Vacuum tension applicator for attaching a wearable medical device to a skin surface and method thereof

Abstract

Vacuum tension applicators for attaching a wearable medical device to a tensed skin surface and methods of using the same are described. The wearable medical device has a plurality of microneedles located on a first rotationally distinct section and a plurality of microneedles located on a second rotationally distinct section.

Description

Background Technology

[0001] The wearable medical and / or fitness monitoring device industry is growing. There is increasing interest in monitoring their health and sharing their health data remotely with physicians or first responders. Many current devices that monitor parameters such as heart rate, blood pressure, and oxygen saturation are in the form of wearable accessories, such as watches, bracelets, rings, and chest straps. However, not all parameters can be measured in this way, and these wearable devices are not discreet enough. For example, continuous glucose monitoring via devices that adhere to the skin is becoming increasingly popular among people with diabetes, and even among those following a low-sugar diet. However, the adhesives required to wear such devices often cause skin damage and infection, especially in older users. It is also known that the adhesives can cause allergic reactions in some individuals, which can be severe enough to prevent some patients from using the devices.

[0002] What is needed is a way to attach the monitoring device to the skin without using adhesives. Summary of the Invention

[0003] In one embodiment, an applicator for attaching a wearable medical device to a skin surface is described. The applicator includes a loading actuator configured to counter-rotately load a first rotationally different segment and a second rotationally different segment of the wearable medical device; a holding system configured to hold the wearable medical device in the counter-rotationally loaded configuration; a skin tensioning system having: a chamber surrounding a region of the wearable medical device housed within the applicator and configured to contact a skin surface region; and a mechanism for applying decompression to the skin surface region; and a mechanism for releasing the wearable medical device from the counter-rotationally loaded configuration.

[0004] In one embodiment, an applicator for attaching a wearable medical device to a skin surface is described. The applicator includes a drive actuator configured to rotate a first rotationally different segment and a second rotationally different segment within the wearable medical device in a counter-rotating manner. The applicator also includes a skin tensioning system having a chamber surrounding a region of the wearable medical device housed within the applicator and configured to contact the skin surface region, and a mechanism for applying pressure relief to the skin surface region.

[0005] In one embodiment, a method for attaching a wearable medical device to a tensioned skin surface is described. The method includes: providing an applicator as described herein, having the wearable medical device therein; and rotating a first rotationally distinct segment and a second rotationally distinct segment of the wearable medical device such that the wearable medical device is in a counter-rotationally loaded configuration. The method further includes contacting the applicator with the skin surface such that a chamber contacts the skin surface; engaging mechanisms for applying decompression to the skin surface to create a tensioned skin surface; and releasing the wearable medical device from the counter-rotationally loaded configuration such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the tensioned skin surface.

[0006] In many embodiments, a method for attaching a wearable medical device to a tense skin surface is described. The method includes: providing an applicator as described herein, having the wearable medical device therein; contacting the applicator with a skin surface such that a chamber contacts the skin surface; and engaging a mechanism for applying pressure to the skin surface to create a tense skin surface. The method further includes: rotating a first segment of the wearable medical device and rotating a second segment of the wearable medical device such that multiple first microneedles and multiple second microneedles of the wearable medical device are driven into the tense skin surface.

[0007] In one embodiment, a kit is described. The kit includes the applicator of this disclosure and a set of instructions for attaching a wearable medical device to a skin surface. Attached Figure Description

[0008] This application can be more fully understood by taking into consideration the following detailed description of various embodiments of this disclosure in conjunction with the accompanying drawings.

[0009] Figure 1A This is a bottom side view of the wearable medical device disclosed herein.

[0010] Figure 1B yes Figure 1A A top view of a wearable medical device.

[0011] Figure 2A This is a top side view of the wearable medical device disclosed herein.

[0012] Figure 2B yes Figure 2A A top view of a wearable medical device.

[0013] Figure 3A This is a bottom side view of the wearable medical device disclosed herein.

[0014] Figure 3B yes Figure 2AA top view of a wearable medical device.

[0015] Figure 4 A side view and elevation angle measurement of the microneedle of this disclosure are shown.

[0016] Figure 5 A top view and orientation angle measurement of the microneedle of this disclosure are shown.

[0017] Figure 6A This is a top view of a wearable medical device with mechanical actuators in an unloaded configuration.

[0018] Figure 6B This is a top view of a wearable medical device with mechanical actuators in a loaded configuration.

[0019] Figure 7A It is an applicator for wearable medical devices that can be inserted.

[0020] Figure 7B yes Figure 7A The applicator in which the wearable medical device is loaded in a reverse rotational configuration.

[0021] Figure 8 This is a diagram of the applicator disclosed herein that tightens the skin surface.

[0022] Figure 9 This is a diagram of the applicator disclosed herein that tightens the skin surface.

[0023] Figure 10 This is part of the applicator of the present disclosure having an example skin tensioning system and an insertable wearable medical device.

[0024] Figure 11A It is part of an example skin tensioning system used in the applicator of this disclosure.

[0025] Figure 11B This is an example tension actuator for use in skin tensioning systems.

[0026] Figure 12 This is a side view of a sample applicator that is part of this disclosure.

[0027] Figure 13 This is an illustration of a part of the applicator of this disclosure that tightens the skin surface.

[0028] Figure 14 This is a diagram of the applicator disclosed herein that tightens the skin surface.

[0029] Reference is made to the accompanying drawings in the following description. Various embodiments of this disclosure are provided by way of illustration. It should be understood that structural changes may be made without departing from the scope of this disclosure. The drawings are not necessarily drawn to scale. Similar numbers used in the drawings refer to similar parts (e.g., 102, 202, 302, etc.; 110, 210, 310, etc.; etc.). Detailed Implementation

[0030] This disclosure describes a wearable medical device that can be attached to the skin via microneedles and an applicator for attaching said wearable medical device to the skin surface. The wearable medical device utilizes opposing forces between rotating segments to not only drive the microneedles into the skin but also to secure them within the skin. Compared to similar devices that adhere to the skin via adhesives, wearable medical devices attached to the skin via microneedles are more resistant to accidental dislodgement and can be worn for longer periods. Furthermore, the wearable medical device of this disclosure is painless to attach and wear, and does not cause skin damage or adverse reactions typically associated with adhesives. Additionally, the wearable medical device of this disclosure allows airflow beneath the device to prevent bacterial growth due to moisture buildup and also allows for cleaning.

[0031] While wearable medical devices may include permanent monitoring devices, the wearable medical device disclosed herein is primarily intended as a base for attaching a removable monitoring device to it. Users can enjoy the flexibility of a modular system.

[0032] The applicator described in this article applies tension to the skin surface to further increase the duration of wear. Attaching a wearable medical device to the tensioned skin surface allows for stronger anchoring of the microneedles when the skin surface loosens. definition

[0033] As used in this article, the term “about” means ±10% of a given value. For example, about 10 means 9 to 11.

[0034] As used herein, the term "adhesive" refers to a polymer composition that bonds two adhesives together. Examples of adhesives are pressure-sensitive adhesives and gel adhesives.

[0035] As used herein, the term "actuation guide" refers to a feature on or within a component of the applicator that is complementary to an applicator guide within a wearable medical device. In a rotational manner within the applicator, the cooperation of the actuation guide and the applicator guide effectively rotates a first rotational segment and / or a second rotational segment within the wearable medical device.

[0036] As used herein, the term "applier guide" or "application 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. In a rotational manner within the applicator, the cooperation of the applicator guide and the actuation guide effectively rotates a first rotationally different segment and / or a second rotationally different segment within the wearable medical device.

[0037] As used herein, the term "barb" describes a feature on the microneedle body that extends outward from the microneedle body at an angle. Barbed needles may be more difficult to remove from the skin surface than unbarbed needles. Similarly, barbed needles prevent complete penetration compared to unbarbed needles. Barbed needles can increase adhesion, thereby extending wear time. Barbed needles can also help achieve the desired gap between the wearable medical device and the skin surface.

