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

• US 9,265,885 B2
• Filed: 09/28/2010
• Issued: 02/23/2016
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Liebel Flarsheim Co LLC (Mallinckrodt plc)
• Original Assignee: Liebel Flarsheim Co LLC (Mallinckrodt plc)
• Inventors: Strobl, Geoffrey S.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US13/201,632
• Publication Number:
  US 20120046546A1
• Time in Patent Office: 1,974 Days
• Field of Search: 604/67
• US Class Current: 1/1
• 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 (300) that may be used for assessing an operating condition of at least one of first and second check valves (304, 308) situated in series along/within a section of a patient-specific section of tubing (244). A pressure sensor (332) may be associated with at least part of the flow path between the first and second check valves (304, 308) and may be operable to provide an indication of a failed condition of at least one of the first and second check valves (304, 308). In one embodiment, the pressure sensor (332) may change from a first state to a second state upon fluid pressure within the flow path between the first and second check valves (304, 308) 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 (304, 308). The change in state may be visually discernible on an exterior of the pressure sensor (332).

Claims

1. A medical fluid tubing set, comprising:

a multi-patient tubing section that is reusable for injection of multiple patients;

a patient-specific tubing section downstream of and detachably connected to said multi-patient tubing section, wherein said patient-specific tubing section is located between said multi-patient tubing section and a patient when delivering fluid to the patient, and wherein said patient-specific tubing section comprises;

first and second check valves that are spaced along said patient-specific tubing section;

a pressure sensor fluidly connected with a first region of said patient-specific tubing section that extends between said first and second check valves, wherein said pressure sensor is responsive to a fluid pressure in said first region of said patient-specific tubing section and comprises means for monitoring for a failed condition, wherein said failed condition is a presumption that at least one of said first and second check valves has failed by remaining open when said at least one of said first and second check valves should be closed, wherein said pressure sensor comprises a movable element that undergoes a change in position when said fluid pressure within said first region falls below a predetermined fluid pressure level to identify said failed condition, wherein said predetermined fluid pressure level is a cracking pressure of at least one of said first and second check valves and where 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, wherein said change in position of said movable element is visually perceptible from an exterior of said pressure sensor, wherein a first position of said movable element is associated with a presumed proper functioning of said first and second check valves, and wherein a second position of said movable element is associated with said failed condition; and

a biasing member that is interconnected with said movable element, wherein said biasing member biases said movable element toward said second position, and wherein a biasing force applied to said movable element is less than said predetermined fluid pressure level.

2. The medical fluid tubing set of claim 1, wherein said predetermined fluid pressure level is said cracking pressure of each of said first and second check valves.

3. The medical fluid tubing set of claim 1, wherein said pressure sensor is situated on said patient-specific tubing section.

4. The medical fluid tubing set of claim 1, wherein said first check valve, said pressure sensor, and said second check valve are situated in series along said patient-specific tubing section.

5. The medical fluid tubing set of claim 1, wherein said pressure sensor is situated between said first and second check valves.

6. The medical fluid tubing set of claim 1, wherein said pressure sensor further comprises a housing.

7. The medical fluid tubing set of claim 6, wherein said movable element comprises a portion that protrudes from said housing in said first position and is substantially concealed by said housing in said second position.

8. The medical fluid tubing set of claim 6, wherein said movable element comprises a portion that protrudes from said housing in said second position and is substantially concealed by said housing in said first position.

9. The medical fluid tubing set of claim 6, wherein at least a portion of said movable element is discernable in one of said first and second positions and is generally not discernable in the other of said first and second positions.

10. The medical fluid tubing set of claim 9, wherein said housing comprises a window, wherein said at least a portion of said movable element is discernable through said window in one of said first and second positions and is not discernable through the window in the other of said first and second positions.

11. The medical fluid tubing set of claim 1, wherein said biasing member is selected from the group consisting of a compression spring, a wave spring, or any combination thereof.

