WO2024011122A2 - Applicator for external wearable device - Google Patents
Applicator for external wearable device Download PDFInfo
- Publication number
- WO2024011122A2 WO2024011122A2 PCT/US2023/069633 US2023069633W WO2024011122A2 WO 2024011122 A2 WO2024011122 A2 WO 2024011122A2 US 2023069633 W US2023069633 W US 2023069633W WO 2024011122 A2 WO2024011122 A2 WO 2024011122A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- wearable device
- external wearable
- actuator
- applicator
- claws
- Prior art date
Links
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- 239000012790 adhesive layer Substances 0.000 claims abstract description 49
- 230000007704 transition Effects 0.000 claims abstract description 25
- 230000001070 adhesive effect Effects 0.000 claims description 27
- 238000003032 molecular docking Methods 0.000 claims description 27
- 239000000853 adhesive Substances 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 25
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- 210000003811 finger Anatomy 0.000 description 3
- 239000002783 friction material Substances 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 239000007943 implant Substances 0.000 description 3
- 230000013011 mating Effects 0.000 description 3
- 230000000881 depressing effect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000000926 neurological effect Effects 0.000 description 2
- 230000008058 pain sensation Effects 0.000 description 2
- 208000035824 paresthesia Diseases 0.000 description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 2
- 239000004810 polytetrafluoroethylene Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 208000020446 Cardiac disease Diseases 0.000 description 1
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- 208000008238 Muscle Spasticity Diseases 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37235—Aspects of the external programmer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
Definitions
- the present technology is generally related to the application of external wearable devices.
- Implantable stimulators have been developed to treat pain, movement disorders, functional disorders, spasticity, cancer, cardiac disorders, and various other medical conditions
- Implantable stimulators generally have an implantable pulse generator and one or more leads that deliver electrical pulses to neurological tissue or muscle tissue.
- the pulse generator applies electrical pulses, which in turn modify the function of the patient's nervous system, such as by altering the patient's responsiveness to sensory stimuli and/or altering the patient's motor-circuit output.
- the pulse generator applies electrical pulses to the electrodes, which in turn can generate sensations that mask or otherwise alter the patient's sensation of pain. For example, in many cases, patients report a tingling or paresthesia that is perceived as more pleasant and/or less uncomfortable than the underlying pain sensation.
- an external wearable device may be used for charging, maintaining, and/or giving instructions to the implanted pulse generator.
- One drawback of utilizing an external wearable device for charging, maintaining, and/or giving instructions to the implanted pulse generator is that the external wearable device may be awkward and/or cumbersome for the patient to apply.
- Another drawback of utilizing an external wearable device for charging, maintaining, and/or giving instructions to the implanted pulse generator is that alignment between the implanted pulse generator and the external wearable device may be required for the external wearable device to operate effectively.
- Embodiments hereof relate to improved techniques and systems for releasably applying an external wearable device to a patient.
- the present disclosure provides an applicator for applying an external wearable device to a target skin location.
- the applicator includes an actuator having a first position and a second position, and a plurality of claws coupled to the actuator.
- the plurality of claws have a retracted state and an extended state in which the plurality of claws radially extend relative to the retracted state.
- the plurality of claws are configured to receive the external wearable device when in the retracted state.
- Transition of the actuator from the first position to the second position causes the plurality of claws to transition from the retracted state to the extended state, and the actuator is configured to exert a force onto the external wearable device as to press the external wearable device onto the target skin location when the actuator is in the second position.
- the disclosure provides that the applicator further includes a spring that is configured to bias the actuator in the first position.
- the spring is helical and is disposed around the actuator.
- the disclosure provides that the applicator further includes a grip disposed around the actuator.
- the grip includes a contoured outer surface.
- the grip includes electronics disposed therein, the series of electronics being configured to detect alignment of the external wearable device with an implanted medical device.
- the electronics are further configured to provide audio or haptic feedback when alignment has been achieved.
- each claw of the plurality of claws includes a flange having a first surface configured to contact a first surface of the external wearable device and a second surface configured to contact the target skin location.
- the first surface of the flange further includes a plurality of rollers.
- the second surface of the flange further includes a plurality of rollers.
- the disclosure provides that the actuator includes an outer circumferential surface that is tapered and configured to push the plurality of claws radially outward as the actuator transitions from the retracted state to the extended state.
- the disclosure provides that the applicator further includes at least one spring that is configured to bias the plurality of claws in the retracted state.
- the actuator is configured to move longitudinally when transitioning from the first position to the second position.
- the disclosure provides that the actuator is configured to rotate when transitioning from the first position to the second position.
- the present disclosure provides a system including an external wearable device and an applicator for applying the external wearable device to a target skin location.
- the external wearable device has a housing and an adhesive layer is coupled to a first surface of the housing.
- the applicator includes an actuator having a first position and a second position, and a plurality of claws coupled to the actuator.
- the plurality of claws have a retracted state and an extended state in which the plurality of claws radially extend relative to the retracted state.
- the plurality of claws are configured to receive the external wearable device when in the closed state. Transition of the actuator from the first position to the second position causes the plurality of claws to transition from the retracted state to the extended state.
- the actuator is configured to exert a force onto the external wearable device as to press the external wearable device onto the target skin location when the actuator is in the second position.
- the disclosure provides that the adhesive layer includes a plurality of cutouts, each cutout being configured to align a flange of a claw of the plurality of claws.
- the disclosure provides that the adhesive layer is detachable from the first surface of the housing. [0016] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the adhesive layer includes a plurality of adhesive sections and a plurality of non-adhesive sections.
- the disclosure provides that the applicator further includes a spring that is configured to bias the actuator in the first position.
- the spring is helical and is disposed around the actuator.
- the disclosure provides that the applicator further includes at least one spring that is configured to bias the plurality of claws in the retracted state.
- the least one spring is a leaf spring.
- each claw of the plurality of claws includes a flange having a first surface configured to contact a first surface of the external wearable device and a second surface configured to contact the target skin location.
- the first surface of the flange further includes a plurality of rollers.
- the second surface of the flange further includes a plurality of rollers.
- the disclosure provides that the actuator includes an outer circumferential surface that is tapered and configured to push the plurality of claws radially outward as the actuator transitions from the retracted state to the extended state.
- the disclosure provides that the external wearable device is configured to charge an implanted medical device.
- the disclosure provides that the external wearable device is configured to supply instructions to an implanted medical device.
- the disclosure provides that the external wearable device is a docking station.
- the housing is configured to receive a second external wearable device and the second external wearable device is configured to charge an implanted medical device or configured to supply instructions to an implanted medical device.
- the housing includes hook and loop fasteners on a second surface thereof, the second surface opposing the first surface.
- the housing includes at least one positioning coil that is configured to detect alignment with an implanted medical device.
- each claw of the plurality of claws includes a detent and the housing of the external wearable device includes a plurality of protrusions that mate with the detents.
- each claw of the plurality of claws includes a protrusion and the housing of the external wearable device includes a plurality of detents that mate with the protrusions.
- the disclosure provides that the actuator is configured to move longitudinally when transitioning from the first position to the second position.
- the present disclosure provides a method for securing an external wearable device onto a target skin location.
- the external wearable device is loaded into an applicator.
- the external wearable device has a housing and an adhesive layer coupled to a surface of the housing, and the applicator has an actuator and a plurality of claws configured to secure the external wearable device.
- the applicator is positioned at the target skin location with the external wearable device secured within the applicator.
- the actuator of the applicator is actuated, and actuation of the actuator radially extends the plurality of claws to release the external wearable device and also pushes the external wearable device onto the target skin location.
- the disclosure provides that alignment of the external wearable device with an implanted medical device is detected prior to the step of actuating the actuator.
- the disclosure provides that the external wearable device is configured to charge the implanted medical device.
- the disclosure provides that the external wearable device is configured to supply instructions to the implanted medical device.
- the disclosure provides that the external wearable device is a docking station.
- a second external wearable device is positioned into the docking station.
- the disclosure provides that the second external wearable device is configured to charge an implanted medical device or configured to supply instructions to an implanted medical device. [0034] Tn an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that after the actuator of the applicator is actuated, the external wearable device is removed with the applicator after a predetermined time period, the external wearable device is repositioned with the applicator, and the external wearable device is reapplied with the applicator. In an embodiment, repositioning the external wearable device includes circumferential rotation of the external wearable device.
- the disclosure provides that after the actuator of the applicator is actuated, the external wearable device with the applicator is removed after a predetermined time period, an adhesive layer of the external wearable device is detached, a second adhesive layer is attached onto the external wearable device and the external wearable device is reapplied with the applicator.
- FIG. 1 depicts a perspective view of an applicator for applying an external wearable device to a target skin location in accordance with an aspect of this disclosure, wherein the applicator is in a closed configuration.
- FIG. 2 depicts side view of the applicator of FIG. 1, wherein the applicator is in the closed configuration.
- FIG. 3 depicts a top view of the applicator of FIG. 1, wherein the applicator is in the closed configuration.
- FIG. 4 depicts a sectional view of the applicator of FIG. 1 , the sectional being taken along line A-A of FIG. 2, wherein the applicator is in the closed configuration.
- FIG. 5 depicts a cross-sectional view of the applicator of FIG. 1, the cross-section being taken along line B-B of FIG. 2, wherein the applicator is in the closed configuration.
- FIG. 6 depicts a top view of the applicator of FIG. 1 in an open configuration.
- FIG 7 depicts a cross-sectional view of the applicator of FIG. 1 , wherein the applicator is in the open configuration.
- FIG. 8 depicts a cross-sectional view of an applicator for applying an external wearable device to a target skin location in accordance with another aspect of this disclosure, wherein the applicator is in a closed configuration.
- FIG. 9 depicts a cross-sectional view of the applicator of FIG. 8, wherein the applicator is in an open configuration.
- FIG. 10 depicts a cross-sectional view of an applicator for applying an external wearable device to a target skin location in accordance with another aspect of this disclosure, wherein the applicator is in a closed configuration.
- FIG. 11A depicts a cross-sectional view of a docking system in accordance with an aspect of the disclosure.
- FIG. 1 IB depicts a bottom view of the docking system of FIG. 11A.
- FIG. 12 depicts another embodiment of an external wearable device in accordance with an aspect of the disclosure.
- FIG. 13A depicts a top view of an adhesive layer of an external wearable device in accordance with an aspect of the disclosure.
- FIG. 13B depicts a top view of another embodiment of an adhesive layer of an external wearable device in accordance with an aspect of the disclosure.
- FIG. 13C depicts a top view of another embodiment of an adhesive layer of an external wearable device in accordance with an aspect of the disclosure.
- FIG. 14 depicts a method for using an applicator for applying an external wearable device to a target skin location in accordance with an aspect of the disclosure.
- Embodiments hereof are directed to applicators for applying an external wearable device to a patient’s skin.
- Some wearable medical devices particularly those that interact with an implant to power or communicate with the implant, need to be positioned or aligned accurately with respect to the implant as to properly function.
- Such a wearable medical device may be applied to the patient’s skin with an adhesive layer, or held in place with a belt, holster, or other accessory. Unintentional movement or errors in positioning may take place when the adhesive layer is being applied.
