USRE43473E1 - Needle safety device - Google Patents

Abstract

A needle assembly includes a needle and a hub mounted to each other. The hub includes a sidewall spaced outwardly from the needle cannula and extending to a distal position between the opposed ends of the needle cannula. A housing integral with the hub defines a sidewall to partially confine a safety shield. The safety shield is slidably disposed about the needle cannula and releasably retained in a proximal position and can be moved to a distal position where the safety shield completely surrounds that portion of the needle hub projecting distally from the hub. The needle assembly includes a spring for propelling the safety shield to the distal position and a latch for releasing the safety shield from the proximal position. The latch may be passively activated by normal usage of the medical implement to which the needle assembly is mounted or alternately activated manually.

Description

RELATED APPLICATION

This application is a non-provisional of U.S. Provisional Patent Appl. No. 60/354,202, filed Nov. 13, 2001.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a needle assembly having a needle cannula, a hub to which the needle cannula is mounted and a safety shield that can be telescoped from a proximal position where the needle cannula is exposed to a distal position where the needle cannula is safely shielded.

2. Description of the Related Art

A typical needle assembly includes a needle cannula having a proximal end, a pointed distal end and a lumen extending between the ends. A thermoplastic hub is mounted securely to the needle cannula at a location spaced from the distal end. The hub is provided with external threads or other surface configurations for removably mounting the prior art needle cannula on another structure. Some needle assemblies are used for drawing a sample of blood or other body fluid from a patient. The needle cannulas for these assemblies typically have pointed proximal and distal ends, and the needle hub is mounted to a location between the opposed ends of the needle cannula.

A needle assembly that is used to draw a sample of blood or other bodily fluid typically is used with a needle holder. The needle holder has a substantially tubular sidewall with a widely opened proximal end and a partly closed distal end. The hub of the prior art needle assembly can be engaged releasably with the partly closed distal end of the needle holder. Thus, the pointed proximal end of the needle cannula projects into the needle holder, while the pointed distal end of the needle cannula projects distally beyond the needle holder.

The combination of a needle assembly and a needle holder is used with an evacuated tube for drawing a sample of blood or other bodily fluid from a patient. The tube has a closed end, an open end, and a sidewall extending between the ends. The tube is evacuated, and the open end is sealed by a septum that retains the vacuum within the tube. The evacuated tube is dimensioned to be slid into the open proximal end of the needle holder. Sufficient sliding of the evacuated tube into the needle holder causes the proximal point of the needle cannula to pierce the septum of the evacuated tube. Thus, the needle cannula can be placed in communication with the interior of the evacuated tube.

The combination of a needle assembly, a needle holder and an evacuated tube is employed by initially urging the pointed distal end of the needle cannula into a blood vessel of a patient. Once the targeted blood vessel has been reached, the evacuated tube is urged into the needle holder so that the proximal point of the needle cannula pierces the septum on the tube. Low pressure conditions within the evacuated tube generate a flow of blood from the patient through the needle cannula and into the evacuated tube. The evacuated tube may be removed from the needle holder after a sufficient quantity of blood has been collected. One or more additional evacuated tubes may similarly be urged into the open end of the needle holder for drawing one or more additional samples of blood to be analyzed.

The needle cannula is withdrawn from the patient after a sufficient volume of blood has been collected for the required analytical procedures. The used needle cannula then must be shielded properly to avoid an accidental stick that could transmit a disease from the patient to the medical practitioner.

Many types of devices are available for shielding a used needle cannula. Some shields are hinged to the needle hub, and can be rotated from a first position, where the hinged shield is spaced from the needle cannula for use. After use, the hinged shield is rotated to a second position in shielding engagement around the needle cannula.

Other shields are telescoped over both the needle cannula and the needle hub. These shields initially are retained in a proximal position where the shield covers the hub but exposes the needle cannula for use. After use, the shield is telescoped distally to cover the needle cannula.

Most shielded needle assemblies are effective at performing their primary function of shielding a used needle cannula. However, many medical practitioners consider the available shieldable needle assemblies cumbersome. In particular, the shield that is telescoped over the needle hub typically will move relative to the needle cannula. Consequently, medical practitioners will grip the needle holder or other medical implement to which the shieldable needle assembly is mounted. However, a gripable region on the needle holder typically is relatively far from the distal end of the needle cannula and leads to at least a perception of poor control of the needle cannula. The perception of poor control increases as the length of the needle cannula is increased. As a result, needle assemblies with shields that telescope over the needle hub necessarily impose a limit on the length of the needle cannula that can be employed.

Additionally, in some cases, practitioners may be rushing and forget to operate the safety shield. Other situations arise where the patient moves suddenly or unexpectedly. Thus the needle cannula may inadvertently be pulled out of the vein and exposed with no time for the phlebotomist to initiate safety shielding. These weaknesses are not addressed adequately in prior art devices.

SUMMARY OF THE INVENTION

The present invention is directed to a needle assembly with means for shielding the user or patient end of the needle cannula. The needle assembly includes a needle cannula having opposed proximal and distal ends and a lumen extending between the ends. At least the distal end of the needle cannula may be pointed.

The needle assembly further includes a hub surrounding portions of the needle cannula. The hub includes opposed proximal and distal ends that are disposed between the proximal and distal ends of the needle cannula. The hub may be mounted securely to the needle cannula. Additionally, the proximal end of the hub may be provided with external structure for releasable engagement with a needle holder or with some other medical implement.

The needle assembly further includes a housing that may be attached to the hub. The primary function of the housing is to provide guidance for a shield telescoped between the needle cannula and hub. The housing partially encloses the shield and constrains shield motion in a longitudinal direction, substantially co-axial with the needle cannula. Additionally, the housing further includes external surface configurations to assist the user in manipulating the device during venous punctures. The housing may have external structure for releasable engagement with a needle holder or with some other medical implement.

The above-referenced shield of the needle assembly surrounds the needle cannula and is telescoped into the housing. The shield initially is retained in a proximal position such that distal portions of the needle cannula are exposed for use. The shield can be moved from the proximal position to a distal position where the shield surrounds at least the pointed distal end of the needle cannula. The shield preferably is dimensioned to cover all of the needle cannula between the housing and the distal end of the needle cannula. Additionally, the shield preferably is constructed for locking engagement with the housing when the shield is in its distal position. Thus, the needle cannula cannot be re-exposed after shielding.

