MXPA97005022A - Assembly needle protector that has a user block unit - Google Patents

Abstract

The present invention relates to a needle guard assembly having a single use driver comprising: a needle cannula having a proximal end, a distal end and a lumen therethrough, a mass having a proximal end for connection to a fluid transfer device and a distal end connected to the proximal end of the needle cannula, a collar connected to the mass, an elongated rigid needle cover that removably couples the mass and covers the needle cannula; elongated needle guard having a distal end and a proximal end hingedly connected to the collar, the needle guard includes two side walls defining a longitudinal opening, the needle guard is capable of pivoting from an open position where the needle cannula is exposed to a closed needle guard position where the needle cannula is within the longitudinal opening of the needle shield a means for preventing the needle guard from being pivoted to the closed position while the needle cover is coupling the mass; means for automatically and permanently locking the needle guard in the closed needle guard position when the needle guard is pivoted in the closed position, the locking means includes a locking arm at the proximal end of the needle guard, a locking pin in one of the collar or the locking arm and a locking opening the other of the collar or the locking arm are positioned so that When the needle guard is pivoted to the closed needle guard position, the locking arm is deflected outwardly until the locking pin engages the latched opening

Description

ASSEMBLY NEEDLE PROTECTOR THAT HAS A SINGLE USE TREADER FIELD OF THE INVENTION The present invention relates to needle shields for hypodermic needles, catheter needles and other medical implements to help prevent accidental contact with the needle.

BACKGROUND Accidental stings with a hypodermic needle can transmit diseases. Most needle assemblies of the prior art have a needle guard. Some needle shields define a rigid sleeve that can be telescoped remotely over the needle cannula. This procedure requires a health worker who holds the needle assembly or associated medical implement in one hand and the protector in the other. Some medical procedures require the application of pressure to the site of penetration after the needle has been removed. Therefore, health workers are often unable to use both hands to protect the needle cannula. In those situations, workers deposit only the medical device used on a nearby surface with the intention of disposal or protection at a more convenient time. However, until the needle is properly protected or disposed of, the device presents a potential danger to another person. A needle guard that is hinged near the base of the needle has the advantage of allowing re-protection of the needle with one hand, thus providing the opportunity for reprotection, under most circumstances, immediately after use. . A hinged needle guard that permanently locks when pivoted into the closed needle protection position has certain advantages. Firstly, there is no doubt about the state of the needle guard assembly and the health worker knows that the needle must be carefully discarded and not used to transfer additional fluid. This is analogous to the rigid needle guard of the prior art which is telescoped onto the needle cannula and fritically engages the mass of the needle. It is evident with the needle assembly of the prior art whether the needle is protected or not protected. However, having a permanently lockable hinged needle guard presents a problem in situations where the needle is intended to be used twice. For example, the needle is first used to penetrate the penetrable stopper of a medicine container for the purpose of filling the syringe with the medicament for subsequent injection into a patient. The needle guard assembly with the syringe attached when transported to the patient's area for injection of the medication. If the needle is permanently re-protected after the syringe is filled it can not be used for injection and a second needle must be installed at the time of use. It is advantageous to have a self-contained needle guard assembly where the adapter for the medical implement, the needle cannula and the needle guard are connected in a unit. The prior art includes syringes having cylindrical sleeves about their outer diameter. After injection, the cuff is advanced to a locked needle protection position. Syringes are important safety devices, although not all syringes are used with a needle. The use of a self-contained needle guard assembly allows the end user to secure the syringe assembly on a variety of syringe sizes and standard stock syringes for all uses. Therefore, a safer, more expensive syringe would not have to be used for applications where safety features are not necessary. It is also advantageous to have a closed needle cover that protects the cleaning of the needle even after the needle guard assembly is removed from its sterile package. A closed needle cover protects all sides of the needle while a hinged needle guard has an open side and exposes the needle to air particles. Although the prior art provides many improved needle protection devices, there is still a need for a self-contained needle guard assembly where the needle guard can be placed in the needle guard position using a one-handed procedure and the needle guard automatically locks into the protective position of the needle guard. needle and is not susceptible to being reused. There is a need for a self-contained protective water assembly that allows the needle to be used twice, once to withdraw the drug into a syringe and then to inject the medication into a patient where the needle may be protected between the first and second uses. There is a need for a needle guard assembly that protects the cleaning of the needle after the needle guard assembly is removed from its sterile package. There is also a need for a needle guard assembly that provides the shortest possible fluid path between the syringe barrel and the needle tip to prevent loss of medicament in the fluid path that can not be expelled.