12. The medical fluid tubing set of claim 1, wherein said movable element comprises a piston that interfaces with a fluid within said first region between said first and second check valves, and wherein said piston is at least substantially non-deformable.

13. The medical fluid tubing set of any of claim 1, wherein said pressure sensor further comprises a housing, wherein said housing comprises a window, wherein said movable element comprises a diaphragm, wherein said diaphragm is visible through said window in each of said first and second positions, and wherein said diaphragm experiences a visually-discernable shape change in response to an at least presumed failed condition of at least one of said first and second check valves in changing from said first position to said second position.

14. A medical fluid tubing set, comprising:

a multi-patient tubing section that is reusable for injection of multiple patients;

a patient-specific tubing section downstream of and detachably connected to said multi-patient tubing section, wherein said patient-specific tubing section is located between said multi-patient tubing section and a patient when delivering fluid to the patient, and wherein said patient-specific tubing section comprises;

first and second check valves that are spaced along said patient-specific tubing section;

a pressure sensor fluidly connected with a first region of said patient-specific tubing section that is between said first and second check valves, wherein said pressure sensor is responsive to a fluid pressure in said first region of said patient-specific tubing section and comprises;

a housing;

a movable element incorporated by said housing;

a biasing member;

a first configuration where a fluid pressure in said first region is greater than a predetermined fluid pressure level and that disposes said movable element in a first position relative to said housing, wherein said predetermined fluid pressure level is a cracking pressure of at least one of said first and second check valves and where 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; and

a second configuration where said fluid pressure in said first region is less than said predetermined fluid pressure level and said movable element is disposed in a second position relative to said housing by said biasing member, wherein said fluid pressure in said first region is less than said predetermined fluid pressure level when at least one of said first and second check valves has failed due to said at least one of said first and second check valves being open when said at least one of said first and second check valves should be closed;

wherein said biasing member exerts a biasing force on said movable member that directs said movable element toward said second position, and wherein said biasing force is less than said predetermined fluid pressure level;

wherein at least part of said movable element is visible from an exterior of said pressure sensor in at least one of said first and second positions of said movable element relative to said housing; and

wherein a change of said movable element from said first position to said second position is visually perceptible from said exterior of said pressure sensor.

15. The medical fluid tubing set of claim 14, wherein said predetermined fluid pressure level is a cracking pressure of each of said first and second check valves.

16. The medical fluid tubing set of claim 14, wherein said pressure sensor is situated on said patient-specific tubing section.

17. The medical fluid tubing set of claim 14, wherein said first check valve, said pressure sensor, and said second check valve are situated in series along said patient-specific tubing section.

18. The medical fluid tubing set of claim 14, wherein said pressure sensor is situated between said first and second check valves.

19. The medical fluid tubing set of claim 14, wherein said movable element comprises a portion that protrudes from said housing in said first position and is substantially concealed by said housing in said second position.

20. The medical fluid tubing set of claim 14, wherein said movable element comprises a portion that protrudes from said housing in said second position and is substantially concealed by said housing in said first position.

21. The medical fluid tubing set of claim 14, wherein at least a portion of said movable element is discernable in one of said first and second positions and is generally not discernable in the other of said first and second positions.

22. The medical fluid tubing set of claim 21, wherein said housing comprises a window, wherein said at least a portion of said movable element is discernable through said window in one of said first and second positions and is not discernable through the window in the other of said first and second positions.

23. The medical fluid tubing set of claim 14, wherein said biasing member is selected from the group consisting of a compression spring, a wave spring, or any combination thereof.

24. The medical fluid tubing set of claim 14, wherein said movable element comprises a piston that interfaces with a fluid within said first region between said first and second check valves, and wherein said piston is at least substantially non-deformable.

25. The medical fluid tubing set of any of claim 14, wherein said housing comprises a window, wherein said movable element comprises a diaphragm, wherein said diaphragm is visible through said window in each of said first and second positions, and wherein said diaphragm experiences a visually-discernable shape change in response to an at least presumed failed condition of at least one of said first and second check valves in changing from said first position to said second position.