WO2015187377A1 - Sensor patches - Google Patents
Sensor patches Download PDFInfo
- Publication number
- WO2015187377A1 WO2015187377A1 PCT/US2015/031884 US2015031884W WO2015187377A1 WO 2015187377 A1 WO2015187377 A1 WO 2015187377A1 US 2015031884 W US2015031884 W US 2015031884W WO 2015187377 A1 WO2015187377 A1 WO 2015187377A1
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- WO
- WIPO (PCT)
- Prior art keywords
- patch
- skin
- sensor
- sensor patch
- electrode
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
Definitions
- the present invention relates to sensor patches and, more particularly, to sensor patches for mounting to a skin surface of a patient.
- sensors to monitor various parameters of a patient.
- Such sensors may include temperature sensors, Electrocardiogram (ECG) sensors, Galvanic Skin Response (GSR) sensors depending on the application of the sensor.
- ECG Electrocardiogram
- GSR Galvanic Skin Response
- the sensors may be attached by wire to a device configured to process and/or display information obtained by the sensors.
- sensors are known to comprise wireless sensors that communicate with another device wirelessly. There is a continued desire to provide wired and wireless sensor patches to monitor various parameters of a patient.
- a wireless sensor patch comprises a printed circuit board and at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board.
- the wireless sensor patch further includes a skin-friendly adhesive patch mounted to a second side of the printed circuit board.
- a flexible cover patch is mounted with respect to the skin-friendly adhesive patch with the electronic component positioned within a space between the flexible cover patch and the skin-friendly adhesive patch.
- a cushion layer is positioned to extend between the electronic component and the flexible cover patch, wherein the cushion layer includes a plurality of apertures configured to permit fluid passage through the cushion layer.
- the printed circuit board includes a plurality of apertures configured to permit fluid passage through the printed circuit board.
- the wireless sensor patch further includes a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board.
- the tie layer includes a plurality of apertures configured to permit fluid passage through the tie layer, wherein the plurality of apertures of the tie layer are each aligned with a corresponding aperture of the printed circuit board.
- the cushion layer comprises a fabric.
- the fabric comprises a nonwoven fabric.
- a wireless sensor patch comprises a printed circuit board including a plurality of apertures configured to permit fluid passage through the printed circuit board.
- the wireless sensor patch further includes at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board.
- a skin-friendly adhesive patch is mounted to a second side of the printed circuit board and a flexible cover patch is mounted with respect to the skin-friendly adhesive patch with the electronic component positioned within a space between the flexible cover patch and the skin-friendly adhesive patch.
- the wireless sensor patch further comprises a cushion layer positioned to extend between the electronic component and the flexible cover patch.
- the cushion layer comprises a fabric.
- the cushion layer comprises a nonwoven fabric.
- the wireless sensor patch further includes a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board.
- the tie layer includes a plurality of apertures configured to permit fluid passage through the tie layer.
- the plurality of apertures of the tie layer are each aligned with a corresponding aperture of the printed circuit board.
- the second aspect discussed above may be provided alone or in combination with any one or more of the examples of the second aspect discussed above.
- the wireless sensor patch further includes a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board.
- the wireless sensor patch further includes at least one electrode extending from a second side of the printed circuit board and extending through a through aperture defined by the skin-friendly adhesive patch.
- an electrode insulation member positioned within the through aperture defined by the skin-friendly adhesive patch and circumscribing the electrode to prevent contact between the electrode and the skin- friendly adhesive patch.
- the electrode extends through an aperture defined by the electrode insulation member.
- the electrode insulation member is received within a single through aperture defined by the skin-friendly adhesive patch.
- the electrode insulation member is 8-shaped.
- the wireless sensor patch further includes at least a first electrode and a second electrode that each extend from a second side of the printed circuit board and each extend through at least one through aperture defined by the skin-friendly adhesive patch.
- at least one electrode insulation member is positioned within the at least one through aperture of the skin-friendly adhesive to prevent contact between at least one of the electrodes and the skin-friendly adhesive patch.
- the electrode insulation member prevents both the first electrode and the second electrode from contacting the skin-friendly adhesive patch.
- the electrode insulation member includes a first aperture receiving the first electrode and a second aperture receiving the second electrode.
- the electrode insulation member is received within a single through aperture defined by the skin-friendly adhesive patch.
- the electrode insulation member is 8-shaped.
- the flexible cover patch has a footprint that is larger than a foot print of the skin-friendly adhesive patch.
- an adhesive footprint of the wireless sensor patch includes a skin-friendly adhesive portion defined by the skin- friendly adhesive patch that is circumscribed by a peripheral adhesive portion defined by an adhesive layer of the flexible cover patch.
- the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
- the first aspect and/or second aspect discussed above may be provided alone or in combination with any one or more of the examples of the first aspect and/or the second aspect discussed above.
- a sensor patch comprises an interface module configured to mount the sensor patch to a skin surface of a patient.
- the sensor patch further includes a sensor module removably mounted to the skin interface module.
- the sensor module is magnetically mounted to the skin interface module.
- the sensor patch comprises a wireless sensor patch.
- the sensor module includes a printed circuit board and at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board.
- at least one magnet removably mounts the printed circuit board to the interface module.
- the sensor module includes a flexible cover patch mounted with respect to the printed circuit board with the electronic component positioned within a space between the flexible cover patch and the printed circuit board.
- the interface module comprises an adhesive patch.
- the adhesive patch comprises a skin-friendly adhesive patch.
- the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
- the interface module further comprises at least one electrode.
- the sensor patch further includes an electrode insulation member circumscribing the electrode.
- the electrode extends through an aperture defined by the electrode insulation member.
- the electrode is configured to provide a removable magnetic mounting of the sensor module to the skin interface module.
- the at least one electrode comprises a magnet attracted to the sensor module to provide the removable magnetic mounting of the sensor module to the skin interface module.
- the sensor module includes at least one magnet attracted to the at least one electrode to provide the removable magnetic mounting of the sensor module to the skin interface module.
- the least one electrode comprises at least a first electrode and a second electrode.
- the third aspect discussed above may be provided alone or in combination with any one or more of the examples of the third aspect discussed above.
- a sensor patch in a fourth aspect of the disclosure, includes an electrode configured to sense an electrical signal from a skin surface and a mounting structure including a plurality of nubs protruding from an outer face of the mounting structure.
- the plurality of nubs each include a blunt apex configured to inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface.
- the blunt apex includes a radius that is greater than or equal to about 0.1 mm.
- the plurality of nubs each protrude with a nub height from the outer face of the mounting structure, and the nub height of each nub is less than or equal to about 2 mm.
- the plurality of nubs each include an average maximum width along a height of the nub that is greater than or equal to about 0.5 mm.
- the plurality of nubs each include an aspect ratio of a nub height with respect to an average maximum width along the nub height that is less than or equal to about 1.3.
- the mounting structure comprises plastic.
- the mounting structure is plated with an electrically conductive material.
- the electrically conductive material comprises Ag/AgCI.
- the plurality of nubs are arranged in a peripheral array about a central axis of the mounting structure.
- the plurality of nubs are arranged in a circular peripheral array about the central axis of the mounting structure.
- the mounting structure defines a central cavity circumscribed by the peripheral array of nubs.
- an electrode is positioned within the central cavity.
- a temperature sensor is positioned within the central cavity.
- an electrogel is positioned within the central cavity.
- the sensor patch further comprises a skin- friendly adhesive patch mounted with respect to the mounting structure.
- the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
- the skin-friendly adhesive patch circumscribes the mounting structure.
- the fourth aspect may be provided alone or in combination with any one or more of the examples of the fourth aspect discussed above.
- FIG. 1 is example an example of a wired or wireless sensor patch in accordance with aspects of the disclosure applied to a skin surface of a patient;
- FIG. 2 is a sectional view of an example wireless sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
- FIG. 3 is a bottom view of the wireless sensor patch of FIG. 2 along line 3-3 of FIG. 2, wherein the release liner is not illustrated for clarity.
- FIG. 4 is a sectional view of another example wireless sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1, wherein a skin interface module is mounted to the skin surface of the patient and a sensor module is removably mounted to the skin interface module;
- FIG. 5 illustrates the wireless sensor patch of FIG. 4 with a sensor module being removed from a skin interface module, while the skin interface module remains mounted to the skin surface of the patient;
- FIG. 6 is a perspective view of an example wired sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
- FIG. 7 is a sectional view of the wired sensor patch along line 7-7 of FIG. 6, wherein the wired sensor patch is mounted to the skin surface of the patient;
- FIG. 8 is a perspective view of another example wired sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
- FIG. 9 is a sectional view of the wired sensor patch along line 9-9 of FIG. 8, wherein the wired sensor patch is mounted to the skin surface of the patient;
- FIG. 10 is a perspective view of still another example wired sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
- FIG. 11 is a sectional view of the wired sensor patch along line 11-11 of FIG. 10, wherein the wired sensor patch is mounted to the skin surface of the patient;
- FIG. 12 schematically illustrates an enlarged view of a mounting structure of the wired sensor patches of FIGS. 6-11 at view 12 of FIGS. 7, 9 and 11;
- FIG. 13 is a sectional view of an example nub of the mounting structure along line 13-13 of FIG. 12 with an outer sectional profile in a shape of a circle;
- FIG. 14 is a sectional view of another example nub along line 13-13 of FIG. 12 with an outer sectional profile in a shape of an ellipse;
- FIG. 15 is a sectional view of still another example nub along line 13-13 of FIG. 12 with an outer sectional profile in a shape of a rectangle;
- FIG. 16 is a sectional view of yet another example nub along line 13-13 of FIG. 12 with an outer sectional profile in a shape of a triangle.
- FIG. 1 illustrates a wired or wireless sensor patch 101 in accordance with aspects of the present disclosure.
- the sensor patch 101 can be designed to monitor various parameters of a patient 103.
- the sensor patch 101 may be adhered to a skin surface 105 of the patient 103.
- Any of the sensor patches discussed throughout the disclosure may be adhered to various alternative skin surfaces of the patient.
- the sensor patch may be adhered to the chest of a patient (e.g., as shown in FIG. 1), on the arm (e.g., on the back of the arm) of the patient or various other locations of the patient depending on the circumstances.
- the sensor patch 101 can include at least one sensor configured to monitor any one or combination of parameters.
- the sensor can comprise a Galvanic Skin Response (GSR) sensor configured to detect changes in the resistance of skin to electrical current due to changes in skin perspiration. Measuring the change in skin perspiration can be designed to detect various physiological and/or psychological conditions.
- GSR Galvanic Skin Response
- ECG Electrocardiogram
- the sensors may be designed to detect features of the skin (e.g., temperature, glucose levels, levels of chemicals, pharmaceuticals, etc.). As such, the sensor patch may have a wide range of applications.
- the wireless sensor patch of the present disclosure can allow for comfortable application and monitoring without necessarily requiring a continuous wired connection. Moreover, the wireless sensor patch can be inexpensively produced, thereby rendering the patch potentially disposable. In disposable applications, a new wireless sensor patch to be provided for each application; thereby avoiding expensive sanitation and cleaning procedures.
- Wireless configurations may provide the sensor patch 101 with a memory device configured to store data collected by the sensor device.
- the wireless sensor patch 101 may include a transmitter configured to transmit wireless signals 107 (e.g., by way of Bluetooth wireless technology) to be received by a device 109.
- the device 109 may be a cell phone or other receiving device that may in turn relay the information by satellite to another location for processing.
- the wireless sensor patch may include a USB port or other interface to allow periodic wired connections (e.g., see wire 113 in FIG. 1) with the wireless sensor patch.
- the patient may temporarily provide a wired connection with the wire 113 extending between the patch and the device 109 (e.g., by a USB cable) to provide communication between the device and the wireless sensor patch.
- information may be gathered by the device 109 continuously (e.g., by a wireless connection) in real time when synced with the device 109 and/or may be periodically sent to the device 109 when the patient makes a wired or other direct connection between the device 109 and the wireless patch.
- Such wired or wireless connections can be used to download information from the wireless sensor patch to the device 109 such as information gathered from the patient and/or current information about the wireless sensor patch.
- the wired or wireless connection may allow information or commands to be uploaded from the device 109 to the wireless sensor patch. For instance commands may be uploaded to change an operating condition of the patch, to provide information to be displayed by the patch, and/or other functionality.
- the wired sensor patch of the present disclosure can allow for comfortable application and while providing periodic or continuous wired connections with the wire 113 that may periodically or continuously provide communication to and/or from the wired sensor patch 101.
- the wired sensor patch may be inexpensively produced.
- the wired configurations may therefore also provide inexpensively produced wired configurations.
- These inexpensive wired configurations may also be disposable, thereby allowing a new sensor patch to be used with each application to avoid expensive sanitation and cleaning procedures.
- the sensor patch 101 may optionally be provided with a memory device configured to store data collected by the sensor device. The data may then be continuously or periodically transferred to the device 109.
- a wired sensor patch 101 may be provided without a memory device. In such applications, the data may be immediately, such as continuously, transferred to the device 109.
- the device 109 may be a cell phone or other receiving device that may in turn relay the information by satellite to another location for processing.
- the wired sensor patch may include a USB port or other interface to allow wired connections (e.g., see wire 113 in FIG. 1) with the wired sensor patch. In such examples, during periods of non-use, the wire may be disconnected from the wired sensor patch. The wired sensor patch can be reattached to the wire with the interface in use.
- the wired or wireless connections can be used to download information from the wireless sensor patch to the device 109 such as information gathered from the patient and/or current information about the wireless sensor patch.
- the wired or wireless connection may allow information or commands to be uploaded from the device 109 to the wireless sensor patch. For instance commands may be uploaded to change an operating condition of the patch, to provide information to be displayed by the patch, and/or other functionality.
- the device 109 may comprise a storage unit configured to store data being transmitted by the sensor patch 101.
- the device 109 may comprise a processing unit configured to process the data.
- the device 109 may optionally transmit wireless signals 111 or signals through the wire 113 to be received by the sensor patch 101. For example, the device 109 may send command signals to the sensor patch 101 to change an operating condition of the sensor patch 101.
- FIG. 2 is a schematic sectional view of an example wireless sensor patch 201 in accordance with aspects of the disclosure that may be provided as the sensor patch 101 schematically illustrated in FIG. 1.
- the wireless sensor patch 201 can include a printed circuit board 203.
- the printed circuit board can comprise a flexible circuit board although substantially nonflexible or even rigid printed circuit boards may be provided in further examples.
- the printed circuit board 203 can be provided with at least one electronic component, such as the illustrated plurality of various electronic components 205 (e.g., silicon packaged electronic components), mounted to the printed circuit board 203.
- the printed circuit board 203 is designed to allow a certain amount of flexing to permit partial or entire conformance of the printed circuit board 203 to the skin surface 105 of the patient 103.
- the one or more electronic components 205 extend from a first side of the printed circuit board 203 and may be selected in accordance with the desired characteristics of the sensor.
- the electronic components 205 may be provided to give the wireless sensor patch 201 any one or combination of functional capabilities described with respect to the wireless sensor patch 101 above.
- at least one electrode such as the illustrated plurality of electrodes 207a, 207b, may be provided to extend from a second side of the printed circuit board 203.
- Various electrode configurations may be provided such as an Ag/AgCI electrode with an optional electrolyte gel.
- the one or more electrodes may be placed in operable communication with an electrical trace or other portion of an electrical circuit supported by the substrate of the printed circuit board 203.
- a conductive coupling element 209 may be used to fix the electrodes 207a, 207b to the appropriate location of the printed circuit board 203.
- the conductive coupling element 209 may comprise a conductive pressure sensitive adhesive and/or gel.
- a skin-friendly adhesive patch 211 may be mounted with respect to a second side of the printed circuit board 203.
- the skin-friendly adhesive patch 211 may comprise a hydrocolloid adhesive patch although other skin-friendly adhesives may be provided such as integrated hydrocolloid or other adhesives capable of absorbing moisture.
- the skin-friendly adhesive patch 211 can comprise a hydrocolloid such as the hydrocolloid material disclosed in any one of U.S. Patent No 7,335,416 that issued on February 6, 2008, U.S. Patent No 6,710,100 that issued on March 23, 2004, U.S. Patent No 6,583,220 that issued on June 24, 2003, U.S. Patent No 6,326,421 that issued on December 4, 2001, U.S. Patent Application No.
- the wireless sensor patch 201 can further include a tie layer 213 configured to mount the skin-friendly adhesive patch 211 to the second side of the printed circuit board 203.
- the tie layer 213 may comprise a double-coated breathable material or may simply comprise a double-sided adhesive tape.
- the printed circuit board 203 can include a plurality of apertures 203a configured to permit fluid passage through the printed circuit board 203 from the skin-friendly adhesive patch 211.
