WO2002070042B1 - Methods, systems, and kits for the extracorporeal processing of blood - Google Patents

Methods, systems, and kits for the extracorporeal processing of blood

Info

Publication number
WO2002070042B1
WO2002070042B1 PCT/US2001/006906 US0106906W WO02070042B1 WO 2002070042 B1 WO2002070042 B1 WO 2002070042B1 US 0106906 W US0106906 W US 0106906W WO 02070042 B1 WO02070042 B1 WO 02070042B1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
flow rate
pump
blood flow
patient
Prior art date
Application number
PCT/US2001/006906
Other languages
French (fr)
Other versions
WO2002070042A1 (en
Inventor
James M Brugger
Charles David Finch
Jeffrey H Burbank
Original Assignee
Nxstage Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nxstage Medical Inc filed Critical Nxstage Medical Inc
Priority to PCT/US2001/006906 priority Critical patent/WO2002070042A1/en
Publication of WO2002070042A1 publication Critical patent/WO2002070042A1/en
Publication of WO2002070042B1 publication Critical patent/WO2002070042B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3626—Gas bubble detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3663—Flow rate transducers; Flow integrators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/279—Peristaltic pumps, e.g. roller pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/438—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/523—Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/546—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood flow, e.g. by adapting rotor speed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate

Abstract

Methods, systems, and kits for extracorporeally circulating and processing blood are described. The systems include a pump, a processing unit, and blood drawn return lines for accessing a patient's vasculature. Blood flow through the return line is measured and pump speed controlled to maintain a desired blood flow rate. Alarm conditions can be initiated when expected pump performance differs from that needed to maintain the control point flow rate. By using an ultrasonic flow detector, gas bubbles in the blood flow can be detected.

