Wearable medical device having dry electrodes and method of use thereof

Abstract

A wearable medical device is described having a plurality of microneedles on a first rotationally distinct segment and a plurality of microneedles on a second rotationally distinct segment. The wearable medical device is a dry electrode for direct attachment to the skin. A method for attaching the wearable medical device to the skin and a method for monitoring biosignals using the device are also described.

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] Other parameters that are desirable to monitor, such as cardiac function, are based on electrical activity within the body. Conductivity within the body is based more on the movement of ions than on the movement of electrons. Therefore, electrodes are needed to monitor parameters based on electrical activity, that is, to convert the biosignals within the body into voltages that can be measured by conventional recording devices. Many current monitoring devices are configured to come into contact with the skin surface, but any electrodes on the skin surface are hindered by the lack of moisture in the stratum corneum. In other words, monitoring parameters involving electrical activity within the body is difficult due to the poor ion mobility at the skin surface.

[0003] Current physiological tests reduce impedance by incorporating a conductive hydrogel between the skin and electrode interface. Specific examples include electrocardiograms (ECG), electroencephalograms (EEG), electrical impedance tomography (EIT), electromyography (EMG), and electrooculography (EOG). However, the use of conductive hydrogels is impractical for monitoring wearable devices over any given long period, as the hydrogel typically dries out and is easily contaminated.

[0004] What is needed is a method for securing a monitoring device to the skin without the need for adhesives, and a method for monitoring parameters based on electrical activity without the need for conductive hydrogels. [Overview of the Initiative]

[0005] In one embodiment, a wearable medical device is described. The wearable medical device includes a conductive base having a first rotatably distinct segment and a second rotatably distinct segment, and an electrical connector communicating with the conductive base. The second rotatably distinct segment at least partially surrounds the first rotatably distinct segment. The wearable medical device further includes at least one communicating member connecting the first rotatably distinct segment and the second rotatably distinct segment, a plurality of first microneedles located on the first rotatably distinct segment, and a plurality of second microneedles located on the second rotatably distinct segment. At least a portion of the first microneedles and / or at least a portion of the second microneedles include an oxidation-reduction pair.

[0006] In one embodiment, a method for attaching the wearable medical device of the present disclosure to a skin surface is described. The method includes rotating a first rotationally different segment and a second rotationally different segment so that the wearable medical device is configured to be reverse-rotatably loaded; bringing the wearable medical device in the reverse-rotatably loaded configuration into contact with a 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 are implanted into the skin surface.

[0007] In one embodiment, a method for attaching the wearable medical device of the present disclosure to a skin surface is described. The method includes bringing the wearable medical device into contact with a skin surface and rotating a first rotationally distinct segment and a second rotationally distinct segment so that a plurality of first microneedles and a plurality of second microneedles are implanted into the skin surface.

[0008] In one embodiment, a method for monitoring biological signals is described. The method includes detecting biological signals using a wearable medical device of the present disclosure attached to the skin surface, and converting the detected biological signals into an output readable by a monitoring device.

[0009] In one embodiment, a kit is described. The kit includes the wearable medical device of the present disclosure and a set of instructions for attaching the wearable medical device to the skin surface. [Brief explanation of the drawing]

[0010] 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 1C] An exemplary microneedle having a redox couple. [Figure 1D] An exemplary microneedle having a redox couple. [Figure 1E] A side view of a portion of an exemplary conductive base having an electrical connector. [Figure 1F] A side view of a portion of an exemplary conductive base having an electrical connector. [Figure 2A] A view of the upper side of the wearable medical device of the present disclosure. [Figure 2B] A top view of the wearable medical device of FIG. 2A. [Figure 3A] A view of the bottom side of the wearable medical device of the present disclosure. [Figure 3B] A top view of the wearable medical device of FIG. 2A. [Figure 4] A side view of the microneedle of the present disclosure and elevation angle measurement are shown. [Figure 5] A top view of the microneedle of the present disclosure and orientation angle measurement are shown. [Figure 6A] An applicator with the wearable medical device of the present disclosure inserted is shown. [Figure 6B] An applicator in a configuration where the wearable medical device is loaded in a reverse rotational manner is shown. [Figure 7A] A top view of a non-loaded configuration of the wearable medical device having a mechanical actuator. [Figure 7B] A top view of a loaded configuration of the wearable medical device having a mechanical actuator.

