System and method for conducting hemodialysis and hemofiltration

• US 8,114,288 B2
• Filed: 11/28/2008
• Issued: 02/14/2012
• 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:
  US12/324,924
• Publication Number:
  US 20090173682A1
• Time in Patent Office: 1,173 Days
• Field of Search: None
• US Class Current: 210/321.71
• 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. Two-way valves in the manifold are used to direct the dialysate flow to the dialyzer in hemodialysis mode of operation and to bypass the dialyzer to direct the flow of infusion grade dialysate directly to the patient in hemofiltration mode of operation.

Claims

1. A manifold for a blood purification system, the manifold comprising:

a first fluid conducting segment wherein said first fluid conducting segment comprises a rigid plastic substrate, wherein said first fluid conducting segment comprises a first portion of a first flow path, and wherein said first fluid conducting segment comprises a first port located at an edge of the first fluid conducting segment;

a second fluid conducting segment parallel to said first fluid conducting segment wherein said second fluid conducting segment comprises a rigid plastic substrate, wherein said second fluid conducting segment comprises a second portion of the first flow path, wherein said second fluid conducting segment comprises a second port located at an edge of the second fluid conducting segment, and wherein said first and second ports are positioned opposite each other;

a connecting fluid conducting segment that is perpendicular to, and separates, the first and second fluid conducting segments; and

a flexible tube having a first end and a second end, wherein said first end of the tube is attached to said first port, wherein said second end of the tube is attached to said second port, wherein said tube serves to connect said first portion of the first flow path to said second portion of the first flow path, and wherein the connecting fluid conducting segment is a parallel to said flexible tube.

2. The manifold of claim 1, wherein said manifold is disposable.

3. The manifold of claim 1, wherein each of said first fluid conducting segment, second fluid conducting segment, and connecting fluid conducting segments comprise external edges that define a boundary bounding a space.

4. The manifold of claim 1 further comprising at least one valve component fixedly attached to at least one of said first fluid conducting segment, second fluid conducting segment, or connecting fluid conducting segments for directing fluid flow through the first flow path, a second flow path, or a third flow path.

5. The manifold of claim 1 further comprising at least one sensor component fixedly attached to at least one of said first fluid conducting segment, second fluid conducting segment, or connecting fluid conducting segments for measuring a fluid characteristic in at least one of the first flow path, a second flow path, or a third flow path.

6. The manifold of claim 5, wherein said fluid characteristic is at least one of temperature or pressure.

7. The manifold of claim 4, wherein activation of said valve component directs fluid flow through one of two separate fluid paths.

8. The manifold of claim 7, wherein said activation of the valve component is dependent upon a mode of operation of the blood purification system.

9. The manifold of claim 8, wherein said mode of operation is selected from the class comprising hemodialysis and hemofiltration.

10. A dialysis machine comprising a manifold as claimed in claim 1, further comprising:

a door with a pressure plate positioned on an interior face of the door;

a housing with a panel wherein said housing and panel define a recessed region configured to receive said interior face of said door; and

an alignment mechanism fixedly attached to said panel, wherein said alignment mechanism detachably receives the manifold on said panel and positions said manifold against said pressure plate when the door is placed in said recessed region.

11. The dialysis machine of claim 10 wherein said alignment mechanism is at least one of contoured guides, pins, or latch.

12. The manifold of claim 1 wherein the first fluid conducting segment comprises a first portion of a second flow path and a third port located at an edge of the first fluid conducting segment.

13. The manifold of claim 12 wherein the second fluid conducting segment comprises a second portion of a second flow path and a fourth port located at an edge of the second fluid conducting segment, wherein said third and fourth ports are parallel to the connecting fluid conducting segment and are positioned opposite each other.

14. The manifold of claim 13 further comprising a second flexible tube having a first end and a second end, wherein said first end of the second tube is attached to said third port, wherein said second end of the second tube is attached to said fourth port, and wherein said second tube serves to connect said first portion of the second flow path to said second portion of the second flow path.

15. The manifold of claim 14 wherein the first fluid conducting segment comprises a first portion of a third flow path and a fifth port located at an edge of the first fluid conducting segment.

16. The manifold of claim 15 wherein the second fluid conducting segment comprises a second portion of a third flow path and a sixth port located at an edge of the second fluid conducting segment, wherein said fifth and sixth ports are parallel to the connecting fluid conducting segment and are positioned opposite each other.

17. The manifold of claim 16 further comprising a third flexible tube having a first end and a second end, wherein said first end of the third tube is attached to said fifth port, wherein said second end of the third tube is attached to said sixth port, and wherein said third tube serves to connect said first portion of the third flow path to said second portion of the third flow path.

18. The manifold of claim 17 wherein the first fluid conducting segment comprises a first portion of a fourth flow path and a seventh port located at an edge of the first fluid conducting segment.

19. The manifold of claim 18 wherein the second fluid conducting segment comprises a second portion of a fourth flow path and a eighth port located at an edge of the second fluid conducting segment, wherein said seventh and eighth ports are parallel to the connecting fluid conducting segment and are positioned opposite each other.

20. The manifold of claim 19 further comprising a fourth flexible tube having a first end and a second end, wherein said first end of the fourth tube is attached to said seventh port, wherein said second end of the fourth tube is attached to said eighth port, and wherein said fourth tube serves to connect said first portion of the fourth flow path to said second portion of the fourth flow path.

21. The manifold of claim 20 wherein each of said first, second, third, and fourth flow paths are isolated from each other.