Pen needle tip

A needle tip assembly includes a needle tip, a needle tip cover structured and arranged to facilitate installation of the needle tip onto at least one of a pen needle, a pre-loaded syringe, and an injection device, and at least one of an arrangement for preventing re-installation or re-use of the needle tip, a safety mechanism coupled to the needle tip via a living hinge, and a safety cover non-removably coupled to the needle tip. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to pen needles, e.g., pre-loaded syringes, such are utilized for injection of medicament into the body tissues of human and animal patients. More specifically, this invention relates to a pen needle having a removable tip which can be prevented from reuse and/or which utilizes one or more mechanisms for preventing the possibility of inadvertent needle pricks.

This invention also relates to pen needle tips for pen needles wherein the pen needle tip is configured to prevent it from being re-used.

This invention also relates to tips for devices such as, e.g., pre-loaded syringes, which can be used only once, i.e., single-use tips, and/or to tips which include one or more mechanisms for preventing the user from being pricked when handling the tip.

2. Discussion of Background Information

U.S. Pat. No. 4,973,318, the disclosure of which is hereby expressly incorporated by reference in its entirety, discloses a disposable syringe includes first and second housing elements which are coupled together for rotation without axial movement therebetween. The first housing element receives a cartridge of a solution to be injected, and mounts a liquid outlet needle at its front end. A piston rod is disposed in the second housing element to move axially therein, and this piston rod includes a rod element and a nut element. The rod element is coupled to the first housing element to move axially therein without relative rotation therewith, and the nut element is threaded to the rod element for telescoping movement therewith and is configured to move axially in the second housing element without relative rotation therein. A pressure receiving element is mounted on the nut element. The housing, rod, nut and pressure receiving elements cooperate such that relative rotation between the housing elements in a selected direction causes relative rotation between the nut and rod elements and thereby increases the effective length of the piston rod and causes the pressure receiving element to extend from the second housing element. A protective cap is removably mounted over the first housing element and is configured to abut second housing element while mounted in place on the first housing element. This protective cap is engaged with the first housing element such that rotation of the cap with respect to the second housing element causes rotation of the first housing element with respect to the second housing element.

This type of syringe is shown inFIGS. 1-7wherein the pre-loaded syringe1has a proximal threaded end2which is configured to accept a needle tip assembly consisting of a needle tip5, a needle tip cover3, and a needle cover4. As is evident fromFIGS. 2 and 3, a user installs the needle tip assembly3/4/5, after removing the assembly from its individual package, onto the threaded proximal end2by simply sliding it onto the end2axially. Because internal threads of the needle tip5are mounted to radially deflectable members, installation over threads of the end2occurs with a ratchet effect. This installation is made safe by the covers4and5which ensure that the user will not be pricked by the needle N. Once installed, the user can remove the needle tip cover3by simply sliding it off axially as is shown inFIG. 4. Next, as shown inFIG. 5, the user can remove the needle cover4to expose the needle N. The pen needle device then assumes the position shown inFIG. 6and is made ready for use in providing an injection to the user. After injection, the user will typically remove the needle tip5and discard the same. To accomplish the removal, the user will typically reinstall the needle tip cover3and rotate it to cause the needle tip to unthread from the threaded end2(some users may even install the needle cover4prior to installing the cover3). Once removed, however, it is still possible to reinstall the used needle tip5by simply repeating the steps noted above.FIG. 7illustrates that the needle tip5can even be installed without the needle covers3and4. Unless the user discards the needle tip5, it is possible that she or other users will not remember or know that it has already been used. That is, there is nothing to prevent reuse of the needle tip5should someone attempt to reinstall the needle tip onto the end2. Furthermore, if the user is unable to locate the covers3and4(i.e., if they have become lost), she must then attempt to grip the needle tip5in order to unthread it from the end2. As is apparent, this action can be risky because the user can possibly inadvertently be pricked by the needle N either in attempting to properly grip the needle tip5, in the action of rotating it to the point it is removed, or even in the handling of the needle tip5after it has been removed and prior to being properly discarded. Still further, if the needle tip5is not properly discarded (such as being correctly placed in a sharps container), others may come in contact with the needle tip5and possibly become injured thereby.

It is therefore desirable to provide a pen needle system which is safer to use compared to the conventional devices discussed above and/or which does not have one or more of the above-noted disadvantageous.

SUMMARY OF THE INVENTION

According to one non-limiting embodiment of the invention, there is provided a pen needle having a removable tip which can be prevented from reuse and/or which utilizes one or more mechanisms for preventing the possibility of inadvertent needle pricks.

According to another non-limiting embodiment of the invention, there is provided a pen needle tip for a pen needle wherein the pen needle tip is configured to prevent it from being re-used.

According to another non-limiting embodiment of the invention, there is provided a needle tip for a device such as, e.g., a pre-loaded syringe, which can be used only once, i.e., single-use tips, and/or to tips which include one or more mechanisms for preventing the user from being pricked when handling the tip.

According to another non-limiting embodiment of the invention, there is provided a needle tip assembly comprising a needle tip, a needle tip cover structured and arranged to facilitate installation of the needle tip onto at least one of a pen needle, a pre-loaded syringe, and an injection device, and at least one of an arrangement for preventing re-installation or re-use of the needle tip, a safety mechanism coupled to the needle tip via a living hinge, and a safety cover non-removably coupled to the needle tip.

The arrangement may comprise a ring which is moveble from a first position to a second position. The arrangement may comprise a ring which is axially moveble. The arrangement may comprise a locking member which is moveble from an unlocked position to a locked position. The arrangement may comprise a movable member mounted to a body of the needle tip, wherein the movable member is axially moveble from a first position to a second position by the needle tip cover. The arrangement may comprise a movable member mounted to a body of the needle tip, wherein the movable member is axially moveble from a first position to a second position, and wherein, when in the second position, the needle tip is prevented from being re-installed. The arrangement may comprise an elastic member mounted to a body of the needle tip, wherein the elastic member is moveble from a first position to a second position, and wherein, when in the second position, the needle tip is prevented from being re-installed. The arrangement may comprise at least one inwardly projecting member adapted to be deflected inwardly. The at least one inwardly projecting member may be biased away from inward deflection. The arrangement may further comprise a ring which is moveble from a first position to a second position causing inward deflection of the at least one inwardly projecting member. The arrangement may further comprise a ring which is axially moveble to a position causing inward deflection of the at least one inwardly projecting member. The arrangement may further comprise a locking member which is moveble from an unlocked position to a locked position causing inward deflection of the at least one inwardly projecting member. The arrangement may further comprise a movable member mounted to a body of the needle tip, wherein the movable member is axially moveble from a first position to a second position by the needle tip cover, whereby the second position causes inward deflection of the at least one inwardly projecting member. The arrangement may further comprise a movable member mounted to a body of the needle tip, wherein the movable member is axially moveble from a first position to a second position, and wherein, when in the second position, the needle tip is prevented from being re-installed by inward deflection of the at least one inwardly projecting member. The arrangement may further comprise an elastic member mounted to a body of the needle tip, wherein the elastic member is moveble from a first position to a second position, and wherein, when in the second position, the needle tip is prevented from being re-installed by inward deflection of the at least one inwardly projecting member. The safety mechanism may comprise a proximal needle cover. The safety mechanism may comprise a member which covers a distal end of the needle tip. The safety cover may comprise a proximal needle cover. The safety cover may comprise a member which covers a distal end of the needle tip. The needle tip cover may be structured and arranged to facilitate removal of the needle tip from the at least one of the pen needle, the pre-loaded syringe, and the injection device.

