Priming system and method for dialysis systems

• US 9,295,772 B2
• Filed: 02/13/2012
• Issued: 03/29/2016
• 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:
  US13/372,202
• Publication Number:
  US 20120204968A1
• Time in Patent Office: 1,506 Days
• Field of Search: None
• US Class Current: 1/1
• 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 priming process for priming a first circuit and a second circuit used in a dialysis machine, said first and second circuits having a manifold and a dialyzer external to said manifold, said priming process comprising:

inserting said manifold into the dialysis machine, wherein said manifold comprises a plurality of molded components which are configured to connect together to form a single operative structure comprising a portion of the first circuit, a portion of the second circuit and a compressible valve structure in fluid communication with each of said first and second circuits, wherein said valve structure is one of said plurality of molded components and has a first state and a second state, wherein, when in said first state, fluid from the first circuit cannot enter into the second circuit within said manifold and is separated from a second fluid within said second circuit by a semi-permeable membrane within said dialyzer and when in said second state, said first fluid from the first circuit can enter into the second circuit within said manifold and said dialyzer;

placing said valve in said second state by removing pressure from said compressible valve structure;

pumping said first fluid through said first and second circuits within said manifold and dialyzer;

placing said valve in said first state by applying pressure to said compressible valve structure; and

removing said first fluid from said second circuit, wherein a venous line and an arterial line of the manifold are connected to a patient when said valve is in said first state and wherein said venous line is not connected to said patient and said arterial line is connected to said patient when said valve is placed in said second state.

2. The priming process of claim 1 wherein the first circuit is a dialysate circuit and wherein the second circuit is a blood circuit.

3. The priming process of claim 2 wherein the fluid is dialysate and wherein, in said second state, the dialysate flows through the dialysate circuit and into the blood circuit.

4. The priming process of claim 3 wherein the dialysate is removed from the blood circuit upon completion of the priming process.

5. The priming process of claim 3 wherein the dialysate is pumped from a dialysate reservoir and not from a separate source of priming fluid.

6. The priming process of claim 1 wherein said valve is placed in said first state or second state by a controller, located within the dialysis machine, actuating a valve interface physically attached to said dialysis machine.

7. The priming process of claim 6 wherein said valve interface is configured to apply pressure to, or remove pressure from, said compressible valve structure upon actuation by said controller.

20. The priming process of claim 1 wherein said compressible valve structure is a diaphragm.

8. A priming process for priming a plurality of circuits in a dialysis machine, said dialysis machine having a manifold and a dialyzer external to said manifold, the priming process comprising the steps of:

receiving said manifold into a cavity located in said dialysis machine, wherein said manifold comprises a plurality of molded components which are configured to connect together to form a single operative structure comprising a dialysate circuit, a blood circuit and a compressible valve structure in fluid communication with each of said dialysate and blood circuits, wherein said valve structure is one of said plurality of molded components and has a treatment state and a priming state, wherein, when in said treatment state, dialysate from the dialysate circuit cannot enter into the blood circuit within said manifold and is separate from blood within said dialysate circuit by a semi-permeable membrane within said dialyzer and, when in said priming state, fluid from the dialysate circuit can enter into the blood circuit within said manifold and said dialyzer;

having said valve in said priming state by not applying pressure to said compressible valve structure;

pumping dialysate through said dialysate and blood circuits within said manifold and said dialyzer;

placing said valve in said treatment state by applying pressure to said compressible valve structure; and

removing dialysate from said blood circuit, wherein a venous line and an arterial line of the manifold are connected to a patient when said valve is in said treatment state and, when said valve is placed in the priming state, said venous line is in fluid communication with a waste container and the arterial line is not connected to the patient.

9. The priming process of claim 8 wherein the dialysate is pumped from a dialysate reservoir and not from a separate source of priming fluid.

10. The priming process of claim 8 wherein said valve is placed in said treatment or priming state by a controller, located within the dialysis machine, that is configured to actuate a valve interface within said dialysis machine.

11. The priming process of claim 10 wherein said valve interface is configured to apply pressure to, or remove pressure from, said compressible valve structure upon actuation by said controller.

12. A priming process for use in a dialysis treatment system, wherein said dialysis treatment system comprises a housing defining a cavity, said cavity capable of receiving a manifold, wherein the manifold comprises a plurality of plastic molded components which are configured to connect together to form a single operative structure comprising a first layer and a second layer, a first flow path defined by a first surface of the first layer and a first surface of the second layer, a second flow path defined by a first surface of the first layer and a first surface of the second layer, and a valve in fluid communication with both said first flow path and said second flow path wherein said valve has a 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 a compressible valve structure in said manifold and positioned over said valve, said priming process comprising the steps of:

receiving said manifold into the cavity;

having said valve in said second state by not applying pressure to said compressible valve structure;

pumping fluid through said first and second flow paths;

placing said valve in said first state by applying pressure to said compressible valve structure; and

removing fluid from said second flow path, wherein a venous line and an arterial line are in fluid communication with both the manifold and the patient when said valve is in first state and wherein said venous line is in fluid communication with a waste container and said arterial line is not connected to said patient when said valve is placed in a second state.

13. The priming process of claim 12 wherein the first flow path is a dialysate flow path and wherein the second flow path is a blood flow path.

14. The priming process of claim 13 wherein the fluid is dialysate and wherein, in said second state, the dialysate flows through the dialysate flow path and into the blood flow path.

15. The priming process of claim 14 wherein the dialysate is removed from the blood flow path upon completion of the priming process.

16. The priming process of claim 14 wherein the dialysate is pumped from a dialysate reservoir and not from a separate source of priming fluid.

17. The priming process of claim 12 wherein said valve is placed in said first state or second state by actuating a valve interface within said dialysis machine.

18. The priming process of claim 17 wherein said valve interface is configured to apply pressure to, or remove pressure from, said compressible valve structure upon actuation by said controller.

19. The priming process of claim 18 wherein said compressible valve structure is a diaphragm.