Abstract:
Fluid collection/injection device comprises a body having a front end, a back end, and a main hollow section arranged between the front and back ends and a needle hub securing section arranged on the front end and being structured and arranged to receive therein a needle member. The fluid collection/injection device is structured and arranged to utilize at least an operational mode, an operational mode, and a post-use mode. In the installation mode, the needle member is coupled to the body via the needle hub securing section. In the operational mode, fluid passes through the needle member and into or out of a receptacle inserted into the main hollow section.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The instant application is a US non-provisional Application that is based on and claims the benefit of U.S. provisional application No. 61/480,787, filed Apr. 29, 2011, the disclosure of which is hereby expressly incorporated by reference hereto in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates generally to devices used to collect fluid samples from and/or inject fluids into patients. More specifically, this invention relates to a device which utilizes a holder having a double-ended needle that can be released or removed from the holder in a more safe and easy manner. The device can be a single-use device. The invention also relates to a method of collecting a fluid sample with the device as well as a method of making the device. The invention also relates to a blood sample collection device that is less costly to produce, is safer to use, and/or is easier to manufacture. 
         [0004]    2. Discussion of Background Information 
         [0005]    Prevention of needle sticks is of paramount concern in the healthcare industry because of serious and deadly risk factors associated with AIDS and other serious communicable diseases. Typical blood collection devices utilize a needle inserted into a patient&#39;s vein so as to draw blood through the needle into an associated separate collection reservoir. Accidental needle sticks from previously used needles can occur during the fluid withdrawing process and subsequent handling and disposal operation. Until such used medical devices are destroyed, they remain a risk to those handling them. 
         [0006]    Devices used for blood sampling are well know and include a collection device sold under the trademark Vacutainer® by Becton Dickinson Corporation. This device has a tubular syringe-like body with a needle in the front end, part of which extends back into a tubular syringe-like shell. Part of the needle extends externally for punching the skin. An evacuated collection tube with a rubber stopper is placed into the open back of the syringe-like shell with the rubber stopper against the internal end of the needle. After the skin is punctured, the collection tube is pushed forward to cause the needle to enter the evacuated tube. Vacuum helps draw blood into the collecting tube. When a sufficient sample has been obtained, the collecting tube and the stopper are simply withdrawn from the tubular shell and sent to the laboratory. This particular device has a permanently extended needle and an opening in the back for the collection tube which remains open after the collection tube is removed, leaving small quantities of blood and an internally exposed needle. 
         [0007]    Medical devices which are used for collecting fluid samples from patients which have quick release needle systems are also known. Such devices include: U.S. Pat. No. 5,797,490 to FUJI et al; U.S. Pat. No. 5,755,673 to KINSEY; U.S. Pat. No. 4,822,343 to BEISER; U.S. Pat. No. 4,984,580 WANAMAKER; U.S. Re. 38,964 to SHILLINGTON; U.S. Pat. No. 5,616,136 to SHILLINGTON et al.; U.S. Pat. No. 5,637,101 to SHILLINGTON; U.S. Pat. No. 5,117,837 to WANAMAKER et al.; U.S. Pat. No. 4,907,600 to SPENCER; U.S. Pat. No. 4,993,426 to SPENCER; U.S. Pat. No. 4,904,244 to HARSH et al.; U.S. Pat. No. 4,490,142 to SILVERN. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties. 
         [0008]    The invention aims to improve devices of the type described above by making a fluid collection holder which is easier to make and use. The device is also believed to be as safe or safer to use and/or dispose-of than the above-noted devices. 
       SUMMARY OF THE INVENTION 
       [0009]    According to one non-limiting aspect of the invention there is provided a fluid collection/injection device including one or more features shown herein in combination with one or more devices disclosed above. In embodiments, there is provided a fluid collection/injection device including one or more features shown herein in combination with one or more devices disclosed in U.S. Ser. No. 12/755,917 filed on Apr. 7, 2010 (US 2010/0286558), and/or U.S. Ser. No. 12/974,908 filed on Dec. 21, 2010 (US 2011/0160613) and/or U.S. Ser. No. 11/738,240 filed on Apr. 20, 2007 (US 2008/0262421). The disclosure of each of these documents is expressly incorporated by reference herein in their entireties. 
