AUSTRALIA Patents Act 1990 BD MEDICAL PRODUCTS PTE. LTD. COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Flashback blood collection needle with needle shield The following statement is a full description of this invention including the best method of performing it known to us:- 2 BACKGROUND OF THE INVENTION 1. Field of the Invention 5 A shieldable blood collection needle assembly with a flashback chamber for providing confirmation of venous entry. 2. Description of Related Art 10 Needle assemblies are used for collecting specimens of fluid, such as blood, from a patient. Some such needle assemblies are intended for use with an evacuated tube, such as tubes sold under the trademark VACUTAINERTM by Becton Dickinson. Needle assemblies for use with an evacuated fluid collection tube include a needle hub with a proximal end, a distal end and a passage extending between the ends. The 15 needle assembly further includes at least one needle cannula mounted to the needle hub. The needle cannula includes a sharply pointed distal end that projects distally beyond the needle hub, a proximal end that projects proximally beyond the needle hub and a lumen that provides communication between the opposed ends of the needle cannula. Some needle assemblies include separate proximal and distal cannulas and 20 rely upon a portion of the needle hub to provide communication between the lumens of the respective cannulas. The distal end of the needle cannula typically is beveled to a tip that is sufficiently sharp for piercing the skin of the patient and accessing the vein or other source of fluid that is to be collected. The proximal end of the needle cannula is configured for piercing the rubber stopper on an evacuated tube. The proximal end of 25 the needle cannula typically is covered by a needle pierceable resealable multi-sample sleeve. The sleeve is compressed by the rubber stopper of the evacuated tube and punctured by the proximal end of the needle cannula as the proximal end of the needle cannula is urged into communication with the evacuated tube. One problem with collecting fluid from a patient relates to uncertainty during attempts 30 to access the proper source of fluid in the patient. For example, a blood collection procedure typically requires the phlebotomist to visually locate a vein and then to enter the vein with the distal end of the needle cannula. The phlebotomist may not have a positive indication of venous entry at this stage. An evacuated tube then is placed in communication with the proximal end of the needle cannula once the phlebotomist is 35 reasonably certain that the targeted blood vessel has been entered. The low pressure within the evacuated tube then cooperates with the higher pressure of the blood to 3 generate a flow of blood into the tube. The flow of blood into the tube may be the first positive indication to the phlebotomist that the targeted blood vessel has been accessed. The initial flow of blood along the long needle cannula and into the evacuated tube may take a relatively long time based on several factors, including the relative pressure 5 levels and the length and cross-sectional dimensions of the needle cannula. The phlebotomist may interpret the absence of an immediate flow of blood as being a sign that the blood vessel was not targeted properly, when in fact the absence of a visible blood flow in the evacuated tube may be attributable to pressure and fluid flow characteristics. Thus, the phlebotomist may unnecessarily withdraw the needle and 10 start the blood collection procedure again. As a result, time is wasted and trauma for the patient is increased. In view of the above problems, many fluid collection needle assemblies are provided with a flashback chamber that communicates with the needle cannula. The flashback chamber typically is formed at least partly from a transparent or translucent material and is intended to receive a portion of the blood flow shortly 15 after a vein has been accessed properly. The blood collection needle assembly is withdrawn from the patient after a suitable number of samples have been collected. The used needle assembly then is discarded. The medical profession is well aware that accidental sticks with a used needle cannula can transmit disease. Accordingly, it is desirable to shield the used needle cannula 20 immediately after the needle cannula has been withdrawn from the patient. Shields have taken many different forms. For example, some shields telescope in a distal to proximal direction over the needle cannula and frictionally engage the needle hub. Shields of this type create the risk of an accidental needle stick during shielding if the shield is misaligned with the needle cannula. Some shields of this general type are 25 provided with