- the tie layer 213, if provided, may also include a plurality of apertures 213a that are likewise configured to permit fluid passage through the tie layer 213 from the skin-friendly adhesive patch 211.
- the plurality of apertures 213a of the tie layer 213 are each aligned with a corresponding aperture of the plurality of apertures 203a of the printed circuit board 203.
- all of the plurality of apertures 213a are aligned although some of the apertures may not be aligned in further examples.
- the apertures of the printed circuit board and/or the tie layer may comprise perforations or relatively larger openings as shown in FIG. 2.
- one of the printed circuit board or the tie layer may include relatively larger apertures than the other of the printed circuit board and the tie layer.
- the printed circuit board may include a pattern of relatively large apertures while the tie layer may include perforations wherein more than one of the apertures of the tie layer may be aligned with a corresponding single aperture in the printed circuit board. In such a manner, it may be easier to align apertures such that fluid may pass through the tie layer and the printed circuit board from the skin-friendly adhesive patch.
- any of the wireless sensor skin patches discussed in the invention disclosure may include a cushion layer for patient comfort, to help protect the printed circuit board, to protect other electrical components such as electrical components associated with the printed circuit board, and/or to help absorb moisture.
- the wireless sensor patch 201 can further include a cushion layer 215 that may help protect the printed circuit board 203 and/or associated electronic components 205 from damage.
- the cushion layer 215 may protect the circuit board and/or electronic components from externally applied forced (e.g., impact forces) that may otherwise damage the wireless sensor patch 201.
- the cushion layer 215 may also enhance comfort to the patient wearing the patch or other individuals encountering the wireless sensor patch 201.
- the cushion layer 215 may act as a protective bumper to avoid otherwise unpleasant encounters with the relatively rigid electronic components.
- the cushion layer 215 may be configured to absorb liquid.
- liquid from the skin-friendly adhesive patch 211 may pass through the apertures 213a, 203a of the tie layer 213 and the printed circuit board 203, respectively, and thereafter be absorbed by the cushion layer 215. As such, the liquid may be wicked away from contacting, and possibly damaging, the electronic components 205.
- the cushion layer 215 may comprise a fabric represented by the cross-hatch pattern illustrated in the drawings.
- the illustrated fabric of the cushion layer 215 comprises a nonwoven fabric although woven fabrics may be provided in further examples.
- the cushion layer 215 may include a plurality of apertures 215a configured to permit fluid passage through the cushion layer 215.
- the apertures 215a may comprise relatively large apertures although the apertures may comprise perforations in further examples.
- the cushion layer 215 may be fabricated from a material that allows permeation of fluid through the cushion layer 215. In such examples, the apertures of the cushion layer 215 may be considered the fluid communication pathways of the fabric of the cushion layer.
- the apertures may be considered to be provided by the negative space not occupied by the network of woven fibers of the woven fabric.
- the cushion layer is not provided from a fluid permeable material, holes or other apertures may be punched through the cushion layer to allow fluid communication through the cushion layer.
- still further apertures may be provided (e.g., punched or otherwise provided) in the cushion layer to further increase permeability of fluid through the cushion layer.
- the cushion layer 215 may also include an adhesive applied to a surface 217 facing the electronic components and printed circuit board.
- the surface 217 may be provided with a pressure sensitive adhesive that may facilitate mounting of the cushion layer 215 in place by adhesive mounting to the electronic components 205, printed circuit board 203, the tie layer 213 and/or the skin-friendly adhesive patch 211.
- the wireless sensor patch 201 can further include a flexible cover patch 219 with outer edge 223 mounted with respect to the skin-friendly adhesive patch 211 with the electronic component 205 positioned within a space between the flexible cover patch 219 and the skin-friendly adhesive patch 211.
- the flexible cover patch 219 can be positioned over the cushion layer 215 such that the cushion layer 215 is positioned to extend between the electronic component 205 and the flexible cover patch 219.
- the flexible cover patch 219 may comprise a polymeric member, such as a closed cell foam material that may be substantially water resistant yet breathable to help protect the electrical components 205 and the printed circuit board 203.
- FIG. 3 is a bottom view of the wireless sensor patch 201 wherein a release liner 221 (shown in FIG. 2), designed to preserve the adhesive surfaces from contamination prior to application, is not illustrated for clarity.
- the flexible cover patch 219 may also include an adhesive layer 301 designed to mount the flexible cover patch 219 to the cushion layer 215.
- the adhesive layer 301 can comprise a pressure sensitive adhesive such as rubber- based adhesive, acrylic adhesive or silicone adhesive that allows a peripheral adhesive portion 303b defined by an adhesive layer 301 of the flexible cover patch 219 to immediately adhere to the skin surface 105 upon application of the wireless sensor patch 201.
- the wireless sensor patch 201 can comprise the skin-friendly adhesive patch 211.
- the peripheral adhesive portion 303b at an outer periphery of the adhesive layer 301 can circumscribe a skin-friendly portion 303a of the skin-friendly adhesive patch 211.
- the flexible cover patch 219 of the wireless skin patch 201 can have a footprint that is larger than a foot print of the skin-friendly adhesive patch 211.
- each wireless skin patch of the present disclosure can include an adhesive footprint with a skin- friendly adhesive portion defined by the skin-friendly adhesive patch that is optionally circumscribed by a peripheral adhesive portion defined by an adhesive layer of the flexible cover patch.
- FIG. 3 illustrates an adhesive footprint of the wireless skin patch 201 with the skin- friendly portion 303a defined by the skin-friendly adhesive patch 211 that is circumscribed by the peripheral adhesive portion 303b defined by an adhesive layer 301 of the flexible cover patch 219.
- an outer peripheral adherence of the wireless sensor patch 201 to the skin surface 105 of the patient 103 may be achieved.
- the skin-friendly adhesive patch 211 may be held in place against the skin surface 105 to allow sufficient time for the skin-friendly adhesive patch 211 to cure into an effective adhesive member.
- the skin-friendly adhesive patch 211 allows the wireless sensor patch 201 to be applied to the skin surface for a significant length of time without aggravating the skin surface when compared to the adhesive layer 301.
- a relatively small peripheral portion 303b of the adhesive layer 301 may allow the peripheral portions of the patch to be immediately adhered to the skin surface while allowing the skin-friendly portion 303a of the skin- friendly adhesive patch 211 sufficient time to cure.
- any of the example wireless or wired sensor patches described throughout the disclosure using a skin-friendly patch with electrodes extending through the skin-friendly patch such sensor patches may be provided with an optional electrode insulation member.
- an electrode insulation member 225 may be positioned within at least one through aperture 227. Although a single aperture 227 is shown, a plurality of apertures may be provided in further examples wherein at least one of the apertures includes an electrode insulation member 225.
- the electrode insulation member 225 can circumscribe at least one electrode to prevent contact between the circumscribed electrode and the skin-friendly adhesive patch 211.
- the electrode insulation member 225 may circumscribe both of the electrodes 207a, 207b although the electrode insulation member 225 may circumscribe a single electrode or less than all of a plurality of electrodes in further examples.
- the electrode insulation member 225 is designed to electrically insulate the electrodes 207a, 207b from one another or other components.
- the electrode insulation member can comprise a closed-cell foam, nonwoven fabric or other material configured to electrically insulate one or more of the electrodes. Electrical insulation can be particularly beneficial since the skin-friendly adhesive patch 211 will tend absorb significant levels of liquid (e.g., water) from the skin surface 105 of a patient 103 over time.
- the electrode insulation member 224 can prevent direct exposure of the electrodes 207a, 207b to the skin-friendly adhesive patch 211, thereby avoiding undesired electrical communication (e.g., short circuiting) of the electrodes 207a, 207b that may otherwise occur through the saturated skin-friendly adhesive patch 211.
- the electrodes may extend through an aperture of the electrode insulation member 225.
- the first electrode 207a may extend through a first aperture 305a of the electrode insulation member 225 while the second electrode 207b may extend through the second aperture 305b.
- each electrode 207a, 207b can extend through a single through aperture 227 of the skin-friendly adhesive patch 211 while extending through corresponding apertures 305a, 305b of the electrode insulation member 225.
- the electrode insulation member 225 can therefore prevent both the first electrode 207a and the second electrode 207b from contacting the skin-friendly adhesive patch 211.
- Insulating both electrodes can help further electrically insulate the electrodes from one another and/or from other components.
- the electrode insulation member may be provided to insulate a single electrode. Insulating a single electrode may reduce material costs, increase available skin-friendly adhesive surface area contact with the skin while still electrically insulating the insulated electrode from the remaining electrode(s).
- the electrode insulation member 225 can optionally comprise bulbous portions 307a, 307b having a footprint larger than the corresponding footprint of the electrodes 207a, 207b to allow the electrode insulating member to circumscribe each of the electrodes.
- a reduced neck portion 309 may be provided between the bulbous portions 307a, 307b such that the outer periphery 311 of the electrode insulation member 225 together with the apertures 305a, 305b provides the electrode insulation member 225 as an 8-shaped electrode insulation member having a shape of the number "8".
- Providing the reduced neck portion 309 allows the bulbous portions to be connected together while still maximizing the surface area of the skin-friendly adhesive available for contacting the skin surface.
- the reduced neck portion can help increase the electrical insulation properties in the area positioned between the electrodes, thereby enhancing thermal insulation characteristics while maximizing the surface area of the skin-friendly adhesive available for contacting the skin surface.
- the bulbous portions 307a, 307b may simply comprise donuts that are not connected to one another.
- a single donut may be provided about a single electrode to electrically insulate a selected electrode from the other electrode(s) and/or other components.
- a plurality of donuts may be provided, for example, about each electrode to electrically insulate all of the electrodes from one another and/or other components.
- the wireless sensor patch 201 shown in FIGS. 2-3 may be easily applied to the skin surface 105 of a patient 103.
- the release liner 221 shown in FIG. 2 may be removed to expose the adhesive layer 301 of the flexible cover patch 219 and the skin-friendly adhesive patch 211.
- the wireless sensor patch 201 may be applied to the skin surface 105 of a patient 103 at an appropriate location.
- the outer peripheral portion 303b of the adhesive layer 301 immediately mounts the wireless sensor patch 201 in place, wherein, after sufficient time, the skin-friendly adhesive patch 211 cures to provide the primary bonding while reducing irritation and/or aggravation to the skin layer that may otherwise occur over long periods of time with only the relatively harsh adhesive layer 301.
- the skin-friendly adhesive patch 211 may absorb liquid.
- a fluid e.g., vapor, gas from the absorbed liquid
- the absorbed liquid itself may pass through the apertures 213a of the tie layer 213 and the apertures 203a of the printed circuit board 203.
- the liquid may then eventually pass through the vapor permeable flexible cover patch 219 to be released to the surrounding atmosphere.
- the cushion layer 215 may also absorb fluid (e.g., liquid such as perspiration) that passes through the apertures of the printed circuit board 203.
- the cushion layer 215 may be designed with the capacity to handle absorbing all of the liquid for the period of time that the sensor patch will be mounted to the skin surface of the patient.
- the cushion layer 215 may include the plurality of apertures 215a to further help pass liquid or other fluids to be passed through the cushion layer to be released through the flexible cover patch 219 and into the surrounding environment.
- FIG. 4 is a schematic sectional view of another example sensor patch 401 in accordance with aspects of the disclosure that may be provided as the sensor patch 101 schematically illustrated in FIG. 1.
- the sensor patch 401 comprises a wireless sensor patch although wired sensor patches may be provided in further examples.
- the sensor patch 401 includes an interface module 403 configured to mount the sensor patch 401 to the skin surface 105 of the patient 103.
- the interface module 403 can have identical or similar features to the construction of the skin-friendly adhesive patch 211, electrode insulation member 225 and the electrodes 207a, 207b.
- the interface module 403 can include an adhesive patch 407 that, in one example, may comprise a skin-friendly adhesive patch.
- the skin-friendly adhesive patch 407 can comprise a hydrocolloid adhesive patch.
- the interface module 403 of the sensor patch 401 can further include at least one electrode.
- the at least one electrode comprises at least a first electrode 409a and a second electrode 409b although, as with the sensor patch 201 described with respect to FIGS. 2-3 above, three or more electrodes may be provided in still further examples.
- the interface module 403 of the sensor patch 401 can further include an optional electrode insulation member 411 that may be similar or identical in construction and shape as the electrode insulation member 225 discussed with respect to the wireless sensor patch 201 discussed with reference to FIGS. 2-3 above. Indeed, the electrode insulation member 225 circumscribe one or more (e.g., all) of the electrodes 409a, 409b. Moreover, the electrodes 409a, 409b can extend through an aperture 413 defined by the electrode insulation member 225.
- the sensor patch 401 includes a sensor module 405.
- the sensor module 405 may include a printed circuit board 415 and at least one electronic component 417 mounted to the printed circuit board 415 and extending from a first side 419 of the printed circuit board 415.
- the printed circuit board 415 can be similar or identical in construction as the printed circuit board 203 discussed with respect to the sensor patch 201 of FIGS. 2-3 above.
- the printed circuit board 415 of the sensor patch 401 can comprise a flexible circuit board although substantially nonflexible or even rigid printed circuit boards may be provided in further examples.
- the sensor module 405 may likewise include a similar or identical flexible cover patch 421 mounted with respect to the printed circuit board 415 with the electronic component 417 positioned within a space 423 between the flexible cover patch 421 and the printed circuit board 415.
- the sensor module 405 may be removably mounted to the skin interface module 403. In such a manner, the sensor module 405 may be removed from the skin interface module 403 while the skin interface module 403 remains mounted to the skin surface 105 of the patient 103. As such, the sensor module 405 may be easily removed for cleaning, recharging, transferring information to another device or the like. Moreover, the sensor module 405 may be removed prior to the patient being exposed to environments that may otherwise be potentially hazardous to the sensor module. For example, the patient may easily remove the sensor module 405 prior to being exposed to water when bathing or the like. As such, fabricating the sensor module 405 with a water-proof construction is not necessarily required since the sensor module may be easily removed prior to expected exposure to such environments.
- the interface module 403 may remain attached to the skin surface 105 of the patient 103 to avoid disturbing the skin surface or the coupling of the electrodes to the skin surface.
- the interface module 403 may be applied once, perhaps by qualified medical professionals, who can confirm successful mounting of the skin-patch and electrical communication of the electrodes with the skin surface. Once the interface module is correctly installed, there is no need to disturb the interface since the patient may easily remove and reattach the sensor module while the interface module remains mounted to the skin surface.
- the sensor module 405 may be removably mounted to the skin interface module 403.
- various mechanical fasteners such as snaps, hook and loop fasteners, reusable releasing adhesives, or the like may be used in accordance with aspects of the disclosure.
- the sensor module 405 may be magnetically mounted to the skin interface module 403.
- one or both of the sensor module 405 and/or the interface module 403 may include one or more magnets configured to removably magnetically mount the sensor module 405 to the skin interface module 403.
- the sensor patch 401 illustrates both the sensor module 405 and the skin interface module 403 including magnets configured to cooperate with one another to provide removable mounting.
- at least one magnet may be provided to removably mount the printed circuit board 415 to the interface module.
- the printed circuit board 415 may comprise one or more magnets 501a, 501b that may be arranged to be attracted to the electrodes 409a, 409b.
- the electrodes may optionally be configured to provide the removable magnetic mounting of the sensor module to the skin interface module.
- the electrodes may also comprise magnets arranged to be attracted to the magnets 501a, 501b provided by the printed circuit board 415. Providing the electrodes as magnets, in addition to the magnets of the printed circuit board, can enhance the strength of the connection between the modules and/or reduce the size of the magnets necessary to achieve a sufficient level of strength.
- the magnet 501a may be mounted such that the positive pole (+) is facing downward while the magnet 501b is mounted such that the negative pole (-) is facing downward.
- One of the magnetic electrode 409a can also be arranged such that the negative pole (-) faces upward while the other electrode 409b is arranged such that the positive pole (+) faces upward.
- the positive pole of the magnet 501a is attracted to the negative pole of the magnetic electrode 409a.
- the negative pole of the magnet 501b is attracted to the positive pole (+) of the magnetic electrode 409b. Accordingly, in the illustrated orientation, the sensor module 405 would be magnetically mounted to the interface module 403 in the manner shown in FIG. 4. However, if a patient attempts to mount the sensor module in an improper orientation, the magnets will resist mounting. For example, in a reverse orientation, the negative pole (-) of the magnet 501b would repel the negative pole (-) of the magnetic electrode 409a. Similarly, the positive pole (+) of the magnet 501a would repel the positive pole (+) of the magnetic electrode 409b. As such, an attempt to mount in the incorrect orientation would not be possible as the like poles of the magnets would repel one another, providing an indication to the patient to reorient the sensor module in the prior position.