         [0010]    According to one non-limiting embodiment of the invention, there is provided a fluid collection/injection device comprising a body having a front end, a back end, and a main hollow section arranged between the front and back ends and a needle hub securing section arranged on the front end and being structured and arranged to receive therein a needle member. The fluid collection/injection device is structured and arranged to utilize at least an operational mode, an operational mode, and a post-use mode. In the installation mode, the needle member is coupled to the body via the needle hub securing section. In the operational mode, fluid passes through the needle member and into or out of a receptacle inserted into the main hollow section. In the post-use mode, a safety cover at least one of: prevents re-use of the fluid collection/injection device; prevents removal of the needle member from the fluid collection/injection device; prevents removal of the needle member from the needle hub securing section; activates release of the needle member from the body such that when the safety cover is in a position covering a needle of the needle member, the needle member can fall out of the needle hub securing section; activates release of the needle member from the body such that when the safety cover is in a position covering a needle of the needle member, the needle member is no longer securely retained to the needle hub securing section; releases a securing engagement between the needle member and the needle hub securing section; unlocks a locking connection between the needle member and the needle hub securing section; and moves a mechanism arranged in an area of the needle hub securing section which releases a connection between the needle member and the needle hub securing section. 
         [0011]    According to one non-limiting embodiment of the invention, the body is one of generally cylindrical and generally tubular. 
         [0012]    According to one non-limiting embodiment of the invention, the needle hub securing section comprises a fixed part and a movable part. 
         [0013]    According to one non-limiting embodiment of the invention, the fixed part is integrally formed with the front end and the movable part is arranged on a member that has one end which is one of: fixed to a portion of the main hollow section; connected to a portion of the main hollow section via a living hinge; removably connected to a portion of the main hollow section; and integrally formed with the main hollow section. 
         [0014]    According to one non-limiting embodiment of the invention, the fixed part and the movable part each generally comprise one-half of an internal locking thread structured and arranged to engage with an external thread of the needle member. 
         [0015]    According to one non-limiting embodiment of the invention, the member has one end which is fixed to the portion of the main hollow section. 
         [0016]    According to one non-limiting embodiment of the invention, the member has one end which is removably connected to the portion of the main hollow section. 
         [0017]    According to one non-limiting embodiment of the invention, the member has one end which is integrally formed with the main hollow section. 
         [0018]    According to one non-limiting embodiment of the invention, the member has one end which is connected to the portion of the main hollow section via the living hinge. 
         [0019]    According to one non-limiting embodiment of the invention, the safety cover is at least one of: pivotally mounted or connected to a portion of the needle member; movably mounted to a portion of the needle member; movable from a position not covering a proximal needle of the needle member to a position covering the proximal needle; and movable from an initial position to a locking position covering the proximal needle. 
         [0020]    According to one non-limiting embodiment of the invention, the body is a one-piece member. 
         [0021]    According to one non-limiting embodiment of the invention, the device further comprises guide projections arranged on the front end of the body. 
         [0022]    According to one non-limiting embodiment of the invention, the front end comprises a through opening sized to receive an inner needle end of the needle member. 
         [0023]    According to one non-limiting embodiment of the invention, the rear end comprises a flange. 
         [0024]    According to one non-limiting embodiment of the invention, the device further comprises a locking mechanism that prevents the needle member from being reinstalled on the body. 
         [0025]    According to one non-limiting embodiment of the invention, the device further comprises a mechanism for preventing re-use of the device. 
         [0026]    According to one non-limiting embodiment of the invention, the device further comprises a mechanism for rendering the device single-use. 
         [0027]    According to one non-limiting embodiment of the invention, there is provided a method of taking a fluid sample using any of the devices described above, wherein the method comprises installing the needle member, inserting a receptacle into the device, removing the receptacle from the device, and moving a safety cover to a needle covering position after use. 
