Biological fluid sampling apparatus, assembly and method

• US 7,479,131 B2
• Filed: 10/24/2002
• Issued: 01/20/2009
• Est. Priority Date: 07/29/1999
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Joie, Michel, Rondeau, Georges, Mathias, Jean-Marie
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US10/279,252
• Publication Number:
  US 20040082899A1
• Time in Patent Office: 2,280 Days
• Field of Search: 604/403, 604/408, 604/409, 604/410, 604/411, 604 401- 501, 604/6.15, 604/262, 600575-580
• US Class Current: 604/409
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/154 Devices using pre-evacuated means
• 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: A61J 2200/10 Coring prevention means, e.g. for plug or septum piecing members
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration

Abstract

A sampling apparatus is disclosed that includes a sample container including at least one wall defining a fluid-receiving interior chamber and including a fluid inlet for receiving fluid into the chamber and a sample device receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber.

Claims

1. Sampling apparatus comprising

a sample container including at least one wall defining a fluid-receiving interior chamber in which the container is adapted to be held in a selected position for withdrawing a fluid sample, in which position the container has a generally vertical axis, the apparatus further comprising a fluid inlet for receiving fluid into the chamber and flexible tubing communicating with the fluid inlet, the tubing being disposed at an acute angle to the vertical axis and

a sample device receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber.

2. The apparatus of claim 1 in which the tubing extends in a coil configuration around the container to provide a compact configuration for packaging.

3. Sampling apparatus comprising:

a sample container including at least one wall defining a fluid-receiving interior chamber and wherein the container has an outer peripheral edge, wherein said container is adapted to be held in a selected position for withdrawing a fluid sample, said container including walls shaped to form a lowermost point in the interior chamber and to direct fluid in the interior chamber to the lowest point in the chamber when the container is in the selected position, the container further including a fluid inlet for receiving fluid into the chamber; and

a sample tube receiver carried by the container wall wherein the receiver is situated such that the receiver is located substantially within the outer peripheral edge and no part of the receiver extends substantially beyond the peripheral edge, the receiver being adapted to removably receive therethrough a sampling tube for withdrawing a fluid sample from the chamber, the receiver communicating with the interior chamber in the vicinity of the lowermost point so that substantially all of the fluid within the interior chamber may be withdrawn.

4. The apparatus of claim 3 in which the sample tube receiver is disposed to receive a sampling tube in a vertical direction when the container is in the selected position.

5. Sampling apparatus comprising

a sample container comprising facing flexible plastic sheets peripherally sealed together to define an interior chamber, wherein the container has an outer peripheral edge, the container further including a fluid inlet for receiving fluid into the chamber, the container being adapted for holding in a generally vertical disposition and the peripheral edges is inclined to direct fluid into a lowermost region of the chamber when the container is in the vertical disposition, and

a sample tube receiver carried by the container wall wherein the receiver is situated such that the receiver is located substantially within the outer peripheral edge and no part of the receiver extends substantially beyond the peripheral edge, the receiver being adapted to removably receive therethrough a sampling tube for withdrawing a fluid sample from the chamber.

6. Sampling apparatus comprising

a sample container including at least one wall defining a fluid-receiving interior chamber and wherein the container has an outer peripheral edge, the container further including a fluid inlet for receiving fluid into the chamber and

a sample tube receiver carried by the container wall wherein the receiver is situated such that the receiver is located substantially within the outer peripheral edge and no part of the receiver extends substantially beyond the peripheral edge, the receiver being adapted to removably receive therethrough a sampling tube for withdrawing a fluid sample from the chamber, the receiver further comprising

a needle assembly including a piercing end and a non-piercing end;

a generally cylindrical housing including a distal end engageable with the needle assembly, a proximal end adapted to receive a blood collection tube, and a sidewall extending between the proximal and distal ends; and

a cover movably associated with the proximal end of the cylindrical body and movable between a closed position covering the proximal end and an open position opening the proximal end.

7. The apparatus of claim 6, wherein the distal end of the housing further comprises a through-bore defined by an interior wall.

8. The apparatus of claim 7 in which the housing and needle assembly have interlocking surfaces for fixedly holding the needle assembly in the through bore.

9. The apparatus of claim 8 wherein the needle assembly includes radially extending rib;

and

the interior wall of the through bore defines a slot for receiving and securing said radial rib of the needle assembly.

10. The apparatus of claim 8, wherein the slot in the interior wall of the through bore is defined between a first inwardly extending radial ledge and a second inwardly extending radial ledge axially spaced from the first inwardly extending ledge.