- the electrodes may comprise magnets and the magnets 501a, 501b of the printed circuit board may simply comprise ferrous metal members or other members attracted to a magnet.
- the magnets 501a, 501b are only provided in the printed circuit board while the electrodes are not magnetized. Using the electrodes to help establish the magnetic connection is not required but can be beneficial to use existing structure to form the magnetic connection.
- the magnets 501a, 501b (or similar ferrous metal or the like) may be optional.
- magnets in the interface module may be designed to be attracted to the printed circuit board itself or other components of the sensor module.
- the at least one electrode of the interface module may comprise a magnet attracted to the sensor module to provide removable magnetic mounting of the sensor module to the skin interface module.
- the sensor module may include at least one magnet attracted to the at least one electrode to provide the removable magnetic mounting of the sensor module to the skin interface module.
- the magnetic connection can establish electrical communication between the electrodes and the circuit of the printed circuit board 415.
- the magnets 501a, 501b or other coupling members may provide electrical communication between the electrodes 409a, 409b and the appropriate locations of the circuit.
- the electrodes 409a, 409b may each be placed in respective electrical communication with the magnets (or other interface members) 501a, 501b to establish electrical connection between the electrodes 409a, 409b and the circuit of the printed circuit board 415.
- the sensor module 405 may be removed from the interface module 403 wherein electrical communication between the electrodes 409a, 409b and the circuit of the sensor module 405 may be temporarily disengaged until the sensor module is then mounted with respect to the interface module as shown in FIG. 4.
- the upper surface 407a of the adhesive patch 407 may be provided with a release liner or other membrane or structure configured to prohibit undesirable adhering of the adhesive patch 407 to the printed circuit board 415.
- a release liner is provided, a further mode of functionality may be provided to allow the interface module to be permanently attached to the sensor module. For example, if removable mounting is not desired, the release liner may be removed, such that the adhesive patch may directly mount to the printed circuit board 415.
- the adhesive patch comprises a hydrocolloid adhesive patch or other skin-friendly adhesive
- the magnetic attraction or other temporary mounting of the interface module with the sensor module may provide sufficient mounting to allow the sensor to remain in contact with the patch until the skin-friendly adhesive cures into a permanent attachment.
- FIGS. 6-11 are views of further example sensor patches 601, 801, 1001 that may comprise the illustrated wired sensor patch, although a wireless sensor patch may be provided in further examples.
- each sensor patch 601, 801, 1001 includes an electrode configured to sense an electrical signal from the skin surface 105.
- each sensor patch 601, 801, 1001 includes a mounting structure 701 including a plurality of nubs 703 protruding from an outer face 705 of the mounting structure 701.
- the plurality of nubs 703 each include a blunt apex 707 configured to inhibit relative lateral movement of the mounting structure 701 relative to the skin surface 105 without penetrating the skin surface 105.
- the blunt apex 707 may include a radius "R" that approaches infinity wherein the blunt apex is considered substantially flat.
- the radius "R” can be 0.1 ⁇ "R" ⁇ , such as within a range from about 0.1 mm to about 1 mm, such as from about 0.1 mm to about 0.8 mm, such as from about 0.1 mm to about 0.7 mm, such as from about 0.1 mm to about 0.6 mm, such as from about 0.1 mm to about 0.5 mm, such as from about 0.1 mm to about 0.4 mm, such as from about 0.1 mm to about 0.3 mm, such as from about 0.1 mm to about 0.2 mm.
- the radius "R" can be 0.2 ⁇ "R" ⁇ , such as from about 0.2 mm to about 1 mm, such as from about 0.2 mm to about 0.8 mm, such as from about 0.2 mm to about 0.7 mm, such as from about 0.2 mm to about 0.6 mm, such as from about 0.2 mm to about 0.5 mm, such as from about 0.2 mm to about 0.4 mm, such as from about 0.2 mm to about 0.3 mm.
- the radius "R" can be 0.3 ⁇ "R" ⁇ , such as from about 0.3 mm to about 1 mm, such as from about 0.3 mm to about 0.8 mm, such as from about 0.3 mm to about 0.7 mm, about 0.3 mm to about 0.6 mm, such as from about 0.3 mm to about 0.5 mm, such as from about 0.3 mm to about 0.4 mm.
- the radius "R” can be 0.4 ⁇ "R" ⁇ , such as from about 0.4 mm to about 1 mm, such as from about 0.4 mm to about 0.8 mm, such as from about 0.4 mm to about 0.7 mm, about 0.4 mm to about 0.6 mm, such as from about 0.4 mm to about 0.5 mm.
- the radius "R” can be 0.5 ⁇ "R" ⁇ , such as from about 0.5 mm to about 1 mm, such as from about 0.5 mm to about 0.8 mm, such as from about 0.5 mm to about 0.7 mm, such as from about 0.5 mm to about 0.6 mm.
- the radius "R” can be 0.6 ⁇ "R” ⁇ , such as from about 0.6 mm to about 1 mm, such as from about 0.6 mm to about 0.8 mm, such as from about 0.6 mm to about 0.7 mm.
- the radius "R” can be 0.7 ⁇ "R” ⁇ , such as from about 0.7 mm to about 1 mm, such as from about 0.7 mm to about 0.8 mm. In yet another example, the radius "R” can be 0.8 ⁇ "R” ⁇ , such as from about 0.8 mm to about 1 mm.
- the plurality of nubs can each protrude with a nub height "H" extending perpendicular between an outer end of the blunt apex 707 and the outer face 705 of the mounting structure 701.
- the nub height "H” can be less than or equal to about 2 mm, such as within a range of from about 0.5 mm to about 2 mm, such as from about 0.6 mm to about 2 mm, such as from about 0.7 mm to about 2 mm, such as from about 0.8 mm to about 2 mm, such as from about 0.9 mm to about 2 mm, such as from about 1 mm to about 2 mm, such as from about 1.2 mm to about 2 mm, such as from about 1.5 mm to about 2 mm, such as from about 1.7 mm to about 2 mm.
- the nub height "H" can be less than or equal to about 1.7 mm, such as within a range of from about 0.5 mm to about 1.7 mm, such as from about 0.6 mm to about 1.7 mm, such as from about 0.7 mm to about 1.7 mm, such as from about 0.8 mm to about 1.7 mm, such as from about 0.9 mm to about 1.7 mm, such as from about 1 mm to about 1.7 mm, such as from about 1.2 mm to about 1.7 mm, such as from about 1.5 mm to about 1.7 mm.
- the nub height "H" can be less than or equal to about 1.5 mm, such as within a range of from about 0.5 mm to about 1.5 mm, such as from about 0.6 mm to about 1.5 mm, such as from about 0.7 mm to about 1.5 mm, such as from about 0.8 mm to about 1.5 mm, such as from about 0.9 mm to about 1.5 mm, such as from about 1 mm to about 1.5 mm, such as from about 1.2 mm to about 1.5 mm.
- the nub height "H" can be less than or equal to about 1.2 mm, such as within a range of from about 0.5 mm to about 1.2 mm, such as from about 0.6 mm to about 1.2 mm, such as from about 0.7 mm to about 1.2 mm, such as from about 0.8 mm to about 1.2 mm, such as from about 0.9 mm to about 1.2 mm, such as from about 1 mm to about 1.2 mm.
- the nub height "H" can be less than or equal to about 1 mm, such as within a range of from about 0.5 mm to about 1 mm, such as from about 0.6 mm to about 1 mm, such as from about 0.7 mm to about 1 mm, such as from about 0.8 mm to about 1 mm, such as from about 0.9 mm to about 1 mm.
- the nub height "H" can be less than or equal to about 0.9 mm, such as within a range of from about 0.5 mm to about 0.9 mm, such as from about 0.6 mm to about 0.9 mm, such as from about 0.7 mm to about 0.9 mm, such as from about 0.8 mm to about 0.9 mm.
- the nub height "H" can be less than or equal to about 0.8 mm, such as within a range of from about 0.5 mm to about 0.8 mm, such as from about 0.6 mm to about 0.8 mm, such as from about 0.7 mm to about 0.8 mm.
- the nub height "H” can be less than or equal to about 0.7 mm, such as within a range of from about 0.5 mm to about 0.7 mm, such as from about 0.6 mm to about 0.7 mm. In still further examples, the nub height "H” can be less than or equal to about 0.6 mm, such as within a range of from about 0.5 mm to about 0.6 mm. In further examples, the nub height "H” can be less than or equal to about 0.5 mm, such less than or equal to about 0.4 mm.
- Example nubs 703 can have a wide range of outer sectional profile shapes.
- FIGS. 13-16 are each sectional views of the nub along line 13-13 of FIG. 12 showing just some examples of outer sectional profiles of example nubs.
- FIG. 13 illustrates an example nub 703a with an outer sectional profile in a shape of a circle.
- FIG. 14 illustrates an alternative example nub 703b with an outer sectional profile is in a shape of an ellipse.
- FIG. 15 illustrates still another alternative example nub 703c with an outer sectional profile in a shape of a rectangle (e.g., square).
- FIG. 16 illustrates still another alternative example nub 703d with an outer sectional profile in the shape of a triangle.
- FIGS. 13-16 demonstrate nubs with example outer sectional profiles in the shape of a circle, ellipse, rectangle, triangle, in further examples other curvilinear and/or polygonal shapes may be provided.
- each cross section along the nub height "H" can be considered to have a maximum cross-sectional width "W”.
- the average maximum cross sectional width "Wav" of the nub is the average of the maximum cross-sectional width "W" along the nub height "H".
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.5 mm, such as from about 0.5 mm to about 2 mm, such as from about 0.5 mm to about 1.9 mm, such as from about 0.5 mm to about 1.8 mm, such as from about 0.5 mm to about 1.7 mm, such as from about 0.5 mm to about 1.6 mm, such as from about 0.5 mm to about 1.5 mm, such as from about 0.5 mm to about 1.4 mm, such as from about 0.5 mm to about 1.3 mm, such as from about 0.5 mm to about 1.2 mm, such as from about 0.5 mm to about 1.1 mm, such as from about 0.5 mm to about 1 mm, such as from about 0.5 mm to about 0.9 mm, such as from about 0.5 mm to about 0.8 mm, such as from about 0.5 mm to about 0.7 mm, such as from about 0.5 mm to about 0.6 mm
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.6 mm, such as from about 0.6 mm to about 2 mm, such as from about 0.6 mm to about 1.9 mm, such as from about 0.6 mm to about 1.8 mm, such as from about 0.6 mm to about 1.7 mm, such as from about 0.6 mm to about 1.6 mm, such as from about 0.6 mm to about 1.5 mm, such as from about 0.6 mm to about 1.4 mm, such as from about 0.6 mm to about 1.3 mm, such as from about 0.6 mm to about 1.2 mm, such as from about 0.6 mm to about 1.1 mm, such as from about 0.6 mm to about 1 mm, such as from about 0.6 mm to about 0.9 mm, such as from about 0.6 mm to about 0.8 mm, such as from about 0.6 mm to about 0.7 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.7 mm, such as from about 0.7 mm to about 2 mm, such as from about 0.7 mm to about 1.9 mm, such as from about 0.7 mm to about 1.8 mm, such as from about 0.7 mm to about 1.7 mm, such as from about 0.7 mm to about 1.6 mm, such as from about 0.7 mm to about 1.5 mm, such as from about 0.7 mm to about 1.4 mm, such as from about 0.7 mm to about 1.3 mm, such as from about 0.7 mm to about 1.2 mm, such as from about 0.7 mm to about 1.1 mm, such as from about 0.7 mm to about 1 mm, such as from about 0.7 mm to about 0.9 mm, such as from about 0.7 mm to about 0.8 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.8 mm, such as from about 0.8 mm to about 2 mm, such as from about 0.8 mm to about 1.9 mm, such as from about 0.8 mm to about 1.8 mm, such as from about 0.8 mm to about 1.7 mm, such as from about 0.8 mm to about 1.6 mm, such as from about 0.8 mm to about 1.5 mm, such as from about 0.8 mm to about 1.4 mm, such as from about 0.8 mm to about 1.3 mm, such as from about 0.8 mm to about 1.2 mm, such as from about 0.8 mm to about 1.1 mm, such as from about 0.8 mm to about 1 mm, such as from about 0.8 mm to about 0.9 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.9 mm, such as from about 0.9 mm to about 2 mm, such as from about 0.9 mm to about 1.9 mm, such as from about 0.9 mm to about 1.8 mm, such as from about 0.9 mm to about 1.7 mm, such as from about 0.9 mm to about 1.6 mm, such as from about 0.9 mm to about 1.5 mm, such as from about 0.9 mm to about 1.4 mm, such as from about 0.9 mm to about 1.3 mm, such as from about 0.9 mm to about 1.2 mm, such as from about 0.9 mm to about 1.1 mm, such as from about 0.9 mm to about 1 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1 mm, such as from about 1 mm to about 2 mm, such as from about 1 mm to about 1.9 mm, such as from about 1 mm to about 1.8 mm, such as from about 1 mm to about 1.7 mm, such as from about 1 mm to about 1.6 mm, such as from about 1 mm to about 1.5 mm, such as from about 1 mm to about 1.4 mm, such as from about 1 mm to about 1.3 mm, such as from about 1 mm to about 1.2 mm, such as from about 1 mm to about 1.1 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.1 mm, such as from about 1.1 mm to about 2 mm, such as from about 1.1 mm to about 1.9 mm, such as from about 1.1 mm to about 1.8 mm, such as from about 1.1 mm to about 1.7 mm, such as from about 1.1 mm to about 1.6 mm, such as from about 1.1 mm to about 1.5 mm, such as from about 1.1 mm to about 1.4 mm, such as from about 1.1 mm to about 1.3 mm, such as from about 1.1 mm to about 1.2 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.2 mm, such as from about 1.2 mm to about 2 mm, such as from about
- 1.2 mm to about 1.9 mm such as from about 1.2 mm to about 1.8 mm, such as from about 1.2 mm to about 1.7 mm, such as from about 1.2 mm to about 1.6 mm, such as from about 1.2 mm to about 1.5 mm, such as from about 1.2 mm to about 1.4 mm, such as from about 1.2 mm to about 1.3 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.3 mm, such as from about 1.3 mm to about 2 mm, such as from about
- 1.3 mm to about 1.9 mm such as from about 1.3 mm to about 1.8 mm, such as from about 1.3 mm to about 1.7 mm, such as from about 1.3 mm to about 1.6 mm, such as from about 1.3 mm to about 1.5 mm, such as from about 1.3 mm to about 1.4 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.4 mm, such as from about 1.4 mm to about 2 mm, such as from about
- 1.4 mm to about 1.9 mm such as from about 1.4 mm to about 1.8 mm, such as from about 1.4 mm to about 1.7 mm, such as from about 1.4 mm to about 1.6 mm, such as from about 1.4 mm to about 1.5 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.5 mm, such as from about 1.5 mm to about 2 mm, such as from about 1.5 mm to about 1.9 mm, such as from about 1.5 mm to about 1.8 mm, such as from about 1.5 mm to about 1.7 mm, such as from about 1.5 mm to about 1.6 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.6 mm, such as from about 1.6 mm to about 2 mm, such as from about 1.6 mm to about 1.9 mm, such as from about 1.6 mm to about 1.8 mm, such as from about 1.6 mm to about 1.7 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.7 mm, such as from about 1.7 mm to about 2 mm, such as from about
- 1.7 mm to about 1.9 mm such as from about 1.7 mm to about 1.8 mm.
- the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.8 mm, such as from about 1.8 mm to about 2 mm, such as from about
- the average maximum cross-sectional width "Wav" along the nub height "H” can be greater than or equal to about 1.9 mm, such as from about 1.9 mm to about 2 mm.
- the nub 703 may be tapered along an extent of the nub height "H". Indeed, as shown in FIG. 12, the nub can have outer walls that taper at an angle a.
- the angle a is greater than or equal to about 0°, such as within a range from about 0° to about 45°, such as from about 0° to about 42°, such as from about 0° to about 40°, such as from about 0° to about 38°, such as from about 0° to about 36°, such as from about 0° to about 33°, such as from about 0° to about 30°, such as from about 0° to about 25°, such as from about 0° to about 20°, such as from about 0° to about 15°, such as from about 0° to about 10°, such as from about 0° to about 5°.
- the angle a is greater than or equal to about 5°, such as within a range from about 5° to about 45°, such as from about 5° to about 42°, such as from about 5° to about 40°, such as from about 5° to about 38°, such as from about 5° to about 36°, such as from about 5° to about 33°, such as from about 5° to about 30°, such as from about 5° to about 25°, such as from about 5° to about 20°, such as from about 5° to about 15°, such as from about 5° to about 10°.
