IP Library Granted Patent US 9,402,945
Granted Patent B2
US 9,402,945 · App. 14/821,325 · Granted Aug 2, 2016

Dialysis system and methods

Inventors: Michael Edward Hogard (Sunnyvale, CA); Gopi Lingam (San Jose, CA); Dean Hu (San Leandro, CA); Balaji M. Maniam (Fremont, CA); James Ritson (San Jose, CA); Andy H. Uchida (Los Altos, CA); John David Stienmier (Arvada, CO); Paul David McGregor (Golden, CO)
Assignee: OUTSET MEDICAL, INC.
A61M1/3643A61M1/1621A61M1/3647A61M1/3649A61M1/1656A61M1/1686A61M1/3646A61M2205/123A61M2205/18A61M2205/3673A61M2230/30Y10T29/49782Y10T29/49897Y10T137/0424
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Quick Facts
Patent No.
US 9,402,945
App. No.
14/821,325
Granted
Aug 2, 2016
Kind
B2
Abstract

Dialysis systems and methods are described which can include a number of features. The dialysis systems described can be to provide dialysis therapy to a patient in the comfort of their own home. The dialysis system can be configured to prepare purified water from a tap water source in real-time that is used for creating a dialysate solution. The dialysis systems described also include features that make it easy for a patient to self-administer therapy. For example, the dialysis systems include disposable cartridge and patient tubing sets that are easily installed on the dialysis system and automatically align the tubing set, sensors, venous drip chamber, and other features with the corresponding components on the dialysis system. Methods of use are also provided, including automated priming sequences, blood return sequences, and dynamic balancing methods for controlling a rate of fluid transfer during different types of dialysis, including hemodialysis, ultrafiltration, and hemodiafiltration.

Claims (20)

1. A method of priming a tubing set and a dialyzer of a dialysis system, comprising the steps of:

operating a blood pump of the dialysis system in a reverse operating mode to flow saline in a reverse direction from a saline source, into the tubing set, into a venous drip chamber, and out of the venous drip chamber, before flowing saline into a blood-side of the dialyzer, to remove air from the tubing set and the blood-side of the dialyzer; and

operating the blood pump in a forward operating mode to flow saline in a forward direction opposite to the reverse direction, into the blood-side of the dialyzer, and out of the blood-side of the dialyzer, before flowing saline into the venous drip chamber.

2. The method of claim 1 , wherein operating the blood pump in the forward operating mode flows at least a portion of the saline out of the tubing set.

3. The method of claim 2 , wherein the saline is delivered to a patient.

4. The method of claim 1 , further comprising:

monitoring a fluid level of the saline in a venous drip chamber of the tubing set; and

stopping operation of the blood pump in the reverse operating mode when the fluid level in the venous drip chamber stabilizes.

5. The method of claim 1 , further comprising:

monitoring the tubing set for the presence of air; and

stopping operation of the blood pump in the reverse operating mode when air no longer circulates through the tubing set.

6. The method of claim 1 , further comprising operating a dialysate pump to flow dialysate from a dialysate source into a dialysate-side of the dialyzer in the reverse direction to remove air from the dialysate-side of the dialyzer.

7. The method of claim 6 , wherein air is removed from the dialysate-side of the dialyzer without physically manipulating an orientation of the dialyzer.

8. The method of claim 6 , wherein air is removed from the dialysate-side of the dialyzer without physically adjusting an orientation of the dialyzer.

9. The method of claim 1 further comprising opening one or more valves of the dialysis system with an electronic controller to allow the saline to flow from the saline source into the tubing set.

10. The method of claim 9 , further comprising periodically actuating the one or more valves to open and close the tubing set to create a pulsing effect that removes air bubbles from the dialyzer.

11. The method of claim 1 wherein the operating steps further comprise operating the blood pump with an electronic controller of the dialysis system.

12. The method of claim 1 wherein the saline flows out of the tubing set through a union joint that attaches a venous line of the tubing set to an arterial line of the tubing set.

13. The method of claim 12 , wherein a predetermined volume of saline flows through the union joint before the dialysis therapy can begin.

14. The method of claim 1 , wherein saline flows into the venous drip chamber and out of the venous drip chamber in both the forward and reverse operating modes through connections located at a bottom of the venous drip chamber.

Assignments (8)
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: GEMINO HEALTHCARE FINANCE, LLC
To: OUTSET MEDICAL, INC.
Reel/Frame 069800/0767 →
RELEASE OF SECURITY INTEREST Recorded Jan 9, 2025
From: SLR INVESTMENT CORP., AS AGENT
To: OUTSET MEDICAL, INC.
Reel/Frame 069858/0267 →
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 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 25, 2016
From: HOGARD, MICHAEL EDWARD; LINGAM, GOPI; HU, DEAN; MANIAM, BALAJI M.; RITSON, JAMES; UCHIDA, ANDY H.; STIENMIER, JOHN DAVID; MCGREGOR, PAUL DAVID
To: OUTSET MEDICAL, INC.
Reel/Frame 037576/0987 →
Continuity (4)
Continuation 14699875 · Apr 29, 2015
Provisional Application 61985779 · Apr 29, 2014
Provisional Application 62127155 · Mar 2, 2015
Related Publication 20150343135A1 · Dec 3, 2015