REDUCED-PRESSURE SYSTEMS, METHODS, AND DEVICES FOR SIMULTANEOUSLY TREATING A PLURALITY OF TISSUE SITES

• US 20130144227A1
• Filed: 11/20/2012
• Published: 06/06/2013
• Est. Priority Date: 11/23/2011
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: Richard Marvin Jr. Kazala
• Inventors: Locke, Christopher Brian, Coulthard, Richard Daniel John, Luckemeyer, James, Kazala, Richard Marvin Jr., Pratt, Benjamin A., Robinson, Timothy Mark
• Granted Patent: US 10,155,071 B2
• Time in Patent Office: Days
• 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 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61M 1/602 Mechanical means for preventing flexible containers from collapsing when vacuum is applied inside, e.g. stents
• CPC Class Codes: A61M 1/67 Containers incorporating a piston-type member to create suction, e.g. syringes cupping glasses A61M1/08; with a flexible member creating suction A61M1/68
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/732 Visual indicating means for vacuum pressure
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• 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 1/918 for multiple suction locations
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing
• CPC Class Codes: A61M 1/98 Containers specifically adapted for negative pressure wound therapy
• CPC Class Codes: A61M 1/982 with means for detecting level of collected exudate
• CPC Class Codes: A61M 1/985 the dressing itself forming the collection container
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/21 insensitive to tilting or inclination, e.g. spill-over prevention
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/84 : for treating several patients simultaneously
• 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

Systems and methods for treating a plurality of tissue sites include a multi-port therapy unit. The multi-port therapy unit includes a plurality of patient-side ports each fluidly coupled to a plurality of conduits and a fluid reservoir fluidly coupled to the plurality of ports. A plurality of pressure sensors are associated with the plurality of patient-side ports to determining a pressure associated with each conduit. A controller is operatively coupled to the plurality of pressure sensors to receive treatment pressure data, monitor pressure for each pressure sensor of the plurality of pressure sensors, and signal an alarm condition if the pressure is outside of a pre-selected range. The system includes a reduced-pressure source fluidly coupled to a dressing at each tissue site through the multi-port therapy unit.

Claims

1. A system for simultaneously treating a plurality of tissue sites, the system comprising:

a plurality of reduced-pressure dressings;

a plurality of multi-lumen reduced-pressure delivery conduits, wherein each multi-lumen reduced-pressure delivery conduit includes at least one pressure-sampling lumen and at least one reduced-pressure supply lumen, each multi-lumen reduced-pressure delivery conduit fluidly coupled to a respective reduced-pressure dressing of the plurality of reduced-pressure dressings;

a multi-port therapy unit comprising;

a plurality of patient-side ports, wherein each of the plurality of patient-side ports is configured to fluidly couple with at least one of the pressure-sampling lumens and one of the reduced-pressure supply lumens,

a plurality of pressure sensors configured to determine a pressure associated with the pressure-sampling lumens of the respective multi-lumen reduced pressure delivery conduit,

a controller operatively coupled to the plurality of pressure sensors for receiving treatment pressure data from the plurality of pressure sensors, wherein the controller comprises a microprocessor and a memory configured to monitor pressure for each pressure sensor of the plurality of pressure sensors and to signal an alarm condition if the pressure is outside of a pre-selected range,

a supply-side port for receiving reduced pressure and

an alarm indicator operatively coupled to the controller for indicating when the controller signals an alarm condition; and

a reduced-pressure source fluidly coupled to the supply-side port of the multi-port therapy unit.

2. The system of claim 1, wherein the multi-port therapy unit further comprises:

a fluid reservoir fluidly coupled to the plurality of patient-side ports;

a drain conduit fluidly coupling the fluid reservoir with an exterior of the multi-port therapy unit for draining the fluid reservoir; and

a valve associated with the drain conduit for selectively allowing fluid flow in the drain conduit.

3. The system of claim 1, wherein the multi-port therapy unit further comprises a plurality of visual indicators disposed on the multi-port therapy unit for providing a visual alert when a pressure below a first reduced-pressure threshold exists in at least one of the plurality of patient-side ports.

