Fluid delivery system, fluid path set, sterile connector and improved drip chamber and pressure isolation mechanism

• US 7,611,503 B2
• Filed: 04/16/2004
• Issued: 11/03/2009
• Est. Priority Date: 04/16/2004
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: McCoppin, Anthony S., Sunday, Jared A., Haury, John A., Gimbel, James M., Spohn, Michael A., Dedig, James Albert, Felix, Susan Lynn, Ehrenberger, Michael J.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Gilbert; Andrew M
• Application Number:
  US10/826,149
• Publication Number:
  US 20050234428A1
• Time in Patent Office: 2,027 Days
• Field of Search: 604/533, 604/251, 604 30- 32, 604/65, 604/247, 604/249, 604256- 7, 137/469, 137/71, 137 74- 5, 137/118.03, 137/115.28, 417/385, 417/388
• US Class Current: 604/533
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/14553 comprising a pressure jacket
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2473 Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
• CPC Class Codes: A61M 2039/2486 Guided stem, e.g. reciprocating stopper
• CPC Class Codes: A61M 2039/2493 Check valve with complex design, e.g. several inlets and outlets and several check valves in one body
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• 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 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626

Abstract

The fluid path set is intended for use in a fluid delivery system. The fluid path set includes a multi-patient use section adapted for connection to a syringe used in the fluid delivery system, and to a source of fluid, such as contrast media, to be loaded into the syringe. The fluid path set further includes a per-patient use section that is removably connected to the multi-patient use section. A connector removably connects the multi-patient use section and the per-patient use section. A drip chamber is provided between the source of fluid and the syringe, and includes a projection for determining a level of fluid in the drip chamber. The per-patient use section includes a pressure isolation mechanism. The pressure isolation mechanism includes a lumen, a pressure isolation port, and a valve member with a biasing portion that biases the valve member to a normally open position.

Claims

1. A fluid path set for use in a fluid delivery system comprising a pressurizing device and fluid source, the fluid path set comprising:

a first section adapted for connection to the pressuring device and to the fluid source, the first section comprising an intervening drip chamber between the fluid source and the pressurizing device;

a second section adapted for removable fluid communication with the first section, the second section comprising a pressure isolation mechanism comprising a lumen having an inlet in fluid connection with the first section and an outlet, a pressure isolation port in fluid communication with the lumen, and a valve member comprising a biasing portion adapted to bias the valve member to a normally open position permitting fluid communication between the inlet and the outlet of the lumen and between the lumen and the pressure isolation port, the biasing portion also adapted to move the valve member to a closed position when fluid pressure in the lumen reaches a predetermined pressure level sufficient to overcome the biasing force of the biasing portion of the valve member, wherein in the closed position the valve member is adapted to allow fluid communication between the inlet and the outlet of the lumen while preventing fluid communication between the lumen and the pressure isolation port; and

a connector providing the removable fluid communication between the first section and the second section, the connector comprising;

a first connector member associated with one of the first section and the second section and comprising an outer housing and a first externally-threaded female luer member coaxially disposed in and recessed within the outer housing and separated therefrom by an annular cavity; and

a second connector member associated with the other of the first section and the second section and comprising a male luer disposed in and recessed within an internally-threaded second member, the internally-threaded second member comprising at least one circumferentially-extending raised structure on an external surface thereof, the at least one raised structure extending into a liquid-trapping chamber defined by an inner wall of the outer housing and the first externally-threaded female luer member and further defining a tortuous path with the inner wall of the outer housing for inhibiting liquid flow from the liquid-trapping chamber between the outer housing and the internally-threaded second member when the first connector member is connected to the second connector member;

wherein the first externally-threaded female luer member and the internally-threaded second member cooperate to securely and releasably connect the first connector member to the second connector member to establish the removable fluid communication between the first section and the second section, and wherein the internally-threaded second member is received in the outer housing of the first connector member when the first connector member is connected to the second connector member.

2. The fluid path set of claim 1, further comprising a protective cap associated with at least one of the first connector member and the second connector member.

3. The fluid path set of claim 2, wherein the first and second connector members each comprise a raised rib adapted to cooperate with a corresponding groove defined internally in the protective cap.

4. The fluid path set of claim 1, wherein the drip chamber comprises a projection.

11. The fluid path set of claim 1, further comprising a pressure transducer in fluid communication with the pressure isolation port.

5. An injector system comprising:

a source of injection fluid;

a pump device;

a fluid path set disposed between the source of injection fluid and the pump device, and comprising a first section adapted for connection to the source of injection fluid and a second section adapted for removable fluid communication with the first section, wherein the second section comprises a pressure isolation mechanism comprising a lumen having an inlet in fluid connection with the first section and an outlet, a pressure isolation port in fluid communication with the lumen, and a valve member comprising a biasing portion adapted to bias the valve member to a normally open position permitting fluid communication between the inlet and the outlet of the lumen and between the lumen and the pressure isolation port, the biasing portion also adapted to move the valve member to a closed position when fluid pressure in the lumen reaches a predetermined pressure level sufficient to overcome the biasing force of the biasing portion of the valve member, wherein in the closed position the valve member is adapted to allow fluid communication between the inlet and the outlet of the lumen while preventing fluid communication between the lumen and the pressure isolation port; and

at least one connector providing the removable fluid communication between the first section and the second section, the connector comprising;

a first connector member associated with one of the first section and the second section and comprising an outer housing and a first externally-threaded female luer member coaxially disposed in and recessed within the outer housing and separated therefrom by an annular cavity; and

a second connector member associated with the other of the first section and the second section and comprising a male luer disposed in and recessed within an internally-threaded second member, the internally-threaded second member comprising at least one circumferentially-extending raised structure on an external surface thereof, the at least one raised structure extending into a liquid-trapping chamber defined by an inner wall of the outer housing and the first externally-threaded female luer member and further defining a tortuous path with the inner wall of the outer housing for inhibiting liquid flow from the liquid-trapping chamber between the outer housing and the internally-threaded second member when the first connector member is connected to the second connector member;

wherein the first externally-threaded female luer member and the internally-threaded second member cooperate to securely and releasably connect the first connector member to the second connector member to establish the removable fluid communication between the first section and the second section, and wherein the internally-threaded second member is received in the outer housing of the first connector member when the first connector member is connected to the second connector member.

6. The injector system of claim 5, further comprising a protective cap associated with at least one of the first connector member and the second connector member.

7. The injector system of claim 6, wherein the first and second connector members each comprise a raised rib adapted to cooperate with a corresponding groove defined internally in the protective cap.

8. The injector system of claim 5, wherein the first section is adapted for connection to a pressurizing device and to the source of injection fluid to be loaded into the pressurizing device, and wherein the first section comprises an intervening drip chamber between the source of injection fluid and the pressurizing device.

9. The injector system of claim 8, wherein the drip chamber comprises a projection.

10. The injector system of claim 5, wherein the first and second connector members comprise wings for grasping by a user while connecting the first and second connector members.

12. The injector system of claim 5, further comprising a pressure transducer in fluid communication with the pressure isolation port.