HK1210402B - Body temperature logging patch - Google Patents

Description

Body temperature recording patch

Cross Reference to Related Applications

This application claims priority to U.S. provisional application serial No. 61/721, 261 filed on month 11, 2012, which is hereby incorporated by reference in its entirety.

Background

Over the past 100 years or so, there have been significant changes in the design and assembly processes of electrical or electronic circuits. Approximately 100 years ago, the dc power supply circuit was hard wired and hand soldered in a box form. High current electronic or electrical components are secured to the box and then they are manually connected by manual weld lines of sufficient diameter to carry the required current and voltage. In many of these circuits, large sized multiple voltage batteries are placed in battery compartments, which are then also manually soldered into the circuit. A typical battery size may be a 6 volt lantern battery or a battery pack consisting of a plurality of 6 "sized unit cells (cells) or possibly even some smaller sized unit cells. When the batteries are depleted, they are desoldered and replaced in the same manner as the circuit was made.

About 60 years ago, the design and fabrication of circuits had changed dramatically with the invention of transistors and other electronic components. Due to the change in electronics, which requires much lower currents and many times lower voltages, circuits can be made in a more efficient and compact manner. This allows the circuit to be fabricated on a circuit board in a wave soldering method. As part of this wave soldering assembly method, a battery holder is also included in the circuit. The power supply size can also be reduced in size due to the substantial reduction in required voltage and current. Typical power supply sizes may now be D, C, AA, AAA, transistor 9V batteries or even coin or button batteries. In these new circuits with battery holders, the consumer can also install the battery when he starts using the device, so that it is very easy to replace the depleted battery.

In recent years, printed electronics on flexible substrates have become a new process and increasingly popular, as described in several Blue Spark patent applications. With this process, some or all of the circuitry and some of the electronic components are printed. Typically this type of circuit may include a display, an IC chip, a sensor, an antenna, a light and a relatively low capacity power supply, such as a flat printed battery. In some applications, the power supply may also be printed in a fully integrated manner.

Alternatively, the power supply may be integrated in a different manner. To reduce costs, the power supply may be a printed or otherwise constructed flat battery that is provided as a complete battery unit for later integration into the required circuitry. A typical battery cell may provide, for example, about 1.5 volts dc. In the case where a larger voltage is required, it is conventionally known to connect two or more battery cells in series to increase the voltage. Similarly, multiple battery cells may be connected together in parallel to increase the effective capacity. For example, a battery may include two battery cells electrically connected in series to provide 3 volts direct current. Nevertheless, it is desirable to reduce the overall size of the battery (even if there are multiple battery cells) for use in small circuits. Various designs and methods of manufacturing flat cells and batteries are described in co-pending U.S. applications serial nos. 11/110202 filed on 20/4/2005, 11/379816 filed on 24/4/2006, 12/809844 filed on 21/6/2010, 13/075620 filed on 30/3/2011, 13/625366 filed on 24/9/2012, 13/899291 filed on 21/5/2013, and issued U.S. patent nos. 8029927, 8268475, 8441411, all of which are incorporated herein by reference.

In recent years, there has been an increasing interest in active medical technology that can take advantage of the increasing power of portable computers, smart phones, and tablets. One such example includes a body temperature recording patch (patch) ("patch") that will be worn on the body and will track and collect in memory the temperature of the patient's body over time. Today, conventional body temperature devices only measure body temperature at a single point in time. In contrast, the patch device described herein may be applied as one patch and worn for a long period of time, such as a 24 hour period (although longer or shorter time periods are contemplated). The patch preferably includes a medical quasi-skin-contacting adhesive suitable for application to the skin of a user, although a variety of generally flexible and compressible materials may also be utilized. Additionally or alternatively, the patch may have the ability to sense various other phenomena, such as by multiple sensors. For example, the patch may sense any or all of the following: multiple temperatures of the patient at the same or different locations, ambient temperature, ambient humidity, ambient pressure, levels of ambient light, sound, and/or radiation, the patient's bodily functions, time, patient movement (e.g., via an accelerometer), and the like.

Disclosure of Invention

The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key or critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

According to one aspect of the present application, an actively powered temperature data logger (logger) patch with wireless data communication includes a first substrate layer and a sealed, flexible battery including a printed electrochemical cell (cell) with an anode and a cathode. At least one of the anode and cathode is formed from a cured or dried ink. A first cell electrode contact and a second cell electrode contact are each electrically coupled to one of the anode and cathode. The patch also includes a flexible circuit including a microprocessor, a temperature sensor configured to sense a temperature of a target object, a wireless communication transceiver, and an antenna. The flexible circuit also includes a first battery contact pad and a second battery contact pad, each electrically coupled (manifold) to one of the first and second battery electrode contacts to thereby electrically provide power to the microprocessor and temperature sensor. The patch further includes a second substrate layer including an adhesive configured to be removably applied to a surface of the target object. The flexible battery and flexible circuit collectively include an electronic neutral (inlay) disposed between the first and second substrate layers in a covered, stacked arrangement. The first substrate layer, the electron intermediate, and the second substrate layer are all flexible and configured to conform to a curved surface of the target object.

In accordance with another aspect of the present application, an actively powered temperature data logger patch with wireless data communication includes a first substrate layer and a sealed, flexible battery including a printed electrochemical cell with an anode and a cathode disposed in a coplanar arrangement. The patch also includes a flexible circuit including a microprocessor, a temperature sensor configured to sense a temperature of a target object, a wireless communication transceiver, and an antenna. The microprocessor actively receives power from the flexible battery, the temperature sensor actively receives power from the microprocessor, and the wireless communication transceiver is passively powered from an external computing device through an electromagnetic field. The patch further includes a second substrate layer including an adhesive configured to be removably applied to a surface of the target object. The flexible battery and flexible circuit are disposed between the first substrate layer and the second substrate layer, and wherein the first substrate layer, electronic neutral, and the second substrate layer are all flexible.

In accordance with another aspect of the present application, an actively-powered medical system for monitoring the body temperature of a patient includes a flexible, actively-powered temperature data logging patch including a sealed, flexible battery including a printed electrochemical cell with an anode and a cathode disposed in a co-planar arrangement. The flexible circuit includes a microprocessor, a temperature sensor configured to sense a temperature of the patient, a timer, a memory, a wireless communication transceiver, and an antenna. The base layer includes an adhesive configured to be removably applied to the skin of the patient. The microprocessor, the temperature sensor, the timer, and the memory of the patch are all actively powered by a flexible battery. The system also includes an external computing device including a programmable microprocessor capable of running an application, an active power source, a display, and a transceiver powered by the active power source and capable of two-way communication with the wireless communication transceiver of the patch via an electromagnetic field. The wireless communication transceiver of the patch is passively powered from the external computing device through the electromagnetic field. The external computing device is configured to transmit an initialization command and an initialization start time to the microprocessor of the patch such that the microprocessor is able to provide power to the temperature sensor and begin obtaining a plurality of temperature samples from the temperature sensor. The microprocessor of the patch is configured to transmit an acknowledgement signal back to the external computing device indicating successful initialization.

Drawings

The foregoing and other features and advantages of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings, in which:

FIG. 1 shows a perspective view of an exemplary patch attached to a person for measuring body temperature using an exemplary smartphone;

fig. 2A shows an exploded view of one embodiment of the exemplary patch;

fig. 2B shows an exploded view of another embodiment of the exemplary patch;

FIG. 3 illustrates a schematic top view of an exemplary electronic center material of the exemplary patch of FIG. 1;

fig. 4 shows a schematic top view of an exemplary electronic circuit of the exemplary patch of fig. 1;

fig. 5 shows a plan view of an exemplary electrochemical cell;

fig. 6 illustrates a cross-sectional view of an electrochemical cell taken through the electrode area along line 6-6 of fig. 5;

fig. 7 shows a cross-sectional view of the electrochemical cell taken through the entire length of the first electrode along line 7-7 of fig. 5;

FIG. 8 shows a cross-sectional view of the electrochemical cell taken through the entire length of the second electrode along line 8-8 of FIG. 5; and

fig. 9 illustrates one exemplary screenshot of a user application for a smartphone or other computing device.

Detailed Description

In this application, a body temperature recording patch ("patch") is described that will be worn on the body and will track the temperature of the patient's body over time and collect that temperature in memory. For example, as shown in fig. 1, patch 10 may be worn on the body of patient 12, such as on the forehead, torso, arms, legs, or other body parts. Conventional body temperature devices today only measure body temperature at a single point in time. In contrast, the patch 10 device described herein may be applied as a patch and worn for a long period of time to provide a large number of measurements, such as a 12, 16 or 24 hour period (although longer or shorter time periods are contemplated). Patch 10 preferably includes a medical-approved skin-contacting adhesive suitable for application to the skin of a user, although a variety of generally flexible and compressible materials may also be utilized. Additionally or alternatively, patch 10 may have the ability to sense various other phenomena, such as by multiple sensors. For example, patch 10 may sense any or all of the following: multiple temperatures of the patient at the same or different locations, ambient temperature, ambient humidity, ambient pressure, levels of ambient light, sound, and/or radiation, the patient's bodily functions, time, patient movement (e.g., via an accelerometer), and the like.

At any point in time when the patient is wearing the patch 10, such as during the described 24-hour period, the patch may be remotely (but relatively close to the body) read by a computing device 14, such as a portable computer, smartphone, tablet, and/or other sensor device that can have the same or compatible radio communication protocol as the patch 10. As shown herein, the computing device 14 is shown as a smartphone, but it is understood that the computing device may be a portable computer, smartphone, tablet, and/or other sensor device configured to communicate with the patch 10 via radio communication. The computing device 14 includes a programmable microprocessor capable of running an application, a power source (battery or AC line power), a display, and a transceiver capable of bi-directional communication with the patch 10. Further, computing device 14 is preferably capable of communicating over a Local Area Network (LAN) or a Wide Area Network (WAN) including the Internet and the world Wide Web. The temperature measurements may be taken as needed and/or at predetermined time intervals, and may be stored locally in the memory of the patch 10 and/or in the memory of a reading device (e.g., smartphone, tablet, laptop, sensor, etc.).

In one embodiment, patch 10 may include a high frequency/Near Field Communication (NFC) radio protocol. Thus, this patch 10 can be read by a standard smartphone (or computer, tablet, sensor, etc.) with a standard radio protocol enabling compatible high frequency/near field communication NFC and ISO-15693 RFID. For example, if one person wearing the patch 10 is sleeping, another person with a smartphone will be able to read the output of the patch 10 with a smartphone capable of high frequency/near field communication NFC and ISO-15693 RFID. Near Field Communication (NFC) is a set of standards for smartphones and similar devices to establish radio communication between each other by touching them together or bringing them within close distance, typically not more than a few centimeters (although it is expected that the range may be increased). The NFC standard encompasses communication protocols and data exchange formats, and is based on existing Radio Frequency Identification (RFID) standards including ISO/IEC 14443, ISO/IEC 15693, and FeliCa. These standards include ISO/IEC 18092 and 21481, and those defined by the NFC forum. NFC is a group of short-range wireless technologies that typically require a distance of 4 centimeters or less. NFC operates over the ISO/IEC 18000-3 air interface at a rate range of 13.56MHz and 106 kbit/s-424 kbit/s. NFC comprises an initiator and a target, wherein the initiator actively generates an RF field that can power the passive target.

