Extracorporeal blood processing methods and apparatus

• US 5,795,317 A
• Filed: 06/07/1995
• Issued: 08/18/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Tandem Computers Incorporated (HP Inc.), Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Hempstead, Russell, Dolecek, Victor D., Brierton, Mark J., Bilodeau, Leon E.
• Primary Examiner(s): Weiss, John
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/486,217
• Time in Patent Office: 1,168 Days
• Field of Search: 604/4-6, 210/646, 210/781, 210/782, 494/35, 494/6, 494/10, 494/60, 494/61
• US Class Current: 604/6.05
• 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 2205/123 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 2205/505 : 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
• CPC Class Codes: G16H 40/63 : for local operation

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 disposable assembly for use in an extracorporeal blood processing system, comprising:

blood removal conduit for transferring whole blood from a donor;

blood return conduit for transferring uncollected blood components to a donor, a first portion of said blood removal conduit and a first portion of said blood return conduit being in direct fluid communication;

a single pressure sensor responsive to positive and negative pressure changes, said pressure sensor interconnected in direct fluid communication to one of said first portion of said blood removal conduit and said first portion of said blood return conduit, wherein said pressure sensor is responsive to pressure changes in said first portions of said blood removal conduit and blood return conduit.

2. A disposable assembly as claimed in claim 1, wherein said pressure sensor includes a diaphragm member, said disposable assembly further comprising:

a molded cassette member having a pressure sensing station, wherein said diaphragm member is mounted to the molded cassette member over said pressure sensing station.

3. A disposable assembly as claimed in claim 2, wherein:

said blood removal conduit and blood return conduit are each partially defined by corresponding integral passageways within said molded cassette member, and wherein one side of said diaphragm member is in fluid communication with one of said integral passageways.

4. A disposable assembly as claimed in claim 3, wherein said blood removal conduit and blood return conduit are each partially defined by first and second corresponding U-shaped tubing loops, respectively, that are supportably connected to and extend outwardly from said cassette member and that are fluidly interconnected to the corresponding integral passageways of said blood removal conduit and blood return conduit.

5. A disposable assembly as claimed in claim 4, further comprising:

a reservoir fluidly interconnected to one end of said blood return conduit and defined within said molded cassette member for accumulating uncollected blood components.

6. A disposable assembly as claimed in claim 1, further comprising:

a single needle, in direct fluid communication with said first portions of said blood removal conduit and blood return conduit, for removal of whole blood from and return of uncollected blood components to donor.

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

a molded cassette member having a reservoir defined therein, said reservoir being fluidly interconnected to said blood return conduit for accumulating uncollected blood components.

8. A device as claimed in claim 3, wherein said opposing side of said diaphragm is recessed relative to a surrounding portion of said molded cassette member.

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

at least one blood component conduit for transferring separated blood components, said blood component conduit being partially defined by a corresponding integral passageway within said molded cassette member, and said blood component conduit being partially defined by a third corresponding U-shaped tubing loop that is supportively connected to and extends outwardly from said cassette and that is fluidly interconnected to the corresponding integral passageway within said molded cassette member.

10. A device as claimed in claim 9, wherein said U-shaped tubing loops are positioned relative to said cassette member to present an asymmetric configuration.

11. A device as claimed in claim 9, wherein each of said integral passageways comprises a corresponding inlet to said cassette member, each of said inlets being positioned along a bottom edge of said molded cassette member, wherein fluid flow into each of said integral passageways progresses at least initially upward.

12. A device as claimed in claim 9, at least one of said blood removal conduit means and blood return conduit means being partially defined by a corresponding integral passageway within said molded cassette member, and further comprising:

a pressure sensor interconnected to said molded cassette member for sensing pressure changes within said one integral passageway partially defining one of said blood removal conduit means and blood return conduit means.

13. A disposable assembly as claimed in claim 1, wherein pressure sensor comprises a flexible diaphragm member.

14. A disposable assembly as claimed in claim 13, wherein said flexible diaphragm member is interconnected to a pressure sensing transducer by an air coupling.

15. A disposable assembly as claimed in claim 14, wherein said diaphragm member is capable of displacement in a first direction corresponding to a positive pressure change and displacement in a second direction corresponding to a negative pressure change.

16. A disposable assembly for use in an extracorporeal blood processing system, comprising:

blood removal conduit for transferring whole blood from a donor;

blood return conduit for transferring uncollected blood components to a donor, said blood removal conduit being fluidly connected to said blood return conduit;

a first blood component conduit for transferring a separated first blood component;

a molded cassette member having;

an integral internal reservoir for accumulating uncollected blood components and interconnected to said blood return conduit;

a first integral internal passageway partially defining said first blood component conduit;

a first flexible tubing line interconnected at a first end to said first integral internal passageway, and interconnected at a second end to said integral internal reservoir;

a second flexible tubing line interconnected at a first end to said first integral internal passageway; and

positioning means for supportably engaging first end portions of both said first and second flexible tubing lines to maintain said first end portion of said first flexible tubing line spaced from said first end portion of said second flexible tubing line.

17. A device as claimed in claim 16, wherein said positioning means is defined by an integral rim portion of said molded cassette member, said rim portion partially defining a window through said cassette member within which said first end portions are located.

18. A device as claimed in claim 16, further comprising:

a second blood component conduit for transferring a separated second blood component;

said molded cassette member further including;

a second integral internal passageway partially defining said second blood component conduit;

a third flexible tubing line interconnected at a first end to said second integral internal passageway and interconnected at a second end to said integral internal reservoir;

a fourth flexible tubing line interconnected at a first end to said second integral internal passageway;

wherein said second ends of said first and third flexible tubing lines are fluidly interconnected to a top end of said integral internal reservoir, immediately adjacent to a sidewall thereof, wherein first and second separated blood components passing through said first and third flexible tubing lines into said integral internal reservoir will flow substantially down the inside of said sidewall during operation of said assembly.