According to another non-limiting embodiment of the invention, there is provided a needle tip assembly comprising a needle tip comprising a body and a needle projecting from the body and a needle tip cover structured and arranged to facilitate installation of the needle tip onto at least one of a pen needle, a pre-loaded syringe, and an injection device, wherein the needle tip cover activates an arrangement for preventing re-installation or re-use of the needle tip.

The assembly may further comprise at least one of a safety mechanism coupled to the needle tip via a living hinge and a safety cover non-removably coupled to the needle tip. The needle tip cover may be structured and arranged to facilitate removal of the needle tip from the at least one of the pen needle, the pre-loaded syringe, and the injection device,

According to another non-limiting embodiment of the invention, there is provided a needle tip assembly comprising a needle tip comprising a body, a needle projecting from the body, and at least one inwardly projecting member adapted to be deflected inwardly and a needle tip cover structured and arranged to facilitate installation of the needle tip onto at least one of a pen needle, a pre-loaded syringe, and an injection device, wherein, when the at least one inwardly projecting member is deflected inwardly, the needle tip is prevented from being re-installed.

The needle tip cover may activate an arrangement for preventing re-installation or re-use of the needle tip. The assembly may further comprise at least one of a safety mechanism coupled to the needle tip via a living hinge and a safety cover non-removably coupled to the needle tip. The needle tip cover may be structured and arranged to facilitate removal of the needle tip from the at least one of the pen needle, the pre-loaded syringe, and the injection device. The assembly may further comprise an arrangement that is moveble from a first position to a second position. The arrangement may comprise a ring which is axially moveble. The arrangement may comprise a locking member which is moveble from an unlocked position to a locked position. The arrangement may comprise a movable member mounted to the body of the needle tip, wherein the movable member is axially moveble from a first position to a second position by the needle tip cover. The arrangement may comprise a movable member mounted to the body of the needle tip, wherein the movable member is axially moveble from a first position to a second position, and wherein, when in the second position, the needle tip is prevented from being re-installed. The arrangement may comprise an elastic member mounted to the body of the needle tip, wherein the elastic member is moveble from a first position to a second position, and wherein, when in the second position, the needle tip is prevented from being re-installed.

According to another non-limiting embodiment of the invention, there is provided a method of using the needle tip assembly of the type described above, wherein the method comprises installing the needle tip assembly onto a proximal end of an injection device, activating the arrangement before using the injection device, and re-installing the needle tip cover and removing the needle tip using the needle tip cover.

According to another non-limiting embodiment of the invention, there is provided a method of using the needle tip assembly of the type described above, wherein the method comprises installing the needle tip assembly onto a proximal end of an injection device, activating with the needle tip cover, an arrangement for preventing re-installation or re-use of the needle tip, and re-installing the needle tip cover and removing the needle tip using the needle tip cover.

According to another non-limiting embodiment of the invention, there is provided a method of using the needle tip assembly of the type described above, wherein the method comprises installing the needle tip assembly onto a proximal end of an injection device and re-installing the needle tip cover and removing the needle tip using the needle tip cover, wherein after removal, the at least one inwardly projecting member is deflected inwardly so as to prevent re-installation of the needle tip.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings and first toFIGS. 8-19which shows a first embodiment of a needle tip assembly. The needle tip assembly includes a needle tip cap30having various generally cylindrical portions with different diameters, a needle cap40, and a needle tip50. The proximal end30aof the needle tip cap30is closed while the distal end includes a circumferential flange30b. The proximal end40aof the needle cap40is closed while the distal end includes a circumferential flange40b. The proximal end of the needle tip50includes a needle N while the distal end includes an opening which is sized to allow the needle tip50to be mounted to the threaded proximal end2of the pen needle device1. In order to ensure that the needle tip50is prevented from being re-installed onto the proximal end2, the needle tip50utilizes a ring60which can move axially from an initial position (seeFIG. 9) to a second position (seeFIG. 10) which causes one or more inwardly deflecting members50aand50bto deflect inwards by an amount which is sufficient to prevent the needle tip50(after being removed) from being re-installed onto the proximal end2. As can be seen inFIG. 8, prior the needle tip assembly being installed onto the threaded proximal end2, the one or more inwardly deflecting members50aand50bare bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50to be installed onto the proximal end2in the conventional manner, i.e., by axially sliding it on or by threading it on.

As can be seen inFIG. 9, the needle tip assembly can be installed onto the threaded proximal end2without activating the re-use prevention mechanism, i.e., without causing the ring60to move axially to the locked position. Accordingly, in the position shown inFIG. 9, the one or more inwardly deflecting members50aand50bare still bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50to be installed onto the proximal end2in the conventional manner. Furthermore, while the ring60is in the position shown inFIG. 9, the needle tip assembly can be removed in the conventional way by, e.g., unthreading it off of the threaded end2.

As can be seen inFIG. 10, after the needle tip assembly is installed onto the threaded proximal end2(as shown inFIG. 9), the needle tip cap30can be further moved axially in the distal direction (as indicated by the arrow inFIG. 10) to the point that it activates the re-use prevention system or mechanism, i.e., it causes the ring60to move axially in the distal direction until it assumes the locked position. The locked position is characterized by engagement between the projections of the one or more inwardly deflecting members50aand50band the inner circumferential recess of the ring60. Accordingly, in the position shown inFIG. 10, the one or more inwardly deflecting members50aand50bhave been deflected inwardly so that they are now biased against the proximal end2and frictionally engage the threads thereof when the needle tip50is unthreaded. Furthermore, while the ring60is in the position shown inFIG. 10, the needle tip assembly can be removed, e.g., in the conventional way by unthreading it off of the threaded end2, but, unlike the prior art, cannot thereafter be reinstalled.

As can be seen inFIG. 11, once the needle tip assembly is installed (FIG. 9) and the re-use prevention system activated (FIG. 10), the needle tip cap30can be removed by sliding it off axially. Then, as shown inFIG. 12, the needle cap40can be removed.FIG. 13shows the pen needle device with the installed needle tip50in a position that is ready for injection. Again, in this position, the ring60has been moved to the locked position which has caused a plurality of inwardly deflecting members50aand50bto frictionally engage the threaded proximal end2of the pen needle device1.

As can be seen inFIG. 14, once the pen needle device with the installed needle tip assembly has been used to perform an injection, the needle tip50can be removed in the following ways: one could simply grip the needle tip50in the area of the ring60and unthread it from the threaded proximal end2. This is risky, of course, because the user can be inadvertently be pricked by the exposed needle N; one could re-install the needle cap40and then grip the needle tip50in the area of the ring60and unthread it from the threaded proximal end2; one could re-install both the needle cap40and the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the entire needle tip assembly thereby causing the needle tip50to become unthreaded from the threaded proximal end2; and one could re-install only the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the needle tip assembly (without the cap40) thereby causing the needle tip50to become unthreaded from the threaded proximal end2. All of these ways are contemplated by the invention, but the first way is the least desirable.

