WO2016010990A2

WO2016010990A2 - Sensor devices and methods of applying a sensor device

Info

Publication number: WO2016010990A2
Application number: PCT/US2015/040322
Authority: WO
Inventors: Michael G. Ginn
Original assignee: Avery Dennison Corporation
Priority date: 2014-07-15
Filing date: 2015-07-14
Publication date: 2016-01-21
Also published as: WO2016010990A3

Abstract

A flexible support ribbon of a sensor device is configured to support a sensor contact at a spaced distance from an electronic module of the sensor device. The sensor device further includes an electrical trace mounted to an intermediate portion of the support ribbon and electrically connecting the sensor contact to the electronic module. In some examples, the electrical trace and the intermediate portion of the flexible support ribbon are configured to be extended along an extension axis. In addition or alternatively, in further examples the intermediate portion includes at least a first set of cuts to increase the flexibility of the intermediate portion. In further examples, methods include mounting a sensor device to a skin surface such that a plurality of spacers space at least one of an electronic module and a flexible support ribbon from the skin surface.

Description

SENSOR DEVICES AND METHODS OF APPLYING A SENSOR DEVICE

Cross-Reference to Related Application

[0001] The present application claims the benefit of U.S. Provisional Application No. 62/024,607, filed July 15, 2014, which is incorporated herein by reference in its entirety.

Field of the Invention

[0001] The present invention relates to sensor devices and methods of applying a sensor device and, more particularly, to sensor devices including an electrical trace and an intermediate portion configured to reduce or eliminate motion artifact between a contact and a skin surface, a sensor devices including spacers, and methods of applying the sensor device to a skin surface.

Background of the Invention

[0002] 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.

Brief Summary of the Invention

[0003] 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 skilli

understand the principles and practices of the present invention.

[0004] In a first aspect of the disclosure, a sensor device comprises an electronic module, a flexible support ribbon attached to the electronic module, and a sensor contact mounted to an end portion of the flexible support ribbon. The flexible support ribbon is configured to support the sensor contact at a spaced distance from the electronic module. The sensor device further includes an electrical trace mounted to an intermediate portion of the support ribbon and electrically connecting the sensor contact to the electronic module. The electrical trace and the intermediate portion of the flexible support ribbon are configured to be extended along an extension axis to increase the spaced distance while the electrical trace maintains the electrical connection between the sensor contact and the electronic module.

[0005] In one example of the first aspect, the intermediate portion defines a serpentine support path for the electrical trace.

[0006] In another example of the first aspect, the electrical trace extends along a serpentine trace path.

[0007] In still another example of the first aspect, the intermediate portion includes a width extending transverse to the extension axis between a first edge and a second edge, wherein the intermediate portion includes a first set of cuts extending through the first edge and a second set of cuts extending through the second edge. In one example, the first set of cuts is not aligned with the second set of cuts. In a further example, the first set of cuts is greater than ½ the width of the intermediate portion. In still another example, the second set of cuts is greater than ½ the width of the intermediate portion.

[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 sensor

module, a flexible support ribbon attached to the electronic module, and a sensor contact mounted to an end portion of the flexible support ribbon. The flexible support ribbon is configured to support the sensor contact at a spaced distance from the electronic module. The sensor device further includes an electrical trace mounted to an intermediate portion of the support ribbon and electrically connecting the sensor contact to the electronic module. The intermediate portion includes a width extending transverse to a support axis between the sensor contact and the electronic module. The width further extends between a first edge and a second edge of the intermediate portion, and the intermediate portion includes a first set of cuts extending through the first edge.

[0010] In one example of the second aspect, the electrical trace and the intermediate portion of the flexible support ribbon are configured to be extended along the support axis to increase the spaced distance while the electrical trace maintains the electrical connection between the sensor contact and the electronic module.

[0011] In another example of the second aspect, a second set of cuts extending through the second edge. In a particular example, the intermediate portion defines a serpentine support path for the electrical trace. In another particular example, the electrical trace extends along a serpentine trace path. In still another example, the first set of cuts is not aligned with the second set of cuts.

[0012] In yet another example of the second aspect, the first set of cuts is greater than ½ the width of the intermediate portion.

[0013] In still another example of the second aspect, the second set of cuts, if provided, is greater than ½ the width of the intermediate portion.

[0014] 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. [0015] In a third aspect of the disclosure, a sensor device c<

flexible support ribbon attached to the electronic module, and a sensor contact mounted to an end portion of the flexible support ribbon. The flexible support ribbon is configured to support the sensor contact at a spaced distance from the electronic module. The sensor device further includes an electrical trace mounted to an intermediate portion of the support ribbon and electrically connecting the sensor contact to the electronic module. The sensor device also includes a plurality of spacers configured to space at least one of the electronic module and the flexible support ribbon from a mounting surface to define an air circulation area between the mounting surface and the at least one of the electronic module and the flexible support ribbon.

[0016] In one example of the third aspect, the sensor device further comprises a breathable skin adhesive configured to adhere the sensor device to the mounting surface. In one particular example, the breathable skin adhesive comprises an adhesive patch.

[0017] In another example of the third aspect, the plurality of spacers comprises a foam spacer.

[0018] In still another example of the third aspect, the plurality of spacers includes at least one ring-shaped spacer.

