Abstract:
A needle device includes a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least one of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The instant application is a US non-provisional Application based on U.S. provisional application No. 61/167,725, filed Apr. 8, 2009, the disclosure of which is hereby expressly incorporated by reference hereto in its entirety. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates generally to needle safety systems for injection devices, e.g., hypodermic syringes, IV infusion sets, etc., such as are utilized for injection of medicament into the body tissues of human and animal patients. More specifically, this invention relates to a needle safety system having a body, a safety shield, a needle, and a system for causing the safety shield to move from a retracted position to an extended position. The extended position preferably prevents the possibility of inadvertent needle pricks and/or prevents subsequent use or re-use of the system. 
     This invention also relates to single-use needle units which automatically deploy the safety shield over the needle when cause to do so and/or activated by the user. 
     This invention also relates to an IV infusion needle which can be used only once and have a built-in safety system which cannot be easily overridden by a user thereof. 
     2. Discussion of Background Information 
     The following devices relate to similar devices: U.S. Pat. No. 5,591,138 to VAILLANCOURT; U.S. Pat. No. 5,403,286 to LOCKWOOD, Jr.; U.S. Pat. No. 7,428,773 to NEWBY et al.; U.S. Pat. No. 7,413,560 to CHONG et al.; U.S. Pat. No. 7,322,963 to GOH; U.S. Pat. No. 7,150,725 to WILKINSON; U.S. Pat. No. 7,144,387 to MILLERD; U.S. Pat. No. 6,375,640 to TERAOKA; D452,000 to CRAWFORD et al; U.S. Pat. No. 5,498,241 to FABOZZI; U.S. Pat. No. 6,210,371 to SHAW; U.S. Pat. No. 5,376,080 to PETRUSSA; U.S. Pat. No. 5,267,977 to FEENEY, Jr.; U.S. Pat. No. 5,242,401 to COLSKY; and U.S. Pat. No. 5,167,635 to HABER et al. The entire disclosure of each of these documents is hereby expressly incorporated by reference in their entireties. The invention provides improvements over such devices such as using a more user friendly and/or less costly and/or more safe safety system. 
     SUMMARY OF THE INVENTION 
     According to one non-limiting aspect of the invention there is provided a needle device comprising a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least one of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. 
     The device may be a single-use needle device. The body may be generally cylindrically shaped. The needle shield may be generally cylindrically shaped. The body may comprise a one-piece member. The needle shield may comprise a one-piece member. The body and the needle shield may each comprise a synthetic resin material. The needle may comprise a generally cylindrical hollow needle. The needle may comprise at least one of metal and stainless steel. The body may comprise at least one releasable retaining member which releasably retains the needle shield in a retracted position. The body may comprise plural releasable retaining members which releasably retains the needle shield in a retracted position. The body may comprise at least one non-releasable retaining member which non-releasably retains the needle shield in a fully extended position. The body may comprise at least one non-deflectable retaining member which non-releasably retains the needle shield in an extended position. The body may comprise plural non-releasable retaining members which lock the needle shield in an extended position. 
     The device may further comprise a trigger device that is structured and arranged to cause movement of the needle shield from the retracted position to the fully extended position. 
     The device may further comprise a trigger device that is structured and arranged to lock to the body after the device is triggered. 
     The needle shield may be movable from an initial position that is intermediate the fully extended position and the retracted position to the retracted position and then to the fully extended position. The needle shield may be movable to the retracted position from an initial position that is intermediate the fully extended position and the retracted position. 
     The device may further comprise a trigger that selectively releases at least one locking member which releasably retains the needle shield in the retracted position. 
     The device may further comprise a biasing member structured and arranged to move the needle shield from the retracted position to the fully extended position. 
     The device may further comprise a helical compression spring structured and arranged to move the needle shield from the retracted position to the fully extended position. 
     The device may further comprise a helical compression spring structured and arranged to maintain the needle shield in an initial position. 
     The safety system may cause the needle shield to move to the extended position when activated by a user. The safety system may releasably retain the needle shield in the retracted position after the user moves the needle shield to the retracted position. The safety system may prevent a user from triggering the device. The safety system may lock the needle shield in the fully extended position. The safety system may prevent the needle shield from being retained in the retracted position after a user moves the needle shield towards the retracted position. The safety system may non-releasably retain the needle shield in the fully extended position after being activated by a user. The safety system may utilize two separate re-use prevent mechanisms. 