BRIEF DESCRIPTION OF THE INVENTION A needle guard assembly having a single use lock of the present invention includes a needle cannula having a proximal end, a distal end and a lumen therethrough. A mass includes a proximal end for concentration towards a fluid transfer device and a distal end connected to the proximal end of the needle cannula that is connected to a collar. An elongated rigid needle cover is removably coupled to the mass and covers the needle cannula. An elongated needle guard having a proximal end and a distal end is connected, through its proximal end, to the collar. The needle guard includes two side walls defining a longitudinal opening. The needle guard is capable of pivoting from an open position where the needle cannula is exposed, to a closed needle protection position where the needle cannula is within the longitudinal opening of the needle shield. The needle guard assembly further includes means for preventing the needle guard from pivoting within the closed position unless the needle cover is removed and means for automatically and permanently locking the needle guard in the protective position of the needle guard. needle closed when the needle guard is pivoted in the closed position. The locking means include a locking arm on the proximal end of the needle guard, a locking pin on one of the collar or the locking arm and a locking opening on the other of the collar or the locking arm positioned so that when the needle guard is pivoted towards the closed needle protection position the locking arm is flexed outwardly until the locking pin engages the locking opening.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a side elevational view of the needle guard assembly of the present invention attached to a syringe before use. Fig. 2 is an exploded view illustrating the assembly of the needle guard assembly of the present invention and a syringe. Fig. 3 is a perspective view of a needle and collar protector assembly for use in the present invention. Fig. 4 is a cross-sectional view of the needle guard of Fig. 1 taken along lines 4-4. Fig. 5 is a cross-sectional view of the needle guard of Fig. 3 taken along lines 5-5. Fig. 6 is a side elevational view of the needle guard assembly of the present invention attached to a syringe at the time of first use. Fig. 7 is a side elevational view of the needle guard assembly of the present invention after use with the needle guard in the closed position. Fig. 8 is a perspective view of an alternative needle and collar protector assembly for use with a needle guard assembly of the present invention. Fig. 9 is a cross-sectional view of the needle guard of Fig. 8 taken along lines 9-9.

Fig. 10 is a cross-sectional view of the needle guard of Fig. 9 taken along lines 10-10.