The person (or automatic device) reading the temperature information will not have to wake the patient wearing the patch 10 and, by such means as a smartphone application (app) or the like, will be immediately able to display graphically and/or in a text-based format (e.g., list, table, chart, etc.) the instantaneous and/or historical body temperature of the patient wearing the patch for some or all of their sleep time. This information is displayed in consideration of the trend history of body temperature. Application functionality may include, but is not limited to, some or all of the following features:

enabling the smartphone to create a data link to the patch;

sending an initialization (or re-initialization) command to the patch and setting a flag (flag) that the electronic device has been successfully initialized;

sending data to the patch, including an initialization timestamp (time stamp) to start data recording, a data sensing time interval, a data retrieval time interval, a data format, an upper temperature boundary level, a lower temperature boundary level, and the like;

reading a unique identifier code programmed into the integrated circuit;

reading time-stamped temperature data stored in a memory of the integrated circuit, including a portion or even all of the data since the patch was activated;

reading the battery voltage level, estimating the battery voltage level, or estimating the amount of time remaining for the patch to operate;

converting the temperature data from degrees Fahrenheit to degrees Celsius, or from degrees Celsius to degrees Fahrenheit, or to other temperature units;

graphically displaying temperature data versus time using a plurality of graphical (graph) display options (i.e., line graphs, bar graphs, etc.);

displaying the relationship of the temperature and the time data in a table form;

performing a data analysis;

setting an alarm level for temperatures approaching or exceeding a predetermined boundary condition, and issuing an alarm signal via visual and/or audible means;

storing historical data;

creating a plurality of user profiles;

a link (link) allowing the unique identifier of the integrated circuit to be linked to a user profile;

email, text or other data transfer to a third party;

re-ordering additional patches online; and

linking to a website for medical consultation or medical contact information.

The wireless radio protocol may enable the smartphone (or computer, tablet, sensor, etc.) to download temperature data from the patch and/or to download some or all of the stored data as required. Additionally or alternatively, the computing device 14 (e.g., smartphone, computer, tablet, other sensor device, etc.) may be configured to download and utilize data from one or more patches and/or other local sensors. Additionally or alternatively, a smartphone application (app) or the like may be configured to utilize and apply analytics to some or all of the collected data to determine data trends, relationships, and the like.

It will be appreciated that although the NFC wireless protocol has been described herein, various other wireless protocols may be used, including standards-based protocols and even proprietary protocols. Exemplary protocols may include any or all of the following (or even others, without limitation): RFID, bluetooth low energy, WiFi, cellular (analog or digital, including all past or present iterations), ZigBee, RuBee, etc. Indeed, while NFC provides a relatively low speed connection with very simple settings, it can be used to guide more capable wireless connections.

In one embodiment as shown in fig. 2A, the patch 10 may include the following layers arranged in a covering, stacked arrangement: (A) a flexible single-sided adhesive 20, wherein the non-adhesive side 22 is preferably a material on which the printing process can be completed, while the adhesive side 24 is coupled to the next layer; (B) an electronic center 30, which may include the following components in various orders: (a.) a flexible printed battery 32 having battery electrodes 33A, 33B; (B.) a flexible circuit 34 (printed or etched or laminated) having battery contact pads (pads) 35A, 35B; (c.) an antenna 36; and (d.) an integrated circuit 38 using a wireless communication protocol (such as HF/NFC and ISO-15693 RFID or other protocols) and capable of taking temperature readings and storing those readings and the time of the reading into an onboard memory; and (C) a double-sided adhesive 40 having a release liner 42, wherein one side 43 (e.g., the outward side) of the adhesive 40 is preferably a skin-contact-permitting adhesive. For example, once completed, the patch 10 may have a single removable layer as the release liner 42 that is removed by the patient immediately prior to adhering the patch 10 to the skin. The flexible circuit 34, including the antenna 36 and the integrated circuit 38, may have relatively small dimensions, such as dimensions of 30mm x 40mm, a thickness of less than 1mm (e.g., such as 0.8mm or less), although various dimensions are contemplated. It is understood that the various layers may include adhesive therebetween, such as a pressure sensitive adhesive that may have a release liner to facilitate manufacture. For example, it is contemplated that some or all of the various layers 20, 32, 34, 40 may be manufactured separately and subsequently assembled together. For example, the battery 32 and the flexible printed circuit 34 may each be manufactured separately and assembled together to make the patch 10. The pressure sensitive adhesive may be attached to some or all of the various layers. Alternatively, the various layers may be coupled together in various other ways, such as via glue, welding, other adhesives, and so forth.

In another exemplary embodiment shown in fig. 2B, the patch 10B may include additional or alternative layers that may provide additional features, such as helping to adhere the patch 10B to the skin of a patient. As shown, the patch 10B may include the following layers arranged in a covering, stacked arrangement: (A) a coated non-woven PSA tape 44 comprising a relatively high performance medical grade adhesive system intended for direct skin contact applications and preferably constructed of a permanent adhesive that exhibits excellent permeability (wetout) to various substrates (substrates); (B) an electronic center 30B, which may be similar to or different from the electronic center 30 described above (and may also optionally include the flexible, single-sided adhesive layer 20), and may include the following components in various orders: (a.) a flexible, printed battery 32; (b.) a flexible circuit 34; (c.) an antenna 36; and (d.) an integrated circuit 38 that uses a wireless communication protocol; (C) a double-sided adhesive 46, preferably a skin-contact-permitting adhesive (and may be similar to the adhesive 40 described above), to provide a thermal conduit between the electronic center 30B and the patient's skin; (D) the addition of a double-sided adhesive layer 48 to aid in the adhesion of the patch 10B to the patient's skin; and (E) a single removable layer as release liner 49 (and may be similar to release liner 42 described above). As for the layers (C), (D), and (E), various materials can be used.

In one embodiment, double-sided adhesive 46 may comprise a hydrogel, which is a material that includes polymer chains that are hydrophilic and exhibit a degree of flexibility that closely resembles natural tissue or skin. Various types of hydrogels may be used, and may include any or all of water, glycerin, acrylate/acrylamide copolymers, and/or other ingredients. Preferably, the hydrogel provides excellent skin adhesion properties while also providing the desired thermal conductivity properties to serve as a thermal conduit between the temperature sensing capabilities of the flexible circuit 34 and the patient's skin. With respect to the additional double-sided adhesive layer 48, it is contemplated that such an adhesive may help promote and maintain adhesion of the patch 10B to the patient for a predetermined period of time (such as 12, 16, 24, or 48 hours, etc.). For example, initial hydrogel adhesion may be poor, which gradually increases as the hydrogel warms to body temperature and begins to peristaltically flow into intimate contact with the skin surface after the hydrogel is applied to the skin. Thus, the additional adhesive layer 48 may provide an immediate initial adhesive bond to allow sufficient time for the hydrogel to properly bond to the skin. Various materials may be used for the additional double-sided adhesive layer 48, such as using a cross-linked polyethylene foam coated on one or both sides with a pressure sensitive adhesive that provides a tack of at least about 50 grams per inch, although greater or lesser amounts of adhesion are contemplated. Such foam may also provide thermal isolation of the temperature sensor from the ambient environment, thereby contributing to temperature accuracy. Preferably, the material is resistant to water, perspiration, humidity or other human or environmental factors that may otherwise reduce or deteriorate the bond between the patch 10B and the patient's skin during the predetermined length of time period.

In addition, the hydrogel 46 may be coated on the underside of the adhesive layer 48, or may be disposed within a recess or even a through-hole of the adhesive layer 48. For example, the adhesive layer 48 may include a hole extending therethrough, and the hydrogel 46 may be partially or completely located within the hole such that the hydrogel 46 and the adhesive layer 48 are substantially coplanar. It is further contemplated that the hydrogel 46 may be disposed directly to the adhesive layer 48, or may be disposed to the electronic ink 30B so as to be disposed indirectly to the adhesive layer 48. Although the hydrogel layer 46 is shown covering a majority of the electronic center 30 and the additional adhesive layer 48 in fig. 2B, it is contemplated that the hydrogel layer 46 may be larger or smaller. For example, because the hydrogel layer 46 is used to provide thermal conductivity between the temperature sensor of the flexible circuit 34 and the skin of the user, the size of the hydrogel layer 46 may be reduced to approximately the size of the integrated circuit 38 (or even just the temperature sensor portion thereof) and above the integrated circuit 38 (or even just the temperature sensor portion thereof). Such a configuration may more closely focus the heat detection capabilities of the temperature sensor, provide improved adhesion capabilities of the additional adhesive layer 48, and/or provide greater protection to the flexible circuit 34 and/or the flexible battery 32. As for the removable release liner 49, it may include various readily removable liners, and is preferably a liner compatible with and readily removable from the hydrogel 46 and adhesive 48, such as a polyolefin-coated or silicone-coated paper and coated film. Preferably, all of the layers 44, 46, and 48 are flexible, capable of being adhered to a curved and/or variable surface (e.g., the patient's skin) for an extended period of time, capable of flexing and moving with the patient's movement, and comfortable to wear. Additionally or alternatively, either or both of outer layers 20, 44 may include a printable surface to provide indicia (indicia), instructions, or even an identifying location for antenna 36 (e.g., a visual target to help a user successfully obtain communication with computing device 14). It is contemplated that some or all of the layers of the patch 10, 10B may be exposed to the external environment, or alternatively, some of the layers may be shielded or protected from the external environment. In one embodiment, the electronic frit may be encapsulated between outer layers (e.g., between layers 20 and 40 or between layers 44 and 46/48). Finally, various adhesive layers and the like may be disposed between any or all of the various layers discussed above.

The various layers of the electronic center 30 will now be discussed in more detail. It is to be understood that the electronic center 30 may be used with any of the described embodiments of the patches 10, 10B, or even other variations thereof. As described above, the electronic center 30 includes the flexible printed circuit 34, which may include the antenna 36 for wireless communication and/or power transmission, and the integrated circuit 38. The flexible printed circuit 34 may further comprise battery contact pads 35A, 35B adapted to be electrically coupled to corresponding battery electrodes 33A, 33B of the printed battery 32. In one exemplary configuration, an etched copper circuit may be disposed on substrate 37 (e.g., a polyester substrate about 0.002 "thick). The electrical component may be an active NFC circuit comprising at least one integrated circuit 34 microprocessor (possibly including internal and/or external memory) and an antenna 36. It is contemplated that substrate 37 may be flexible or rigid. Copper circuitry is merely an example for this cell/cell attachment and may be used with any commercially available circuit material, such as etched aluminum or printed carbon, silver or any other metal substrate, etc. The circuitry may provide electrical communication between various components on the substrate 37 and also provide connections to the flexible battery 32.

In addition, circuit subassembly contacts may be provided, as well as a non-conductive Pressure Sensitive Adhesive (PSA) of about 0.002 "thick that may be applied to electrical components (including processors and antennas) and substrates. The PSA layer may have an exemplary thickness ranging from about 0.0005 "to about 0.005" and may have dimensions similar to those of the power source (e.g., single cell or multiple cells) used. It is also contemplated that the power source (e.g., battery 32) may be printed onto the substrate, or may be attached later as a complete unit cell(s). In one embodiment, the battery 32 may be mechanically and electrically coupled to the circuit 34 by ultrasonically welding the battery electrodes 33A, 33B to the battery contact pads 35A, 35B. Alternatively, conductive adhesives, conductive inks, conductive pads, and the like may also be used to mechanically and electrically couple the battery 32 to the circuitry 34. Additionally or alternatively, a pressure sensitive adhesive or the like may provide additional coupling between the battery 32 and the substrate 37 of the circuit 34. Additionally or alternatively, the battery 32 may be printed on the same substrate as the flexible printed circuit 34 (including either or both of the antenna 36 and the integrated circuit 38). Such a configuration may place the battery 32 on the same side of the common substrate as the flexible printed circuit 34 or on the opposite side. Additionally or alternatively, a toggle switch or even a one-time switch may be provided to enable the battery 32 to be activated only when the user intends to use the patch 10, which may conserve battery power during long periods of storage.

