Flashback Blood Collection Needle

• US 20110178427A1
• Filed: 02/01/2011
• Published: 07/21/2011
• Est. Priority Date: 03/07/2008
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Schneider, James C., Saulenas, William G., Moh, Jon Yaohan, White, Steven Mark, Sim, Tiong Yee, Tan, Alvin Chee Leong, Ellis, Robert G.
• Granted Patent: US 8,603,009 B2
• Time in Patent Office: Days
• US Class Current: 600/578
• CPC Class Codes: A61B 5/1422 provided with indicating means, e.g. for vein entry
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150496 Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• 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 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/1545 comprising means for indicating vein or arterial entry

Abstract

A needle assembly includes a transparent or translucent housing with a fluid inlet and outlet end, a flashback chamber, and a venting mechanism therebetween. The venting mechanism includes a blocking member to control the fluid flow in the venting mechanism so that it flows along the longest path through the vent. Substantially axially aligned inlet and outlet cannulas extend from the housing and communicate with the chamber. A sealable sleeve covers the external end of the outlet cannula. Relative volumes of the cannulas, the chamber, and the sleeve are selected to provide rapid reliable flashback indicative of venous entry with an internal vent positioned within the housing to divide the interior into first and second chambers, with the second chamber being adapted to maintain a negative pressure therein relative to the external environment so as to inhibit leakage of blood from the needle tip on withdrawal from the patient.

Claims

1. A needle assembly comprising:

a housing defining a housing interior, said housing comprising at least one cannula having a patient puncture tip extending from a first end of the housing and a non-patient puncture tip extending from a second end of the housing, the non-patient puncture tip and the patient puncture tip being in fluid communication with each other within the housing interior; and

a porous vent positioned within the housing interior separating the housing interior into a first chamber and a second chamber, the porous vent including pores for passage of fluid therethrough from the first chamber to the second chamber, said porous vent including a blocking member to control the flow of the fluid through the porous vent,

wherein the sole communication path between the housing interior and the external environment is via the patient puncture tip.

2. The needle assembly of claim 1, wherein the porous vent is configured to reduce the flow of fluid along the shorter and least resistant paths through the porous vent.

3. The needle assembly of claim 1, wherein the porous vent comprises a tubular member having a first end face, a second end face, and a central portion extending between the first end face and the second end face, the tubular member having an axial hole configured for surrounding at least a portion of the at least one cannula.

4. The needle assembly of claim 3, wherein the porous vent is configured to cause said fluid to flow along a controlled longitudinal path from the first end face to one of the central portion and the second end face of the porous vent and through a central opening between the first and the second chamber wherein said central opening is located adjacent to said central portion of the porous vent.

5. The needle assembly of claim 1, wherein the porous vent comprises a tubular member having a first end face and a second end face, the tubular member having an axial hole configured for surrounding at least a portion of the at least one cannula and wherein the porous vent is configured to cause said fluid to flow along a controlled longitudinal path from the first end face to the second end face and into the second chamber through one of the first end face and/or the second end face.

6. The needle assembly of claim 1, wherein the porous vent is configured to cause said fluid to flow along a controlled radial path from the first chamber and an inner surface of the porous vent and out through a circumferential end surface of the porous vent into the second chamber.

7. The needle assembly of claim 1, wherein the blocking member blocks at least a portion of the porous vent to render this portion of the vent non-porous to control the flow of fluid therethrough.

8. The needle assembly of claim 7, wherein the blocking member blocks at least a portion of an inside surface of the axial hole surrounding the at least a portion of the cannula.

9. The needle assembly of claim 8, wherein the blocking member comprises a bushing press-fitted into the inside surface of the porous vent.

10. The needle assembly of claim 9, wherein the bushing comprises one of a steel cannula, an extruded plastic tube, and a tubular molded part and wherein the bushing has a length substantially equal to a length of the porous vent.

11. The needle assembly of claim 8, wherein the blocking member comprises one of an adhesive or sealant located between an inside surface of the porous vent and an outer diameter of the cannula or a member abutted against the inside surface of the porous vent.

12. The needle assembly of claim 11, wherein an end surface of the porous member or a central portion of the porous member is blocked with an adhesive material to control the flow of fluid through the porous vent.

13. The needle assembly of claim 8, wherein the blocking member comprises a melted or fused inner surface portion of the porous vent.

14. The needle assembly of claim 1, wherein the at least one cannula comprises a single cannula extending through the housing, said single cannula including a lumen extending therethrough, a first end comprising the patient puncture tip, a second end comprising the non-patient puncture tip, and an opening through the cannula into the lumen at a location between the first end and the second end providing fluid communication between the lumen of the cannula and the first chamber of the housing.