[0011] 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. Similar numbers used within the drawings refer to similar components (e.g., 102, 202, 302, etc., 110, 210, 310, etc.).

Best Mode for Carrying Out the Invention

[0012] The present disclosure describes a wearable medical device in the form of a dry electrode (i.e., one that does not require a hydrogel) that can be fixed to the skin via a microneedle. The microneedles are inserted through the water-rich stratum corneum, and at least some of the microneedles contain a redox pair coated on the microneedles, at least some of the microneedles are composed of at least a part of the redox pair, or a combination of both. The wearable medical device is in communication with an electrical connector for attaching a monitoring device onto the wearable medical device.

[0013] The wearable medical device utilizes the opposing forces between the rotating segments to not only drive the microneedles into the skin but also fix the microneedles within the skin. A wearable medical device attached to the skin via a microneedle has much higher resistance to accidental removal and a longer wearing period compared to an equivalent device adhered to the skin via an adhesive. Furthermore, 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 enabling cleaning.

[0014] The 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. The user can enjoy the versatility of the modular system.

[0015] Definitions As used herein, the term "about" means ±10 percent of a given value. For example, about 10 means 9 to 11.

[0016] As used herein, the term “adhesive” refers to a polymer composition that bonds two adherends together. Examples of adhesives include pressure-sensitive adhesives and gel adhesives.

[0017] As used herein, the term “actuator guide” refers to a feature on or within an applicator component that is complementary to the applicator guide within a wearable medical device. The mating of the actuator guide and the applicator guide by a rotating means within the applicator is effective for rotating a first rotationally distinct segment and / or a second rotationally distinct segment within a wearable medical device.

[0018] As used herein, the terms “applicator guide” or “applicating guide” refer to a feature on or within a component of a wearable medical device that is complementary to the operating guide within the applicator. The mating of the applicator guide and the operating guide by a rotating means within the applicator is effective for rotating a first rotationally distinct segment and / or a second rotationally distinct segment within the wearable medical device.

[0019] As used herein, the term "barb" refers to 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 wearing period. Barbed needles can also help achieve a desired gap between the wearable medical device and the skin surface.

[0020] As used herein, “biosignal” means measurable biomolecules, bioactivity, or any changes thereof within a subject’s body. For example, the electrical activity of the heart is a biosignal propagated within a subject’s body by ions. Such ion flows can be detected by combining the electrodes of the wearable medical device of this disclosure with a suitable monitoring device.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] As used herein, "conductive" means the ability to convert ions into electrons through charge transfer. High electrical performance can be obtained by non-precious metal materials (e.g., Ag / AgCl). When a metal electrode comes into contact with an electrolyte, the metal atom (M) ions tend to lose electrons, thus ion exchange (i.e., M⇔M) occurs. +n +n e- An electrochemical reaction occurs due to ) and metal ions (M +n ) moves to the electrolyte, suggesting a negatively charged electrode compared to the electrolyte (i.e., oxidation reaction). Similarly, in the electrolyte, metal ions (M +n ) removes electrons, forming metal atoms (M) that are deposited on the electrode, suggesting a positively charged electrode relative to the electrolyte (i.e., a reduction reaction). In equilibrium, the ion exchange rates in both directions are balanced, and the resulting current is equal to zero (i.e., the currents flowing in opposite directions are equal). However, the resulting potential difference at the electrode-electrolyte interface, called the half-cell potential, is not zero and depends on the concentrations of both the ions and the metal electrode, and can be obtained by the Nernst equation.

[0025] As used herein, “electrical connector” is an article (e.g., a conductive metal) that can allow electrons to flow through it. Similarly, a conductive material can allow electrons to flow through it. An electrical connector is made of a conductive material or is coated with a conductive material.

[0026] 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.

