HK1177157B - Needle tip protector housing positioned inside a catheter hub - Google Patents

Description

Needle tip protector housing within a catheter hub

Technical Field

Needle assemblies are generally discussed herein, and specifically, needle assemblies having a tip protector that includes an enclosing wall for preventing contact with a needle tip from one side.

Background

The insertion process of an IV catheter assembly comprises four basic steps: (1) medical personnel insert the needle and catheter together into a patient's vein (vein); (2) after insertion into a vein with the needle tip, the medical professional pushes the catheter with his or her finger, advancing the catheter into the patient's vein; (3) the medical professional withdraws the needle by grasping the hub end (opposite the needle tip) while applying pressure to the patient's skin at the insertion site with his or her empty hand; and (4) the medical professional then ties the currently inserted catheter to the patient's skin with a band and connects the exposed end of the catheter (catheter hub) to a fluid source that will administer the drug into the patient's vein.

The problem is that immediately after the needle is withdrawn from the patient's vein, the medical staff, who at this point involves at least two emergency procedures, must immediately place the exposed needle tip in a nearby position and perform the work required to complete the needle withdrawal. The exposed needle tip at this critical time creates a risk of accidental needle sticks, in which case medical personnel are exposed to a variety of dangerous blood-borne (blood-borne) pathogen infections, including AIDS and hepatitis.

Other types of needles also expose medical personnel to the risk of accidental needle sticks. For example, a physician administering an injection using a straight needle, a Huber needle, an epidural needle, or the like, may place the used needle in a tray for subsequent disposal by a nurse. Used needles are a potential source of disease transmission for personnel working near or around the needle during the period between the time the used needle is placed in a tray or a working site and the time the needle is discarded. Therefore, all needles should be covered immediately after use to ensure a greater degree of safety for the user. Ideally, the procedure of covering the needle tip should be passive, self-activating, or at least simple to perform. Furthermore, the device covering the needle should be reliable and robust.

Disclosure of Invention

According to an aspect of the invention, a needle tip protector is provided that blocks a needle tip and prevents direct contact with the needle tip.

More preferably, the tip protector incorporates a plurality of side walls for shielding the tip from view and exposure to blood dripping from inside the tip.

In another aspect of the invention, a deflection plate is provided to deflect the needle to prevent the needle from inadvertently re-emerging from within the tip protector.

In yet another aspect of the present invention, the deflector plate is at least partially used to position the tip protector within a housing.

It is another object of the present invention to incorporate the needle tip protector in a safety IV catheter for automatically shielding the needle tip upon removal of the needle from the catheter tube by resilient engagement between the needle tip protector and the catheter hub. The resilient engagement allows for relatively smoother release without having to reduce standard manufacturing tolerances.

Aspects of the invention may be practiced by providing a tip protector for blocking a needle tip, the tip protector comprising: a tip protector housing located within a hub having an inner surface; a needle passing through the needle tip protector and the housing; a first arm extending from a distal wall of the tip protector housing biased against the inner surface; a second arm extending from a proximal wall of the tip protector housing biased against the inner surface; and a third arm extending from the proximal wall of the tip protector housing, biased against a side of the needle.

The invention may be practiced by providing a tip protector for mounting on a needle to shield the needle tip, the tip protector comprising: a first protector body comprising a proximal wall and an arm extending distally of the proximal wall; the arm further includes: a distal wall at one end of the arm for blocking the needle tip; a non-uniform arm width for accommodating a needle extending from between the proximal and distal walls; a second protector body attached to the first protector body, the second protector body including a distal wall and two side walls defining a cavity for receiving the first protector body; and a deflector plate comprising a protrusion extending into the cavity, the protrusion and the distal wall at the end of the arm configured to limit distal movement of a needle tip toward the distal wall of the second protector body.

In a further aspect of the invention there is provided a tip protector for mounting on a needle to shield a needle tip, the tip protector comprising: a first protector body attached to a second protector body, the first protector body comprising a proximal wall and an arm extending distally of the proximal wall, the arm comprising a distal end of the arm; the second protector body comprises two side walls and two end walls defining a cavity for housing the first protector body; the two sidewalls each comprise a first edge and a second edge; a deflector plate comprising a protrusion extending into the cavity, the deflector plate configured to deflect and move relative to both the first edge and the second edge; and wherein the projection and the distal end of the arm are configured to be located 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.