enlarged collars that are intended to minimize the risk of accidental sticks during shielding. However, shields of this general type are not preferred. Other shields are telescoped over the needle hub and can be moved distally over the needle cannula to effect shielding. Shields of this general type are safe and effective and are used in many situations. However, shields of this type can interfere with the normal 30 usage of some medical implements. Other shields are hingedly mounted to or near the needle hub and can be rotated from an open position where the needle cannula is exposed to a closed position where the needle cannula is shielded. Shields of this type also work very well and are widely accepted. However, the existence of a hinged shield on a fluid collection needle assembly with a flashback chamber is intuitively 35 problematic in view of the complexities of providing both shielding and an unobstructed view of the flashback chamber.
4 SUMMARY OF THE INVENTION The subject invention is directed to a shieldable fluid collection needle assembly. The needle assembly includes a housing with a proximal end wall, a distal end wall and an external sidewall extending between the proximal and distal end walls such that a 5 chamber is defined between the end walls and the external sidewall. The external sidewall may be formed unitarily with at least one of the end walls. Additionally, at least a portion of the external sidewall is formed from a transparent or translucent material so that the interior of the chamber within the housing is visible. A proximal passage extends through the proximal end wall of the housing and a distal passage 10 extends through the distal end wall of the housing. The proximal and distal passages maybe axially aligned with one another. The housing may further include an internal sidewall extending proximally from the distal end wall and surrounding the entry of the distal passage into the chamber. The internal sidewall also is a transparent or translucent material. 15 The needle assembly further includes a distal cannula mounted in the distal passage of the housing and projecting distally beyond the housing. The distal cannula includes a distal end spaced externally from the housing. The distal end may be beveled to a tip that is sufficiently sharp to pierce skin of a patient. The distal cannula includes a lumen that extends from the distal end of the distal cannula and communicates with the 20 chamber of the housing. The needle assembly further includes a proximal cannula mounted in the proximal passage of the housing. The proximal cannula includes a proximal end that projects proximally beyond the housing. Additionally, the proximal cannula includes a lumen that extends from the proximal end and into communication with the chamber. The 25 proximal cannula also includes a distal end that may extend into the chamber so that the proximal end of the distal cannula and the distal end of the proximal cannula substantially align with one another and are slightly spaced from one another. In an alternate embodiment, distal and proximal cannula may be integral with one another and may include a transverse slot or aperture to provide communication between the 30 lumens of the distal and proximal cannulas with the chamber in the housing. The proximal end of the distal cannula preferably is at or near the distal end wall of the housing. Additionally, the distal end of the proximal cannula preferably extends through a major portion of the chamber of the housing and to a location near the distal end wall of the housing. Thus, both the distal and proximal cannulas preferably 35 communicate with the chamber of the needle assembly at a location near the distal end wall of the housing. As a result, the first indication of fluid flow through the distal 5 cannula will occur at a location at or substantially adjacent the distal end wall of the housing. In a preferred embodiment, the housing may have the internal sidewall described above and the distal end of the proximal cannula may project axially into the cylindrical space bounded by the internal sidewall. 