[0038] As used in this article, "center" refers to the point where two perpendicular planes intersect and each region in the corresponding four quadrants is equal. For example, the center of the microneedle base is the center of the region that contacts the segment with the corresponding rotation.

[0039] As used herein, the term "connecting member" refers to a material that connects a first rotating segment and a second rotating segment, but said material does not prevent the independent rotation of the first rotating segment and the second rotating segment. As used herein, the term "tensioned connecting member" refers to an article that connects a first rotating segment and a second rotating segment, wherein when the first rotating segment and the second rotating segment rotate, the article deforms and stores potential energy, and when the article is allowed to return at least partially to its original state, the potential energy is converted into kinetic energy. As used herein, "rolling connecting member" refers to a rotating article that is at least partially located between a first rotating segment and a second rotating segment, wherein the rotating article rotates accordingly when the first rotating segment and the second rotating segment rotate.

[0040] As used herein, the term "rotating in opposite directions" describes how a first segment rotates differently from a second segment rotates differently relative to each other. One segment rotates clockwise, and the other segment rotates counterclockwise.

[0041] As used herein, “flexible” describes an article that can be stretched, bent, compressed or otherwise twisted under the action of a force, but returns at least partially to a state where it was not stretched, bent, compressed or twisted when the force is removed.

[0042] As used in this article, the term “microneedle” refers to a microstructured protrusion having a tip configured to penetrate the skin.

[0043] As used in this article, "rotation" refers to moving a certain distance around an axis of rotation.

[0044] As used in this article, the phrase "rotates differently" describes a component that can rotate independently of another component. For example, two components that rotate differently and are otherwise connected can rotate to a certain extent in opposite directions. Attached Figure Description

[0045] Figure 1A This is a bottom view of the wearable medical device 100 of this disclosure, showing the first main surface of the base 102. The wearable medical device 100 includes a base 102 comprising a first rotationally different segment 104 having a plurality of first microneedles 106 thereon and a second rotationally different segment 108 having a plurality of second microneedles 110 thereon. The first rotationally different segment 104 and the second rotationally different segment 108 are shown in the shape of concentric cylindrical rings connected by a (tensioned) connecting member 112 (shown herein as a flexible rod or band). The connecting member 112 is depicted as connecting the first rotationally different segment 104 and the second rotationally different segment 108 in a non-radial manner. During application, a loading actuator (not shown) rotates a first, disarticulated segment 104 in the opposite direction to the tip of the first microneedle 106 (shown clockwise here) and a second, disarticulated segment 108 in the opposite direction to the tip of the second microneedle 110 (shown counterclockwise here), thereby contracting the connecting member 112. The connecting member 112 stretches as the first and second disarticulated segments rotate. Alternative arrangements in which the connecting member 112 is otherwise bent are readily conceivable. A retaining element (not shown) holds the respective disarticulated segments 104 / 108 in a configuration of counter-rotational loading. Upon contact with skin, the retaining element (not shown) disengages to release the wearable medical device 100, wherein the first and second microneedles 106 / 110, in opposite directions, are each driven into the skin surface by at least partially returning to a relaxed state through the (tensioned) connecting member 112.

[0046] Figure 1B yes Figure 1A A top view of the wearable medical device 100 shows the second main surface of the base 102. The first rotating segment 104 and the second rotating segment 108 are shown in the shape of concentric cylindrical rings connected by a connecting member 112.

[0047] Figure 2AThis is a top side view of the wearable medical device 200 of this disclosure, showing a first main surface 202a and a second main surface 202b of a base 202. The wearable medical device 200 includes a base 202 comprising a first rotationally differentiating segment 204 having a plurality of first microneedles 206 thereon and a second rotationally differentiating segment 208 having a plurality of second microneedles 210 thereon. The first rotationally differentiating segment 204 and the second rotationally differentiating segment 208 are shown in the shape of concentric cylindrical rings mechanically connected by a (rolling) connecting member 212 (shown herein as a rolling disc). During application, a drive actuator (not shown) rotates the first rotationally differentiating segment 204 in a direction aligned with the tips of the first microneedles 206 (shown herein as clockwise) and rotates the second rotationally differentiating segment 208 in a direction aligned with the tips of the second microneedles 210 (shown herein as counterclockwise), thereby causing the connecting member 212 to roll. When in contact with the skin, the drive actuator drives the first microneedle and the second microneedle 206 / 210 into the skin surface.

[0048] Figure 2B yes Figure 2A A top view of the wearable medical device 200 shows the second main surface of the base 202. A first rotating segment 204 and a second rotating segment 208 are shown in the shape of concentric cylindrical rings, which are mechanically connected by a (rolling) connecting member 212.

[0049] Figure 3AThis is a bottom side view of a wearable medical device 300, showing a first main surface 302a and a second main surface 302b of a base 302. The wearable medical device 300 includes a base 302 comprising a first rotationally different segment 304 having a plurality of first microneedles 306 thereon and a second rotationally different segment 308 having a plurality of second microneedles 310 thereon. The first rotationally different segment 304 and the second rotationally different segment 308 are shown in the shape of concentric cylindrical rings, and the corresponding microneedles 306 / 310 are each arranged in three flush rows. The wearable medical device 300 also includes a flexible membrane 311 in contact with the second main surface 302b. The flexible membrane 311 adheres to the first rotationally different segment 304 and the second rotationally different segment 308 and acts as a (tensioned) connecting member 312 between them. During application, a loading actuator (not shown) rotates a first rotationally dissimilar segment 304 in the opposite direction to the tip of the first microneedle 306 (shown here as counterclockwise) and a second rotationally dissimilar segment 308 in the opposite direction to the tip of the second microneedle 310 (shown here as clockwise), thereby stretching the flexible membrane 311 / connecting member 312 therebetween. A retaining element (not shown) holds the respective rotationally dissimilar segments 304 / 308 in a configuration of counter-rotational loading. Upon contact with skin, the retaining element (not shown) can disengage to release the wearable medical device 300, wherein the opposing first and second microneedles 306 / 310 are driven into the skin surface by at least partially returning to a relaxed state through the flexible membrane 311 / connecting member 312.

[0050] Figure 3B yes Figure 1AA top view of the wearable medical device 300 shows the second main surface of the base 302. A portion of the flexible membrane 311 / connecting member 312 can be observed between an inner placement backing 314 covering a first rotationally dissimilar segment (not shown) and an outer placement backing 316 covering a second rotationally dissimilar segment (not shown). The inner placement backing 314 is shown having an inner application guide 318, and the outer placement backing 316 is shown having an outer application guide 320. During application, a loading actuator (not shown) rotates the first rotationally dissimilar segment (not shown) in one direction (shown clockwise here) through communication with the inner placement backing 314 / inner application guide 318, and rotates the second rotationally dissimilar segment (not shown) in the opposite direction (shown counterclockwise here) through communication with the outer placement backing 316 / outer application guide 320. In practice, the flexible membrane 311 / connecting member 312 is stretched or otherwise twisted. A retaining element (not shown) holds the corresponding rotational segments in a configuration of reverse rotational loading. Upon contact with skin, the retaining element (not shown) can disengage to release the wearable medical device 300, wherein the first and second microneedles (not shown) are driven into the skin surface, at least partially returning to a relaxed state via a flexible membrane 311 / connecting member 312.

[0051] Figure 4 A side view of an example first microneedle 406 (or second microneedle) of this disclosure is shown. The first microneedle 406 is shown as having a microneedle base 422 that contacts a segment 404 that is at a different rotation. The microneedle base 422 extends into the microneedle body 424 and terminates at the microneedle tip 426. The first microneedle 406 is shown at an elevation angle 428 ("θ"). EA Angle 428 is measured from plane A, which is parallel to the surface of the segment 404 in which the first microneedle 406 contacts the first rotation, to the microneedle tip 426 (see plane C), relative to plane B passing through the center of the microneedle base 422—planes A and B are perpendicular to each other, i.e., 90°.