         [0028]    According to one non-limiting embodiment of the invention, there is provided a method of taking a fluid sample using any device described above, wherein the method comprises inserting a receptacle into the body, removing the receptacle from the body, and moving a safety cover to a needle covering position. 
         [0029]    According to one non-limiting embodiment of the invention, there is provided a method of taking a fluid sample using any device described above, wherein the method comprises inserting a receptacle into the main hollow section, removing the receptacle, and preventing re-use of the device. 
         [0030]    According to one non-limiting embodiment of the invention, there is provided a fluid collection device comprising a body having a front end, a back end, and a main hollow section arranged between the front and back ends and a needle hub securing section arranged on the front end and being structured and arranged to receive therein a needle member. The fluid collection/injection device is structured and arranged to utilize at least an operational mode, an operational mode, and a post-use mode. In the installation mode, the needle member is coupled to the body via the needle hub securing section. In the operational mode, fluid passes through the needle member and into a receptacle inserted into the main hollow section. In the post-use mode, a safety cover at least one of: prevents re-use of the fluid collection/injection device; prevents removal of the needle member from the fluid collection/injection device; prevents removal of the needle member from the needle hub securing section; activates release of the needle member from the body such that when the safety cover is in a position covering a needle of the needle member, the needle member can fall out of the needle hub securing section; activates release of the needle member from the body such that when the safety cover is in a position covering a needle of the needle member, the needle member is no longer securely retained to the needle hub securing section; releases a securing engagement between the needle member and the needle hub securing section; unlocks a locking connection between the needle member and the needle hub securing section; and moves a mechanism arranged in an area of the needle hub securing section which releases a connection between the needle member and the needle hub securing section. 
         [0031]    According to one non-limiting embodiment of the invention, there is provided a needle assembly structured and arranged for use on a fluid collection device comprising a body having a front end, a back end, and a main hollow section arranged between the front and back ends, a needle hub securing section arranged on the front end and being structured and arranged to receive therein the needle assembly, the needle assembly being configured to operate in at least an operational mode, an operational mode, and a post-use mode. In the installation mode, the needle assembly being coupled to the body via the needle hub securing section. In the operational mode, fluid passes through a needle of the needle assembly into or out of a receptacle inserted into the main hollow section. In the post-use mode, a safety cover of the needle assembly at least one of prevents re-use of the fluid collection/injection device; prevents removal of the needle member from the fluid collection/injection device; prevents removal of the needle member from the needle hub securing section; activates release of the needle member from the body such that when the safety cover is in a position covering a needle of the needle member, the needle member can fall out of the needle hub securing section; activates release of the needle member from the body such that when the safety cover is in a position covering a needle of the needle member, the needle member is no longer securely retained to the needle hub securing section; releases a securing engagement between the needle member and the needle hub securing section; unlocks a locking connection between the needle member and the needle hub securing section; and moves a mechanism arranged in an area of the needle hub securing section which releases a connection between the needle member and the needle hub securing section. 
