin surface TSS. The applicator 801 is pressed against the skin surface SS so that the chamber 835 is in contact with the skin surface SS. A mechanism for applying decompression into the chamber 835, such as a syringe 839, is engaged to reduce the pressure within the chamber 835 to produce a stretched skin surface TSS. The wearable medical device 800 of the present disclosure is shown housed within the boundaries of the chamber 835. The wearable medical device 800 (shown having a first microneedle 806 and a second microneedle 810) is either (1) released into the stretched skin surface TSS from a reverse-rotating loaded configuration, or (2) driven into the stretched skin surface TSS via a drive actuator (not shown). Although not shown, a docking platform may extend the wearable medical device 800 from the applicator body so that the wearable medical device 800 contacts the stretched skin surface TSS.

[0038] Figure 9 shows a cross-sectional view of the applicator 901 of the present disclosure, in which the skin tensioning system 913 has a chamber 935 located inside / inside the applicator body 937, and the applicator 901 is used to apply tension to the skin surface SS to produce a stretched skin surface TSS. The applicator 901 is pressed against the skin surface SS so that the chamber 935 is in contact with the skin surface SS. A mechanism for applying decompression into the chamber 935, such as a syringe 939, is engaged to reduce the pressure within the chamber 935 to produce a stretched skin surface TSS. The wearable medical device 900 of the present disclosure is shown housed within the boundaries of the chamber 935. The wearable medical device 900 (shown having a first microneedle 906 and a second microneedle 910) is either (1) released into the stretched skin surface TSS from a reverse-rotating loaded configuration, or (2) driven into the stretched skin surface TSS via a drive actuator (not shown). Although not shown, a docking platform may extend the wearable medical device 900 from the applicator body so that the wearable medical device 900 contacts the stretched skin surface TSS.

[0039] Figure 10 shows a portion of the applicator 1001 of the present disclosure, in which a portion of an exemplary skin tensioning system 1013b having a plurality of tensioning needles 1017 / 1021 surrounds the region on which the wearable medical device 1000 is located. The portion of the skin tensioning system having a chamber is not shown. The applicator 1001 is shown to include the skin tensioning system 1013b, which has a first rotationally distinct tensioning segment 1015 having a plurality of first tensioning microneedles 1017 thereon, and a second rotationally distinct tensioning segment 1019 having a plurality of second tensioning microneedles 1021 thereon. The first rotationally distinct tensioning segment 1015 and the second rotationally distinct tensioning segment 1019 are configured to operate similarly to the wearable medical device 1000, although there are no connecting members.

[0040] Figure 11A shows a portion of an exemplary skin tensioning system 1113b for use with the applicator of the present disclosure. The skin tensioning system 1113b is shown to include a first rotationally distinct tensioning segment 1115 having a plurality of first tensioning microneedles 1117 thereon, and a second rotationally distinct tensioning segment 1119 having a plurality of second tensioning microneedles 1121 thereon. The skin tensioning system 1113 is further shown to include a tensioning actuator 1123 configured to rotate the first rotationally distinct tensioning segment 1115 and the second rotationally distinct tensioning segment 1119.

[0041] Figure 11B shows the tension-applying actuator 1123 of Figure 11A without tension-applying segments. The tension-applying actuator 1123 includes a ring gear 1125 configured to rotate a first rotationally distinct tension-applying segment (not shown), a sun gear 1127 configured to rotate a second rotationally distinct tension-applying segment (not shown), and a planetary gear 1129 located between them.

[0042] Figure 12 shows a partial side view of the applicator 1201 of the present disclosure, which has an applicator housing 1231 and a torsional drive shaft 1233. The tension-applying drive shaft 1233 is an element of the skin tension-applying system and is configured to drive a tension-applying actuator 1223. The applicator 1201 is further shown to include a plurality of first tension-applying microneedles 1219 and a plurality of second tension-applying microneedles 1221.

[0043] Figure 13 shows a cross-sectional view of a portion of the applicator 1301 of the present disclosure, which applies tension to the skin surface SS. The applicator 1301 is pressed against the skin surface SS and applies a force F from the first tension-applying microneedle 1317 and the second tension-applying microneedle 1321. A However, the opposite force F is exerted by the skin surface SS. O The skin surface SS is deformed. The tension-applying drive shaft 1333 is twisted to rotate a first rotationally different tension-applying segment (not shown) having a first tension-applying microneedle 1317 on it, and a second rotationally different tension-applying segment (not shown) having a second tension-applying microneedle 1321 on it, thereby applying tension to the skin surface region between the tension-applying microneedles to form a stretched skin surface TSS. The stretched skin surface TSS is maintained in this stretched state, and the wearable medical device 1300 is released from its reverse-rotating loaded configuration so that the first microneedle 1306 and the second microneedle 1310 are driven into the stretched skin surface TSS.

[0044] Figure 14 shows a cross-sectional view of an applicator 1401 of the present disclosure, which has a skin tensioning system 1413 comprising (1) a chamber 1435 and a mechanism (not shown) for reducing pressure within the chamber 1435, and (2) a plurality of tensioning microneedles 1417 and a tensioning actuator (not shown), wherein the chamber 1435 and the tensioning microneedles 1417 are arranged around a region within the applicator 1401 in which a wearable medical device 1400 (having a first microneedle 1406 and a second microneedle 1410) is housed. The wearable medical device 1400 is either (1) released into the stretched skin surface TSS from a reverse-rotating loading configuration, or (2) driven into the stretched skin surface TSS via a drive actuator (not shown). Although not shown, the docking platform may extend the wearable medical device 1400 from the applicator body so that the wearable medical device 1400 contacts the stretched skin surface TSS.

[0045] Wearable medical devices Wearable medical devices are described in various embodiments. A wearable medical device may include a base having a first rotationally distinct segment and a second rotationally distinct segment. The second rotationally distinct segment may at least partially surround the first rotationally distinct segment. At least one communicating member may communicate with the first rotationally distinct segment and the second rotationally distinct segment. The wearable medical device may further 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.

[0046] Further details and features of the wearable medical device are described below. Please understand that the details and features described below may be incorporated individually or in combination, unless otherwise specified.

[0047] base The base and all components within the base may be characterized by a first principal surface and a second principal surface. The first principal surface is considered the skin contact surface, while the second principal surface is on the opposite side of the first principal surface and does not come into contact with the skin when the wearable medical device is in use. Accordingly, all first and second microneedles described herein are located on the first principal surface of the base.

[0048] In some embodiments, the base may further include one or more applicator guides for mating with an applicator, the applicator guides configured to rotate a first rotationally distinct segment and a second rotationally distinct segment. For example, the applicator guides may be in the form of one or more notches, projections, pins, pinholes, etc., and the applicator guides may be complementary to the working guides within the applicator. The applicator guides may be located on a second principal surface, along a peripheral (secondary) surface, or a combination thereof.