DETAILED DESCRIPTION While the invention is satisfactory by the embodiments in many different forms, the preferred embodiments of the invention are shown in detail in the drawings and are described in detail with the knowledge that the present disclosure is to be considered as illustrative of the principles of invention and is not intended to limit the scope of the invention to the illustrated embodiments. The scope of the invention will be measured by the appended claims and their equivalents. Referring to FIGS. 1-7, a needle guard assembly having a single use lock, such as the needle guard assembly 20, includes a needle cannula 21 having a proximal end 22, a distal end 23 and a lumen. through it that defines a longitudinal axis 25. In this preferred embodiment, the distal end of the needle cannula includes the sharp tip 26. It is within the scope of the present invention to include the blunt cannulae which are cannulas without sharp tips. Blunt cannulae are known in the art and are generally used to inject liquid into an I.V. or another fluid path having an access port with a pre-cut septum. The blunt cannula is forced through the cut in the septum and in fluid communication with the fluid flow path. Upon removal of the blunt cannula, the cutting portion of the septum is automatically sealed. A mass 28 includes a proximal end 29 and a distal end 31 connected to the proximal end 22 of the needle cannula. A collar 41 is connected to the ground. There are many ways to connect the collar to the mass, through interference fit, adhesives, ultrasonic welding and the like. It is within the scope of the present invention to include a mass and a collar that are of a unitary piece structure. The structure of a piece can be achieved by means of many methods including injection molding of the collar and the base member as a one piece unit thus eliminating the need to assemble the base member to the mass during the manufacturing process . In this preferred embodiment, the collar is rotationally connected to the mass in a jump adjustment arrangement that allows the collar, through the application of manual force, to be rotated around the mass. The rotational connection of the collar and the mass is achieved by the interaction between the structure of the mass including the proximal raised portion 32, the distal raised portion 33 and the collar receiving recess 34 and the collar. The distance through the proximal raised portion 32 and the distal elevated portion 33 is greater than the internal diameter of the collar 41 and greater than the diameter or distance through the recess 34. During assembly, the collar is passed over the distal end of the collar. the mass and forced on the distant raised portion 33 so that it fits within the space between the raised portion 32 and the raised portion 33 and is caught in that position. It is preferred that there is a certain amount of frictional engagement between the collar and the mass so that the collar can rotate freely with respect to the mass. This can be achieved in many ways, such as by making the distance between the raised portion 32 and the raised portion 33 less than the thickness of the collar 41 and / or by making the diameter or distance through the recess 34 slightly larger than the inner diameter. of the collar. The advantages of rotationally connecting the collar to the mass will be explained in more detail below. An elongated rigid needle cover 37 having a cylindrically shaped side wall 38 and an open proximal end 39 removably couples the mass 28 and covers the needle cannula 21, as best illustrated in Fig. 1. A needle cover is an important advantage of the present invention. Preferably, the needle assembly is fabricated and sterilized in a protective package with the needle cover in place. The needle cover provides a barrier to contamination for the needle after the needle guard assembly is removed from the sterile package. Therefore, the user has the security of a clean needle at the time of first use. At the time of first use, the needle cover is removed, as illustrated in FIG. 6, overcoming the coupling forces between the needle mass and the open proximal end of the needle cover.