         [0032]    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 
         [0033]    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: 
           [0034]      FIG. 1  shows a side view of one non-limiting embodiment of a needle assembly according to the invention. The needle assembly includes a double-ended needle member, a removable cover, and a safety cover movable (or pivoted) from an initial position to a needle covering position. The removable cover and pivoting safety cover/shield is shown in cross-section; 
           [0035]      FIG. 2  shows the needle assembly of  FIG. 1  with the removable cover removed; 
           [0036]      FIG. 3  shows a side view of one non-limiting embodiment of a body for a fluid collection device in accordance with the invention. The body is shown in cross-section and in an initial, original and/or normal position; 
           [0037]      FIG. 4  shows the body of  FIG. 3  in an activated, open and/or needle releasing position; 
           [0038]      FIG. 5  shows the needle assembly of  FIG. 2  installed on the body of  FIG. 3 . Normally, the needle assembly of  FIG. 1  is threaded or slid into the body when in the open position shown in  FIG. 4  (this can preferably occur in a factory setting). The body is then allowed to assume the normal position (and packaged in this state with the removable cover installed). At the time of use, a user removes the device from its packaging, and then removes the removable cover. The device is then ready for use and is shown in a use position/configuration; 
           [0039]      FIG. 6  shows the device of  FIG. 5  after the safety cover or shield is moved and locks in the covering position. The device shown is in a post-use position. Movement of the safety cover to the locked covering position has automatically caused the portion of the body retaining the needle assembly to disengage there from. The needle assembly can now be removed safely from the body by simply pulling it off or allowing it to drop out and into a sharps container; 
           [0040]      FIG. 7  shows the device of  FIG. 6  with the user optionally applying a force to maintain open the portion of the body that retains the needle assembly; 
           [0041]      FIG. 8  shows the device of  FIG. 6  after the needle assembly is removed from the body. The needle assembly can now be safely discarded. The body can also discarded or possibly re-used. Once the user stops gripping the body, it will return to the normal, position; 
           [0042]      FIG. 9  shows an enlarged view of the needle assembly shown in  FIG. 8 ; 
           [0043]      FIG. 10  shows a side view of the safety cover or shield used on the needle assembly shown in  FIG. 9 ; 
           [0044]      FIG. 11  shows a side cross-section view of  FIG. 10 ; 
           [0045]      FIG. 12  shows a bottom view of  FIG. 10 ; 
           [0046]      FIG. 13  shows a side view of the needle member used on the needle assembly shown in  FIG. 9  rotated 90 degrees; 
           [0047]      FIG. 14  shows a side view of the needle member used on the needle assembly shown in  FIG. 9 ; 
           [0048]      FIG. 15  shows another non-limiting embodiment of a needle assembly according to the invention. The needle assembly includes a double-ended needle member, a removable cover, and a safety cover movable (or pivoted) from an initial position to a needle covering position. The removable cover and pivoting safety cover/shield is shown in cross-section; 
           [0049]      FIG. 16  shows the needle assembly of  FIG. 15  in the process of being installed on the body of  FIGS. 3 and 4 . After the user manipulates the body to allow the needle assembly to be installed therein, he/she may thereafter remove the removable cover; 
           [0050]      FIG. 17  shows the needle assembly of  FIG. 16  after removal of the removable cover. A torsion spring (not shown in  FIGS. 15 and 16 ) is shown installed thereon; 
           [0051]      FIGS. 18 and 19  show various views of the torsion spring shown in  FIG. 17 ; 
           [0052]      FIG. 20  shows another non-limiting embodiment of a needle assembly according to the invention. The needle assembly includes a double-ended needle member, a removable cover (not shown), and a safety cover or shield movable (or pivoted) from an initial position to covering position. In  FIG. 20 , the safety cover is shown locked in the covering position; 
           [0053]      FIGS. 21-23  show side, cross-section and bottom views of the safety cover or shield used on the needle assembly shown in  FIG. 20 ; 
           [0054]      FIG. 24  shows a non-limiting embodiment of the device utilizing another embodiment of a needle assembly having an engaging flange, which is shown being removed from the body of  FIGS. 3 and 4  after use. In  FIG. 24 , the user moves the safety cover to the locked covering position which causes the portion of the body retaining the needle to open and allows for removal of the needle assembly; 
           [0055]      FIG. 25  shows a non-limiting embodiment of the device utilizing another embodiment of a needle assembly, which is shown preventing removal of the needle assembly from the body. In  FIG. 24 , the user must discard the entire device because the safety cover is locked via a lock retainer and prevents the user from opening the portion of the body retaining the needle assembly. The device is thereby rendered single-use; 
