Extracorporeal blood processing methods and apparatus

• US 5,676,644 A
• Filed: 06/07/1995
• Issued: 10/14/1997
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Kappus, John J., Brierton, Mark J., Shouldice, David R., Toavs, Coy, Blakeslee, Jeffrey J.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/476,542
• Time in Patent Office: 860 Days
• Field of Search: 604/4-6
• US Class Current: 604/6.11
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3624 Level detectors; Level control
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 Pressure isolators
• CPC Class Codes: A61M 1/3652 using gas, e.g. air
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/14 : Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3382 : Upper level detectors
• CPC Class Codes: A61M 2205/3386 : Low level detectors
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: B04B 2005/045 : having annular separation channels
• CPC Class Codes: B04B 5/0442 : with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: B04B 9/08 : Arrangement or disposition of transmission gearing for solid bowl screw centrifuges B04B1/2016; Couplings; Brakes

Abstract

An extracorporeal blood processing system is disclosed which includes a variety of novel components and which may be operated in accordance with a variety of novel methodologies. For instance, the system includes a graphical operator interface which directs the operator through various aspects of the apheresis procedure. Moreover, the system also includes a variety of features relating to loading a blood processing vessel into a blood processing channel and removing the same after completion of the procedure. Furthermore, the system also includes a variety of features relating to utilizing a blood priming of at least portions of the apheresis system in preparation for the procedure. In addition, the system includes a variety of features enhancing the performance of the apheresis system, including the interrelationship between the blood processing vessel and the blood processing vessel and the utilization of high packing factors for the procedure.

Claims

1. A device for use in an extracorporeal blood processing system in which blood is removed from an individual for processing and at least some components of the blood are returned to the individual, comprising:

a cassette member having a reservoir for accumulating the blood components in a first mode and for supplying said accumulated blood components for return to the individual in a second mode separate from said first mode;

a first ultrasonic sensor positionable adjacent to an upper section of said reservoir, wherein said first ultrasonic sensor senses when the blood components have accumulated to a predetermined first level in said reservoir and provides a first signal in response thereto, whereupon said first mode ends and said second mode is initiated; and

a second ultrasonic sensor positionable adjacent to a lower section of said reservoir, wherein said second ultrasonic sensor provides a second signal until it senses said accumulated blood components have been removed down to a predetermined second level in said reservoir, whereupon said second mode ends and said first mode is initiated.

2. A device as claimed in claim 1 wherein:

said reservoir is substantially rigid; and

said first and second ultrasonic sensors each include a single transducer and resilient contact surface for dry coupling with said upper and lower sections of said reservoir.

3. A device as claimed in claim 1, wherein:

said reservoir includes front and back surfaces, and an intermediate section, said intermediate section having a width from said front surface to said back surface that is greater than widths of said upper and lower sections from said front surface to said back surface.

4. A device as claimed in claim 1, further comprising:

processor control means for receiving said first and second signals and controlling the initiation and end of said first and second modes in response thereto.

5. A device as claimed in claim 1, further comprising:

a first pump responsive to said second signal for pumping said accumulated blood components from said reservoir to said individual during said second mode.

6. A device as claimed in claim 5, wherein said first pump is reversible to pump blood from the individual into said reservoir during a priming mode, said priming mode being separate from said first and second modes, and wherein in the priming mode said second ultrasonic sensor senses when blood has accumulated to said second level in said reservoir and provides a third signal in response thereto, whereupon the priming mode ends.

7. A device as claimed in claim 6, further comprising:

processor control means for receiving said first, second and third signals and for controlling the initiation and end of said first, second and priming modes in response thereto.

8. A device as claimed in claim 6, further comprising:

means for receiving and containing sterile gas from said reservoir during said first and priming modes, and for supplying said contained gas back to said reservoir during said second mode.

9. A device as claimed in claim 5, further comprising:

a single needle assembly for removing said blood from a donor during the first mode, and for returning blood components pumped by the first pump during the second mode; and

a second pump to pump blood from the single needle assembly for blood processing during said first and second modes, wherein the volume transfer rate of said first pump is greater than the volume transfer rate of said second pump during said second mode.

10. A device as claimed in claim 9, wherein said first pump is reversible to pump blood from the single needle assembly during a priming mode, and said second pump is employable to pump blood from the single needle assembly during a priming mode.

11. A device as claimed in claim 9, further comprising:

processor control means for controlling said volume transfer rates of said first and second pumps based, at least in part, upon a sensed pressure corresponding with a fluid pressure in said single needle assembly.

12. A device as claimed in claim 1, further comprising:

means for receiving and containing sterile gas from said reservoir during said first mode, and for supplying said contained gas back to said reservoir during said second mode.

13. A device as claimed in claim 12, wherein said means for receiving comprises a bag interconnected via tubing to a top end of said reservoir.

14. A device as claimed in claim 12, wherein said means for receiving is disposed, at least in part, in said cassette member.

15. A device as claimed in claim 1, wherein said cassette is separate from and positionable in a predetermined desired position relative to said first and second ultrasonic sensors, and wherein at least one of said first and second ultrasonic sensors senses when said cassette member is positioned in the predetermined desired position and provides an indicating signal in response thereto.

16. A device as claimed in claim 15, wherein each of said first and second ultrasonic sensors provide a corresponding indicating signal when the cassette is positioned in the predetermined desired position, and wherein the provision of indicating signals from both of said first and second ultrasonic sensors is required to initiate blood processing.

17. A device as claimed in claim 15, further comprising:

means for applying at least a predetermined load pressure between said reservoir and at least one of said first and second ultrasonic sensors when said cassette member is in said predetermined desired position.