Disposable apparatus and kit for conducting dialysis

• US 10,758,661 B2
• Filed: 06/25/2018
• Issued: 09/01/2020
• 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:
  US16/016,958
• Publication Number:
  US 20180361049A1
• Time in Patent Office: 799 Days
• Field of Search: None
• 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 disposable apparatus for a blood purification system comprising:

a rigid plastic substrate, wherein the rigid plastic substrate comprises a first layer and a second layer; and

a first flexible tube having a first end and a second end, wherein the first end of the first flexible tube is attached to a first port on the rigid plastic substrate, wherein the second end of the first flexible tube is attached to a second port on the rigid plastic substrate wherein the first port and the second port are aligned to fit a straight tube therebetween, and wherein the first flexible tube serves to connect a first portion of a first flow path in the rigid plastic substrate to a second portion of the first flow path in the rigid plastic substrate, and wherein the first flow path is defined by channels positioned between the first layer and the second layer;

elastomeric components for valving or pressure sending, wherein the elastomeric components are positioned between the first layer and the second layer;

a second flexible tube having a first end and a second end, wherein the first end of the second flexible tube is attached to a third port on the rigid plastic substrate and the second end of the second flexible tube is attached to a waste collection reservoir configured to receive waste fluid;

a third flexible tube having a first end and a second end, wherein the first end of the third flexible tube is attached to a fourth port on the rigid plastic substrate and the second end of the third flexible tube is attached to a fluid reservoir configured to supply fluid;

a fourth flexible tube having a first end and a second end, wherein the first end of the fourth flexible tube is attached to a fifth port on the rigid plastic substrate and the second end of the fourth flexible tube is attached to a dialysate regeneration system configured to regenerate dialysate;

a fifth flexible tube having a first end and a second end, wherein the first end of the fifth flexible tube is attached to a sixth port on the rigid plastic substrate and the second end of the fifth flexible tube is attached to an inlet of a dialyzer configured to filter blood; and

a sixth flexible tube having a first end and a second end, wherein the first end of the sixth flexible tube is attached to a seventh port on the rigid plastic substrate and the second end of the sixth flexible tube is attached to an outlet of the dialyzer.

2. The disposable apparatus of claim 1 wherein the disposable apparatus comprises an alignment mechanism for attaching the disposable apparatus to a panel positioned within a housing of a dialysis machine.

3. The disposable apparatus of claim 2 wherein the alignment mechanism comprises a plurality of holes in a surface of the plastic substrate.

4. The disposable apparatus of claim 2 wherein the alignment mechanism comprises a plurality of tabs in a surface of the plastic substrate, wherein the tabs are adapted to mate with latches on a surface of the panel.

5. A The disposable apparatus for a blood purification system of claim 1 wherein the

the rigid substrate has an I shape comprising a top member, a bottom member, and a connecting member and

wherein the first port is on the top member and the second port is on the bottom member.

6. The disposable apparatus of claim 5 wherein the disposable apparatus comprises an alignment mechanism for attaching the disposable apparatus to a panel positioned within a housing of a dialysis machine.

7. The disposable apparatus of claim 6 wherein the alignment mechanism comprises at least one of a plurality of holes in a surface of the plastic substrate, a plurality of tabs in a surface of the plastic substrate, wherein the tabs are adapted to mate with latches on a surface of the panel, or a plurality of contoured guides.

8. The disposable apparatus of claim 5 wherein the top member comprises a first portion of a second flow path and an eighth port located at an edge of the top member and wherein the bottom member comprises a second portion of the second flow path and a ninth port located at an edge of the bottom member.

9. The disposable apparatus of claim 8 further comprising a seventh flexible tube having a first end and a second end, wherein the first end of the seventh flexible tube is attached to the eighth port and wherein the second end of the seventh flexible tube is attached to the ninth port.

10. The disposable apparatus of claim 9 wherein the first flexible tube is substantially parallel to the seventh flexible tube.

11. The disposable apparatus of claim 1 wherein the rigid substrate has a H shape comprising a left member comprising the first port, a right member comprising the second port, and a connecting member.

12. The disposable apparatus of claim 1 wherein the left member comprises a first portion of a second flow path and an eighth port located at an edge of the left member and wherein the right member comprises a second portion of the second flow path and a ninth port located at an edge of the right member.

13. The disposable apparatus of claim 12 further comprising a seventh flexible tube having a first end and a second end, wherein the first end of the seventh flexible tube is attached to the eighth port and wherein the second end of the seventh flexible tube is attached to the ninth port.

14. The disposable apparatus of claim 13 wherein the first flexible tube is substantially parallel to the seventh flexible tube.

15. The disposable apparatus of claim 14 wherein each of the first and second flow paths are isolated from each other.

16. The disposable apparatus of claim 1 wherein the rigid substrate further comprises a third layer between the first layer and the second layer and wherein the channels are positioned between a first side of the third layer and the first layer and the elastomeric components are positioned between a second side of the third layer and the second layer.

17. The disposable apparatus of claim 10 wherein each of the first and second flow paths are isolated from each other.

18. The disposable apparatus of claim 5 wherein the rigid substrate further comprises a third layer between the first layer and the second layer and wherein the channels are positioned between a first side of the third layer and the first layer and the elastomeric components are positioned between a second side of the third layer and the second layer.