Some embodiments described herein relate generally to systems, methods, and apparatus for coupling a wearable patch assembly to a surface of a user. For example, some embodiments described herein relate generally to systems, methods, and apparatus for coupling an elastic wearable sensor that is able to accommodate skin de-formation to a user.
Patch assemblies can be attached to a surface of a user for various purposes. For example, patch assemblies including a sensor device can be used to non-invasively measure electrical potential differences (e.g., biosignals) between locations on the skin of a human or animal to diagnose and/or monitor a condition of the human or animal. Sensor devices can also be disposed on the skin of a human or animal and be configured to communicate with implanted or digested devices (e.g., digital medicines).
Patch assemblies may be challenging to place properly on the skin of a user due to their tendency to change shape (e.g., twist or wrinkle). Additionally, if an underside of the patch assembly is touched (e.g., by a finger) prior to being placed on the skin, adhesive and/or hydrogel on the underside of the patch assembly may be disrupted.
Thus, there is a need for systems, methods, and apparatus for properly applying patch assemblies to the skin.
In some embodiments, a system includes a patch assembly and a frame. The patch assembly includes an adhesive portion. The patch assembly is configured to be coupled to a surface of a user via the adhesive portion. The patch assembly has a first patch configuration and a second patch configuration. The frame defines an opening. The patch assembly is configured to be disposed within the opening. The frame has a first frame configuration in which the frame is coupled to the patch assembly via a group of connectors such that the frame prevents the patch assembly from transitioning between the first patch configuration and the second patch configuration. The frame has a second frame configuration in which the group of connectors are broken and the frame is separated from the patch assembly.
In some embodiments, a system includes a patch assembly and a frame. The patch assembly includes an adhesive portion. The patch assembly is configured to be coupled to a surface of a user via the adhesive portion. The patch assembly has a first patch configuration and a second patch configuration. The frame defines an opening. The patch assembly is configured to be disposed within the opening. The frame has a first frame configuration in which the frame is coupled to the patch assembly via a group of connectors such that the frame prevents the patch assembly from transitioning between the first patch configuration and the second patch configuration. The frame has a second frame configuration in which the group of connectors are broken and the frame is separated from the patch assembly.
In some embodiments, a system includes a patch assembly, a frame assembly, and a protective layer. The patch assembly includes an adhesive portion configured to couple the patch assembly to a surface of a user. The frame assembly defines an opening. The frame assembly includes a top layer, an adhesive layer, and a liner layer. The adhesive layer is disposed between the top layer and the liner layer. The patch assembly is configured to be disposed within the opening and coupled to the frame via a group of connectors extending between the frame and the patch, and the frame is configured to be removed from the patch assembly by breaking each connector from the group of connectors in a sequential manner such that the connectors are broken in series. The protective layer is coupled to the adhesive portion and disposed in contact with a bottom surface of the liner layer.
In some embodiments, a system includes a patch assembly and a frame. The patch assembly includes an adhesive portion configured to couple the patch assembly to a surface of a user. The patch assembly has an outer perimeter. The frame defines an opening. The patch assembly is configured to be disposed within the opening and coupled to the frame via a group of connectors extending between the frame and the outer perimeter of the patch. A larger portion of the outer perimeter of the patch is free from the group of connectors than a total portion of the outer perimeter of the patch coupled to a connector from the group of connectors. The protective layer is coupled to the adhesive portion and in direct contact with a bottom surface of the frame.
In some embodiments, a method includes separating a portion of a protective layer from a bottom surface of a patch assembly such that the protective layer is decoupled from an adhesive portion of the patch assembly. The patch assembly is disposed within an opening defined by a frame, the patch assembly coupled to the frame via a group of connectors extending between the frame and the patch. The patch assembly and the frame can be disposed on a surface of a user such that the adhesive portion couples the patch assembly to the surface. Each of the connectors can be decoupled from the group of connectors such that the patch assembly remains coupled to the surface and the frame is removed from the surface.