The needle assembly may further include biasing means for urging the shield from the proximal position to the distal position. The biasing means may comprise a coil spring disposed within the housing and extending between a portion of the hub and a portion of the shield. The spring may be in a compressed condition when the shield is in its proximal position. The spring then is operative to propel the shield to the distal position.

Actuating means are provided for releasing the shield from the proximal position and enabling the biasing means to propel the shield to the distal position. The actuating means may be actuated automatically and passively in response to an operational condition indicative of use of the needle assembly. For example, the needle assembly intended for use with an evacuated tube may have an actuating means that is triggered by the movement of the evacuated tube into communication with the proximal end of the needle cannula. Alternatively, the actuating means may comprise a latch that is accessible at an external location such as on the hub or housing.

The needle assembly of the present invention enables a medical practitioner to hold portions of the housing that surround the shield during venipuncture. Thus, the medical practitioner is able to grip a portion of the needle assembly relatively close to the distal end of the needle cannula. Gripping may be facilitated by structural elements disposed externally on the housing. Thus, for example, the housing may include at least one flat dimensioned and disposed for convenient gripping. Alternatively, the housing or hub may be provided with corrugations, dimples, recesses, concave surfaces, roughening or other structure that will facilitate manual gripping by a medical practitioner.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the needle assembly of the present invention.

FIG. 2 is an exploded view of the device shown inFIG. 1.

FIG. 3 is a perspective view with the packaging shield covering the needle cannula before use.

FIG. 4 is a perspective ofFIG. 1 with the needle shield covering the needle cannula after use.

FIG. 5 is an exploded view of the cannula and hub sub-assembly as it fits within the housing and holder sub-assembly.

FIG. 6 is a partially exploded view of the cannula and hub sub-assembly aligned for assembly with the housing.

FIG. 7 is a magnified view of the portion ofFIG. 6 showing the proximal end of the housing with snap retainers.

FIG. 8 is an exploded perspective view of a needle assembly with detached holder of the present invention.

FIG. 9 is an exploded perspective view of the needle assembly inFIG. 8 with non-patient shield detached.

FIG. 10 is an exploded perspective view of the needle assembly inFIG. 8 with the packaging and non-patient shields removed from the housing.

FIG. 11A is a front view of the housing of the present invention.

FIG. 11B is a sectional perspective view of the housing cut along the line depicted inFIG. 11A.

FIG. 11C is a sectional perspective view of the housing cut along the line depicted inFIG. 11A.

FIG. 12A is perspective view of the safety shield of the present invention.

FIG. 12B is a perspective view of the needle shield of the present invention.

FIG. 12C is an elevation view of the needle shield of the present invention with the deflectable member in an unbiased position.

FIG. 12D is an elevation view of the needle shield of the present invention similar toFIG. 12C, but with the deflectable member in a deflected state.

FIG. 13 is an elevation view of the actuator of the present invention.

FIG. 14 is a perspective view of the actuator of the present invention.

FIG. 15 is a perspective view of the hub of the present invention.

FIG. 16 is an elevation view of the hub ofFIG. 15.

FIG. 17 is an elevation view of the needle assembly during use before shielding.

FIG. 18 is an elevation view of the needle assembly after shielding.

FIG. 19A is a sectional view of the present invention shown before actuator safety shield release.

FIG. 19B is a sectional view of the present invention shown during actuator safety shield release.

FIG. 19C is a sectional view of the present invention shown after actuator safety shield release but prior to complete shielding.

FIG. 19D is a sectional view of the present invention shown after actuator safety shield release and after complete shielding.

FIG. 20A is a perspective sectional view of the present invention shown before actuator safety shield release.

FIG. 20B is a perspective sectional view of the present invention shown during actuator safety shield release.

FIG. 20C is a perspective sectional view of the present invention shown after actuator safety shield release but prior to complete shielding.

FIG. 20D is a perspective sectional view of the present invention shown after actuator safety shield release and after complete shielding.

FIG. 21 is a perspective view of an alternate needle assembly of the present invention prior to use and with the packaging shield covering the needle cannula.

FIG. 22 is an exploded perspective view similar toFIG. 2, but showing the alternate embodiment ofFIG. 21.

FIG. 23 is a cross-sectional view taken along line23-23 inFIG. 21.

FIG. 24 is a perspective view of the holder for use with the embodiment ofFIGS. 21-23.

FIG. 25 is a perspective view of the hub for use with the embodiment ofFIGS. 21-24.

FIG. 26 is a side elevational view of the actuator of the embodiment ofFIGS. 21-25.

FIG. 27 is a perspective view of the actuator ofFIG. 26.

FIG. 28 is a perspective view of an alternate embodiment of the actuator that permits both manual actuation and tube actuation of the shield.

DETAILED DESCRIPTION

Theneedle assembly10 of the present invention is shown inFIGS. 1-7 and11-20. It will be noted that the term “distal” as used herein refers to the end of the needle assembly that punctures the patient's skin while “proximal” means the end of the needle assembly that punctures an evacuated container.Needle assembly10 is mounted to aneedle holder12, as shown inFIGS. 1,3, and4.Needle holder12 has aproximal end14, adistal end16 and atubular sidewall18 extending between ends14 and16.Proximal end14 ofneedle holder12 is widely open and is adapted to receive ablood collection tube20 as shown inFIGS. 17,19A-19D, and20A-20D. However,proximal end14 ofholder12 may have a removable seal orcap15 for sterility.Proximal end14 ofholder12 also has a radially alignedfinger flange17 to facilitate manipulation ofholder12.Flange17 is non-circular to preventholder12 from rolling.Flange17 preferably has a linear edge to provide a clear indication of the top and bottom sides.Distal end16 ofneedle holder12 includes structure to whichneedle assembly10 is mounted. In particular,distal end16 ofneedle holder12 may be formed with non-threaded mounting means, such thatneedle holder12 is substantially fixed toneedle assembly10 after assembly. The non-threaded mounting means comprises a combination ofexternal rings81 and keyways to secureneedle assembly10 axially and circumferentially. It is preferred thatneedle assembly10 is mounted toneedle holder12 by the manufacturer so that the device is ready for fast and convenient use. Most importantly,pre-assembled needle assemblies10 andneedle holders12 ensure that the proximal point of the needle is enclosed withinholder12 before, during, and after blood collection. Alternately, however, the distal end of the needle holder may be formed with an internal array of threads that are engagable by external threads on the needle assembly.

