Manifold for wearable artificial kidney

• US 9,956,335 B2
• Filed: 12/13/2013
• Issued: 05/01/2018
• Est. Priority Date: 12/21/2012
• 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: Giordano, Renato, Swenson, Phil
• Primary Examiner(s): Gilbert, Andrew
• Assistant Examiner(s): FREDRICKSON, COURTNEY B
• Application Number:
  US14/650,576
• Publication Number:
  US 20150314056A1
• Time in Patent Office: 1,600 Days
• 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 1/1627 Dialyser of the inside perfusion type, i.e. blood flow inside hollow membrane fibres or tubes
• CPC Class Codes: A61M 1/1633 with more than one dialyser unit
• CPC Class Codes: A61M 1/1645 with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/3486 Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 2209/088 on the body

Abstract

Flexible manifolds configured for use in a wearable artificial kidney are provided and can include an array of manifold plates defining one or more flow path and which are adapted to receive dialysis components including cleaning columns and dialyzers. Wearable artificial kidneys are also provided. For example, a wearable artificial kidney can include a flexible manifold, a first flow path, a second flow path, a third flow path, a first cleaning column, a first dialyzer, a second dialyzer, a second cleaning column, and at least one pump. Systems for performing dialysis are further provided. The systems can include a wearable artificial kidney and manifold inlet and outlet lines for connecting the peritoneum of a dialysis patient to the wearable artificial kidney. Methods for performing dialysis utilizing the flexible manifolds, wearable artificial kidneys, and systems containing the same, are also provided.

Claims

1. A flexible manifold configured for use as part of a wearable artificial kidney, the flexible manifold comprising:

an array of manifold plates comprising

a first manifold plate comprising a first lateral edge, a first portal, and a first conduit in fluid communication with the first portal,

a second manifold plate comprising a second lateral edge, a second portal, a second conduit in fluid communication with the second portal, a third lateral edge, a third portal, and a third conduit in fluid communication with the third portal, the first lateral edge positioned adjacent to the second lateral edge, and

a third manifold plate comprising a fourth lateral edge, a fourth portal along the fourth lateral edge, and a fourth conduit in fluid communication with the fourth portal, the third lateral edge positioned adjacent to the fourth lateral edge;

a first flexible hinge joining the first manifold plate and the second manifold plate at the first and second lateral edges, the first flexible hinge comprising a first flexible tube joining the first conduit and the second conduit to form a first flow path; and

a second flexible hinge joining the second manifold plate and the third manifold plate at the third and fourth lateral edges, the second flexible hinge comprising a second flexible tube joining the fourth conduit in fluid communication with the second conduit to form a segment of the first flow path.

2. The flexible manifold of claim 1, wherein:

the first manifold plate further comprises a fifth portal and a fifth conduit in fluid communication with the fifth portal; and

the first flexible hinge further comprises a third flexible tube joining the fifth conduit and the third conduit to form a second flow path.

3. The flexible manifold of claim 2, wherein:

the first manifold plate further comprises a sixth portal and a sixth conduit in fluid communication with the sixth portal;

the second manifold plate further comprises a seventh portal and a seventh conduit in fluid communication with the seventh portal; and

the first flexible hinge further comprises a fourth flexible tube joining the sixth conduit and the seventh conduit to form a third flow path.

4. A flexible manifold configured for use as part of a wearable artificial kidney, the flexible manifold comprising:

an array of manifold plates comprising

a first manifold plate comprising a first lateral edge, a first portal, a first conduit in fluid communication with the first portal, a third portal, a third conduit in fluid communication with the third portal, a fifth portal, and a fifth conduit in fluid communication with the fifth portal,

a second manifold plate comprising a second lateral edge, a third lateral edge, a second portal, a second conduit in fluid communication with the second portal, a fourth portal, a fourth conduit in fluid communication with the fourth portal, a sixth portal, a sixth conduit in fluid communication with the sixth portal, the first lateral edge being positioned adjacent to the second lateral edge, and

a third manifold plate comprising a fourth lateral edge, a seventh portal along the fourth lateral edge, and a seventh conduit in fluid communication with the seventh portal;

a first flexible hinge joining the first manifold plate and the second manifold plate at the first and second lateral edges, the first flexible hinge comprising a first flexible tube joining the first conduit and the second conduit to form a first flow path, a second flexible tube joining the third conduit and the fourth conduit to form a second flow path, and a third flexible tube joining the fifth conduit and the sixth conduit to form a third flow path; and

a second flexible hinge joining the second manifold plate and the third manifold plate at the third and fourth lateral edges, the second flexible hinge comprising a fourth flexible tube joining the seventh conduit in fluid communication with the second conduit, or sixth conduit to form a segment of the first or third flow paths.

