Abstract:
A winged needle set is disclosed. The winged needle set has a housing and opposed wings which can be grasped between the fingers for insertion of the needle into a body. The winged needle set has a finned member which is rotatable about the axis of the needle. Rotation of the finned member towards one of the wings actuates a needle shield, which moves along the needle in the distal direction. In one embodiment, the needle shield has includes a blocking object (such as a ball), a biasing spring and a holder for the blocking object.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This patent application claims priority from, and expressly incorporates by reference, the following provisional patent applications:
       60/659,226—Shielding Apparatus for Locking onto a Needle—filed on Mar. 7, 2005;   60/659,217—Needle Shielding Apparatus with Tubular Needle Cover—filed on Mar. 7, 2005;   60/659,213—Needle Shielding Apparatus with Tether to Needle Hub—filed on Mar. 7, 2005;   60/714,954—Blood Collection Device with Needle Shield—filed on Sep. 7, 2005.       
 
     
    
     BACKGROUND 
       [0006]    This patent application describes and relates to medical devices for collecting blood or other bodily fluids or infusing fluids, such devices using needles to pierce a human or animal body. It includes a device for shielding such needles. 
       SUMMARY OF THE INVENTION 
       [0007]    An embodiment of the invention is a winged needle set which has a housing with at least one outwardly extending wing (preferably two). A finned member is secured to the housing. The finned member is oriented generally radially outward relative to the longitudinal axis of the needle and is rotatable relative to the housing from a first non-shielding position to a second shielding position. A needle shield assembly is mounted relative to the housing such that the needle shield assembly is slidable longitudinally along the needle. When the finned member is rotated from the first non-shielding position to the second shielding position, the needle shield assembly is unlocked by a release mechanism and permitted to slide relative to the housing along the needle shaft, shielding the needle. In the first non-shielding position, the finned member is oriented from approximately vertical to approximately 60 degrees from vertical. The wing is moveable and can be brought towards the finned member (or rotated or folded) when the finned member is in the first non-shielding position. A spring biases the needle shield assembly to the second shielding position. The wings may be rotatable relative to the housing such that the wings can be brought towards the fined member when the finned member is in the first non-shielding position. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is an isometric view of a device incorporating the invention before deployment of the needle shield; 
           [0009]      FIG. 2  is an isometric view of a device incorporating the invention after deployment of the needle shield; 
           [0010]      FIG. 3  is a cross-sectional side view of a device incorporating the invention before deployment of the needle shield; 
           [0011]      FIG. 4  is a cross-sectional isometric view of a device incorporating the invention before deployment of the needle shield; 
           [0012]      FIG. 5  is a cross-sectional side view of a device incorporating the invention after deployment of the needle shield; 
           [0013]      FIG. 6  is a cross-sectional isometric view of a device incorporating the invention after deployment of the needle shield; 
           [0014]      FIG. 7  is a side view of a device incorporating the invention before deployment of the needle shield; 
           [0015]      FIG. 8  is a cross sectional view through section A-A in  FIG. 7 . 
           [0016]      FIG. 9  is an isometric view of part of the needle shield actuator of a device incorporating the invention; 
           [0017]      FIG. 10  is an isometric view of the distal end of part of a needle shield used in a device incorporating the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    The following is a description of the preferred embodiment of the invention as applied to a blood collection device. A similar structure may be used for infusing fluids. The purpose of the blood collection device  5  is to pierce a blood vessel (or other organ) using needle  10  and remove blood (or other fluid) to a receptacle via tube  15 . This device makes use of technology described in U.S. Provisional Patent Application No&#39;s 60/659,213, 60/659,217 and 60/659,226 which are incorporated herein by reference. 
         [0019]    The preferred embodiment of the device is made up of the following basic components: 
         [0020]    Housing  20 , with wings  225  and  230 . 
         [0021]    Needle  10 , secured to needle hub  50  and in fluid communication with tube  15 . 
         [0022]    Needle shield assembly  110 . 
         [0023]    Actuator assembly  30 , with rotatable fin  300 . 
         [0024]    Housing  20  has a generally cylindrical body  200 , having distal end  205  and proximal end  210 . Distal end  205  has an opening  215 . Proximal end  210  has an opening  220 . A passageway  236  extends between the openings in the proximal and distal ends. Passageway  236  is dimensioned such that shield assembly  110  fits axially in it, and such that shield assembly  110  can slide axially along it. Housing  20  is provided with wings  225  and  230 , which can bend upwards towards each other and towards fin  300  on actuator assembly  30 . Fillet  227  facilitates molding of wings  225  and  230  and housing  20 . An identical fillet is provided to stabilize wing  230 . Wings  225  and  230  are provided with indentations  250  and  255  respectively. These are shaped and dimensioned to accommodate fin  300 . Housing body  200  is provided with a slot  260 , designed to accommodated key  190  on shield assembly  110  (described below). Slot  260  extends from proximal end  210  (where it is open) towards distal end  205  of housing body  200 , where it is closed. Slot  260  has a proximal end  265  and a distal end  270 . 
