Needle safety device

Abstract

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

1. A shieldable needle assembly comprising:
 a needle cannula having a proximal end and a distal end; 
 a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula; 
 a substantially tubular housing, at least a portion of which extends in a distal direction and projects distally from said hub toward said distal end of said needle cannula beyond said hub in said distal direction; 
 a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; 
 a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and 
 an actuator slidably mounted movably attached to said hub needle assembly, said actuator being movable distally in a direction relative to said hub and said safety shield housing, a portion of said actuator being configured for releasing said safety shield, such that said spring element is able to propel said safety shield toward said distal position, 
 wherein the actuator is inaccessible from a lateral side of the needle assembly. 
 
     
     
       2. The needle assembly of  claim 1 , wherein one of said housing and said safety shield includes a latch, and wherein the other of said housing and said safety shield includes a detent for releasably engaging the latch and for releasably holding said safety shield in said proximal position. 
     
     
       3. The needle assembly of  claim 2 , wherein said actuator comprises a proximal end extending proximally from said hub and a distal end substantially aligned with said latch, such that said a portion of said actuator being configured for releasing said safety shield said latch from said detent in response to said movement of said actuator. 
     
     
       4. The needle assembly of  claim 3 , wherein said actuator includes a portion disposed externally of said housing for permitting manual actuation. 
     
     
       5. The needle assembly of  claim 3 , wherein said proximal end of said housing is capable of being engaged with a detachable holder useful for receiving collection containers. 
     
     
       6. The needle assembly of  claim 5  claim 1, wherein said a proximal end of said housing is capable of being engaged with a holder useful for receiving a collection container and a proximal end of said actuator is movable in the a distal direction by insertion of a the collection container into the proximal end of said holder. 
     
     
       7. The needle assembly of  claim 2 , wherein said housing includes a latch recess, said latch being on said safety shield and being engageable with said latch recess of said housing when said safety shield is in said distal position for preventing further distal movement of said safety shield from said distal position and for preventing a return proximal movement of said safety shield from said distal position. 
     
     
       8. The needle assembly of  claim 1 , wherein the safety shield is substantially tubular and is spaced radially outwardly from said needle cannula, said spring element being a coil spring surrounding said needle cannula and engaged with said tubular safety shield. 
     
     
       9. The needle assembly of  claim 8  claim 1, wherein said coil spring exerts aspring force of 0.02-0.20 pounds between said safety shield and one of said hub or said housing while said safety shield is in the proximal position. 
     
     
       10. The needle assembly of  claim 1 , wherein said housing includes at least one non-cylindrical external outer region for digital gripping of said housing. 
     
     
       11. The needle assembly of  claim 10 , wherein said distal end of said needle cannula is beveled to a point, said bevel being oriented having a predetermined orientation with respect to non-cylindrical the at least one region for gripping of said housing. 
     
     
       12. The needle assembly of  claim 10 , wherein said non-cylindrical region includes a pair of opposed flats extending longitudinally along portions of said housing on opposite respective sides of said housing, said flats each including at least one surface irregularity for facilitating gripping. 
     
     
       13. The needle assembly of  claim 1 , further comprising a distal packaging cap removably disposed over said distal end of said needle cannula. 
     
     
       14. The needle assembly of  claim 1 , wherein said housing is formed from a transparent translucent plastic material. 
     
     
       15. The needle assembly of  claim 1 , wherein said safety shield includes is formed with indicia for providing visual indications of movement of said shield relative to said housing. 
     
     
       16. The needle assembly of  claim 15 , wherein said distal end of said needle cannula is beveled to a point, said indicia on said shield being aligned with said bevel. 
     
     
       17. A blood collection assembly comprising:
 a substantially cylindrical holder having an open proximal end, a distal end and a tubular sidewall extending between said ends, said tubular sidewall being configured for possible insertion of a collection container, an end wall at said distal end of said holder, said end wall having a aperture with needle mounting structure formed thereon; and 
 a needle assembly comprising
 a needle cannula having a pointed proximal end and a pointed distal end thereof, 
 a hub directly mounted to said needle cannula between said pointed proximal end and said pointed distal end thereof,  
 
 a housing spaced radially outwardly from said needle cannula and projecting distally from said distal end of said hub to a location spaced proximally from said distal end of said needle cannula, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction, 
 a safety shield surrounding said needle cannula and having at least a portion disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position such that said safety shield is disposed proximally of said distal end of said needle cannula, said safety shield being movable to a distal position where said safety shield encloses said pointed distal end of said needle cannula, 
 a spring for propelling said safety shield from said proximal position to said distal position, and 
 an actuator slidably mounted movably attached to said hub needle assembly, said actuator being movable distally in a direction relative to said hub and said safety shield housing, a portion of said actuator being configured for releasing said safety shield, such that said spring element is able to propel said safety shield toward said distal position, 
 wherein said actuator is accessible at said proximal end of the hub. 
 