[0052] Figure 5 A top view of the present disclosure is shown of a first rotationally different segment 504 (or a second microneedle on a second rotationally different segment) on which a plurality of first microneedles 506 are arranged. Each of the plurality of first microneedles 506 is independently arranged at an orientation angle 530 ("θ"). OA The orientation angle 530 is measured relative to the radial plane D and the tangential plane E (i.e., the tangential plane E is tangent to the radial plane D, i.e., 90°). Plane F is parallel to plane E and is used only for visual assistance. Each radial plane D passes through the center of the microneedle base 522 (see...). Figure 4Plane B, i.e., radial plane D, is perpendicular to plane B in the z-direction; tangential planes E and A are in the x-direction. The first microneedle 506a, aligned with tangential planes E and F, has an orientation angle of 0° 530°, i.e., θ. OA =0°. The first microneedle 506b, which is angled toward the axis of rotation, is characterized by an orientation angle 530, i.e., θ, that is less than 0° to a measurable degree. OA <0°, for example -10°. The first microneedle 506c, which is at an angle away from the axis of rotation, is characterized by an orientation angle 530° greater than 0° to a measurable degree, i.e., θ. OA >0°, for example, 10°. The description does not need to be limited to circular constructions.

[0053] Figure 6A A top view (second main surface) of a wearable medical device 600 having a set of mechanical actuators 632a / 632b is shown, wherein the medical device is shown in an unloaded configuration. The wearable medical device 600 includes a base 602 having a first rotationally different segment 604, a second rotationally different segment 608, and a connecting member 612. The first mechanical actuator 632a communicates with the first rotationally different segment 604, and the second mechanical actuator 632b communicates with the second rotationally different segment 608. When the mechanical actuators 632a / 632b are pressed together, the first rotationally different segment 604 rotates counterclockwise, and the second rotationally different segment 608 rotates clockwise. The mechanical actuators 632a / 632b can be used to attach the wearable medical device to or remove the wearable medical device from the skin surface.

[0054] Figure 6B A top view of a wearable medical device 600 with a set of mechanical actuators 632a / 632b is shown, wherein the medical device is shown in a loaded configuration. Figure 6A Compared to the unloaded configuration, the connecting member 612 is shown as stretched.

[0055] Figure 7A An example applicator 701 with an inserted wearable medical device 700 in an unloaded configuration is shown. Applicator 701 does not include a skin tensioning system as described in this disclosure. Applicator 701 is shown to illustrate aspects of an applicator in relation to loading the wearable medical device. Applicator 701 is shown to include a first segment actuation guide 703 within an inner wall 705 that engages with a first applicator guide 707 located on a first rotationally different segment 704. Applicator 701 is also shown to include a second segment actuation guide 709 within an outer wall 711 that engages with a second applicator guide 713 located on a second rotationally different segment 708.

[0056] Figure 7B An example applicator 701 is shown with a wearable medical device 700 in a counter-rotating loading configuration. A first rotating segment 704 has been rotated clockwise, and a second rotating segment 708 has been rotated counter-clockwise. The applicator 701 holds the wearable medical device 700 in this counter-rotating loading configuration (holding element not shown) until the applicator 701 contacts the skin surface. Upon disengaging the holding element (not shown), the wearable medical device 700 is released from the loading configuration, and multiple microneedles on each segment are driven into the skin surface.

[0057] Figure 8 This is a cross-sectional view of the applicator 801 of this disclosure, wherein the skin tensioning system 813 has a chamber 835 located outside / outside the applicator body 837, and the applicator 801 is used to tension a skin surface SS to produce a tensioned skin surface TSS. The applicator 801 presses against the skin surface SS such that the chamber 835 contacts the skin surface SS. A mechanism for applying decompression within the chamber 835, such as a syringe 839, is engaged to reduce the pressure within the chamber 835, thereby producing a tensioned skin surface TSS. The wearable medical device 800 of this disclosure is shown as being housed within the chamber 835. The wearable medical device 800 (shown as having a first microneedle 806 and a second microneedle 810) is either 1) released from a counter-rotatingly loaded configuration into the tensioned skin surface TSS, or 2) driven into the tensioned skin surface TSS via a drive actuator (not shown). Although not shown, the docking platform may extend from the applicator body of the wearable medical device 800 so that the wearable medical device 800 meets the taut skin surface TSS.

[0058] Figure 9This is a cross-sectional view of the applicator 901 of this disclosure, wherein the skin tensioning system 913 has a chamber 935 located inside / within the applicator body 937, and the applicator 901 is used to tension the skin surface SS to produce a tensioned skin surface TSS. The applicator 901 presses against the skin surface SS such that the chamber 935 contacts the skin surface SS. A mechanism for applying decompression within the chamber 935, such as a syringe 939, is engaged to reduce the pressure within the chamber 935, thereby producing a tensioned skin surface TSS. The wearable medical device 900 of this disclosure is shown as being housed within the chamber 935. The wearable medical device 900 (shown as having a first microneedle 906 and a second microneedle 910) is either 1) released from a counter-rotatingly loaded configuration into the tensioned skin surface TSS, or 2) driven into the tensioned skin surface TSS via a drive actuator (not shown). Although not shown, the docking platform may extend from the applicator body to the wearable medical device 900, allowing the wearable medical device 900 to meet the taut skin surface TSS.

[0059] Figure 10 A portion of the applicator 1001 of this disclosure is shown, which includes a portion of an example skin tensioning system 1013b having multiple tensioning needles 1017 / 1021 surrounding the area where the wearable medical device 1000 is located. A portion of the skin tensioning system having a chamber is not shown. The applicator 1001 is shown as including the skin tensioning system 1013b, which includes a first rotationally different tensioning segment 1015 having multiple first tensioning microneedles 1017 thereon and a second rotationally different tensioning segment 1019 having multiple second tensioning microneedles 1021 thereon. The first rotationally different tensioning segment 1015 and the second rotationally different tensioning segment 1019 are configured to operate in a manner similar to that of the wearable medical device 1000, but without a connecting member.

[0060] Figure 11A A portion of an example skin tensioning system 1113b for use in the applicator of this disclosure is shown. The skin tensioning system 1113b is shown as including a first rotationally different tensioning segment 1115 having a plurality of first tensioning microneedles 1117 thereon and a second rotationally different tensioning segment 1119 having a plurality of second tensioning microneedles 1121 thereon. The skin tensioning system 1113b is also shown as including a tension actuator 1123 configured to rotate the first rotationally different tensioning segment 1115 and the second rotationally different tensioning segment 1119.

[0061] Figure 11B It shows the section without tension. Figure 11AThe tension actuator 1123 includes a ring gear 1125 configured to rotate a first rotationally different tension section (not shown), a sun gear 1127 configured to rotate a second rotationally different tension section (not shown), and a planetary gear 1129 located therebetween.

[0062] Figure 12 A side view of a portion of the applicator 1201 of this disclosure, having an applicator housing 1231 and a torsion drive shaft 1233, is shown. The tension drive shaft 1233 is a component of the skin tensioning system and is configured to drive the tension actuator 1223. The applicator 1201 is also shown as including a plurality of first tensioning microneedles 1219 and a plurality of second tensioning microneedles 1221.

[0063] Figure 13 This is a cross-sectional view showing a portion of the applicator 1301 of this disclosure, which tensions the skin surface SS. The applicator 1301 presses against the skin surface SS, such that the applied force F from the first tensioning microneedle 1317 and the second tensioning microneedle 1321... A The opposite force F exhibited by the skin surface SS O The skin surface SS is deformed. The tension drive shaft 1333 is twisted to rotate a first rotationally different tensioning segment (not shown) having a first tensioning microneedle 1317 and a second rotationally different tensioning segment (not shown) having a second tensioning microneedle 1321, thereby tensioning the skin surface area between the tensioning microneedles to form a tensioned skin surface TSS. The tensioned skin surface TSS remains in this tensioned state while the wearable medical device 1300 is released from a counter-rotating loading configuration, such that the first microneedle 1306 and the second microneedle 1310 are driven into the tensioned skin surface TSS.