[0049] In some embodiments, the base may further include one or more monitoring device fixing features for attaching the monitoring device to a wearable medical device. Examples of monitoring device fixing features include clips, hooks, latches, brackets, threaded components for mating with threaded monitoring devices, adhesives, or combinations thereof. The monitoring device fixing features may be located on a second principal surface, along a peripheral (secondary) surface, or in combination thereof.

[0050] In some embodiments, the base may further include a first mechanical actuator communicating with a first rotationally distinct segment and a second mechanical actuator communicating with a second rotationally distinct segment. Figures 6A and 6B illustrate exemplary mechanical operation of a wearable medical device without the applicator described herein. Figures 6A and 6B show the reverse rotational loading of the wearable medical device (i.e., pushing the mechanical actuators together), although the reverse is also conceivable. For example, a wearable medical device having a rolling communication member (e.g., Figure 2A) may include mechanical actuators that can be used to drive multiple microneedles into the skin surface (i.e., the mechanical actuators are pushed apart).

[0051] In some embodiments, a wearable medical device may be applied to and / or removed from the skin surface using a mechanical actuator, with or without the applicator described herein. While a mechanical actuator is not required to use the applicator described herein, the applicator may be configured to actuate such mechanical actuator. In other words, any such mechanical actuator, when combined with the applicator, may be considered an “applicator guide” as used herein.

[0052] In some embodiments, the base may further include a flexible membrane, which is bonded to or otherwise connected to a second principal surface and extends at least from a first rotationally distinct segment to a second rotationally distinct segment, so that the first rotationally distinct segment can communicate with the second rotationally distinct segment (i.e., it is a communicating member). In some embodiments, the flexible membrane may extend over the entire second principal surface of the base. In some embodiments, the flexible membrane may extend beyond the periphery of the base. A base having a flexible membrane extending beyond the periphery may further include an adhesive thereon that can function as a secondary skin attachment aspect.

[0053] In some embodiments, the flexible membrane may be made of a material such as woven fabric (e.g., cotton, rayon, polyvinyl chloride, polyethylene, or polyurethane), latex, etc. In some embodiments, the flexible membrane may be breathable and waterproof.

[0054] In some embodiments, the flexible membrane may further include an adhesive on one or more surfaces. In some embodiments, the preferred adhesive may consist of acrylates, methacrylates, epoxy diacrylates, and the like. The adhesive may be located on the surface that contacts the skin surface when applied and thus may function as a secondary means for securing the wearable medical device to the skin. The adhesive may also be located on the surface opposite to the skin surface when applied and may function as a means for attaching a mounting backing and / or a monitoring device (i.e., a monitoring device fixing feature). In some embodiments, the flexible membrane may be in the form of double-sided tape.

[0055] In many embodiments, the flexible membrane may be light-transmitting. In many embodiments, the flexible membrane may be composed of a material that can be easily punctured (e.g., by a needle). In other embodiments, the flexible membrane may include areas without material for the passage of a needle (e.g., a needle extending from an attached glucose monitoring device), light (e.g., transmitted from an attached oxygen concentration meter device), an electrode, or some other skin-contact or penetrating probe.

[0056] In many embodiments, the base may further include the flexible membrane described herein and one or more placement backings. The one or more placement backings may be reversibly or irreversibly bonded to the flexible membrane using an adhesive, or otherwise sewn onto the flexible membrane. The placement backings may include applicating guides configured to mate with a loading actuator in the applicator. In some embodiments, the placement backings may include an inner placement backing configured to rotate a first rotationally distinct segment (e.g., by an inner applicating guide) and an outer placement backing that at least partially surrounds the inner placement backing and is configured to rotate a second rotationally distinct segment (e.g., by an outer applicating guide).

[0057] Rotationally different segments In many embodiments, the first and second rotationally distinct segments may be arranged so as to share a common axis of rotation. While separate axes of rotation may be conceived and intended to be included within the scope of this disclosure, a shared axis of rotation is the simplest and most concise structure.

[0058] In many embodiments, the first and second rotationally distinct segments are configured to rotate in opposite directions (i.e., clockwise and counterclockwise relative to each other), and this rotation induces stress within the communicating member to which each segment communicates. This stress can take the form of elongation, compression, torsion, bending, coiling, rolling, or rotation. The applicator of this disclosure, or other applicator means, may be configured to fix the first and second rotationally distinct segments in a rotated state and withstand the potential energy within the stressed communicating member. The kinetic energy provided by the release of stress within the communicating member is effective in undoing the rotation of the rotationally distinct segments, allowing the microneedles on them to be driven into the skin with some force.

[0059] The first and second rotationally distinct segments may be of any size and shape independently, as long as neither segment obstructs the rotation of the other. Exemplary shapes include cylindrical or semi-cylindrical, elliptical, frustoconical, rectangular, square, and frustoconical, and the shape may be solid or annular (i.e., ring-shaped). An annular first rotationally distinct segment may allow light transmission from the attached monitoring device, or otherwise allow physical contact between the skin surface and the attached monitoring device. In some embodiments, the first and second rotationally distinct segments may each be cylindrical rings (i.e., washer-shaped) and arranged concentrically. In other embodiments, the first rotationally distinct segment may be a solid cylinder, and the second rotationally distinct segment may be a concentrically arranged cylindrical ring. Some shapes may be better suited to different applications, such as adapting to different areas of the body or to different shaped monitoring devices.

[0060] In many embodiments, the first and second rotationally distinct segments are arranged such that at least one principal surface of each segment is coplanar with each other. In any embodiment where the first and second rotationally distinct segments are not coplanar with each other, the wearable medical device requires that the lengths of the first and second microneedles be different so that each pair of microneedles can make contact with the skin.

[0061] In some embodiments, the first and second rotationally distinct segments may be independently characterized by a maximum length and / or width of approximately 5 mm to approximately 75 mm. For example, the maximum length and / or width may be selected in mm from approximately 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75, or may be within a range between any of the aforementioned values, for example, within a range of approximately 25 to approximately 40.

[0062] In some embodiments, the first and second rotationally distinct segments may be independently characterized by an average thickness of about 1 mm to about 10 mm. For example, the average thickness may be selected in mm from 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 it may be a value within any of the aforementioned ranges, for example, from about 3 to about 8.

[0063] In many embodiments, the first and second rotationally distinct segments may each contain at least 10 microneedles. In some embodiments, the first and second rotationally distinct segments may each independently contain 10 to 500 microneedles. For example, the first and second rotationally distinct segments may each independently contain 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 microneedles, or a number of microneedles within a range between any of the aforementioned values, for example, within a range of about 50 to about 100. The number of needles in each of the rotationally different segments may be selected according to various factors such as the intended device placement, skin type, user activity level, and intended wearing period.

