Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This is a continuation of U.S. application Ser. No. 13/604,089 filed Sep. 5, 2012, which is a continuation of U.S. application Ser. No. 11/496,769 now U.S. Pat. No. 8,382,718, filed Jul. 31, 2006, the contents of which are expressly incorporated herein by reference. 
     
    
     FIELD 
       [0002]    Needle assemblies are generally discussed herein with particular discussions extended to needle assemblies having a tip protector comprising enclosed wall surfaces for preventing contact with the needle tip from a side. 
       BACKGROUND 
       [0003]    Insertion procedure for an IV catheter assembly contains four basic steps: (1) the healthcare worker inserts the needle and catheter together into the patient&#39;s vein; (2) after insertion into the vein with the needle point, the catheter is forwarded into the vein of the patient by the healthcare worker pushing the catheter with his or her finger; (3) the healthcare worker withdraws the needle by grasping the hub end (opposite the point end) while at the same time applying pressure to the patient&#39;s skin at the insertion site with his or her free hand; and (4) the healthcare worker then tapes the now inserted catheter to the patient&#39;s skin and connects the exposed end of the catheter (the catheter hub) to the source of the fluid to be administered into the patient&#39;s vein. 
         [0004]    The problem is that, immediately after the withdrawal of the needle from the patient&#39;s vein, the healthcare worker, who is at this time involved in at least two urgent procedures, must place the exposed needle tip at a nearby location and address the tasks required to accomplish the needle withdrawal. It is at this juncture that the exposed needle tip creates a danger of an accidental needle stick, which, under the circumstances, leaves the healthcare worker vulnerable to the transmission of various dangerous blood-borne pathogens, including AIDS and hepatitis. 
         [0005]    Other needle types similarly expose healthcare workers to risks of accidental needle sticks. For example, a doctor administering an injection, using a straight needle, a Huber needle, an epidural needle, etc., may place the used needle on a tray for subsequent disposal by a nurse. For the period between placing the used needle on a tray or a work station to the time it is discarded, the used needle is a potential source for disease transmissions for those that work near or around the needle. Accordingly, all needles should be covered immediately following use to ensure greater worker safety. Ideally, the procedure for covering the needle tip should be passive, self activating, or at least simple to perform. In addition, the device for covering the needle should be reliable and robust. 
       SUMMARY 
       [0006]    In accordance with aspects of the present invention, a tip protector is provided that blocks the needle tip from direct contact with a needle tip. 
         [0007]    More preferably, the tip protector incorporates side walls for providing shielding the needle tip from view and exposure to blood dripping from the inside of the needle tip. 
         [0008]    In a further aspect of the present invention, a deflector plate is provided to deflect e needle from inadvertently re-emerging from within the tip protector. 
         [0009]    In yet another aspect of the present invention, the deflector plate is used, at least in part, to position the tip protector within a housing. 
         [0010]    It is another object of the present invention to incorporate the tip protector in a safety IV catheter for automatically shielding a needle tip upon removal of a needle from a catheter tube by means of a resilient engagement between the tip protector and the catheter hub. The resilient engagement allowing for a relatively smoother release without having to reduce typical manufacturing tolerances. 
         [0011]    Aspects of the present invention may be practiced by providing a tip protector for blocking a needle tip comprising: a tip protector housing positioned inside a hub having an interior surface; a needle passing through the tip protector and the housing; a first arm extending from a distal wall of the tip protector housing biased against the interior surface; a second arm extending from a proximal wall of the tip protector housing biased against the interior surface; and a third arm extending from the proximal wall of the tip protector housing and biased against a side of the needle. 
         [0012]    The present invention may also be practiced by providing a tip protector for mounting on a needle to shield a needle tip comprising: a first protector body comprising a proximal wall and an arm extending distally of the proximal wall; said arm further comprising: a distal wall at an end of the arm for blocking a needle tip; a non-uniform arm width for accommodating a needle extending from between the proximal wall and the distal wall; a second protector body attached to the first protector body, the second protector body comprising a distal wall and two side walls defining a cavity for accommodating the first protector body; and a deflector plate comprising a projection projecting into the cavity, the projection and the distal wall at the end of the arm are configured to limit movement of a needle tip from moving distally of the distal wall of the second protector body. 