[0064] Figure 14 This is a cross-sectional view of an applicator 1401 with a skin tensioning system 1413 according to the present disclosure. The skin tensioning system includes: 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 housing a wearable medical device 1400 (having a first microneedle 1406 and a second microneedle 1410). The wearable medical device 1400 is either 1) released from a counter-rotating loading configuration into the tensioned skin surface TSS, or 2) driven into the tensioned skin surface TSS via a drive actuator (not shown). Although not shown, a docking platform may extend from the applicator body to the wearable medical device 1400 such that the wearable medical device 1400 encounters the tensioned skin surface TSS. Wearable medical devices

[0065] In various embodiments, a wearable medical device is described. The wearable medical device may include a base having a first rotationally different segment and a second rotationally different segment. The second rotationally different segment may at least partially surround the first rotationally different segment. At least one connecting member may communicate with the first rotationally different segment and the second rotationally different segment. The wearable medical device may also include a plurality of first microneedles located on the first rotationally different segment and a plurality of second microneedles located on the second rotationally different segment.

[0066] Further details and features of the wearable medical device are described below. It should be understood that, unless otherwise stated, the details and features described below may be incorporated individually or in combination. base

[0067] The base and all components within it can be characterized by a first primary surface and a second primary surface. The first primary surface is considered to be the skin-contact surface, while the second primary surface is opposite to the first primary surface and does not contact the skin when the wearable medical device is in use. Therefore, all the first and second microneedles described herein are located on the first primary surface of the base.

[0068] In some embodiments, the base may further include one or more applicator guides for cooperating with the applicator, the applicator guides being configured to rotate a first rotationally different segment and a second rotationally different segment. For example, the applicator guides may be in the form of one or more notches, protrusions, pins, pin holes, etc., wherein the applicator guides may be complementary to an actuation guide within the applicator. The applicator guides may be located on a second primary surface, along a periphery (subsurface), or a combination thereof.

[0069] In some embodiments, the base may also include one or more monitoring device securing features for attaching the monitoring device to a wearable medical device. Example monitoring device securing features may include clips, hooks, latches, brackets, threaded components for mating with threaded monitoring devices, adhesives, or combinations thereof. The monitoring device securing features may be located on a second primary surface, along the periphery (subsurface), or a combination thereof.

[0070] In some embodiments, the base may further include a first mechanical actuator connected to a segment different from the first rotation and a second mechanical actuator connected to a segment different from the second rotation. Figure 6A and Figure 6B An example mechanical actuation of a wearable medical device without the use of the applicator described herein is shown. Although Figure 6A and Figure 6BThe experiment demonstrates loading a wearable medical device with reverse rotation (i.e., mechanical actuators are pushed together), but the reverse is also conceivable. For example, a wearable medical device with a rolling connecting member (e.g., Figure 2A It may include mechanical actuators that can be used to drive multiple microneedles into the skin surface (i.e., the mechanical actuators are pushed apart).

[0071] In some implementations, with or without the applicator described herein, a mechanical actuator can be used to apply a wearable medical device to and / or remove a wearable medical device from the skin surface. While a mechanical actuator is not required to employ the applicator described herein, the applicator can be configured to actuate the mechanical actuator. In other words, when combined with an applicator, any such mechanical actuator can be considered an "applicator guide" as used herein.

[0072] In some embodiments, the base may further include a flexible membrane adhered to or otherwise attached to the second primary surface and extending at least from a first rotationally dissimilar segment to a second rotationally dissimilar segment such that the first rotationally dissimilar segment is in communication with the second rotationally dissimilar segment (i.e., a communication member). In some embodiments, the flexible membrane may span the entire second primary 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 of the base may also include an adhesive thereon, which may serve as an auxiliary form of skin attachment.

[0073] In some embodiments, the flexible membrane may be made of materials such as fabrics (e.g., cotton, rayon, polyvinyl chloride, polyethylene, or polyurethane), latex, etc. In some embodiments, the flexible membrane may be breathable and waterproof.

[0074] In some embodiments, the flexible membrane may also include an adhesive on one or more surfaces. In some embodiments, a suitable adhesive may be composed of acrylates, methacrylates, epoxy diacrylates, etc. The adhesive may be located on the surface that contacts the skin surface upon application and thus serve as an aid in securing a wearable medical device to the skin. The adhesive may be located on the surface opposite the skin surface upon application and may serve as a means of attaching a backing and / or monitoring device (i.e., a monitoring device mounting feature). In some embodiments, the flexible membrane may be in the form of double-sided tape.

[0075] In many embodiments, the flexible membrane may be light-transmitting. In many embodiments, the flexible membrane may be made of a material that is easily punctured (e.g., through 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 installed glucose monitor device), light (e.g., emitted from an installed pulse oximeter device), an electrode, or some other skin contact or penetrating probe.

[0076] In many embodiments, the base may also include the flexible membrane described herein and one or more placement backings. The one or more placement backings may be reversibly or irreversibly adhered to the flexible membrane using an adhesive, or may otherwise be sewn thereto. The placement backing may include an application guide configured to cooperate with a loading actuator within the applicator. In some embodiments, the placement backing may include: an inner placement backing configured to rotate a first rotationally different segment (e.g., via an inner application guide); and an outer placement backing at least partially surrounding the inner placement backing and configured to rotate a second rotationally different segment (e.g., via an outer application guide). Rotate different sections

[0077] In many embodiments, the first and second rotationally distinct segments can be arranged such that they share a common axis of rotation. While separate axes of rotation are conceivable and intended to be covered by the scope of this disclosure, a shared axis of rotation is the simplest and most concise configuration.

[0078] In many embodiments, a first and second rotating segments are configured to rotate in opposite directions (i.e., clockwise and counterclockwise relative to each other), wherein the rotation induces stress within a connecting member communicating with each segment. The stress can be in the form of tension, compression, torsion, bending, coiling, winding, rotation, etc. The applicator or other applicator device of this disclosure can be configured to hold the first and second rotating segments in a rotating state and withstand the potential energy within the stress connecting member. The kinetic energy provided by the release of stress within the connecting member effectively removes the rotation from the rotating segments, allowing microneedles on the segments to be driven into the skin under some force.

[0079] The first and second rotationally different segments can independently have any size and shape, as long as neither segment impedes the rotation of the other. Example shapes include full cylinders or semi-cylinders, elliptical cylinders, truncated cones, rectangles, squares, etc.; the shape can be solid or annular (i.e., ring-shaped). An annular first rotationally different segment allows light from the mounted monitoring device to pass through, or other physical contact between the skin surface and the mounted monitoring device. In some embodiments, the first and second rotationally different segments can each be a cylindrical ring (i.e., washer-shaped) and arranged concentrically. In other embodiments, the first rotationally different segment can be a solid cylinder, and the second rotationally different segment can be a concentrically arranged cylindrical ring. Some shapes may be better suited for different applications, such as to accommodate different areas of the body, to accommodate monitoring devices of different shapes, etc.

[0080] In many embodiments, the first and second rotated-different segments are arranged such that at least one main surface of each segment is flush with each other. In any embodiment where the first and second rotated-different segments do not include at least one main surface of each segment in the flush-with-each-segment segments, the wearable medical device will require the first and second microneedles to be of unequal length so that each set of microneedles can contact the skin.

[0081] In some implementations, the first rotationally distinct segment and the second rotationally distinct segment can be independently characterized by a maximum length and a maximum width of about 5 mm to about 75 mm. For example, the maximum length and / or maximum width can be selected from values ​​(in mm) within the range of about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75 or between any of the foregoing values ​​(e.g., between about 25 and about 40, etc.).