Needle assembly10 ideally is packaged in a blister package having a thermoformed blister and top web. The top web is comprised of a material that may be permeable to gas such as ethylene oxide gas. Optionally, theproximal end14 ofholder12 can be covered with a paper-like membrane that is thermally or adhesively sealed onto theproximal end14 of the holder. Examples of materials used for a paper-like membrane are Tyvek® manufactured by DuPont and examples of materials to be used for a thermoformed blister package include glycol modified polyethylene terephthalate (PETG), polyethylene terephthalate (PET), high-density polyethylene, polypropylene, polycarbonate, nylon, and K-resin. In the configuration with a paper-like membrane covering the openproximal end14 ofholder12, a thermoformed blister and top web would not be required, and the entire assembly can be sterilized by ethylene oxide gas orcobalt 60 irradiation.

Needle assembly10 includes aneedle cannula22, aneedle hub24, apackaging shield26, asafety shield28, asleeve39, ahousing80, anactuator30, and aspring32. In other embodiments, a portion of the needle assembly (e.g., the housing) can be integral or unitary with the needle holder to reduce assembly steps by the manufacturer and the user.

Needle cannula22 includes a pointedproximal end34, as shown inFIGS. 1,5 and6, a sharply beveleddistal end36 and alumen38 extending therebetween.Proximal end34 ofneedle cannula22 is covered by an elastomeric multiple sample sleeve39 (shown inFIGS. 2,9 and10) that can be pierced by pointedproximal end34 ofneedle cannula22.

Needle hub24 is illustrated in greater detail inFIGS. 15 and 16.Needle hub24 includes aproximal end40, adistal end42, and alumen38 extending therebetween. Housing attachment means is provided externally ofhub24 to achieve fixed engagement betweenhub24 andneedle housing80. The housing attachment means may include ultrasonic welding, heat staking, solvent bonding, mechanical latches with receiving latch detents, adhesive bonding, friction fit joints, irreversible threads, or any of the like. In the embodiment ofFIGS. 5,6,7,15 and16 the housing attachment means are defined bymechanical latches86 that extend distally fromneedle hub24 for engagement indetents88 onneedle housing80.Hub24 is mounted securely to locations onneedle cannula22 between proximal anddistal ends34 and36 thereof and in a specified rotational orientation relative to the bevel atdistal end36 ofneedle cannula22. More particularly an adhesive well is formed onneedle hub24 and receives adhesive to bondneedle cannula22 tohub24. Alternately,needle hub24 andneedle housing80 may be combined as one molded component. However it is generally easier to manufactureneedle hub24 andhousing80 as two components.

Needle housing80 is illustrated in greater detail inFIGS. 11A-11C.Needle housing80 includes aproximal end82, adistal end84 and atubular wall44 extending between ends82 and84. As shown inFIGS. 11A-11C,tubular wall44 is of generally circular or elliptical cross-section. Alternately,tubular wall44 may have a non-circular cross-section or rectangular cross-section. The specific cross-sectional shape is not critical, and shapes other than those shown herein are contemplated.Housing80 preferably is formed from a transparent or translucent material to permit user observation ofsafety shield28. Thus, the medical practitioner can observe movement ofsafety shield28, as explained below, to provide a visual indication that proper shielding is taking place. Additionally,proximal end82 ofhousing80 may have one of many optional means for attachment to aneedle holder12, such as a threaded connection, interference fit, adhesive bonding, solvent bonding, ultrasonic welding, heat staking, snap fit, or any other means. More specifically, the housing may have external threads and may be mounted to internal threads of the distal end of the needle holder. Alternately,housing80 has non-threaded mounting means to engageholder12 in an interlocking manner. External rings81 are illustrated inFIGS. 5-7 and define one preferred non-threaded mounting means that provide sufficient frictional or interlocking forces to resisthousing80 from unintentionally releasing fromholder12 during puncturing ofseptum21 byproximal end34 ofneedle cannula22. In the illustrated embodiment,hub24 is mounted indirectly to theholder12 throughneedle housing80.Housing80 preferably is non-rotatably mounted toholder12 to ensure that the bevel at distal end ofneedle cannula22 faces up relative to the bottom edge offlange17 ofholder12.Distal end84 ofneedle housing80 is characterized by diametrically opposed V-shaped notches as shown inFIG. 11B.Notches85 cooperate with corresponding structure onpackaging shield26.

Housing80 has a length such thatdistal end84 ofhousing80 is spaced proximally fromdistal end36 ofneedle cannula22 sufficiently to enable convenient use ofneedle cannula22. Portions oftubular wall44 fromdistal end84 towardproximal end82 ofhousing80 are spaced outwardly fromneedle cannula22 for permitting telescoped movement ofsafety shield28 betweenneedle cannula22 andhousing80, as explained further below. Additionally, as shown inFIGS. 1,3, and4,tubular sidewall44 ofhousing80 is provided with external surface configurations or grips46 to facilitate digital manipulation. Surface configurations or grips46 include elongate recesses or flats having small bumps thereon. However, other surface configurations may be employed, such as a plurality of ridges or grooves, or concave detents shaped to conform to a user's fingers.Grips46 preferably are orthogonal to the bottom edge offinger flange17 ofholder12.

Housing80 has internal features to restrict movement ofsafety shield28 relative tohousing80.Tubular wall44 ofhousing80 is formed with a first proximal facingstop surface48. As shown inFIG. 11B,housing80 further includes an axially extendinglatch channel52 formed on an upper interior surface oftubular wall44.Latch channel52 extends from the first proximal facingstop surface48 shown inFIG. 11C to a location substantially adjacentdistal end84 ofhousing80 as shown inFIG. 11B. Adistal detent47 is located near the distal end oftubular wall44 ofhousing80, as shown, and is at the distal end oflatch channel52.Distal detent47 has a distally facingstop surface54.Distal detent47 and distally facingstop surface54 are dimensioned to receive alatch68 onsafety shield28, as explained below.Tubular wall44 further includes astop channel50 extending distally and ending with a second proximally facingstop surface58 neardistal end82 ofhousing80 as shown inFIG. 11C.

