Medical injection systems and methods related to user activated control devices

• US 9,480,788 B2
• Filed: 11/30/2012
• Issued: 11/01/2016
• Est. Priority Date: 11/30/2012
• Status: Active Grant

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Inventors: Wagner, Reed Brian
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): SHAH, NILAY J
• Application Number:
  US13/689,966
• Publication Number:
  US 20140155742A1
• Time in Patent Office: 1,432 Days
• Field of Search: 604/65, 604/66, 604/503, 604/890.1, 604/505, 604/67
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/353 using mechanical means, e.g. subcutaneous pushbuttons
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A control module for a medical injection system generates an injection control signal based on sensed internal pressure of a user activated control device, for example, in response to an applied external force that causes the sensed internal pressure to increase from a baseline pressure, and continues to sense the internal pressure of the device, following release of the applied external force, so that, if the sensed internal pressure drops below the baseline pressure, the control module may generate a notification. Thus, an operator of the system may monitor internal pressure of the control device for a drop below the baseline pressure, and then, if such a drop is detected, inspect the control device for leaks and reconnect, replace or repair the control device, or simply reconnect or replace the control device.

Claims

1. A method for setting up a user activated control device in a medical injection system, the control device having been coupled to a control module of the system via a connection between a tubing line of the control device and a control panel containing the control module, the tubing line being in fluid communication with an internal volume of the control device, the control module including a pressure sensor in fluid communication with the connected tubing line, wherein the internal volume of the control device, the tubing line, and the pressure sensor are included in a closed internal volume intended to prevent fluid from flowing out of the closed internal volume, and the method comprising:

applying an external force to an elastic portion of the control device, to compress the internal volume thereof from a first volume to a second volume, and holding the external force for a period of time, the applied external force increasing an internal pressure of the control device from an initial baseline pressure;

monitoring the internal pressure of the control device during the period of time, the internal pressure being sensed by the pressure sensor of the control module;

if the monitored internal pressure does not significantly drop during the period of time, establishing an injection control signal to correspond to the monitored internal pressure;

releasing the applied external force to allow the elastic portion to rebound to the first volume while continuing to monitor the internal pressure; and

if the internal pressure drops below the baseline pressure, after releasing the applied external force, inspecting the control device for leaks in the closed internal volume, wherein the baseline pressure is zero differential pressure with respect to atmospheric.

2. The method of claim 1, wherein inspecting the control device comprises checking the connection of the tubing line of the control device to the control module.

3. The method of claim 1, wherein monitoring the internal pressure of the control device comprises looking for a visual notification generated from signals received from the pressure sensor of the control module.

4. The method of claim 1, wherein monitoring the internal pressure of the control device comprises listening for an audible notification, the audible notification being generated in response to signals received from the pressure sensor of the control module, when the internal pressure drops below the baseline pressure.

5. A method for controlling a medical injection system, the method comprising:

sensing an internal pressure of a compressible internal volume of a control device having an elastic portion, the compressible internal volume being a closed volume intended to prevent fluid from flowing out of the compressible internal volume, the control device being coupled to the system, the internal pressure being greater than a baseline pressure, and the internal pressure being in response to an external force applied to the elastic portion of the control device by an operator of the system to compress the internal volume from a first volume to a second volume;

generating an injection control signal based upon the internal pressure;

continuing to sense the internal pressure of the control device after release of the applied external force and a rebounding of the elastic portion to the first volume; and

generating a notification, if the sensed internal pressure drops below the baseline pressure after the release of the applied external force.

6. The method of claim 5, wherein the notification comprises a visual signal.

7. The method of claim 5, wherein the notification comprises an audible signal.

8. The method of claim 5, wherein the notification comprises an indication of a leak in the compressible internal volume.

9. A method for controlling a medical injection system, the method comprising:

applying an external force to an elastic portion with a compressible closed internal volume of a control device, the control device being coupled to the injection system, the external force compressing the closed internal volume from a first volume to a second volume and increasing an internal pressure of the closed internal volume from a baseline pressure, and the internal pressure being sensed to generate an injection control signal based upon the internal pressure;

releasing the applied external force to allow the elastic portion to rebound to the first volume; and

monitoring if the sensed internal pressure drops below the baseline pressure after the release of the applied external force.

10. The method of claim 9, wherein monitoring the sensed internal pressure comprises listening for an audible notification.

11. The method of claim 9, wherein monitoring the sensed internal pressure comprises looking for a visual notification.

12. The method of claim 9, further comprising inspecting the control device for leaks in the closed internal volume, if the monitored sensed internal pressure drops below the baseline pressure.

13. The method of claim 12, wherein inspecting the control device comprises checking a connection of the device to the system.

14. The method of claim 12, wherein inspecting the control device comprises checking junctions within the device.

15. The method of claim 9, further comprising replacing the control device, if the monitored sensed internal pressure drops below the baseline pressure.

16. The method of claim 9, further comprising reconnecting the control device, if the monitored sensed internal pressure drops below the baseline pressure.

17. The method of claim 9, wherein the baseline pressure is zero differential pressure with respect to atmospheric.

18. A medical injection system comprising a pump, a fluid reservoir configured to hold a fluid for injecting into a patient, an injection control module, and a user activated control device coupled to the control module;

the control device including an elastic portion with an internal volume compressible by application of an external force to the elastic portion;

the control module comprising a pressure sensor in fluid communication with the internal volume of the control device, wherein the internal volume of the control device is included in a closed volume that is separate from and not in fluid communication with the fluid reservoir; and

the control module being configured to perform a method comprising the steps of;

sensing an internal pressure of the internal volume of the control device, the internal pressure being greater than a baseline internal pressure, and the internal pressure being in response to the application of the external force to the elastic portion that compresses the internal volume from a first volume to a second volume;

generating an injection control signal based upon the internal pressure;

continuing to sense the internal pressure of the control device after release of the application of the external force and a rebounding of the elastic portion to the first volume; and

generating a notification, if the sensed internal pressure drops below the baseline pressure, after the release of the application of the external force.

19. The system of claim 18, wherein the notification comprises a visual signal.

20. The system of claim 18, wherein the notification comprises an audible signal.

21. The system of claim 18, wherein the notification is indicative of a leak in the closed volume.