- a target location for application may be determined prior to exposing the adhesive layer, and, during the process of removing a backing or cover from the adhesive layer, the wearable medical device may be inadvertently moved relative to the intended target location for application.
- the adhesive layer may be prematurely exposed, or peeled, prior to finding the intended target location and the adhesive layer may accidently interact with skin areas outside of the intended target location, resulting in a difficult and frustrating experience for the user to apply the device and an increased risk of mispositioning the wearable medical device. Therefore, for wearable external devices that are to be applied in difficult to reach areas, such as a patient’s back, a need exists to assist the user in positioning and applying the wearable external device.
- FIGS. 1-7 An applicator 100 according to an embodiment hereof is shown in FIGS. 1-7.
- FIG. 1 illustrates a perspective view of the applicator 100
- FIG. 2 is a side view of the applicator 100 while being applied to a target skin location 211.
- FIG. 3 is a top view of the applicator 100.
- FIG. 4 is a sectional view taken along line A-A of FIG. 2
- FIG. 5 is a cross-sectional view taken along line B-B of FIG. 2.
- the applicator 100 has a closed configuration which is depicted in FIGS. 1-5, and an open configuration which is shown in the top and cross-sectional views of FIGS. 6 and 7, respectively.
- the applicator 100 is configured to apply an external wearable device 102 to the target skin location 211.
- the target skin location 211 is shown in FIG. 2 and may coincide with the position of an implanted medical device 201 underneath the skin of a patient.
- the implanted medical device 201 may be configured to monitor a patient’s condition and/or provide treatment for a number of potential diseases or ailments.
- the implanted medical device 201 is an implanted pulse generator. Once implanted, the implanted medical device 201 may need to receive instructions or commands from the external wearable device 102, may need to be powered or charged by the external wearable device 102, and/or may need to receive updates or other maintenance tasks from the external wearable device 102.
- the external wearable device 102 when aligned with and in proximity to the implanted medical device 201, is configured to electrically communicate with the implanted medical device 201 as to provide the necessary instructions, power, or maintenance. Therefore, the target skin location 211 is chosen by the user based on the position and alignment required for the external wearable device 102 to initiate and maintain electrical communication with the implanted medical device 201.
- the external wearable device 102 includes a housing 103 having a first surface 105 and a second surface 107 that opposes the first surface 105.
- the first surface 105 is configured to contact the target skin location 211 and is adhered to the skin using an adhesive layer 112.
- the housing 103 of the external wearable device 102 further includes one or more positioning coils (not shown) that are configured to monitor alignment of the external wearable device 102 in relation to the implanted medical device 201 in order to establish and maintain electrical communication as described above.
- positioning coils may be similar to positioning coils described in more detail herein with respect to FIG. 1 IB.
- the applicator 100 includes an actuator 104, a plurality of claws 106, an actuator spring 108, a grip 109, and a hub 113.
- the applicator 100 has a closed configuration, shown in FIGS. 1- 5, in which the actuator 104 is in a first position and the plurality of claws 106 is in a retracted state. When the applicator 100 is in the closed configuration, the applicator 100 is configured to hold or receive the external wearable device 102 within the plurality of claws 106.
- the applicator 100 also has an open configuration, shown in FIGS. 6-7, in which the actuator 104 is in a second position and the plurality of claws 106 is in an extended state.
- the applicator 100 When the applicator 100 is in the open configuration, the applicator 100 is configured to apply or secure the external wearable device 102 to the target skin location 211. As will be described in more detail herein, actuation or movement of the actuator 104 from the first position to the second position causes the plurality of claws 106 to transition from the retracted state to the extended state. In the embodiment of FIGS. 1-7, the actuator 104 is configured to be depressed as to move the actuator 104 from the first position to the second position.
- the actuator 104 When the applicator 100 transitions from the closed configuration to the open configuration, the plurality of claws 106 radially extend as to release the external wearable device 102 and the actuator 104 applies or exerts a force onto the external wearable device 102 as to press or push the external wearable device 102 onto the target skin location 211. [0060] The components of the applicator 100 will now be described in more detail. As best shown in FIG. 5, the actuator 104 has a first end 104A and a second end 104B opposing the first end 104A.
- the actuator 104 may be considered to include two integral portions including a domeshaped portion 140, which forms the first end 104A of the actuator 104, and a cylindrical portion 121 that extends between the dome-shaped portion 140 and the second end 104B of the actuator 104.
- a first or top surface 140A of the dome-shaped portion 140 is rounded or curved so as to provide the user with a smooth and atraumatic surface for interaction therewith.
- a second or underside surface 140B of the dome-shaped portion 140 defines a flange for interacting with the actuator spring 108.
- the second end 104B of the actuator 104 includes a cam or tapered circumferential surface 123 for interacting with the plurality of claws 106.
- the tapered circumferential surface 123 is configured to push the plurality of claws 106 radially outward as the actuator 104 moves from the first position to the second position.
- the grip 109 is disposed around the cylindrical portion 121 of the actuator 104.
- the grip 109 is a generally tubular component, with an inner surface 109B defining a central lumen 109C therethrough.
- the central lumen 109C is sized to receive the actuator 104 therethrough and allows for the actuator 104 to freely move within.
- the grip 109 is configured to grasped by a user and remains stationary during operation of the applicator 100 (i.e., remains stationary during movement of the actuator 104, as well as during movement of the plurality of claws 106).
- the grip 109 may further include a concave outer surface 109A as to provide the user with a contoured surface to grasp.
- the grip 109 is configured to allow the applicator 100 to be used with one hand in that the user may grasp the concave outer surface 109A with one or more digits while another finger presses down the actuator 104.
- the grip 109 may include electronics 117 positioned within.
- a patient may have the implanted medical device 201 positioned within their body which may need to receive instructions or commands from the external wearable device 102, may need to be powered or charged by the external wearable device 102, and/or may need to receive updates or other maintenance tasks from the external wearable device 102. Alignment of the external wearable device 102 relative to the implanted medical device 201 is important for proper electrical communication between the two components.
- the electronics 117 in addition to or as an alternative to the positioning coils of the external wearable device 102, may be configured to detect alignment of the external wearable device 102 relative to the implanted medical device 201.
- the overall size or footprint of the external wearable device 102 may be minimized as alignment electronics therein may be removed.
- the electronics 117 may be further configured to provide audio and/or haptic feedback to the user when proper alignment between the external wearable device 102 and the implanted medical device 201 is reached.
- the position of the electronics 117 within the grip 109 shown in the figures is merely exemplary, and it is envisioned that the electronics 117 may be positioned at any location within the grip 109.
- the actuator spring 108 is disposed around a portion of the cylindrical portion 121 of the actuator 104 to bias the actuator 104 in the first position.
- the spring 208 is a coil or helical component
- the actuator spring 108 extends between the second or underside surface 140B of the dome-shaped portion 140 of the actuator 104 and the grip 109. More particularly, the actuator spring 108 has a first end 108A attached to the grip 109 and a second end 108B attached to the second or underside surface 140B of the dome-shaped portion 140.
- the actuator spring 108 is biased in an extended configuration as to maintain the actuator 104 in the first position, and the actuator spring 108 is configured to be compressed when sufficient force is applied to the domeshaped portion 140 of the actuator 104.
- a force in order to transition the actuator 104 from the first position to the second position, a force must be placed on the actuator 104 as to counteract or overcome the bias of the actuator spring 108.
- the user may press down or place a force on the actuator 104, overcoming the bias of the actuator spring 108, and thereby moving the actuator 104 from the first portion to the second position.
- the actuator spring 108 is configured to return the actuator 104 from the second position to the first position when the applied force is removed. Stated another way, the actuator spring 108 is configured to resume its extended configuration when no force is applied thereto.
- the hub 113 is an annular component that includes a central opening 113A defined by an inner surface 113B.
- the central opening 113A is aligned with the central lumen 109C of the grip 109 as to allow for the linear axial movement of the actuator 104.
- the hub 113 is integrally formed with the grip 109.
- the hub 113 may be separately formed from the grip 109 and subsequently attached or secured thereto.
- a plurality of channels 1 13C are positioned within the hub 1 13 and are configured to slidingly receive the plurality of claws 106. Each channel 113C extends in a radial direction and extents from the inner surface 113B of the hub 113 to an outer circumferential surface thereof.
- a claw of the plurality of claws 106 is housed within each channel 113C as to couple the plurality of claws 106 to the hub 113.
- each channel 113C is C-shaped as to allow for radial movement of the claws 106, while limiting any possible axial or longitudinal movement of the claws relative to the hub 113.
- the plurality of claws 106 are slidingly disposed within the plurality of channels 113C of the hub 113.
- the applicator 100 includes exactly three channels 113C and exactly three claws 106, although it will be apparent to one of ordinary skill in the art that the number of slots and claws may vary.
- each claw 106 includes three integral portions including an elongated portion 106A which extends generally perpendicular to the actuator 104, an axial portion 106B which extends generally parallel to the actuator 104, and a flange 110 which is configured to support the first surface 105 of the external wearable device 102.
- the axial portion 106B of each claw 106 extends between the elongated portion 106A and the flange 110.
- the elongated portion 106A extends radially away from the actuator 104 and is slidingly disposed within a channel 113C of the plurality of channels 113C of the hub 113.
- the flange 110 is generally parallel to the elongated portion 106A of the claw 106.
- the flange 110 includes a first or exterior surface 115 which is configured to contact the target skin location 211 and a second or interior surface 114 that is configured to contact the first surface 105 of the external wearable device 102 when the applicator 100 is in the closed configuration, with the plurality of claws 106 in the retracted state.
- each claw 106 of the plurality of claws 106 may be made of a low friction material such as but not limited to polytetrafluoroethylene (PTFE).
- PTFE polytetrafluoroethylene
- the first or exterior surface 115 of the flange 110 of each claw 106 may further include a plurality of rollers or balls 119 to assist the user in moving the applicator 100 along the patient’s skin to the target skin location 211.
- the second or interior surface 114 of the flange 110 also includes a plurality of rollers or balls 119 to increase slidability of the claws 106 relative to the external wearable device 102 so that the plurality of claws 106 may easily move across the external wearable device 102 as the plurality of claws 106 radially extend and retract.
- the plurality of claws 106 may be made of a low friction material as described above to prevent the plurality of claws 106 from sticking to the adhesive layer 112.
- each spring 118 is herein referred to as a claw spring 118 since it is attached to a claw and is configured to bias the claw 106 in the retracted state.
- Each claw spring 118 may be, for example, a plastic molded spring, a metal leaf spring, or other type of compression spring known to one of ordinary skill in the art.
- Each claw spring 118 has a first end 118A and a second end 118B. The first end 118A of each claw spring 118 is attached to the inner surface 113B of the hub 113 and the second end 118B of each claw spring 118 is attached to the first end 106D of a claw.
- Each claw spring 118 is biased in the curved shape depicted in FIG. 4 and is configured to be compressed when the claw 106 is radially extended. Each claw spring 118 is configured to return to the curved shaped depicted in FIG. 4 due to the bias thereof when no force is applied thereto. As such, after radial extension of the claws 106, the claw springs 118 retract the claws 106 when no user force is applied to the applicator 100.
