Negative pressure wound treatment apparatus and method

• US 8,480,641 B2
• Filed: 06/15/2009
• Issued: 07/09/2013
• Est. Priority Date: 06/13/2008
• Status: Expired due to Fees

• Current Assignee: Premco Medical Systems, Inc.
• Original Assignee: Premco Medical Systems, Inc.
• Inventors: Jacobs, Harold L
• Primary Examiner(s): Hand, Melanie
• Assistant Examiner(s): LEE, JOSHUA S
• Application Number:
  US12/997,662
• Publication Number:
  US 20110092958A1
• Time in Patent Office: 1,485 Days
• Field of Search: None
• US Class Current: 604/318
• 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: A61F 2013/00412 for use with needles, tubes or catheters
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/95 with sensors for exudate composition
• 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 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3382 Upper level detectors
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

A wound treatment apparatus includes a negative pressure source, a bandage configured to cover a wound and provide a sealed region around the wound, a drainage tube coupled to the bandage and the negative pressure source to drain fluid from the wound. The apparatus also includes a controller coupled to the negative pressure source.

Claims

1. A method of treating a wound comprising:

providing a wound treatment apparatus having a negative pressure source, a bandage configured to cover the wound and provide a sealed region around a perimeter of the wound, at least one drainage tube coupled to the bandage and the negative pressure source, a controller coupled to the negative pressure source, and a data collector coupled to the at least one drainage tube and the controller;

transmitting data collected by the data collector from the controller of the wound treatment apparatus to at least one of a caregiver'"'"'s computer and an insurance company'"'"'s computer at a remote location via a communication network;

receiving a reimbursement authorization from the insurance company'"'"'s computer at the controller of the wound treatment apparatus via the communication network based on data transmitted from the controller of the wound treatment apparatus to an insurance company'"'"'s computer at a remote location via the communication network; and

beginning a treatment therapy using the controller of the wound treatment apparatus after receipt of the authorization from the insurance company'"'"'s computer.

2. The method of claim 1, wherein the treatment therapy includes storing actual pressures applied to the wound and an elapsed therapy time during a therapy session in a database to provide a historical database for the therapy session.

3. The method of claim 2, further comprising analyzing the historical database to develop a new treatment protocol.

4. The method of claim 1, wherein the wound treatment apparatus further includes at least one of an oxygen sensor, a carbon dioxide sensor, a pH sensor, and a temperature sensor in fluid communication with the drainage tube to provide at least one of an oxygen saturation level of fluid drained from the wound, a carbon dioxide level fluid drained from the wound, a pH level of fluid drained from the wound, and a temperature of fluid drained from the wound, respectively.

5. The method of claim 4, further comprising adjusting the negative pressure source with the controller based the at least one output signal from the at least one sensor to maintain at least one of the oxygen saturation level, the carbon dioxide level, the pH level, and the temperature of the wound at substantially a desired level.

6. The method of claim 4, further comprising issuing an alarm when at least one of the oxygen saturation level, the carbon dioxide level, the pH level, and the temperature of the wound crosses a preset threshold level.

7. The method of claim 4, wherein at least two of the oxygen sensor, the carbon dioxide sensor, the pH sensor, and the temperature sensor are in fluid communication with the drainage tube and coupled to the controller, and further comprising adjusting the negative pressure source with the controller based on output signals from the at least two sensors.

8. The method of claim 4, wherein at least three of the oxygen sensor, the carbon dioxide sensor, the pH sensor, and the temperature sensor are in fluid communication with the drainage tube and coupled to the controller, and further comprising adjusting the negative pressure source with the controller based on output signals from the at least three sensors.

9. The method of claim 4, wherein the treatment therapy includes sending data from the at least one sensor via a communication network to a caregiver'"'"'s computer at a remote location, receiving control instructions from the caregiver'"'"'s computer via the communication network, and adjusting the negative pressure source with the controller based on the received instructions.

10. The method of claim 1, wherein the treatment therapy includes maintaining a negative pressure applied by the negative pressure source at a predetermined set point within a tolerance of 2 mmHg or less.

11. The method of claim 1, wherein the treatment therapy includes maintaining a negative pressure applied by the negative pressure source at a predetermined set point within a tolerance of 1 mmHg or less.

12. A method of treating a wound comprising:

providing a wound treatment apparatus having a negative pressure source, a bandage configured to cover the wound and provide a sealed region around a perimeter of the wound, at least one drainage tube coupled to the bandage and the negative pressure source, a controller coupled to the negative pressure source, and a data collector coupled to the at least one drainage tube and the controller;

transmitting identification data from the controller of the wound treatment apparatus to a manufacturer'"'"'s computer at a remote location via the communication network;

receiving an activation code from the manufacturer'"'"'s computer at the controller;

beginning a treatment therapy using the controller of the wound treatment apparatus after receipt of the activation code from the manufacturer'"'"'s computer; and

transmitting data collected by the data collector from the controller of the wound treatment apparatus to at least one of a caregiver'"'"'s computer and an insurance company'"'"'s computer at a remote location via a communication network.

13. The method of claim 12, wherein the identification data includes a serial number of the wound treatment apparatus.

14. The method of claim 12, wherein the treatment therapy includes storing actual pressures applied to the wound and an elapsed therapy time during a therapy session in a database to provide a historical database for the therapy session.

15. The method of claim 12, further comprising analyzing the historical database to develop a new treatment protocol.

16. The method of claim 12, wherein the wound treatment apparatus further includes at least one of an oxygen sensor, a carbon dioxide sensor, a pH sensor, and a temperature sensor in fluid communication with the drainage tube to provide at least one of an oxygen saturation level of fluid drained from the wound, a carbon dioxide level fluid drained from the wound, a pH level of fluid drained from the wound, and a temperature of fluid drained from the wound, respectively.

17. The method of claim 16, further comprising adjusting the negative pressure source with the controller based the at least one output signal from the at least one sensor to maintain at least one of the oxygen saturation level, the carbon dioxide level, the pH level, and the temperature of the wound at substantially a desired level.

18. The method of claim 16, further comprising issuing an alarm when at least one of the oxygen saturation level, the carbon dioxide level, the pH level, and the temperature of the wound crosses a preset threshold level.

19. The method of claim 16, wherein at least two of the oxygen sensor, the carbon dioxide sensor, the pH sensor, and the temperature sensor are in fluid communication with the drainage tube and coupled to the controller, and further comprising adjusting the negative pressure source with the controller based on output signals from the at least two sensors.

20. The method of claim 16, wherein at least three of the oxygen sensor, the carbon dioxide sensor, the pH sensor, and the temperature sensor are in fluid communication with the drainage tube and coupled to the controller, and further comprising adjusting the negative pressure source with the controller based on output signals from the at least three sensors.

21. The method of claim 16, wherein the treatment therapy includes sending data from the at least one sensor via a communication network to a caregiver'"'"'s computer at a remote location, receiving control instructions from the caregiver'"'"'s computer via the communication network, and adjusting the negative pressure source with the controller based on the received instructions.

22. The method of claim 12, wherein the treatment therapy includes maintaining a negative pressure applied by the negative pressure source at a predetermined set point within a tolerance of 2 mmHg or less.

23. The method of claim 12, wherein the treatment therapy includes maintaining a negative pressure applied by the negative pressure source at a predetermined set point within a tolerance of 1 mmHg or less.