IP Library Granted Patent US 9,895,480
Granted Patent B2
US 9,895,480 · App. 14/309,494 · Granted Feb 20, 2018

Dialysis system

Inventors: Julie S. Wrazel (Corvallis, OR); James R. Curtis (Portland, OR); Ladislaus Nonn (Portland, OR); Richard B. Peterson (Corvallis, OR); Hailei Wang (Corvallis, OR); Robbie Ingram-Goble (Portland, OR); Luke W. Fisher (Denver, CO); Anna E. Garrison (Philomath, OR); M. Kevin Drost (Corvallis, OR); Goran Jovanovic (Corvallis, OR); Richard Todd Miller (Corvallis, OR); Bruce W. Johnson (Corvallis, OR); Alana Anderson (Phoenix, AZ); Eric K. Anderson (Phoenix, AZ)
Assignees: Oregon State University; Outset Medical, Inc.
A61M1/1686A61M1/14A61M1/16A61M1/1656A61M1/1662A61M1/1666B01D63/085C02F1/02C02F1/44C02F9/005F24H1/121A61M2205/0244B01D2313/08C02F1/20C02F1/283C02F1/441C02F1/444C02F2103/026C02F2209/03C02F2209/05C02F2303/04F24H9/0021F28D7/12F28D2021/005F28F3/08F28F2260/02Y10T29/494
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Quick Facts
Patent No.
US 9,895,480
App. No.
14/309,494
Granted
Feb 20, 2018
Kind
B2
Abstract

A dialysis system includes a filtration system capable of filtering a water stream, a water purification system capable of purifying said water stream in a non-batch process, a mixing system capable of producing a stream of dialysate from mixing one or more dialysate components with the water stream in a non-batch process, and a dialyzer system. The dialyzer may be a microfluidic dialyzer capable of being fluidly coupled to the stream of dialysate and a blood stream.

Claims (40)

1. A dialysis system, comprising:

a water purification system comprising a microfluidic channel, flow field, or both, the water purification system capable of processing a household water stream in a non-batch process to produce a pasteurized water stream, the water purification system comprising a heat exchange system comprising

a fluid pathway having a water inlet and a water outlet, the fluid pathway further comprising

(a) a first region where water flows in a first direction at a first temperature;

(b) a heater region downstream of the first region, the water flowing into the heater region at the first temperature and the heater region comprising at least one heater that transfers heat into the water flowing through the heater region to increase the temperature to a second temperature greater than the first temperature;

(c) a second region downstream of the heater region where water flows in a second direction at a temperature greater than the first temperature, wherein water flowing in the second region thermally communicates with water flowing in the first region such that heat transfers from water flowing in the second region to water flowing in the first region resulting in a temperature reduction in the water as it flows through the second region, wherein water flows out of the fluid pathway through the water outlet at a temperature less than the second temperature;

a dialysate preparation system capable of mixing the pasteurized water stream with dialysate components to produce a dialysate stream; and

a dialyzer capable of being fluidly coupled to the dialysate stream and a blood stream, the dialyzer comprising a microfluidic channel, flow field, or both, and a membrane across which dialysis of the blood stream occurs by operating the dialysis system, the membrane interleaved between and separating the dialysate stream and the blood stream.

2. The system of claim 1 , wherein the dialyzer comprises a flow field.

3. The system of claim 2 , wherein the flow field comprises a plurality of structures having a form selected from pins, wall segments, bumps, protrusions or combinations thereof.

4. The system of claim 3 , wherein the flow-field comprises two opposed walls and the plurality of structures are positioned in groups in a general flow space between the two opposed walls such that each single group forms a segmented line parallel to the two opposed walls.

5. The system of claim 4 , wherein the structures are wall segments, and each wall segment is angled relative to a long axis of the opposed walls.

6. The system of claim 1 , wherein the water purification system comprises a microfluidic channel.

7. The system of claim 1 , further comprising:

a plurality of pumps capable of pumping the dialysate stream through the dialyzer; and

a controller operatively coupled to the plurality of pumps, the controller capable of controlling a flow rate of the dialysate stream through one or more of the plurality of pumps so as to perform one or both of the processes of ultrafiltration and hemodiafiltration on the blood stream while the blood stream is undergoing dialysis.

8. The system of claim 1 , further comprising:

a flow balancer system that regulates dialysate flow to and from the dialyzer, the flow balance system comprising

a first pump coupled to a fluid inlet pathway to the dialyzer and configured to pump dialysate through the fluid inlet pathway toward the dialyzer;

a second pump coupled to a fluid outlet pathway from the dialyzer and configured to pump the fluid through the fluid outlet pathway away from the dialyzer; and

a third pump coupled to the fluid outlet pathway, the third pump configured to work in cooperation with the second pump to achieve a desired flow rate of fluid to or from the dialyzer.

9. The system of claim 8 , wherein the outlet pathway bifurcates into a main outlet pathway and a secondary outlet pathway, and wherein the second pump is coupled to the main outlet pathway and the third pump is coupled to the secondary outlet pathway.

10. The system of claim 1 , wherein at least a portion of the fluid pathway is at least one microfluidic channel or at least one flow field.

