Electronic devices

Abstract

SOLUTION: To provide an electronic device for long term adhesion for a mammal which includes a housing having an electronic part, the electronic device comprises a first blade and a second blade integrally formed with the housing, an electrode is positioned on a bottom face of each blade, the electrode is electrically connected to the electric part, an adhesive agent layer is provided for adhesion to a surface of the mammal, the adhesive agent layer covers a part of the bottom face of the blade, the adhesive agent layer does not cover the electrode or the bottom face of the housing, the housing is not adhered to the mammal, however, using the adhesive agent covering the bottom faces of the first and second blades, is held to a proper portion on the mammal.EFFECT: As an effect, it is possible to maintain contact of a device and a function of the device for a long term.SELECTED DRAWING: Figure 1C

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Patent Application No. 61 / 334,081, entitled "Apparatus Mechanism and Components for Long-Term Adhesion," filed May 12, 2010, which is incorporated by reference as if fully set forth herein.

[0002] [Incorporated by reference] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] This application relates to a body worn device to monitor, record, report, and / or treat the person wearing the device. Improvements in device components and functionality are disclosed to maintain device contact and function for extended periods of time, typically greater than 24 hours. [Background technology]

[0004] The ability of a medical device to adhere to the human body for extended periods of time depends on a variety of factors. In addition to the type and quality of the adhesive selected, another factor is the mechanical design of the device. This design addresses, but is not limited to, the device shape, size, weight, flexibility, and rigidity. These design elements are influenced by many additional factors, including, but not limited to, the location on the body to which the device is attached and the duration of attachment, the humidity conditions of the location, the motion conditions of the location, the stretch conditions of the location, the interaction of the location with external factors such as clothing, and the intentional and / or unintentional interactions between the person wearing the device and the device.

[0005] Since many devices are typically used on the body for periods of less than 24 hours, the devices are not designed to withstand longer periods of adhesion. Thus, there is a need to provide device features and components that provide the functionality, shape, size, weight, flexibility, and rigidity of the device while having the ability to improve the likelihood of the device adhering to the human body for periods of 24 hours or more. Summary of the Invention

[0006] In one aspect of the invention, there is an electronic device for long-term adhesion to a mammal. The device has a housing containing an electronic component having a first wing and a second wing formed integrally with the housing. There is an electrode disposed on a bottom surface of each wing with the electrode connected to the electronic component. An adhesive layer is provided for adhesion to a surface of the mammal. The adhesive layer covers over a portion of the bottom surfaces of the wings. The adhesive layer does not cover the electrodes or the bottom surface of the housing.

[0007] The electronic components of any of the devices described herein may include a processor with a memory having computer readable instructions for recording signals from the first and second electrodes while the electronic device is attached to the mammal. The processor may be configured simply to convert the signals from the electrodes to digital signals, filter those signals, and store the signals in memory.

[0008] In another embodiment, the device includes a flap connected to each wing. The flap may extend below the housing. Additionally or alternatively, an adhesive layer covers the bottom surface of the flap.

[0009] In another aspect, the device includes a connecting segment. In one aspect, the connecting segment is configured to connect each of the flaps together. In another aspect, the connecting segment is located at least partially below the housing. Additionally, the connecting segment is not attached to the housing.

[0010] In another, the adhesive layer covers the bottom surface of the flap.

[0011] In yet another aspect, the adhesive for adhesion to a mammalian surface is an adhesive capable of absorbing fluid. In another aspect, the adhesive capable of absorbing fluid is a hydrocolloid adhesive. In another aspect, the adhesive for adhesion to a mammalian surface is a pressure sensitive adhesive. The pressure sensitive adhesive is selected from the group consisting of polyacrylates, polyisobutylenes, and polysiloxanes. In another, the device includes a diffusion barrier between the adhesive layer and each wing. The device may also include an additional adhesive layer and a layer of material between the adhesive layer for adhesion to a mammal and the wing. The layer of material is configured to prevent diffusion of adhesive components from the adhesive layer to the wing. The diffusion barrier may be made of polyester or other suitable synthetic material.

[0012] In one aspect of the device, all or nearly all of the electronics are within the housing. In another aspect, the wing has no electronics. In one aspect, the wing is more flexible than the housing. In another, the wing and housing are made from the same material. In another, the wing and housing are made from different materials. In another, the wing is made from a woven fabric. In yet another aspect, the material used to make the wing includes synthetic fibers. In yet another, the wing and flap are composed of the same material.

[0013] In another, the device includes a hinge between the housing and the wing. The hinge is configured to allow the device to flex between the housing and the wing. In one embodiment, the hinge is between a rigid portion of the device and a flexible portion of the device. In another embodiment, the rigid portion of the device corresponds to a housing portion that includes the electronic components and the flexible portion of the device includes the wing.

[0014] In one embodiment, the bottom surface of the wing and the bottom surface of the flap are in contact. In another embodiment, the bottom surfaces of the wing, the flap, and the connector are in contact. In yet another embodiment, the flap and the connector are in contact.

[0015] In another embodiment, the connector has at least one hole extending therethrough, which may have any of a number of shapes, such as annular, elliptical, circular, triangular, etc.

[0016] In one embodiment, the housing is thicker at the center of the housing than at the edges of the housing.

[0017] In another embodiment of the device, the housing is not attached to the mammal when the electrodes contact the mammal.