- the actuator 104 is in a first position, the plurality of claws 106 is in a retracted state, and the applicator 100 is configured to hold or receive the external wearable device 102 within the plurality of claws 106.
- the tapered circumferential surface 123 of the actuator 104 is disposed directly above or adjacent to the first ends 106D of the plurality of claws 106.
- a portion of the tapered circumferential surface 123 may be in contact with the first ends 106D of the plurality of claws, but not to an extent so as to cause the plurality of claws 106 to radially extend.
- the second end 104B of the actuator 104 is spaced apart from the second surface 107 of the external wearable device 102 and is not yet in contact therewith.
- FIG. 7 depicts a cross-section of the external wearable device 102 in the open configuration.
- the actuator 104 in a second position and the plurality of claws 106 is in an extended state.
- the applicator 100 is configured to apply or secure the external wearable device 102 to the target skin location 211.
- the actuator 104 is configured to be depressed or pushed as to linearly move the actuator 104 from the first position to the second position.
- the actuator spring 108 compresses axially when the actuator 104 is depressed or pushed downwards.
- the actuator 104 travels longitudinally or axially relative through the central lumen 109C of the grip 109 and through the central opening 113A of the hub 113 as the actuator 104 transitions between the first position and the second position.
- the tapered circumferential surface 123 of the actuator 104 contacts or presses against the first ends 106D of the plurality of claws 106, overcoming the bias of the claw springs 118 and pushing the plurality of claws 106 radially outward, thereby causing the claws 106 to radially extend.
- the claw springs 118 are compressed or deformed due to the force applied by the actuator 104, and the plurality of claws 106 radially extend as to release the external wearable device 102. Referring specifically to FIG.
- each claw 106 is no longer in contact with the external wearable device 102. More specifically, the flange 110 is radially spaced apart from and no longer in contact with the external wearable device 102 and, therefore, the external wearable device 102 is released from the plurality of claws 106.
- the second end 104B of the actuator 104 comes in contact with and applies an axial force to the second surface 107 of the external wearable device 102, thereby pressing the external wearable (which has been released from the plurality of claws 106 as described above) onto the target skin location 211.
- the actuator 104 applies or exerts axial force onto the external wearable device 102 as to press or push the external wearable device 102 onto the target skin location 211 when the actuator 104 is in the second position.
- the user may remove the applicator 100 from the user’s skin.
- the applicator 100 will revert to its closed configuration. More particularly, when axial force is no longer applied to the actuator 104, the actuator 104 will revert to its first position as the actuator spring 108 resumes its original configuration due to the bias thereof.
- the tapered circumferential surface 123 of the actuator 104 will cease to press against first ends 106D of the plurality of claws 106, allowing for the claw springs 118 to resume their original configuration due to the bias thereof and thereby retract the plurality of claws 106 radially inward.
- the user may place the applicator 100 into the open configuration by depressing the actuator 104 such that the plurality of claws 106 are transitioned into the extended state. Once the plurality of claws 106 are in the extended state, the user may position the external wearable device 102 within the plurality of claws 106 and then release the actuator 104 (i.e., remove the force applied thereto) such that the plurality of claws 106 resume their retracted state with the external wearable device 102 positioned therein.
- FIG. 8 depicts a cross-sectional view of another embodiment of the applicator 800 for applying an external wearable device 802 in accordance with another aspect of this disclosure.
- the applicator 800 is the same as the applicator 100, and the external wearable device 802 is the same as the external wearable device 102, except that the external wearable device 802 includes a plurality of detents 822 configured to mate with a plurality of protrusions 820 on a plurality of the claws 806 of the applicator 800.
- the plurality of protrusions 820 extend radially inward and are configuration to be received with the plurality of detents 822 when the external wearable device 802 is positioned within the plurality of claws 806 and the applicator 800 is in the closed configuration.
- the mating relationship between the detents 822 and protrusions 820 prevent the external wearable device 802 from unintentionally rotating or moving relative to the plurality of claws 806.
- the detents 822 are shown to be on a circumferential surface 803A of a housing 803 of the external wearable device 802.
- the detents 822 may be positioned at other locations on the external wearable device 802 so long as the detents 822 are positioned to align with the protrusions 820 on the plurality of claws 806.
- the protrusions 820 positioned on the plurality of claws 806 are shown to be disposed on the axial portions 806B of each claw 806, however, this is merely exemplary, and it is envisioned that the protrusions 820 may be positioned at other locations on the plurality of claws 806 so long as the protrusions 820 are positioned to align with the detents 822 on the external wearable device 802.
- each claw 806 may include a plurality of protrusions 820 and it is not required that each claw 806 of the plurality of claws 806 include a protrusion.
- the number of mating protrusions and detents may vary from the depicted embodiment.
- the detents 822 may be positioned on the plurality of claws 106 and the protrusions 820 may be positioned on the external wearable device 802.
- FIG. 9 depicts a cross-sectional view of the applicator 800 and the external wearable device 802 when the plurality of claws 806 are in the open configuration. As shown, when the applicator 800 is in the open configuration, the protrusions 820 are no longer disposed or received within the detents 822.
- FIG. 10 depicts a cross-sectional view of another embodiment of an applicator 1000 for applying an external wearable device 1002 in accordance with another aspect of the disclosure.
- the applicator 1000 is the same as the applicator 100, and the external wearable device 1002 is the same as the external wearable device 102, except that an actuator 1004 of the applicator 1000 is configured to be rotated or twisted rather than depressed or pressed down.
- the actuator 1004 includes a series of threads 1038 on an external surface thereof that interact and mate with a series of threads 1039 on an inner surface 1009B of a grip 1009. Since the grip 1009 is stationary during rotation of the actuator 1004, the actuator 1004 moves axially or longitudinally in a first direction, towards the external wearable device 1002, when the actuator 1004 is rotated due to the threaded relationship between the grip 1009 and the actuator 1004. Stated another way, a user rotates the actuator 1004 in order to transition the actuator 1004 between the first position and the second position.
- the actuator 1004 provides a user with more control over the transition or movement of the actuator 1004, and subsequently the transition of the plurality of claws 1006 between the retracted state and the extended state.
- the applicators are used to apply an external wearable device that is configured to electrically communicate with an implanted medical device as to provide the necessary instructions, power, or maintenance thereto.
- an applicator described herein may be desirable to utilize any applicator described herein to apply a docking station to a patient’s skin.
- the docking station may be configured to receive an external wearable device that is configured to electrically communicate with an implanted medical device as to provide the necessary instructions, power, or maintenance thereto.
- the applicator may be configured to apply a first external wearable device, which is a docking station, and the first external wearable device is configured to receive a second external wearable device that is configured to electrically communicate with an implanted medical device as to provide the necessary instructions, power, or maintenance thereto.
- a first external wearable device or docking station 1120 is shown in FIGS. 11A and 1 IB.
- FIG. 11 A depicts a side view of the docking station 1120 after being applied to the target skin location 211
- FIG. 1 IB depicts a bottom view of the docking station 1120.
- the docking station 1120 includes a first surface 1122 configured to contact and adhere to the target skin location 211 and a second surface 1124 that is configured to receive and secure a second external wearable device 1102 to the docking station 1120.
- the first surface 1122 of the docking station 1120 includes an adhesive layer 1112 that is configured to adhere to the target skin location 211 to releasably attach the docking station 1120 to the patient’s skin.
- the second surface 1124 releasably secures the second external wearable device 1102 to the docking station 1120 using hook and loop fasteners 1123 A, such as VELCRO, or other methods known in the art.
- the second external wearable device 1102 includes a housing 1103 having a first surface 1105 and a second surface 1107 opposing the first surface 1105.
- the first surface 1105 of the second external wearable device 1102 is configured to mate with the hook and loop fasteners 1123A of the second surface 1124 of the docking station 1120, for example, using mating hook and loop fasteners 1123B, such as VELCRO, or other methods known in the art.
- the second external wearable device 1102 is removable from the docking station 1120 without the docking station 1120 being removed and/or repositioned. Thus, the second external wearable device 1102 may be easily serviced without removing and reapplying the docking station 1120 from the target skin location 211.
- the second external wearable device 1102 may be reattached to the docking station 1120.
- the docking station 1120 includes a plurality of positioning coils 1125 configured to communicate with the implanted medical device 201 so as to properly align the docking station 1120 with the implanted medical device 201.
- Using a plurality of positioning coils 1125 allows for the docking station 1120 to triangulate the position of the implanted medical device 201 as to provide a more accurate detection of alignment compared to the use of a singular positioning coil.
- the pattern and number of the plurality of positioning coils 1125 shown in FIG. 11B is merely exemplary and it is envisioned that a different configuration or number of positioning coils may be used.
- proper alignment between the second external wearable device 1102 and the implanted medical device 201 is needed to initiate and maintain electrical communication between the devices.
- the external wearable device 1202 includes a base portion 1228 and a functional portion 1226.
- the functional portion 1226 of the external wearable device 1202 is positioned at or aligned with the implanted medical component, and the base portion 1228 is spaced apart from the functional portion 1226 and is configured to attach or adhere to the patient.
- any applicator described herein may be used to apply and secure the base portion 1228 of the external wearable device 1202 to a patient’s skin.
- the base portion 1228 includes an adhesive layer (not shown in FIG. 12) that is configured to adhere to the patient’s skin to releasably attach the base portion 1228 to the patient’s skin.
- the base portion 1228 is not aligned with an implanted medical device. Rather, the base portion 1228 is spaced apart from the implanted medical device 201 and a rod 1230 (which may also be considered a bar or an extension arm) is disposed between the base portion 1228 and the functional portion 1226 as to maintain a fixed distance between the base portion 1228 and the functional portion 1226.
- the functional portion 1226 is aligned with the implanted medical device 201 and is configured to electrically communicate with the implanted medical component. However, the functional portion 1226 is not adhered to the patient’s skin, but rather is maintained in place over the implanted medical device via the rod 1230.
- the positioning of the base portion 1228 on the skin of the patient may be moved or relocated as desired, thereby protecting the user’s skin.
- the base portion 1228 may be removed and relocated by any applicator 100, 800, 1000 described herein.
- the functional portion 1226 may remain aligned with the implanted medical device 201 while the base portion 1228 may be relocated to other positions denoted by the dashed circles around the functional portion 1226.
- the base portion 1228 may be positioned at different locations of a patient’s skin.
- the repeated application and removal of an external wearable device to a singular target skin location may cause the patient’s skin may become irritated. Therefore, by moving the application position of the base portion 1228, the skin of the patient may recover in between applications of the base portion 1228, reducing the risk of irritation, rashes, or other injuries caused by repetitive application.
- FIGS. 13A, 13B, and 13C Other concepts for protecting the patient’s skin are depicted in FIGS. 13A, 13B, and 13C. These embodiments depict various configurations of the adhesive layer that may be utilized on any external wearable device that is configured to be adhered to a patient’s skin. For sake of simplicity, the adhesive layers will be described herein for use with the external wearable device 102 and the applicator 100.