- the angle a is greater than or equal to about 10°, such as within a range from about 10° to about 45°, such as from about 10° to about 42°, such as from about 10° to about 40°, such as from about 10° to about 38°, such as from about 10° to about 36°, such as from about 10° to about 33°, such as from about 10° to a bout 30°, such as from about 10° to about 25°, such as from about 10° to about 20°, such as from about 10° to about 15°.
- the angle a is greater than or equal to about 15°, such as within a range from about 15° to about 45°, such as from about 15° to about 42°, such as from about 15° to about 40°, such as from about 15° to about 38°, such as from about 15° to about 36°, such as from about 15° to about 33°, such as from about 15° to a bout 30°, such as from about 15° to about 25°, such as from about 15° to about 20°.
- the angle a is greater than or equal to about 20°, such as within a range from about 20° to about 45°, such as from about 20° to about 42°, such as from about 20° to about 40°, such as from about 20° to about 38°, such as from about 20° to about 36°, such as from about 20° to about 33°, such as from about 20° to about 30°, such as from about 20° to about 25°.
- the angle a is greater than or equal to about 25°, such as within a range from about 25° to about 45°, such as from about 25° to about 42°, such as from about 25° to about 40°, such as from about 25° to about 38°, such as from about 25° to about 36°, such as from about 25° to about 33°, such as from about 25° to about 30°.
- the angle a is greater than or equal to about 30°, such as within a range from about 30° to about 45°, such as from about 30° to about 42°, such as from about 30° to about 40°, such as from about 30° to about 38°, such as from about 30° to about 36°, such as from about 30° to about 33°.
- the angle a is greater than or equal to about 33°, such as within a range from about 33° to about 45°, such as from about 33° to about 42°, such as from about 33° to about 40°, such as from about 33° to about 38°, such as from about 33° to about 36°.
- the angle a is greater than or equal to about 36°, such as within a range from about 36° to about 45°, such as from about 36° to about 42°, such as from about 36° to about 40°, such as from about 36° to about 38°.
- the angle a is greater than or equal to about 38°, such as within a range from about 38° to about 45°, such as from about 38° to about 42°, such as from about 38° to about 40°. In still additional examples, the angle a is greater than or equal to about 40°, such as within a range from about 40° to about 45°, such as from about 40° to about 42°. In yet additional examples, the angle a is greater than or equal to about 42°, such as within a range from about 42° to about 45°. In further examples, the angle a is greater than or equal to about 45°.
- the nub 703 may have various aspect ratios "AR".
- the aspect ratio "AR” can be less than or equal to about 1.3, such as from about 0.7 to about 1.3, such as from about 0.8 to about 1.3, such as from about 0.9 to about 1.3, such as from about 1 to about 1.3, such as from about 1.1 to about 1.3, such as from about 1.2 to about 1.3.
- the aspect ratio "AR" can be less than or equal to about 1.2, such as from about 0.7 to about 1.2, such as from about 0.8 to about 1.2, such as from about 0.9 to about 1.2, such as from about 1 to about 1.2, such as from about 1.1 to about 1.2.
- the aspect ratio "AR” can be less than or equal to about 1.1, such as from about 0.7 to about 1.1, such as from about 0.8 to about 1.1, such as from about 0.9 to about 1.1, such as from about 1 to about 1.1. [00127] In further examples, the aspect ratio "AR” can be less than or equal to about 1, such as from about 0.7 to about 1, such as from about 0.8 to about 1, such as from about 0.9 to about 1. In additional examples, the aspect ratio "AR” can be less than or equal to about 0.9, such as from about 0.7 to about 0.9, such as from about 0.8 to about 0.9. In further examples, the aspect ratio "AR” can be less than or equal to about 0.8, such as from about 0.7 to about 0.8. In still further examples, the aspect ratio "AR” can be less than or equal to about 0.7.
- nubs may include features outside of the ranges listed below.
- nubs may include one or more of the features below while not including other features listed below.
- an example nub may include any one of the features of the Radius "R”, Height “H”, Average Maximum Cross-Sectional Width “Wav”, Angle “a”, Aspect Ratio "AR” listed in the ranges below, either alone or in combination with one or more (e.g., all) of the other features, for example, in the ranges listed below.
- the ranges and dimensions below may include the exact dimension and/or the exact endpoints of the ranges, or may include dimensions that are about the dimension listed below or ranges with endpoints that are about the endpoints listed below.
- the mounting structures 701 can comprise a wide range of materials.
- the mounting structure can comprise plastic.
- example configurations of the mounting structures may be fabricated with an injection molding procedure to produce the mounting structure from plastic.
- the mounting structures 701 may be provided as a substrate support for an electrode 603 that may be optionally integrated together with the mounting structures 701.
- FIGS. 6, 7, 10 and 11 illustrate example sensor patches 601, 1001 that may include an electrode 603 that is integrated together with the corresponding mounting structure 701.
- the mounting structure 701 may optionally be plated with an electrically conductive material 709, such as Ag/AgCI or other material.
- the nubs 703 may be useful to inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface.
- each of the nubs of the present disclosure have features (see FIG. 12) that allow the surface of the skin to conform to the outer periphery of the nub to inhibit lateral movement without penetrating the skin surface.
- plating the mounting structure 701 includes plating over the nubs wherein the conformed, and nonpenetrated, surface of the skin comes into intimate contact with the electrically conductive material. As such, electrical signals from the skin may be easily transmitted over the plated skin of the mounting structure to be transmitted through the wire 711 for further processing.
- the plurality of nubs 703 may be arranged in a peripheral array about a central axis 605, 805, 1005 of the sensor patch 601, 801, 1001.
- the effective footprint of the nub periphery can be maximized to enhance the ability of the mounting structure to inhibit lateral movement relative to the skin surface.
- the plurality of illustrated nubs are arranged in a circular peripheral array about the central axis 605, 806, 1005 although a periphery in the shape of an ellipse or other peripheral shape is possible in further examples.
- arranging in a circular periphery may be desirable in certain instances to help distribute bearing stress to several nubs to avoid excessive bearing stress at the skin surface.
- the mounting structure can further include a central cavity circumscribed by the peripheral array of nubs.
- the mounting structure includes a central cavity 607 circumscribed by the peripheral array of nubs 703.
- the central cavity 607 can provide an accumulation zone for the surface of the skin that may bulge into this zone after mounting, that further helps inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface.
- any of the sensor patches 601, 801, 1001 may include a temperature sensor 715a that may be positioned within the central cavity 607.
- a temperature sensor 715b may be provided within the mounting structure 701.
- the temperature sensor 715b may be encapsulated within the material of the mounting structure or may be housed within an area of the mounting structure.
- the electrode 901 may be positioned within the central cavity 607 of the mounting structure 701.
- the mounting structure 701 is not necessarily plated wherein the nubs 703 only function to inhibit lateral movement of the sensor patch and do not function to deliver signals (e.g., by conductive plating over the nubs).
- one or more electrodes 901 may be mounted and placed in communication, by way of wire 903 to another location to process the signals.
- the sensor patch 801 may comprise a wireless sensor patch wherein electrical components are housed within an area 905 between a flexible cover patch 421 and the mounting structure 701.
- the sensor patch may also include an electrogel 807 positioned within the central cavity 607.
- the electrogel can help enhance electrical connection between the electrode 901 and the skin surface and is particularly useful in applications where the electrode is not provided the nubs as shown in FIGS. 6 and 7.
- FIG. 11 illustrates still another example, where the mounting structure is integrated with the electrode in the form of plating with an electrically conductive material 709, such as Ag/AgCI or other material.
- another electrode 901 may be mounted within the central cavity 607.
- An electrical insulation member 1101 may be provided to prevent short circuiting between the electrically conductive material 709 and the electrode 901.
- the sensor patches 601, 801, 1001 of FIGS. 6-11 can also include a skin-friendly adhesive patch 609 mounted with respect to the mounting structure 701.
- the skin-friendly adhesive patch may comprise a hydrocolloid adhesive patch or other adhesive material.
- a foam flexible material layer 611 may also be provided that provides flexibility to the patch.
- a woven or nonwoven backing 613 may be adhered with a tie layer 615 to tie together the skin-friendly adhesive patch 609 with the mounting structure 701.
- the skin-friendly adhesive patch 609 may circumscribe the mounting structure 701 to more securely adhere the sensor patch in place.
- the nubs may help reduce lateral movement without penetrating the skin.
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Abstract
A wireless sensor patch (201) can include a cushion layer (215) with a plurality of apertures (215a), positioned to extend between the electronic component (205) and the flexible cover patch (219). In one example, a wireless sensor patch can include a printed circuit board (203) with a plurality of apertures (203a). In yet another example, a sensor patch comprises a sensor module removably mounted to a skin interface module (403). In still another example, a sensor patch includes a mounting structure with a plurality of nubs (703)protruding from an outer face of the mounting structure. The plurality of nubs each include a blunt apex configured to inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface.
Description
SENSOR PATCHES
Cross-Reference to Related Application
[0001] The present application claims the benefit of U.S. Provisional Application No. 62/006,356 filed on June 2, 2014, which is incorporated herein by reference in its entirety.
Field of the Invention
[0002] The present invention relates to sensor patches and, more particularly, to sensor patches for mounting to a skin surface of a patient.
Background of the Invention
[0003] It is known for sensors to monitor various parameters of a patient. Such sensors may include temperature sensors, Electrocardiogram (ECG) sensors, Galvanic Skin Response (GSR) sensors depending on the application of the sensor. In some applications, the sensors may be attached by wire to a device configured to process and/or display information obtained by the sensors. In further examples, sensors are known to comprise wireless sensors that communicate with another device wirelessly. There is a continued desire to provide wired and wireless sensor patches to monitor various parameters of a patient.
Brief Summary of the Invention
[0004] The embodiments of the present invention described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present invention.
[0005] In a first aspect of the disclosure, a wireless sensor patch comprises a printed circuit board and at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board. The wireless sensor patch further includes a skin-friendly adhesive patch mounted to a second side of the printed circuit board. A flexible cover patch is mounted with respect to the skin-friendly adhesive patch with the electronic component positioned within a space between the flexible cover patch and the skin-friendly adhesive patch. A cushion layer is positioned to extend between the electronic component and the flexible cover patch, wherein the cushion layer includes a plurality of apertures configured to permit fluid passage through the cushion layer.
[0006] In one example of the first aspect, the printed circuit board includes a plurality of apertures configured to permit fluid passage through the printed circuit board. In one particular example, the wireless sensor patch further includes a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board. The tie layer includes a plurality of apertures configured to permit fluid passage through the tie layer, wherein the plurality of apertures of the tie layer are each aligned with a corresponding aperture of the printed circuit board.
[0007] In another example of the first aspect, the cushion layer comprises a fabric. In one example, the fabric comprises a nonwoven fabric.
[0008] The first aspect discussed above may be provided alone or in combination with any one or more of the examples of the first aspect discussed above.
[0009] In a second aspect of the disclosure, a wireless sensor patch comprises a printed circuit board including a plurality of apertures configured to permit fluid passage through the printed circuit board. The wireless sensor patch further includes at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board. A skin-friendly adhesive patch is mounted to a second side of the printed circuit board and a flexible cover patch is mounted with respect to the skin-friendly adhesive patch with the electronic component positioned within a space between the flexible cover patch and the skin-friendly adhesive patch.
[0010] In one example of the second aspect, the wireless sensor patch further comprises a cushion layer positioned to extend between the electronic component and the flexible cover patch. In one example, the cushion layer comprises a fabric. In one particular example, the cushion layer comprises a nonwoven fabric.
[0011] In another example of the second aspect, the wireless sensor patch further includes a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board. The tie layer includes a plurality of apertures configured to permit fluid passage through the tie layer. The plurality of apertures of the tie layer are each aligned with a corresponding aperture of the printed circuit board.
[0012] The second aspect discussed above may be provided alone or in combination with any one or more of the examples of the second aspect discussed above.
[0013] In one example of the first aspect and/or the second aspect discussed above, the wireless sensor patch further includes a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board.
[0014] In another example of the first aspect and/or the second aspect, the wireless sensor patch further includes at least one electrode extending from a second side of the printed circuit board and extending through a through aperture defined by the skin-friendly adhesive patch. In one example,
an electrode insulation member positioned within the through aperture defined by the skin-friendly adhesive patch and circumscribing the electrode to prevent contact between the electrode and the skin- friendly adhesive patch. In one particular example, the electrode extends through an aperture defined by the electrode insulation member. In still another example, the electrode insulation member is received within a single through aperture defined by the skin-friendly adhesive patch. In another example, the electrode insulation member is 8-shaped.
[0015] In still another example of the first aspect and/or the second aspect, the wireless sensor patch further includes at least a first electrode and a second electrode that each extend from a second side of the printed circuit board and each extend through at least one through aperture defined by the skin-friendly adhesive patch. In one example, at least one electrode insulation member is positioned within the at least one through aperture of the skin-friendly adhesive to prevent contact between at least one of the electrodes and the skin-friendly adhesive patch. In one particular example, the electrode insulation member prevents both the first electrode and the second electrode from contacting the skin-friendly adhesive patch. In another example, the electrode insulation member includes a first aperture receiving the first electrode and a second aperture receiving the second electrode. In still another example, the electrode insulation member is received within a single through aperture defined by the skin-friendly adhesive patch. In another example, the electrode insulation member is 8-shaped.
[0016] In still another example of the first aspect and/or the second aspect, the flexible cover patch has a footprint that is larger than a foot print of the skin-friendly adhesive patch.
[0017] In yet another example of the first aspect and/or the second aspect, an adhesive footprint of the wireless sensor patch includes a skin-friendly adhesive portion defined by the skin- friendly adhesive patch that is circumscribed by a peripheral adhesive portion defined by an adhesive layer of the flexible cover patch.
[0018] In still another example of the first aspect and/or the second aspect, the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
[0019] The first aspect and/or second aspect discussed above may be provided alone or in combination with any one or more of the examples of the first aspect and/or the second aspect discussed above.
[0020] In a third aspect of the disclosure, a sensor patch comprises an interface module configured to mount the sensor patch to a skin surface of a patient. The sensor patch further includes a sensor module removably mounted to the skin interface module.
[0021] In one example of the third aspect, the sensor module is magnetically mounted to the skin interface module.
[0022] In another example of the third aspect, the sensor patch comprises a wireless sensor patch.
[0023] In still another example of the third aspect, the sensor module includes a printed circuit board and at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board. In one example, at least one magnet removably mounts the printed circuit board to the interface module. In another example, the sensor module includes a flexible cover patch mounted with respect to the printed circuit board with the electronic component positioned within a space between the flexible cover patch and the printed circuit board.
[0024] In yet another example of the third aspect, the interface module comprises an adhesive patch. In one example, the adhesive patch comprises a skin-friendly adhesive patch. In one particular example, the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
[0025] In a further example of the third aspect, the interface module further comprises at least one electrode. In one example, the sensor patch further includes an electrode insulation member circumscribing the electrode. In one particular example, the electrode extends through an aperture
defined by the electrode insulation member. In another example, the electrode is configured to provide a removable magnetic mounting of the sensor module to the skin interface module. In one particular example, the at least one electrode comprises a magnet attracted to the sensor module to provide the removable magnetic mounting of the sensor module to the skin interface module. In an additional or alternative particular example, the sensor module includes at least one magnet attracted to the at least one electrode to provide the removable magnetic mounting of the sensor module to the skin interface module. In another example, the least one electrode comprises at least a first electrode and a second electrode.
[0026] The third aspect discussed above may be provided alone or in combination with any one or more of the examples of the third aspect discussed above.
[0027] In a fourth aspect of the disclosure, a sensor patch includes an electrode configured to sense an electrical signal from a skin surface and a mounting structure including a plurality of nubs protruding from an outer face of the mounting structure. The plurality of nubs each include a blunt apex configured to inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface.
[0028] In one example of the fourth aspect, the blunt apex includes a radius that is greater than or equal to about 0.1 mm.
[0029] In another example of the fourth aspect, the plurality of nubs each protrude with a nub height from the outer face of the mounting structure, and the nub height of each nub is less than or equal to about 2 mm.
[0030] In still another example of the fourth aspect, the plurality of nubs each include an average maximum width along a height of the nub that is greater than or equal to about 0.5 mm.
[0031] In yet another example of the fourth aspect, the plurality of nubs each include an aspect ratio of a nub height with respect to an average maximum width along the nub height that is less than or equal to about 1.3.
[0032] In still another example of the fourth aspect, the mounting structure comprises plastic.
[0033] In a further example of the fourth aspect, the mounting structure is plated with an electrically conductive material. In one particular example, the electrically conductive material comprises Ag/AgCI.