An elongated needle guard 45 having a distal end 46 and a proximal end 47 is hingedly connected to the collar 41. In this preferred embodiment, the needle guard 45 is hingedly connected to the collar 41 through the active hinge 44 is within range of the present invention include any structure for loosely connecting the shield to the collar so that the needle shield can be pivoted with respect to the collar. These structures include known mechanical hinges and various links or combinations of hinges and links. The needle guard 45 includes two side walls 50 and 51 defining a longitudinal opening 52 and a rear wall 53. The needle guard assembly of the present invention is suitable for use with a wide variety of fluid transfer devices such as syringes, catheters, blood collection devices, tubing equipment for collection and supply of blood and the like. For the purpose of illustration, the needle guard assembly 20 is illustrated connected to the hypodermic syringe 70 which comprises a syringe barrel having a distal end 73, a proximal end 74 and a circular wall 75 defining a chamber 76 for holding the fluid. The distal end of the syringe barrel is connected to the mass such that the lumen of the needle cannula is in fluid communication with the chamber 76 of the syringe barrel. In this embodiment, the distal end 73 of the syringe barrel includes a trunco-conical sharp tip 77 having a passage therethrough that provides a fluid path between the cannula and the chamber. The sharp truncated-conical tip of the syringe barrel frictionally couples a truncated-conical cavity in the needle mass. The distal end of the syringe barrel also includes a "luer" type collar 79 that concentrically surrounds the tip. The "luer" collar has an internal threading that engages the needle mass to hold it securely in the cylinder. It is within the scope of the present invention to include various mass configurations for joining a wide variety of fluid handling devices. The mass configuration described hitherto in the present, having an internal cavity of truncated-conical shape, reflects one of those possibilities. Many syringes, fluid handling devices, such as stopcocks and adapters, and other fluid handling devices contain "luer" and "luer" type slide fittings to which the mass of a truncated inner cavity conical will fit properly. It is also within the scope of the present invention to provide a needle guard assembly wherein the mass is integrally molded with the syringe barrel. It is an important feature of the present invention that all elements of the needle guard assembly are connected to the ground and that the ground is capable of directly connecting to a fluid handling device such as a syringe. Some of the prior art devices contain a separate housing that mounts between the needle mass and the syringe, wherein the needle guard is hingedly connected to the separate housing. A separate housing extends the fluid path between the chamber in the syringe and the distal end of the needle cannula thereby wasting the medicament, since it can not be expelled, the fluid path through the housing must be filled with the medicine before it can leave the proximal end of the needle. In some cases, the medication may cost more than a hundred times as much as the syringe and small amounts of medication lost over a substantial number of syringes may result in an unnecessary loss of valuable medication. Also, the additional element increases the length between the syringe and the needle tip making the precise placement of the needle possibly a little more difficult., for example in the vein of a patient. The needle guard 45 is capable of pivoting from an open position where the needle cannula is exposed, as best illustrated in Figure 6, to a closed needle guard position where the needle cannula is within the opening longitudinally, as best illustrated in Figure 7. As will be explained in greater detail hereinafter, an important feature of the present invention includes means for preventing the needle guard from being pivoted into the closed position before the Needle cover removed. In this preferred embodiment the means for preventing it are achieved by forming at least a portion of the side walls so that the longitudinal opening is smaller than the needle cover, so that the needle cover can be removed before the needle cover is removed. needle guard is pivoted in the closed needle guard position. It is within the scope of the present invention to include many structures that prevent movement of the needle guard within the closed needle protection position before the needle cover is removed. Such structures may include a projection on the needle guard, the needle cover or on both elements that create an interference between the needle guard and the needle cover which prevents the needle guard from moving within the needle position. closed protection. Another important feature of the present invention includes means for automatically locking the needle guard in the closed needle protection position when the needle guard is pivoted into the closed position. "Automatically" is meant to mean that the movement of the needle guard sufficiently within the needle protection position will cause the lock to occur automatically without additional action by the user. "Permanently" is intended to mean that there is no unclamping structure and, the needle will remain protected until the proper disposal. The lock must generally withstand the normal forces encountered during proper disposal of the needle guard assembly.