     
     
       18. The blood collection assembly of  claim 17  wherein said housing includes a detent, and wherein said safety shield includes a latch for releasably retaining said safety shield in said proximal position. 
     
     
       19. The blood collection assembly of  claim 18 , wherein said actuator including a proximal end disposed within said needle holder and a distal end disposed substantially adjacent said latch of said safety shield, said proximal end of said actuator being engageable by a collection container for urging said actuator distally and into a position for disengaging said latch from said detent on said housing. 
     
     
       20. The blood collection assembly of  claim 17 , wherein said actuator includes a actuator button disposed externally of said holder and said needle assembly for permitting manual actuation of said safety shield. 
     
     
       21. The blood collection assembly of  claim 18 , wherein said actuator includes an actuator button disposed externally of said holder and a proximal end extending into said holder, said actuator including a distal end disposed adjacent said latch of said safety shield, wherein distal movement of said actuator is moveable by either insertion of a collection container into said proximal end of said holder or manual movement of said actuator button. 
     
     
       22. The blood collection assembly of  claim 17 , wherein said safety shield is substantially tubular and includes a sidewall spaced outwardly from said needle cannula, said spring element being a coil spring surrounding said needle and engaged with said tubular safety shield. 
     
     
       23. The blood collection assembly of  claim 17 , additionally comprising a holder for receiving a collection container wherein said holder includes a flange projecting outwardly at said a proximal end of said holder, said flange including a flat edge aligned substantially perpendicular to a plane passing symmetrically through said distal end of said needle cannula. 
     
     
       24. The blood collection assembly of  claim 23 , wherein said pointed distal end of said cannula comprises a bevel oriented to said flange of said holder. 
     
     
       25. The blood collection assembly of  claim 17 , wherein said housing is formed from a transparent translucent material. 
     
     
       26. The blood collection assembly of  claim 17 , wherein said safety shield is formed with indicia for providing visible indication of movement of said safety shield relative to said housing. 
     
     
       27. A method of making a blood collection assembly comprising the steps of:
 (a) providing the components of:
 (i) a hub; 
 (ii) a needle cannula comprising a proximal end, a distal end, and a lumen extending therebetween, said cannula is being mounted to said hub; 
 (iii) a housing engageable to said hub and extending distally from said hub, at least a portion of which extends in a distal direction and projects beyond said hub in the distal direction when engaged with said hub, said housing comprising a safety guide; 
 (iv) a safety shield longitudinally moveable with respect to said housing by said safety shield guide from a proximal position to a distal position at which the distal end of said cannula is fully covered; 
 (v) a compression spring between one of said hub or said housing and said safety shield, said spring configured to move said safety shield from the proximal position, to an intermediate position, and further to the a fully extended distal position; 
 (vi) an actuator slidably mounted movably attached to said hub, said actuator being movable distally in a direction relative to said hub and said safety shield housing, a portion of said actuator being configured for releasing said safety shield, such that said compression spring element is able to propel said safety shield toward said distal position; and 
 
 (b) assembling said components, 
 wherein the actuator is inaccessible from a lateral side of the needle assembly and wherein said spring exerts sufficient force to move said safety shield to said distal position without exerting enough force to rush push said needle cannula out of a patient into which said cannula has been inserted while said safety shield is in said intermediate position. 
 
     
     
       28. The method of making a blood collection assembly of  claim 27 , wherein said safety shield guide comprises a channel. 
     
     
       29. The needle assembly of claim 1, wherein said actuator includes a latch component movable radially relative to said hub. 
     
     
       30. The needle assembly of claim 1, wherein said actuator is accessible at a proximal end of the hub. 
     
     
       31. The needle assembly of claim 1, wherein said actuator comprises a latch component on at least one of said hub or housing. 
     
     
       32. The needle assembly of claim 1, wherein the actuator is movable in a distal direction relative to said hub. 
     
     
       33. The needle assembly of claim 1, wherein the actuator is an assembly and includes a deflectable member on one of said housing and safety shield, said deflectable member includes a latch, and the needle assembly additionally includes a detent for releasably engaging the latch and for releasably holding said safety shield in said proximal position. 
     
     
       34. The needle assembly of claim 33, wherein a proximal surface of said actuator is engageable by a collection container for disengaging said latch from said detent. 
     
     
       35. The needle assembly of claim 1, wherein said housing includes a latch recess, and the safety shield includes a latch that is engageable with said latch recess of said housing when said safety shield is in said distal position to hinder further distal movement of said safety shield from said distal position and to hinder a return proximal movement of said safety shield from said distal position. 
     
     
       36. The needle assembly of claim 1, wherein a proximal end of the needle assembly is configured for receiving a collection container, in which insertion of the collection container into the proximal end of said needle assembly causes movement of said safety shield from the proximal position to the distal position. 
     
