Needle tip protector housing positioned inside a catheter hub

[0001] The object of this study is to discuss needle sets, with particular regard to needle sets having a needle tip protector with closed walls to prevent contact with the needle tip from the outside.

BACKGROUND OF THE INVENTION [0002] The procedure for introducing an intravenous catheter kit comprises four basic steps: (1) a medical worker inserts a needle together with a catheter into a patient's vein; (2) after inserting the tip of the needle into the patient's vein, the medical worker moves the catheter deep into the vein, pushing it with his finger; (3) the medical worker removes the needle, grasping the cap (opposite the needle tip) and simultaneously pressing the patient's skin with the free hand at the injection site; and then (4) the medical worker attaches the catheter thus inserted to the patient's skin with adhesive tape and connects the exposed end of the catheter (catheter cap) to the source of fluid to be administered into the patient's vein.

[0003] The problem is that immediately after removing the needle from the patient's vein, a medical worker who is busy performing at least two urgent procedures at this time must place the exposed tip of the needle nearby and perform the tasks associated with removing the needle. In such situations, the exposed tip of the needle creates the risk of accidental needle injury, which in such circumstances may expose the medical worker to the risk of infection with dangerous blood-borne pathogens, including viruses that cause AIDS or hepatitis.

[0004] Other types of needles similarly expose medical workers to the risk of accidental needle injury. For example, a doctor who makes an injection using a simple needle, Huber needle, epidural anesthesia needle etc. can place the used needle on the tray for further disposal by a nurse. It is in the period between putting the used needle into a tray or workstation and the moment of its disposal that such used needle is a potential source of disease transmission to persons who work near such a needle or with such a needle. Accordingly, all needles immediately after use

EP 2 604 308 B1 should be shielded to increase occupational safety. Ideally, the needle tip shielding procedure should be effortless, self-starting, or at least straightforward. Needle protection equipment should also be reliable and durable.

[0005] WO 01/10488 AI relates to a device for preventing inadvertent contact with the needle tip (122), comprising a wire guide passing through the needle channel. The device housing (102) includes an internal chamber. The rotary element (110) is housed in a chamber having a distal hole and a proximal hole, the dimensions of which are chosen so as to allow the needle to pass through these holes. When the needle tip is inside the chamber and the needle is withdrawn from the bore of the distal rotary element, a spring (126) or similar compressible element places the rotary element in the needle locking position to prevent any further movement of the needle.

[0006] US2004 / 0236288 AI relates to a needle shielding assembly constructed to securely shield a sharp needle tip and to limit further movement of the needle tip using a tilting or deflecting plate after shielding the tip.

[0007] WO 99/08742 A1, US 6117108 and US 6616630 B1 relate, respectively, to intravenous catheter protection comprising a composite, resilient needle shield disposed in the catheter hub. The needle guard consists of a proximal arm or wall in which there is an opening through which the needle passes during axial movements. When withdrawing the needle from the catheter, it releases a force that previously prevented the movement of the needle guard in the catheter hub. This, in turn, causes the needle shield to be locked in a position in which its distal wall blocks access to the needle tip. Then the resilient needle shield and needle can be removed from the catheter hub.

[0008] EP 2 000 165 A1 relates to a safety guard located on the needle body that includes the long main body of the needle and a wider part thereof which is on the distal side of the main body of the needle and whose outer diameter is wider than the diameter of the main body of the needle. The shield can be moved from the first position - along the needle body axis - to the second position in which the shield protects the needle tip of the needle body. The cover consists of the body of the cover, which includes the first part,

Formed within a first opening adapted to receive the needle body as the needle body passes through the part; a second part formed with a second opening, and a third part adapted to connect the first and second parts.

[0009] US 2005/0075609 A1 describes needle protective clamps with a plurality of interlocking elements and forces influencing the locking of the needle tip and its protection. Exemplary needle clamps include those that have a safety device with an opening that moves radially from the inside to the outside when the needle moves proximal to the opening. Additional elements can be used, each of which will have a hole to extend the needle. As the needle moves proximal to the first hole of the first safety element, the holes of the other safety elements wedge the side of the needle, as a result of which the clamp is secured on the needle.

[0010] WO 01/93940 A2 relates to a kit with a needle according to the introduction to claim 1.