In yet another aspect of the present invention, there is provided a needle assembly comprising: a housing including a wall having an interior wall surface defining a cavity in which the tip protector is disposed; a needle having a needle shaft with a first side and a second side defined by a centerline and a needle tip passing through the housing and the needle tip protector; the tip protector comprises a distal wall, two side walls, a proximal wall, a first arm extending from the proximal wall towards the distal wall, a second arm shorter than the first arm and extending from the proximal wall, and a wall opposite the second arm; and wherein a wall opposite the second arm and the second arm are both biased against an inner wall surface of the housing.

Other aspects and features of the tip protectors provided herein will be better understood with reference to the specification, claims and drawings.

Drawings

The drawings comprise:

FIGS. 1A and 1B are semi-schematic partial cross-sectional views of a prior art safety IV catheter incorporating a needle tip protector comprising an upper wall and two side walls;

fig. 2 is a semi-schematic perspective view of a tip protector provided in accordance with aspects of the present invention, the tip protector including first and second protector bodies for blocking a needle tip;

FIG. 3 is a top view of the tip protector of FIG. 2;

FIG. 4 is a bottom view of the tip protector of FIG. 2;

FIG. 5 is a semi-schematic cross-sectional side view of the clamp of FIG. 4 taken along line 5-5;

FIG. 6 is a semi-schematic end view of the clamp of FIG. 5 taken along line 6-6;

FIG. 7 is a semi-schematic front view of the clamp of FIG. 5 taken along line 7-7;

fig. 8 is a semi-schematic cross-sectional side view of the first protector body shown in fig. 2, without showing the second protector body;

FIG. 9 is a semi-schematic cross-sectional end view of the arm of the first protector body of FIG. 8 taken along line 9-9;

FIG. 10 is a semi-schematic end view of the first protector body of FIG. 8 taken along line 10-10;

FIG. 11 is a semi-schematic cross-sectional side view of a catheter assembly incorporating the tip protector of FIG. 2, shown with the tip protector in a ready-to-use position;

FIG. 12 is a cross-sectional end view of the catheter assembly of FIG. 11 taken along line 12-12;

FIG. 13 is a partial cross-sectional side view of the catheter assembly of FIG. 11 in a used position with the needle hub retracted from the catheter tube and the tip protector blocking the needle tip;

FIG. 14 is a partial cross-sectional side view with the needle hub completely removed from the catheter hub, with the tip protector of FIG. 2 left on the needle to block the needle tip; and is

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

The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of a needle tip protector for use with multiple 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 utilizing 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 that are also intended to be encompassed within the spirit and scope of the invention, particularly embodiments incorporating combinations of features shown in the different embodiments encompassed herein. When referred to elsewhere herein, the same reference numerals are intended to indicate the same or similar elements or features.

FIGS. 1A and 1B illustrate a prior art spring clip needle guard (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-reference purposes, fig. 1A and 1B shown herein are labeled and discussed in the' 630 patent as fig. 4A and 4B. As shown and reproduced herein in fig. 1A and 1B, the spring clip needle guard 40a includes a distal arm 65, the distal arm 65 terminating at an upper end thereof with a curved lip 66 and at a lower end thereof with a U-shaped portion 67, the U-shaped portion 67 in the ready position shown in fig. 1A contacting a tab 68 formed in the lower interior wall of the catheter hub 26.

A transverse segment 69 having a central opening 70 extends proximally and upwardly and terminates in an upper U-shaped portion 72. As disclosed in the' 630 patent, the opening is configured to hold the needle in the used position, i.e., at points d and e, which have been added. A proximal wall 74 with an opening 76 extends perpendicularly from the portion 72 and then distally in a horizontal lower section 78, the lower section 78 having an opening 80 through which the distal arm 65 and the lower half of the transverse section 69 extend in the ready position of the needle guard. Segment 78 extends upwardly at its distal end at a front wall 82, front wall 82 having a central opening 84 axially aligned with openings 70, 76. The distal front wall 82 extends in a proximal direction in an upper section 86 at its upper end, the upper section 86 contacting the upper inner wall of the catheter hub along substantially its entire length, as shown in fig. 1A.