           [0056]      FIGS. 26 and 27  show side views of another non-limiting embodiment of the device. The needle assembly in this embodiment can be installed at the time of use and is shown already installed on the body in  FIG. 26  and after the removable cover is removed.  FIG. 27  shows how the safety cover does not prevent or obstruct removal of the needle assembly from the body in  FIG. 27 ; 
           [0057]      FIG. 28  shows another non-limiting embodiment of the device utilizing another embodiment of a needle assembly, which is shown already installed on the body with the safety cover locked in the covering position and preventing removal of the needle assembly from the body; 
           [0058]      FIG. 29  shows another non-limiting embodiment of the device in accordance with the invention. In this embodiment, the needle assembly of  FIG. 1  is shown already installed on the body. The body utilizes a locking ring to prevent removal of the needle assembly from the body after it is threaded therein and regardless of the position of the safety cover. Once the needle assembly is installed, it cannot be removed. After use, the safety cover can be moved to the covering position and the entire device can be discarded; 
           [0059]      FIG. 30  shows an enlarged view of a portion of  FIG. 29 ; 
           [0060]      FIG. 31  shows an enlarged view of a portion of  FIG. 29  prior to installation of the needle assembly; and 
           [0061]      FIGS. 32-24  show various enlarged views of another non-limiting embodiment of the device in accordance with the invention. This embodiment utilizes another embodiment of a needle assembly, which is shown already installed on the body in  FIG. 32 . In this embodiment, an activatable locking ring is utilized to prevent removal of the needle assembly from the body only when the safety cover is in the covering position. Once the needle assembly is installed, it can be removed by unthreading it from the body. On the other hand, after use of the device, the safety cover can be moved to the covering position shown in  FIG. 34 , and, when locked therein, prevents the needle assembly from being removed. At this point, the entire device can, should and/or must be discarded. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0062]      FIGS. 1-14  show one non-limiting embodiment of the invention.  FIG. 1  shows one non-limiting embodiment of a needle assembly NA according to the invention. The needle assembly NA includes a double-ended needle member  40 , a removable cover  70 , and a safety cover or shield  60  movable (or pivoted) from an initial position (see  FIG. 5 ) to a needle covering position (see  FIG. 6 ). The removable cover  70  will typically be installed when the needle assembly NA is packaged and remains installed until the needle assembly NA is installed on the body  10 . 
         [0063]    With reference to  FIGS. 2 ,  13  and  14 , it can be seen that the needle member  40  of the needle assembly NA includes a first hollow needle (not shown) but arranged within flexible puncturable cover  45  as is the case with conventional fluid sampling needle members, a main body  42 , an external thread  43  for threading into the internal thread of the body  10 , a second hollow or injection needle  44 , and two oppositely arranged mounting projections  46  to which the needle cover  60  can be pivotally mounted. In embodiments, the needle member  40  can be of any conventional type provided it can be modified to include a mechanism for movably mounting the cover  60 . As is the case with some known double-ended needle assemblies, the body  42  can include an elastically compressible section which is compressed when installed on the device (see accordion configuration of body in  FIG. 5 ). Furthermore, although the needle member  40  utilizes projections  46  to mount the cover  60 , the invention contemplates utilizing openings on the body  42  instead of projections  46  and projections on the cover  60  instead of openings  64  (see  FIG. 10 ). 
         [0064]    With reference to FIGS.  2  and  10 - 12 , it can be seen that the needle cover or shield  60  of the needle assembly NA includes an elongated needle covering portion  61  defining an internal space for retaining therein the needle  44 , main body sidewalls  62 , an engaging shoulder  63 , two oppositely arranged mounting openings  64  receiving therein one of the projections  46  and allowing the cover  60  to be pivotally mounted to the needle member  40 , needle receiving slot  65  sized to receive therein the needle  44 , and plural oppositely arranged engaging and locking projections  66 . The projections  66  can deflect somewhat to allow the needle  44  to pass thereby and have rounded ends to facilitate the same. Of course, the free ends of the projections  66  can have any shape (such as tapered ends) so as to allow the needle  44  to pass thereby while also preventing the needle  44  from then passing by in the opposite direction—once in the locked position, the cover  60  cannot become unlocked based on the configuration of the projections  66 . In embodiments, a spacing (see  FIG. 12 ) between the free ends of the opposite projections  66  is sized to be smaller than the diameter of the needle  44  so that when the cover  60  is moved to the position shown in  FIG. 6 , the engagement is such that prevent the cover  60  from being pivoted back to the initial position. In embodiments, the cover  60  is a one-piece member. However, the invention contemplates utilizing a multi-piece member. 
