Filtration system and process for peritoneal dialysis

Patent metadata

Field	Value
Publication number	US-11116881-B2
Application number	US-201715606515-A
Country	US
Kind code	B2
Filing date	May 26, 2017
Priority date	May 27, 2016
Publication date	Sep 14, 2021
Grant date	Sep 14, 2021

Abstract

Described are peritoneal dialysis systems and methods that involve the use of crossflow filtration of a used dialysate withdrawn from the peritoneal space of a patient. The filtration forms a retentate containing amounts of an osmotic agent and a permeate containing amounts of water and nitrogen-containing waste products of the patient. The retentate, or a fraction thereof, can be returned to the peritoneal space of the patient to return osmotic agent to the patient. The permeate, or a fraction thereof, can be discarded to discard nitrogen-containing waste products of the patient.

First claim

The invention claimed is:

1. A method for processing a used peritoneal dialysate recovered from a peritoneal space of a patient, the used peritoneal dialysate containing a polymeric osmotic agent, urea, creatinine, and sodium, method comprising:
(i) allowing a peritoneal dialysis fluid to dwell in the peritoneal space of the patient for a dwell time of about 1 to about 12 hours so as to form a used dialysate, wherein no amount of the peritoneal dialysis fluid is withdrawn from the peritoneal space of the patient during said dwell time;
(ii) after said allowing, operating a pump of an apparatus worn by the patient to withdraw the used dialysate from the peritoneal space of the patient
(iii) filtering the used dialysate under crossflow filtration conditions across a membrane received in a filter chamber of said apparatus and having a molecular weight cutoff lower than a weight average molecular weight of the osmotic agent, said filtering conducted with a throughput of the used dialysate through the filter chamber of about 50 ml/minute to about 200 ml/minute, said filtering being powered by said pump, and said filtering generating:
a retentate containing at least 70% by weight of the osmotic agent present in the used dialysate, a first concentration of urea from the used dialysate, a first concentration of creatinine from the used dialysate, and a first concentration of sodium from the used dialysate; and
a permeate containing a second concentration of urea from the used dialysate, a second concentration of creatinine from the used dialysate, and a second concentration of sodium from the used dialysate;

wherein said molecular weight cutoff is in the range of about 3 kDa to about 15 kDa;
wherein said filtering includes maintaining a high pressure side of said membrane and a low pressure side of said membrane, with the used dialysate being introduced to the high pressure side of said membrane, wherein the high pressure side of said membrane is maintained at a pressure in the range of about 15 psi to about 100 psi; and
wherein said filtering generates a flow of the permeate and a flow of the retentate, wherein a ratio of the flow of the permeate to the flow of the retentate is in the range of about 1:40 to about 1:15;
(iv) forming a reconstituted peritoneal dialysate, said forming a reconstituted dialysate including adding an amount of a replenishing polymeric osmotic agent to the retentate or to a fraction of the retentate, wherein the replenishing polymeric osmotic agent is the same as the polymeric osmotic agent in the retentate or the fraction of the retentate but having a weight average molecular weight that is lower than that of the polymeric osmotic agent in the retentate or fraction of the retentate; and
(v) introducing the reconstituted peritoneal dialysate into the peritoneal space of the patient.

2. The method of claim 1 , wherein:
said osmotic agent in said used peritoneal dialysate has a weight average molecular weight in the range of about 10 kDa to about 30 kDa.

3. The method of claim 1 , wherein:
the retentate, or a fraction thereof, is returned to the patient in said reconstituted peritoneal dialysate without having subjected the retentate to further membrane filtration.

4. The method of claim 1 , wherein:
said osmotic agent comprises a polymer of glucose.

5. The method of claim 1 , wherein:
said osmotic agent comprises Icodextrin.

6. The method of claim 1 , wherein:
the ratio of the flow of permeate to the flow of retentate is in the range of about 1:35 to about 1:20.

7. The method of claim 6 , wherein said pressure is in the range of about 20 psi to about 50 psi.

8. The method of claim 7 , wherein said pressure is in the range of about 20 psi to about 30 psi.

9. The method of claim 1 , wherein the membrane comprises a polyethersulfone polymer membrane.

10. The method of claim 1 , wherein:
said forming a reconstituted peritoneal dialysate also includes adding sodium, potassium, calcium, magnesium, lactate, acetate, and/or bicarbonate to the retentate or to a fraction of the retentate.

11. The method of claim 1 , wherein:
the replenishing osmotic agent has a weight average molecular weight of at least 10 kDa.

12. The method of claim 11 , wherein the replenishing osmotic agent is a polymer of glucose.

13. The method of claim 1 , also comprising:
discarding the permeate without returning the permeate or any fraction thereof to the peritoneal space of the patient; or
recovering a fraction of the permeate for return to the patient without having subjected the permeate to nanofiltration and/or reverse osmosis filtration.

14. The method of claim 1 , wherein:
said operating a pump withdraws the used dialysate from the peritoneal space of the patient through a catheter lumen.

15. The method of claim 1 , wherein:
said introducing the reconstituted peritoneal dialysate includes passing the reconstituted peritoneal dialysate through a catheter lumen and into the peritoneal space of the patient.

16. The method of claim 1 , wherein said dwell time is about 2 hours to about 6 hours.

17. The method of claim 1 , wherein said operating a pump is for a duration of about 1 hour to about 12 hours.

18. The method of claim 16 , wherein said operating a pump is for a duration of about 2 hours to about 6 hours.

19. The method of claim 17 , conducted so as to generate a liquid volume exchange in the peritoneal space of the patient of about 8 to about 20 liters per day.

Assignees

• Cook Medical Technologies Llc

Inventors

• Hahne Kalub
• Milner Keith
• Blatter Duane
• Isch Andrew

Classifications

• A61M1/1696 Primary

  with dialysate regeneration · CPC title

• A61M2205/8206

  battery-operated · CPC title

• A61M2205/75

  with filters · CPC title

• A61K31/19

  Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60) · CPC title

• A61M1/3482

  by filtrating the filtrate using another cross-flow filter, e.g. a membrane filter · CPC title