5 The needle assembly of the subject invention further includes a shield that may be hinged to a location on the housing proximally of the location where the first indication of flashback occurs. The shield initially is in an open position where the shield is spaced from the distal cannula and the chamber. Hence, the shield does not impede usage of the distal cannula or visual observation of the chamber when the shield is in its 10 open position. However, the shield can be rotated from the open position to a closed position where the shield surrounds the distal cannula. The shield and/or the housing may include at least one locking element for locking the shield in the closed position. The locking means can include a resiliently deflectable cannula lock configured for engaging the needle cannula when the shield is in the closed position. The shield may 15 further include locks for engaging structure on the housing when the shield is in the closed position. The engagement between structure on the shield and structure on the housing may function to lock the shield in the closed position. Alternatively, primary locking of the shield in the closed position may be achieved by the cannula lock, and the engagement between the shield and the housing may be provided primarily for 20 audible and tactile indication of complete shielding. DESCRIPTION OF THE DRAWINGS FIG. I is an exploded perspective view of a needle assembly in accordance with the invention. FIG. 2 is a longitudinal cross-sectional view of the needle assembly prior to use. 25 FIG. 3 is a side elevational view of the needle assembly after being placed in communication with a blood vessel, but before being placed in communication with an evacuated tube. FIG. 4 is a longitudinal cross-sectional view of the needle assembly during use and after being placed in communication with an evacuated tube. 30 FIG. 5 is a side elevational view of the needle assembly after complete shielding. DETAILED DESCRIPTION A needle assembly in accordance with the subject invention is identified generally by the numeral 10 in FIGS. 1-5. Needle assembly 10 includes a housing 12 with a proximal end 14, a distal end 16 and a generally frustum-shaped outer sidewall 18 35 extending between the ends. Outer sidewall 18 is formed from a transparent or translucent plastic material and defines a chamber 20 within housing 12 between 6 proximal end 14 and distal end 16. A proximal passage (not shown) extends through proximal end 14 of housing 12 and communicates with chamber 20. A distal passage 22 extends through distal end 16 of housing 12 and also communicates with chamber 20. Housing 12 further includes a cylindrical inner sidewall 24 that extends from distal 5 end 16 toward proximal end 14. Inner sidewall 24 is substantially concentrically disposed within outer sidewall 18 and is substantially concentrically generated about distal passage 22. Inner sidewall 24 also is formed from a transparent or translucent plastic material. Hence, a fluid material in a portion of chamber 20 bounded by inner sidewall 24 is readily visible from locations externally of outer sidewall 18. Thus, 10 inner sidewall 24 in this embodiment defines a flashback chamber 26, and fluid collected in flashback chamber 26 can be observed from locations externally of needle assembly 10. Chamber 26 communicates with chamber 20, and hence chamber 20 may also contribute to an indication of flashback. Needle assembly 10 further includes an IV cannula 30 with a proximal end 32, a distal 15 end 34 and a lumen 36 extending between the ends. Distal end 34 of IV cannula 30 is disposed externally of housing 12 and is beveled to a sufficiently sharp tip for piercing skin and tissue of a patient. IV cannula 30 is mounted in distal passage 22 of housing 12 so that proximal end 32 of IV cannula 30 is substantially adjacent distal end 16 of housing 12. Thus, lumen 36 through IV cannula 30 communicates with flashback 20 chamber 26 at a location substantially adjacent distal end 16 of housing 12. Needle assembly 10 further includes a non-patient (NP) cannula 40 mounted in the proximal passage at proximal end 14 of housing 12. NP cannula 40 includes a proximal end 42 disposed externally of housing 12, a distal end 44 disposed in flashback chamber 26 and a lumen (not shown) extending between the ends. The 25 proximal end 42 is beveled to a sufficiently sharp tip for piercing a rubber stopper of an evacuated tube as explained further herein. The lumen through NP cannula 40 is aligned substantially axially with lumen 36 through IV cannula 30. Distal end 44 of NP cannula 40 preferably is spaced only a short distance from proximal end 32 of IV cannula 30, such as 0.5 mm - 1.2 mm. 30 Needle assembly 10 further includes a sleeve 46 mounted over portions of NP cannula 40 that are disposed externally of housing 12. Sleeve 46 is mounted to proximal end 14 of housing 12, and is formed from a material that is substantially impervious to liquid and fluid. However, sleeve 46 also is formed from a material that is readily pierceable by proximal end 42 of NP cannula 40 and that is resiliently resealable. Thus, the 35 rubber stopper of an evacuated tube can be urged against sleeve 46 and will cause sleeve 46 to collapse distally. As a result, the beveled tip at proximal end 42 of NP 7 cannula 40 will pierce through sleeve 46 and through the rubber stopper on the evacuated tube. IV cannula 30, NP