1300. In an implementation, the power supply unit 1300 may be a stack of Lithium polymer or similar batteries providing 3.3 V and 140 mAh, for example. In an implementation, the power supply unit 1300 may be a flexible battery. The power supply unit 1300 provides power to the various components on the vital signs monitoring patch with display 1000.

Layer 4 is the PCBA layer 1400 which may include active and passive components as described herein and adhere to layer 2. In an implementation, the PCBA layer 1400 may include, but is not limited to, an accelerometer, pH sensor, and temperature sensor(s). In an implementation, the accelerometer may be used for activity tracking such as steps, sleep efficiency, and sleep staging. In an implementation, one or more temperature sensors may be used to determine a temperature profile for a wound, for example. The one or more temperature sensors may sense or monitor surface temperatures of a localized body area. In an implementation, the pH sensor may monitor the pH levels of a localized body area. The pH level may vary from 0 to 14 and as stated herein, may be displayed via layer 1. For example, pH of normal healing wounds ranges from 5.5 to 6.5 and pH of nonhealing wounds is greater than 6.5. In an implementation, the pH sensors may be potentiometric pH sensors. In an implementation, the pH sensors may be implemented using carbon/polyaniline and Ag—AgCl electrodes.

A bottom side of a layer 5 is shown in FIG. 1. Layer 5 is a sensor layer 1500 which may adhere to the PCBA layer 1400. The sensor layer 1500 may include reflection mode oximetry measurement components 1525 and a bottom ECG electrode 1550. In an implementation, the bottom ECG electrode 1550 may be a screen-printed Ag—AgCl ECG electrode which interfaces with a user skin via a hydrogel layer. For example, the bottom ECG electrode 1550 may contact the skin area on the chest near the heart. Other skin surface areas may also be used. Operationally, a user may contact the top ECG electrode 1150, for example using an index finger of the hand from the opposing side of the body (right hand if patch is placed near heart). Contact of the index finger with the top ECG electrode 1150 completes the circuit with the bottom ECG electrode 1550 for single lead (two electrode-based) ECG measurements.

In an implementation, the data may be streamed to a device application through a Bluetooth® connection. FIGS. 11A-B are an example diagram of an interface screen 11000 on a device for interacting with a vital signs monitoring patch with display in accordance with certain implementations. The interface screen 11000 may have a link or tab 11100 for selection of a sub-menu for EGG graphic display 11200. The ECG graphic display 11200 may stream the live ECG signal showing distinct QRS complexes and reports the heart rate and heart rate variability derived from the R-R peak intervals.

Oximeters sense oxygen saturation in tissues by optically quantifying concentrations of oxyhemoglobin (HbO₂) and deoxyhemoglobin (Hb). Pulse oximetry is one modality for ratiometric optical measurements on pulsatile arterial blood by leveraging photoplethysmography (PPG) at a minimum of two distinct wavelengths. PPG comprises optoelectronic components such as LEDs and photodiodes. In an implementation, the reflection mode oximetry measurement components 1525 (also referred to as an oximetry layer) of layer 5 may include a 4×4 array 1530 of red LEDs (4) 1535, NIR LEDs (4) 1545, and photodiodes (8) 1540 for a total of 16 pixels to facilitate reflection mode oximetry measurements. In an implementation, the 4×4 array 1530 provides a flexible reflection oximetry platform for single point measurements of heart rate, heart rate variability, SpO₂and 2D oxygenation mapping of localized tissues.

The molar absorption coefficients of HbO₂and Hb are disparate at the red and NIR wavelengths. The red LEDs 1535 and the NIR LEDs 1545 act as emitters (converting electrical energy into light energy) where light is transmitted at 610 nm and 725 nm wavelengths, respectively. In an implementation and as shown in FIG. 3, red and green (530 nm) may also be used as LED combinations.

The photodiodes 1540 sense the non-absorbed light from the LEDs. The signals are inverted by means of an operational amplifier. These signals are interpreted as light that has been absorbed by the tissue being probed and are assigned to direct current (DC) and alternating current (AC) components. The DC component is treated as light absorbed by the tissue, venous blood, and non-pulsatile arterial blood. The AC component is treated as pulsatile arterial blood.

Data from the reflection mode oximetry measurement components 1525 of layer 5 may be streamed to a device application. FIGS. 12A-B are an example diagram of an interface screen 12000 on a device for interacting with a vital signs monitoring patch with display in accordance with certain implementations. The interface screen 12000 may have a link or tab 12100 for selection of a sub-menu for a Patch Oximetry display 12200. At the Patch Oximetry display 12200, a user may view a live stream of the PPG waveform with well-delineated anacrotic (rising) and dicrotic (notch) characteristics. In an implementation, the Patch Oximetry display 12200 may display 2D contour maps 12300 in real-time that provide the perfusion status of a localized region sampled by the oximetry layer, where the oximetry layer includes the LEDs and photodiodes. The 2D contour maps 12300 are enabled via the array 1530 as described with respect to FIGS. 2A-E, and the PCBA layer 7600 of FIG. 7, for example. In an implementation, the Patch Oximetry display 12200 may display parameters reflecting PPG-specific heart rate, heart rate variability, and oxygen saturation. In an implementation, the Patch Oximetry display 12200 may display surface temperature, pH levels, and other biomarker or physiological parameters.