[0018] In another embodiment of the device for long-term adhesion to a mammal, the device includes a housing having a first wing extending laterally from the housing and a second wing extending laterally from the housing without overlapping the first wing. There is a first electrode disposed on a bottom surface of the first wing and a second electrode disposed on a bottom surface of the second wing. An electronic memory is disposed within the housing. The electronic memory is configured to receive and store electronic signals from the first and second electrodes while the electronic device is attached to the mammal. Also, there is an adhesive layer on a portion of the bottom surfaces of the first and second wings. The adhesive is not present on the bottom surface of the housing. When the device is attached to the mammal, only the adhesive layer is attached to the mammal.

[0019] In one embodiment, the bottom portions of the first and second wings do not include the first and second electrodes. In one device embodiment, the first and second wings and the housing are formed from the same material. In yet another embodiment, the first and second wings and the housing together form a monolithic structure. In other embodiments, the angle formed by the first and second wings and the housing is between about 90 and 180 degrees. In one variation, the angle is approximately 180 degrees. In another variation, the angle is approximately 135 degrees.

[0020] In yet another embodiment, there is a first hinged portion between the first electrode and the processor and a second hinged portion between the second electrode and the housing.

[0021] In a further embodiment, at least a portion of the body that is not covered is not attached to the mammal when signals from the electrodes are being recorded in the memory.

[0022] In another embodiment, the device includes a first flap connected to a first wing inward of the first electrode and a second flap connected to a second wing inward of the second electrode, each flap may extend below the housing.

[0023] The device may also include a connecting segment configured to connect the flaps together, hi one embodiment, the connecting segment is at least partially located below the housing, but is not attached to the housing.

[0024] In another aspect, there is an electronic device having a patch including a housing containing an electronic component. There is an electrode located on a bottom surface of the patch, the electrode being electrically connected to the electronic component. There is a first adhesive strip extending around the periphery of the patch and a second adhesive strip extending around the periphery of the first adhesive strip. In one aspect, the first adhesive cover overlies the first adhesive strip and the second adhesive cover overlies the second adhesive strip. The first and second adhesive covers may be configured to be separately removed from the first and second adhesive strips. In another aspect, the first adhesive strip extends between the first and second adhesive covers. In another aspect, the adhesive in the first and second adhesive strips is a fluid-absorbent adhesive. In yet another aspect, the fluid-absorbent adhesive is a hydrocolloid adhesive. In another aspect, the adhesive in the first and second adhesive strips is a pressure-sensitive adhesive. In some embodiments, the pressure sensitive adhesive is a polyacrylate, polyisobutylene, or polysiloxane.

[0025] In another embodiment, the second adhesive strip partially overlaps the first adhesive strip.In another embodiment, the second adhesive strip is attached to a shell, where the shell overlaps the first adhesive strip.

[0026] In yet another device for long-term adhesion to a mammal, the device includes a patch having a housing with electronic components contained therein. There is an electrode disposed on a bottom surface of the patch. The electrode is in electrical communication with the electronic components. There is a porous foam pad configured to be positioned between the electronic components and the mammal. In one embodiment, the porous foam pad comprises a biocompatible foam material. In one variation, the porous foam pad is capable of absorbing fluids. In yet another embodiment, the porous foam pad is attached to the housing. In another embodiment, the porous foam pad is configured to be attached to the mammal. In another request, the porous foam pad is capable of absorbing fluids.

[0027] In one embodiment of the method of attaching an electronic device, there is the step of removing a first adhesive cover from a first wing of the electronic device to expose an electrode and an adhesive covering a bottom surface of the first wing. There is the step of placing the exposed electrode in contact with the mammal by adhering the adhesive covered bottom surface of the first wing to the mammal. There is also the step of removing a second adhesive cover from a second wing of the electronic device to expose an adhesive covering a bottom surface of the second wing and another exposed electrode. There is also the step of adhering the adhesive covered bottom surface of the second wing to the mammal to place the other exposed electrode in contact with the mammal. After performing the removing and placing steps, the housing is not attached to the mammal but is held in place on the mammal using the adhesive covered bottom surfaces of the first and second wings.

[0028] In one alternative method of attaching a device, the electronic device includes a first flap connected to a first wing and a second flap connected to a second wing. The first and second flaps each extend below the housing. The step of removing the first adhesive cover from the first wing may also include exposing an adhesive covering a bottom surface of the first flap. The step of removing the second adhesive cover from the second wing may also include exposing an adhesive covering a bottom surface of the second flap.

[0029] In yet another method of attaching the device, after the removal and placement steps are performed, the housing is held in place on the mammal using only the first wing, the second wing, the first flap, and the adhesive covered bottom surface of the second flap.

[0030] In another aspect of the method of affixing an electronic device to a mammal for long term adhesion, the method includes removing a first adhesive cover from a first wing of the electronic device to expose an electrode and an adhesive covering a bottom surface of the first wing. There is also the step of removing a second adhesive cover from a second wing of the electronic device to expose an adhesive covering a bottom surface of the second wing and another exposed electrode. There is also the step of placing the exposed electrode in contact with the mammal by attaching the adhesive covering the bottom surfaces of the first and second wings to the mammal. After the removing and placing steps, the housing is not attached to the mammal but is held in place on the mammal by the adhesive covering the bottom surfaces of the first and second wings.

[0031] Also provided is a method of applying an electronic device to a mammal for long-term adhesion, the electronic device including a patch. The patch includes an electronic component with electrodes disposed on a bottom surface of the patch and electrically connected to the electronic component. There is a first adhesive strip extending around the periphery of the patch and a second adhesive extending around the periphery of the first adhesive strip. One embodiment of the method of applying the device includes removing an adhesive cover from the second adhesive strip of the electronic device. There is a step of applying pressure to the second adhesive strip to adhere the second adhesive strip to the mammal such that the electrodes are in contact with the mammal. And after a period of time, there is a step of removing the adhesive cover from the first adhesive strip of the electronic device. There is then a step of applying pressure to the first adhesive strip to adhere the first adhesive strip to the mammal such that the electrodes remain in contact with the mammal.

