THERAPY DELIVERY SYSTEMS AND METHODS

• US 20100069829A1
• Filed: 05/15/2009
• Published: 03/18/2010
• Est. Priority Date: 09/18/2008
• Status: Active Grant

• Current Assignee: KCI Licensing Incorporated (3M Company)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Mormino, Richard Paul, Hutchinson, George
• Granted Patent: US 8,216,175 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• CPC Class Codes: A61F 13/0203 with fluid retention members
• 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 13/148 Abdomen bandages or bandaging garments
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing
• CPC Class Codes: A61M 2210/1021 Abdominal cavity
• 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
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Fluid removal systems and methods for removing fluid from a tissue site are presented. The system includes a semi-permeable inbound conduit, which is fluidly coupled to a treatment-fluid delivery unit, for placement proximate to a tissue site, and a semi-permeable outbound conduit, which is fluidly coupled to the inbound conduit and to a treatment-fluid collector, for placement proximate to the tissue site on the patient. The treatment-fluid collector receives the treatment fluid and a recruited fluid from the tissue site. A recruited-fluid determination unit may be coupled to the treatment-fluid collector to determine a volume of fluid recruited from the patient. The treatment fluid is any fluid (including a gas) that pulls fluid from the interstitial and intracellular space. A reduced-pressure treatment subsystem may also be included, among other things, for removing ascites and other fluids from a body cavity.

Claims

1. A fluid removal system for removing fluid from a tissue site, the system comprising:

a semi-permeable inbound conduit for placement proximate to the tissue site;

a treatment-fluid delivery unit fluidly coupled to the inbound conduit for delivering treatment fluid to the inbound conduit;

a semi-permeable outbound conduit for placement proximate to the tissue site wherein the outbound conduit is fluidly coupled to the inbound conduit; and

a treatment-fluid collector fluidly coupled to the outbound conduit for receiving the treatment fluid and a recruited fluid from the tissue site.

2. The system for removing fluid from a tissue site of claim 1, further comprising a recruited-fluid determination unit coupled to the treatment-fluid collector for determining a volume of recruited fluid.

3. The system for removing fluid from a tissue site of claim 1, further comprising a treatment fluid disposed within the inbound conduit and outbound conduit, wherein the treatment fluid is selected from the group consisting of a hypertonic saline solution, a CaC12 solution, a KCI solution, a NaCI solution, a Dextran solution and a dry gas.

4. The system for removing fluid from a tissue site of claim 1, further comprising:

a volume transducer for developing a signal indicative of the volume of treatment fluid and recruited fluid; and

a treatment controller, the treatment controller comprising;

a microprocessor,

a memory device associated with the microprocessor,

a input device associated with the microprocessor for receiving input signals,

the volume transducer coupled to the input device,

an output means associated with the microprocessor for delivering output signals, and

wherein the microprocessor and memory device are operable to receive an input signal from the volume transducer and to determine a recruited-fluid volume, and to develop a control signal to deliver to the output means whereby the treatment-fluid delivery unit may be controlled in response to the control signal.

5. The system for removing fluid from a tissue site of claim 4 wherein the microprocessor and memory device are further operable to develop a control signal to adjust a flow rate in the treatment-fluid delivery unit.

6. The system for removing fluid from a tissue site of claim 4 wherein the treatment-fluid delivery unit further comprises a heating element and wherein the system further comprises an inbound conduit temperature transducer coupled to the treatment controller and wherein the treatment controller is further operable to receive an input signal from the temperature transducer and to develop a control signal for delivery to the treatment-fluid delivery unit to adjust the heating element.

7. The system for removing fluid from a tissue site of claim 1, further comprising a conduit interface for coupling the inbound conduit and the outbound conduit, wherein the conduit interface comprises a plurality of tributary conduits.

8. The system for removing fluid from a tissue site of claim 7 wherein the tributary conduits are sized and provided in a quantity to provide a desired surface area.