[0011] US 2005/0096592 A1 relates to a protective cover comprising a safety device, with a piercing element having a proximal tip, a distal tip, and defining a longitudinal axis. A protective shield reduces the occurrence of unintentional and unwanted cuts from a contaminated piercing element and limits exposure to pathogens. The clamp determines the size of the first chamber of a size that allows the longitudinal movement of the piercing element and is oriented in a transverse axis to the longitudinal axis. The first chamber can move between a movable position and a locked position. The clamp includes a first branch that defines a second chamber that has dimensions that allow the piercing member to move in the chamber, and a distal portion configured to connect it to the medical device. The clamp is also equipped with a second branch with a surface that allows the piercing element to be blocked. The branches are angled to make converging movements such that the first chamber is in the locking position and the distal portion of the first branch is detached from the medical device.

[0012] US 2005/0080378 A1 relates to a medical needle kit comprising a needle cannula which has a body and a tip. The tip is located at the distal end of the cannula. The elongated element has two ends - first and second. The first end is firmly attached to the needle cannula body at the connection point, and the second end extends radially out of the needle body. The shield is slidably attached to the needle, allowing movement between proximal and distal positions. The shield consists of a shield body having a central chamber, a distal tip and a proximal tip, and a plate attached to the shield body and specifying the size of the hole. When the sheath is in the distal position, the second end of the elongated member extends radially out of the needle body, preventing the elongated member from passing through the opening. This element can be attached to the cannula body to limit the movement of the shield relative to the needle.

[0013] US 2003/0060771 A1 relates to a catheter and an insertion kit with a needle having a needle attached to the needle hub and an enlarged section located immediately behind it, and with a tubular catheter in which the needle of the introducer is axially inserted into the catheter. The kit includes a needle tip protector positioned within the catheter hub and comprising at least one free, radiating outward edge disposed distal to the annular rib so as to maintain the shield within the hub. The sheath is equipped with a proximal hole located at the proximal end, having a free size larger than the diameter of the needle and smaller than the enlarged zone, so that when removing the needle from the catheter, the shield remains attached to the needle.

[0014] US 2005/0182362 A1 discloses a needle protector (1) based on a biasing plate (6) that engages to lock the needle shaft (2) both when removing the needle tip inside the protector (1) and whenever attempting to extend the needle end from the cover (1).

SUMMARY [0015] The invention includes a needle kit as defined in claim 1.

[0016] According to the assumptions of the present invention, the needle tip protector is designed to prevent direct contact with the needle tip.

[0017] More preferably, the needle tip protector has sidewalls completely covering the needle tip and protecting against contact with blood dripping from the center of the needle tip.

[0018] In a further embodiment of the present invention, the shield is equipped with a shielding plate, the purpose of which is to deflect the needle to prevent it from unintentionally sliding out of the tip protector.

[0019] In a further embodiment of the present invention, a shielding plate is used, at least in part, for positioning the tip protector within the housing.

[0020] Another object of the present invention is to incorporate the tip protector into a intravenous safety catheter to automatically shield the tip of the needle when removing the needle from the catheter tube using a flexible contact mechanism between the tip protector and the catheter hub. This flexible contact mechanism enables a relatively smoother release without having to reduce typical manufacturing tolerances.

[0021] Further disclosed is a tip protector for blocking the needle tip consisting of: a tip protector housing positioned within a cap having an internal surface; a needle passing through the tip protector and housing; a first element (arm) protruding from the distal wall of the tip protective housing against the internal surface; a second element (arm) extending from the wall of the proximal tip protective housing against the inner surface; and a third element (arm) extending from the wall of the proximal tip protective housing and the needle resting on the side.

[0022] Further disclosed is a needle protector for mounting on the needle to provide protection for the needle tip, consisting of: a first protector body consisting of a proximal wall and an element (arm) extending distally from the proximal wall; said arm in turn consists of: a distal wall at the end of the arm for blocking the needle tip; variable arm width to adapt to a needle protruding from between the proximal wall and the distal wall; the body of the second protective shield attached to the body of the first shield, wherein the body of the second protective shield consists of a distal wall

And two side walls forming a channel including the body of the first shell; and a shielding plate having a projection protruding into this channel, the projection and the distal wall at the end of the arm are configured to limit the movement of the needle tip distally from the distal wall of the body of the second protective shield.

[0023] Furthermore, a needle protector for being mounted on a needle is described to provide protection for the needle tip, consisting of: a first protector body attached to the second protector body; the body of the first shield consists of a proximal wall and an element (arm) consisting of a distal end of the arm extending distally from the proximal wall; the body of the second shell consists of two side walls and two end walls forming a channel for the body of the first shell; each of the two side walls has a first and a second edge; the shielding plate has a projection projecting into the channel, the shielding plate is configured to deflect and slide relative to both the first and second edges; and where the tab and the distal end of the arm are configured to be on different sides of the needle shaft defined by the centerline while the tip protector is mounted on the needle and the tip protector is in the ready-to-use position.