[0032] In yet another method of applying an electronic device to a mammal for long-term adhesion, the electronic device includes a patch, an electronic component, and an electrode disposed on a bottom surface of the patch and electrically connected to the electronic component. There is a first adhesive strip extending around the periphery of the patch. The method includes applying pressure to the first adhesive strip to adhere it to the mammal such that the electrode contacts the mammal. After a period of time, a second adhesive strip is placed around the first adhesive strip. Thereafter, there is applying pressure to the second adhesive strip to adhere it to the mammal such that the electrode remains in contact with the mammal.

[0033] Any of the above-mentioned devices may include additional aspects. The device may also include a first wire connecting the first electrode and the processor or electronic memory, and a second wire connecting the second electrode and the processor or electronic memory. The first and second wires extend within the body and the first and second wings. In one aspect, the first and second wires extend within the body and the first and second wings and are completely enclosed within the body and the first and second wings. In one aspect, a conduit is provided within the body and the wings, and the wires pass through the conduit. In another aspect, the conduit extends from the processor or electronic memory to the electrode such that the wires are completely within the conduit. In yet another aspect of the above-mentioned device, each of the first and second wires connecting the electrode to the processor or electronic component includes slack between the electrode and the processor. In one aspect, the slack is located in a portion of each wing that is configured flat or curved. In another aspect, the slack is a portion of the wire within the wing that is wrapped at least partially around the first or second electrode, hi yet another aspect, the slack is provided by a portion of the wire formed into a coil, wave pattern, or sinusoidal pattern along its length from a connection point on the electronic component to a connection point on the electrode.

[0034] In yet another alternative embodiment, the devices described above may be applied to any of a wide variety of conventional physiological data monitoring, recording, and / or transmission devices. Any of the improved adhesive design features and aspects may be applied to conventional devices useful in electronically controlled and / or time-released delivery of medications or blood testing such as glucose monitors or other blood testing devices. Additional alternatives to the described devices may include specific components for a particular application such as electronics, antennas, power or charging connections, data ports or connections for downloading or offloading information from the device, adding or releasing fluids from the device, monitoring or sensing elements such as electrodes, probes, sensors, or other components, components required by the device for a particular function. In yet another alternative embodiment, the electronic components in any of the devices described above are electronic systems configured to perform one or more of the following electronic functions, or any combination thereof, in conjunction with the mammal's electronic signals detected by the electrodes, namely, monitoring, recording, analyzing, or processing the electronic signals from the mammal using one or more algorithms. Additionally, any of the above-described devices may include suitable components such that the device may be used to detect, record, process, or transmit signals or information relating to signals generated by a mammal to which the device is attached, including, but not limited to, signals generated by one or more of an EKG, EEG, and / or EMG. [Brief description of the drawings]

[0035] [Figure 1] FIG. 1 is a plan view of a patch having two wings. [Figure 1A] FIG. 1A is a representative cross-sectional view of the patch embodiment shown in FIG. [Figure 1B] FIG. 1B is a representative cross-sectional view of another embodiment of the patch shown in FIG. [Figure 1C] FIG. 1C is a representative cross-sectional view of another embodiment of the patch shown in FIG. [Figure 1D] FIG. 1D is a representative cross-sectional view of another embodiment of the patch shown in FIG. [Figure 1E] FIG. 1E is a representative cross-sectional view of another embodiment of the patch shown in FIG. [Figure 1F] FIG. 1F is a plan view of a three-winged patch illustrating the electrode-electronics-electrode orientation. [Figure 2A] FIG. 2A is a schematic diagram of the electronic components contained within the patch. [Figure 2B] FIG. 2B is a schematic diagram of a patch having wiring with slack in the form of undulations between the electronic components and the electrodes. [Figure 2C] FIG. 2C is a schematic diagram of a patch with wiring having slack in the form of a coil between the electronics and the electrodes. [Diagram 3] FIG. 3 is a bottom view of the patch with adhesive thereon. [Figure 4A] FIG. 4A shows the patch as it would be worn by a person who has rolled onto their side. [Figure 4B] FIG. 4B shows the patch as it would be worn by a golfer. [Figure 5A] FIG. 5A shows a patch that corresponds to a concave curved surface of the skin. [Figure 5B] FIG. 5B shows a patch that corresponds to a convex curved surface of the skin. [Figure 5C] FIG. 5C shows a patch that corresponds to a convex curved surface of the skin. [Figure 6A] FIG. 6A is a bottom view of a patch having a connection between two flaps. [Figure 6B] FIG. 6B is a cross-sectional view of the patch of FIG. 6A. [Figure 7A] FIG. 7A is a bottom view of a patch having multiple covers forming adhesive strips. [Figure 7B] FIG. 7B is a cross-sectional view of the patch of FIG. 7A. [Figure 8A] FIG. 8A is a bottom view of a patch having multiple covers forming adhesive strips around each electrode. [Figure 8B] FIG. 8B is a cross-sectional view of the patch of FIG. 8A. [Figure 9A]FIG. 9A shows a patch having multiple layers formed thereon. [Figure 9B] FIG. 9B shows a patch having multiple layers formed thereon. [Figure 10A] FIG. 10A shows a patching having multiple layers formed thereon, each layer having multiple patches of adhesive. [Figure 10B] FIG. 10B shows a patch having multiple layers formed thereon, each layer having multiple patches of adhesive. [Figure 11] FIG. 11 shows a patch having an open cell backing. [Figure 12] FIG. 12 shows a patch having an annular open cell support. [Figure 13A] FIG. 13A shows a patch having a protective shell thereon. [Figure 13B] FIG. 13B shows a cross section of the patch of FIG. 13A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention may be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and which take into account the accompanying drawings.