[0019] In yet another example of the third aspect, the electrical trace and the intermediate portion of the flexible support ribbon are configured to be extended along an extension axis to increase the spaced distance while the electrical trace maintains the electrical connection between the sensor contact and the electronic module. In one example, the intermediate portion defines a serpentine support path for the electrical trace. In another example, the electrical trace extends along a serpentine trace path. In still another example, the intermediate portion includes a width extending transverse to the extension axis between a first edge and a second edge, wherein the intermediate portion includes a first set of cuts extending through the first edge and a second set of cuts extending through the second edge. For instance, in one example, the first set of cuts is not aligned

another example, the first set of cuts is greater than ½ the width of the intermediate portion. In still another example the second set of cuts is greater than ½ the width of the intermediate portion.

[0020] In a further example of the third aspect, a method of applying the sensor device comprises mounting the sensor device to a skin surface such that the plurality of spacers space at least one of the electronic module and the flexible support ribbon from the skin surface to define an air circulation area between the skin surface and the at least one of the electronic module and the flexible support ribbon.

[0021] The third aspect may be provided alone or in combination with any one or more of the examples of the third aspect discussed above.

[0022] Other features and advantages of the present invention will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description of the various embodiments and specific examples, while indicating preferred and other embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications.

Brief Description of the Drawings

[0023] 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:

[0024] FIG. 1 is an example sensor patch in accordance with aspects of the disclosure applied to a skin surface of a patient; [0025] FIG. 2 is a top view of the sensor patch of FIG. 1;

[0026] FIG. 3 is a side view of the sensor patch of FIG. 1;

[0027] FIG. 4 is a bottom view of the sensor patch of FIG. 1;

[0028] FIG. 5 is an exploded upper perspective view of a sensor patch of FIG. 1;

[0029] FIG. 6 is a sectional view of the sensor patch along line 6-6 of FIG. 5;

[0030] FIG. 7 is a sectional view of the sensor patch along line 7-7 of FIG. 5;

[0031] FIG. 8 is a bottom perspective view of a sensor device of the sensor patch of FIG. 5;

[0032] FIG. 9 illustrates enlarged portions of the sensor device of FIG. 8;

[0033] FIG. 10 illustrates the enlarged portions of the sensor device of FIG. 9 in an extended configuration;

[0034] FIG. 11 illustrates enlarged portions of another example sensor device;

[0035] FIG. 12 illustrates enlarged portions of yet another example sensor device;

[0036] FIG. 13 is a schematic view illustrating method steps of assembling an example sensor patch; and

[0037] FIG. 14 is another example sensor device in accordance with aspects of the disclosure applied to a skin surface of a patient.

Detailed Description of the Invention

[0038] 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.

[0039] FIG. 1 illustrates a sensor patch 101, such as the illustrated sensor patch, in accordance with aspects of the present disclosure. Aspects of the disclosure are illustrated with wireless applications although wired sensor patches may be incorporated in furt

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 skin 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.

[0040] As discussed below, the sensor patch 101 can include at least one sensor contact configured to monitor any one or combination of parameters. For instance, the sensor contact can comprise a Galvanic Skin Response (GSR) sensor contact 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 some examples, it is contemplated that a sensor contact may work in concert with other sensors to account for skin perspiration that may be produced by other activities (e.g., physical activity). In addition or alternatively, one or more Electrocardiogram (ECG) sensor contacts may be provided to monitor the electrical activity of the patient's heart. In still further examples, the sensor contacts 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. As discussed below, the wireless skin patch of the present disclosure can allow for comfortable application and monitoring without necessarily requiring a continuous wired connection. Moreover, the sensor patch can be inexpensively produced, thereby rendering the patch potentially disposable. In disposable applications, a new sensor patch to be provided for each application; thereby avoiding expensive sanitation and cleaning procedures. [0041] The sensor patch 101 may include a memory d

collected by the sensor device. In addition or alternatively, in wireless applications, the sensor patch 101 may include a transmitter configured to transmit wireless signals 107 (e.g., by way of Bluetooth or Bluetooth derivative 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 to another location for processing. In further examples, the sensor patch may include a USB port or other interface to allow periodic wired connections with the sensor patch. In such examples, after a period of time, the patient may temporarily provide a wired connection between the patch and the device 109 (e.g., by a USB cable) to provide communication between the device and the 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 sensor patch to the device 109 such as information gathered from the patient and/or current information about the sensor patch. In further examples, the wired or wireless connection may allow information or commands to be uploaded from the device 109 to the 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. Still further permanent wired connections may be provided in still further examples, wherein the permanent wired connections provide one or more of the above-referenced functional features.

[0042] 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 signals 111 (e.g., wireless signals, or signals through a wired connection) configured to be received by the sensor patch 101. For example, the device 109 may sen

patch 101 to change an operating condition of the sensor patch 101.

[0043] FIG. 2 is a top view of the example sensor patch 101 shown in FIG. 1. The sensor patch 101 includes a flexible support patch 201. As shown in FIG. 3, the flexible support patch 201 includes a thickness defined between a first face 301 and a second face 303. As shown in FIGS. 2 and 4, the flexible support patch 201 includes an outer periphery 203 defining a footprint of the flexible support patch 201. The outer periphery 203 can comprise a wide range of shapes and sizes configured to be appropriately attached to the skin surface 105 of the patient 103. The flexible support patch 201 can comprise a wide range of materials configured to provide support while still providing flexibility to allow the sensor patch 101 to conform to a wide range of skin surface shapes. For example, the flexible support patch 201 can comprise a fabric a represented by the cross-hatch pattern illustrated in the drawings. The illustrated fabric comprises a nonwoven fabric although woven fabrics may be provided in further examples.