- an adhesive pattern 1332A of an adhesive layer 1312A is circular and is configured to be substantially the same size and shape as the first surface 105 of the external wearable device 102. The adhesive pattern 1332A is thus configured to cover the entirety of the first surface 105.
- the adhesive layerl312A is configured to be detachable from the first surface 105, and therefore be replaceable after each use.
- the adhesive layer 1312A is releasably attached or detachable to the external wearable device 102 using hook and loop fasteners such as VELCRO or other methods known in the art. Detachability and replacement of the adhesive layer 1312A allows the user to apply a new adhesive layer between applications of the external wearable device 102, reducing the risk of irritation, rashes, or other injuries caused by repetitive application.
- FIG. 13B An adhesive pattern 1332B of an adhesive layer 1312B is shown in FIG. 13B. Similar to the adhesive layer 1312A shown in FIG. 13A, the adhesive layer 1312B may be detachable from the external wearable device 102 to allow the user to apply a new adhesive layer between applications of the external wearable device 102, reducing the risk of irritation, rashes, or other injuries caused by repetitive application.
- the adhesive pattern 1332B is similar to the adhesive pattern 1332A, except that the adhesive pattern 1332B includes a plurality of cutouts 1334 that coincide or align with the position of the flanges 110 of the plurality of claws 106. The cutouts 1334 do not have adhesive properties.
- the cutouts 1334 may be openings that expose the first surface 105 of the external wearable device 102, or may be formed via non-adhesive material.
- the cutouts 1334 allow for the plurality of claws 106 to move radially without the movement being restricted by the adhesive pattern 1332B as the plurality of claws 106 transition between the retracted state to the extended state.
- An adhesive pattern 1332C of an adhesive layer 1312C is shown in FIG. 13C. Similar to the adhesive layer 1312A of FIGS. 13A and 13B, the adhesive layer 1312C may be detachable from the external wearable device 102 as to allow the user to apply a new adhesive layer between applications.
- the adhesive pattern 1332C includes a plurality of adhesive areas 1336 to adhere to the target skin location 211 and a plurality of non-adhesive areas 1337 that lack any adhesive properties.
- the configuration of the adhesive areas 1336 relative to the non-adhesive areas 1337 allows for the external wearable device 102 to be rotated by the user at predetermined intervals between applications.
- the area of the skin which is contacted by the adhesive areas 1336 and the non-adhesive areas 1337 is changed, allowing for the previously contacted skin area to recover from any damage done by the adhesive areas 1336, ultimately reducing the risk of irritation, rashes, or other injuries caused by repetitive and prolonged application of the external wearable device 102 to the skin.
- FIG. 14 depicts a method 1450 for applying an external wearable device to a target skin location using any of the applicators 100, 800, 1000 described herein. For sake of simplicity, the method of use will be described herein with the external wearable device 102 and the applicator 100.
- the external wearable device 102 is loaded into the applicator 100.
- the user may place the applicator 100 into the open configuration by depressing the actuator 104 (or by rotating the actuator 1004, in the embodiment of FIG.
- the user may position the external wearable device 102 within the plurality of claws 106 and then release the actuator 104 (i.e., remove the force applied thereto) such that the plurality of claws resume their retracted state with the external wearable device 102 positioned therein.
- the external wearable device 102 is oriented such that the adhesive layer 112 is substantially parallel with and adjacent to the target skin location.
- the applicator 100 is moved across the skin until alignment is detected by positioning coils of the external wearable device 102 and/or by the electronics 117 positioned within the grip 109 of the applicator 100.
- the applicator 100 may be held stationary after initial alignment detection as to confirm that the feedback is unchanged.
- the actuator 104 of the applicator 100 is actuated or moved by the user from the first position to the second position as shown in step 1456 of FIG. 14.
- the user depresses or presses the actuator 104 (or rotates the actuator 1004, in the embodiment of FIG. 10) such that the plurality of claws 106 are transitioned into the extended state and the external wearable device 102 is released from the plurality of claws 106.
- the actuator 104 in the second position also places an axial force on the external wearable device 102, pressing the external wearable device 102 onto the target skin location 211.
- Step 1456 may be accomplished by the user with a single hand.
- the user may hold the grip 109 with two digits (i.e., thumb and middle finger) while a single digit (i.e., index finger) may be used to depress and transition the actuator 104 between the first position and the second position.
- the applicator 100 is removed, leaving the external wearable device 102 adhered to the target skin location. After removal of the applicator 100, the user may optionally manually press down on the external wearable device 102 as to ensure that the adhesive layer 112 is properly and uniformly secured to the skin.
- the applicator 100 may also be utilized to remove, reposition, and/or reapply using the external wearable device 102.
- the adhesive layer 112 of the external wearable device 102 is removed and a second adhesive layer is applied onto the external wearable device 102 as described above with respect to FIG. 13A.
- the external wearable device 102 may then be reapplied to a patient’s skin.
- the external wearable device 102 may circumferentially rotated by the user in between applications to apply the adhesive portions of the adhesive layer to a different portion of the patient’s skin as described above with respect to FIG. 13C.
- additional features or components may be added to the applicator 100 to further assist a single user in applying the external wearable medical device.
- an extension handle or belt may extend from the actuator 104 as to allow for the user to easily access and actuate the actuator 104. This may be particularly useful in users that have limited mobility or flexibility as the strain will be reduced on the user’s arm when positioning the external wearable device on the back. It may be further beneficial for the applicator 100 to be coupled to an automated and/or motorized positioning mechanism that can either be worn temporarily by the user or placed on a chair or other supporting structure while the user rests their back against it. The automation of the positioning may greatly reduce or eliminate difficulties or strain placed on the user’s arm while applying the external wearable device 102.
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Abstract
An applicator for applying an external wearable device to a target skin location, the external wearable device having an adhesive layer coupled thereto. The applicator includes an actuator and a plurality of claws configured to receive the external wearable device when in a retracted state. Actuation of the actuator from a first position to a second position causes the plurality of claws to transition from the retracted state to an extended state. The actuator in the second position also places an axial force onto the external wearable device as to press the adhesive layer of the external wearable device onto the target skin location.
Description
APPLICATOR FOR EXTERNAL WEARABLE DEVICE
FIELD
[0001] The present technology is generally related to the application of external wearable devices.
BACKGROUND
[0002] Neurological stimulators have been developed to treat pain, movement disorders, functional disorders, spasticity, cancer, cardiac disorders, and various other medical conditions Implantable stimulators generally have an implantable pulse generator and one or more leads that deliver electrical pulses to neurological tissue or muscle tissue. Once implanted, the pulse generator applies electrical pulses, which in turn modify the function of the patient's nervous system, such as by altering the patient's responsiveness to sensory stimuli and/or altering the patient's motor-circuit output. In pain treatment, the pulse generator applies electrical pulses to the electrodes, which in turn can generate sensations that mask or otherwise alter the patient's sensation of pain. For example, in many cases, patients report a tingling or paresthesia that is perceived as more pleasant and/or less uncomfortable than the underlying pain sensation.
[0003] In order for the implanted pulse generator to function effectively, it needs to be charged, maintained, and given instructions. In some situations, an external wearable device may be used for charging, maintaining, and/or giving instructions to the implanted pulse generator.
[0004] One drawback of utilizing an external wearable device for charging, maintaining, and/or giving instructions to the implanted pulse generator is that the external wearable device may be awkward and/or cumbersome for the patient to apply. Another drawback of utilizing an external wearable device for charging, maintaining, and/or giving instructions to the implanted pulse generator is that alignment between the implanted pulse generator and the external wearable device may be required for the external wearable device to operate effectively. Embodiments hereof relate to improved techniques and systems for releasably applying an external wearable device to a patient.
SUMMARY
[0005] According to a first embodiment hereof, the present disclosure provides an applicator for applying an external wearable device to a target skin location. The applicator includes an actuator
having a first position and a second position, and a plurality of claws coupled to the actuator. The plurality of claws have a retracted state and an extended state in which the plurality of claws radially extend relative to the retracted state. The plurality of claws are configured to receive the external wearable device when in the retracted state. Transition of the actuator from the first position to the second position causes the plurality of claws to transition from the retracted state to the extended state, and the actuator is configured to exert a force onto the external wearable device as to press the external wearable device onto the target skin location when the actuator is in the second position.
[0006] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the applicator further includes a spring that is configured to bias the actuator in the first position. In an embodiment, the spring is helical and is disposed around the actuator.
[0007] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the applicator further includes a grip disposed around the actuator. In an embodiment, the grip includes a contoured outer surface. In an embodiment, the grip includes electronics disposed therein, the series of electronics being configured to detect alignment of the external wearable device with an implanted medical device. In an embodiment, the electronics are further configured to provide audio or haptic feedback when alignment has been achieved.
[0008] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that each claw of the plurality of claws includes a flange having a first surface configured to contact a first surface of the external wearable device and a second surface configured to contact the target skin location. In an embodiment, the first surface of the flange further includes a plurality of rollers. In an embodiment, the second surface of the flange further includes a plurality of rollers.
[0009] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the actuator includes an outer circumferential surface that is tapered and configured to push the plurality of claws radially outward as the actuator transitions from the retracted state to the extended state.
[0010] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the applicator further includes at least one spring that is configured to bias the plurality of claws in the retracted state.
[0011] Tn an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the actuator is configured to move longitudinally when transitioning from the first position to the second position.
[0012] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the actuator is configured to rotate when transitioning from the first position to the second position.
[0013] According to a second embodiment hereof, the present disclosure provides a system including an external wearable device and an applicator for applying the external wearable device to a target skin location. The external wearable device has a housing and an adhesive layer is coupled to a first surface of the housing. The applicator includes an actuator having a first position and a second position, and a plurality of claws coupled to the actuator. The plurality of claws have a retracted state and an extended state in which the plurality of claws radially extend relative to the retracted state. The plurality of claws are configured to receive the external wearable device when in the closed state. Transition of the actuator from the first position to the second position causes the plurality of claws to transition from the retracted state to the extended state. The actuator is configured to exert a force onto the external wearable device as to press the external wearable device onto the target skin location when the actuator is in the second position.
[0014] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the adhesive layer includes a plurality of cutouts, each cutout being configured to align a flange of a claw of the plurality of claws.
[0015] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the adhesive layer is detachable from the first surface of the housing. [0016] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the adhesive layer includes a plurality of adhesive sections and a plurality of non-adhesive sections.
[0017] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the applicator further includes a spring that is configured to bias the actuator in the first position. In an embodiment, the spring is helical and is disposed around the actuator.
[0018] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the applicator further includes at least one spring that is configured to
bias the plurality of claws in the retracted state. Tn an embodiment, the least one spring is a leaf spring.
[0019] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that each claw of the plurality of claws includes a flange having a first surface configured to contact a first surface of the external wearable device and a second surface configured to contact the target skin location. In an embodiment, the first surface of the flange further includes a plurality of rollers. In an embodiment, the second surface of the flange further includes a plurality of rollers.
[0020] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the actuator includes an outer circumferential surface that is tapered and configured to push the plurality of claws radially outward as the actuator transitions from the retracted state to the extended state.
[0021] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the external wearable device is configured to charge an implanted medical device.
[0022] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the external wearable device is configured to supply instructions to an implanted medical device.