[0027] As used herein, the term “microneedle” refers to a microstructure projection with a pointed tip that is configured to penetrate the skin.

[0028] As used herein, the term “redox pair” refers to a reducing agent (M+n- ) and an oxidizing agent (M), and this combination is represented by the formula: M⇔M +n +n e- where n is an integer and e - is an electron. Exemplary redox couples are Ag 0 (s) and Ag + Cl - , that is, Ag⇔Ag +1 +1 e- .

[0029] As used herein, "rotation" means to move a certain extent around the axis of rotation.

[0030] As used herein, the phrase "rotationally different" represents a component that can be rotated independently of another component. For example, two rotationally different components that are otherwise connected can be rotated a certain extent in opposite directions.

[0031] Description of the Drawings Figure 1A is a bottom view of the wearable medical device 100 of the present disclosure, illustrating the first main surface of a conductive 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. An electrical connector 134 is shown communicating with the second rotationally distinct segment 108. 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 (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).

[0032] 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. An electrical connector 134 is shown communicating with the second rotationally distinct segment 108.

[0033] Figure 1C shows an exemplary microneedle 110 having a redox pair 136. The redox pair 136 is shown as a double coating consisting of a reducing agent 138 (e.g., silver chloride) and an oxidizing agent 140 (e.g., metallic silver). Double coating means that the entire microneedle 110 is first coated with the oxidizing agent 140 and then at least partially coated with the reducing agent 138.

[0034] Figure 1D shows an exemplary microneedle 110 having a redox pair 136. The redox pair 136 is shown as a coating consisting of a reducing agent 138 (e.g., silver chloride) on a microneedle composed of an oxidizing agent 140 (e.g., metallic silver). The microneedle base 122 is shown as being composed of the oxidizing agent 140.

[0035] Figure 1E shows a side view of a portion of an exemplary conductive base 102. As shown, the second rotationally distinct segment 108 is made of a conductive material (e.g., metallic silver), and the second microneedle 110 is made of a conductive material (e.g., metallic silver), as shown in the microneedle base 122. The second microneedle 110 is further shown coated with a reducing agent 136 (e.g., silver chloride). The electrical connector 134 is made of a conductive material and communicates with the second rotationally distinct segment 108, thereby communicating with the second microneedle 110.

[0036] Figure 1F shows a side view of an exemplary conductive base 102. As shown, a second rotationally distinct segment 108 is made of a non-conductive material. A conductive coating 144 (e.g., metallic silver) is bonded to the second rotationally distinct segment 108 by an adhesive 142. The conductive coating 144 communicates with a second microneedle 110 having an oxidation-reduction pair. The second microneedle 110 is shown to have a double coating consisting of a reducing agent 138 (e.g., silver chloride) and an oxidizing agent 140 (e.g., metallic silver). An electrical connector 134 is shown communicating with the conductive coating 144, which communicates with the oxidation-reduction pair of the second microneedle 110. The electrical connector 134 extends from the first main surface 102a to the second main surface 102b, where it can be connected to a monitoring device.

[0037] 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 (shown here as a rolling disk). An electrical connector 234 is shown in communication with the first rotationally distinct segment 204. 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.

[0038] 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. An electrical connector 234 is shown communicating with the first rotationally distinct segment 204.

[0039] 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. Although not shown, the wearable medical device 300 also includes electrical connectors spanning the first and second main surfaces of the base 302. 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.

[0040] 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 twisted in another way. 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.

[0041] 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°.

[0042] Figure 5 shows a top view of a first rotationally distinct segment 504 (or a second rotationally distinct segment on which a plurality of first microneedles 506 are arranged) of the present disclosure. 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.

[0043] Figure 6A shows an exemplary applicator 601 with an unloaded wearable medical device 600 inserted. Applicator 601 is shown to include a first segment actuation guide 603 in the inner wall 605, which mates with a first applicator guide 607 located on a first rotationally distinct segment 604. Applicator 601 is further shown to include a second segment actuation guide 609 in the outer wall 611, which mates with a second applicator guide 613 located on a second rotationally distinct segment 608.