[0044] As represented by the vertical lines set forth in FIG. 4, the sensor patch 101 may also include an adhesive layer 401 applied to the first face 301 of the flexible support patch 201. The adhesive layer can comprise a pressure sensitive adhesive such as rubber-based adhesive, acrylic adhesive or silicone adhesive that allows the patch to immediately adhere to the skin surface 105 upon application of the sensor patch 101. Moreover, the sensor patch 101 can comprise a skin-friendly adhesive patch 403 such as the illustrated first and second skin-friendly adhesive patch portions 403a, 403b mounted to the first face 301 of the flexible support patch 201 with the adhesive layer 401. In one example, the skin-friendly adhesive patch 403 can 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 403 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

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.

[0045] As shown in FIG. 4, an outer periphery of the adhesive layer 401 can circumscribe the skin-friendly adhesive patch 403. As such, an outer peripheral adherence of the sensor patch 101 to the skin surface 105 of the patient 103 may be achieved. At the same time, the skin-friendly adhesive patch 403 may be held in place against the skin surface 105 to allow sufficient time for the skin-friendly adhesive patch 403 to cure into an effective adhesive member. The skin-friendly adhesive patch 403 allows the sensor patch 101 to be applied to the skin surface for a significant length of time without aggravating the skin surface when compared to the adhesive layer 401. At the same time, a relatively small peripheral portion of the adhesive layer 401 may allow the peripheral portions of the patch to be immediately adhered to the skin surface while allowing the skin-friendly adhesive patch 403 sufficient time to bond.

[0046] FIG. 5 illustrates an exploded view of the sensor patch 101. FIG. 6 is a cross- sectional view of the flexible support patch 201 demonstrating the adhesive layer 401 being applied to the first face 301 of the flexible support patch 201. FIG. 7 is a cross-sectional view of the skin-friendly adhesive patch 403 along line 7-7 of FIG. 5. As shown, the skin-friendly adhesive patch 403 can include a flexible substrate 701 with a skin-friendly adhesive layer 703 applied to a first face 705 of the flexible substrate 701. In some examples, the flexible substrate 701 can comprise a transparent or translucent substrate 701 to allow viewing of indicia 501 that may be printed on the second face 707 of the flexible substrate (e.g., see FIGS. 4 and 5). In such examples, the indicia 501 may be printed in reverse such that the information may be deciphered by viewing the indicia through the skin-friendly adhesive layer and the flexible substrate 701. The skin-friendly adhesive layer 703 can comprise a hydrocolloid adhesive or other skin-friendly adhesive that can facilitate adhesion to the skin s

relatively low aggravation to the skin layer.

[0047] As further illustrated in FIG. 5, the sensor patch 101 further includes a sensor device 503 including features illustrated schematically in FIGS. 5 and 8 and in more detail in the enlarged views of FIGS. 9 and 10. FIG. 5 illustrates a top perspective view of one example sensor device 503 while FIG. 8 illustrates a bottom perspective view of the sensor device 503 along line 8-8 of FIG. 5. As shown in FIG. 8, the sensor device 503 can include a pair of Galvanic Skin Response (GSR) sensor contacts 801a, 801b configured to interact with the skin surface 105 to detect changes in the resistance of skin to electrical current due to changes in skin perspiration. The sensor device 503 can also include a pair of Electrocardiogram (ECG) sensor contacts 803a, 803b configured to monitor the electrical activity of the heart.

[0048] An electronic module 805 may be provided that can receive signals from the pair of GSR sensor contacts 801a, 801b and/or the pair of ECG sensor contacts 803a, 803b. In some examples, the sensor patch 101 may only be configured to operate with one of the sensor types although both sensor types may be configured to operate in further examples. As shown in FIG. 4, both the GSR sensor contacts 801a, 801b and the ECG sensor contacts 803a, 803b are exposed to communicate through the flexible support patch 201 to sense the skin surface of the patient. As shown in FIG. 5, the flexible support patch 201 are provided with apertures 505a, 505b for the ECG sensor contacts 803a, 803b in addition to a central aperture 507 for the GSR sensor contacts 801a, 801b.

[0049] As further shown in FIG. 8, the sensor device 503 can also include identification indicia 807 such as a UPC code or the like to refer to the specific sensor device 503 or a type of sensor device. Referring back to FIG. 5, the sensor device 503 can also include a battery 509 configured to power the sensor device 503 and a control button 510 configured to operate the sensor device. In some examples, the sensor device 503 may be provided alone or, as shown in FIGS. 1-5, may be incorporated as part of the overall sensor patch 101. For instance, in the illustrated

device 503 can be mounted, as discussed below, such that at least one of the sensor contacts is aligned with the apertures. Indeed, as shown, the GSR sensor contacts 801a, 801b are aligned with the central aperture 507 extending through the flexible support patch. Such alignment allows a portion of the GSR sensor contacts 801a, 801b to protrude from the central aperture 507 as shown in FIG. 3. Moreover, as shown in FIG. 5, the ECG sensor contacts 803a, 803b may be aligned with the corresponding apertures 505a, 505b extending through the flexible support patch 201. Although not shown in the example of FIGS. 1-5, a hydrogel or conductive agent may also be used to provide an interface or coupling from the ECG sensor contacts 803a, 803b through the corresponding apertures 505a, 505b to the skin.

