Priming system and method of dialysis systems

• US 9,968,725 B2
• Filed: 02/16/2016
• Issued: 05/15/2018
• Est. Priority Date: 11/29/2007
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Fulkerson, Barry Neil, Hering, Martin, Isackson, Frank
• Primary Examiner(s): Menon, Krishnan S
• Application Number:
  US15/044,194
• Publication Number:
  US 20170021085A1
• Time in Patent Office: 819 Days
• Field of Search: None
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3647 with recirculation of the priming solution
• CPC Class Codes: A61M 1/3649 using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3652 using gas, e.g. air
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3372 Temperature compensation
• CPC Class Codes: Y10T 137/0491 : Valve or valve element assembling, disassembling, or replacing

Abstract

The application is directed to an extracorporeal blood processing system capable of using dialysate to prime the system. A plastic molded compact manifold supports molded blood and dialysate fluidic pathways along with relevant sensors, valves and pumps. The compact manifold is also disposable in one embodiment and can be detachably installed in the dialysis machine. A two-way valve in the manifold is used to direct the dialysate flow through the blood circuit to prime the circuit for use in treatment.

Claims

1. A dialysis system comprising:

a housing comprising a panel;

a dialyzer;

a dialysate source;

a return line to a patient;

a rigid plastic manifold configured to be positioned on the panel, wherein the manifold defines a first flow path and a second flow path, wherein the first flow path defines a portion of a fluid pathway between the dialysate source and the dialyzer, and wherein the second flow path defines a portion of a fluid pathway between the dialysate source and the return line to a patient;

a first valve positioned in the manifold at an intersection of the first flow path and the second flow path, wherein, in a first state of the first valve, the first flow path is active and directs dialysate from the dialysate source to the dialyzer and wherein, in a second state of the first valve, the second flow path is active and directs dialysate from the dialysate source to the return line; and

an elastomeric material positioned in the manifold and over the first valve, wherein the elastomeric material is configured to cause the first valve to switch between the first state and the second state based upon an amount of pressure applied to the elastomeric material.

2. The dialysis system of claim 1 further comprising a second valve positioned in the second flow path between the first valve and a distal end of the return line.

3. The dialysis system of claim 2 wherein the second valve is closed when the first valve is in the first state and wherein the second valve is open when the first valve is in the second state.

4. The dialysis system of claim 1 wherein, when the dialysis system is in a hemodialysis mode of operation, the first valve is in the first state.

5. The dialysis system of claim 1 wherein, when the dialysis system is in a hemofiltration mode of operation, the first valve is in the second state.

6. The dialysis system of claim 1 further comprising a valve interface physically attached to the housing, wherein the valve interface is configured to apply the pressure to, or remove the pressure from, the elastomeric material to cause the first valve to switch between the first state and the second state.

7. The dialysis system of claim 1 wherein the second valve is a single state valve configured to either allow or stop fluid flow in the second flow path.

8. A dialysis system comprising:

a housing comprising a panel;

a dialyzer;

a first dialysate source;

a second dialysate source;

a return line to a patient;

a rigid plastic manifold configured to be positioned on the panel, wherein the manifold defines a first flow path and a second flow path, wherein the first flow path defines a portion of a fluid pathway between the first dialysate source and the dialyzer, and wherein the second flow path defines a portion of a fluid pathway between the second dialysate source and the return line to a patient;

a first valve positioned in the manifold at an intersection of the first flow path and the second flow path, wherein, in a first state of the first valve, the first flow path is active and directs dialysate to the dialyzer from the first dialysate source and wherein, in a second state of the first valve, the second flow path is active and directs dialysate from the second dialysate source to the return line; and

an elastomeric material positioned in the manifold and over the first valve, wherein the elastomeric material is configured to cause the first valve to switch between the first state and the second state based upon an amount of pressure applied to the elastomeric material.

9. The dialysis system of claim 8 further comprising a second valve positioned in the second flow path between the first valve and a distal end of the return line.

10. The dialysis system of claim 9 wherein the second valve is closed when the first valve is in the first state and wherein the second valve is open when the first valve is in the second state.

11. The dialysis system of claim 8 wherein, when the dialysis system is in a hemodialysis mode of operation, the first valve is in the first state and wherein, when the dialysis system is in a hemofiltration mode of operation, the first valve is in the second state.

12. The dialysis system of claim 8 further comprising a valve interface physically attached to the housing, wherein the valve interface is configured to apply the pressure to, or remove the pressure from, the elastomeric material to cause the first valve to switch between the first state and the second state.

13. The dialysis system of claim 8 wherein the second valve is a single state valve configured to either allow or stop fluid flow in the second flow path.

14. The dialysis system of claim 8 wherein the first dialysate source comprises a reservoir containing dialysate that is not sterile.

15. The dialysis system of claim 8 wherein the second dialysate source comprises a reservoir containing infusion grade dialysate.

16. A method for operating a dialysis system in a first mode or a second mode, wherein the dialysis system comprises a housing with a panel, a dialyzer, a first dialysate source, a second dialysate source, a return line to a patient, a rigid plastic manifold configured to be positioned on the panel, wherein the manifold defines a first flow path and a second flow path, wherein the first flow path defines a portion of a fluid pathway between the first dialysate source and the dialyzer, and wherein the second flow path defines a portion of a fluid pathway between the second dialysate source and the return line to a patient, and a first valve positioned in the manifold at an intersection of the first flow path and the second flow path, wherein, in a first state of the first valve, the first flow path is active and directs dialysate to the dialyzer from the first dialysate source and wherein, in a second state of the first valve, the second flow path is active and directs dialysate from the second dialysate source to the return line, the method comprising:

placing the dialysis system in the first mode;

in response to placing the dialysis system in the first mode, modifying an amount of pressure being applied to a diaphragm positioned in the manifold and over the first valve, wherein the diaphragm is configured to cause the first valve to switch between the first state and the second state based upon an amount of pressure applied to the diaphragm;

in response to placing the dialysis system in the first mode, directing dialysate from the first dialysate source to the dialyzer;

placing the dialysis system in the second mode;

in response to placing the dialysis system in the second mode, modifying the amount of pressure being applied to the diaphragm; and

in response to placing the dialysis system in the second mode, directing dialysate from the second dialysate source to the return line.

17. The method of claim 16 further comprising activating a valve interface to modify the amount of pressure being applied to the diaphragm, wherein the valve interface is physically attached to the housing and configured to apply the pressure to, or remove the pressure from, the diaphragm to cause the first valve to switch between the first state and the second state.

18. The method of claim 16 wherein the first dialysate source comprises a reservoir containing dialysate that is not sterile and wherein the second dialysate source comprises a reservoir containing infusion grade dialysate.

19. The method of claim 16 further comprising a second valve positioned in the second flow path between the first valve and a distal end of the return line.

20. The method of claim 16 wherein the second valve is closed when the first valve is in the first state and wherein the second valve is open when the first valve is in the second state.