[0044] Figure 6B shows an exemplary applicator 601 in which the wearable medical device 600 is loaded in a counter-rotating configuration. The first rotationally distinct segment 604 is rotated clockwise, and the second rotationally distinct segment 608 is rotated counter-clockwise. The applicator 601 holds the wearable medical device 600 in this counter-rotating configuration until the applicator 601 makes contact with the skin surface (retaining elements are not shown). When the retaining elements (not shown) are disengaged, the wearable medical device 600 is released from the loaded configuration, and multiple microneedles on each segment are injected into the skin surface.

[0045] Figure 7A shows a top view (second main view) of a wearable medical device 700 having a pair of mechanical actuators 732a / 732b, the medical device being shown in an unloaded configuration. The wearable medical device 700 includes a base 702, which has a first rotatably distinct segment 704, a second rotatably distinct segment 708, and a communicating member 712. The first rotatably distinct segment 704 is shown as a solid circular plate, and the second rotatably distinct segment 708 is shown as a ring concentrically surrounding the solid circular plate. An electrical connector 734 is shown communicating with the first rotatably distinct segment 704. The first mechanical actuator 732a communicates with the first rotatably distinct segment 704, and the second mechanical actuator 732b communicates with the second rotatably distinct segment 708. When the mechanical actuators 732a / 732b are grasped together, the first rotationally distinct segment 704 rotates counterclockwise, and the second rotationally distinct segment 708 rotates clockwise. The mechanical actuators 732a / 732b can be used to attach or detach a wearable medical device from the skin surface.

[0046] Figure 7B shows a top view of a wearable medical device 700 having a pair of mechanical actuators 732a / 732b, the medical device being shown in a loaded configuration. The connecting member 712 is shown extended compared to the unloaded configuration in Figure 7A.

[0047] Wearable medical devices Wearable medical devices are described in various embodiments. A wearable medical device may include a conductive base having a first rotationally distinct segment and a second rotationally distinct segment, and an electrical connector communicating with the conductive base. 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, wherein at least a portion of the plurality of first microneedles and / or at least a portion of the second microneedles may include redox pairs.

[0048] 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.

[0049] conductive base The conductive base ("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.

[0050] The base may be considered "conductive" by a material (e.g., a conductive metal) that constitutes at least some of the base's components. Alternatively, the base may be considered "conductive" by a conductive material (e.g., a conductive metal) coating any of the base's components. In any case, the microneedle containing the redox pair must be in contact with the conductive portion of the base. Similarly, the electrical connector must be in contact with the conductive portion of the base.

[0051] In many embodiments, the base may be composed at least partially of a conductive metal, a conductive polymer, graphene, or other carbon composite material, or a combination thereof. Examples of conductive metals include silver, gold, copper, aluminum, iron, and steel. Examples of conductive polymers include polyacetylene, polyphenylene vinylene, polypyrrole, polythiophene, polyaniline, and polyphenylene sulfide. In some embodiments, a base composed at least partially of a conductive material (i.e., an oxidizing agent, e.g., metallic silver) may be further coated with a reducing agent (e.g., silver chloride) to form a redox pair.

[0052] In other embodiments, the base may be composed of a non-conductive material, but may include a coating thereon, the coating consisting at least partially of a conductive metal, a conductive polymer, graphene, or other carbon composite, or a combination thereof. In some embodiments, the conductive coating may be bonded to the base by an adhesive. In some embodiments, the base coated with a conductive material (e.g., metallic silver) may be further coated with a reducing agent (e.g., silver chloride).

[0053] 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.

[0054] 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.

[0055] 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 7A and 7B illustrate exemplary mechanical operation of a wearable medical device without the applicator described herein. Figures 7A and 7B show the reverse rotational loading of the wearable medical device (i.e., pushing and aligning the mechanical actuator), although the reverse may also be envisioned. For example, a wearable medical device having a rolling communication member (e.g., Figure 2A) may include a mechanical actuator that can be used to drive a plurality of microneedles into the skin surface (i.e., the mechanical actuator is pushed and released).

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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).