As is evident fromFIG. 14, once the needle tip50is removed from the threaded proximal end2(and because the ring60has been moved to the locked position), the plurality of inwardly deflecting members50aand50bare caused to move inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50back onto the threaded proximal end2of the pen needle device1. This is evident fromFIG. 15which shows how the plurality of inwardly deflecting members50aand50bhave been moved inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50back onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50.

As is evident fromFIGS. 16 and 17, the needle cap40has a closed proximal end40a, an open distal end having a circumferential flange40b, a distal opening40csized to frictionally engage with a hub portion of the needle tip50, and a tapered portion40dwhich is sized to safely receive therein the needle N. Of course, the needle cap40can have any desired configuration provided that it functions for its intended purpose, and can even be dispensed with without leaving the scope of the invention.

As is evident fromFIGS. 18 and 19, the needle tip cap30has a closed proximal end30a, an open distal end having a circumferential flange30b, a distal opening30csized to receive therein the ring60, a shoulder30cwhich engages with a distal end of the ring60so as to cause the ring60to move to the locked position, a generally circumferential surface30ewhich is sized to frictionally engage with an outer surface of the needle tip50so as to cause it to rotate relative to the proximal end2, and a tapered and/or stepped portion30fwhich is sized to safely receive therein the needle N and the needle cap40. Of course, the needle tip cap30can have any desired configuration provided that it functions for its intended purpose, and can even be dispensed with without leaving the scope of the invention. In the later case, only the needle cap40(or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and the user could activate the re-use prevention system by gripping the ring60and sliding it distally until it assumes the locked position.

FIGS. 20-28shows a second embodiment of a needle tip assembly. The needle tip assembly includes a needle tip cap30having various generally cylindrical portions with different diameters, a needle cap40, and a needle tip50′. As the needle tip cap30, the needle cap40, and the ring60of the instant embodiment are essentially identical to those used in the previous embodiment, they have been accorded the same reference numerals. The proximal end30aof the needle tip cap30is closed while the distal end includes a circumferential flange30b. Similarly, the proximal end40aof the needle cap40is closed while the distal end includes a circumferential flange40b. The proximal end of the needle tip50′ includes a needle N while the distal end includes an opening which is sized to allow the needle tip50′ to be mounted to the threaded proximal end2of the pen needle device1. In order to ensure that the needle tip50′ is prevented from being re-installed onto the proximal end2, the needle tip50′ utilizes a ring60which can move axially from an initial position (seeFIG. 21) to a second position (seeFIG. 22) which causes one or more inwardly deflecting members50′aand50′bto deflect inwards by an amount which is sufficient to prevent the needle tip50′ (after being removed) from being re-installed onto the proximal end2. As can be seen inFIG. 20, prior the needle tip assembly being installed onto the threaded proximal end2, the one or more inwardly deflecting members50′aand50′bare bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50′ to be installed onto the proximal end2in the conventional manner, i.e., by axially sliding it on or by threading it on.

As can be seen inFIG. 21, the needle tip assembly can be installed onto the threaded proximal end2without activating the re-use prevention system or mechanism, i.e., without causing the ring60to move axially to the locked position. Accordingly, in the position shown inFIG. 21, the one or more inwardly deflecting members50′aand50′bare still bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50′ to be installed onto the proximal end2. Furthermore, while the ring60is in the position shown inFIG. 21, the needle tip assembly can be removed in the conventional way, e.g., by unthreading it off of the threaded end2.

As can be seen inFIG. 22, after the needle tip assembly is installed onto the threaded proximal end2(as shown inFIG. 21), the needle tip cap30can be further moved axially in the distal direction (as indicated by the arrow inFIG. 22) to the point that it activates the re-use prevention system or mechanism, i.e., it causes the ring60to move axially in the distal direction until it assumes the locked position. The locked position is characterized by engagement between the projections of the one or more inwardly deflecting members50′ and50′ and the inner circumferential recess of the ring60. Accordingly, in the position shown inFIG. 22, the one or more inwardly deflecting members50′aand50′bhave been deflected inwardly so that they are now biased against the proximal end2and frictionally engage the threads thereof when the needle tip50′ is unthreaded. Furthermore, while the ring60is in the position shown inFIG. 22, the needle tip assembly can be removed, e.g., in the conventional way by unthreading it off of the threaded end2, but, unlike the prior art, cannot thereafter be reinstalled.

As can be seen inFIG. 23, once the needle tip assembly is installed (FIG. 21) and the re-use prevention system activated (FIG. 22), the needle tip cap30can be removed by sliding it off axially. Then, as shown inFIG. 24, the needle cap40can also be removed axially.FIG. 25shows the pen needle device with the installed needle tip50′ in a position that is ready for injection. Again, in this position, the ring60has been moved to the locked position which has caused a plurality of inwardly deflecting members50′aand50′bto frictionally engage the threaded proximal end2of the pen needle device1.

As can be seen inFIGS. 26 and 27, once the pen needle device with the installed needle tip assembly has been used to perform an injection, the needle tip50′ can be removed in the following ways: one could simply grip the needle tip50′ in the area of the ring60and unthread it from the threaded proximal end2. This is risky, of course, because the user can be inadvertently be pricked by the exposed needle N; one could re-install the needle cap40and then grip the needle tip50′ in the area of the ring60and unthread it from the threaded proximal end2; one could re-install both the needle cap40and the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the entire needle tip assembly thereby causing the needle tip50′ to become unthreaded from the threaded proximal end2; and one could re-install only the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the needle tip assembly (without the cap40) thereby causing the needle tip50′ to become unthreaded from the threaded proximal end2. As was the case in the previous embodiment, all of these ways are contemplated by the invention for this embodiment, with, however, the first way being the least desirable.

As is evident fromFIG. 28, once the needle tip50′ is removed from the threaded proximal end2(and because the ring60has been moved to the locked position), the plurality of inwardly deflecting members50′aand50′bare caused to move inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50′ back onto the threaded proximal end2of the pen needle device1. This is evident fromFIG. 28which shows how the plurality of inwardly deflecting members50′aand50′bhave been moved inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50′ back onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50′. As is evident from comparingFIGS. 28 and 15, the needle tip50′ differs from the needle tip50in that it does not utilize any internal threads in the body of the needle tip50′ (i.e., the distal opening which receives therein the threaded proximal end2is generally cylindrical and smooth) and with regard to the shape of the projections which extend inwardly from the members50a/50′aand50b/50′b. That is, the projections which extend inwardly from the members50aand50bhave a generally blunt end or rectangular-shaped cross-section whereas the projections which extend inwardly from the members50′aand50′bhave a generally tapered end or triangular-shaped cross-section so as to threadably engage with the threads of the proximal end2.

Although not shown, the embodiment shown inFIGS. 20-28can instead, like the previous embodiment, utilize the needle tip cap shown inFIGS. 47-49. Of course, the needle tip cap30can have any desired configuration provided that it functions for its intended purpose, and can even be dispensed with without leaving the scope of the invention. In the later case, only the needle cap40(or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and the user could activate the re-use prevention system by gripping the ring60and sliding it distally until it assumes the locked position.

