# US 2022/0031231 A1 · Integrated sensor enabled wound monitoring and/or therapy dressings and systems

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- Number: US 2022/0031231 A1
- Document ID: US20220031231A1
- Status: Published application
- Kind: A1
- Application number: 16/763,950
- Filed: 2018-11-14
- Published: 2022-02-03
- Earliest claimed: 2017-11-15
- Assignees: Smith & Nephew, Inc.
- Applicants: Smith & Nephew PLC
- Inventors: Allan Kenneth Frazer Grugeon Hunt; William Kelbie; Marcus Damian Phillips; Felix Clarence Quintanar; Daniel Lee Steward
- Web page: https://patentgrep.com/patent/US20220031231A1

## CPC

- A61F 13/05: specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/445: {Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore}
- A61B 5/6802: {Sensor mounted on worn items}
- A61F 13/0276: {Apparatus or processes for manufacturing adhesive dressings or bandages}
- A61M 1/73: {comprising sensors or indicators for physical values}
- A61M 1/913: {having a bridging element for transferring the reduced pressure from the connector to the dressing}
- A61M 1/915: {Constructional details of the pressure distribution manifold}
- A61M 1/92: {with liquid supply means}
- A61M 1/95: {with sensors for exudate composition}
- A61M 1/966: {having a pressure sensor on or near the dressing}
- A61M 1/962: {having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction}
- A61M 1/985: {the dressing itself forming the collection container}
- A61M 2205/3306: Optical measuring means
- A61M 2205/3324: PH measuring means
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/50: Temperature
- A61M 2230/63: Motion, e.g. physical activity
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A wound monitoring and/or therapy system can include a substantially stretchable substrate supporting a plurality of electronic components, including sensors, and a plurality of electronic connections that connect at least some of the electronic components. The electronic components can also include a circuit board supporting at least one controller configured to control at least some of the sensors, the circuit board configured to operate without failure when the substrate is flexed as a result of strain. A calibration track can be positioned on the substrate and connected to a monitoring circuit configured to measure a change in resistance of the calibration track indicative of resistance change of at least some of the plurality of electronic connections. The system can include a controller with a circuit board supporting a plurality of electrical components and an antenna configured to communicate with the substrate, the antenna at least partially enclosing the circuit board.

## Claims

### Claim at position 1

1-14. (canceled)

### Claim 15

A wound monitoring and/or therapy system comprising:
a wound dressing configured to be positioned over a wound, the wound dressing comprising a stretchable substrate supporting a plurality of electronic components and a plurality of electronic connections that connect at least some of the plurality of the electronic components, the plurality of electronic components comprising a plurality of sensors configured to obtain measurement data of at least one of the wound or periwound; and
a control module configured to be connected to the wound dressing, the control module comprising a first controller configured to obtain the measurement data from the plurality of sensors and a first power source configured to provide power to the first controller and the plurality of sensors, the first controller and first power source enclosed in an enclosure.

### Claim 16 (depends on 15)

The system of claim 15, wherein the enclosure comprises a first portion supporting the first controller and first power source and a second portion configured to be attached to at least one pin positioned on the first portion.

### Claim 17 (depends on 15)

The system of claim 15, wherein the enclosure is configured to shield the first controller from at least one of electromagnetic interference (EMI) or electrostatic discharge (ESD).

### Claim 18

A method of manufacturing a wound dressing configured to be positioned over a wound and be used in a wound monitoring and/or therapy system, the method comprising:
pre-straining a circuit board comprising a controller by at least one of:
stretching at least a portion of a substantially flexible substrate of the wound dressing, positioning the circuit board on at least the portion of the substrate, and subsequently relaxing at least the portion of the substrate; or
compressing the circuit board and subsequently positioning the circuit board on the substrate,
wherein the substrate supports a plurality of sensors configured to obtain measurement data of at least one of the wound or periwound and a plurality of electronic connections that connect at least some of the plurality of the sensors and the controller, and wherein the controller is configured to control at least some of the plurality of sensors, and
wherein pre-straining the circuit board increases resiliency of the circuit board to flexing and causes the circuit board to operate without failure when the circuit board is flexed as a result of strain being applied to the substrate.

### Claim at position 6

19-28. (canceled)

### Claim 29

A method of operating a wound monitoring and/or therapy apparatus comprising a wound dressing including a substantially stretchable substrate supporting a plurality of sensors configured to obtain measurements of at least one of a wound or periwound and a plurality of conductive tracks electrically connecting the plurality of sensors, the method comprising:
with a monitoring circuit of the apparatus, measuring a first change in resistance of at least one calibration track positioned on the substrate, the first change in resistance of the at least one calibration track corresponding to a change in resistance of at least some of the plurality of conductive tracks.

### Claim at position 8

30-44. (canceled)

### Claim 45 (depends on 15)

The system of claim 15 wherein the plurality of electronic components comprises a second controller positioned on a circuit board, the second controller configured to control at least some of the plurality of sensors, and wherein the circuit board is formed from reinforced material and configured to operate without failure when the circuit board is flexed as a result of strain on the wound dressing.

### Claim 46 (depends on 45)

The system of claim 45, wherein the reinforced material of the circuit board has been reinforced by being subjected to compression in order to increase resiliency of the reinforced material of the circuit board to flexing.

### Claim 47 (depends on 45)

The system of claim 45, wherein the reinforced material of the circuit board has been reinforced by being pre-strained.

### Claim 48 (depends on 45)

The system of claim 45 wherein the wound dressing comprises a coating covering at least some of the plurality of electronic components and at least some of the plurality of electronic connections, and wherein the reinforced material of the circuit board has been reinforced by the coating compressing the reinforced material of the circuit board when being applied to the wound dressing.

### Claim 49 (depends on 48)

The system of claim 48, wherein the coating is at least one of hydrophobic or biocompatible.

### Claim 50 (depends on 45)

The system of claim 45, wherein the wound dressing further includes an antenna configured to communicate measurement data to a remote computing device.

### Claim 51 (depends on 45)

The system of claim 45, further comprising a second power source positioned on the substrate, the second power source configured to power the plurality of electronic components.

### Claim 52 (depends on 51)

The system of claim 51, wherein the second power source is not enclosed in a separate casing or enclosure.

### Claim 53 (depends on 51)

The system of claim 51, wherein the substrate comprises first and second portions, wherein the second power source comprises an anode supported by the first portion of the substrate and a cathode supported by the second portion of the substrate, and wherein the second power source further comprises an electrolyte layer positioned between the anode and cathode.

### Claim 54 (depends on 53)

The system of claim 53, wherein the anode is positioned on a first electronic connection of the plurality of electronic connections and the cathode is positioned on a second electronic connection of the plurality of electronic connections.

### Claim 55 (depends on 45)

The system of claim 45, wherein the second controller is configured to be activated by one or more of: flexing the wound dressing, activating an activation switch, bursting a bubble of conductive material, charging a transistor, initiating a magnetic trigger, or triggering a piezoelectric element.

### Claim 56 (depends on 45)

The system of claim 45, wherein the substrate comprises a plurality of perforations configured to allow fluid to pass through the substrate.

### Claim 57 (depends on 45)

The system of claim 45, further comprising a negative pressure source configured to be fluidically connected to the wound dressing, the negative pressure source configured to supply negative pressure to the wound.