Systems and method for assessing functionality of dual check valve arrangements in medical tubing sets

• US 9,943,680 B2
• Filed: 02/05/2016
• Issued: 04/17/2018
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Liebel-Flarsheim Company (Mallinckrodt plc)
• Original Assignee: Liebel-Flarsheim Company (Mallinckrodt plc)
• Inventors: Strobl, Geoffrey S.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US15/017,302
• Publication Number:
  US 20160151619A1
• Time in Patent Office: 802 Days
• CPC Class Codes: A61B 6/548 Remote control of the apparatus or devices
• CPC Class Codes: A61M 2005/14553 comprising a pressure jacket
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G01L 7/00 Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements G01L11/004 takes precedence; transmitting or indicating the displacement of mechanical pressure-sensitive elements by electric , e.g., photoelectric or magnetic means G01L9/00; measuring differences of two or more pressure values G01L13/00; measuring two or more pressure values simultaneously G01L15/00
• CPC Class Codes: G01L 9/00 Measuring steady of quasi-steady pressure of fluid or fluent solid material by electric or magnetic pressure-sensitive elements G01L11/004 takes precedence; Transmitting or indicating the displacement of mechanical pressure-sensitive elements, used to measure the steady or quasi-steady pressure of a fluid or fluent solid material, by electric or magnetic means measuring differences of two or more pressure values G01L13/00; measuring two or more pressure values simultaneously G01L15/00

Abstract

A dual one-way check valve arrangement that may be used for assessing an operating condition of at least one of first and second check valves situated in series along/within a section of a patient-specific section of tubing. A pressure sensor may be associated with at least part of the flow path between the first and second check valves and may be operable to provide an indication of a failed condition of at least one of the first and second check valves. In one embodiment, the pressure sensor may change from a first state to a second state upon fluid pressure within the flow path between the first and second check valves falling below a predetermined level. For instance, the predetermined level may be a cracking pressure of at least one of the first and second check valves. The change in state may be visually discernible on an exterior of the pressure sensor.

Claims

1. A method of delivering fluid using a medical fluid tubing set that comprises a multi-use tubing section, a first single-use tubing section, and a connector between said multi-use tubing section and said first single-use tubing section, wherein said first single-use tubing section comprises first and second check valves that are spaced along and are located within said first single-use tubing section, and wherein said first single-use tubing section is used for only a single patient, the method comprising:

operating an injection device, wherein said operating step comprises a first operating step, wherein said first operating step directs a flow of fluid through said multi-use tubing section, then through said first single-use tubing section, and then to a first patient such that each of said multi-use tubing section and said first single-use tubing section are located between said injection device and said first patient;

monitoring a fluid pressure in said first single-use tubing section at a location that extends between said first and second check valves and including when both of said first and second check valves are open and when both of said first and second check valves are closed, wherein said monitoring step uses a pressure sensor that is positioned within said first single-use tubing section at a location that is between said first and second check valves;

assessing an operating condition of at least one of said first and second check valves of said first single-use tubing section based on said monitoring step, wherein said assessing step comprises using said monitoring step to identify an occurrence of a first condition, said first condition being that said fluid pressure between said first and second check valves of said first single-use tubing section has dropped below a predetermined fluid pressure level;

providing an indication upon identifying the occurrence of said first condition;

replacing said first single-use tubing section prior to using said multi-use tubing section for an injection of another patient; and

discarding said multi-use tubing section upon identifying the occurrence of said first condition.

2. The method of claim 1, wherein said monitoring step comprises mechanically monitoring said fluid pressure.

3. The method of claim 1, wherein said monitoring step comprises electrically monitoring said fluid pressure.

4. The method of claim 1, wherein said indication is selected from the group consisting of visual, audible, tactile, or any combination thereof.

5. The method of claim 1, wherein said assessing step comprises comparing said fluid pressure from said monitoring step to a cracking pressure of at least one of said first and second check valves.

6. The method of claim 1, wherein said assessing step comprises associating a failed condition of at least one of said first and second check valves with identifying the occurrence of said first condition.