The patch assembly 102 can have a first patch configuration and a second patch configuration. For example, the patch assembly 102 or a portion of the patch assembly 102 may have a different shape (e.g., outer profile) and/or a different length in the first patch configuration compared to the second patch configuration. When the frame 140 is in the first frame configuration relative to the patch assembly 102, the frame 140 can maintain the patch assembly 102 in the first patch configuration via the connectors 150. In some embodiments, the patch assembly 102 or a portion of the patch assembly 102 can be elastic and/or flexible. In some embodiments, the patch assembly 102 can be biased toward the first patch configuration. The frame 140 can be substantially inelastic. For example, the frame 140 can be inelastic along its longitudinal axis such that, when in the first frame configuration when the frame 140 is coupled to the patch assembly 102, the frame 140 can prevent the patch assembly 102 from changing shape via the connectors 150. For example, the frame 140 can prevent the patch assembly 102 from transitioning between the first patch configuration and the second patch configuration.
In some embodiments, the shape of the opening 142 of the frame 140 can correspond to the shape of the patch assembly 102 or a portion of the patch assembly 102. For example, the patch assembly 102 can include a connecting member joining a first portion of the patch assembly 102 and a second portion of the patch assembly 102. The connecting member can have a first configuration when the patch assembly 102 is in the first patch configuration and a second configuration when the patch assembly 102 is in the second patch configuration. The connecting member can include a first segment coupled to a second segment via a flexible hinge. The first segment and the second segment can be arranged at a first angle when the connecting member is in the first configuration. The opening 142 of the frame 140 can include a first opening portion configured to receive the first segment and a second opening portion configured to receive the second segment. The first opening portion can be disposed at a second angle relative to the second opening portion and the second angle can be the same as the first angle. In some embodiments, a connecting member of the patch assembly 102 can have a first sinusoidal shape having a first frequency in the first configuration and a second sinusoidal shape having a second frequency in the second configuration. The second frequency can be different from the first frequency. The opening 142 of the frame 140 can include an opening portion having a sinusoidal shape having the first frequency. In some embodiments, the connecting member can be biased toward the first configuration of the connecting member.
Although the system 100 is shown as having two connectors 150 in
In some embodiments, a larger number of connectors 150 can be coupled to a first portion (e.g., a half) of the patch assembly 102 compared to a second portion of the patch assembly 102 (e.g., the other half). For example, fewer connectors 150 can be coupled to a first half of the patch assembly 102 compared to a second half of the patch assembly 102. The first half of the patch assembly 102 can be a side of the patch assembly 102 in which the separation between the patch assembly 102 and the frame 140 is intended to be initiated (e.g., via pulling the frame 140 away from the patch assembly 102 to break the connectors 150). In some embodiments, a portion of each connector 150 can be formed of one or more different materials than a remainder of each connector 150 such that each connector 150 breaks in a particular location (e.g., the particular location of each connector 150 requires reduced shear forces to break compared to a remainder of each connector 150). In some embodiments, each connector 150 or a portion of each connector 150 can be formed of a different material than one or more layers of the frame 140 (e.g., a top layer of the frame) and/or the patch assembly 102 (e.g., a top layer of the patch assembly 102).
In use, the system 100 can be coupled to a surface of a user via the adhesive portion 114 with the frame 140 in the first frame configuration and the patch assembly 102 in the first patch configuration. The user can handle the system 100 to couple the system 100 to the patient via gripping the frame 140, which does not include adhesive on a top or bottom surface. With the patch assembly 102 coupled to the user via the adhesive portion 114, the frame 140 can be separated from the patch assembly 102 via breaking the connectors 150. For example, the frame 140 can be pulled away from the surface of the user and the patch assembly 102 with a force great enough to break the interfaces between each of the connectors 150 and the patch assembly 102. The force used to break each of the connectors 150 can be sufficiently low such that pulling the frame 140 away from the patch assembly 102 breaks the connectors 150 (e.g., at the interface between each of the connectors 150 and the patch assembly 102) but does not disrupt the adhesive interface between the adhesive portion 114 and the surface of the user such that the patch assembly 102 remains coupled to the surface of the user during and after the separation of the frame 140 from the patch assembly 102. The patch assembly 102 can then transition from the first patch configuration to the second patch configuration while remaining coupled to the surface of the patient via the adhesive portion 114.