         [0025]    Needle hub  50  has a stepped distal end  550  forming a hollow open ended cylinder  555  which mates with opening  215  in proximal end  210  of housing body  200 . The step forms a flange  570 . Stepped proximal end  550  is provided with a slot  560  (see  FIG. 6 ), which aligns with slot  260  and extends from flange  570 , along cylinder  555  to its open end. Slot  560  also accommodates key  190 . Slot  560  is open at the front to allow key  190  to move in it and closed at the back to prevent key  190  from leaving it. 
         [0026]    Proximal end  75  of needle  10  is glued into needle hub  50 . Rear end  565  is an open ended cylinder extending proximally which is designed to mate with tube  15 , thus permitting fluid to flow through needle  10  and tube  15  and into a receptacle for collection. 
         [0027]    Fin assembly  30  has a cylindrical body section  350  having a proximal end  365  and a distal end  360 . Proximal and distal ends  365 ,  360  are respectively provided with openings  366  and  367 . A passage  370  extends between the proximal and distal ends. Passage  370  has an inner surface  372 . Fin assembly  30  fits concentrically over cylindrical body  200  and can rotate about the axis of cylindrical body  200 , constrained by wings  225  and  230 . Near proximal end  365 , inner surface  372  is provided with a circumferential rim  375 . Rim  375  has sections removed from it forming openings  380  and  382  (only  380  is shown,  382  being substantially identical to  380 ), dimensioned to allow passage of key  190 . These openings start at about + 70  degrees and −70 degrees to the vertical and describe arcs of about 30 degrees. When fin assembly  30  is in a first position, rim  375  blocks key  190 . In that first position, when key  190  is blocked by rim  375 , fin  300  is vertical. When fin  300  is rotated clockwise or counter-clockwise, cylindrical body section  350  (and hence rim  375 ) rotates about the axis of body section  200 . When fin assembly  30  is rotated to a second position (anywhere from about 60 degrees to the vertical to about 90 degrees to the vertical, clockwise or counter-clockwise) in which key  190  aligns with opening  380  or  382  (depending on the direction of rotation) key  190  is free to travel distally in slot  260 . When that happens, under the influence of coil spring  180  abutting inner wall  114  of cylindrical body  112 , needle shield assembly  110  will move in the distal direction, thus shielding the needle. 
         [0028]    The combination of rim  375  and key  190  thus forms part of a triggering mechanism which allows shield assembly to be unlocked and to move in the distal direction when needle  10  is to be shielded. 
         [0029]    When fin  300  has been rotated to a position against either wing  225  or wing  230 , fin  300  may be secured to the skin of the patient. To that end, fin  300  may be provided with an adhesive strip. Needle shield assembly  110  has a cylindrical body  112  having a proximal end  120  and distal end  115 . Lumen  117  extends between proximal end  120  and distal end  115  and is dimensioned to accommodate needle  10  axially such that it can slide over needle  10 . Needle shield assembly  110  fits axially into housing body  200  such that it can slide axially along passageway  236 . Proximal end  120  is provided with key  190 . As described above, key  190  fits into slot  260  and slot  560 . Key  190  prevents shield assembly  110  from rotating relative to housing body  200 . It also prevents shield assembly  110  from exiting opening  220  of housing body  200  in the proximal direction, when it abuts distal end  270  of slot  260 . 
         [0030]    At distal end  115  of needle shield assembly there is a stop mechanism  116  for preventing shield assembly from sliding backwards once needle  70  is shielded. Proximal end  115  has a stepped section  150 , i.e. a region of reduced diameter in comparison with the remaining cylindrical part of cylindrical body  112 . Lumen  117  also has a reduced diameter in stepped section  150  compared with the diameter of lumen  117 . In this region, lumen  117  is referred to as lumen  118 . The diameter of lumen  11   8  is only slightly larger than the outer diameter of needle  10 . Coil spring  111  is threaded over stepped section  150 . The rear end of coil spring  111  abuts the wall  114  formed at the intersection of stepped section  150  and the remainder of cylindrical body  112 . Coil spring  111  is a compression spring which exerts its force axially in the proximal and distal directions. Stepped section  150  is also provided with opening  160  in the form of a specially shaped slot extending in a distal direction approximately from the mid point of stepped section  150  to distal end  115  of cylindrical body  112  (see  FIG. 10 ). This opening  160  is dimensioned and shaped such that ball  122  rests in it, with part of ball  122  extending into lumen  118  of cylindrical body  112  and abutting outer surface  11  of needle  10 . The force in coil spring  111  keeps ball  122  pressed against needle  10 . Shield assembly  110  can thus slide along needle  10  with very low frictional force. Opening  160  is also dimensioned and shaped such that when ball  122  no longer abuts needle  10  (i.e. the tip has passed ball  122 ), ball  122  can move distally towards distal end of  115  of cylindrical body  112  and radially further into lumen  118 , thus blocking axial movement of needle  10  in the distal direction. This is described in greater detail below. 
