EXTRACORPOREAL BLOOD TREATMENT AND SYSTEM HAVING REVERSIBLE BLOOD PUMPS

• US 20130261529A1
• Filed: 05/29/2013
• Published: 10/03/2013
• Est. Priority Date: 12/03/2004
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro UF Solutions, Inc. (Baxter International Inc.)
• Inventors: O'Mahony, John
• Granted Patent: US 9,089,653 B2
• Time in Patent Office: Days
• US Class Current: 604/6.07
• CPC Class Codes: A61M 1/16 with membranes
• 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 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3306 Optical 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 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• 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 60/408 the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/857 Implantable blood tubes

Abstract

An extracorporeal blood processing method using a blood circuit comprising a pair of blood passages attached to opposite flow ends of a blood treatment device and said blood circuit is mounted on a blood pump console, the method includes: withdrawing blood from a vascular system of a human patient and drawing the blood into the blood circuit; pumping the withdrawn blood through one of the pair of blood passages using a first blood pump of the console and into the blood treatment device; pumping the treated blood from the treatment device through the other of the pair of blood passages using a second blood pump of the console; infusing the treated blood from the other blood passage and into the vascular system of the patient, and periodically reversing a flow direction of blood through the pair of blood passages and blood treatment device.

Claims

1. An extracorporeal blood processing method using a blood circuit comprising a pair of blood passages attached to opposite flow ends of a blood treatment device and said blood circuit is mounted on a blood pump console, said method comprising:

a. withdrawing blood from a vascular system of a human patient and drawing the blood into the blood circuit;

b. pumping the withdrawn blood through one of the pair of blood passages using a first blood pump of the console and into the blood treatment device;

c. pumping the treated blood from the treatment device through the other of the pair of blood passages using a second blood pump of the console;

d. infusing the treated blood from the other blood passage and into the vascular system of the patient, and

e. periodically reversing a flow direction of blood through the pair of blood passages and blood treatment device.

2. The extracorporeal blood processing method in claim 1 wherein the blood treatment device is a blood filter.

3. The extracorporeal blood processing method in claim 1 wherein the pair of blood passages are similar in length.

4. The extracorporeal blood processing method in claim 1 wherein the blood treatment device is an ultrafiltration blood filter.

5. The extracorporeal blood processing method in claim 1 wherein a pump controller of said console cyclically switches the first and second blood pumps to reverse the blood flow direction after a volume of blood pumped through one of said pair of blood passage is in a range of 50 ml to 200 ml.

6. The extracorporeal blood processing method in claim 1 wherein the pair of blood passages each include a tube connectable to a catheter.

7. The extracorporeal blood processing method in claim 1 wherein the pair of blood passages each include a tube connectable to an implanted blood access device.

8. The extracorporeal blood processing method in claim 1 wherein said treatment device further comprises a filter having a filtrate output tube and said system further comprises a filtrate pump connectable to the filtrate output tube, wherein the filtrate pump is temporarily stopped while the flow direction is reversed.

9. The extracorporeal blood processing method in claim 1 wherein said controller operates the blood pumps to move blood through the circuit at a flow rate in a range of five milliliters per minute (ml/min) to fifteen ml/min.

10. The extracorporeal blood processing method in claim 1 wherein the circuit comprises an air in blood detection device coupled to each of the pair of blood passages, and said method further comprises monitoring for air in the blood flow through the pair of blood passages and stopping the blood flow in the circuit if air is detected in the blood flow.

11. The extracorporeal blood processing method in claim 1 wherein a rate of pumping the withdrawn blood is initially selected by human operator and thereafter is automatically adjusted by a controller of the pump console.

12. The extracorporeal blood processing method in claim 1 wherein the flow direction is cyclically reversed.

13. The extracorporeal blood processing method in claim 1 wherein the flow direction is reversed in a response to an abnormal pressure detected in the blood passage.

14. The extracorporeal blood processing method in claim 1 wherein the flow direction is reversed when a blood volume through the circuit is in a range of 50 ml to 200 ml.

15. The extracorporeal blood processing method in claim 1 further comprising adding an anticoagulant to the withdrawn blood upstream of the treatment device during both flow directions.

16. The extracorporeal blood processing method in claim 1 further comprising adding an anticoagulant to the withdrawn blood upstream of the treatment device during both flow directions, wherein a pair of one-way valves connected to the blood passages and on opposite sides of the blood treatment device allow the anticoagulant to enter the blood passages upstream of the blood treatment device.