[0034] In still a further example of the fourth aspect, the plurality of nubs are arranged in a peripheral array about a central axis of the mounting structure. In one particular example, the plurality of nubs are arranged in a circular peripheral array about the central axis of the mounting structure. In another particular example, the mounting structure defines a central cavity circumscribed by the peripheral array of nubs. In one example, an electrode is positioned within the central cavity. In another example, a temperature sensor is positioned within the central cavity. In still another example, an electrogel is positioned within the central cavity.
[0035] In another example of the fourth aspect, the sensor patch further comprises a skin- friendly adhesive patch mounted with respect to the mounting structure. In one particular example, the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch. In another particular example, the skin-friendly adhesive patch circumscribes the mounting structure.
[0036] The fourth aspect may be provided alone or in combination with any one or more of the examples of the fourth aspect discussed above.
Brief Description of the Drawings
[0037] These, as well as other objects and advantages of this invention, will be more completely understood and appreciated by referring to the following more detailed description of the
presently preferred exemplary embodiments of the invention in conjunction with the accompanying drawings, of which:
[0038] FIG. 1 is example an example of a wired or wireless sensor patch in accordance with aspects of the disclosure applied to a skin surface of a patient;
[0039] FIG. 2 is a sectional view of an example wireless sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
[0040] FIG. 3 is a bottom view of the wireless sensor patch of FIG. 2 along line 3-3 of FIG. 2, wherein the release liner is not illustrated for clarity.
[0041] FIG. 4 is a sectional view of another example wireless sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1, wherein a skin interface module is mounted to the skin surface of the patient and a sensor module is removably mounted to the skin interface module;
[0042] FIG. 5 illustrates the wireless sensor patch of FIG. 4 with a sensor module being removed from a skin interface module, while the skin interface module remains mounted to the skin surface of the patient;
[0043] FIG. 6 is a perspective view of an example wired sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
[0044] FIG. 7 is a sectional view of the wired sensor patch along line 7-7 of FIG. 6, wherein the wired sensor patch is mounted to the skin surface of the patient;
[0045] FIG. 8 is a perspective view of another example wired sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
[0046] FIG. 9 is a sectional view of the wired sensor patch along line 9-9 of FIG. 8, wherein the wired sensor patch is mounted to the skin surface of the patient;
[0047] FIG. 10 is a perspective view of still another example wired sensor patch in accordance with aspects of the disclosure that may be provided as the sensor patch of FIG. 1;
[0048] FIG. 11 is a sectional view of the wired sensor patch along line 11-11 of FIG. 10, wherein the wired sensor patch is mounted to the skin surface of the patient;
[0049] FIG. 12 schematically illustrates an enlarged view of a mounting structure of the wired sensor patches of FIGS. 6-11 at view 12 of FIGS. 7, 9 and 11;
[0050] FIG. 13 is a sectional view of an example nub of the mounting structure along line 13-13 of FIG. 12 with an outer sectional profile in a shape of a circle;
[0051] FIG. 14 is a sectional view of another example nub along line 13-13 of FIG. 12 with an outer sectional profile in a shape of an ellipse;
[0052] FIG. 15 is a sectional view of still another example nub along line 13-13 of FIG. 12 with an outer sectional profile in a shape of a rectangle; and
[0053] FIG. 16 is a sectional view of yet another example nub along line 13-13 of FIG. 12 with an outer sectional profile in a shape of a triangle.
Detailed Description of the Invention
[0054] The present invention is now illustrated in greater detail by way of the following detailed description which represents the best presently known mode of carrying out the invention. However, it should be understood that this description is not to be used to limit the present invention, but rather, is provided for the purpose of illustrating the general features of the invention.
[0055] FIG. 1 illustrates a wired or wireless sensor patch 101 in accordance with aspects of the present disclosure. The sensor patch 101 can be designed to monitor various parameters of a patient 103. For instance, as shown, the sensor patch 101 may be adhered to a skin surface 105 of the patient 103. Any of the sensor patches discussed throughout the disclosure may be adhered to various
alternative skin surfaces of the patient. For instance, the sensor patch may be adhered to the chest of a patient (e.g., as shown in FIG. 1), on the arm (e.g., on the back of the arm) of the patient or various other locations of the patient depending on the circumstances.
[0056] As discussed below, the sensor patch 101 can include at least one sensor configured to monitor any one or combination of parameters. For instance, the sensor can comprise a Galvanic Skin Response (GSR) sensor configured to detect changes in the resistance of skin to electrical current due to changes in skin perspiration. Measuring the change in skin perspiration can be designed to detect various physiological and/or psychological conditions. In addition or alternatively, one or more Electrocardiogram (ECG) sensors may be provided to monitor the condition of the heart muscle in a patient. In still further examples, the sensors may be designed to detect features of the skin (e.g., temperature, glucose levels, levels of chemicals, pharmaceuticals, etc.). As such, the sensor patch may have a wide range of applications.
[0057] With wireless configurations, the wireless sensor patch of the present disclosure can allow for comfortable application and monitoring without necessarily requiring a continuous wired connection. Moreover, the wireless sensor patch can be inexpensively produced, thereby rendering the patch potentially disposable. In disposable applications, a new wireless sensor patch to be provided for each application; thereby avoiding expensive sanitation and cleaning procedures.
[0058] Wireless configurations may provide the sensor patch 101 with a memory device configured to store data collected by the sensor device. In addition or alternatively, the wireless sensor patch 101 may include a transmitter configured to transmit wireless signals 107 (e.g., by way of Bluetooth wireless technology) to be received by a device 109. The device 109 may be a cell phone or other receiving device that may in turn relay the information by satellite to another location for processing. In further examples, the wireless sensor patch may include a USB port or other interface to allow periodic wired connections (e.g., see wire 113 in FIG. 1) with the wireless sensor patch. In such
examples, after a period of time, the patient may temporarily provide a wired connection with the wire 113 extending between the patch and the device 109 (e.g., by a USB cable) to provide communication between the device and the wireless sensor patch. In such a manner, information may be gathered by the device 109 continuously (e.g., by a wireless connection) in real time when synced with the device 109 and/or may be periodically sent to the device 109 when the patient makes a wired or other direct connection between the device 109 and the wireless patch. Such wired or wireless connections can be used to download information from the wireless sensor patch to the device 109 such as information gathered from the patient and/or current information about the wireless sensor patch. In further examples, the wired or wireless connection may allow information or commands to be uploaded from the device 109 to the wireless sensor patch. For instance commands may be uploaded to change an operating condition of the patch, to provide information to be displayed by the patch, and/or other functionality.
[0059] With wired configurations, the wired sensor patch of the present disclosure can allow for comfortable application and while providing periodic or continuous wired connections with the wire 113 that may periodically or continuously provide communication to and/or from the wired sensor patch 101. Moreover, as with wireless configurations, the wired sensor patch may be inexpensively produced. The wired configurations may therefore also provide inexpensively produced wired configurations. These inexpensive wired configurations may also be disposable, thereby allowing a new sensor patch to be used with each application to avoid expensive sanitation and cleaning procedures.
[0060] With wired configurations, the sensor patch 101 may optionally be provided with a memory device configured to store data collected by the sensor device. The data may then be continuously or periodically transferred to the device 109. In further examples, a wired sensor patch 101 may be provided without a memory device. In such applications, the data may be immediately, such as continuously, transferred to the device 109. The device 109 may be a cell phone or other
receiving device that may in turn relay the information by satellite to another location for processing. In further examples, the wired sensor patch may include a USB port or other interface to allow wired connections (e.g., see wire 113 in FIG. 1) with the wired sensor patch. In such examples, during periods of non-use, the wire may be disconnected from the wired sensor patch. The wired sensor patch can be reattached to the wire with the interface in use.
[0061] In the wired or wireless configurations, the wired or wireless connections can be used to download information from the wireless sensor patch to the device 109 such as information gathered from the patient and/or current information about the wireless sensor patch. In further examples, the wired or wireless connection may allow information or commands to be uploaded from the device 109 to the wireless sensor patch. For instance commands may be uploaded to change an operating condition of the patch, to provide information to be displayed by the patch, and/or other functionality.
[0062] In further examples, the device 109 may comprise a storage unit configured to store data being transmitted by the sensor patch 101. In further examples, the device 109 may comprise a processing unit configured to process the data. In still further examples, the device 109 may optionally transmit wireless signals 111 or signals through the wire 113 to be received by the sensor patch 101. For example, the device 109 may send command signals to the sensor patch 101 to change an operating condition of the sensor patch 101.
[0063] FIG. 2 is a schematic sectional view of an example wireless sensor patch 201 in accordance with aspects of the disclosure that may be provided as the sensor patch 101 schematically illustrated in FIG. 1. The wireless sensor patch 201 can include a printed circuit board 203. In some examples, the printed circuit board can comprise a flexible circuit board although substantially nonflexible or even rigid printed circuit boards may be provided in further examples. The printed circuit board 203 can be provided with at least one electronic component, such as the illustrated plurality of
various electronic components 205 (e.g., silicon packaged electronic components), mounted to the printed circuit board 203. The printed circuit board 203 is designed to allow a certain amount of flexing to permit partial or entire conformance of the printed circuit board 203 to the skin surface 105 of the patient 103. As shown, the one or more electronic components 205 extend from a first side of the printed circuit board 203 and may be selected in accordance with the desired characteristics of the sensor. For example, the electronic components 205 may be provided to give the wireless sensor patch 201 any one or combination of functional capabilities described with respect to the wireless sensor patch 101 above. In some examples, at least one electrode, such as the illustrated plurality of electrodes 207a, 207b, may be provided to extend from a second side of the printed circuit board 203. Various electrode configurations may be provided such as an Ag/AgCI electrode with an optional electrolyte gel. The one or more electrodes may be placed in operable communication with an electrical trace or other portion of an electrical circuit supported by the substrate of the printed circuit board 203. For example, a conductive coupling element 209 may be used to fix the electrodes 207a, 207b to the appropriate location of the printed circuit board 203. In some examples, the conductive coupling element 209 may comprise a conductive pressure sensitive adhesive and/or gel.
[0064] A skin-friendly adhesive patch 211 may be mounted with respect to a second side of the printed circuit board 203. In one example, the skin-friendly adhesive patch 211 may comprise a hydrocolloid adhesive patch although other skin-friendly adhesives may be provided such as integrated hydrocolloid or other adhesives capable of absorbing moisture. For example, the skin-friendly adhesive patch 211 can comprise a hydrocolloid such as the hydrocolloid material disclosed in any one of U.S. Patent No 7,335,416 that issued on February 6, 2008, U.S. Patent No 6,710,100 that issued on March 23, 2004, U.S. Patent No 6,583,220 that issued on June 24, 2003, U.S. Patent No 6,326,421 that issued on December 4, 2001, U.S. Patent Application No. 12/866,750 filed August 9, 2010, and U.S. Provisional Patent 61/467,553 filed March 25, 2011, which are herein incorporated by reference in their entireties.
[0065] The wireless sensor patch 201 can further include a tie layer 213 configured to mount the skin-friendly adhesive patch 211 to the second side of the printed circuit board 203. The tie layer 213 may comprise a double-coated breathable material or may simply comprise a double-sided adhesive tape. In some examples, the printed circuit board 203 can include a plurality of apertures 203a configured to permit fluid passage through the printed circuit board 203 from the skin-friendly adhesive patch 211. In some examples, the tie layer 213, if provided, may also include a plurality of apertures 213a that are likewise configured to permit fluid passage through the tie layer 213 from the skin-friendly adhesive patch 211. As shown in FIG. 2, the plurality of apertures 213a of the tie layer 213 are each aligned with a corresponding aperture of the plurality of apertures 203a of the printed circuit board 203. As shown in FIG. 2, all of the plurality of apertures 213a are aligned although some of the apertures may not be aligned in further examples. The apertures of the printed circuit board and/or the tie layer may comprise perforations or relatively larger openings as shown in FIG. 2. In alternative examples, one of the printed circuit board or the tie layer may include relatively larger apertures than the other of the printed circuit board and the tie layer. For instance, the printed circuit board may include a pattern of relatively large apertures while the tie layer may include perforations wherein more than one of the apertures of the tie layer may be aligned with a corresponding single aperture in the printed circuit board. In such a manner, it may be easier to align apertures such that fluid may pass through the tie layer and the printed circuit board from the skin-friendly adhesive patch.
[0066] Any of the wireless sensor skin patches discussed in the invention disclosure may include a cushion layer for patient comfort, to help protect the printed circuit board, to protect other electrical components such as electrical components associated with the printed circuit board, and/or to help absorb moisture. For example, as shown further illustrated in FIG. 2, the wireless sensor patch 201 can further include a cushion layer 215 that may help protect the printed circuit board 203 and/or associated electronic components 205 from damage. Indeed, the cushion layer 215 may protect the
circuit board and/or electronic components from externally applied forced (e.g., impact forces) that may otherwise damage the wireless sensor patch 201. Moreover, the cushion layer 215 may also enhance comfort to the patient wearing the patch or other individuals encountering the wireless sensor patch 201. Indeed, rather than encounter relatively rigid electronic components 205, the cushion layer 215 may act as a protective bumper to avoid otherwise unpleasant encounters with the relatively rigid electronic components. In further examples, the cushion layer 215 may be configured to absorb liquid. For example, liquid from the skin-friendly adhesive patch 211 may pass through the apertures 213a, 203a of the tie layer 213 and the printed circuit board 203, respectively, and thereafter be absorbed by the cushion layer 215. As such, the liquid may be wicked away from contacting, and possibly damaging, the electronic components 205.
[0067] In one example, the cushion layer 215 may comprise a fabric represented by the cross-hatch pattern illustrated in the drawings. The illustrated fabric of the cushion layer 215 comprises a nonwoven fabric although woven fabrics may be provided in further examples. In some examples of the disclosure, the cushion layer 215 may include a plurality of apertures 215a configured to permit fluid passage through the cushion layer 215. The apertures 215a may comprise relatively large apertures although the apertures may comprise perforations in further examples. Moreover, in some applications, the cushion layer 215 may be fabricated from a material that allows permeation of fluid through the cushion layer 215. In such examples, the apertures of the cushion layer 215 may be considered the fluid communication pathways of the fabric of the cushion layer. For example, if the cushion layer comprises a woven fabric, the apertures may be considered to be provided by the negative space not occupied by the network of woven fibers of the woven fabric. In further examples, if the cushion layer is not provided from a fluid permeable material, holes or other apertures may be punched through the cushion layer to allow fluid communication through the cushion layer. In still further examples, even if the cushion layer comprises fluid permeable material, still further apertures may be provided (e.g.,
punched or otherwise provided) in the cushion layer to further increase permeability of fluid through the cushion layer.
[0068] The cushion layer 215 may also include an adhesive applied to a surface 217 facing the electronic components and printed circuit board. For example, the surface 217 may be provided with a pressure sensitive adhesive that may facilitate mounting of the cushion layer 215 in place by adhesive mounting to the electronic components 205, printed circuit board 203, the tie layer 213 and/or the skin-friendly adhesive patch 211.
[0069] The wireless sensor patch 201 can further include a flexible cover patch 219 with outer edge 223 mounted with respect to the skin-friendly adhesive patch 211 with the electronic component 205 positioned within a space between the flexible cover patch 219 and the skin-friendly adhesive patch 211. As shown, the flexible cover patch 219 can be positioned over the cushion layer 215 such that the cushion layer 215 is positioned to extend between the electronic component 205 and the flexible cover patch 219. The flexible cover patch 219 may comprise a polymeric member, such as a closed cell foam material that may be substantially water resistant yet breathable to help protect the electrical components 205 and the printed circuit board 203.
[0070] FIG. 3 is a bottom view of the wireless sensor patch 201 wherein a release liner 221 (shown in FIG. 2), designed to preserve the adhesive surfaces from contamination prior to application, is not illustrated for clarity. As represented by the vertical lines set forth in FIG. 3, the flexible cover patch 219 may also include an adhesive layer 301 designed to mount the flexible cover patch 219 to the cushion layer 215. The adhesive layer 301 can comprise a pressure sensitive adhesive such as rubber- based adhesive, acrylic adhesive or silicone adhesive that allows a peripheral adhesive portion 303b defined by an adhesive layer 301 of the flexible cover patch 219 to immediately adhere to the skin surface 105 upon application of the wireless sensor patch 201. Moreover, as mentioned previously, the wireless sensor patch 201 can comprise the skin-friendly adhesive patch 211.