         [0031]    Cap  100  is a metal stamping, dimensioned to fit over stepped section  150 , thus enclosing coil spring  111 . Cap  100  is provided with opening  170 , dimensioned such that part of ball  122  can fit into it, when needle  10  abuts ball  122 , but such that ball  122  cannot escape through it. Cap  100  may be limited in size to fit over distal end  115  of cylindrical body  110  or it can extend along the entire length of cylindrical body  115  as a unitary sheath. 
         [0032]    Behind stepped section  150 , within lumen  117  of cylindrical body  112  lies coil spring  180 . Coil spring  180  is a compression spring whose force is exerted axially in the proximal and distal directions. Distal end  191  of coil spring  180  abuts the back of inner wall  114  just behind stepped section  150 . Proximal end  195  of coil spring  180  abuts proximal face  552  of needle hub  50  (i.e. in the region of flange  570 , but inside cylinder  555 . Coil spring  180  is therefore trapped within cylindrical body  112  of shield assembly  110  and inside housing  20 . When shield assembly  110  is in its un-actuated position, coil spring  180  is compressed. 
         [0033]    The operation of stop mechanism  116  will now be described. Needle tip  70  has a beveled tip with two bevels, first bevel  71  and second bevel  72 . When needle shield assembly  110  slides along the length of needle  10  in the distal direction, ball  122  aligns with bevel  71 . When ball  122  encounters bevel  71 , it is less radially constrained by needle  10  and it moves radially towards the axis of needle  10  under the influence of the force in coil spring  111 . Ball  122  thus moves out of opening  170  in cap  100  and radially inwards, further into lumen  118 . Ball  122  pivots about edge  155  in opening  170  and slides distally along the length of opening  160 . When second bevel is aligned with ball  122 , it moves as far as it can in opening  160  and is positioned directly above second bevel  72 . At that point it will have traveled as far into lumen  117  as it can, constrained by the dimensions of opening  160  and by distal end  101  of cap  100 . Spring  111  has expanded and now constrains ball  122  radially. Ball  122  partially occludes lumen  118 , thus blocking the passage of needle tip  70  and preventing shield assembly  110  from being pulled back to expose needle tip  70 . 
         [0034]    At this point, key  190  has reached distal end  270  of slot  260 , so further distal movement of shield assembly  110  relative to needle  10  is prevented. The distance from key  190  to needle tip  70  is set so that when tip  70  is aligned with ball  122 , there is sufficient space for ball  122  to move beneath cap  100  in opening  160 . Upper surface  136  of distal end  101  of cap  100  (i.e. the part of the needle shield assembly  110  that is immediately radially outward of ball  122  and which ball  122  abuts when the shield is deployed) forms an angle a tangential to ball  122  when ball  122  is moving into its position at least partially occluding lumen  118 . This can be seen in  FIG. 5 . This angle α is set at a value less than the smallest bevel angle β of needle tip  70  (bevel  72  in this case). In the described embodiment, the angle α between the upper surface  136  of distal end  101  and ball  122  is about zero degrees. If that angle is made too large relative to angle β, ball  122  will not be trapped. Distal end  158  of stepped area  155  and cap  100  are dimensioned to overhang so that tip  70  can never emerge from shield assembly  110 . It is possible to employ multiple balls sitting in multiple openings the same as opening  160  and  170 . If this is done, the overhang can be reduced. 
         [0035]    After deployment, but before needle  10  moves distally, part of ball  122  lies in lumen  118  and part of it is urged against the inside of distal end  101  of cap  100  by spring  111 . The top of ball  122  lies beneath upper surface  136  of distal end  101  of cap  100 . In an alternative embodiment, spring  111 , having expanded, closes off the opening  170 . If needle  10  moves distally, it will abut ball  122 , which will be forced against the inside of end  101  of cap  100 . Further distal movement of needle  10  and hence emergence of needle tip  70  from shield assembly  110  will be prevented. 