When the catheter is in the ready position, the needle shaft passes through openings 70, 76 and 84 and rests on curved lip 66, and curved lip 66 pushes arm 65 against tab 68 in the lower wall of the catheter hub. This engagement, in conjunction with the resilient engagement of the upper segment 86 with the upper interior wall of the catheter hub, holds the spring clip 40a in a ready position in the catheter hub.

When needle hub 12 and needle 16 are retracted to the right a sufficient length, as shown in fig. 1A, needle tip 18 moves proximally of lip 66 and eventually passes under lip 66. At this point, the downward force on the arm 65 is released, allowing the arm 65 to snap upward to the retracted position shown in fig. 4B, in which the arm 65 and lip 66 extend over the needle tip 18, preventing accidental contact with the needle tip. In this case, the needle guard 40a is clamped on the needle shaft 16 at points d and e of the opening 70, and the needle guard clamped thereon can be easily removed from the catheter hub.

While the prior art tip protector 40a shown in fig. 1A and 1B is well designed for its intended use, there are improvements to the tip protector 40a that make it more reliable, efficient, and easier to manufacture.

Referring now to fig. 2, there is shown a tip protector, generally designated 100, designed according to an aspect of the present invention. In an exemplary embodiment, the tip protector 100 includes a first protector body (see also fig. 5) 102, the first protector body 102 being at least partially surrounded by a second protector body 104.

In one embodiment, the second protector body 104 includes a distal wall 106, the distal wall 106 including an opening 108 that is preferably of circular configuration. Extending distally of the distal wall 106 are a plurality of walls including two side walls 110A, 110B and a deflecting wall, plate or arm 112. The second protector body 104 is preferably formed from a single stamped or cut out piece of "T" -shaped stainless steel having a circular cut out 108 at the intersection of the three branches of the "T" for forming an opening 108 in the distal wall 106. In an exemplary embodiment, the intersection of the T-shaped tabs is pressed against a die, such as a stencil or a die, such as carbide, and then forms a curved perimeter profile 114 around the perimeter of the distal wall 106 while pushing the two sidewalls 110A, 110B and deflector plate 112 proximally. The bottom perimeter profile may also be formed by this process.

In one embodiment, the two sidewalls 110A, 110B and the edge 116 of the deflector plate 112 are formed to fit within the same mold used to form the curved perimeter profile 114 of the distal wall 106. Thus, the intersection 118 between the two sidewalls 110A, 110B and the deflection plate 112 is generally curved or smooth, rather than a right angle (as shown in FIGS. 6 and 7). As discussed further below, the smooth edge 116 allows the tip protector 100 to contact the inner surface of the clamp housing or catheter hub over a larger surface area than a corner with a simple right angle that would create a single point of contact. The side walls and deflector plate are preferably close enough to shield the needle tip from view and to trap within the needle tip any blood droplets that may drip from the needle.

In an exemplary embodiment, a protrusion or recess 120 is incorporated on the deflector plate 112 for limiting movement of the needle in the activated position, as discussed further below. The width of the recess 120 extending from one sidewall 110A to the other sidewall 110B is slightly less than the width of the deflector plate immediately proximal and distal to the recess. The different widths along the deflector plate 112 allow the recess 120 to be formed after the smooth edge 116 is formed. However, the tip protector 100 may incorporate right angle corners at each intersection 118 and have the deflection plate 112 have a uniform width (less preferred) without departing from the spirit and scope of the present invention. An optional opening 122 may be incorporated in the deflector plate 112 for ease of assembly. For example, a pin (not shown) may be inserted through the opening 122 to push the arm 140 (fig. 5) of the first protector body downward. This may facilitate assembly of the butt end of the cannula or needle through the protector. Preferably, the opening is not necessary when the distal wall 150 of the first protector body 102 is angled so that the abutment end of the sleeve can simply deflect the distal wall downward for automatic assembly.