     
       37. The needle assembly of claim 1, wherein said housing employs at least one surface configuration for user manipulation. 
     
     
       38. A shieldable needle assembly comprising:
 a needle cannula having a proximal end and a distal end;   a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;   a housing, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction, said housing including a plurality of recesses in the outer surface for user manipulation;   a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and   a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield   wherein the actuation of the safety shield to the distal position is effected by the movement of a collection container in a distal direction and said distal end of said needle cannula is beveled to a point, said bevel having a predetermined orientation with respect to the recesses of said housing.   
     
     
       39. The needle assembly of claim 38, additionally comprising an actuator movably attached to said assembly, said actuator being movable in a direction relative to said hub and said housing, a portion of said actuator being configured for releasing said safety shield, such that said spring is able to propel said safety shield toward said distal position. 
     
     
       40. A shieldable needle assembly comprising:
 a needle cannula having a proximal end and a distal end;   a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;   a housing, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;   a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing;   a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and   a latch component that releases said safety shield, such that the spring element is able to propel said safety shield toward said distal position, said latch component being movably attached to said needle assembly,   wherein the latch component is inaccessible from a lateral side of the needle assembly.   
     
     
       41. The needle assembly of claim 40, wherein said latch component is movable radially relative to said hub. 
     
     
       42. The needle assembly of claim 41, wherein said latch component is accessible at a proximal end of the hub. 
     
     
       43. The needle assembly of claim 40, wherein said latch component is on said hub. 
     
     
       44. A shieldable needle assembly comprising:
 a needle cannula having a proximal end and a distal end;   a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;   a housing at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;   a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing;   a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and   a trigger that activates the spring element to propel said safety shield toward said distal position, wherein the trigger is movably attached to said needle assembly.   
     
     
       45. The needle assembly of claim 44, wherein said trigger includes a latch component that is movable radially relative to said hub and housing. 
     
     
       46. The needle assembly of claim 44, wherein said trigger is accessible at said proximal end of the hub. 
     
     
       47. The needle assembly of claim 44, wherein said trigger includes a latch component on said hub. 
     
     
       48. The blood collection assembly of claim 17, wherein said actuator includes a latch component that is movable radially relative to said hub. 
     
     
       49. The blood collection assembly of claim 17, wherein said actuator is accessible at said proximal end of the hub. 
     
     
       50. The blood collection assembly of claim 17, wherein said actuator includes a latch component on at least one of said hub or housing. 
     
     
       51. The blood collection assembly of claim 50, wherein one of said housing and safety shield includes a deflectable member, said deflectable member includes a latch, and the needle assembly includes a detent for releasably engaging said latch and for releasably holding said safety shield in said proximal position. 
     
     
       52. The blood collection assembly of claim 51, wherein a proximal surface of said actuator is engageable by a collection container for disengaging said latch from said detent on said needle assembly. 
     
     
       53. A blood collection assembly comprising:
 a needle assembly comprising:   a needle cannula having a proximal end and a distal end;   a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;   a housing, at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction, said housing including a plurality of depressions at an outer surface configured to ease user manipulation;   a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and   a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield   whereby the actuation of the safety shield to the distal position is effected by the insertion of the collection container into the holder a sufficient distance to effect release of the safety shield and   wherein said distal end of said needle cannula is beveled to a point, said bevel having a predetermined orientation with respect to the depressions of said housing.   
     
     
       54. The blood collection assembly of claim 53, additionally comprising an actuator movably attached to said needle assembly, said actuator being movable in a direction relative to said hub and said housing, a portion of said actuator being configured for releasing said safety shield, such that said spring element is able to propel said safety shield toward said distal position. 
     
     
       55. The blood collection assembly of claim 54, wherein said outer surface configurations comprises at least one non-cylindrical region which includes a depression extending longitudinally along a portion of said housing. 
     
     
       56. A blood collection assembly comprising:
 a needle assembly comprising:   a needle cannula having a proximal end and a distal end;   a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;   a housing at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;   a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and   a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and   a latch component that releases said safety shield, such that the spring element is able to propel said safety shield toward said distal position and said latch component is movably attached to said needle assembly,   wherein the latch component is inaccessible from a lateral side of the needle assembly.   
     
     
       57. The blood collection assembly of claim 56, wherein said latch component is movable radially relative to said hub and housing. 
     