     The device may further comprise a connecting interface for allowing the device to be mounted to an injection or sampling device. The connecting interface may have a Luer-Lok configuration. 
     The device may further comprise a system preventing the user from inadvertently moving the needle shield to the retracted position from an initial position. The system preventing the user from inadvertently moving the needle shield to the retracted position from the initial position may at least one of require the user to rotate unthread the needle shield from the body and require the user to remove a removable use prevention device. 
     The invention also provides for a single-use needle device comprising a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least two of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. 
     The invention also provides for an IV infusion needle device comprising a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least one of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. 
     The invention also provides for a method of using the device described above, wherein the method comprises moving the needle shield from an initial position to the retracted position, causing the needle shield to move to a fully extended position whereby the needle shield projects out beyond a needle tip, and at least one of preventing the needle shield from moving back to the initial position and preventing the needle shield from being retained in the retracted position. 
     The invention also provides for a needle device comprising at least one feature shown in at least one the drawings of the instant application. 
     Other exemplary embodiments and advantages of the present invention may be ascertained by reviewing the present disclosure and the accompanying drawing. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein: 
         FIG. 1  shows a side cross-section view of a first non-limiting embodiment of the device according to the invention. The needle portion is not shown in cross-section. The deflectable retaining member and the deflectable releasable locking member arranged behind the needle is not shown for clarity.  FIG. 1  shows the device with the needle shield in an initial position and with the device being in a ready-to-use configuration; 
         FIG. 2  shows the device of  FIG. 1  with the needle shield being releasably locked in the retracted position after it is moved by the user to the retracted position; 
         FIG. 3  shows the device of  FIG. 2  in a triggered position after a trigger sleeve is moved to a triggering position that will allow the needle shield to move forwardly; 
         FIG. 4  shows the device of  FIG. 3  after the needle shield has moved to a fully extended position and become non-releasably locked therein. The trigger sleeve is also non-releasably locked to the body. In this configuration, the device is rendered unusable and can be safely handled and discarded; 
         FIG. 5  shows the device of  FIG. 1  with the needle shield and trigger sleeve removed; 
         FIG. 6  shows the device of  FIG. 5 , but no longer in cross-section; 
         FIG. 7  shows a side view of the needle shield used in the embodiment of  FIG. 1 ; 
         FIG. 8  shows a side cross-section view of the needle shield of  FIG. 7 ; 
         FIG. 9  shows a front end view of the needle shield of  FIG. 7 ; 
         FIG. 10  shows a rear end view of the needle shield of  FIG. 7 ; 
         FIG. 11  shows a cross-section view of a needle shield biasing spring used the device of  FIG. 1 ; 
         FIG. 12  shows a front end view of a trigger sleeve used the device of  FIG. 1 ; 
         FIG. 13  shows a side cross-section view of a trigger sleeve used the device of  FIG. 1 ; 
         FIG. 14  shows a side cross-section view of a second non-limiting embodiment of the device according to the invention. The needle portion is not shown in cross-section. The deflectable releasable locking member arranged behind the needle is not shown for clarity.  FIG. 14  shows the device with the needle shield in an initial position and with the device being in a ready-to-use configuration. This embodiment is similar to the device of  FIGS. 1-13  except that the needle shield and body has a tapered proximal end and the device utilizes a retaining ring to axially retain the trigger sleeve; 
         FIGS. 15 and 16  show partial side cross-section views of another non-limiting embodiment of the device. The deflectable members arranged behind the needle are not shown for purposes of clarity. This embodiment is similar to the device of  FIGS. 1-13  except that the body utilizes a visual indicator to inform the user that the device has been used, i.e., that the needle shield has moved to the fully extended position and/or become non-releasably locked in this position and/or has already been used.  FIG. 15  shows the device with the needle shield in an initial position.  FIG. 16  shows the device after the needle shield has moved to a fully extended position and become non-releasably locked therein; 
         FIG. 17  shows a side cross-section view of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that it additionally utilizes a use prevention device or wrapping which must be removed by the user before the user can move the needle shield to the retracted position; 