11. The system of claim 1 , wherein the fluid pathway further comprises (d) a dwell chamber downstream of the heater region and upstream of the second region, wherein the water is within the dwell chamber at or above the second temperature for at least a predetermined amount of time relative to a fluid flow rate through the dwell chamber, prior to flowing into the second region.

12. The system of claim 11 , wherein the predetermined amount of time is calculated from a volume of the dwell chamber and the fluid flow rate.

13. The system of claim 11 , wherein the first region, heater region, dwell chamber and second region are contained within a single laminar body.

14. The system of claim 1 , wherein the second temperature is at least 138° Celsius.

15. The system of claim 1 , further comprising:

a pump upstream of the water inlet; and

a throttling valve downstream of the water outlet.

16. The system of claim 15 , wherein the pump and throttling valve are arranged in a closed loop control arrangement for maintaining water in the fluid pathway above a saturation pressure such that the water does not change state at any point while present in the system.

17. The system of claim 1 , wherein the system weighs less than five pounds when dry.

18. A method of making the system of claim 1 , comprising:

providing the water purification system, the dialysate preparation system and the dialyzer; and

assembling the water purification system, the dialysate preparation system and the dialyzer to make the dialysis system of claim 1 .

19. A method of using the dialysis system of claim 1 , comprising:

providing the dialysis system of claim 1 ;

flowing a household water stream to the dialysis system;

flowing a blood stream to the dialysis system; and

performing dialysis using the dialysis system.

Assignments (14)
SECURITY INTEREST Recorded Jan 15, 2025
From: OUTSET MEDICAL, INC.
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 069880/0739 →
RELEASE OF SECURITY INTEREST Recorded Jan 9, 2025
From: SLR INVESTMENT CORP., AS AGENT
To: OUTSET MEDICAL, INC.
Reel/Frame 069858/0267 →
RELEASE OF SECURITY INTEREST Recorded Jan 9, 2025
From: GEMINO HEALTHCARE FINANCE, LLC
To: OUTSET MEDICAL, INC.
Reel/Frame 069800/0767 →
SECURITY INTEREST Recorded Nov 4, 2022
From: OUTSET MEDICAL, INC.
To: GEMINO HEALTHCARE FINANCE, LLC
Reel/Frame 061654/0556 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Nov 3, 2022
From: OUTSET MEDICAL, INC.
To: SLR INVESTMENT CORP., AS AGENT
Reel/Frame 061879/0764 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 15, 2021
From: OREGON STATE UNIVERSITY
To: OUTSET MEDICAL, INC.
Reel/Frame 058112/0875 →
RELEASE OF SECURITY INTEREST Recorded Jul 3, 2020
From: PERCEPTIVE CREDIT HOLDINGS, LP, AS COLLATERAL AGENT
To: OUTSET MEDICAL, INC.
Reel/Frame 053115/0307 →
PATENT SECURITY AGREEMENT Recorded Jun 30, 2017
From: OUTSET MEDICAL, INC.
To: PERCEPTIVE CREDIT HOLDINGS, LP
Reel/Frame 043070/0791 →
RELEASE OF PATENT SECURITY INTEREST Recorded Jun 30, 2017
From: CRG SERVICING LLC
To: OUTSET MEDICAL, INC.
Reel/Frame 043070/0784 →
SHORT-FORM PATENT SECURITY AGREEMENT Recorded Jun 5, 2015
From: OUTSET MEDICAL, INC.
To: CRG PARTNERS III L.P.; CRG PARTNERS III - PARALLEL FUND "B" (CAYMAN) L.P.; CRG PARTNERS III (CAYMAN) L.P.
Reel/Frame 035837/0662 →
ENTITY CONVERSION Recorded Apr 27, 2015
From: STATE OF OREGON ACTING BY AND THROUGH THE STATE BOARD OF HIGHER EDUCATION ON BEHALF OF OREGON STATE UNIVERSITY
To: OREGON STATE UNIVERSITY
Reel/Frame 035507/0201 →
CHANGE OF NAME Recorded Apr 27, 2015
From: HOME DIALYSIS PLUS, LTD.
To: OUTSET MEDICAL, INC.
Reel/Frame 035507/0216 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2014
From: WRAZEL, JULIE; CURTIS, JAMES R.; NONN, LADISLAUS
To: HOME DIALYSIS PLUS, LTD.
Reel/Frame 033263/0691 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2014
From: PETERSON, RICHARD B.; WANG, HAILEI; INGRAM-GOBLE, ROBBIE; FISHER, LUKE W.; GARRISON, ANNA E.; DROST, M. KEVIN; JOVANOVIC, GORAN; MILLER, RICHARD TODD; JOHNSON, BRUCE; WARNER-TUHY, ALANA; ANDERSON, ERIC
To: STATE OF OREGON ACTING BY AND THROUGH THE STATE BOARD OF HIGHER EDUCATION ON BEHALF OF OREGON STATE UNIVERSITY
Reel/Frame 033263/0633 →
Continuity (2)
Continuation 12795444 · Jun 7, 2010
Related Publication 20140299545A1 · Oct 9, 2014