IP Library Granted Patent US 8,496,606
Granted Patent B2
US 8,496,606 · App. 12/866,017 · Granted Jul 30, 2013

Fluid separation devices, systems and methods

Inventors: Edward F. Leonard (Bronxville, NY); Ilan K. Reich (New York, NY); Stanley Cortell (New York, NY)
Assignee: The Trustees of Columbia University in the City of New York
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Quick Facts
Patent No.
US 8,496,606
App. No.
12/866,017
Granted
Jul 30, 2013
Kind
B2
Abstract

A membraneless separation device can be applied to a variety of treatments, such as the ultrafiltration of blood for a patient with end stage renal disease. An ultrafiltration device can include a membraneless separation device, which separates an incoming blood flow into a substantially cytoplasmic body-free plasma flow and remaining fraction, and a dialysate-free second stage, which selectively removes excess fluid, toxins and other substances from the plasma flow and returns the processed plasma to the membraneless separation device. A treatment protocol can include ultrafiltering blood of a patient using the ultrafiltration device and performing a secondary treatment on the blood of the patient at a reduced frequency compared to the ultrafiltering. The membraneless separation device can also be applied to treatment, analysis, and/or exchange of plasma from blood, or combined with conventional dialyzers to perform dialysis on a cytoplasmic body-free plasma fraction.

Claims (25)

1. A method for treating chronic renal disease of a patient comprising:

(a) for a duration of at least 4 hours, performing an ultrafiltration process by using a portable treatment device having a membraneless microfluidic channel, said performing including:

(a1) passing blood at a flow rate into the membraneless microfluidic channel having dimensions such that, at the blood flow rate, a fraction depleted of cytoplasmic bodies from the blood is generated;

(a2) removing a portion of the fraction depleted of cytoplasmic bodies from the membraneless microfluidic channel;

(a3) extracting at least water from the removed portion of the fraction depleted of cytoplasmic bodies using a first membrane; and

(a4) returning the removed portion of the fraction depleted of cytoplasmic bodies, minus some water, back to the patient;

an ultrafiltration rate of the ultrafiltration process resulting in a rate of production of ultrafiltrate of less than 0.4 l/hr;

(b) repeating the performing an ultrafiltration process at least daily, the ultrafiltration process requiring no continuous consumption of exogenous fluid; and

(c) at a frequency that is less than daily, using another treatment device to perform a renal replacement therapy in which blood components are exchanged between blood and a sorbent or between blood and a substantial supply of exogenous fluid across a second membrane, the blood contacting the second membrane or the sorbent of the another treatment device;

the repeating either being done on days in which the performing a renal replacement therapy is done or being skipped on the days in which the performing a renal replacement therapy is done.

2. The method of claim 1 , wherein the removing a portion of the fraction depleted of cytoplasmic bodies includes blocking the exit of cytoplasmic bodies from the membraneless microfluidic channel by passing the fraction depleted of cytoplasmic bodies through a wall filter having an array of holes whose sizes are less than 1000 nm, the wall filter forming a part of a wall of the membraneless microfluidic channel.

3. The method of claim 1 , wherein the removing a portion of the fraction depleted of cytoplasmic bodies includes blocking the exit of cytoplasmic bodies from the membraneless microfluidic channel by passing the fraction depleted of cytoplasmic bodies through a wall filter having an array of holes whose sizes are between 600 and 1000 nm, the wall filter forming a part of a wall of the membraneless microfluidic channel and forming a continuous unobstructed and smooth surface with the wall of the membraneless microfluidic channel.

4. The method of claim 1 , wherein the blood flow rate is at least 0.5 ml/second and less than 5 ml/sec.

5. The method of claim 1 , wherein the ultrafiltration process includes positioning the portable device, including the membraneless microfluidic channel, proximate the patient such that blood volume outside the patient's body is minimized by minimizing a volume of blood channels.

6. The method of claim 1 , wherein the renal replacement therapy includes at least one of hemofiltration, hemodialysis, and hemodiafiltration.

7. The method of claim 1 , wherein the renal replacement therapy includes sorption-based dialysis.

8. The method of claim 1 , wherein the renal replacement therapy includes dialysis in which blood and a supply of dialysate of at least 10 L are passed across opposite sides of a membrane at least to clear uremic toxins from the blood.

9. The method of claim 1 , wherein the ultrafiltration process includes passing the fraction depleted of cytoplasmic bodies across a sorbent configured to remove at least urea therefrom.

10. The method of claim 1 , further comprising, prior to the performing an ultrafiltration process, priming the membraneless microfluidic channel and wetting the first membrane of the portable treatment device.

11. The method of claim 1 , wherein:

the portable treatment device comprises a detector that monitors the blood flow or the removed portion of the fraction depleted of cytoplasmic bodies; and

said performing an ultrafiltration process is performed responsively to a signal from said detector.

12. The method of claim 1 , further comprising, periodically reversing flow through the wall filter in the membraneless microfluidic channel so as to flush a surface of the wall filter.

13. The method of claim 1 , wherein the portable treatment device comprises a waste receptacle that receives the at least water extracted from the removed portion of the fraction depleted of cytoplasmic bodies.

14. The method of claim 1 , wherein the portable treatment device is configured to perform a treatment without use of exogenous fluids, and the another treatment device is a non-portable device configured to perform a treatment using exogenous fluids.

Assignments (3)
CONFIRMATORY LICENSE Recorded Feb 6, 2015
From: COLUMBIA UNIV NEW YORK MORNINGSIDE
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 034915/0350 →
CONFIRMATORY LICENSE Recorded Mar 28, 2011
From: COLUMBIA UNIV NEW YORK MORNINGSIDE
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 026028/0183 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2010
From: LEONARD, EDWARD F.; REICH, ILAN K.; CORTELL, STANLEY
To: THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK
Reel/Frame 025124/0153 →
Continuity (3)
Provisional Application 61006866 · Feb 4, 2008
Provisional Application 61073951 · Jun 19, 2008
Related Publication 20110105982A1 · May 5, 2011