# US 2021/0330246 A1 · Systems and Methods for Monitoring a Patient

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- Number: US 2021/0330246 A1
- Document ID: US20210330246A1
- Status: Published application
- Kind: A1
- Application number: 17/245,643
- Filed: 2021-04-30
- Published: 2021-10-28
- Earliest claimed: 2016-01-15
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Hanmin Lee; Sachin Rangarajan; Isabelle Chumfong
- Web page: https://patentgrep.com/patent/US20210330246A1

## CPC

- A61B 5/447: {specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed}
- A61B 5/0004: {characterised by the type of physiological signal transmitted}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/1115: {Monitoring leaving of a patient support, e.g. a bed or a wheelchair}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/6833: {Adhesive patches}
- A61B 5/6892: {Mats}
- A61B 5/7225: {Details of analogue processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation (input circuits for detecting, measuring, or recording bioelectric or biomagnetic signals A61B5/30; specific diagnostic methods using bioelectric or biomagnetic signals A61B5/316)}
- A61B 5/7242: {using integration}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/7405: {using sound}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/7455: {characterised by tactile indication, e.g. vibration or electrical stimulation}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61B 2562/0247: Pressure sensors
- A61B 2562/046: in a matrix array
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Provided herein are methods and systems for monitoring a patient using a pressure-sensing device containing a pressure-sensitive region configured to selectively overlie a pressure ulcer-prone body part of the patient. In some embodiments, the pressure-sensing device includes a multilayered sensing unit containing a pressure-sensing layer to sense force and an adhesive layer configured to attach the pressure-sensing device to the body part. Also provided is a kit that includes the pressure-sensing device. The present methods, systems, and kits may fmd use in reducing the risk of pressure ulcer development in a patient.

## Claims

### Claim at position 1

1-36. (canceled)

### Claim 37

A system for a user to monitoring a patient, comprising:
a) one or more pressure-sensing devices, wherein each of the pressure-sensing devices comprises a pressure-sensitive region configure to:
be overlaid on one of one or more pressure ulcer-prone body parts of a body of a patient; and sense force applied to the body part,
and wherein each of the pressure-sensing devices is configured to generate data comprising two pressure measurements from different times based on the sensed force;
b) a controller comprising a communication unit configured to transmit the data generated by the one or more pressure-sensing devices;
c) a computational unit comprising:
a processor; and
a non-transient computer-readable memory comprising instructions that, when executed by the processor, causes the computational unit to:
i) obtain the data transmitted by the one or more pressure-sensing devices;
ii) process the two pressure measurements from different times of the data to generate a processed pressure datum; and
determine whether the processed pressure datum meets a threshold value; and
d) a user-interface unit comprising an output unit configured to display an output comprising:
the data, or the processed pressure datum; and/or
an indication of whether the threshold value is met by the data.

### Claim 38 (depends on 37)

The system of claim 37, wherein each of the pressure-sensing comprises a multilayered sensing unit comprising:
a pressure-sensing layer comprising an array of interconnected pressure-sensitive elements, wherein each pressure-sensitive element of the array is configured to sense the force applied to the body part and generate a signal representative of a magnitude of the force; and
an adhesive layer configured to attach the pressure-sensing device to the body part.

### Claim 39 (depends on 38)

The system of claim 38, wherein the pressure-sensing layer comprises a first conductive layer comprising a first substrate, a second conductive layer comprising a second substrate, and a piezoresistive layer comprising a pressure-sensitive polymer, wherein the piezoresistive layer is interposed between the first and second conductive layers.

### Claim 40 (depends on 39)

The system of claim 39, wherein the pressure-sensitive elements each comprises a conductive element disposed in each of the first conductive layer and the second conductive layer, wherein the conductive elements are in contact with the piezoresistive layer.

### Claim 41 (depends on 39)

The system of claim 39, wherein the pressure-sensitive polymer comprises a piezoresistive polymer.

### Claim 42 (depends on 38)

The system of claim 38, wherein the array is a grid comprising one or more rows and one or more columns of pressure-sensitive elements.

### Claim 43 (depends on 42)

The system of claim 42, wherein a location within the grid of each of the pressure-sensitive elements is specified by a row number and a column number.

### Claim 44 (depends on 42)

The system of claim 42, wherein the data comprises information about a location within the grid of the pressure-sensitive element from which the signal originated.

### Claim 45 (depends on 38)

The system of claim 38, wherein each pressure-sensitive element is substantially circular.

### Claim 46 (depends on 38)

The system of claim 38, wherein each pressure-sensitive element has an average diameter in the range of 0.1 to 5 cm.

### Claim 47 (depends on 38)

The system of claim 38, wherein the distance between adjacent pressure sensitive elements is in the range of 0.5 to 10.0 cm.

### Claim at position 13

48-62. (canceled)
Please enter the following new claims:

### Claim 63 (depends on 37)

The system of claim 37, wherein the processing comprises calculating a time-differential of the data:
dP
⁡
(
t
)
dt
,
where P(t) is a function comprising a temporal sequence of the pressure measurements value, pt.

### Claim 64 (depends on 37)

The system of claim 37, wherein the processing comprises calculating a time-integral of the data: ∫0t0 P(t) dt, wherein t0 is the time of a current pressure measurement.

### Claim 65 (depends on 37)

The system of claim 37, wherein the threshold value is a patient-specific threshold value.

### Claim 66 (depends on 65)

The system of claim 65, wherein the patient-specific threshold value is based on patient-specific risk factors for pressure ulcer development.

### Claim 67 (depends on 37)

The system of claim 37, wherein the output further comprises an indication of a risk of developing a pressure ulcer.

### Claim 68 (depends on 37)

The system of claim 37, wherein the computation unit also determines whether the processed pressure datum meets a second threshold value, and the output is a tiered output comprising a plurality of tiers of output, wherein the tier of the output is based on whether the processed pressure datum meets the threshold value and whether the processed pressure datum meets the second threshold value.

### Claim 69 (depends on 37)

The system of claim 37, wherein the processing comprises calculating a second-order time-differential of the data:
d
2
⁢
P
n
⁡
(
t
)
dt
2
where P(t) is a function comprising a temporal sequence of the pressure measurements value, pt.

### Claim 70 (depends on 37)

The system of claim 37, wherein the output further comprises instructions related to positioning of the patient's body.

### Claim 71 (depends on 70)

The system of claim 70, wherein the instructions comprise instructions to: continue monitoring the patient; turn the patient's body now; turn the patient's body within a predetermined amount of time; provide a level of intervention other than repositioning the patient; and/or seek medical attention.