Implantable fluid management system for the removal of excess fluid

• US 20060036208A1
• Filed: 08/04/2005
• Published: 02/16/2006
• Est. Priority Date: 02/25/2002
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: Theranova, Llc
• Inventors: Burnett, Daniel R.
• Granted Patent: US 7,195,608 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 2039/248 Ball-valve
• CPC Class Codes: A61M 2205/103 rotating
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2205/8287 operated by an external magnetic or electromagnetic field
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/101 Pleural cavity
• CPC Class Codes: A61M 2210/1017 Peritoneal cavity
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 2210/106 Small intestine
• CPC Class Codes: A61M 2210/1064 Large intestine
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: A61M 2230/50 Temperature
• 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: A61M 27/006 : Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/24 : Check- or non-return valves
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Claims

1. An implantable fluid management system for draining fluid from a peritoneal cavity of a mammal to a bladder of the mammal comprising:

a first tube member having a first end, a second end, and a first length which defines a first lumen therethrough;

a second tube member having a first end, a second end, and a second length which defines a second lumen therethrough;

a pump fluidly coupled to the first tube member and the second tube member, wherein the pump can be actuated; and

a first pressure sensing element on the first tube, wherein the first pressure sensing element is configured to influence actuation of the pump,

2. The system of claim 1, further comprising a second pressure sensing element on the second tube, wherein the second pressure sensing element is configured to influence actuation of the pump.

3. The system of claim 2, wherein the first end of the first tube member comprises a tip, and wherein the first pressure sensing element is on the tip.

4. The system of claim 2, wherein the first end of the second tube member comprises a tip, and wherein the second pressure sensing element is on the tip.

5. A method of draining fluid from a peritoneal cavity of a mammal to a bladder of the mammal comprising:

implanting the system of claim 1 in the mammal, wherein the first end of the first tube is implanted in the peritoneal cavity, and wherein the first end of the second tube is implanted in the bladder.

6. An implantable fluid management system for draining fluid to a bladder of a mammal comprising:

a tube member having a first end, a second end, and a length which defines a lumen therethrough;

a pump fluidly coupled to the first tube member; and

an integrated mechanism in fluid communication with the tube, wherein the mechanism is configured to ensure uni-directional flow.

7. The system of claim 6, wherein the integrated mechanism is configured to prevent a reflux of fluids through the mechanism.

8. The system of claim 6, wherein the mechanism comprises a passive ball-valve mechanism.

9. The system of claim 6, wherein the mechanism allows for drainage of fluid whenever a certain minimum threshold pressure is achieved in the tube.

10. The system of claim 6, wherein the mechanism comprises an active valve.

11. The system of claim 10, wherein the active valve is configured to control drainage of fluid whenever the active valve is actuated.

12. An implantable fluid management system for draining fluid to a bladder of a mammal comprising:

a tube having a first end, a second end, and a length which defines a lumen therethrough; and

a pump fluidly coupled to the first tube member;

and wherein the tube is configured to anchor the second end of the tube to a wall of the bladder,

13. The system of claim 12, wherein the tube is anchored to the wall of the bladder in a fluid-tight seal.

14. The system of claim 12, wherein the tube comprises a shunt.

15. The system of claim 14, wherein the shunt comprises a flange.

16. The system of claim 14, wherein the shunt comprises a pigtail coil.

17. The system of claim 12, wherein the tube is coated with a hydrophilic material.

18. An implantable fluid management system, for managing fluid flow from a first location in a mammal to a second location in the mammal, comprising:

a first tube member having a first end, a second end, and a length which defines a lumen therethrough;

a pump fluidly coupled to the first tube member, wherein the pump can be actuated; and

a first chemical sensing element on the first tube, wherein the first chemical sensing element is configured to influence actuation of the pump.

19. The system of claim 18, further comprising:

a second tube member having a first end, a second end, and a second length which defines a second lumen therethrough; and

a second chemical sensing element on the second tube, wherein the second chemical sensing element is configured to influence actuation of the pump.

20. The system of claim 18, wherein the first end of the first tube member comprises a tip, and wherein the first chemical sensing element is on the tip.

21. The system of claim 18, wherein the first chemical sensing element is configured to detect pH of a fluid in the mammal.

22. The system of claim 18, wherein the first chemical sensing element is configured to detect the presence of a certain chemical.

23. The system of claim 18, wherein the first chemical sensing element is configured to provide positive and/or negative feedback to the control mechanism.

24. An implantable fluid management system for draining fluid to a bladder of a mammal comprising:

a first tube member,

a pump fluidly coupled to the first tube member, wherein the pump can be activated; and

an transdermal communicator attached to the system.

25. The system of claim 24, wherein the transdermal communicator is an inductive charging coil

26. The system of claim 25, wherein the inductive charging coil is configured to recharge the system.

27. An implantable fluid management system for draining fluid to a bladder of a mammal comprising:

a first tube member,

a pump fluidly coupled to the first tube member, wherein the pump can be activated; and

a power supply, wherein the power supply is carried by the system.

28. The system of claim 27, wherein the power supply comprises a battery.

29. A method of using a fluid management system in a patient comprising:

placing the pump within the patient, wherein placing the pump comprises placing in the peritoneal cavity,

activating the pump remotely.

30. The method of claim 29, further comprising setting the fluid management system so the pump operates independently.

31. The method of claim 30, wherein operating independently comprises operating based on pressure signals.

32. The method of claim 29, wherein the activating comprises activating based on pressure signals.

33. The method of claim 32, further comprising tethering the pump to an inductive charging coil.

34. A method of using a fluid management system in a patient comprising:

Placing the pump within the patient, wherein placing the pump comprises placing in subcutaneous space and

anchoring the pump to surrounding tissue with an anchoring device.

35. The method of claim 34, wherein the anchoring device comprises pins.

36. The method of claim 34, wherein the anchoring device comprises materials designed to promote fibrotic ingrowth.

37. The method of claim 34, wherein the anchoring device comprises screw threading defined on outside surfaces of the pump.

38. The method of claim 34, wherein the anchoring device comprises staples

39. The method of claim 34, wherein the anchoring device comprises sutures

40. The method of claim 34, wherein the anchoring device comprises adhesive compounds.

41. The method of claim 34, wherein the anchoring device comprises a porous solid configured to promote interstitial cell growth.

42. A method of implanting a fluid management system for draining fluid to a bladder of a mammal comprising:

implanting a pump fluidly coupled to the first tube member;

deploying a tube having a first end, a second end, and a length which defines a lumen therethrough; and

anchoring the fluid management system to surrounding tissue.

43. The method of claim 42, wherein anchoring comprises anchoring the tube to a wall of the bladder.

44. The method of claim 43, wherein anchoring comprises anchoring the second end of the tube to a wall of the bladder.

45. The method of implanting a fluid management system for draining fluid to a bladder of a mammal comprising:

tunneling a first tubing subcutaneously to the site of drainage;

channeling a second tubing subcutaneously to the bladder.

46. The method of claim 45, further comprising, guiding the first tubing with ultrasound assistance.

47. The method of claim 45, further comprising attaching the first tubing to the pump.

48. The method of claim 45, further comprising attaching the second tubing to the pump.