Blood-processing machine system

• US 5,769,811 A
• Filed: 10/31/1995
• Issued: 06/23/1998
• Est. Priority Date: 10/31/1995
• Status: Expired due to Term

• Current Assignee: Haemonetics Corporation
• Original Assignee: Haemonetics Corporation
• Inventors: Stacey, Gary, York, Frederick, Lamborghini, David, Liberatore, Steven
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/551,150
• Time in Patent Office: 966 Days
• Field of Search: 604/4-6, 604/407, 604/408-410, 604/30, 604/31, 604/65, 604/67
• US Class Current: 604/4.01
• 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 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• 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 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• 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 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6072 Bar codes

Abstract

A multiprotocol blood-processing machine and disposable units for use therewith. The disposable units generally comprise a centrifuge bowl for separating whole blood into blood constituents, an inlet tube for conveying blood into the bowl, an outlet tube for conveying the blood constituents away from the bowl, and a manifold for placing the inlet tube and the outlet tube in fluid communication with a tube from a donor. The manifold has a machine-readable bar-code label for identifying to the blood processing machine which type of disposable unit is being coupled to it. The machine itself comprises a central processing unit that controls overall operation, a first computer memory containing safety-monitoring instructions that cause the central processing unit to monitor various state parameters in order to ensure donor safety, and a second computer memory containing instructions that define at least one apheresis or blood-processing protocol. In some implementations, the second computer memory is removable from and insertable into the blood processing machine by an operator.

Claims

1. A blood-processing machine comprising:

a. means for collecting whole blood from a donor;

b. processing means for (i) separating the collected whole blood into isolated blood components and (ii) returning at least some of the blood components back to the donor in accordance with steps defining one of a plurality of protocols;

c. means for accepting a disposable set comprising blood-compatible tubing configured for at least one specific protocol, and a machine-readable indication for identifying the disposable set to the blood-processing machine;

d. means for reading the machine-readable indication;

e. means for removably receiving a computer memory device comprising stored instructions defining one of the protocols;

f. means for implementing the defined protocol according to the stored instructions; and

g. control means configured to determine compatibility between the disposable set and the defined protocol and, absent said compatibility, to disable the machine.

2. The machine of claim 1 further comprising:

a. a database comprising a plurality of stored instruction sets, each set directing execution of a specific protocol by the implementing means;

b. means for selecting an instruction set from the database for execution by the protocol-implementing means.

3. The machine of claim 2 wherein the means for selecting is an operator-responsive means for enabling selection of a protocol.

4. The machine of claim 2 wherein the means for determining compatibility is configured to select the instruction set from the database based on the machine-readable indication.

5. A multiprotocol blood-processing machine comprising:

a. means for collecting whole blood from a donor;

b. a central processing unit for controlling the blood-processing machine to (i) separate the collected whole blood into isolated blood components and (ii) return at least some of the blood components back to the donor in accordance with steps defining one of a plurality of protocols;

c. a plurality of sensors for monitoring a plurality of machine parameters affecting operational safety;

d. a first computer memory containing stored instructions which, when executed by the central processing unit cause the machine to periodically assess the machine parameters and effect machine disablement if any of the parameters indicate unsafe machine operation; and

e. a second computer memory, computationally distinct from the first computer memory, containing instructions that correspond to machine functions defining at least one protocol.

6. The machine of claim 5 further comprising means for accepting a disposable set comprising (i) blood-compatible tubing configured for at least one specific protocol, and (ii) a machine-readable indication for identifying the disposable set to the blood-processing machine, the parameters indicating unsafe machine operation depending on the machine-readable indication.