[0082] In some implementations, the first rotationally distinct segment and the second rotationally distinct segment can be independently characterized by an average thickness of about 1 mm to about 10 mm. For example, the average thickness can be selected from a range of values ​​(in mm) of about 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 or between any of the foregoing values ​​(e.g., between about 3 and about 8, etc.).

[0083] In many embodiments, the first and second rotating segments may each include at least 10 microneedles. In some embodiments, the first and second rotating segments may each independently include 10 to 500 microneedles. For example, the first and second rotating segments may each independently include a number of microneedles ranging from 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, or 500, or between any of the foregoing values ​​(e.g., between about 50 and about 100, etc.). The number of needles in each rotating segment may be selected based on various factors such as intended device placement, skin type, user activity level, intended wear time, etc.

[0084] 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 within the applicator described herein. The one or more first applicator guides may be located on the inner perimeter (subsurface) 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 within the applicator described herein. The one or more second applicator guides may be located on the outer perimeter (subsurface) of the second rotationally distinct segment. In some embodiments, the first and second applicator guides may independently take the form of notches, protrusions, pins, pinholes, etc.

[0085] In some implementations, the first rotating segment and the second rotating segment may be made of a material selected from metals, plastics, or combinations thereof.

[0086] In some embodiments, the wearable medical device may have only two rotationally distinct segments. In other embodiments, the wearable medical device may have more than two rotationally distinct segments, wherein any additional rotationally distinct segments may be characterized in a manner similar to any rotationally distinct segment described herein. Connecting components

[0087] In some embodiments, the connecting member may be a tensioned connecting member selected from flexible rods or belts, springs, flexible membranes (as described above), combinations thereof, etc. In other embodiments, the connecting member may be a rolling connecting member, such as a rolling disc.

[0088] In some implementations, the connecting member may be in the form of a flexible rod, a flexible band, or a spring.

[0089] In many embodiments, the connecting member may at least partially connect the first and second rotated segments via a secondary surface (e.g., the inner or outer wall of a ring-shaped, rotated segment). In some embodiments, the connecting member may at least partially connect the first and second rotated segments via a primary surface (e.g., a second primary surface opposite to the first primary surface having microneedles).

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

[0091] In some embodiments, the type and number of connecting elements present in the wearable medical device of this disclosure can be selected based on the desired kinetic energy used to drive the rotation of different segments. For example, the wearable medical device can be customized for the type of skin surface on which the device will be applied (which may require greater or less force to fully or safely mount the wearable medical device onto the skin surface).

[0092] In some embodiments, the wearable medical device may include one to 20 connecting elements (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 18, or 20, or values ​​between any of the foregoing values, such as between 2 and 6). In some embodiments, each connecting element is of the same type. In other embodiments, a mixture of connecting elements may exist within the wearable medical device. microneedles

[0093] In many embodiments, the first and second microneedles can be arranged in a circular or semi-circular array extending around the axis of rotation, regardless of the shape of the first and second rotationally different segments. In many embodiments, multiple first microneedles can be arranged in one or more rows along the first rotationally different segment. Similarly, multiple second microneedles can be arranged in one or more rows along the second rotationally different segment in a circular path. In some embodiments, rows can be flush with adjacent rows or can be staggered. In some embodiments, each of the multiple first and second microneedles can be arranged in 1 to 5 rows, such as 1, 2, 3, 4, or 5 rows, such as 2 to 3 rows.

[0094] In some implementations, multiple first and second microneedles may be arranged in a row, and each microneedle may be independently separated from each other by a distance of about 1 mm to about 10 mm. For example, any microneedle in the microneedles may be separated by a distance (in mm) of about 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 or a value between any of the foregoing values ​​(e.g., between about 4 and about 6, etc.).

[0095] In embodiments with more than one row, rows can be independently separated by a distance of about 5 mm to about 10 mm. For example, rows can be independently separated by a distance of about 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 or 10 or a value between any of the foregoing values ​​(e.g., between about 6 and about 8, etc.).

[0096] In some embodiments, each of the first and second microneedles can be independently characterized by an elevation angle of approximately 40° to approximately 80° relative to the plane to which the microneedle is attached (i.e., the corresponding rotating segments). For example, the first and second microneedles can be independently characterized by an elevation angle of approximately 40, 42, 45, 48, 50, 52, 55, 58, 60, 62, 65, 68, 70, 72, 75, 78, or 80, or a value within a range of any of the foregoing values ​​(e.g., between approximately 45 and approximately 50, etc.) (°). For reference, a microneedle perpendicular to a parallel plane passing through the corresponding rotating segments is characterized by an elevation angle of 90°. Elevation angles outside the above ranges are still within the scope of this disclosure; however, it is believed that the above ranges can provide benefits to the user in terms of pain reduction, maintenance of skin health, and longer wear time. Obviously, any elevation angle can be measured as an acute or obtuse angle depending on the reference point. Therefore, the aforementioned elevation angles can be considered their obtuse counterparts (i.e., approximately 140° to approximately 100°, and all angles in between). The elevation angle is measured from a parallel plane passing through the respective rotating segments to the center of the microneedle tip relative to a plane perpendicular to the parallel plane and passing through the center of the microneedle base.

[0097] In many embodiments, each microneedle in the first microneedle can be characterized by the same elevation angle. In other embodiments, at least a portion of the first microneedle can be characterized by one elevation angle, and at least another portion of the first microneedle can be characterized by another elevation angle. In some cases, a mixture of elevation angles may be beneficial for tailoring the wearable medical device to the intended area of ​​the body where it will be worn. In many embodiments, each microneedle in the second microneedle can be characterized by the same elevation angle. Similarly, in other embodiments, at least a portion of the second microneedle can be characterized by one elevation angle, and at least another portion of the second microneedle can be characterized by another elevation angle. In some embodiments, each of the first and second microneedles can be characterized by the same elevation angle, or a portion of the first or second microneedle can be characterized by different elevation angles.

[0098] In embodiments having at least a portion of first microneedles characterized by an elevation angle other than 90°, all of these first microneedles at the elevation angle must point to the same direction of rotation (i.e., all tips pointing clockwise or counterclockwise). Similarly, in embodiments having at least a portion of second microneedles characterized by an elevation angle other than 90°, all of these second microneedles at the elevation angle must point to the same direction of rotation. Furthermore, in embodiments having both first and second microneedles characterized by an elevation angle not equal to 90°, the first microneedles at the elevation angle may be located in opposite directions of rotation relative to the second microneedles at the elevation angle. In other words, each first microneedle characterized by an elevation angle not equal to 90° (e.g., 40° to 80°) may be oriented such that the tip of the first microneedle faces a direction of rotation, and each second microneedle characterized by an elevation angle not equal to 90° (e.g., 40° to 80°) may be oriented such that the direction of rotation facing the tip of the second microneedle is opposite to the direction of rotation of the tip of the first microneedle. When referring to opposite directions of rotation, a shared axis of rotation is implied.

[0099] In some embodiments, each of the first and second microneedles, characterized by an elevation angle not equal to 90°, can be independently arranged at an orientation angle of approximately -25° to approximately 0° (aligned with the tangent) or approximately 0° (aligned with the tangent) to approximately 25° relative to the tangent of the rotation vector (i.e., rotation about different segments of the respective rotation). Negative orientation angle values ​​indicate that the needle points towards the axis of rotation, while positive orientation angle values ​​indicate that the needle points away from the axis of rotation. For example, any given microneedle can 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 between any of the aforementioned values ​​on either side of 0 (e.g., between approximately -15 and approximately -8, between approximately 5 and approximately 12, etc.). In many embodiments, each of the first and second microneedles can be arranged such that the entire needle body is tangentially aligned with the rotation vector relative to the respective rotational segment (i.e., an orientation angle of 0°). The orientation angle is measured from a tangential plane passing through the center of the microneedle base to the center of the microneedle tip. In other words, a microneedle parallel to the tangent of the rotation vector is characterized by an orientation angle of 0°. Furthermore, for reference, a microneedle characterized by an orientation angle of 90° would be perpendicular to the rotation vector and would not be able to pierce the skin surface at all during operation of the wearable medical device.