Turning now to fig. 4, one exemplary circuit 34 will be described in more detail. While shown as a three-chip solution, it is contemplated that more or fewer chips may be used, such as a single-chip solution. Further, while different exemplary microchips are discussed herein, it is understood that various other microchips capable of sensing, processing, powering, communicating, etc., may be used. As shown in fig. 4, the three-chip solution may generally include a microprocessor 50, a temperature sensor 52 chip, and a communication chip 54. It is contemplated that the communication chip 54 is electrically connected to the antenna 36 and may include one or more of the communication protocols discussed herein, including NFC, RFID, bluetooth low energy, WiFi, cellular (analog or digital, including all past or present iterations), ZigBee, RuBee, and the like.

In one embodiment, the microprocessor 50 may be a programmable microprocessor that may include various features and functions. Microprocessor 50 includes a programmable computing core having any or all of the capabilities to process commands, perform calculations, track/read data, store data, analyze data, adjust/manipulate data, receive new commands or instructions, and the like. Microprocessor 50 is capable of operating temperature sensor 52 chip (and any optional auxiliary temperature sensor 53) at predetermined or variable temperature reading intervals, operating timer 60, and storing temperature and time recorded data points in on-board memory 62 and/or even in auxiliary memory storage device 64, transmitting temperature and time recorded data points between different storage devices, receiving commands and/or data from computing device 14, outputting commands and/or data to computing device 14, and transmitting stored temperature data to computing device 14 since the last connection time. Further, each time the computing device 14 approaches the patch 10, 10B (e.g., within communication range of the communication protocol being used), the microprocessor 50 should transmit updated data to the computing device 14. If the computing device 14 is constantly in proximity to the patch 10, 10B, updated data may be sent periodically at predetermined intervals (e.g., every 5s, every 10s, every minute, etc.) or at adjustable intervals (e.g., manually or automatically adjusted via a software application). In other embodiments, the microprocessor 50 may include error checking and control functions to ensure data integrity of the measured temperature. The error checking and control function may operate on various data flowing to or from the microprocessor 50, including temperature reading data, data stored in and/or read from memory, and/or data transferred into and/or out of the patch 10. It is contemplated that the wireless communication subsystem will also include error checking and control functions and that the microprocessor 50 may operate with such a subsystem or independently of such a communication subsystem.

The microprocessor 50 may also include an electrical connection 56 to the flexible battery 32, and may selectively distribute power to either or both of the temperature sensor 52 chip and the communication chip 54 via wires 57A, 57B. The microprocessor 50 may include any or all of a voltage regulator or trimmer (modifier)58 (which may or may not include a coil 58B), such as a voltage upconverter or downconverter, a power regulator, and/or a capacitor(s) 59 to stabilize voltage and power flow. In one embodiment, the temperature sensor chip 52 may operate at about 3 Volts Direct Current (VDC), while the single flexible battery 32 provides only about 1.5 volts dc. Accordingly, when it is desired to operate the temperature sensor chip 52, the microprocessor 50 may up-convert the 1.5VDC of the battery 32 via the voltage regulator or trimmer 58 to selectively provide 3VDC to the temperature sensor chip 52. Alternatively, it is further contemplated that a 3VDC (or larger) battery (including two or more 1.5VDC batteries in series) may be utilized, in which case the voltage regulator or trimmer 58 and/or capacitor 59 may not be used. When the temperature sensor chip 52 is not operating, the microprocessor 50 may stop supplying power to the temperature sensor chip 52 to save power. It is contemplated, however, that the voltage regulator or trimmer 58 and/or the capacitor 59 may be separately provided from the microprocessor 50. Also, the microprocessor 50 may selectively provide power to the communication chip 54 for various reasons. When using a passively powered communication protocol (e.g., NFC or RFID), the microprocessor 50 may provide limited or even no power to the communication chip 54. Instead, all of the power for the communication chip 54 may be obtained from NFC or RFID (or other) transfer. Further, the secondary memory 64 may be capable of being powered by NFC or RFID (or other) transfer, thereby enabling data reading even if the battery 32 has been depleted. Nonetheless, if the communication chip 54 includes additional features (e.g., the secondary memory 64), the communication chip 54 may still receive some continuous or intermittent power from the microprocessor 50. When using an actively powered communication protocol (e.g., bluetooth low energy, WiFi, cellular, etc.), the microprocessor 50 may provide continuous or intermittent power to the communication chip 54 for operation of the communication chip 54. It is contemplated that the microprocessor 50 may periodically cease power to the communication chip 54 to conserve power.

Microprocessor 50 may include additional features. For example, the microprocessor 50 includes a timer 60, which may be a real time clock or other mechanism for tracking time. Thus, the microprocessor 50 can associate each temperature read from the temperature sensor 52 chip with a time stamp, and preferably a time stamp indicating the real-time local time at which the temperature reading was made. It is also contemplated that the timer 60 can track and report time based on a standard time zone, and the software application can provide adjustments to the user's local time zone. Alternatively, it is contemplated that the timer 60 may not track real-time, but may track some time-related data that is interpreted, estimated, or translated by the software application as a true timestamp. Additionally or alternatively, the timer 60 or other portion of the microprocessor 50 may accept a timer initialization command from the computing device 14 and related software application to initiate operation of the timer 60 whenever a user begins using the patch 10, which would normally be in a passive or very low power state during storage. The timer initialization command may initiate operation of the timer 60 and may also provide an accurate, actual start time (or time-related data) so that the timer 60 may begin accurately reporting and recording a time stamp for each temperature reading. Additionally or alternatively, the timer 60 may be configured to accept one or more timer adjustment signals to periodically ensure that the timer 60 is accurately maintaining time.

The microprocessor 50 may also include on-board memory 62, the on-board memory 62 configured to store some or all of the temperature reading data and associated time stamps. It is contemplated that each temperature reading from the temperature sensor 52 chip will have at least one time stamp associated therewith, and that each discrete temperature reading will be stored in memory along with its time stamp. Each temperature reading may also be stored along with additional data such as a temperature reading reference number, a patch 10 device unique ID (UID, which may be hard coded into the microprocessor 50 or communication chip 52), a flag indicating whether each discrete temperature reading data point has been wirelessly communicated to the computing device 14, a flag indicating whether each discrete temperature reading data point has been adjusted, modified, converted, etc., and/or various other portions of the data associated with each temperature reading data point. The on-board memory 62 of the microprocessor 50 is sufficient to retain a portion, such as all, of the temperature data point readings during the operating life of the patch 10 (e.g., typically dictated by the available life of the battery 32). For example, on-board memory 62 may retain each temperature data point reading regardless of whether the data point has been wirelessly transmitted to computing device 14. During each wireless transfer, the software application may re-read a complete copy of the data, or only re-read the most recent unread incremental data points. Alternatively, the on-board memory 62 of the microprocessor 50 is only sufficient to store a fixed amount of data less than all of the temperature data points. In one embodiment, the on-board memory 62 is only capable of storing 25% or 50% of all temperature data points that are intended to be read during the operational life of the patch 10. Thus, a computing device 14, typically having a much larger memory space, may retain the complete temperature data reading history for each patch 10, while the on-board memory 62 of the microprocessor 50 retains only a small fixed amount, such as the last 500 data points or data points within the last few minutes or hours, or other amounts of data, etc. It will be appreciated that various mechanisms may be used to accommodate a fixed amount of on-board memory 62. For example, when the memory is full, the microprocessor 50 may continuously overwrite the oldest memory register so that the most recent temperature reading is always available for reading by the software application and computing device 14, or the microprocessor 50 may even stop storing temperature readings.

Additionally or alternatively, the circuit 34 may include a secondary memory storage device 64 preferably having sufficient capacity to record all expected temperature reading data points. In one embodiment, the secondary memory storage 64 may be a separate chip or may be incorporated as part of another chip, such as part of the communication chip 54. In one embodiment, secondary storage 64 may have 64 kilobytes of memory capable of storing approximately 100,000 data points, although more or less memory (within one or more storage devices) is contemplated. Accordingly, some or all of the temperature reading data points stored in the on-board memory 62 of the microprocessor 50 may be transmitted to a relatively large secondary storage device 64 for long term storage. The transmission of such data points may be performed according to various schedules, on-demand, and the like. For example, the transmission of some or all of the data points from the on-board memory 62 to the larger secondary storage device 64 may be performed at preset time intervals, such as every 30 seconds, every minute, every five minutes, and so forth. In another embodiment, the transfer of some or all of the data points from the onboard memory 62 to the larger secondary storage device 64 may be performed once the onboard memory 62 has reached a predetermined capacity, such as 50%, 75%, 90%, or 100% of full capacity, or the like. In another embodiment, the transfer of data points from the on-board storage 62 to the secondary storage 64 may be performed on a rolling basis. For example, the data points initially written to the on-board memory 62 may then be sequentially transmitted to the secondary storage 64, or once the on-board memory 62 is full, the oldest data point may be transmitted to the secondary storage 64, thereby making room for the next newest data point to be written to the on-board memory 62. It is also contemplated that data may be transferred from secondary storage 64 back to on-board memory 62, if desired. Finally, it is contemplated that either or both of on-board memory 62 and secondary storage 64 may include volatile or non-volatile memory that may or may not require continuous power.

The temperature sensor 52 chip may utilize various types of sensors or techniques to determine the temperature of the patient, such as an on-chip PN junction sensor. For body temperature readings, the temperature sensor 52 chip is highly accurate within the typical human body temperature range of 35-43 degrees Celsius (e.g., 95-110 degrees Fahrenheit). Preferably, the temperature sensor will have a high degree of accuracy, such as +/-0.5 degrees Celsius or more preferably +/-0.25 degrees Celsius. Nevertheless, various other types of internal and/or external temperature sensors may be utilized, such as thermistors and Resistance Temperature Detectors (RTDs). Thus, the chip of the temperature sensor 52 may sense the body temperature of the user through the skin contact adhesive 40. It is contemplated that the temperature sensor 52 may directly sense the body temperature of the user, or may even indirectly interpolate/estimate the temperature based on a predetermined algorithm or the like. Further, it is contemplated that the patch 10 may utilize a predetermined algorithm or the like to provide an indication of the core body temperature of the user based on skin surface temperature measurements. The microprocessor 50 may periodically obtain temperature data points from the temperature sensor 52 at every predetermined time interval (e.g., every 1 second, every 5 seconds, every 10 seconds, every minute, etc.) or at adjustable time intervals. In one embodiment, the microprocessor 50 can obtain temperature data points at fixed time intervals during the operational life of the patch 10. In another embodiment, the microprocessor 50 may acquire temperature data points at variable time intervals, which may be dynamically adjusted by the microprocessor 50 or software application, or even by the user. In another embodiment, the microprocessor 50 can obtain temperature data points at different rates depending on certain variables, such as the time of operation of the patch 10. For example, the microprocessor 50 may obtain temperature data points at relatively close intervals (e.g., read every second or every 5 seconds) during the first 5-10 minutes of operation so that the user may have relatively quick and immediate feedback of the patient's temperature. Thereafter, the temperature reading interval may be reduced to 1 reading every 30 seconds or every minute to conserve battery power or memory. The software application may still provide a "boost" mode to enable fast data acquisition planning to be re-implemented on demand if desired. Alternatively, the data sensing interval may be based on battery life (e.g., less data reads are obtained when the battery is drained below a threshold amount), memory capacity (e.g., less data reads are obtained when available memory capacity is below a threshold amount), or even the temperature sensed by temperature sensor 52 (e.g., data reads are slower when the sensed temperature is within a predetermined normal range and data reads are faster when the sensed temperature exceeds a predetermined elevated or reduced range).