         [0013]    In yet another aspect of the present invention, there is provided a tip protector for mounting on a needle to shield a needle tip comprising: a first protector body attached to a second protector body; the first protector body comprising a proximal wall and an arm, which comprises a distal end portion of the arm, extending distally of the proximal wall; the second protector body comprising two side walls and two end walls defining a cavity for accommodating the first protector body; the two side walls each comprising a first edge and a second edge; a deflector plate comprising a projection projecting into the cavity, the deflector plate is configured to deflect and move relative to both the first edge and the second edge; and wherein the projection and the distal end portion of the arm are configured to be on different sides of a needle shaft defined by a centerline when the tip protector is mounted on a needle and the tip protector is in a ready to use position. 
         [0014]    In still yet another aspect of the present invention, there is provided a needle assembly comprising: a housing comprising a wall having an interior wall surface defining a cavity having a tip protector disposed therein; a needle, which has a shaft having a first side and a second side defined by a centerline and a needle tip, passing through the housing and the tip protector; the tip protector comprising a distal wall, two side walls, a proximal wall, a first arm extending from the proximal wall towards the distal wall, a second arm, which is shorter than the first arm, extending from the proximal wall, and a wall opposite the second arm; and wherein the wall opposite the second arm and the second arm are both biased against the interior wall surface of the housing. 
         [0015]    Other aspects and features of the tip protectors provided herein may be better appreciated as the same become better understood with reference to the specification, claims, and appended drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    The appended drawings include: 
           [0017]      FIGS. 1A and 1B  are semi-schematic views in partial cross-section of a prior art safety IV catheter incorporating a tip protector comprising an upper wall and two side walls; 
           [0018]      FIG. 2  is a semi-schematic perspective view of a tip protector provided in accordance with aspects of the present invention comprising a first protector body and a second protector body for blocking a needle tip; 
           [0019]      FIG. 3  is a top view of the tip protector of  FIG. 2 ; 
           [0020]      FIG. 4  is a bottom view of the tip protector of  FIG. 2 ; 
           [0021]      FIG. 5  is a semi-schematic cross-sectional side view of the clip of  FIG. 4  taken along line  5 - 5 ; 
           [0022]      FIG. 6  is a semi-schematic end view of the clip of  FIG. 5  taken along line  6 - 6 ; 
           [0023]      FIG. 7  is a semi-schematic front view of the clip of  FIG. 5  taken along line  7 - 7 ; 
           [0024]      FIG. 8  is a semi-schematic cross-section side view of the first protector body of  FIG. 2  shown without the second protector body; 
           [0025]      FIG. 9  is a semi-schematic cross-sectional end view of an arm of he first protector body of  FIG. 8  taken along line  9 - 9 ; 
           [0026]      FIG. 10  is a semi-schematic end view of the first protector body of  FIG. 8  taken along line  10 - 10 ; 
           [0027]      FIG. 11  is a semi-schematic cross-sectional side view of a catheter assembly incorporating the tip protector of  FIG. 2  shown in a ready to use position; 
           [0028]      FIG. 12  is a cross-sectional end view of the catheter assembly of  FIG. 11  taken along line  12 - 12 ; 
           [0029]      FIG. 13  is a partial cross-sectional side-view of the catheter assembly of  FIG. 11  shown with the needle hub retracted from the catheter tube and the tip protector blocking the needle tip, in a used position; 
           [0030]      FIG. 14  is a partial cross-sectional side view of the needle hub completely removed from the catheter hub with the tip protector of  FIG. 2  remained on the needle for blocking the needle tip; and 
           [0031]      FIG. 15  is a semi-schematic perspective view of an alternative second protector body provided in accordance with aspects of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0032]    The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of a tip protector for use on a number of needles or needle assemblies provided in accordance with aspects of the present invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and the steps for constructing and using the tip protector of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments also intended to be encompassed within the spirit and scope of the invention, especially those incorporating a combination of features shown in the different embodiments included herein. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features. 