[0024] Furthermore, a needle assembly is also described comprising: a housing having a wall with an inner surface forming a channel with a needle tip protector disposed therein; a needle whose first side and second side are defined by the center line and the tip of the needle passing through the housing and the tip protector; a tip protector consisting of a distal wall, two side walls, a proximal wall, a first arm extending from the proximal wall towards the distal wall, a second arm that is shorter than the first arm extending from the proximal wall, and a wall opposite the second arm; and where the wall opposite to the second arm and the second arm are deflected relative to the surface of the inner wall of the housing.

[0025] Other implementations and features of the tip covers disclosed herein may be better appreciated when they become more easily understood by reference to the specifications, claims and the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

EP 2 604 308 B1 [0026] The following drawings are attached to the document:

FIGURES 1A and 1B are semi-schematic views of partial sections of an earlier solution for a safe intravenous catheter with a tip protector consisting of an upper wall and two side walls;

LYNX. 2 is a semi-schematic perspective view of a tip protector made according to the present invention having a first protector body and a second protector body for blocking the needle tip;

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

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

LYNX. 5 is a semi-schematic side view of the caliper in FIG. 4 made along lines 5-5;

LYNX. 6 is a semi-schematic rear view of the clamp from FIG. 5 made along lines 6-6;

LYNX. 7 is a semi-schematic front view of the caliper from FIG. 5 made along lines 7-7;

LYNX. 8 is a semi-schematic side view of the cross section of the body of the first shield 15 of FIG. 2 shown without the body of the second cover.

LYNX. 9 is a semi-schematic cross-sectional view of the end of the arm of the first shell in FIG. 8 made along lines 9-9;

LYNX. 10 is a semi-schematic end view of the first shield body of FIG. 8 along lines 10-10;

LYNX. 11 is a semi-schematic side view of a catheter assembly including the tip protector of FIG. 2 shown in the position ready for use.

LYNX. 12 is a cross-sectional view of the end of the catheter assembly of FIG. 11 made along lines 12-12;

LYNX. 13 is a side view of a partial section of the catheter assembly of FIG. 11 with the needle hub removed from the catheter tube and the tip protector blocking the needle tip in the post-use position;

EP 2 604 308 B1

LYNX. 14 is a side view of a partial cross section of the needle hub completely removed from the catheter hub with the tip protector in FIG. 2 remaining on the needle to block the needle tip; and

LYNX. 15 is a semi-schematic perspective view of an alternative body of the second shell made in accordance with the present invention.

DETAILED DESCRIPTION [0027] The purpose of the following detailed description of the invention, together with the accompanying drawings, is to describe the currently preferred methods for making the tip protector for the various needles or needle sets provided in accordance with the present invention. This description defines the features and the next steps regarding the construction and use of the tip protector encompassed by the present invention in combination with illustrations of exemplary embodiments. It is understood, however, that the same or equivalent functions and structures can be achieved by other implementations that are also intended to fall within the scope of the present invention. As indicated elsewhere in this document, similar item numbers are intended to indicate similar or similar items or features.

[0028] FIGURES 1A and 1B show a spring clip needle cover known in the art and described in US Patent No. 6,616,630 by Woehr et al. For comparative purposes, FIGURES 1A and 1B presented herein are designated and discussed in the '630 patent as FIGURES 4A and 4B. As shown and reproduced above in FIGURES 1A and 1B, the needle protector with a spring clip 40a includes a distal arm 65 ending at its upper end with a bail 66 and at its end a lower U-shaped element 67, which in position ready for work shown in FIG. 1A, contacts the stop 68 formed in the lower inner wall of the catheter hub 26.

[0029] Transverse segment 69 having a central hole 70 proximal and upwardly extends and ends in a U-shaped top member 72. As disclosed in the '630 patent, the hole is configured to lock the needle in a position after use in die points that have been added. The wall of the proximal end 74, having an opening 76, extends vertically from the element 72 and then extends distally in the 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-to-use position of the needle shield. The segment 78, at its distal end, extends upwards at the front wall 82 having a central opening 84, aligned axially with the holes 70, 76. At its upper end, the distal front wall 82 extends proximal in the upper segment 86, which is shown it's in FIG. 1A, contacts the upper inner wall of the catheter hub substantially along its entire length.

[0030] When the catheter is in the ready to use position, the needle shaft passes through the holes 70, 76 and 84, and then rests on the bow 66, which presses the arm 65 against the stop 68 in the bottom wall of the catheter hub. This engagement, together with the elastic engagement of the upper segment 86 with the upper inner wall of the catheter hub, maintains the spring clip 40a in its ready position for use inside the catheter hub.