         [0065]    With reference to  FIGS. 3-8 , it can be seen that the body  10  includes an elongated main opening sized to contain therein a proximal end a container or vial which will receive the fluid sample as with conventional devices, a flange  11  also used on conventional devices, and a needle receiving standard interface NRS used on conventional devices. However, unlike conventional devices, the body  10  and interface NRS utilizes a deflectable element  20  having an activatable portion AP and a movable jaw or retaining portion  25 . A fixed jaw or retaining portion  15  is arranged on the body  10 . As can be seen in  FIG. 4 , when the user moves the deflectable portion  21 , the movable jaw  25  coupled thereto moves to the open position so that needle assembly NA can disengage from the interface NRS and fall out of the body  10 . 
         [0066]      FIG. 5  shows the needle assembly NA installed on the body  10  of the fluid sampling device  1 . In embodiments, the needle assembly NA is threaded (or optionally slid) into the body  10  when placed by the user in the open position shown in  FIG. 4 . In embodiments, this can occur in a factory setting so that the device of  FIG. 5  is packaged as is with the removable cover  70  installed thereon. On the other hand, if the needle assembly NA is installed by a user at the time of use, after installation the body  10  can be allowed to assume the normal or use position shown in  FIG. 5 . At the time of use, a user ideally removes the removable cover  70  only immediately before use for fluid sampling. 
         [0067]      FIG. 6  shows the device  1  of  FIG. 5  used and after the safety cover or shield  60  is moved and locks in the covering position. The device  1  is thus shown in a post-use position. To place the device  1  in this position, the user simply grips the shield  60  and rotates or pivots it from the position shown in  FIG. 5  to that of  FIG. 6 . Movement of the safety cover  60  to the position shown in  FIG. 6  causes it to become locked in covering position owing to the locking engagement between the projections  66  and the needle  44 . This movement also simultaneously and/or automatically causes the portion  25  of the body  10  retaining the needle assembly NA to disengage there from. This is as a result of the shoulder or wall  63  contacting and causing movement of the activating projection AP. This can also be facilitated or assisted by the user pressing on the element  20  toward the body  10  as illustrated by arrow F in  FIG. 7 . The needle assembly NA can now be removed safely from the body  10  by simply pulling it off or allowing it to drop out (under the force of gravity) of the body  10  as illustrated in  FIG. 8 . Preferably, at least the needle assembly NA in the safely locked configuration shown in  FIG. 9  is allowed to fall into a sharps container. 
         [0068]    As should be apparent from  FIGS. 1 ,  2  and  9 - 12 , the configuration of the safety cover or shield  60  is such that the slot  65  allows the needle  44  to move therein (or vice versa) the with the closed end of the slot  65  contacting (and serving as a stop) the needle  44  in the position shown in  FIG. 2 . 
         [0069]      FIGS. 15-19  show another non-limiting embodiment of the invention.  FIG. 15  shows another non-limiting embodiment of a needle assembly NA′ according to the invention. The needle assembly NA′ includes a double-ended needle member  40 ′, a removable cover  70 ′, and a safety cover or shield  60 ′ movable (or pivoted) from an initial position (see  FIG. 15 ) to a use position (see  FIG. 17 ) to a needle covering position (not shown but similar to  FIG. 20 ). The removable cover  70 ′ will typically be installed when the needle assembly NA′ is packaged and remains installed until the needle assembly NA′ is installed on the body  10 . 