         [0033]      FIGS. 1A and 1B  illustrate a prior art spring clip needle guard shown and described in U.S. Pat. No. 6,616,630 to Woehr et al., the contents of which are expressly incorporated herein by reference. For cross-referencing purposes,  FIGS. 1A and 1B  shown herein are labeled and discussed in the &#39;630 patent as  FIGS. 4A and 4B . As therein shown and reproduced above as  FIGS. 1A and 1B , the spring clip needle guard  40   a  includes a distal arm  65  terminating at its upper end in a curved lip  66  and at its lower end in a U-shaped portion  67  which, in the ready position illustrated in  FIG. 1A , contacts a bump  68  formed in the lower inner wall of the catheter hub  26 . 
         [0034]    A transverse segment  69  having a central opening  70  extends proximally and upwardly and terminates at an upper U-shaped portion  72 . As disclosed in the &#39;630 patent, the opening is configured to clamp the needle in a used position, at points d and e, which have been added. A proximal end wall  74  having an opening  76  extends vertically from portion  72  and then extends distally in a horizontal lower segment  78 , which has an opening  80  through which the lower halves of the distal arm  65  and the transverse segment  69  extend in the ready position of the needle guard. Segment  78 , at its distal end, extends upwardly at a front wall  82  which has a central opening  84  axially aligned with openings  70 ,  76 . At its upper end, the distal front wall  82  extends in the proximal direction in an upper segment  86 , which, as shown in  FIG. 1A , contacts the upper inner wall of the catheter hub along substantially its entire length. 
         [0035]    When the catheter is in the ready position, the needle shaft passes through openings  70 ,  76  and  84  and rests on the curved lip  66 , which urges the arm  65  against the bump  68  in the lower wall of the catheter hub. That engagement, along with the resilient engagement of the upper segment  86  with the upper interior wall of the catheter hub, retains the spring clip  40   a  in its ready position within the catheter hub. 
         [0036]    When the needle hub  12  and needle  16  are retracted to the right, as viewed in  FIG. 1A , by a sufficient amount, the needle tip  18  moves proximal of the lip  66  and eventually passes below the lip  66 . When this occurs, the downward force on the arm  65  releases thus allowing the arm  65  to snap upwards to the retracted position illustrated in  FIG. 4B , in which the arm  65  and the lip  66  extend over the needle tip  18  to thereby prevent accidental contact with the needle tip. In this condition, the needle guard  40   a  is clamped onto the needle shaft  16  at points d and e of opening  70  and the needle and needle guard clamped thereto can be readily removed from the catheter hub. 
         [0037]    While the prior art tip protector  40   a  shown in  FIGS. 1A and 1B  is well-designed for its intended purposes, there remains a number of improvements to the tip protector  40   a  that could be made to make it more reliable, effective, and easier to manufacture. 
         [0038]    With reference now to  FIG. 2 , a tip protector provided in accordance with aspects of the present invention is shown, which is generally designated  100 . In one exemplary embodiment, the tip protector  100  comprises a first protector body (See, also  FIG. 5 )  102  surrounded, at least in part, by a second protector body  104 . 
         [0039]    In one embodiment, the second protector body  104  comprises a distal wall  106  comprising an opening  108 , which is preferably circular in configuration. A plurality of walls extend distally of the distal wall  106 , which include two side walls  110 A,  110 B and a deflector wall, plate, or arm  112 . The second protector body  104  is preferably formed from a single stamped or cut-out stainless steel sheet resembling a “T”, which has a circular cut-out  108  at the intersection of the three branches of the “T” for forming the opening  108  on the distal wall  106 . In one exemplary embodiment, the intersection of the T-shape sheet is pressed against a metal form or die, such as carbide, which then forms the curvilinear perimeter contour  114  around the perimeter of the distal wall  106  while concurrently pushing the two side walls  110 A,  110 B and the deflector plate  112  proximally. A bottom perimeter contour can also formed by this process. 
         [0040]    In one exemplary embodiment, the edges  116  of the two side walls  110 A,  110 B and the deflector plate  112  are formed fitted in the same die used to form the curvilinear perimeter contour  114  of the distal wall  106 . Thus, the intersections  118  between the two side walls  110 A,  110 B and the deflector plate  112  are generally curved or smooth rather than at right angles (also shown in  FIGS. 6 and 7 ). As further discussed below, the smooth edges  116  allow the tip protector  100  to contact an interior surface of a clip housing or catheter hub over a larger surface area as compared to corners having a simple right-angle, which would result in a single point contact. The side walls and deflector plate are preferably close enough together to shield the needle tip from view and catch any drop of blood that may drip from the needle while inside the needle tip. 