[0031] When the needle cap 12 and needle 16 are moved to the right as shown in FIG. 1A, to the appropriate extent, the tip of the needle 18 moves proximally from edge 66 to finally pass under edge 66. When this happens, the downward force on arm 65 is released, allowing arm 65 to move upward to the retracted position shown in FIG. 4B, in which the arm 65 and the edge 66 extend over the tip of the needle 18, thereby preventing accidental contact with the needle tip. Under these conditions, the needle shield 40a is clamped on the needle body 16 at the die points of the opening 70, and the needle and the needle shield clamped on it can easily be removed from the catheter hub.

[0032] While the prior art tip protector 40a shown in FIGURES 1A and 1B has been appropriately designed for its intended purpose, there remain a number of improvements to the tip protector 40a that can be made to make it more reliable, efficient and easier to manufacture. .

[0033] Referring now to FIG. 2, it shows a tip protector in accordance with the present invention; which is generally designated 100. In one exemplary embodiment, the tip protector 100 consists of a first protector body (see also FIG. 5) 102 surrounded, at least in part, by the second protector body 104.

[0034] In another embodiment, the body of the second shell 104 has a distal wall 106 having an opening 108, which is more preferably of a circular configuration. The series of walls extends distally from the distal wall 106, including two side walls 110A, 110B and a shielding wall, plate or arm 112. More preferably, the body of the second shell 104 is made of a single molding or blank pattern of a "T" -like stainless steel sheet that has a circular cutout 108 at the intersection of the three "T" arms to form a hole 108 on the distal wall 106. In one example execution, the point of intersection of the arms of the "T" sheet is pressed against a metal mold or matrix, e.g. made of carbide, which then forms a curvilinear contour 114 around the periphery of distal wall 106, while proximal shifting the two side walls 110A, 110B and shielding plate 112. The lower perimeter may also be formed by this process.

[0035] In one exemplary embodiment, the edges 116 of the two side walls 110A, 110B and the shielding plate 112 are formed using the same matrix used to form the curvilinear contour of the distal wall 106. Thus, the intersection points 118 between the two side walls 110A, 110B and shielding plate 112 are, as a rule, curved or smooth rather than set at right angles (see also FIGURES 6 and 7). As discussed below, the smooth edges 116 allow the tip sheath 100 to contact the inside surface of the caliper housing or catheter hub over a larger surface area compared to the corners with the usual right angles giving one point of contact. More preferably, the sidewalls and shielding plate are close enough to shield the needle tip and catch any drop of blood that may drip from the center of the needle tip. [0036] In one exemplary embodiment, a projection or recess 120 is used in the shielding plate 112 in to limit the movement of the needle in the active position as discussed below. The width of the cavity section 120 extending from one side wall 110A to the other side wall 110B is slightly smaller than the width of the screening plate located directly proximal and distal from the cavity section. The varying widths along the screening plate 112 allow the recess 120 to be formed after smooth corners 116 are formed. The tip protector 100 may, however, have right angles at various points of intersection 118 and a shielding plate 112 of uniform width, which is a less preferred solution,

Although it still remains in the spirit and within the scope of the present invention. An optional aperture 122 can be used in the shielding plate 112 to facilitate assembly. For example, a pin (not shown) could be inserted through the hole 122 to press the arm 140 (FIG. 5) of the first cover body downwards. This would help to mount the thicker end of the cannula or needle through the sheath. More preferably, this opening will not be necessary if the distal wall 150 of the first shell body 102 is formed at an angle, whereby the thicker end of the cannula will simply deflect the distal wall downwards, allowing automatic assembly.

[0037] FIG. 3 is a top view of the tip protector 100 of FIG. 2. In one exemplary embodiment, the reduced proximal section 124 is used in the shielding plate 112, which section has a narrower width than the section located directly distal. A gap 126 is formed on each side of the reduced proximal section 124, which is partially delimited by the side walls 110A, 110B and the reduced proximal element 124. The two gaps 126 may, however, be filled by maintaining the same width by the overall length of screening plate 112.

[0038] In one exemplary embodiment, the side wall connection plate 128A, 128B is built into the proximal end of both side walls 110A, 110B. If a center line or axis is taken along the tip protector 100, then the two sidewall connections 128A, 128B will be at right angles to the axis and will be essentially flush. The two terminal boards 128A, 128B may, however, overlap and not be on one plane without departing from the spirit and scope of the present invention. As discussed in more detail below, the two terminal plates 128A, 128B provide components for mounting the body of the second shield 104 to the body of the first shield 102.