[0050] As further shown in the example of FIGS. 1-5, the sensor device 503 may be mounted to the second face 303 of the flexible support patch 201 with various adhesive configurations. For instance, as shown in FIG. 5, adhesive in the form of a tie layer patch 511 can be provided to help mount the sensor device 503 to the second face 303 of the flexible support patch 201. As shown, apertures 513a, 513b may be provided in alignment with the ECG sensor contacts 803a, 803b to facilitate appropriate interaction with the skin surface 105. Likewise, apertures 515a, 515b may be provided in alignment with the GSR sensor contacts 801a, 801b to facilitate appropriate interaction with the skin surface 105. In some examples, the tie layer may be transparent and/or translucent to allow viewing of the identification indicia 807 from below as shown in FIG. 4.

[0051] The sensor patch 101 can further include an optional flexible cover patch 517 mounted to the second face 303 of the flexible support patch 201 wherein the sensor device 503 is at least partially housed within a pocket 519 defined by at least one of the flexible support patch 201 and the flexible cover patch 517. For example, a protruding portion of the electronic module 805 can be housed within a preformed pocket 519 of the flexible cover patch 517. In some designs, the control button 510 may be activated by depressing a side portion of the flexible preformed pocket 519. The flexible cover patch, if provided, may comprise a polymeric member, su

that may be substantially water resistant to help protect the electrical components of the electronic module 805. As shown, the tie layer patch 511 may function to mount the flexible cover patch 517 to the second face 303 of the flexible support patch 201.

[0052] As further illustrated in FIG. 2, the flexible cover patch 517 includes an outer periphery 205 defining a footprint of the flexible cover patch 517. As shown, in one example, the footprint of the flexible support patch 201 defined by the outer periphery 203 of the flexible support patch 201 is larger than a footprint of the flexible cover patch 517. Providing the flexible cover patch 517 with a larger footprint can help prevent overlapping of the periphery 205 of the flexible cover patch 517 that may provide a peeling point. As such, the sensor patch 101 can be securely applied to the skin surface 105 with a reduced chance of inadvertent peeling of the sensor patch 101 from the skin surface 105.

[0053] Referring to FIGS. 3-5, a release liner 305 may be provided to help preserve the adhesive layer 401 and the skin-friendly adhesive layer 703 from adhering to other surfaces and/or contamination prior to application of the sensor patch.

[0054] As mentioned previously, FIG. 5 illustrates example of upper portions of the sensor device 503 with some features shown schematically and in more detail in FIGS. 9 and 10. As further mentioned above, FIG. 8 illustrated a bottom view of the sensor device 503 with some features also shown schematically and in more detail in FIGS. 9 and 10.

[0055] In some examples, the electronic module can comprise an adaptor configured to receive one or more electronic components such as an electrical circuit, battery, components of an electrical circuit or other components to permit electronic functioning of the sensor device. The adaptor may include electrical connection ports to receive the electronic components. The electronic component of the electronic module 805 may comprise one component or 50 or more components. In addition or alternatively, the electronic module may comprise a housing

components and protect the electronic components from potential damage from the external environment. In further examples, the electronic module may comprise the electronic components without an adapter or housing.

[0056] In the illustrated example, the electronic module 805 includes electronic components housed without a protective casing and with the battery 509. A wide variety of batteries may be provided in accordance with aspects of the disclosure. For example, the battery may optionally comprise a 1.5 or 3 volt coin cell battery. In one example, a C 2032 battery may be used (e.g., having a diameter of 20 mm and a thickness of 3.2 mm). Various alternative batteries may be used and sized according to the parameters of the sensor device. Indeed, some examples may include a battery with a diameter of 9.5-24.5 mm, such as 20 mm and a thickness of 1.2-10.8 mm. Larger or smaller batteries may be provided and can match the size for a compact arrangement that has a footprint that can extend within the footprint of the electronic component configuration. In further examples, the battery may comprise a rechargeable or nonrechargeable battery. Moreover, although the illustrated battery is circular in shape, the battery may comprise other shapes such as square or oblong shapes in further examples.

[0057] As shown in FIG. 8, the sensor device 503 can include at least one sensor extension member 809a, 809b. The sensor extension member 809a, 809b is shown schematically in FIGS. 5 and 8 and in more detail in FIG. 9. In one example, as shown in FIG. 8 the sensor device 503 includes a first sensor extension member 809a and a second diametrically opposed second extension member 809b although a single or three or more sensor extension members may be provided in further examples. Providing the first and second sensor extension members 809a, 809b oriented in the illustrated diametrically disposed manner can facilitate support of ECG sensor contacts 803a, 803b relatively far away from one another. Each sensor extension member 809a, 809b may include a flexible support ribbon 811a, 811b attached to the electronic module 805. The flex

allows for the ECG sensor contacts 803a, 803b to easily confirm to the skin surface 105 of the patient 103. In one example, the patient may comprise a human although the patient may comprise animals in further examples. As such, thanks to the flexible nature of the support ribbon 811a, 811b the sensor device may easily accommodate movements of the patient without losing sensor contact with the skin surface and without damaging the sensor device.

