MXPA97003645A - Assemble impulsed needle protector manualme - Google Patents

Abstract

The present invention relates to a protective assembly and syringe assembly comprising: a syringe assembly that includes a syringe barrel having opposite proximal and distant ends, a needle cannula projecting remotely from the distal end of the barrel syringe, and a protective assembly including a guide secured to a portion of the syringe assembly in proximity to the needle cannula and, the protector having a support wall and a pair of spaced apart side walls projecting from the support wall , the side walls being spaced apart from each other sufficiently to receive the needle cannula therebetween, the shield being slidably coupled with the guide and being movable along a path having a generally sharp angle with and toward the needle cannula, from a proximal position where the needle cannula is exposed to a distant position where the needle cannula is protected in between the side walls of the protect

Description

ASSEMBLY MANUALLY DRIVEN NEEDLE PROTECTOR BACKGROUND OF THE INVENTION 1. Field of the invention. The present invention relates to a protector to prevent accidental contact with a needle cannula. 2. Description of the Prior Art. Accidental punctures with the sharp pointed end of a needle cannula are painful and can lead to infection. Accidental punctures or other contact with used needle cannulas can also transmit diseases. Most needles of the prior art have safety guards to prevent accidental punctures. For example, an elongated rigid cap is mounted on most of the needles of the prior art before use. The cap can be frictionally mounted to the needle hub or to the distal portions of a syringe barrel to which the needle is attached. To use the syringe, the medical or nursing staff holds the cap in one hand and the syringe barrel in the opposite hand. The respective hands move in opposite directions to separate the needle cover. The syringe used can be protected by repositioning the cap on the needle cannula. However, this protective operation requires the medical or nursing staff to hold the cap in one hand and the hypodermic syringe used in the other hand. The hands are then moved towards each other to reposition the lid. A lack of alignment or sudden movement of any hand can cause accidental pricking. Additionally, medical or nursing staff should frequently apply pressure to the patient's puncture site immediately after removing the needle. Therefore, the doctor or nurse may not have both hands free to complete the protective operation. In those cases, the medical or nursing staff can leave the unprotected needle near the patient with the intention of completing the protective operation at a more convenient time. However, distractions in hospital facilities can result in the needle not being adequately protected at any time. The unprotected needle remains a danger to unsuspecting patients and medical and nursing staff. The prior art also includes safety guards that do not require medical or nursing staff to place a hand in front of the unprotected needle. For example, the prior art includes hypodermic syringes with a rigid telescope tube on the syringe barrel. Those syringes of the prior art can be used in conventional manner. The medical or nursing staff then holds the proximal end of the syringe barrel in one hand and the guard in the other hand. The shield is then advanced remotely along the barrel of the syringe and is put in place after the distal end of the shield passes the sharply sharpened distant tip of the needle cannula. Those protected hypodermic syringes are an improvement over needle assemblies that require a cap to be telescoped in a proximal direction over the needle cannula. However, protected syringes require the action of both hands. The prior art also includes smaller protectors intended for one-handed action. One such structure is shown in U.S. Patent No. 5,466,223. The protector in U.S. Patent No. 5,466,223 includes a guide structure mounted to the needle hub and an elongated barrier arm slidably mounted to the guide structure. The distal end of the barrier arm includes a barrier element that is telescoped around the needle cannula. This prior art needle shield is used by merely pushing the barrier arm away from the barrier element in sufficient manner to cover and protectively surround the sharp tip distant tip of the needle cannula. The barrier shown in United States Patent No. 5, 466,223 is effective to prevent accidental punctures with the sharp tip distant end of a used needle cannula. This barrier is also effective to allow one-handed action of the barrier without placing a hand near the tip of the used needle cannula. However, portions of the used needle cannula near the tip remain exposed and can be touched. In some cases it is desirable to avoid contact with blood or other bodily fluids which may be disposed at intermediate positions along the length of the needle cannula.