[0039] FIG. 4 is a bottom view of the tip cover 100 of FIG. 2. The body of the first shield 102 is clearly shown positioned between the two side walls 110A, 110B of the body of the second shield 104. In one exemplary embodiment, an arm 130 is used to stabilize the tip protector 100 inside the housing or cap. Arm 130 extends distally from proximal wall 132 (see also FIG. 5) and includes a bend or apex 133 defined by an upward section 134 oriented at an angle toward 12

EP 2 604 308 B1 at the bottom of section 136 (see also FIG. 5). As discussed in more detail below, the arm 130 is configured to rotate, bend or support at 138 on the proximal end of the tip protector 100 that acts as a hinge. The proximal wall 132 and the two terminal plates 128A, 128B together define the proximal end of the sheath 129.

[0040] The arm 140, relatively larger in length than the arm 130, for stabilizing and blocking the needle tip, also extends from the proximal wall 132. In one exemplary embodiment, the arm 140 has an aperture 142 and two ribs 144. More preferably, the aperture 142 is shaped elongated, and two ribs 144 are formed in precision extrusion technology. The arm 140, in turn, has a front arm section 146, a return section 148 (FIG. 5), and a distal wall 150 (FIG. 5) to lock the needle tip and end section or trigger 152 (FIG. 5) to cover the needle portion in position after use. Front arm section 146, return section 148, distal wall 150 and trigger 152 are further collectively referred to as the locking distal arm section. In one exemplary embodiment, the arm section with the aperture 142 is wider than the other arm sections. This configuration provides space not only for accommodating the hole 142, but also for the two extruded ribs 144. Alternatively, an overlap or tab can be placed on each edge of the arm section and then bent to form two ribs. The alternative arm, without embossed ribs, can have a uniform width throughout.

[0041] FIG. 5 is a side cross-sectional view of the catheter assembly of FIG. 4 made along lines 5-5. Two arms 130, 140 are seen as extending from two different edges of the proximal wall 132. As shown in FIG. 11, when the tip protector 100 is placed on the needle, the two arms start on opposite sides of the needle as seen from the centerline of the needle. However, the longer arm 140 extends distally from the proximal wall 132 at an angle and intersects the axis of the needle while the needle passes through the opening 142 on the arm. The short arm 130 does not, however, touch or cut the needle. More preferably, the end edge 154 of the short arm 130 is separated from the needle in both the ready to use position and the post-use position.

[0042] As discussed in more detail below, when the tip protector 100 is in the ready to use position, the long arm 140 is deflected radially at 13

Outwardly towards the short arm 130 and trigger 152, contacting the side of the needle. To this end, the long arm 140 bends, at least partially, around point 156 on the proximal wall 132 when it adheres to the side of the needle.

[0043] Referring again to FIG. 3 in conjunction with FIG. 5, the shielding plate 112 supports the contour of the periphery 114 of the distal wall 106 of the body of the second shell 104. This allows the entire shielding plate 112, and more specifically the reduced proximal part 124, to deflect like a trampoline. In one example embodiment, the distance between the tip 133 of the short arm 130 and the rounded edges 116 of the shielding plate 112 should be greater than the internal curvature of the housing in which the tip protector is to be positioned, so that both shielding plate 112 and short arm 130 were leaning inwards against the housing wall surface. In other words, when the tip of the sheath 100 is positioned inside the housing, such as the catheter adapter shown in FIG. 11, the tip protector will be squeezed between two rounded edges on the shield plate 112 and the short arm 130. This squeezing operation allows removable attachment of the tip protector to the housing or cap.

[0044] FIG. 6 is a rear view of the tip cover from Fig. 5 taken along line 6-6. The two side connection plates 128A, 128B are shown in contact with the proximal face of the proximal wall 132. In one example embodiment, the two connection plates 128A, 128B are welded, using ultrasound, high frequency welding or laser beam, with the proximal wall 130 . An aperture 158 is provided in the proximal wall 130 of the body of the first sheath 102 for receiving a needle (not shown). Both connection walls 128A, 128B have notches 160 resembling two semicircles whose combined diameter is greater than the diameter of the opening 158 on proximal wall 130. Alternatively, the two walls of connections 128A, 128B may overlap and each of them may have a separate opening with a larger diameter than the diameter of the hole 158 on the proximal wall.

[0045] FIG. 7 is a front view of the tip protector 100 of FIG. 5 made along the line

7-7. As can be clearly seen, the body of the second shell 104 includes a plurality of structures having walls, i.e. two side walls 110A, 110B and a shielding plate

112, front wall 106 and two walls of connections 128A, 128B (not shown on 14

EP 2 604 308 B1), which form a closed area consisting of chamber 155 and central access opening 162 (see also FIG. 5). Referring to FIGURES 5 and 6, in conjunction with FIG. 7, the short arm 130 exits through the central access opening 162 to provide a contact point between the tip protector and the housing, such as the catheter hub. Long arm 140 (FIG. 5) similarly exits through central access opening 162 in the ready to use position, but slides into chamber 155 when in the post-use position, as discussed in more detail below.