Fig. 3 is a top view of the tip protector 100 of fig. 2. In an exemplary embodiment, a reduced proximal portion 124 is incorporated on the deflector plate 112, and the deflector plate 112 has a smaller width dimension immediately distal of the proximal portion 124. A gap 126 is formed on each side of the reduced proximal portion 124, the gap 126 being defined in part by the respective sidewalls 110A, 110B and the reduced proximal portion 124. However, both gaps 126 may be filled by maintaining the same width over the entire length of the deflector plate 112.

In one exemplary embodiment, a sidewall attachment plate 128A, 128B is incorporated at a proximal end of each sidewall 110A, 110B. If a centerline or axis is drawn along the lengthwise direction of the tip protector 100, the two sidewall attachment plates 128A, 128B are positioned orthogonal to the axis and are substantially coplanar. However, the two attachment plates 128A, 128B may overlap and not be coplanar without departing from the spirit and scope of the present invention. As discussed further below, these two attachment plates 128A, 128B are means of attaching the second protector body 104 to the first protector body 102.

Fig. 4 is a bottom view of the tip protector of fig. 2. The first protector body 102 is clearly shown between the two side walls 110A, 110B of the second protector body 104. In an exemplary embodiment, an arm 130 is incorporated for stabilizing the tip protector 100 in a housing or hub. Arm 130 extends distally from a proximal wall 132 (see also fig. 5) and includes a curve or apex 133 defined by an upstream portion 134 positioned at an angle to a downstream portion 136 (see also fig. 5). As discussed further below, arm 130 is configured to pivot, flex or hang about a point 138 at the proximal end of the tip protector 100, point 138 serving as a hinge. The proximal wall 132 and the two attachment plates 128A, 128B together define a protector proximal end 129.

An arm 140 of relatively longer length than the arm 130 for stabilization also extends from the proximal wall 132 for blocking the needle tip. In an exemplary embodiment, the arm 140 includes an opening 142 and two ribs 144. Preferably, the opening 142 is oblong and the two ribs 144 are formed by a coining process. The arm 140 further includes a forearm portion 146, a return portion 148 (fig. 5), a distal wall 150 (fig. 5) for blocking the needle tip, and an end or finger portion 152 (fig. 5) for covering a portion of the needle in the used position. Together, forearm portion 146, return portion 148, distal wall 150, and finger 152 are collectively referred to herein as a distal arm block. In an exemplary embodiment, the portion of the arm having the opening 142 is wider than the rest of the arm. This configuration provides space to not only engage the opening 142 but also to engage the two coined ribs 144. Alternatively, tabs or lipped flaps may be incorporated on each edge of the arms, which are then bent to form two ribs. The optional arms without embossed ribs may have a uniform width throughout.

Fig. 5 is a cross-sectional side view of the tip protector of fig. 4 taken along line 5-5. It can be seen that two arms 130, 140 extend 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 start from opposite sides of the needle (as viewed from the centerline of the needle). However, the longer arm 140 extends distally of the proximal wall 132 at an angle and intersects the axis of the needle, and the needle passes through an opening 142 in the arm. However, the short arm 130 does not contact or intersect the needle. More preferably, the end edge 154 of the short arm 130 is spaced from the needle in both the ready to use position and the used position.

As discussed further below, when the tip protector 100 is in the ready to use position, the long arm 140 is biased radially outward toward the short arm 130 and the finger 152 that contacts one side of the needle. To this end, the long arm 140 flexes at least partially about a point 156 at the proximal wall 132 when it abuts one side of the needle.

Referring again to fig. 3 in conjunction with fig. 5, the deflector plate 112 is suspended from a peripheral profile 114 of the distal wall 106 of the second protector body 104. This allows the entire deflector plate 112 (and more particularly the reduced proximal portion 124) to deflect similar to a diving board. In an exemplary embodiment, the dimension between the apex 133 of the short arm 130 and the rounded edge 116 of the deflection plate 112 should be greater than the inner curvature of the housing in which the tip protector is to be placed, such that both the deflection plate 112 and the short arm 130 are biased inwardly by the wall of the housing. In other words, when the tip protector 100 is mounted within a housing (e.g., a catheter hub as 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 enables the tip protector to be removably secured to the housing or hub.