[0062] Rotationally different segments In many embodiments, the first rotationally distinct segment and / or the second rotationally distinct segment may be composed at least partially of a conductive material. Exemplary conductive materials may include conductive metals, conductive polymers, graphene, or other carbon composites, or combinations thereof. In other embodiments, the first rotationally distinct segment and / or the second rotationally distinct segment may be at least partially coated with a conductive material, such as a conductive metal, conductive polymer, graphene, or other carbon composite, or combinations thereof. Exemplary conductive metals include silver, gold, copper, aluminum, iron, and steel. Exemplary conductive polymers include polyacetylene, polyphenylene vinylene, polypyrrole, polythiophene, polyaniline, and polyphenylene sulfide. In some embodiments, the first rotationally distinct segment and / or the second rotationally distinct segment may be composed at least partially of a conductive material and at least partially coated with a conductive material. In many embodiments, the conductive material may be metallic silver.

[0063] In some embodiments, the first rotationally distinct segment and the second rotationally distinct segment are composed of a non-conductive material, but at least a portion of the first rotationally distinct segment and / or the second rotationally distinct segment includes a conductive material (e.g., metallic silver) coated thereon. In some embodiments, the conductive material coating may be directly on each segment. In other embodiments, the conductive material coating may be bonded to each segment by an adhesive (e.g., a pressure-sensitive adhesive, such as natural rubber, synthetic rubber, styrene block copolymer, polyvinyl ether, acrylic, polyolefin, silicone, polyurethane, polyurea, or a combination thereof).

[0064] 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.

[0065] 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 unrotating the rotationally distinct segments, allowing the microneedles on them to be driven into the skin with some force.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] In some embodiments, the first and second rotationally distinct segments may be made of a material selected from metal, plastic, or a combination thereof.

[0073] 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.

[0074] Electrical connector In many embodiments, the electrical connector communicates with the conductive portion of the base.

[0075] In many embodiments, the electrical connector may be composed at least partially of a conductive material selected from conductive metals, conductive polymers, graphene, or other carbon composites, or combinations thereof. Examples of conductive metals include silver, gold, copper, aluminum, iron, and steel. Examples of conductive polymers include polyacetylene, polyphenylene vinylene, polypyrrole, polythiophene, polyaniline, and polyphenylene sulfide.

[0076] In some embodiments, the electrical connector may span a first principal surface of the base and a second principal surface of the base. A portion of the electrical connector extending from the second principal surface of the base may be configured to electrically connect to a monitoring device.

[0077] In some embodiments, the electrical connector may be located on or within a first rotationally distinct segment. In other embodiments, the electrical connector may be located on or within a second rotationally distinct segment. In some embodiments, one electrical connector may be located on or within a first rotationally distinct segment, and another electrical connector may be located on or within a second rotationally distinct segment.

[0078] In some embodiments, the wearable medical device may include two or more electrical connectors.

[0079] Connecting 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.

[0080] In some embodiments, the communicating member may be in the form of a flexible rod, a flexible band, or a spring.

[0081] 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).

[0082] 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, 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 rotationally different segments.

[0083] 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. 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.

[0084] 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.

[0085] Microneedles In many embodiments, at least a portion of a plurality of microneedles (i.e., a first microneedle and / or a second microneedle) may be coated with a reducing agent and then with an oxidizing agent (i.e., a redox pair). In some embodiments, a portion of the microneedles may be first coated with an oxidizing agent (e.g., metallic silver) and then coated with a reducing agent (e.g., silver chloride). A variety of redox pairs can be appropriately selected based on the engineer's understanding of the chemistry of the reference electrode. Currently, the most common redox pair used in biosensor technology is Ag / AgCl. In other embodiments, a portion of the microneedles may be first coated with a reducing agent and then coated with an oxidizing agent. In some embodiments, the double coating encompasses the entire microneedle. In other embodiments, the double coating encompasses a portion of the microneedle insofar as that portion includes a region that penetrates the stratum corneum. Double coating is necessary when the microneedle is not composed of a suitable oxidizing agent material (e.g., metallic silver).

