Abstract
A needle tip for an injection device includes a body having a front portion, a back portion configured to be removably connected to the pre-loaded injection device, and a wall separating the front and back portions. A hollow needle has a first piercing portion projecting back from the separating wall and a second piercing portion projecting forward from the separating wall. A safety shield that is axially movable relative to the body at least between an initial position, a retracted position, and a post use locking position. 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.
Claims
1. A needle tip for an injection device, comprising: a body having a front portion, a back portion having a distal end configured to be removably connected to a pre-loaded injection device via a threadable engagement, and a needle support wall separating the front and back portions; a hollow needle having a first piercing portion projecting back from the needle support wall and a second piercing portion projecting forward from the needle support wall; and a safety shield that is axially movable relative to the body at least between an initial position, a retracted position, and a post use locking position, wherein the safety shield: is at least partially disposed axially within the front portion of the body; rotates at least partially in two opposite directions as the safety shield axially moves from the initial position to the retracted position; and has a locking system including projections extending into guiding recesses arranged on the body, wherein the projections are oppositely arranged on the safety shield and configured to deflect inwardly to engage with the guiding recesses and wherein, when the needle tip is not in the post use locking position, the locking system is configured to prevent the safety shield from locking, and when the needle tip is in the post use locking position, the locking system is configured prevent contact by a user's fingers with the locking system.
2. The needle tip of claim 1, wherein the body is one piece.
3. The needle tip of claim 1, wherein the safety shield is one piece.
4. The needle tip of claim 1, wherein the guiding recesses comprise a linear section and an angled section.
5. The needle tip of claim 1, wherein the guiding recesses comprise a linear section and a curved section.
6. The needle tip of claim 1, wherein the needle tip is configured to provide a visual indication to the user that the needle tip has been used.
7. A needle tip for an injection device, comprising: a body having a front portion, a back portion having a distal end configured to be removably connected to a pre-loaded injection device via a threadable engagement, and a needle support wall separating the front and back portions; a hollow needle having a first piercing portion projecting back from the needle support wall and a second piercing portion projecting forward from the needle support wall; a safety shield that is axially movable relative to the body at least between an initial position, a retracted position, and a post use locking position, wherein the safety shield: is at least partially disposed within the front portion of the body; and has a locking system including at least one projection extending into one or more guiding recesses arranged on the body, wherein, when the needle tip is not in the post use locking position, the locking system is configured to prevent the safety shield from locking, and when the needle tip is in the post use locking position, the locking system is configured prevent contact by a user's fingers with the locking system; wherein the needle tip is configured to provide a visual indication to the user that the needle tip has been used, the visual indication arranged on a skin engaging side of the safety shield.
8. A needle tip for an injection device, comprising: a body having a front portion, a back portion having a distal end configured to be removably connected to a pre-loaded injection device via a threadable engagement, and a needle support wall separating the front and back portions; a hollow needle having a first piercing portion projecting back from the needle support wall and a second piercing portion projecting forward from the needle support wall; and a safety shield that is axially movable relative to the body at least between an initial position, a retracted position, and a post use locking position, wherein the safety shield: is at least partially disposed axially within the front portion of the body; rotates at least partially in two opposite directions as the safety shield axially moves from the initial position to the retracted position; axially moves from the retracted position to the post use locking position without rotation; and has a locking system including at least one projection extending into one or more guiding recesses arranged on the body, wherein, when the needle tip is not in the post use locking position, the locking system is configured to prevent the safety shield from locking, and when the needle tip is in the post use locking position, the locking system is configured prevent contact by a user's fingers with the locking system.
9. The needle tip of claim 8, wherein the safety shield comprises an indicator that provides a tactile indication to the user that the needle tip has been used.
10. The needle tip of claim 8, wherein the safety shield does not cover or extend past a free end of the second piercing portion when in the initial position.
11. The needle tip of claim 8, wherein the safety shield covers or extends past a free end of the second piercing portion when in the initial position.
12. The needle tip of claim 8, wherein the body is one piece.
13. The needle tip of claim 8, wherein the safety shield is one piece.
14. The needle tip of claim 8, wherein the needle tip is configured with a depth adjustment mechanism that controls a depth of injection for the second piercing portion of the hollow needle in the user.