The frame assembly 240 can have a first frame configuration in which the frame assembly 240 is coupled to the patch assembly 202 via the group of connectors 250 and a second frame configuration in which the group of connectors 250 are broken and the frame assembly 240 is separated from the patch assembly 202. The patch assembly 202 can have a first patch configuration and a second patch configuration. For example, the patch assembly 202 or a portion of the patch assembly 202 may have a different shape (e.g., outer profile) and/or a different length in the first patch configuration compared to the second patch configuration. When the frame assembly 240 is in the first frame configuration relative to the patch assembly 202, the frame assembly 240 can maintain the patch assembly 202 in the first patch configuration via the group of connectors 250. The frame assembly 240 can be substantially inelastic. For example, the frame assembly 240 can be inelastic along its longitudinal axis such that, when in the first frame configuration when the frame assembly 240 is coupled to the patch assembly 202, the frame assembly 240 can prevent the patch assembly 202 from changing shape via the group of connectors 250. For example, the frame assembly 240 can prevent the patch assembly 202 from transitioning between the first patch configuration and the second patch configuration.
As shown in
The protective layer 260 is configured to be coupled to the patch assembly 202 via the adhesive portion 214. The protective layer 260 is shaped and sized to contact and protect the bottommost surface of the frame assembly 240 prior to use of the system 200 (e.g., during storage). The protective layer 260 can be configured to protect at least the adhesive portion 214 and/or any hydrogel portion of the underside of the patch assembly 202. The protective layer 260 can be separated from the frame assembly 240 and the patch assembly 202 via, for example, peeling the protective layer 260 away from the adhesive portion 214. After the protective layer 260 is separated from the frame assembly 240 and the patch assembly 202, the frame assembly 240 and the patch assembly 202 can be coupled to a surface (e.g., a skin) of a user via the adhesive portion 214. In some embodiments, the protective layer 260 is configured to remain coupled to a portion of the frame assembly 240 (e.g., via being bound or glued to an end of the frame assembly 240 forming a hinge portion) after the protective layer 260 is separated from the adhesive portion 214 of the patch assembly 202 such that the patch assembly 202 can be coupled to a surface of the user via the adhesive portion 214 with the protective layer 260 coupled to a portion of the frame assembly 240, as described in further detail herein.
In some embodiments, the frame assembly 240 can optionally include an adhesive layer 246 and a liner layer 248. The adhesive layer 246 can be disposed between the top layer 244 and the liner layer 248. Although not shown, in some embodiments, the adhesive layer 246 and the adhesive portion 214 can be formed as one layer that is separated or separable at an interface between the frame assembly 240 and the patch assembly 202 (e.g., via breaking the group of connectors 250). In some embodiments, each connector from the group of connectors 250 can also include an adhesive portion such that the adhesive layer 246, the adhesive portion of each of the connectors 250, and the adhesive portion 214 can be formed of a monolithic or unitary adhesive layer. The liner layer 248 can be configured to prevent the adhesive layer 246 from being exposed to the protective layer 260 and/or a surface of the user.
In some embodiments, each connector 250 can include a portion of the top layer 244 and/or the housing 206 in addition to another material. For example, in some embodiments, the frame assembly 240 can include one or more additional layers or portions of material between the top layer 244 and the liner layer 248 and/or between the top layer 244 and the adhesive layer 246. A portion of each of the connectors 250 (e.g., a weakest portion) can be formed by the same material as the additional layer or portion of material of the frame assembly 240 (e.g., monolithically or integrally formed as one piece with the additional layer or portion of the frame assembly 240). For example, the top layer 244 and/or the housing 206 can be formed of non-woven cotton and the one or more additional layers or portions of material can be formed of, for example, metal such as copper shaped to break at a particular location (e.g., via including one or more cut outs). In some embodiments, the patch assembly 202 can also include such an additional layer or portion of the same material as the portion of each of the connectors that is formed of a material different from the top layer 244 and/or the housing 206.
In some embodiments, the patch assembly 202 can optionally include an electronics subassembly 204. The electronics subassembly 204 can include any suitable electronic components such as, for example, one or more electrodes, a processor, a memory, and/or an energy storage device. In some embodiments, the housing 206 can be configured such that some or all of the electronic components of the electronics subassembly 204 are disposed between an upper housing portion and a lower housing portion of the housing 206. In some embodiments, the lower housing portion can define at least one opening through which an electrode of the electronics subassembly 204 can contact a surface of a user. In some embodiments, the adhesive portion 214 can define at least one opening through which an electrode of the electronics subassembly 204 can contact a surface of a user.