[0100] In some implementations, each of the first and second microneedles can be independently characterized by a length of about 0.2 mm to about 3.0 mm. For example, each of the first and second microneedles can be independently characterized by a length (in mm) of about 0.2, 0.5, 0.8, 1.0, 1.2, 1.5, 1.8, 2.0, 2.2, 2.5, 2.8, or 3.0, or a value between any of the foregoing values ​​(e.g., between about 0.5 and about 0.8, etc.). The needle length can be selected according to application needs. For example, shorter needles may be more comfortable for elderly users or for areas where the skin may be thinner.

[0101] In some embodiments, each of the first and second microneedles can be independently characterized by a diameter of about 1 μm to about 25 μm. For example, each of the first and second microneedles can be independently characterized by a diameter (in μm) of a value in the range of about 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25, or between any of the foregoing values ​​(e.g., between about 8 and about 12, etc.). In some embodiments, any microneedle described herein can have a uniform or non-uniform diameter within the above-mentioned range. A non-uniform diameter can be characterized by a diameter that decreases along the microneedle body toward the tip. For example, a non-uniform diameter can decrease in diameter along the microneedle body toward the tip at a rate of about 5% to 25% (e.g., 5%, 8%, 10%, 12%, 15%, 18%, 20%, 22%, or 25%, or between any of the foregoing values ​​(e.g., between 10% and about 15%, etc.)). The non-uniform diameter may also include regions with a larger diameter within the microneedle body, or isolated regions with a larger diameter. These larger diameter regions may be in the form of barbs. Microneedles with barbs can be used to better anchor the microneedle within the skin surface. The larger diameter regions also prevent the entire microneedle from penetrating the skin, effectively leaving an area between the skin surface and the base to allow airflow and prevent moisture buildup and / or bacterial growth. In some embodiments, at least a portion of the first and / or second microneedles may be characterized by a non-uniform diameter.

[0102] In many implementations, it is desirable to leave 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 with a certain length and / or diameter. In other words, the microneedles can be inserted into the skin at only a certain percentage of their path. For example, the microneedles can be inserted into the skin at 25% to 75% of their length, such as 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75% of that length, or values ​​within a range of any of the foregoing values. In some implementations, the wearable medical device may have a gap thickness of about 0.15 mm to about 1 mm (e.g., 0.15 mm, 0.2 mm, 0.25 mm, 0.3 mm, 0.35 mm, 0.4 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.60 mm, 0.65 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm or 1 mm or a value within the range of any of the foregoing values) located above the skin surface.

[0103] In some embodiments, any microneedle described herein may also include a microneedle base. The microneedle base can be of any shape, but it is typically at least 25% larger than the diameter of the microneedle. The microneedle base provides stability but also serves to prevent the microneedle from being 100% inserted into the skin surface, thus leaving 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 truncated or tapered truncated section.

[0104] In many embodiments, any microneedles described herein may be made of plastic, metal, absorbable material, or a combination thereof. Suitable plastics include polyolefin materials, polyester, polyurethane, etc. Suitable metals include stainless steel, titanium, and nitinol (nickel / titanium alloy), etc. Absorbable materials include materials used to form absorbable sutures, such as polyglycolic acid (e.g., DEXON). ™ ), poly(glycolic acid / lactide) random copolymers (e.g., VICRYL) ™ )wait.

[0105] In some implementations, any microneedles described herein may be coated with one or more conductive materials, enabling wearable medical devices to be used as dry electrodes.

[0106] In some implementations, any microneedles described herein may be solid or hollow. Hollow microneedles allow therapeutic agents to pass through.

[0107] In some embodiments, each of the first microneedle and the second microneedle may be the same. In other embodiments, any of the first microneedles or any of the second microneedles may differ from each other in one or more of the foregoing aspects. Applicator

[0108] In many embodiments, an applicator for attaching a wearable medical device of this disclosure to a skin surface is described. The applicator may include: a loading actuator configured to counter-rotately load a first rotationally different segment and a second rotationally different segment of the wearable medical device; a holding system configured to hold the wearable medical device in the counter-rotationally loaded configuration; a skin tensioning system having: a chamber surrounding a region of the wearable medical device housed within the applicator and configured to contact a skin surface region; and a mechanism for applying decompression to the skin surface region; and a mechanism for releasing the wearable medical device from the counter-rotationally loaded configuration. For example, an applicator with a loading actuator may be suitable for wearable medical devices described herein with tensioning communication members.

[0109] In many embodiments, an applicator for attaching a wearable medical device of this disclosure to a skin surface is described. The applicator may include a drive actuator configured to rotate a first rotationally different segment and a second rotationally different segment within the wearable medical device in a counter-rotating manner; a skin tensioning system having a chamber surrounding a region of the wearable medical device housed within the applicator and configured to contact the skin surface region; and a mechanism for applying pressure relief to the skin surface region. For example, an applicator with a drive actuator may be suitable for wearable medical devices described herein that have a rolling connecting member.

[0110] In some implementations, any skin tensioning system may also include a plurality of tension needles and a tension actuator configured to rotate the plurality of tension needles around an area of ​​the wearable medical device housed within the applicator.

[0111] In some embodiments, the features of the described applicator may be strictly mechanically driven. In other embodiments, the features of the applicator may be at least partially electrically driven.

[0112] While the applicator described herein relates to the attachment of wearable medical devices of the present disclosure, the applicator may be used to attach wearable medical devices that may be outside the scope of the present disclosure, provided that the wearable medical device includes a first rotating segment, a second rotating segment, and multiple microneedles.

[0113] In some embodiments, the described applicator can also be configured to remove a wearable medical device from the skin surface. To remove the wearable medical device, the applicator can be brought into contact with the wearable medical device and engaged with a loading actuator to effectively rotate a first and a second dissimilar segment, causing the first and second microneedles to leave the skin surface.

[0114] Further details about the applicator are described below. Loading actuator

[0115] In some embodiments, the loading actuator may include any combination of mechanical components for performing rotation of a first rotationally different segment and a second rotationally different segment. For example, the loading actuator may include one or more of a spring, gear, piston, pump, etc. In some embodiments, the loading actuator may include a planetary gear transmission system having a ring gear, a sun gear, and one or more planetary gears. For example, the ring gear can effectively rotate the second rotationally different segment of the wearable medical device, and the sun gear can effectively rotate the first rotationally different segment. In other words, the rotationally different segment of the wearable medical device may have gear teeth complementary to the corresponding gear. In some embodiments, the applicator may include a mechanism for engaging the loading actuator. For example, this mechanism may include a torsion applicator, a retracting plunger, etc.

[0116] In some implementations, the loading actuator can be tuned to a specific tensioning connector or a specific number of connectors. For example, the loading actuator can be configured to load the wearable medical device in a counter-rotating manner at a selected degree of rotation, such that once the wearable medical device is attached to the skin surface, the relaxation of the connector is complete or incomplete. Connectors that are incompletely relaxed once the wearable medical device is attached to the skin surface can be used to further secure the wearable medical device to the skin surface, as the remaining tension will continuously pull the opposing microneedles into the skin. However, excessive residual tension in the connector while in the skin surface can lead to injury. Conversely, the connector may be overstretched during application. In other words, connectors that have relaxed beyond their original configuration can actually be re-tensioned. When the wearable medical device is attached to the skin surface, the overstretched connector can ultimately act to pull the microneedles out of the skin surface due to forces that favor returning to their original configuration, thereby reducing wear time. Drive actuator

[0117] In some embodiments, the drive actuator may include any combination of mechanical components for performing rotation in a first segment of rotation and a second segment of rotation. For example, the drive actuator may include one or more of a spring, a gear (e.g., a planetary gear transmission), a piston, a pump, etc. In some embodiments, the applicator may include a mechanism for engaging the drive actuator. For example, the mechanism may include a torsion applicator, a retractable plunger, etc. Maintain system

[0118] In some embodiments, the retention system may include any combination of mechanical components for holding a first, differently rotated segment and a second, differently rotated segment of a wearable medical device in a configuration of counter-rotating loading. In some embodiments, the retention system may include retention elements such as pins, latches, brackets, etc.

