Clot retainer

• US 7,294,311 B2
• Filed: 04/05/2005
• Issued: 11/13/2007
• Est. Priority Date: 04/05/2004
• Status: Expired due to Fees

• Current Assignee: Bio/Data Corp.
• Original Assignee: Bio/Data Corp.
• Inventors: Coville, William E.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US11/099,350
• Publication Number:
  US 20050226785A1
• Time in Patent Office: 952 Days
• Field of Search: 436/69, 436/63, 436/174, 436/177, 422/73, 422/99, 422/101, 422/102, 422/103, 73/644.1, 600/368, 600/369, 210/516, 210/518, 210/645, 210/780, 210/781, 210/782
• US Class Current: 422/534
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• 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 5/154 Devices using pre-evacuated means
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 3/0289 Apparatus for withdrawing or distributing predetermined quantities of fluid B01L3/02 takes precedence; sample taking G01N1/00; sample taking within automatic analysers G01N35/00; volume measuring in general G01F
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

A clot retainer for generally separating liquid from solid components in a specimen enclosed in a container having a closure. The clot retainer includes fingers that are adapted to displace solid components of the specimen. The clot retainer can be inserted through the closure of the container without removing the container. A method of separating liquid from solid components in a specimen is also disclosed.

Claims

1. A clot retainer for generally separating serum from a patient blood specimen enclosed in a container having a closure, the clot retainer comprising:

an elongate shaft;

a piercing tip positioned on an end of the elongate shaft to pierce the closure on the container to insert the clot retainer into the container without removal of the closure; and

fingers to displace solid components of the patient blood specimen toward a base of the container while allowing the serum to flow through interstices between the fingers, each of the fingers comprising a solid extension member having a first end connected to the elongate shaft and a second free end and being moveable from a first position, in which the finger is ready for use and is in a generally radially extending position, to a second position, in which the finger is ready for insertion and is in a generally axially extending position along the elongate shaft, each of the fingers being in the second position during insertion prior to returning to the first position after insertion.

2. The clot retainer of claim 1, wherein the elongate shaft includes at least one recess to receive at least one of the fingers therein during insertion of the clot retainer through the closure.

3. The clot retainer of claim 1, wherein the piercing tip is generally conically shaped and has a base, located proximate to the elongate shaft, having a base diameter greater than a shaft diameter of the elongate shaft.

4. The clot retainer of claim 3, wherein a general overall diameter of the elongate shaft and the fingers, when the fingers are in the second position, is generally the same as or less than the base diameter of the piercing tip.

5. The clot retainer of claim 1, wherein the fingers comprise a first set of the fingers that extend radially outwardly from a first portion of the shaft in the first position.

6. The clot retainer of claim 5, wherein the fingers further comprise a second set of the fingers positioned on the elongate shaft and axially spaced from the first set of the fingers.

7. The clot retainer of claim 5, wherein a width, as measured in a direction tangential to a cross section of the elongate shaft as taken perpendicular to a longitudinal axis thereof, of each of the fingers is generally constant.

8. The clot retainer of claim 5, wherein at least one of the plurality of fingers is generally rectilinearly shaped.

9. The clot retainer of claim 5, wherein a width, as measured in a circumferential direction, of each of the fingers increases when moving along the fingers in a generally radially outward direction.

10. The clot retainer of claim 5, wherein at least one of the fingers is generally wedge-shaped.

11. The clot retainer of claim 5, wherein the first set of the fingers generally forms a layer having a permeable free space of generally less than fifty (50%) percent.

12. The clot retainer of claim 11, wherein the layer has a permeable free space of generally less than twenty-five (25%) percent.

13. The clot retainer of claim 11, wherein the fingers further comprise a second set of the fingers positioned on the elongate shaft and spaced apart from the first set of the fingers.

14. The clot retainer of claim 1, further comprising a passageway through at least a portion of the elongate shaft to allow withdrawal of serum from the container while the elongate shaft is positioned through the closure.

15. The clot retainer of claim 1, wherein the fingers are formed of an elastic material and move elastically from the second position to the first position.

16. The clot retainer of claim 1, wherein the elongate shaft comprises:

a base member; and

a piercing member slidably disposed on the base member, the piercing tip being positioned on an end of the piercing member distal from the base member.

17. The clot retainer of claim 1, wherein the fingers are connected to the elongate shaft at a position apart from the piercing tip.