In this preferred embodiment, the means for automatically and permanently locking the needle guard in the closed needle protection position includes two parallel opposed locking arms 55 and 56 at the proximal end of the needle shield containing locking openings 57 and 58 respectively. The collar further includes two opposing locking pins 61 and 62. The locking arms are formed and positioned so that when the needle guard is pivoted to the closed needle protection position, the locking arms are flexed outwards until the locking pins 61 and 62 engage locking openings 57 and 58 respectively, to permanently lock the needle guard in the closed position. It is within the scope of the present invention to have less than and more than two locking arms and the related structure to lock the needle guard in a closed position. For example, the present invention may include at least one locking arm at the proximal end of the needle guard, a locking pin located on one of the locking arm or the collar and a locking opening on the other of the collar or locking arm, so that when the needle guard is pivoted into the closed needle protection position the locking arm is flexed outwardly until the locking pin engages the locking opening. As best illustrated in Figure 7, it is preferred that when the needle guard is in the closed position, the needle guard must be pivoted far enough so that the rear wall 53 contacts and possibly slightly flexes the needle cannula 21. . This contact relationship ensures that the needle cannula is positioned in the needle shield as deeply as possible to minimize the opportunity for re-exposure of the needle through the minor deflection of the needle shield. With reference to Figs. 6 and 7 it can be seen that the needle guard can be moved from the open position to the closed position using a one-hand procedure. For example, by holding the syringe 70 with the fingers and advancing from the needle guard from the open position to the closed position by pressing on the back wall within the thumb until the needle guard is in the closed locked position. To facilitate the operation of a hand of the needle guard, the digital pad 69 is provided at the proximal end of the needle guard. It is desirable to have means for releasably retaining the needle guard in the open position. Holding the needle guard in the open position prevents it from interfering with the injection process either visually or physically. The releasable retention of the needle guard in the open position can be achieved by dimensioning parts of the assembly so that friction is created in the hinge or by using hinge on the articulated center or creating some interference between the needle guard and the collar that must be forcefully overcome to move the needle guard out of the open position. In this modality, the existing structure is used to achieve this result. In particular, the locking pins 61 and 62 couple concave detents 63 and 64 respectively when the needle guard is in the open position. Additional force is required to pivot the needle guard out of the open position. In the open position it is preferred that the longitudinal opening 52 be oriented between about 90 ° to 180 ° from the longitudinal axis 25 of the needle cannula, as best illustrated in Fig. 6, where the needle guard is rotated in a manner that the longitudinal opening 52 is approximately 150 ° from the longitudinal axis 25 of the needle cannula. As best illustrated in FIG. 6, the sharp tip 26 of the needle cannula 21 is sharpened to a shape of bevel having a bevel surface 27 oriented at angle A with respect to longitudinal axis 25. Bevel surface 27 confronts direction B. The rotational connection of the collar to the mass is an important feature of the present invention as it allows rotation of the needle guard so that the bevel surface confronts the same side of the collar as the needle guard when the needle guard is in the open position. Rotation of the needle guard to this position makes it easier to insert the needle into a patient's vein. Therefore, it is desirable to have the bevel surface 27 facing the same side of the needle assembly as the needle guard when the needle guard is in the open position, so that the needle guard does not interfere with the placement of the syringe near the needle. The patient's body, for example, the patient's arm, when trying to gain access into a vein. The needle guard can also be placed on the same side of the needle guard as the bevel designing the elements and / or the manufacturing process so that the assembling of the needle guard assembly achieves this result. Fig. 1 illustrates the needle guard assembly 2o connected to the hypodermic syringe 70 in a configuration in which it is to be equally supplied, in sterile form, from a manufacturer. The positioning of the needle guard 45 in an intermediate position between the closed position and the open position, closer to the closed position, creates a configuration that occupies less space for packing and shipping. This is especially true when the needle guard assembly is being shipped separately without being attached to a fluid supply instrument such as a syringe. Also, in this intermediate position, the needle guard assembly is easier to handle for the purposes of installing it on a fluid supply device, such as screwing the dough onto a standard luer-type tester equipment. Accordingly, it is desirable to provide means for releasably retaining the needle guard at an intermediate position between the open position and the closed position. In this preferred embodiment the means for loosely retaining the needle guard in the intermediate position include concave detents 67 and 68 on the locking arms 55 and 56 respectively. The concave detents 67 and 68 function exactly like the concave detents 63 and 64 which cooperate with the locking pins 61 and 62 to retain the needle guard in the open position. However, the detents 67 and 68 hold the needle guard in the intermediate position and require additional force to pivotally move the needle guard from the intermediate position. Figs. 8-10 illustrate an alternative needle and collar protector assembly for use with the needle guard assembly of the present invention. The needle and alternating collar protector function in a manner similar to the needle and collar protector assembly of FIGS. 1-7, except that the position of the locking openings, the locking pins and the seals have been reversed. The needle and alternating collar protector assembly 80 includes a collar 141 and a needle guard hingedly connected to the collar through a hinge 144. Means for locking the needle guard in the closed needle protection position includes two opposing locking arms parallels 155 and 156 at the proximal end of the needle guard and the locking pins 161 and 162 on each arm respectively. The collar 141 includes two opposing locking openings 157 and a second opening, not shown, on the opposite side of the collar as the opening 157. The locking arms are positioned such that when the needle guard is pivoted towards the needle guard position When closed, the locking arms are bent outwardly until the locking pins engage the locking openings to permanently lock the needle guard in the closed position. Means for releasably retaining the needle guard in the open position includes convex or radiated detents 163 and 164 which engage the locking openings 157 and 158 respectively when the needle guard is in the open position. The term retainer as used herein includes concave detents and convex detents, whichever is appropriate to cooperate with the opposing structure to provide the releasable retention function. Equally, the convex seals as a convex stop 168 are provided to hold the needle guard in the intermediate position in a similar manner as described for the embodiment of Figs. 1 -7. It can be seen that the present invention provides a self-contained needle guard assembly wherein the needle guard can be placed in the needle guard position using a one-handed procedure and the needle guard automatically locks into the protective position of the needle guard. needle so that the needle is not susceptible to reuse. The needle guard assembly of the present invention also provides the structure to protect sterility and cleanliness of the needle until it is used for the first time. The present invention also provides a self-contained needle guard assembly that allows the needle to be used twice, once to withdraw the medicament into the syringe and then to inject the medicament into a patient while providing to prevent permanent lock of the needle guard until the end use preventing the needle guard from being pivoted into the closed position while the needle cover is installed.