[0086] In many embodiments, at least some of the microneedles (i.e., first microneedles and / or second microneedles) may be made of a conductive material (e.g., metallic silver) and coated with a reducing agent (e.g., silver chloride).

[0087] 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.

[0088] 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.

[0089] In embodiments having two or more rows, the rows may be separated independently by a distance of approximately 5 mm to approximately 10 mm. For example, the rows 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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®).

[0099] 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.

[0100] In some embodiments, any microneedles described herein may be solid or hollow. Hollow microneedles may allow the passage of therapeutic agents.

[0101] 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.

[0102] 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 drive actuator configured to drive a first rotationally distinct segment and a second rotationally distinct segment in opposite rotations. For example, an applicator having a drive actuator may be suitable for the wearable medical device described herein, which has a rolling communication member.

[0103] In many embodiments, applicators for attaching the wearable medical device of this disclosure to a skin surface are described. The applicator may comprise a loading actuator configured to load a first rotationally distinct segment and a second rotationally distinct segment in opposite rotations; a holding element for holding the wearable medical device in the reverse-rotating loaded configuration; and a mechanism for releasing the wearable medical device from the reverse-rotating loaded configuration. For example, an applicator having a loading actuator may be suitable for the wearable medical device described herein having a tension-applying communicating member.

[0104] 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 applicator may include a mechanism for engaging with the loading actuator. For example, the mechanism may include twisting the applicator, retracting a plunger, etc.

[0105] In some embodiments, the loading actuator may be tuned to a specific tension-applying communicating member, or several 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 tension-applied 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.

[0106] In some embodiments, the described applicator may further include a docking platform for holding a wearable medical device within the applicator.

[0107] 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 6A and 6B). The actuator guide may assist the independent rotation of the first and second rotationally distinct segments and may therefore be of any structure. For example, the actuator guide may be a track, a pin, a gear, a friction-inducing component, and the like.

[0108] In some embodiments, the retaining element may include any combination of mechanical components for holding the first and second rotationally distinct segments in a configuration that is loaded in opposite rotations. Examples of retaining elements include pins, latches, brackets, and the like.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] The applicators described herein are intended to assist in the attachment of the wearable medical devices of this disclosure, but it should be understood that the applicators may also be useful in 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 multiple microneedles.

[0113] How to apply In many embodiments, methods for attaching a wearable medical device to a skin surface are described. The methods may include preparing the wearable medical device according to this specification (e.g., having a tension-applying communicating member), and rotating a first rotationally distinct segment and a second rotationally distinct segment so that the wearable medical device is configured to be reverse-rotatably loaded. The methods may also include bringing the wearable medical device in the reverse-rotatably loaded configuration into contact with a 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 are embedded in the skin surface. In some embodiments, the rotation of the first rotationally distinct segment and the second rotationally distinct segment may be via a mechanical actuator of the wearable medical device. In other embodiments, the rotation of the first rotationally distinct segment and the second rotationally distinct segment may be via an applicator described herein.

[0114] In many embodiments, methods for attaching a wearable medical device to a skin surface are described. These methods may include: preparing the wearable medical device of this disclosure (e.g., having a rolling communication member); bringing the wearable medical device into contact with a skin surface; and rotating a first rotationally distinct segment and a second rotationally distinct segment so that a plurality of first microneedles and a plurality of second microneedles are embedded in the skin surface. In some embodiments, the rotation of the first rotationally distinct segment and the second rotationally distinct segment may be via a mechanical actuator of the wearable medical device. In other embodiments, the rotation of the first rotationally distinct segment and the second rotationally distinct segment may be via an applicator described herein.

[0115] In many embodiments, methods for attaching a wearable medical device of the present disclosure (e.g., having a tension-applying communicating member) to a skin surface are described. The method may include providing an applicator of the specification 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 reverse-loaded. The method may further include bringing the wearable medical device in the reverse-loaded configuration into contact with a skin surface, and releasing the wearable medical device from the reverse-loaded configuration so that a plurality of first microneedles and a plurality of second microneedles are embedded in the skin surface.

