IP Library Granted Patent US 9,545,469
Granted Patent B2
US 9,545,469 · App. 15/225,712 · Granted Jan 17, 2017

Dialysis system with ultrafiltration control

Inventors: James R. Curtis (Portland, OR); Ladislaus F. Nonn (Portland, OR); Julie Wrazel (Portland, OR)
Assignee: OUTSET MEDICAL, INC.
A61M1/1647A61M1/16A61M1/1601A61M1/165A61M1/34G05D7/0676A61M2205/3331A61M2205/3334A61M2205/70A61M2205/702
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Quick Facts
Patent No.
US 9,545,469
App. No.
15/225,712
Granted
Jan 17, 2017
Kind
B2
Abstract

Systems and methods are disclosed for performing hemodialysis that include fluid handling systems that provide accurate control over the type and level of hemodialysis being performed. The system includes a first pump for pumping dialysate into a dialyzer and a second pump for pumping dialysate out of the dialyzer. The system also includes a third pump that provides improved control of a level of ultrafiltration, hemodiafiltration, or both.

Claims (40)

1. A method of calibrating a dialysis system comprising a dialyzer, a dialysate inlet pump, an inlet fluid flow pathway extending from the dialysate inlet pump to the dialyzer, a dialysate outlet pump, an outlet fluid flow pathway extending from the dialyzer to the dialysate outlet pump, the dialysate outlet pump being the only pump positioned for pumping dialysate out of and away from the dialyzer through the outlet fluid flow pathway, a bypass fluid flow pathway extending from the inlet fluid flow pathway to the outlet fluid flow pathway and bypassing the dialyzer, the method comprising:

flowing fluid from the dialysate inlet pump through the bypass fluid flow pathway to the dialysis outlet pump;

comparing pressure of the fluid in the inlet fluid flow pathway to pressure of the fluid in the outlet fluid flow pathway;

based on a result of the comparing step, adjusting a pump rate of the dialysate inlet pump or the dialysate outlet pump to achieve a balanced flow rate through the inlet fluid flow pathway and the outlet fluid flow pathway; and

after the adjusting step, controlling the pump rate of the dialysate inlet pump or the dialysate outlet pump to pump fluid from the dialysate inlet pump through the inlet fluid flow pathway to the dialyzer at an inlet flow rate and through the outlet fluid flow pathway to the dialysate outlet pump from the dialyzer at an outlet flow rate different than the inlet flow rate.

2. The method of claim 1 wherein the adjusting step comprises adjusting the pump rate of the dialysate inlet pump or the dialysate outlet pump so that the pressure of the fluid in the inlet fluid flow pathway is equal to the pressure of the fluid in the outlet fluid flow pathway.

3. The method of claim 1 wherein the adjusting step comprises adjusting the pump rate such that pump rates of the dialysate inlet pump and the dialysate outlet pump are equal.

4. The method of claim 1 further comprising:

performing the step of flowing fluid from the dialysate inlet pump through the dialyzer to the dialysate outlet pump for 60 minutes;

after the performing step, flowing fluid from the dialysate inlet pump through the bypass fluid flow pathway to the dialysis outlet pump;

comparing pressure of the fluid in the inlet fluid flow pathway to pressure of the fluid in the outlet fluid flow pathway;

based on a result of the comparing step, adjusting the pump rate of the dialysate inlet pump or the dialysate outlet pump to achieve a balanced flow rate through the inlet fluid flow pathway and the outlet fluid flow pathway; and

after the adjusting step, controlling the pump rate of the dialysate inlet pump or the dialysate outlet pump to pump fluid from the dialysate inlet pump through the inlet fluid flow pathway to the dialyzer at an inlet flow rate and through the outlet fluid flow pathway to the dialysate outlet pump from the dialyzer at an outlet flow rate different than the inlet flow rate.

5. A method of calibrating a dialysis system comprising a dialyzer, a dialysate inlet pump, an inlet fluid flow pathway extending from the dialysate inlet pump to the dialyzer, a dialysate outlet pump, an outlet fluid flow pathway extending from the dialyzer to the dialysate outlet pump, the dialysate outlet pump being the only pump positioned for pumping dialysate out of and away from the dialyzer through the outlet fluid flow pathway, a bypass fluid flow pathway extending from the inlet fluid flow pathway to the outlet fluid flow pathway and bypassing the dialyzer, the method comprising:

flowing fluid from the dialysate inlet pump through the bypass fluid flow pathway to the dialysis outlet pump;

sensing pressure of the flowing fluid;

based on a result of the sensing step, adjusting a pump rate of the dialysate inlet pump or the dialysate outlet pump to achieve a balanced flow rate through the inlet fluid flow pathway and the outlet fluid flow pathway; and

after the adjusting step, controlling the pump rate of the dialysate inlet pump or the dialysate outlet pump to pump fluid from the dialysate inlet pump through the inlet fluid flow pathway to the dialyzer at an inlet flow rate and through the outlet fluid flow pathway to the dialysate outlet pump from the dialyzer at an outlet flow rate different than the inlet flow rate.