5. The system of claim 1, wherein the reduced-pressure source is a mobile therapy unit.

6. The system of claim 1, wherein the reduced-pressure source is wall suction.

4. (canceled)

7. A method for treating a plurality of tissue sites, the method comprising:

deploying a plurality of reduced-pressure dressings proximate to the plurality of tissue sites;

fluidly coupling the plurality of reduced-pressure dressings to a multi-port therapy unit wherein the multi-port therapy unit comprises;

a plurality of patient-side ports, wherein each of the plurality of patient-side ports is configured to fluidly couple with one of the plurality of multi-lumen reduced-pressure delivery conduits and with at least one of the pressure-sampling lumens and one of the reduced-pressure supply lumens therein,

a fluid reservoir fluidly coupled to the plurality of patient-side ports,

a plurality of pressure sensors, wherein the plurality of pressure sensors are associated with the plurality of patient-side ports for determining a pressure associated with each of the plurality of pressure-sampling lumens,

a controller operatively coupled to the plurality of pressure sensors for receiving treatment pressure data from the plurality of pressure sensors, wherein the controller comprises a microprocessor and memory configured to monitor pressure for each of the plurality of pressure sensors and to signal an alarm condition if the pressure is outside of a pre-selected range,

an electrical source operatively coupled to the controller,

a supply-side port for receiving reduced pressure, wherein the supply-side port is fluidly coupled to the fluid reservoir, and

an alarm indicator operatively coupled to the controller for indicating when the controller signals an alarm condition; and

activating the multi-port therapy unit to delivery reduced pressure simultaneously to the plurality of reduced-pressure dressings and to monitor pressure for each of the plurality of reduced-pressure dressings.

8. A system for simultaneously treating a plurality of tissue sites, the system comprising:

a plurality of reduced-pressure dressings;

a plurality of multi-lumen reduced-pressure delivery conduits, wherein each multi-lumen reduced-pressure delivery conduit includes at least one pressure-sampling lumen and at least one reduced-pressure supply lumen, each multi-lumen reduced-pressure delivery conduit fluidly coupled to a respective reduced-pressure dressing of the plurality of reduced-pressure dressings;

a fluid storage device fluidly coupled to the plurality of reduced-pressure dressings for receiving and at least temporarily storing fluids; and

a multi-port therapy unit comprising;

a controller,

a plurality of patient-side ports fluidly coupled to a respective multi-lumen reduced-pressure delivery conduit of the plurality of multi-lumen reduced-pressure delivery conduits,

a plurality of reduced-pressure plenums fluidly coupled to the plurality of patient-side ports so that each reduced-pressure plenum is associated with a respective patient-side port,

a plurality of treatment pressure sensors configured to determine a pressure associated with each multi-lumen reduced-pressure delivery conduit and operatively coupled to the controller to provide a treatment pressure signal to the controller,

a plurality of plenum pressure sensors, wherein each plenum pressure sensor of the plurality of plenum pressure sensors is associated with a respective reduced-pressure plenum of the plurality of reduced-pressure plenums and is operatively coupled to the controller for supplying a plenum pressure signal,

a first plurality of control valves, wherein a control valve of the first plurality of control valves is fluidly coupled between a respective reduced-pressure plenum of the plurality of reduced-pressure plenums and a respective patient-side port of the plurality of patient-side ports, and is operatively coupled to the controller,

a vacuum source fluidly coupled to each reduced-pressure plenum of the plurality of reduced-pressure plenums for supplying reduced pressure to each of the plurality of reduced-pressure plenums;

a second plurality of control valves, wherein a control valve of the second plurality of control valves is fluidly coupled between a respective reduced-pressure plenum of the plurality of reduced-pressure plenums and the vacuum source, and

wherein the controller is operative to regulate the reduced pressure supplied from the plurality of reduced-pressure plenums to the plurality of patient-side ports by controlling the first plurality of control valves and to regulate the reduced pressure supplied to the plurality of reduced-pressure plenums using the second plurality of control valves.

