Closed, one-handed blood sampling system

• US 5,961,472 A
• Filed: 09/26/1997
• Issued: 10/05/1999
• Est. Priority Date: 09/26/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Evans, David J., Couchman, W. Scott, Swendson, David L., Morris, Wesley M.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US08/937,670
• Time in Patent Office: 739 Days
• Field of Search: 600/573, 600/577, 600/578, 600/579
• US Class Current: 600/573
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61M 5/3148 Means for causing or aiding aspiration or plunger retraction

Abstract

A one-handed blood sampling reservoir for an infusion line having a configuration which allows discard fluid to be drawn into the reservoir and then returned to the patient in two squeezing motions. Both drawing and returning steps are performed by squeezing two of a plurality of finger grips provided on the reservoir. The reservoir may include a bracket which enables one-handed operation in either a hand-held or a pole-mounted configurations. In the alternative, the reservoir and finger grips may be formed by telescoped inner and outer housings without a bracket. The reservoir desirably includes a syringe-like body forming a chamber and a plunger/piston assembly reciprocal therein to vary the volume of the chamber. A narrow gap is provided in the chamber open to both inlet and outlet ports when the piston is fully seated to ensure a consistent and minimum flush volume in the chamber. The piston may be spring-loaded against the syringe body to simplify manufacturing by reducing the number of close tolerance parts required. The reservoir is preferably placed within an infusion line having a pressure transducer therein, and the spring loaded piston may be adjustable to vary the dynamic response of the fluid pressure system.

Claims

1. A reservoir for use in a fluid sampling system, comprising:

a reservoir body defining a chamber within;

a piston having a piston wall facing the chamber and displaceable within the body from a first position to a second position to vary the volume of the chamber;

a fluid inlet port and a fluid outlet port open to the chamber;

structure on either the body or the piston which maintains a minimum gap between the piston wall and the body when the piston is in the first position, the gap defining a volume to which the inlet and outlet ports communicate to allow fluid to flow therebetween; and

a biasing member which urges the piston wall into the first position.

2. The reservoir of claim 1, wherein the reservoir comprises a syringe-like device having an axis with the inlet port located at one axial end of the chamber and the piston being axially displaceable along the axis between the first and second positions.

3. The reservoir of claim 2, wherein the chamber is centered about the axis and the inlet port is located off-center in the one axial end.

4. The reservoir of claim 1, wherein the piston wall faces the inlet port and the inlet port is oriented substantially perpendicularly with respect to said piston wall.

5. The reservoir of claim 1, further including a plunger assembly reciprocal within the reservoir body comprising the piston on a first end and a plunger on a second end extending outside of the body, wherein the biasing member is positioned between and urges apart the piston and plunger.

6. The reservoir of claim 5, wherein the body and plunger assembly cooperate to form a syringe-like device with the plunger assembly reciprocal along an axis defined by the body, and wherein the biasing member acts substantially in the axial direction.

7. The reservoir of claim 6, wherein the plunger includes locking detents which cooperate with apertures in the piston to couple the plunger and piston together while allowing relative axial movement therebetween.

8. The reservoir of claim 7, further including complementary structure on the plunger and on the body which maintains the plunger in a retracted position urging the piston wall into the first position.

9. The reservoir of claim 8, further including a trigger on the plunger which releases the plunger from the retracted position.

10. The reservoir of claim 9, wherein the trigger comprises a cantilevered lever member biased outward against an edge when the plunger is in the retracted position, the edge being fixed with respect to the body, the lever member including a detent which interferes with the edge and maintains the plunger in the retracted position until the lever member is displaced inwardly.

11. The reservoir of claim 1, wherein the structure which maintains a minimum gap between the piston wall and the body when the piston is in the first position comprises a protrusion on the piston wall.

12. The reservoir of claim 1, wherein the structure which maintains a minimum gap between the piston wall and the body when the piston is in the first position comprises a protrusion on an inner wall of the body facing the piston wall.

13. The reservoir of claim 12, wherein there are three protrusions on the inner wall generally evenly distributed about a circle spaced from side walls of the chamber.

14. The reservoir of claim 1, wherein the inlet port is in fluid communication with a line leading from a fluid source, and the outlet port is in fluid communication with a line leading to a fluid system of a patient.

15. The reservoir of claim 1, wherein magnitude of the biasing member is adjustable.

16. The reservoir of claim 15, further including a plunger reciprocal within the reservoir body and coupled to the piston with axial play therebetween, wherein the biasing member is a spring positioned between and urging apart the piston and plunger.

17. A method of flushing a reservoir used in a fluid sampling system, comprising:

providing a reservoir having a chamber and a displaceable piston having a piston wall facing the chamber and displaceable within the body to vary the volume of the chamber;

connecting a proximal portion of tubing between a source of flushing fluid and an inlet to the variable volume chamber;

connecting a distal portion of tubing between a fluid system of a patient and an outlet to the variable volume chamber;

biasing the piston into a first position within the variable volume chamber with the piston wall adjacent the inlet and outlet ports; and

maintaining a minimum gap between the piston wall and the chamber when the piston is in the first position with structure on either the chamber or the piston, the gap defining a volume to which the inlet and outlet ports communicate and allow fluid to flow from the proximal portion of tubing to the distal portion of tubing.