cannula 40 and housing 12 cooperate to provide an early indication of venous entry due to the flashback of blood in chamber 26 and/or chamber 20 of 5 housing 12. However, other flashback designs can be incorporated into the needle assembly of the subject invention. These other designs include arrangements were blood first fills the equivalent of sleeve 46 on needle assembly 10 and then flows into a flashback chamber. Still other designs include the use of a vented plug. Flashback chamber designs that can be incorporated into the subject invention are shown, for 10 example, in U.S. Patent No. 5,542,932, U.S. Patent No. 5,824,001 and others. Needle assembly 10 further includes a collar 50 securely mounted around proximal portions of housing 12. Collar 50 may be secured mechanically in position on housing 12, may be bonded to housing 12 or may be molded as part of housing 12. Collar 50 includes a proximal end 52 substantially aligned with proximal portions of chamber 20 15 and a distal end 54 disposed proximally of proximal end 32 of IV cannula 30 and near proximal end of inner sidewall 24. Accordingly, collar 50 will not impair the ability to observe regions of flashback chamber 26 adjacent proximal end 32 of IV cannula 30. Distal end 54 of collar 50 is provided with a C-shaped hook 56 generated about an axis that extends transverse to IV cannula 30 and NP cannula 40. Collar 50 further includes 20 a chevron-shaped projection 58 at a location diametrically opposite hook 56. Collar 50 preferably is secured to housing 12 such that a plane passing symmetrically through C shaped hook 56 and through the diametrically opposite chevron-shaped projection 58 also passes symmetrically through the bevel at distal end 34 of IV cannula 30. However, in other embodiments collar 50 may be rotatably mounted to housing 12 so 25 that the orientation of the plane passing symmetrically through hook 56 and through projection 58 can be varied relative to a plane passing symmetrically through the bevel at distal end 34 of IV cannula 30. Needle assembly 10 further includes a shield 60 with a proximal end 62 and a distal end 64. Portions of shield 60 near proximal end 62 include a hinge pin 66 that is 30 snapped into engagement with hook 56 so that shield 60 can rotate relative to hook 56 from an open position shown in FIGS. 1 and 2 to a closed position shown in FIG. 5. In the open position, shield 60 is spaced from IV cannula 30 and is aligned to IV cannula 30 at an obtuse angle of about 1200. The preferred orientation of collar 50 relative to the bevel at distal end 34 of IV cannula 30 provides a clear indication of the preferred 35 bevel-up orientation of IV cannula 30 that is employed by most health care technicians during use. Additionally, the orientation of collar 50 on housing 12 ensure that shield 8 60 will not interfere with the view of IV cannula 30 during insertion. The above referenced option of a rotatable collar enables the user to select a preferred orientation of shield 60 relative to the bevel at distal end 34 of IV cannula 30 and relative to the patient and other medical equipment that may be placed in communication with the 5 patient. Portions of shield 60 near proximal end 62 further include a top wall 68 and sidewalls 70 and 72 that project from top wall 68. Portions of sidewalls 70 and 72 at proximal end 62 of shield 60 are spaced apart by a distance that equals or exceeds the width of outer sidewall 18 of housing 12. Thus, sidewalls 70 and 72 easily can be rotated on opposite respective sides of outer sidewall 18 as shield 60 is rotated within 10 hook 56. The wide spacing of sidewalls 70 and 72 also facilitates observations of the flashback chamber 26. Opposed facing surfaces of sidewalls 70 and 72 at proximal end 62 of shield 60 are formed with collar catches 74 and 76 respectively. Collar catches 74 and 76 are configured to snap into engagement with chevron-shaped latch 58 on collar 50. Top wall 68 is provided with an array of tactile bumps on the surface facing 15 away from sidewalls 70 and 72 to provide a visual indication of an actuation landing for a thumb or forefinger and to enhance frictional engagement by the thumb or forefinger when rotating shield 60. Shield 60 narrows at locations between top wall 68 and distal end 64 and defines a substantially U-shaped channel of sufficient width to receive IV cannula 30. As shown 20 most clearly in FIG. 5, channel 78 is sufficiently long to encompass all of IV needle 30. Interior portions of channel 78 include a resiliently deflectable cannula lock 80 that is angled from one sidewall of channel 78 toward the opposed sidewall and toward the top wall. Cannula lock 80 will yield in response to contact with IV cannula 30 as shield 60 is rotated toward IV cannula 30. Cannula