9. The system of claim 8, wherein the controller is configured to:

receive the plenum pressure signal for each reduced-pressure plenum of the plurality of reduced-pressure plenums, and if a plenum pressure signal is less than a plenum threshold pressure, to at least partially open the associated control valve of the second plurality of control valves to deliver additional reduced pressure to the reduced-pressure plenum associated with the plenum pressure signal that is less than the plenum threshold pressure; and

receive the treatment pressure signal for each of the plurality of treatment pressure sensors, and if a treatment pressure signal is less than a minimum treatment pressure threshold, to at least partially open the associated control valve of the first plurality of control valves, and if the treatment pressure signal is greater than a high treatment pressure threshold, to at least partially close the associated control valve of the first plurality of control valves.

10. The system of claim 8, wherein the controller is further operative to prioritize filling the plurality of reduced-pressure plenums such that a reduced-pressure plenum having a plenum pressure signal below a plenum threshold for a predetermined time period will be filled only after other reduced-pressure plenums of the plurality of reduced-pressure plenums.

11. The system of claim 8, further comprising a plurality of indicators, each indicator of the plurality of indicators associated with a respective patient-side port of the plurality of patient-side ports and is operatively coupled to the controller, wherein the controller configured to activate an indicator of the plurality of indicators if the system is not able to maintain a desired pressure range for at least one of the associated pressure-sampling lumen and the associated reduced-pressure plenum.

12. The system of claim 8, wherein the fluid storage device is a plurality of absorbent layers associated with each of the plurality reduced-pressure dressings.

13. The system of claim 8, wherein the fluid storage device is a plurality of in-line fluid reservoirs fluidly coupled to the plurality of multi-lumen reduced-pressure delivery conduits.

14. The system of claim 8, wherein the fluid storage device is a fluid reservoir associated with the multi-port therapy unit.

15. The system of claim 8, wherein the plurality of first control valves are a plurality of proportional valves.

16. The system of claim 8, wherein the plurality of second control valves are a plurality of proportional valves.

17. The system of claim 8, wherein each reduced-pressure plenum of the plurality of plenums is a fixed-volume pressure vessel.

18. The system of claim 8, wherein each reduced-pressure plenum of the plurality of reduced-pressure plenums is a variable-volume pressure vessel having a biased wall to assist in maintaining reduced pressure.

19. A system for simultaneously treating a plurality of tissue sites on a patient, the system comprising:

a plurality of reduced-pressure dressings;

a plurality of multi-lumen reduced-pressure delivery conduits, wherein each multi-lumen reduced-pressure delivery conduit includes at least a pressure-sampling lumen and at least a reduced-pressure supply lumen;

a fluid storage device fluidly coupled to the plurality of reduced-pressure dressings;

a multi-port therapy unit comprising;

a plurality of pressure ports, wherein each pressure port of the plurality of pressure ports is configured to fluidly couple with at least one of the pressure-sampling lumens of a respective multi-lumen reduced-pressure delivery conduit of the plurality of multi-lumen reduced-pressure delivery conduits,

a treatment pressure sensor fluidly coupled to the plurality of pressure sampling lumens associated with the plurality of multi-lumen reduced-pressure delivery conduits,

a valve fluidly coupled to the treatment pressure sensor and the plurality of pressure ports for selectively controlling the flow from each of the plurality of pressure ports to the treatment pressure sensor,

a reduced-pressure source fluidly coupled to the plurality of reduced-pressure dressings, and

a controller operatively coupled to the treatment pressure sensor, the valve, and the reduced-pressure source, wherein the controller is configured to monitor the reduced pressure of each of the plurality of pressure-sampling lumens associated with the plurality of multi-lumen reduced-pressure delivery conduits, and in response, to control the reduced pressure delivered by the reduced-pressure source.