18. The method of claim 17, wherein the reservoir comprises a syringe-like device having an axis with the inlet port located at one axial end of the chamber and the method includes axially displacing the piston along the axis into the first position.

19. The method of claim 18, wherein the chamber is centered about the axis and the inlet port is located off-center in the one axial end, the method including flowing flushing fluid into the chamber through the inlet port when the piston is in the first position.

20. The method of claim 17, wherein the piston wall of the piston faces the inlet port and the inlet port is oriented substantially perpendicularly with respect to the piston wall, the method including flowing flushing fluid into the chamber through the inlet port when the piston is in the first position, wherein flushing fluid contacts the piston wall perpendicularly and fans out within the gap.

21. The method of claim 17, including a plunger reciprocal within the reservoir body and coupled to the piston with axial play therebetween, wherein the method includes adjusting the magnitude of the biasing member.

22. The method of claim 17, further including a plunger assembly reciprocal within the reservoir body comprising the piston on a first end and a plunger on a second end extending outside of the body, wherein the biasing member is positioned between and urges apart the piston and plunger, and wherein the body and plunger assembly cooperate to form a syringe-like device with the plunger assembly reciprocal along an axis defined by the body, the method including biasing the piston in the axial direction into the first position.

23. The method of claim 22, including coupling the plunger and piston together while allowing relative axial movement therebetween.

24. The method of claim 22, including maintaining the plunger in a retracted position urging the piston into the first position.

25. The method of claim 24, further including actuating a trigger on the plunger to release the plunger from the retracted position.

26. The method of claim 17, including maintaining the minimum gap between the piston wall and the body when the piston is in the first position with a protrusion on the piston wall.

27. The method of claim 17, including maintaining the minimum gap between the piston wall and the body when the piston is in the first position with a protrusion on an inner wall of the body facing the piston.

28. A reservoir for use in a fluid sampling system, comprising:

a reservoir body defining a variable volume chamber within, the body having a peripheral wall and a bottom wall;

a fluid inlet port extending perpendicularly through the bottom wall of the body and open to the chamber;

a fluid outlet port open to the chamber;

a piston displaceable within the body from a first position adjacent the bottom wall to a second position spaced farther away from the bottom wall to increase the volume of the chamber, the piston having a pressure surface which is spaced from the bottom wall to form a narrow gap therebetween when the piston is in the first position, the fluid inlet and outlet ports being open to the gap; and

a seal surrounding the pressure surface and providing a fluid-tight seal between the piston against the peripheral wall of the chamber, wherein fluid entering the chamber through the inlet port when the piston is in the first position is directed generally in a 360°

sheet across the bottom wall and toward the peripheral wall of the chamber.

29. The reservoir of claim 28, wherein the pressure surface is substantially flat and disposed parallel to the bottom wall.

30. The reservoir of claim 28, including a protrusion on the pressure surface which contacts the bottom wall and forms the gap.

31. The reservoir of claim 28, including a protrusion on the bottom wall surface which contacts the pressure surface and forms the gap.

32. The reservoir of claim 31, wherein there are three protrusions on the bottom wall generally evenly distributed about a circle spaced inwardly from peripheral wall.

33. The reservoir of claim 28, wherein the pressure surface is spaced between approximately 0.005 inches and 0.030 inches from the bottom wall when the piston is in the first position.

34. The reservoir of claim 28, wherein the fluid outlet port extends perpendicularly through the bottom wall of the body.

35. The reservoir of claim 28, wherein the inlet port is offset from the peripheral wall and the outlet port is adjacent the peripheral wall.

36. A method of sampling fluid from a human, comprising:

providing a reservoir body defining a variable volume chamber within, the reservoir body having a peripheral wall and a bottom wall;

connecting the chamber to a vessel of the human by connecting a first conduit to a fluid outlet port open to the chamber;

connecting the chamber to a source of flushing solution by connecting a second conduit to a fluid inlet port extending perpendicularly through the bottom wall and offset from the peripheral wall;

providing a piston displaceable within the reservoir body from a first position adjacent the bottom wall to a second position spaced farther away from the bottom wall to increase the volume of the chamber, the piston having a pressure surface facing the bottom wall and including a seal surrounding the pressure surface and providing a fluid-tight seal between the piston against the peripheral wall of the chamber; and

flushing the chamber between the piston and the bottom wall such that fluid entering the chamber through the inlet port when the piston is in the first position is directed generally in a 360°

sheet across the bottom wall and toward the peripheral wall of the chamber.

37. The method of claim 36, wherein the pressure surface is substantially flat and disposed parallel to the bottom wall.

38. The method of claim 36 wherein the fluid inlet port and fluid outlet port extend perpendicularly through the bottom wall and parallel to each other.