15. The needle assembly of claim 1, wherein the at least one cannula comprises a first cannula extending from the housing and comprising the patient puncture tip, and a second cannula extending from the housing and comprising the non-patient puncture tip, the first cannula and the second cannula being substantially axially aligned within said housing interior and separated from each other by a gap in fluid communication with the first chamber of the housing.

16. The needle assembly of claim 1, wherein the first chamber and the second chamber are configured, such that upon insertion of the patient puncture tip into a patient, to cause blood to flow into the first chamber without sealing the porous vent, and upon application of a negative pressure source to said non-patient puncture tip, blood and air are drawn from said first chamber and air is drawn from said second chamber, thereby establishing a negative pressure within said second chamber with respect to an external environment of the needle assembly.

17. The needle assembly of claim 16, wherein upon removal of the patient puncture tip from the patient, the negative pressure within the second chamber is sufficient to prevent blood droplets from being present at the patient puncture tip.

18. A needle assembly comprising:

a housing defining a housing interior, said housing comprising at least one cannula having a patient puncture tip extending from a first end of the housing and a non-patient puncture tip extending from a second end of the housing, the non-patient puncture tip and the patient puncture tip being in fluid communication with each other within the housing interior; and

a porous vent positioned within the housing interior to separate the housing interior into a first chamber and a second chamber, the porous vent including pores for passage of fluid therethrough from the first chamber to the second chamber and a blocking member to control flow of the fluid through the porous vent such that the fluid flows in an axial direction through the porous vent,

wherein the sole communication path between the housing interior and the external environment is via the patient puncture tip, and

wherein the first end of the housing comprises an elongate longitudinal first portion having a first diameter and the second end of the housing comprises a second portion having a second diameter larger than the first diameter of the first portion.

19. The needle assembly of claim 18, wherein the porous vent is positioned within the housing interior between the first portion having a first diameter and the second portion having a second diameter at a location spanning a transition point between the first diameter of the first position and the second diameter of the second position.

20. The needle assembly of claim 19, wherein the porous vent comprises a tubular member having a first end face, a second end face, and a central portion located between the first end face and the second end face, the tubular member further including an axial hole configured for surrounding at least a portion of the cannula, said axial hole defining an inside surface, the blocking member being located at the inside surface of the axial hole for blocking at least a portion of the porous vent to render this portion of the vent non-porous to cause the fluid to flow along a controlled longitudinal path from the first end face to one of the central location and the second end face and subsequently through a central aperture opening between the first chamber and the second chamber.

21. The needle assembly of claim 20, wherein the blocking member is selected from the group consisting of a bushing press-fit into the inside surface of the porous vent;

an adhesive or sealant located between an inside surface of the porous vent and an outer diameter of the cannula;

a fused inner surface portion of the porous vent; and

a member positioned adjacent to the inside surface of the porous vent.

22. A needle assembly comprising:

a housing defining a housing interior, said housing comprising at least one cannula having a patient puncture tip extending from a first end of the housing and a non-patient puncture tip extending from a second end of the housing, the non-patient puncture tip and the patient puncture tip being in fluid communication with each other within the housing interior; and

a porous vent positioned within the housing interior separating the housing interior into a first chamber and a second chamber, the porous vent including pores for passage of fluid therethrough from the first chamber to the second chamber, said porous vent including a blocking member to control flow of the fluid such that the fluid flows in an axial direction through the porous vent,

wherein the housing includes a rear hub having a cylindrical portion extending therefrom and into the first chamber toward the first end of the housing to define a portion of the first chamber, said cylindrical portion forming at least a portion of the blocking member, and

wherein the sole communication path between the housing interior and the external environment is via the patient puncture tip.

23. The needle assembly of claim 22, wherein the porous vent comprises a tubular member having a first end face, a second end face, and a central portion extending between the first end face and the second end face, the tubular member including an axial hole configured for surrounding at least a portion of the cylindrical portion extending from the rear hub, said at least one cannula being located within at least a portion of the cylindrical portion.

24. The needle assembly of claim 23, wherein the blocking member renders a portion of the vent non-porous to cause said fluid to flow along a controlled longitudinal path and subsequently through either a central aperture opening between the first and the second chamber or through one of the first end face or the second end face.

25. The needle assembly of claim 24, wherein the rear hub and the cylindrical portion extending therefrom block the second end face of the porous vent to prevent fluid flow through the second end face.