         [0041]    In one exemplary embodiment, a projection or dimple  120  is incorporated on the deflector plate  112  for delimiting needle movement in an activated position, as further discussed below. The width of the dimple section  120 , extending from one side wall  110 A to another side wall  110 B, is slightly less than the width of the deflector plate immediately proximally and distally of the dimple section. The dissimilar widths along the deflector plate  112  allow the dimple  120  to be formed following formations of the smooth corners  116 . However, the tip protector  100  may incorporate right angle corners at the various intersections  118  and the deflector plate  112  having a uniform width, which are less preferred, without deviating from the spirit and scope of the present invention. An optional opening  122  may be incorporated on the deflector plate  112  for ease of assembly. For example a pin (not shown) could be inserted through the opening  122  to push the arm  140  ( FIG. 5 ) of the first protector body downwards. This could assist in assembling the butt end of a cannula or needle through the protector. Preferably the opening is not necessary as the distal wall  150  of the first protector body  102  is formed at an angle thus allowing the butt end of the cannula to simply deflect the distal wall downwards for an automatic assembly. 
         [0042]      FIG. 3  is a top view of the tip protector  100  of  FIG. 2 . In one exemplary embodiment, a reduced proximal section  124  is incorporated on the deflector plate  112 , which has a smaller width dimension that the section immediately distally. A gap  126  is created on each side of the reduced proximal section  124 , which is defined in part by each side wall  110 A,  110 B and the reduced proximal portion  124 . The two gaps  126 , however, can be filled by keeping the same width the entire length of the deflector plate  112 . 
         [0043]    In one exemplary embodiment, a side wall attachment plate  128 A,  128 B is incorporated at a proximal end of each side wall  110 A,  110 B. If a centerline or axis is drawn lengthwise of the tip protector  100 , the two side wall attachment plates  128 A,  128 B are positioned orthogonally of the axis and are generally coplanar. However, the two attachment plates  128 A,  128 B can overlap and be non-coplanar without deviating from the spirit and scope of the present invention. As further discussed below, the two attachment plates  128 A,  128 B are means by which the second protector body  104  attaches to the first protector body  102 . 
         [0044]      FIG. 4  is a bottom view of the tip protector  100  of  FIG. 2 . The first protector body  102  is clearly shown positioned between the two side walls  110 A,  110 B of the second protector body  104 . In one exemplary embodiment, an arm  130  for stabilizing the tip protector  100  within a housing or hub is incorporated. The arm  130  extends distally from a proximal wall  132  (See also  FIG. 5 ) and includes a bend or apex  133  defined by an upstream section  134  positioned at an angle to a downstream section  136  (See also  FIG. 5 ). As further discussed below, the arm  130  is configured to pivot, flex, or cantilevered about a point  138  at a proximal end of the tip protector  100 , which acts like a hinge. The proximal wall  132  and the two attachment plates  128 A,  128 B together define a protector proximal end  129 . 
         [0045]    An arm  140 , of relatively longer length than the arm  130  for stabilizing, for blocking a needle tip also extends from the proximal wall  132 . In one exemplary embodiment, the arm  140  comprises an opening  142  and two ribs  144 . Preferably, the opening  142  has an oblong shape and the two ribs  144  are formed by a coining process. The arm  140  further includes a forearm section  146 , a return section  148  ( FIG. 5 ), a distal wall  150  ( FIG. 5 ) for blocking a needle tip, and an end section or finger  152  ( FIG. 5 ) for overlapping a portion of the needle in the used position. Together, the forearm section  146 , the return section  148 , the distal wall  150 , and the finger  152  are collectively referred to herein as a distal arm blocking section. In one exemplary embodiment, the section of the arm with the opening  142  is wider than the remaining arm sections. This configuration provides room to not only incorporate the opening  142  but also the two coined ribs  144 . Alternatively, a tab or flab may be incorporated on each edge of the arm section and then bending them to form two ribs. The alternative arm, without the coined ribs, may have a uniform width throughout. 