9. The system for removing fluid from a tissue site of claim 1 wherein the inbound conduit comprises a first portion having a distal end and a proximal end, and a second portion having a distal end and a proximal end, wherein the distal end of the first portion of the inbound conduit and proximal end of the second portion of the inbound conduit are coupled by a first coupler.

10. The system for removing fluid from a tissue site of claim 9, wherein the outbound conduit comprises a first portion having a distal end and a proximal end, and a second portion having a distal end and a proximal end, wherein the distal end of the first portion of the outbound conduit and proximal end of the second portion of the outbound conduit are coupled by a second coupler.

11. The system for removing fluid from a tissue site of claim 1 further comprising an open-cavity, reduced-pressure subsystem for removing fluids from a body cavity of a patient.

12. The system for removing fluid from a tissue site of claim 11 wherein the open-cavity, reduced-pressure subsystem comprises:

a treatment device comprising;

a fenestrated non-adherent drape,

a plurality of encapsulated leg members coupled to the non-adherent drape, each having an interior portion with a leg manifold member and formed with fenestrations operable to allow fluid flow into the interior portion, and

a central connection member fluidly coupled to the plurality of encapsulated legs, the central connection member having a first side and a second, patient-facing side;

a manifold for disposing proximate the first side of the central connection member and operable to distribute reduced pressure to the central connection member;

a sealing member for disposing on a portion of the patient'"'"'s epidermis and operable to form a pneumatic seal over the body cavity;

a reduced-pressure delivery conduit; and

a reduced-pressure interface for coupling to the sealing member and operable to fluidly couple the reduced-pressure delivery conduit to the manifold.

13. The system for removing fluid from a tissue site of claim 12 wherein the central connection member has a connection manifold member and wherein each leg manifold member is in fluid communication with the connection manifold member.

14. The system for removing fluid from a tissue site of claim 12 wherein the outbound conduit and inbound conduit are coupled to at least one of the plurality of encapsulated leg members.

15. The system for removing fluid from a tissue site of claim 12, further comprising a treatment fluid disposed within the inbound conduit and outbound conduit, wherein the treatment fluid is selected from the group consisting of a hypertonic saline solution, a CaC12 solution, a KC1 solution, a NaCI solution, a Dextran solution and a dry gas.

16. The system for removing fluid from a tissue site of claim 12, further comprising a volume transducer for developing a signal indicative of the volume of treatment fluid and recruited fluid, and a treatment controller, the treatment controller comprising:

a microprocessor;

a memory device associated with the microprocessor;

a input device associated with the microprocessor for receiving input signals;

the volume transducer coupled to the input device;

an output device associated with the microprocessor for delivering output signals; and

wherein the microprocessor and memory device are operable to receive an input signal from the volume transducer and to determine a recruited-fluid volume, and to develop a control signal to deliver to the output device whereby the treatment-fluid delivery unit may be controlled in response to the control signal.

17. The system for removing fluid from a tissue site of claim 16 wherein the microprocessor and memory device are further operable to develop a control signal to adjust a flow rate in the treatment-fluid delivery unit.

18. The system for removing fluid from a tissue site of claim 17 wherein the treatment-fluid delivery unit further comprises a heating element and wherein the system further comprises an inbound conduit temperature transducer coupled to the treatment controller and wherein the treatment controller is further operable to receive an input signal from the temperature transducer and to develop a control signal for delivery to the treatment-fluid delivery unit to adjust the heating element.

19. The system for removing fluid from a tissue site of claim 12 wherein each encapsulated leg member of the plurality of encapsulated leg members comprises:

a fenestrated first leg encapsulating member;

a fenestrated second leg encapsulating member;

wherein the leg manifold member has a first side, a second side, a first lateral edge, and a second lateral edge;

wherein the first leg encapsulating member is disposed proximate the first side of the leg manifold member, the second leg encapsulating member is disposed proximate the second patient-facing side of the leg manifold member, and the first leg encapsulating member and second leg encapsulating member are coupled proximate the first lateral edge and second lateral edge of the leg manifold member to form the first encapsulated leg member.

