Abstract:
The present invention is a safety shield assembly having a shield and a collar for connecting the shield to a fluid handling device whereby the shield may be pivoted with respect to the collar. The safety shield assembly of the present invention also includes a thumb ramp for orienting a user&#39;s hand with the safety shield assembly. Preferably, the safety shield assembly may be used with a needle assembly, an intravenous infusion set, a syringe, a catheter or other fluid handling devices or assemblies that contain piercing elements.

Description:
RELATED APPLICATIONS  
       [0001]    This application is a continuation-in-part of pending Appl. Ser. No. 09/378,976 filed on Aug. 23, 1999 and provisional patent application No. 60/098,282 filed on Aug. 28, 1998. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of Invention  
           [0003]    The present invention relates to a shield which may be easily manipulated from an open to a closed position with respect to a needle, and more particularly to a safety shield assembly that may be used in conjunction with a syringe assembly, a hypodermic needle, a needle assembly, a needle assembly with a needle holder, a blood collection needle, a blood collection set, an intravenous infusion set or other fluid handling devices or assemblies that contain piercing elements.  
           [0004]    2. Description of Related Art  
           [0005]    Disposable medical devices having piercing elements for administering a medication or withdrawing a fluid, such as hypodermic needles, blood collecting needles, fluid handling needles and assemblies thereof, require safe and convenient handling. The piercing elements include, for example, pointed needle cannula or blunt ended cannula.  
           [0006]    Safe and convenient handling of disposable medical devices is recognized by those in the medical arts as being necessary as to minimize exposure to blood borne pathogens. One manner in which to achieve safe and convenient handling of disposable medical devices is to dispose of the medical devices intact.  
           [0007]    As a result of this recognition, numerous devices have been developed for shielding needles after use. Many of these devices are somewhat complex and costly. In addition, many of these devices are cumbersome to use in performing procedures. Furthermore, some of the devices are so specific that they preclude use of the device in certain procedures or with certain devices and/or assemblies.  
           [0008]    Therefore, there exists a need for a syringe with a safety shield assembly: (i) that is easily manufactured; (ii) that is applicable to many devices; (iii) that is safe and simple to use with one hand; (iv) that can be safely disposed of, (v) that does not interfere with normal practices of needle use; (vi) that has tactile features whereby the user may be deterred from contacting the needle, the user may easily orient the needle with the patient and easily actuate and engage the shield assembly; (vii) that has visual features whereby the user may be deterred from contacting the needle, the user may easily orient the needle with the patient and easily actuate and engage the shield assembly; (viii) that is not bulky; (ix) that includes means for minimizing exposure to the user of residual fluid leaking from the needle; and (x) provides minimal exposure to the user because the needle shield is immediately initiated by the user after the needle is withdrawn from the patient&#39;s vein or artery; and (xi) that is easy to activate without pushing the safety shield assembly against a hard surface, and (xi) which may be safely and easily manipulated between an open and closed position.  
         SUMMARY OF THE INVENTION  
         [0009]    The present invention provides a safety shielded needle assembly that includes a needle holder, a needle extending from said needle holder, a shield pivotally connected to said needle holder for pivotal movement toward said needle, a finger pad for urging said shield toward said needle, and a thumb ramp adjacent to said finger pad to assure proper placement of hand with respect to said needle.  
           [0010]    More specifically, the present invention provides a needle shield assembly and needle assembly. The needle assembly includes a hub and a needle connected to said hub. The needle includes a non-patient end and intravenous end having a bevel end. The needle shield assembly is connected to the needle assembly and includes a collar, a shield and a thumb ramp. The collar is connected to said hub of said needle assembly. The shield is movably connected to said collar whereby said shield by be pivoted with respect to said collar and easily moved between several positions with respect to said needle. The thumb ramp is connected to said hub adjacent to said shield to allow proper orientation of a user&#39;s hand.  