Claims (10)

1. CLAIMS 1 . A needle guard assembly having a single use lock comprising: a needle cannula having a proximal end, a distal end or a lumen therethrough; a mass having a proximal end for connection to a fluid transfer device and a distal end connected to the proximal end of the needle cannula; a collar connected to the mass; an elongated rigid needle cover that removably couples said mass and covers the needle cannula; an elongated needle guard having a distal end and a proximal end hingedly connected to the collar the needle guard includes two side walls defining a longitudinal opening, the needle guard capable of pivoting from an open position where the needle cannula is exposed, to a closed needle protection position wherein the needle cannula is within the longitudinal opening of the needle shield; means for preventing the needle guard from being pivoted into the closed position while the needle cover is engaging the mass; means for automatically locking the needle guard in the closed needle guard position when the needle guard is pivoted into the closed position, the locking means includes a locking arm at the proximal end of the needle guard, a locking pin on one of the collar or the locking arm and a locking opening on the other of the collar or the locking arm positioned so that when the needle guard is pivoted towards the closed needle protection position the locking arm is flexed outwards until the pin Lock engages the locking opening.
2. 2. The protective guard assembly of claim 1, wherein the locking means includes a second opposing locking arm from the locking arm and a second locking pin on one of the second locking arm or the second collar and a second locking opening on the locking arm. the other of the second locking arm or the collar.
3. 3. The needle guard assembly of claim 1, further including means for releasably retaining the needle guard in the open position.
4. The needle guard assembly of claim 1, further including means for releasably retaining the needle guard in an intermediate position between the open position and the closed position.
5. The needle guard assembly of claim 1, wherein the distal end of the needle cannula includes a sharp pointed tip bevel having a bevel surface.
6. 6. The needle guard assembly of claim 5, wherein the bevel surface confronts the same side as the collar as the needle guard when the needle guard is in the open position. The needle guard assembly of claim 1, wherein the collar is rotationally connected to the mass so that the collar can be rotated about the mass. The needle guard assembly of claim 1, further including a syringe barrel having a distal end, a proximal end and a circular side wall therethrough that define a chamber for holding the fluid, the distal end of the cylinder of the syringe being connected to the mass so that the lumen in the needle cannula is in fluid communication with the chamber. The needle guard assembly of claim 8, wherein the mass and the syringe barrel are made of a one-piece construction. The needle guard assembly of claim 1, wherein the needle guard includes a back wall between the two side walls and opposite the longitudinal opening, wherein the rear wall makes contact with the needle cannula when the needle guard The needle is in the closed position. SUMMARY A needle guard assembly that has A single use lock includes a needle cannula having a proximal end connected to a mass. A collar is connected to the mass and an elongated rigid needle cover that removably couples the mass and covers the needle cannula. An elongated needle guard is connected loosely to the collar. The needle guard has two side walls that define a longitudinal opening. The needle guard is capable of pivoting from an open position where the needle cannula is exposed, to a closed needle protection position where the needle cannula is within the longitudinal opening of the needle guard. The structure is provided to prevent the needle guard from being pivoted into the closed needle protection position until the needle guard is removed. The structure is also provided to automatically lock the needle guard in the closed needle guard position when the needle guard is pivoted into the closed position.