# US 12,178,955 B2 · Securing control of settings of wound therapy apparatuses

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- Number: US 12,178,955 B2
- Document ID: US12178955B2
- Status: Granted
- Kind: B2
- Application number: 18/378,878
- Filed: 2023-10-11
- Published: 2024-02-01
- Granted: 2024-12-31
- Earliest claimed: 2018-03-19
- Assignees: T.J.Smith and Nephew, Limited
- Applicants: T.J.Smith and Nephew, Limited
- Inventors: Felix Clarence Quintanar
- Web page: https://patentgrep.com/patent/US12178955B2

## CPC

- A61M 1/92: {with liquid supply means}
- A61M 1/962: {having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction}
- G06F 21/62: Protecting access to data via a platform, e.g. using keys or access control rules
- A61M 1/982: {with means for detecting level of collected exudate}
- A61M 1/985: {the dressing itself forming the collection container}
- A61M 2205/27: preventing use
- A61M 2205/276: preventing unwanted use
- A61M 2205/3331: Pressure; Flow
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- 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)}
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)

## Abstract

Embodiments of secure wound therapy systems and methods for operating the systems are disclosed. In some embodiments, the apparatus includes a pressure source, a user interface, and a locking mechanism. The locking mechanism can be in one of at least two states, the at least two states including a first state in which the locking mechanism physically prevents user adjustment of one or more operational parameters with the user interface and a second state in which the locking mechanism does not physically prevent user adjustment of the one or more operational parameters with the user interface. The locking mechanism can include an authentication key and a receiver configured to receive an authentication input, which may be compared to the authentication key. Providing a sufficiently matching authentication input can transition the locking mechanism from the first state to the second state, permitting adjustments to the one or more operational parameters.

## Claims

### Claim 1

A wound therapy apparatus comprising:
a pressure source configured to provide negative pressure via a fluid flow path to a wound dressing and operate according to an operational parameter;
a user interface configured to enable a user adjustment of the operational parameter; and
a locking mechanism configured to:
operate in at least two states comprising a first state in which a cover of the locking mechanism prevents the user adjustment of the operational parameter with the user interface and a second state in which the cover permits the user adjustment of the operational parameter with the user interface; and
transition from the first state to the second state by retracting the cover or permitting removal of the cover responsive to a manipulation of the locking mechanism with a physical key or a match between an authentication input and an authentication key.

### Claim 2 (depends on 1)

The wound therapy apparatus of claim 1, wherein in the first state, the locking mechanism is configured to physically prevent at least a portion of the user interface from receiving a user input to adjust the operational parameter.

### Claim 3 (depends on 1)

The wound therapy apparatus of claim 1, wherein the locking mechanism is configured to transition from the first state to the second state by retracting the cover.

### Claim 4 (depends on 1)

The wound therapy apparatus of claim 1, wherein the locking mechanism is configured to transition from the first state to the second state by permitting removal of the cover.

### Claim 5 (depends on 1)

The wound therapy apparatus of claim 1, wherein the user interface is positioned in a compartment of a housing, and wherein the locking mechanism is configured to prevent access to the compartment when the locking mechanism is in the first state.

### Claim 6 (depends on 1)

The wound therapy apparatus of claim 1, wherein the authentication input is provided via an electromagnetic transmission.

### Claim 7 (depends on 1)

The wound therapy apparatus of claim 1, wherein the operational parameter comprises a pressure setpoint, a mode of operation setting, or a pump operation profile.

### Claim 8 (depends on 1)

The wound therapy apparatus of claim 1, wherein the locking mechanism is configured to periodically verify the match between the authentication input and the authentication key.

### Claim 9 (depends on 1)

The wound therapy apparatus of claim 1, wherein the locking mechanism is configured to transition from the second state to the first state responsive to a passage of a threshold time duration without the user interface receiving a user input at the user interface.

### Claim 10 (depends on 1)

The wound therapy apparatus of claim 1, wherein the locking mechanism is configured to transition from the second state to the first state responsive to a passage of a threshold time duration without receiving a subsequent authentication input.

### Claim 11 (depends on 1)

A kit comprising the wound therapy apparatus of claim 1 and the wound dressing.

### Claim 12

A method of operating a negative pressure wound therapy apparatus, the method comprising:
at a first time:
providing negative pressure via a fluid flow path to a wound dressing with a pressure source operating according to an operational parameter; and
with a locking mechanism that comprises a cover, preventing a user adjustment of the operational parameter with a user interface while the locking mechanism is in a first state; and
at a second time:
determining that an authentication input matches an authentication key;
in response to determining that the authentication input matches the authentication key, transitioning the locking mechanism from the first state to a second state by retracting the cover or permitting removal of the cover;
permitting the user adjustment of the operational parameter with the user interface while the locking mechanism is in the second state; and
providing negative pressure via the fluid flow path to the wound dressing with the pressure source operating according to the operational parameter after the user adjustment of the operational parameter.

### Claim 13 (depends on 12)

The method of claim 12, wherein preventing the user adjustment of the operational parameter with the user interface comprises physically preventing at least a portion of the user interface from receiving a user input to adjust the operational parameter.

### Claim 14 (depends on 12)

The method of claim 12, further comprising, at a third time:
determining that a user input has not been received at the user interface over a threshold duration of time; and
in response to determining that the user input has not been received at the user interface over the threshold duration of time, transitioning the locking mechanism from the second state to the first state.

### Claim 15 (depends on 12)

The method of claim 12, further comprising, at a third time:
determining that a subsequent authentication input has not been received over a threshold duration of time; and
in response to determining that the subsequent authentication input has not been received over the threshold duration of time, transitioning the locking mechanism from the second state to the first state.

### Claim 16 (depends on 12)

The method of claim 12, further comprising, at a third time, periodically verifying the match of the authentication input and the authentication key.

### Claim 17

A method of operating a negative pressure wound therapy apparatus, the method comprising:
at a first time:
providing negative pressure via a fluid flow path to a wound dressing with a pressure source operating according to an operational parameter; and
with a locking mechanism that comprises a cover, preventing a user adjustment of the operational parameter with a user interface while the locking mechanism is in a first state; and
at a second time:
detecting a manipulation of the locking mechanism with a physical key;
in response to detecting the manipulation of the locking mechanism with the physical key, transitioning the locking mechanism from the first state to a second state by retracting the cover or permitting removal of the cover;
permitting the user adjustment of the operational parameter with the user interface while the locking mechanism is in the second state; and
providing negative pressure via the fluid flow path to the wound dressing with the pressure source operating according to the operational parameter after the user adjustment of the operational parameter.

### Claim 18 (depends on 17)

The method of claim 17, further comprising, at a third time, transitioning the locking mechanism from the second state to the first state responsive to a removal of the physical key.

### Claim 19 (depends on 17)

The method of claim 17, further comprising, at a third time:
determining that a user input has not been received at the user interface over a threshold duration of time; and
in response to determining that the user input has not been received at the user interface over the threshold duration of time, transitioning the locking mechanism from the second state to the first state.

### Claim 20 (depends on 17)

The method of claim 17, wherein preventing the user adjustment of the operational parameter with the user interface comprises physically preventing at least a portion of the user interface from receiving a user input to adjust the operational parameter.
