Wearable continuous renal replacement therapy device

• US 7,896,829 B2
• Filed: 02/09/2007
• Issued: 03/01/2011
• Est. Priority Date: 11/16/2001
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Gura, Victor, Rambod, Edmond
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US11/673,419
• Publication Number:
  US 20070179425A1
• Time in Patent Office: 1,481 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 wearable Continuous Renal Replacement Therapy (CRRT) device comprising:

a dialyzer;

a blood circuit configured to move blood from a patient through said dialyzer and back to said patient;

a dialysate circuit configured to circulate dialysate through said dialyzer and to refresh said dialysate;

a microcontroller configured to control the movement of blood and dialysate through said blood circuit and said dialysate circuit respectfully;

a dual-channel pulsatile pump, controlled by the microcontroller, the dual-channel pulsatile pump comprising a single motor, a first pump channel in the blood circuit and a second pump channel in the dialysate circuit, the dual-channel pulsatile pump adapted to be powered by a battery;

a covering substantially covering said wearable CRRT device;

means for enabling a patient to wear said wearable CRRT device attached to said covering;

a moisture sensor, inside said covering for sensing moisture, said moisture sensor providing a moisture signal that indicates moisture presence on the inside the covering, to said microcontroller.

2. The wearable CRRT device of claim 1, adapted to operate between 5 watts and 10 watts of power.

3. The wearable CRRT device of claim 1, adapted to electrically connect to and hold a rechargeable battery, said rechargeable battery adapted to provide at least 5 hours of continuous power to said wearable CRRT device.

4. The wearable CRRT device of claim 1, wherein said dialysate circuit is configured to circulate and refresh said dialysate for at least 24 hours without requiring said dialysate to be replaced.

5. The wearable CRRT device of claim 1, further comprising at least one filter in said dialysate circuit for refreshing said dialysate.

6. The wearable CRRT device of claim 5, further comprising a dialysate sensor for sensing a physical attribute of said dialysate, said physical attribute being indicative of whether at least one filter has decreased efficiency.

7. The wearable CRRT device of claim 6, wherein said dialysate sensor senses for at least one of pH and ammonia.

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

9. The wearable CRRT device of claim 1, wherein said microcontroller is configured to monitor a plurality of sensing circuits and to determine if an alarm condition exists, the microcontroller being further configured to set an alarm condition wherein the patient is informed of the alarm condition.

10. The wearable CRRT device of claim 9, wherein said microcontroller is configured to turn off predetermined parts of said wearable CRRT device in the event of the alarm condition.

11. The wearable CRRT device of claim 1, wherein said dialysate circuit comprises at least one filter cartridge that is removable and replaceable by the patient.

12. The wearable CRRT device of claim 1, further comprising a micropump connected to add dialysate additives to said dialysate circuit, said micropump adapted to add an additive at a rate of 0.1 ml to 400 ml per hour.

13. The wearable CRRT device of claim 1, further comprising:

a fluid valve connected to said dialysate circuit for extracting fluid from said dialysate circuit; and

a bladder, in fluid connection with said fluid valve, said microcontroller configured to control said fluid valve, said microcontroller adapted to receive a signal from said bladder indicative of the fullness of said bladder.

14. The wearable CRRT device of claim 1 further comprising a gas valve for removing bubbles or gas from said dialysate circuit.

15. A wearable Continuous Renal Replacement Therapy (CRRT) device comprising:

a dialyzer;

a dual-channel pulsatile pump, the dual channel pulsatile pump comprises a single motor, a first pump channel for blood, and a second pump channel for dialysate, the dual-channel pulsatile pump adapted to accept power from a battery source;

a blood circuit comprising the first pump channel and the dialyzer, the blood circuit being configured to carry blood from a patient, through the first pump channel, through the dialyzer, and back to the patient;

a filter section configured to recycle the dialysate for continued use;

a dialysate circuit comprising the second pump channel, the dialyzer and a dialysate filter, the dialysate circuit being configured to circulate dialysate through the second pump channel, through the dialyzer, through the dialysate filter and back to the second pump channel;

a microcontroller configured to monitor and control the movement of blood and dialysate through the blood circuit and the dialysate circuit respectively;

a covering substantially covering the blood circuit and the dialysate circuit;

a moisture sensor inside the covering, the moisture sensor provides a moisture signal to the microcontroller that is indicative of the humidity or a liquid being present on the inside of the covering of the wearable CRRT device; and

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