Closed blood sampling system with isolated pressure monitoring

• US 7,744,573 B2
• Filed: 09/13/2006
• Issued: 06/29/2010
• Est. Priority Date: 09/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Drori, Hagay, Couchman, Scott, Gordon, Mark, Liu, John
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US11/521,610
• Publication Number:
  US 20070179407A1
• Time in Patent Office: 1,385 Days
• Field of Search: 137/555, 137/556, 137/556.6, 600/573, 600/576, 600/578, 600/579, 600/581, 600/584, 604/32, 604/248, 604/401
• US Class Current: 604/248
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/1535 comprising means for indicating vein or arterial entry A61B5/1545 takes precedence

Abstract

A closed blood sampling system within a pressure monitoring line having a control valve that enables a clearance reservoir to be isolated from the pressure column when no samples are being taken. The valve is a stopcock-like device that includes a rotating valve member and attached control handle with clear visible and tactile indicators for the mode of operation. The rotating valve member has a number of internal and circumferential channels for connecting or disconnecting select ports in the core of the valve. By isolating the clearance reservoir, the quality of the pressure signal is improved such that the sampling line can be lengthened for greater convenience in the intensive care or operating room. The valve may also incorporate a blunt cannula sampling site therewithin.

Claims

1. A medical system for fluid sampling and pressure monitoring of a fluid system of a patient, comprising:

a conduit line with a proximal segment adapted to be supplied with a physiological fluid and a distal segment adapted to be in communication with a fluid system of a patient;

a control valve with a manifold defining an interior chamber, the manifold having a proximal port fluidly connected to the proximal segment, a distal port fluidly connected to the distal segment, and at least one reservoir port, wherein each of the manifold ports opens to the interior chamber,

a pressure transducer connected to the conduit line for sensing the pressure of the fluid therein;

a fluid sampling port in the medical system;

a reservoir in fluid communication with the at least one reservoir port of the control valve manifold;

the control valve further including a valve member movable within the interior chamber and having a plurality of channels therein that selectively communicate with the manifold ports, wherein the plurality of channels comprises a first fluid path and a second fluid path, wherein the first fluid path is separate from the second fluid path, the valve member being movable into at least two positions;

a first position that provides open fluid communication from the proximal segment to the patient through the control valve so as to eliminate any dead spaces therein, wherein the first fluid path provides an open fluid passage from the proximal port to one of the at least one reservoir ports, wherein the second fluid path provides an open fluid passage from the distal port to one of the at least one reservoir ports, and wherein reduced pressure within the reservoir pulls fluid from the distal segment through the control valve and into the reservoir sufficient to draw fluid from the fluid system of the patient past the sampling port, and

a second position that provides open fluid communication from the proximal segment to the proximal port and through the first fluid path in the valve member to the distal segment, and wherein the proximal segment and distal segment are not in fluid contact with the reservoir and second fluid path and sampling port, such that the pressure of fluid within the conduit line exclusive of the reservoir can be sensed by the pressure transducer.

2. The system of claim 1, wherein the valve member has a third position that provides open fluid communication from the distal segment to the sampling port via the second fluid path but prevents communication between the sampling port and both the reservoir and the proximal segment.

3. The system of claim 1, wherein the valve member comprises a core rotatable within the interior chamber of the manifold and a control handle external to the manifold, further including coordinated visible features on the control handle and manifold that provide symbolic indicators of both first and second positions of the valve member.

4. The system of claim 1, wherein the sampling port is formed within the control valve.

5. The system of claim 4, wherein the sampling port is formed within the valve member and communicates with a sampling cavity formed internally within the valve member and open to the second fluid path of the valve member.

6. The system of claim 4, further including a second sampling port having a sampling cavity positioned along the distal segment of the conduit line.

7. The system of claim 6, further including a second control valve interposed between the second sampling port and the distal segment and having a valve member movable into at least three positions:

a first position that provides open fluid communication from the conduit line through the control valve to the sampling cavity and back to the conduit line,

a second position that provides open fluid communication from the conduit line through the valve member and back to the conduit line while bypassing the second sampling port, such that the pressure of fluid within the conduit line exclusive of the second sampling port can be sensed by the pressure transducer, and

a third position that provides open fluid communication from the distal segment through the control valve to the second sampling port but prevents communication between the second sampling port and the conduit line proximal from the second sampling port.

