Universal portable artificial kidney for hemodialysis and peritoneal dialysis

• US 10,549,023 B2
• Filed: 07/20/2016
• Issued: 02/04/2020
• Est. Priority Date: 03/14/2013
• 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: Updyke, Palmer David, Fulkerson, Barry, De Leon De Leon, Amaury, Bayly, Michelle
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Darb, Hamza A
• Application Number:
  US15/215,404
• Publication Number:
  US 20160325037A1
• Time in Patent Office: 1,294 Days
• 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 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2205/75 with filters

Abstract

Methods, systems, and kits are provided for performing hemodialysis, hemodiafiltration, and peritoneal dialysis on a portable machine suitable for both clinical and home use. Peritoneal dialysate can be flowed into and out of the peritoneal cavity, and can also be regenerated within the system, without the need for introducing fresh dialysate. Common hardware and software can be utilized for both peritoneal dialysis and other forms of dialysis such as hemodialysis, hemofiltration, and hemodiafiltration, allowing for facile transition between different dialysis modes using the same dialysis machine.

Claims

1. A method of performing peritoneal dialysis, the method comprising:

flowing dialysate in a dialysate circuit through a first flow path, and into a dialysate reservoir, the first flow path comprising a flow path through a manifold and through a sorbent cartridge, wherein a first tube and a second tube are present along the first flow path, the first tube connects the manifold to the dialysate circuit, the second tube connects the manifold to the dialysate reservoir, the manifold comprises a first internal conduit, a first tube port, and a second tube port, the first internal conduit is in fluid communication with the first tube via the first tube port, the first internal conduit is in fluid communication with the second tube via the second tube port, and the first flow path connects the dialysate circuit, the manifold, and the dialysate reservoir in fluid communication with one another via the first tube, the second tube, and the first internal conduit;

flowing the dialysate out of the dialysate reservoir along a second flow path, through the manifold, and to a filter, wherein the manifold further comprises a third tube port, a fourth tube port, and a second internal conduit, the second flow path comprises a third tube that connects the dialysate reservoir and the second internal conduit in fluid communication, the third tube is connected to the manifold via the third tube port, the second flow path further comprises a fourth tube that connects the filter and the second internal conduit in fluid communication, the fourth tube is connected to the manifold via the fourth tube port, the filter comprises a first inlet that connects the fourth tube to the filter, and the second flow path differs from the first flow path;

flowing the dialysate in a first direction across the filter, out of the filter, and into a peritoneum circuit, the filter and peritoneum circuit being in fluid communication with each other via a fifth tube connecting the peritoneum circuit to a first outlet of the filter;

flowing the dialysate through the peritoneum circuit and into a peritoneal cavity;

maintaining the dialysate in the peritoneal cavity for a dwell time, to form spent peritoneal dialysate;

flowing the spent peritoneal dialysate out of the peritoneal cavity, through the peritoneum circuit, into the filter via a second inlet on the filter, through the filter via internal fluid flow that connects, in fluid communication, the second inlet to a second outlet of the filter, out of the second outlet of the filter, into the manifold, through the manifold via a third internal conduit, and into the dialysate circuit via a third flow path, wherein the third flow path connects the peritoneal cavity, the filter via the first inlet and the first outlet, the third internal conduit of the manifold, and the dialysate circuit, in fluid communication with each other;

further flowing the spent peritoneal dialysate through the third flow path through the sorbent cartridge to form regenerated dialysate; and

flowing the regenerated dialysate from the sorbent cartridge to the dialysate reservoir.

2. The method of claim 1, further comprising heating the dialysate in the dialysate reservoir.

3. The method of claim 1, further comprising (1) weighing the dialysate in the dialysate reservoir before the dialysate is flowed into the peritoneum circuit, to obtain a first weight, (2) weighing the regenerated dialysate after the regenerated dialysate is flowed into the dialysate reservoir, to obtain a second weight, or (3) both (1) and (2).

4. The method of claim 3, wherein the weighing comprises weighing the dialysate in the dialysate reservoir before the dialysate is flowed into the peritoneum circuit, to obtain a first weight, and weighing the regenerated dialysate in the dialysate reservoir after the dialysate is returned to the dialysate reservoir, to obtain a second weight, and the method further comprises determining at least one of an ultrafiltration volume and an ultrafiltration rate based on a difference between the second weight and the first weight.

5. The method of claim 1, wherein the dialysate, the spent dialysate, and the regenerated dialysate are flowed using at least one peristaltic pump.

6. The method of claim 5, wherein the at least one peristaltic pump comprises a pump configured to control dialysate flow in more than one of the flow paths.

7. The method of claim 1, further comprising detecting the presence of air in at least one of the flow paths.

8. The method of claim 1, further comprising measuring a pressure of dialysate in at least one of the second and third flow paths.

9. The method of claim 8, further comprising adjusting the flow of (1) dialysate into the peritoneal cavity, (2) spent dialysate out of the peritoneal cavity, or (3) both (1) and (2), to control dialysate pressure and keep it below a pre-determined pressure.

10. The method of claim 1, wherein, after flowing the regenerated dialysate through the third flow path to the dialysate reservoir, the method is repeated by flowing regenerated dialysate from the dialysate reservoir through the second flow path.

11. The method of claim 1, wherein the filter comprises a dialyzer.

12. The method of claim 1, further comprising splitting the flow of dialysate in the second flow path between at least two different branch lines before passing the flow in both branch lines across the filter.

13. The method of claim 1, further comprising engaging the manifold with a dialysis machine configured to carry out the method, and forming a fluid communication between the manifold and a supply of dialysate.

14. The method of claim 1, wherein the manifold comprises

a first transom comprising a first edge, and second and third edges substantially parallel to the first edge,

a trunk substantially perpendicular and adjacent to the first transom, and

a second transom comprising a fourth edge, and fifth and sixth edges substantially parallel to the first, second, and third edges, wherein the second transom is substantially perpendicular and adjacent to the trunk and substantially parallel to the first transom.

15. A peritoneal dialysis system configured to perform the method of claim 1, the system comprising:

the manifold;

a dialysis machine in operable communication with the manifold and configured to pump the dialysate through the first flow path, configured to pump the dialysate through the second flow path, and configured to pump spent dialysate and regenerated dialysate through the third flow path;

the dialysate reservoir in fluid communication with the manifold;

the filter in fluid communication with the manifold;

the sorbent cartridge in fluid communication with the manifold;

a scale configured to weigh the dialysate reservoir; and

a heater configured to heat dialysate in the dialysate reservoir.