15. The needle tip of claim 8, wherein the one or more guiding recesses comprise a linear section and a curved section.
16. A needle tip for an injection device, comprising: a body having a front portion, a back portion having a distal end configured to be removably connected to a pre-loaded injection device via a threadable engagement, and a needle support wall separating the front and back portions; a hollow needle having a first piercing portion projecting back from the needle support wall and a second piercing portion projecting forward from the needle support wall; and a safety shield that is axially movable relative to the body at least between an initial position, a retracted position, and a post use locking position, wherein the safety shield: is at least partially disposed axially within the front portion of the body; rotates at least partially in two opposite directions as the safety shield axially moves from the initial position to the retracted position; and has a locking system including at least one projection extending into one or more guiding recesses arranged on the body, wherein, when the needle tip is not in the post use locking position, the locking system is configured to prevent the safety shield from locking, and when the needle tip is in the post use locking position, the locking system is configured prevent contact by a user's fingers with the locking system, wherein the one or more guiding recesses limit the axial movement of the safety shield between the initial position, the retracted position, and the post use locking position where the safety shield axially extends a first distance in the initial position and axially extends a second distance greater than the first distance.
17. The needle tip of claim 16, wherein the needle tip is configured for use with a removable protective cap.
18. The needle tip of claim 16, wherein the needle tip is configured with a depth adjustment mechanism that controls a depth of injection for the second piercing portion of the hollow needle in the user.
19. The needle tip of claim 16, comprising indicia informing the user of a current setting for depth of injection of the needle tip.
20. The needle tip of claim 16, wherein the one or more guiding recesses comprise a linear section and an angled section.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein:
(2) FIGS. 1-13 show a first non-limiting embodiment of the pen needle or needle tip in accordance with the invention. In FIGS. 1-9 and 11, for example, the body, shield, spring and protective cover are shown in full or partial cross-section while the injector, threaded section and needle are not;
(3) FIG. 14 shows a second non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(4) FIGS. 15-18 show a third non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(5) FIGS. 19-22 show a fourth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(6) FIGS. 23-26 illustrates how the fourth non-limiting embodiment of the pen needle or needle tip is used in accordance with the invention;
(7) FIG. 27 shows a fifth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(8) FIG. 28 shows a sixth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(9) FIGS. 29 and 30 illustrates how a seventh non-limiting embodiment of the pen needle or needle tip can be utilized in accordance with the invention;
(10) FIGS. 31-35 show an eight non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(11) FIG. 36 shows a ninth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(12) FIGS. 37-39 show a tenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(13) FIGS. 40-41 show an eleventh non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(14) FIGS. 42-43 show a twelfth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(15) FIG. 44 shows a thirteenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(16) FIGS. 45-46 show a fourteenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(17) FIG. 47 shows a fifteenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(18) FIGS. 48-49 show a sixteenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(19) FIG. 50 shows a seventeenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(20) FIG. 51 shows a eighteenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(21) FIG. 52 shows a nineteenth non-limiting embodiment of the pen needle or needle tip in accordance with the invention;
(22) FIG. 53 shows a twentieth non-limiting embodiment of the pen needle or needle tip in accordance with the invention; and
(23) FIG. 54 shows a twenty first non-limiting embodiment of the pen needle or needle tip in accordance with the invention.
DETAILED DESCRIPTION OF THE INVENTION
(24) FIGS. 1-13 show a first non-limiting embodiment of the pen needle or needle tip 100 in accordance with the invention. The needle tip 100 has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100 has a body portion 10, e.g., one-piece or integrally formed body, and a safety shield 20, e.g., a one-piece or integrally framed safety shield. In embodiments, a protective cap or cover PC is utilized so that the needle tip 100 can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100 is installed, the protective cap PC can be removed and even discarded.
(25) In the position shown in FIG. 2, the safety-shield 20 of the needle tip 100 is in an intermediate position. In this position, (and after the protective cap PC is removed) the safety-shield 20 is free to move generally axially. For example, the safety-shield 20 shown in FIG. 2 does not extend out all the way so as to cover the proximal needle N. This allows a user to see the needle tip so that he/she can accurately position the needle N at a desired injection location. The position of the shield 20 shown in FIG. 2 is essentially determined by the biasing force of the spring S1 and contact between projections 28 and shoulders or projections 19 of the body 10.
