Implantable fluid management system for the removal of excess fluid

• US 7,311,690 B2
• Filed: 11/03/2003
• Issued: 12/25/2007
• Est. Priority Date: 02/25/2002
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: NovaShunt AG (Sequana Medical NV)
• Inventors: Burnett, Daniel R.
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/700,863
• Publication Number:
  US 20040147871A1
• Time in Patent Office: 1,513 Days
• Field of Search: 604 7- 10, 604/890.1, 604/891.1, 604/93.01, 604/94.01, 604/96.01, 604/104, 604/264, 604245-247, 604/540, 604/544, 623/3.1, 623/3.26, 623/11.11, 623/3.28, 623/23.64, 623/23.65, 623/66.1, 128/898
• 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, comprising:

a first tube member having a first end, a second end, and a length which defines a lumen therethrough and having at least one opening at the first end or along the length;

a second 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 the second tube member for urging fluid through each tube member;

a shunt connected to the second end of the second tube member, wherein the shunt is adapted to anchor the second end of the second tube member to a wall of a hollow body organ in a fluid-tight seal; and

wherein the shunt comprises an anti-bacterial covering or coating selected from the group consisting of bacteriostatic materials, bacteriocidal materials, antibiotic dispensers, antibiotic eluting materials, entrained radioisotopes, heating elements, bioactive plastics, epithelialization-promoting materials, bacterial adhesion-inhibiting materials, and combinations thereof.

2. The device of claim 1 wherein the first tube member and the second tube member are detachably coupled to the pump.

3. The device of claim 1 wherein the first tube member defines a plurality of openings along the length of the first tube member for passing fluid therethrough.

4. The device of claim 1 wherein the at least one opening comprises a screen positioned over the opening.

5. The device of claim 1 wherein the first and the second tube members each comprise flexible tube members.

6. The device of claim 1 further comprising at least one valve positioned within the first tube member.

7. The device of claim 6 wherein the valve is adapted to permit uni-directional fluid flow therethrough.

8. The device of claim 6 wherein the valve is adapted to open when a threshold pressure is attained or surpassed by the fluid.

9. The device of claim 6 wherein the valve is adapted to actuate upon receiving a signal from a remotely located controller.

10. The device of claim 1 wherein the pump comprises an electromechanical or magnetically coupled pump.

11. The device of claim 10 further comprising a driver for actuating the pump, the driver comprising at least one drive magnet rotatably positioned within a housing which defines a receiving channel adapted to circumferentially surround a corresponding magnet within the pump.

12. The device of claim 10 wherein the pump is adapted to urge the fluid when exposed to a magnetic field which corresponds to the pump.

13. The device of claim 10 wherein the pump comprises a type selected from the group consisting of peristaltic pumps, gear pumps, turbine pumps, impeller pumps, radial-flow pumps, centrifugal pumps, and piston pumps.

14. The device of claim 10 wherein the pump comprises at least two counter-rotating or counter-oscillating elements adapted to balance a net torquing force generated by the pump.

15. The device of claim 1 wherein the pump is adapted to be implanted within a subcutaneous space or musculature of a user.

16. The device of claim 1 wherein the pump is adapted to urge the fluid uni-directionally through the tube members.

17. The device of claim 1 wherein the pump is adapted to be remotely activated.

18. The device of claim 1 wherein the pump further comprises at least one sensor.

19. The device of claim 18 wherein the sensor is adapted to detect a magnetic engagement between the pump and a remotely located driver.

20. The device of claim 18 wherein the sensor is adapted to detect fluid flow rate and/or fluid pressure.

21. The device of claim 18 wherein the sensor further comprises a transmitter for transmitting sensed information to a remotely located receiver.

22. The device of claim 18 wherein the sensor is adapted to detect a fluid pressure from within the hollow body organ.

23. The device of claim 1 wherein the pump is adapted to actuate when a threshold pressure is attained or surpassed by the fluid.

24. The device of claim 1 wherein the pump is adapted to actuate upon receiving a signal from a remotely located controller.

25. The device of claim 1 wherein the pump is adapted to be secured within a patient.

26. The device of claim 25 wherein the pump is anchored within the patient via at least one fastener selected from the group consisting of barbs, screws, staples, sutures, adhesives, pins, tissue growth promoting materials, and combinations thereof.