18. The clot retainer of claim 1, wherein the entire length of the fingers are foldable along the elongate shaft in the axially extending position.

19. A clot retainer for generally separating liquid from solid in a specimen enclosed in a container having a closure, the clot retainer comprising:

an elongate shaft;

a piercing tip positioned on an end of the elongate shaft to pierce the closure on the container to insert the clot retainer into the container without removal of the closure; and

specimen separation fingers to displace solid components of the specimen toward a base of the container while allowing the liquid to flow through interstices between the specimen separation fingers, each of the specimen separation fingers comprising a solid extension member having a first end and a second free end, the first end of the specimen separation fingers connected to the elongate shaft at a position apart from the piercing tip and being moveable from a first position, in which the specimen separation finger is ready for use and is in a generally radially extending position, to a second position, in which the specimen separation finger is ready for insertion and is in a generally axially extending position along the elongate shaft, each of the specimen separation fingers being in the second position during insertion prior to returning to the first position after insertion.

20. A method of harvesting serum from a patient blood specimen, the method comprising the steps of:

providing a container enclosing a patient blood specimen, the container having a closure and a base;

providing a clot retainer comprising an elongate shaft having a piercing tip positioned thereon and solid elongated fingers extending from the elongate shaft;

inserting the clot retainer, piercing tip first, into the container by piercing the closure with the piercing tip, the solid elongated fingers displacing solid components of the patient blood specimen toward the base of the container to separate the solid components from serum components in the patient blood specimen; and

harvesting the separated serum components from the container.

21. The method of claim 20, wherein the step of providing the container comprises providing a test tube.

22. The method of claim 21, wherein the step of providing the clot retainer further comprises providing the clot retainer having a first set of the fingers positioned on the elongate shaft and a second set of the fingers positioned on the elongate shaft and axially spaced apart from the first set of the fingers.

23. The method of claim 20, wherein the step of inserting the clot retainer comprises inserting the clot retainer until a second end, opposite from an end on which the piercing tip is positioned, of the elongate shaft is generally aligned with an outer surface of the closure.

24. The method of claim 23, further comprising the step of further inserting the clot retainer into the container such that the entire elongate shaft is located inside the container past the closure by pressing the second end of the elongate shaft toward the base of the container using a spike.

25. The method of claim 24, further comprising withdrawing serum from the patient blood specimen in the container via the spike.

26. The method of claim 25, wherein the step of withdrawing serum comprises gravity pulling the serum from the container through the spike.

27. The method of claim 25, further comprising filtering the serum withdrawn through the spike.

28. The method of claim 20, further comprising the step of removing serum from the container via a passageway in the elongate shaft.

29. The method of claim 20, further comprising:

folding the fingers into an axially extending position by the fingers contacting the closure during insertion of a portion of the shaft; and

allowing the fingers to unfold elastically to a radially extending position after passing through the closure.

30. The method of claim 20, wherein the step of providing the clot retainer further comprises providing the clot retainer having the elongate shaft, comprising:

a base member; and

a piercing member slidably disposed on the base member, the piercing tip being positioned on an end of the piercing member distal from the base member.

31. A combination closure and clot retainer for generally separating serum from a patient blood specimen enclosed in a container, the combination comprising:

an elongated shaft, comprising;

a base member having first and second ends; and

a piercing member adjustably disposed on the first end of the base member so as to slidably move onto or into the base member to accommodate containers of various lengths;

a closure positioned on the second end of the base member;

a piercing tip positioned on an end of the piercing member to pierce a clot in the specimen; and

solid elongated fingers connected to the elongate shaft to displace solid components of the patient blood specimen toward a base of the container while allowing the serum to flow through interstices between the fingers.

32. The combination of claim 31, wherein each of the fingers is moveable from a first position, in which the finger is ready for use and is in a generally radially extending position, to a second position, in which the finger is in a generally axially extending position along the elongate shaft, each of the fingers being in the second position during insertion into the container prior to returning to the first position after insertion.

33. The combination of claim 31, wherein each of the fingers are generally rigid and extend in a generally radially extending position.

34. The combination of claim 31, wherein the base member and the piercing member each have a passageway to allow fluid flow through at least a portion of the elongated shaft.

35. The combination of claim 34, wherein the closure includes a luer connection in communication with the passageway.