[0064] In some embodiments, the first rotationally distinct segment may include one or more first applicator guides configured to mate with one or more actuator guides in the applicator described herein. The one or more first applicator guides may be located on the inner circumference (sub-surface) of the first rotationally distinct segment. In some embodiments, the second rotationally distinct segment may include one or more second applicator guides configured to mate with one or more actuator guides in the applicator described herein. The one or more second applicator guides may be located on the outer circumference (sub-surface) of the second rotationally distinct segment. In some embodiments, the first and second applicator guides may independently be in the form of notches, protrusions, pins, pinholes, etc.

[0065] In some embodiments, the first and second rotationally distinct segments may be made of a material selected from metal, plastic, or a combination thereof.

[0066] In some embodiments, the wearable medical device may have only two rotationally distinct segments. In other embodiments, the wearable medical device may have three or more rotationally distinct segments, any additional rotationally distinct segments may be characterized in the same way as any rotationally distinct segments described herein.

[0067] (Communicating member) In some embodiments, the communicating member may be a tension-applying communicating member selected from a flexible rod or band, a spring, a flexible membrane (as described above), or a combination thereof. In other embodiments, the communicating member may be a rolling communicating member such as a rolling disk.

[0068] In some embodiments, the communicating member may be in the form of a flexible rod, a flexible band, or a spring.

[0069] In many embodiments, the communicating member may connect a first rotationally distinct segment and a second rotationally distinct segment at least partially via a secondary surface (e.g., the inner or outer walls of the rotationally distinct segments in the shape of a ring). In some embodiments, the communicating member may connect a first rotationally distinct segment and a second rotationally distinct segment at least partially via a primary surface (e.g., the second primary surface opposite to the first primary surface having microneedles).

[0070] In some embodiments, the wearable medical device may include one or more communicating members in the form of a flexible rod or band extending from the outer wall of a first rotationally distinct segment having a ring shape and the inner wall of a second rotationally distinct segment having a ring shape. In some embodiments, the flexible rod or band may extend radially (i.e., parallel to the radius) between the first rotationally distinct segment and the second rotationally distinct segment. In other embodiments, the flexible rod or band may extend non-radially (e.g., at an angle with respect to the radial plane) between the first rotationally distinct segment and the second rotationally distinct segment. Non-radial arrangements can be measured according to one end of a connecting member which lies on the radial plane and the other end of the connecting member which is measured at an angle of about 1° to 45° with respect to the radial plane, for example, an angle of 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, 25, 28, 30, 32, 35, 38, 40, 42, or 45 degrees (°), or within any of the aforementioned ranges, for example, within a range of about 20 to about 40 degrees. A non-radial arrangement flexible rod or band can be positioned in one of two orientations, i.e., one of / or \, and the flexible rod or band can be stretched or bent depending on the rotational direction of the rotationally different segments.

[0071] In some embodiments, the type and number of communicating members present in the wearable medical device of this disclosure may be selected according to the desired kinetic energy for driving rotationally different segments together. For example, the wearable medical device may be tailored to the type of skin surface to which it will be applied, and greater or less force may be required to properly or securely attach the wearable medical device to the skin surface.

[0072] In some embodiments, the wearable medical device may include 1 to 20 communicating members, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 18, or 20, or a range between any of the aforementioned values, for example, a range of 2 to 6. In some embodiments, each of the communicating members is of the same type. In other embodiments, a mixture of communicating members may be present within the wearable medical device.

[0073] Microneedles In many embodiments, the first and second microneedles may be arranged in a circular or semicircular array extending around a rotation axis, regardless of the shapes of the first and second rotationally distinct segments. In many embodiments, a plurality of first microneedles may be arranged in one or more rows along the first rotationally distinct segments. Similarly, a plurality of second microneedles may be arranged in one or more rows along the second rotationally distinct segments in a circular path. In some embodiments, the rows may be coplanar with adjacent rows or staggered. In some embodiments, each of the plurality of first and second microneedles may be arranged in 1 to 5 rows, for example, 1, 2, 3, 4, or 5 rows, for example, 2 to 3 rows.

[0074] In some embodiments, multiple first and second microneedles may be arranged in a row, and each microneedle may be independently separated from one another by a distance of about 1 mm to about 10 mm. For example, each microneedle may 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 mm, or by a distance within any of the aforementioned values, for example, a distance within a range of about 4 to about 6.

[0075] In embodiments having two or more columns, the columns may be separated independently by a distance of approximately 5 mm to approximately 10 mm. For example, the columns may be separated independently by a distance of approximately 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 mm, or by a distance within any of the aforementioned values, for example, a distance within a range of approximately 6 to approximately 8.

[0076] In some embodiments, each of the first and second microneedles may be independently characterized by an elevation angle of about 40° to about 80° with respect to the plane on which the microneedles are attached (i.e., each rotationally distinct segment). For example, the first and second microneedles may be independently characterized by elevation angles (°) of about 40, 42, 45, 48, 50, 52, 55, 58, 60, 62, 65, 68, 70, 72, 75, 78, or 80, or within a range of any of the aforementioned values, for example, within a range of about 45 to about 50. For reference, a microneedle perpendicular to a parallel plane passing through each rotationally distinct segment is characterized by an elevation angle of 90°. Elevation angles outside the above range are still within the scope of this disclosure, but within the above range, it is thought that they may benefit the user in terms of pain relief, maintenance of skin health, and longer wearing periods. Naturally, each elevation angle can be measured as acute or obtuse depending on the reference point. Therefore, the elevation angles mentioned above can be considered as obtuse angles (i.e., approximately 140° to approximately 100°, and all angles in between). The elevation angle is measured from a parallel plane passing through each rotationally different segment to the center of the microneedle tip, with reference to a plane perpendicular to that parallel plane, passing through the center of the microneedle base.

[0077] In many embodiments, each of the first microneedles may be characterized by the same elevation angle. In other embodiments, at least a portion of the first microneedles may be characterized by one elevation angle, and at least another portion of the first microneedles may be characterized by a different elevation angle. In some cases, a mixture of elevation angles may be beneficial for tailoring the wearable medical device to the area of ​​the body to which it is intended to be worn. In many embodiments, each of the second microneedles may be characterized by the same elevation angle. Similarly, in other embodiments, at least a portion of the second microneedles may be characterized by one elevation angle, and at least another portion of the second microneedles may be characterized by a different elevation angle. In some embodiments, each of the first and second microneedles may be characterized by the same elevation angle, or a portion of either the first or second microneedles may be characterized by different elevation angles.

