ENHANCED CLEARANCE IN AN ARTIFICIAL KIDNEY INCORPORATING A PULSATILE PUMP

• US 20110125073A1
• Filed: 12/23/2010
• Published: 05/26/2011
• Est. Priority Date: 11/16/2001
• Status: Active Grant

• 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
• Granted Patent: US 8,641,655 B2
• Time in Patent Office: Days
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1617 using measurements made during a temporary variation of a characteristic of the fresh dialysis fluid
• CPC Class Codes: A61M 1/1649 with pulsatile dialysis fluid flow
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• CPC Class Codes: A61M 1/882 Draining devices provided with means for releasing antimicrobial or gelation agents in the drained fluid
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• 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 2205/50 : 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
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/232 : Centrifugal pumps
• CPC Class Codes: A61M 60/258 : Piston pumps
• CPC Class Codes: A61M 60/279 : Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/37 : Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/546 : of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/562 : for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
• CPC Class Codes: B01D 2311/14 : Pressure control
• CPC Class Codes: B01D 61/32 : Controlling or regulating

Abstract

A continuous renal replacement therapy (CRRT) device is provided that weighs between 2 and 10 pounds. The CRRT device can be portable, mobile or completely worn on the person of the patient. Blood and dialysate are each pumped in a pulsed or pulsatile manner through a dialyzer such that a significant portion of the peak pulse of the blood flow coincides with a significant portion of a low pulse portion of the dialysate flow. An differential pressure between a dialysate inlet of the dialyzer and the blood inlet of the dialyzer periodically changes from a high differential pressure of between 70 and 120 mmHg for a first time period and a low differential pressure of between −10 and 10 mmHg for a first time period and a low differential pressure of between −10 and 10 mmHg for a second time period. The frequency of the high and low differential pressure cycle is between about 0.5 and 4 Hz.

Claims

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

a blood pump channel for providing a pulsed blood flow, said pulsed blood flow being periodic such that each period comprises a high blood pressure portion having a first duration and a low blood pressure portion having a second duration, said first duration and said second duration having a duration ratio between about 3;

4 and 4;

3;

a dialysate pump channel for providing a pulsed dialysate flow;

said pulsed dialysate flow being periodic such that each period comprises a high dialysate pressure portion having said second duration and a low dialysate pressure portion having said first duration;

wherein said high blood pressure portion and said low dialysate pressure portion occur, at least in part, during a first periodic time frame; and

a dialyzer comprising;

a blood inlet for receiving said pulsed blood flow;

a plurality of fibers, each fiber comprising a semi permeable membrane exterior and a lumen extending the length of the fiber, said lumen being for said pulsed blood flow to flow through;

a blood outlet for said pulsed blood flow to exit said dialyzer;

a dialysate inlet for receiving said pulsed dialysate flow;

a dialysate chamber, about said plurality of fibers, for said pulsed dialysate flow to flow through, and semi permeable membranes of said plurality of fibers being between each said lumen and said dialysate chamber; and

a dialysate outlet for said pulsed dialysate flow to exit said dialyzer;

wherein said blood pump channel, said dialysate channel and said dialyzer are configured to establish a peak Trans Membrane Pressure (TMP) across said semi permeable membranes of said plurality of fibers and between said pulsed blood flow in said lumens and said pulsed dialysate flow in said dialysate chamber, said peak TMP occurring during said first periodic time frame, said peak TMP being between about 70 mmHg and 120 mmHg.

2. The CRRT device of claim 1, wherein said low blood pressure portion and said high dialysate pressure portion both occur, at least in part, during a second periodic time frame, and wherein said blood pump channel, said dialysate channel and said dialyzer are configured to establish a minimum TMP across said semi permeable membranes of said plurality of fibers and between said pulsed blood flow in said lumens and said pulsed dialysate flow in said dialysate chamber, and wherein said minimum TMP occurs during said second periodic time frame, said minimum TMP being between about 10 mmHg and −

10 mmHg.

3. The CRRT device of claim 1, wherein said CCRT device is completely wearable on a patient.

4. The CCRT device of claim 1, wherein said blood pump channel provides said pulsed blood flow with a periodic flow rate of between 0.5 and 4 Hz and wherein said dialysate pump channel provides a pulsed dialysate flow with said periodic flow rate.

5. The CRRT device of claim 2, wherein the combination of said peak TMP that occurs during said first periodic time frame and said minimum TMP that occurs during said second periodic time frame inhibit clogging of said lumens and semi permeable membranes.

6. The CRRT device of claim 1, wherein said pulsed blood flow is a pulsatile blood flow.

7. The CRRT device of claim 1, wherein said pulsed blood flow a pulsatile blood flow.

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

a blood pump channel for providing a pulsatile blood flow, said pulsatile blood flow being periodic such that each period comprises a high blood pressure portion having a first duration and a low blood pressure portion having a second duration, said first duration and said second duration having a duration ratio of between about 3;

4 and about 4;

3;

a dialysate pump channel for providing a pulsatile dialysate flow;

said pulsatile dialysate flow being periodic such that each period comprises a high dialysate pressure portion having said second duration and a low dialysate pressure portion having said first duration;

wherein said high blood pressure portion and said low dialysate pressure portion occur, at least in part, during a first periodic time frame; and

a dialyzer comprising;

a blood inlet for receiving said pulsatile blood flow;

a plurality of fibers, each fiber comprising a semi permeable membrane exterior and a lumen extending the length of the fiber, said lumen being for said pulsatile blood flow to flow through;

a blood outlet for said pulsatile blood flow to exit said dialyzer;

a dialysate inlet for receiving said pulsatile dialysate flow;

a dialysate compartment, about said plurality of fibers, for said pulsatile dialysate flow to flow through; and

a dialysate outlet for said pulsatile dialysate flow to exit said dialyzer;

wherein said blood pump channel, said dialysate channel and said dialyzer are configured to establish a peak blood inlet-to-dialysate outlet differential pressure, said peak blood inlet-to-dialysate outlet differential pressure occurring during said first periodic time frame, said peak blood inlet-to-dialysate outlet differential pressure being between about 60 mmHg and about 150 mmHg.