20. The system of claim 19, wherein the valve is a multiplexing control valve.

21. The system of claim 19, wherein the valve is a plurality of control valves, each valve of the plurality of valves associated with a respective pressure port of the plurality of pressure ports.

22. The system of claim 19, wherein the fluid storage device comprises at least one absorbent layer associated with each reduced-pressure dressing of the plurality reduced-pressure dressings.

23. The system of claim 19, wherein the fluid storage device comprises a plurality of in-line fluid reservoirs, and an in-line fluid reservoir of the plurality of in-line fluid reservoirs is fluidly coupled to a respective multi-lumen reduced-pressure delivery conduit of the plurality of multi-lumen reduced-pressure delivery conduits.

24. The system of claim 19, wherein the fluid storage device comprises a fluid reservoir associated with the multi-port therapy unit.

25. The system of claim 19, wherein the controller is operable to determine a number of pressure ports in use, to identify a gross-flow-rate limit for the number of pressure ports in use, and to compare the gross-flow-rate limit of the number of pressure ports in use to an actual flow rate of the pressure ports in use, and if the actual flow rate is greater than the gross-flow-rate limit, to activate an alert.

26. The system of claim 19, wherein the controller is configured to identify a leaking reduced-pressure dressing by sequentially turning off the valve for a particular reduced pressure port associated with a particular reduced pressure dressing, measuring a pressure decay pattern of the particular reduced-pressure dressing, and comparing the decay pattern to a standard decay pattern, and if a variance exists beyond a set margin, to activate an alert.

27. The system of claim 26, wherein the standard decay pattern is a median decay pattern for the plurality of reduced-pressure dressings.

28. The system of claim 19, wherein the controller is configured to identify a leaking reduced-pressure dressing by sequentially turning off the valve for a particular reduced pressure port associated with a particular reduced pressure dressing, for a first time period and then reactivating the reduced-pressure source for the particular reduced pressure dressing by opening the valve while measuring a pressure build-up pattern of the particular reduced-pressure dressing, and comparing the build-up pattern to a standard build-up pattern, and if a variance exists beyond a set margin, activating an alert.

29. A system for simultaneously treating a plurality of tissue sites on a patient, the system comprising:

a plurality of reduced-pressure dressings;

a plurality of multi-lumen reduced-pressure delivery conduits, wherein each multi-lumen reduced-pressure delivery conduit includes at least one pressure-sampling lumen and at least one reduced-pressure supply lumen, each multi-lumen reduced-pressure deliver conduit fluidly coupled to a respective reduced-pressure dressing of the plurality of reduced-pressure dressings;

a fluid storage device fluidly coupled to the plurality of reduced-pressure dressings;

a multi-port therapy unit comprising;

a controller,

a plurality of pressure ports, wherein each pressure port of the plurality of pressure ports is configured to fluidly couple with at least one of the pressure-sampling lumens of the plurality of multi-lumen reduced-pressure delivery conduits,

a plurality of treatment pressure sensors fluidly coupled to the plurality of pressure ports and operatively coupled to the controller, and

a reduced-pressure source fluidly coupled to the plurality of reduced-pressure dressings,

wherein the controller is operatively coupled to the plurality of treatment pressure sensors and the reduced-pressure source, and configured to monitor the reduced pressure of each of the plurality of pressure-sampling lumens associated with the plurality of multi-lumen reduced-pressure delivery conduits and in response to control the reduced pressure delivered by the reduced-pressure source.

33. The system of claim 29, wherein the controller is operable to determine a number of pressure ports in use, to identify a gross-flow-rate limit for the number of pressure ports in use and to compare the gross-flow-rate limit of the number of pressure ports in use to an actual flow rate of the pressure ports in use, and if the actual flow rate is greater than the gross-flow-rate limit, to activate an alert.

34. The system of claim 29, wherein the controller is configured to identify a leaking reduced-pressure dressing by sequentially turning off the valve for a particular reduced pressure port associated with a particular reduced pressure dressing, measuring a pressure decay pattern of the particular reduced-pressure dressing, and comparing the decay pattern to a standard decay pattern, and if a variance exists beyond a set margin, to activate an alert.