27. The device of claim 1 wherein the pump is adapted to prevent clogging within the pump via an ultrasonic transducer.

28. The device of claim 1 wherein the shunt is anchored to the wall of the hollow body organ via a mechanical fastener selected from the group consisting of flanges, screw threads, staples, sutures, adhesives, barbs, interstitial cell growth-promoting materials, and combinations thereof.

29. The device of claim 1 wherein the shunt is adapted for uni-directional flow therethrough into the hollow body organ.

30. The device of claim 29 wherein the shunt comprises a valve which is biased to close the shunt and open when the fluid surpasses a threshold pressure.

31. The device of claim 29 wherein the valve is a ball valve.

32. The device of claim 29 wherein the valve is actuatable via a remotely located controller.

33. The device of claim 1 further comprising a filter adapted to retain particulate matter within the fluid while permitting fluid flow therethrough.

34. The device of claim 33 wherein the filter comprises a semi-permeable membrane.

35. The device of claim 1 wherein the hollow body organ comprises a urinary bladder.

36. The device of claim 1 wherein the hollow body organ comprises a vein or artery.

37. The device of claim 1 wherein the hollow body organ comprises a stomach.

38. An implantable fluid management system, comprising:

a first tube member having a first end, a second end, and a length which defines a lumen therethrough and having at least one opening at the first end or along the length;

a second 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 the second tube member for urging fluid through each tube member;

a biocompatible housing encasing the pump;

an anti-bacterial covering or coating selected from the group consisting of bacteriostatic materials, bacteriocidal materials, antibiotic dispensers, antibiotic eluting materials, entrained radioisotopes, heating elements, bioactive plastics, epithelialization-promoting materials, bacterial adhesion-inhibiting materials, and combinations thereof; and

a shunt connected to the second end of the second tube member, wherein the shunt is adapted to anchor the second end of the second tube member to a wall of a hollow body organ in a fluid-tight seal.

39. The device of claim 38 further comprising a covering or coating adapted to promote fibrotic in-growth over the housing.

40. A method of removing excess fluid from within a body space, comprising:

drawing the excess fluid through at least one opening defined in a first tube member which is positioned within the body space;

urging the fluid through the first tube member with an implanted electromechanical or magnetically coupled pump;

passing the fluid through a second tube member in fluid communication with a urinary bladder; and

positioning the first tube member within a pleural cavity prior to drawing the excess fluid.

41. The method of claim 40 further comprising remotely actuating the pump via a corresponding driver prior to drawing the excess fluid.

42. The method of claim 41 wherein actuating the pump comprises exposing the pump to a magnetic field from the corresponding driver.

43. The method of claim 42 further comprising detecting whether magnetic engagement has occurred between the pump and the driver.

44. The method of claim 40 wherein urging the fluid further comprises metering the fluid via a valve.

45. The method of claim 44 wherein metering the fluid comprises metering the fluid via a passive valve.

46. The method of claim 44 wherein metering the fluid comprises metering the fluid via an actively controlled valve.

47. The method of claim 40 wherein drawing the excess fluid comprises creating a negative pressure within the first tube member with the pump.

48. The method of claim 40 wherein drawing the excess fluid comprises drawing the fluid through a plurality of openings defined in the first tube member.

49. The method of claim 40 further comprising positioning the first tube member within a peritoneal cavity prior to drawing the excess fluid.

50. The method of claim 40 further comprising positioning the first tube member within a cerebrospinal region prior to drawing the excess fluid.

51. The method of claim 40 wherein drawing the excess fluid further comprises filtering the fluid.

52. The method of claim 40 wherein urging the fluid comprises uni-directionally forcing the fluid through the first tube member.

53. The method of claim 40 further comprising detecting a fluid flow rate and/or fluid pressure while urging the fluid.

54. The method of claim 40 further comprising transmitting sensed information from the fluid to a remotely located receiver while urging the fluid.

55. The method of claim 40 further comprising sensing whether a threshold pressure has been attained or surpassed by the fluid prior to drawing the excess fluid.

56. The method of claim 40 further comprising implanting the pump within a subcutaneous space or musculature of a user prior to drawing the excess fluid.

57. The method of claim 40 further comprising anchoring the second tube member to a wall of the urinary bladder via a shunt.

58. The method of claim 57 further comprising remotely controlling a valve to actuate within the shunt.

59. The method of claim 57 further comprising sensing a fluid pressure within the urinary bladder via the shunt.

60. The method of claim 57 further comprising filtering the fluid via the shunt.