9. The CRRT device of claim 8, wherein said low blood pressure portion and said high dialysate pressure portion both occur, at least in part, during a second periodic time frame, and wherein said blood pump channel, said dialysate channel and said dialyzer are configured to establish a minimum blood inlet-to-dialyzer output differential pressure, and wherein said minimum blood inlet-to-dialyzer output differential pressure occurs during said second periodic time frame, said minimum blood inlet-to-dialyzer output differential pressure being between about 10 mmHg and about −

10 mmHg.

10. The CRRT device of claim 8, further comprising a dual channel pulsatile pump that comprises said blood pump channel and said dialysate pump channel

11. The CRRT device of claim 8, wherein said CRRT device is completely wearable as a single device on a patient.

12. A method of continuous renal replacement therapy (CRRT) comprising:

pumping blood, by a pulsatile blood pump, to provide a pulsatile blood flow, said pulsatile blood flow being periodic such that each period comprises a high blood pressure portion having a first duration and low blood pressure portion having a second duration, said first duration and said second duration having a duration ratio of between about 3;

4 and 4;

3;

pumping dialysate, by a pulsatile dialysate pump, to provide a pulsatile dialysate flow, said pulsatile dialysate flow being periodic such that each period comprises a high dialysate pressure portion having said second duration and a low dialysate pressure portion having said first duration;

wherein said high blood pressure portion and said low dialysate portion occur, at least in part, during a first periodic time frame;

establishing a blood inlet-to-dialysate outlet differential pressure between a blood inlet of a dialyzer and a dialysate outlet of said dialyzer;

wherein said blood inlet-to-dialysate outlet differential pressure oscillates between a maximum differential pressure and a minimum differential pressure at a pump frequency of between 0.5 and 4 Hz;

wherein said maximum differential pressure has a range of between about 60 mmHg and about 150 mmHg.

13. The method of claim 12, wherein said minimum differential pressure has a range of between about 10 mmHg and about −

10 mmHg for said pump frequency of between 0.5 and 4 Hz.

14. The method of claim 12, wherein said pulsatile blood pump and said pulsatile dialysate pump are each a separate pump channel of a dual channel pulsatile pump and are each operated by a same mechanical mechanism.

15. The method of claim 12, wherein pumping blood, by said pulsatile blood pump, further comprises pumping blood at an average pulsatile flow rate of between 30 and 90 milliliters/minute (ml/min).

16. The method of claim 12, wherein pumping dialysate, by said dialysate pump, further comprises pumping dialysate at an average pulsatile flow rate of between 30 and 90 ml/min.

17. A method of dialysis comprising:

receiving blood in a blood circuit of a dialysis device;

pumping the blood in a pulsed manner to provide an average pulsatile blood flow rate of between 30 and 90 ml/min;

pumping dialysate, in a dialysate circuit of said dialysis device, in a pulsed manner to provide an average pulsatile dialysate flow rate of between 30 and 90 ml/min;

receiving said pumped blood at a blood inlet of a dialyzer; and

receiving said pumped dialysate at a dialysate inlet of said dialyzer, wherein a pressure differential between said blood in said blood inlet and said dialysate in said dialysate inlet fluctuates at a periodic rate between 0 mmHg+/−

10 mmHg and 120 mmHg+/−

20 mmHg; and

transferring urea molecules from said blood to said dialysate while said blood and said dialysate are passing through said dialyzer;

cleaning said dialysate by a filtration means, said cleaned dialysate being recirculated in said dialysate circuit.

18. The method of claim 17, wherein cleaning said dialysate further comprises regenerating said dialysate by adding predetermined additivies to said dialysate.

19. The method of claim 17, wherein said periodic rate is between 0.5 and 4 Hz.

20. The method of claim 17, wherein said method is provided by at least one of a completely wearable and a portable dialysis device.

21. The method of claim 17, wherein said pumping of said blood further comprises pumping of said blood by a first channel of a dual channel pulsatile pump and said pumping of said dialysate further comprises pumping of said dialysate by a second channel of said dual channel pulsatile pump.

22. The method of claim 17, wherein said dual channel pulsatile pump pumps said blood and pumps said dialysate such that a peak flow of said blood occurs in an alternating pattern with a peak flow of said dialysate.

23. The method of claim 17, wherein said pumping said blood in a pulsed manner comprises providing in an alternating manner a high blood flow rate portion and a low blood flow portion, and wheren said pumping dialysate in a pulsed manner comprises providing in an alternating manner a high dialysate flow rate portion and a low dialysate flow rate portion, said high blood flow rate portion and said low dialysate flow rate portion each occurring, at least for a majority of their durations, at the same time.