11. The apparatus of claim 6, further comprising a sleeve disposed over the piercing end of the needle assembly.

12. The apparatus of claim 11 in which the interior wall of the through bore further includes an inwardly projecting member engageable with the sleeve.

13. The apparatus of claim 6, wherein said cover is attached to said housing by a hinge.

14. The apparatus of claim 13, further comprising a closure member that has a first end attached to the cover and a second end attached to the housing, the closure member being disposed to hold the cover in either the open or closed position and to move the cover preferentially from an intermediate position to the open or closed position.

15. A disposable fluid circuit assembly for processing, storing, separating or treating a biological fluid such as blood or blood components,

an inlet for receiving a biological fluid into the fluid circuit assembly;

one or more flow paths for conducting the biological fluid or components thereof between selected locations within the fluid circuit;

a sample container including at least one wall defining a fluid-receiving interior chamber and wherein the container has an outer peripheral edge, the container further including a fluid inlet for receiving biological fluid or component into the chamber; and

a sample device receiver carried by the container wall and in fluid communication with the chamber wherein the receiver is situated such that the receiver is located substantially within the outer peripheral edge and no part of the receiver extends substantially beyond the peripheral edge, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber.

16. The fluid circuit assembly of claim 15 in which the container is adapted to collect fluid at a selected area in the interior chamber and the sample device receiver communicates with the chamber at the selected area.

17. The fluid circuit assembly of claim 15 in which the tubing extends in a coil configuration around the container to provide a compact configuration for packaging.

18. The fluid circuit assembly of claim 15 in which the container comprises facing flexible plastic sheets peripherally sealed together to define the interior chamber, the receiver overlying one of the sheets and communicating through such sheet with the interior chamber.

19. The fluid circuit assembly of claim 15 in which the container comprises walls shaped to direct fluid to the selected area in the interior chamber.

20. The fluid circuit assembly of claim 15 in which the container is adapted for holding in a generally vertical disposition and the container includes walls shaped to direct fluid in the interior chamber to the lowest point in the chamber when the container is in the vertical disposition, the receiver communicating with the interior chamber in the vicinity of the lowest point so that substantially all of the fluid within the interior chamber may be withdrawn.

21. The fluid circuit assembly of claim 20 in which the sample device receiver is disposed to receive a sampling device in a vertical direction when the container is in the vertical disposition.

22. The fluid circuit assembly of claim 15 in which the container comprises facing flexible plastic sheets peripherally sealed together to define the interior chamber, the container being adapted for holding in a generally vertical disposition and the peripheral edges are inclined to direct fluid into a lowermost region of the chamber when the container is in the vertical disposition.

23. The fluid circuit assembly of claim 22 in which the receiver communicates with the lowermost region of the chamber.

24. The fluid circuit assembly of claim 15 in which the receiver comprises a tubular member, one end of the tubular member being open or openable for receiving a sample tube and the other end communicating with the chamber, the tubular member including a hollow piercing member located in the interior of the tubular member and in fluid communication with the interior chamber and disposed to enter a sample tube inserted into the tubular member.

25. The fluid circuit assembly of claim 24 in which the sample container is adapted to be held in a vertical orientation and the tubular member is disposed to extend in a generally vertical direction, with the one end facing upwardly when the sample container is in a vertical orientation so as to allow a sample tube to be inserted vertically downwardly into the tubular member.

26. The fluid circuit assembly of claim 15 in which the receiver comprises:

a needle assembly including a piercing end and a non-piercing end;

a generally cylindrical housing including a distal end engageable with the needle assembly, a proximal end adapted to receive a blood collection tube, and a sidewall extending between the proximal and distal ends; and

a cover movably associated with the proximal end of the cylindrical body and movable between a closed position covering the proximal end and an open position opening the proximal end.

27. The fluid circuit assembly of claim 26, wherein the distal end of the housing further comprises a through bore defined by an interior wall.

28. The fluid circuit assembly of claim 27 wherein the needle assembly and housing have interlocking surfaces for fixedly positioning the needle assembly in the through bore.

29. The fluid circuit assembly of claim 28, wherein a slot is defined in the interior wall of the through bore and the needle assembly includes an annular rib for interfitting in the slot.

30. The fluid circuit assembly of claim 27, wherein the needle assembly further includes a sleeve disposed over the piercing end of the needle assembly.

31. The fluid circuit assembly of claim 26, wherein said cover is attached to said housing by a hinge.

32. The fluid circuit assembly of claim 31, further comprising a closure member with a first end attached to the cover and a second end attached to the housing, the closure member being disposed to hold the cover in either the open or close position and to move the cover preferentially from an intermediate position to the open or closed position.

