Disposable apparatus and kit for conducting dialysis

• US 9,415,152 B2
• Filed: 05/30/2014
• Issued: 08/16/2016
• 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: Robinson, Thomas Patrick, Clemens, Charles E., Mishelevich, David Jacob, Braig, James Roswell, Fulkerson, Barry Neil, Ghidoli, Daniele, Joseph, Russell Thomas
• Primary Examiner(s): Menon, Krishnan S
• Application Number:
  US14/291,448
• Publication Number:
  US 20140339149A1
• Time in Patent Office: 809 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/1563 Details of incorporated filters
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• 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 1/3417 using distinct filters for dialysis and ultra-filtration
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2202/0413 : Blood
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: A61M 2209/00 : Ancillary equipment
• CPC Class Codes: A61M 39/08 : Tubes; Storage means specially adapted therefor
• CPC Class Codes: Y10T 137/85938 : Non-valved flow dividers

Abstract

An extracorporeal blood processing system comprises a plastic molded compact manifold that supports a plurality of molded blood and dialysate fluidic pathways along with a plurality of relevant sensors, valves and pumps. A disposable dialyzer is connected to the molded manifold to complete the blood circuit of the system. The compact manifold is also disposable in one embodiment and can be detachably installed in the dialysis machine.

Claims

1. A dialysis system configured to operate in a hemodialysis mode and a hemofiltration mode, said dialysis system comprising:

a dialyzer having a dialysate side and a blood side, wherein the dialysate side and blood side are separated by a membrane;

a blood circuit wherein said blood circuit directs blood from a patient, through the blood side of the dialyzer, and back to the patient;

a dialysate circuit wherein said dialysate circuit directs dialysate through the dialysate side of the dialyzer, the dialysate circuit comprising

a first valve wherein, in a first state, the first valve directs a fluid through a channel to the dialysate side of the dialyzer and, in a second state, directs the fluid through a channel and into the blood circuit;

a first container comprising a first material;

a second container comprising a second material; and

a second valve in fluid communication with the first and second container, wherein, in a first state, the second valve places the first material in physical communication with the fluid in the dialysate circuit and wherein, in a second state, the second valve places the second material in physical communication with the fluid in the dialysate circuit

a sorbent cartridge;

a fluid reservoir; and

a plastic manifold having a plurality of ports, wherein a first of the plurality of ports connects to said sorbent cartridge via a first tube, a second of the plurality of ports connects to the water reservoir via a second tube, and wherein the plastic manifold houses a portion of the blood circuit and a portion of the dialysate circuit.

2. The dialysis system of claim 1 wherein the portion of the dialysate circuit housed by the plastic manifold includes the first valve and the second valve.

3. The dialysis system of claim 1 wherein the dialysate circuit further comprises a third valve downstream of the dialyzer.

4. The dialysis system of claim 3 wherein the dialysate circuit further comprises a primary channel directing fluid passing through said third valve to the sorbent cartridge.

5. The dialysis system of claim 4 wherein the dialysate circuit further comprises a fluid container.

6. The dialysis system of claim 5 wherein the dialysate circuit further comprises an auxiliary channel, extending off of said primary channel and downstream of said third valve, for directing a portion of said fluid to the fluid container.

7. The dialysis system of claim 6 wherein the portion of the dialysate circuit housed by the plastic manifold includes the third valve, primary channel, and auxiliary channel.

8. The dialysis system of claim 1 wherein the dialysate circuit further comprises a flow restrictor positioned after the sorbent.

9. The dialysis system of claim 1 wherein a flow path between the dialyzer and sorbent cartridge comprises a flow restrictor, temperature sensor, flow sensor, and pressure sensor.

10. The dialysis system of claim 1 wherein, when operating in hemofiltration mode, the first valve is in the second state.

11. The dialysis system of claim 1 wherein, when operating in hemodialysis mode, the first valve is in the first state.

12. The dialysis system of claim 1 wherein the first material is concentrate.

13. The dialysis system of claim 1 wherein the second material is infusate.

14. The dialysis system of claim 1 further comprising four pumps configured to apply pressure to the dialysate circuit.

15. The dialysis system of claim 1 further comprising one pump configured to apply pressure to the blood circuit.

16. The dialysis system of claim 1 further comprising an alignment mechanism for receiving and positioning the plastic manifold in the dialysis system.

17. The dialysis system of claim 16 wherein the alignment mechanism comprises at least one of a plurality of holes in a surface of the plastic manifold, a plurality of tabs in a surface of the plastic manifold, or a plurality of contoured guides.

18. The dialysis system of claim 1 further comprising a plurality of pumps, wherein the plastic manifold comprises a plurality of tubes, and wherein, when the plastic manifold is installed within the dialysis system, a portion of said plurality of tubes is positioned adjacent to each of said plurality of pumps such that, during operation, each of said plurality of pumps apply a force to the portion of said plurality of tubes.

19. The dialysis system of claim 18 wherein the dialysis system comprises at least four pumps.