FIGS. 29 and 30show an optional needle tip50″ which can be used with any of the embodiments disclosed herein. For purposes of clarity, the ring60has been removed. Unlike the previous embodiments which utilize two oppositely arranged inwardly deflecting members50a/50′aand50b/50′bwhich are caused to move inwardly by the ring60, this embodiment utilizes four equally angularly spaced members50″a,50″b,50″cand50″d, which can be moved inwardly by the ring60to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50″ back onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50″. Although the members50″a,50″b,50″cand50″dare shown deflected inwardly (for purposes of clarity), of course this would not occur until the ring60has been moved to the locked position. The needle tip50″, like the second embodiment, does not utilize any internal threads in the body of the needle tip50″ (i.e., the distal opening which receives therein the threaded proximal end2is generally cylindrical and smooth) and utilizes projections P which extend inwardly from the members50″a,50″b,50″cand50″dand have a generally tapered end or triangular-shaped cross-section so as to threadably engage with the threads of the proximal end2. The projections P can extend all the way across the width of each of the members50″a,50″b,50″cand50″d(as shown inFIG. 29) or they have other forms such as ones which are shorter than the width of the members50″a,50″b,50″cand50″d. The projections P may even have the form of centrally disposed circular or rounded projections. Other configurations may also be utilized provided they are capable of locking with an/or frictionally engaging with the ring60.

As is evident fromFIGS. 31 and 32, the ring60which can be used in the previous embodiments is generally cylindrical and has a proximal end60dwhich engages the shoulder30cof the needle tip cap30, a distal end having a tapered inner surface60cconfigured to facilitate sliding over the deflecting members50a/50bor50′a/50′bor50″a/50″b/50″c//50″d, a circumferential recess60asized and configured to receive therein the projections P of the members50a/50bor50′a/50′bor50″a/50″b/50″c//50″d, and an inner cylindrical surface60bwhich is sized to slide over the needle tip body. Of course, the ring60can have any desired configuration provided that it functions for its intended purpose.

FIG. 33shows still another embodiment of a needle tip assembly. The needle tip assembly includes a needle tip cap30having various generally cylindrical portions with different diameters, a needle cap40, and a needle tip50III. As the needle tip cap30and the needle cap40of the instant embodiment are essentially identical to those used in the previous embodiment, they have been accorded the same reference numerals. In this embodiment also, the proximal end30aof the needle tip cap30is closed while the distal end includes a circumferential flange30b. Similarly, the proximal end40aof the needle cap40is closed while the distal end includes a circumferential flange40b. The proximal end of the needle tip50IIIincludes a needle N while the distal end includes an opening which is sized to allow the needle tip50IIIto be mounted to the threaded proximal end2of the pen needle device1. In order to ensure that the needle tip50IIIis prevented from being re-installed onto the proximal end2, the needle tip50IIIutilizes a ring60′ which can move axially from an initial position (similar to the position shown inFIG. 21) to a second position (similar to the position shown inFIG. 22) which causes the four inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdto deflect inwards by an amount which is sufficient to prevent the needle tip50III(after being removed) from being re-installed onto the proximal end2. As can be seen inFIG. 33, prior to the needle tip assembly being installed onto the threaded proximal end2(not shown inFIG. 33), the four inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdare bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIIto be installed onto the proximal end2in the conventional manner, i.e., by axially sliding it on or by threading it on.

In a manner similar to that shownFIG. 21, the needle tip assembly ofFIG. 33can be installed onto the threaded proximal end2without activating the re-use prevention system or mechanism, i.e., without causing the ring60′ to move axially to the second or activated position. Accordingly, in the position shown inFIG. 33, the one or more inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdare still bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIIto be installed onto the proximal end2. Furthermore, while the ring60′ is in the position shown inFIG. 33, the needle tip assembly can be removed in the conventional way, e.g., by unthreading it off of the threaded end2.

In the same way as was shown inFIG. 22, after the needle tip assembly shown inFIG. 33is installed onto the threaded proximal end2(similar to that shown inFIG. 21), the needle tip cap30can be further moved axially in the distal direction (as indicated by the arrow inFIG. 22) to the point that it activates the re-use prevention system or mechanism, i.e., it causes the ring60′ to move axially in the distal direction until it assumes the second or activated position. Unlike the previous embodiments which provide for a locking position, i.e., characterized by engagement between the projections of the inwardly deflecting members and the inner circumferential recess of the ring, this embodiment utilizes no projections on the members50IIIa,50IIIb,50IIIcand50IIIdand does not therefore utilize the recess for receiving the same on the ring60′. Instead, the ring60′ merely frictionally engages with the outer surfaces of the members50IIIa,50IIIb,50IIIcand50IIIdwhen it is moved to the second or activated position. In order to ensure that the ring60′ does not move back to the original position (after being moved to the second position), the inner circumferential surface of the ring60′ and the outer surface of the members50IIIa,50IIIb,50IIIcand50IIIdcan be provided with high friction surfaces such as e.g., a knurl, a high friction coating, etc. Although not shown, when the ring60′ is moved to the second or activated position, the inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdwill be deflected inwardly (as was the case in the previous embodiments) so that they will biased against the proximal end2and frictionally engage the threads thereof when the needle tip50IIIis unthreaded.

As was the case in the previous embodiments, once the needle tip assembly shown inFIG. 33is installed and the re-use prevention system activated, the needle tip cap30can be removed by sliding it off axially. Then, the needle cap40can also be removed axially. Once the pen needle device with the installed needle tip assembly has been used to perform an injection, the needle tip50IIIcan be removed in the following ways: one could simply grip the needle tip50IIIin the area of the ring60′ and unthread it from the threaded proximal end2. This is risky, of course, because the user can be inadvertently be pricked by the exposed needle N; one could re-install the needle cap40and then grip the needle tip50IIIin the area of the ring60′ and unthread it from the threaded proximal end2; one could re-install both the needle cap40and the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the entire needle tip assembly thereby causing the needle tip50IIIto become unthreaded from the threaded proximal end2; and one could re-install only the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the needle tip assembly (without the cap40) thereby causing the needle tip50IIIto become unthreaded from the threaded proximal end2. As was the case in the previous embodiments, all of these ways are contemplated by the invention for this embodiment, with, however, the first way being the least desirable.

As was the case in the embodiment shown inFIGS. 20-28, once the needle tip50IIIis removed from the threaded proximal end2(and because the ring60′ has been moved to the activated position), the plurality of inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdare caused to move inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50IIIback onto the threaded proximal end2of the pen needle device1. This occurs in substantially the same way as was shown inFIG. 28which shows how the plurality of inwardly deflecting members have been moved inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50IIIback onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50III.

Although not shown, the embodiment shown inFIG. 33can, like the previous embodiments, utilize the needle tip cap shown inFIGS. 47-49instead of the needle tip cap30shown inFIG. 33. Of course, the needle tip cap30can also have any desired configuration provided that it functions for its intended purpose, and can even be dispensed with without leaving the scope of the invention. In the later case, only the needle cap40(or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and the user could activate the re-use prevention system by gripping the ring60′ and sliding it distally until it assumes the activated position.