         FIG. 18  shows a side cross-section view of another non-limiting embodiment of the device according to the invention. The needle portion is not shown in cross-section. The deflectable releasable locking member arranged behind the needle is not shown for clarity.  FIG. 18  shows the device with the needle shield in an initial position and with the device being in a ready-to-use configuration. This embodiment is similar to the device of  FIGS. 1-13  except that the needle shield threadably engages the body so as to prevention use of the device until the user rotates the needle shield. The threads also prevent the user from inadvertently moving the needle shield to the fully extended position; 
         FIG. 19  shows the device of  FIG. 18  after the needle shield is unthreaded (unlocked) and moved by the user to the retracted position and is releasably retained therein; 
         FIG. 20  shows the device of  FIG. 19  after the needle shield has moved to an intermediate position just prior to the fully extended position wherein it will become non-releasably locked therein. Although not shown, in this position the trigger sleeve is also non-releasably locked to the body; 
         FIG. 21  shows the device of  FIG. 20  after the needle shield has been threaded towards the forward end and moved to a fully extended position by the user rotating the needle shield in a direction opposite that use to allow the user to move it to the retracted position. The needle shield has become non-releasably locked therein; 
         FIGS. 22 and 23  show side cross-section views of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that the needle shield has a very short needle guide and the body is configured to cause a side cocking of the needle shield when it moved to the fully extended position.  FIG. 22  shows the device with the needle shield in an initial position.  FIG. 23  shows the device after the needle shield has moved to a fully extended position and become non-releasably locked therein. The side cocked configuration of the needle shield shown in  FIG. 23  provides an indication to the user that the device has already been used and prevents re-use because the opening is no longer aligned with the needle; 
         FIG. 24  shows a side cross-section view of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that the initial position of the needle shield is the same as the fully retracted position and the device lacks mechanism for non-releasably locking the needle shield in the extended position; 
         FIG. 25  shows a side cross-section view of another non-limiting embodiment of the device. This embodiment is similar to the device of  FIG. 24  except that the trigger sleeve is removed so that the device can be triggered by the user depressing the releasably locking devices; 
         FIG. 26  shows a side cross-section view of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that a rear or distal end of the device utilizes a connecting interface or configuration allowing the device to be connected to a sample and/or injection device; 
         FIG. 27  shows a partial side cross-section view of another non-limiting embodiment of the device. This embodiment is similar to the device of  FIG. 26  except that a trigger spring is utilized; and 
         FIGS. 28-30  show various views of another non-limiting embodiment of the device. In  FIG. 28 , the deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that a rear or distal end of the device utilizes a connecting interface or configuration allowing the device to be connected to a tube of an IV infusion set and a distal area which can receive a butterfly member.  FIG. 30  shows an end view of the butterfly member. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the drawings and first to  FIGS. 1-13  which shows a first embodiment of an injection device  1 . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. The device  1  includes an elongate generally cylindrical body or barrel  10  having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1  also utilizes an axially movable and retractable safety sleeve  30  arranged at a proximal end of the body  10  and an axially movable trigger sleeve  40  arranged at an area of a distal end of the body  10 . Finally, the device  1  utilizes a spring  50  which is configured to bias the axially movable and retractable safety sleeve  30  towards an extended position covering the puncturing end of the needle N. 
     Referring to  FIG. 1 , the device  1  is shown in an initial or ready-to-use position. In this position, the needle shield  30  covers the proximal end of the needle N owing to the fact that the spring  50  biases the needle shield  30  towards the extended position. This position is maintained by contact between the distal flange  34  of the needle shield  30  and a plurality of deflectable projections  14 . The position or configuration shown in  FIG. 1  is, in embodiments, that which can be utilized when the device  1  is packaged. 
     Referring to  FIG. 2 , the device  1  is shown in a usable or using position. In this position, the needle shield  30  is retracted by the user (applying the equivalent of a force F sufficient to compress the spring  50 ) to expose the proximal end of the needle N. This occurs when the user moves the needle shield  30  back in a manner which compresses the spring  50 . This retracted position is maintained by locking engagement between the distal flange  34  of the needle shield  30  and a plurality of deflectable locking members  15 . The position or configuration shown in  FIG. 2  is, in embodiments, that which can be utilized when the device  1 , i.e., the puncturing end of the needle N, is injected. 