     
       58. The blood collection assembly of claim 57, wherein said latch component is accessible at a proximal end of the hub. 
     
     
       59. The blood collection assembly of claim 56, wherein said latch component is on at least one of said hub or housing. 
     
     
       60. A blood collection assembly comprising:
 a needle assembly comprising:   a needle cannula having a proximal end and a distal end;   a hub directly mounted to said needle cannula at a location spaced from said distal end of said needle cannula;   a housing at least a portion of which extends in a distal direction and projects beyond said hub in said distal direction;   a safety shield telescoped over said needle cannula and having at least a portion slidably disposed between said needle cannula and said housing, said safety shield being releasably retained in a proximal position where said safety shield is spaced from said distal end of said needle cannula, said safety shield being movable from said proximal position to a distal position where said safety shield surrounds portions of said needle cannula distally of said housing; and   a spring for propelling said safety shield from said proximal position to said distal position, upon release of said safety shield; and   a trigger that activates the spring element to propel said safety shield toward said distal position, wherein the trigger is movably attached to said needle assembly.   
     
     
       61. The blood collection assembly of claim 60, wherein said trigger includes a latch component that is movable radially relative to said hub. 
     
     
       62. The blood collection assembly of claim 60, wherein said trigger is accessible at a proximal end of the hub. 
     
     
       63. The blood collection assembly of claim 60, wherein said trigger includes a latch component on at least one of said hub or housing. 
     
     
       64. The method of making a blood collection assembly of claim 27, wherein the actuator is movable distally relative to said hub and said housing. 
     
     
       65. A method of automatically and passively activating a safety shield for a shielded needle assembly including a needle cannula having a hub, a housing, the safety shield and a release mechanism, said method including the steps of:
 inserting a blood collection tube into a proximal end of the needle assembly, wherein the safety shield is movable from a proximal position to a distal position where the safety shield substantially covers the distal end of the needle cannula and at least a portion of the housing extends in a distal direction and projects beyond said hub in said distal direction and   engaging the release mechanism with the blood collection tube as the tube moves in the distal direction, wherein said engagement of the release mechanism effects the movement of the safety shield from the proximal position to the distal position.   
     
     
       66. The method of claim 65, further comprising the step of guiding the distal end of the needle cannula into a vein of a patient for the purpose of drawing blood and
 wherein the step of inserting the blood collection tube into the proximal end of the needle assembly causes said blood to flow into the blood collection tube and causes deflection of a deflectable member of said safety shield so that the safety shield moves from the proximal position to the distal position.   
     
     
       67. The method of claim 66, wherein the needle assembly further includes a spring biasing the safety shield in the distal direction so that when the safety shield moves from the proximal position to the distal position, the spring propels the shield toward the distal direction. 
     
     
       68. The method of claim 66, wherein once the step of inserting the blood collection tube into the proximal end of the needle assembly occurs and the safety shield moves from the proximal position to the distal position, the needle cannula is prevented from being unshielded. 
     
     
       69. The method of claim 66, wherein the safety shield is substantially flush with said housing and the movement of the safety shield from the proximal position to the distal position is effected by a latch component that is movable radially relative to a hub attached to the needle. 
     
     
       70. The method of claim 69, wherein said latch component is effected by the blood collection container being inserted at the proximal end of the needle assembly. 
     
     
       71. The method of claim 66, wherein the movement of the safety shield from the proximal position to the distal position is effected by a latch component on said hub. 
     
     
       72. The method of claim 66, wherein the step of insertion of the collection tube causes the release mechanism to move distally relative to said hub and releases the safety shield. 
     
     
       73. The blood collection assembly of claim 17, further comprising a holder configured for possible insertion of a collection container disposed on the proximal end of the blood collection assembly. 
     
     
       74. The needle assembly of claim 1, wherein the safety shield is substantially flush with said housing when the safety shield is in the proximal position. 
     
     
       75. The blood collection assembly of claim 17, wherein the safety shield is substantially flush with said housing when the safety shield is in the proximal position. 
     
     
       76. The method of claim 27, wherein the safety shield is substantially flush with said housing when the safety shield is in the proximal position. 
     
     
       77. The needle assembly of claim 1, wherein the safety shield is projecting slightly from the housing when the safety shield is in the proximal position. 
     
     
       78. The blood collection assembly of claim 17, wherein the safety shield is projecting slightly from the housing when the safety shield is in the proximal position. 
     
     
       79. The method of claim 27, wherein the safety shield is projecting slightly from the housing when the safety shield is in the proximal position. 
     
     
       80. The method of claim 66, wherein the safety shield is projecting slightly from the housing. 
     
     
       81. The needle assembly of claim 1, wherein the actuator is slidably mounted to said hub. 
     
     
       82. The needle assembly of claim 81, additionally comprising a holder for receiving a collection container, wherein a proximal end of said actuator is slidable in a distal direction by insertion of the collection container into a proximal end of said holder. 
     
     
       83. The blood collection assembly of claim 17, wherein the actuator is slidably mounted to said hub. 
     
     
       84. The method of claim 27, wherein the actuator is slidably mounted to said hub. 
     
     
       85. The needle assembly of claim 11, wherein said at least one region for gripping is a non-cylindrical region which includes a depression extending longitudinally along a portion of said housing.