(26) In the position shown in FIG. 3, the safety-shield 20 of the needle tip 100 is in a puncturing or retracted position. In this position, the safety-shield 20 is typically pressed against a skin surface being injected with a force sufficient to cause compression of the spring S1 and to move the shield 20 to the fully or nearly fully retracted position from the initial or intermediate position shown in FIG. 2. For example, the safety-shield 20 shown in FIG. 3 exposes a maximum amount of the needle N available for injection. The maximum axial retraction movement of the shield 20 can be made or set to a desired amount by, e.g. setting the relative location or position of contact between surface 22 and wall 16 (see FIG. 4). The maximum axial retraction movement can also occur alternatively or simultaneously via setting the relative location or position of contact between each surface 29 and projection 19.
(27) In the position shown in FIG. 4, the safety-shield 20 of the needle tip 100 is in a locked, non-removably and fully or nearly fully extended position. In this position, the safety-shield 20 has automatically moved from that shown in FIG. 3 to that of FIG. 4 under the action or biasing force of the spring S1 and which has occurred very rapidly. That is, once the user stops pressing the needle tip 100 against the injection site, the spring S1 responds or axially expands essentially instantaneously and causes forward movement of the shield 20 toward the position shown in FIG. 4. However, this rapid axial expansion of the spring S1 coupled with the mass of the shield 20 provides sufficient energy or momentum so that the shield 20 is able to move past or beyond the position shown in FIG. 2 and to, in fact, reach the locked position shown in FIG. 4. Much of this energy is used to cause deflection of the deflectable members 27 so that the tapered projections 28 can pass by the projections 19. Once past by the projections 19, the projections 28 spring back to an original position shown in FIG. 4. Moreover, because of the tapered shape or configuration of the projections 28, the shield 20 cannot move back more than a very slight amount and cannot move by an amount which would expose the tip of the needle N. Thus, the recesses 25 serve to trap the projections 19 and prevent significant axial movement of shield 20 either forwards or backwards. Additionally, because the projections 28 are recessed within grooves containing therein the deflectable members 27, a user cannot easily cause the projections 28 to deflect inwardly so as to intentionally release the locked configuration shown in FIG. 4. Even if this was done, however, the force of the spring S1 would have to be overcome (by causing the shield 20 to move backwards) to allow the needle N to be exposed to the user. Nor can the user easily (without causing damage to the tip 100) remove the shield 20 from the body 10 by pulling it off, for example. Even a tilting or sideways deflection of the shield 20 relative to the body 10 is prevented or limited by the interaction between the projections 19 and the recesses or openings 25. Further still, because of the locked configuration shown in FIG. 4, the needle tip 100 is prevented from re-use and is thereby rendered a single-use tip 100. The user thus has no option by to remove the tip 100 from the injection device 1 and to discard it.
(28) As is apparent from FIG. 5, removal of the tip 100 can be safely accomplished because the needle N is covered by the shield 20. Such removal can occur in the typical manner by, e.g., unthreading it off of the threaded section 2. Once removed, one can see from FIG. 5 that both the rear or distal needle and the front needle are covered, protected or otherwise not exposed.
(29) As is apparent from FIGS. 6-8, the needle tip 100 has three main components, i.e., a body 10 containing therein a hollow double-ended needle N, a wire compression spring S1, and a shield 20. Both the body 10 and the shield 20 can preferably be made of synthetic resin with the exception of the needle N which can be made of metal such a stainless steel. The spring S1 can also be made of metal such a stainless steel.
(30) As is apparent from FIGS. 9 and 10, the body 10 includes a forward or proximal end 11, a rear or distal end 12, a generally cylindrical outer surface 13, a rear or distal inner space 14 sized and configured to receive therein the threaded section 2, one or more threads, thread sections, or partial thread sections 15 configured to threadably engage with the threads of the threaded section 2, a separating wall 16 containing a hub H that fixedly retains the double-ended needle N, a front opening 17 that received therein the shield 20, a front or proximal inner space 18 sized and configured to receive therein the shield 20, and plural equally spaced or oppositely arranged inward facing or oriented projections 19.
(31) As is apparent from FIGS. 11-13, the shield 20 includes a forward or proximal end 21, a rear or distal end 22, a generally cylindrical outer surface 23, a main inner space 24, plural oppositely arranged recesses 25, plural oppositely arranged retaining flanges or shoulders 26 contacted by one end of the spring S1, plural oppositely arranged deflecting or deflectable members 27 each having a tapered projection 28. Oppositely arranged inner shoulders 29 are arranged on the shield 20.