Fig. 6 is an end view of the tip protector of fig. 5 taken along line 6-6. Two side attachment plates 128A, 128B are illustrated in contact with the proximal opposing surfaces of the proximal wall 132. In one exemplary embodiment, the two attachment plates 128A, 128B are welded to the proximal wall 132 using ultrasound, high frequency welding, or a laser. An opening 158 for receiving a needle (not shown) is incorporated in the proximal wall 132 of the first protector body 102. Both attachment walls 128A, 128B incorporate cutouts 160 resembling two semi-circles, the cutouts 160 together having a diameter larger than the diameter of the opening 158 in the proximal wall 132. Alternatively, the two attachment walls 128A, 128B may overlap each other and each incorporate a separate opening having a diameter larger than the diameter of the opening 158 of the proximal wall.

Fig. 7 is a front view of the tip protector 100 of fig. 5 taken along line 7-7. As best shown, the second protector body 104 incorporates a plurality of walled structures, namely two side walls 110A, 110B and a deflector 112, a front wall 106, and two attachment walls 128A, 128B (not shown), forming an enclosure including a cavity 155 and a central access opening 162 (see also fig. 5). Referring to fig. 5 and 6 in addition to fig. 7, the short arm 130 protrudes through the central access opening 162 to provide a point of contact between the tip protector and a housing such as a catheter hub. The long arm 140 (fig. 5) similarly protrudes through the central access opening 162 in the ready-to-use position, but moves into the cavity 155 in the used position, as discussed further below.

Fig. 8 is a cross-sectional side view of the first protector body 102 of fig. 1, without showing the second protector body 104. In an exemplary embodiment, the first protector body 102 is formed from a single unitary piece of stainless steel. Before the first protector body 102 is formed into the shape shown in fig. 8, the opening 142 should be punched out and the two ribs 144 should be stamped.

Fig. 9 is a cross-sectional end view of the first protector body 102 of fig. 8 taken along line 9-9. Portions of two ribs 144, an opening 142 between the two ribs, and the proximal wall 132 are shown.

Fig. 10 is an end view of the first protector body 102 of fig. 8 taken along line 10-10. Portions of the oblong opening 142 and the distal wall 150 may be visible through the opening 158 in the proximal wall 132. In one exemplary embodiment, four cutouts 164 are formed in each corner of the proximal wall 132. The notch 164 is configured to reduce the amount of spring force generated by the two arms 130 and 140. The size of the cut-outs can be varied to obtain the desired spring force.

Referring to fig. 5, the tip protector disclosed herein may be viewed as a device having a housing with three movable arms 112, 130, and 140. The tip protector may also be seen as having a housing with a deflector plate or arm in which the tip protector is arranged, the tip protector having an arm for blocking a needle tip and an arm for resiliently securing the tip protector to a hub or a clip housing together with the deflector plate.

Fig. 11 is a semi-schematic cross-sectional side view of a catheter assembly 166 incorporating the tip protector 100 of fig. 2-10. Broadly, the catheter assembly 168 includes a needle hub including a needle 170 attached thereto. The needle 170 includes a sharpened tip 172, a non-uniform needle portion 175 (fig. 13), and protrudes through the tip protector 100, the catheter hub 174, and the catheter tube 176. The non-uniform needle portion 175 may be a hemmed piece, a material accumulation piece, a bent piece, or a combination thereof. In a preferred embodiment, the needle hub 168 incorporates a nose 178, the nose 178 extending into an interior wall surface of the catheter hub 174. The male nose 178 is configured to push the protector proximal end 129 of the tip protector 100 to a desired depth or length within a cavity 182, the cavity 182 being defined by a wall 180 of the catheter hub 174 (fig. 11) in a ready-to-use position.