Distal end36 ofneedle cannula22 is used to pierce the patient's skin and must be kept very sharp. Thus apackaging shield26, as shown inFIGS. 1-3 and8-10, is used to enclose thedistal end36 ofneedle cannula22. Thepackaging shield26 preferably is formed with two opposing relativelyflat walls19 to facilitate easy handling by the phlebotomist who is likely to be wearing gloves that may even be wet with alcohol prep solution. In the embodiment shown, the open end of thepackaging shield26 fits partially over thedistal end84 ofhousing80. Thepackaging shield26 andhousing80 are dimensioned so that there is an interference fit that desirably provides a sterile barrier between thepackaging shield26 andhousing80 in those embodiments that do not employ blister packaging. In those embodiments, the interference fit betweenpackaging shield26 andhousing80 they make separation ofpackaging shield26 difficult. Accordingly, for those embodiments,packaging shield26 is provided with a pair of diametrically opposed ribs (not shown) on the interior surface. The ribs terminate at a V-shaped point or an arcuate end facing toward the open end ofpackaging shield26. The ends of the ribs are disposed, dimensioned and configured to mate with the V-shapednotches85 atdistal end84 ofhousing80. The engagement of the ends of the rib with V-shapednotches85 develops ramping forces in response to twisting ofpackaging shield26. Thus, the rotational movement applied topackaging shield26 generates a corresponding axial movement ofpackaging shield26 relative tohousing80, and hence facilitates separation of packingshield26. Additionally, a tamper-evidence indicator may be placed between thepackaging shield26 and thehousing80 to provide indication of prior usage.

Safety shield28, as shown inFIGS. 12A-12D, includes aproximal end60, adistal end62 and a substantiallytubular sidewall64 extending between the ends.Tubular sidewall64 ofsafety shield28 preferably is imprinted with indicia at a location aligned with the bevel-up side ofneedle cannula22. This is the portion oftubular sidewall64 that will be the most visible to the medical practitioner. The existence of indicia on this portion of tubular sidewall provides a physical indication to the medical practitioner that shielding is taking place. The indicia should be in a form that will provide evidence of movement. For example, a plurality of intermittent markings or a marking that changes its dimensions along its length would be most beneficial.Safety shield28 initially is retained releasably in a proximal position with at least a major portion ofsafety shield28 disposed in the space betweenneedle cannula22 andtubular wall44 ofhousing80. In this proximal position,proximal end60 ofsafety shield28 is substantially adjacent first proximally facingstop surface48 ofhousing80. Additionally, as shown inFIG. 1,distal end62 ofsafety shield28 is flush with or projects only slightly fromdistal end84 ofhousing80 whensafety shield28 is in its proximal position.Safety shield28 can be released from its proximal position and is movable to a distal position that is shown inFIGS. 4,18,19D and20D. When moved into its distal position,safety shield28 completely covers portions ofneedle cannula22 betweenneedle hub24 anddistal end36 ofneedle cannula22.

As shown inFIGS. 12B-12D,safety shield28 has a hingeddeflectable member66 that is cantilevered towardproximal end60.Deflectable member66 is deflectable outwardly or in a transverse direction. Alatch68 is formed ondeflectable member66 nearproximal end60 ofsafety shield28 and enterslatch channel52 whendeflectable member66 is deflected outwardly. Hingeddeflectable member66 further includes acam surface70 at the extreme proximal end thereof.Cam surface70 is aligned at an acute angle to a radial plane passing throughneedle assembly10. Axially aligned distally directed forces oncam surface70 will generate a transverse deflection ofdeflectable member66 so thatlatch68 enters intolatch channel52.Latch68 further includes a distalfacing locking face72, and a proximally facing lockingface73. Both locking faces72 and73 are aligned substantially perpendicular to the axis ofneedle assembly10.FIG. 12C showsdeflectable member66 in its non-deflected state andFIG. 12D showsdeflectable member66 in its deflected state. Distal movement ofactuator30 movesdeflectable member66 from the position shown inFIG. 12C indirection69 depicted inFIG. 12C to the position shown inFIG. 12D untillatch68 is no longer resisted by first proximally facingstop surface48 ofhousing80 and therefore is free to move distally with respect to theneedle cannula22 under spring energy supplied byspring32.

Safety shield28 further includes astop74 disposed substantially diametricallyopposite latch68.Stop74 is in a plane passing through the axis ofneedle assembly10 and includes a lockingsurface76 facing in the distal direction as shown inFIG. 12A.Stop74 preventsspring32 from pushingsafety shield28past housing80.

Hub24 is connected to theproximal end82 of housing89.Hub24 further includes anactuator channel56 extending substantially parallel tohousing80 as shown inFIGS. 15 and 16.Actuator30, as shown inFIGS. 13 and 14, is disposed slidably inactuator channel56 ofhub24.Actuator30 includes aproximal end78 substantially adjacent toneedle cannula22 that will lie withinneedle holder12.Actuator30 also includes adistal end79 that will lie substantiallyadjacent cam surface70 oflatch68.Distal end79 ofrelease actuator30 is angularly aligned to mate withcam surface70 oflatch68, such that distal movement ofrelease actuator30 will generate transverse deflection ofdeflectable member66.

As shown inFIGS. 13 and 14,actuator30 has an integrated anti-reset feature or latch29 that interfaces withhub24 upon activation of the device. Once atube20 is inserted and interfaces with theproximal end78 ofactuator30,latch29 will interface with thehub channel56 thus deforminglatch29 temporarily inward thereby permittinglatch29 to advance intolatch recess23. Oncelatch29 is withinlatch recess23,latch29 will return resiliently towards an undeflected position so thatactuator30 is prevented from moving back to a proximal position that would allowsafety shield28 to be completely reset to its original position.

Aspring32 surrounds portions ofneedle cannula22 that are surrounded bysafety shield28. Thusspring32 is compressed to retain stored energy whensafety shield28 is in the proximal position withintubular wall44 ofhousing80.Spring32 then will propelsafety shield28 distally after activation. The proximal end31 ofspring32 remains in fixed relation to theholder12,hub24, andhousing80 while the distal end33 ofspring32 moves relative to theholder12,hub24, andhousing80.

The force applied byspring32 tosafety shield28 is essential to proper operation ofneedle assembly10. In particular,spring32 must exert sufficient force to ensure thatsafety shield28 will be propelled sufficiently towarddistal end36 ofneedle cannula22 to complete its essential shielding function. Howeverspring32 should not exert enough force to pushneedle cannula22 out of the patient. Additionally, forces exerted bysafety shields28 on the skin of the patient should not be so large as to cause a patient to react and move suddenly away from the shield. A spring force of 0.02-0.20 pounds, and preferably about 0.09 pounds has been found to meet the objectives of ensuring complete shielding without excessive force against the skin of the patient. Additionally, a fine lubricating spray may be applied to the sliding parts ofsafety shield22,hub24 and/orhousing80 to ensure complete and efficient movement ofsafety shield28 with a low spring force.

