AUTONOMOUS FLUID INSTILLATION SYSTEM AND METHOD WITH TISSUE SITE PRESSURE MONITORING

• US 20150165182A1
• Filed: 12/05/2014
• Published: 06/18/2015
• Est. Priority Date: 12/18/2013
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Pratt, Benjamin Andrew, Locke, Christopher Brian
• Granted Patent: US 9,907,940 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 1/772 operating alternately
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 1/912 Connectors between dressing and drainage tube
• CPC Class Codes: A61M 1/92 with liquid supply means
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/962 having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2039/226 Spindles or actuating means
• 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 3/0202 with electronic control means or interfaces
• CPC Class Codes: A61M 3/022 Volume; Flow rate
• CPC Class Codes: A61M 3/0258 by means of electric pumps
• CPC Class Codes: A61M 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405

Abstract

A system and method for providing fluid to a tissue site is described. The method fluidly couples an instillation therapy system to the tissue site and monitors a pressure supplied to the tissue site by a reduced-pressure source with the instillation therapy system for a time period. The method provides fluid to the tissue site with the instillation therapy system in response to the pressure at the tissue site during the time period. The system includes a pressure sensor fluidly coupled to the tissue site to measure a pressure proximate the tissue site. A valve and a flow meter are fluidly between a fluid reservoir and the tissue site. A controller is communicatively coupled to the pressure sensor and the valve and configured to monitor the pressure at the tissue site and a volume of fluid flow to the tissue and, in response, operate the valve.

Claims

1. A method for providing fluid to a tissue site, the method comprising:

fluidly coupling an instillation therapy system to the tissue site;

monitoring a pressure supplied to the tissue site by a reduced-pressure source with the instillation therapy system for a time period; and

providing fluid to the tissue site with the instillation therapy system in response to the pressure at the tissue site during the time period.

2. The method of claim 1, wherein providing fluid to the tissue site comprises opening a valve fluidly coupled between the tissue site and a fluid reservoir.

3. The method of claim 2, further comprising operating a pump fluidly coupled between the valve and the fluid reservoir.

4. The method of claim 1, wherein providing fluid to the tissue site comprises operating a pump fluidly coupled between the tissue site and a fluid reservoir.

5. The method of claim 1, wherein monitoring a pressure at the tissue site for a time period comprises:

operating the reduced-pressure source fluidly coupled to the tissue site in an intermittent mode;

monitoring the pressure at the tissue site to determine a pressure profile; and

determining one or more operating parameters of a reduced-pressure treatment from the pressure profile.

6. The method of claim 5, wherein the one or more operating parameters comprise one or more of a maximum reduced pressure, a minimum reduced pressure, a trigger pressure, and an on period and an off period for the reduced-pressure source.

7. The method of claim 5, wherein providing fluid to the tissue site comprises opening a valve fluidly coupled between the tissue site and a fluid reservoir in response to the one or more operating parameters.

8. The method of claim 7, wherein opening the valve in response to the one or more operating parameters comprises opening the valve when the pressure at the tissue site reaches a trigger pressure.

9. The method of claim 7, wherein opening the valve in response to the one or more operating parameters comprises opening the valve during an off period of the reduced-pressure source.

10. The method of claim 7, wherein opening the valve in response to the one or more operating parameters comprises opening the valve during an on period of the reduced-pressure source.

11. The method of claim 1, further comprising:

monitoring a reduced-pressure ramp-down period while providing fluids; and

reporting that a fluid reservoir is empty in response to a deviation of the reduced-pressure ramp-down period from an expected reduced-pressure ramp-down period.

12. A method for providing fluid to a tissue site, the method comprising:

fluidly coupling an instillation therapy system to the tissue site;

operating a reduced-pressure treatment system fluidly coupled to the tissue site to provide reduced-pressure therapy in an intermittent mode;

monitoring a pressure at the tissue site;

determining a pressure profile of the reduced-pressure therapy at the tissue site; and

opening a valve fluidly coupled between the tissue site and a fluid reservoir in response to the pressure profile.

13. The method of claim 12, further comprising operating a pump fluidly coupled between the valve and the fluid reservoir.

14. The method of claim 12, further comprising determining one or more operating parameters of the reduced-pressure therapy from the pressure profile.

15. The method of claim 14, wherein the one or more operating parameters comprise one or more of a maximum reduced pressure, a minimum reduced pressure, a trigger pressure, and an on period and an off period for a reduced-pressure source of the reduced-pressure treatment system.

16. The method of claim 15, wherein opening a valve fluidly coupled between the tissue site and a fluid reservoir comprises opening the valve in response to the one or more operating parameters.

17. The method of claim 16, wherein opening the valve in response to the one or more operating parameters comprises opening the valve when the pressure at the tissue site reaches the trigger pressure.

18. The method of claim 16, wherein opening the valve in response to the one or more operating parameters comprises opening the valve during the off period of the reduced-pressure source.

19. The method of claim 16, wherein opening the valve in response to the one or more operating parameters comprises opening the valve during the on period of the reduced-pressure source.

20. The method of claim 12, further comprising:

determining an expected reduced-pressure ramp-down period from the pressure profile;

monitoring the reduced-pressure ramp-down period when the valve is open; and

reporting that a fluid reservoir is empty in response to a deviation of the reduced-pressure ramp-down period from the expected reduced-pressure ramp-down period.