     Referring to  FIG. 3 , the device  1  is shown in a post-use position. In this position, the needle shield  30  is ready to be released from the retracted by the user (applying the equivalent of a force F sufficient to move the trigger sleeve  40 ) and to move to a fully extended position (shown in  FIG. 4 ) covering the proximal end of the needle N. This occurs when the user moves the trigger sleeve  40  forward in a manner which causes inward deflection of the locking members  15  (occurring also when the inside diameter of the flange  34  engages with tapered surfaces  15   b ) which in turn causes the members  15  to disengage and/or unlock from the flange  34 . This triggering position in effect releases the locking engagement between the distal flange  34  of the needle shield  30  and a plurality of deflectable locking members  15 . The position or configuration shown in  FIG. 3  is, in embodiments, that which can be utilized immediately after the device  1  is used so that the device  1  will be rendered safe to handle and dispose. 
     Referring to  FIG. 4 , the device  1  is shown in a final disposable position. In this position, the needle shield  30  has been automatically moved to the fully extended position by the spring  50  as soon as the device is triggered (see  FIG. 3 ). As is apparent from a fair comparison of  FIGS. 1 and 4 , the spring  50  has caused the flange  34  to move forward of the deflectable members  14 . The members  14  were thus to caused to deflect inwardly (as the flange  34  moved over them and slidably engaged with their tapered surfaces). The members  14  then spring back to an original position. The flange  34  thus cones to rest against a distal surface  13  (see  FIGS. 5 and 6 ) of the shoulder  12  of the body  10 . In this position, the needle shield  30  is non-removably locked in the fully extended position. This is due to the fact that the members  14  prevent substantial axial movement of the needle shield  30  relative to the body  10 . This occurs because the members  14  each have an outer projecting portion that extends outwardly more than an inner diameter of the flange  34 . In this position, the device  1  has been rendered single-use since the user no longer has the ability to retract the needle shield  30 . Thus, locking the needle shield  30  in the fully extended position provides a first level of safety in preventing re-use of the device  1  and allows the user to handle the device  1  without fear of being pricked by the needle N. The device  1 , however, also provides a second level of safety in regards to rendering the device single-use and/or providing an indication to the user that the device has already been used. This additional level of safety relates to the fact that the trigger sleeve  40  is non-releasably locked in the triggering position. This is due to the fact that the members  15  prevent substantial axial movement of the trigger sleeve  40  relative to the body  10 . This occurs because the members  15  each have an outer projecting portion that extends into a groove  41  (see  FIG. 13 ) outwardly more than an inner diameter  43  of the trigger sleeve  40 . As is apparent from a fair comparison of  FIGS. 1 ,  3  and  4 , during triggering, the members  15  were caused to deflect inwardly (as the tapered surface  42  moves over the projections  15   a  of the members  15 . The members  15  then spring back to an original position with the projections seated within the groove  41 . The trigger sleeve  40  thus becomes non-releasably axially locked in the position shown in  FIG. 4 . The two safety systems described above are ensured because the user has no readily apparent mechanism to releasing the locking engagement between the body  10  and the needle shield  30  and between the body  10  and the trigger sleeve  40 . 
     Referring to  FIGS. 5 and 6 , the body  10  is, in embodiments, a one-piece integrally formed member having a generally cylindrical main section  11 , a generally cylindrical proximal section  12 , an annular stop surface or shoulder  13  which is contacted by the flange  34  of the needle shield  30  in the fully extended position, four equally circumferentially spaced (i.e., arranged 90 degrees apart) deflectable retaining members  14  (for purposes of clarity the one behind the needle N in  FIG. 5  is now shown), four equally circumferentially spaced (i.e., arranged 90 degrees apart) deflectable locking members  15  (for purposes of clarity the one behind the needle N in  FIG. 5  is now shown), a retaining flange or shoulder  16  which limits axial movement of the trigger sleeve  40 , a generally cylindrical proximal space  17  sized and configured to receive therein the spring  50  and to allow for inward deflection of the members  14 , and an another generally cylindrical space  18  sized and configured to allow for inward deflection of the members  15 . The members  14  have a tapered section which is contacted by the flange  34  of the needle shield  30  when in the position shown in  FIG. 1  and can deflect inwardly and return or spring back to an original or relaxed position (see e.g.,  FIG. 5 ). The members  15  have a tapered section  15   b  which is contacted by the flange  34  of the needle shield  30  when moved to the retracted position shown in  FIG. 2  and a projection  15   a  which is contacted by the tapered surface  42  of the trigger sleeve  40  (see  FIGS. 3 and 13 ) when moved to the triggering position shown in  FIG. 3 , and can deflect inwardly (see e.g.,  FIG. 3 ) and return or spring back to an original or relaxed position (see e.g.,  FIG. 5 ). In embodiments, the device can utilize as few as two equally spaced members  14  and  15  and as many as ten of each. 