In an implementation, the size of the array may vary without departing from the scope of the specification or claims. In an implementation, the number of pixels may vary without departing from the scope of the specification or claims. In an implementation, the number of LEDs for specific wavelengths or frequencies may vary without departing from the scope of the specification or claims. In an implementation, different wavelengths or frequencies may be used without departing from the scope of the specification or claims.

Layer 6 is a spacer ribbon-like layer 1600 around layer 5. The spacer ribbon-like layer 1600 may bond to the skin of the user and may hold the entire patch in position on the skin. For example, the spacer ribbon-like layer 1600 may be a medical tape which consists of a porous, highly breathable, white elastic multilayer polyurethane/synthetic rubber based non-woven fabric. The non-woven fabric may be coated on one side with a pressure sensitive adhesive which bonds to a user skin surface and an adhesive on the other side for bonding with layer 5.

As referenced herein above, the vital signs monitoring patch with display may also include an application which may run on a device such as mobile devices, end user devices, cellular telephones, Internet Protocol (IP) devices, mobile computers, laptops, handheld computers, PDAs, personal media devices, smartphones, notebooks, notepads, phablets, smart watches, and the like (collectively “user device”). The vital signs monitoring patch with display may wirelessly communicate with the user device and the application together with the user device may analyze, display and provide alerts to a user the vitals signs data collected by the vital signs monitoring patch with display. The vital signs monitoring patch with display may interface with the application to measure, stream and record real-time data for providing comprehensive sensing information to user(s). FIGS. 11A-B and FIGS. 12A-B are example diagrams of interface screens for reviewing the sensor data as described herein.

FIGS. 2A-E are diagrams of reflection mode oximetry measurement components 2000 in accordance with certain implementations. The reflection mode oximetry measurement components 2000 may include an array of red LEDs 2100, NIR LEDs 2200, and photodiodes 2300, where a shaded area reflects a light emitting area. In an implementation, the reflection mode oximetry measurement components 2000 may include a red LED array layer 2005, a NIR LED array layer 2010, and a photodiode array layer 2015. The red LED array layer 2005 may include the red LEDs 2100 in a defined pattern and a connector 2105. The NIR LED array layer 2010 may include the NIR LEDs 2200 in a defined pattern and a connector 2205. The photodiode array layer 2015 may include the photodiodes 2300 in a defined pattern and a connector 2305. The reflection mode oximetry measurement components 2000 may include an interface board 2400 which connects to a PCBA such as PCBA layer 1400 of FIG. 1. The connectors 2105, 2205, and 2305 each connect to connectors 2110, 2210, and 2310, respectively, on the interface board 2400 to carry or send signals to the appropriate components on the PCBA.

In an implementation, the red LEDs 2100 may emit approximately at 610 nm and the NIR LEDs 2200 may emit around 725 nm. In an implementation, the LED active areas for the red LEDs 2100 and the NIR LEDs 2200 may be approximately 7.0×7.0 mm². In an implementation, the photodiode active area may be approximately 7.0×7.0 mm². In an implementation, the spacing between the red LEDs 2100, NIR LEDs 2200, and photodiodes 2300 may be approximately 5.0 mm AC and DC signal magnitudes drop off exponentially with increased spacing between emitters and detectors (or photodiodes). The array configuration and spacing of the red LEDs 2100, NIR LEDs 2200, and photodiodes 2300 enable 2D contour mapping for the skin surface proximate to the patch contact area. This permits determination of blood flow, temperature, and other physiological parameters at different points relative to the patch contact area and therefore the physiological conditions at different points with respect to, for example, a wound. For example, analysis of the 2D contour maps may show healing at one part of the wound but not at another part of the wound.

FIG. 3 is a diagram of reflection mode oximetry measurement components 3000 in accordance with certain implementations. In an implementation, the reflection mode oximetry measurement components 3000 may include an array of red LEDs 3100, green LEDs 3200, and photodiodes 3300. In an implementation, the red LEDs 3100 may emit approximately at 610 nm and the green LEDs 3200 may emit around 530 nm. In an implementation, the LED active areas for the red LEDs 3100 and the green LEDs 3200 may be approximately 10.0×10.0 mm². In an implementation, the spacing between the red LEDs 3100, NIR LEDs 3200, and photodiodes 3300 may be approximately 5.0 mm.