[0037] The following device features and components may be implemented into any device that is attached to the human body for an extended period of time, typically greater than 24 hours. As an example, the following device features and components may be used for long-term adhesion of a cardiac rhythm monitoring patch ("patch") to a person's chest.

[0038] 1 and 1A, the long-term adhesive patch 100 includes a housing 102. The housing 102 can be formed from any flexible and durable material, such as a biocompatible polymer, e.g., silicone. The housing 102 can include electronic components 108 therein. As shown in FIG. 2, the electronic components 108 can include a printed circuit board 220, a battery 225, and a communication port mounted to the printed circuit board 220. The printed circuit board 220 can include analog circuitry 2110, digital circuitry 215, and an activation or event indication button or switch 130. The electronic components 108 can be used, for example, to record continuous physiological signals from a mammal wearing the patch 100. A system for continuously recording data is further described in commonly owned U.S. Application No. 11 / 703,428, filed February 6, 2007, the entire contents of which are incorporated herein by reference.

[0039] As shown in Figures 1 and 1A, the wings 104, 106 can be connected to the housing 102. The wings 104, 106 can be integral with the housing 102 and in some embodiments can be formed of the same material as the housing 102. The wings 102, 104 can be more flexible than the electronics 108, which can be substantially rigid. The electrodes 124, 126 can extend through the bottom surface of each wing 104, 106. The electrodes can be positioned to detect an ECG of a mammal wearing the patch 100 for processing by the electronics 108. For example, the electrodes are present more than 2 cm apart, more than 3 cm apart, for example at least 6 cm apart. The electrodes 124, 126 can be integral with the wings 104, 106 such that they cannot be separated from the wings 104, 106 when the patch is in use.

[0040] For the patch 100 to be fully flexible and able to stretch and adapt to the movements and conditions of the chest beneath the device, the adhesive can be placed over the entire surface of the device that contacts the body, except for areas where sensors, electronics, or other elements such as electrodes that interact with the body for the function of the device may be incorporated. Thus, as shown in FIG. 3, the adhesive layer 164, 166 can cover the bottom of the patch 100 for attachment to the skin. For patches 100 where there may be some areas (e.g., electronics 108) that are not fully flexible and may not be able to stretch, i.e. may shrink, the adhesive may be omitted from the portions of the patch 100 beneath those areas. Thus, for example, the bottom surface 302 of the housing 102, which contains the electronics, can be left free of adhesive. As shown in FIG. 1A, by not coating the bottom surface of the housing 102 with adhesive, the housing 102 can float above the adhesive, as described further below, which allows for increased flexibility of the patch. Additionally, as shown in FIG. 3, the bottom surfaces of the electrodes 124, 126 can be left free of adhesive. For example, an adhesive-free ring 362 can be formed around each electrode 124, 126 to separate the electrodes from the adhesive 164. The adhesive can be, for example, a pressure sensitive adhesive such as polyacrylate, polyisobutylene, or polysiloxane. Alternatively, the adhesive can be a hydrocolloid that advantageously absorbs water.

[0041] The wings 104, 106 and housing 102 may form a smooth, contacting outer surface to the patch 100. When viewed from the top, as shown in FIG. 1A, the housing 102 and wings 104, 106 together may form a substantially elliptical rectangular shape. Additionally, the housing 102 may have a thickness that is greater than the thickness of the wings 104, 106. When viewed from the side, the housing 102 and each of the wings 104, 106 may each form a dome that has a greater height at the center than at the ends of the respective parts, i.e., some or all of the parts may be tapered at the ends and / or sides.

[0042] The electronic components 108 can extend along only a portion of the distance between the electrodes 104 and 106. For example, the electronic components can occupy less than 90%, such as less than 80%, of the distance between the electrodes. By having the electronic components 108 in a relatively limited space between the electrodes 124, 126, flexibility of the patch 100 can be increased.

[0043] The housing 102 may provide a waterproof enclosure 110 for the electronic components 108 of the patch 100. The electronic components 108 may be decoupled from the housing 102 such that the electronic components 108 are free to move within the waterproof enclosure 110. Allowing the relatively rigid electronic components 108 to move freely within the housing 102 advantageously increases the overall flexibility of the patch 100. The wings 104, 106 may have waterproof enclosures 114, 116 therein, respectively, that may contact the waterproof enclosure 110 of the housing 102.

[0044] Wires 120 or other suitable electrical connections can connect the electrodes 124, 126 to the electrical components 108 of the housing. In some embodiments, as shown in Figures 1B-1E, the continuous nature of the housing 110 and the housings 112, 116 allows the wires 120 to extend within the patch 100 from the electrodes 124, 126 to the electronic components 108. In other embodiments, one or more channels, tubes or conduits are provided between the housing 102 and the wings 104, 106 to provide space for the wires 120. The tubes or channels may be straight or curved. In use, the wires 120 located in the housings 110, 112, 116 or within the tubes or channels may move relative to them to maintain flexibility within the housing. In one aspect, flexible channels or tubes are formed within the device housing such that when the housing is stretched, the housing may move or extend without affecting the ability of components such as wires that may connect to more rigid structures.

