System for Monitoring and Controlling Negative Pressure Wound Therapy

• US 20150133829A1
• Filed: 11/14/2014
• Published: 05/14/2015
• Est. Priority Date: 11/14/2013
• Status: Active Grant

• Current Assignee: Deroyal Industries Incorporated
• Original Assignee: Deroyal Industries Incorporated
• Inventors: DeBusk, Brian C., Alleman, Timothy A., Zufelt, Nephi
• Granted Patent: US 9,700,462 B2
• Time in Patent Office: Days
• US Class Current: 601/6
• CPC Class Codes: 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]
• CPC Class Codes: A61M 1/743 by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/982 with means for detecting level of collected exudate
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system for monitoring and controlling negative pressure wound therapy includes a microcontroller that controls means for maintaining reduced air pressure based on a pressure signal from a pressure sensor. The means for maintaining reduced air pressure may include a vacuum pump and valve. The system includes a mobile communication device having a microprocessor, touchscreen display, data storage device, GPS module, and wireless transceiver. The microprocessor generates control signals sent to the microcontroller to control the means for maintaining reduced air pressure to provide continuous or intermittent reduced air pressure. The microprocessor monitors the pressure signal and generates a closed-system alarm, leak-detected alarm or open-system alarm. The closed-system alarm indicates an air pressure leak rate below a closed-system threshold. The leak-detected alarm indicates an air pressure leak rate above a leak-detected threshold and below an open-system threshold. The open-system alarm indicates an air pressure leak rate above the open-system threshold.

Claims

1. A system for monitoring and controlling negative pressure wound therapy for treating a wound on a person'"'"'s body, the system comprising:

means for maintaining reduced air pressure in an airspace over the wound;

a pressure sensor for sensing air pressure and generating a pressure signal based on sensed air pressure;

a microcontroller in electrical communication with the means for maintaining reduced air pressure and the pressure sensor, the microcontroller for controlling the means for maintaining reduced air pressure based at least in part on the pressure signal from the pressure sensor; and

a mobile communication device comprising;

a microprocessor in electrical communication with the microcontroller;

a touch-sensitive display in electrical communication with the microprocessor;

a data storage device in electrical communication with the microprocessor;

a GPS module in electrical communication with the microprocessor; and

a wireless transceiver in electrical communication with the microprocessor,

wherein the microprocessor of the mobile communication device executes software instructions to generate control signals that are provided to the microcontroller to control the means for maintaining reduced air pressure to maintain one or more of a continuous reduced air pressure state or an intermittent reduced air pressure state in the airspace over the wound, and

wherein the microprocessor of the mobile communication device executes software instructions to monitor the pressure signal and generate one or more of

a closed-system alarm if the pressure signal indicates an air pressure leak rate that is below a closed-system threshold,

a leak-detected alarm if the pressure signal indicates an air pressure leak rate that is above a leak-detected threshold and below an open-system threshold, and

an open-system alarm if the pressure signal indicates an air pressure leak rate that is above the open-system threshold.

2. The system of claim 1 further comprising:

a first housing for enclosing at least a portion of the means for maintaining reduced air pressure and the microcontroller, the first housing having a recess in an outer surface thereof; and

a second housing for enclosing the mobile communications device, the second housing sized to fit substantially within the recess in the outer surface of the first housing.

3. The system of claim 2 further comprising a hinged connection between the first housing and the second housing, whereby the second housing is rotatable on the hinged connection to move from a first position in which an outer surface of the second housing is substantially flush with the outer surface of the first housing to a second position in which the outer surface of the second housing is tilted with respect to the outer surface of the first housing.

4. The system of claim 2 further comprising:

a power source disposed in the first housing for providing power to at least the means for maintaining reduced air pressure; and

a tether harness connected between the first housing and the second housing through which the mobile communication device in the second housing is in electrical communication with the microcontroller in the first housing.

5. The system of claim 1 further comprising:

a canister for receiving fluid drained from the wound; and

a fluid sensor for sensing a quantity of fluid in the canister and generating a fluid signal based thereon, the fluid sensor in electrical communication with the microcontroller,

wherein the microcontroller is operable to control the means for maintaining reduced air pressure based at least in part on the fluid signal.

6. The system of claim 5 further comprising:

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks;

the microprocessor of the mobile communication device for generating a canister filling rate signal based on the fluid signal;

the wireless transceiver of the mobile communication device for transmitting the canister filling rate signal to the negative pressure wound treatment service provider computer via the communication network; and

the negative pressure wound treatment service provider computer for sending an alert communication based on the canister filling rate signal to the healthcare provider computer via the one or more communication networks.