BRIEF DESCRIPTION OF THE INVENTION The present invention is directed to a protective assembly for protecting a needle in a protective manner. The needle may be part of a needle assembly comprising a needle cannula and a mallet. The needle cannula may include a proximal end securely mounted to the hub and a distant end of the opposite sharpened tip. The hub of the needle assembly can be threadably engageable with a front neck surrounding the tip of the syringe barrel of the prior art. Alternatively, the protective assembly of the present invention may be employed with a hypodermic syringe of the prior art having a needle cannula permanently affixed thereto and extending from the distal end of the prior art syringe barrel. The protective assembly of the present invention includes a guide and a protector. The guide can be placed securely in a location proximate the needle cannula. For example, the guide may be rigidly mounted to a needle hub or may be unitarily formed as part of the needle hub. Alternatively, the guide can be securely mounted to or formed "unitarily as part of the distal end of a syringe barrel.The guard is an elongated structure slidably engaged with the guide.The guard includes opposite proximal and distal ends defining a general length that preferably Exceeds the length of the needle cannula to be protected The shield includes a substantially elongate substantially substantial support wall extending continuously from the proximal end to the distal end of the shield The separate side walls project from the support wall and define a narrow space between them.The space is wide enough to receive the needle cannula therein, although preferably narrow enough to prevent a finger from being pushed between the side walls and brought into contact with the needle cannula, the protector and the guide can be configured to slide the shield at an acute angle toward the axis of the needle cannula. Thus, the shield can be movable from a proximal position where the shield is misaligned from the axis of the needle cannula to a distal position where the shield intersects the axis of the needle cannula.

The guide and protector can be configured to obtain the linear movement of the protector. Alternatively, the guide and / or protector can be configured to obtain non-linear movement. This latter mode may allow the protector to remain closer to the syringe barrel when the guard is in its proximal position. The side walls of the protector may include a pair of tabs slidably engaged with the channels formed on the guide. Alternatively, the side walls of the guard may include slots or notches that are slidably coupled with the corresponding structure on the guide. The shield and guide may include releasable coupling means for releasably retaining the guard in its proximal position to allow unobstructed use of the needle cannula and the associated syringe. The shield and guide may further include additionally cooperating locking structures to lock the guard in a position that prevents inadvertent contact with the needle cannula. For example, the protector may include catches at the proximal end of the protector. The detents may be configured to engage the corresponding structure on the guide when the protector has been advanced far enough distance to substantially enclose the needle. The locking structures may be configured to provide an audible and / or tactile indication that the guard has been advanced sufficiently. to safely and permanently protect the needle cannula. One embodiment of the present invention includes a protective assembly and a syringe assembly comprising a hypodermic syringe assembly that includes a syringe barrel having opposite proximal and distant ends. A needle cannula projects remotely from the distal end of the syringe barrel. A protective assembly includes a guide secured to a portion of the syringe assembly in proximity to the needle cannula. A protector is operatively connected to the guide. The protector includes a support wall and a pair of spaced side walls projecting from the support wall. At least a portion of the side walls are spaced apart from each other sufficiently to receive the needle cannula therebetween. The shield is slidably coupled with the guide and is movable along a path having a generally sharp angle with and generally towards the needle cannula from a proximal position where the needle cannula is exposed to a distant position where the cannula The needle is protected between the side walls of the protector.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a side elevation view of a hypodermic syringe having a protective assembly in accordance with the present invention securely mounted thereto and placed in an unprotected arrangement. Fig. 2 is a side elevational view of the guide of the protective assembly. Fig. 3 is a bottom plan view of the guide shown in Fig. 2. Fig. 4 is a cross-sectional view taken along line 4-4 in Fig. 3. Fig. 5 is a side elevational view of the protector shown in Fig. 1. Fig. 6 is a front elevation view of the protector shown in Fig. 1. Fig. 7 is a cross-sectional view taken along the line 7-7 in Figure 5. Fig. 8 is a side elevational view similar to Fig. 1 but showing the protector in an alternate position relative to the guide and the hypodermic syringe. Fig. 9 is a side elevational view similar to Fig. 1, but showing a second embodiment of the protective assembly. Fig. 10 is a side elevational view similar to Fig. 8, but showing the second embodiment of the protective assembly.

