Dialysis system with ultrafiltration control

• US 9,545,469 B2
• Filed: 08/01/2016
• Issued: 01/17/2017
• Est. Priority Date: 12/05/2009
• Status: Active Grant

• Current Assignee: Outset Medical, Inc.
• Original Assignee: Outset Medical, Inc.
• Inventors: Curtis, James R., Nonn, Ladislaus F., Wrazel, Julie
• Primary Examiner(s): Kim, John
• Application Number:
  US15/225,712
• Publication Number:
  US 20160339162A1
• Time in Patent Office: 169 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/1647 with flow rate measurement of the dialysis fluid, upstream and downstream of the dialyser
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3427 back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: G05D 7/0676 by action on flow sources G05D7/0688, G05D7/0694 take precedence

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

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.