Priming System and Method for Dialysis Systems

• US 20100116740A1
• Filed: 10/07/2009
• Published: 05/13/2010
• Est. Priority Date: 11/29/2007
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Xcorporeal, Inc.
• Inventors: Isackson, Frank, Hering, Martin, Fulkerson, Barry Neil
• Granted Patent: US 8,137,553 B2
• Time in Patent Office: Days
• US Class Current: 210/646
• 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 treatment system capable of operating in a priming mode and a treatment mode, comprising:

a. a housing defining a cavity, said cavity capable of receiving a manifold wherein said manifold comprises;

i. a plastic substrate comprising a first layer and a second layer;

ii. a first flow path defined by a first surface of the first layer and a first surface of the second layer;

iii. a second flow path defined by a first surface of the first layer and a first surface of the second layer; and

iv. a valve in fluid communication with both said first flow path and said second flow path wherein said valve has first state and a second state and wherein, when in said first state, the first flow path and second flow path are in fluid isolation and when in said second state, the first flow path and second flow path are in fluid communication; and

b. a valve interface physically attached to said housing, wherein said valve interface is configured to transmit a signal to said valve to cause said valve to switch between said first state and said second state.

2. The dialysis treatment system of claim 1 wherein said manifold further comprises a first pump outlet, wherein said first pump outlet receives blood being pumped by a first pump, and a second pump outlet, wherein said second pump outlet receives dialysate being pumped by a second pump.

3. The dialysis treatment system of claim 2 wherein said valve is located adjacent said first pump outlet and said second pump outlet.

4. The dialysis treatment system of claim 3 wherein, when the valve is in said first state, the first pump outlet and second pump outlet are in fluid isolation from each other.

5. The dialysis treatment system of claim 3 wherein, when the valve is in said second state, the first pump outlet and second pump outlet are in fluid communication with each other.

6. The dialysis treatment system of claim 1 further comprising a controller, wherein said controller generates the signal to cause said valve to switch between said first state and said second state.

7. The dialysis treatment system of claim 6 wherein said controller generates a signal to cause said valve to switch from said first state to said second state in response to a command for the dialysis treatment system to operate in priming mode.

8. The dialysis treatment system of claim 6 wherein said controller generates a signal to cause said valve to switch from said second state to said first state in response to a command for the dialysis treatment system to operate in treatment mode.

9. The dialysis treatment system of claim 1 further comprising a dialysate reservoir.

10. The dialysis treatment system of claim 9 wherein priming of said manifold is effectuated using dialysate from said dialysate reservoir and not from a separate source of priming fluid.

11. A manifold capable of operating in a priming mode and a treatment mode, comprising:

a. plastic substrate comprising a first layer and a second layer;

b. a first flow circuit defined by a first surface of the first layer and a first surface of the second layer;

c. a second flow circuit defined by a first surface of the first layer and a first surface of the second layer;

d. a valve in fluid communication with both said first flow circuit and said second flow circuit wherein said valve has first state and a second state and wherein, when in said first state, fluid from said first flow circuit and cannot enter into said second flow circuit and when in said second state, fluid from said first flow circuit can enter into said second flow circuit; and

e. an interface to receive a signal from a signal source to cause said valve to switch between said first state and said second state.

12. The manifold of claim 11 wherein said manifold further comprises a first pump outlet, wherein said first pump outlet receives blood being pumped by a first pump, and a second pump outlet, wherein said second pump outlet receives dialysate being pumped by a second pump.

13. The manifold of claim 12 wherein said valve is located adjacent said first pump outlet and said second pump outlet.

14. The manifold of claim 13 wherein, when the valve is in said first state, the first pump outlet and second pump outlet are in fluid isolation from each other.

15. The manifold of claim 13 wherein, when the valve is in said second state, the first pump outlet and second pump outlet are in fluid communication with each other.

16. The manifold of claim 11 wherein said interface causes said valve to switch from said first state to said second state in response to a signal to operate in priming mode.

17. The manifold of claim 11 wherein said interface causes said valve to switch from said first state to said second state in response to a signal to operate in treatment mode.

18. A priming process for priming a manifold within a dialysis machine for use in a dialysis treatment, comprising the steps of:

a. Inserting said manifold into the dialysis machine, wherein said manifold comprises a blood circuit and a dialysate circuit, each defined by a substrate, and a valve in fluid communication with each of said blood circuit and dialysate circuit, wherein said valve has first state and a second state and wherein, when in said first state, fluid from the dialysate circuit cannot enter into the blood circuit and when in said second state, fluid from the dialysate circuit can enter into the blood circuit;

b. Placing said valve in said second state;

c. Pumping dialysate through said blood circuit;

d. Placing said valve in said first state; and

e. Removing dialysate from said blood circuit.

19. The priming process of claim 18 wherein said dialysate is pumped from a dialysate reservoir and not from a separate source of priming fluid.

20. The priming process of claim 18 wherein said valve is placed in said first state or second state by communicating a signal from a controller located within the dialysis machine.