26. The needle assembly of claim 24, wherein the blocking member comprises the cylindrical portion extending from the rear hub, said cylindrical portion being located adjacent to the inside surface of the porous vent.

27. A method of preventing leakage of blood from a patient needle tip in a needle assembly comprising:

a) receiving blood through a patient puncture tip and into a first chamber of a needle assembly, the needle assembly comprising;

i) a needle housing defining a housing interior, said housing comprising at least one cannula having a patient puncture tip extending from a first end of the housing and a non-patient puncture tip extending from a second end of the housing; and

ii) a porous vent positioned within the housing interior and separating the housing interior into a first chamber and a second chamber, with the non-patient puncture tip and the patient puncture tip being in fluid communication with each other within the first chamber such that the sole communication path between the housing interior and the external environment is via the patient puncture tip, the porous vent including pores for passage of blood and air therethrough from the first chamber into the second chamber, said porous vent including a blocking member to control flow of the blood and air through the porous vent;

b) establishing fluid communication between the non-patient puncture tip and a negative pressure source such that blood contained within the first chamber is drawn out of the non-patient puncture tip and air is drawn out of the second chamber through the porous vent, thereby establishing a negative pressure within the second chamber relative to the external environment of the needle assembly such that blood flows through the cannula into the first chamber and contacts the porous vent; and

c) drawing blood and air through the pores of the porous vent toward the second chamber based upon the negative pressure established within the second chamber such that blood contained within a lumen of the patient puncture tip is displaced away from the patient puncture tip and toward the second chamber to prevent blood droplets from being present at the patient puncture tip.

28. The method of claim 27, wherein the receiving step a) comprises receiving blood through the lumen of the patient puncture tip from a patient'"'"'s bloodstream, and the drawing step c) displaces blood away from the patient puncture tip after removing the patient puncture tip from the patient'"'"'s bloodstream.

29. The method of claim 27, including a further step after step b) and prior to step c) comprising releasing the fluid communication between the non-patient puncture tip and the negative pressure source.

30. The method of claim 27 wherein the porous vent comprises a tubular member having a first end face and a second end face, the tubular member further including an axial hole configured for surrounding at least a portion of the cannula, said method including rendering the inside surface of the axial hole non-porous to cause the fluid to flow along a controlled longitudinal path through the porous vent and subsequently into the second chamber.

31. The method of claim 27, wherein the porous vent is configured to cause said fluid to flow along a controlled radial path from the first chamber and an inner surface of the porous vent and out through a circumferential end surface of the porous vent into the second chamber.

32. The method of claim 29, including positioning said blocking member within the inside surface of the axial hole to render this inside surface non-porous.

33. The method of claim 32, wherein the blocking member is selected from the group consisting of a bushing press-fitted into the inside surface of the porous vent, an adhesive or sealant located between an inside surface of the porous vent, an outer diameter of the cannula, a fused inner surface portion of the porous vent, and a separate member positioned adjacent the inside surface of the porous vent.

34. A needle assembly comprising:

a housing defining a housing interior, said housing comprising at least one cannula having a patient puncture tip extending from a first end of the housing and a non-patient puncture tip extending from a second end of the housing, the non-patient puncture tip and the patient puncture tip being in fluid communication with each other within the housing interior;

a porous vent including an axial bore positioned within the housing interior separating the housing interior into a first chamber and a second chamber wherein the axial bore surrounds at least a portion of the at least one cannula, the porous vent including pores for passage of fluid therethrough from the first chamber to the second chamber; and

a blocking member located adjacent to or within the axial bore of said porous vent, said blocking member configured to control flow of the fluid such that the fluid flows in an axial direction along a longitudinal path through the porous vent,

wherein the sole communication path between the housing interior and the external environment is via the patient puncture tip.

35. The needle assembly of claim 34, wherein the blocking member is selected from the group consisting of a bushing press-fitted into the inside surface of the porous vent, an adhesive located between an inside surface of the porous vent and an outer diameter of the cannula, a fused inner surface portion of the porous vent, and a member positioned adjacent the inside surface of the porous vent.

36. The needle assembly of claim 34, wherein the blocking member comprises a bushing press-fitted within the axial bore of the porous vent and wherein the bushing is formed from a material selected from the group consisting of metal, plastic, composite, and a combination thereof.

37. The needle assembly of claim 34, wherein the blocking member comprises a cylindrical member extending from a portion of the housing into the porous vent and adjacent to the inside surface of the porous vent.