(32) Thus, in the non-limiting embodiment of FIGS. 1-13, there is provided a needle tip 100 for an injection device 1 which includes a body 10 having a front portion, a back portion configured to be removably connected to the pre-loaded injection device 1, and a wall 16 or needle support H separating the front and back portions. A hollow needle N has a first piercing portion projecting back from the separating wall 16 or needle support H and a second piercing portion projecting forward from the separating wall 16 or needle support H. A safety shield 20 is axially movable relative to the body 10 at least between an initial position (see FIG. 2), a retracted position (see FIG. 3), and a post use locking position (see FIG. 4).
(33) Also, in the non-limiting embodiment of FIGS. 1-13, the safety shield 20, in embodiments, is at least partially disposed within the front portion of the body 10, e.g., end 22 is arranged within space 18, includes a locking system, e.g., one or more elements 28/25/19, which is prevented from being contacted by a user's fingers, and moves linearly, e.g., axially linearly, without also rotating, e.g., the interaction of the projections 19 with the guiding grooves containing the deflectable members 27 prevents rotation of the shield 20 relative to the body 10.
(34) Also or alternatively, in the non-limiting embodiment of FIGS. 1-13, the safety shield 20, in embodiments, includes at least one projection 19 that extends into a guide recess comprising at least one locking mechanism 25/28 for retaining the safety shield 20 in the post use locking position (see FIG. 4).
(35) Also or alternatively, in the non-limiting embodiment of FIGS. 1-13, the safety shield 20, in embodiments, includes at least one mechanism 28 for preventing a locking of the safety shield 20 when said shield in not in the post use locking position, i.e., is in the intermediate position shown in FIG. 2.
(36) FIG. 14 shows another non-limiting embodiment of the pen needle or needle tip 100.sup.I in accordance with the invention. The needle tip 100.sup.I has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.I has a body portion 10.sup.I, e.g., one-piece or integrally formed body, and a safety shield 20, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover PC is utilized so that the needle tip 100.sup.I can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.I is installed, the protective cap PC can be removed and even discarded. Although similar to that of FIGS. 1-13, the protective cap PC includes one or more retaining recesses RR which engage with one or more retaining projections RP arranged on the body 10.sup.I.
(37) FIGS. 15-18 show another non-limiting embodiment of the pen needle or needle tip 100.sup.II in accordance with the invention. The needle tip 100.sup.II has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.II has a body portion 10.sup.II, e.g., one-piece or integrally formed body, and a safety shield 20.sup.II, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.II can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.II is installed, the protective cap can be removed and even discarded. Although similar to that of FIGS. 1-13, the needle shield 20.sup.II includes oppositely arranged guiding projections GP which engage with one or more guiding recesses GR arranged on the body 10.sup.II.
(38) FIGS. 19-26 show another non-limiting embodiment of the pen needle or needle tip 100.sup.III in accordance with the invention. The needle tip 100.sup.III has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.III has a body portion 10.sup.III, e.g., one-piece or integrally formed body, and a safety shield 20.sup.III, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.III can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.III is installed, the protective cap can be removed and even discarded. Although similar to that of FIGS. 15-18, the needle shield 20.sup.III includes oppositely arranged guiding projections GP which can deflect inwardly and engage with one or more guiding recesses GR arranged on the body 10.sup.III.
(39) As is evident from FIGS. 23-26, the configuration of each guiding recess GR is that they each guide or guidingly engage with one of the guiding projections GP of the shield 20.sup.III from the initial or intermediate position shown in FIG. 23, to a partially retracted position shown in FIG. 24, to the fully retracted position shown in FIG. 24, and then to the fully extended or locked post-use position shown in FIG. 26. Thus, when the shield 20.sup.III moves from the initial or intermediate position shown in FIG. 23 to a partially retracted position shown in FIG. 24, it experiences axial and partial rotation movement in two directions. When the shield 20.sup.III moves from the position shown in FIG. 24 to position shown in FIG. 25, it experiences axial and partial rotation movement in one direction. When the shield 20.sup.III moves from the position shown in FIG. 25 to position shown in FIG. 26, it experiences only axial linear movement.