[0119] In some embodiments, the retention system may also include a docking platform for holding the wearable medical device within the applicator. In some embodiments, the docking platform may extend beyond the periphery of the applicator. For example, when tensioning the skin surface, it may not be desirable for the multiple microneedles of the wearable medical device to contact the skin surface during tensioning. Therefore, the docking platform may be configured to retract the wearable medical device away from the skin surface before tensioning and / or extend the wearable medical device toward the skin surface after tensioning. Skin tension system

[0120] In some embodiments, the chamber may be housed within the applicator body / shell. 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 / shell.

[0121] In some implementations, the chamber can be characterized independently by a length and width of about 10 mm to about 100 mm. For example, the chamber can be characterized by a length and width (in mm) of a value independently selected from 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100, or between any of the foregoing values ​​(e.g., between about 50 and about 80, etc.). The shape of the chamber can be any shape. For example, the surface of the chamber that contacts the skin can be circular, elliptical, etc. The size of the chamber can be selected based on the desired level of tension, the size of the wearable medical device to be attached, or a combination thereof.

[0122] In some implementations, the chamber may be configured to contact the skin surface such that the area within the chamber is approximately 75 mm². 2 Approximately 8000mm 2For example, the area within the chamber can be selected as approximately 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 between any of the aforementioned values ​​(e.g., between approximately 200 and approximately 350, etc.) (in mm). 2 (unit)

[0123] In some implementations, the mechanism for reducing the pressure in the chamber that comes into contact with the skin surface may include an electric vacuum pump, a mechanical vacuum pump, a suction bulb, a syringe, or a combination thereof.

[0124] In some implementations, the skin tensioning system may also include multiple tensioning microneedles and a tensioning actuator configured to rotate the multiple tensioning microneedles around an area of ​​the wearable medical device housed within the applicator. Further details regarding the tensioning microneedles and tensioning actuator are provided below. Skin tension actuator

[0125] In many embodiments, the tension actuator may be configured to rotate multiple tensioned microneedles about an area of ​​the wearable medical device housed within the applicator (e.g., a retention system, such as a docking platform). In some embodiments, the tension actuator may include a planetary gear transmission system for rotating the multiple microneedles about the retention system.

[0126] In some implementations, the tension actuator may be configured to rotate multiple first microneedles in one direction of rotation and multiple second microneedles in the opposite direction of rotation (i.e., reverse rotation). Tension microneedle

[0127] In many embodiments, multiple tensioning microneedles may exist as a first plurality of tensioning microneedles and a second plurality of tensioning microneedles. In some embodiments, the first plurality of tensioning microneedles may be located on a first rotationally different tensioning segment, and the second plurality of tensioning microneedles may be located on a second rotationally different tensioning segment, wherein the second rotationally different tensioning segment at least partially surrounds the first rotationally different tensioning segment. The first and second rotationally different tensioning segments may be configured to rotate in opposite directions about a rotation axis (i.e., in a counter-rotating manner). In many embodiments, the first and second rotationally different tensioning segments are each in the shape of a cylindrical ring and are arranged concentrically.

[0128] In embodiments having a first rotationally different tensioning section and a second rotationally different tensioning section, the tension actuator may include a planetary gear transmission system having a ring gear, a sun gear, and one or more planetary gears. For example, the ring gear can effectively rotate the second rotationally different tensioning section, and the sun gear can effectively rotate the first rotationally different tensioning section. In other words, the rotationally different tensioning sections may have gear teeth complementary to the corresponding gears.

[0129] In some embodiments, multiple tensioning microneedles can be independently characterized by an elevation angle of approximately 40° to approximately 80° relative to the plane to which the microneedles are attached (e.g., correspondingly rotating different tensioning segments). For example, at least a portion of the multiple tensioning microneedles can be independently characterized by an elevation angle of approximately 40, 42, 45, 48, 50, 52, 55, 58, 60, 62, 65, 68, 70, 72, 75, 78, or 80, or between any of the foregoing values ​​(e.g., between approximately 45 and approximately 50, etc.). Elevation angles outside the aforementioned range (e.g., 90°) are still within the scope of this disclosure but may be insufficient to tension the skin surface. The elevation angle for measuring tensioning microneedles is the same as that for measuring microneedles in the aforementioned wearable medical devices. In embodiments having a first plurality of tensioning microneedles and a second plurality of tensioning microneedles on corresponding rotational tensioning sections, wherein at least a portion of the first plurality of tensioning microneedles and the second plurality of tensioning microneedles are characterized by an elevation angle (e.g., 40° to 80°), the plurality of first tensioning microneedles may be oriented such that the tips of the first tensioning microneedles face a rotational direction, and the plurality of second tensioning microneedles may be oriented such that the rotational direction faced by the tips of the second microneedles is opposite to the rotational direction of the tips of the first tensioning microneedles.

[0130] In some implementations, each of the first and second tensioning microneedles, characterized by an elevation angle not equal to 90°, can be independently arranged at an orientation angle of approximately -25° to approximately 0° (aligned with the tangent) or approximately 0° (aligned with the tangent) to approximately 25° relative to the tangent of the rotation vector (i.e., rotation with respect to the respective tensioning segments). Negative orientation angle values ​​indicate that the needle points towards the axis of rotation, while positive orientation angle values ​​indicate that the needle points away from the axis of rotation. For example, any given tensioning microneedle can 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 between any of the aforementioned values ​​on either side of 0 (e.g., between approximately -15 and approximately -8, between approximately 5 and approximately 12, etc.). In many embodiments, each of the first and second tensioning microneedles can be arranged such that the rotation of the entire needle body relative to the respective tensioning segment is tangentially aligned with the rotation vector (i.e., an orientation angle of 0°). The orientation angle is measured from a tangential plane passing through the center of the microneedle base to the center of the microneedle tip, as described above regarding microneedles in wearable medical devices.

[0131] In some embodiments, each of the first and second tensioning microneedles can be independently characterized by a length of about 0.5 mm to about 3.5 mm. For example, each of the first and second microneedles can be independently characterized by a length (in mm) of a value within the range of about 0.5, 0.8, 1.0, 1.2, 1.5, 1.8, 2.0, 2.2, 2.5, 2.8, 3.0, or 3.5 or between any of the foregoing values ​​(e.g., between about 0.5 and about 0.8, etc.). The length of the needle can be selected according to application needs. For example, a shorter needle may be more comfortable for elderly users or for areas where the skin may be thinner. In many embodiments, the length of the tensioning microneedle can be selected to be longer than the microneedles of the wearable medical device. Alternatively, where 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 tensioning microneedle can be selected to be equal to or shorter than the microneedles of the wearable medical device.

[0132] In some embodiments, each of the first and second tensioning microneedles can be independently characterized by a diameter of about 1 μm to about 25 μm. For example, each of the first and second tensioning microneedles can be independently characterized by a diameter (in μm) of about 1, 2, 5, 8, 10, 12, 15, 18, 20, 22, or 25, or a value between any of the foregoing values ​​(e.g., between about 8 and about 12, etc.). In some embodiments, any tensioning microneedle described herein may have a uniform or non-uniform diameter within the aforementioned range.

[0133] In some implementations, multiple tensioned microneedles can be arranged in circular or semi-circular rows extending around the axis of rotation. For example, multiple tensioned microneedles can be arranged in 1 to 5 rows.