17. The extracorporeal blood processing method in claim 1 further comprising adding an anticoagulant to the withdrawn blood upstream of the treatment device during both flow directions, wherein said one-way valves are connected to both pair of blood passages and are on opposite sides of the blood treatment device allow the anticoagulant to enter only the blood passage which has the lowest pressure.

18. The extracorporeal blood processing method in claim 16 wherein the one-way valves prevent anticoagulant flowing in one of the blood passages downstream of the blood treatment device.

19. The extracorporeal blood processing method of claim 16 wherein the one-way valves operate automatically.

20. The extracorporeal blood processing method of claim 16 wherein the one-way valves are actuated by a pressure in the blood passages.

21. The extracorporeal blood processing method of claim 16 wherein the one-way valves are actuated to an open position by a relative positive pressure in one of the blood passages and to a closed position by a relative negative pressure in the other blood passage.

22. The extracorporeal blood processing method of claim 1 further comprising detecting a leak in the blood passages by monitoring the blood passages for air entrained in the blood flow.

23. The extracorporeal blood processing method of claim 22 wherein the flow direction is reversed before a volume of the treated blood infused into the patient exceeds a predetermined volume in a range of 50 ml to 200 ml.

24. A method of extracorporeal blood processing using a blood circuit comprising a pair of blood passages attached to opposite flow ends of a blood treatment device and the blood circuit is mounted on a blood pump console, said method comprising:

a. withdrawing blood from a vascular system of a human patient and drawing the blood into the blood circuit;

b. pumping the withdrawn blood through one of the pair of blood passages using a first blood pump of the console and into the blood treatment device;

c. pumping the treated blood from the treatment device through the other of the pair of blood passages using a second blood pump of the console;

d. infusing the treated blood from the other blood passage and into the vascular system of the patient;

e. periodically reversing a flow direction of blood through the pair of blood passages and blood treatment device, and

f. sensing a pressure in the blood passage downstream of the blood treatment device during both flow directions, and

g. controlling a pumping rate of blood through the downstream blood passages based on the pressure in the downstream blood passage.

25. A method as in claim 24 wherein the pressure is sensed is a blood infusion pressure downstream of the second blood pump.

26. A method as in claim 24 wherein the first blood pump is controlled based on the sensed pressure in the downstream passage.

27. A method as in claim 24 wherein the blood treatment device is a filter and said method further comprises pumping filtrate from the filter at a filtrate rate and said controlling the pumping rate comprises determining a pumping rate for the blood passage downstream of the filter based on a difference between the pumping rate of the upstream blood passage and the filtrate rate.

28. A method as in claim 24 further comprising, upon detecting an occlusion in the withdrawal of blood, controlling a pumping rate for the upstream passage based on a pressure in the upstream passage.

29. A method as in claim 24 wherein the pressure in the downstream blood passage is sensed between an outlet of the blood treatment device and a downstream pump coupled to the downstream blood passage.

30. A method as in claim 24 further comprising, upon detecting an occlusion in the infusion of blood, controlling a pumping rate for the downstream passage based on a pressure in the downstream passage between the downstream pump and where the blood is infused.

31. A method as in claim 24 further comprising, upon detecting the occlusion in the infusion of blood, controlling a pumping rate for the blood passage upstream of the blood treatment device based on the pressure in the downstream blood passage between the blood treatment device and the downstream pump.

32. A method for monitoring a volume of filtrate in a collection bag comprising:

a. placing the collection bag in a walled container having a displaceable surface;

b. filtering filtrate from extracorporeal blood flowing through a blood circuit;

c. filling the collection bag with the filtrate;

d. as the collection bag fills with filtrate, the bag expands and displaces the displaceable surface;

e. sensing a degree of displacement of the displaceable surface, and

f. ceasing filling the collection bag with filtrate when the degree of displacement exceeds a threshold value.

33. A method as in claim 32 wherein the displacement surface is biased by a spring and sensing the degree of displacement by sensing a force applied by the spring.

34. A method as in claim 32 wherein the displacement surface is biased by a spring and sensing the degree of displacement by a mechanical relay.

35. A filtrate collection container system comprising:

a container having at least one wall to receive the collection container;

a displaceable wall of said container abutting the collection container;

a bias applied to dispose the displaceable wall against the collection container, and

a sensor detecting a force applied by the collection container against the displaceable wall.