lock 80 is further dimensioned to 25 move passed IV cannula 30 when shield 60 approaches the closed position. Hence, cannula lock 80 will return resiliently toward an undeflected position and will trap IV cannula 30 within shield 60. Although the figures herein depict a single cannula lock 80, plural cannula locks may be provided. Additionally, cannula locks may extend from each of the two sidewalls of U-shaped channel 80. Other structures for locking 30 IV cannula 30 in shield 60 can be provided. These include other configurations for plastic or metal cannula locks that deflect in response to contact with IV cannula 30 and then resiliently move to trap IV cannula 30. Alternatively, the cannula lock may require some form of user activation, such as rotation or axial movement of a portion of the shield. 35 Needle assembly 10 further include an IV shield 82 and a NP shield 84 mounted respectively over IV cannula 30 and NP cannula 40 and frictionally retained on collar 9 50. Shields 82 and 84 can be separated by an appropriate application of pulling and/or slight twisting force. Needle assembly 10 is used by first separating NP shield 84 from collar 50 and then threading distal end 14 of housing 12 into a needle holder 86. Shield 60 then is rotated 5 into the fully open position shown in FIGS. I and 2 where shield 60 is spaced from IV cannula 30 and is aligned to IV cannula 30 at an obtuse angle of about 1200. IV shield 78 then is removed from its engagement with collar 50. The phlebotomist then guides distal end 34 of IV cannula 30 into a targeted blood vessel. A pressure differential between the blood in the vein and the pressure within housing 12 will cause blood to 10 flow through lumen 36 of IV cannula 30. Blood will appear in flashback chamber 26 very quickly after access to the blood vessel has been attained. This blood can be seen in flashback chamber 26 by the phlebotomist due to the disposition and alignment of shield 60 in the open position. The phlebotomist then inserts an evacuated tube 88 into needle holder 82. Evacuated tube 88 includes a rubber stopper 90 that collapses sleeve 15 46 distally. As a result, proximal end 42 of NP cannula 40 pierces rubber sleeve 46 and then pierces stopper 90 of evacuated tube 88. The phlebotomist accumulates one or more samples of blood in this manner. After collecting the last sample of blood, the phlebotomist urges needle assembly 10 and needle holder 86 from the patient and immediately exerts pressure with a thumb or 20 forefinger on top wall 68 of shield 60. As a result, shield 60 rotates about hook 56 into a closed position, as shown in FIG. 5, so that IV cannula 30 is surrounded by channel 78 of shield 60. Sufficient rotation causes cannula lock 80 to engage IV cannula 30 and to deflect. Further rotation of shield 60 causes cannula lock 80 to pass IV cannula 30. As a result, cannula lock 80 resiliently returns toward and undeflected condition and 25 traps IV cannula 30. Simultaneously, collar catches 74 and 76 snap into engagement with chevron-shaped latch 58 on collar 50 to provide an audible and tactile indication of shielding. The safely shielded needle assembly then can be discarded in a sharps receptacle. The needle assembly provides effective shielding without impeding use of needle 30 assembly 10 and without obscuring observation of flashback chamber 26. The high visibility of flashback chamber 26 is partly attributable to the extreme distal position of the space between IV cannula 30 and NP cannula 40 and the corresponding proximal position of shield 60 in the open position. Additionally, as shown most clearly in FIG. 1, proximal end 62 of shield 60 is widely open between sidewalls 70 and 72 to provide 35 a broad range of acceptable viewing angles.
10 The above-described needle assembly has hinge pin 66 of shield 60 snapped into engagement with C-shaped hook 56 on collar 50 for hinged rotation of shield 60 relative to collar 50 and relative to housing 12. However, other structures for accommodating hinged movement of shield 60 relative to collar 50 and/or housing 12 5 can be provided. These include forming shield 60 unitarily with collar 50 so that a living hinged connection between shield 60 and collar 50 is provided. A shield with a living hinge is shown, for example, in U.S. Patent No. 5,681,295. Such hinged connections can also include an over-center hinge where the shield is substantially unbiased in the fully open position and in the fully closed position. However, the user 10 may have to overcome a bias in the over-center hinge during the initial phases of rotation from the open position to the closed position. The over-center hinge then resiliently returns toward an unbiased condition and accelerates the hinge towards the closed position.