7. The system of claim 1 wherein the healthcare provider computer is a mobile communication device carried by a healthcare provider assigned to attend to treatment of the person'"'"'s wound.

8. The system of claim 1 further comprising:

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks;

the wireless transceiver of the mobile communication device for transmitting one or more of the pressure signal, the open-system alarm, the leak-detected alarm, and the closed-system alarm to the negative pressure wound treatment service provider computer via the one or more communication networks; and

the negative pressure wound treatment service provider computer for sending an alert communication based on one or more of the pressure signal, the open-system alarm, the leak-detected alarm, and the closed-system alarm to the healthcare provider computer via the one or more communication networks.

9. The system of claim 1 further comprising:

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks;

the GPS module of the mobile communication device for generating location coordinate information indicative of the geographic location of the mobile communication device;

the microprocessor of the mobile communication device for determining whether the location coordinate information indicates that the mobile communication device has moved from inside to outside a geofence boundary and for generating a geofence alert message based thereon;

the wireless transceiver of the mobile communication device for transmitting the geofence alert message to the negative pressure wound treatment service provider computer via the one or more communication networks; and

the negative pressure wound treatment service provider computer for sending a geofence alert communication based on the geofence alert message to the healthcare provider computer via the one or more communication networks.

10. The system of claim 1 further comprising:

the GPS module of the mobile communication device for generating location coordinate information indicative of the geographic location of the mobile communication device;

the wireless transceiver of the mobile communication device for transmitting the location coordinate information via the one or more communication networks;

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks, the negative pressure wound treatment service provider computer for determining whether the location coordinate information indicates that the mobile communication device has moved from inside to outside a geofence boundary, and for sending a geofence alert communication to the healthcare provider computer via the one or more communication networks.

11. The system of claim 10 wherein the healthcare provider computer updates a healthcare insurance reimbursement condition indicator based on the geofence alert communication.

12. The system of claim 1 wherein

the mobile communication device further comprises an imaging device for capturing a digital image of the wound, and

the wireless transceiver of the mobile communication device further for transmitting the digital image of the wound to a negative pressure wound treatment service provider.

13. The system of claim 1 further comprising:

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks, the negative pressure wound treatment service provider computer operable to generate a pressure-setting command message and transmit the pressure-setting command message to the mobile communication device via the one or more communication networks;

the wireless transceiver of the mobile communication device for receiving the pressure-setting command message via the one or more communication networks; and

the microprocessor of the mobile communication device for executing software instructions to generate control signals based on the pressure-setting command message, wherein the control signals are provided to the microcontroller to control the means for maintaining reduced air pressure to maintain a reduced air pressure in the airspace over the wound.

14. The system of claim 1 further comprising:

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks;

the GPS module of the mobile communication device for determining a geographic location of the mobile communication device after the person whose wound is being treated by the system has been discharged from a healthcare facility;

the microprocessor of the mobile communication device for generating a location message based on the geographic location;

the wireless transceiver of the mobile communication device for transmitting the location message to the negative pressure wound treatment service provider computer via the one or more communication networks; and

the negative pressure wound treatment service provider computer for providing location information via the one or more communication networks to a mobile communication device carried by a healthcare provider, the location information indicating to the healthcare provider a location at which to find the person whose wound is being treated by the system.

15. The system of claim 1 wherein the data storage device of the mobile communication device stores an identification number for uniquely identifying the mobile communication device, and wherein the system further comprises:

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks, the negative pressure wound treatment service provider computer receiving from the healthcare provider computer identification information for identifying the person whose wound is being treated by the system;

the microprocessor of the mobile communication device for generating a message that includes the identification number stored in the data storage device of the mobile communication device;

the wireless transceiver of the mobile communication device for transmitting the message that includes the identification number to the negative pressure wound treatment service provider computer via the one or more communication networks; and

the negative pressure wound treatment service provider computer for associating the identification number transmitted from the mobile communication device with the identification information sent from the healthcare provider computer.