Additionally or alternatively, the patch 10 may include one or more secondary temperature sensors to measure, for example, multiple body temperatures or even ambient environmental conditions near the user. The one or more auxiliary temperature sensors 53 may be electrically coupled to the temperature sensor 52 chip via optional external connections, or may even be built-in. The patch 10 may utilize these secondary temperature sensors to dynamically adjust the temperature readings of the user and/or the alarms of the software application based on ambient conditions. For example, if a user is located in a very hot climate, the user may be expected to have a slightly higher body temperature than a user located in a very cold climate. The software application may dynamically adjust the high temperature alarm to accommodate such environmental variables. It is also contemplated that the temperature sensor 52 chip may also include various other sensors such as ambient humidity, ambient pressure, ambient light, sound, and/or radiation levels, patient body function, time, patient movement (e.g., via an accelerometer), etc., and that the software application may dynamically adjust alarms or the like based on one or a combination of various variable readings. Finally, it is preferred that the temperature sensor 52 (and the circuit 34 as a whole) will not be exposed to high temperatures during the assembly process, and as such, the temperature sensor 52 chip can be calibrated at the factory. However, it is contemplated that the temperature sensor 52 chip may be self-calibrating and/or may be calibrated by the microprocessor 50 and/or computing application.

Finally, microprocessor 50 may include various additional optional features. In one embodiment, the microprocessor 50 may include one or more output devices to provide feedback to the user, such as indicators, alarms, and the like. The output devices may include any or all of visual (e.g., LED lights 66, a display, etc.), audible (e.g., a speaker, etc.), or tactile (e.g., vibration, etc.). In one embodiment, one or more optional LED lights 66 (or other types of lights, displays, etc.) may be used to indicate that a user of the patch 10 has a low, normal, or high temperature. The LED lamp 66 may be illuminated yellow for low temperatures, green for normal temperatures, or the LED lamp 66 may be illuminated red to indicate high temperatures, or these indications may be provided by varying flashing intervals. In another embodiment, the LED lights 66 may be used to dynamically (e.g., via color changes, blinking intervals, etc.) indicate the battery status and/or the actual or estimated remaining run time of the patch 10. In another embodiment, the LED lights 66 may be used to indicate an operational status of the patch 10, such as on/off, normal/wrong operation, successful or failed connection with the computing device 14, active communication with the computing device, and the like. The microprocessor 50 may be connected to any or all of the temperature sensor 52, the communication chip 54, or other components in various ways, such as a two-wire interface or the like.

As described herein, the patch 10 is at least partially active device having an onboard power source. For example, the electronic center 30 may include a thin, flexible battery 32. The flexible battery 32 may be provided with various capacities, such as 5, 10, 15, or other capacities. While the wireless communication may be partially or fully powered by the wireless signal (e.g., NFC communication protocol) itself, any or all of the onboard microprocessor, timer, memory, and/or temperature sensor may be actively powered. In an effort to make the patch small, thin, lightweight, and flexible, a thin printed battery may be provided as an on-board power source. Flat cells can be manufactured using a number of different methods. In one embodiment, the electrochemical cells (i.e., batteries) are typically printed and/or laminated on a continuous, flexible substrate web, and may be formed into rolls or the like. The individual batteries may be removed from the roll, such as one at a time. For example, the cells may be cut from a roll, and/or perforations of a roll of flexible substrate may be provided for easy tearing. Furthermore, the battery may also be manufactured in an integrated process with one or more electrical components, such as an antenna, a display, and/or a processor. Aspects of the present application may be used in the described overall package and/or they may be used individually or in any combination.

As used herein, all percentages are weight percentages unless explicitly indicated otherwise. Further, as used herein, when a range is given, such as "5-25" (or "about 5-25"), this means at least about 5 for at least one embodiment, and separately and independently is not greater than about 25, and unless otherwise indicated, the range should not be construed strictly, but is given as an acceptable example. Herein, ranges in parentheses following the listed or preferred values indicate broader ranges of the values according to other embodiments of the present application.

One method of mass producing such cells involves depositing aqueous and/or non-aqueous solvent-type inks and/or other coatings in a pattern on a specialized substrate, such as a laminated polymer film layer. The deposition may be by means of, for example, printing electrochemical inks and/or laminating metal foils (e.g., zinc foils) on one or more high speed web rotary screen printers, especially if the desired capacity is very large. Relatively slow methods, such as web printing using flat screen, may be suitable if the capacity is relatively small, assuming only about a few million or less. If the volume is even smaller, such as hundreds or thousands, for example, a sheet fed flatbed printer may be utilized. Nevertheless, various printing methods can be used in various desired amounts.

After the ink is printed and/or after the solids have been properly placed, the cell may be completed (e.g., sealed, die cut, stacked and/or perforated and wound into a roll, or stacked if paper sheets are used on a printer). This cell manufacturing process can also be used to integrate one or more individual cells with the actual electronic application, or to integrate one or more individual cells into a battery comprising a plurality of cells connected in series or in parallel, or some series and a plurality of cells connected in parallel. Examples of such an apparatus and corresponding process will be described subsequently, but many other embodiments are also contemplated.

As discussed above, the battery may be described as printed, flexible, and thin. Such a cell/battery may include, for example, utilizing a lower film substrate having a particular polymer laminate with particular characteristics, such as including a high moisture barrier layer centered around the polymer film on both sides. In addition, one or both of the exterior side surfaces may be made print receptive for information, logos, instructions, logos, serial numbers, graphics, or other information or images as desired.

Depending on which structure is used in the cell, one of the layers in the multi-layer substrate may also serve as a heat seal layer, which may be co-extruded adjacent to the barrier coating. Further, a portion of a base layer of a battery cell in at least some embodiments may utilize a cathode (cathode) current collector (collector) and/or an anode (anode) current collector, such as, for example, carbon printed or coated or otherwise applied on a portion of a film substrate. The outer contact area of this collector may also be printed with a layer of ink having a relatively high conductivity, such as carbon, gold, silver, nickel, zinc or tin, if desired, to improve the conductivity to the application connection. However, if the battery application is used for relatively low current requirements, the higher conductive layer contact material, or even the current collector, may not be used for one or both of the electrodes.

For at least some embodiments, the water-based ink electrochemical layer is printed as a cathode. Such cathode layers may include, for example, manganese dioxide (MnO2), carbon (e.g., graphite), a polymeric binder, and water. Other formulations for the cathode layer with or without any of these materials may also be utilized. If a cathode collector layer is used, the cathode electrochemical layer will be printed on at least a portion of the cathode current collector that is printed or otherwise first applied to the substrate. Nevertheless, the cathode current collector may or may not be formed as part of the cathode layer.

As for the anode, a dry film adhesive layer, possibly using a release liner, may be applied to the zinc foil in an off-line operation. The zinc foil may then be laminated to a base substrate. Furthermore, the anode layer may be applied by printing a zinc ink onto the substrate or on top of the current collector (such as carbon). Where carbon is used, it may be printed in the same location as the carbon collectors for the cathode and the bridge.

Optionally, printed on one or both of the anode and cathode is a starch ink (stark) or similar material. The starch ink may act as an electrolyte absorbent to keep the electrodes "wet" after an aqueous electrolyte solution is added to the cell. The starch ink may also include an electrolyte salt and water for cell reaction. Paper layers may be used on the anode and cathode instead of printed starch. In at least one embodiment, the structure of the printed starch layer with the additional aqueous electrolyte may be replaced, for example, by a printable viscous liquid (which may include a gel, or some other viscous material) that effectively covers at least a portion (such as substantially all) of each electrode. One such printable gel is described in U.S. patent publication 2003/0165744a1, published 9/4/2003, which is incorporated herein by reference. These viscous formulations may, for example, utilize electrolyte formulations and concentrations as discussed herein.

Optionally, for some embodiments, an optional battery cell "picture frame" may be added after the two electrodes are in place (with or without starch layer (s)). This can be done using a number of different methods. For example, one approach is to print this optional battery cell picture frame with dielectric ink and/or adhesive. Another approach is to utilize an optional polymer sheet or a laminated polymer sheet including an adhesive layer that is stamped, die cut, laser cut, or the like to form appropriate "receptacles" (one or more interior spaces) to receive the material of each unit cell and to expose electrical contacts to connect the devices. It is contemplated that the flexible battery may be formed with or without a frame. For example, while the frame may provide a method of providing an interior space for an electrochemical cell, it is also contemplated that the first and second substrates may be secured together to provide an interior space for an electrochemical cell without the use of a frame.

To ensure a good seal of the picture frame to the substrate, and to provide a good seal of the contact-feed-throughs (providing an electrical path from the inside of the battery cell to the outside of the battery cell), a sealing or caulking adhesive may be printed on the contact feed-throughs and the substrate, such as in the same pattern as the battery cell frame, for example, before the frame is printed or before the polymer sheet is inserted.

The sealing or caulking material may be a pressure sensitive material and/or a heat sensitive material, or any other type of material that will facilitate sealing to both surfaces.

After the dielectric picture frame is printed and dried and/or cured, a heat sensitive sealing adhesive may be printed on top of the frame to allow the top substrate to seal well to the cell frame. This battery cell picture frame may also include a polymer or laminate film that is about 0.015 "thick (in the range of about 0.003" -0.050 ") that is pre-perforated and then laminated in an aligned manner to match the pre-printed caulk adhesive layer described above.

Zinc chloride (ZnCl2) may be selected as the electrolyte, for at least some embodiments, for example, in a concentration range of about 18% -45% by weight. In one embodiment, about 27% is preferred. For example, electrolyte may be added to the open cell. To facilitate processing on a production line, this or a different electrolyte may be enriched to a level of about 0.6 wt% (a range of about 0.05% -1.0%) using, for example, CMC.

For example, other useful electrolyte formulations may also be used, such as ammonium chloride (NH4C1), mixtures of zinc chloride (ZnCl2) and ammonium chloride (NH4C1), zinc acetate (Zn (C2H2O2), zinc bromide (ZnBr2), zinc fluoride (ZnF2), zinc tartrate (znc4h4o6.h2o), zinc chlorate Zn (ClO4)2.6H2O), potassium hydroxide, sodium hydroxide, or organics.

Zinc chloride may be the electrolyte of choice, providing excellent electrical performance against common environmental conditions typically encountered. Likewise, in addition, any of the alternative electrolytes mentioned above may be used at a concentration (by weight) in the range of, for example, about 18% -50%, with a range of about 25% -45% being used in at least some other embodiments. Such components may also provide acceptable performance under normal ambient conditions. When zinc acetate is used to achieve improved low temperature performance for low temperature applications, zinc acetate concentrations in the range of about 31-33 (weight percent) are often acceptable, although ranges of about 30-34, about 28-36, about 26-38, and even about 25-40 (weight percent) may also be utilized.

The use of electrolytes other than zinc chloride can provide improved cell electrical performance/battery electrical performance under a number of different environmental conditions. For example, about 32% (by weight) of zinc acetate (f.p. -freezing point-about 28 ℃) exhibits a freezing point lower than about 32% (by weight) of zinc chloride (f.p. about-23 ℃). Both solutions exhibited freezing points lower than about 27% zinc chloride (f.p. about-18 ℃). Other zinc acetate concentrations, such as about 18-45 or 25-35 weight percent, also exhibit reduced freezing points. Alternatively, an alkaline electrolyte, such as sodium hydroxide (NaOH) or potassium hydroxide (KOH), may be used as the electrolyte to provide improved cell/battery electrical performance under a number of different environmental conditions. Cell performance can be greatly enhanced due to the much higher conductivity of KOH electrolyte. For example, a good working range for KOH may be a concentration (by weight) in the range of about 23% -45%.