(40) Thus, the non-limiting embodiment of FIGS. 19-26 provides for a safety shield 20.sup.III that rotates at least partially in opposite directions as it moves from the initial position (see FIG. 23) to the retracted position (see FIG. 25). Additionally or alternatively, the safety shield 20.sup.III includes at least one projection GP that extends into a guide recess GR comprising at least a linear section and a curved section. Additionally or alternatively, the safety shield 20.sup.III includes at least one projection GP that extends into a guide recess GR comprising at least a linear section and an angled section.
(41) FIG. 27 shows another non-limiting embodiment of the pen needle or needle tip 100.sup.IV in accordance with the invention. The needle tip 100.sup.IV has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.IV has a body portion 10.sup.IV, e.g., one-piece or integrally formed body, and a safety shield 20.sup.IV, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.IV can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.IV is installed, the protective cap can be removed and even discarded. Similar to that of FIGS. 19-26, the needle shield 20.sup.IV includes oppositely arranged guiding projections GP which can deflect inwardly and engage with one or more guiding recesses GR arranged on the body 10.sup.IV.
(42) As is evident from FIG. 27, the configuration of each guiding recess GR is that they each guide or guidingly engage with one of the guiding projections GP of the shield 20.sup.IV from the initial or intermediate position shown in FIG. 27, to a partially retracted position (not shown but similar to that shown in FIG. 24), to the fully retracted position shown (not shown but similar to that in FIG. 24), and then to the fully extended or locked post-use position (not shown but similar to that shown in FIG. 26). Thus, when the shield 20.sup.IV moves from the initial or intermediate position shown in FIG. 27 to a partially retracted position, it experiences axial and partial rotation movement in two directions. When the shield 20.sup.IV moves from the retracted position to post-use position, it experiences only axial linear movement.
(43) Thus, the non-limiting embodiment of FIG. 27 provides for a safety shield 20.sup.IV that rotates at least partially in opposite directions as it moves from the initial position (see FIG. 27) to the retracted position. Additionally or alternatively, the safety shield 20.sup.IV includes at least one projection GP that extends into a guide recess GR comprising at least a linear section and a curved section.
(44) FIG. 28 shows another non-limiting embodiment of the pen needle or needle tip 100.sup.V in accordance with the invention. The needle tip 100.sup.V has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.V has a body portion 10.sup.V, e.g., one-piece or integrally formed body, and a safety shield 20.sup.V, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.V can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.V is installed, the protective cap can be removed and even discarded. Similar to that of FIG. 27, the needle shield 20.sup.V includes oppositely arranged guiding projections GP which can deflect inwardly and engage with one or more guiding recesses GR arranged on the body 10.sup.V.
(45) As is evident from FIG. 28, the configuration of each guiding recess GR is that they each guide or guidingly engage with one of the guiding projections GP of the shield 20.sup.V from the initial or intermediate position shown in FIG. 28, to a partially retracted position (not shown but similar to that shown in FIG. 24), to the fully retracted position shown (not shown but similar to that in FIG. 24), and then to the fully extended or locked post-use position (not shown but similar to that shown in FIG. 26). Thus, when the shield 20.sup.V moves from the initial or intermediate position shown in FIG. 28 to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield 20.sup.V moves from the retracted position to post-use position, it experiences only axial linear movement.
(46) Thus, the non-limiting embodiment of FIG. 28 provides for a safety shield 20.sup.V that rotates at least partially in one direction as it moves from the initial position (see FIG. 28) to the retracted position. Additionally or alternatively, the safety shield 20.sup.V includes at least one projection GP that extends into a guide recess GR comprising at least two linear sections and can trace at least a partially curved path.
(47) FIGS. 29 and 30 show another non-limiting embodiment of the pen needle or needle tip 100.sup.VI in accordance with the invention. The needle tip 100.sup.VI has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.VI has a body portion 10.sup.VI, e.g., one-piece or integrally formed body, and a safety shield 20.sup.VI, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.VI can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.VI is installed, the protective cap can be removed and even discarded. Similar to that of FIG. 28, the needle shield 20.sup.VI includes oppositely arranged guiding projections GP which can deflect inwardly and engage with one or more guiding recesses GR.sup.IV arranged on the body 10.sup.VI.