[0058] As shown in FIGS. 8 and 9, the flexible support ribbon 811a, 811b is configured to support the sensor contact at a spaced distance "Dl" from the electronic module. The flexible support ribbon may have a relatively small thickness "T" compared to the spaced distance "Dl" and the width "W" of the flexible support ribbon. Moreover, in some examples, the spaced distance "Dl" may be greater than the width "W" of the flexible support ribbon. In some examples, the thickness of the ribbon can be from about 0.001 inches to about 0.01 inches. Smaller thicknesses within this range may be selected to impart more flexibility to the ribbon while larger thicknesses within this range may allow more structural support while still providing a sufficient level of flexibility. The flexible support ribbon may have a spaced distance "Dl" of from about 1 inch to about 6 inches, such as from about 2 inches to about 4 inches. In some examples, the width "W" can be from about 5% to about 90% of the spaced distance "Dl" such as from about 10% to about 75%, such as from about 10% to about 50%, such as from about 10% to about 25% of the spaced distance "Dl". A smaller ratio of the width with respect to the length may be selected to impart more flexibility to the ribbon while a larger ratio of the width with respect to the length allow more structural support while still providing a sufficient level of flexibility. The flexible support ribbon may comprise a wide range of materials such as polymers (e.g., PET) that may take the form of a polymer film.

[0059] Referring back to FIG. 8, the flexible support ribbon 811a, 811b further includes an end portion 813a, 813b and an intermediate portion 815a, 815b extending between the respective end portion 813a, 813b and the electronic module 805. FIG. 5 shows a

support ribbon 811a, 811b while FIG. 8 shows a lower surface of the flexible support ribbon 811a, 811b wherein the thickness "T" is understood to be defined between the upper and lower surface. As shown in FIG. 8, the ECG sensor contacts 803a, 803b may be mounted to the respective end portion 813a, 813b of the flexible support ribbon 811a, 811b. In some examples the sensor contacts may be mounted to the lower surface of the flexible support ribbon 811a, 811b. For instance, the sensor contacts may be printed or etched to the lower surface of the flexible support ribbon 811a, 811b. In one example, the ECG sensor contacts 803a, 803b may be constructed as a layer of material comprising Ag/AgCI although other materials may be used in further examples.

[0060] As further illustrated in FIG. 8, the sensor device further includes electrical traces 817a, 817b that are each mounted to the respective intermediate portion 815a, 815b. In some examples, the electrical traces can comprise printed conductive material such as silver, conductive polymer or other material. In further examples, the trace can comprise an etched conductive path of copper or aluminum. In further examples, the electrical traces can comprise fine wire that may be laminated or otherwise mounted to the intermediate portion of the flexible support ribbon.

[0061] FIGS. 9-10 illustrate features of the first extension member 809a with the understanding that the second sensor extension member 809b may be similar or identical to the first extension member 809a. As shown in FIGS. 9 and 10, the extension member 809a is provided wherein the electrical trace 817a and the intermediate portion 815a of the flexible support ribbon 811a are configured to be extended along an extension axis 901 to increase the spaced distance while the electrical trace 817a maintains the electrical connection between the ECG sensor contact 803a and the electronic module 805. Indeed, as shown in FIG. 10, the electrical trace 817a and the intermediate portion 815a may be extended along the extension axis 901 to increase the spaced distance from the nonextended distance "Dl" illustrated in FIG. 9 to the extended distance "D2" shown in FIG. 10. In some examples, the extended distance "D2" may be about 2% to aboul

from about 5% to about 25%, such as from about 8% to about 15% such as from about 10% to about 15% greater than "Dl".

[0062] Providing the extension member with the ability to be extended to increase the spaced distance may be desirable to accommodate typical stretching or flexing of the skin surface 105 of the patient when wearing the sensor device. Indeed, typical stretching or flexing of the skin surface 105 may promote an increase in the spaced distance between the ECG sensor contact and the electronic module. As the extension member 809a is designed to permit extension of the electrical trace 817a and the intermediate portion 815a along the extension axis 901, damage to the sensor device or inadvertent dismounting of a portion of the sensor device from the skin surface can be avoided. As such, motion artifact can be reduced or eliminated that might otherwise occur with a nonextendable member. Throughout the disclosure, motion artifact refers to, for example, electrical signals or electrical signal interference resulting from skin stretching or relative motion between the sensor/conducting gel and the skin.

[0063] FIGS. 9 and 10 illustrate one example structure that may permit the electrical trace and the intermediate portion of the flexible support ribbon to be extended while the electrical trace maintains the electrical connection between the sensor contact and the electronic module. For instance, as shown in FIG. 9, the intermediate portion 815a includes a first edge 903a and a second edge 903b wherein the width "W" extends transverse to the extension axis 901 between the first edge 903a and the second edge 903b. As shown, the edges 903a, 903b may be parallel with respect to one another and with respect to the extension axis 901 although none parallel orientations may be provided in further examples. Moreover, as shown, the extension axis 901 and/or edges 903a, 903b may be substantially linear although nonlinear configurations may also be provided. [0064] In one example, the intermediate portion 815a incl