The use of such electrolyte formulations as a replacement for zinc chloride or in various mixtures used in battery cells may allow for improved performance under low temperature conditions. For example, it has been found that using about 32% zinc acetate electrolyte significantly improves the low temperature (i.e., below about-20 ℃) performance of a photovoltaic cell. The improved performance of this type of electrochemical cell under low temperature conditions can be utilized in the growing business of, for example, battery-assisted RFID tags and/or other transitory (transportable) electrically operated devices that can be used in cold environments, such as smart active signage and temperature tags.

For example, many products loaded today (such as food, pharmaceuticals, blood, etc.) may require cryogenic storage and cryogenic transport conditions, or even cryogenic operation. To ensure secure shipment of such goods, the items may be tracked with RFID tags, sensors, and/or displays. These labels and/or tags may require electrochemical cells and/or batteries to operate effectively at-20 ℃ or even below-20 ℃, such as about-23 ℃, -27 ℃, or even about-30 ℃ or less.

The upper substrate of the battery cell package may utilize a specific laminated polymer film. The upper layer is sealed around the edges of the cell frame by means of a Pressure Sensitive Adhesive (PSA) and/or a heat seal layer using a pre-printed heat sensitive adhesive or using only both the upper and lower substrates, thereby confining the internal components within the cell frame.

The above configuration may be a wet cell configuration; however, using a similar cell structure, the battery can also be made into a reserve cell configuration, which has the benefit of providing an extended pot life prior to application of the liquid. The fabrication of printable, flexible, thin zinc chloride cells is environmentally friendly.

A large number of devices may use this technique. Devices utilizing relatively low power or limited life (one to three years and possibly longer) may have the functionality of utilizing thin battery cells/batteries of the type described herein. As explained in the above and following paragraphs, a battery cell can often be inexpensively mass-produced so that it can be used in, for example, disposable products. The low cost allows previously expensive applications to now be commercially viable.

Electrochemical cells/batteries according to the present application may have one or more of the following advantages:

flat and of relatively uniform thickness, with the edges thinner than the thickness at the center;

relatively thin;

flat and of relatively uniform thickness, with the edges having about the same thickness as at the center;

flexibility;

many geometries are possible;

a sealed container;

a simple construction;

designed for high speed and mass production;

low cost;

reliable performance under many temperature conditions;

good low temperature performance;

disposable and environment-friendly;

two battery cells/battery contacts disposed on opposite surfaces, or even on the same surface;

two battery cells/battery contacts may be provided at a number of locations on the outside of the battery;

ease of assembly into an application; and

can be easily integrated in a continuous process while electronic applications are being made.

A general description of various battery cell configurations according to some embodiments of this application is provided above, and further details are provided below using the figures. Battery cells and battery production processes for battery cell manufacturing, printing, and/or assembly will also be described.

In one embodiment, multiple rolls may be used, such as where relatively high speed, high output manufacturing (e.g., 50 linear feet per minute or another relatively high speed) may be contemplated. It should be understood that the plurality of webs may be generally continuous and may be utilized with known web manufacturing equipment. The first web may be relatively thin (such as-0.001 "-0.010", and preferably about 0.002-0.006 "), including a multi-layer laminate structure or a flexible base substrate of a single layer material. In one embodiment, the multilayer structure may include five layers. Alternatively, the single layer material may comprise various materials, such as kapton, polyolefin or polyester. In addition, if the 0.001 "layer is too thin to be efficiently handled on press and/or in other operations, a thicker disposable support layer (a low touch pressure sensitive adhesive layer) with a low touch pressure sensitive adhesive layer may be laminated to the thin substrate layer. In addition, this 0.001 "base layer may be made of more than one layer with a very thin oxide layer that acts as a water barrier on the inner surface. After the printing and assembly operations are completed, the disposable support layer may then be removed.

The second web may be a relatively thick laminate structure comprising a PVC or polyester film about 0.003 "to 0.030" thick, and preferably about 0.006 "to 0.015" thick. The second web may have a pressure sensitive adhesive layer (without a release liner) on one or both sides that is about 1-5 mils thick. After this lamination of the second web is completed, the second web may be applied to the first web. Additionally or alternatively, any type of mechanical device may be used to pattern cut the second web to account for multiple cavities for cell active material and an optional cavity for cell/battery contacts. The third web may be of the same and/or similar relatively thin laminate construction as the first web. The completed three web structures may have pressure sensitive adhesive on either side to allow the individual device assemblies to be applied as signage. The cells/batteries may be of the thin cell type as described in co-pending U.S. applications filed on 4/20/2005 with serial No. 11/110202, 11/379816 on 24/2006, 12/809844 on 21/6/2010, 13/075620 on 30/3/2011, 13/625366 on 24/9/2012, 13/899291 on 21/5/2013, and issued U.S. patents nos. 8029927, 8268475, 8441411, all of which are incorporated herein by reference.

Depending on the cell configuration, cell application, and/or cell environment, it may be advantageous to have different barrier properties appropriate for the substrate. Since a wide range of available vapor transmission rates can be provided, the barrier layer can be selected as desired for each particular application and configuration. In some cases, for example where the cell is designed to have a higher gassing rate and/or short life, it may be appropriate and desirable to use a membrane with a higher permeation rate to allow a greater amount of gas to escape, thereby minimizing cell swelling. The barrier layer is designed to minimize water loss but still allow gases generated by normal electrochemical reactions to escape, thereby reducing the chance of thin battery cells swelling. Another example is an application with a long pot life or in a hot and dry environment such as a desert. In such cases, a barrier film having a low permeation rate may be desirable to prevent the cell from losing too much moisture. At least one of the first and second substrate layers may comprise a plurality of laminate layers including an oxide barrier layer having a gas transmission rate that allows gas to escape through the plurality of laminate layers of the first or second substrate layers, but still reduces (e.g., minimizes) the escape of water vapor.

Various embodiments of exemplary configurations of laminate film substrates may be utilized. In most cases, and for most applications, the lower and upper laminate film layers may be the same material. In at least one embodiment, these film layers may be comprised of, for example, a five-layer laminate film. In another embodiment, the laminate film substrate may have four layers. The top layer placed on the inside of the cell has an exemplary thickness of about 0.48 mil thick (about 0.2-5.0 mils) and is a high moisture barrier polymer layer film that provides a flexible, heat sealable web with the following barrier properties: an oxygen transmission rate of less than about 0.045 cubic centimeters per 100 square inches per 24 hours at about 30 ℃ and 70% relative humidity; and an MVTR of between about 0.006 and 0.300 grams of water per 100 square inches per 24 hours at about 40 ℃ and 90% relative humidity.

Typically, such polyester films have an oxide coating or a metallized coating on the inside of the laminate structure. These polymer (polyester) based barrier films may have different moisture transmission values depending on the type and amount of vacuum deposited oxide or metal, and may be laminated to the bottom polyester layer and serve as a structural layer with a urethane adhesive. The inner layer of these substrates may include a heat seal layer. Another alternative high moisture barrier may be a flexible, heat sealable web having the following barrier properties: an oxygen transmission rate of less than about 0.045 cubic centimeters per 100 square inches per 24 hours at about 73F and 50% relative humidity; and an MVTR of about 0.300 grams of water per 100 square inches per 24 hours at about 100F and 90% relative humidity.

In another embodiment, the outer side layer (or structural layer) of the multilayer structure may comprise an Oriented Polyester (OPET) layer of about 2.0 mils (about 0.5-10.0 mils) laminated to the other layers by means of, for example, a urethane adhesive of about 0.1 mils thickness. Such "structural layer" may be a polyester Oriented (OPET) film or a polyester based synthetic paper, which is designated as white micro-space oriented polyester (WMVOPET).

By increasing any or all of the polymer thickness, the use of a thicker substrate may have some advantages: these may include one or both of the following: because thicker substrates are less sensitive to temperature, the cells can be better processed on a printing press; and the battery cell package is more rigid and robust.

In addition to the above description, either or both of the lateral and medial layers may include additional print-receptive surfaces for the desired ink. If desired, the inner layer may be used for functional ink (such as the current collector and/or the electrochemical layer), while the outer layer may be used for graphic ink. Flat cell constructions with sealing systems may utilize a laminate structure including a metallized film and/or a very thin metal foil or foils as a moisture barrier. While such a structure using a metal layer may have better moisture barrier properties than the construction used for some of the embodiments described above, it may also have some drawbacks. These disadvantages may include one or more of the following: for example, laminate structures with metal barriers (thin metal foils or vacuum metalized layers) may be more expensive; the laminated structure having the metal layer has a possibility of causing an internal short circuit; and laminated structures comprising metal barriers may interfere with the function of applied electronics, such as RFID antennas.

The film substrate may include many variations of polymer films, with or without barrier layers (including metals or other materials), and may utilize single or multi-layer films, such as polyesters or polyolefins. Polyester is a very good material available because it provides improved strength, permits the use of thinner gauge films, and is generally not easily stretched when used on multi-station printers. Vinyl, cellophane, and even paper may also be used as a film layer or as one or more layers in a laminate construction. If a very long pot life is desired and/or environmental conditions are extreme, the multilayer laminated polymer may be modified to include a metallized layer, such as obtained by vacuum deposition of aluminum instead of an oxide coating.

Alternatively, very thin aluminum foil may be laminated into the film layer structure, such as for the layers, or at a different location. Such a change can reduce already low water loss to almost zero. On the other hand, if the application is for a relatively short pot life and/or short operating life, the more expensive barrier layer may be replaced with a less efficient barrier layer that has a lower cost and still allows the battery cell to function for the desired life.

In applications where only a very short life is required, the battery cell package may instead use a low cost film layer of a polymer substrate (e.g., polyester or polyolefin). It is possible that the pressure sensitive adhesive sealing system used to adhere the frame to the top and lower substrates may be replaced with a heat sealing system on the laminate.

In a simplified structure of the upper laminate substrate and/or the lower laminate substrate, the laminate barrier layer may be laminated together, for example, together with a polyurethane adhesive layer. Alternatively, the substrate may be provided with an additional layer which is a barrier coated on the barrier layer. Further, these layers may be laminated together along with a polyurethane adhesive layer.

Alternatively, one exemplary seven-layer laminate substrate may be used for the substrate of the battery cell. A heat seal layer may be laminated to the aforementioned structure using an adhesive layer. The approximately 50 gauge (gauge) heat seal layer may be a composite layer that also includes a heat seal coating on a polymer film (e.g., polyester), such as amorphous polyester (APET or PETG), semi-Crystalline Polyester (CPET), polyvinyl chloride (PVC), or polyolefin polymer, among others. The top and/or bottom substrates of the battery cell previously described are then fabricated into a seven-layer construction. Depending on the thickness of the various layers, the total thickness of these laminates can be about 0.003 "for any of these structures (three-layer laminate, four-layer laminate, and seven-layer laminate, respectively), with the total thickness ranging from 0.001 to 0.015" for at least some embodiments. Alternatively, different substrate constructions comprising more or fewer layers may likewise be utilized, depending on the desired application and quality.