[0071] As further shown in FIG. 3, the peripheral adhesive portion 303b at an outer periphery of the adhesive layer 301 can circumscribe a skin-friendly portion 303a of the skin-friendly adhesive patch 211. Indeed, as apparent in FIG. 2-3, the flexible cover patch 219 of the wireless skin patch 201 can have a footprint that is larger than a foot print of the skin-friendly adhesive patch 211. As such, each wireless skin patch of the present disclosure can include an adhesive footprint with a skin- friendly adhesive portion defined by the skin-friendly adhesive patch that is optionally circumscribed by a peripheral adhesive portion defined by an adhesive layer of the flexible cover patch. For instance, by way of illustration, FIG. 3 illustrates an adhesive footprint of the wireless skin patch 201 with the skin- friendly portion 303a defined by the skin-friendly adhesive patch 211 that is circumscribed by the peripheral adhesive portion 303b defined by an adhesive layer 301 of the flexible cover patch 219.
[0072] As such, an outer peripheral adherence of the wireless sensor patch 201 to the skin surface 105 of the patient 103 may be achieved. At the same time, the skin-friendly adhesive patch 211 may be held in place against the skin surface 105 to allow sufficient time for the skin-friendly adhesive patch 211 to cure into an effective adhesive member. The skin-friendly adhesive patch 211 allows the wireless sensor patch 201 to be applied to the skin surface for a significant length of time without aggravating the skin surface when compared to the adhesive layer 301. At the same time, a relatively small peripheral portion 303b of the adhesive layer 301 may allow the peripheral portions of the patch to be immediately adhered to the skin surface while allowing the skin-friendly portion 303a of the skin- friendly adhesive patch 211 sufficient time to cure.
[0073] In any of the example wireless or wired sensor patches described throughout the disclosure using a skin-friendly patch with electrodes extending through the skin-friendly patch, such sensor patches may be provided with an optional electrode insulation member. For example, as illustrated in FIGS. 2-3, an electrode insulation member 225 may be positioned within at least one through aperture 227. Although a single aperture 227 is shown, a plurality of apertures may be
provided in further examples wherein at least one of the apertures includes an electrode insulation member 225. The electrode insulation member 225 can circumscribe at least one electrode to prevent contact between the circumscribed electrode and the skin-friendly adhesive patch 211. For example, as shown, the electrode insulation member 225 may circumscribe both of the electrodes 207a, 207b although the electrode insulation member 225 may circumscribe a single electrode or less than all of a plurality of electrodes in further examples. In some examples, the electrode insulation member 225 is designed to electrically insulate the electrodes 207a, 207b from one another or other components. In one example, the electrode insulation member can comprise a closed-cell foam, nonwoven fabric or other material configured to electrically insulate one or more of the electrodes. Electrical insulation can be particularly beneficial since the skin-friendly adhesive patch 211 will tend absorb significant levels of liquid (e.g., water) from the skin surface 105 of a patient 103 over time. The electrode insulation member 224 can prevent direct exposure of the electrodes 207a, 207b to the skin-friendly adhesive patch 211, thereby avoiding undesired electrical communication (e.g., short circuiting) of the electrodes 207a, 207b that may otherwise occur through the saturated skin-friendly adhesive patch 211.
[0074] In one example, the electrodes may extend through an aperture of the electrode insulation member 225. For instance, as shown in FIG. 3, the first electrode 207a may extend through a first aperture 305a of the electrode insulation member 225 while the second electrode 207b may extend through the second aperture 305b. As such, in some examples each electrode 207a, 207b can extend through a single through aperture 227 of the skin-friendly adhesive patch 211 while extending through corresponding apertures 305a, 305b of the electrode insulation member 225. In such an example, the electrode insulation member 225 can therefore prevent both the first electrode 207a and the second electrode 207b from contacting the skin-friendly adhesive patch 211. Insulating both electrodes can help further electrically insulate the electrodes from one another and/or from other components. Although not shown, the electrode insulation member may be provided to insulate a
single electrode. Insulating a single electrode may reduce material costs, increase available skin-friendly adhesive surface area contact with the skin while still electrically insulating the insulated electrode from the remaining electrode(s).
[0075] As further shown in FIG. 3, the electrode insulation member 225 can optionally comprise bulbous portions 307a, 307b having a footprint larger than the corresponding footprint of the electrodes 207a, 207b to allow the electrode insulating member to circumscribe each of the electrodes. Moreover, a reduced neck portion 309 may be provided between the bulbous portions 307a, 307b such that the outer periphery 311 of the electrode insulation member 225 together with the apertures 305a, 305b provides the electrode insulation member 225 as an 8-shaped electrode insulation member having a shape of the number "8". Providing the reduced neck portion 309 allows the bulbous portions to be connected together while still maximizing the surface area of the skin-friendly adhesive available for contacting the skin surface. Still further, the reduced neck portion can help increase the electrical insulation properties in the area positioned between the electrodes, thereby enhancing thermal insulation characteristics while maximizing the surface area of the skin-friendly adhesive available for contacting the skin surface. Although not shown, the bulbous portions 307a, 307b may simply comprise donuts that are not connected to one another. In such an example, a single donut may be provided about a single electrode to electrically insulate a selected electrode from the other electrode(s) and/or other components. Alternatively, a plurality of donuts may be provided, for example, about each electrode to electrically insulate all of the electrodes from one another and/or other components.
[0076] The wireless sensor patch 201 shown in FIGS. 2-3 may be easily applied to the skin surface 105 of a patient 103. The release liner 221 shown in FIG. 2 may be removed to expose the adhesive layer 301 of the flexible cover patch 219 and the skin-friendly adhesive patch 211. Next, the wireless sensor patch 201 may be applied to the skin surface 105 of a patient 103 at an appropriate location. Once applied, the outer peripheral portion 303b of the adhesive layer 301 immediately
mounts the wireless sensor patch 201 in place, wherein, after sufficient time, the skin-friendly adhesive patch 211 cures to provide the primary bonding while reducing irritation and/or aggravation to the skin layer that may otherwise occur over long periods of time with only the relatively harsh adhesive layer 301. In use, the skin-friendly adhesive patch 211 may absorb liquid. To easily release the liquid, a fluid (e.g., vapor, gas from the absorbed liquid) or the absorbed liquid itself may pass through the apertures 213a of the tie layer 213 and the apertures 203a of the printed circuit board 203. The liquid may then eventually pass through the vapor permeable flexible cover patch 219 to be released to the surrounding atmosphere. In such a way, liquid build-up such as perspiration from the skin surface may be avoided and may pass through the sensor patch. If provided, the cushion layer 215 may also absorb fluid (e.g., liquid such as perspiration) that passes through the apertures of the printed circuit board 203. The cushion layer 215 may be designed with the capacity to handle absorbing all of the liquid for the period of time that the sensor patch will be mounted to the skin surface of the patient. Alternatively, the cushion layer 215 may include the plurality of apertures 215a to further help pass liquid or other fluids to be passed through the cushion layer to be released through the flexible cover patch 219 and into the surrounding environment.
[0077] FIG. 4 is a schematic sectional view of another example sensor patch 401 in accordance with aspects of the disclosure that may be provided as the sensor patch 101 schematically illustrated in FIG. 1. As shown, the sensor patch 401 comprises a wireless sensor patch although wired sensor patches may be provided in further examples. The sensor patch 401 includes an interface module 403 configured to mount the sensor patch 401 to the skin surface 105 of the patient 103. In one example, unless otherwise indicated, the interface module 403 can have identical or similar features to the construction of the skin-friendly adhesive patch 211, electrode insulation member 225 and the electrodes 207a, 207b. Indeed, as shown in FIGS. 4 and 5, the interface module 403 can include an adhesive patch 407 that, in one example, may comprise a skin-friendly adhesive patch. As with the skin-
friendly adhesive patch 211 discussed above, the skin-friendly adhesive patch 407 can comprise a hydrocolloid adhesive patch.
[0078] The interface module 403 of the sensor patch 401 can further include at least one electrode. For instance, in the illustrated example, the at least one electrode comprises at least a first electrode 409a and a second electrode 409b although, as with the sensor patch 201 described with respect to FIGS. 2-3 above, three or more electrodes may be provided in still further examples. The interface module 403 of the sensor patch 401 can further include an optional electrode insulation member 411 that may be similar or identical in construction and shape as the electrode insulation member 225 discussed with respect to the wireless sensor patch 201 discussed with reference to FIGS. 2-3 above. Indeed, the electrode insulation member 225 circumscribe one or more (e.g., all) of the electrodes 409a, 409b. Moreover, the electrodes 409a, 409b can extend through an aperture 413 defined by the electrode insulation member 225.
The sensor patch 401 includes a sensor module 405. In one example, features of the sensor module may be identical or similar to the configuration shown in the wireless sensor patch 201 of FIGS. 2-3. For example, the sensor module 405 may include a printed circuit board 415 and at least one electronic component 417 mounted to the printed circuit board 415 and extending from a first side 419 of the printed circuit board 415. The printed circuit board 415 can be similar or identical in construction as the printed circuit board 203 discussed with respect to the sensor patch 201 of FIGS. 2-3 above. Moreover, as with the printed circuit board 203, the printed circuit board 415 of the sensor patch 401 can comprise a flexible circuit board although substantially nonflexible or even rigid printed circuit boards may be provided in further examples. In still further examples, line the sensor patch 201 of FIGS. 2-3 above, as illustrated in FIGS. 4 and 5, the sensor module 405 may likewise include a similar or identical flexible cover patch 421 mounted with respect to the printed circuit board 415 with the
electronic component 417 positioned within a space 423 between the flexible cover patch 421 and the printed circuit board 415.
[0079] The sensor module 405 may be removably mounted to the skin interface module 403. In such a manner, the sensor module 405 may be removed from the skin interface module 403 while the skin interface module 403 remains mounted to the skin surface 105 of the patient 103. As such, the sensor module 405 may be easily removed for cleaning, recharging, transferring information to another device or the like. Moreover, the sensor module 405 may be removed prior to the patient being exposed to environments that may otherwise be potentially hazardous to the sensor module. For example, the patient may easily remove the sensor module 405 prior to being exposed to water when bathing or the like. As such, fabricating the sensor module 405 with a water-proof construction is not necessarily required since the sensor module may be easily removed prior to expected exposure to such environments. At the same time, the interface module 403 may remain attached to the skin surface 105 of the patient 103 to avoid disturbing the skin surface or the coupling of the electrodes to the skin surface. As such, in some examples, the interface module 403 may be applied once, perhaps by qualified medical professionals, who can confirm successful mounting of the skin-patch and electrical communication of the electrodes with the skin surface. Once the interface module is correctly installed, there is no need to disturb the interface since the patient may easily remove and reattach the sensor module while the interface module remains mounted to the skin surface.
[0080] Various features may be provided to allow the sensor module 405 to be removably mounted to the skin interface module 403. For example, various mechanical fasteners, such as snaps, hook and loop fasteners, reusable releasing adhesives, or the like may be used in accordance with aspects of the disclosure. In further examples, the sensor module 405 may be magnetically mounted to the skin interface module 403. Indeed, one or both of the sensor module 405 and/or the interface module 403 may include one or more magnets configured to removably magnetically mount the sensor
module 405 to the skin interface module 403. The sensor patch 401 illustrates both the sensor module 405 and the skin interface module 403 including magnets configured to cooperate with one another to provide removable mounting. In one example, at least one magnet may be provided to removably mount the printed circuit board 415 to the interface module.
[0081] In one example, as shown in FIG. 5, the printed circuit board 415 may comprise one or more magnets 501a, 501b that may be arranged to be attracted to the electrodes 409a, 409b. As such, the electrodes may optionally be configured to provide the removable magnetic mounting of the sensor module to the skin interface module. In one example, the electrodes may also comprise magnets arranged to be attracted to the magnets 501a, 501b provided by the printed circuit board 415. Providing the electrodes as magnets, in addition to the magnets of the printed circuit board, can enhance the strength of the connection between the modules and/or reduce the size of the magnets necessary to achieve a sufficient level of strength. Still further, providing both the interface module 403 and the sensor module 405 with a plurality of magnets can help properly mount the interface module and the sensor module in the desired orientation. For example, as shown in FIG. 5, the magnet 501a may be mounted such that the positive pole (+) is facing downward while the magnet 501b is mounted such that the negative pole (-) is facing downward. One of the magnetic electrode 409a can also be arranged such that the negative pole (-) faces upward while the other electrode 409b is arranged such that the positive pole (+) faces upward. As such, in the proper orientation shown in FIG. 5, the positive pole of the magnet 501a is attracted to the negative pole of the magnetic electrode 409a. Likewise, the negative pole of the magnet 501b is attracted to the positive pole (+) of the magnetic electrode 409b. Accordingly, in the illustrated orientation, the sensor module 405 would be magnetically mounted to the interface module 403 in the manner shown in FIG. 4. However, if a patient attempts to mount the sensor module in an improper orientation, the magnets will resist mounting. For example, in a reverse orientation, the negative pole (-) of the magnet 501b would repel the negative pole (-) of the magnetic
electrode 409a. Similarly, the positive pole (+) of the magnet 501a would repel the positive pole (+) of the magnetic electrode 409b. As such, an attempt to mount in the incorrect orientation would not be possible as the like poles of the magnets would repel one another, providing an indication to the patient to reorient the sensor module in the prior position.
[0082] In further examples, the electrodes may comprise magnets and the magnets 501a, 501b of the printed circuit board may simply comprise ferrous metal members or other members attracted to a magnet. In still further examples, the magnets 501a, 501b are only provided in the printed circuit board while the electrodes are not magnetized. Using the electrodes to help establish the magnetic connection is not required but can be beneficial to use existing structure to form the magnetic connection. Moreover, the magnets 501a, 501b (or similar ferrous metal or the like) may be optional. For instance, magnets in the interface module may be designed to be attracted to the printed circuit board itself or other components of the sensor module.
[0083] As such, in one example, the at least one electrode of the interface module may comprise a magnet attracted to the sensor module to provide removable magnetic mounting of the sensor module to the skin interface module. In addition, or alternatively, the sensor module may include at least one magnet attracted to the at least one electrode to provide the removable magnetic mounting of the sensor module to the skin interface module. Still further, the magnetic connection can establish electrical communication between the electrodes and the circuit of the printed circuit board 415. For example, the magnets 501a, 501b or other coupling members may provide electrical communication between the electrodes 409a, 409b and the appropriate locations of the circuit. As such, once mounted as shown in FIG. 4, the electrodes 409a, 409b may each be placed in respective electrical communication with the magnets (or other interface members) 501a, 501b to establish electrical connection between the electrodes 409a, 409b and the circuit of the printed circuit board 415. As shown in FIG. 5, the sensor module 405 may be removed from the interface module 403 wherein
electrical communication between the electrodes 409a, 409b and the circuit of the sensor module 405 may be temporarily disengaged until the sensor module is then mounted with respect to the interface module as shown in FIG. 4.
[0084] Although not shown, the upper surface 407a of the adhesive patch 407 may be provided with a release liner or other membrane or structure configured to prohibit undesirable adhering of the adhesive patch 407 to the printed circuit board 415. If a release liner is provided, a further mode of functionality may be provided to allow the interface module to be permanently attached to the sensor module. For example, if removable mounting is not desired, the release liner may be removed, such that the adhesive patch may directly mount to the printed circuit board 415. In applications where the adhesive patch comprises a hydrocolloid adhesive patch or other skin-friendly adhesive, the magnetic attraction or other temporary mounting of the interface module with the sensor module may provide sufficient mounting to allow the sensor to remain in contact with the patch until the skin-friendly adhesive cures into a permanent attachment.
[0085] FIGS. 6-11 are views of further example sensor patches 601, 801, 1001 that may comprise the illustrated wired sensor patch, although a wireless sensor patch may be provided in further examples. As discussed more fully below, each sensor patch 601, 801, 1001 includes an electrode configured to sense an electrical signal from the skin surface 105. Moreover, each sensor patch 601, 801, 1001 includes a mounting structure 701 including a plurality of nubs 703 protruding from an outer face 705 of the mounting structure 701. The plurality of nubs 703 each include a blunt apex 707 configured to inhibit relative lateral movement of the mounting structure 701 relative to the skin surface 105 without penetrating the skin surface 105. As shown in FIG. 12, the blunt apex 707 may include a radius "R" that approaches infinity wherein the blunt apex is considered substantially flat.
[0086] In example nubs, the radius "R" can be 0.1 < "R" <∞, such as within a range from about 0.1 mm to about 1 mm, such as from about 0.1 mm to about 0.8 mm, such as from about 0.1 mm
to about 0.7 mm, such as from about 0.1 mm to about 0.6 mm, such as from about 0.1 mm to about 0.5 mm, such as from about 0.1 mm to about 0.4 mm, such as from about 0.1 mm to about 0.3 mm, such as from about 0.1 mm to about 0.2 mm.