         [0046]      FIG. 5  is a cross-sectional side view of the tip protector of  FIG. 4  taken along line  5 - 5 . The two arms  130 ,  140  can be seen extending from two different edges of the proximal wall  132 . As shown in  FIG. 11 , when the tip protector  100  is positioned on a needle, the two arms originate from opposite side of the needle, viewed from a needle centerline. However, the longer arm  140  extends distally of the proximal wall  132  at an angle and transects the needle axis, with the needle passing through the opening  142  on the arm. The short arm  130 , however, does not touch or intersect the needle. More preferably, the end edge  154  of the short arm  130  is spaced apart from the needle, both in a ready to use position and a used position. 
         [0047]    As further discussed below, when the tip protector  100  is in a ready to use position, the long arm  140  is biased radially outwardly towards the short arm  130  and the finger  152  in contact with a side of the needle. To that end, the long arm  140  is flexed, at least in part, about a point  156  at the proximal wall  132  when in abutting contact with a side of the needle. 
         [0048]    Referring again to  FIG. 3  in combination with  FIG. 5 , the deflector plate  112  is cantilevered from the perimeter contour  114  of the distal wall  106  of the second protector body  104 . This allows the whole deflector plate  112 , and more specifically the reduced proximal portion  124 , to deflect like a springboard. In one exemplary embodiment, the dimension between the apex  133  of the short arm  130  and the rounded edges  116  of the deflector plate  112  should be larger than the internal curvature of a housing the tip protector is to be placed into so that both the deflector plate  112  and the short arm  130  are biased inwardly by the wall surface of the housing. Said differently, when the tip protector  100  is mounted inside a housing, such as the catheter hub shown in  FIG. 11 , the tip protector is squeezed at the two rounded edges on the deflector plate  112  and the short arm  130 . This squeezing action allows the tip protector to be removeably secured to the housing or hub. 
         [0049]      FIG. 6  is an end view of the tip protector of  FIG. 5  taken along line  6 - 6 . The two side attachment plates  128 A,  128 B are shown in contact with the proximally facing surface of the proximal wall  132 . In one exemplary embodiment, the two attachment plates  128 A,  128 B are welded, using ultrasound, high frequency welding, or laser, to the proximal wall  130 . An opening  158  is incorporated on the proximal wall  130  of the first protector body  102  for receiving a needle (not shown). The two attachment walls  128 A,  128 B both incorporate cut-outs  160  resembling two semi-circles that together have a larger diameter than the opening  158  on the proximal wall  130 . Alternatively, the two attachment walls  128 A,  128 B can overlap one another and each incorporating a separate opening having a larger diameter than the diameter on the opening  158  of the proximal wall. 
         [0050]      FIG. 7  is a front view of the tip protector  100  of  FIG. 5  taken along line  7 - 7 . As clearly shown, the second protector body  104  incorporates a plurality of walled structures, namely the two side walls  110 A,  110 B and the deflector plate  112 , a front wall  106 , and two attachment walls  128 A,  128 B (not shown) to form an enclosure comprising a cavity  155  and a central access opening  162  (See also  FIG. 5 ). With reference to  FIGS. 5 and 6  in addition to  FIG. 7 , the short arm  130  projects out through the central access opening  162  to provide a contact point between the tip protector and a housing, such as a catheter hub. The long arm  140  ( FIG. 5 ) similarly projects out through the central access opening  162  when in a ready-to-use position but moves into the cavity  155  when in a used position, as further discussed below. 
         [0051]      FIG. 8  is a cross-sectional side view of the first protector body  102  of  FIG. 1 , shown without the second protector body  104 . In one exemplary embodiment, the first protector body  102  is formed from an single integral stainless steel sheet. The opening  142  should be stamped and the two ribs  144  coined before the first protector body  102  is formed to the shape shown in  FIG. 8 . 
         [0052]      FIG. 9  is a cross-sectional end view of the first protector body  102  of  FIG. 8  taken along line  9 - 9 . Part of the two ribs  144 , the opening  142  between the two ribs, and the proximal wall  132  are shown. 