[0046] FIG. 8 is a side cross-sectional view of the body of the first shield 102 of FIG. 1 is shown without the body of the second shell 104. In one exemplary embodiment, the body of the first shell 102 is formed from one sheet of stainless steel. The hole 142 should be punched and the two ribs 144 pressed before the body of the first shell 102 is formed into the shape shown in FIG. 8.

[0047] FIG. 9 is a cross-sectional view of the end body of the first shield 102 of FIG. 8 15 made along lines 9-9. The drawing shows a part of two ribs 144, an opening 142 between two ribs and a proximal wall 132.

[0048] FIG. 10 is an end view of the body section 102 of the first shell of FIG. 8 made along lines 10-10. A portion of the elongate hole 142 and the distal wall 150 is visible through the hole 158 in the proximal wall 132. In one exemplary embodiment, four notches 164 are formed at each corner of the proximal wall 132. The notches 164 are configured to reduce the spring force generated through two arms 130 and 140. The number of notches may vary depending on the desired spring force to be obtained.

[0049] Referring again to FIG. 5, the tip protector disclosed here can be seen as a device having a housing with three movable arms 112, 130 and 140. The tip protector can also be viewed as having a housing with a shielding plate or arm with the tip of the housing disposed therein and having an arm used for locking the needle tip and arm, together with the shielding plate, for elastically attaching the tip protector to the cap or terminal housing.

EP 2 604 308 B1 FIG. 11 is a semi-schematic side view of a catheter set 166 having a tip protector 100 from FIGURES 2-10. Generally speaking, the catheter set 168 consists of a needle cap having a needle 170 attached to the cap. The needle 170 consists of a pointed needle tip 172, a non-uniform needle section 175 (FIG. 13) and passes through the tip protector 100, catheter hub 174, and catheter tube 176. The non-uniform section of the needle 175 may be a fold, a thickening of the material, a fold, or a combination of the above. In a preferred embodiment, the needle hub 168 has a nose section 178 that fits into the inner wall surface 180 of the catheter hub 174. The nasal section 178 is configured to allow the proximal end 129 of the tip protector 100 to be moved to the desired depth or length within the chamber 182, defined by the wall surface 180 of the catheter hub 174 in the ready-to-use position (FIG. 11).

[0051] In one exemplary embodiment, the chamber 182 has a recessed section

184, which may enlarge the overall internal perimeter of the chamber along the chord, width, or partial perimeter, as shown. The recessed section 184 provides additional space at the distal end of the first body section 102 so as to reduce downforce or bias on the trigger section 152 and return section 148. This in turn reduces the tension between the trigger section 152 and the side of the needle 170 during relative movement between the needle and tip protector 100. Of course, the needle set 166 can be made without recessed section 184, although this is not preferred.

[0052] As shown, the recessed section 184 has a proximal tapering section 186 and a distally tapering section. Referring to FIG. 5 and in addition to FIG. 11, front arm section 146, return section 148 and distal wall 150 of first body section 102 are all located distally and spaced from proximally tapering section 186. This distance configuration was introduced because physical contact between the proximal tapering section 186 and the blocking section of the distal arm is not necessary to maintain constant contact 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 these two sections can be provided without departing from the spirit and scope of the present invention.

[0053] Referring to FIG. 12, which is a cross-sectional view of the end of the catheter assembly of FIG. 11 taken along lines 12-12, the tip protector 100 is shown in contact with the inner wall surface 180 of the catheter adapter 174 on two curved edges 116 on the shielding plate 112 and two edges of the short arm 130 in the apex area 133. Four contact points are shown in FIG. . 12 using the four contact arrows. Thus, in one exemplary embodiment, the arm 130 is supported at the proximal end of the body of the first sheath 102, and the next arm 112 is supported at the distal end of the body of the second sheath 104 to hold the sheath of the tip 100 within the catheter hub. In other words, the tip sheath is shown here having an arm supported on the wall of the proximal sheath housing and a second arm supported on the distal wall of the same sheath housing. In an alternative embodiment, the cantilever arm 112 is eliminated, and the two side walls 110A, 110B together with the short arm 130 are configured to removably attach an alternative shield tip protector to a housing, such as a catheter hub or clamp housing.

