IP Library Granted Patent US 11,305,040
Granted Patent B2
US 11,305,040 · App. 14/821,362 · Granted Apr 19, 2022

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.
A61M1/1621A61M1/166A61M1/1658A61M1/1672A61M1/3643A61M1/3644A61M1/3647A61M1/3649A61M2205/121A61M2205/123A61M2205/14A61M2205/18B01D19/0063Y10T29/49782Y10T29/49897Y10T137/0424
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Quick Facts
Patent No.
US 11,305,040
App. No.
14/821,362
Granted
Apr 19, 2022
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 (33)

1. A method of controlling a fluid level in a venous drip chamber of a dialysis system, the dialysis system having a blood pump and an air pump, the method comprising the steps of:

operating the blood pump in a first operating mode to flow saline in a first direction from a saline source, into a patient tubing set, into a venous drip chamber through a first port disposed at a bottom portion of the venous drip chamber, out of the venous drip chamber through a second port disposed at the bottom portion of the venous drip chamber, and into a dialyzer;

monitoring a saline fluid level in the venous drip chamber with at least one sensor;

operating the blood pump in a second operating mode to move blood in a second direction opposite to the first direction through a continuous pathway of the dialysis system, comprising moving blood with the blood pump from a patient into the patient tubing set via an arterial access point, moving blood with the blood pump through the dialyzer, moving blood with the blood pump into the venous drip chamber through the second port, moving blood with the blood pump out of the venous drip chamber through the first port, and moving blood out of the patient tubing set and back into the patient via a venous access point;

monitoring a blood fluid level in the venous drip chamber with the at least one sensor;

raising the blood fluid level in the venous drip chamber by automatically pumping air out of the venous drip chamber with the air pump if the fluid level is below a level detected by the at least one sensor; and

lowering the blood fluid level by automatically pumping air into the venous drip chamber with the air pump if the blood fluid level is above a level detected by the at least one sensor.

2. The method of claim 1 wherein the at least one sensor comprises at least one ultrasonic sensor.

3. The method of claim 1 wherein the at least one sensor comprises at least one optical sensor.

4. The method of claim 1 wherein the at least one sensor comprises at least one capacitive sensor.

5. The method of claim 1 , wherein the arterial access point comprises an arterial needle and the venous access point comprises a venous needle.

6. The method of claim 1 , wherein the arterial access point comprises an arterial catheter and the venous access point comprises a venous catheter.

7. A method of controlling a fluid level in a venous drip chamber of a dialysis system, the dialysis system having a blood pump and an air pump, the method comprising the steps of:

operating the blood pump in a first operating mode to flow saline in a first direction from a saline source, into a patient tubing set, into a venous drip chamber through a first port disposed at a bottom portion of the venous drip chamber, out of the venous drip chamber through a second port disposed at the bottom portion of the venous drip chamber, and into a dialyzer;

monitoring a saline fluid level in the venous drip chamber with at least one sensor;

operating the blood pump in a second operating mode to move blood with the blood pump in a second direction opposite to the first direction through a continuous pathway of the dialysis system, comprising moving blood with the blood pump from a patient into the patient tubing set via an arterial access point, moving blood with the blood pump through the dialyzer, moving blood with the blood pump into the venous drip chamber through the second port, moving blood with the blood pump out of the venous drip chamber through the first port, and moving blood out of the patient tubing set and back into the patient via a venous access point;

monitoring a blood fluid level in the venous drip chamber with the at least one sensor; and

automatically maintaining the blood fluid level in the venous drip chamber by pumping air out of the venous drip chamber with the air pump if the at least one sensor detects the blood fluid level dropping below a lower threshold and pumping air into the venous drip chamber with the air pump if the at least one sensor detects the blood fluid level rising above an upper threshold.

8. The method of claim 7 wherein the at least one sensor comprises at least one ultrasonic sensor.

9. The method of claim 7 wherein the at least one sensor comprises at least one optical sensor.

10. The method of claim 7 wherein the at least one sensor comprises at least one capacitive sensor.

11. The method of claim 7 wherein pumping air out of the venous drip chamber raises the blood fluid level in the venous drip chamber above the lower threshold.

12. The method of claim 7 wherein pumping air into the venous drip chamber lowers the blood fluid level in the venous drip chamber below the upper threshold.

13. The method of claim 7 , wherein the arterial access point comprises an arterial needle and the venous access point comprises a venous needle.

14. The method of claim 7 , wherein the arterial access point comprises an arterial catheter and the venous access point comprises a venous catheter.

15. A method of controlling a fluid level in a venous drip chamber of a dialysis system, the dialysis system having a blood pump and an air pump, the method comprising the steps of:

operating the blood pump in a first operating mode to flow saline in a first direction from a saline source, into a patient tubing set, into a venous drip chamber through a first port disposed at a bottom portion of the venous drip chamber, out of the venous drip chamber through a second port disposed at the bottom portion of the venous drip chamber, and into a dialyzer;

operating the blood pump in a second operating mode to move blood with the blood pump in a second direction opposite to the first direction through a continuous pathway of the dialysis system, comprising moving blood with the blood pump from a patient into the patient tubing set via an arterial access point, moving blood with the blood pump through the dialyzer, moving blood with the blood pump into the venous drip chamber through the second port, moving blood with the blood pump out of the venous drip chamber through the first port, and moving blood out of the patient tubing set and back into the patient via a venous access point;

monitoring a blood fluid level in the venous drip chamber with at least one sensor;

automatically pumping air out of the venous drip chamber with the air pump to raise the blood fluid level if the monitored fluid level is below a level detected by the at least one sensor; and

automatically pumping air into the venous drip chamber with the air pump to lower the blood fluid level if the monitored fluid level is above a level detected by the at least one sensor.

16. The method of claim 15 , wherein the arterial access point comprises an arterial needle and the venous access point comprises a venous needle.

17. The method of claim 15 , wherein the arterial access point comprises an arterial catheter and the venous access point comprises a venous catheter.

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 037577/0047 →
Continuity (4)
Continuation 14699875 · Apr 29, 2015
Provisional Application 61985779 · Apr 29, 2014
Provisional Application 62127155 · Mar 2, 2015
Related Publication 20150343133A1 · Dec 3, 2015
Cited By (1)
US 12,465,671