[0045] As shown in FIG. 1, the wire 120 is a straight line of connection between the electrodes 124, 126 and the electronic component 108. FIG. 1 illustrates an embodiment where the length of the wire 120 connecting the electrodes 124, 126 to the electronic component 108 is approximately the same as the distance between the electrode connection point on the electronic component 108 and the electrodes 124, 126. FIG. 1F also illustrates a straight type connection where the wire 120 length is almost the same as the spacing between the electronic component 108 and the electrodes 124, 126. However, when the patient moves, the patch 100 will bend with the patient's movement. As shown in FIG. 4B and FIG. 5C, bending of the patch may be severe and will occur during long-term monitoring. To address possible displacement or breakage of the wire 120, the length or shape of the wire 120 may be selected to allow bending of the patch to reduce the risk of pulling the wire 120 from the electrodes or electronic component. A number of alternatives are possible to compensate for bending of the patch. Exemplary corroborations include undulations or zigzags 231 shown in FIG. 2B, coils 233 shown in FIG. 2C, or configurations that wrap partially or completely around the electrodes. In some embodiments, the circuit board or other components such as the electrodes may alternatively or additionally include additional lengths to help accommodate stretching or movement. When the patch 100 is attached to a mammal, slack in the wires 120 allows the patch 100 to flex without stressing the wires 120.

[0046] Although the embodiment illustrated in Figures 1A-1D shows only two wings and shows the electrodes and electronics in a straight line (i.e., the alignment of electrode 124, electronics 108, and electrode 126 is at approximately 180 degrees), other configurations are possible. For example, as shown in Figure IF, the wings 104, 106 are aligned at an orientation less than 180 degrees. In the illustrated embodiment, the angle formed by the electrodes and electronics is approximately 135 degrees. Other ranges are possible as long as electrode spacing is provided to allow ECG monitoring. The orientation of the wings 104, 106 on the housing 102 also illustrates the use of an additional adhesive tab 105. The tab 105 is shown as a semicircular extension of the body 102. The bottom surface of the tab 105 can include an adhesive as described herein and is used to provide additional fixation of the patch to the patient. The tab 105 can be formed in any of a number of alternative shapes, such as a rectangle, an oval, a circle, or a strip. Additionally, in some embodiments, the tabs 105 can perform a function similar to wings, for example, and can include electrodes therethrough that connect to the electronic components 108 .

[0047] 1A-1D and 2B-2C, the hinged portions 194, 196 in the patch 100 can extend between each electrode 124, 126 and the electronics 108. The hinged portions 194, 196 can have a thickness less than the thickness of the surrounding portions of the patch 100. For example, if the hinged portions 194, 196 are in the wings 104, 106, their thickness can be less than the adjacent portions of the wings. Similarly, the hinged portions 194, 196 can have a width less than the adjacent portions of the patch 100, for example less than the adjacent portions of the wings 104, 106. Alternatively, the hinged portions can be formed by attachments between the stiff portion, i.e. the electronics 108, and the more flexible portion. The hinged portions allow the patch 100 to flex between the housing 102 and the wings 104, 106 to compensate for any movements made by the patient. As shown in Figures 2B and 2C, slack in the wire 120 can be provided at or near the hinge portions 194, 196 to allow the wire 120 to bend at the hinge portions 194, 196 without straining or breaking.

[0048] 4A and 4B, having an adhesive on the bottom surface of the patch 100, except in the area generally around the electrodes and the area directly beneath the housing 102, allows for the creation of a floating portion 455 above the skin of the mammal to which the patch 100 is attached. This floating portion 455 can accommodate stiffer or less flexible electronic components while allowing the flexible wings 104, 106 to adhere to the skin and provide the necessary flexibility to hold the patch 100 in place. As a result of the selective use of adhesive and non-adhesive regions, the constraints on device flexibility caused by the less flexible floating portion can be alleviated or reduced by bouncing the floating portion with one or more adhesive flexible regions. Thus, the flexible portion can adhere to the body even if the floating portion is free to move above the skin while the underlying portion of the body is stretched and / or contracted, for example, when the person wearing the device turns over in their sleep (as shown in FIG. 4A) or engages in an activity that can result in skin movement (as shown in FIG. 4B).

[0049] 1B-1E, each wing 104, 106 can include a material layer 214, 216 between the adhesive 164, 166 and the wing 104, 106. The material layer 214, 216 can be, for example, a polyester layer. The material layer 214, 216 can be attached to the patch 100 along with a layer of adhesive 204, 206. The adhesive 204, 206 can be the same or different from the adhesive 164, 166. For example, the adhesive 204, 206 can be a silicone adhesive. The material layer 214 can serve as a barrier to prevent the diffusion or migration of adhesive components, such as tackifiers, from the adhesive 164, 166 into the wing 104, 106 or into the housing 102. The material layer 214 can thus advantageously serve to maintain the strength of the adhesive 104, 106 over time.

[0050] 1B-1E, the patch 100 can further include a first flap 154 ​​connected to the first wing 104 and a second flap 156 connected to the second wing 106. The flaps 154, 156 can both extend from an inner portion of the electrodes of the wings 104, 106 to an underlying portion of the housing 102, such as underlying the electronic component 108. The flaps 154, 156 can remain unattached to the housing 102. As a result, a gap 144, 146 can be formed between the flaps 134, 136 and the housing 102. This gap can provide additional "floating" for the housing 102 and the relatively rigid components 108 contained therein.