Needle assembly10 is used by attaching proximal end ofhub24 andhousing80 intoneedle holder12 such thatproximal end34 ofneedle cannula22 andproximal end78 ofactuator30 lie withinneedle holder12.Packaging shield26 then is removed fromhousing80 to expose pointeddistal end36 ofneedle cannula22. The medical practitioner then manually engageshousing80 atgrips46 and guidesdistal end36 ofneedle cannula22 into a targeted vein of a patient Activation ofshield28 is achieved automatically and passively by insertion ofblood collection tube20 intoproximal end14 ofneedle holder12. Sufficient insertion ofblood collection tube12 will causeproximal end34 ofneedle cannula22 to pierce through theelastomeric septum21 that extends across the open end ofblood collection tube20, as shown inFIGS. 19A-19D. Distal movement ofblood collection tube20 intoneedle holder12 also will causeblood collection tube20 to engageproximal end78 ofactuator30, thereby causingactuator30 to slide distally throughactuator channel56 ofhub24 This distal movement ofactuator30 will causedistal end79 ofactuator30 to engagecam surface70 of hingeddeflectable member66 ofsafety shield28 with sufficient force to pivotdeflectable member66 transversely aboutbinge67 sufficiently to disengage lockingface72 oflatch68 from first proximally facingstop surface48 ofhousing80.

Disengagement oflatch68 from first proximally facingstop surface48 intolatch channel52 causessafety shield28 to be propelled distally under the action ofspring32.Latch68 will be guided inlatch channel52 assafety shield28 is moved towarddistal end84 ofhousing80. Sufficient distal movement ofsafety shield28 will causelatch68 to engage indistal detent47 ofhousing80. While indistal detent47,latch68 interferes with distal facingstop surface54 and preventssafety shield28 from being unshielded. Additionally, stop74 onsafety shield28 rides alongstop channel50 untilstop74 engages second proximally facingstop surface58 thereby preventingsafety shield28 movement in the distal direction afterneedle point36 has been shielded. As a result ofstop74 andlatch68,safety shield28 is prevented from moving either distally or proximally from this locked position as shown inFIGS. 18,19D, and20D.

The above-described needle assembly is completely passive in that shielding is achieved without any required user activation other than the normal insertion of a fluid collection tube into the openproximal end14 ofholder12. There may be instances, however, where a user may want direct control over the initiation of shielding or where a user may want dual control where shielding can be actuated by insertion of a fluid collection tube and/or by direct digital activation by the user. These options can be achieved without a complete redesign of the above-described needle assembly. In particular, an alternate needle assembly is identified generally by the numeral10a inFIGS. 21-27.Assembly10a include aneedle cannula22, ahub24, apacking shield26 and ahousing80, all of which are substantially identical to corresponding parts of the first embodiment described and illustrated above. However,assembly10a includes aholder12a that is slightly different fromholder12 described and illustrated above. In particular, as shown most clearly inFIG. 24,holder12a includes a tubular sidewall18a that has a proximal end14a, a distal end16a. Anotch17a extends into tubular sidewall18a at distal end16a. Additionally,notch17a is disposed on a portion of sidewall18a that will align with the bevel-up side ofneedle cannula22.Notch17a is partly surrounded by an elongate flat orrecess19a in tubular sidewall18a to minimize the projection of an actuator, as explained herein and to provide a visible indication of a region to be accessed by a user for carrying out a manual actuation of the shielding.

Needle assembly10a further includes anactuator30a as shown inFIGS. 26 and 27, that differs fromactuator30 described above and illustrated inFIGS. 13 and 14. In particular,actuator30a includes anactuating beam31a with adistal end79a that is structurally and functionally virtually identical todistal end79 ofactuator30. Additionally, actuating beam3k includes ananti-reset latch29a that is structurally and functionally substantially identical to latch29 ofactuator30.Actuator30a further includes a mountingcollar77a that is disposed and configured to mount slidably over proximal portions ofhub24. Additionally, mountingcollar77a is dimensioned for slidable disposition withinholder12a.Actuator30a further includes anarm90a that projects distally fromcollar77a.Ann90a is dimensioned for slidable insertion innotch17a ofholder12a, and terminates at anactuating button92a.

Needle assembly10a is assembled substantially asneedle assembly10, described and illustrated above. However,collar77a ofactuator30a is slidably disposed over and around proximal portions ofhub24. The subassembly ofneedle cannula22,hub24, packingshield26,housing80 andactuator30a can be mounted in bolder12a substantially as described above. However,arm90a will project slidably throughnotch17a such thatactuating button92a is slidably disposed on the outer circumferential surface ofhousing80.

Needle assembly10a is used substantially in the conventional manner as explained above. However,safety shield28 is actuated by digital pressure exerted by a thumb or forefinger of the user onactuator button92a. In particular, the user urges actuator button distally along outer surface of housing80 a sufficient distance fordistal end79a ofactuator30a to actuatesafety shield28 as explained above.

In certain instances, a user may want to have the ability to shield the needle cannula independently of the passive actuation described above with respect to the first embodiment. For example, a user may have some reason to terminate a specimen collection procedure prior to insertion of an evacuated tube into the holder. This objective can be achieved byalternate actuator30b.Actuator30b is effectively a hybrid ofactuator30 andactuator30a. Specifically,actuator30b, as shown inFIG. 28, is identical toactuator30a in all respects, but further includes aproximal end78b that is identical toproximal end78 ofactuator30. Thus,actuator30b permits shielding to be completed either by insertion of an evacuated tube into holder or by digital pressure onactuator button92b.

The internal disposition ofsafety shield28 within the housing in any of these embodiments provides several significant advantages. In particular, a medical practitioner employingneedle assembly10 can holdneedle assembly10 much closer todistal end32 ofneedle cannula22. This distal location for grippingneedle assembly10 provides better balance and feel for the medical practitioner and facilitates alignment and aiming ofneedle assembly10.

