Perfusion system with RFID feature activation

• US 9,132,214 B2
• Filed: 10/27/2014
• Issued: 09/15/2015
• Est. Priority Date: 09/19/2012
• Status: Active Grant

• Current Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Rossi, Ivan, Bombarda, Raffaella
• Primary Examiner(s): Wiest, Philip R
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US14/524,105
• Publication Number:
  US 20150105642A1
• Time in Patent Office: 323 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• 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 2205/18 with alarm
• CPC Class Codes: A61M 2205/27 preventing use
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/279 : Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/515 : Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 : Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: G06F 21/00 : Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity

Abstract

The disclosure pertains to a perfusion system that is easy to set-up, use and monitor during a bypass procedure. In some embodiments, the disclosure pertains to a perfusion system in which at least some of the disposable components used with the perfusion system are configured to be able to communicate set-up and/or operational parameters to the perfusion system in order to unlock further functionality within the perfusion system.

Claims

1. An integrated perfusion system comprising:

a heart lung machine including

a plurality of pump modules, each pump module having a control unit;

a controller in communication with each of the control units;

an input device in communication with the controller and configured to accept operational settings information from a user; and

an output device in communication with the controller and configured to display operational parameters of the plurality of pump modules;

a data management system in communication with the controller, the data management system including

an RF sensor; and

a processor in communication with the RF sensor;

wherein the data management system is configured to compute and display metabolic parameters;

one or more disposable elements comprising at least one oxygenator configured to be used in conjunction with the heart lung machine and each disposable element including an RFID tag programmed with identifying information that can be read by the RF sensor and used by the processor to unlock an algorithm in the data management system if appropriate disposable elements are identified, wherein the data management system is configured such that upon receipt of the identifying information from the one or more disposable elements, the processor uses the algorithm and computes and displays the metabolic parameters; and

an alarm, wherein the data management system is configured to set alarm values that will trigger the alarm to alert the user of a certain level of the metabolic parameters.

2. The integrated perfusion system of claim 1, wherein the data management system is configured to receive and record data from the heart lung machine and optionally from external sources.

3. The integrated perfusion system of claim 2, wherein the data management system is configured to display data received from the heart lung machine and optionally from external sources.

4. The integrated perfusion system of claim 1, wherein the one or more disposable elements include one or more of a blood reservoir, an oxygenator, a heat exchanger, or an arterial filter.

5. The integrated perfusion system of claim 4, wherein the blood reservoir comprises a venous blood reservoir, a suction blood reservoir, a vent blood reservoir or a combination thereof.

6. The integrated perfusion system of claim 1, wherein the one or more disposable elements include a passive RFID tag.

7. The integrated perfusion system of claim 1, wherein the input device comprises a touch screen computer.

8. The integrated perfusion system of claim 1, wherein the RFID tag is further programmed with information identifying performance characteristics of the one or more disposable elements.

9. The integrated perfusion system of claim 8, wherein the data management system is configured to display a priming volume simulator utilizing the identified performance characteristics of the one or more disposable elements.

10. The integrated perfusion system of claim 1, wherein the metabolic parameters include DO2, VO2, VCO2, DO2i, VO2i, and VCO2i.

11. The integrated perfusion system of claim 1, wherein the metabolic parameters include ratios of DO2i/VCO2i, VCO2i/VO2i and VO2i/DO2i.

12. A method of configuring an integrated perfusion system including a heart lung machine and a data management system, the data management system including an RF sensor, wherein the data management system is configured to compute and display metabolic parameters and set alarm values, the method comprising steps of:

attaching a disposable component comprising an oxygenator and having an RFID tag with identifying information about the disposable component to the heart lung machine;

reading the RFID tag with the RF sensor;

unlocking an algorithm within the data management system in accordance with information read from the RFID tag; and

operating the unlocked algorithm, wherein the data management system is configured such that upon receipt of the identifying information from the RFID tag, the data management system operates the unlocked algorithm and displays a priming volume in accordance with the identifying information read from the RFID tag, and the data management system is configured to set alarm values such that the alarm values will trigger an alarm to alert the user of a certain level of the metabolic parameters.

13. The method of claim 12, further comprising displaying information provided from the RFID tag to the RF sensor.

14. The method of claim 12, wherein attaching the disposable component having an RFID tag to the heart lung machine precedes reading the RFID tag with the RF sensor.