35. The system of claim 34, wherein the standard decay pattern is a median decay pattern for the plurality of reduced-pressure dressings.

36. The system of claim 29, wherein the controller is configured to identify a leaking reduced-pressure dressing by sequentially turning off the valve for a particular reduced pressure port associated with a particular reduced pressure dressing, for a first time period and then reactivating the reduced-pressure source for the particular reduced pressure dressing by opening the valve while measuring a pressure build-up pattern of the particular reduced-pressure dressing, and comparing the build-up pattern to a standard build-up pattern, and if a variance exists beyond a set margin, activating an alert.

30. (canceled)

31. (canceled)

32. (canceled)

37. (canceled)

38. A system for treating a plurality of tissues sites, the system comprising:

a plurality of dressings, each dressing adapted to be placed adjacent a respective tissue site of the plurality of tissue sites;

a plurality of conduits, each conduit of the plurality of conduits fluidly coupled to a respective dressing of the plurality of dressings, wherein each conduit of the plurality of conduits has at least one supply lumen and at least one sampling lumen;

a multi-port therapy unit comprising;

a plurality of ports, wherein each of the ports is fluidly coupled to one of the conduits,

a fluid reservoir fluidly coupled to the plurality of ports,

a plurality of pressure sensors, wherein each pressure sensor is coupled to a sampling lumen of one of the conduits,

a controller operatively coupled to the pressure sensors to receive treatment data and to signal an alarm condition if the treatment data is outside of a preselected range,

an alarm indicator operatively coupled to the controller for indicating the alarm condition; and

a reduced-pressure source fluidly coupled to the plurality of conduits to supply reduced pressure to the plurality of conduits.

39. A method for treating a plurality of tissue sites, the method comprising:

deploying a plurality of reduced-pressure dressings proximate to the plurality of tissue sites;

fluidly coupling each of the reduced-pressure dressings to a fluid reservoir through a respective patient-side port of a multi-port therapy unit;

supplying reduced-pressure to the plurality of reduced-pressure dressings; and

monitoring each patient-side port with a respective pressure sensor to determine a pressure associated with each reduced-pressure dressing of the plurality of reduced-pressure dressings.

40. A multi-port therapy unit for treating a tissue site with reduced-pressure, the multi-port therapy unit comprising:

at least two side ports disposed on an exterior of the multi-port therapy unit and each side port configured to fluidly couple to a delivery conduit;

a fluid reservoir fluidly coupled to the side ports;

a controller;

at least two pressure sensors, operatively coupled to the controller and configured to generate a pressure signal corresponding to a respective side port; and

an indicator operatively coupled to the controller and configured to display a status of a respective side port; and

wherein the controller is configured to receive the pressure signal of a side port, determine the status of the side port in response to the pressure signal, and operate the indicator to display the status.

41. The multi-port therapy unit of claim 40, wherein the indicator is a user interface.

42. The multi-port therapy unit of claim 40, wherein the indicator is a plurality of light emitting diodes operable to provide a color indication of pressure in response to the status determined by the controller.

43. The multi-port therapy unit of claim 40, wherein the indicator is a plurality of indicators, each side port having a first indicator, a second indicator, and a third indicator, each indicator configured to display a status.

44. The multi-port therapy unit of claim 40, wherein the indicator is a plurality of indicators, each side port having a first indicator, a second indicator, and a third indicator, wherein:

the first indicator is configured to display a green light and is operated by the controller when the pressure at the respective side port is between about −

75 mm Hg and about −

150 mm Hg;

the second indicator is configured to display a yellow light and is operated by the controller if the controller determines that the pressure signal for the respective side port indicates that side port is losing reduced pressure; and

the third indicator is configured to display a red light and is operated by the controller to display a continuous red light when the pressure at the respective side port is not providing adequate therapy and is operated by the controller to display a flashing red light when the pressure at the respective side port is an over pressure.