[0078] In embodiments where at least a portion of the first microneedles are characterized by an elevation angle other than 90°, all of the first microneedles at the elevation angle must point in the same direction of rotation (i.e., all of their tips must be pointing clockwise or counterclockwise). Similarly, in embodiments where at least a portion of the second microneedles are characterized by an elevation angle other than 90°, all of the second microneedles at the elevation angle must point in the same direction of rotation. Furthermore, in embodiments having both first and second microneedles characterized by an elevation angle ≠ 90°, the first microneedles at the elevation angle may be positioned in the opposite direction of rotation to the second microneedles at the elevation angle. In other words, each first microneedle characterized by an elevation angle ≠ 90° (e.g., 40° to 80°) may be oriented such that the tip of the first microneedle points in one direction of rotation, and each second microneedle characterized by an elevation angle ≠ 90° (e.g., 40° to 80°) may be oriented such that the tip of the second microneedle points in a direction of rotation opposite to that of the tip of the first microneedle. When referring to opposite directions of rotation, it is implied that the axis of rotation is shared.

[0079] In some embodiments, each of the first and second microneedles, characterized by an elevation angle ≠ 90°, may be independently positioned at orientation angles of approximately -25° to approximately 0° (aligned with the tangent) or approximately 0° (aligned with the tangent) to approximately 25° with respect to the tangent to the rotation vector (i.e., with respect to the rotation of each rotationally distinct segment). Negative orientation angle values ​​indicate that the needle is pointing toward the axis of rotation, while positive orientation angle values ​​indicate that the needle is pointing toward the axis of rotation. For example, any given microneedle may be characterized by orientation angles (°) of approximately -25, -22, -20, -18, -15, -12, -10, -8, -5, -2, 0, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25, or within a range between any of the aforementioned values ​​on either side of 0, for example, within a range of approximately -15 to approximately -8, approximately 5 to approximately 12, etc. In many embodiments, each of the first and second microneedles may be positioned such that the entire needle body is aligned tangentially to the rotation vector (i.e., orientation angle 0°) with respect to the rotation of each rotationally distinct segment. The orientation angle is measured from the tangent 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 rotation vector is characterized by an orientation angle of 0°. Furthermore, for reference, a microneedle characterized by an orientation angle of 90° is perpendicular to the rotation vector and can never puncture the skin surface during operation of a wearable medical device.

[0080] In some embodiments, each of the first and second microneedles may be independently characterized by a length of approximately 0.2 mm to approximately 3.0 mm. For example, each of the first and second microneedles may be independently characterized by a length of approximately 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 mm, or within a range between any of the aforementioned values, for example, within a range of approximately 0.5 to approximately 0.8 mm. The needle length may be selected based on the needs of the application. For example, shorter needles may be more comfortable for older users or in areas where the skin may be thinner.

[0081] In some embodiments, each of the first and second microneedles may be independently characterized by a diameter of about 1 μm to about 25 μm. For example, each of the first and second microneedles may be independently characterized by a diameter of about 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25 in μm, or within a range between any of the aforementioned values, for example, within a range of about 8 to about 12. In some embodiments, any microneedle described herein may have a uniform or non-uniform diameter within the above range. A non-uniform diameter may be characterized by a diameter that decreases towards the tip along the microneedle body. For example, a non-uniform diameter may decrease by a rate of about 5 to 25% along the microneedle body towards the tip, for example, by a rate of 5, 8, 10, 12, 15, 18, 20, 22, or 25%, or within a range between any of the aforementioned values, for example, within a range of 10 to about 15. The non-uniform diameter may also include regions within the microneedle body that may have a larger diameter, or isolated regions that may otherwise have a larger diameter. Such regions with a larger diameter may be in the form of thorns. Microneedles with thorns may function to better secure the microneedle within the skin surface. Regions with a larger diameter may also prevent the entire microneedle from piercing the skin, effectively leaving a region between the skin surface and the base, allowing airflow between them and preventing moisture buildup and / or bacterial growth. In some embodiments, at least a portion of the first and / or second microneedles may be characterized by non-uniform diameters.

[0082] In many embodiments, it is desirable to leave a space between the skin surface and the wearable medical device so that airflow can prevent moisture buildup and bacterial growth. One way to achieve this is to select microneedles of a particular length and / or a particular diameter. In other words, the microneedles only need to be inserted into the skin to a certain extent. For example, the microneedles may be inserted into the skin only 25-75% of their length, for example, within the range of 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75% of their length, or any of the aforementioned values. In some embodiments, the wearable medical device may be seated above the skin surface with a gap thickness of approximately 0.15 mm to approximately 1 mm, for example, with a gap thickness within the range of 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.60, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, or 1 mm, or any of the aforementioned values.

[0083] In some embodiments, any microneedle described herein may further include a microneedle base. The microneedle base may be of any shape, but is typically at least 25% larger than the diameter of the microneedle. The microneedle base not only provides stability but can also function to prevent the microneedle from being 100% inserted into the skin surface, and thus leave a desired gap between the skin surface and the wearable medical device. In some embodiments, the microneedle base may be in the shape of a frustum or truncated cone.

[0084] In many embodiments, any microneedles described herein may be composed of plastic, metal, absorbent material, or a combination thereof. Suitable plastics include polyolefin materials, polyester, and polyurethane. Suitable metals include stainless steel, titanium, and nitinol (nickel / titanium alloy). Suitable absorbent materials include materials used to form absorbable sutures, such as polyglycolide (e.g., DEXON®) and poly(glycolide / lactide) random copolymer (e.g., VICRYL®).

[0085] In some embodiments, any microneedles described herein may be coated with one or more conductive materials so that the wearable medical device can function as a dry electrode.

[0086] In some embodiments, any microneedles described herein may be solid or hollow. Hollow microneedles may allow the passage of therapeutic agents.

[0087] In some embodiments, the first and second microneedles may be the same. In other embodiments, one of the first microneedles or one of the second microneedles may be different from each other in one or more embodiments described above.

[0088] Applicator In many embodiments, applicators for attaching the wearable medical device of this disclosure to a skin surface are described. The applicator may include a loading actuator configured to load the wearable medical device in a counter-rotating manner onto a first rotationally distinct segment and a second rotationally distinct segment; a holding system configured to hold the wearable medical device in the counter-rotating loaded configuration; a skin tensioning system having a chamber configured to surround the area in which the wearable medical device is housed within the applicator and to contact an area of ​​the skin surface; and a mechanism for applying decompression to the area of ​​the skin surface; and a mechanism for releasing the wearable medical device from the counter-rotating loaded configuration. For example, an applicator having a loading actuator may be suitable for the wearable medical device described herein having a tensioning communicating member.

[0089] In many embodiments, applicators for attaching the wearable medical device of this disclosure to a skin surface are described. The applicator may include a drive actuator configured to rotate a first rotationally distinct segment and a second rotationally distinct segment within the wearable medical device in opposite directions, and a skin tensioning system having a chamber configured to surround a region within the applicator in which the wearable medical device is housed and to contact a region of the skin surface, and a mechanism for applying decompression to the region of the skin surface. For example, an applicator having a drive actuator may be suitable for the wearable medical device described herein having rolling connecting members.