In an exemplary embodiment, the cavity 182 includes a recess 184, and the recess 184 may extend along the entire inner circumference of the cavity along a band or width or partial circumference, as shown. The recess 184 provides increased space for the distal end of the first protector body 102, thereby reducing the magnitude of the compressive or biasing force on the fingers 152 and return 148. This in turn reduces the drag between the fingers 152 and the side of the needle 170 during relative movement between the needle and the tip protector 100. It is apparent that the needle assembly 166 can be implemented without the recess 184, but is not preferred.

As shown, the recess 184 includes a proximal taper 186 and a distal taper. Referring to fig. 5 in addition to fig. 11, the forearm portion 146, the return portion 148 and the distal wall 150 of the first protector body 102 are all positioned distal of and spaced apart from the proximal taper 186. The spaced apart configuration is included because no physical contact is required between the proximal taper 186 and the distal arm stop 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, it is also possible to include contact between the two without departing from the spirit and scope of the present invention.

Referring now to FIG. 12, FIG. 12 is a cross-sectional end view of the catheter assembly of FIG. 11 taken along line 12-12 showing, in the general area of apex 133, tip protector 100 in contact with inner wall surface 180 of catheter hub 174 at two constrained edges 116 on deflector plate 112 and at two edges of short arm 130. Fig. 12 shows four contact points with four contact arrows. Thus, in one exemplary embodiment, the arm 130 is cantilevered from the proximal end of the first protector body 102 and the other arm 112 is cantilevered from the distal end of the second protector body 104 to retain the tip protector 100 in the catheter hub. In other words, the tip protector provided herein has an arm that depends from a proximal wall of the protector housing and a second arm that depends from a distal wall of the same protector housing. In an alternative embodiment, the suspension arm 112 is omitted and the two side walls 110A, 110B along with the short arm 130 are configured to removably secure the alternative tip protector to a housing, such as a catheter hub or a clip housing.

Fig. 13 is a partial cross-sectional side view of the catheter assembly 166 of fig. 11 in a used position with the needle 170 retracted to the right of fig. 11. The needle tip protector 100 (and thus the needle 170) is moved to the used position shown in fig. 13 by grasping the catheter hub 174 with one hand while withdrawing the needle hub 168 to the right in fig. 11 (and vice versa, i.e., grasping the needle hub 168 while moving the catheter hub 174 to the left in fig. 11). As the needle tip 172 moves proximally of the finger 152, the biasing force on the arm 140 is removed, allowing the arm to spring back to its less deflected state, which is shown in fig. 13. As the needle hub 168 continues to move to the right, the non-uniform needle portion 175 on the needle 170 contacts the opening 158 and pushes the proximal wall to the right via engagement with the periphery of the opening 158, wherein the non-uniform needle portion 175 is larger in cross-sectional size than the opening 158 on the proximal wall 132 of the first protector body 102. If the pulling force on the proximal wall 132 is greater than the friction between the suspension arms 112, the short arms 130 and the inner surface 180 of the catheter hub, then the friction is overcome and the tip protector 100 is separated from the catheter hub.

Fig. 14 shows the tip protector 100 removed from the catheter hub 174 and the distal wall 150 blocking the needle tip. When the tip protector incorporates two side walls 110A, 110B and a deflector plate 112, the tip protector covers approximately three quarters of the circumference of the needle 170 near the tip of the needle. The remaining portion of the needle 170 near the needle tip 172 is also partially covered by the short arm 130 and the distal barrier of the first protector body 102. The needle tip is shielded from view or contact. Blood that may drip from the needle tip is trapped by one of the walls.

As shown in fig. 14, if a force is applied at the distal end of the tip protector near point 189, the needle 170 may pivot away from the shield provided by the fingers 152 and be manipulated to reappear out of the opening 108 of the distal wall 106 of the second protector body 104. Thus, in one exemplary embodiment, the recesses or protrusions 120 on the deflector plate 112 are configured to impede or limit the movement of the needle in the event that a direct or incidental force is applied at or near the point 189 on the tip protector. The protrusion 120 is configured to prevent movement of the needle tip 172 in a radial direction of the finger 152.