[0051] In some embodiments, as shown in FIG. 1B, the flaps 154, 156 can be attached to the wings 104, 106 with an adhesive 134, 136. The adhesive 134, 136 can be the same as or different from the adhesive 164, 166. For example, the adhesive 134, 136 could be a silicone adhesive. In other embodiments, as shown in FIGS. 1C-1E, the flaps 154, 156 can be integral with the wings 102, 104. For example, the flaps 154, 156 can be welded and / or formed during the molding process of the wings 104, 105 such that the hinges 184, 186 are formed below the wings 104, 106. Additionally or alternatively, one or more flaps 132, 136 can be separately attached to the wings 104, 106. In some embodiments, the material that makes up the flaps 154, 156 can extend all the way to the side edges of the patch 100, as shown in Figures 1B and 1C. In other embodiments, the flaps can extend on either side of the electrode, i.e., one flap can extend inwardly and the other can extend laterally, as shown in Figure 1D. In some embodiments, the laterally and inwardly extending flaps are part of the same annular flap. In other embodiments, the flaps and the material that makes them extend only from a location on the inside of the electrode just below the housing, as shown in Figure 1E.

[0052] The flaps 154, 156 may be positioned in virtually any relationship to the attached flexible region such that when attached in use, the attachment of one or more flaps effectively dampens anticipated external forces acting on the device, particularly forces that may displace the attached flexible region. Additionally, in embodiments where there are more than two wings, such as shown in FIG. 1F, there can be a flap corresponding to each additional wing.

[0053] The adhesive layer 164, 166 can cover all or a portion of the bottom surface of the respective flap 124, 126. In some embodiments, the adhesive 164, 166 extends continuously from the bottom surface of the wings 104, 106 to the bottom surface of the flaps 154, 156, except in the areas adjacent the electrodes 124, 126. Additionally, the top surfaces of the flaps 154, 156, i.e., the surfaces closest to the housing 102, can be left free of adhesive to ensure that the housing 102 remains floating. In some embodiments, the only portions of the patch 100 that include adhesive for adhesion to the skin can be the flaps 154, 156.

[0054] 5A-5C, the flaps 154, 156 can provide a hinge-like behavior with respect to the patch 100. Thus, as shown in FIG. 5A, when the skin 501 is stretched or bent in a concave manner, the gaps 144, 146 between the flaps 154, 156 and the housing 102 can approach zero so that the patch 100 can sit substantially flat on the skin 501. As shown, the hinges 194, 196 between the housing 102 and the wings 104, 106 can provide additional flexibility to the concave bending by flattening out as the patch 100 is stretched. In contrast, as shown in FIGS. 5B and 5C, when the skin 501 is bent in a more convex manner, the gaps 144, 146 between the flaps 154, 156 and the housing 102 can increase. This allows the flexible wings 104, 106 to remain attached to the skin and allows the rigid housing 102 to float above the skin. As shown, hinges 194, 196 between the housing and wings 104, 106 can provide additional flexibility in convex bending by folding inward as the patch 100 bends.

[0055] When placed substantially horizontally on the skin 501, the patch 100 can have a height that extends 2 cm or less away from the skin, for example a height of 1.5 cm or less from the skin, 4 cm or less when laid flat on the patient, and cm or less from the skin when floating above the skin. The relatively low height of the patch 100 can improve long term adhesion by reducing the likelihood of the patch 100 being snapped off the skin or ripped off.

[0056] Advantageously, the flaps 154, 156 can act as anchors for the adhesive to cushion shear forces. The flaps 154, 156 can be oriented differently with respect to the acute and chronic forces to which the device is subjected due to stretching, contraction, or twisting that occurs across both the flaps as well as the flexible adhesive regions. Furthermore, by pre-aligning the orientation of the floating portions, the adhesive flexible regions, and the flaps, the device may be better able to tolerate (i.e., remain attached to the body and be used) and / or tune the interaction of forces acting on the device to better withstand the acute and chronic forces to which the device is subjected. Tailoring the response of the device to anticipated forces is one factor that improves the likelihood of long-term device adhesion.

[0057] It is recognized that the dimensions, flexibility, attachment technique, and / or orientation between the flap and another part may vary depending on the purpose of the particular flap, since the flap can be used to counteract forces acting on a particular device. Thus, a flap may have the same or different characteristics as another flap or part in the device. In one embodiment, at least one flap is more flexible than other flaps in a particular device. In another embodiment, each flap has similar flexibility. In yet another embodiment, at least one flap is more flexible than the attached or existing device part. In yet another embodiment, at least one flap is less flexible than the attached or existing device part.

[0058] 6A and 6B, in one embodiment, the flaps 154, 156 may be augmented by a connecting segment 607 that is used to connect the flaps together. The connecting segment 607 may extend below the housing 102 but remain unattached to the housing 102. As shown in FIG. 6A, the flaps 154, 156 and the connecting segment 607 together may form a butterfly shape. In one embodiment, the connecting segment 607 and the flaps 154, 156 are formed from a single piece of material. The connecting segment 607 may be made of the same or different material as the flaps 154, 156. In one embodiment, the bottom surface of the connecting segment is covered with an adhesive. In another embodiment, the bottom surface of the connecting segment does not include any adhesive. Additionally, as shown in FIG. 6B, the connecting segment 607 may be thicker in the middle under the housing 102 than near the edges, i.e., closer to the electrodes. The variable thickness can help prevent the connecting portion 607 from catching moisture underneath it. The connecting segment 607 can advantageously prevent the device from tipping over when attached to a patient.

[0059] The linking segment 607 can include one or more holes 614, 616. In some configurations, the linking segment may trap moisture and / or inadvertently stick to the body. The holes 614, 616 can advantageously minimize the possibility of unwanted adhesion or moisture collection. The size, shape, and placement of the holes mitigates or reduces moisture collection and / or unwanted adhesion while still providing sufficient structural integrity to the linking segment (i.e., the linking segment allows the flaps to be connected to each other to prevent the flaps from folding over). Additionally or alternatively, the holes in the linking segment may also allow for preferential distribution of forces along certain axes of the linking segment to maximize the ability of the device to adhere long term despite significant acute and chronic forces due to stretching, contraction, and twisting.