[0090] In some embodiments, any skin tensioning system may further include a plurality of tensioning needles and a tensioning actuator configured to rotate the plurality of tensioning needles around an area in which a wearable medical device is housed within an applicator.

[0091] In some embodiments, the applicator features described may be driven strictly mechanically. In other embodiments, the applicator features may be driven at least partially electrically.

[0092] The applicators described herein are intended to assist in the attachment of the wearable medical devices of this disclosure, but the applicators may also be useful for attaching wearable medical devices that deviate from the scope described herein, insofar as such wearable medical devices include a first rotationally distinct segment, a second rotationally distinct segment, and a plurality of microneedles.

[0093] In some embodiments, the described applicator may be further configured to remove the wearable medical device from the skin surface. To remove the wearable medical device, the applicator may be brought into contact with the wearable medical device and a loading actuator may be effectively engaged to rotate the first and second rotationally distinct segments so that the first and second microneedles are removed from the skin surface.

[0094] Further details about the applicator are described below.

[0095] Loading actuator In some embodiments, the loading actuator may include any combination of mechanical components for bringing about the rotation of first and second rotationally distinct segments. For example, the loading actuator may include one or more of the following: springs, gears, pistons, pumps, etc. In some embodiments, the loading actuator may include an epicycle gear system having a ring gear, a sun gear, and one or more planetary gears. For example, a ring gear may be effective for rotating a second rotationally distinct segment of a wearable medical device, and a sun gear may be effective for rotating a first rotationally distinct segment. In other words, rotationally distinct segments of a wearable medical device may have gear teeth complementary to each other with respect to their respective gears. In some embodiments, the applicator may include a mechanism for engaging with the loading actuator. For example, the mechanism may include twisting the applicator, retracting a plunger, etc.

[0096] In some embodiments, the loading actuator may be tuned to a specific tension-applying communicating member, or a combination of communicating members. For example, the loading actuator may be configured to load the wearable medical device in a reverse rotational manner onto the wearable medical device with a selected degree of rotation so that the communicating member is fully or partially de-stretched when the wearable medical device is attached to the skin surface. A communicating member that is not fully de-stretched after the wearable medical device is attached to the skin surface may function to further secure the wearable medical device within the skin surface, as the remaining stretch continues to pull the opposing microneedles into the skin. However, excessive residual stretch in the communicating member while within the skin surface can cause damage. Conversely, it is also possible to over-stretch the communicating member during application. In other words, a communicating member that has been de-stretched past its original configuration can effectively be stretched again. If the communicating members are excessively stretched while a wearable medical device is attached to the skin surface, the force that favors returning them to their original configuration may eventually cause the communicating members to pull the microneedles away from the skin surface, thereby shortening the wearing period.

[0097] Drive actuator In some embodiments, the drive actuator may include any combination of mechanical components for producing rotation of first and second rotationally distinct segments. For example, the drive actuator may include one or more of the following: a spring, gears (e.g., an epicycle gear system), a piston, a pump, etc. In some embodiments, the applicator may include a mechanism for engaging with the drive actuator. For example, the mechanism may include twisting the applicator, retracting a plunger, etc.

[0098] Holding system In some embodiments, the retention system may include any combination of mechanical components for holding first and second rotationally distinct segments of a wearable medical device in a configuration that is loaded in opposite rotations. In some embodiments, the retention system may include retention elements such as pins, latches, and brackets.

[0099] In some embodiments, the retention system may further include a docking platform for holding a wearable medical device within the applicator. In some embodiments, the docking platform may be extendable beyond the periphery of the applicator. For example, when applying tension to a skin surface, it may be undesirable to have multiple microneedles of the wearable medical device in contact with the skin surface while tension is being applied. Therefore, the docking platform may be configured to retract the wearable medical device away from the skin surface before tension is applied and / or extend the wearable medical device toward the skin surface after tension is applied.

[0100] Skin tensioning system In some embodiments, the chamber may be housed within the applicator body / housing. For example, only a portion of the chamber intended to contact the skin surface may be visible. In other embodiments, the chamber may extend from the applicator body / housing.

[0101] In some embodiments, the chamber may be independently characterized by a length and width of from about 10 mm to about 100 mm. For example, the chamber may be characterized by a length and width, in mm, selected from 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100, or a value within the range between any of the foregoing values, for example, a value within the range of about 50 to about 80. The shape of the chamber can be any shape. For example, the surface of the chamber that contacts the skin surface can be circular, elliptical, or the like. The size of the chamber can be selected according to the desired level of stretch, the size of the wearable medical device to be attached, or a combination thereof.

[0102] In some embodiments, the chamber may be configured to contact the skin surface such that the area within the boundaries of the chamber is from about 75 mm 2 to about 8000 mm 2 For example, the area within the boundaries of the chamber may be selected, in mm 2 units, from about 75, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, 500, 600, 700, 800, 900, 1000, 1500, 2000, 2500, 3000, 4000, 4500, 5000, 6000, 7000, or 8000, or a value within the range between any of the foregoing values, for example, a value within the range of about 200 to about 350.

[0103] In some embodiments, the mechanism for reducing the pressure within the chamber that contacts the skin surface may include an electric vacuum pump, a mechanical vacuum pump, a suction valve, a syringe, or a combination thereof.

[0104] In some embodiments, the skin tensioning system may further include a plurality of tensioning microneedles and a tensioning actuator configured to rotate the plurality of tensioning microneedles around the region in which a wearable medical device is housed within the applicator. Further details relating to the tensioning microneedles and tensioning actuator are provided below.

[0105] Skin tension actuator In many embodiments, the tension-applying actuator may be configured to rotate a plurality of tension-applying microneedles around an area (e.g., a holding system, e.g., a docking platform) in which a wearable medical device is housed within the applicator. In some embodiments, the tension-applying actuator may include an epicycle gear system for rotating the plurality of microneedles around the holding system.

[0106] In some embodiments, the tension-applying actuator may be configured to rotate a plurality of first microneedles in one rotational direction and a plurality of second microneedles in the opposite rotational direction (i.e., in reverse rotation).

[0107] Tension-applying microneedles In many embodiments, the tension-applying microneedles may exist as a first set of tension-applying microneedles and a second set of tension-applying microneedles. In some embodiments, the first set of tension-applying microneedles may be mounted on a first rotationally distinct tension-applying segment, and the second set of tension-applying microneedles may be mounted on a second rotationally distinct tension-applying segment, the second rotationally distinct tension-applying segment at least partially surrounding the first rotationally distinct tension-applying segment. The first and second rotationally distinct tension-applying segments may be configured to rotate in opposite directions (i.e., in reverse rotation) around an axis of rotation. In many embodiments, the first and second rotationally distinct tension-applying segments are each in the shape of a cylindrical ring and are arranged concentrically.