5. The flexible manifold of claim 4, wherein:

the first flow path further comprises an eighth conduit in the first manifold plate, a ninth conduit in the second manifold plate, a tenth conduit in the second manifold plate, an eleventh conduit in the second manifold plate, a twelfth conduit in the second manifold plate, a thirteenth conduit in the third manifold plate, and the seventh conduit in the third manifold plate;

the first flexible hinge further comprises a fifth flexible tube joining the eight conduit and the ninth conduit; and

the second flexible hinge further comprises

a sixth flexible tube joining the tenth conduit and the thirteen conduit,

a seventh flexible tube joining the thirteenth conduit and the eleventh conduit, and

an eighth flexible tube joining the seventh conduit and the twelfth conduit.

6. The flexible manifold of claim 5, wherein:

the second flow path further comprises a fourteenth conduit in the first manifold plate, a fifteenth conduit in the first manifold plate, and a sixteenth conduit in the second manifold plate, and a first loop tube joining the third conduit and the fourteenth conduit in fluid communication.

7. The flexible manifold of claim 6, wherein:

the third flow path further comprises a seventeenth conduit in first manifold plate, an eighteen conduit in the second manifold plate, a nineteenth conduit in the second manifold plate, a twentieth conduit in the third manifold plate, a twenty-first conduit in the third manifold plate, and a second loop tube joining the fifth conduit and the seventeenth conduit in fluid communication;

the first flexible hinge further comprises a tenth flexible tube joining the seventeenth conduit and the eighteenth conduit; and

the second flexible hinge further comprises an eleventh flexible tube joining the eighteenth conduit and the twentieth conduit, and a twelfth flexible tube joining the nineteenth conduit and the twenty-first conduit.

8. The flexible manifold of claim 7, wherein:

the first manifold plate further comprises a first cleaning column inlet connector portal in fluid communication with the second flow path and a first cleaning column outlet connector portal in fluid communication with the second flow path;

the second manifold plate further comprises a first dialyzer dialysate inlet connector portal in fluid communication with the first flow path, a first dialyzer dialysate outlet portal in fluid communication with the first flow path, a first dialyzer cleaning fluid inlet connector portal in fluid communication with the second flow path, a first dialyzer cleaning fluid outlet connector portal in fluid communication with the second flow path, a second dialyzer dialysate inlet connector portal in fluid communication with the first flow path, a second dialyzer dialysate outlet portal in fluid communication with the first flow path, a second dialyzer cleaning fluid inlet connector portal in fluid communication with the third flow path, and a second dialyzer cleaning fluid outlet connector portal in fluid communication with the third flow path; and

the third manifold plate further comprises a second cleaning column inlet connector portal in fluid communication with the third flow path and a second cleaning column outlet connector portal in fluid communication with the third flow path.

9. A wearable artificial kidney comprising:

the flexible manifold of claim 8;

a first cleaning column in fluid communication with the second flow path and comprising a first cleaning column inlet connected to the first cleaning column inlet connector portal and a first cleaning column outlet connected to the first cleaning column outlet connector portal;

a first dialyzer in fluid communication with the first and second flow paths and comprising a first dialyzer inlet connected to the first dialyzer dialysate inlet connector portal, a first dialyzer dialysate outlet connected to the first dialyzer dialysate outlet portal, a first dialyzer cleaning fluid inlet connected to the first dialyzer cleaning fluid inlet connector portal, and a first dialyzer cleaning fluid outlet connector connected to the first dialyzer cleaning fluid outlet connector portal;

a second dialyzer in fluid communication with the first and third flow paths and comprising a second dialyzer inlet connected to the second dialyzer dialysate inlet connector portal, a first dialyzer dialysate outlet connected to the first dialyzer dialysate outlet portal, a second dialyzer cleaning fluid inlet connected to the second dialyzer cleaning fluid inlet connector portal, and a second dialyzer cleaning fluid outlet connector connected to the second dialyzer cleaning fluid outlet connector portal; and

a second cleaning column in fluid communication with the third flow path comprising a second cleaning column inlet connected to the second cleaning column inlet connector portal and a second cleaning column outlet connected to the second cleaning column outlet connector portal.