[0116] In many embodiments, methods for attaching a wearable medical device to a skin surface are described. The method may include providing an applicator, as described herein, having a wearable medical device inside; and rotating a first rotationally distinct segment and a second rotationally distinct segment so that the wearable medical device is configured to be reverse-rotatably loaded. The method may further include bringing the reverse-rotatably loaded wearable medical device into contact with a skin surface; and releasing the wearable medical device from the reverse-rotatably loaded configuration so that a plurality of microneedles are embedded in the skin surface. The wearable medical device may be any wearable medical device, insofar as it includes a first rotationally distinct segment, a second rotationally distinct segment, and a plurality of microneedles.

[0117] In many embodiments, methods for attaching a wearable medical device of the Disclosure (e.g., having a rolling communication member) to a skin surface are described. The methods may include: providing an applicator, which has the wearable medical device inside, bringing the applicator into contact with a skin surface; and rotating a first rotationally distinct segment and then rotating a second rotationally distinct segment so that a plurality of microneedles are driven into the skin surface. The wearable medical device may be any wearable medical device, insofar as it includes a first rotationally distinct segment, a second rotationally distinct segment, and a plurality of microneedles.

[0118] In many embodiments, methods for attaching a wearable medical device (e.g., having a rolling communication member) to a skin surface are described. The method may include providing an applicator, as described herein, having a wearable medical device inside; bringing the applicator into contact with a skin surface; and rotating a first rotationally distinct segment and a rotationally distinct segment so that a plurality of microneedles are driven into the skin surface. The wearable medical device may be any wearable medical device insofar as it includes a first rotationally distinct segment, a second rotationally distinct segment, and a plurality of microneedles.

[0119] In some embodiments, any method described herein using the applicator may further include selecting the 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).

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] Monitoring method Many embodiments describe methods for monitoring biological signals. These methods may include detecting biological signals using a wearable medical device of the Disclosure attached to the skin surface, and converting the detected biological signals into an output readable by a monitoring device.

[0125] In some embodiments, the biosignal may be selected from electrical signals, ionic signals, chemical signals, optical emission signals, or a combination thereof.

[0126] In some embodiments, the method may be similar to an electrocardiogram (ECG), electroencephalogram (EEG), electrical impedance tomography (EIT), electromyography (EMG), or electrooculography (EOG).

[0127] The method may further include attaching a wearable medical device to the skin surface.

[0128] The method may further include attaching a monitoring device to a wearable medical device attached to the skin surface.

[0129] kit In many embodiments, a kit is described. The kit may include the wearable medical device of the Disclosure and a set of instructions for attaching the wearable medical device to a skin surface. In some embodiments, the kit may further include one or more monitoring devices. In some embodiments, the kit may further include the applicators described herein.

[0130] In many embodiments, a kit is described. The kit may include the wearable medical device of this disclosure, the applicator described herein, and a set of instructions for attaching the wearable medical device to a skin surface. In some embodiments, the kit may further include a monitoring device.

[0131] In some embodiments, any kit described herein may further include one or more auxiliary fixing articles.

Claims

1. It is a wearable medical device, A conductive 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, The present invention comprises a plurality of second microneedles located on the second rotationally different segments, At least a portion of the first microneedle and / or at least a portion of the second microneedle comprises a conductive base including an oxidation-reduction pair, An electrical connector communicating with at least a portion of the conductive base, An applicator comprising at least one communicating member that connects the first rotationally distinct segment and the second rotationally distinct segment.

2. The wearable medical device according to claim 1, wherein the base further comprises one or more monitoring device fixing features for fixing a monitoring device to the wearable medical device.

3. The wearable medical device according to claim 1 or 2, wherein the base further comprises a first mechanical actuator communicating with a first rotationally different segment and a second mechanical actuator communicating with a second rotationally different segment.

4. The wearable medical device according to any one of claims 1 to 3, wherein the base further comprises a flexible membrane extending beyond the peripheral portion of the base, and the flexible membrane contains an adhesive.

5. The wearable medical device according to claim 4, wherein the flexible membrane comprises one or more applicator guides thereon.

6. The wearable medical device according to any one of claims 1 to 5, wherein the first rotationally distinct segment and the second rotationally distinct segment are each in the shape of a cylindrical ring and are arranged concentrically.