Alternately to the embodiments described above, the needle assembly can be made in a detachable holder orhard pack assembly100 configuration using all the components of the needle assembly described above with the addition of a non-patient needle shield90 for enclosingproximal end34 ofneedle cannula22 shown inFIGS. 8-10. Non-patient needle shield90 is reversibly detachable to one or both ofneedle housing80 andhub24. The user removes non-patient needle shield90 fromhardpack assembly100 and attachesholder12 to the proximal end ofhousing80 prior to use. Onceholder12 is attached tohousing80, the user can removepackaging shield26 and use the needle device in a similar manner to the needle assembly embodiment described herein.

It will be apparent that other variations can be made to the present invention without departing from the scope of the invention as defined by the appended claims. In alternate embodiments, the actuator can deflect a latch radial inwardly or in some other direction to effect disengagement from the housing. In addition, the actuator and the latch may be configured to generate rotation of the shield relative to the housing for disengaging a latch on the shield from a detent on the housing. Still further, other configurations for the exterior of the housing may be provided for convenient and secure digital manipulation, such as the exterior of the shield may include an array of ribs, grooves or dimples instead of or in addition to the flats shown in the illustrated embodiments.

In a further embodiment, the invention provides a method of making a blood collection assembly comprising the steps of:

• (a) providing the components of:
  • (i) a hub;
  • (ii) a needle cannula comprising a proximal end, a distal end, and a lumen extending therebetween, said cannula is mourned to said hub;
  • (iii) a housing engageable to said hub and extending distally from said hub, said housing comprising a safety shield guiding means;
  • (iv) a safety shield longitudinally moveable with respect to said housing by said safety shield guiding means from a proximal position to a distal position;
  • (v) a compression spring between one of said hub or said housing and said safety shield, said spring having a spring constant a free length and compressed length;
• (b) identifying a first friction force between a typical patient's skin and said needle cannula;
• (c) identifying a second friction force between said blood collection assembly and a patient's skin;
• (d) assembling said components wherein said shield has a proximal position, an intermediate position, and a fully extended distal position in relation to said housing;
• (e) providing a spring constant and spring length combination suitable for said spring to exert a force on said safety shield tat is in equilibrium with said first and second friction forces while said distal end of said cannula is percutaneously inserted into a patient's skin and said safety shield is in said intermediate position.

Claims (85)

1. A shieldable needle assembly comprising:

a needle cannula having a proximal end and a distal end;

a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;

a substantially tubular housing, at least a portion of which extends in a distal direction and projects distally from said hub toward said distal end of said needle cannula beyond said hub in said distal direction;

a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing;

a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and

an actuator slidably mounted movably attached to said hub needle assembly, said actuator being movable distally in a direction relative to said hub and said safety shield housing, a portion of said actuator being configured for releasing said safety shield, such that said spring element is able to propel said safety shield toward said distal position,

wherein the actuator is inaccessible from a lateral side of the needle assembly.

2. The needle assembly ofclaim 1, wherein one of said housing and said safety shield includes a latch, and wherein the other of said housing and said safety shield includes a detent for releasably engaging the latch and for releasably holding said safety shield in said proximal position.

3. The needle assembly ofclaim 2, wherein said actuator comprises a proximal end extending proximally from said hub and a distal end substantially aligned with said latch, such that said a portion of said actuator being configured for releasing said safety shield said latch from said detent in response to said movement of said actuator.

4. The needle assembly ofclaim 3, wherein said actuator includes a portion disposed externally of said housing for permitting manual actuation.

5. The needle assembly ofclaim 3, wherein said proximal end of said housing is capable of being engaged with a detachable holder useful for receiving collection containers.

6. The needle assembly ofclaim 5 claim 1, wherein said a proximal end of said housing is capable of being engaged with a holder useful for receiving a collection container and a proximal end of said actuator is movable in the a distal direction by insertion of a the collection container into the proximal end of said holder.

7. The needle assembly ofclaim 2, wherein said housing includes a latch recess, said latch being on said safety shield and being engageable with said latch recess of said housing when said safety shield is in said distal position for preventing further distal movement of said safety shield from said distal position and for preventing a return proximal movement of said safety shield from said distal position.

8. The needle assembly ofclaim 1, wherein the safety shield is substantially tubular and is spaced radially outwardly from said needle cannula, said spring element being a coil spring surrounding said needle cannula and engaged with said tubular safety shield.

9. The needle assembly ofclaim 8 claim 1, wherein said coil spring exerts aspring force of 0.02-0.20 pounds between said safety shield and one of said hub or said housing while said safety shield is in the proximal position.

10. The needle assembly ofclaim 1, wherein said housing includes at least one non-cylindrical external outer region for digital gripping of said housing.

11. The needle assembly ofclaim 10, wherein said distal end of said needle cannula is beveled to a point, said bevel being oriented having a predetermined orientation with respect to non-cylindrical the at least one region for gripping of said housing.

12. The needle assembly ofclaim 10, wherein said non-cylindrical region includes a pair of opposed flats extending longitudinally along portions of said housing on opposite respective sides of said housing, said flats each including at least one surface irregularity for facilitating gripping.

13. The needle assembly ofclaim 1, further comprising a distal packaging cap removably disposed over said distal end of said needle cannula.

14. The needle assembly ofclaim 1, wherein said housing is formed from a transparent translucent plastic material.

15. The needle assembly ofclaim 1, wherein said safety shield includes is formed with indicia for providing visual indications of movement of said shield relative to said housing.

16. The needle assembly ofclaim 15, wherein said distal end of said needle cannula is beveled to a point, said indicia on said shield being aligned with said bevel.

17. A blood collection assembly comprising:

a substantially cylindrical holder having an open proximal end, a distal end and a tubular sidewall extending between said ends, said tubular sidewall being configured for possible insertion of a collection container, an end wall at said distal end of said holder, said end wall having a aperture with needle mounting structure formed thereon; and

a needle assembly comprising

a needle cannula having a pointed proximal end and a pointed distal end thereof,

a hub directly mounted to said needle cannula between said pointed proximal end and said pointed distal end thereof,

a housing spaced radially outwardly from said needle cannula and projecting distally from said distal end of said hub to a location spaced proximally from said distal end of said needle cannula, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction,

a safety shield surrounding said needle cannula and having at least a portion disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position such that said safety shield is disposed proximally of said distal end of said needle cannula, said safety shield being movable to a distal position where said safety shield encloses said pointed distal end of said needle cannula,

a spring for propelling said safety shield from said proximal position to said distal position, and

an actuator slidably mounted movably attached to said hub needle assembly, said actuator being movable distally in a direction relative to said hub and said safety shield housing, a portion of said actuator being configured for releasing said safety shield, such that said spring element is able to propel said safety shield toward said distal position,

wherein said actuator is accessible at said proximal end of the hub.

