Implantable fluid management system for the removal of excess fluid

• US 7,195,608 B2
• Filed: 08/04/2005
• Issued: 03/27/2007
• 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:
  US11/198,079
• Publication Number:
  US 20060036208A1
• Time in Patent Office: 600 Days
• Field of Search: 604 7- 10, 604/891.1, 604/890.1, 604/93.01, 604/94.01, 604/96.01, 604245-247, 604/264, 604/540, 604/544, 604/19, 604/48, 604/30, 604/500, 604/507, 604/508, 604/514, 604/517, 604/131, 604/151, 604/541, 604/164.01, 604/164.11, 604/317, 604/323, 604/104, 623/3.1, 623/3.26, 623/3.28, 623/11.11, 623 2364- 2365, 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 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;

wherein the mechanism comprises a passive ball-valve mechanism.

2. The system of claim 1, wherein the mechanism comprises an active valve.

3. The system of claim 2, wherein the active valve is configured to control drainage of fluid whenever the active valve is actuated.

4. The system of claim 1, wherein the integrated mechanism is configured to prevent a reflux of fluids through the mechanism.

5. The system of claim 1, wherein the mechanism allows for drainage of fluid whenever a certain minimum threshold pressure is achieved in the tube.

6. 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;

wherein the tube is coated with a hydrophilic material.

7. The system of claim 6, wherein the tube is anchored to the wall of the bladder in a fluid-tight seal.

8. 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;

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

wherein the tube comprises a shunt;

wherein the tube comprises a shunt;

and wherein the shunt comprises a flange.

9. 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;

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

wherein the tube comprises a shunt;

wherein the tube comprises a shunt;

and wherein the shunt comprises a pigtail coil.

10. 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;

wherein the first chemical sensing element is configured to detect the presence of a certain chemical.

11. The system of claim 10, 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.

12. The system of claim 10, wherein the first end of the first tube member comprises a tip, and wherein the first chemical sensing element is on the tip.

13. The system of claim 10, wherein the first chemical sensing element is configured to provide positive and/or negative feedback to the control mechanism.

14. 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;

wherein the first chemical sensing element is configured to detect pH of a fluid in the mammal.

15. The system of claim 14, wherein the first end of the first tube member comprises a tip, and wherein the first chemical sensing element is on the tip.

16. The system of claim 14, wherein the first chemical sensing element is configured to provide positive and/or negative feedback to the control mechanism.

17. The system of claim 14, 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.

18. 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;

wherein the transdermal communicator comprises an inductive charging coil.

19. The system of claim 18, wherein the inductive charging coil is configured to recharge the system.

20. 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, wherein the activating comprises activating based on pressure signals; and

tethering the pump to an inductive charging coil.

21. The method of claim 20, further comprising setting the fluid management system so the pump operates independently.

22. The method of claim 21, wherein operating independently comprises operating based on pressure signals.

23. 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;

anchoring the pump to surrounding tissue with an anchoring device; and

wherein the anchoring device comprises a porous solid configured to promote interstitial cell growth.

24. The method of claim 23, wherein the anchoring device comprises pins.

25. The method of claim 23, wherein the anchoring device comprises materials designed to promote fibrotic ingrowth.

26. The method of claim 23, wherein the anchoring device comprises screw threading defined on outside surfaces of the pump.

27. The method of claim 23, wherein the anchoring device comprises staples.

28. The method of claim 23, wherein the anchoring device comprises sutures.

29. The method of claim 23, wherein the anchoring device comprises adhesive compounds.