33. The disposable fluid circuit assembly of claim 15 wherein said sample container comprises a pair of flexible facing plastic sheets peripherally sealed together along a peripheral edge to define an interior chamber and adapted for holding in a generally vertical disposition, a blood component inlet tube communicating between the chamber and one or more flow paths or selected locations within the fluid circuit, the peripheral edge being inclined to direct blood component in the chamber to a lowermost region of the chamber when in the vertical position and a blood component sample exit opening located in one of the sheets in the lowermost region.

34. The fluid circuit assembly of claim 33 wherein the sample container includes a main pouch region and at least one laterally offset pouch region and the blood component inlet tube is attached to the pouch at the laterally offset region.

35. The fluid circuit assembly of claim 33 further includes a blood component removal tube communicating with the chamber.

36. The fluid circuit assembly of claim 35 wherein the sample container includes a main pouch area and opposed laterally offset pouch regions, the blood component inlet tube being attached to the pouch at one of the laterally offset regions and the blood component removal tube being attached at the other laterally offset region.

37. A disposable fluid circuit assembly for processing, storing, separating or treating a biological fluid such as blood or blood components,

an inlet for receiving a biological fluid into the fluid circuit assembly;

one or more flow paths for conducting the biological fluid or components thereof between selected locations within the fluid circuit;

a sample container including at least one wall defining a fluid-receiving interior chamber and including a fluid inlet for receiving biological fluid or component into the chamber in which the container has a generally vertical axis and in which the assembly further comprises flexible tubing communicating with the fluid inlet, the tubing being disposed at an acute angle to the vertical axis; and

a sample device receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber.

38. The fluid circuit assembly of claim 37 wherein the inlet is adapted for withdrawing whole blood from a human and the fluid circuit comprises a flow path for conducting the whole blood or a component thereof to a desired location within the fluid circuit, the fluid inlet to the interior chamber communicating with the blood or blood component flow path for receiving a sample of the blood or blood component into the chamber.

39. A disposable fluid circuit assembly for processing, storing, separating or treating a biological fluid such as blood or blood components,

an inlet for receiving a biological fluid into the fluid circuit assembly;

one or more flow paths for conducting the biological fluid or components thereof between selected locations within the fluid circuit;

a sample container including at least one wall defining a fluid-receiving interior chamber and including a fluid inlet for receiving biological fluid or component into the chamber and in which the container includes a main chamber region and at least one laterally offset chamber region and the fluid inlet to the chamber is located in the laterally offset region and;

a sample device receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber.

40. The fluid circuit assembly of claim 39 in which the container includes opposed laterally offset chamber regions.

41. The fluid circuit assembly of claim 40 further comprising a fluid outlet located in laterally offset chamber region.

42. A method for taking a sample of biological fluid comprising:

providing a sampling apparatus comprising a sample container including at least one wall defining a fluid-receiving interior chamber and including a fluid inlet for receiving fluid into the chamber;

a sample device receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber wherein the sample receiver further comprises a tubular member with a proximal end and a distal end and a cover removably covering the proximal end and the method includes opening the cover;

holding the sample device receiver and sample containers such that the receiver is disposed to receive the sample device into operative position for sample withdrawal in a generally vertical direction;

inserting the sample device into the receiver in a generally vertically downward direction, the sample receiver communicating with a lowermost region of the sample container as held so as to withdraw a sample generally vertically into the sample device; and

withdrawing the sample device after a sample is withdrawn and closing the cover over the proximal end.

43. Sampling apparatus comprising

a sample container including at least one wall defining a fluid-receiving interior chamber and including a fluid inlet for receiving fluid into the chamber and wherein said sample container comprises a pair of flexible facing plastic sheets peripherally sealed together along a peripheral edge to define an interior chamber, the container being adapted for holding in a generally vertical disposition, a blood component inlet tube communicating with the chamber, the peripheral edge being inclined to direct blood component in the chamber to a lowermost region of the chamber when in the vertical position and a blood component sample exit opening located in one of the sheets in the lowermost region, and

a sample tube receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to removably receive therethrough a sampling tube for withdrawing a fluid sample from the chamber.

44. The sampling apparatus of claim 43 wherein the sample container includes a main pouch region and at least one laterally offset pouch region and the blood component inlet tube is attached to the pouch at the laterally offset region.

45. The sampling apparatus of claim 43 further includes a blood component removal tube communicating with the chamber.

46. The sampling apparatus of claim 45 wherein the sample container includes a main pouch area and opposed laterally offset pouch regions, the blood component inlet tube being attached to the pouch at one of the laterally offset regions and the blood component removal tube being attached at the other laterally offset region.