21. A system for providing instillation therapy to a tissue site, the system comprising:

a fluid interface configured to be fluidly coupled to the tissue site;

a pressure sensor fluidly coupled to the fluid interface and configured to measure a pressure proximate the tissue site;

a valve fluidly coupled to the fluid interface and having an open position configured to permit fluid communication through the valve and a closed position configured to prevent fluid communication through the valve;

a flow meter configured to be fluidly coupled between the valve and the fluid interface;

a fluid reservoir fluidly coupled to the valve; and

a controller communicatively coupled to the pressure sensor and the valve, the controller configured to monitor the pressure measured by the pressure sensor and a volume of fluid flow through the flow meter and, in response, operate the valve.

22. The system of claim 21, wherein the controller is configured to operate the valve in response to one or more of a maximum reduced pressure, a minimum reduced pressure, a trigger pressure, an on-state and an off-state of a reduced-pressure therapy system, and a duration of fluid delivery and an interval of fluid delivery.

23. The system of claim 21, wherein the controller is configured to determine a pressure profile in response to the pressure measured by the pressure sensor.

24. The system of claim 23, wherein the controller is configured to determine one or more operating parameters in response to the pressure profile.

25. The system of claim 24, wherein the one or more operating parameters comprise one or more of a maximum reduced pressure, a minimum reduced pressure, a trigger pressure, and an on-state and an off-state of a reduced-pressure therapy system.

26. The system of claim 21, further comprising a user interface operationally coupled to the controller and configured to present one or more operating parameters of the system.

27. The system of claim 26, wherein the one or more operating parameters comprise one more of a maximum reduced pressure, a minimum reduced pressure, a trigger pressure, and an on-state and an off-state of a reduced-pressure therapy system.

28. The system of claim 26, wherein the user interface is further configured to receive operational input and communicate the operational input to the controller.

29. The system of claim 28, wherein the operational input may comprise one or more of a maximum reduced pressure, a minimum reduced pressure, a trigger pressure, a duration of fluid delivery, and an interval of fluid delivery.

30. The system of claim 21, further comprising a pump fluidly coupled between the fluid reservoir and the valve, the pump being operationally coupled to the controller.

31. The system of claim 21, further comprising a disposable connector fluidly coupled between the pressure sensor and the fluid interface.

32. The system of claim 21, further comprising at least one sensor fluidly coupled to a tube fluidly coupling the valve to the fluid interface and further operationally coupled to the controller, the at least one sensor configured to detect blockages in the tube.

33. A method for providing fluid to a tissue site, comprising:

fluidly coupling an instillation therapy system to the tissue site;

operating the instillation therapy system in a training mode;

determining a pressure profile of a reduced pressure source fluidly coupled to the tissue site in response to the training mode; and

delivering fluid in response to the pressure profile.

34. The method of claim 33, wherein the training mode comprises:

measuring and storing a reduced pressure at the tissue site at a first time;

measuring and storing a reduced pressure at the tissue site at a second time; and

comparing the reduced pressure at the first time to the reduced pressure at the second time.

35. The method of claim 34, further comprising:

storing the reduced pressure at the second time as a minimum reduced-pressure if the reduced pressure at the first time is greater than the reduced pressure at the second time; and

storing the reduced pressure at the second time as a maximum reduced-pressure if the reduced pressure at the first time is less than the reduced pressure at the second time.

36. The method of claim 35, further comprising:

repeating the steps of measuring and storing a reduced pressure at the tissue site at a first time, measuring and storing a reduced pressure at the tissue site at a second time, and comparing the reduced pressure at the first time to the reduced-pressure at the second time until the reduced pressure at the first time is substantially the same as the reduced pressure at the second time, and in response, determining that the pressure profile is in at least one of a reduced-pressure therapy period or a soak period;

measuring and storing a reduced pressure at the tissue site at a third time in response to determining that the pressure profile is in at least one of a reduced-pressure therapy period or a soak period;

comparing the reduced pressure at the third time to the maximum reduced-pressure;

determining that the pressure profile is in a reduced-pressure therapy period if the reduced pressure at the third time is substantially the same as the maximum reduced-pressure;

comparing the reduced pressure at the third time to the minimum reduced-pressure if the reduced pressure at the third time is less than the maximum reduced-pressure; and

determining that the pressure profile is in a soak period if the reduced pressure at the third time is substantially the same as the minimum reduced-pressure.

37. The method of claim 34, further comprising:

measuring and storing a reduced pressure at the tissue site at a third time;

comparing the reduced pressure at the third time to the maximum reduced-pressure;

determining that the pressure profile is in a reduced-pressure ramp-up time and storing the reduced pressure at the third time as the maximum reduced-pressure if the reduced pressure at the third time is greater than the maximum reduced-pressure;

determining that the pressure profile is in a reduced-pressure ramp-down period if the reduced pressure at the third time is less than the maximum reduced-pressure;

comparing the reduced pressure at the third time to the minimum reduced-pressure; and

storing the reduced pressure at the third time as the minimum reduced-pressure if the reduced pressure at the third time is less than the minimum reduced-pressure.

38. A method for delivering fluid to a tissue site, the method comprising:

coupling an instillation therapy system to the tissue site;

monitoring a pressure at the tissue site;

delivering fluids to the tissue site if the pressure at the tissue site is about a trigger pressure and continuing to monitor the pressure at the tissue site if the pressure at the tissue site is not about the trigger pressure;

monitoring a fluid flow to the tissue site in response to delivering fluids to the tissue site;

determining if the fluid flow is about a dosage of fluids;

stopping fluid delivery if the fluid flow is about the dosage of fluids;

determining if a reduced-pressure source fluidly coupled to the tissue site is about to start an on period if the fluid flow is not about the dosage of fluids;

continuing to deliver fluids if the reduced-pressure source is not about to start the on period;

stopping fluid delivery if the reduced-pressure source is about to enter the on period; and

incrementing the trigger pressure if the reduced-pressure source is about to start the on period.

39. The systems, apparatuses, and methods substantially as described herein.