         [0070]    As can be seen in  FIG. 16 , installation can occur when the needle assembly NA′ is threaded or slid into the body  10 . This is facilitated when the use places the body  10  in the open position. At this point, the use can remove the removable cover  70 ′. When this happens, the safety cover or shield  60 ′ will automatically move (or pivot) from an initial position (see  FIG. 15 ) to the use position (see  FIG. 17 ) via one or more torsion springs  80  (see  FIGS. 17-19 ). In embodiments, a single spring  80  is mounted to one of the projections  46 ′ and is arranged to bias the shield  60 ′ towards the use position as shown in  FIG. 17 . Although this embodiment can preferably utilize a cover similar to that of  FIGS. 20-23  (described in detail below), the invention contemplates the user moving the shield  60 ′ against the biasing force of the spring  80  back to the position shown in  FIG. 15  and, while retained therein, the cover  70 ′ being reinstalled. In other embodiments, the spring  80  is reconfigured so that it biases the cover  60 ′ towards the closed or covering portion shown in  FIG. 15  and can be moved to the open or use position shown in  FIG. 17  only against the biasing force of the spring. 
         [0071]      FIGS. 20-23  show another non-limiting embodiment of the invention.  FIG. 20  shows another non-limiting embodiment of a needle assembly NA″ according to the invention. The needle assembly NA″ includes a double-ended needle member  40 ″, an optional removable cover (not shown, but similar to cover  70 ′) and a safety cover or shield  60 ″ movable (or pivoted) from an initial position (not shown but similar to that of see  FIG. 1 ) to a use position (not shown but similar to  FIG. 2 ) to a needle covering position (see  FIG. 20 ). After installation of the needle assembly NA″ and removable of the removable cover, the device is used for fluid sampling. Thereafter, the user moves the shield  60 ″ to the locked and closed position shown in  FIG. 20 . Unlike the embodiment of  FIG. 1 , however, non-releasable locking occurs via deflectable locking members  67 ″ (see  FIG. 23 ). 
         [0072]      FIG. 24  shows another non-limiting embodiment of the device  1 ″. In this embodiment, the needle assembly NA III  is similar to that of  FIG. 2 , but additionally includes an engaging flange EF arranged on the safety cover or shield. The engaging flange EF is such when it is moved (or pivoted) from a use position to a needle covering position (as is apparent from  FIG. 24 ) the engaging flange EF contacts or engages with the activatable projection AP and causes the needle retaining interface of the device body  10  to open so that the needle assembly NA III  can fall out or otherwise be easily removed. 
         [0073]      FIG. 25  shows another non-limiting embodiment of the device  1 ′″. In this embodiment, the needle assembly NA IV  is similar to that of  FIG. 2 , but additionally includes a lock retainer LR arranged on the safety cover or shield. The lock retainer LR is such when it is moved (or pivoted) from a use position to a needle covering position (as is apparent from  FIG. 25 ), the lock retainer LR contacts or engages with the activatable projection AP′ and causes the needle retaining interface of the device body  10  to open so that the needle assembly NA IV  can fall out or otherwise be easily removed. Furthermore, the tapered configuration of the lock retainer LR and the activatable projection AP′ is such that once the needle shield is positioned (which is allowed to happen by the tapered engaging surfaces) in the covering position shown in  FIG. 25 , the needle shield is prevented from moving back to the use position by the engagement between the lock retainer LR (and the recess disposed behind the same) and the activatable projection AP′. Additionally, the tapered configuration of the lock retainer LR and the activatable projection AP′ is such that as the needle shield is positioned in the covering, engagement between the tapered surfaces followed by release of the same causes a clicking sound—thereby providing an audible signal to the user that the device is locked. In the locked position shown in  FIG. 25 , the device  1 ′″ is rendered unusable (making the device single-use) and can then be safely disposed of with both needles of the needle assembly NA IV  protected, i.e., the distal needle is safely arranged within the device body  10  and the proximal or injection needle is covered by the needle shield. 