18. The blood collection assembly ofclaim 17 wherein said housing includes a detent, and wherein said safety shield includes a latch for releasably retaining said safety shield in said proximal position.

19. The blood collection assembly ofclaim 18, wherein said actuator including a proximal end disposed within said needle holder and a distal end disposed substantially adjacent said latch of said safety shield, said proximal end of said actuator being engageable by a collection container for urging said actuator distally and into a position for disengaging said latch from said detent on said housing.

20. The blood collection assembly ofclaim 17, wherein said actuator includes a actuator button disposed externally of said holder and said needle assembly for permitting manual actuation of said safety shield.

21. The blood collection assembly ofclaim 18, wherein said actuator includes an actuator button disposed externally of said holder and a proximal end extending into said holder, said actuator including a distal end disposed adjacent said latch of said safety shield, wherein distal movement of said actuator is moveable by either insertion of a collection container into said proximal end of said holder or manual movement of said actuator button.

22. The blood collection assembly ofclaim 17, wherein said safety shield is substantially tubular and includes a sidewall spaced outwardly from said needle cannula, said spring element being a coil spring surrounding said needle and engaged with said tubular safety shield.

23. The blood collection assembly ofclaim 17, additionally comprising a holder for receiving a collection container wherein said holder includes a flange projecting outwardly at said a proximal end of said holder, said flange including a flat edge aligned substantially perpendicular to a plane passing symmetrically through said distal end of said needle cannula.

24. The blood collection assembly ofclaim 23, wherein said pointed distal end of said cannula comprises a bevel oriented to said flange of said holder.

25. The blood collection assembly ofclaim 17, wherein said housing is formed from a transparent translucent material.

26. The blood collection assembly ofclaim 17, wherein said safety shield is formed with indicia for providing visible indication of movement of said safety shield relative to said housing.

27. A method of making a blood collection assembly comprising the steps of:

(a) providing the components of:

(i) a hub;

(ii) a needle cannula comprising a proximal end, a distal end, and a lumen extending therebetween, said cannula is being mounted to said hub;

(iii) a housing engageable to said hub and extending distally from said hub, at least a portion of which extends in a distal direction and projects beyond said hub in the distal direction when engaged with said hub, said housing comprising a safety guide;

(iv) a safety shield longitudinally moveable with respect to said housing by said safety shield guide from a proximal position to a distal position at which the distal end of said cannula is fully covered;

(v) a compression spring between one of said hub or said housing and said safety shield, said spring configured to move said safety shield from the proximal position, to an intermediate position, and further to the a fully extended distal position;

(vi) an actuator slidably mounted movably attached to said hub, said actuator being movable distally in a direction relative to said hub and said safety shield housing, a portion of said actuator being configured for releasing said safety shield, such that said compression spring element is able to propel said safety shield toward said distal position; and

(b) assembling said components,

wherein the actuator is inaccessible from a lateral side of the needle assembly and wherein said spring exerts sufficient force to move said safety shield to said distal position without exerting enough force to rush push said needle cannula out of a patient into which said cannula has been inserted while said safety shield is in said intermediate position.

28. The method of making a blood collection assembly ofclaim 27, wherein said safety shield guide comprises a channel.

29. The needle assembly of claim 1, wherein said actuator includes a latch component movable radially relative to said hub.

30. The needle assembly of claim 1, wherein said actuator is accessible at a proximal end of the hub.

31. The needle assembly of claim 1, wherein said actuator comprises a latch component on at least one of said hub or housing.

32. The needle assembly of claim 1, wherein the actuator is movable in a distal direction relative to said hub.

33. The needle assembly of claim 1, wherein the actuator is an assembly and includes a deflectable member on one of said housing and safety shield, said deflectable member includes a latch, and the needle assembly additionally includes a detent for releasably engaging the latch and for releasably holding said safety shield in said proximal position.

34. The needle assembly of claim 33, wherein a proximal surface of said actuator is engageable by a collection container for disengaging said latch from said detent.

35. The needle assembly of claim 1, wherein said housing includes a latch recess, and the safety shield includes a latch that is engageable with said latch recess of said housing when said safety shield is in said distal position to hinder further distal movement of said safety shield from said distal position and to hinder a return proximal movement of said safety shield from said distal position.

36. The needle assembly of claim 1, wherein a proximal end of the needle assembly is configured for receiving a collection container, in which insertion of the collection container into the proximal end of said needle assembly causes movement of said safety shield from the proximal position to the distal position.

37. The needle assembly of claim 1, wherein said housing employs at least one surface configuration for user manipulation.

38. A shieldable needle assembly comprising:

a needle cannula having a proximal end and a distal end;

a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;

a housing, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction, said housing including a plurality of recesses in the outer surface for user manipulation;

a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and

a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield

wherein the actuation of the safety shield to the distal position is effected by the movement of a collection container in a distal direction and said distal end of said needle cannula is beveled to a point, said bevel having a predetermined orientation with respect to the recesses of said housing.

39. The needle assembly of claim 38, additionally comprising an actuator movably attached to said assembly, said actuator being movable in a direction relative to said hub and said housing, a portion of said actuator being configured for releasing said safety shield, such that said spring is able to propel said safety shield toward said distal position.

40. A shieldable needle assembly comprising:

a needle cannula having a proximal end and a distal end;

a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;

a housing, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;

a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing;

a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and

a latch component that releases said safety shield, such that the spring element is able to propel said safety shield toward said distal position, said latch component being movably attached to said needle assembly,

wherein the latch component is inaccessible from a lateral side of the needle assembly.

41. The needle assembly of claim 40, wherein said latch component is movable radially relative to said hub.

42. The needle assembly of claim 41, wherein said latch component is accessible at a proximal end of the hub.

43. The needle assembly of claim 40, wherein said latch component is on said hub.

44. A shieldable needle assembly comprising:

a needle cannula having a proximal end and a distal end;

a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;

a housing at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;

a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing;

a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and

a trigger that activates the spring element to propel said safety shield toward said distal position, wherein the trigger is movably attached to said needle assembly.

45. The needle assembly of claim 44, wherein said trigger includes a latch component that is movable radially relative to said hub and housing.