Fig. 11 is a side elevational view similar to Fig. 1 but showing a third embodiment of the protective assembly. Fig. 12 is a top plan view of the assembly shown in Fig. 11. Fig. 13 is a side elevational view similar to FIG. 1 but showing a fourth embodiment of the protective assembly. Fig. 14 is a top plan view of the assembly shown in Fig. 13.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES While this invention is satisfactory by means of the embodiments in many different forms, the preferred embodiments of the invention will be described in detail in the drawings and will be described in detail with the understanding that the present description is considered illustrative of the principles of the invention and is not intended to limit the scope of the invention to the illustrated embodiments. The scope of the invention will be delimited by the appended claims and their equivalents. A protective assembly according to the present invention is identified by the number 10 in Fig. 1. The protective assembly 10 is used with a hypodermic syringe assembly of the prior art 12 comprising a syringe barrel 14, a plunger 16. and a needle assembly 18. The syringe barrel 14 has an elongated tubular side wall 20 with an open proximal end 22, a distal proximal end 23 defined by an inwardly extending shoulder 24 and a fluid receiving chamber 26 between the extremes. A tip 28 projects remotely from the shoulder 24 and includes a passage 30 extending axially therethrough. The passage 30 through the tip 28 communicates with the chamber 26 of the syringe barrel and allows a flow of fluid in or out of the chamber 26. The syringe barrel 14 further includes a front neck 32 projecting remotely from the shoulder 24 and the surrounding tip 28. The front neck 32 includes an internal threading. The plunger 16 is slidably mounted in fluid tight engagement within the chamber 26 of the syringe barrel 14. The movement of the plunger 16 in a proximal direction from the position shown in FIG. 1 pushes fluid proximal through passage 30 and into chamber 26. Distant movement of plunger 16 expels fluid from chamber 26. Needle assembly 18 comprises a needle cannula 34 having a distal end sharp tip 36 including a sharp tip 37, a proximal end 38 and a lumen extending continuously between them. The needle assembly 18 further includes a hub 40 securely mounted to the proximal end 38 of the needle cannula 34. The hub 40 includes projections that are threadably engaged with the front neck 32. Therefore,, the hub 40 allows the lumen of the needle cannula 34 to be placed in communication with the passage 30 through the tip 28 of the syringe barrel 14. The protective assembly 109 includes a guide 42 and a shield 44 slidably coupled with the guide 42. Guide 42 as shown in Figs. 2-4 is preferably molded from a plastic material and includes opposite proximal and distant ends 45 and 46. A hub mounting opening 47 extends between the ends 45 and 46 and is dimensioned and configured to be permanently mounted to the hub portions 40 projecting remotely beyond the front neck 32. Thus, the guide 42 will not impede the threaded coupling of the hub 40 with the front neck 32. A protected channel 48 is formed on the portions of the guide 42 spaced apart from the hub mounting opening 47. The channel 48 is defined by a bottom surface 50 and a pair of side walls 52 and 54. Side wall portions 52 and 54 remote from the bottom surface 50 include inwardly projecting flanges 56 and 58. Thus, channel 48 defines a main width "a" adjacent to the bottom surface 50 and a smaller width "b" between the flanges 56 and 58. As more clearly shown in Fig. 4, the channel 48 is aligned at an acute angle to the hub mounting opening 47 and defines a length "c" . As will be explained below, the acute angle of the channel 48 allows the protector 44 to be slid towards the needle cannula 34.

The protector 44, as shown more clearly in Figs. 5-7, is preferably molded in unitary form from a rigid plastic and includes a proximal end 66 and an opposite distant end 68. A support wall 70 extends continuously from the proximal end 66 to the distal end 68 and, the side walls 72 and 74 extend rigidly from the support wall 70 in parallel relation spaced apart from one another. The side walls 72 and 74 are separated from one another by a distance "d", as shown in Fig. 6. The dimension "d" is sufficiently large to allow the needle cannula 18 to be received between the side walls. 72 and 74, although it is narrow enough to avoid the insertion of a finger. The side walls 72 and 74 of this embodiment are desirable, although not necessarily, generally trapezoidal in shape and define a smaller width adjacent the proximal end 66 and a greater width adjacent the distal end 68. The side walls 72 and 74 are formed with tabs which extend outwardly 76 and 78 in portions far away from the supporting wall 70. The flanges 76 and 78 define a larger external width "e", as shown in Figure 7, which is slightly less than the greater width " "of the channel 48, although larger than the smaller width" b "of the channel 48. The portions of the side wall 72 and 74 separated from the flanges 76 and 78 define a smaller external width" f ", as shown in FIG. Fig. 7, which is slightly smaller than the smaller width "b" of the channel 48. Thus, the flanges 76 and 78 of the protector 44 can be slidably received in the larger width portions of the channel 48, while the portions of the walls laterals 72 and 74 adjacent to the flanges 76 and 78 can be slidably received between the flanges 56 and 58 of the guide 42. The flanges 76 and 78 are formed with inclined retention projections 80 and 82 include faces confronted at a distance inclined toward the lashes 76 and 78 and confronting work surfaces proximate orthogonal to tabs 76 and 78. Tabs 76 and 78 further include detent projections 84 and 86 substantially adjacent to proximal end 66. Retainer projections 82 include remotely confronted surfaces that extend substantially orthogonal to the flanges 76 and 78. The inclined working projections 88 and 90 extend outwardly from the flanges 76 and 78 at a location thereof spaced a distance "g" away from the detent projections 84 and 86. Labor projections 88 and 90 include facing surfaces at a distance inclined toward the tabs 76 and 78 at an acute angle and confronted surfaces proximate orthogonal to the flanges 76 and 78. The distance "g" is slightly larger than the length "c" of the channels 48 in the guide 42.