         [0074]      FIGS. 26-27  show another non-limiting embodiment of the device  1   IV . In this embodiment, the needle assembly NA V  is similar to that of  FIG. 2 , but is utilized with a different device body  10 ′. The device body  10 ′ is different in that it lacks an activatable projection AP. As such, no part of the needle shield contacts or engages with an activatable projection AP and/or any part of the device body  10 ′ when the needle assembly NA V  is placed in any of its positions, i.e., the use and covering position. For example, in the use position shown in  FIG. 26 , the needle assembly NA V  can be used while being retained on the body  10 ′. However, it can also be removed by moving member  20 ′ toward the body  10 ′. Although this is not recommended, this embodiment allows for such to happen at the user&#39;s discretion. In the post-use position shown in  FIG. 27 , the needle assembly NA V  can be rendered un-usable while being retained on the body  10 ′. Moreover, it can also be removed by moving member  20 ′ toward the body  10 ′. 
         [0000]    Although this is not recommended, this embodiment allows for such to happen at the user&#39;s discretion—in case the user wishes to reuse the body  10 ′, i.e., by installing another, a new and/or un-used needle assembly NA V . 
         [0075]      FIG. 28  show another non-limiting embodiment of the device  1   V . In this embodiment, the needle assembly NA VI  is similar to that of  FIG. 2 , but additionally utilizes the needle shield locking arrangement  65 ″/ 67 ″ shown in  FIG. 23  so as to provide a secondary and/or back-up and/or redundant and/or dual locking system. The device body  10 ′ is otherwise similar to that of  FIGS. 26-27  and can be used in a similar manner. 
         [0076]      FIGS. 29-31  show another non-limiting embodiment of the device  1   VI  in accordance with the invention. In this embodiment, the needle assembly NA of  FIG. 1  is shown already installed on a device body  110 . The body  110  utilizes a locking ring  90  on the connecting interface to prevent removal of the needle assembly NA from the body  110  after it is threaded therein. As such, no deflectable member (i.e., member  20  in  FIG. 3 ) need be utilized. The ring  90  (or more specifically the tapered configuration of the front-side deflectable fingers of the ring  90  (see  FIG. 31 ) engaging with a flange or shoulder of the member  40 ) is configured such that one can thread on (or otherwise install) the needle assembly NA, but, once fully threaded therein or installed, prevents its removal regardless of the position of the safety cover or needle shield  60 . As can be seen in  FIG. 30 , full insertion causes elastic compression (illustrated by an accordion or corrugated shape) of the body of the needle member  40 . Once the needle assembly NA is installed, it cannot be removed even after use. After use, the safety cover  60  is moved to the covering position and the entire device  1   VI  can (or more properly, must) be discarded as a connected unit. In embodiments, the ring  90  is made out of a spring type material such as, e.g., spring steel, and be a sprit ring so as to facilitate seating of the circumferential projections P with the circumferential grooves G (see  FIG. 30 ). 
         [0077]      FIGS. 32-34  show various enlarged views of another non-limiting embodiment of the device in accordance with the invention. This embodiment utilizes another embodiment of a needle assembly NA V , which is shown already installed on the device body  110  in  FIG. 32 . In this embodiment, an activatable locking ring  90 ′ is utilized to prevent removal of the needle assembly NA V  from the body  110  only when the safety cover or needle shield  160  is in the covering position (see  FIG. 34 ). This occurs because a stop projection  163  causes a deflectable finger  91 ′ to move inwardly and engage with a flange of the needle member  140 . While in contact therewith, the projection  163 /finger  91 ′ prevent removal of the needle assembly NA V  from the device body  110 . Once the needle assembly NA V  is installed (e.g., it can be installed in the same as that of  FIGS. 29-31 ), it can be removed by unthreading it from the body  110 . On the other hand, after use of the device, the safety cover  160  can be moved to the covering position shown in  FIG. 34 , and, when locked therein, prevents (via projection  163  engaging with finger  91 ′) the needle assembly NA V  from being removed. At this point, the entire device can, should and/or must be discarded as a unit. 
         [0078]    The devices described herein can also utilize one or more features disclosed in the prior art documents expressly incorporated by reference herein. Furthermore, one or more of the various parts of the device 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 or all disclosed features of one embodiment may be used on any one or all other disclosed embodiments to the extent such modifications function for their intended purpose. 
         [0079]    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.