         [0036]    Lumen  118  is sized such that needle  10  fits in it snugly. Thus when needle  10  is moved distally (i.e. shield assembly  110  is moved proximally) and ball  122  abuts needle tip  70 , needle  10  will not move away from ball  122 . Lumen  170  thus provides support opposite ball  122  to prevent needle  10  from wiggling, and to prevent tip  70  from moving such that it pierces the wall of lumen  118 . 
         [0037]    In an alternative embodiment, ball  122  fully enters lumen  118 . Ball  122  thus has a diameter slightly larger than that of lumen  118 . Ball  122  is then axially constrained by lumen  118  and needle  10 . In this case, lumen  118  is also dimensioned to provide support for needle  10  opposite ball  122 , thus preventing wiggle of the needle and preventing tip  70  from piercing the wall of lumen  118 . 
         [0038]    Ball  122  moves a distance at least equal to the amount by which it protrudes from opening  155  in cap  100 . When the shield is deployed, ball  122  extends into lumen  118  by an amount approximately equal to that distance. This leaves part of lumen  118  un-occluded. If a small gauge needle is used a larger ball is needed in order to occlude lumen  118  sufficiently to prevent tip  70  from poking through the un-occluded part of lumen  118  and so that ball  122  will extend from the surface of needle  10  into opening  160 . The same effect can be obtained by making cap  100  smaller and using the same sized ball. If a large gauge needle is used (i.e. a needle having large diameter), the ball can be smaller. 
         [0039]    Device  5  is assembled in the following way: 
         [0040]    1. Needle shield assembly  110  is dropped into housing  20  from proximal end  210  of housing  20 . Key  190  is aligned with slot  260  of housing  20 . 
         [0041]    2. Finned member  30  is slid over housing  20 , from proximal end  210  of housing  20 . During this step, fin  300  is at about 60-90 degrees to the vertical, thus aligning opening  380  or opening  382  with key  190 . Finned member  30  is then rotated to the vertical position, locking key  190  behind rim  375 . 
         [0042]    3. Spring  180  is placed inside lumen  117  of shield assembly  110 , also from proximal end  210  of housing  20 . Distal end  190  of spring  180  abuts the back of wall  114  of needle shield. 
         [0043]    4. Needle hub  50  is snapped or glued onto proximal end  210  of housing  20 , compressing spring  180 . Slot  570  in cylindrical wall of hub  50  is aligned with slot  260  on housing  20 . 
         [0044]    5. Needle  10  is threaded into hole  113  of needle shield assembly  110 , through lumens  118 ,  117  and spring  180  and glued into needle hub  55 . 
         [0045]    6. Tube  15  is glued into proximal end  555  of needle hub  55 . 
         [0046]    The device is used in the following way: 
         [0047]    The user grasps wings  225  and  230  between his or her fingertips and brings them together so that they touch fin  300 . Alternatively, the device can be held simply by grasping fin  300  between the finger tips. Finger grips are provided in fin  300  for that purpose. Holding the device in either of those two ways, with fin  300  in the vertical (first) position, the user pierces the patient&#39;s skin and blood vessel with needle tip  70 . Once the blood vessel has been pierced and blood can flow through needle  10 , the user rotates fin  300  down towards either wing  225  or  230 , thus unblocking key  190  (the second position). Needle shield assembly  110  is thus free to slide axially over the needle in the distal direction, urged by spring  180 . Fin  300  is placed in cutout  250  or  255 , so it is flush with the relevant wing. Wings  225  and  230  and fin  300  can be taped to the patient&#39;s skin while the blood is collected. 
         [0048]    In this blood collection (second) position, needle shield assembly  110  has slid axially in the distal direction due to the force of spring  180 . Distal end  115  of needle shield assembly lies against the patient&#39;s skin. As needle tip  70  is withdrawn, distal end  115  of needle shield assembly, still under the influence of spring  180 , moves in the distal direction until, as tip  70  is removed from the patient, it is completely shielded. 
         [0049]    The shielding mechanism at the tip of the needle prevents needle shield assembly  110  from sliding in the proximal direction and re-exposing needle tip  70 . Key  190  abuts distal end  270  of slot  260 , thus preventing distal movement of needle shield assembly  110 . Needle  10  is thus completely shielded. Even if fin  300  is rotated back into the first position (to facilitate removal of needle  10  from the patient), shield assembly  110  cannot be retracted because it is blocked from proximal movement by ball  122 . Key  190  has moved distally with respect to circumferential rim  375 . 
         [0050]    Although limited embodiments of the winged needle assemblies, their components, and their applications on different needle devices have been specifically described and illustrated, the descriptions are not intended to limit the scope of the basic invention. Many modifications and variations will be apparent to those skilled in the art. Accordingly, it is to be understood that the winged needle assemblies and their components constructed according to principles of this invention may be embodied other than as specifically described herein. The invention is also defined in the following claims.