[0108] In embodiments having a first rotationally distinct tensioning segment and a second rotationally distinct tensioning segment, the tensioning actuator may include an epicycle gear system having a ring gear, a sun gear, and one or more planetary gears. For example, the ring gear may be effective in rotating the second rotationally distinct tensioning segment, and the sun gear may be effective in rotating the first rotationally distinct tensioning segment. In other words, the rotationally distinct tensioning segments may have gear teeth complementary to each other.

[0109] In some embodiments, multiple tension-applying microneedles may be independently characterized by an elevation angle of about 40° to about 80° with respect to the plane on which the microneedles are mounted (e.g., each rotationally different tension-applying segment). For example, at least some of the multiple tension-applying microneedles may 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 within a range of any of the aforementioned values, for example, within a range of about 45 to about 50. Elevation angles outside the above range (e.g., 90°) are still within the scope of this disclosure, but may not be sufficient to apply tension to the skin surface. Measuring the elevation angle of tension-applying microneedles is equivalent to measuring the elevation angle of microneedles on the wearable medical device described above. In embodiments having a first plurality of tension-applying microneedles and a second plurality of tension-applying microneedles on their respective rotationally different tension-applying segments, at least a portion of the first and second plurality of tension-applying microneedles are characterized by an elevation angle (e.g., 40 to 80°), the plurality of first tension-applying microneedles may be oriented so that the tips of the first tension-applying microneedles face one rotational direction, and the plurality of second tension-applying microneedles may be oriented so that the tips of the second microneedles face a rotational direction opposite to the rotational direction of the tips of the first tension-applying microneedles.

[0110] In some embodiments, each of the first and second tension-applying microneedles, characterized by an elevation angle ≠ 90°, may be independently positioned at orientation angles of approximately -25° to approximately 0° (aligned with the tangent) or approximately 0° (aligned with the tangent) to approximately 25° with respect to the tangent of the rotation vector (i.e., with respect to the rotation of each rotationally distinct tension-applying segment). Negative orientation angle values ​​indicate that the needle is pointing toward the axis of rotation, while positive orientation angle values ​​indicate that the needle is pointing toward the axis away from the axis of rotation. For example, any given tension-applying microneedle may be characterized by an orientation angle (°) of approximately -25, -22, -20, -18, -15, -12, -10, -8, -5, -2, 0, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25, or within a range between any of the aforementioned values ​​on either side of 0, for example, within a range of approximately -15 to approximately -8, approximately 5 to approximately 12, etc. In many embodiments, each of the first and second tension-applying microneedles may be positioned such that the entire needle body is aligned tangentially with the rotation vector (i.e., orientation angle 0°) with respect to the rotation of each rotationally different tension-applying segment. The orientation angle is measured from the tangential plane passing through the center of the microneedle base to the center of the microneedle tip, as described above with respect to microneedles on wearable medical devices.

[0111] In some embodiments, each of the first and second tension-applying microneedles may be independently characterized by a length of approximately 0.5 mm to approximately 3.5 mm. For example, each of the first and second microneedles may be independently characterized by a length of approximately 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 mm, or within a range between any of the aforementioned values, for example, within a range of approximately 0.5 to approximately 0.8 mm. The needle length may be selected based on the needs of the application. For example, shorter needles may be more comfortable for older users or in areas where the skin may be thinner. In many embodiments, the length of the tension-applying microneedles may be selected to be longer than the microneedles of the wearable medical device. Alternatively, if the applicator has means for extending the wearable medical device beyond the periphery of the applicator (e.g., an extendable docking platform), the length of the tension-applying microneedle may be selected to be equal to or shorter than the microneedle of the wearable medical device.

[0112] In some embodiments, each of the first and second tension-imparting microneedles may be independently characterized by a diameter of about 1 μm to about 25 μm. For example, each of the first and second tension-imparting microneedles may be independently characterized by a diameter of about 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25 in μm, or within a range between any of the aforementioned values, for example, within a range of about 8 to about 12. In some embodiments, any tension-imparting microneedle described herein may have a uniform or non-uniform diameter within the above range.

[0113] In some embodiments, the tension-applying microneedles may be arranged in circular or semicircular rows extending around a rotation axis. For example, the tension-applying microneedles may be arranged in 1 to 5 rows.

[0114] In some embodiments, the tension-applying microneedles may be made of metal, plastic, rubber, silicone, or a combination thereof.

[0115] In many embodiments, the tension-applying microneedles may be driven into the skin surface before rotation. In other embodiments, the tension-applying microneedles may operate by friction (e.g., by rubber microneedles with blunt blades) rather than puncturing the skin surface.

[0116] (Release mechanism) In some embodiments, the mechanism for releasing a wearable medical device from a reverse-rotating loaded configuration may include any combination of mechanical components for disengaging the retaining element. The mechanism may include buttons, plungers, switches, and the like. When the retaining element is disengaged, the potential energy stored in the loaded communicating member may drive the wearable medical device back to its original state, or at least partially to a disengaged state.

[0117] Additional features In some embodiments, the described applicator may further include a docking platform for holding a wearable medical device within the applicator. In some embodiments, the docking platform may be extendable beyond the periphery of the applicator. For example, when applying tension to a skin surface, it may be undesirable to have multiple microneedles of the wearable medical device in contact with the skin surface while tension is being applied. Therefore, the docking platform may be configured to retract the wearable medical device away from the skin surface before tension is applied and / or extend the wearable medical device toward the skin surface after tension is applied.

[0118] In some embodiments, the described applicator may further include an actuator guide configured to mate with applicator guides on first and second rotationally distinct segments. Alternatively, the applicator may include a docking platform for holding a wearable medical device within the applicator, and an actuator guide configured to mate with applicator guides on the docking platform. In some embodiments, the actuator guide may be a track in a stationary wall within the applicator. The track in the stationary wall of the applicator may be angled to accommodate the rotation of the first and / or second rotationally distinct segments (see, for example, Figures 7A and 7B). The actuator guide may assist the independent rotation of the first and second rotationally distinct segments and may therefore be of any structure. Examples of actuator guides include tracks, pins, gears, friction-inducing components, and the like.

[0119] How to apply In many embodiments, methods are described for attaching a wearable medical device (e.g., a wearable medical device of this disclosure having a tension-applying communicating member) to a skin surface. The method may include providing an applicator, as described herein, having a wearable medical device inside, and rotating a first rotationally different segment and a second rotationally different segment so that the wearable medical device is configured to be loaded in a reverse rotation. The method may further include bringing the applicator into contact with the skin surface so that the chamber is in contact with the skin surface, engaging a mechanism for applying decompression to the skin surface to generate a stretched skin surface, and releasing the wearable medical device from the reverse rotation loaded configuration so that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the stretched skin surface.