20. A method of manufacturing a fluid removal system, the method comprising the steps of:

forming an inbound conduit from semi-permeable material, the inbound conduit for placement proximate to a tissue site on a patient;

providing a treatment-fluid delivery unit for delivering treatment fluid to the inbound conduit;

forming an outbound conduit from semi-permeable material, the outbound conduit for placement proximate to the tissue site on the patient; and

providing a treatment-fluid collector for receiving the treatment fluid and recruited fluids from the tissue site.

21. The method of manufacturing a fluid removal system of claim 20 further comprising the step of providing a recruited-fluid determination unit for determining a volume of recruited fluid.

22. A method for removing fluid from a tissue site, the method comprising the steps of:

placing asemi-permeable inbound conduit proximate to the tissue site;

fluidly coupling a treatment-fluid delivery unit to the inbound conduit, the treatment-fluid delivery unit operable to deliver treatment fluid to the inbound conduit;

placing a semi-permeable outbound conduit proximate to the tissue site, the outbound conduit formed from a semi-permeable material;

fluidly coupling the outbound conduit to the inbound conduit;

disposing a treatment fluid within the treatment-fluid delivery unit.

23. The method of claim 22 further comprising the step of fluidly coupling a treatment-fluid collector to the outbound conduit, the treatment-fluid collector for receiving the treatment fluid and a recruited fluid from the tissue site.

24. The method of claim 22 further comprising the step of coupling a recruited-fluid determination unit to the treatment-fluid collector, the recruited-fluid determination unit operable to determine a volume of fluid recruited from the patient.

25. The method of claim 22 wherein the treatment fluid is selected from the group consisting of a hypertonic saline solution, a CaC12 solution, a KCI solution, a NaCI solution, a Dextran solution and a dry gas.

26. The method of claim 22 further comprising the steps of:

introducing a treatment device into a body cavity proximate the tissue site, the treatment device comprising;

a fenestrated non-adherent drape,

a plurality of encapsulated leg members coupled to the non-adherent drape, each encapsulated leg member having an interior portion with a leg manifold member and formed with fenestrations operable to allow fluid flow into the interior portion, and

a central connection member coupled to the non-adherent drape and to the plurality of encapsulated legs, wherein the central connection member has a connection manifold member and wherein each leg manifold member is in fluid communication with the connection manifold member, the central connection member having a first side and a second, patient-facing side;

disposing a manifold proximate the first side of the central connection member, the manifold operable to distribute reduced pressure to the central connection member;

disposing a sealing member on a portion of the tissue site to form a pneumatic seal over the body cavity; and

fluidly coupling a reduced-pressure delivery conduit to the manifold.

27. The method of claim 22 further comprising the step of sizing the inbound conduits and outbound conduits to fit within the body cavity.

28. The method of claim 22 wherein the inbound conduit comprises a first portion having a distal end and a proximal end, and a second portion having a distal end and a proximal end, wherein the distal end of the first portion of the inbound conduit and the proximal end of the second portion of the inbound conduit are coupled by a first coupler, and further comprising the step of decoupling the first coupler and sealing the distal end of the first portion.

29. The method of claim 22 further comprising the steps of:

sizing the treatment device for use in the body cavity; and

decoupling the inbound conduit and outbound conduit to correspond with the treatment device after the dressing has been sized.

30. A method for removing fluid from a tissue site, the method comprising the steps of:

placing a semi-permeable conduit proximate to the tissue site;

disposing a treatment fluid within the treatment-fluid delivery unit; and

circulating the treatment fluid,

wherein the treatment fluid recruits fluid from the tissue site into the semi-permeable conduit.

31. The method of claim 30 further comprising the step of determining the volume of recruited fluid.

32. The method of claim 30 further comprising the step of selecting the treatment fluid from the group consisting of a hypertonic saline solution, a CaC12 solution, a KCI solution, a NaCI solution, a Dextran solution and a dry gas.