         [0053]      FIG. 10  is an end view of the first body section  102  of  FIG. 8  taken alone line  10 - 10 . Part of the oblong opening  142  and the distal wall  150  can be seen through the opening  158  on the proximal wall  132 . In one exemplary embodiment, four cut-outs  164  are formed at each corner of the proximal wall  132 . The cut-outs  164  are configured to reduce the amount of spring force the two arms  130  and  140  generate. The amount of cut out can be varied to obtain a desired spring force. 
         [0054]    With reference again to  FIG. 5 , the tip protector disclosed herein may be viewed as a device having a housing with three moveable arms  112 ,  130 , and  140 . The tip protector may also be viewed as having a housing with a deflector plate or arm with a tip protector disposed therein having an arm for blocking a needle tip and an arm, together with the deflector plate, for resiliently securing the tip protector to a hub or clip housing. 
         [0055]      FIG. 11  is a semi-schematic cross-sectional side view of a catheter assembly  166  incorporating the tip protector  100  of  FIGS. 2-10 . Broadly speaking, the catheter assembly  168  comprises a needle hub comprising a needle  170  attached thereto. The needle  170  comprises a sharpened needle tip  172 , a non-uniform needle section  175  ( FIG. 13 ), and projects through the tip protector  100 , the catheter hub  174 , and the catheter tube  176 . The non-uniform needle section  175  may be a crimp, a material build-up, a bend, or combinations thereof. In a preferred embodiment, the needle hub  168  incorporates a nose section  178  that projects into the interior wall surface  180  of the catheter hub  174 . The nose section  178  is configured to push the protector proximal end  129  of the tip protector  100  to a desired depth or length inside the cavity  182  defined by the wall surface  180  of the catheter hub  174  in the ready to use position ( FIG. 11 ). 
         [0056]    In one exemplary embodiment, the cavity  182  includes a recessed section  184 , which may extend the entire internal circumference of the cavity along a band or width or a partial circumference, as shown. The recessed section  184  provides added space for the distal end of the first body section  102  so as to reduce the amount of compression or biasing force on the finger section  152  and the return section  148 . This in turn, reduces the drag between the finger section  152  and the side of the needle  170  during relative movement between the needle and the tip protector  100 . Obviously, the needle assembly  166  may be practiced without the recessed section  184 , but not as preferred. 
         [0057]    As shown, the recessed section  184  comprises a proximal tapered section  186  and a distal tapered section. With reference to  FIG. 5  in addition to  FIG. 11 , the forearm section  146 , the return section  148 , and the distal wall  150  of the first body section  102  are all positioned distally of and spaced apart from the proximal tapered section  186 . The space apart configuration is incorporated as physical contact between the proximal tapered section  186  and the distal arm blocking section is not required to maintain a fixed relationship between the catheter hub  174  and the tip protector  100  during movement of the needle hub  168  relative to the catheter hub. However, contact between the two may be incorporated without deviating from the spirit and scope of the present invention. 
         [0058]    Referring now to  FIG. 12 , which is a cross-sectional end view of the catheter assembly of  FIG. 11  taken along line  12 - 12 , the tip protector  100  is shown contacting the interior wall surface  180  of the catheter hub  174  at the two curbed edges  116  on the deflector plate  112  and two edges of the short arm  130 , in the general area of the apex  133 . The four contact points are shown in  FIG. 12  with four contact arrows. Thus, in one exemplary embodiment, an arm  130  is cantilevered from a proximal end of the first protector body  102  and another arm  112  is cantilevered from a distal end of the second protector body  104  to retain the tip protector  100  within a catheter hub. Said differently, a tip protector is herein provided having an arm cantilevered from a proximal wall of a protector housing and a second arm cantilevered from a distal wall of the same protector housing. In an alternative embodiment, the cantilever arm  112  is eliminated and the two side walls  110 A,  110 B along with the short arm  130  are configured to removeably secure the alternative tip protector to a housing, such as a catheter hub or a clip housing. 