The various conductive inks described herein may be based on many types of conductive materials, such as carbon, silver, gold, nickel, silver coated copper, silver chloride, zinc, and/or mixtures of these. For example, one such material that exhibits useful properties in terms of conductivity and flexibility is silver ink. In addition, various circuits, electrical paths, antennas, etc., which may be part of a printed circuit system, may be made by etching aluminum, copper, or similar types of metal foils laminated to a polymer (e.g., a polyester substrate). This may be applicable to many types (sizes and frequencies) of paths and/or antennas, whether they are etched or printed.

A thin, printed, flexible electrochemical cell includes a printed cathode deposited on a printed cathode collector (e.g., a highly conductive carbon cathode collector) with a printed anode or foil strip anode positioned adjacent to the cathode. Electrochemical cells/batteries of this type are described in co-pending U.S. applications serial nos. 11/110202 filed on 20/4/2005, 11/379816 filed on 24/4/2006, 12/809844 filed on 21/6/2010, 13/075620 filed on 30/3/2011, 13/625366 filed on 24/9/2012, and 13/899291 filed on 21/5/2013, and in U.S. patents assigned to 8029927, 8268475, 8441411, the disclosures of which are incorporated herein by reference. The electrochemical cell/battery may also include a viscous or gel electrolyte dispensed onto a separator covering all or a portion of the anode and cathode, and the top laminate may then be sealed to the picture frame. This type of electrochemical cell is designed to be easily made by printing (e.g., by using a printer) and allows, for example, the cell/battery to be integrated directly with electronic applications.

Turning now to fig. 5-8, a flexible battery for generating electrical current is shown in various detail views. Although not explicitly stated, the flexible battery may include any of the battery structures or methodologies described herein. A flexible battery including one or more battery cells is printed on a single side of a single substrate (the top substrate is not shown in fig. 5 for clarity). It will be appreciated that portions of the battery may be printed on opposite sides of the substrate, although it may be more cost effective to print the battery on a single side of the substrate. Further, while the cells may be formed for each element using a printing process, some or all of the elements may be provided by a non-printing process, such as a laminate, adhesive, strip of material, or the like.

The battery includes a thin, printed, flexible electrochemical cell that may include an optional sealed "picture frame" structure, including a printed cathode deposited on a printed cathode collector (e.g., a highly conductive carbon cathode collector), with a printed anode or foil strip anode placed adjacent to the cathode. The electrochemical cell/battery also includes a viscous or gel electrolyte dispensed onto a separator that covers all or a portion of the anode and cathode, and the top laminate can then be sealed to the picture frame. This type of electrochemical cell is designed to be easily made by printing (e.g., by using a printer) and allows, for example, the cell/battery to be integrated directly with electronic applications.

The flexible printed battery 32 used in the electronic center 30 is further described herein by way of fig. 5-8, which show embodiments of a complete unit cell 200 in top and cross-sectional views. Battery unit 200 includes a top laminate film substrate (layer) 112, a lower laminate film substrate (layer) 111, and an extension region 180 having a positive contact 140 and a negative contact 250. For greater clarity, the battery cell 200 in fig. 5 is shown without the top laminate 112, but the top laminate 112 is shown in fig. 6. The positive contact 140 and the negative contact 250 are exposed on the outside of the electrochemical cell for connection to the electronic media of the patch. Either or both of the positive contact 140 and the negative contact 250 may have a printed or laminated conductive layer thereon, such as printed silver ink or the like, or may include other layers that facilitate coupling or conductivity to electronic media. The positive and negative contacts 140, 250 may be the same as, or even different from, the battery contact pads 35A, 35B electrically coupled to the respective battery electrodes 33A, 33B of the flex circuit 34.

In addition, the battery cell 200 includes a cathode layer 130 and an anode layer 116, the cathode layer 130 and the anode layer 116 each including an electrochemical layer of different composition that can generate an electrical current through electrolyte interaction. In various embodiments, the flexible battery may be fabricated (i.e., printed) directly or indirectly on the lower laminate substrate 111, or may even be fabricated separately (in whole or in part) and then attached directly or indirectly to the lower laminate substrate 111. In one embodiment, the lower laminate substrate 111 is a laminated film. The flexible battery also includes a top laminate 112 connected to the lower laminate substrate 111 and disposed in overlying relation to the lower laminate substrate 111. The second top laminate 112 may also be a single laminate film or a multi-layer laminate film. It is contemplated that the top laminate 112 may be used as the top layer of the battery and/or that some or all of the elements of the electrochemical cell may be on the top laminate 112 or integrated with the top laminate 112.

The lower laminate substrate 111 and/or the top laminate substrate 112 may be a material comprising a plurality of laminate layers. The plurality of laminate layers may include a structural layer with an integrated barrier and/or heat seal layer, as any of those described herein. The plurality of laminate layers may include any or all of the following: an inner layer comprising a polymeric film and/or a heat seal coating, a high moisture barrier layer, a first adhesive layer for attaching the inner layer to the high moisture barrier layer, an outer structural layer comprising oriented polyester, and/or a second adhesive layer for attaching the high moisture layer to the outer structural layer. The high moisture barrier layer may include an oxide-coated moisture barrier layer that non-hermetically isolates the battery from moisture, and may not include a metal foil layer. The plurality of laminate layers may optionally include a metallization layer.

In addition, a current collector layer may be disposed under each of the cathode and anode of the electrochemical cell. The current collector layer may be provided via a dried or cured ink (e.g., printed) or via a non-printing process, such as a laminate, adhesive, strip of material, or the like. In practice, the current collector, anode and cathode may all be provided in a cured or dried ink. Generally, the current collector layer is provided as a material different from that of the anode and the cathode. Additional current collectors may be provided under the remaining cathodes and anodes. The anode and cathode of each battery cell may be printed on each cathode collector and/or anode collector, respectively. It is contemplated that any or all of the current collectors may be disposed directly on the lower laminate substrate 111 in the same printing station, but any or all of the current collectors may be disposed on top of the optional intermediate layer.

For example, before applying the cathode layer 130, a cathode collector 131 of highly conductive carbon is printed on the lower laminate substrate 111, and any or all of these may be provided as a plurality of layers. Optionally, a similar anode current collector layer may also be provided beneath the anode. The anode and cathode of each unit cell may be printed in a coplanar arrangement. The anode and cathode may be comprised of cured or dried ink. In at least one embodiment, cathode layer 130 is printed using an ink comprising manganese dioxide, a conductor such as, for example, carbon (e.g., graphite), a binder, and water over a large area portion of cathode collector 131. In various other embodiments, the cathode may be printed using an ink including one or more of manganese dioxide, carbon, NiOOH, silver oxide Ag2O and/or AgO, mercury oxide, oxygen 02 in the form of air cells, and vanadium oxide V02. Anode layer 116 can be printed as a conductive zinc ink or, as shown in the figure, provided as a zinc foil (116) PSA (260) laminate, either of which can be made about 0.20 "wide and about 0.002" (0.001 "-0.010") thick. In various other embodiments, the anode may be printed using an ink including one or more of zinc, nickel, cadmium, metal hydrides of the AB2 and AB3 types, iron, and FeS 2. The anode and/or cathode may still be provided by a non-printing process, such as a laminate, an adhesive, a strip of material, and the like. In an alternative embodiment, the anodes may be provided as zinc foil PSA laminates, either of which may be made with corresponding geometries to match the cell geometry and be about 0.002 "(0.001" -0.010 ") thick.

After the electrode layers (anode layer 116 and cathode layer 130) are in place, an optional "picture frame" 113 may be placed around the electrodes as spacers. One approach is to print this cell picture frame using, for example, a dielectric ink, such as a cured or dried adhesive ink. Another method is to form an appropriate "pocket" (one or more interior spaces) using a polymer sheet, punching, die cutting, laser cutting, or similar method to accommodate the material of each unit cell. In the simplified construction discussed herein, the picture frame may include a die-cut polymer laminate, such as polyester or polyvinyl chloride (PVC), in the middle, having two outer layers (e.g., top and bottom surfaces) of pressure sensitive adhesive with a release liner. The top PSA layer adheres and seals the top laminate substrate to the picture frame, and the bottom PSA layer may be used to adhere and seal the bottom laminate substrate to the picture frame. Alternatively, the picture frame may be replaced by a printed or laminated adhesive provided in the shape of the frame described above.

In the illustrated embodiment, the optional picture frame 113 may include a die-cut polymer laminate, such as polyester or polyvinyl chloride (PVC), and may be further provided with two pressure sensitive adhesive layers (118 on the top surface and 117 on the bottom surface). A top Pressure Sensitive Adhesive (PSA) layer 118 seals the top laminate substrate 112 to the picture frame 113, and a bottom PAS layer 117 may be used to seal the bottom laminate substrate 111 to the picture frame 113. Typically, when a stamped frame is used, each "picture frame" has a total thickness (excluding the thickness of the liner) of about 0.010 "(about 0.005" -0.50 "). The "picture frame" may be placed on the bottom laminate structure after the bottom liner is removed, such that the anode and cathode are centered on the frame. When printed frames are used, they are typically much thinner, having a thickness of about 0.002 "(e.g., about 0.0005" -0.005 "). In some cases, to ensure a leak-free construction, sealing and/or caulking adhesives, heat sensitive sealants, and/or double-sided PSA tape may be placed and/or printed on top of the anode layer and in the area below the picture frame on top of the cathode collector. A sealing adhesive may also be provided under the remaining portion of the picture frame. In the embodiment shown, the picture frame may be placed on the bottom laminate base 111 after removal of the bottom liner, such that the electrodes are centrally located within the frame. In some cases, to ensure a leak-free configuration, a sealing and/or caulking adhesive, heat sensitive sealant, and/or double-sided PSA tape 253 may be placed and/or printed on top of the anode 116 and in the area of the top of the cathode collector 131 below the picture frame 113. A sealing adhesive 253 may also be provided under the remaining portion of the optional picture frame 113. In various illustrated embodiments, the "picture frame" may have an exterior geometry generally corresponding to the overall geometry of the battery, and an interior region generally providing interior space for each electrochemical cell.

The anode and cathode of an electrochemical cell interact through an electrolyte to produce an electric current. The electrolyte may include: one or more of zinc chloride, ammonium chloride, zinc acetate, zinc bromide, zinc iodide, zinc tartrate, zinc perchlorate, potassium hydroxide, and sodium hydroxide. The liquid electrolyte layer may include a polymeric thickener comprising one or more of polyvinyl alcohol, starch, modified starch, ethyl and hydroxyethyl cellulose, methyl cellulose, polyethylene oxide, and polyacrylamide (polyacrylamides). In addition, the electrolyte layer may further include an absorbent paper separator (separator). As described herein, the electrolyte is a viscous or gel electrolyte. If the electrolyte is not part of the gel coat, the cell electrolyte 120 is provided to an absorbent material, such as a "paper separator" 126 (not shown in fig. 5 for clarity, see fig. 6), that covers or partially covers both electrodes. The electrolyte may be an aqueous solution of zinc chloride at a weight percent of about 27% (about 23% -43%), which may also contain a thickener such as carboxymethyl cellulose (CMC) or other similar material at a level of about 0.6% (about 0.1% -2%). Any electrolyte may include additives to prevent or reduce gassing in the electrochemical cell (e.g., prevent or reduce hydrogen gas generation in the cell).