[0023] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the external wearable device is a docking station. In an embodiment, the housing is configured to receive a second external wearable device and the second external wearable device is configured to charge an implanted medical device or configured to supply instructions to an implanted medical device. In an embodiment, the housing includes hook and loop fasteners on a second surface thereof, the second surface opposing the first surface.
[0024] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the housing includes at least one positioning coil that is configured to detect alignment with an implanted medical device.
[0025] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that each claw of the plurality of claws includes a detent and the housing of the external wearable device includes a plurality of protrusions that mate with the detents.
[0026] Tn an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that each claw of the plurality of claws includes a protrusion and the housing of the external wearable device includes a plurality of detents that mate with the protrusions.
[0027] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the actuator is configured to move longitudinally when transitioning from the first position to the second position.
[0028] According to a third embodiment hereof, the present disclosure provides a method for securing an external wearable device onto a target skin location. The external wearable device is loaded into an applicator. The external wearable device has a housing and an adhesive layer coupled to a surface of the housing, and the applicator has an actuator and a plurality of claws configured to secure the external wearable device. The applicator is positioned at the target skin location with the external wearable device secured within the applicator. The actuator of the applicator is actuated, and actuation of the actuator radially extends the plurality of claws to release the external wearable device and also pushes the external wearable device onto the target skin location.
[0029] In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that alignment of the external wearable device with an implanted medical device is detected prior to the step of actuating the actuator.
[0030] In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the external wearable device is configured to charge the implanted medical device.
[0031] In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the external wearable device is configured to supply instructions to the implanted medical device.
[0032] In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the external wearable device is a docking station. A second external wearable device is positioned into the docking station.
[0033] In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the second external wearable device is configured to charge an implanted medical device or configured to supply instructions to an implanted medical device.
[0034] Tn an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that after the actuator of the applicator is actuated, the external wearable device is removed with the applicator after a predetermined time period, the external wearable device is repositioned with the applicator, and the external wearable device is reapplied with the applicator. In an embodiment, repositioning the external wearable device includes circumferential rotation of the external wearable device.
[0035] In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that after the actuator of the applicator is actuated, the external wearable device with the applicator is removed after a predetermined time period, an adhesive layer of the external wearable device is detached, a second adhesive layer is attached onto the external wearable device and the external wearable device is reapplied with the applicator.
BRIEF DESCRIPTION OF DRAWINGS
[0036] The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments thereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the art to make and use the invention. The drawings are not to scale.
[0037] FIG. 1 depicts a perspective view of an applicator for applying an external wearable device to a target skin location in accordance with an aspect of this disclosure, wherein the applicator is in a closed configuration.
[0038] FIG. 2 depicts side view of the applicator of FIG. 1, wherein the applicator is in the closed configuration.
[0039] FIG. 3 depicts a top view of the applicator of FIG. 1, wherein the applicator is in the closed configuration.
[0040] FIG. 4 depicts a sectional view of the applicator of FIG. 1 , the sectional being taken along line A-A of FIG. 2, wherein the applicator is in the closed configuration.
[0041] FIG. 5 depicts a cross-sectional view of the applicator of FIG. 1, the cross-section being taken along line B-B of FIG. 2, wherein the applicator is in the closed configuration.
[0042] FIG. 6 depicts a top view of the applicator of FIG. 1 in an open configuration.
[0043] FIG 7 depicts a cross-sectional view of the applicator of FIG. 1 , wherein the applicator is in the open configuration.
[0044] FIG. 8 depicts a cross-sectional view of an applicator for applying an external wearable device to a target skin location in accordance with another aspect of this disclosure, wherein the applicator is in a closed configuration.
[0045] FIG. 9 depicts a cross-sectional view of the applicator of FIG. 8, wherein the applicator is in an open configuration.
[0046] FIG. 10 depicts a cross-sectional view of an applicator for applying an external wearable device to a target skin location in accordance with another aspect of this disclosure, wherein the applicator is in a closed configuration.
[0047] FIG. 11A depicts a cross-sectional view of a docking system in accordance with an aspect of the disclosure.
[0048] FIG. 1 IB depicts a bottom view of the docking system of FIG. 11A.
[0049] FIG. 12 depicts another embodiment of an external wearable device in accordance with an aspect of the disclosure.
[0050] FIG. 13A depicts a top view of an adhesive layer of an external wearable device in accordance with an aspect of the disclosure.
[0051] FIG. 13B depicts a top view of another embodiment of an adhesive layer of an external wearable device in accordance with an aspect of the disclosure.
[0052] FIG. 13C depicts a top view of another embodiment of an adhesive layer of an external wearable device in accordance with an aspect of the disclosure.
[0053] FIG. 14 depicts a method for using an applicator for applying an external wearable device to a target skin location in accordance with an aspect of the disclosure.
DETAILED DESCRIPTION
[0054] Specific embodiments of the present invention are now described with reference to the figures to the figures. The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of embodiments here is in the context of attaching or applying an external wearable device to a target skin location, the invention may also be used with reference to the application of other devices where it is deemed useful. Furthermore, there is no intention to be bound by any
expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description.
[0055] Embodiments hereof are directed to applicators for applying an external wearable device to a patient’s skin. Some wearable medical devices, particularly those that interact with an implant to power or communicate with the implant, need to be positioned or aligned accurately with respect to the implant as to properly function. Such a wearable medical device may be applied to the patient’s skin with an adhesive layer, or held in place with a belt, holster, or other accessory. Unintentional movement or errors in positioning may take place when the adhesive layer is being applied. For example, a target location for application may be determined prior to exposing the adhesive layer, and, during the process of removing a backing or cover from the adhesive layer, the wearable medical device may be inadvertently moved relative to the intended target location for application. In another example, the adhesive layer may be prematurely exposed, or peeled, prior to finding the intended target location and the adhesive layer may accidently interact with skin areas outside of the intended target location, resulting in a difficult and frustrating experience for the user to apply the device and an increased risk of mispositioning the wearable medical device. Therefore, for wearable external devices that are to be applied in difficult to reach areas, such as a patient’s back, a need exists to assist the user in positioning and applying the wearable external device.
[0056] An applicator 100 according to an embodiment hereof is shown in FIGS. 1-7. FIG. 1 illustrates a perspective view of the applicator 100, while FIG. 2 is a side view of the applicator 100 while being applied to a target skin location 211. FIG. 3 is a top view of the applicator 100. FIG. 4 is a sectional view taken along line A-A of FIG. 2 and FIG. 5 is a cross-sectional view taken along line B-B of FIG. 2. The applicator 100 has a closed configuration which is depicted in FIGS. 1-5, and an open configuration which is shown in the top and cross-sectional views of FIGS. 6 and 7, respectively. The applicator 100 is configured to apply an external wearable device 102 to the target skin location 211.
[0057] The target skin location 211 is shown in FIG. 2 and may coincide with the position of an implanted medical device 201 underneath the skin of a patient. The implanted medical device 201 may be configured to monitor a patient’s condition and/or provide treatment for a number of potential diseases or ailments. In an embodiment, the implanted medical device 201 is an implanted pulse generator. Once implanted, the implanted medical device 201 may need to receive
instructions or commands from the external wearable device 102, may need to be powered or charged by the external wearable device 102, and/or may need to receive updates or other maintenance tasks from the external wearable device 102. The external wearable device 102, when aligned with and in proximity to the implanted medical device 201, is configured to electrically communicate with the implanted medical device 201 as to provide the necessary instructions, power, or maintenance. Therefore, the target skin location 211 is chosen by the user based on the position and alignment required for the external wearable device 102 to initiate and maintain electrical communication with the implanted medical device 201.
[0058] The external wearable device 102 includes a housing 103 having a first surface 105 and a second surface 107 that opposes the first surface 105. The first surface 105 is configured to contact the target skin location 211 and is adhered to the skin using an adhesive layer 112. In some embodiments, the housing 103 of the external wearable device 102 further includes one or more positioning coils (not shown) that are configured to monitor alignment of the external wearable device 102 in relation to the implanted medical device 201 in order to establish and maintain electrical communication as described above. Such positioning coils may be similar to positioning coils described in more detail herein with respect to FIG. 1 IB.
[0059] The applicator 100 includes an actuator 104, a plurality of claws 106, an actuator spring 108, a grip 109, and a hub 113. The applicator 100 has a closed configuration, shown in FIGS. 1- 5, in which the actuator 104 is in a first position and the plurality of claws 106 is in a retracted state. When the applicator 100 is in the closed configuration, the applicator 100 is configured to hold or receive the external wearable device 102 within the plurality of claws 106. The applicator 100 also has an open configuration, shown in FIGS. 6-7, in which the actuator 104 is in a second position and the plurality of claws 106 is in an extended state. When the applicator 100 is in the open configuration, the applicator 100 is configured to apply or secure the external wearable device 102 to the target skin location 211. As will be described in more detail herein, actuation or movement of the actuator 104 from the first position to the second position causes the plurality of claws 106 to transition from the retracted state to the extended state. In the embodiment of FIGS. 1-7, the actuator 104 is configured to be depressed as to move the actuator 104 from the first position to the second position. When the applicator 100 transitions from the closed configuration to the open configuration, the plurality of claws 106 radially extend as to release the external
wearable device 102 and the actuator 104 applies or exerts a force onto the external wearable device 102 as to press or push the external wearable device 102 onto the target skin location 211. [0060] The components of the applicator 100 will now be described in more detail. As best shown in FIG. 5, the actuator 104 has a first end 104A and a second end 104B opposing the first end 104A. The actuator 104 may be considered to include two integral portions including a domeshaped portion 140, which forms the first end 104A of the actuator 104, and a cylindrical portion 121 that extends between the dome-shaped portion 140 and the second end 104B of the actuator 104. A first or top surface 140A of the dome-shaped portion 140 is rounded or curved so as to provide the user with a smooth and atraumatic surface for interaction therewith. A second or underside surface 140B of the dome-shaped portion 140 defines a flange for interacting with the actuator spring 108. As will be described in more detail herein, the second end 104B of the actuator 104 includes a cam or tapered circumferential surface 123 for interacting with the plurality of claws 106. The tapered circumferential surface 123 is configured to push the plurality of claws 106 radially outward as the actuator 104 moves from the first position to the second position.
[0061] The grip 109 is disposed around the cylindrical portion 121 of the actuator 104. The grip 109 is a generally tubular component, with an inner surface 109B defining a central lumen 109C therethrough. The central lumen 109C is sized to receive the actuator 104 therethrough and allows for the actuator 104 to freely move within. The grip 109 is configured to grasped by a user and remains stationary during operation of the applicator 100 (i.e., remains stationary during movement of the actuator 104, as well as during movement of the plurality of claws 106). The grip 109 may further include a concave outer surface 109A as to provide the user with a contoured surface to grasp. The grip 109 is configured to allow the applicator 100 to be used with one hand in that the user may grasp the concave outer surface 109A with one or more digits while another finger presses down the actuator 104.