[0060] The adhesive can be selectively applied to the connecting segments and / or flaps to provide a desired attachment location to the body depending on the particular use of the device. For example, a piece of material comprising flaps and connecting segments can be attached with adhesive along two or more edges and / or covering only certain areas. In another embodiment, at least a portion of the skin contacting surface of a single flap connecting structure does not include any adhesive. Additionally or alternatively, the connecting segments incorporating the flaps may be an integral part of a larger device housing (e.g., may be molded as part of the device housing or housing).

[0061] In some embodiments, the patch 100 may include one or more release liners to cover the adhesive portion prior to application. Particularly for devices having multiple adhesive areas and / or multiple adhesive components (i.e., flaps and flexible portions), the method of application of the device may be specifically detailed to ensure that the device and adhesive portions properly engage. In one particular embodiment, the release liners are removed in a particular order to minimize the possibility of the device adhesive being misused. For example, a portion of the adhesive may be exposed first and used to apply the device to the body. Thereafter, a second set of adhesive liners may be removed to expose one or more flaps for application to the body. A stepwise adhesive exposure method may be implemented during device application so that elements such as one or more flaps do not fold over on themselves, for example.

[0062] Dividing the area where the adhesive is used to adhere the device, in any of the other techniques mentioned above, whether dividing it into solid areas to create flaps or connecting segments with holes, may also have advantages in preventing moisture bridging that can act as a conductive path between electrical sensing elements such as electrodes, which may short out electrical connections and / or prevent the device from functioning properly, especially if the device has electrical functionality such as sensing via electrodes.

[0063] In some applications, long-term patches may suffer from excessive forces due to acute (quick and / or rapid) or chronic (slow and / or prolonged) contraction, stretching, or twisting. In such applications, the hinge between the floating rigid portion and the flexible attached portion may be altered to align with and counteract or mitigate the predominant direction of forces acting on the patch. In some device conditions or configurations, the magnitude and direction of acute or chronic forces may be so strong that the forces imparted to the adhesive surfaces or components of the device may be distributed differently in addition to or as an alternative to the hinges described above.

[0064] Additionally, the device structure can be made in such a way that the housing is shaped so that the axis of the housing is perhaps assembled and positioned along or against the direction of various forces during certain states such as sleep, so that the device itself can help counteract those forces and improve long term adhesion.

[0065] Advantageously, the patches described herein can provide long-term adhesion to the skin. Having various flexible and / or hinged sections can compensate for stresses that occur when the skin is stretched or bent, while allowing the stiff sections to float above the skin. As a result, the devices described herein can be substantially continuously attached to the skin for more than 24 hours, more than 3 days, such as more than 7 days, more than 14 days, or more than 21 days.

[0066] Another mechanism for adhering the patch to the skin for an extended period of time is described with respect to Figures 7 to 10. As shown in the embodiments of Figures 7 to 10, one or more portions of the patch may be used in a temporary manner to improve adhesion. Adhesives used in the embodiments described below may include hydrocolloids or pressure sensitive adhesives, such as polyacrylates, polyisobutylenes, or polysiloxanes.

[0067] In one embodiment, as shown in Figures 7A and 7B, the patch 700 can be surrounded by an adhesive 760 having multiple covers 701, 703, 705 thereon that can be peeled off in sequence to expose strips of adhesive 760 underneath. The covers 701, 703, 705 can be configured to be concentric with one another and peeled off separately in sequence starting from the inside of the patch 700. Each additional exposed area of ​​adhesive 760 can increase the adhesive life of the patch 700. Although only three covers are shown in Figure 7A, other numbers such as two, four, five, or more are possible. Additionally, the electrodes 124, 126 of the patch 700 can include barriers 714, 716, respectively, to protect the electrodes 124, 126 from shortage.

[0068] In another embodiment shown in Figures 8A and 8B, each electrode 124, 126 can be surrounded by a patch of adhesive 864, 866. Thus, a set of covers 801, 803, 805, 807 can be positioned in succession around each electrode 124, 126 on the adhesive 864, 866. The covers 801, 803, 805, 807 can be configured to be concentric with each other and to be peeled off successively starting from the inside. Each additional exposed strip of adhesive 864, 866 can increase the adhesive life of the patch 100. Although only four covers are shown in Figure 8A, other numbers such as 2, 3, 5, or more are possible. Additionally, each electrode 124, 126 of the patch 800 can include a barrier 814, 816 to protect the electrode 124, 126 from shortage.

[0069] In another embodiment, referring to Figures 9A and 9B, the shell or layers 901, 902, 903 can extend over all or part of the patch 900. Each layer 901, 902, 903 can include an adhesive strip 962 on the bottom surface and an adhesive guard 982 that protects the adhesive. As shown in Figure 9B, when the patch 900 is worn for a period of time, the layers 901, 902, 903 can be removed in succession. The adhesive guard 982 of that layer can be peeled away so that a new layer is exposed and the adhesive 962 of the new layer is available to adhere the patch 900 to the skin. In a similar embodiment, referring to Figures 10A-10B, each of the layers 1001, 1002, 1003 can include multiple portions of adhesive to aid in the adhesion of the layer to both the skin and the patch itself. As in the embodiment of Figures 7-8, the number of layers in the embodiment of Figures 9 and 10 can be varied. For example, there can be 2, 3, 4, 5 or even more layers.