The cell is completed by applying and sealing the top laminate 112 to a picture frame using PSA and/or with heat sealing. The top laminate substrate 112 is connected to the bottom laminate substrate 112 to contain a liquid electrolyte such that the electrochemical cell is sealed. The top laminate substrate 112, if present, may be sealed over the optional picture frame. Prior to application of the top laminate base 112, a release liner (not shown), if present, is removed from the adhesive layer on top of the optional picture frame. In another embodiment, a printed adhesive may be used to join the top laminate substrate 111 and the bottom laminate substrate 112. Furthermore, the printed adhesive may extend over and cover at least a portion of the anode layer and/or the cathode layer. In another embodiment, the top laminate substrate 111 and the bottom laminate substrate 112 may be directly connected to each other without an intermediate adhesive or picture frame. It is also contemplated that the top laminate substrate 112 is connected to the bottom laminate substrate 111 without utilizing a picture frame to form an interior space containing a liquid electrolyte.

When the top laminate substrate 112 is sealed over the bottom laminate substrate 111, an outer seal area is formed. The sealing region prevents, such as prevents, liquid electrodes from leaking out of each cell. The width of the sealing region may vary based on the overall size and geometry of the cell. In one embodiment, the sealing region may have a minimum width of about 0.075 inches. The maximum width may vary based on the various batteries and may be as large as 0.250 inches, or even larger. It is also possible to make such cell structures with the same geometry using a commercially available bag filling machine without the bulky frame. It is contemplated that the sealing region may be substantially the same around the perimeter of each battery cell, or may be different along the perimeter of each battery cell, as desired.

The cells described herein have a coplanar configuration. The co-planar configuration provides several advantages because they are easy to manufacture, provide consistent, reliable performance, and have their contacts on the same side of the cell/battery. Typically, each electrochemical cell described herein can provide about 1.5 volts. However, if higher voltages and/or high capacities are desired, several electrochemical cells may be electrically coupled together. For example, a 3 volt battery is obtained by connecting two 1.5 volt unit cell units in series, but other voltages and/or currents may be obtained by using unit cell units of different voltages and/or by combining different numbers of cell units together in series and/or in parallel. Different electrochemical systems can be customized for different battery configurations. Preferably, if different battery cells are used to obtain a higher voltage, all battery cells in each battery should belong to the same electrochemical system. Therefore, applications using a larger voltage may connect the unit battery cells in series, and for applications requiring a larger current and/or capacity, the unit battery cells may be connected in parallel, and applications using a larger voltage and requiring a larger current and/or capacity may utilize various sets of battery cells connected in series and further connected in parallel. Accordingly, a variety of different unit cell and/or battery configurations may be used to support a variety of different applications that use different voltages and currents.

An exemplary manufacturing scheme for a battery will now be discussed. It may be advantageous to print the entire battery (including all of the battery cells) in a single printing process to avoid later difficulties in connecting multiple battery cells together. The printing process may be partially or fully automated, and may utilize a plurality of individual sheet or roll-to-roll processes. The individual batteries may be removed from the carrier for use.

To make the cell/battery manufacturing process more efficient and/or achieve greater economies of scale, cells/batteries may be manufactured using a substantially continuous web in a reel-to-reel (reel) printing process, providing products at high speed and low cost. An exemplary manufacturing process is described in the following paragraphs. In this exemplary process, the battery cells/cells pass through multiple stations compatible with high speed printers that run a roll-to-roll setting. Although not further described herein, the processing and assembly may be integrated with the manufacture of the flexible battery or its components powered by the battery, such as electrical components and the like.

Depending on the available printing presses, a single pass or multiple passes may be used to fabricate the battery cells on a given printing press, for example. As an example, two rows of individual cells on a web; however, the number of rows is limited only by the size of the unit cells and the maximum width that the printer can handle. Because there may be many steps and thus it is possible to utilize long, complex printers, some of these steps and some of the materials therein may be modified, and/or multiple passes of one printer or multiple printers may be used. Some modified process summaries will be shown after the preliminary discussion is completed. Furthermore, any or all of the printing steps may be carried out by screen printing, such as by a flat screen or even a rotary screen station. Furthermore, those skilled in the art will recognize that it is difficult to find and/or operate a printer having more than five stations, and thus the process discussed below may be performed on one or more printers or even multiple passes of a printer.

Various optional operations may or may not be performed during manufacturing. For example, the optional operations may include one or both of thermal stabilization of the web and graphic printing (which may include logos, contact polarities, printed codes, and the addition of registration marks on the outside surface of the web). If these optional operations are performed on a web, the web may be flipped over and the functional ink may be printed on the inside surface (i.e., the heat seal layer).

Those skilled in the art will recognize that many methods, materials, and sequences of operations may be used, and that more or fewer, similar, or different multiple stations may be utilized. It should be understood, however, that the following process may be used in the fabrication of various other integrated electrical devices. Furthermore, for purposes of clarity, only one column of cells is shown and described, it being understood that such description may similarly apply to the other columns. Further, it is understood that any or all of the following elements may be comprised of any of the various materials, chemical compositions, etc. described in this disclosure. Further, the various steps are intended to be merely exemplary steps, and it is understood that the steps may include various other steps, alternative steps, and the like, as discussed herein.

As discussed herein, any or all of the substrates may be provided as a generally continuous web that can be processed through a "reel-to-reel" manufacturing process. For example, the first substrate may be provided as a substantially continuous web or the like from a source station (which may be a source reel or the like). Some or all of the various process steps may then be performed by passing the generally continuous web through a printing station or even multiple printing and/or converting stations, such as the step of providing the cathode and anode collectors, cathode layers, anode layers, contacts, optional frames, optional printed circuitry, and the like. Additionally or alternatively, the process may be adapted to pass the web through the printing station in multiple passes. Finally, the cells completed on the substantially continuous roll may be collected at a take-up (take-up) station (which may include a collection reel). Alternatively, the completed cells may be provided on a flat sheet having a plurality of cells, with each sheet having, for example, 20 or more cells.

The manufacturing process may include various other stages, steps, etc. For example, before or after the printing station, the web may pass through an auxiliary station in which various electrical components may be disposed. Further, any or all of the various layers, substrates, etc. may be provided from a supplemental roll along the process. For example, additional substrate (i.e., spacer layer) may be provided by a supplemental roll via a supplemental web. Although described as being near the beginning of the printing station, it is understood that any or all of the make-up webs may be provided at various locations along the manufacturing process. Additionally or alternatively, waste material (such as a peel ply or the like) may be removed as a waste web and taken up by a waste spool or the like. Various other pre-treatment and/or post-treatment stages, steps, etc. may also be included. It should be understood that the various stations, rolls, etc. of the described process may be utilized in various sequences, and that even additional equipment (e.g., idler rollers, tension rollers, turning bars, slits or punches, etc.) may be provided to facilitate the feeder or reel-to-reel process.

Various other additional steps may be used to provide additional structure, features, etc. to the completed battery cell and electrical components. In one embodiment, an external portion of the device, such as either or both of the first substrate or the second substrate, may be provided using a method of attaching the battery cell to another object, surface, or the like. As described herein, the battery 32 may be mechanically and electrically coupled to the circuitry 34 by ultrasonic welding, such as via the battery electrodes 33A, 33B to the battery contact pads 35A, 35B. In other embodiments, the substrate(s) may include a pressure sensitive adhesive, another adhesive layer, hook-and-loop fasteners, a liquid or hot melt adhesive, and the like. In another embodiment, an exterior portion of the battery cell, such as either or both of the first substrate or the second substrate, may be provided with printed indicia or even a label or the like.

Turning now to FIG. 9, the functionality of the software application will be described in more detail. It is contemplated that the computing device 14 includes a microprocessor capable of running a software application configured to interface bi-directionally with the patch 10, and a display that graphically presents temperature data points and other information to a user. As shown, one exemplary visual display of software application 300 is shown running on a display of computing device 14. Although shown in one particular manner, it is understood that the graphical display of software application 300 may appear in many configurations in different ways, as is known in the software art.

In operation, the first time the patch 10 is used, the software application 300 may accept one or more initialization commands from the computing device 14, including any or all of the following: a high temperature boundary level, a low temperature boundary level, a temperature read interval, a timestamp initialized to start recording data, and a flag that the electronic device has successfully started. The microprocessor of the patch 10, 10B can transmit an acknowledgement signal or flag back to the external computing device 14 indicating a successful activation. It is contemplated that if the electronics are not successfully started, the software application 300 may accept one or more reinitialization commands from the computing device 14 until the patch 10 is successfully started, or until the software application 300 determines that the patch 10 is faulty.

Generally, once activated, the software application 300 displays the patient's temperature history over time 310 in a graphical manner, such as a line graph, bar graph, or the like. Graphical temperature history 310 may be scrollable and may allow for dynamic zoom in/out functionality to allow a user to better understand the temperature changes sensed over a desired time scale. The temperature data may also be presented in a scrollable table or chart format, and the user may toggle between the two views by an on-screen button 320 or the like. It is also contemplated that as the user zooms the entire temperature history 310 graph in/out or scrolls the entire temperature history 310 graph, the coordinate axes (x-axis time, y-axis temperature) of the graph may be dynamically adjusted to present a more relevant view of information to the user according to the temperature data points shown in a particular zoomed or scrolled view. Furthermore, since the patch 10 is available for an extended period of time, the x-axis timeline may be dynamically adjusted between minutes or hours of display based on a particular zoom or scroll view or the total elapsed time.

Software application 300 also displays the current temperature 312 of the patient based on the most recent temperature data point obtained. Other temperature information may be provided, including preprogrammed and/or adjustable upper or lower temperature limits. For example, the upper or lower temperature limits may be graphically represented on the temperature history 310 chart for comparison with sensed temperature trends over time, and/or may be used to set an alarm to alert the user that the patient's temperature is approaching or has exceeded a particular threshold temperature. For example, such an alert may trigger computing device 14 to issue a visual, audible, and/or tactile (e.g., vibratory) alert to alert the user. In one embodiment, a visual alert 330 (static or flashing) may be shown at a status location of computing device 14, such as along the top of a graphical display. Thus, even if the user is not actively viewing the software application 300, it may still be running in the background (possibly still collecting temperature data) and, if appropriate, raising an alert 330.

The software application 300 may also display time data 314 such as any or all of the time the patch 10 is activated, the time the patch 10 is deactivated or ceases to transmit, the delay time between activation of the patch 10 and deactivation of the patch 10, and/or the last time the communication with the patch 10 was made. Additionally or alternatively, the time data 314 may also display an actual or estimated amount of remaining operating time of the patch 10 before the available battery power is depleted. The amount of operating time left for the patch 10 may be an actual amount of time based on a sensed voltage of a battery or the like communicated by the patch 10, which may be related to a known rate of power consumption of the battery based on an initial voltage, battery capacity, temperature reading interval, communication interval, or the like. Alternatively, the amount of operating time left for the patch 10 may be a time estimated based on a known start time and a known expected operating time (e.g., 12, 16, or 24 hours) for the patch 10. The estimated operating time may be adjusted by the software application 300 based on predetermined knowledge of the battery, and/or even by certain dynamic variables, such as temperature reading intervals, communication intervals, and the like.

The software application 300 may also display ancillary information 316 regarding the status of the patch 10, such as any or all of the number of temperature data points taken, the average temperature detected, the maximum temperature detected, and the minimum temperature detected. Some or all of this data may be visible to the end user or may be selectively hidden. It is contemplated that any or all of the average temperature, the maximum temperature, and the minimum temperature may be based on a portion, such as some or all, of the collected temperature data points. In one embodiment, any or all of the average, maximum, and minimum temperatures may be dynamically displayed based on user-selected data, such as the zoom-in/out or scrolling view shown in the temperature history 310 or associated tabular data. Additionally or alternatively, the software application 300 may include an optional feature to adjust the display of data, such as a temperature unit switch 324 that may dynamically adjust and display temperature data points in degrees fahrenheit or celsius (or other temperature units, if desired).

