Flashback Blood Collection Needle

• US 20100262038A1
• Filed: 06/28/2010
• Published: 10/14/2010
• Est. Priority Date: 03/07/2008
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Sim, Stanley, Moh, Jon, Tan, Chee Leong Alvin
• Granted Patent: US 8,282,605 B2
• Time in Patent Office: Days
• US Class Current: 600/576
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150488 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• 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 5/1545 comprising means for indicating vein or arterial entry
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: Y10S 604/90 Telltale showing entry of blood into body inserted conduit

Abstract

A needle assembly includes a transparent or translucent housing with a fluid inlet end, a fluid outlet end, a flashback chamber, and a venting mechanism therebetween. 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 so as 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 on withdrawal from the patient.

Claims

1. A needle assembly comprising:

a housing defining a housing interior, said housing comprising 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 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 blood therethrough from the first chamber to the second chamber; and

a sleeve extending about the non-patient puncture tip,

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 first chamber and the second chamber are configured such that upon insertion of the patient puncture tip into a patient blood flows into the first chamber without sealing the porous vent, and upon application of a negative pressure source to said non-patient puncture tip, blood is 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.

3. The needle assembly of claim 1, further comprising 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.

4. The needle assembly of claim 1, further comprising 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.

5. The needle assembly of claim 1, wherein upon at least a portion of air being drawn from said first chamber and said second chamber, said second chamber draws blood from the first chamber through the porous vent.

6. The needle assembly of claim 1, wherein at least a portion of said housing forming said first chamber is formed from a transparent or translucent material.

7. The needle assembly of claim 1, wherein said porous vent is formed from a porous hydrophobic carrier material.

8. The needle assembly of claim 1, 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.

9. The needle assembly of claim 8, 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.

10. The needle assembly of claim 8, wherein the porous vent is positioned within the housing interior at a location spanning the transition between the first diameter of the first position and the second diameter of the second position.

11. A needle assembly comprising:

a housing defining a housing interior, said housing comprising 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, wherein the sole communication path between the housing interior and the external environment is via the patient puncture tip; and

a porous vent positioned within the housing interior to separate the housing interior into a first chamber and a second chamber with the patient puncture tip and the non-patient puncture tip both in fluid communication with the first chamber of the housing, the porous vent including pores for passage of blood therethrough from the first chamber to the second chamber,

wherein the first chamber and the second chamber are configured such that upon insertion of the patient puncture tip into a patient blood flows into the first chamber without sealing the porous vent, and upon application of a source of negative pressure to said non-patient puncture tip, blood is 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.

12. The needle assembly of claim 11, further comprising 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.

13. The needle assembly of claim 11, further comprising 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.

14. The needle assembly of claim 11, further comprising a sealable sleeve extending about the non-patient puncture tip.

15. A method of preventing leakage of blood from 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 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 therethrough from the first chamber into the second chamber;

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 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.

16. The method of claim 15, 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.

17. The method of claim 15, 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.

18. The method of claim 17, wherein the negative pressure source comprises an evacuated collection container and wherein the step of releasing the fluid communication comprises removing the evacuated collection container from the non-patient puncture tip and sealing the non-patient puncture tip from the external environment.

19. The method of claim 18, wherein the needle assembly comprises a sealable sleeve extending about the non-patient puncture tip, said sealable sleeve being displaceable so as to permit the fluid communication between the evacuated collection container and the non-patient puncture tip in step b), and so as to reseal upon removal of the evacuated collection container from the non-patient puncture tip.

20. The method of claim 19, including a further step after said step of releasing the fluid communication between the non-patient puncture tip and the evacuated collection container, comprising establishing fluid communication between the non-patient puncture tip and a second evacuated collection container, such that blood is drawn through the lumen of the patient puncture tip into the second evacuated collection container, followed by releasing the fluid communication between the non-patient puncture tip and the second evacuated collection container.