extend through the first edge 903a. Providing a first set of cuts may increase the flexibility of the intermediate portion 815a. As such, due to the increased flexibility, inadvertent dismounting of a portion of the sensor device from the skin surface can be avoided. Indeed, motion artifact can be reduced or eliminated that might otherwise occur with a less flexible member without a set of cuts through one of the edges. Optionally, the intermediate portion 815a may further include a second set of cuts 905b that extend through the second edge 903b. The second set of cuts, in combination with the first set of cuts, may provide the intermediate portion 815a with even further flexibility and can also allow the intermediate portion to act as the extension member discussed above to increase the spaced distance to thereby further reduce or eliminate motion artifact between the contact and the skin surface during typical stretching or flexing of the skin surface 105 of the patient when wearing the sensor device. As shown, in one example, the first set of cuts 905a are not aligned with the second set of cuts 905b. As such, the cuts may be arranged along the length of the intermediate portion 815a to alternate between the first and second sets of cuts that may be equally spaced apart from one another. Moreover, as shown, in further examples the first and/or second set of cuts 905a, 905b may have a length that is greater than ½ the width "W" of the intermediate portion 815a. For instance, each of the cuts may have a length of from about 50% to about 80% such as from about 60% to about 70% of the width "W". In the illustrated example each of the cuts 905a, 905b has a length of about 2/3 the width "W". Furthermore, the cuts may be parallel to one another and/or can be perpendicular to the extension axis 901 in further examples.

[0065] Providing the first set of cuts 905a and the second set of cuts 905b in the arrangement illustrated in FIGS. 9 and 10 provides the intermediate portion 815a with an uninterrupted serpentine support path that follows a winding path about each of the first and second cuts between the ECG sensor contact 803a and the electronic module 805. As shown, the serpentine support path of the intermediate portion 815a supports the electrical trace 817a that

serpentine trace path.

[0066] In operation, the electrical trace 817a and the intermediate portion 815a of FIG. 9 may be extended along the extension axis 901 to increase the spaced distance to distance "D2" as shown in FIG. 10. As the intermediate portion 815a is extended, the first and second set of cuts 905a, 905b of FIG. 9 may open into V-shaped slots 1001 (see FIG. 10) to allow extension of the overall length of the intermediate portion 815a. Moreover, the relatively compact serpentine arrangement of the electrical trace 817a shown in FIG. 9 can be expanded (see FIG. 10) to accommodate the opening of the cuts into the V-shaped slots without disturbing the mounting of the electrical trace 817a to the serpentine support path of the intermediate portion 815a. Still further, providing an edge of the intermediate portion with at least one set of cuts can increase the flexibility of the intermediate portion. As such, the increased flexibility and/or ability of the intermediate portion to be extended along the extension axis can help reduce motion artifact between the contact and the skin surface, thereby increasing sensor performance since appropriate electrical communication can be maintained between the contact and the skin surface during movements (and consequential skin stretching, shape changes) of the patient.

[0067] FIGS. 11 and 12 illustrate alternative embodiments of the first end second extension member. Indeed, FIGS. 11 and 12 respectively illustrate an extension member 1101, 1201 with a flexible support ribbon 1103, 1203 having an intermediate portion 1105, 1205 that each includes a serpentine support path configured to support a corresponding electrical trace 1107, 1207 along a serpentine support path. ECG sensor contacts 1109, 1209 are mounted to an end portion 1111, 1211 of the flexible support ribbon 1103, 1203. As with the extension member 809a illustrated in FIGS. 9 and 10, the extension member 1101 of FIG. 11 includes serpentine support and trace paths that have a smooth sinusoidal shape while the extension member 1201 of FIG. 12 shows the serpentine support and trace paths having a stepped function. Each of the intermediate |

respective first edge 1113a, 1213a and a respective second edge 1113b, 1213b that is parallel to the first edge. However, unlike the edges 903a, 903b of the extension member 809a illustrated in FIGS. 9 and 10, the edges of each of the intermediate portions 1105, 1205 follow a serpentine edge path. The electrical trace 1107, 1207 and the intermediate portion 1105, 1205 of each flexible support ribbon 1103, 1203 are configured to be extended along the extension axis 901 to increase the spaced distance while the electrical trace maintains the electrical connection between the sensor contact and the electronic module.

[0068] The sensor patch 101 shown in FIGS. 1-5 may be easily applied to the skin surface 105 of a patient 103. As shown in FIGS. 3 and 5, the release liner 305 may be initially removed to expose the adhesive layer 401 and the skin-friendly adhesive layer 703 as shown in FIG. 4. Moreover, as shown in FIG. 4, the indicia 501 may be read through the skin friendly adhesive. Moreover, the indicia 807 associated with the sensor device 503 may be read through the tie layer patch 511. Next, the sensor patch 101 may be applied to the skin surface 105 of a patient 103 at an appropriate location. Once applied, the outer peripheral portion of the adhesive layer 401 immediately mounts the sensor patch 101 in place, wherein, after sufficient time, the skin-friendly adhesive layer 703 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 401.

[0069] The ability of the electrical trace and the intermediate portion of the flexible support ribbon to be extended and/or providing the intermediate portion with increased flexibility due to at least one of the edges being provided with cuts can increase the performance of the sensor device. Indeed, such features can allow for typical flexing and stretching of the skin 105 of the patient 103 without damaging the electrical connection between the sensor contact and the electronic module. Moreover, motion artifact between the sensor and the skin surface can be reduced or eliminated such that electrical communication between the contact and the skin may t

stretching of the skin.