[0062] As shown in FIG. 5, the grip 109 may include electronics 117 positioned within. As noted above, a patient may have the implanted medical device 201 positioned within their body which may need to receive instructions or commands from the external wearable device 102, may need to be powered or charged by the external wearable device 102, and/or may need to receive updates or other maintenance tasks from the external wearable device 102. Alignment of the external wearable device 102 relative to the implanted medical device 201 is important for proper electrical communication between the two components. The electronics 117, in addition to or as an
alternative to the positioning coils of the external wearable device 102, may be configured to detect alignment of the external wearable device 102 relative to the implanted medical device 201. By incorporating the electronics 117 into the grip 109 of the applicator 100, the overall size or footprint of the external wearable device 102 may be minimized as alignment electronics therein may be removed. The electronics 117 may be further configured to provide audio and/or haptic feedback to the user when proper alignment between the external wearable device 102 and the implanted medical device 201 is reached. The position of the electronics 117 within the grip 109 shown in the figures is merely exemplary, and it is envisioned that the electronics 117 may be positioned at any location within the grip 109.
[0063] The actuator spring 108 is disposed around a portion of the cylindrical portion 121 of the actuator 104 to bias the actuator 104 in the first position. The spring 208 is a coil or helical component The actuator spring 108 extends between the second or underside surface 140B of the dome-shaped portion 140 of the actuator 104 and the grip 109. More particularly, the actuator spring 108 has a first end 108A attached to the grip 109 and a second end 108B attached to the second or underside surface 140B of the dome-shaped portion 140. The actuator spring 108 is biased in an extended configuration as to maintain the actuator 104 in the first position, and the actuator spring 108 is configured to be compressed when sufficient force is applied to the domeshaped portion 140 of the actuator 104. Stated another way, in order to transition the actuator 104 from the first position to the second position, a force must be placed on the actuator 104 as to counteract or overcome the bias of the actuator spring 108. For example, once the applicator 100 is positioned as desired relative to the target skin location 211, the user may press down or place a force on the actuator 104, overcoming the bias of the actuator spring 108, and thereby moving the actuator 104 from the first portion to the second position. In addition to biasing the actuator 104, the actuator spring 108 is configured to return the actuator 104 from the second position to the first position when the applied force is removed. Stated another way, the actuator spring 108 is configured to resume its extended configuration when no force is applied thereto.
[0064] The hub 113 is an annular component that includes a central opening 113A defined by an inner surface 113B. The central opening 113A is aligned with the central lumen 109C of the grip 109 as to allow for the linear axial movement of the actuator 104. In an embodiment, the hub 113 is integrally formed with the grip 109. In another embodiment, the hub 113 may be separately formed from the grip 109 and subsequently attached or secured thereto. A plurality of channels
1 13C are positioned within the hub 1 13 and are configured to slidingly receive the plurality of claws 106. Each channel 113C extends in a radial direction and extents from the inner surface 113B of the hub 113 to an outer circumferential surface thereof. A claw of the plurality of claws 106 is housed within each channel 113C as to couple the plurality of claws 106 to the hub 113. In an embodiment, each channel 113C is C-shaped as to allow for radial movement of the claws 106, while limiting any possible axial or longitudinal movement of the claws relative to the hub 113. [0065] The plurality of claws 106 are slidingly disposed within the plurality of channels 113C of the hub 113. In an embodiment, the applicator 100 includes exactly three channels 113C and exactly three claws 106, although it will be apparent to one of ordinary skill in the art that the number of slots and claws may vary. Collectively, the plurality of claws 106 are configured to receive or hold the external wearable device 102 therein when the plurality of claws 106 is in the retracted state. With reference to FIG. 5, each claw 106 includes three integral portions including an elongated portion 106A which extends generally perpendicular to the actuator 104, an axial portion 106B which extends generally parallel to the actuator 104, and a flange 110 which is configured to support the first surface 105 of the external wearable device 102. The axial portion 106B of each claw 106 extends between the elongated portion 106A and the flange 110. The elongated portion 106A extends radially away from the actuator 104 and is slidingly disposed within a channel 113C of the plurality of channels 113C of the hub 113. The flange 110 is generally parallel to the elongated portion 106A of the claw 106. The flange 110 includes a first or exterior surface 115 which is configured to contact the target skin location 211 and a second or interior surface 114 that is configured to contact the first surface 105 of the external wearable device 102 when the applicator 100 is in the closed configuration, with the plurality of claws 106 in the retracted state.
[0066] To assist the user in moving the applicator 100 along the patient’s skin to the target skin location 211, each claw 106 of the plurality of claws 106 may be made of a low friction material such as but not limited to polytetrafluoroethylene (PTFE). Alternatively, or in addition to the low friction material, the first or exterior surface 115 of the flange 110 of each claw 106 may further include a plurality of rollers or balls 119 to assist the user in moving the applicator 100 along the patient’s skin to the target skin location 211. In some embodiments, the second or interior surface 114 of the flange 110 also includes a plurality of rollers or balls 119 to increase slidability of the claws 106 relative to the external wearable device 102 so that the plurality of claws 106 may easily
move across the external wearable device 102 as the plurality of claws 106 radially extend and retract. Additionally, the plurality of claws 106 may be made of a low friction material as described above to prevent the plurality of claws 106 from sticking to the adhesive layer 112.
[0067] As best shown in FIG. 4, a pair of springs 118 is disposed at a first end 106D of each claw 106. Each spring 118 is herein referred to as a claw spring 118 since it is attached to a claw and is configured to bias the claw 106 in the retracted state. Each claw spring 118 may be, for example, a plastic molded spring, a metal leaf spring, or other type of compression spring known to one of ordinary skill in the art. Each claw spring 118 has a first end 118A and a second end 118B. The first end 118A of each claw spring 118 is attached to the inner surface 113B of the hub 113 and the second end 118B of each claw spring 118 is attached to the first end 106D of a claw. Each claw spring 118 is biased in the curved shape depicted in FIG. 4 and is configured to be compressed when the claw 106 is radially extended. Each claw spring 118 is configured to return to the curved shaped depicted in FIG. 4 due to the bias thereof when no force is applied thereto. As such, after radial extension of the claws 106, the claw springs 118 retract the claws 106 when no user force is applied to the applicator 100.
[0068] With the structure of all components of the applicator 100 described above, the operation of the applicator 100 will now be described in more detail. As stated above, in the closed configuration of the applicator shown in FIGS. 1-5, the actuator 104 is in a first position, the plurality of claws 106 is in a retracted state, and the applicator 100 is configured to hold or receive the external wearable device 102 within the plurality of claws 106. When the actuator 104 is in the first position, the tapered circumferential surface 123 of the actuator 104 is disposed directly above or adjacent to the first ends 106D of the plurality of claws 106. A portion of the tapered circumferential surface 123 may be in contact with the first ends 106D of the plurality of claws, but not to an extent so as to cause the plurality of claws 106 to radially extend. In addition, when the actuator 104 is in the first position, the second end 104B of the actuator 104 is spaced apart from the second surface 107 of the external wearable device 102 and is not yet in contact therewith. [0069] Actuation or movement of the actuator 104 from the first position to the second position causes the applicator 100 to transition from the closed configuration to the open configuration and causes the plurality of claws 106 to transition from the retracted state to the extended configuration. FIG. 6 depicts a top view of the applicator 100 in the open configuration and FIG. 7 depicts a cross-section of the external wearable device 102 in the open configuration. As stated above, in
the open configuration, the actuator 104 is in a second position and the plurality of claws 106 is in an extended state. When the applicator 100 is in the open configuration, the applicator 100 is configured to apply or secure the external wearable device 102 to the target skin location 211. In the embodiment of FIGS. 1-7, the actuator 104 is configured to be depressed or pushed as to linearly move the actuator 104 from the first position to the second position. The actuator spring 108 compresses axially when the actuator 104 is depressed or pushed downwards. The actuator 104 travels longitudinally or axially relative through the central lumen 109C of the grip 109 and through the central opening 113A of the hub 113 as the actuator 104 transitions between the first position and the second position. As the actuator 104 moves downward, the tapered circumferential surface 123 of the actuator 104 contacts or presses against the first ends 106D of the plurality of claws 106, overcoming the bias of the claw springs 118 and pushing the plurality of claws 106 radially outward, thereby causing the claws 106 to radially extend. The claw springs 118 are compressed or deformed due to the force applied by the actuator 104, and the plurality of claws 106 radially extend as to release the external wearable device 102. Referring specifically to FIG. 7, after being radially extended, the flange 110 of each claw 106 is no longer in contact with the external wearable device 102. More specifically, the flange 110 is radially spaced apart from and no longer in contact with the external wearable device 102 and, therefore, the external wearable device 102 is released from the plurality of claws 106.
[0070] Additionally, as the actuator 104 transitions from the first position to the second position, the second end 104B of the actuator 104 comes in contact with and applies an axial force to the second surface 107 of the external wearable device 102, thereby pressing the external wearable (which has been released from the plurality of claws 106 as described above) onto the target skin location 211. Stated another way, the actuator 104 applies or exerts axial force onto the external wearable device 102 as to press or push the external wearable device 102 onto the target skin location 211 when the actuator 104 is in the second position.
[0071] Once the external wearable device 102 has been adhered to the target skin location 211, the user may remove the applicator 100 from the user’s skin. When axial force is no longer applied to the actuator 104, the applicator 100 will revert to its closed configuration. More particularly, when axial force is no longer applied to the actuator 104, the actuator 104 will revert to its first position as the actuator spring 108 resumes its original configuration due to the bias thereof. As the actuator 104 begins to move upward towards the first position, the tapered circumferential
surface 123 of the actuator 104 will cease to press against first ends 106D of the plurality of claws 106, allowing for the claw springs 118 to resume their original configuration due to the bias thereof and thereby retract the plurality of claws 106 radially inward.
[0072] Notably, in order to initially load the external wearable device 102 into the applicator 100, the user may place the applicator 100 into the open configuration by depressing the actuator 104 such that the plurality of claws 106 are transitioned into the extended state. Once the plurality of claws 106 are in the extended state, the user may position the external wearable device 102 within the plurality of claws 106 and then release the actuator 104 (i.e., remove the force applied thereto) such that the plurality of claws 106 resume their retracted state with the external wearable device 102 positioned therein.
[0073] FIG. 8 depicts a cross-sectional view of another embodiment of the applicator 800 for applying an external wearable device 802 in accordance with another aspect of this disclosure. The applicator 800 is the same as the applicator 100, and the external wearable device 802 is the same as the external wearable device 102, except that the external wearable device 802 includes a plurality of detents 822 configured to mate with a plurality of protrusions 820 on a plurality of the claws 806 of the applicator 800. The plurality of protrusions 820 extend radially inward and are configuration to be received with the plurality of detents 822 when the external wearable device 802 is positioned within the plurality of claws 806 and the applicator 800 is in the closed configuration. The mating relationship between the detents 822 and protrusions 820 prevent the external wearable device 802 from unintentionally rotating or moving relative to the plurality of claws 806. In the shown example, the detents 822 are shown to be on a circumferential surface 803A of a housing 803 of the external wearable device 802. However, this is merely exemplary, and it is envisioned that the detents 822 may be positioned at other locations on the external wearable device 802 so long as the detents 822 are positioned to align with the protrusions 820 on the plurality of claws 806. Similarly, the protrusions 820 positioned on the plurality of claws 806 are shown to be disposed on the axial portions 806B of each claw 806, however, this is merely exemplary, and it is envisioned that the protrusions 820 may be positioned at other locations on the plurality of claws 806 so long as the protrusions 820 are positioned to align with the detents 822 on the external wearable device 802. Although FIG. 8 is depicted with a single protrusion 820 on each claw 806, each claw 806 may include a plurality of protrusions 820 and it is not required that each claw 806 of the plurality of claws 806 include a protrusion. Stated another way, the
number of mating protrusions and detents may vary from the depicted embodiment. Further, it is envisioned that the detents 822 may be positioned on the plurality of claws 106 and the protrusions 820 may be positioned on the external wearable device 802. FIG. 9 depicts a cross-sectional view of the applicator 800 and the external wearable device 802 when the plurality of claws 806 are in the open configuration. As shown, when the applicator 800 is in the open configuration, the protrusions 820 are no longer disposed or received within the detents 822.
