METHOD FOR INSTALLING AND SERVICING A WEARABLE CONTINUOUS RENAL REPLACEMENT THERAPY DEVICE

• US 20060241543A1
• Filed: 06/28/2006
• Published: 10/26/2006
• Est. Priority Date: 11/16/2001
• Status: Abandoned Application

• Current Assignee: Consolidated Metco Incorporated (Amsted Industries Incorporated)
• Original Assignee: National Quality Care Inc.
• Inventors: Gura, Victor
• Application Number:
  US11/427,267
• Publication Number:
  US 20060241543A1
• Time in Patent Office: Days
• US Class Current: 604/5.10
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3382 Upper level detectors
• CPC Class Codes: A61M 2205/3386 Low level detectors
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 2209/088 on the body

Abstract

A continuous renal replacement therapy (CRRT) device that is completely worn on the body of a patient. A protocol is provided for installing the completely wearable CRRT device on a patient and changing or exchanging various CRRT device parts and fluids at predetermined intervals. A dialyzer or hemofilter is changed in a sterile environment while the dialysate and dialysate filters can be changed in a non-sterile environment by the patient.

Claims

1. A method of installing and servicing a completely wearable CRRT device comprising:

installing a double catheter in a patient from at least one of the superior vena cava, the subclavian vein and the jugular vein, under a patient'"'"'s skin, to an exit location near the patient'"'"'s waist;

connecting said double catheter to a completely wearable CRRT device in a sterile environment;

incorporating less than 1 liter of sterile dialysate into said completely wearable CRRT;

changing a dialyzer in said completely wearable CRRT device, in a sterile environment, after a first predetermined time period;

continuously adding an anticoagulation substance, by said completely wearable CRRT device, at an input side of said completely wearable CRRT device while said completely wearable CRRT device is operating;

changing a dialysate purification system after a second predetermined time period;

recharging or replacing a portable power source in said completely wearable CRRT device after a third predetermined time period.

exchanging the sterile dialysate in the completely wearable CRRT device with new sterile dialysate after a fourth predetermined time period; and

replenishing one or more additives in said completely wearable CRRT device.

2. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said incorporating of less than 1 liter of sterile dialysate is performed by inserting a fluid cartridge into said completely wearable CRRT device.

3. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said changing of said dialysate purification system comprises changing at least one filter cartridge.

4. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said changing of said dialysate purification system is performed by said patient.

5. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said first predetermined time period is one to fourteen days.

6. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said second predetermined period is 12 to 96 hours.

7. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said third predetermined period is 12 to 24 hours.

8. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said fourth predetermined time period is 24 to 96 hours.

9. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein said sterile dialysate is also ultra pure dialysate.

10. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein the exchanging the sterile dialysate is performed by the patient.

11. The method of installing and servicing a completely wearable CRRT device of claim 1, wherein replenishing one or more additives is performed by the patient.

12. A method of servicing a completely wearable CRRT device comprising:

changing a dialyzer in said completely wearable CRRT device, in a sterile environment, after a first predetermined time period;

continuously adding an anticoagulation additive, by said completely wearable CRRT device, at an input side of said completely wearable CRRT device while said completely wearable CRRT device is operating;

changing a dialysate purification system after a second predetermined time period;

recharging or replacing a portable power source in said completely wearable CRRT device after a third predetermined time period.

exchanging the sterile dialysate in the completely wearable CRRT device with new sterile dialysate after a fourth predetermined time period; and

replenishing one or more additives in said completely wearable CRRT device.

13. The method of servicing a completely wearable CRRT device of claim 12, wherein said first predetermined time period is between about one to about thirty days.

14. The method of servicing a completely wearable CRRT device of claim 12, wherein said second predetermined period is greater than 12 hours.

15. The method of servicing a completely wearable CRRT device of claim 12, wherein said third predetermined period is greater than 12 hours.

16. The method of servicing a completely wearable CRRT device of claim 12, wherein said fourth predetermined time period is 24 to 96 hours.

17. The method of servicing a completely wearable CRRT device of claim 12, wherein said changing said dialysate purification system is performed by a patient wearing said completely wearable CRRT device.

18. The method of servicing a completely wearable CRRT device of claim 12, wherein said exchanging of said sterile dialysate is performed by said patient.

19. The method of servicing a completely wearable CRRT device of claim 12, wherein exchanging said sterile dialysate requires an exchange of less than 1 liter sterile dialysate.

20. In a completely wearable CRRT device that operates with less than about 1 liter of dialysate, a method of servicing said completely wearable CRRT device comprising:

installing less than about 1 liter of sterile dialysate into said completely wearable CRRT device;

changing a dialyzer in said completely wearable CRRT device, every 2 to 30 days of device operation, in a substantially sterile environment;

changing a dialysate filter cartridge every 12 to 96 hours of device operation;

changing said less than about 1 liter of sterile dialysate, every 24 to 96 hours of device operation; and

adding dialysate additives to said completely wearable CRRT device every 24 to 96 hours of operation.