[0070] Various methods may be used to manufacture the sensor patch 101. For example, referring to FIG. 5, the method can include the step of providing the flexible support patch 201 including the first face 301 and the second face 303 with the outer periphery 203 defining the footprint of the flexible support patch 201. The method can also include providing the adhesive layer 401 to the first face 301 of the flexible support patch 201. In further examples, the skin-friendly adhesive patch 403 may be mounted to the first face 301 of the flexible support patch 201 with the adhesive layer 401. In one example, indicia 501 may be printed in reverse on the surface being adhered to the adhesive layer 401. As such, the indicia may be viewed through the skin-friendly adhesive patch 403 as shown in FIG. 4.

[0071] Referring back to FIG. 5, the method of manufacturing the skin patch can further include the step of mounting the sensor device 503 to the second face 303 of the flexible support patch 201 by way of the tie layer patch 511. At least one sensor contact of the sensor device can be aligned with an aperture extending through the flexible support patch prior to mounting the sensor device to the second face of the flexible support patch with the tie layer patch 511. For example, as shown in FIG. 5, the GSR sensor contacts 801a, 801b can be aligned with the central aperture 507 of the flexible support patch 201. Likewise, the ECG sensor contacts 803a, 803b may be aligned with the corresponding apertures 505a, 505b extending through the flexible support patch 201.

[0072] The method of manufacturing can further include the step of mounting the flexible cover patch 517 to the second face 303 of the flexible support patch 201 by way of an adhesive. For example, the tie layer patch 511 or other adhesive may be used to mount the flexible cover patch 517 to the second face 303 of the flexible support patch 201. After mounting the flexible cover patch 517, the protruding portion of the electronic module 805 is at least partially housed within the pocket 519 defined by the flexible cover patch 517. Although not shown, in addii

support patch 201 may include a pocket for at least a portion of the sensor device 503.

[0073] The efficiency and speed of manufacturing the sensor patch may be enhanced by various methods of manufacturing a plurality of sensor patches, for example, sequentially manufacturing a plurality of the sensor patches.

[0074] FIG. 13 is a schematic view illustrating method steps of assembling an example sensor patch wherein the sensor device may be held on a suitable liner to allow the sensor device to be easily dropped into an adhesive patch as an in-line process. Indeed, in one example, sensor devices 503 may be provided on a release liner 1301 rolled up on a roll 1303 of sensor devices. The roll 1303 may rotate in direction 1305 such that the release liner transports the sensor devices 503 along travel path 1307. The sensor devices 503 are then transferred to a lower adhesive envelop provided on release liner 1309.

[0075] FIG. 14 illustrates another example of a sensor device 1401 in accordance with further aspects of the disclosure. The sensor device can include any of the features of the sensor device 503 described above and may have expansion capabilities as described with respect to any of the examples shown in FIGS. 9-12 above. For illustrative purposes, the sensor device of FIGS. 9-10 is illustrated with further features to provide the sensor device 1401. Indeed, the sensor device 1401 may optionally include a flexible cover patch 1403 comprised of a polymeric member, such as a closed cell foam material that may be substantially water resistant yet breathable to help protect the electrical components 1405 and the printed circuit board 1408.

[0076] The sensor device 1401 can also include a plurality of spacers configured to space at least one of the electronic module 805 and the flexible support ribbon 811a, 811b from a mounting surface (e.g., skin surface 105) to define an air circulation area between the mounting surface and the at least one of the electronic module and the flexible support ribbon. For example, as shown in FIG. 14, the plurality of spacers may comprise one or more electronic module :

thin strips of material wherein an air circulation area 1407 is defined between the electronic module spacers 1406. As such, air may freely pass along the skin surface 105 and underneath the electronic module to allow evaporation of moisture from the vicinity of the sensor device 1401. Moisture accumulation is thereby avoided that may otherwise damage or interfere with operation of the electronic components of the sensor device 1401.

[0077] In further examples, the plurality of spacers can comprise spacers configured to space the flexible support ribbon from the mounting surface (e.g., skin surface). For example, the sensor device can include one or more ring-shaped spacers 1409a, 1409b that are configured to space the flexible support ribbon 811a, 811b from the skin surface 105 to define further air circulation areas 1413a, 1413b. As such, air may freely pass along the skin surface 105 and underneath the flexible support ribbon 811a, 811b to allow further evaporation of moisture from the vicinity of the sensor device 1401. Moisture accumulation is thereby further avoided that may otherwise damage or interfere with operation of the electronic components of the sensor device 1401.

[0078] The ring-shaped nature of the spacers 1409a, 1409b can also provide a containment area for an electrolyte gel 1411. The electrolyte gel 1411 can allow electrical signals to pass from the skin surface 105 to the ECG sensor contacts 803a, 803b. As such, the ring-shaped spacers 1409a, 1409b can provide a dual function of spacing the flexible support ribbon away from the skin surface while also providing a containment area for electrolyte gel to facilitate electrical communication between the ECG sensor contacts and the skin surface of the patient.

