Wearable peritoneum-based system for continuous renal function replacement and other biomedical applications

• US 5,944,684 A
• Filed: 06/02/1997
• Issued: 08/31/1999
• Est. Priority Date: 08/31/1995
• Status: Expired due to Term

• Current Assignee: The United States of America As Represented By The Secretary of Agriculture
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Roberts, Martin, Lee, David Be-Nyi
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/866,972
• Time in Patent Office: 820 Days
• Field of Search: 604/4, 604/5, 604/6, 604/28, 604/29, 210/259, 210/638, 210/646-648, 210/650-651, 210/806-807, 128/898
• US Class Current: 604/5.04
• 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 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 2209/088 on the body

Abstract

A wearable peritoneal dialysis device providing continuous removal of waste metabolites from the blood using a small volume (250-1000 mls) of protein-containing dialysate having an overall flow rate of about 2-3 liters per hour. The device may be worn in several places on the torso and limbs. Included are methods for peritoneal dialysis having improved efficiency, as well as methods for providing hormones, nutrients or therapeutic agents to a patient.

Claims

1. A method for the continuous removal of protein-bound uremic toxins from the blood which enters the peritoneal cavity of a patient, comprising the steps of:

a) introducing from about 250 to about 1000 ml of dialysate into the peritoneal cavity, wherein protein-bound uremic toxins from the blood translocate into said dialysate;

b) removing the used dialysate from said peritoneal cavity;

c) separating the used dialysate through a filter into a protein-containing fraction and an ultrafiltrate fraction;

d) treating said ultrafiltrate fraction to remove waste products present in said ultrafiltrate fraction, thereby generating a purified ultrafiltrate fraction;

e) treating said protein-containing fraction from said filter to remove undesirable proteins and noxious uremic substances bound to proteins, thereby generating detoxified proteins;

f) combining said detoxified proteins and purified ultrafiltrate fraction to from regenerated dialysate;

g) reintroducing said regenerated dialysate into the peritoneal cavity.

2. The method of claim 1, further comprising the step of sterilizing said regenerated dialysate prior to reintroduction into the peritoneal cavity.

3. The method of claim 1, wherein said step c) comprises:

a") passing the used dialysate through a sieve, whereby cellular debris and mucoid material are removed therefrom; and

b") passing said dialysate from which cellular debris and mucoid material have been removed through a filter, wherein said dialysate is separated into said protein-containing and ultrafiltrate fractions.

4. The method of claim 1, wherein said step e) comprises contacting said protein containing fraction with a matrix of materials which selectively removes noxious substances and undesirable proteins from said fraction.

5. The method of claim 1, wherein said step d) of treating said ultrafiltrate fraction comprises passing said ultrafiltrate fraction through sorbent phases comprising urease, zirconium phosphate, hydrated zirconium oxide and activated carbon.

6. The method of claim 1, wherein the overall flow rate through the cavity is about 2 to 3 liters per hour.

7. The method of claim 1 further comprising the step of adding to said regenerated dialysate one or more compounds selected from the group consisting of hormones, vitamins, sugars, minerals and other therapeutic agents.