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

• US 7,004,924 B1
• Filed: 10/19/1998
• Issued: 02/28/2006
• Est. Priority Date: 02/11/1998
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Brugger, James M., Burbank, Jeffrey H., Finch, Charles David
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Maiorino, Roz
• Application Number:
  US09/174,721
• Time in Patent Office: 2,689 Days
• Field of Search: 604/4, 604/7, 604/5, 604/6, 604/48, 604/95, 604/118, 604/123, 604/151, 604/186, 604/246, 604/540, 604/543, 604 401- 613, 604/65, 604/67, 604/28, 604/508, 600/16, 738/612.5, 73/191, 417 19- 54
• US Class Current: 604/6.13
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• 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 60/438 the force acting on the blood contacting member being mechanical
• CPC Class Codes: A61M 60/523 using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed

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 a ultrasonic flow detector, gas bubbles in the blood flow can be detected.

Claims

1. 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;

a blood return line connectable between the processing unit and the patient;

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;

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.

2. A system as in claim 1, wherein the pump is a positive displacement pump.

3. A system as in claim 2, wherein the positive displacement pump is a peristaltic pump.

4. A system as in claim 1, wherein the processing unit is selected from the group consisting of hemodialysis units, hemofiltration units, hemodiafiltration units, and apheresis units.

5. A system as in claim 1, 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 wherein the return line comprises a catheter having a patient access connector at one end and a processing unit connector at the other end.

6. A system as in claim 5, wherein both catheters are free from drip chambers.

7. A system for processing blood, comprising:

a fluid circuit connectable for drawing blood from patient;

a pump connectable to said fluid circuit to pump drawn blood at a predetermined stroke volume and rate which corresponds to a theoretical pumped blood flow rate;

a flow sensor connectable to said fluid circuit to directly measure the actual blood flow rate delivered by the pump;

a controller configured to compare the actual blood flow rate with the rate of the pump, and;

said controller being configured such that if a difference between said actual blood flow rate and a flow rate corresponding said rate of said pump exceeds a predetermined minimum value, generating an indication thereof.

8. The system of claim 7, wherein said controller is connected to control said pump and is configured to slow or stop said pump has said predetermined minimum value.

9. A system as in claim 7, wherein said flow sensor is a non-contact flow sensor.

10. A device for extracorporeally processing blood, comprising:

a fluid circuit connectable for drawing blood from patient;

a pump connectable to said fluid circuit to pump drawn blood at a predetermined stroke volume and rate which corresponds to a theoretical pumped blood flow rate;

a flow sensor connectable to said fluid circuit to directly measure the actual blood flow rate delivered by the pump;

a controller configured to compare the actual blood flow rate with a rate corresponding to the pump speed, and;

said controller being configured such that if a difference of a predetermined minimum value exists between said actual blood flow rate and the rate corresponding to the pump speed, actual blood flow rate and the rate corresponding to the pump speed”

rather than altering the pumping speed so the blood flow rate corresponding to the pump speed has a value that more closely matches the actual blood flow rate.

11. Apparatus for extracorporeally processing blood, comprising:

an extracorporeal blood treatment device including a positive displacement pump with a controller and configured to pump blood at a rate selected by said controller;

a flow sensor configured to measure an actual blood flow rate of the pump;

said controller being configured to determine whether a high pressure condition exists from a flow rate indicated by said flow sensor and a flow rate indicated by said pump speed and to generate a signal in response thereto indicating whether a theoretical flow rate based on said pump speed corresponds to the flow rate indicated by said flow sensor;

said signal indicating a command to change a speed of said pump such that said theoretical and measured flow rates are closer in magnitude.

12. Apparatus for extracorporeally processing blood, comprising:

a blood circuit with a blood flow sensor and a pump;

a controller configured to control a speed of said pump to maintain a blood flow in said blood circuit, indicated by said blood flow sensor, at a control point;

a processing mechanism to process blood in said blood circuit;

said controller being configured to detect and generate an indication of a failure in the extracorporeal blood flood flow circuit responsively to a comparison of said pump speed and the measured blood flow rate value such that said indication is generated when a theoretical flow rate of said pump is different by a threshold amount from the measure flow rate value.

13. Apparatus as in claim 12 further comprising an alarm configured to activate in response to said indication.

14. Apparatus as in claim 12 wherein said processing mechanism is configured to perform one of dialysis, hemofiltration, hemodifiltration, and apheresis.

15. Apparatus as in claim 12 wherein said controller calculates a theoretical flow rate from said pump speed, compares a result to the measured blood flow rate, compares a difference thereof to a threshold value, and generates an error signal responsively to said difference thereof.