FIG. 34shows still another embodiment of a needle tip assembly. The needle tip assembly includes a needle tip cap30having various generally cylindrical portions with different diameters, a needle cap40, and a needle tip50IIof the type shown inFIGS. 29 and 30. As the needle tip cap30and the needle cap40of the instant embodiment are essentially identical to those used in previous embodiments, they have been accorded the same reference numerals. In this embodiment also, the proximal end30aof the needle tip cap30is closed while the distal end includes a circumferential flange30b. Similarly, the proximal end40aof the needle cap40is closed while the distal end includes a circumferential flange40b. The proximal end of the needle tip50IIincludes a needle N while the distal end includes an opening which is sized to allow the needle tip50IIto be mounted to the threaded proximal end2of the pen needle device1. In order to ensure that the needle tip50IIis prevented from being re-installed onto the proximal end2, the needle tip50IIutilizes a ring60′ which can move axially from an initial position (similar to the position shown inFIG. 21) to a second position (similar to the position shown inFIG. 22) which causes the four inwardly deflecting members50IIa,50IIb,50IIcand50IIdto deflect inwards by an amount which is sufficient to prevent the needle tip50II(after being removed) from being re-installed onto the proximal end2. As can be seen inFIG. 34, prior to the needle tip assembly being installed onto the threaded proximal end2(not shown inFIG. 34), the four inwardly deflecting members50IIa,50IIb,50IIcand50IIdare bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIto be installed onto the proximal end2in the conventional manner, i.e., by axially sliding it on or by threading it on.

In a manner similar to that shownFIG. 21, the needle tip assembly ofFIG. 34can be installed onto the threaded proximal end2without activating the re-use prevention system or mechanism, i.e., without causing the ring60′ to move axially to the second or activated position. Accordingly, in the position shown inFIG. 34, the one or more inwardly deflecting members50IIa,50IIb,50IIcand50IIdare still bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIto be installed onto the proximal end2. Furthermore, while the ring60′ is in the position shown inFIG. 34, the needle tip assembly can be removed in the conventional way, e.g., by unthreading it off of the threaded end2.

In the same way as was shown inFIG. 22, after the needle tip assembly shown inFIG. 34is installed onto the threaded proximal end2(similar to that shown inFIG. 21), the needle tip cap30can be further moved axially in the distal direction (as indicated by the arrow inFIG. 22) to the point that it activates the re-use prevention system or mechanism, i.e., it causes the ring60′ to move axially in the distal direction until it assumes the second or activated position. Unlike the previous embodiments which provide for a locking position, i.e., characterized by engagement between the projections of the inwardly deflecting members and the inner circumferential recess of the ring, this embodiment utilizes projections on the members50IIa,50IIb,50IIcand50IId, but does not utilize the recess for receiving the same on the ring60′. Instead, the ring60′ merely frictionally engages with the projections of the members50IIa,50IIb,50IIcand50IId(thereby causing the members50IIa,50IIb,50IIcand50IIdto deflect inwardly to a greater extent than would be the case without the projections) when it is moved to the second or activated position. In order to ensure that the ring60′ does not move back to the original position (after being moved to the second position), the inner circumferential surface of the ring60′ and the projections of the members50IIa,50IIb,50IIcand50IIdcan be provided with high friction surfaces such as e.g., a knurl, a high friction coating, etc. Although not shown, when the ring60′ is moved to the second or activated position, the inwardly deflecting members50IIa,50IIb,50IIcand50IIdwill be deflected inwardly (as was the case in the previous embodiments) so that they will biased against the proximal end2and frictionally engage the threads thereof when the needle tip50IIis unthreaded.

As was the case in the previous embodiments, once the needle tip assembly shown inFIG. 34is installed and the re-use prevention system activated, the needle tip cap30can be removed by sliding it off axially. Then, the needle cap40can also be removed axially. Once the pen needle device with the installed needle tip assembly ofFIG. 34has been used to perform an injection, the needle tip50IIcan be removed in the following ways: one could simply grip the needle tip50IIin the area of the ring60′ and unthread it from the threaded proximal end2. This is risky, of course, because the user can be inadvertently be pricked by the exposed needle N; one could re-install the needle cap40and then grip the needle tip50IIin the area of the ring60′ and unthread it from the threaded proximal end2; one could re-install both the needle cap40and the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the entire needle tip assembly thereby causing the needle tip50IIto become unthreaded from the threaded proximal end2; and one could re-install only the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the needle tip assembly (without the cap40) thereby causing the needle tip50IIto become unthreaded from the threaded proximal end2. As was the case in the previous embodiments, all of these ways are contemplated by the invention for this embodiment, with, however, the first way being the least desirable.

As was the case in the embodiment shown inFIGS. 20-28, once the needle tip50IIis removed from the threaded proximal end2(and because the ring60′ has been moved to the activated position), the plurality of inwardly deflecting members50IIa,50IIb,50IIcand50IIdare caused to move inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50IIback onto the threaded proximal end2of the pen needle device1. This occurs in substantially the same way as was shown inFIG. 28which shows how the plurality of inwardly deflecting members have been moved inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50IIback onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50II.

Although not shown, the embodiment shown inFIG. 34can, like the previous embodiments, utilize the needle tip cap shown inFIGS. 47-49instead of the needle tip cap30shown inFIG. 34. Of course, the needle tip cap30can also have any desired configuration provided that it functions for its intended purpose, and can even be dispensed with without leaving the scope of the invention. In the later case, only the needle cap40(or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and the user could activate the re-use prevention system by gripping the ring60′ and sliding it distally until it assumes the activated position.

FIG. 35shows still another embodiment of a needle tip assembly. The needle tip assembly includes a needle tip cap30having various generally cylindrical portions with different diameters, a needle cap40, and a needle tip50IIIof the type shown inFIG. 33. As the needle tip cap30and the needle cap40of the instant embodiment are essentially identical to those used in the previous embodiments, they have been accorded the same reference numerals. In this embodiment also, the proximal end30aof the needle tip cap30is closed while the distal end includes a circumferential flange30b. Similarly, the proximal end40aof the needle cap40is closed while the distal end includes a circumferential flange40b. The proximal end of the needle tip50IIIincludes a needle N while the distal end includes an opening which is sized to allow the needle tip50IIIto be mounted to the threaded proximal end2of the pen needle device1. In order to ensure that the needle tip50IIIis prevented from being re-installed onto the proximal end2, the needle tip50IIIutilizes a ring60″ which can move axially from an initial position (similar to the position shown inFIG. 21) to a second position (similar to the position shown inFIG. 22) which causes the four inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdto deflect inwards by an amount which is sufficient to prevent the needle tip50III(after being removed) from being re-installed onto the proximal end2. As can be seen inFIG. 35, prior to the needle tip assembly being installed onto the threaded proximal end2(not shown inFIG. 35), the four inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdare bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIIto be installed onto the proximal end2in the conventional manner, i.e., by axially sliding it on or by threading it on.

In a manner similar to that shownFIG. 21, the needle tip assembly ofFIG. 35can be installed onto the threaded proximal end2without activating the re-use prevention system or mechanism, i.e., without causing the ring60″ to move axially to the second or activated position. Accordingly, in the position shown inFIG. 35, the one or more inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdare still bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIIto be installed onto the proximal end2. Furthermore, while the ring60″ is in the position shown inFIG. 35, the needle tip assembly can be removed by e.g., sliding or threading it off of the threaded end2.

