Granted Patent B2

US 12,533,457 · App. 17/729,786 · Granted Jan 27, 2026

Inventors: Edward Yerbury Hartwell (Hull, GB); Felix C. Quintanar (Hull, GB); Jason Peter De Villiers (Cambridge, GB)

Assignee: Smith & Nephew, Inc.

A61M1/73A61M1/732A61M1/734A61M1/96A61M1/74A61M1/962A61M1/98A61M2205/18A61M2205/3334A61M2205/50

Abstract

Claims (31)

1 . A method of operating an apparatus for applying negative pressure to a wound, the method comprising:

providing negative pressure from a negative pressure source, via a fluid flow path, to a wound covered by a wound dressing;

at a first time:

detecting a blockage in the fluid flow path based on an activity level of the negative pressure source; and

in response to detecting the blockage in the fluid flow path, providing a first indication that the blockage is present in the fluid flow path; and

at a second time:

detecting presence of blood in the fluid flow path based on a pressure monitored in the fluid flow path and the activity level of the negative pressure source; and

in response to detecting the presence of blood in the fluid flow path, providing a second indication that blood is present in the fluid flow path.

2 . The method of claim 1 , wherein the negative pressure source comprises a pump operated by an actuator, and wherein the activity level comprises at least one of a pump speed, a pulse width modulation (PWM) signal configured to drive the actuator, or a current signal configured to drive the actuator.

3 . The method of claim 1 , further comprising:

computing a first indicator associated with change in the pressure over a time duration and a second indicator associated with change in the activity level over the time duration; and

detecting presence of blood based on the first and second indicators.

4 . The method of claim 3 , wherein at least one of the first or second indicators comprises a statistical indicator.

5 . The method of claim 3 , further comprising performing a time series analysis to determine that at least one of the first or second indicators deviates from a threshold and in response to the deviation, detect presence of blood.

6 . The method of claim 5 , wherein the time series analysis comprises determination of a cumulative sum (Cusum) of at least one of the first or second indicators.

7 . The method of claim 6 , wherein the Cusum of at least one of the first or second indicators comprises a sliding causal Cusum.

8 . The method of claim 3 , wherein the first indicator comprises mean pressure over the time duration and the second indicator comprises standard deviation of standard deviation of a current signal over the time duration.

9 . The method of claim 1 , wherein the second indication that blood is present in the fluid flow path comprises one or more of: activation of an alarm, release of negative pressure in the fluid flow path, decrease of a target negative pressure provided by the negative pressure source, or deactivation of the negative pressure source.

10 . The method of claim 1 , further comprising, at a third time, detecting and providing a third indication of one or more of: presence of water in the fluid flow path, presence of exudate in the fluid flow path, presence of gas leak in the fluid flow path, or change in the pressure in the fluid flow path.

11 . The method of claim 10 , further comprising:

computing a plurality of indicators associated with change in the pressure over a time duration and change in the activity level over the time duration; and

detecting and providing the third indication of one or more of presence of water in the fluid flow path, presence of exudate in the fluid flow path, presence of gas leak in the fluid flow path, or change in the pressure in the fluid flow path based on the plurality of indicators.

12 . The method of claim 11 , wherein at least some of the plurality of indicators comprise a statistical indicator.

13 . The method of claim 11 , further comprising performing, at the third time, a time series analysis to determine that at least some of the plurality of indicators deviate from one or more thresholds and, in response to the deviation, detect one or more of presence of water in the fluid flow path, presence of exudate in the fluid flow path, presence of gas leak in the fluid flow path, or change in negative pressure in the fluid flow path.

14 . The method of claim 13 , wherein the time series analysis comprises determination of a cumulative sum (Cusum) of at least some of the plurality of indicators.

15 . The method of claim 14 , wherein the Cusum of at least some of the plurality of indicators comprises a sliding causal Cusum.

16 . The method of claim 11 , wherein an indicator associated with change in the pressure in the fluid flow path comprises mean pressure over the time duration, an indicator associated with presence of gas leak in the fluid flow path comprises standard deviation of a mean of a current signal, and an indicator associated with presence of water or exudate in the fluid flow path comprises kurtosis of standard deviation of a pump speed.

17 . The method of claim 11 , further comprising determining malfunction of a pressure sensor of the apparatus based on at least one of the plurality of indicators.

18 . The method of claim 1 , further comprising, at a third time, determining a viscosity of a fluid in the fluid flow path based on a change of the pressure monitored in the fluid flow path over a time duration.

19 . The method of claim 18 , wherein the change of the pressure monitored in the fluid flow path indicates an increase in pressure resulting from flow of a first fluid having a higher viscosity than a second fluid.

20 . The method of claim 1 , wherein the second indication comprises decreasing a target negative pressure provided by the negative pressure source or deactivating the negative pressure source.

Continuity (5)

References Cited (400)