[0079] The electronic module spacers 1406 and ring-shaped spacers 1409a, 1409b can comprise a wide range of materials. For instance, the spacers can comprise foam spacers although other spacer constructions may be provided in further examples. [0080] In further examples, the sensor device may also in<

to adhere the sensor device to the mounting surface. For example, as shown in FIG. 14, the sensor device 1401 can include a breathable adhesive patch 1415 that allows the mounting of the sensor device 1401 to the skin surface 105. As the adhesive patch is breathable, moisture from the skin may easily pass through the breathable adhesive patch 1415 to be evaporated and carried away by air circulating through the air circulation areas 1407, 1413a, 1413b.

[0081] 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

CLAIMS What is claimed is:

1. A sensor device comprising:

an electronic module;

a flexible support ribbon attached to the electronic module;

a sensor contact mounted to an end portion of the flexible support ribbon, wherein the flexible support ribbon is configured to support the sensor contact at a spaced distance from the electronic module; and

an electrical trace mounted to an intermediate portion of the support ribbon and electrically connecting the sensor contact to the electronic module,

wherein the electrical trace and the intermediate portion of the flexible support ribbon are configured to be extended along an extension axis to increase the spaced distance while the electrical trace maintains the electrical connection between the sensor contact and the electronic module.

2. The sensor device of claim 1, wherein the intermediate portion defines a serpentine support path for the electrical trace.

3. The sensor device of any one of claims 1 and 2, wherein the electrical trace extends along a serpentine trace path.

4. The sensor device of any one of claims 1-3, wherein the intermediate portion includes a width extending transverse to the extension axis between a first edge and a second edge, wherein the intermediate portion includes a first set of cuts extending through the fi

extending through the second edge.

5. The sensor device of claim 4, wherein the first set of cuts is not aligned with the second set of cuts.

6. The sensor device of any one of claims 4 and 5, wherein the first set of cuts is greater than ½ the width of the intermediate portion.

7. The sensor device of any one of claims 5-6, wherein the second set of cuts is greater than ½ the width of the intermediate portion.

8. A sensor device comprising:

an electronic module;

a flexible support ribbon attached to the electronic module;

an electrical trace mounted to an intermediate portion of the support ribbon and electrically connecting the sensor contact to the electronic module, wherein the intermediate portion includes a width extending transverse to a support axis between the sensor contact and the electronic module, and the width further extending between a first edge and a second edge of the intermediate portion, wherein the intermediate portion includes a first set of cuts extending through the first edge.

9. The sensor device of claim 8, wherein the electrical tra

of the flexible support ribbon are configured to be extended along the support axis to increase the spaced distance while the electrical trace maintains the electrical connection between the sensor contact and the electronic module.

10. The sensor device of any one of claims 8 and 9, further comprising a second set of cuts extending through the second edge.

11. The sensor device of claim 10, wherein the intermediate portion defines a serpentine support path for the electrical trace.

12. The sensor device of any one of claims 10 and 11, wherein the electrical trace extends along a serpentine trace path.

13. The sensor device of any one of claims 10-12, wherein the first set of cuts is not aligned with the second set of cuts.

14. The sensor device of any one of claims 8-13, wherein the first set of cuts is greater than ½ the width of the intermediate portion.

15. The sensor device of any one of claims 10-13, wherein the second set of cuts is greater than ½ the width of the intermediate portion.

16. A sensor device comprising: an electronic module;

a flexible support ribbon attached to the electronic module;

an electrical trace mounted to an intermediate portion of the support ribbon and electrically connecting the sensor contact to the electronic module; and

a plurality of spacers configured to space at least one of the electronic module and the flexible support ribbon from a mounting surface to define an air circulation area between the mounting surface and the at least one of the electronic module and the flexible support ribbon.

17. The sensor device of claim 16, further comprising a breathable skin adhesive configured to adhere the sensor device to the mounting surface.

18. The sensor device of claim 17, wherein the breathable skin adhesive comprises an adhesive patch.

19. The sensor device of any one of claims 16-18, wherein the plurality of spacers comprises a foam spacer.

20. The sensor device of any one of claims 16-19, wherein the plurality of spacers includes at least one ring-shaped spacer.

21. The sensor device of any one of claims 16-19, when

intermediate portion of the flexible support ribbon are configured to be extended along an extension axis to increase the spaced distance while the electrical trace maintains the electrical connection between the sensor contact and the electronic module.

22. The sensor device of claim 21, wherein the intermediate portion defines a serpentine support path for the electrical trace.

23. The sensor device of any one of claims 21 and 22, wherein the electrical trace extends along a serpentine trace path.

24. The sensor device of any one of claims 16-23, wherein the intermediate portion includes a width extending transverse to the extension axis between a first edge and a second edge, wherein the intermediate portion includes a first set of cuts extending through the first edge and a second set of cuts extending through the second edge.

25. The sensor device of claim 24, wherein the first set of cuts is not aligned with the second set of cuts.

26. The sensor device of any one of claims 24 and 25, wherein the first set of cuts is greater than ½ the width of the intermediate portion.

27. The sensor device of any one of claims 24-26, wherein the second set of cuts is greater than ½ the width of the intermediate portion.

28. A method of applying the sensor device of any one of claims 16-27 comprising:

mounting the sensor device to a skin surface such that the plurality of spacers space at least one of the electronic module and the flexible support ribbon from the skin surface to define an air circulation area between the skin surface and the at least one of the electronic module and the flexible support ribbon.