Systems and methods for status indication in a single-use biomedical and bioprocess system

• US 10,522,025 B2
• Filed: 10/01/2018
• Issued: 12/31/2019
• Est. Priority Date: 11/21/2013
• Status: Active Grant

• Current Assignee: Cytiva Sweden AB (Danaher Corporation)
• Original Assignee: GE Healthcare Bio-Sciences AB (GE Healthcare Technologies, Inc.)
• Inventors: Potyrailo, Radislav A., Gebauer, Klaus, Stridsberg-Friden, Kajsa, Wortley, Timothy A.
• Primary Examiner(s): Alam, Mirza F
• Application Number:
  US16/149,018
• Publication Number:
  US 20190043333A1
• Time in Patent Office: 456 Days
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: C12M 41/48 Automatic or computerized control automatic analysis G01N35/00
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G06K 19/0702 the arrangement including a battery
• CPC Class Codes: G06K 19/0707 the arrangement being capable of collecting energy from external energy sources, e.g. thermocouples, vibration, electromagnetic radiation G06K19/0702 takes precedence
• CPC Class Codes: G06K 19/07745 Mounting details of integrated circuit chips
• CPC Class Codes: G08B 21/18 Status alarms G08B21/02 takes precedence
• CPC Class Codes: H04Q 2209/30 using a wired architecture
• CPC Class Codes: H04Q 2209/47 using RFID associated with sensors
• CPC Class Codes: H04Q 9/00 Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom

Abstract

Methods, systems, and apparatus to monitor component status in a bioprocessing environment are disclosed and described. Certain examples provide a sensor device for a disposable bioprocessing component. The example sensor device includes a first portion affixed to the component, the first portion configured to provide an identifier associated with the component. The example sensor device also includes a second portion configured to provide a status indication based on a state of the component. The example sensor device is configured to transmit the identifier and status indication to a control computer associated with a bioprocessing platform including the component.

Claims

1. A bioprocessing component comprising:

a manually operable tubing clamp configured to close a flexible fluid tube when actuated into a first position by squeezing the clamp, or when actuated into a second position, having the flexible fluid tube open to allow flow within the flexible fluid tube;

the manually operable tubing clamp further comprising;

a sensor operable to (i) monitor an actuation status of the manually operable tubing clamp with respect to the flexible fluid tube wherein the actuation status is indicative of the manually operable tubing clamp being in the first position or the second position, and (ii) indicate the actuation status to an external control system when the manually operable tubing clamp is in the first position or the second position; and

an identifier to identify said manually operable tubing clamp and/or sensor, and the identifier is configured to be transmitted to the external control system;

wherein the sensor and the identifier form part of a circuit for remote wireless communication with said external control system; and

wherein the external control system is arranged to prompt an action based on the transmitted identifier and the actuation status indication, the action comprising at least one of a confirmation, an alert, an alarm, a recording, an instruction to change configuration of the bioprocessing component, and a change in operation of the external control system.

2. The component of claim 1, wherein the sensor is removably mounted on the component.

3. The component of claim 1, wherein the sensor comprises first and second closeable portions at least one of the portions including a radio frequency identification (RFID) tag which changes its status indication in response to said closing.

4. The component of claim 3, wherein the RFID tag comprises a sterilizable RFID tag.

5. The component of claim 4, wherein the is sterilization is at least one of gamma irradiation, autoclaving, steam, electron beam, and gas.

6. The component of claim 5, wherein the RFID tag comprises at least one of a high frequency (HF) RFID tag, a low frequency (LF) RFID tag, and a near field communication (NFC) RFID tag.

7. The component of claim 4, wherein the first portion of the sensor comprises a radio frequency identification tag and the second portion of the sensor comprises a wireless sensor node.

8. The component of claim 7, wherein the second portion activates the first portion to transmit the status indication when the second portion is brought into close proximity with the first portion.

9. A method to monitor the bioprocessing component, as claimed in claim 1, in a bioprocessing system including a bioprocessing subsystem and a control subsystem, said method comprising:

identifying the component based on feedback from a first portion of the sensor associated with the component;

determining a state of the component based on feedback from a second portion of the sensor associated with the component; and

facilitating triggering of an action based on the state and identification of the component provided wirelessly by the sensor.

10. The component of claim 1, wherein the circuit includes one of:

a wireless transmitter including an RFID parts, a BLUETOOTH™

sensor circuit, a Wi-Fi sensor circuit, and an NFC sensor.

11. A bioprocessing system/arrangement comprising:

a component in the form of a manually operable tubing clamp configured to close a flexible fluid tube when actuated into a first position by squeezing the clamp, or when actuated into a second position, having the flexible fluid tube open to allow flow within the flexible fluid tube, the manually operable tubing clamp comprising;

a sensor operable to (i) monitor an actuation status of the manually operable tubing clamp with respect to the flexible fluid tube wherein the actuation status is indicative of the manually operable tubing clamp being in the first position or the second position, and (ii) indicate the actuation status to an external control system when the manually operable tubing clamp is in the first position or the second position; and

an identifier to identify said manually operable tubing clamp and/or sensor, and the identifier is configured to be transmitted to the external control system,

wherein the sensor and the identifier form part of a circuit for remote wireless communication with said external control system, and wherein the external control system is arranged to prompt an action based on the transmitted identifier and the actuation status indication, the action comprising at least one of a confirmation, an alert, an alarm, a recording, an instruction to change configuration of the component, and a change in operation of the external control system.

12. The bioprocessing system/arrangement of claim 11, wherein the circuit includes one of:

a wireless transmitter including an RFID parts, a BLUETOOTH™

sensor circuit, a Wi-Fi sensor circuit, and an NFC sensor.