[0054] FIG. 13 is a side view of a partial section of the catheter set 166 of FIG. 11, shown in the post-use position, with the needle 170 extended to the right FIG. 11. The tip protector 100, and thus the needle 170, are moved to the use position shown in FIG. 13, holding the catheter 174 in one hand after withdrawing the needle cap 168 on the right FIG. 11 (or vice versa, i.e., holding the needle hub 168 while moving the catheter hub 174 on the left FIG. 11). When the tip of the needle 172 is moved proximal from the trigger section 152, the biasing force acting on the shoulder 140 stops working, thereby allowing the arm to return to its less bent state, as shown in FIG.

13. As needle cap 168 moves further to the right, the non-uniform section 175 on the needle 170, which has a larger diameter than the hole 158 on the proximal wall 132 of the body of the first shield 102, comes into contact with the hole 168 and pulls the proximal wall clockwise through meshing with perimeter of the hole 168. If the pulling force acting on the proximal wall 132 is greater than the friction force between the bracket arm 112, the short arm 130 and the inner surface 180 of the catheter hub, the friction force is overcome and the tip protector 100 disconnects from the catheter hub.

EP 2 604 308 B1 FIG. 14 shows the tip protector 100 removed from the catheter hub 174 and the distal wall 150 blocking the needle tip. While the tip protector has two side walls 110A, 110B and shielding plate 112, the tip protector covers about three quarters of the circumference of the needle 170 near the tip of the needle. The remaining portion of the needle 170 near the tip of the needle 172 is also partially covered by the short arm 130 and the distal locking section of the body of the first shield 102. The tip of the needle is shielded from view or contact. Blood that may drip from the tip of the needle is oriented so that it is caught through one of the walls.

[0056] As shown in FIG. 14, if force is finally exerted near the distal needle shield near point 189, the needle 170 may rotate in the opposite direction from the shield provided by the trigger section 152 such that it reappears through the hole 108 of the distal wall 106 of the second shield body 104 . Accordingly, in one example embodiment, the recess or projection 120 on the shielding plate 112 has been configured to prevent or limit needle movement in the event of direct magnifying glass by accidental force on the tip protector at or near point 189. The projection 120 has been configured to prevent the needle tip 172 from moving radially from the trigger section 152.

[0057] FIG. 15 is a semi-schematic perspective view of the body of the second shell 188 made in accordance with the features of the present invention. The alternative body of the second shield 188 may mate with the first shield body shown in FIGURES 8-10 to form an alternative tip protector. In one embodiment, the alternative body of the second shield 188 has a shielding plate 190 having a substantially curvilinear outer surface, an overlap 192 formed by making a cutout 194 on the shielding plate, and having two resting points 196. The tab 192, like the projection or recess 120 on the previously discussed body of the second sheath, is configured to prevent the needle from rotating in the opposite direction from the inner space of the tip sheath. In one embodiment, the shielding plate 190 is inseparably formed with the side walls 110A and 110B. This can be done using, for example, drawing (deep forming) technology. Alternatively, the two side walls 110A and 110B and the shielding plate 190 may have a gap between them.

[0058] In one embodiment, at least a portion of the curvilinear outer surface of the shielding plate 190 is configured to contact the inner surface of the catheter adapter when it is positioned there as part of a catheter assembly. Alternatively, the shielding plate 190 has such a flat surface that only two side edges 198 with two side walls 110A and 110B contact the inner surface of the catheter attachment or clamp housing.

[0059] Although only a limited number of embodiments of the tip protector and needle devices utilizing the tip protector have been described in detail and illustrated herein, a number of further modifications and variants will be apparent to those skilled in the art. For example, the tip protector described herein can be used in conjunction with a needle sleeve having a bend, as shown in US Patent No. 6,585,704 by Luther et al. Alternatively, the tip protector described herein may be used with an outer housing on a needle for use with a syringe, as disclosed in US Patent No. 6,595,955 by Fergusson et al. Alternatively, the tip protector described herein can be used with a handle to slide the tip protector along the needle, as shown in Patent No. 10 / 856,315, entitled PROTECTION DEVICE FOR THE INJECTION NEEDLE. In this connection, it is to be understood that the tip protector and components thereof constructed in accordance with the principles of the present invention may be implemented in a different manner than described in detail herein. The subject description further includes the following implementations.

[0060] Implementation 1: A tip protector for blocking the needle tip comprising: a tip protector housing disposed within a cap having an inner surface; a needle passing through the tip protector and the housing; first arm extending from the wall of the distal casing of the protective tip based on the inner surface; a second arm extending from the wall of the proximal housing of the protective tip based on the inner surface; a third arm extending from the wall of the proximal housing of the protective tip resting on the side of the needle.