In use, with the frame in the first frame configuration and the patch in the first patch configuration, the protective layer 260 can be separated from the bottommost surface of the frame assembly 240 (e.g., from the top layer 244 or the optional liner layer 248) and the adhesive portion 214 of the patch assembly 202 (e.g., via being peeled). The frame assembly 240 and the patch assembly 202 can then be coupled to a surface of the user via the adhesive portion 214. The user can handle the system 200 to couple the system to the patient via gripping the frame assembly 240, which does not include adhesive on a top or bottom surface. With the patch assembly 202 coupled to the user via the adhesive portion 214 in the first patch configuration, the frame assembly 240 can be separated from the patch assembly 202 via breaking the group of connectors 250. For example, the frame 240 can be pulled away from the surface of the user with a force great enough to break the interfaces between each of the connectors 250 and the patch assembly 202. The force used to break each connector from the group of connectors 250 can be sufficiently low such that pulling the frame 240 away from the patch assembly 202 breaks the connectors 250 (e.g., at the interface between each of the connectors 250 and the patch assembly 202) but does not disrupt the adhesive interface between the adhesive portion 214 and the surface of the user such that the patch assembly 202 remains coupled to the surface of the user during and after the separation of the frame 240 from the patch assembly 202. The patch assembly 202 can then transition to the second patch configuration.
In some embodiments, any of the patch assemblies described herein can be the same or similar to any of the patch assemblies described in International Patent Application No. PCT/JP2020/002521, filed Jan. 24, 2020, titled “Elastic Wearable Sensor” (hereinafter “the '521 application”) and/or U.S. Provisional Patent Application No. 62/796,435, filed Jan. 24, 2019, titled “Elastic Wearable Sensor,” each of which is incorporated by reference herein in its entirety. For example, any of the patch assemblies described herein can include patch assembly 302 shown in
A frame assembly, such as any of the frame assemblies described herein, can be coupled to the patch assembly 302 via connectors coupled to the first assembly 310, the second assembly 320, and/or the connecting member 330 such that the frame assembly can maintain the patch assembly 302 in a first patch configuration. For example, the frame assembly can maintain an intended distance between the first assembly 310 and the second assembly 320 such that, when the patch assembly 302 is coupled to a user's skin via adhesive, the first assembly 310 and the second assembly 320 are separated by the intended distance. For instance, the first assembly 310 and the second assembly 320 may each include an electrode, and the frame assembly may be configured to maintain an electrode to electrode distance of the patch assembly 302 such that the electrodes can be properly spaced apart when the patch assembly 302 is coupled to a user's skin. Additionally, in some embodiments, an opening defined by the frame assembly can be shaped to correspond to an outer profile of at least a portion of the patch assembly disposed within the opening. For example, the connecting member 330 may have a sinusoidal shape and the opening defined by the frame assembly can have a sinusoidal shape corresponding to an outer profile of at least a portion of the connecting member 330.
In some embodiments, any of the patch assemblies described herein can include patch assembly 402 shown in
The second assembly 420 includes a second upper housing 454, a portion 484 of the composite assembly 480, a second lower housing 494, and a second adhesive portion (not shown). The portion 484 can include any suitable electronic components (e.g., an energy storage device such as a coin cell battery). The second lower housing 494 defines an opening 494A such that an electrode 483 disposed on a bottom side of the portion 484 is accessible through the opening 494A. The second adhesive portion can also define an opening (e.g., similar in size and shape to the opening 494A) such that the electrode 483 disposed on a bottom side of the portion 484 is accessible through the opening 492A. The second assembly 420 also includes a hydrogel portion 474.