36. The filtration collection container system of claim 35 wherein the sensor outputs signal indicative of the force, and

said system further comprises a filtrate pump and a pump controller, wherein the controller stops the filtrate pump upon receipt of a the sensor output signal indicative of a force above a predetermined threshold level.

37. The filtration collection container system of claim 35 wherein the bias further comprises a spring applying a force against the displaceable wall.

38. A method of collecting filtrate in a filtration bag of an extracorporeal blood circuit having a blood filter, said method comprising:

a. withdrawing blood from a mammalian patient into the blood circuit and filtering the blood with the filter;

b. withdrawing filtrate from the filter and collecting the filtrate in an expandable container;

c. sensing an expansion of the container as filtrate is collected in the container, and

d. determining the container is filled with filtrate based on the expansion of the container.

39. The method as in claim 38 wherein the container is a collection bag.

40. The method as in claim 38 wherein the circuit further comprises a chamber for the container and said chamber includes a displaceable wall and a bias applying a force to the displaceable wall, wherein said method further comprises positioning the container against the displaceable wall, displacing the wall by the expansion of the container, and sensing a displacement of the wall due to the expansion of the container.

41. A extracorporeal blood treatment system comprising:

a blood circuit comprising a first blood passage coupled to a blood filter and a second blood passage coupled to the blood filter, wherein said first and second blood passages are each configured to be coupled to a vascular system of a human patient;

a first blood pump connectable to the first blood passage and a second blood pump connectable to the second blood passage, wherein said first and second blood pumps are configured to move blood through the first and second blood passages and the blood filter in a first direction and in a reverse direction,

a filtrate pump configured to withdraw filtrate from the filter, and

a pump controller operatively connected to the first and second blood pumps and to said filtrate pump.

42. The extracorporeal blood treatment system of claim 41 wherein said controller is configured to operate the blood pumps to cyclically move blood through the first and second blood passages in the first direction and the reverse direction.

43. The extracorporeal blood treatment system of claim 41 wherein said controller cyclically ceases the filtrate pump during periods during which blood through the filter is reversed.

44. The extracorporeal blood treatment system of claim 41 further comprising pressure sensors on each of said first blood passage and said second blood passage, and wherein said controller maintains the filter under a continuous negative pressure.

45. The extracorporeal blood treatment system of claim 44 wherein the continuous negative pressure is within a predetermined pressure range.

46. The extracorporeal blood treatment system of claim 41 further comprising pressure sensors on each of said first blood passage and said second blood passage, and wherein said controller controls a speed of the blood pump downstream of the filter based on a pressure in the blood passage downstream of the filter.

47. The extracorporeal blood treatment system of claim 46 wherein said controller controls a speed of the blood pump upstream of the filter based on the speed of the downstream pump.

48. The extracorporeal blood treatment system of claim 46 wherein said controller controls a speed of the blood pump upstream of the filter based on the speed of the downstream pump and a speed of a filtrate pump.

49. The extracorporeal blood treatment system of claim 41 further comprising a harness wearable by the patient and said harness supports the blood treatment system.

50. The extracorporeal blood treatment system of claim 49 wherein the harness comprises a belt which wraps around a waist of the patient and said belt supports the blood pumps, filter pump, pump controller and filter.

51. A portable extracorporeal blood treatment system comprising:

a blood circuit comprising a first blood passage coupled to a blood filter and a second blood passage coupled to the blood filter, wherein said first and second blood passages are each configured to be coupled to a vascular system of a human patient;

at least one blood pump connectable to the first blood passage, wherein said pump is configured to move blood through the first and second blood passages and the filter,

a filtrate collection container receiving filtrate withdrawn from the filter,

a pump controller operatively connected to the blood pump to control a blood withdrawal rate into the blood circuit, and

a harness wearable by the patient and said harness supports the blood pump, filter, pump controller and filtrate collection container.

52. A portable extracorporeal blood treatment system as in claim 51 further comprising a pump controller user interface comprising a display and a user input device.

53. A portable extracorporeal blood treatment system as in claim 52 wherein the user input device is a key pad.

54. A portable extracorporeal blood treatment system as in claim 52 wherein the pump periodically reverses a blood flow direction through the passages.

55. A portable extracorporeal blood treatment system as in claim 54 wherein pump periodically reverses the blood flow direction after a volume of blood flow through the circuit is no greater than 200 ml.