           [0011]    Most preferably, the present invention provides a safety shield assembly including a safety shield. The safety shield uses tactile and visual means that includes touch pump end coloring for guiding the user&#39;s fingers to move the shield into various positions. A top finger guide area includes a first ramp that extends slightly on an upwardly slope from said rearward end of said shield to a shoulder. A thumb ramp is positioned adjacent to said shield to provide for proper orientation of a users hand. 
       
    
    
     DESCRIPTION THE DRAWINGS  
       [0012]    [0012]FIG. 1 shows a safety shielded needle assembly of the present invention.  
         [0013]    FIGS.  2 - 6  show a hub for use with a safety shielded needle assembly of the present invention in front, top, side, bottom and end views.  
         [0014]    FIGS.  7 - 11  show a safety shield for use with a safety shielded needle assembly of the present invention in front, top, side, bottom and end views. 
     
    
     DETAILED DESCRIPTION  
       [0015]    While this invention is satisfied by embodiments in many different forms, there is shown in the drawings and will herein be described in detail, the preferred embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. Various other modifications will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents.  
         [0016]    Referring to the drawings in which like reference numerals refer to like parts throughout, FIG. 1 illustrates a safety shielded needle assembly  10  of the present invention. The shielded needle assembly  10  includes a cannular/needle  12 , a syringe body  14  which supports the needle, a hub  16 , a safety shield  18  pivotally connected to the hub, and a needle sleeve  20  which removably covers the patient end  22  of needle  12  prior to use. The needle  12  may be connected to syringe body in convention fashion such that the patient end  22  of needle  12  extends outwardly therefrom while a syringe body is shown. The present invention may be used in combination with any needle holder or similar device.  
         [0017]    Referring additionally to FIGS. 2 through 6, hub  16  includes a forward annular skirt  24  and a rearward annular skirt  26 . The forward annular skirt  24  is cylindrical and defines an inner side wall  25  and an outer side wall  30  and mates with rearward annular skirt  26  at shoulder  27 . Rearward annular skirt  26  is cylindrical and includes an inner side wall  29  and an outer side wall  31  and extends from shoulder  27  opposite of forward annular skirt  24 . The rearward annular skirt  26  may include a luer type connection for assembly onto a luer lock syringe. The forward annular skirt  24  includes a needle mount  28  for mounting needle  12  thereto in conventional fashion.  
         [0018]    Extending from an outer sidewall  30  of forward skirt  24  is a hook member  32 . Located opposite or downwardly of hook member  32  on outer sidewall  30  or opposed locking dents or protrusions  34 . Extending rearwardly from hook member  32  on sidewall  30  is a thumb ramp  36  which will be described in detail hereinbelow.  
         [0019]    Referring additionally to FIGS. 7 through 11, safety shield  18  includes a rearward end  38  and a forward end  40 .  
         [0020]    Forward end  40  of shield  18  includes a slot or longitudinal opening  42  formed by sidewalls  44  that extend downwardly from a top section  45  and run substantially opposite of one another in parallel along the length of slot  42  toward forward end wall  46 . The needle  12  may be trapped in slot  42  by the inclusion of an arm  48  that is located at one of the sidewalls  44  across slot  42  to secure the used needle  12 .  
         [0021]    Arm  48  is deflectable by the needle  12  when the needle enters the slot. Once the needle passes the end of the arm, the arm moves back to its original position whereby the needle is trapped within slot  42  by arm  48 .  
         [0022]    At the rearward end  38  of shield  18  is a hub engaging area  50  which is a continuation of slot  42 . Hub engaging area  50  includes a rearward end  52  and a forward end  54 , a top finger guide area  56 , parallel sidewalls  58  that extend downwardly and inwardly from top finger guide area  56  and into sidewalls  44 , an underside area  60  for surrounding hub  16  and extending arms  62  to hold hanger bar  64 . Parallel sidewalls  58  include an inner surface  66  where barb dents  68  are located.  