16. The system of claim 1 wherein the mobile communication device further comprises:

the data storage device for storing electronic documentation of standard practices with which law requires medical device suppliers to abide and to disclose to persons being treated by the system;

the touch-sensitive display for displaying the standard practices for viewing by the person being treated by the system;

the touch-sensitive display for receiving an indication from the person being treated by the system confirming that the person has viewed the standard practices; and

the wireless transceiver further for transmitting the indication to a negative pressure wound treatment service provider computer via the one or more communication networks.

17. The system of claim 1 wherein the mobile communication device further comprises:

the data storage device for storing information regarding characteristics of the wound and treatment of the wound;

the touch-sensitive display for displaying the information regarding characteristics of the wound and treatment of the wound for viewing by a healthcare provider attending to the person being treated by the system;

the touch-sensitive display for receiving information from the healthcare provider regarding characteristics of the wound and treatment of the wound provided to the person by the healthcare provider; and

the wireless transceiver further for transmitting information regarding characteristics of the wound and treatment of the wound to a negative pressure wound treatment service provider computer via the one or more communication networks.

18. The system of claim 1 wherein the mobile communication device further comprises:

the touch-sensitive display for displaying a prompt for viewing by a healthcare provider, the prompt requesting input regarding whether use of the system for treatment of the person'"'"'s wound is covered by a particular type of healthcare insurance;

the touch-sensitive display for receiving information from the healthcare provider in response to the prompt displayed on the display screen; and

the wireless transceiver further for transmitting the information input by the healthcare provider to a negative pressure wound treatment service provider computer via the one or more communication networks.

19. The system of claim 1 wherein the means for maintaining reduced pressure in an airspace over the wound comprises:

a vacuum pump in electrical communication with the microcontroller;

a valve in electrical communication with the microcontroller and in fluid communication with the vacuum pump; and

a suction dome disposed over the wound and in fluid communication with the valve.

20. A microprocessor-implemented method for maintaining reduced air pressure in an airspace over a wound on a person'"'"'s body using a negative pressure wound therapy unit, the method comprising:

(a) the negative pressure wound therapy unit sensing air pressure in the airspace over the wound and generating a pressure signal based on sensed air pressure;

(b) the negative pressure wound therapy unit generating control signals to control a vacuum pump in the negative pressure wound therapy unit to maintain a continuous reduced air pressure state or an intermittent reduced air pressure state in the airspace over the wound, the control signals based at least in part on the pressure signal from the pressure sensor;

(c) the negative pressure wound therapy unit generating one or more of a

a closed-system alarm if the pressure signal indicates an air pressure leak rate that is below a closed-system threshold,

a leak-detected alarm if the pressure signal indicates an air pressure leak rate that is above a leak-detected threshold and below an open-system threshold, and

an open-system alarm if the pressure signal indicates an air pressure leak rate that is above the open-system threshold;

(d) the negative pressure wound therapy unit wirelessly transmitting one or more of the pressure signal, the closed-system alarm, the leak-detected alarm, and the open-system alarm from the negative pressure wound therapy unit to a negative pressure wound treatment service provider computer via one or more communication networks; and

(e) the negative pressure wound treatment service provider computer sending an alert communication based on one or more of the pressure signal, the closed-system alarm, the leak-detected alarm, and the open-system alarm to a healthcare provider computer via the one or more communication networks.

21. A system for monitoring and controlling negative pressure wound therapy for treating a wound on a person'"'"'s body, the system comprising:

means for maintaining reduced air pressure in an airspace over the wound;

a canister for receiving fluid drained from the wound; and

a fluid sensor for sensing a quantity of fluid in the canister and generating a fluid signal based thereon, the fluid sensor in electrical communication with the microcontroller;

a microcontroller in electrical communication with the means for maintaining reduced air pressure and the fluid sensor, the microcontroller operable to control the means for maintaining reduced air pressure based at least in part on the fluid signal; and

a mobile communication device comprising;

a microprocessor in electrical communication with the microcontroller;

a touch-sensitive display in electrical communication with the microprocessor;

a data storage device in electrical communication with the microprocessor;

a GPS module in electrical communication with the microprocessor; and

a wireless transceiver in electrical communication with the microprocessor,

wherein the microprocessor of the mobile communication device executes software instructions to generate control signals that are provided to the microcontroller to control the means for maintaining reduced air pressure to maintain one or more of a continuous reduced air pressure state or an intermittent reduced air pressure state in the airspace over the wound.