[0120] In many embodiments, methods are described for attaching a wearable medical device (e.g., a wearable medical device of this disclosure having rolling connecting members) to a skin surface. The method may include providing an applicator, which is an applicator described herein and has a wearable medical device inside it; bringing the applicator into contact with the skin surface so that a chamber is in contact with the skin surface; and engaging a mechanism for applying decompression to the skin surface to generate a stretched skin surface. The method may further include rotating a first rotationally different segment and rotating a first rotationally different segment so that a plurality of first microneedles and a plurality of second microneedles are driven into the stretched skin surface.

[0121] In some embodiments, any method described herein may further include engaging a tension-applying actuator such that a plurality of tension-applying microneedles in contact with the skin surface rotate to produce a stretched skin surface.

[0122] In some embodiments, any method described herein may further include selecting a degree of rotation for rotating a first rotationally different segment and a second rotationally different segment, whether for loading a wearable medical device (e.g., having a tension-applying communicating member) or for driving a wearable medical device (e.g., having a rolling communicating member).

[0123] In some embodiments, any method described herein for attaching a wearable medical device may further include attaching a monitoring device to the wearable medical device.

[0124] In some embodiments, any method described herein for attaching a wearable medical device to a skin surface may further include applying an auxiliary fixation article to the wearable medical device, or to a wearable medical device having a monitoring device thereon. The auxiliary fixation article may be a bandage, a protective cover (e.g., waterproof / sweatproof), etc. In some embodiments, the auxiliary fixation article may include a lining and a skin-compatible adhesive.

[0125] In some embodiments, methods for removing a wearable medical device from the skin surface are described. The methods may include engaging a mechanical actuator on the wearable medical device so that the wearable medical device is configured to be loaded in a reverse rotational manner, and lifting the wearable medical device from the skin surface.

[0126] In some embodiments, methods for removing a wearable medical device from a skin surface are described. The methods may include bringing an applicator into contact with the wearable medical device on the skin surface, engaging a loading actuator within the applicator so that the wearable medical device is configured to be loaded in a reverse rotational manner, and lifting the wearable medical device from the skin surface.

[0127] Monitoring methods In many embodiments, methods for monitoring biological signals are described. These methods may include detecting biological signals using a monitoring device immobilized on a wearable medical device of the present disclosure attached to the skin surface.

[0128] In some embodiments, the biosignal may be selected from electrical signals, chemical signals, optical emission signals, or a combination thereof.

[0129] The method may further include attaching a wearable medical device to the skin surface.

[0130] The method may further include attaching a monitoring device to a wearable medical device attached to the skin surface.

[0131] kit In many embodiments, a kit is described. The kit may include the applicator of the Disclosure and a set of instructions for attaching the wearable medical device to the skin surface.

[0132] In some embodiments, the kit may further include one or more wearable medical devices of the present disclosure.

[0133] In some embodiments, the kit may further include one or more monitoring devices.

[0134] In some embodiments, the kit may further include one or more auxiliary fixing articles. This disclosure includes the following embodiments of the invention: <Aspect 1> An applicator for applying a wearable medical device to the skin surface, A loading actuator configured to load a first rotationally distinct segment and a second rotationally distinct segment within the wearable medical device in opposite rotational directions, A holding system for holding the wearable medical device in a reverse-rotating loaded configuration, A skin tensioning system, A chamber is configured to surround the area in which the wearable medical device is housed together with the applicator, and to come into contact with the area of ​​the skin surface. A skin tensioning system comprising a mechanism for applying reduced pressure to the area of ​​the skin surface, The wearable medical device comprises a mechanism for releasing it from the reverse-rotating loaded configuration, The aforementioned wearable medical device, The base, The first rotationally different segment, A second rotationally distinct segment, at least partially surrounded by the first rotationally distinct segment, A plurality of first microneedles located on the first rotationally different segments, A base comprising a plurality of second microneedles located on the second rotationally different segments, An applicator comprising at least one communicating member that connects the first rotationally distinct segment and the second rotationally distinct segment. <Aspect 2> An applicator for attaching a wearable medical device to the skin surface, A drive actuator configured to rotate a first rotationally distinct segment within the wearable medical device and rotate a second rotationally distinct segment in the opposite direction, A skin tensioning system, A chamber is configured to surround the area in which the wearable medical device is housed together with the applicator, and to come into contact with the area of ​​the skin surface. A skin tensioning system comprising a mechanism for applying reduced pressure to the area of ​​the skin surface, The aforementioned wearable medical device, The base, The first rotationally different segment, A second rotationally distinct segment, at least partially surrounded by the first rotationally distinct segment, A plurality of first microneedles located on the first rotationally different segments, A base comprising a plurality of second microneedles located on the second rotationally different segments, An applicator comprising at least one communicating member that connects the first rotationally distinct segment and the second rotationally distinct segment. <Aspect 3> The applicator according to embodiment 1 or 2, wherein the chamber is housed together with the applicator body. <Aspect 4> The applicator according to embodiment 1 or 2, wherein the chamber extends from the applicator body. <Aspect 5> The applicator according to any one of embodiments 1 to 4, wherein the mechanism for applying reduced pressure includes an electric vacuum pump, a mechanical vacuum pump, a suction valve, a syringe, or a combination thereof. <Aspect 6> The aforementioned skin tensioning system, Multiple tension-applying microneedles, The applicator according to any one of embodiments 1 to 5, further comprising a tension-applying actuator configured to rotate the plurality of tension-applying microneedles around a region in the applicator where the wearable medical device is housed. <Aspect 7> The aforementioned skin tensioning system, The present invention further comprises a first rotationally distinct tension-applying segment, and a second rotationally distinct tension-applying segment that at least partially surrounds the first rotationally distinct tension-applying segment. The plurality of tension-applying microneedles comprises a plurality of first tension-applying microneedles and a plurality of second tension-applying microneedles, The applicator according to embodiment 6, wherein the plurality of first tension-applying microneedles are located on the first rotationally different tension-applying segments, and the plurality of second tension-applying microneedles are located on the second rotationally different tension-applying segments. <Aspect 8> The applicator according to embodiment 7, wherein the first rotationally different tension-applying segment and the second rotationally different tension-applying segment are each in the shape of a cylindrical ring and are arranged concentrically. <Pattern 9> The applicator according to embodiment 7 or 8, wherein the plurality of first tension-applying microneedles and the plurality of second tension-applying microneedles are independently characterized by an elevation angle of about 40 to about 80°, and each of the plurality of first tension-applying microneedles is oriented such that the tip of the first microneedle faces a rotational direction opposite to the rotational direction facing the tip of the second microneedle of each of the plurality of second tension-applying microneedles. <Aspect 10> A method for attaching a wearable medical device to a stretched skin surface, The applicator described in any one of the embodiments 1 to 9, wherein the applicator has the wearable medical device inside, The wearable medical device is configured to be loaded in a reverse rotational manner by rotating a first rotationally different segment and then rotating a second rotationally different segment. The applicator is brought into contact with the skin surface so that the chamber comes into contact with the skin surface, Engaging the mechanism for applying decompression to the skin surface in order to produce an elongated skin surface, A method comprising releasing the wearable medical device from the reverse-rotating loaded configuration into the stretched skin surface. <Aspect 11> A method for attaching a wearable medical device to a stretched skin surface, The applicator described in any one of the embodiments 1 to 9, wherein the applicator has the wearable medical device inside, The applicator is brought into contact with the skin surface so that the chamber comes into contact with the skin surface, Engaging the mechanism for applying decompression to the skin surface in order to produce an elongated skin surface, A method comprising rotating a first rotationally different segment and a second rotationally different segment so that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the stretched skin surface. <Aspect 12> The method according to embodiment 10 or 11, further comprising engaging a tension-applying actuator so that a plurality of tension-applying microneedles in contact with the skin surface rotate to produce an stretched skin surface. <Aspect 13> It's a kit, An applicator described in any one of the descriptions 1 to 9, A kit comprising instructions for attaching a wearable medical device to the skin surface. <Aspect 14> The kit according to embodiment 13, further comprising one or more wearable medical devices. <Aspect 15> The kit according to embodiment 13 or 14, further comprising a monitoring device.