In the same way as was shown inFIG. 22, after the needle tip assembly shown inFIG. 35is installed onto the threaded proximal end2(similar to that shown inFIG. 21), the needle tip cap30can be further moved axially in the distal direction (as indicated by the arrow inFIG. 22) to the point that it activates the re-use prevention system or mechanism, i.e., it causes the ring60″ to move axially in the distal direction until it assumes the second or activated position. Unlike the previous embodiments which provide for a locking position, i.e., characterized by engagement between the projections of the inwardly deflecting members and the inner circumferential recess of the ring, this embodiment utilizes no projections on the members50IIIa,50IIIb,50IIIcand50IIIdand does not therefore utilize the recess for receiving the same on the ring60″. Furthermore, unlike the embodiment shown inFIG. 33, the ring60″ of this embodiment utilizes no inner tapered section. Instead, the ring60″ merely frictionally engages with the outer surfaces of the members50IIIa,50IIIb,50IIIcand50IIIdwhen it is moved to the second or activated position. In order to ensure that the ring60″ does not move back to the original position (after being moved to the second position), the inner circumferential surface of the ring60″ and the outer surface of the members50IIIa,50IIIb,50IIIcand50IIIdcan be provided with high friction surfaces such as e.g., a knurl, a high friction coating, etc. Although not shown, when the ring60″ is moved to the second or activated position, the inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdwill be deflected inwardly (as was the case in the previous embodiments) so that they will biased against the proximal end2and frictionally engage the threads thereof when the needle tip50IIIis unthreaded.

As was the case in the previous embodiments, once the needle tip assembly shown inFIG. 35is installed and the re-use prevention system activated, the needle tip cap30can be removed by sliding it off axially. Then, the needle cap40can also be removed axially. Once the pen needle device with the installed needle tip assembly has been used to perform an injection, the needle tip50IIIcan be removed in the following ways: one could simply grip the needle tip50IIIin the area of the ring60″ and unthread it from the threaded proximal end2. This is risky, of course, because the user can be inadvertently be pricked by the exposed needle N; one could re-install the needle cap40and then grip the needle tip50IIIin the area of the ring60″ and unthread it from the threaded proximal end2; one could re-install both the needle cap40and the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the entire needle tip assembly thereby causing the needle tip50IIIto become unthreaded from the threaded proximal end2; and one could re-install only the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the needle tip assembly (without the cap40) thereby causing the needle tip50IIIto become unthreaded from the threaded proximal end2. As was the case in the previous embodiments, all of these ways are contemplated by the invention for this embodiment, with, however, the first way being the least desirable.

As was the case in the embodiment shown inFIGS. 20-28, once the needle tip50IIIis removed from the threaded proximal end2(and because the ring60″ has been moved to the activated position), the plurality of inwardly deflecting members50IIIa,50IIIb,50IIIcand50IIIdare caused to move inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50IIIback onto the threaded proximal end2of the pen needle device1. This occurs in substantially the same way as was shown inFIG. 28which shows how the plurality of inwardly deflecting members have been moved inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50IIIback onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50III.

Although not shown, the embodiment shown inFIG. 35can, like the previous embodiments, utilize the needle tip cap shown inFIGS. 47-49instead of the needle tip cap30shown inFIG. 33. Of course, the needle tip cap30can also have any desired configuration provided that it functions for its intended purpose, and can even be dispensed with without leaving the scope of the invention. In the later case, only the needle cap40(or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and the user could activate the re-use prevention system by gripping the ring60″ and sliding it distally until it assumes the activated position.

FIGS. 36 and 37show an optional needle tip50IVwhich can be used with any of the embodiments disclosed herein. Unlike the previous embodiments which utilize a essentially rigid or semi-rigid ring, this embodiment utilizes an elastic-type ring60III; that is a ring which functions like an expanded rubber band that wants to contract. Indeed, the invention contemplates that the ring60IIIcan be a rubber band ring or even a split spring metal ring which wants to contract but is kept expanded by virtue of being mounted to a portion of the body of the needle tip50IVwhich prevents its contraction. Furthermore, unlike the previous embodiments which utilize inwardly deflecting members which are caused to move inwardly by the ring, this embodiment utilizes four equally angularly spaced slots50IVa,50IVb,50IVcand50IVd, which weakens the distal end of the needle tip50IVto the point that when, the ring60IIIis moved over the slots50IVa,50IVb,50IVcand50IVd, the distal end of the needle tip50IVwill deflect inwardly to the point that it will not permit (i.e., it will interfere with) re-installation of the needle tip50IVback onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50IV. The needle tip50IV, like the second embodiment, does not utilize any internal threads in the body of the needle tip50IV(i.e., the distal opening which receives therein the threaded proximal end2is generally cylindrical and smooth).

As is evident fromFIG. 38, once the needle tip50IVis removed from the threaded proximal end2(and because the ring60IIIhas been moved to the activated position), the distal end of the needle tip50IVdeflects inwardly to the point that it will not permit (i.e., will interfere with) re-installation of the needle tip50IVback onto the threaded proximal end2of the pen needle device1. When this occurs, the distal end of the needle tip50IVeffectively reduces the diameter of the distal opening of the needle tip50IV.

FIGS. 39 and 40show an optional needle tip50Vwhich can be used with any of the needle tip assembly embodiments disclosed herein. The ring60can be, by way of non-limiting example, of the type described above inFIGS. 31 and 32. The needle tip50Vcan be, by way of non-limiting example, of the type described above inFIGS. 29 and 30, except that it additionally utilizes a plurality of, e.g., equally angularly spaced, guide/engaging projections50Vewhich are sized and configured to slide within correspondingly placed guide/engaging recesses30′garranged on the needle tip cap30′. This embodiment similarly utilizes four equally angularly spaced members50Va,50Vb,50Vcand50Vd, which can be moved inwardly by the ring60to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50Vback onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50V.

FIG. 40shows a needle tip cap30′ which can be used with the needle tip50Vshown inFIG. 39. The needle tip cap30′ is similar to the cap shown inFIGS. 18 and 19except that it also utilizes e.g., equally angularly spaced, guide/engaging recesses30′gwhich are sized and configured to slidably receive therein correspondingly placed guide/engaging projections50Vearranged on the needle tip50V. The needle tip cap30′ has a closed proximal end30′a, an open distal end having a circumferential flange30′b, a distal opening30′csized to receive therein the ring60, a shoulder30′cwhich engages with a distal end of the ring60so as to cause the ring60to move to the locked position, a generally circumferential surface30′ewhich is sized to slide over an outer surface of the needle tip50Vand allow for engagement between guide/engaging projections50Veand guide/engaging recesses30′g. Of course, the needle tip cap30′ can have any desired configuration provided that it functions for its intended purpose.