Claims

22
AMENDED CLAIMS
[received by the International Bureau on 4 February 2002 (04.02.02); original claims 16, 30, 36 and 41 amended; remaining claims unchanged (5 pages)]
15. A method as in claim 1, wherein the processing step comprises a treatment selected from the group consisting of hemodialysis, hemofϊliraiion, hemodiafiltration, and apheresis.
16. A system for processing blood, said system comprising: a pump having a known relationship between pump speed and output flow rate; a processing unit connectable to receive blood from the pump; a blood draw line connectable between a patient and the pump and without an air-blood interface; a blood return line connectable between the processing unit and the patient and without an air-blood interface; an external flow detector that can be positioned adjacent to an exterior surface of the blood return line to provide a measured blood flow rate; and a control unit connectable to the pump and the external flow detector, wherein the control unit adjusts the pump speed to maintain the measured flow rate at a control point.
17. A system as in claim 16, wherein the pump is a positive displacement pump.
18. A system as in claim 17, wherein the positive displacement pump is a peristaltic pump.
19. A system as in claim 16, wherein the processing unit is selected from the group consisting of hemodialysis units, hemofiltration units, hemodiafiltration units, and apheresis units.
20. A system as in claim 16, wherein the blood draw line comprises a catheter having a patient access connector at one end and a pump connector at the other end, and wherem the return line comprises a catheter having a patient access connector at one end and a processing unit connector at the other end.
21, A system as in claim 20, wherein both catheters are free from drip chambers.
22, A system as in claim 16, wherein the external flow detector comprises an ultrasonic detector.
23. A system as in claim 22, wherein the ultrasonic detector also detects gas bubbles in blood passing through the return line.
24, A system as in claim 16, wherein the control unit comprises a microprocessor.
25. A system as in claim 16, wherein the control unit received user input to set the control point in the range from 100 ml/min to 1000 ml/min.
26. A system as in claim 16. wherein the control unit determines an expected blood flow rate based on the adjusted pump speed, determines a difference between the expected flow rate and the measured flow rate, and initiates an alarm condition when the difference exceeds a threshold value.
27. A system as in claim 16, wherein the control unit receives a value of actual pump power consumption from the pump, determines an expected pump power consumption value based on the pump speed, determines a difference between the actual and expected values of pump power consumption; and initiates an alarm condition if the difference exceeds a threshold value.
28. A system as in claim 16, further comprising an external pressure detector that can be positioned adjacent to an exterior surface of the blood return line, wherem the control unit is connectable to the pressure detector to detennine if the pressure 24
exceeds a threshold value.
29. A system as in claim 28, wherein the pressure detector comprises a constriction placed over the return line and a gauge for monitoring radially outward forces on the constriction, wherein an output of the gauge is fed back lo the control unit.
30. A kit comprising: a blood draw catheter; a blood return catheter; and instructions for use setting forth a method comprising the steps of: pumping blood through tubing with a pump having a theoretical relationship between pump speed and flow rate, die tubing adapted for drawing blood from a patient and for returning blood to the patient without an air-blood interface; measuring the actual blood flow rate delivered by the pump; controlling the pump speed to maintain the measured blood flow rate at a control point; and processing the blood.
31. A method for extracorporeally processing blood, said method comprising: drawing blood from patient; pumping the drawn blood with a peristaltic pump at a predetermined stroke volume and rate which corresponds to a theoretical pumped blood flow rate; directly measuring the actual blood flow rate delivered by the pump; comparing the actual blood flow rate with the theoretical pumped blood flow rate, and, if a difference of a predeteπnined minimum value exists, signaling an alarm condition.
32. The method of claim 31 comprising the step of slowing or slopping pump operation when said difference has said predetermined minimum value. 25
33. The method of claim 31 wherein the measuring step comprises: ultrasonically measuring the flow rate using a sensor disposed externally to the blood flow.
34. A method for extracorporeally processing blood, said method comprising: drawing blood from patient; pumping the drawn blood with a peristaltic pump at a predetermined stroke volume and rate which corresponds to a theoretical pumped blood flow rale; directly measuring the actual blood flow rate delivered by the pump; comparing the actual blood flow rate with the theoretical pumped blood flow rate, and, if a difference of a predetermined minimum value exists, altering the pumping rate to change said pumped blood flow rate to a value that more closely matches the theoretical pumped blood flow rate.
35. The method of claim 34, wherein the measuring step comprises: ultrasonically measuring the flow rate using a sensor disposed externally ro the blood flow.
36. Apparatus for extracorporeally processing blood, which comprises: tubing having connectors for drawing blood from a patient and for returning blood to the patient without an air-blood interface, said tubing being connectable to or comprising a section of peristaltic pump tubing; a controller which operates said peristaltic pump at a desired stroke volume and rate which corresponds to a theoretical pumped blood flow rate; apparatus which directly measures the actual blood flow rate delivered by the pump Lhrough the tubing; apparatus which compares the directly measured actual blood flow rate with the theoretical pumped blood flow rate and which generates a signal if a difference exists in said rates of a predeteπnined minimum value. 26
37- The apparatus of claim 36 comprising a system that stops operation responsive to said signal.
38. The apparatus of claim 36 in which the apparatus that measures flow comprises an ultrasonic sensor.
39. The apparatus of claim 36 which further comprises a system which alters the pumping rale to change said actual pumped blood flow rale to a value thai closely matches the theoretical pumped blood flow rate when a difference between the theoretical pumped blood flow rate and the actual blood flow rate exists.
40. The apparatus of claim 36 in which said mbing is free of air- containing chambers.
41. A blood processing system comprising: a pump operable at different pump speeds to convey blood through a padi of tubing for drawing blood from a patient and returning blood to the palient without an air-blood interface; a sensor to monitor blood flow rate through the path and output a monitored blood flow rate; and a controller coupled lo ihe pump and the sensor lo adjust pump speed as a function of the monitored blood flow rate.
42. A system according to claim 41, said system further including a sensor to sense presence of air in the path.
43. A system according to claim 41, wherein the sensor monitors both presence of air and the blood flow rate.
44. A system according to claim 41, wherein the sensor transmits ultrasonic energy.
PCT/US2001/006906 1998-02-11 2001-03-01 Methods, systems, and kits for the extracorporeal processing of blood WO2002070042A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2001/006906 WO2002070042A1 (en) 1998-02-11 2001-03-01 Methods, systems, and kits for the extracorporeal processing of blood

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US7438798P 1998-02-11 1998-02-11
PCT/US2001/006906 WO2002070042A1 (en) 1998-02-11 2001-03-01 Methods, systems, and kits for the extracorporeal processing of blood

Publications (2)

Publication Number Publication Date
WO2002070042A1 WO2002070042A1 (en) 2002-09-12
WO2002070042B1 true WO2002070042B1 (en) 2002-10-31

Family

ID=21742376

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/006906 WO2002070042A1 (en) 1998-02-11 2001-03-01 Methods, systems, and kits for the extracorporeal processing of blood

Country Status (2)

Country Link
US (2) US7004924B1 (en)
WO (1) WO2002070042A1 (en)

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