(48) As is evident from FIGS. 29 and 30, the configuration of each guiding recess GR.sup.IV is that they each guide or guidingly engage with one of the guiding projections GP of the shield 20.sup.VI from the initial position shown in FIG. 30 (which covers or extends out past the needle tip unlike previous embodiments), to a partially retracted position shown in FIG. 29, to the fully retracted position shown (not shown but similar to that in FIG. 24), and then to the fully extended or locked post-use position (not shown but similar to that shown in FIG. 26). Thus, when the shield 20.sup.VI moves from the initial position shown in FIG. 30 to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield 20.sup.VI moves axially further back is rotates in another direction. From the retracted position to post-use position, it experiences only axial linear movement.
(49) Thus, the non-limiting embodiment of FIGS. 29 and 30 provides for a safety shield 20.sup.VI that rotates at least partially in two directions as it moves from the initial position (see FIG. 30) to the retracted position. Additionally or alternatively, the safety shield 20.sup.VI includes at least one projection GP that extends into a guide recess GR.sup.IV comprising at least two linear sections and at least two curved sections that can trace at least a partially curved path.
(50) FIGS. 31-35 show another non-limiting embodiment of the pen needle or needle tip 100.sup.VII in accordance with the invention. The needle tip 100.sup.VII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.VII has a body portion 10.sup.VII, e.g., one-piece or integrally formed body, and a safety shield 20.sup.VII, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.VII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.VII is installed, the protective cap can be removed and even discarded. The needle shield 20.sup.VII includes oppositely arranged guiding projections GP which engage with one or more guiding recesses GR.sup.V arranged on the body 10.sup.VII. Unlike the previous embodiments, however, the needle shield 20.sup.VII includes an inner circumferential wall ICW and an outer circumferential wall OCW that is axially longer. The wall OCW provides a further way of preventing the user from attempting to reuse the tip 100.sup.VII after being used once and provides a way to locate the guide recess GR.sup.V on an outer cylindrical surface of the body 10.sup.VII.
(51) As is evident from FIGS. 31-35, the configuration of each guiding recess GR.sup.V is that they each guide or guidingly engage with one of the guiding projections GP of the shield 20.sup.VII from the initial position shown in FIG. 31 to the fully retracted position shown FIG. 32, and then to the fully extended or locked post-use position shown in FIG. 33. Thus, when the shield 20.sup.VII moves from the initial position shown in FIG. 31 to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield 20.sup.VI moves axially further back is rotates in another direction. From the retracted position to post-use position, it experiences only axial linear movement.
(52) Thus, the non-limiting embodiment of FIGS. 31-35 provides for a safety shield 20.sup.VII that rotates at least partially in two directions as it moves from the initial position (see FIG. 31) to the retracted position (see FIG. 32). Additionally or alternatively, the safety shield 20.sup.VII includes at least one projection GP that extends into a guide recess GR.sup.V comprising three linear sections and at least one curved section that can trace at least a partially curved path.
(53) FIG. 36 shows another non-limiting embodiment of the pen needle or needle tip 100.sup.VIII in accordance with the invention. The needle tip 100.sup.VIII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.VIII has a body portion 10.sup.VIII, e.g., one-piece or integrally formed body, and a safety shield (not shown, but similar to that shown in FIG. 33). In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.VIII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.VIII is installed, the protective cap can be removed and even discarded. The needle shield includes oppositely arranged guiding projections which engage with one or more guiding recesses GR.sup.VI arranged on the body 10.sup.VIII.
(54) As is evident from FIG. 36, the configuration of each guiding recess GR.sup.VI is such that they each guide or guidingly engage with one of the guiding projections of the shield from the initial position shown in FIG. 36 to the fully retracted position, and then to the fully extended or locked post-use position. Thus, when the shield moves from the initial position to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield moves axially further back past the deflectable guide member DGM is rotates slightly in another direction. From the retracted position to post-use position, it experiences both axial and rotational movement. Moreover, the deflectable guide member DGM can be moved by the guide projection to allow the safety shield to reach the fully retracted position and thereafter move back due to its elastic naturewhich prevents the guiding projection of the needle shield from moving back into the original position.
(55) Thus, the non-limiting embodiment of FIG. 36 provides for a safety shield that rotates at least partially in two directions as it moves from the initial position to the retracted position. Additionally or alternatively, the safety shield includes at least one projection that extends into a guide recess GR.sup.VI comprising at least two linear sections, two angled sections, and/or at least one deflectable guide member DGM.
