Methods and systems for monitoring an automated infusion system

• US 9,757,591 B2
• Filed: 02/11/2013
• Issued: 09/12/2017
• Est. Priority Date: 02/11/2013
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Agamaite, James A.
• Primary Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US13/764,426
• Publication Number:
  US 20140228617A1
• Time in Patent Office: 1,674 Days
• Field of Search: 600 1- 8
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3327 Measuring
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/1785 : comprising radioactive shield means syringe shields or holders for storage of radioactive sources G21F5/018
• CPC Class Codes: A61N 5/1007 : Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1075 : for testing, calibrating, or quality assurance of the radiation treatment apparatus
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Methods and systems for monitoring an automated radiopharmaceutical infusion apparatus are disclosed. A user interface graphically representing infusion apparatus components may be presented on a display device. Multiple sensors may be arranged within an infusion apparatus to measure property information associated with infusion apparatus components, including fluid pathways. The property information may include radioactivity and flow information. The property information may be compared with expected results. If the property information does not match the expected results, a fault condition may be indicated on the display device. The user interface may provide information and/or functions to manage the fault conditions.

Claims

1. A system for monitoring an automated radiopharmaceutical infusion apparatus, the system comprising:

a plurality of fluid pathways comprising a radiopharmaceutical source pathway and a radiopharmaceutical delivery pathway;

a plurality of sensors, each of which is positioned to measure at least one property associated with one of the plurality of fluid pathways, wherein at least one of the plurality of sensors is positioned to measure a level of radioactivity of a fluid in the radiopharmaceutical source pathway and at least one of the plurality of sensors is positioned to measure a level of radioactivity of a fluid in the radiopharmaceutical delivery pathway at a point after which saline is expected to have been added to the fluid in the radiopharmaceutical delivery pathway;

a display device;

a processor in communication with the plurality of sensors and the display device; and

a non-transitory, computer-readable storage medium in operable communication with the processor, wherein the computer-readable storage medium contains one or more programming instructions that, when executed, cause the processor to;

receive property information, including at least the level of radioactivity of the fluid in each of the radiopharmaceutical source pathway and the radiopharmaceutical delivery pathway, from the plurality of sensors,

present an apparatus display graphically representing apparatus components based on the property information, including at least the level of radioactivity of the fluid in each of the radiopharmaceutical source pathway and the radiopharmaceutical delivery pathway, on the display device,

compare the property information, including at least the level of radioactivity of the fluid in each of the radiopharmaceutical source pathway and the radiopharmaceutical delivery pathway, with expected results, wherein comparing the property information with the expected results comprises determining a difference between the level of radioactivity of the fluid in the radiopharmaceutical source pathway and the level of radioactivity of the fluid in the radiopharmaceutical delivery pathway,

generate a fault condition, when the system is infusing a patient with a radiopharmaceutical, responsive to the difference between the level of radioactivity of the fluid in the radiopharmaceutical source pathway and the level of radioactivity of the fluid in the radiopharmaceutical delivery pathway not matching the expected results, and

graphically represent the fault condition on the apparatus display.

2. The system of claim 1, wherein the plurality of fluid pathways further comprise at least one of a saline pathway, a dose meter inlet pathway, a dose meter outlet pathway, and a waste pathway.

3. The system of claim 1, wherein at least one of the plurality of sensors comprises at least one of a silicon diode, a silicon PIN diode, an avalanche diode, a scintillator, a photomultiplier, a solid state crystal, a semiconductor, Geiger tubes, an ionization-chamber, a silicon photodiode, a microdischarge-based sensor, a sodium iodide crystal sensor, a bismuth tri-iodide crystal sensor, a cadmium tellurium crystal sensor, a cadmium zinc tellurium semiconductor sensor, and combinations thereof.

4. The system of claim 1, comprising at least one of a temperature sensor, a pressure sensor, an optical sensor, an analyte sensor, a concentration sensor, a flow sensor, an electro-resistive device, an electro-capacitive device, and an ultrasound device.

5. The system of claim 1, wherein the plurality of fluid pathways comprises at least one of a dose meter outlet pathway and a waste pathway, and wherein at least one of the plurality of sensors is associated with one of the dose meter outlet pathway and the waste pathway.

6. The system of claim 5, wherein the property information received from the plurality of sensors comprises the level of radioactivity from the at least one of the plurality of sensors associated with at least one of the dose meter outlet pathway and the waste pathway.

7. The system of claim 1, further comprising a communication port configured to provide wireless communication between one or, more of the infusion apparatus, the plurality of sensors, the processor, the display device, and a network.