[0070] In some embodiments, layers or covers of the embodiments described herein can be applied to the device over time to improve adhesion. Additionally, multiple layers or covers of the embodiments described herein can overlap. Additionally, in some embodiments, adhesive strips can overlap.

[0071] Advantageously, the use of multiple covers or layers can aid the performance of the adhesive of the base or core device because the added surface area or adhesive strength of the combined outer layers may help prevent the layers from pulling apart and / or act to distribute forces acting on them away from the core device by distributing those forces over a wider area.

[0072] 11 and 12, the support 1330 or open cells made of porous foam can be used to support the stiffer or less flexible portion 1302 of the patch 1300. As shown in FIG. 11, the open cells made of the support 1330 can completely fill the area below the stiff portion 1302. Also, as shown in FIG. 12, the open cells made of the support 1330 can be annular in shape or have other shapes that include spaces between adjacent portions of the support. The open cells made of the support 1302 can be attached to both the skin and the stiff portion, only to the stiff portion, or only to the skin. Due to the open cell structure of the support, the flexible movements of the skin can be fully or partially absorbed by the structure such that the stiff portion has no effect or has a low effect on the ability of the device to accommodate the movements and remain attached. Additionally, the open cell support may have a thickness selected to improve the comfort of the patient so that the stiffer portion of the device does not press against the skin. In one embodiment, the open cell structure is a biocompatible foam. In another embodiment, the open cell material is positioned between the electronic module of the device and the skin when worn by a patient. The open cell support can advantageously absorb fluids to prevent the electrodes from shorting out.

[0073] Referring to Fig. 13, the patch can have a shell structure. The adhesive can be provided on the peripheral edge of the bottom ring. The circuit board and electrode unit can be disposed within the bottom ring. And the shell can be disposed on the circuit board and the electrodes. The peripheral adhesive can create a waterproof chamber therein.

[0074] The shape of a particular electronic device embodiment may vary. The shape, footprint, perimeter or boundary of the device may be circular or circular (see FIG. 13A), elliptical (see FIGS. 1A, 2A), triangular or generally triangular (see FIG. 1F), or a compound curve. Example device embodiments having a compound curve shape are shown in FIGS. 2B, 2C, 3, 6A, 7A, and 8A. In some embodiments, the compound curve includes one or more concave curved surfaces and one or more convex curved surfaces. FIG. 3 illustrates a device having a convex curved surface along the top edge (here designated by reference numeral 102), a concave curved surface along the bottom edge, and convex edges around the electrodes 124, 126. FIGS. 2B and 2C illustrate an embodiment of the device having convex shapes on one side of the electronic component 108 and around the electrodes 124, 126. The convex shapes are separated by concave shapes. The concave shapes are between the convex portions on the electronic component and the convex portions on the electrodes. In some embodiments, the recess at least partially corresponds to a hinge, hinge region, or area of ​​reduced thickness between the body and the wing.

[0075] Although described with respect to a cardiac monitor, the device adhesive improvements described herein are not so limited. The improvements described in this application may be applied to any of a wide variety of conventional physiological data monitoring, recording, and / or transmission devices. The improved adhesive design features may also be applied to conventional devices useful for electronically controlled and / or timed drug delivery, or blood testing, such as glucose monitors or other blood testing devices. Thus, the descriptions, features, and functions of the components described herein may be modified as required to include specific components of a particular application, such as electronic components, antennas, power or charging connections, data ports or connections for downloading or offloading information from the device, additional or offloading fluids from the device, monitor or sensing elements or other components such as electrodes, probes, or sensors, or components required for a particular function of the device. Additionally or alternatively, the devices described herein may be used to detect, record, or transmit signals or information related to signals generated by the body, including, but not limited to, one or more of EKG, EEG, and / or EMG.

Claims

1. An electronic device for long-term attachment to a user, comprising: a housing including physiological data collection circuitry, the housing being positioned on a flexible layer extending beyond the housing, the flexible layer including electrodes positioned at a bottom of the flexible layer distal to the housing, the flexible layer having a top layer positioned above electrical connections extending from the physiological data collection circuitry to the electrodes, the top layer attached to a bottom layer positioned below the electrical connections; a bottom adhesive layer overlying the flexible layer and configured to adhere the electrode to a user; An electronic device comprising:

2. The electronic device of claim 1, further comprising a flap extending beneath the housing.

3. The electronic device of claim 1, wherein the housing is rigid.

4. The electronic device of claim 1, wherein the housing is configured to remain connected to the flexible layer when the housing is tilted at an angle relative to the lower adhesive layer in response to user movement.

5. The electronic device of claim 1, further comprising a hinge portion adjacent to the housing.

6. The electronic device of claim 1, wherein the lower adhesive layer is made of a hydrophilic colloid adhesive.

7. The electronic device of claim 1, further comprising a synthetic material layer positioned on the lower adhesive layer.

8. The electronic device of claim 1, wherein the physiological data collection circuitry is configured to collect cardiac rhythm data from a user.

9. The electronic device of claim 1, wherein the upper layer extends horizontally away from the housing beyond the boundary of the electrode.

10. The electronic device of claim 1, further comprising an upper adhesive layer positioned on the upper layer.

11. The electronic device of claim 10, wherein the upper adhesive layer is located above the electrode.

12. The electronic device of claim 11, wherein the upper adhesive layer extends horizontally away from the housing beyond the boundary of the upper layer.

13. The electronic device of claim 1, wherein the upper layer is made of a polymer.

14. The electronic device of claim 1, wherein the lower adhesive layer extends at least partially beneath the housing.

15. The electronic device of claim 1, wherein the lower adhesive layer does not extend below the housing.

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