6. The method of claim 5 wherein the adjusting step comprises adjusting the pump rate of the dialysate inlet pump or the dialysate outlet pump so that the pressure of the fluid in the inlet fluid flow pathway is equal to the pressure of the fluid in the outlet fluid flow pathway.

7. The method of claim 5 wherein the adjusting step comprises adjusting the pump rate such that pump rates of the dialysate inlet pump and the dialysate outlet pump are equal.

8. The method of claim 5 further comprising:

performing the step of flowing fluid from the dialysate inlet pump through the dialyzer to the dialysate outlet pump for 60 minutes;

after the performing step, flowing fluid from the dialysate inlet pump through the bypass fluid flow pathway to the dialysis outlet pump;

sensing the pressure of the flowing fluid;

based on a result of the sensing step, adjusting the pump rate of the dialysate inlet pump or the dialysate outlet pump to achieve a balanced flow rate through the inlet fluid flow pathway and the outlet fluid flow pathway; and

after the adjusting step, controlling the pump rate of the dialysate inlet pump or the dialysate outlet pump to pump fluid from the dialysate inlet pump through the inlet fluid flow pathway to the dialyzer at an inlet flow rate and through the outlet fluid flow pathway to the dialysate outlet pump from the dialyzer at an outlet flow rate different than the inlet flow rate.

9. A method of calibrating a dialysis system comprising a dialyzer, a dialysate inlet pump, an inlet fluid flow pathway extending from the dialysate inlet pump to the dialyzer, a dialysate outlet pump, an outlet fluid flow pathway extending from the dialyzer to the dialysate outlet pump, a bypass fluid flow pathway extending from the inlet fluid flow pathway to the outlet fluid flow pathway and bypassing the dialyzer, and a drain, the system having no control bag between the dialyzer and the drain, the method comprising:

flowing fluid from the dialysate inlet pump through the bypass fluid flow pathway to the dialysis outlet pump;

sensing pressure of the flowing fluid;

based on a result of the sensing step, adjusting a pump rate of the dialysate inlet pump or the dialysate outlet pump to achieve a balanced flow rate through the inlet fluid flow pathway and the outlet fluid flow pathway; and

after the adjusting step, controlling the pump rate of the dialysate inlet pump or the dialysate outlet pump to pump fluid from the dialysate inlet pump through the inlet fluid flow pathway to the dialyzer at an inlet flow rate and through the outlet fluid flow pathway to the dialysate outlet pump from the dialyzer at an outlet flow rate different than the inlet flow rate.

10. The method of claim 9 wherein the adjusting step further comprises balancing a flow rate from the dialysate inlet pump with a flow rate of the dialysate outlet pump.

11. The method of claim 9 wherein the adjusting step comprises adjusting the pump rate of the dialysate inlet pump or the dialysate outlet pump so that the pressure of the fluid in the inlet fluid flow pathway is equal to the pressure of the fluid in the outlet fluid flow pathway.

12. The method of claim 9 wherein the adjusting step comprises adjusting the pump rate such that pump rates of the dialysate inlet pump and the dialysate outlet pump are equal.

13. The method of claim 9 further comprising:

performing the step of flowing fluid from the dialysate inlet pump through the dialyzer to the dialysate outlet pump for 60 minutes;

after the performing step, flowing fluid from the dialysate inlet pump through the bypass fluid flow pathway to the dialysis outlet pump;

comparing the pressure of the fluid in the inlet fluid flow pathway to the value of the characteristic of the fluid in the outlet fluid flow pathway;

based on a result of the comparing step, adjusting the pump rate of the dialysate inlet pump or the dialysate outlet pump to achieve a balanced flow rate through the inlet fluid flow pathway and the outlet fluid flow pathway; and

after the adjusting step, controlling the pump rate of the dialysate inlet pump or the dialysate outlet pump to pump fluid from the dialysate inlet pump through the inlet fluid flow pathway at an inlet flow rate to the dialyzer and through the outlet fluid flow pathway to the dialysate outlet pump from the dialyzer at an outlet flow rate different than the inlet flow rate.

Assignments (9)
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 →
CHANGE OF NAME Recorded Sep 28, 2016
From: HOME DIALYSIS PLUS, LTD.
To: OUTSET MEDICAL, INC.
Reel/Frame 039880/0186 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 28, 2016
From: CURTIS, JAMES R.; NONN, LADISLAUS F.; WRAZEL, JULIE
To: HOME DIALYSIS PLUS, LTD.
Reel/Frame 039880/0137 →
Continuity (4)
Continuation 14305952 · Jun 16, 2014
Continuation 12795498 · Jun 7, 2010
Provisional Application 61267043 · Dec 5, 2009
Related Publication 20160339162A1 · Nov 24, 2016