Wearable continuous renal replacement therapy device

• US 7,309,323 B2
• Filed: 09/14/2004
• Issued: 12/18/2007
• Est. Priority Date: 11/16/2001
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: National Quality Care Inc.
• Inventors: Gura, Victor, Rambod, Edmond
• Primary Examiner(s): Deak; Leslie R.
• Application Number:
  US10/940,862
• Publication Number:
  US 20050101901A1
• Time in Patent Office: 1,190 Days
• Field of Search: 604/6.09, 604/6.11, 604/5.01, 604/5.04, 604/6.15, 604/6.16, 210645-646, 210/600, 210/634, 210/644, 210/195.2, 210/416.1, 210/433.1, 210/321.71, 210/500.21, 210/258, 210/259, 210/739, 422/44
• US Class Current: 604/5.04
• 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 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3386 Low level detectors
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 adapted to be worn on a portion of the body of a patient. The CRRT device is worn by the patient and operates on rechargeable batteries for more than 5 hours. Dialysate is used to remove impurities from the blood. The dialysate is recycled and refreshed by a filter section. Less than one liter of dialysate is required to circulate through the wearable CRRT device.

Claims

1. A continuous renal replacement therapy (CRRT) device comprising:

means for enabling a patient to wear the entire CRRT device;

a microcontroller, said microcontroller adapted to be powered by a battery;

a dual channel pulsatile pump, controlled by said microcontroller, said dual channel pulsatile pump comprising a single motor, a first pump channel and a second pump channel, said dual channel pulsatile pump adapted to be powered by said battery;

a blood circuit comprising;

a blood inlet tube for receiving blood from a patient;

said first pump channel for pumping blood in a pulsatile manner through said blood circuit;

a first micropump for pumping an anticoagulant into said blood circuit, said micro pump being controlled by said microcontroller;

a dialyzer receiving blood pumped by said first pump channel;

a pressure transducer for providing a blood circuit pressure signal to said microcontroller;

an outlet port for allowing blood to go back into said patient after being received by said dialyzer; and

a dialysate circuit for circulating dialysate through said dialyzer and for removing contaminants from said circulating dialysate, said dialysate circuit comprising;

a filter section for reacting with predetermined substances in said dialysate in order to refresh said dialysate for continued usage in said dialysate circuit;

said second pump channel for pumping dialysate at a flow rate between 40 ml/min and 100 ml/min (pulsatile) through said dialysate circuit;

a sensor, attached to said dialysate circuit, providing a signal to said microprocessor indicating that said filter section requires maintenance;

a degasser, attached to said dialysate circuit, for removing gas from said dialysate circuit; and

said CRRT device being adapted to operate on less than 10 watts of power.

2. The CRRT device of claim 1, wherein said CRRT device being adapted to operate on less than 3 watts of power.

3. The CRRT device of claim 1, wherein said battery can power said CRRT device for more than six continuous hours.

4. The CRRT device of claim 1, farther comprising a moisture sensor for providing a signal to said microcontroller indicating that said moisture sensor is sensing moisture in said CRRT device.

5. The CRRT device of claim 4, wherein said microcontroller initiates an alarm condition upon an indication that said moisture sensor is sensing moisture in said CRRT device.

6. The CRRT device of claim 1, further comprising a wireless communication device in electrical communication with said microcontroller, said communication device adapted to communicate wirelessly with a medical facility.

7. The CRRT device of claim 1, wherein said first pump channel and said second pump channel, of said dual channel pulsatile pump, pump in opposing directions.

8. The CRRT device of claim 1, wherein said first pump channel can pump blood at a variably controlled rate between zero to about 100 ml/min.

9. The CRRT device of claim 1, wherein said first pump channel can pump blood at a controlled rate between zero to about 80 ml/min.

10. The CRRT device of claim 1, wherein said first pump channel and said second pump channel each pulsatile pump a predetermined number of degrees out of phase.

11. The CRRT device of claim 1, wherein said CRRT device is adapted to weigh less than about 5 pounds when operating.

12. The CRRT device of claim 1, wherein said dual channel pulsatile pump provides an occlusion signal to said microcontroller.

13. The CRRT device of claim 1, wherein said blood circuit further comprises an additional micropump for adding at least one of electrolytes, blood additives, drugs, vitamins and hormones to said blood prior to said blood returning to said patient.

14. The CRRT device of claim 1, wherein said micropump is adapted to pump a fluid at a rate between 0.1 and 400 ml/hr.

15. The CRRT device of claim 1, wherein said first micropump requires between 1 and 500 milli watts to operate.

16. The CRRT device of claim 1, further comprising an anticoagulant reservoir in fluid communication with said first micropump and a fluid sensor associated with said anticoagulant reservoir, said fluid sensor providing a signal to said microcontroller when a volume of anticoagulant in said anticoagulant reservoir is below a predetermined volume.

17. The CRRT device of claim 1, wherein said filter section comprises at least one filter and wherein said at least one filter is adapted to be inserted and removed from said means for enabling said patient to wear the entire CRRT device as a disposable cartridge.

18. The CRRT device of claim 1, wherein said second pump channel is adapted to variably pump said dialysate at a flow rate between zero and 80 ml/min.

19. The CRRT device of claim 1, wherein said CRRT device is adapted to operate with a volume of dialysate between 100 ml and 1 liter while operating continuously for twenty-four hours.

20. The CRRT device of claim 1, wherein said CRRT device is adapted to operate with between 100 and 300 ml of dialysate for a period of twenty-four hours.

21. The CRRT device of claim 1, wherein said dialysate comprises ultra-pure dialysate.

22. The CRRT device of claim 1, wherein said CRRT device is adapted to circulate less than about 1 liter of dialysate.

23. The CRRT device of claim 1, wherein said dialyzer comprises less than 0.5 meters of dialyzing surface area.

24. The CRRT device of claim 1, wherein said filter section comprises a plurality of filter cartridges.

25. The CRRT device of claim 1, wherein said sensor senses a pH of said dialysate.

26. The CRRT device of claim 1, wherein said sensor senses a presence of a predetermined substance in said dialysate.

27. The CRRT device of claim 26, wherein said predetermined substance is ammonia.

28. The CRRT device of claim 1, wherein said degasser is an integral part of said filter section.

29. The CRRT device of claim 28, wherein said filter section comprises at least one filter cartridge and said degasser is an integral part of at least one filter cartridge.