22. The system of claim 21 further comprising:

a negative pressure wound treatment service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks;

the microprocessor of the mobile communication device for generating a canister filling rate signal based on the fluid signal;

the wireless transceiver of the mobile communication device for transmitting the canister filling rate signal to the negative pressure wound treatment service provider computer via the communication network; and

the negative pressure wound treatment service provider computer for sending an alert communication based on the canister filling rate signal to the healthcare provider computer via the one or more communication networks.

23. A system for monitoring status of an item of durable medical equipment (DME) dispensed to a person for treating or rehabilitating a medical condition of the person, the system comprising:

one or more sensors disposed on the item of durable medical equipment for sensing one or more operational aspects of the item of durable medical equipment and generating one or more sensor signals based thereon; and

a mobile communication device disposed on the item of durable medical equipment, the mobile communication device comprising;

a data interface for receiving data based on the sensor signals generated by the one or more sensors;

a microprocessor in electrical communication with the data interface;

a data storage device in electrical communication with the microprocessor;

a GPS module in electrical communication with the microprocessor, the GPS module for generating location coordinate information indicative of the geographic location of the mobile communication device; and

a wireless transceiver in electrical communication with the microprocessor, the wireless transceiver for transmitting the location coordinate information via the one or more communication networks; and

a service provider computer in communication with the wireless transceiver of the mobile communication device via one or more communication networks and in communication with a healthcare provider computer via the one or more communication networks, the service provider computer for determining whether the location coordinate information indicates that the mobile communication device has moved from inside to outside a geofence boundary, and for sending a geofence alert communication to the healthcare provider computer via the one or more communication networks.

24. The system of claim 23 wherein the healthcare provider computer updates a healthcare insurance reimbursement condition indicator based on the geofence alert communication.

25. The system of claim 23 further comprising:

the GPS module of the mobile communication device for determining a geographic location of the mobile communication device after the person whose medical condition is being treated by the item of durable medical equipment has been discharged from a healthcare facility;

the microprocessor of the mobile communication device for generating a location message based on the geographic location;

the wireless transceiver of the mobile communication device for transmitting the location message to the service provider computer via the one or more communication networks; and

the service provider computer for providing location information via the one or more communication networks to a mobile communication device carried by a healthcare provider, the location information indicating to the healthcare provider a location at which to find the person whose medical condition is being treated by the item of durable medical equipment.

26. The system of claim 23 wherein the data storage device of the mobile communication device stores an identification number for uniquely identifying the mobile communication device, and wherein the system further comprises:

the service provider computer receiving from the healthcare provider computer identification information for identifying the person whose medical condition is being treated by the item of durable medical equipment;

the microprocessor of the mobile communication device for generating a message that includes the identification number stored in the data storage device of the mobile communication device;

the wireless transceiver of the mobile communication device for transmitting the message that includes the identification number to the service provider computer via the one or more communication networks; and

the service provider computer for associating the identification number transmitted from the mobile communication device with the identification information sent from the healthcare provider computer.

27. The system of claim 23 wherein the mobile communication device further comprises:

the data storage device for storing electronic documentation of standard practices with which law requires medical device suppliers to abide and to disclose to persons being treated by the item of durable medical equipment;

a touch-sensitive display for displaying the standard practices for viewing by the person being treated by the item of durable medical equipment;

the touch-sensitive display for receiving an indication from the person being treated by the item of durable medical equipment confirming that the person has viewed the standard practices; and

the wireless transceiver further for transmitting the indication to the service provider computer via the one or more communication networks.

28. The system of claim 23 wherein the mobile communication device further comprises:

the data storage device for storing information regarding the medical condition of the person;

a touch-sensitive display for displaying the information regarding the medical condition of the person and treatment of the medical condition for viewing by a healthcare provider attending to the person being treated by the item of durable medical equipment;

the touch-sensitive display for receiving information from the healthcare provider regarding characteristics of the medical condition and treatment of the medical condition by the healthcare provider; and

the wireless transceiver further for transmitting information regarding characteristics of the medical condition and treatment of the medical condition to the service provider computer via the one or more communication networks.

29. The system of claim 23 wherein the mobile communication device further comprises:

a touch-sensitive display for displaying a prompt for viewing by a healthcare provider, the prompt requesting input regarding whether use of the item of durable medical equipment for treatment of the person'"'"'s medical condition is covered by a particular type of healthcare insurance;

the touch-sensitive display for receiving information from the healthcare provider in response to the prompt displayed on the display screen; and

the wireless transceiver further for transmitting the information input by the healthcare provider to the service provider computer via the one or more communication networks.