In some implementations, the composite assembly 480 includes a tab contact 488. The tab contact 488 can be integrally formed with the composite board of the composite assembly 480 and can be folded to contact the top of the energy storage device of the portion 484 as shown in
The connecting member 430 includes a third upper housing 456, a portion 482 of the composite assembly 480, a third lower housing 496, and a third adhesive portion (not shown). The third lower housing 496 has a skin-facing surface 485 along the full length of the portion 482. The portion 482 can include a composite board including an insulator and at least one conductive trace (e.g., a flexible printed circuit board). The insulator can include, for example, polyimide. The at least one conductive trace can include, for example, copper. In some implementations, the composite board can include a polyimide with double-sided copper conductors. In some implementations, the portion 482 can include multiple layers (e.g., two, three, or more layers), each layer including at least one conductive trace. In some implementations, the portion 482 can include multiple layers including at least one conductive trace, each layer including at least one conductive trace coupled to another layer including at least one conductive trace via an insulative layer. In some implementations, the third adhesive portion can cover the entire skin-facing surface 485 of the third lower housing 496. In some implementations, the patch assembly 402 includes three conductive traces extending from the first assembly 410 to the second assembly 420. For example, a first conductive trace can extend from a positive side of the energy storage device of the portion 484 to the portion 486, a second conductive trace can extend from a negative side of the energy storage device of the portion 484 to the portion 486, and the third conductive trace can extend from the electrode 483 to the portion 486. Similarly as described above with reference to the connecting member 130, in some implementations the connecting member 430 (and/or the portion 482) may have a thickness equal to or less than 100 μm. In some implementations, the height of the connecting member 430 (and/or the portion 482) can be, for example, equal to or less than 36 μm. In some implementations, the spring constant of the connecting member 430 (and/or the portion 482) (in the X-direction) can increase proportionally to a cube of the thickness of the connecting member 430 (and/or the portion 482) and linearly with respect to the height of the connecting member 430 (and/or the portion 482).
As shown in
A frame assembly, such as any of the frame assemblies described herein, can be coupled to the patch assembly 402 via connectors coupled to the first assembly 410, the second assembly 420, and/or the connecting member 430 such that the frame assembly can maintain the patch assembly 402 in a first patch configuration. For example, the frame assembly can maintain an intended distance between the first assembly 410 and the second assembly 420 and a particular shape of the connecting member 430 such that, when the patch assembly 402 is coupled to a user's skin via adhesive, the first assembly 410 and the second assembly 420 are separated by the intended distance and the connecting member 430 conformally couples to the skin of the user. For instance, the first assembly 410 and the second assembly 420 may each include an electrode, and the frame assembly may be configured to maintain an electrode to electrode distance of the patch assembly 402 such that the electrodes can be properly spaced apart when the patch assembly 402 is coupled to a user's skin. Additionally, in some embodiments, an opening defined by the frame assembly can be shaped to correspond to an outer profile of at least a portion of the patch assembly disposed within the opening. For example, the connecting member 430 may have a sinusoidal shape and the opening defined by the frame assembly can have a sinusoidal shape corresponding to an outer profile of at least a portion of the connecting member 430.
The patch assembly 802 can be the same or similar in structure and/or function to any of the systems described herein. For example, the patch assembly 802 includes a first assembly 810, a second assembly 820, and a connecting member 830. As shown in
As shown in
The frame assembly 840 has a first end 841 and a second end 843. In use, the system 800 can be disposed on a surface (e.g., skin) of a user such that the patch assembly 802 is in the first patch configuration and coupled to the surface via an adhesive portion (not shown). A user can grip the frame assembly 840 to apply the system 800 to the surface of the user without touching an adhesive portion of the patch assembly 802. The frame assembly 840 can then be separated from the patch assembly 802 via pulling the first end 841 of the frame assembly 840 in the direction of arrow C (e.g., toward the second end 843 of the frame assembly 840) such that each of the connectors 850A-850H breaks (e.g., due to a shear force) and the frame assembly 840 is separated from the patch assembly 802. A portion of the frame assembly 840 (e.g., an end such as the first end 841) can function as a handle during the separation of the frame assembly 840 from the patch assembly 802. The patch assembly 802 can remain disposed on the surface after the frame assembly 840 is separated from the patch assembly 802. The patch assembly 802, having been separated from the frame assembly 840, can then transition between a first patch configuration and a second patch configuration to accommodate skin deformations of the user and reduce stress at the skin-adhesive interface.
As shown in
As shown in
Although the connectors 850A-850H of the system 800 are shown as being rectangular, the systems described herein can include connectors having any suitable shape. For example,
Each of the connectors 950A-950H can have a triangular shape such that the connectors 950A-950H taper from the frame assembly 940 to the patch assembly 902. Thus, since the portion of each connector 950A-950H adjacent the patch assembly 902 is the most narrow portion of each connector 950A-950H, the connectors 950A-950H are likely and/or configured to separate from the patch assembly 902 when a first end 941 of the frame assembly 940 is pulled in the direction of arrow D (e.g., toward a second end 943 of the frame assembly 940).