[0087] In another example, the radius "R" can be 0.2 < "R" <∞, such as from about 0.2 mm to about 1 mm, such as from about 0.2 mm to about 0.8 mm, such as from about 0.2 mm to about 0.7 mm, such as from about 0.2 mm to about 0.6 mm, such as from about 0.2 mm to about 0.5 mm, such as from about 0.2 mm to about 0.4 mm, such as from about 0.2 mm to about 0.3 mm.
[0088] In still another example, the radius "R" can be 0.3 < "R" <∞, such as from about 0.3 mm to about 1 mm, such as from about 0.3 mm to about 0.8 mm, such as from about 0.3 mm to about 0.7 mm, about 0.3 mm to about 0.6 mm, such as from about 0.3 mm to about 0.5 mm, such as from about 0.3 mm to about 0.4 mm.
[0089] In yet another example, the radius "R" can be 0.4 < "R" <∞, such as from about 0.4 mm to about 1 mm, such as from about 0.4 mm to about 0.8 mm, such as from about 0.4 mm to about 0.7 mm, about 0.4 mm to about 0.6 mm, such as from about 0.4 mm to about 0.5 mm.
[0090] In another example, the radius "R" can be 0.5 < "R" <∞, such as from about 0.5 mm to about 1 mm, such as from about 0.5 mm to about 0.8 mm, such as from about 0.5 mm to about 0.7 mm, such as from about 0.5 mm to about 0.6 mm. In yet another example, the radius "R" can be 0.6 < "R" <∞, such as from about 0.6 mm to about 1 mm, such as from about 0.6 mm to about 0.8 mm, such as from about 0.6 mm to about 0.7 mm. In still another example, the radius "R" can be 0.7 < "R" <∞, such as from about 0.7 mm to about 1 mm, such as from about 0.7 mm to about 0.8 mm. In yet another example, the radius "R" can be 0.8 < "R" <∞, such as from about 0.8 mm to about 1 mm.
[0091] As further shown in FIG. 12, the plurality of nubs can each protrude with a nub height "H" extending perpendicular between an outer end of the blunt apex 707 and the outer face 705 of the mounting structure 701. In some examples, the nub height "H" can be less than or equal to about
2 mm, such as within a range of from about 0.5 mm to about 2 mm, such as from about 0.6 mm to about 2 mm, such as from about 0.7 mm to about 2 mm, such as from about 0.8 mm to about 2 mm, such as from about 0.9 mm to about 2 mm, such as from about 1 mm to about 2 mm, such as from about 1.2 mm to about 2 mm, such as from about 1.5 mm to about 2 mm, such as from about 1.7 mm to about 2 mm.
[0092] In further examples, the nub height "H" can be less than or equal to about 1.7 mm, such as within a range of from about 0.5 mm to about 1.7 mm, such as from about 0.6 mm to about 1.7 mm, such as from about 0.7 mm to about 1.7 mm, such as from about 0.8 mm to about 1.7 mm, such as from about 0.9 mm to about 1.7 mm, such as from about 1 mm to about 1.7 mm, such as from about 1.2 mm to about 1.7 mm, such as from about 1.5 mm to about 1.7 mm.
[0093] In still further examples, the nub height "H" can be less than or equal to about 1.5 mm, such as within a range of from about 0.5 mm to about 1.5 mm, such as from about 0.6 mm to about 1.5 mm, such as from about 0.7 mm to about 1.5 mm, such as from about 0.8 mm to about 1.5 mm, such as from about 0.9 mm to about 1.5 mm, such as from about 1 mm to about 1.5 mm, such as from about 1.2 mm to about 1.5 mm.
[0094] In yet further examples, the nub height "H" can be less than or equal to about 1.2 mm, such as within a range of from about 0.5 mm to about 1.2 mm, such as from about 0.6 mm to about 1.2 mm, such as from about 0.7 mm to about 1.2 mm, such as from about 0.8 mm to about 1.2 mm, such as from about 0.9 mm to about 1.2 mm, such as from about 1 mm to about 1.2 mm.
[0095] In further examples, the nub height "H" can be less than or equal to about 1 mm, such as within a range of from about 0.5 mm to about 1 mm, such as from about 0.6 mm to about 1 mm, such as from about 0.7 mm to about 1 mm, such as from about 0.8 mm to about 1 mm, such as from about 0.9 mm to about 1 mm.
[0096] In still further examples, the nub height "H" can be less than or equal to about 0.9 mm, such as within a range of from about 0.5 mm to about 0.9 mm, such as from about 0.6 mm to about 0.9 mm, such as from about 0.7 mm to about 0.9 mm, such as from about 0.8 mm to about 0.9 mm.
[0097] In yet further examples, the nub height "H" can be less than or equal to about 0.8 mm, such as within a range of from about 0.5 mm to about 0.8 mm, such as from about 0.6 mm to about 0.8 mm, such as from about 0.7 mm to about 0.8 mm.
[0098] In further examples, the nub height "H" can be less than or equal to about 0.7 mm, such as within a range of from about 0.5 mm to about 0.7 mm, such as from about 0.6 mm to about 0.7 mm. In still further examples, the nub height "H" can be less than or equal to about 0.6 mm, such as within a range of from about 0.5 mm to about 0.6 mm. In further examples, the nub height "H" can be less than or equal to about 0.5 mm, such less than or equal to about 0.4 mm.
[0099] Example nubs 703 can have a wide range of outer sectional profile shapes. For example, FIGS. 13-16 are each sectional views of the nub along line 13-13 of FIG. 12 showing just some examples of outer sectional profiles of example nubs. For example, FIG. 13 illustrates an example nub 703a with an outer sectional profile in a shape of a circle. FIG. 14 illustrates an alternative example nub 703b with an outer sectional profile is in a shape of an ellipse. FIG. 15 illustrates still another alternative example nub 703c with an outer sectional profile in a shape of a rectangle (e.g., square). Still further, FIG. 16 illustrates still another alternative example nub 703d with an outer sectional profile in the shape of a triangle. While FIGS. 13-16 demonstrate nubs with example outer sectional profiles in the shape of a circle, ellipse, rectangle, triangle, in further examples other curvilinear and/or polygonal shapes may be provided. As shown in FIGS. 13-16 each cross section along the nub height "H" can be considered to have a maximum cross-sectional width "W". Referring back to FIG. 12, the average maximum cross
sectional width "Wav" of the nub is the average of the maximum cross-sectional width "W" along the nub height "H".
[00100] In some examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.5 mm, such as from about 0.5 mm to about 2 mm, such as from about 0.5 mm to about 1.9 mm, such as from about 0.5 mm to about 1.8 mm, such as from about 0.5 mm to about 1.7 mm, such as from about 0.5 mm to about 1.6 mm, such as from about 0.5 mm to about 1.5 mm, such as from about 0.5 mm to about 1.4 mm, such as from about 0.5 mm to about 1.3 mm, such as from about 0.5 mm to about 1.2 mm, such as from about 0.5 mm to about 1.1 mm, such as from about 0.5 mm to about 1 mm, such as from about 0.5 mm to about 0.9 mm, such as from about 0.5 mm to about 0.8 mm, such as from about 0.5 mm to about 0.7 mm, such as from about 0.5 mm to about 0.6 mm.
[00101] In further examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.6 mm, such as from about 0.6 mm to about 2 mm, such as from about 0.6 mm to about 1.9 mm, such as from about 0.6 mm to about 1.8 mm, such as from about 0.6 mm to about 1.7 mm, such as from about 0.6 mm to about 1.6 mm, such as from about 0.6 mm to about 1.5 mm, such as from about 0.6 mm to about 1.4 mm, such as from about 0.6 mm to about 1.3 mm, such as from about 0.6 mm to about 1.2 mm, such as from about 0.6 mm to about 1.1 mm, such as from about 0.6 mm to about 1 mm, such as from about 0.6 mm to about 0.9 mm, such as from about 0.6 mm to about 0.8 mm, such as from about 0.6 mm to about 0.7 mm.
[00102] In still further examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.7 mm, such as from about 0.7 mm to about 2 mm, such as from about 0.7 mm to about 1.9 mm, such as from about 0.7 mm to about 1.8 mm, such as from about 0.7 mm to about 1.7 mm, such as from about 0.7 mm to about 1.6 mm, such as from about 0.7 mm to about 1.5 mm, such as from about 0.7 mm to about 1.4 mm, such as from about 0.7 mm to about 1.3 mm, such as
from about 0.7 mm to about 1.2 mm, such as from about 0.7 mm to about 1.1 mm, such as from about 0.7 mm to about 1 mm, such as from about 0.7 mm to about 0.9 mm, such as from about 0.7 mm to about 0.8 mm.
[00103] In yet further examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.8 mm, such as from about 0.8 mm to about 2 mm, such as from about 0.8 mm to about 1.9 mm, such as from about 0.8 mm to about 1.8 mm, such as from about 0.8 mm to about 1.7 mm, such as from about 0.8 mm to about 1.6 mm, such as from about 0.8 mm to about 1.5 mm, such as from about 0.8 mm to about 1.4 mm, such as from about 0.8 mm to about 1.3 mm, such as from about 0.8 mm to about 1.2 mm, such as from about 0.8 mm to about 1.1 mm, such as from about 0.8 mm to about 1 mm, such as from about 0.8 mm to about 0.9 mm.
[00104] In additional examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 0.9 mm, such as from about 0.9 mm to about 2 mm, such as from about 0.9 mm to about 1.9 mm, such as from about 0.9 mm to about 1.8 mm, such as from about 0.9 mm to about 1.7 mm, such as from about 0.9 mm to about 1.6 mm, such as from about 0.9 mm to about 1.5 mm, such as from about 0.9 mm to about 1.4 mm, such as from about 0.9 mm to about 1.3 mm, such as from about 0.9 mm to about 1.2 mm, such as from about 0.9 mm to about 1.1 mm, such as from about 0.9 mm to about 1 mm.
[00105] In still additional examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1 mm, such as from about 1 mm to about 2 mm, such as from about 1 mm to about 1.9 mm, such as from about 1 mm to about 1.8 mm, such as from about 1 mm to about 1.7 mm, such as from about 1 mm to about 1.6 mm, such as from about 1 mm to about 1.5 mm, such as from about 1 mm to about 1.4 mm, such as from about 1 mm to about 1.3 mm, such as from about 1 mm to about 1.2 mm, such as from about 1 mm to about 1.1 mm.
[00106] In yet additional examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.1 mm, such as from about 1.1 mm to about 2 mm, such as from about 1.1 mm to about 1.9 mm, such as from about 1.1 mm to about 1.8 mm, such as from about 1.1 mm to about 1.7 mm, such as from about 1.1 mm to about 1.6 mm, such as from about 1.1 mm to about 1.5 mm, such as from about 1.1 mm to about 1.4 mm, such as from about 1.1 mm to about 1.3 mm, such as from about 1.1 mm to about 1.2 mm.
[00107] In further examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.2 mm, such as from about 1.2 mm to about 2 mm, such as from about
1.2 mm to about 1.9 mm, such as from about 1.2 mm to about 1.8 mm, such as from about 1.2 mm to about 1.7 mm, such as from about 1.2 mm to about 1.6 mm, such as from about 1.2 mm to about 1.5 mm, such as from about 1.2 mm to about 1.4 mm, such as from about 1.2 mm to about 1.3 mm.
[00108] In further examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.3 mm, such as from about 1.3 mm to about 2 mm, such as from about
1.3 mm to about 1.9 mm, such as from about 1.3 mm to about 1.8 mm, such as from about 1.3 mm to about 1.7 mm, such as from about 1.3 mm to about 1.6 mm, such as from about 1.3 mm to about 1.5 mm, such as from about 1.3 mm to about 1.4 mm.
[00109] In yet further examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.4 mm, such as from about 1.4 mm to about 2 mm, such as from about
1.4 mm to about 1.9 mm, such as from about 1.4 mm to about 1.8 mm, such as from about 1.4 mm to about 1.7 mm, such as from about 1.4 mm to about 1.6 mm, such as from about 1.4 mm to about 1.5 mm.
[00110] In additional examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.5 mm, such as from about 1.5 mm to about 2 mm, such as from about
1.5 mm to about 1.9 mm, such as from about 1.5 mm to about 1.8 mm, such as from about 1.5 mm to about 1.7 mm, such as from about 1.5 mm to about 1.6 mm.
[00111] In still additional examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.6 mm, such as from about 1.6 mm to about 2 mm, such as from about 1.6 mm to about 1.9 mm, such as from about 1.6 mm to about 1.8 mm, such as from about 1.6 mm to about 1.7 mm.
[00112] In additional examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.7 mm, such as from about 1.7 mm to about 2 mm, such as from about
1.7 mm to about 1.9 mm, such as from about 1.7 mm to about 1.8 mm.
[00113] In further examples, the average maximum cross-sectional width "Wav" can be greater than or equal to about 1.8 mm, such as from about 1.8 mm to about 2 mm, such as from about
1.8 mm to about 1.9 mm. In still further examples, the average maximum cross-sectional width "Wav" along the nub height "H" can be greater than or equal to about 1.9 mm, such as from about 1.9 mm to about 2 mm.
[00114] Still further, in some examples, the nub 703 may be tapered along an extent of the nub height "H". Indeed, as shown in FIG. 12, the nub can have outer walls that taper at an angle a. In some examples, the angle a is greater than or equal to about 0°, such as within a range from about 0° to about 45°, such as from about 0° to about 42°, such as from about 0° to about 40°, such as from about 0° to about 38°, such as from about 0° to about 36°, such as from about 0° to about 33°, such as from about 0° to about 30°, such as from about 0° to about 25°, such as from about 0° to about 20°, such as from about 0° to about 15°, such as from about 0° to about 10°, such as from about 0° to about 5°.
[00115] In further examples, the angle a is greater than or equal to about 5°, such as within a range from about 5° to about 45°, such as from about 5° to about 42°, such as from about 5° to about 40°, such as from about 5° to about 38°, such as from about 5° to about 36°, such as from about 5° to
about 33°, such as from about 5° to about 30°, such as from about 5° to about 25°, such as from about 5° to about 20°, such as from about 5° to about 15°, such as from about 5° to about 10°.
[00116] In still further examples, the angle a is greater than or equal to about 10°, such as within a range from about 10° to about 45°, such as from about 10° to about 42°, such as from about 10° to about 40°, such as from about 10° to about 38°, such as from about 10° to about 36°, such as from about 10° to about 33°, such as from about 10° to a bout 30°, such as from about 10° to about 25°, such as from about 10° to about 20°, such as from about 10° to about 15°.
[00117] In yet further examples, the angle a is greater than or equal to about 15°, such as within a range from about 15° to about 45°, such as from about 15° to about 42°, such as from about 15° to about 40°, such as from about 15° to about 38°, such as from about 15° to about 36°, such as from about 15° to about 33°, such as from about 15° to a bout 30°, such as from about 15° to about 25°, such as from about 15° to about 20°.
[00118] In yet further examples, the angle a is greater than or equal to about 20°, such as within a range from about 20° to about 45°, such as from about 20° to about 42°, such as from about 20° to about 40°, such as from about 20° to about 38°, such as from about 20° to about 36°, such as from about 20° to about 33°, such as from about 20° to about 30°, such as from about 20° to about 25°.
[00119] In further examples, the angle a is greater than or equal to about 25°, such as within a range from about 25° to about 45°, such as from about 25° to about 42°, such as from about 25° to about 40°, such as from about 25° to about 38°, such as from about 25° to about 36°, such as from about 25° to about 33°, such as from about 25° to about 30°.
[00120] In additional examples, the angle a is greater than or equal to about 30°, such as within a range from about 30° to about 45°, such as from about 30° to about 42°, such as from about 30° to about 40°, such as from about 30° to about 38°, such as from about 30° to about 36°, such as from about 30° to about 33°.
[00121] In still additional examples, the angle a is greater than or equal to about 33°, such as within a range from about 33° to about 45°, such as from about 33° to about 42°, such as from about 33° to about 40°, such as from about 33° to about 38°, such as from about 33° to about 36°.
[00122] In yet additional examples, the angle a is greater than or equal to about 36°, such as within a range from about 36° to about 45°, such as from about 36° to about 42°, such as from about 36° to about 40°, such as from about 36° to about 38°.
[00123] In additional examples, the angle a is greater than or equal to about 38°, such as within a range from about 38° to about 45°, such as from about 38° to about 42°, such as from about 38° to about 40°. In still additional examples, the angle a is greater than or equal to about 40°, such as within a range from about 40° to about 45°, such as from about 40° to about 42°. In yet additional examples, the angle a is greater than or equal to about 42°, such as within a range from about 42° to about 45°. In further examples, the angle a is greater than or equal to about 45°.