[0074] In the previous embodiments, the actuator of the applicator is configured to be depressed or pushed as to linearly move the actuator from the first position to the second position. In another embodiment hereof, the actuator of the applicator may be configured to be rotated or twisted in order to linearly move the actuator from the first position to the second position. More particularly, FIG. 10 depicts a cross-sectional view of another embodiment of an applicator 1000 for applying an external wearable device 1002 in accordance with another aspect of the disclosure. The applicator 1000 is the same as the applicator 100, and the external wearable device 1002 is the same as the external wearable device 102, except that an actuator 1004 of the applicator 1000 is configured to be rotated or twisted rather than depressed or pressed down. The actuator 1004 includes a series of threads 1038 on an external surface thereof that interact and mate with a series of threads 1039 on an inner surface 1009B of a grip 1009. Since the grip 1009 is stationary during rotation of the actuator 1004, the actuator 1004 moves axially or longitudinally in a first direction, towards the external wearable device 1002, when the actuator 1004 is rotated due to the threaded relationship between the grip 1009 and the actuator 1004. Stated another way, a user rotates the actuator 1004 in order to transition the actuator 1004 between the first position and the second position. The actuator 1004 provides a user with more control over the transition or movement of the actuator 1004, and subsequently the transition of the plurality of claws 1006 between the retracted state and the extended state.
[0075] In previous embodiments, the applicators are used to apply an external wearable device that is configured to electrically communicate with an implanted medical device as to provide the necessary instructions, power, or maintenance thereto. However, it may be desirable to utilize any applicator described herein to apply a docking station to a patient’s skin. The docking station may be configured to receive an external wearable device that is configured to electrically communicate with an implanted medical device as to provide the necessary instructions, power, or maintenance thereto. Stated another way, the applicator may be configured to apply a first external wearable
device, which is a docking station, and the first external wearable device is configured to receive a second external wearable device that is configured to electrically communicate with an implanted medical device as to provide the necessary instructions, power, or maintenance thereto. An example of such a first external wearable device or docking station 1120 is shown in FIGS. 11A and 1 IB. FIG. 11 A depicts a side view of the docking station 1120 after being applied to the target skin location 211, while FIG. 1 IB depicts a bottom view of the docking station 1120.
[0076] The docking station 1120 includes a first surface 1122 configured to contact and adhere to the target skin location 211 and a second surface 1124 that is configured to receive and secure a second external wearable device 1102 to the docking station 1120. To be more specific, the first surface 1122 of the docking station 1120 includes an adhesive layer 1112 that is configured to adhere to the target skin location 211 to releasably attach the docking station 1120 to the patient’s skin. The second surface 1124 releasably secures the second external wearable device 1102 to the docking station 1120 using hook and loop fasteners 1123 A, such as VELCRO, or other methods known in the art. The second external wearable device 1102 includes a housing 1103 having a first surface 1105 and a second surface 1107 opposing the first surface 1105. The first surface 1105 of the second external wearable device 1102 is configured to mate with the hook and loop fasteners 1123A of the second surface 1124 of the docking station 1120, for example, using mating hook and loop fasteners 1123B, such as VELCRO, or other methods known in the art. The second external wearable device 1102 is removable from the docking station 1120 without the docking station 1120 being removed and/or repositioned. Thus, the second external wearable device 1102 may be easily serviced without removing and reapplying the docking station 1120 from the target skin location 211. Once the second external wearable device 1102 is serviced, the second external wearable device 1102 may be reattached to the docking station 1120. In an embodiment, as shown on FIG. 1 IB, the docking station 1120 includes a plurality of positioning coils 1125 configured to communicate with the implanted medical device 201 so as to properly align the docking station 1120 with the implanted medical device 201. Using a plurality of positioning coils 1125 allows for the docking station 1120 to triangulate the position of the implanted medical device 201 as to provide a more accurate detection of alignment compared to the use of a singular positioning coil. The pattern and number of the plurality of positioning coils 1125 shown in FIG. 11B is merely exemplary and it is envisioned that a different configuration or number of positioning coils may be used. As noted above, proper alignment between the second external wearable device 1102 and
the implanted medical device 201 is needed to initiate and maintain electrical communication between the devices.
[0077] In any embodiment hereof, if the external wearable device that is adhered to the target skin location 211 is required to be adhered to the patient’s skin for a relatively long time (i.e., longer than 24 hours), it may be desired to add certain features to the applicator and/or the external wearable device to protect the patient’s skin from irritation or harm. One concept for protecting the patient’s skin is depicted in FIG. 12. In the embodiment of FIG. 12, the external wearable device 1202 includes a base portion 1228 and a functional portion 1226. The functional portion 1226 of the external wearable device 1202 is positioned at or aligned with the implanted medical component, and the base portion 1228 is spaced apart from the functional portion 1226 and is configured to attach or adhere to the patient.
[0078] More particularly, any applicator described herein may be used to apply and secure the base portion 1228 of the external wearable device 1202 to a patient’s skin. The base portion 1228 includes an adhesive layer (not shown in FIG. 12) that is configured to adhere to the patient’s skin to releasably attach the base portion 1228 to the patient’s skin. However, in this embodiment, the base portion 1228 is not aligned with an implanted medical device. Rather, the base portion 1228 is spaced apart from the implanted medical device 201 and a rod 1230 (which may also be considered a bar or an extension arm) is disposed between the base portion 1228 and the functional portion 1226 as to maintain a fixed distance between the base portion 1228 and the functional portion 1226. The functional portion 1226 is aligned with the implanted medical device 201 and is configured to electrically communicate with the implanted medical component. However, the functional portion 1226 is not adhered to the patient’s skin, but rather is maintained in place over the implanted medical device via the rod 1230.
[0079] Advantageously, the positioning of the base portion 1228 on the skin of the patient may be moved or relocated as desired, thereby protecting the user’s skin. The base portion 1228 may be removed and relocated by any applicator 100, 800, 1000 described herein. For example, and as shown in FIG. 12 and denoted by dashed circles, the functional portion 1226 may remain aligned with the implanted medical device 201 while the base portion 1228 may be relocated to other positions denoted by the dashed circles around the functional portion 1226. By relocating the base portion 1228, the base portion 1228 may be positioned at different locations of a patient’s skin. In some circumstances, the repeated application and removal of an external wearable device to a
singular target skin location may cause the patient’s skin may become irritated. Therefore, by moving the application position of the base portion 1228, the skin of the patient may recover in between applications of the base portion 1228, reducing the risk of irritation, rashes, or other injuries caused by repetitive application.
[0080] Other concepts for protecting the patient’s skin are depicted in FIGS. 13A, 13B, and 13C. These embodiments depict various configurations of the adhesive layer that may be utilized on any external wearable device that is configured to be adhered to a patient’s skin. For sake of simplicity, the adhesive layers will be described herein for use with the external wearable device 102 and the applicator 100. In the embodiment depicted in FIG. 13A, an adhesive pattern 1332A of an adhesive layer 1312A is circular and is configured to be substantially the same size and shape as the first surface 105 of the external wearable device 102. The adhesive pattern 1332A is thus configured to cover the entirety of the first surface 105. In order to protect the patient’s skin, the adhesive layerl312A is configured to be detachable from the first surface 105, and therefore be replaceable after each use. In one embodiment, the adhesive layer 1312A is releasably attached or detachable to the external wearable device 102 using hook and loop fasteners such as VELCRO or other methods known in the art. Detachability and replacement of the adhesive layer 1312A allows the user to apply a new adhesive layer between applications of the external wearable device 102, reducing the risk of irritation, rashes, or other injuries caused by repetitive application.
[0081] An adhesive pattern 1332B of an adhesive layer 1312B is shown in FIG. 13B. Similar to the adhesive layer 1312A shown in FIG. 13A, the adhesive layer 1312B may be detachable from the external wearable device 102 to allow the user to apply a new adhesive layer between applications of the external wearable device 102, reducing the risk of irritation, rashes, or other injuries caused by repetitive application. The adhesive pattern 1332B is similar to the adhesive pattern 1332A, except that the adhesive pattern 1332B includes a plurality of cutouts 1334 that coincide or align with the position of the flanges 110 of the plurality of claws 106. The cutouts 1334 do not have adhesive properties. The cutouts 1334 may be openings that expose the first surface 105 of the external wearable device 102, or may be formed via non-adhesive material. The cutouts 1334 allow for the plurality of claws 106 to move radially without the movement being restricted by the adhesive pattern 1332B as the plurality of claws 106 transition between the retracted state to the extended state.
[0082] An adhesive pattern 1332C of an adhesive layer 1312C is shown in FIG. 13C. Similar to the adhesive layer 1312A of FIGS. 13A and 13B, the adhesive layer 1312C may be detachable from the external wearable device 102 as to allow the user to apply a new adhesive layer between applications. The adhesive pattern 1332C includes a plurality of adhesive areas 1336 to adhere to the target skin location 211 and a plurality of non-adhesive areas 1337 that lack any adhesive properties. The configuration of the adhesive areas 1336 relative to the non-adhesive areas 1337 allows for the external wearable device 102 to be rotated by the user at predetermined intervals between applications. When the external wearable device 102 is rotated between applications, the area of the skin which is contacted by the adhesive areas 1336 and the non-adhesive areas 1337 is changed, allowing for the previously contacted skin area to recover from any damage done by the adhesive areas 1336, ultimately reducing the risk of irritation, rashes, or other injuries caused by repetitive and prolonged application of the external wearable device 102 to the skin. The adhesive pattern 1332C is merely exemplary and is not limiting to the scope of adhesive patterns envisioned. [0083] FIG. 14 depicts a method 1450 for applying an external wearable device to a target skin location using any of the applicators 100, 800, 1000 described herein. For sake of simplicity, the method of use will be described herein with the external wearable device 102 and the applicator 100. In a first step 1452 of FIG. 14, the external wearable device 102 is loaded into the applicator 100. In order to load the external wearable device 102 into the applicator 100, the user may place the applicator 100 into the open configuration by depressing the actuator 104 (or by rotating the actuator 1004, in the embodiment of FIG. 10) such that the plurality of claws 106 are transitioned into the extended state. Once the plurality of claws 106 are in the extended state, the user may position the external wearable device 102 within the plurality of claws 106 and then release the actuator 104 (i.e., remove the force applied thereto) such that the plurality of claws resume their retracted state with the external wearable device 102 positioned therein.
