Implantable device and method for removing fluids from the blood of a patient method for implanting such a device and method for treating a patient experiencing renal failure

• US 5,902,336 A
• Filed: 10/15/1996
• Issued: 05/11/1999
• Est. Priority Date: 10/15/1996
• Status: Expired due to Fees

• Current Assignee: Mirimedical LLC
• Original Assignee: Mirimedical LLC
• Inventors: Mishkin, Gary J.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Nguyen, Tram A.
• Application Number:
  US08/732,852
• Time in Patent Office: 938 Days
• Field of Search: 623/11, 623/12, 604/4, 604/5, 604/6, 604/27, 604/28, 604/29, 604/274-278
• US Class Current: 623/11.11
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1611 Weight of the patient
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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

Abstract

An implantable ultrafiltration device for removing low to medium molecular weight solutes and fluids from the blood of a patient experiencing renal failure, the device including: a pump having an inlet and an outlet; a first component for forming a first fluid flow path between the patient'"'"'s vascular system and the pump inlet; a filter interposed in the first fluid flow path, the filter being permeable to water and substantially impermeable to blood cells and proteins; and a second component for forming a second fluid flow path between the pump outlet and the patient'"'"'s bladder, wherein the pump, the first and second components, and the filter are all constructed to be surgically implanted in the patient'"'"'s body. For removing unwanted fluids from the blood of a patient experiencing renal failure the first component is connected in the vascular system of the patient and the second component is implanted in the patient'"'"'s bladder or ureter; and the pump is then operated to cause fluid to flow through the filter at a controlled rate in order to maintain the volume of the blood in the vascular system and total body volume at a selected value. The infusion of peritoneal solution free of osmotic agents can also be carried out in conjunction with conventional hemodialysis or with operation of the implanted device.

Claims

1. An implantable ultriltration device for removing fluid from a patient experiencing renal failure, said device comprising:

regulator means having an inlet, an outlet and means for regulating the flow of fluid from the inlet to the outlet;

first means for forming a first fluid flow path between the patient'"'"'s vascular system and said regulator means inlet;

a filter interposed in the first fluid flow path, said filter being permeable to water and substantially impermeable to blood cells and protein; and

second means for forming a second fluid flow path between said regulator means outlet and the patient'"'"'s bladder, wherein said regulator means, said first means, said second means and said filter are all constructed to be surgically implanted in the patient'"'"'s body.

2. The device of claim 1 wherein said first means comprise a tubular graft permanently implantable to form a section of a vascular system.

3. The device of claim 2 wherein said filter is a hollow fiber membrane.

4. The device of claim 3 wherein said filter is permeable to low to medium molecular weight solutes, plasma and water.

5. The device of claim 1 further comprising means for controlling said regulator means in response to a measured parameter representative of the fluid content of the vascular system.

6. The device of claim 1 further comprising means for permitting fluid to flow through said second flow path in only one direction from said regulator means.

7. The device of claim 1 wherein said first means and said filter are constructed to produce a fluid flow through said filter at a finite rate not greater than 15 ml/min.

8. The device of claim 1 wherein said filter has a frustoconic form.

9. The device of claim 1 wherein the fluids to be removed contain low to medium molecular weight solutes.

10. The device defined in claim 1, said implanted by:

implanting the regulator means and the second means in the patient'"'"'s pelvic region;

inserting the first means into vasculature in the pelvic region with the filter disposed outside the vasculature; and

implanting an outlet end of said second means in a component of the patient'"'"'s urinary system.

11. The device according to claim 10 wherein the vasculature is an artery.

12. The device according to claim 10 wherein the vasculature is a vein.

13. The device according to claim 10 wherein the vasculature is an artery and vein.

14. The device according to claim 10 wherein the component is the ureter.

15. The device according to claim 10 wherein the component is the bladder.

16. The device according to claim 1 used for removing excess fluids from the blood of a patient experiencing renal failure by connecting the first means in the vascular system of the patient and implanting the second means in the patient'"'"'s bladder or ureter;

and

operating the regulator means to regulate the flow through the filter at a controlled rate in order to maintain the fluid volume in the patient'"'"'s body at a selected value.

17. The device according to claim 16, which is used together with periodically infusing a quantity of a peritoneal solution which is substantially free of osmotic agents into the peritoneal cavity of the patient, and allowing the solution to be absorbed into the patient'"'"'s circulatory system.

18. The device of claim 1 wherein said regulator means comprise a pump.

19. The device of claim 1 wherein said filter comprises a body of material which extends across the first fluid flow path and is permeable to water and substantially impermeable to blood cells and protein.

20. A method of treating a patient experiencing renal failure, comprising introducing a quantity of a peritoneal solution which is substantially free of osmotic agents directly into the peritoneal cavity of the patient, and allowing the solution to be absorbed into the patient'"'"'s blood and removing absorbed fluid by a means for filtration.