In some embodiments, a protective layer can be configured to remain attached to a frame assembly after being separated from a patch assembly. For example,
As shown in
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As shown in
At 1204, the patch assembly and the frame can be disposed on a surface of a user such that the adhesive portion couples the patch assembly to the surface. At 1206, each of the connectors from the set of connectors can be decoupled such that the patch assembly remains coupled to the surface and the frame is removed from the surface. In some embodiments, each of the connectors of the plurality of connectors can be decoupled by pulling a first end of the frame toward a second end of the frame such that each connector from the set of connectors breaks in series.
In some embodiments, a portion of each connector of a system can include a gap between a top layer of the connector and either a patch assembly or a frame assembly of the system to reduce an amount of shear force needed to separate the patch assembly from the frame assembly of the system.
The patch assembly 1302 can be the same or similar in structure and/or function to any of the systems described herein. For example, the patch assembly 1302 includes a first assembly 1310, a second assembly 1320, and a connecting member 1330. As shown in
As shown in
The frame assembly 1340 has a first end 1341 and a second end 1343. In use, the system 1300 can be disposed on a surface (e.g., skin) of a user such that the patch assembly 1302 is in the first patch configuration and coupled to the surface via an adhesive portion (not shown). A user can grip the frame assembly 1340 to apply the system 1300 to the surface of the user without touching an adhesive portion of the patch assembly 1302. The frame assembly 1340 can then be separated from the patch assembly 1302 via pulling the first end 1341 of the frame assembly 1340 in the direction of arrow F (e.g., toward the second end 1343 of the frame assembly 1340) such that each of the connectors 1350A-1350F breaks (e.g., due to a shear force) and the frame assembly 1340 is separated from the patch assembly 1302. A portion of the frame assembly 1340 (e.g., an end such as the first end 1341) can function as a handle during the separation of the frame assembly 1340 from the patch assembly 1302. The patch assembly 1302 can remain disposed on the surface after the frame assembly 1340 is separated from the patch assembly 1302. The patch assembly 1302, having been separated from the frame assembly 1340, can then transition between a first patch configuration and a second patch configuration to accommodate skin deformations of the user and reduce stress at the skin-adhesive interface.
As shown in
As shown in
Additionally, as shown in
For example,
Although the connectors 1350A-1350F of the system 1300 are shown as being triangular and tapered toward the patch assembly 1302, the systems described herein can include connectors having any suitable shape (e.g., tapered toward the frame assembly 1340, rectangular, etc.).
In some embodiments, a system can include a set of connectors that are disposed asymmetrically relative to a midpoint of a patch assembly of the system along a longitudinal axis of the patch assembly. For example,
The patch assembly 1402 is in a first patch configuration and is coupled to the frame assembly 1440 via eight connectors 1450A-1450H. Specifically, the patch assembly 1402 is coupled to the frame assembly 1440 via a first connector 1450A, a second connector 1450B, a third connector 1450C, a fourth connector 1450D, a fifth connector 1450E, a sixth connector 1450F, a seventh connector 1450G, and an eighth connector 1450H. Although the system 1400 is shown as including six connectors, in some embodiments the system can include any suitable number of connectors.
The patch assembly 1402 can be the same or similar in structure and/or function to any of the systems described herein. For example, the patch assembly 1402 includes a first assembly 1410, a second assembly 1420, and a connecting member 1430. As shown in
As shown in
The frame assembly 1440 has a first end 1441 and a second end 1443. In use, prior to disposing the frame assembly 1440 and the patch assembly 1402 on the surface, the protective layer can be pulled away from the frame assembly 1440 and the patch assembly 1402 in the direction of arrow G such that the protective layer does not contact the patch assembly 1402 but remains coupled to the first end 1441 of the frame assembly 1440 at the hinge portion 1449. The system 1400 can be disposed on a surface (e.g., skin) of a user such that the patch assembly 1402 is in the first patch configuration and coupled to the surface via an adhesive portion (not shown). A user can grip the frame assembly 1440 to apply the system 1400 to the surface of the user without touching an adhesive portion of the patch assembly 1402. The frame assembly 1440 can then be separated from the patch assembly 1402 via pulling the first end 1441 of the frame assembly 1440 in the direction of arrow H (e.g., toward the second end 1443 of the frame assembly 1440) such that each of the connectors 1450A-1450H breaks (e.g., due to a shear force) and the frame assembly 1440 is separated from the patch assembly 1402. A portion of the frame assembly 1440 (e.g., an end such as the first end 1441 and/or the hinge portion 1449) can function as a handle during the separation of the frame assembly 1440 from the patch assembly 1402. The patch assembly 1402 can remain disposed on the surface after the frame assembly 1440 is separated from the patch assembly 1402. The patch assembly 1402, having been separated from the frame assembly 1440, can then transition between a first patch configuration and a second patch configuration to accommodate skin deformations of the user and reduce stress at the skin-adhesive interface.