The protective assembly 10 is assembled by sliding the needle assembly 18 into the hub opening 47 of the guide 42. Sufficient distal movement of the needle assembly 18 will securely lock or capture the hub 40 in the guide 42. The shield 44 it is then propelled in a distal direction into the channel 48 of the guide 42. More particularly, the distal end portions of the flanges 76 and 78 are urged into the portions of the channel 48 between the bottom surface 50 and the flanges 56 and 58 Of the same. The inclined surfaces of the retention projections 80 and 82 will flex the side walls 52 and 54 of the guide 42 away from each other enough so that the projections 80 and 82 pass through the channel 48. The side walls 52 and 54 will return elastically it did a non-flexed condition when the retention projections 80 and 82 pass remotely past the guide 42. The projections 80 and 82 cooperate with the guide to function as means to prevent the guard from moving proximally from the next position out of engagement with the guide. Other projections not shown could be replaced inwards from the projections 80 and 82 at a distance greater than the guide to provide means for retaining the guide in its next retracted needle exposure position. Sufficient force would have to be applied to the guide to move the guide from a distance and overcome the resistance of the additional projections and the guide channel. The flanges 56 and 58 of the guide 52 will then preferably frictionally couple the side walls 72 and 74 of the shield 44.

These frictional forces will prevent the shield 44 from slipping inadvertently away from the guide 42. Although a slight frictional engagement between the shield and the guide is preferred, it is not necessary to carry out the present invention. The frictional forces prevent the guide from moving inadvertently. This same result can be obtained by having projections on the guide or protector and the recesses or other projections on the other element so that the movement of the protector is slightly prevented. However, for the locking functions a more aggressive jump adjustment arrangement is preferred as taught. All these structures fall within the competence of the present invention. Simultaneously, the closely confronted surfaces of the retention projections 80 and 82 will help to prevent guard 44 being removed next to channel 48 in guide 42. A protective cap (not shown) can be mounted on needle cannula 34 and in FIG. frictional engagement with the guide 42. The protective cap will prevent accidental punctures before use of the syringe assembly 12. The protective cap can be removed shortly before use of the syringe assembly 12. The syringe assembly 12 can then be used in the manner conventionally by initially extracting a selected medicament into the fluid receiving chamber 26 and subsequently injecting the medicament into the patient. As noted above, the portions of the needle cannula 34 near the distant tip 36 may have been exposed to infectious body fluids and are capable of transmitting diseases. After use of the syringe assembly 12, the digital forces can be exerted on the proximal end 66 of the shield 44 by the thumb or the index finger of the hand holding the syringe barrel 14. Those digital forces directed at a distance on the protector 44 will overcome frictional forces between shield 44 and guide 42 and will propel shield 44 remotely relative to guide 42. Sufficient distal movement of protector 44 relative to guide 42 will cause the working projections 84 and 86 of protector 44 makes contact with the side walls 52 and 54 of the guide 42. The inclined surfaces of the projections 84 and 86 will generate sufficient flexure of the side walls 52 and 54 to allow additional movement of the protector 44. After sufficient distance movement , the working projections 84 and 86 will pass remotely beyond the guide 42, allowing the side walls 52 and 54 Elastically stick to a non-flexed condition. Although the preferred embodiment relies on the bending of the side walls it is within the competence of the present invention to design the joint parts either for the guard or for the guide is the bending member or that the parts are designed in such a way that Both elements flex slightly to obtain the desired result. The structure described heretofore in the present is merely preferred and is not intended to limit the invention. The further distal movement of the protector 44 is completely prevented by contact between the retainer surfaces 88 and 90 on the flanges 76 and 78 with the proximal end 45 of the guide 42. The return movement of the protector 44 which could expose the Needle cannula 34 is prevented by the proximal surfaces of the locking projections 84 and 86. Therefore, the protector 44 is locked completely in the position shown in Fig. 8 with the needle cannula 34 placed securely between the walls laterals 72 and 74 of protector 44. The used syringe assembly can be discarded in a conventional tip container. Figs. 9 and 10 show a second embodiment of a protective assembly that is identified by the numeral 1. The protective assembly 1 10 is mounted to the aforementioned syringe assembly 12 and includes, a guide 42 substantially identical to the guide described and illustrated above. However, the protective assembly 1 10 includes a protector 144 with non-linear flanges 176 and 1 78 formed therein. The non-linear or curvilinear flanges 176 and 178 allow guard 144 to move in a non-linear or curvilinear path between the proximal position shown in FIG. 9 and the distal portion shown in FIG. 10. The curvilinear shape of the flanges 176 and 178 allows the shield 144 to remain close to the syringe barrel 14 and therefore, defines a smaller cross-sectional dimension in the ready-to-use close position of FIG. 9 as compared to the comparable position of the protective assembly 10 shown in FIG. 1 . However, as shown in Fig. 10, the protector 144 obtains approximately the same guarding protection of the needle cannula 34 as the protector 44 described above. Allowing the shield to move in a non-linear or curvilinear path along a generally sharp angle to the needle cannula is an important feature of the present invention. The position of the guard in the near and far positions can be optimized. In the distant position, the shield can move sharply towards the needle cannula so that the cannula is deep inside the shield and well protected when the shield is in the distant position. Also, through the curvilinear movement, the protector can take its proximal position very close to the cylinder of the syringe and be less obstructive during the normal operation of the syringe. With the curvilinear tabs on the protector the direction of the groove does not necessarily have to be angled with respect to the needle and can be parallel with the needle. The trajectory of the protector with respect to the needle follows a generally sharp trajectory towards the needle as the protector moves towards its needle protection position. In Figs. 1 1 and 12 a third embodiment of the protective assembly is shown and is identified with the numeral 210. The protective assembly 210 includes a guide 242 with an individual side wall 252 and a pair of channels 256 and 258 formed therein. The protective assembly 21 0 further includes a shield 244 with the side walls 272 and 274 having inwardly projecting flanges 276 and 278 dimensioned for reception in the channel 256 and 258 of the guide 242. In all functional aspects, the assembly shield 210 operates similarly as protective assembly 10 described and illustrated in Figs. 1-7. In Figs. 13 and 14 a fourth embodiment of the protective assembly is shown and is identified with the numeral 310. The protective assembly 310 includes a guide 42 substantially as described and illustrated above. The protective assembly 310 further includes a shield 344 with side walls 372 and 374. The side walls 372 and 374 are not formed with tabs as in the above embodiment. Instead, the side walls 372 and 374 are formed with elongated slots 376 and 378 that extend completely therethrough. The slots 376 and 378 are sized to receive the flanges 56 and 58 of the guide 42. In all other aspects, the protective assembly 310 functions in a manner similar to the protector 10 described above and illustrated in Figs. 1-7.