Software application 300 may also include other additional features. In one embodiment, a Unique Identification (UID)328 of the patch 10 may be displayed. The UID 328 may be displayed in real text, or the UID of the patch 10 may be assigned a more easily understood alias (e.g., the patient's name or hospital code). The user may also switch between the UID 328 and the alias as desired, or this feature may even be restricted or protected to provide anonymity to the patient. Finally, software application 300 may provide the ability to save and/or transmit the collected temperature data. For example, a save button 322 can be provided to save some or all of the collected data points in local or remote computer storage memory for later retrieval. Additionally or alternatively, a send button 323 can be provided to transmit some or all of the collected data points to a remote party, such as a doctor, hospital, or other individual. It is contemplated that the saved and/or transmitted data may include some or all of temperature data points, time information, UID information, and the like. The software application 300 may also provide a patient who often uses multiple patches 10 with a personal profile of the patient over time, such as a child who may use the patch 10 each time they are ill. Thus, the parent or doctor may also recall the historical temperature of this child, enabling comparison and diagnosis. It is also contemplated that the saved and/or transmitted data may be encrypted locally or remotely or even made anonymous. In another feature, the software application 300 may provide programmable or predetermined reminders for the user or patient to take certain actions, such as changing the patch 10, synchronizing with the patch 10, attending a doctor, communicating data to a doctor, scheduling a doctor's visit, and so forth.

Additionally or alternatively, various security and/or privacy layers may be provided to either or both of the patch 10 and the computing device 14. For example, the transmitted and received wireless data may be encrypted via hardware and/or software mechanisms local to the patch and/or computing device 14. Either or both of the patch and the computing device 14 may utilize a user ID and a password. Wireless data transmission and/or reception may be limited to authorized pairing devices and/or wireless data transmission range may be artificially limited to a predetermined distance. The security protocol of NFC can be used to secure and direct other wireless connections. The patch may include hardware and/or software switches to inhibit or limit wireless data transmission and/or reception. In one embodiment, a hardware switch may completely disable the patch. In another embodiment, the timing lock may limit wireless data transmission and/or reception during a particular time or time interval. The data read from the patch may be automatically deleted or retained in the software application and/or memory of the patch 10. Any or all of the foregoing security and/or privacy layers may be used together, and additional layers may also be used.

The invention has been described above using specific examples and embodiments; it will be understood by those skilled in the art, however, that various alternatives may be used and equivalents may be substituted for elements and/or steps described herein without departing from the scope of the invention. Modifications may be made to adapt the invention to a particular situation or to particular needs without departing from the scope of the invention. It is intended that the invention not be limited to the particular embodiments and examples described herein, but that the claims be given their broadest interpretation to cover all embodiments, literal or equivalent, covered thereby, whether disclosed or not.

Claims (24)

1. A partially actively powered temperature data recorder patch (10) with wireless data communication, comprising:

a first substrate layer (20);

a sealed, flexible battery (32) comprising a printed electrochemical cell (200) with an anode (116) and a cathode, at least one of the anode (116) and cathode being formed from a cured or dried ink, the sealed, flexible battery further comprising a first battery electrode contact and a second battery electrode contact, each battery electrode contact electrically coupled to one of the anode (116) and the cathode;

a flexible circuit including a microprocessor (50) having a timer (60), a temperature sensor (52) configured to sense a temperature of a target object, and first (35A) and second (35B) battery contact pads, each battery contact pad electrically coupled to one of the first and second battery electrode contacts, thereby electrically providing power to the microprocessor (50) and the temperature sensor (52);

a second substrate layer (40) comprising an adhesive configured to be removably applied to a surface of the target object, wherein the first substrate layer (20), flexible battery (32), flexible circuit, and second substrate layer (40,46) define respective layers;

wherein the flexible battery (32) and the flexible circuit together define an electronic neutral material (30) disposed between the first and second substrate layers in a covered, stacked arrangement, and

wherein the first substrate layer, the electron intermediate, and the second substrate layer are all flexible and configured to conform to a curved surface of the target object,

wherein the flexible circuit includes a wireless communication transceiver and an antenna (36), and

characterized in that the wireless communication transceiver of the temperature data logger patch (10) is configured to be passively powered from an external computing device (14) by an electromagnetic field, while the microprocessor (50) and the temperature sensor (52) of the temperature data logger patch (10) are configured to be continuously actively powered by the flexible battery (32),

wherein the actively powered microprocessor (50), with its timer (60), is configured to obtain a plurality of temperature samples from the temperature sensor (52) at periodic time intervals, and

wherein the wireless communication transceiver of the temperature data recorder patch (10) is configured to transmit the plurality of temperature samples only when the wireless communication transceiver is passively powered from the external computing device (14) through an electromagnetic field.

2. The patch (10) of claim 1, wherein the wireless communication transceiver utilizes a standard NFC or RFID communication protocol.

3. The patch (10) of claim 1, wherein the microprocessor (50) includes a unique identification code (UID).

4. The patch (10) according to claim 3, wherein the microprocessor (50) further comprises a memory (62) for storing the temperature samples together with an associated time stamp for each temperature sample.

5. The patch (10) of claim 4, wherein the flexible circuit further comprises a secondary memory storage (64), and the microprocessor (50) is configured to transfer data between the memory (62) of the microprocessor (50) and the secondary memory storage (64).

6. The patch (10) of claim 3, wherein the microprocessor (50) is configured to wirelessly communicate the plurality of temperature samples to the external computing device (14) via the wireless communication transceiver and antenna (36).

7. The patch (10) of claim 1, wherein the first and second battery electrode contacts of the flexible battery (32) are mechanically and electrically coupled to the first and second battery contact pads (35A, 35B) of the flexible circuit by ultrasonic welding.

8. A patch (10) according to claim 1 wherein the second substrate layer (40,46) at least partially comprises a hydrogel disposed in overlying relation over the temperature sensor (52) and configured to be removably applied to the skin of a patient.

9. A patch (10) according to claim 1 wherein the second substrate layer (40,46) comprises, at least in part, polyethylene foam coated on at least one side (43) with a pressure sensitive adhesive configured to be removably applied to the skin of a patient.

10. A patch (10) according to claim 1 wherein the electronic centre (30) is encapsulated between the first and second substrate layers.

11. The patch (10) of claim 1, wherein the anode (116) and the cathode of the electrochemical cell (200) both comprise cured or dried ink, and the anode (116) and the cathode are disposed in a co-planar arrangement.

12. The patch (10) of claim 4, wherein the microprocessor (50), the temperature sensor (52), the timer (60), and the memory (62) of the patch (10) are all actively powered by the flexible battery (32).

13. A patch (10) according to claim 1 wherein the second substrate layer (40) is double-sided adhesive and the second substrate layer (40) comprises a hydrogel.

14. A partially actively powered temperature data recorder patch with wireless data communication, comprising:

a first substrate layer (20);

a sealed, flexible battery (32) comprising a printed electrochemical cell (200) with an anode (116) and a cathode disposed in a co-planar arrangement;

a flexible circuit including a microprocessor having a timer (60), a temperature sensor (52) chip configured to sense a temperature of a target object, a wireless communication transceiver, a communication chip (54), and an antenna (36),

wherein the communication chip (54) is electrically connected to the antenna (36) and the communication chip (54) includes one or more passively powered communication protocols; and

a second substrate layer (40) comprising an adhesive configured to be removably applied to a surface of the target object,

wherein the flexible battery and the flexible circuit are disposed between the first and second substrate layers, and wherein the first substrate layer, the electronic neutral, and the second substrate layer define respective layers and are all flexible, an

Characterized in that the microprocessor actively receives power from the flexible battery, the temperature sensor actively receives power from the microprocessor, and the wireless communication transceiver is passively powered from an external computing device through an electromagnetic field, and the microprocessor (50) does not provide power to the communication chip (54), all power of the communication chip (54) being obtained through the wireless communication transceiver;

wherein the actively powered microprocessor (50), with its timer (60), is configured to obtain a plurality of temperature samples from the temperature sensor (52) at periodic time intervals, an

Wherein the wireless communication transceiver of the temperature data recorder patch (10) is configured to transmit the plurality of temperature samples only when the wireless communication transceiver is passively powered from the external computing device (14) through an electromagnetic field.

15. The patch of claim 14, wherein the microprocessor is configured to selectively provide power to the temperature sensor only when the microprocessor obtains temperature samples from the temperature sensor.

16. The patch of claim 14, wherein the wireless communication transceiver utilizes a standard NFC communication protocol.

17. The patch of claim 14, wherein the microprocessor further comprises a memory for storing the temperature samples along with an associated time stamp for each temperature sample.

18. The patch of claim 14, wherein the microprocessor is configured to wirelessly transmit each temperature sample to the external computing device via the wireless communication transceiver and antenna.

19. An actively powered medical system for monitoring the body temperature of a patient, comprising:

a flexible, partially actively powered temperature data logging patch (10), comprising: a sealed, flexible battery (32) comprising a printed electrochemical cell (200) with an anode (116) and a cathode disposed in a coplanar arrangement; a flexible circuit including a microprocessor (50), a temperature sensor (52) configured to sense a temperature of the patient, a timer (60), a memory (62), a wireless communication transceiver and antenna (36), a communication chip (54); and a substrate layer comprising an adhesive configured to be removably applied to the skin of the patient, an

An external computing device (14) comprising a programmable microprocessor capable of running an application, an active power source, a display, and a transceiver powered by the active power source and capable of two-way communication with the wireless communication transceiver of the patch via an electromagnetic field,

wherein the external computing device is configured to transmit an initialization command and an initialization start time to the microprocessor of the patch such that the microprocessor is able to provide power to the temperature sensor and begin obtaining a plurality of temperature samples from the temperature sensor, and wherein the microprocessor of the patch is configured to transmit an acknowledgement signal back to the external computing device indicating successful initialization, and

characterized in that the microprocessor, the temperature sensor, the timer and the memory of the patch are all actively powered by the flexible battery, while the wireless communication transceiver of the patch is passively powered from the external computing device through the electromagnetic field, whereby the microprocessor (50) does not provide power to the communication chip (54), all power of the communication chip (54) is obtained from the external computing device through the wireless communication transceiver and the electromagnetic field, and

wherein the actively powered microprocessor (50) is configured to obtain a plurality of temperature samples from the temperature sensor (52) at periodic time intervals, and

wherein the wireless communication transceiver of the patch is configured to transmit the plurality of temperature samples only when the wireless communication transceiver is passively powered from the external computing device (14) through an electromagnetic field.

20. The medical system of claim 19, wherein the microprocessor of the patch is further configured to store the plurality of temperature samples in the memory of the patch along with an associated timestamp for each temperature sample.

21. The medical system of claim 20, wherein the external computing device is further configured to transmit periodic time reading intervals to the microprocessor of the patch, and the microprocessor of the patch is configured to obtain the plurality of temperature samples from the temperature sensor at a rate corresponding to the periodic time reading intervals.

22. The medical system of claim 20, wherein the microprocessor of the patch is configured to transmit the plurality of temperature samples and the associated timestamps to the external computing device, and wherein the external computing device is configured to graphically display the plurality of temperature samples and associated timestamps on the display.

23. The medical system of claim 22, wherein the external computing device is further configured to save the plurality of temperature samples and associated timestamps in an on-board memory for future retrieval.

24. The medical system of claim 19, wherein the external computing device is further configured to: if the external computing device determines that the patch is not successfully initialized, the external computing device transmits a re-initialization command and a re-initialization start time to the microprocessor of the patch.