Claims

1. An applicator for applying a wearable medical device to the skin surface, A loading actuator configured to load a first rotationally distinguishable segment and a second rotationally distinguishable segment within the wearable medical device in a counter-rotating manner, A holding system for holding the wearable medical device in a reverse-rotating loaded configuration, A skin tensioning system, A chamber is configured to surround the area in which the wearable medical device is housed together with the applicator, and to come into contact with the area of ​​the skin surface. A skin tensioning system comprising a mechanism for applying reduced pressure to the area of ​​the skin surface, The wearable medical device comprises a mechanism for releasing it from the reverse-rotating loaded configuration, The aforementioned wearable medical device, The base, A first rotationally distinguishable segment, A second rotationally distinguishable segment, at least partially surrounded by the first rotationally distinguishable segment, A plurality of first microneedles located on the first rotationally distinguishable segment, A base comprising a plurality of second microneedles located on the second rotatably distinguishable segment, An applicator comprising at least one communicating member that connects the first rotatably distinguishable segment and the second rotatably distinguishable segment.

2. An applicator for attaching a wearable medical device to the skin surface, A drive actuator configured to rotate a first rotatably distinguishable segment within the wearable medical device and rotate a second rotatably distinguishable segment in the opposite direction, A skin tensioning system, A chamber is configured to surround the area in which the wearable medical device is housed together with the applicator, and to come into contact with the area of ​​the skin surface. A skin tensioning system comprising a mechanism for applying reduced pressure to the area of ​​the skin surface, The aforementioned wearable medical device, The base, A first rotationally distinguishable segment, A second rotationally distinguishable segment, at least partially surrounded by the first rotationally distinguishable segment, A plurality of first microneedles located on the first rotationally distinguishable segment, A base comprising a plurality of second microneedles located on the second rotatably distinguishable segment, An applicator comprising at least one communicating member that connects the first rotatably distinguishable segment and the second rotatably distinguishable segment.

3. The applicator according to claim 1, wherein the chamber is housed together with the applicator body.

4. The applicator according to claim 1, wherein the chamber extends from the applicator body.

5. The applicator according to claim 1, wherein the mechanism for applying reduced pressure includes an electric vacuum pump, a mechanical vacuum pump, a suction valve, a syringe, or a combination thereof.

6. The aforementioned skin tensioning system, Multiple tension-applying microneedles, The applicator according to claim 1, further comprising a tension-applying actuator configured to rotate the plurality of tension-applying microneedles around a region in the applicator where the wearable medical device is housed.

7. The aforementioned skin tensioning system, The present invention further comprises a first rotationally distinguishable tension-applying segment, and a second rotationally distinguishable tension-applying segment that at least partially surrounds the first rotationally distinguishable tension-applying segment. The plurality of tension-applying microneedles comprises a plurality of first tension-applying microneedles and a plurality of second tension-applying microneedles. The applicator according to claim 6, wherein the plurality of first tension-applying microneedles are located on the first rotationally distinguishable tension-applying segment, and the plurality of second tension-applying microneedles are located on the second rotationally distinguishable tension-applying segment.

8. The applicator according to claim 7, wherein the first rotationally distinguishable tension-applying segment and the second rotationally distinguishable tension-applying segment are each in the shape of a cylindrical ring and are arranged concentrically.

9. The applicator according to claim 7, wherein the plurality of first tension-applying microneedles and the plurality of second tension-applying microneedles are independently characterized by an elevation angle of 40 to 80°, and each of the plurality of first tension-applying microneedles is oriented such that the tip of the first microneedle faces a rotational direction opposite to the rotational direction facing the tip of the second microneedle of each of the plurality of second tension-applying microneedles.

10. A method for attaching a wearable medical device to a stretched skin surface (excluding human skin), An applicator according to any one of claims 1 to 9, wherein the applicator has the wearable medical device inside, The wearable medical device is configured to be loaded in a reverse rotational manner by rotating the first rotationally distinguishable segment and the second rotationally distinguishable segment, The applicator is brought into contact with the skin surface so that the chamber comes into contact with the skin surface, Engaging the mechanism for applying decompression to the skin surface in order to produce an elongated skin surface, A method comprising releasing the wearable medical device from the reverse-rotating loaded configuration into the stretched skin surface.

11. A method for attaching a wearable medical device to a stretched skin surface (excluding human skin), An applicator according to any one of claims 1 to 9, wherein the applicator has the wearable medical device inside, The applicator is brought into contact with the skin surface so that the chamber comes into contact with the skin surface, Engaging the mechanism for applying decompression to the skin surface in order to produce an elongated skin surface, A method comprising rotating a first rotationally distinguishable segment and rotating a second rotationally distinguishable segment such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the stretched skin surface.

12. The method according to claim 10, further comprising engaging a tension-applying actuator such that a plurality of tension-applying microneedles in contact with the skin surface (excluding human skin) rotate to produce an stretched skin surface.

13. It's a kit, An applicator according to any one of claims 1 to 9, A kit comprising instructions for attaching a wearable medical device to the skin surface.

14. The kit according to claim 13, further comprising one or more wearable medical devices, monitoring devices, or combinations thereof.

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