         [0059]      FIG. 13  is a partial cross-sectional side view of the catheter assembly  166  of  FIG. 11 , shown in a used position, with the needle  170  retracted to the right of  FIG. 11 . The tip protector  100 , hence the needle  170 , is moved to the used position shown in  FIG. 13  by holding the catheter hub  174  in one hand while withdrawing the needle hub  168  to the right of  FIG. 11  (or vice-versa, i.e., holding the needle hub  168  while moving the catheter hub  174  to the left of  FIG. 11 ). As the needle tip  172  moves proximally of the finger section  152 , the biasing force acting on the arm  140  is removed thus allowing the arm to recoil to its less flexed state, which is shown in  FIG. 13 . As the needle hub  168  continues to move to the right, the non-uniform section  175  on the needle  170 , which has a larger cross-sectional dimension than the opening  158  on the proximal wall  132  of the first protector body  102 , contacts the opening  168  and pulls the proximal wall, via the engagement with the perimeter of the opening  168 , to the right. If the pulling force on the proximal wall  132  is greater than the friction force between the cantilever arm  112 , the short arm  130 , and the interior surface  180  of the catheter hub, the friction is overcome and the tip protector  100  disengages from the catheter hub. 
         [0060]      FIG. 14  shows the tip protector  100  removed from the catheter hub  174  and the distal wall  150  blocking the needle tip. As the tip protector incorporates two side walls  110 A,  110 B, and a deflector plate  112 , the tip protector covers about three quarters of the circumference of the needle  170  proximate the needle tip. The remaining section of the needle  170  proximate the needle tip  172  is also partly covered by the short arm  130  and the distal blocking section of the first protector body  102 . The needle tip is shielded from view or contact. Blood, which may drip from the needle tip, is configured to be caught by one of the walls. 
         [0061]    As shown in  FIG. 14 , if a force is exerted at the distal end of the tip protector near point  189 , the needle  170  could pivot away from the shielding provided by the finger section  152  and manipulated so that it re-emerges out the opening  108  of the distal wall  106  of the second protector body  104 . Accordingly, in one exemplary embodiment, the dimple or projection  120  on the deflector plate  112  is configured to inhibit or delimit movement of the needle in the event of a direct or incidental force on the tip protector at or near point  189 . The projection  120  is configured to prevent movement of the needle tip  172  radially of the finger section  152 . 
         [0062]      FIG. 15  is a semi-schematic perspective view of a second protector body  188  provided in accordance with aspects of the present invention. The alternative second protector body  188  may cooperate with the first protector body shown in  FIGS. 8-10  to form an alternative tip protector. In one exemplary embodiment, the alternative second protector body  188  incorporates a deflector plate  190  comprising a generally curvilinear external surface, a tab  192  formed by making a cut-out  194  on the deflector plate and including two relief points  196 . The tab  192 , like the projection or dimple  120  on the prior second protector body, is configured to prevent a needle from pivoting out from the tip protector internal space. In one exemplary embodiment, the deflector plate  190  is integrally formed to the side walls  110 A and  110 B. This can be done, for example, using a deep draw forming process. Still alternatively, the two side walls  110 A,  110 B and the deflector plate  190  may have a notch of cut-out between them. 
         [0063]    In one exemplary embodiment, a least a portion of the curvilinear external surface of the deflector plate  190  is configured to contact the interior surface of a catheter hub when the same is placed therein as part of a catheter assembly. Alternatively, the deflector plate  190  incorporates a flat surface such that only the two side edges  198  with the two side walls  110 A,  110 B contact the interior surface of the catheter hub or clip housing. 
         [0064]    Although limited embodiments of the tip protector and needle devices incorporating the tip protector have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the tip protector described herein may be used in combination with a sleeve on a needle having a bend such as that shown in U.S. Pat. No. 6,585,704 to Luther et al. Alternatively, the tip protector described herein may be used with an outer housing on a needle for use with a syringe, such as that shown in U.S. Pat. No. 6,595,955 to Fergusson et al. Still alternatively, the tip protector described herein may be used with a grip part for sliding the tip protector along a needle, such as that shown in Ser. No. 10/856,315, entitled PROTECTIVE DEVICE FOR AN INJECTION NEEDLE. The foregoing patents and application are expressly incorporated herein by reference as if set forth in full. Accordingly, it is to be understood that the tip protector and its 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.

Technology Category: 1