[0061] Implementation 2: A tip protector according to embodiment 1, wherein the tip protector housing consists of two connector plates attached to the proximal wall.

[0062] Implementation 3: A tip protector according to implementation 1, wherein the third arm has a hole.

[0063] Implementation 4: A tip protector according to embodiment 3, the needle passing through the hole.

[0064] Implementation 5: A tip protector according to implementation 1, wherein the first arm has two framed edges, which edges are in contact with the inner surface.

[0065] Implementation 6: A tip protector according to implementation 1, wherein the distal wall has an opening and the proximal wall has an opening and the needle passes through both of these openings.

[0066] Implementation 7: A needle protector for mounting on a needle to a needle protector, comprising: a first protector body having a proximal wall and an arm extending distally from the proximal wall; said arm in turn has a distal wall at the end of the arm for blocking the needle tip; non-uniform shoulder width to receive a needle extending between the proximal wall and the distal wall; a second shell body attached to the first body, wherein the body of the second shell has a distal wall and two side walls forming a channel enclosing the body of the first shell; a shielding plate having a tongue extending into the channel, the tongue and the distal wall at the end of the arm are configured to limit the movement of the needle tip distally from the distal wall of the body of the second shield.

[0067] Implementation 8: A tip protector according to embodiment 7, further comprising at least one rib on the shoulder.

[0068] Implementation 9: A tip protector according to embodiment 7, further comprising a trigger positioned at the end of the distal wall.

[0069] Implementation 10: A tip protector according to embodiment 7, further comprising a second arm that is shorter than the first arm.

[0070] Implementation 11: A tip protector according to embodiment 7, wherein the arm is provided with an opening.

[0071] Implementation 12: A needle protector for mounting on a needle for a needle tip protector, comprising: a first protector body attached to the second protector body; the body of the first shield consists of a proximal wall and an arm that has a distal end of the arm extending distally from the proximal wall; the body of the second shell consists of two side walls and two end walls defining a channel for the body of the first shell; each of the two side walls has a first and a second edge; the shielding plate has a projection entering the channel, the shielding plate is configured to deflect and slide relative to both the first and second edges; and wherein both the tab and the distal end of the arm are configured to be on different sides of the needle shaft defined by the centerline when the tip protector is placed on the needle and when the tip protector is in the ready-to-use position.

[0072] Implementation 13: A tip protector according to embodiment 12, further comprising a rib formed in the fine extrusion process.

[0073] Implementation 14: A tip protector according to implementation 12, further including an opening provided on the arm.

[0074] Implementation 15: A tip protector according to embodiment 12, further comprising a second arm extending from the proximal wall of the first protector body.

[0075] Implementation 16: A tip protector according to embodiment 12, wherein the protector of the tip is positioned, at least partially, inside the cap.

[0076] Implementation 17: A tip protector according to implementation 12, wherein one of the two edges is framed.

[0077] Implementation 18: A kit with a needle, comprising: a housing consisting of a wall with an inner surface of the wall forming a channel with a needle tip protector disposed therein; a needle that has a shank, the first side and the second side of which are defined by a centerline and needle tip, passing through the housing and tip protector; a tip protector consisting of a distal wall, two side walls, a proximal wall, a first arm extending from the proximal wall towards the distal wall, a second arm that is shorter than the first arm extending from the proximal wall, and a wall opposite the second arm;

And where the wall opposite the second arm and the second arm rest on the surface of the inner wall of the housing.

[0078] Implementation 19: A needle assembly according to embodiment 18, wherein the second arm and the wall opposite the second arm are elastically engaged with the surface of the inner wall of the housing.

[0079] Implementation 20: A needle kit according to embodiment 18, wherein the two side walls, the second arm and the wall opposite the second arm are in contact with the surface of the inner wall of the housing.

[0080] Implementation 21: A kit with a needle according to implementation 18, wherein the wall opposite the second arm is provided with a projection.

[0081] Embodiment 22: A needle kit according to embodiment 18, wherein the housing is a catheter hub.

[0082] Embodiment 23: A needle assembly according to embodiment 18, wherein the first arm has a non-uniform width.

[0083] Implementation 24: A tip protector according to embodiment 1, wherein the third arm is positioned on the body of the first shield and the first arm and the second arm are positioned on the body of the second shield.

[0084] Implementation 25: A tip protector according to embodiment 24, wherein the first protector body is attached to the second protector body.

[0085] Implementation 26: A tip protector according to embodiment 1, wherein the protector of the tip is located, at least partially, inside the cap.

[0086] The invention is only defined by the following claims.