10. The wearable artificial kidney of claim 9, further comprising

a first pump in operable communication with the first flow path;

a second pump in operable communication with the second flow path; and

a third pump in operable communication with the third flow path.

11. The wearable artificial kidney of claim 10, wherein the second and third pumps are peristaltic pumps, the second pump engages the second loop tube, and the third pump engages the third loop tube.

12. The wearable artificial kidney of claim 9, wherein the first dialyzer comprises a membrane selectively-permeable to anions and the first cleaning column comprises a first layer comprising activated carbon and a second layer comprising an anion exchange resin, hydrous zirconium oxide, or a combination thereof.

13. The wearable artificial kidney of claim 9, wherein the second dialyzer comprises a membrane selectively-permeable to urea and the second cleaning column comprises an acid cation exchange resin, an ion exchange sorbent, or a combination thereof.

14. The wearable artificial kidney of claim 9, wherein the second dialyzer comprises a membrane selectively-permeable to urea and the second cleaning column comprises a first layer comprising urease and a second layer comprising an acid cation exchange resin, an ion exchange sorbent, or a combination thereof.

15. The wearable artificial kidney of claim 9, further comprising a strap, belt, harness, frame, holster, or other attachment device configured to attach the flexible manifold to a dialysis patient.

16. A system comprising:

the wearable artificial kidney of claim 9;

a manifold inlet line configured to be in fluid communication with a peritoneal cavity of a dialysis patient and the first flow path;

a manifold outlet line configured to be in fluid communication with the peritoneal cavity of the dialysis patient, and the first flow path;

a dialysate fluid in the first flow path;

a first cleaning fluid in the second flow path; and

a second cleaning fluid in the third flow path.

17. A method of regenerating dialysate fluid in the system of claim 16, the method comprising:

cycling the dialysate fluid in the first flow path;

cycling the first cleaning fluid in the second flow path; and

cycling the second cleaning fluid in the second flow path;

wherein dialysate fluid is in need of regeneration before entering the flexible manifold and has been regenerated once the dialysate fluid has exited the flexible manifold.

18. The method of claim 17, further comprising replacing one or more of the first cleaning column, the first dialyzer, the second dialyzer, and the second cleaning column, and repeating the cycling of the dialysate fluid, the first cleaning fluid, and the second cleaning fluid.

19. A wearable artificial kidney comprising:

a flexible manifold comprising a first manifold plate, a second manifold plate joined to the first manifold plate by a first flexible hinge, and a third manifold plate joined to the second manifold plate by a second flexible hinge;

a first flow path comprising one or more conduits located in one or more of the first, second, and third manifold plates;

a second flow path comprising one or more conduits located in one or more of the first, second, and third manifold plates;

a third flow path comprising one or more conduits located in one or more of the first, second, and third manifold plates;

a first cleaning column mounted on the first manifold plate and in fluid communication with the second flow path;

a first dialyzer mounted on the second manifold plate and in fluid communication with the first and second flow paths;

a second dialyzer mounted on the second manifold plate and in fluid communication with the first and third flow paths;

a second cleaning column mounted on the third manifold plate in fluid communication with the third flow path; and

at least one pump configured to cycle a dialysate fluid through the first flow path, a first cleaning fluid through the second flow path, and a second cleaning fluid through the third flow path.

20. The wearable artificial kidney of the claim 19, wherein:

the first dialyzer comprises a membrane selectively-permeable to anions;

the first cleaning column comprises a first layer comprising activated carbon and a second layer comprising an anion exchange resin, hydrous zirconium oxide, or a combination thereof;

the second dialyzer comprises a membrane selectively-permeable to urea; and

the second cleaning column comprises a first layer comprising urease and a second layer comprising an acid cation exchange resin, an ion exchange sorbent, or a combination thereof.