Patency check with pressure monitoring

• US 8,348,896 B2
• Filed: 11/19/2008
• Issued: 01/08/2013
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Liebel-Flarsheim Company (Mallinckrodt plc)
• Original Assignee: Mallinckrodt LLC (Mallinckrodt plc)
• Inventors: Wagner, Gary S.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/742,938
• Publication Number:
  US 20100249704A1
• Time in Patent Office: 1,511 Days
• Field of Search: 604/118, 604/121, 604/151, 604 65- 71
• US Class Current: 604/118
• CPC Class Codes: A61M 2005/14553 comprising a pressure jacket
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A patency check protocol (150) for evaluating a patency check injection (156) is disclosed. The protocol (150) incorporates a pressure standard (152) (e.g., a pressure threshold; a target pressure curve). A pressure associated with the patency check injection is monitored (160) and compared against this pressure standard (164). If a first condition is identified (166) (e.g., if the pressure threshold is reached; if the monitored pressure deviates from the target pressure curve by more than a certain predetermined amount), one or more actions may be undertaken (168) (e.g., one or more notifications or alerts may be issued; the flow rate may be reduced for the patency check injection; the patency check injection may be suspended/terminated).

Claims

1. A power injector, comprising:

a powerhead;

a syringe plunger drive assembly;

patency check logic configured to execute a patency check injection to assess for both blockage in a flowpath to a patient'"'"'s vein and existence of an extravasation condition where fluid is being introduced into a patient'"'"'s tissue instead of a vein, wherein said patency check logic comprises a pressure standard;

pressure monitoring logic, wherein an output from said pressure monitoring logic is provided to said patency check logic for comparison with said pressure standard, wherein said patency check logic is configured to identify an existence of a first condition, wherein said first condition is either when a monitored pressure during a patency check injection reaches or exceeds a pressure threshold, or when a monitored pressure during a patency check injection deviates from a target pressure curve by more than a certain amount; and

injection protocol logic, separate from said patency check logic, configured to execute an injection protocol after said patency check logic executes a patency check injection, wherein said injection protocol logic comprises a comparator, wherein a first input to said comparator comprises a pressure from a patency check injection when said patency check logic failed to identify an occurrence of said first condition, and wherein a second input to said comparator comprises a monitored pressure during a subsequent execution of an injection protocol.

2. The power injector of claim 1, further comprising a syringe mounted on said powerhead, wherein said syringe comprises a syringe barrel and a plunger movably disposed within said syringe barrel, and wherein said syringe plunger drive assembly may interact with said plunger to move said plunger.

3. The power injector of claim 1, wherein said first input for said comparator is one of a maximum pressure encountered during a patency check injection and an average pressure encountered during a patency check injection.

4. The power injector of claim 1, wherein said pressure monitoring logic is configured to monitor a back-pressure during a patency check injection.

5. The power injector of claim 1, wherein said pressure standard comprises said pressure threshold.

6. The power injector of claim 1, wherein said pressure standard comprises said target pressure curve.

7. The power injector of claim 1, further comprising at least one data entry device operatively interconnected with said patency check logic, wherein said pressure standard may be input using said at least one data entry device.

8. The power injector of claim 7, wherein said at least one data entry device is selected from the group consisting of a touch screen display, a soft key display, a keyboard, a mouse, touch pad, and a track ball.

9. The power injector of claim 1, further comprising a display, wherein said patency check logic is configured to present on said display a representation of a monitored pressure from a patency check injection.

10. The power injector of claim 9, wherein said representation of a monitored pressure is selected from the group consisting of a numeric representation of a pressure value, a graphical representation of a pressure value, or a combination thereof.

11. The power injector of claim 9, wherein said patency check logic is configured to present said representation of a monitored pressure on said display on a real-time basis.

12. The power injector of claim 9, wherein said patency check logic is configured to present said representation of a monitored pressure on said display after completion of a patency check injection.

13. The power injector of claim 1, wherein said patency check logic is configured to provide at least one notification when said patency check logic identifies an occurrence of said first condition.

14. The power injector of claim 13, wherein said at least one notification is selected from the group consisting of a textual message, an alphanumeric message, at least one visual alarm, at least one audible alarm, or any combination thereof.

15. The power injector of claim 1, wherein said patency check logic is configured to terminate a patency check injection if said patency check logic identifies an occurrence of said first condition.

16. The power injector of claim 1, wherein user input is required if said patency check logic identifies an occurrence of said first condition.

17. The power injector of claim 1, wherein said patency check logic is configured to reduce a flow rate for a patency check injection if said patency check logic identifies an occurrence of said first condition.

18. The power injector of claim 1, wherein said patency check logic is configured to initiate a first action if there is a first relationship between said pressure standard and a monitored pressure from a patency check injection, wherein said first action is selected from the group consisting of suspending the patency check injection, terminating the patency check injection, reducing a flow rate for the patency check injection, providing at least one notification, or any combination thereof.

19. The power injector of claim 1, wherein said patency check logic is configured to display a message upon completion of a patency check injection procedure.

20. The power injector of claim 19, wherein said injection protocol logic is operatively interconnected with said patency check logic, and wherein user input is required after execution of a patency check injection using said patency check logic and prior to executing an injection protocol using said injection protocol logic.

21. A method for executing a first medical procedure, comprising the steps of:

fluidly interconnecting a patient with a power injector;

injecting a first fluid into said patient using said power injector, wherein said first fluid is an initial fluid injected into said patient by said power injector for said first medical procedure;

monitoring said injecting a first fluid step for an occurrence of a first condition, wherein said first condition is either when a pressure during said injecting a first fluid step reaches or exceeds a pressure threshold, or when a pressure during said injecting a first fluid step deviates from a target pressure curve by more than a certain amount;

assessing for both blockage in a flowpath to said patient and existence of an extravasation condition where fluid is being introduced into said patient'"'"'s tissue instead of a vein, said assessing step comprising comparing an output of said monitoring step for said first fluid with a first standard, wherein said comparing step is executed by power injector control logic;

injecting a second fluid into said patient using said power injector, wherein said injecting a second fluid step is executed after said injecting a first fluid step; and

monitoring said injecting a second fluid step, comprising comparing a pressure from said injecting a second fluid step with a pressure from said injecting a first fluid step when said monitoring step for said first fluid failed to identify an occurrence of said first condition.

22. A power injector, comprising:

a powerhead;

a syringe plunger drive assembly;

patency check logic configured to execute a patency check injection to assess for both blockage in a flowpath to a patient'"'"'s vein and existence of an extravasation condition where fluid is being introduced into a patient'"'"'s tissue instead of a vein, wherein said patency check logic comprises a pressure standard;

injection protocol logic, separate from said patency check logic, configured to execute an injection protocol after said patency check logic executes a patency check injection; and

pressure monitoring logic, wherein an output from said pressure monitoring logic is used by both said patency check logic and said injection protocol logic.