FIGS. 41-44show still another embodiment of a needle tip assembly. The needle tip assembly includes a needle tip cap300having a generally cylindrical configuration, a needle cap40, and a needle tip50IIof the type shown inFIGS. 29 and 30, and except that the ring60IVhas a different configuration. In this embodiment, the ring60IVis generally cylindrical and has a proximal end60IVdwhich engages the shoulder300cof the needle tip cap300, a distal end having a tapered inner surface60IVcconfigured to facilitate sliding over the deflecting members50″a/50″b/50″c//50″d, a circumferential recess60IVasized and configured to receive therein the projections P of the members50″a/50″b/50″c//50″d, and an inner cylindrical surface60IVbwhich is sized to slide over the needle tip body. Of course, the ring60IVcan have any desired configuration provided that it functions for its intended purpose. Additionally, the ring60IVhas a generally circumferential proximal flange60IVdwhich prevents the needle tip cap300from sliding off the ring60IVin the proximal direction. The ring60IValso has a generally circumferential retaining projection60IVfwhich ensures that the needle tip cap300is able to move the ring60IVin the distal direction so as to cause it to lock to the needle tip50″. However, after the ring60IVbecomes locked to the needle tip50″, the projection60IVfwill not be able to prevent further movement of the cap300and is, in fact, configured to allow (upon exertion of a predetermined force) the inwardly projecting circumferential projection300eto pass over the projection60IVfuntil the annular surface300cof the projection300eengages the proximal shoulder of the pen needle device1. This is shown inFIG. 42. As the needle cap40of the instant embodiment is essentially identical to that used in the previous embodiment, it has been accorded the same reference numeral. In this embodiment, the proximal end300aof the needle tip cap300is open (unlike the previous embodiments) while the distal end is configured to slide over the proximal portion of the device1. Similarly, the proximal end40aof the needle cap40is closed while the distal end includes a circumferential flange40b. The proximal end of the needle tip50IIincludes a needle N while the distal end includes an opening which is sized to allow the needle tip50IIto be mounted to the threaded proximal end2of the pen needle device1. In order to ensure that the needle tip50IIis prevented from being re-installed onto the proximal end2, the needle tip50IIutilizes the ring60IVwhich can move axially from an initial position (shown inFIG. 41) to a second or locked position (shown inFIG. 42) which causes the four inwardly deflecting members50IIa,50IIb,50IIcand50IIdto deflect inwards by an amount which is sufficient to prevent the needle tip50II(after being removed) from being re-installed onto the proximal end2. As can be seen inFIG. 41, prior to activation, the four inwardly deflecting members50IIa,50IIb,50IIcand50IIdare bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIto be installed onto the proximal end2, i.e., by axially sliding it on or by threading it on.

As can be seen inFIG. 41, the needle tip assembly ofFIG. 41can be installed onto the threaded proximal end2without activating the re-use prevention system or mechanism, i.e., without causing the ring60IVto move axially to the second or activated position. Accordingly, in the position shown inFIG. 41, the one or more inwardly deflecting members50IIa,50IIb,50IIcand50IIdare still bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50IIto be installed onto the proximal end2. Furthermore, while the ring60IVis in the position shown inFIG. 41, the needle tip assembly can be removed, e.g., by sliding it off of the threaded end2.

As is evident fromFIG. 42, after the needle tip assembly shown inFIG. 41is installed onto the threaded proximal end2, the needle tip cap300can be further moved axially in the distal direction (as indicated by the arrow in FIG.42) to the point that it activates the re-use prevention system or mechanism, i.e., it causes the ring60IVto move axially in the distal direction until it assumes the second or locked or activated position. Like many of the previous embodiments, locking occurs because of engagement between the projections of the inwardly deflecting members and the inner circumferential recess of the ring60IV. This locking engagement also ensures that the ring60IVdoes not move back to the original position (after being moved to the second position) when the cap300is moved in the proximal direction to protect inadvertent contact with the needle N (seeFIG. 44). As is evident fromFIG. 42, when the ring60IVis moved to the second or activated position, the inwardly deflecting members50IIa,50IIb,50IIcand50IIdwill be deflected inwardly (as was the case in the previous embodiments) so that they will biased against the proximal end2and frictionally engage the threads thereof when the needle tip50IIis unthreaded.

Once the needle tip assembly shown inFIG. 41is installed and the re-use prevention system activated (seeFIG. 42), the needle tip cap300can be, after being in the position allowing it to be used for injection (seeFIG. 43), slid in the proximal direction (seeFIG. 44), but, unlike the previous embodiments, it is not removed. Then, the needle cap40can also be removed axially (in a manner similar to the previous embodiments). Once the pen needle device with the installed needle tip assembly has been used to perform an injection, the needle tip50IIcan be removed in the following way: one could re-install the needle cap40and then grip the needle tip cap300and slid it in the proximal direction until it assumes the position shown inFIG. 44; or one could simply grip the needle tip cap300and slid it in the proximal direction until it assumes the position shown inFIG. 44without re-installing the needle cap40. In either case, the user can then safely remove the entire needle tip assembly by either removing it axially or unthreading it axially. Of course, once removed, the needle tip assembly will be prevented from being re-installed because of the configuration of the ring60IVand50″. As was the case in the previous embodiments, all of these ways are contemplated by the invention for this embodiment.

Although not shown, the embodiment shown inFIGS. 41-44can, like the previous embodiments, utilize a needle cap of the type shown inFIGS. 53 and 54).

FIG. 45shows a needle tip assembly according to still another embodiment of the invention. The needle tip assembly is substantially similar to that shown inFIGS. 41-44except that it utilizes a coil compression spring S to bias the needle tip cap300in a proximal direction, i.e., towards the original position.

FIG. 46shows still another embodiment of a needle tip50IVwhich can be used in one or more of the herein disclosed embodiments. The needle tip50VIcan be utilized with a needle tip cap of the types disclosed herein or not with the former being preferred. A needle cap40(not shown) can also be utilized. The needle tip50VIcan be substantially similar to the embodiment shown inFIGS. 29 and 30, except that it also includes a circumferential retaining shoulder RS which ensures that the ring60Vis axially retained on the body of the needle tip50VI. The proximal end of the needle tip50VIincludes a needle N while the distal end includes an opening which is sized to allow the needle tip50VIto be mounted to the threaded proximal end2of the pen needle device1. In order to ensure that the needle tip50VIis prevented from being re-installed onto the proximal end2, the needle tip50VIutilizes a ring60Vwhich can move axially from an initial position (similar to the position shown inFIG. 21) to a second or activated position (shown inFIG. 46) which causes the four inwardly deflecting members50VIa,50VIb,50VIcand50VIdto deflect inwards by an amount which is sufficient to prevent the needle tip50VI(after being removed) from being re-installed onto the proximal end2. Although not shown, prior to the needle tip assembly being installed onto the threaded proximal end2, the four inwardly deflecting members50VIa,50VIb,50VIcand50VIdare bent outwardly or deflected outwardly by an amount which is sufficient to allow the needle tip50VIto be installed onto the proximal end2.