8. The system of claim 1, wherein the valve member comprises a core movable within the interior chamber of the manifold and a control handle external to the manifold, the core having an external channel formed along an exterior surface of the core and an internal channel formed along an interior bore of the core.

9. The system of claim 8, wherein the internal channel opens to the exterior surface of the core at two separated locations spaced from the external channel.

10. The system of claim 1, further including means for pressurizing the physiological fluid such that at least some fluid continues to flow through the conduit line to the patient when the valve member is in the first position.

11. The system of claim 1, wherein the manifold comprises at least two reservoir ports, wherein a first of the at least two reservoir ports is a reservoir outlet port and a second of the at least two reservoir ports is a reservoir inlet port, wherein the reservoir has an inlet open to the reservoir outlet port of the control valve manifold and an outlet open to the reservoir inlet port of the control valve manifold, and wherein the first position of the valve member provides open fluid communication between the control valve flow passages through the inlet and outlet of the reservoir to flush a chamber of the reservoir.

12. A medical system for fluid sampling of a fluid system of a patient, comprising:

a conduit line with a proximal segment adapted to be supplied with a physiological fluid and a distal segment adapted to be in communication with a fluid system of a patient;

a control valve connected between the proximal segment and the distal segment of the conduit line;

a fluid sampling port having a flow path therethrough whose opposite ends open to internal channels in the control valve;

a reservoir in fluid communication with a reservoir port of the control valve manifold;

the control valve further including a valve member movable into at least three positions;

a first position that provides open fluid communication from the proximal segment through the reservoir to the distal segment, wherein at least some fluid from the proximal segment must pass through the reservoir to reach the distal segment,

a second position that provides open fluid communication from the proximal segment to the distal segment while bypassing the reservoir and sampling port, and

a third position that provides open fluid communication from the distal segment to the sampling port but prevents communication between the sampling port and both the reservoir and the proximal segment.

13. The system of claim 12, wherein:

the control valve further includes a manifold defining an interior chamber, the manifold having a proximal port fluidly connected to the proximal segment of the conduit line, a distal port fluidly connected to the distal segment, an outlet port, and an inlet port, wherein each of the manifold ports opens to the interior chamber, and wherein the valve member comprises a core movable within the interior chamber of the manifold and having channels therein that selectively communicate with the manifold ports, and the reservoir has an inlet open to the manifold outlet port and an outlet open to the manifold inlet port, and wherein;

the first position provides open fluid communication from the proximal segment to the proximal port and the outlet port of the control valve, through the inlet and outlet of the reservoir, to the inlet port and the distal port of the control valve to the distal segment,

the second position provides open fluid communication from the proximal segment to the proximal port and through at least one channel in the valve member core to the distal segment while bypassing the reservoir and sampling port, and

the third position provides open fluid communication from the distal segment to distal port and one of the channels of the valve member core, and to the sampling port.

14. The system of claim 13, wherein the valve member core has an external channel formed along an exterior surface of the core and an internal channel formed along an interior bore of the core.

15. The system of claim 14, wherein the internal channel opens to the exterior surface of the core at two separated locations spaced from the external channel.

16. The system of claim 12, wherein the control valve further includes a manifold defining an interior chamber in which the valve member moves, and wherein the sampling port is formed within the valve member and includes a sampling cavity open to channels within the valve member that communicate with the manifold interior chamber.

17. The system of claim 12, wherein the control valve further includes a manifold defining an interior chamber and the valve member comprises a movable within the interior chamber of the manifold and a control handle external to the manifold, and further including coordinated visible features on the control handle and manifold that provide symbolic indicators of all three positions of the valve member.