     Referring to  FIGS. 7-10 , the needle shield  30  is, in embodiments, a one-piece integrally formed member having an annular proximal end  31 , a generally cylindrical main section  33 , a generally cylindrical inner guide sleeve section  36 , an annular stop flange  34 , a generally cylindrical inner space  32  sized and configured to receive therein the needle N, and a generally cylindrical main space  35  sized and configured to receive therein the shoulder portion  12  of the body  10 . In embodiments, the surface  33  can have a friction increasing portion, e.g., a knurl, a texture, etc., to make it easier to be gripped by a user. 
     Referring to  FIG. 11 , the spring  50  is, in embodiments, a one-piece integrally formed member having the form of a helical compression spring which, in embodiments, is made of spring steel. 
     Referring to  FIGS. 12 and 13 , the trigger sleeve  40  is, in embodiments, a one-piece integrally formed member having an annular proximal and distal ends, a tapered section  42 , a generally cylindrical inner groove  41 , a generally cylindrical inner surface  43  sized and configured to slidably engage with a comparably sized surface of the body  10 , and a generally cylindrical main outer surface  44 . In embodiments, the surface  44  can have a friction increasing portion, e.g., a knurl, a texture, etc., to make it easier to be gripped by a user. 
     Referring now to  FIG. 14  which shows another embodiment of an injection device  1 ′. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device  1 ′ includes an elongate generally cylindrical body or barrel  10 ′ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1 ′ also utilizes an axially movable and retractable safety sleeve  30 ′ arranged at a proximal end of the body  10 ′ and an axially movable trigger sleeve  40 ′ arranged at an area of a distal end of the body  10 ′. Finally, the device  1 ′ utilizes a spring  50 ′ which is configured to bias the axially movable and retractable safety sleeve  30 ′ towards an extended position covering the puncturing end of the needle N. The deflectable member  14 ′ and  15 ′ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that the needle shield  30 ′ and body  10 ′ have comparable tapered proximal ends TPE and the device  1 ′ optionally utilizes a separate retaining ring RR to axially retain the trigger sleeve  40 ′. 
     Referring now to  FIGS. 15 and 16 , which show another embodiment of an injection device  1 ″. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device  1 ″ includes an elongate generally cylindrical body or barrel  10 ″ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1 ″ also utilizes an axially movable and retractable safety sleeve  30 ″ arranged at a proximal end of the body  10 ″ and an axially movable trigger sleeve  40 ″ arranged at an area of a distal end of the body  10 ″. Finally, the device  1 ″ utilizes a spring  50 ″ which is configured to bias the axially movable and retractable safety sleeve  30 ″ towards an extended position covering the puncturing end of the needle N. The deflectable member  14 ″ and  15 ″ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that the body  10 ″ utilizes a visual indicator  60  to inform the user that the device  1 ″ has been used, i.e., that the needle shield  30 ″ has moved to the fully extended position and/or become non-releasably locked in this position and/or has already been used.  FIG. 15  shows the device  1 ″ with the needle shield in an initial position (similar to  FIG. 1 ).  FIG. 16  shows the device  1 ″ after the needle shield  30 ″ has moved to a fully extended position and become non-releasably locked therein. In the fully extended position, the visual indicator  60  is now visible whereas it was previously covered by a distal portion of the needle shield  30 ″ in  FIG. 15 . In embodiments, the visual indicator  60  is a colored band, i.e., a narrow section of having a color that is different from that of the surface  11 ″. Other forms of visual indication can also be utilized which are not visible in the configuration of  FIG. 15 , but are visible in the configuration of  FIG. 16 . 