In the same way as was shown inFIG. 22, after the needle tip assembly shown inFIG. 46is installed onto the threaded proximal end2, the needle tip cap30(not shown) can be further moved axially in the distal direction to the point that it activates the re-use prevention system or mechanism, i.e., it causes the ring60Vto move axially in the distal direction until it assumes the second or activated position shown inFIG. 46. Unlike the previous embodiments which provide for a locking position, i.e., characterized by engagement between the projections of the inwardly deflecting members and the inner circumferential recess of the ring, this embodiment utilizes projections on the members50VIa,50VIb,50VIcand50VIdand a recess in the ring60Vfor receiving the same, but does not provide for a locking engagement between these members. Instead, the inner recess of the ring60Vmerely frictionally engages with the projections of the members50VIa,50VIb,50VIcand50VIdwhen it is moved to the second or activated position. In order to ensure that the ring60Vdoes not move back to the original position (after being moved to the second position), the inner circumferential surface of the ring60Vand the outer surface of the members50VIa,50VIb,50VIcand50VIdcan be provided with high friction surfaces such as e.g., a knurl, a high friction coating, etc. As shown inFIG. 46, when the ring60Vis moved to the second or activated position, the inwardly deflecting members50VIa,50VIb,50VIcand50VIdare deflected inwardly (as was the case in the previous embodiments) so that they will biased against the proximal end2and frictionally engage the threads thereof when the needle tip50VIis unthreaded.

Once the re-use prevention system is activated (as shown inFIG. 46), the needle tip cap30(not shown) can be removed by sliding it off axially. Then, the needle cap40(not shown) can also be removed axially. Once the pen needle device with the installed needle tip assembly has been used to perform an injection, the needle tip50VIcan be removed in the following ways: one could simply grip the needle tip50VIin the area of the ring60Vand unthread it from the threaded proximal end2. This is risky, of course, because the user can be inadvertently be pricked by the exposed needle N; one could re-install the needle cap40and then grip the needle tip50VIin the area of the ring60Vand unthread it from the threaded proximal end2; one could re-install both the needle cap40and the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the entire needle tip assembly thereby causing the needle tip50VIto become unthreaded from the threaded proximal end2; and one could re-install only the needle tip cap30, and then grip the needle tip cap30in the area just in front of the flange30band thereafter unthread the needle tip assembly (without the cap40) thereby causing the needle tip50VIto become unthreaded from the threaded proximal end2. As was the case in the previous embodiments, all of these ways are contemplated by the invention for this embodiment, with, however, the first way being the least desirable.

As was the case in, e.g., the embodiment shown inFIGS. 20-28, once the needle tip50VIis removed from the threaded proximal end2(and because the ring60Vhas been moved to the activated position), the plurality of inwardly deflecting members50VIa,50VIb,50VIcand50VIdare caused to move inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50VIback onto the threaded proximal end2of the pen needle device1. This occurs in substantially the same way as was shown inFIG. 28which shows how the plurality of inwardly deflecting members have been moved inwardly to the point that they will not permit (i.e., they will interfere with) re-installation of the needle tip50VIback onto the threaded proximal end2of the pen needle device1owing to the fact that they effectively reduce the diameter of the distal opening of the needle tip50VI.

Although not shown, the embodiment shown inFIG. 46can, like the previous embodiments, utilize the needle tip cap shown inFIGS. 47-49instead of the needle tip cap30. Of course, the needle tip cap30can also have any desired configuration provided that it functions for its intended purpose, and can even be dispensed with without leaving the scope of the invention. In the later case, only the needle cap40(or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and the user could activate the re-use prevention system by gripping the ring60Vand sliding it distally until it assumes the activated position.

FIGS. 47-49show an optional needle tip cap3000which can be used in one or more of the embodiments described herein. The needle tip cap3000can be similar to that shown inFIGS. 18 and 19except that it utilize a two-piece folding connectable construction instead of the simple one-piece integral construction shown inFIGS. 18 and 19. In order to connect the two parts3000A and3000B, the cap3000utilizes a living hinge LH at one end and a lock system utilizing a lock member LM and a locking projection LP. This type of cap is advantageous because it allows the user to position the cap3000from the side instead of from the needle end. As a result, one can install the cap3000with a lower risk of being inadvertently punctured by the needle.

FIGS. 50-52show another non-limiting embodiment of a needle tip assembly which can be installed onto the proximal end of pen needle device1. The needle tip assembly is similar to that shown in the prior artFIGS. 1-7except that the needle tip50VIIincludes a rear end cap member EC which is mounted to the needle tip body via a living hinge LH′. The needle tip cap also includes a mechanism which allows the rear cap member EC to temporarily lock thereto.FIG. 51shows the needle tip assembly ofFIG. 50after the rear end cap EC is unlocked from the needle tip cap and been deflected distally. In this position, the needle tip cap can then be removed in the manner shown inFIG. 4.FIG. 52shows the needle tip50VIIused in the embodiment shown inFIG. 50and illustrates how the rear cap EC can be deflected via the living hinge LH′ to a position prior to covering the distal end of the needle tip50VII. The end cap EC can also be utilized in one or more of the embodiments disclosed herein.

FIG. 53shows a needle tip assembly according to another embodiment of the invention. The needle tip is similar to that shown in the prior artFIGS. 1-7except that the needle tip includes a needle cap member40′ which is mounted to the needle tip body via a living hinge LH″. The needle cap also includes a mechanism which allows the needle cap member40′ to temporarily lock to the needle tip body.FIG. 54shows the needle tip assembly ofFIG. 53after the needle cap40′ is unlocked from the needle tip and been deflected distally. In this position, the needle tip can be used to perform an injection.

FIGS. 55-57show one non-limiting way in which a plurality of needle tip assemblies of either the prior art variety shown inFIGS. 2-7or those of the invention described herein can be packaged in a housing H. The housing H performs the function of storing a number of needle tip assemblies and also functions as a tool for installing one needle tip assembly at a time onto the end of a pen needle. The housing H can be a generally cylindrical member with an open front end and a closed rear end. A plurality of spring retaining members RM can be arranged near the front open end. These members RM normally extend inwardly to prevent the needle tip assembly which is to be installed onto a pen needle from moving back into the housing H. Once in the position shown inFIG. 55, the user can grip the housing H and use it to force it onto the pen needle end1. Of course, the user will first remove the removable sealing material layer (not shown) which is typically adhesively arranged on the open end of the needle tip cap, e.g.,3. Once the housing H is used to install one of the needle tip assemblies, the user can either leave the housing in the position shown inFIG. 56. Then, when the user desires to install a fresh needle tip assembly on the pen needle end1, the user can slide the push button PB in the direction of the open end of the housing H until the next needle tip assembly reaches the position shown inFIG. 57. In this regard, the inwardly bent free ends of retaining members RM (a total of e.g., four, can be utilized) are designed to deflect outwardly in order to allow the next needle tip assembly to pass by. Installation can then occur in the same way as was described with regard toFIG. 55. Once, all of the needle tip assemblies, e.g., five, are utilized, the housing H can be discarded. As is evident fromFIGS. 55-57, the push-button slides within an elongated slot SL formed in the side wall of the housing H and has an inner portion which is configured to engage and cause to move the needle tip assemblies arranged in series. Of course, the housing H can also have other configurations and can house as few as two or more than five assemblies.

The pen needle device described above can also utilize one or more features disclosed in the prior art documents expressly incorporated by reference herein. Furthermore, one or more of the various parts of the needle tip assembly can preferably be made as one-piece structures by e.g., injection molding, when doing so reduces costs of manufacture. Non-limiting materials for most of the parts include synthetic resins such as those approved for syringes or other medical devices. Furthermore, the invention also contemplates that any or all disclosed features of one embodiment may be used on other disclosed embodiments, to the extent such modifications function for their intended purpose.