Device for removing fluid from blood in a patient

• US 8,241,239 B2
• Filed: 02/23/2009
• Issued: 08/14/2012
• Est. Priority Date: 08/24/2006
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Solomon, Barry A., Erman, Gregory S., Fazio, Frank A.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US12/380,185
• Publication Number:
  US 20090234266A1
• Time in Patent Office: 1,268 Days
• Field of Search: 604 401- 616, 604 27- 29, 604274-278, 623/11, 623/12
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/1627 Dialyser of the inside perfusion type, i.e. blood flow inside hollow membrane fibres or tubes
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• 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 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2209/088 on the body
• CPC Class Codes: B01D 2313/10 Specific supply elements
• CPC Class Codes: B01D 2313/12 Specific discharge elements
• CPC Class Codes: B01D 2313/21 Specific headers, end caps
• CPC Class Codes: B01D 61/145 Ultrafiltration
• CPC Class Codes: B01D 63/026 Wafer type modules or flat-surface type modules
• CPC Class Codes: B01D 65/08 Prevention of membrane fouling or of concentration polarisation

Abstract

An ultrafiltration device and method for the removal of excess fluid in hypervolemic patients and/or removal of toxins in the blood including for patients suffering from either renal or cardiovascular disease is disclosed. An embodiment of the device includes a housing containing multiple large bore hollow fiber membranes which are connected to the patient'"'"'s vascular system via a connecting element comprising bifurcated fluid pathway elements to physiologically channel the blood flow either to or from each hollow fiber membrane of the device, a channel to direct the fluid removed by the device to a suitable collection container or the patient'"'"'s bladder, and controls that control excessive removal of the water from the patient. Devices can be either worn extracorporeally or surgically implanted in order to allow for continuous fluid removal with ambulatory freedom.

Claims

1. An implantable apparatus for removing fluid from a patient, comprising:

a) a first elongated header defining a first flow path having a single inlet and multiple outlets, the first header comprising a plurality of diverging bifurcated flow paths extending therethrough for uniformly distributing fluid flow from the single inlet to the multiple outlets;

b) a second elongated header defining a second flow path having multiple inlets and a single outlet;

c) a filter in fluid communication with and substantially coplanar with said first elongated header and said second elongated header to facilitate implantation, said filter including a plurality of hollow fiber membranes, each of the plurality of hollow fiber membranes being aligned with each of the multiple outlets on a one-to-one basis, and each of the plurality of hollow fiber membranes being aligned with each of the multiple inlets on a one-to-one basis;

d) a first graft for connecting the vascular system of the patient to the single inlet;

e) a second graft for connecting the single outlet to the vascular system of the patient;

f) a housing adapted to collect fluid that passes through the filter; and

g) a drain conduit connected to the housing.

2. The apparatus of claim 1, wherein said second header comprises a plurality of converging bifurcated flow paths extending therethrough for uniformly distributing fluid flow from the multiple inlets to the single outlet.

3. The apparatus of claim 2, wherein uniformly distributing fluid flow from the multiple inlets to the single outlet comprises one or more flow restricting neck regions located near one or more of the multiple inlets.

4. The apparatus of claim 2, wherein uniformly distributing fluid flow from the multiple inlets to the single outlet comprises the second flow path progressively converging from the multiple inlets to the single outlet.

5. The apparatus of claim 1, wherein uniformly distributing fluid flow from the single inlet to the multiple outlets comprises one or more flow restricting neck regions located near one or more of the multiple outlets.

6. The apparatus of claim 1, wherein said first header and said second header are substantially the same size and shape.

7. The apparatus of claim 1, wherein the drain conduit is adapted to be in fluid communication with the bladder of the patient.

8. The apparatus of claim 1, wherein said filter has a total membrane surface area of about 600 square centimeters (cm²) or less.

9. The apparatus of claim 1, wherein said hollow fibers are between about 1 and about 7 millimeters (mm) in diameter.

10. The apparatus of claim 1, wherein the number of hollow fiber membranes is between about 12 and about 60 hollow fibers.

11. The apparatus of claim 1, further comprising a means for controlling the amount of fluid removed by the apparatus.

12. The apparatus of claim 11, wherein said means for controlling the amount of fluid removed comprises a valve controlled by a sensor monitoring a physiological parameter of the patient.

13. The apparatus of claim 12, wherein the physiological parameter is selected from the group consisting of blood pressure, weight, lung capacity, blood pressure, blood oncotic pressure, blood osmolality, blood constituent level, blood gas levels, and combinations thereof.

14. The apparatus of claim 1, further comprising a valve adapted to restrict fluid flow through the drain conduit.

15. The apparatus of claim 14, wherein the valve is a manual valve.

16. The apparatus of claim 1, wherein the filter is substantially permeable to water and substantially impermeable to blood cells and proteins.