Although the connectors 1450A-1450H of the system 1400 are shown as being triangular and tapered toward the patch assembly 1402, the systems described herein can include connectors having any suitable shape (e.g., tapered toward the frame assembly 1440, rectangular, etc.). Additionally, each of the connectors can be the same or similar in structure and/or function to any of the connectors described herein with respect to their composition and/or location relative to the patch assembly 1402 and/or the frame assembly 1440. In some embodiments, alternatively or additionally to the connectors 1450A-1450H being disposed asymmetrically about the midpoint of the patch assembly 1402, a subset of the connectors 1450A-1450H can be of a different shape, size, and/or material such that the subset is easier to break (e.g., requires less shear force) to separate the patch assembly 1402 from the frame assembly 1440. In some embodiments, the system 1400 does not include a protective layer and the end 1441 can be used as a handle to separate the frame assembly 1440 from the patch assembly 1402.
While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.
In some embodiments, the systems (or any of its components) described herein can include a non-transitory computer-readable medium (also can be referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include transitory propagating signals per se (e.g., a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable). The media and computer code (also can be referred to as code) may be those designed and constructed for the specific purpose or purposes. Examples of non-transitory computer-readable media include, but are not limited to: magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as Application-Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM) devices.
Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of the embodiments where appropriate.
In some embodiments, a system includes a patch assembly and a frame. The patch assembly includes an adhesive portion and is configured to be coupled to a surface of a user via the adhesive portion. The patch assembly has a first patch configuration and a second patch configuration. The frame defines an opening. The patch assembly is configured to be disposed within the opening. The frame has a first frame configuration in which the frame is coupled to the patch assembly via a plurality of connectors such that the frame prevents the patch assembly from transitioning between the first patch configuration and the second patch configuration. The frame has a second frame configuration in which the plurality of connectors are broken and the frame is separated from the patch assembly.
In some embodiments, the adhesive portion is a first adhesive portion. The patch assembly includes a first assembly including the first adhesive portion, a second assembly including a second adhesive portion, and a connecting member coupled to the first assembly and the second assembly. The connecting member is configured to transition between a first configuration and a second configuration. The connecting member is in the first configuration when the patch assembly is in the first patch configuration and in the second configuration when the patch assembly is in the second patch configuration. A distance between the first end and the second end of the connecting member in the first configuration is a first distance. A distance between the first end and the second end of the connecting member in the second configuration is a second distance different from the first distance. The patch assembly is configured to be disposed within the opening and coupled to the frame via the plurality of connectors in the first configuration. The patch assembly is prevented from transitioning to the second configuration by the connection between the plurality of connectors and the frame.
In some embodiments, the connecting member is biased toward the first configuration.
In some embodiments, the patch assembly includes a first assembly including a first electrode and a second assembly including a second electrode.
In some embodiments, each connector from the plurality of connectors extends non-parallel to a longitudinal axis of the patch assembly.
In some embodiments, the frame is inelastic in a direction along a longitudinal axis of the patch assembly.
In some embodiments, each connector from the plurality of connectors is arranged such that each laterally-extending plane disposed perpendicular to a longitudinal axis of the patch assembly includes either a single connector or no connector.
In some embodiments, a system further comprises a protective layer removably coupled to a skin-facing surface of the patch assembly and non-removably coupled to a portion of a skin-facing surface of the frame.
In some embodiments, each connector from the plurality of connectors includes a first end coupled to the frame and a second end coupled to the patch assembly, each connector tapering from the first end to the second end.
In some embodiments, the shape of the opening defined by the frame corresponds to the shape of the patch assembly.