8. The system of claim 7, wherein the display device comprises one or more of a server, a personal computer, a tablet computer, a computing appliance, and a smart phone device, and wherein the network comprises one or more of a communications network, a health information network, and a picture archiving and communications system network.

9. The system of claim 7, wherein the communication port is configured to provide wireless communication over a Wi-Fi connection.

10. A method for monitoring an automated radiopharmaceutical infusion apparatus, the method comprising:

providing a plurality of sensors positioned to measure at least one property associated with a plurality of fluid pathways comprising a radiopharmaceutical source pathway and a radiopharmaceutical delivery pathway, wherein at least one of the of the plurality of sensors is positioned to measure a level of radioactivity of a fluid in the radiopharmaceutical source pathway and at least one of the of the plurality of sensors is positioned to measure a level of radioactivity of a fluid in the radiopharmaceutical delivery pathway at a point after which saline is expected to have been added to the fluid in the radiopharmaceutical delivery pathway;

providing a processor operatively connected to a display device and the plurality of sensors; and

causing the processor to enable monitoring of the automated radiopharmaceutical infusion apparatus, wherein monitoring of the apparatus comprises;

receiving property information including at least the level of radioactivity of the fluid in each of the radiopharmaceutical source pathway and the radiopharmaceutical delivery pathway, from the plurality of sensors,

presenting an apparatus display graphically representing apparatus components based on the property information including at least the level of radioactivity of the fluid in each of the radiopharmaceutical source pathway and the radiopharmaceutical delivery pathway, on the display device,

comparing the property information including at least the level of radioactivity of the fluid in each of the radiopharmaceutical source pathway and the radiopharmaceutical delivery pathway with expected results, wherein comparing the property information with the expected results comprises determining a difference between the level of radioactivity of the fluid in the radiopharmaceutical source pathway and the level of radioactivity of the fluid in the radiopharmaceutical delivery pathway,

generating a fault condition, when the automated radiopharmaceutical infusion apparatus is infusing a patient with a radiopharmaceutical, responsive to the difference between the level of radioactivity of the fluid in the radiopharmaceutical source pathway and the level of radioactivity of the fluid in the radiopharmaceutical delivery pathway not matching the expected results, and

graphically representing the fault condition on the apparatus display.

11. The method of claim 10, wherein monitoring of the apparatus further comprises receiving, with the processor, a signal of a selection by a user of one or more of the apparatus components.

12. The method of claim 10, wherein monitoring of the apparatus further comprises receiving, with the processor, a signal of a selection by a user of the graphically represented fault condition.

13. The method of claim 10, wherein monitoring of the apparatus further comprises presenting, by the processor, at least one function for managing the graphically represented fault condition.

14. The method of claim 13, wherein the at least one function comprises at least one of stopping infusion and closing at least one of the plurality of fluid pathways.

15. The method of claim 10, further comprising, providing at least one of a temperature sensor, a pressure sensor, an optical sensor, an analyte sensor, a concentration sensor, a flow sensor, an electro-resistive device, an electro-capacitive device, and an ultrasound device.

16. The method of claim 10, wherein the apparatus components comprise at least one fluid pathway.

17. The method of claim 10, wherein the apparatus components comprise a directional valve configured to connect at least two of the plurality of fluid pathways.

18. The method of claim 10, wherein the fault condition comprises the difference between the level of radioactivity of the fluid in the radiopharmaceutical source pathway and the level of radioactivity of the fluid in the radiopharmaceutical delivery pathway being above a threshold value.

19. The method of claim 10, wherein the plurality of fluid pathways comprises at least one of a dose meter outlet pathway and a waste pathway, and wherein at least one of the plurality of sensors is associated with one of the dose meter outlet pathway and the waste pathway.

20. The method of claim 19, wherein the property information received from the plurality of sensors comprises the level of radioactivity from the at least one of the plurality of sensors associated with at least one of the dose meter outlet pathway and the waste pathway.

21. The method of claim 10, wherein providing the processor operatively connected to the display device and the plurality of sensors comprises providing a processor that is wirelessly connected to one of the display device and the plurality of sensors.

22. The method of claim 21, wherein presenting an apparatus display graphically representing apparatus components on the display device comprises wirelessly transmitting the apparatus display from the processor to the display device via a communication port, and wherein graphically representing the fault condition on the apparatus display comprises wirelessly transmitting the fault condition from the processor to the display device via the communication port,

wherein the communication port is configured to provide wireless communication over a Wi-Fi connection.

23. The method of claim 21, wherein one or more of the apparatus display and the fault condition are wirelessly transmitted to an external computer network via a communication port, the external computer network being one or more of a communications network, a health information network and a picture archiving and communications system network, and

wherein the communication port is configured to provide wireless communication over a Wi-Fi connection.