[00124] Still further, in some examples, the nub 703 may have various aspect ratios "AR". The "AR" of the nub is defined by the equation AR= H/Wav, i.e., the aspect ratio "AR" is the nub height "H" divided by the average maximum cross-sectional width "Wav". In some examples, the aspect ratio "AR" can be less than or equal to about 1.3, such as from about 0.7 to about 1.3, such as from about 0.8 to about 1.3, such as from about 0.9 to about 1.3, such as from about 1 to about 1.3, such as from about 1.1 to about 1.3, such as from about 1.2 to about 1.3.
[00125] In further examples, the aspect ratio "AR" can be less than or equal to about 1.2, such as from about 0.7 to about 1.2, such as from about 0.8 to about 1.2, such as from about 0.9 to about 1.2, such as from about 1 to about 1.2, such as from about 1.1 to about 1.2.
[00126] In still further examples, the aspect ratio "AR" can be less than or equal to about 1.1, such as from about 0.7 to about 1.1, such as from about 0.8 to about 1.1, such as from about 0.9 to about 1.1, such as from about 1 to about 1.1.
[00127] In further examples, the aspect ratio "AR" can be less than or equal to about 1, such as from about 0.7 to about 1, such as from about 0.8 to about 1, such as from about 0.9 to about 1. In additional examples, the aspect ratio "AR" can be less than or equal to about 0.9, such as from about 0.7 to about 0.9, such as from about 0.8 to about 0.9. In further examples, the aspect ratio "AR" can be less than or equal to about 0.8, such as from about 0.7 to about 0.8. In still further examples, the aspect ratio "AR" can be less than or equal to about 0.7.
[00128] Table 1 listed below includes just some example features of nubs mentioned above. Although Table 1 lists various features, in further examples, nubs may include features outside of the ranges listed below. In further examples, nubs may include one or more of the features below while not including other features listed below. For example, an example nub may include any one of the features of the Radius "R", Height "H", Average Maximum Cross-Sectional Width "Wav", Angle "a", Aspect Ratio "AR" listed in the ranges below, either alone or in combination with one or more (e.g., all) of the other features, for example, in the ranges listed below. Moreover, the ranges and dimensions below may include the exact dimension and/or the exact endpoints of the ranges, or may include dimensions that are about the dimension listed below or ranges with endpoints that are about the endpoints listed below.
Table 1
[00129] The mounting structures 701 can comprise a wide range of materials. In one example, the mounting structure can comprise plastic. As such, example configurations of the mounting structures may be fabricated with an injection molding procedure to produce the mounting structure from plastic. In some examples, the mounting structures 701 may be provided as a substrate support for an electrode 603 that may be optionally integrated together with the mounting structures 701. For example, FIGS. 6, 7, 10 and 11 illustrate example sensor patches 601, 1001 that may include an electrode 603 that is integrated together with the corresponding mounting structure 701. Indeed, as apparent in the cross-sectional views of FIGS. 7 and 11, the mounting structure 701 may optionally be plated with an electrically conductive material 709, such as Ag/AgCI or other material. In such an example, the nubs 703 may be useful to inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface. Indeed, each of the nubs of the present disclosure have features (see FIG. 12) that allow the surface of the skin to conform to the outer periphery of the nub to inhibit lateral movement without penetrating the skin surface. Moreover, plating the mounting structure 701 includes plating over the nubs wherein the conformed, and nonpenetrated, surface of the skin comes into intimate contact with the electrically conductive material. As such, electrical signals from the skin may be easily transmitted over the plated skin of the mounting structure to be transmitted through the wire 711 for further processing.
[00130] As shown in FIGS. 6, 8 and 10, the plurality of nubs 703 may be arranged in a peripheral array about a central axis 605, 805, 1005 of the sensor patch 601, 801, 1001. As such, the effective footprint of the nub periphery can be maximized to enhance the ability of the mounting structure to inhibit lateral movement relative to the skin surface. In just one example, the plurality of illustrated nubs are arranged in a circular peripheral array about the central axis 605, 806, 1005 although a periphery in the shape of an ellipse or other peripheral shape is possible in further examples.
However arranging in a circular periphery may be desirable in certain instances to help distribute bearing stress to several nubs to avoid excessive bearing stress at the skin surface.
[00131] The mounting structure can further include a central cavity circumscribed by the peripheral array of nubs. For example, as shown in FIGS. 6-11 the mounting structure includes a central cavity 607 circumscribed by the peripheral array of nubs 703. The central cavity 607 can provide an accumulation zone for the surface of the skin that may bulge into this zone after mounting, that further helps inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface. Moreover, as shown schematically in FIG. 7, any of the sensor patches 601, 801, 1001 may include a temperature sensor 715a that may be positioned within the central cavity 607. In addition or alternatively, a temperature sensor 715b may be provided within the mounting structure 701. For example, the temperature sensor 715b may be encapsulated within the material of the mounting structure or may be housed within an area of the mounting structure.
[00132] As shown in FIGS. 8 and 9, the electrode 901 may be positioned within the central cavity 607 of the mounting structure 701. In such examples, the mounting structure 701 is not necessarily plated wherein the nubs 703 only function to inhibit lateral movement of the sensor patch and do not function to deliver signals (e.g., by conductive plating over the nubs). As such, one or more electrodes 901 may be mounted and placed in communication, by way of wire 903 to another location to process the signals. In further examples, the sensor patch 801 may comprise a wireless sensor patch wherein electrical components are housed within an area 905 between a flexible cover patch 421 and the mounting structure 701.
[00133] As further illustrated in FIGS. 8-9, the sensor patch may also include an electrogel 807 positioned within the central cavity 607. The electrogel can help enhance electrical connection between the electrode 901 and the skin surface and is particularly useful in applications where the electrode is not provided the nubs as shown in FIGS. 6 and 7.
[00134] FIG. 11 illustrates still another example, where the mounting structure is integrated with the electrode in the form of plating with an electrically conductive material 709, such as Ag/AgCI or other material. In addition, another electrode 901 may be mounted within the central cavity 607. An electrical insulation member 1101 may be provided to prevent short circuiting between the electrically conductive material 709 and the electrode 901.
[00135] The sensor patches 601, 801, 1001 of FIGS. 6-11 can also include a skin-friendly adhesive patch 609 mounted with respect to the mounting structure 701. The skin-friendly adhesive patch may comprise a hydrocolloid adhesive patch or other adhesive material. A foam flexible material layer 611 may also be provided that provides flexibility to the patch. Still further a woven or nonwoven backing 613 may be adhered with a tie layer 615 to tie together the skin-friendly adhesive patch 609 with the mounting structure 701. As shown, the skin-friendly adhesive patch 609 may circumscribe the mounting structure 701 to more securely adhere the sensor patch in place. At the same time, the nubs may help reduce lateral movement without penetrating the skin.
[00136] Although some of the sensor patches described above have been illustrated and described as wireless sensor patches, such examples may be provided as wired sensor patches in further examples. Moreover, as some sensor patches above have been described as wired sensor patches, further concepts may be provided as wireless sensor patches.
[00137] The inventors hereby state their intent to rely on the Doctrine of Equivalents to determine and assess the reasonably fair scope of their invention as it pertains to any apparatus, system, method or article not materially departing from but outside the literal scope of the invention as set out in the following claims.
Claims
1. A wireless sensor patch comprising:
a printed circuit board;
at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board;
a skin-friendly adhesive patch mounted to a second side of the printed circuit board;
a flexible cover patch mounted with respect to the skin-friendly adhesive patch with the electronic component positioned within a space between the flexible cover patch and the skin-friendly adhesive patch; and
a cushion layer positioned to extend between the electronic component and the flexible cover patch, wherein the cushion layer includes a plurality of apertures configured to permit fluid passage through the cushion layer.
2. The wireless sensor patch of claim 1, wherein the printed circuit board includes a plurality of apertures configured to permit fluid passage through the printed circuit board.
3. The wireless sensor patch of claim 2, further including a tie layer mounting the skin- friendly adhesive patch to the second side of the printed circuit board, wherein the tie layer includes a plurality of apertures configured to permit fluid passage through the tie layer, wherein the plurality of apertures of the tie layer are each aligned with a corresponding aperture of the printed circuit board.
4. The wireless sensor patch of any one of claims 1-3, wherein the cushion layer comprises a fabric.
5. The wireless sensor patch of claim 4, wherein the fabric comprises a nonwoven fabric.
6. A wireless sensor patch comprising:
a printed circuit board including a plurality of apertures configured to permit fluid passage through the printed circuit board;
at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board;
a skin-friendly adhesive patch mounted to a second side of the printed circuit board; and a flexible cover patch mounted with respect to the skin-friendly adhesive patch with the electronic component positioned within a space between the flexible cover patch and the skin-friendly adhesive patch.
7. The wireless sensor patch of claim 6, further comprising a cushion layer positioned to extend between the electronic component and the flexible cover patch.
8. The wireless sensor patch of claim 7, wherein the cushion layer comprises a fabric.
9. The wireless sensor patch of claim 7, wherein the fabric comprises a nonwoven fabric.
10. The wireless sensor patch of any one of claims 6-9, further including a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board, wherein the
tie layer includes a plurality of apertures configured to permit fluid passage through the tie layer, wherein the plurality of apertures of the tie layer are each aligned with a corresponding aperture of the printed circuit board.
11. The wireless sensor patch of any one of claims 1, 2 and 6-9, further including a tie layer mounting the skin-friendly adhesive patch to the second side of the printed circuit board.
12. The wireless sensor patch of any one of claims 1-11, further including at least one electrode extending from a second side of the printed circuit board and extending through a through aperture defined by the skin-friendly adhesive patch.
13. The wireless sensor patch of claim 12, further comprising an electrode insulation member positioned within the through aperture defined by the skin-friendly adhesive patch and circumscribing the electrode to prevent contact between the electrode and the skin-friendly adhesive patch.
14. The wireless sensor patch of claim 13, wherein the electrode extends through an aperture defined by the electrode insulation member.
15. The wireless sensor patch of any one of claims 1-11, further including at least a first electrode and a second electrode that each extends from a second side of the printed circuit board and each extends through at least one through aperture defined by the skin-friendly adhesive patch.
16. The wireless sensor patch of claim 15, further comprising at least one electrode insulation member positioned within the at least one through aperture of the skin-friendly adhesive to prevent contact between at least one of the electrodes and the skin-friendly adhesive patch.
17. The wireless sensor patch of claim 16, wherein the electrode insulation member prevents both the first electrode and the second electrode from contacting the skin-friendly adhesive patch.
18. The wireless sensor patch of any one of claims 16-17, wherein the electrode insulation member includes a first aperture receiving the first electrode and a second aperture receiving the second electrode.
19. The wireless sensor patch of any one of claims 13, 14 and 16-18, wherein the electrode insulation member is received within a single through aperture defined by the skin-friendly adhesive patch.
20. The wireless sensor patch of any one of claims 13, 14 and 16-19, wherein the electrode insulation member is 8-shaped.
21. The wireless sensor patch of any one of claims 1-20, wherein the flexible cover patch has a footprint that is larger than a foot print of the skin-friendly adhesive patch.
22. The wireless sensor patch of any one of claims 1-21, wherein an adhesive footprint of the wireless sensor patch includes a skin-friendly adhesive portion defined by the skin-friendly adhesive
patch that is circumscribed by a peripheral adhesive portion defined by an adhesive layer of the flexible cover patch.
23. The wireless sensor patch of any one of claims 1-22, wherein the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
24. A sensor patch comprising:
an interface module configured to mount the sensor patch to a skin surface of a patient; and a sensor module removably mounted to the skin interface module.
25. The sensor patch of claim 24, wherein the sensor module is magnetically mounted to the skin interface module.
26. The sensor patch of and one of claims 24 and 25, wherein the sensor patch comprises a wireless sensor patch.
27. The sensor patch of any one of claims 24-26, wherein the sensor module includes a printed circuit board and at least one electronic component mounted to the printed circuit board and extending from a first side of the printed circuit board.
28. The sensor patch of claim 27, wherein at least one magnet removably mounts the printed circuit board to the interface module.
29. The sensor patch of any one of claims 27-28, wherein the sensor module includes a flexible cover patch mounted with respect to the printed circuit board with the electronic component positioned within a space between the flexible cover patch and the printed circuit board.
30. The sensor patch of any one of claims 24-29, wherein the interface module comprises an adhesive patch.
31. The sensor patch of claim 30, wherein the adhesive patch comprises a skin-friendly adhesive patch.
32. The sensor patch of claim 31, wherein the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
33. The sensor patch of any one of claims 24-32, wherein the interface module further comprises at least one electrode.
34. The sensor patch of claim 33, further comprising an electrode insulation member circumscribing the electrode.
35. The sensor patch of claim 34, wherein the electrode extends through an aperture defined by the electrode insulation member.
36. The sensor patch of any one of claims 33-35, wherein the electrode is configured to provide a removable magnetic mounting of the sensor module to the skin interface module.
37. The sensor patch of claim 36, wherein the at least one electrode comprises a magnet attracted to the sensor module to provide the removable magnetic mounting of the sensor module to the skin interface module.
38. The sensor patch of claim 36, wherein the sensor module includes at least one magnet attracted to the at least one electrode to provide the removable magnetic mounting of the sensor module to the skin interface module.
39. The sensor patch of any one of claims 33-38, wherein the at least one electrode comprises at least a first electrode and a second electrode.
40. A sensor patch including:
an electrode configured to sense an electrical signal from a skin surface; and
a mounting structure including a plurality of nubs protruding from an outer face of the mounting structure, wherein the plurality of nubs each include a blunt apex configured to inhibit relative lateral movement of the mounting structure relative to the skin surface without penetrating the skin surface.
41. The sensor patch of claim 40, wherein the blunt apex includes a radius that is greater than or equal to about 0.1 mm.
42. The sensor patch of any one of claims 40 and 41, wherein the plurality of nubs each protrude with a nub height from the outer face of the mounting structure, and the nub height of each nub is less than or equal to about 2 mm.
43. The sensor patch of any one of claims 40-42, wherein the plurality of nubs each include an average maximum width along a height of the nub that is greater than or equal to about 0.5 mm.
44. The sensor patch of any one of claims 40-43, wherein the plurality of nubs each include an aspect ratio of a nub height with respect to an average maximum width along the nub height of less than our equal to about 1.3.
45. The sensor patch of any one of claims 40-44, wherein the mounting structure comprises plastic.
46. The sensor patch of any one of claims 40-45, wherein the mounting structure is coated with an electrically conductive material.
47. The sensor patch of claim 46, wherein the electrically conductive material comprises Ag/AgCI.
48. The sensor patch of any one of claims 40-47, wherein the plurality of nubs are arranged in a peripheral array about a central axis of the mounting structure.
49. The sensor patch of claim 48, wherein the plurality of nubs are arranged in a circular peripheral array about the central axis of the mounting structure.
50. The sensor patch of any one of claims 48-49, wherein the mounting structure defines a central cavity circumscribed by the peripheral array of nubs.
51. The sensor patch of claim 50, wherein an electrode is positioned within the central cavity.
52. The sensor patch of any one of claims 50-51, wherein a temperature sensor is positioned within the central cavity.
53. The sensor patch of any one of claims 50-52, further comprising an electrogel positioned within the central cavity.
54. The sensor patch of any one of claims 40-53, further comprising a skin-friendly adhesive patch mounted with respect to the mounting structure.
55. The sensor patch of claim 54, wherein the skin-friendly adhesive patch comprises a hydrocolloid adhesive patch.
56. The sensor patch of any one of claims 54-55, wherein the skin-friendly adhesive patch circumscribes the mounting structure.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462006356P | 2014-06-02 | 2014-06-02 | |
| US62/006,356 | 2014-06-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2015187377A1 true WO2015187377A1 (en) | 2015-12-10 |
Family
ID=53373595
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2015/031884 Ceased WO2015187377A1 (en) | 2014-06-02 | 2015-05-21 | Sensor patches |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2015187377A1 (en) |
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| EP3251585A1 (en) * | 2016-05-30 | 2017-12-06 | Roche Diabetes Care GmbH | Body-mountable device |
| WO2018022117A1 (en) * | 2016-07-29 | 2018-02-01 | VivaLnk, Inc. | Wearable thermometer patch for accurate measurement of human skin temperature |
| CN108158562A (en) * | 2017-12-31 | 2018-06-15 | 维灵(杭州)信息技术有限公司 | A kind of body temperature patch |
| CN110913759A (en) * | 2017-03-08 | 2020-03-24 | 门塔拉布有限公司 | System for detecting biological signals |
| US11872144B2 (en) | 2018-03-23 | 2024-01-16 | The Alfred E. Mann Foundation For Scientific Research | Skin patches for sensing or affecting a body parameter |
| US11911174B2 (en) | 2016-06-06 | 2024-02-27 | University Of Massachusetts | Systems and methods for prevention of pressure ulcers |
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