         [0023]    Top finger guide area  56  includes a first ramp  70  that extends slightly on an upward slope from the rear end of the hub engaging area  50  to a shoulder  72 . Preferably, first ramp  70  includes one or more touch bumps  76  thereon. Touch bumps  76  provides a tactile and visual guide to alert the user that the user&#39;s finger has contacted the shield, and that the shield is in a defined or controlled position. Touch bumps  76  may be any configuration as long as they extend and are distinct from the top finger guide area. Touch bumps  76  may also be of distinguishing color as compared with the top finger guide area or shield.  
         [0024]    Shield  18  further includes a second ramp  74  having an interior surface  78  for urging the needle towards the center of slot  42  as the shield is being rotated into the closed position. The exterior surfaces  58  are slightly inclined, extending radially from the second ramp. The interior surfaces  78  are especially helpful if the longitudinal axis of the needle is misaligned with respect to the longitudinal axis of the hub.  
         [0025]    Extending arms  62  are located at rearward end  52  and at the beginning of top finger area  56  and hold hanger bar  64 .  
         [0026]    Located downwardly and extending from arms  62  and hanger bar  64 , and on inner surface  66  of parallel sidewalls  58  are barb dents  68 . Barb dents cooperate with locking dents on hub  16  to secure the shield in its final locked position.  
         [0027]    In a preferred embodiment, the needle  12  is connected to syringe body  14  by use of hub  16 . The needle  12  may be secured to the needle mount  28  of needle hub  16  which is then secured to syringe body  14  in conventional fashion. Joining techniques such as adhesive and ultrasonic welding may be employed. As assembled, the hook arm of the hub is aligned with the bevel up of the needle. The needle sleeve  20  is fitted over the needle  12  and is force-fitted over the forward skirt  24  of hub  16 . Thereafter, shield  18  is connected to hub  16  whereby hanger bar  64  is force-fitted into hook member  32  whereby slot  42  faces needle sleeve  20 . Preferably, the shield is connected to the hub by a force-fit or interference-fit between the hanger bar and the hook bar. Therefore, the shield is always oriented in a stable position. This allows the shield to be rotated and maintained in any position through its 270° arc of motion so that it does not interfere with any procedure for which the syringe is required. The shield will not move unless movement of the shield is positively initiated by the user. The shield is movable between two extreme positions of motion. These positions are fully opened when the shield is rotated to its maximum rearward position and fully closed whereby the shield is rotated fully forward and completely covers the needle. The shield can be maneuvered into any position inbetween and is held there by friction between hook member  32  and hanger bar  64 . In the fully opened position, the needle can be clearly observed, allowing precise manipulation of the syringe and visibility of the needle bevel. In the fully closed position, the shield surrounds the point of the needle.  
         [0028]    The safety shield assembly of the present invention further includes a thumb ramp  36  which is located on the hub  16  and is positioned adjacent to the first ramp  70  and spaced therefrom. As pressure is exerted on the first ramp  70 , the shield  18  pivots relative to the hub  16  to cover the needle  12 . The thumb ramp  36  provides a stable area of orientation for hand operating the safety shield  18 , assuring that the user&#39;s hand not only will remain behind the needle but will reduce the likelihood of slipping during engagement of the shield. The thumb ramp  36  may also include a touch bump  37  similar to that on the first ramp  70 . This will serve as an additional indicator that the user&#39;s hand is properly oriented with respect to the needle assembly  10 .  
         [0029]    After use of the cannula/sharp device, the user easily rotates the shield from its open position towards the intravenous needle to an intermediate position. The user then pushes on the top finger guide area to move the shield to its final, unretractable locked position whereby the needle is trapped in the longitudinal opening within the arm of the needle shield and the barb dents of the shield, and held by locking dents of the hub  16 . As the shield is pivoted, barb dents deflect over and are held by the locking dents.