FIG. 4 is a perspective view of a vital signs monitoring patch with display 4000 in accordance with certain implementations. FIG. 5 is a top view of the vital signs monitoring patch with display of FIG. 4 in accordance with certain implementations. FIG. 6 is a side view of the vital signs monitoring patch with display of FIG. 4 in accordance with certain implementations. The vital signs monitoring patch with display 4000 may include a power button 4100, a display section 4200, and a front or top ECG electrode 4300. In an implementation, the vital signs monitoring patch with display 4000 may include a charging port 4400. The power button 4100 is configured to power on or off the vital signs monitoring patch with display 4000. The display section 4200 depicts information related to physiological parameters sensed or captured by the vital signs monitoring patch with display 4000 as described herein. The display section 4200 is implemented as described herein. The front or top ECG electrode 4300 is part of a two ECG electrode configuration, where a bottom of the vital signs monitoring patch with display 4000 includes a bottom ECG electrode 4350 as shown in FIG. 6, and functions or operates as described herein. The front or top ECG electrode 4300 is configured such that accidental or incidental touching of the front or top ECG electrode 4300 is minimized. In an implementation, the front or top ECG electrode 4300 is touchable at a plane below the plane of the display section 4200. The charging port 4400 permits charging of the vital signs monitoring patch with display 4000. In an implementation, the vital signs monitoring patch with display 4000 may include a wireless charger.

FIG. 7 is a diagram of the multiple layers of the vital signs monitoring patch with display 4000 in accordance with certain implementations.

Layer 1 is a top cover 7100 which includes a cut-out 7110 for contact access to a front or top ECG electrode 7620, a cut-out 7120 for a display 7400, and a power button indicator 7130 for a plunger or power button 7200. In an implementation, the top cover 7100 may be sticker paper or acrylic material which includes an adhesive on the bottom surface of the top cover 7100.

Layer 2 is the plunger or power button 7200 which is in contact with the top cover 7100 at the power button indicator 7130 and with the PCBA layer 7600 of layer 6 via a cut-out 7330 in layer 3. Pressing at the power button indicator 7130 engages the plunger or power button 7200, which in turn switches a switch on the PCBA layer 7600, for example, to power on the vital signs monitoring patch with display 4000.

Layer 3 is a foam spacer 7300 which includes a cut-out 7310 for the front or top ECG electrode 7620, a cut-out 7320 for the display 7400, and a cut-out 7330 for the plunger or power button 7200. In an implementation, the foam spacer 7300 is a double sided, adhesive coated urethane foam tape for bonding with the top cover 7000 and the PCBA layer 7600. In an implementation, the foam spacer 7300 has a defined thickness to mitigate inadvertent ECG circuit completion, provide placement of the display 7400, and provide placement of a battery 7500.

Layer 4 is the display 7400. In an implementation, the display 7400 is a 3-digit, 7-segment display which depicts at least the physiological parameters described herein. In an implementation, the display 7400 is implemented as described herein. The display 7400 is electrically and mechanically connected to the PCBA layer 7600.

Layer 5 is the battery 7500. In an implementation, the battery 7500 is a polymer Lithium battery or battery stack. In an implementation, the battery 7500 is rechargeable. The battery 7500 is connected to the PCBA layer 7600 and/or the display 7400.

Layer 6 is the PCBA layer 7600. The PCBA 7600 includes active and passive components section 7610, the front or top ECG electrode 7620 on one side or a top surface of the PCBA layer 7600 and a bottom ECG electrode on another side or bottom surface of the PCBA layer 7600.

Layer 7 is a double-sided medical tape layer 7700 which includes a cut-out 7710 for the active and passive components section 7610 and a cut-out 7720 for the bottom ECG electrode. The double-sided medical tape layer 7700 has adhesive on both sides which bonds to the PCBA layer 7600 and the medical tape layer 7800

Layer 8 is the medical tape layer 7800 which includes a cut-out 7810 for the active and passive components section 7610 and a cut-out 7820 for the bottom ECG electrode. The medical tape layer 7800 includes a medical adhesive to bond to the user skin surface.

Layer 9 is a hydrogel conductive adhesive patch 7900 which is connected to the bottom ECG electrode 7630.