7. The wearable medical device according to any one of claims 1 to 6, wherein each of the first rotationally distinct segment and the second rotationally distinct segment includes one or more applicator guides.

8. A wearable medical device according to any one of claims 1 to 7, wherein one or more of the first rotationally distinct segments and the second rotationally distinct segments are coated with metallic silver.

9. The wearable medical device according to any one of claims 1 to 8, wherein the oxidation-reduction pair comprises metallic silver and silver chloride.

10. A wearable medical device according to any one of claims 1 to 9, wherein at least a portion of the first microneedle containing an oxidation-reduction pair and / or at least a portion of the second microneedle are at least partially coated with metallic silver and at least partially coated with silver chloride.

11. A wearable medical device according to any one of claims 1 to 10, wherein at least a portion of the plurality of first microneedles and at least a portion of the plurality of second microneedles are independently characterized by an elevation angle of about 40° to 80°.

12. A wearable medical device according to any one of claims 1 to 11, wherein each first microneedle, characterized by an elevation angle of approximately 40° to 80°, is oriented such that the tip of the first microneedle faces in one direction of rotation, and each second microneedle, characterized by an elevation angle of approximately 40° to 80°, is oriented such that the tip of the second microneedle faces in a direction of rotation opposite to the direction of rotation of the tip of the first microneedle.

13. A wearable medical device according to any one of claims 1 to 12, wherein at least a portion of the plurality of first microneedles and at least a portion of the plurality of second microneedles are independently characterized by an elevation angle of about 40° to 80° and independently arranged at an orientation angle of -25° to 25°.

14. A wearable medical device according to any one of claims 1 to 13, wherein each of the plurality of first microneedles and the plurality of second microneedles is independently characterized by a length of about 0.2 mm to about 3.0 mm.

15. A wearable medical device according to any one of claims 1 to 14, wherein each of the plurality of first microneedles and the plurality of second microneedles is independently characterized by a diameter of about 1 μm to about 25 μm.

16. A wearable medical device according to any one of claims 1 to 15, wherein at least a portion of the plurality of first microneedles or at least a portion of the plurality of second microneedles are characterized by non-uniform diameters.

17. A wearable medical device according to any one of claims 1 to 16, wherein at least some of the plurality of first microneedles or at least some of the plurality of second microneedles are barbed.

18. The wearable medical device according to any one of claims 1 to 17, wherein the plurality of first microneedles are arranged in at least one row, and the plurality of second microneedles are arranged in at least one row.

19. The wearable medical device according to any one of claims 1 to 18, wherein the at least one communicating member is selected from a flexible rod, a flexible band, and a spring.

20. The wearable medical device according to any one of claims 1 to 19, wherein the at least one communicating member is a rolling disk.

21. A method for attaching a wearable medical device to the skin surface, To provide a wearable medical device as described in any one of claims 1 to 20, The wearable medical device is configured to be loaded in a reverse rotational manner by rotating the first rotationally different segment and the second rotationally different segment, The wearable medical device, configured to be loaded in the reverse direction, is brought into contact with the skin surface. A method comprising: releasing the wearable medical device from the reverse-rotating loaded configuration so that the plurality of first microneedles and the plurality of second microneedles are injected into the skin surface.

22. A method for attaching a wearable medical device to the skin surface, To provide a wearable medical device as described in any one of claims 1 to 20, The wearable medical device is brought into contact with the skin surface, A method comprising rotating a first rotationally distinct segment and rotating a second rotationally distinct segment so that the plurality of first microneedles and the plurality of second microneedles are implanted into the skin surface.

23. A method for monitoring biological signals, A wearable medical device according to any one of claims 1 to 20, attached to the skin surface, is used to detect biological signals. A method comprising converting a detected biological signal into an output readable by a monitoring device.

24. It's a kit, A wearable medical device according to any one of claims 1 to 20, A kit comprising: a set of instructions for instructing the user to attach the wearable medical device to the skin surface;

25. The kit according to claim 24, further comprising one or more monitoring devices.

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