     Referring now to  FIG. 17 , which show another embodiment of an injection device  1 ′″. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device  1 ′″ includes an elongate generally cylindrical body or barrel  10 ′″ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1 ′″ also utilizes an axially movable and retractable safety sleeve  30 ′″ arranged at a proximal end of the body  10 ′″ and an axially movable trigger sleeve  40 ′″ arranged at an area of a distal end of the body  10 ′″. Finally, the device  1 ′″ utilizes a spring  50 ′″ which is configured to bias the axially movable and retractable safety sleeve  30 ′″ towards an extended position covering the puncturing end of the needle N. The deflectable member  14 ′″ and  15 ′″ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that it additionally utilizes a removable retaining member  70  arranged on the body  10 ′″. The member  70  serves to inform the user that the device  1 ′″ has not yet been used and also prevents accidental rearward movement of the needle shield  30 ′″. In order to use the device  1 ′″, the user first removes the member  70  and then uses the device in the same way as described above regarding the embodiment of  FIGS. 1-13 .  FIG. 17  shows the device  1 ′″ with the needle shield in an initial position (similar to  FIG. 1 ). In embodiments, the member  70  is a colored adhesive wrap, i.e., a narrow section of adhesive tape having a color that is different from that of the surface  11 ′″. Other forms of the member  70  can also be utilized which prevent rearward axial movement of the needle shield  30 ′″ until removed. The member  70  has a protruding free end  71  which can be gripped by the user to allow for unwrapping from the surface  11 ′″. 
     Referring now to  FIGS. 18-21 , which show another embodiment of an injection device  1   IV . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device  1   IV  includes an elongate generally cylindrical body or barrel  10   IV  having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1   IV  also utilizes an axially movable and retractable safety sleeve  30   IV  arranged at a proximal end of the body  10   IV  and an axially movable trigger sleeve  40   IV  arranged at an area of a distal end of the body  10   IV . Finally, the device  1   IV  utilizes a spring  50   IV  which is configured to bias the axially movable and retractable safety sleeve  30   IV  towards an extended position covering the puncturing end of the needle N. The deflectable member  14   IV  and  15   IV  arranged behind the needle N are not shown for clarity. 
     Referring to  FIG. 18 , the device  1   IV  is shown in an initial or ready-to-use position. In this position, the needle shield  30   IV  covers the proximal end of the needle N owing to the fact that the spring  50   IV  biases the needle shield  30   IV  towards the extended position and because external thread of section  36   IV  threadably engage with internal threads arranged on a proximal end of the body  10   IV . This position is thus maintained by both contact between the distal flange  34   IV  of the needle shield  30   IV  and a plurality of deflectable projections  14   IV , but mainly as a result of the engagement between external thread of section  36   IV  and internal threads arranged on a proximal end of the body  10   IV . The position or configuration shown in  FIG. 18  is, in embodiments, that which can be utilized when the device  1   IV  is packaged and ensures that the needle shield  30   IV  cannot substantially move axially forwards or backwards relative to the body  10   IV . 
     Referring to  FIG. 19 , the device  1   IV  is shown in a usable or using position. In this position, the needle shield  30   IV  is retracted by the user (applying the equivalent of a force F sufficient to compress the spring  50   IV ) to expose the proximal end of the needle N. This occurs when the user moves the needle shield  30   IV  back in a manner which compresses the spring  50   IV . This retracted position is maintained by locking engagement between the distal flange  34   IV  of the needle shield  30   IV  and a plurality of deflectable locking members  15   IV . The position or configuration shown in  FIG. 19  is, in embodiments, that which can be utilized when the device  1   IV , i.e., the puncturing end of the needle N, is injected. In order to cause rearward movement of the needle shield  30   IV , the user first rotates the needle shield  30   IV  relative to the body  10   IV  in a first rotation direction which causes the threaded engagement between the needle shield  30   IV  and the body  10   IV  to disengage. Then, the user causes rearward movement of the needle shield  30   IV  as in the embodiment shown in  FIG. 2 . 
     Referring to  FIG. 20 , the device  1   IV  is shown in a post-use and triggered position. In this position, the needle shield  30   IV  has been released from the retracted by the user (applying the equivalent of a force F sufficient to move the trigger sleeve  40   IV ) and to move to an intermediate position just short of the fully extended position (shown in  FIG. 21 ) covering the proximal end of the needle N. This occurs when the user moves the trigger sleeve  40   IV  forward in a manner which causes inward deflection of the locking members  15   IV  which in turn causes the members  15   IV  to disengage and/or unlock from the flange  34 . This triggering position in effect releases the locking engagement between the distal flange  34   IV  of the needle shield  30   IV  and a plurality of deflectable locking members  15   IV . The position or configuration shown in  FIG. 20  is, in embodiments, that which can be utilized immediately after the device  1   IV  is used so that the device  1   IV  will be rendered somewhat safer to handle. 
