Universal portable artificial kidney for hemodialysis and peritoneal dialysis

• US 9,433,720 B2
• Filed: 03/14/2013
• Issued: 09/06/2016
• 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): Hayman, Imani
• Assistant Examiner(s): Darb, Hamza
• Application Number:
  US13/828,636
• Publication Number:
  US 20140276371A1
• Time in Patent Office: 1,272 Days
• Field of Search: 604/29, 604/28, 604/30, 604/6.13, 604/5.01, 604/5.04, 604/6.09, 604/6.11
• US Class Current: 1/1
• 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 comprising:

flowing dialysate along a first flow path through a manifold and into a dialysate reservoir, the manifold comprising a manifold body that defines a plurality of internal passageways and a plurality of ports providing fluid communication to fluid passageways external to the manifold body, the manifold further comprising a first pumping tube, a second pumping tube, and a third pumping tube each in fluid communication with the plurality of internal passageways, the plurality of internal passageways partially defining each of the first flow path, a second flow path, a third flow path, and a fourth flow path, the first flow path including the first pumping tube;

weighing the dialysate in the dialysate reservoir to obtain a first weight;

flowing the dialysate out of the reservoir, along the second flow path through the manifold, and into a peritoneal cavity, the second flow path including the second pumping tube;

flowing the dialysate out of the peritoneal cavity, along the third flow path through the manifold, and into a drain reservoir, the third flow path including the third pumping tube;

weighing the dialysate in the drain reservoir to obtain a second weight; and

flowing the dialysate out of the drain reservoir and along the fourth flow path through the manifold, the fourth path also including the third pumping tube,

wherein the flowing the dialysate along the third flow path comprises pumping the dialysate through the third pumping tube in a first direction, and the flowing the dialysate along the fourth flow path comprises pumping the dialysate through the third pumping tube in a second direction that is opposite the first direction.

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

3. The method of claim 1, wherein the dialysate reservoir and the drain reservoir are weighed using a single scale.

4. The method of claim 1, further comprising determining the difference between the first weight and the second weight;

and

determining at least one of ultrafiltration volume and ultrafiltration rate based on the difference determined.

5. The method of claim 1, wherein at least one of the first, second, third, and fourth flow paths is fluidly isolated from the other three flow paths.

6. The method of claim 1, wherein the dialysate is caused to flow by using at least one pump.

7. The method of claim 6, wherein the at least one pump comprises at least one peristaltic pump.

8. The method of claim 6, wherein the at least one pump comprises a first pump configured to control dialysate flow in one of the flow paths, and a second pump configured to control dialysate flow in a different one of the flow paths.

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

10. The method of claim 1, further comprising detecting for the presence of air in one or more of the flow paths.

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

12. The method of claim 11, further comprising adjusting the flow of dialysate (1) into the peritoneal cavity, (2) out of the peritoneal cavity, or (3) both, to control the dialysate pressure and keep it below a pre-determined pressure.

13. The method of claim 1, wherein, after flowing the dialysate through the fourth flow path, the method is repeated starting with flowing a fresh supply of dialysate through the first flow path.

14. The method of claim 1, wherein the plurality of internal passageways include a fifth flow path and the method further comprises flowing a fresh supply of dialysate through the fifth flow path in the manifold, and into the dialysate reservoir, after flowing the dialysate through the fourth flow path.

15. The method of claim 14, wherein the fresh supply of dialysate differs in composition from the dialysate flow into the dialysate reservoir.

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

17. The method of claim 1, wherein the manifold body 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.

18. 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 flow the dialysate through the first, second, third, and fourth flow paths;

the dialysate reservoir in fluid communication with the manifold;

the drain reservoir in fluid communication with the manifold;

a scale configured to weigh at least one of the dialysate reservoir and the drain reservoir; and

a heater configured to heat dialysate in the dialysate reservoir.

19. The method of claim 1, wherein the manifold body further comprises a first pair of intra-manifold ports comprising respective first and second intra-manifold ports that are connected to opposite ends of the first pumping tube, a second pair of intra-manifold ports comprising respective third and fourth intra-manifold ports that are connected to opposite ends of the second pumping tube, and a third pair of intra-manifold ports comprising fifth and sixth intra-manifold ports that are connected to opposite ends of the third pumping tube.