In some embodiments, the connecting member includes a first segment coupled to a second segment via a flexible hinge. The first segment and the second segment is arranged at a first angle when the connecting member is in the first configuration. The opening includes a first opening portion configured to receive the first segment and a second opening portion configured to receive the second segment. The first opening portion is disposed at a second angle relative to the second opening portion. The second angle is the same as the first angle.
In some embodiments, the connecting member has a first sinusoidal shape having a first frequency in the first configuration and a second sinusoidal shape having a second frequency in the second configuration. The second frequency is different from the first frequency. The opening in the frame includes an opening portion having a sinusoidal shape having the first frequency.
In some embodiments, a system includes a patch assembly, a frame assembly, and a protective layer. The patch assembly includes an adhesive portion configured to couple the patch assembly to a surface of a user. The frame assembly defines an opening. The frame assembly includes a top layer, an adhesive layer, and a liner layer. The adhesive layer is disposed between the top layer and the liner layer. The patch assembly is configured to be disposed within the opening and coupled to the frame via a plurality of connectors extending between the frame and the patch. The frame is configured to be removed from the patch assembly by breaking each connector from the plurality of connectors in a sequential manner. The protective layer is coupled to the adhesive portion and disposed in contact with a bottom surface of the liner layer.
In some embodiments, the adhesive portion is a first adhesive portion. The patch assembly includes a first subassembly including the first adhesive portion, a second subassembly including a second adhesive portion, and a connecting member coupled to the first subassembly and the second subassembly.
In some embodiments, the connecting member includes a third adhesive portion, the third adhesive portion coupled to the protective layer.
In some embodiments, the first adhesive portion, the second adhesive portion, and the third adhesive portion are included in a continuous adhesive layer.
In some embodiments, the first adhesive portion, the second adhesive portion, the third adhesive portion, the adhesive layer of the frame, and a portion of each connector of the plurality of connectors are included in a continuous adhesive layer.
In some embodiments, the first subassembly includes a first electrode and the second subassembly includes a second electrode.
In some embodiments, the protective layer has a first end and a second end and the frame assembly has a first end and a second end. The first end of the protective layer is bonded to the first end of the frame.
In some embodiments, a system includes a patch assembly, a frame, and a protective layer. The patch assembly includes an adhesive portion configured to couple the patch assembly to a surface of a user. The patch assembly has an outer perimeter. The frame defines an opening. The patch assembly is configured to be disposed within the opening and coupled to the frame via a plurality of connectors extending between the frame and the outer perimeter of the patch. A larger portion of the outer perimeter of the patch is free from the plurality of connectors than a total portion of the outer perimeter of the patch coupled to a connector from the plurality of connectors. The protective layer is coupled to the adhesive portion and in direct contact with a bottom surface of the frame.
In some embodiments, the adhesive portion is a first adhesive portion. The patch assembly includes a first subassembly including the first adhesive portion, a second subassembly including a second adhesive portion, and a connecting member coupled to the first subassembly and the second subassembly.
In some embodiments, a method includes separating a portion of a protective layer from a bottom surface of a patch assembly such that the protective layer is decoupled from an adhesive portion of the patch assembly. The patch assembly is disposed within an opening defined by a frame. The patch assembly is coupled to the frame via a plurality of connectors extending between the frame and the patch. The patch assembly and the frame are disposed on a surface of a user such that the adhesive portion couples the patch assembly to the surface. Each of the connectors from the plurality of connectors is decoupled such that the patch assembly remains coupled to the surface and the frame is removed from the surface.
In some embodiments, the portion of the protective layer from the bottom surface of the patch assembly is separated such that the protective layer remains coupled to the frame.
In some embodiments, decoupling each of the connectors of the plurality of connectors includes pulling a first end of the frame toward a second end of the frame such that each connector from the plurality of connectors breaks in series.
This application claims priority to and the benefit of U.S. Provisional Application No. 62/815,137, filed Mar. 7, 2019, entitled “Methods And Apparatus For a Frame Surrounding a Wearable Patch,” the entire content of which is hereby expressly incorporated by reference for all purposes.
Filing Document | Filing Date | Country | Kind |
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PCT/JP2020/009803 | 3/6/2020 | WO | 00 |
Number | Date | Country | |
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62815137 | Mar 2019 | US |