46. The needle assembly of claim 44, wherein said trigger is accessible at said proximal end of the hub.

47. The needle assembly of claim 44, wherein said trigger includes a latch component on said hub.

48. The blood collection assembly of claim 17, wherein said actuator includes a latch component that is movable radially relative to said hub.

49. The blood collection assembly of claim 17, wherein said actuator is accessible at said proximal end of the hub.

50. The blood collection assembly of claim 17, wherein said actuator includes a latch component on at least one of said hub or housing.

51. The blood collection assembly of claim 50, wherein one of said housing and safety shield includes a deflectable member, said deflectable member includes a latch, and the needle assembly includes a detent for releasably engaging said latch and for releasably holding said safety shield in said proximal position.

52. The blood collection assembly of claim 51, wherein a proximal surface of said actuator is engageable by a collection container for disengaging said latch from said detent on said needle assembly.

53. A blood collection assembly comprising:

a needle assembly comprising:

a needle cannula having a proximal end and a distal end;

a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;

a housing, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction, said housing including a plurality of depressions at an outer surface configured to ease user manipulation;

a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and

a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield

whereby the actuation of the safety shield to the distal position is effected by the insertion of the collection container into the holder a sufficient distance to effect release of the safety shield and

wherein said distal end of said needle cannula is beveled to a point, said bevel having a predetermined orientation with respect to the depressions of said housing.

54. The blood collection assembly of claim 53, additionally comprising an actuator movably attached to said needle assembly, said actuator being movable in a direction relative to said hub and said housing, a portion of said actuator being configured for releasing said safety shield, such that said spring element is able to propel said safety shield toward said distal position.

55. The blood collection assembly of claim 54, wherein said outer surface configurations comprises at least one non-cylindrical region which includes a depression extending longitudinally along a portion of said housing.

56. A blood collection assembly comprising:

a needle assembly comprising:

a needle cannula having a proximal end and a distal end;

a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;

a housing at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;

a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and

a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and

a latch component that releases said safety shield, such that the spring element is able to propel said safety shield toward said distal position and said latch component is movably attached to said needle assembly,

wherein the latch component is inaccessible from a lateral side of the needle assembly.

57. The blood collection assembly of claim 56, wherein said latch component is movable radially relative to said hub and housing.

58. The blood collection assembly of claim 57, wherein said latch component is accessible at a proximal end of the hub.

59. The blood collection assembly of claim 56, wherein said latch component is on at least one of said hub or housing.

60. A blood collection assembly comprising:

a needle assembly comprising:

a needle cannula having a proximal end and a distal end;

a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;

a housing at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;

a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and

a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and

a trigger that activates the spring element to propel said safety shield toward said distal position, wherein the trigger is movably attached to said needle assembly.

61. The blood collection assembly of claim 60, wherein said trigger includes a latch component that is movable radially relative to said hub.

62. The blood collection assembly of claim 60, wherein said trigger is accessible at a proximal end of the hub.

63. The blood collection assembly of claim 60, wherein said trigger includes a latch component on at least one of said hub or housing.

64. The method of making a blood collection assembly of claim 27, wherein the actuator is movable distally relative to said hub and said housing.

65. A method of automatically and passively activating a safety shield for a shielded needle assembly including a needle cannula having a hub, a housing, the safety shield and a release mechanism, said method including the steps of:

inserting a blood collection tube into a proximal end of the needle assembly, wherein the safety shield is movable from a proximal position to a distal position where the safety shield substantially covers the distal end of the needle cannula and at least a portion of the housing extends in a distal direction and projects beyond said hub in said distal direction and

engaging the release mechanism with the blood collection tube as the tube moves in the distal direction, wherein said engagement of the release mechanism effects the movement of the safety shield from the proximal position to the distal position.

66. The method of claim 65, further comprising the step of guiding the distal end of the needle cannula into a vein of a patient for the purpose of drawing blood and

wherein the step of inserting the blood collection tube into the proximal end of the needle assembly causes said blood to flow into the blood collection tube and causes deflection of a deflectable member of said safety shield so that the safety shield moves from the proximal position to the distal position.

67. The method of claim 66, wherein the needle assembly further includes a spring biasing the safety shield in the distal direction so that when the safety shield moves from the proximal position to the distal position, the spring propels the shield toward the distal direction.

68. The method of claim 66, wherein once the step of inserting the blood collection tube into the proximal end of the needle assembly occurs and the safety shield moves from the proximal position to the distal position, the needle cannula is prevented from being unshielded.

69. The method of claim 66, wherein the safety shield is substantially flush with said housing and the movement of the safety shield from the proximal position to the distal position is effected by a latch component that is movable radially relative to a hub attached to the needle.

70. The method of claim 69, wherein said latch component is effected by the blood collection container being inserted at the proximal end of the needle assembly.

71. The method of claim 66, wherein the movement of the safety shield from the proximal position to the distal position is effected by a latch component on said hub.

72. The method of claim 66, wherein the step of insertion of the collection tube causes the release mechanism to move distally relative to said hub and releases the safety shield.

73. The blood collection assembly of claim 17, further comprising a holder configured for possible insertion of a collection container disposed on the proximal end of the blood collection assembly.

74. The needle assembly of claim 1, wherein the safety shield is substantially flush with said housing when the safety shield is in the proximal position.

75. The blood collection assembly of claim 17, wherein the safety shield is substantially flush with said housing when the safety shield is in the proximal position.

76. The method of claim 27, wherein the safety shield is substantially flush with said housing when the safety shield is in the proximal position.

77. The needle assembly of claim 1, wherein the safety shield is projecting slightly from the housing when the safety shield is in the proximal position.

78. The blood collection assembly of claim 17, wherein the safety shield is projecting slightly from the housing when the safety shield is in the proximal position.

79. The method of claim 27, wherein the safety shield is projecting slightly from the housing when the safety shield is in the proximal position.

80. The method of claim 66, wherein the safety shield is projecting slightly from the housing.

81. The needle assembly of claim 1, wherein the actuator is slidably mounted to said hub.

82. The needle assembly of claim 81, additionally comprising a holder for receiving a collection container, wherein a proximal end of said actuator is slidable in a distal direction by insertion of the collection container into a proximal end of said holder.

83. The blood collection assembly of claim 17, wherein the actuator is slidably mounted to said hub.

84. The method of claim 27, wherein the actuator is slidably mounted to said hub.

85. The needle assembly of claim 11, wherein said at least one region for gripping is a non-cylindrical region which includes a depression extending longitudinally along a portion of said housing.

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