18. A method of taking samples and measuring the pressure of a fluid system of a patient, comprising:

providing a fluid sampling system with a conduit line and a reservoir connected thereto between a proximal segment adapted to be supplied with a physiological fluid and a distal segment adapted to be in communication with a fluid system of a patient;

interposing a control valve between the reservoir and the conduit line having a movable valve member with a control handle, the valve member movable into at least a first position and a second position;

providing a pressure transducer connected to the conduit line for sensing the pressure of the fluid therein;

providing a fluid sampling port in the sampling system;

selecting the first position of the valve member to provide open fluid communication from the proximal segment to the distal segment via the control valve and the reservoir, and creating a reduced pressure within the reservoir such that fluid flows from the distal segment through the control valve into the reservoir sufficient to draw fluid from the fluid system of the patient past the sampling port; and

selecting the second position of the valve member to provide open fluid communication from the proximal segment to the distal segment via the control valve while bypassing the reservoir, and monitoring the pressure sensed by the pressure transducer.

19. The method of claim 18, wherein the valve member has a third position, and the method includes selecting the third position of the valve member to provide open fluid communication from the distal segment to the sampling port but prevent communication between the sampling port and both the reservoir and the proximal segment, and sampling fluid from the conduit line through the sampling port.

20. The method of claim 19, wherein the fluid system of the patient is the blood system, and further including means for pressurizing the physiological fluid such that at least some fluid continues to flow through the conduit line to the patient when the valve member is in the first position, the method including the steps of:

selecting the first position of the valve member such that the physiological fluid flows through the conduit line to the patient;

then creating a reduced pressure within reservoir and collecting sufficient fluid therein such that blood flows past the sampling port;

then

selecting the third position of the valve member;

then

sampling blood from the conduit line through the sampling port;

then

creating an elevated pressure within the reservoir to expel blood therefrom into the distal segment of the conduit line;

then

selecting the first position of the valve member such that the physiological fluid flows through the conduit line to the patient and flushes the reservoir of blood; and

then

selecting the second position of the valve member and monitoring the pressure sensed by the pressure transducer.

21. The method of claim 18, wherein the control valve includes visible features that provide symbolic indicators of the first and second positions of the control handle, the method of selecting the first and second positions further includes interpreting the symbolic indicators to determine the placement of the control handle corresponding to the first and second positions.

22. A medical system for fluid sampling of a fluid system of a patient, comprising:

a conduit line with a proximal end adapted to be supplied with a physiological fluid and a distal end adapted to be in communication with a fluid system of a patient;

a pressure transducer connected to the conduit line for sensing the pressure of the fluid therein;

a fluid sampling port having a sampling cavity;

a control valve interposed between the conduit line and the sampling port and having a manifold defining an interior chamber, the manifold having a proximal port fluidly connected to the conduit line, a distal port fluidly connected to the conduit line, an outlet port, and an inlet port, wherein each of the manifold ports opens to the interior chamber,

the control valve further including a valve member movable within the interior chamber and having channels therein that selectively communicate with the manifold ports, the valve member being movable into at least three positions;

a first position that provides a first path of open fluid communication from the conduit line to the proximal port and the outlet port of the control valve, and a second path of open fluid communication from the inlet port and the distal port of the control valve to the conduit line via the sampling cavity, wherein the first path is separate from the second path of open fluid communication,

a second position that provides open fluid communication from the conduit line to the proximal port and through at least one channel in the valve member and back to the conduit line while bypassing the sampling port, such that the pressure of fluid within the conduit line exclusive of the sampling port can be sensed by the pressure transducer, and

a third position that provides open fluid communication from the distal end of the conduit line through the control valve to the sampling port but prevents communication between the sampling port and the proximal end of the conduit line.

23. The system of claim 22, wherein the valve member comprises a core movable within the interior chamber of the manifold and having an external channel formed along an exterior surface of the core and an internal channel formed along an interior bore of the core.

24. The system of claim 23, wherein the internal channel opens to the exterior surface of the core at two separated locations spaced from the external channel.

25. The system of claim 22, wherein the sampling port is formed within the valve member and the sampling cavity is open to the valve member channels.

26. The system of claim 22, wherein the valve member comprises a core movable within the interior chamber of the manifold and a control handle external to the manifold.

27. The system of claim 26, further including coordinated visible features on the control handle and manifold that provide symbolic indicators of all three positions of the valve member.