     Referring to  FIG. 21 , the device  1   IV  is shown in a final disposable position. In this position, the needle shield  30   IV , which was automatically moved to the position shown in  FIG. 20  by the spring  50   IV , is moved to the fully extended position first by the user rotating the needle shield  30   IV  relative to the body  10   IV  in a second opposite direction to cause engagement of the threads. Once the threads disengage with one another, the spring  50   IV  will automatically cause the needle shield  30   IV  to move to the fully extended position shown in  FIG. 21 . As is apparent from a fair comparison of  FIGS. 18 and 21 , the spring  50   IV  has caused the flange  34   IV  to move forward of the deflectable members  14   IV . The members  14   IV  were thus to caused to deflect inwardly (as the flange  34   IV  moved over them and slidably engaged with their tapered surfaces). The members  14   IV  then spring back to an original position. The flange  34   IV  thus cones to rest against a distal surface of the shoulder  12   IV  of the body  10   IV . In this position, the needle shield  30   IV  is non-removably locked in the fully extended position. This is due to the fact that the members  14   IV  prevent substantial axial movement of the needle shield  30   IV  relative to the body  10   IV . This occurs because the members  14   IV  each have an outer projecting portion that extends outwardly more than an inner diameter of the flange  34   IV . In this position, the device  1   IV  has been rendered single-use since the user no longer has the ability to retract the needle shield  30   IV . Should this locking engagement fail, the user will still be prevented from moving the needle shield  30   IV  to the retracted position by the threads (unless the user deliberately rotates the needle shield  30   IV  in a manner which causes engagement between the threads. Thus, locking the needle shield  30   IV  in the fully extended position provides a first level of safety in preventing re-use of the device  1   IV  and allows the user to handle the device  1   IV  without fear of being pricked by the needle N. The device  1   IV , however, also provides a second level of safety in regards to rendering the device single-use and/or providing an indication to the user that the device has already been used. This additional level of safety relates to the fact that the trigger sleeve  40   IV  is non-releasably locked in the triggering position in a manner similar to that described above regarding  FIG. 4 . The two, or more accurately three, safety systems described above are ensured because the user has no readily apparent mechanism to releasing the locking engagement between the body  10   IV  and the needle shield  30   IV  and between the body  10   IV  and the trigger sleeve  40   IV . 
     Referring now to  FIGS. 22 and 23 , which show another embodiment of an injection device  1   V . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device  1   V  includes an elongate generally cylindrical body or barrel  10   V  having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1   V  also utilizes an axially movable and retractable safety sleeve  30   V  arranged at a proximal end of the body  10   V  and an axially movable trigger sleeve  40   V  arranged at an area of a distal end of the body  10   V . Finally, the device  1   V  utilizes a spring  50   V  which is configured to bias the axially movable and retractable safety sleeve  30   V  towards an extended position covering the puncturing end of the needle N. The deflectable member  14   V  and  15   V  arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that the body  10   V  utilizes a proximal shoulder  12   V  which has upper and lower stop surfaces that result in the needle shield  30   V  assuming a side cocked position (because of the different axial locations of stop surfaces  13   V a and  13   V b) when it moves to the fully extended position (see  FIG. 23 ). This provides an indication to the user that the device has already been used. It also prevents the user from moving the needle shield  30   V  back to a retracted position.  FIG. 22  shows the device  1   V  with the needle shield  30   V  in an initial position (similar to  FIG. 1 ).  FIG. 23  shows the device  1   V  after the needle shield  30   V  has moved to a fully extended position and become cocked and non-releasably locked therein. In the fully extended position, the visual indication is provided by the cocked configuration of the needle shield  30   V . 
     Referring now to  FIG. 24  which shows another embodiment of an injection device  1   VI . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device  1   VI  includes an elongate generally cylindrical body or barrel  10   VI  having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1   VI  also utilizes an axially movable and retractable safety sleeve  30   VI  arranged at a proximal end of the body  10   VI  and an axially movable trigger sleeve  40   VI  arranged at an area of a distal end of the body  10   VI . Finally, the device  1   VI  utilizes a spring  50   VI  which is configured to bias the axially movable and retractable safety sleeve  30   VI  towards an extended position covering the puncturing end of the needle N. Unlike the previous embodiments, however, this embodiment utilizes no deflectable members to retain the needle shield  30   VI  in the fully extended position, and, in fact, the original position of the needle shield is the same as the final extended position. The deflectable member  15   VI  arranged behind the needle N is not shown for clarity. This embodiment is otherwise similar to the device of  FIGS. 1-13 . 