FIG. 8 is a bottom view of the PCBA layer 7600 in accordance with certain implementations. A bottom surface 8000 of the PCBA layer 7600, for example, includes a first temperature sensor 8100, a second temperature sensor 8200, a bottom ECG electrode 8300, and reflection mode oximetry measurement components 8400. In an implementation, the bottom ECG electrode 8300 may be a screen-printed Ag—AgCl electrode. In an implementation, the reflection mode oximetry measurement components 8400 may be configured and function and operate as shown in FIGS. 2A-2E. In an implementation, the reflection mode oximetry measurement components 8400 may be configured and function and operate as described in the specification herein. In an implementation, the reflection mode oximetry measurement components 8400 may include red LEDs 8410, NIR LEDs 8420, and photodiodes 8430 which function and operate as described in the specification herein. The first temperature sensor 8100 and the second temperature sensor 8200 permit generation of a temperature profile for a wound, for example, to see whether healing is progressing. The parameters may be displayed on the display 7400 or transmitted to another device which may show, for example, a 2D thermal contour.

FIG. 8A is a diagram of the reflection mode oximetry measurement components 8400 in accordance with certain implementations. The reflection mode oximetry measurement components 8400 may be configured in an array 8405 which may include an array of red LEDs 8410 (shown as R1-R4), array of NIR LEDs 8420 (shown as N1-N4), and an array of photodiodes 8430 (shown as P1-P8), where each array is configured in a defined pattern. Readout from the array 8405 may be implemented by sampling in a raster format. In an implementation, a raster pattern 8500 may be done from top to bottom. In an implementation, the array 8405 may be read out by sampling readout blocks 8600 from readout block 1 to readout block 9 (RB1-RB9). As an illustrative example, RB1 may include P1, R1, N1 and P2, RB2 may include R1, P3, P2 and N2, RB3 may include P3, R2, N2 and P4, RB4 may include N1, P8, P2 and R4, RB5 may include P2, R4, N2 and P6, RB6 may include N2, P6, P4 and R3, RB7 may include P8, N4, R4 and P7, RB8 may include R4, P7, P6 and N3, and RB9 may include P6, N3, R3 and P5.

FIG. 8B is a block diagram of a readout circuit 8600 for a reflection mode oximetry measurement system in accordance with certain implementations. The readout circuit 8600 includes a multiplexor 8700 which is connected to analog front-end (AFE) 8750 and a low power processor with Bluetooth 8800. The AFE 8750 is connected to and receives inputs (IN1-IN3) from photodiodes (PD) 8900 and controls transmission (TX1-TX4) by red LEDs 8910 and NIR LEDs 8920. In an implementation, the red LEDs 8910 and NIR LEDs 8920 are switched on/off by the multiplexer 8700 and a current source within the AFE 8750. The current produced by the photodiodes 8900 are converted into voltages (transimpedance amplifier), time demultiplexed, and digitized back through the AFE 8750 and then transmitted to an application on a mobile device 8950. The AFE 8750, the red LEDs 8910, the NIR LEDs 8920, the photodiodes 8900, and the low power processor with Bluetooth 8800 may function and operate as described in the specification herein.

FIG. 9 is an example diagram of a hardware architecture of a vital signs monitoring patch with display 9000 in accordance with certain implementations. The vital signs monitoring patch with display 9000 includes printed Ag—AgCl electrodes 9100, negative and a positive electrodes, for taking ECG measurements. In an implementation, the printed Ag—AgCl electrodes 9100 are screen-printed on different sides of a PCB. The Ag—AgCl electrodes 9100 are connected to an analog front-end (AFE) 9200, which further includes connections from an accelerometer 9300 and a PPG sensor 9400 (shown as oximetry SpO₂) The AFE 9200 is connected to a processor 9500, which is further connected to a LED display 9600, temperature sensor(s) 9700, pH sensor 9800, and antenna 9900. In an implementation, the processor 9500 is a low power MCU with integrated Bluetooth®. In an implementation, the antenna 9900 is a Bluetooth® which may communicate with a device 9950 using a corresponding antenna 9975. In an implementation, the hardware architecture may, in part, be implemented on the PCBA layer 7600.

FIG. 10 is an example diagram of a software architecture of a vital signs monitoring patch with display 10000 in accordance with certain implementations. A processor software/firmware of the vital signs monitoring patch with display 10000 includes, but is not limited to, a power module 10100, a data transfer module 10150, and drivers 10200 for the LEDs 10210, AFE 10220, Bluetooth® stack 10230, accelerometer 10240, display 10250, temperature sensor 10260, oximetry 10270, serial peripheral interface 10280, ECG sensor, and the like. An application device 10500 may include, but is not limited to, applications to process and display PPG data 10510, ECG data 10520, heart rate variability data 10530, temperature 10540, step count/fall detection (via accelerometer) 10550, blood pressure and like data. The application device further includes a data storage mode 10580, a Bluetooth® stack 10585, and other libraries 10590. In an implementation, the software/firmware architecture may, in part, be implemented on or with the processor 9500.

FIG. 13 is a flowchart for a method 13000 for reflection mode oximetry measurement for a vital signs monitoring patch with display in accordance with some implementations. The method