Claims (10)

1. A protective assembly and syringe assembly comprising: a syringe assembly that includes a syringe barrel having opposite proximal and distant ends, a needle cannula projecting remotely from the distal end of the syringe barrel; and a protective assembly including a guide secured to a portion of the syringe assembly in proximity to the needle cannula and, the protector having a support wall and a pair of spaced apart side walls projecting from the support wall, the side walls being spaced apart from each other sufficiently to receive the needle cannula therebetween, the guard being slidably engaged with the guide and being movable along a path having a generally sharp angle with and towards the needle cannula, from a proximal position where the needle cannula is exposed to a distant position where the needle cannula is protected between the side walls of the shield.

2. The assembly of claim 1, further comprising locking means for locking the guard in the distal position.

The assembly of claim 1, further including means for preventing the guard from moving in proximity to the proximal position out of engagement with the guide.

4. The assembly of claim 1, wherein the guide includes a pair of spaced side walls of the guard that is slidably engaged between the side walls of the guide.

The assembly of claim 4, wherein the side walls of the guide define a channel, the channel having a lower surface extending between the side walls of the guides, the side walls of the guide including further a pair of flanges projecting towards each other at locations on the side walls separated from the lower surface of the channel, the side walls of the protector being slidably coupled with the flanges of the side walls on said guide.

The assembly of claim 1, wherein the protector includes opposed proximal and distant ends, the side walls being substantially trapezoidal and having a greater width substantially adjacent to the distal end of the protector and a smaller width substantially adjacent to the proximal end of the protector.

The assembly of claim 1, wherein the guide includes a pair of channels facing in opposite directions on the guide, the guard including a pair of tabs projecting toward each other on the respective side walls, the tabs of the side walls being slidably engaged within the channels of the guide.

8. The assembly of claim 1, wherein the guide and guard are configured for non-linear sliding movement of the guard relative to the guide. The assembly of claim 1, wherein the hypodermic syringe assembly includes a needle hub securely connected to the needle cannula and releasably engageable with the syringe barrel, the guide being connected to the hub. The assembly of claim 1, further including means for controlling the path of the guard between the proximal position and the distal position so that the path is curvilinear.