[0134] In some implementations, the multiple tensioned microneedles may be made of metal, plastic, rubber, silicone, or a combination thereof.

[0135] In many implementations, multiple tensioned microneedles can be driven into the skin surface before rotation. In other implementations, the multiple tensioned microneedles may not pierce the skin surface, but rather be manipulated by friction (e.g., with blunt rubber microneedles). Release agency

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

[0137] In some embodiments, the described applicator may also include a docking platform for holding the wearable medical device within the applicator. In some embodiments, the docking platform may extend beyond the periphery of the applicator. For example, when tensioning a skin surface, it may not be desirable for the multiple microneedles of the wearable medical device to contact the skin surface during tensioning. Therefore, the docking platform may be configured to retract the wearable medical device away from the skin surface before tensioning and / or extend the wearable medical device toward the skin surface after tensioning.

[0138] In some embodiments, the described applicator may further include an actuation guide configured to engage with an applicator guide on a first rotationally different segment and a second rotationally different segment. Alternatively, the applicator may include a docking platform for holding a wearable medical device within the applicator, and an actuation guide configured to engage with an applicator guide on the docking platform. In some embodiments, the actuation guide may be a track within a fixed wall within the applicator. The track within the fixed wall of the applicator may be angled to accommodate rotation of the first rotationally different segment and / or the second rotationally different segment (see, for example...). Figure 7A and Figure 7B The actuation guide can assist the independent rotation of a first segment that rotates differently from a second segment that rotates differently, and therefore can have any configuration. For example, the actuation guide may include a track, pin, gear, friction-inducing component, etc. Application method

[0139] In many embodiments, a method for attaching a wearable medical device (e.g., a wearable medical device of this disclosure having a tensioned communication member) to a skin surface is described. The method may include: providing an applicator as described herein, having the wearable medical device therein; and rotating a first rotationally different segment and a second rotationally different segment such that the wearable medical device is in a counter-rotationally loaded configuration. The method may also include contacting the applicator with the skin surface such that a chamber contacts the skin surface; engaging a mechanism for applying decompression to the skin surface to create a tensioned skin surface; and releasing the wearable medical device from the counter-rotationally loaded configuration such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the tensioned skin surface.

[0140] In many embodiments, a method for attaching a wearable medical device (e.g., a wearable medical device of this disclosure having a rolling connecting member) to a skin surface is described. The method may include: providing an applicator as described herein, having the wearable medical device therein; contacting the applicator with a skin surface such that a chamber contacts the skin surface; and engaging a mechanism for applying pressure to the skin surface to create a tensioned skin surface. The method may also include rotating a first segment of rotation and further rotating the segment of rotation such that a plurality of first microneedles and a plurality of second microneedles of the wearable medical device are driven into the tensioned skin surface.

[0141] In some implementations, any of the methods described herein may also include engaging a tension actuator such that multiple tension microneedles in contact with the skin surface rotate to create a tensioned skin surface.

[0142] In some implementations, any method described herein may also include selecting the degree of rotation for rotating a first rotationally different segment and for rotating a second rotationally different segment, whether for loading a wearable medical device (e.g., having a tensioned connecting member) or driving a wearable medical device (e.g., having a rolling connecting member).

[0143] In some implementations, any of the methods described herein for attaching a wearable medical device may also include attaching a monitoring device to the wearable medical device.

[0144] In some embodiments, any method described herein for attaching a wearable medical device to a skin surface may also include applying supplemental fixation garments to the wearable medical device or to a wearable medical device having monitoring devices. Supplemental fixation garments may be bandages, protective coverings (e.g., waterproof / sweatproof), etc. In some embodiments, supplemental fixation garments may include a backing and a skin-compatible adhesive.

[0145] In some embodiments, a method for removing a wearable medical device from the skin surface is described. The method may include: engaging a mechanical actuator on the wearable medical device such that the wearable medical device is in a counter-rotating loaded configuration; and lifting the wearable medical device from the skin surface.

[0146] In some embodiments, a method for removing a wearable medical device from a skin surface is described. The method may include: contacting an applicator with the wearable medical device on the skin surface; engaging a loading actuator within the applicator such that the wearable medical device is in a counter-rotating loading configuration; and lifting the wearable medical device from the skin surface. Monitoring methods

[0147] In many embodiments, a method for monitoring biosignals is described. This method may include detecting biosignals using a monitoring device attached to a wearable medical device that is fixed to the skin surface of this disclosure.

[0148] In some implementations, the biosignal may be selected from electrical signals, chemical signals, light emission signals, or combinations thereof.

[0149] The method may also include attaching a wearable medical device to the skin surface.

[0150] The method may also include attaching the monitoring device to a wearable medical device that is attached to the skin surface. kit

[0151] In many embodiments, a kit is described. This kit may include the applicator of this disclosure and a set of instructions for attaching a wearable medical device to a skin surface.

[0152] In some implementations, the kit may also include one or more wearable medical devices of this disclosure.

[0153] In some implementations, the kit may also include one or more monitoring devices.

[0154] In some implementations, the kit may also include one or more supplementary fastening devices.

Claims

1. An applicator for applying a wearable medical device to a skin surface, the applicator comprising: A loading actuator is configured to load a first rotating segment and a second rotating segment within the wearable medical device in a counter-rotating manner. A holding system for holding the wearable medical device in a reverse rotationally loaded configuration; A skin tensioning system, the skin tensioning system comprising: A chamber surrounding the area of ​​the wearable medical device housed within the applicator and configured to contact a skin surface area, and A mechanism for applying pressure to the skin surface area; and A mechanism for releasing the wearable medical device from the counter-rotatingly loaded configuration. The wearable medical device includes: Base, the base comprising: First rotation section, The second rotation segment is at least partially surrounded by the first rotation segment. Multiple first microneedles located on the first rotating section, and Multiple second microneedles located on the second rotating section; and At least one connecting member, which is connected to the first rotating segment and the second rotating segment.

2. An applicator for attaching a wearable medical device to a skin surface, the applicator comprising: A drive actuator configured to rotate a first rotating segment and a second rotating segment within the wearable medical device in a counter-rotating manner; and A skin tensioning system, the skin tensioning system comprising: A chamber surrounding the area of ​​the wearable medical device housed within the applicator and configured to contact a skin surface area, and A mechanism for applying pressure relief to the skin surface area. The wearable medical device includes: Base, the base comprising: First rotation section, The second rotation segment is at least partially surrounded by the first rotation segment. Multiple first microneedles located on the first rotating section, and Multiple second microneedles located on the second rotating section; and At least one connecting member, which is connected to the first rotating segment and the second rotating segment.

3. The applicator according to claim 1, wherein the chamber is housed within 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 decompression comprises an electric vacuum pump, a mechanical vacuum pump, a suction bulb, a syringe, or a combination thereof.

6. The applicator according to claim 1, wherein the skin tensioning system further comprises: Multiple tensioned microneedles, and A tension actuator is configured to rotate the plurality of tension microneedles around the area of ​​the wearable medical device housed within the applicator.

7. The applicator according to claim 6, wherein the skin tensioning system further comprises: A first rotational tensioning section and a second rotational tensioning section, wherein the second rotational tensioning section at least partially surrounds the first rotational tensioning section. The multiple tensioning microneedles include multiple first tensioning microneedles and multiple second tensioning microneedles. The plurality of first tensioning microneedles are located on the first rotating tensioning section, and the plurality of second tensioning microneedles are located on the second rotating tensioning section.

8. The applicator according to claim 7, wherein the first rotary tensioning section and the second rotary tensioning section are each in the shape of a cylindrical ring and are arranged concentrically.

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

10. A kit comprising: The applicator according to any one of claims 1 to 9; and Instructions for attaching wearable medical devices to the skin surface.

11. The kit of claim 10, further comprising one or more wearable medical devices.

12. The kit of claim 10 further includes a monitoring device.

Images