7. The method of claim 1, wherein said assessing step comprises associating a failed condition of at least one of said first and second check valves by identifying when said fluid pressure is less than a cracking pressure of at least one of said first and second check valves.

8. The method of claim 1, wherein said assessing step comprises associating a failed condition of at least one of said first and second check valves by identifying when said fluid pressure is less than a cracking pressure of each of said first and second check valves.

9. The method of claim 1, further comprising the steps of:

opening each of said first and second check valves in response to said first operating step;

terminating said first operating step; and

closing said first and second check valves in response to said terminating step, wherein said assessing step comprises determining if at least one of said first and second check valves has opened after said closing step and prior to any further initiation of said operating step.

10. The method of claim 1, wherein said operating step further comprises a second operating step, wherein said replacing step comprises replacing said first single-use tubing section with a second single-use tubing section after said first operating step, wherein said second single-use tubing section comprises third and fourth check valves that are spaced along said second single-use tubing section, said method further comprising the steps of:

executing said second operating step after said replacing step, wherein said second operating step directs a flow of fluid through said multi-use tubing section, then through said second single-use tubing section, and then to a second patient such that each of said multi-use tubing section and said second single-use tubing section are located between said injection device and said second patient;

executing a second monitoring step comprising monitoring a fluid pressure in said second single-use tubing section at a location that is between said third and fourth check valves of said second single-use tubing section; and

executing a second assessing step comprising assessing an operating condition of at least one of said third and fourth check valves of said second single-use tubing section based on said second monitoring step, wherein said second assessing step comprises using said second monitoring step to identify an occurrence of a second condition, said second condition being that said fluid pressure between said third and fourth check valves of said second single-use tubing section has dropped below said predetermined fluid pressure level.

11. The method of claim 10, further comprising:

replacing said multi-use tubing section prior to said second operating step, wherein said replacing said multi-use tubing section step is executed in response to said assessing step identifying a presumed failed condition of at least one of said first and second check valves of said first single-use tubing section.

12. The method of claim 1, further comprising:

perceiving a change in state of said pressure sensor used by said monitoring step, wherein said assessing step comprises associating a failed condition of at least one of said first and second check valves with said perceived change in state.

13. The method of claim 12, wherein said step of perceiving said change in state comprises perceiving said change in state when said fluid pressure in said monitoring step falls below said predetermined fluid pressure level.

14. The method of claim 13, wherein said predetermined fluid pressure level is a cracking pressure of at least one of said first and second check valves, and wherein a check valve cracking pressure is a minimum amount by which an upstream pressure of the check valve must be greater than a downstream pressure of the check valve before the check valve will open when functioning properly.

15. The method of claim 12, wherein said perceiving step comprises identifying a change in position of a movable element of said pressure sensor, wherein said change in state is said change in position.

16. The method of claim 15, wherein said step of identifying said change in position comprises identifying a change from a first position of said movable element that is associated with a presumed proper functioning of said first and second check valves to a second position of said movable element that is associated with said failed condition of at least one of said first and second check valves.

17. The method of claim 16, further comprising:

biasing, with a biasing force, said movable element from said first position into said second position when said fluid pressure in said monitoring step falls below said predetermined fluid pressure level, wherein said biasing force is less than said predetermined fluid pressure level.

18. The method of claim 17, wherein said predetermined fluid pressure level is a cracking pressure of at least one of said first and second check valves, and wherein a check valve cracking pressure is a minimum amount by which an upstream pressure of the check valve must be greater than a downstream pressure of the check valve before the check valve will open when functioning properly.

19. The method of claim 15, wherein said step of identifying said change in position comprises identifying said change in position when said fluid pressure in said monitoring step falls below said predetermined fluid pressure level.

20. The method of claim 1, wherein said assessing step comprises associating a condition in which at least one of said first and second check valves remains open when said at least one of said first and second check valves should be closed.

21. The method of claim 19, wherein said predetermined fluid pressure level is a cracking pressure of at least one of said first and second check valves, and wherein a check valve cracking pressure is a minimum amount by which an upstream pressure of the check valve must be greater than a downstream pressure of the check valve before the check valve will open when functioning properly.