     Referring now to  FIG. 25  which shows another embodiment of an injection device  1   VII . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device  1   VII  includes an elongate generally cylindrical body or barrel  10   VII  having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1   VII  also utilizes an axially movable and retractable safety sleeve  30   VII  arranged at a proximal end of the body  10   VII . Finally, the device  1   VII  utilizes a spring  50   VII  which is configured to bias the axially movable and retractable safety sleeve  30   VII  towards an extended position covering the puncturing end of the needle N. Unlike the previous embodiments, however, this embodiment utilizes no deflectable members to retain the needle shield  30   VII  in the fully extended position, and, in fact, the original position of the needle shield is the same as the final extended position. Also, unlike the previous embodiments, this embodiment utilizes no an axially movable trigger sleeve. Instead, the user directly depresses the deflectable members  15   VII  to cause the needle shield  30   VII  to move to the fully extended position from the retracted position. The deflectable member  15   VII  arranged behind the needle N is not shown for clarity. This embodiment is otherwise similar to the device of  FIG. 24 . 
     Referring now to  FIG. 26  which shows another embodiment of an injection device  100 . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device  100  includes an elongate generally cylindrical body or barrel  110  having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  100  also utilizes an axially movable and retractable safety sleeve  130  arranged at a proximal end of the body  110  and an axially movable trigger sleeve  140  arranged at an area of a distal end of the body  110 . Finally, the device  100  utilizes a spring  150  which is configured to bias the axially movable and retractable safety sleeve  130  towards an extended position covering the puncturing end of the needle N. The deflectable member  114  and  115  arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that it additionally includes a connecting interface CI for connecting the device  100  to an injection device. In embodiments, the interface IC is a luer-lok or luer lock type interface. 
     Referring now to  FIG. 27  which shows another embodiment of an injection device  100 ′. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device  100 ′ includes an elongate generally cylindrical body or barrel  110 ′ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  100 ′ also utilizes an axially movable and retractable safety sleeve  130 ′ arranged at a proximal end of the body  110 ′ and an axially movable trigger sleeve  140 ′ arranged at an area of a distal end of the body  110 ′. Finally, the device  100 ′ utilizes a spring  150 ′ which is configured to bias the axially movable and retractable safety sleeve  130 ′ towards an extended position covering the puncturing end of the needle N. The deflectable member  114 ′ and  115 ′ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of  FIG. 27  except that it additionally includes a spring  80  for biasing the trigger sleeve  140 ′ towards a forward position. In embodiments, the interface IC′ is a luer-lok or luer lock type interface. 
     Referring now to  FIGS. 28-30 , which shows another embodiment of an injection device  1000 . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device  1000  includes an elongate generally cylindrical body or barrel  1010  having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device  1000  also utilizes an axially movable and retractable safety sleeve  1030  arranged at a proximal end of the body  1010  and an axially movable trigger sleeve  1040  arranged at an area of a distal end of the body  1010 . Additionally, the device  1000  utilizes a spring  1050  which is configured to bias the axially movable and retractable safety sleeve  1030  towards an extended position covering the puncturing end of the needle N. The deflectable member  1014  and  1015  arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of  FIGS. 1-13  except that it additionally includes a connecting interface CI″ for connecting the device  1000  to a fluid injection and/or removing device. In embodiments, the interface IC″ includes an arrangement allowing a tube or tubing T to connect the device  1000  to the fluid container (not shown). The device  1000  also utilizes an axially retained removable butterfly member  90  arranged at a distal end of the body  1010 . A non-limiting embodiment of the butterfly member is shown in  FIG. 30 . In embodiments, other butterfly members, whether conventional or otherwise, can be utilized with the devices disclosed herein such as that shown in  FIG. 28 . 
     The devices described herein can also utilize one or more features disclosed in prior art documents expressly incorporated by reference in pending U.S. patent application Ser. No. 11/616,196 (Publication No. 2008/0154212). This application/publication and the documents expressly incorporated therein is hereby expressly incorporated by reference in the instant application. Furthermore, one or more of the various parts of the device(s) can preferably be made as one-piece structures by e.g., injection molding, when doing so reduces costs of manufacture. Non-limiting materials for most of the parts include synthetic resins such as those approved for syringes, blood collection devices, or other medical devices. Furthermore, the invention also contemplates that any one or all disclosed features of one embodiment may be used on other disclosed embodiments, to the extent such modifications function for their intended purpose. 
     It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.