Fig. 15 is a semi-schematic perspective view of a second protector body 188 provided in accordance with aspects of the present invention. The optional second protector body 188 may cooperate with the first protector body shown in fig. 8-10 to form an optional tip protector. In an exemplary embodiment, the optional second protector body 188 incorporates a deflector plate 190 and a tab 192, the deflector plate 190 including a generally curvilinear outer surface, the tab 192 being formed by making a cut 194 in the deflector plate and including two relief points (relief points) 196. The tab 192, similar to the protrusion or recess 120 on the existing second protector body, is configured to prevent the needle from pivoting out of the interior space of the tip protector. In an exemplary embodiment, the deflector plate 190 is integrally formed to the sidewalls 110A and 110B. This can be achieved, for example, by using a deep drawing (deep draw) forming process. Still alternatively, the two sidewalls 110A, 110B and deflector plate 190 may have a cut-out notch therebetween.

In an exemplary embodiment, at least a portion of the curvilinear outer surface of the deflector plate 190 is configured to contact the inner surface of the catheter hub when it is disposed therein as part of a catheter assembly. Optionally, the deflector plate 190 incorporates a flat surface such that only two side edges 198 and two side walls 110A, 110B are in contact with the inner surface of the catheter hub or clamp housing.

While limited embodiments of the tip protector and needle devices incorporating the tip protector have been specifically described and illustrated herein, it will be apparent to those skilled in the art that numerous modifications and variations can be made. For example, the tip protectors described herein may be used in conjunction with a sleeve on a needle having a bend, such as shown in U.S. patent No.6,585,704 to Luther et al. Alternatively, the tip protector described herein may be used with an outer housing on a needle used with a syringe, such as that shown in U.S. patent No.6,595,955 to Fergusson et al. Still alternatively, the tip protector described herein may be used with a grip portion FOR sliding the tip protector along the NEEDLE, such as shown in serial No.10/856,315 entitled PROTECTIVE DEVICE FOR AN INJECTION NEEDLE. The above patents and applications are expressly incorporated herein by reference as if fully set forth. Thus, it should be understood that a tip protector and its components constructed in accordance with the principles of the present invention may be practiced otherwise than as specifically described herein. The invention is also defined in the following claims.

Claims (11)

1. A needle tip protector for mounting on a needle to shield a needle tip, the needle tip protector comprising:

a first protector body comprising a proximal wall and an arm extending distally of the proximal wall; the arm further includes:

a distal wall at the end of the arm for blocking the needle tip;

a non-uniform arm width for accommodating a needle extending from between the proximal and distal walls;

a second protector body attached to the first protector body, the second protector body including a distal wall and two side walls defining a cavity for receiving the first protector body; and

a deflector plate including a protrusion extending into the cavity, the protrusion and the distal wall at an end of the arm configured to limit distal movement of a needle tip toward the distal wall of the second protector body.

2. The tip protector of claim 1, further comprising at least one rib on the arm.

3. The tip protector of claim 1, further comprising a finger on an end of the distal wall of the arm of the first protector body.

4. The tip protector of claim 1, further comprising a second arm shorter than the arm.

5. The tip protector of claim 1, wherein the arm includes an opening.

6. A needle tip protector for mounting on a needle to shield a needle tip, the needle tip protector comprising:

a first protector body attached to a second protector body;

a first protector body comprising a proximal wall and an arm extending distally of the proximal wall, the arm comprising a distal end of the arm;

a second protector body comprising two side walls and two end walls defining a cavity for receiving the first protector body; the two sidewalls each comprising a first edge and a second edge;

a deflector plate comprising a protrusion extending into the cavity, the deflector plate configured to deflect and move relative to both the first edge and the second edge; and is

Wherein the distal end of the arm and the protrusion are configured to be located on different sides of the needle shaft defined by the centerline when the tip protector is mounted on the needle and the tip protector is in the ready to use position.

7. The tip protector of claim 6, further comprising a rib formed by a stamping process.

8. The tip protector of claim 6, further comprising an opening in the arm.

9. The tip protector of claim 6, further comprising a second arm extending from the proximal wall of the first protector body.

10. The tip protector of claim 6, wherein the tip protector is at least partially disposed in the hub.

11. The tip protector of claim 6, wherein one of the first and second edges is constrained.