[0084] The applicator 100 in its closed configuration, with the external wearable device 102 held within the plurality of claws 106 in the retracted state, is positioned at the target skin location 211 by the user as shown in step 1454 of FIG. 14. The external wearable device 102 is oriented such that the adhesive layer 112 is substantially parallel with and adjacent to the target skin location. In order to detect alignment between the external wearable device 102 and an implanted medical device 201, the applicator 100 is moved across the skin until alignment is detected by positioning coils of the external wearable device 102 and/or by the electronics 117 positioned within the grip
109 of the applicator 100. In order to ensure a proper reading, the applicator 100 may be held stationary after initial alignment detection as to confirm that the feedback is unchanged.
[0085] Once aligned as desired, the actuator 104 of the applicator 100 is actuated or moved by the user from the first position to the second position as shown in step 1456 of FIG. 14. To actuate the actuator 104, the user depresses or presses the actuator 104 (or rotates the actuator 1004, in the embodiment of FIG. 10) such that the plurality of claws 106 are transitioned into the extended state and the external wearable device 102 is released from the plurality of claws 106. Additionally, as previously described above, the actuator 104 in the second position also places an axial force on the external wearable device 102, pressing the external wearable device 102 onto the target skin location 211. The user presses down the actuator 104 as to open the claws 106 and continues to press down on the actuator 104 until the adhesive layer 112 is securely adhered to the target skin location 211. Step 1456, as described above, may be accomplished by the user with a single hand. For example, the user may hold the grip 109 with two digits (i.e., thumb and middle finger) while a single digit (i.e., index finger) may be used to depress and transition the actuator 104 between the first position and the second position. In step 1458, the applicator 100 is removed, leaving the external wearable device 102 adhered to the target skin location. After removal of the applicator 100, the user may optionally manually press down on the external wearable device 102 as to ensure that the adhesive layer 112 is properly and uniformly secured to the skin.
[0086] Although the method of FIG. 14 describes initial application of the external wearable device 102 to a patient’s skin, the applicator 100 may also be utilized to remove, reposition, and/or reapply using the external wearable device 102. In some embodiments, after removing the external wearable device 102, the adhesive layer 112 of the external wearable device 102 is removed and a second adhesive layer is applied onto the external wearable device 102 as described above with respect to FIG. 13A. The external wearable device 102 may then be reapplied to a patient’s skin. Further, in some embodiments, during repositioning of the external wearable device 102, the external wearable device 102 may circumferentially rotated by the user in between applications to apply the adhesive portions of the adhesive layer to a different portion of the patient’s skin as described above with respect to FIG. 13C.
[0087] In some embodiments, additional features or components may be added to the applicator 100 to further assist a single user in applying the external wearable medical device. For example, an extension handle or belt may extend from the actuator 104 as to allow for the user to easily
access and actuate the actuator 104. This may be particularly useful in users that have limited mobility or flexibility as the strain will be reduced on the user’s arm when positioning the external wearable device on the back. It may be further beneficial for the applicator 100 to be coupled to an automated and/or motorized positioning mechanism that can either be worn temporarily by the user or placed on a chair or other supporting structure while the user rests their back against it. The automation of the positioning may greatly reduce or eliminate difficulties or strain placed on the user’s arm while applying the external wearable device 102.
[0001] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e g , all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.
Claims
1. An applicator for applying an external wearable device to a target skin location, the applicator comprising: an actuator having a first position and a second position; and a plurality of claws coupled to the actuator, the plurality of claws having a retracted state and an extended state in which the plurality of claws radially extend relative to the retracted state, the plurality of claws being configured to receive the external wearable device when in the retracted state, wherein transition of the actuator from the first position to the second position causes the plurality of claws to transition from the retracted state to the extended state, and wherein the actuator is configured to exert a force onto the external wearable device as to press the external wearable device onto the target skin location when the actuator is in the second position.
2. The applicator of claim 1, further comprising a spring that is configured to bias the actuator in the first position.
3. The applicator of claim 2, wherein the spring is helical and is disposed around the actuator.
4. The applicator of claim 1, further comprising a grip disposed around the actuator.
5. The applicator of claim 4, wherein the grip includes a contoured outer surface.
6. The applicator of claim 4, wherein the grip includes electronics disposed therein, the electronics being configured to detect alignment of the external wearable device with an implanted medical device.
7. The applicator of claim 6, wherein the electronics are further configured to provide audio or haptic feedback when alignment has been achieved.
8. The applicator of claim 1, wherein each claw of the plurality of claws includes a flange having a first surface configured to contact a first surface of the external wearable device and a second surface configured to contact the target skin location.
9. The applicator of claim 8, wherein the first surface of the flange further includes a plurality of rollers.
10. The applicator of claim 8, wherein the second surface of the flange further includes a plurality of rollers.
11. The applicator of claim 1, wherein the actuator includes an outer circumferential surface that is tapered and configured to push the plurality of claws radially outward as the actuator transitions from the retracted state to the extended state.
12. The applicator of claim 1, further comprising at least one spring that is configured to bias the plurality of claws in the retracted state.
13. The applicator of claim 1, wherein the actuator is configured to move longitudinally when transitioning from the first position to the second position.
14. The applicator of claim 1, wherein the actuator is configured to rotate when transitioning from the first position to the second position.
15. A system comprising: an external wearable device having a housing, wherein an adhesive layer is coupled to a first surface of the housing; and an applicator for applying the external wearable device to a target skin location, the applicator including an actuator having a first position and a second position, and a plurality of claws coupled to the actuator, the plurality of claws having a retracted state and an extended state in which the plurality of claws radially extend relative to the retracted state, the plurality of claws being configured to receive the external wearable device when in the retracted state, wherein transition of the actuator from the first position to the second position causes the plurality of claws to transition from the retracted state to the extended state, and wherein the actuator is configured to exert a force onto the external wearable device as to press the external wearable device onto the target skin location when the actuator is in the second position.
16. The system of claim 15, wherein the adhesive layer includes a plurality of cutouts, each cutout being configured to align a flange of a claw of the plurality of claws.
17. The system of claim 15, wherein the adhesive layer is detachable from the first surface of the housing.
18. The system of claim 15, wherein the adhesive layer includes a plurality of adhesive sections and a plurality of non-adhesive sections.
19. The system of claim 15, further comprising a spring that is configured to bias the actuator in the first position.
20. The system of claim 19, wherein the spring is helical and is disposed around the actuator.
21. The system of claim 15, further comprising at least one spring that is configured to bias the plurality of claws in the retracted state.
22. The system of claim 21, wherein the at least one spring is a leaf spring.
23. The system of claim 15, wherein each claw of the plurality of claws includes a flange having a first surface configured to contact a first surface of the external wearable device and a second surface configured to contact the target skin location.
24. The system of claim 23, wherein the first surface of the flange further includes a plurality of rollers.
25. The system of claim 23, wherein the second surface of the flange further includes a plurality of rollers.
26. The system of claim 15, wherein the actuator includes an outer circumferential surface that is tapered and configured to push the plurality of claws radially outward as the actuator transitions from the retracted state to the extended state.
27. The system of claim 15, wherein the external wearable device is configured to charge an implanted medical device.
28. The system of claim 15, wherein the external wearable device is configured to supply instructions to an implanted medical device.
29. The system of claim 15, wherein the external wearable device is a docking station.
30. The system of claim 29, wherein the housing is configured to receive a second external wearable device, the second external wearable device being configured to charge an implanted medical device or configured to supply instructions to an implanted medical device.
31. The system of claim 29, wherein the housing includes hook and loop fasteners on a second surface thereof, the second surface opposing the first surface.
32. The system of claim 29, wherein the housing includes at least one positioning coil that is configured to detect alignment with an implanted medical device.
33. The system of claim 15, wherein each claw of the plurality of claws includes a detent and the housing of the external wearable device includes a plurality of protrusions that mate with the detents.
34. The system of claim 15, wherein each claw of the plurality of claws includes a protrusion and the housing of the external wearable device includes a plurality of detents that mate with the protrusions.
35. The system of claim 15, wherein the actuator is configured to move longitudinally when transitioning from the first position to the second position.
36. A method for securing an external wearable device onto a target skin location, the method comprising: loading the external wearable device into an applicator, the external wearable device having a housing and an adhesive layer coupled to a surface of the housing, and the applicator having an actuator and a plurality of claws configured to secure the external wearable device; positioning the applicator at the target skin location with the external wearable device secured within the applicator; and actuating the actuator of the applicator, wherein actuation of the actuator radially extends the plurality of claws to release the external wearable device and also pushes the external wearable device onto the target skin location.
37. The method of claim 36, further comprising detecting alignment of the external wearable device with an implanted medical device prior to the step of actuating the actuator.
38. The method of claim 37, wherein the external wearable device is configured to charge the implanted medical device.
39. The method of claim 37, wherein the external wearable device is configured to supply instructions to the implanted medical device.
40. The method of claim 36, wherein the external wearable device is a docking station, and the method further includes positioning a second external wearable device into the docking station.
41. The method of claim 40, wherein the second external wearable device is configured to charge an implanted medical device or configured to supply instructions to an implanted medical device.
42. The method of claim 36, further comprising, after the step of actuating the actuator of the applicator, removing the external wearable device with the applicator after a predetermined time period, repositioning the external wearable device with the applicator, and reapplying the external wearable device with the applicator.
43. The method of claim 42, wherein the step of repositioning the external wearable device includes circumferential rotation of the external wearable device.
44. The method of claim 36, further comprising, after the step of actuating the actuator of the applicator, removing the external wearable device with the applicator after a predetermined time period, detaching an adhesive layer of the external wearable device, attaching a second adhesive layer onto the external wearable device and reapplying the external wearable device with the applicator.
Applications Claiming Priority (2)
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US202263358303P | 2022-07-05 | 2022-07-05 | |
US63/358,303 | 2022-07-05 |
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WO2024011122A2 true WO2024011122A2 (en) | 2024-01-11 |
WO2024011122A3 WO2024011122A3 (en) | 2024-02-15 |
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PCT/US2023/069633 WO2024011122A2 (en) | 2022-07-05 | 2023-07-05 | Applicator for external wearable device |
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EP2288297A4 (en) * | 2008-05-06 | 2014-08-06 | Merit Medical Systems Inc | Radial artery compression device |
JP5480340B2 (en) * | 2012-07-26 | 2014-04-23 | ファナック株式会社 | Take-out robot system using roller device |
TWM509629U (en) * | 2015-04-28 | 2015-10-01 | Cheng Uei Prec Ind Co Ltd | Detachable type of adhesive wear products |
KR102286062B1 (en) * | 2019-11-12 | 2021-08-04 | 주식회사 휴먼자숨 | Local pressure band device for dry muscle joint with improved pressure fastening structure |
CN112429310B (en) * | 2020-11-19 | 2022-07-01 | 萍乡市兄弟瓷业有限公司 | Domestic ceramic multilayer stack apparatus for producing |
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