(56) FIGS. 37-39 show another non-limiting embodiment of the pen needle or needle tip 100.sup.IX in accordance with the invention. The needle tip 100.sup.IX has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.IX has a body portion 10.sup.IX, e.g., one-piece or integrally formed body, and a safety shield 20.sup.IX. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.IX can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.IX is installed, the protective cap can be removed and even discarded. The needle shield includes oppositely arranged guiding projections GP which engage with one or more guiding recesses GR.sup.V arranged on the body 10.sup.IX.
(57) As is evident from FIG. 39, the configuration of each guiding recess GR.sup.V is such that they each guide or guidingly engage with one of the guiding projections of the shield 20.sup.IX from the initial position to the fully retracted position, and then to the fully extended or locked post-use position. Thus, when the shield 20.sup.IX moves from the initial position to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield moves axially further back past the first deflectable guide member DGM-1 is rotates slightly in another direction. When the shield moves axially forward and past the second deflectable guide member DGM-2 is rotates slightly as well. From the retracted position to post-use position, it experiences both axial and rotational movement. Moreover, the deflectable guide members DGM-1 and DGM-2, which can be moved by the guide projection to allow the safety shield to reach the fully retracted position and to the locked fully extended position respectively, thereafter move back to an original position due to its elastic naturewhich prevents the guiding projection(s) GP of the needle shield from moving back into the original position and to the retracted position respectively.
(58) Thus, the non-limiting embodiment of FIGS. 37-39 provides for a safety shield 20.sup.IX that rotates at least partially in two directions as it moves from the initial position to the retracted position. Additionally or alternatively, the safety shield includes at least one projection that extends into a guide recess GR.sup.V comprising at least one linear section, two angled sections, and/or two deflectable guide members DGM-1 and DGM-2. The non-limiting embodiment of FIGS. 37-39 also provides for a safety shield 20.sup.IX that includes at least one projection GP that extends into a guide recess GR.sup.V comprising at least one locking mechanism DGM-2 for retaining the safety shield 20.sup.IX in the post use locking position.
(59) FIGS. 40-41 show another non-limiting embodiment of the pen needle or needle tip 100.sup.X in accordance with the invention. The needle tip 100.sup.X has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.X has a body portion 10.sup.X, e.g., one-piece or integrally formed body, and a safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.X can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.CX is installed, the protective cap can be removed and even discarded. The needle shield includes oppositely arranged guiding projections which engage with one or more guiding recesses GR.sup.VI arranged on the body 10.sup.X. The arrangement of the one or more guiding recesses GR.sup.VI arranged on the body 10.sup.X is similar to that of the previous embodiment, except that the portions containing the two deflectable guide members DGM-1 and DGM-2 are separate members which can be inserted into appropriately sized and configured areas of the recess GR.sup.VI.
(60) FIGS. 42-43 show another non-limiting embodiment of the pen needle or needle tip 100.sup.XI in accordance with the invention. The needle tip 100.sup.XI has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XI has a body portion 10.sup.XI, e.g., one-piece or integrally formed body, and a safety shield 20.sup.XI. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.XI can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.XI is installed, the protective cap can be removed and even discarded. The needle shield 20.sup.XI includes oppositely arranged guiding projections GP.sup.IV which engage with one or more guiding recesses (not shown but similar to those of FIG. 39 or 40) arranged on the body 10.sup.XI. The arrangement of the one or more guiding recesses GR.sup.IV arranged on the body 10.sup.XI is similar to that of the previous embodiment it that it utilizes the two deflectable guide members DGM-1 and DGM-2. With such an arrangement, at least one projection GI.sup.IV extends into a guide recess comprising at least one locking mechanism, i.e., one of deflectable guide members DGM-1 and DGM-2 (see FIG. 39 or 40) and one, i.e., deflectable guide member DGM-2, can be utilized to retain the safety shield 20.sup.XI in the post use locking position. In this embodiment, the inner cylindrical wall does not participate in locking the safety shield 20.sup.XI in the post use locking position unlike certain previous embodiments. Furthermore, the safety shield 20.sup.XI can be formed of two main components 20.sup.XIA and 20.sup.XIB attachable via, e.g., a snap connection between one or more projections and one or more recesses as shown in FIG. 43.
(61) FIG. 44 shows another non-limiting embodiment of the pen needle or needle tip 100.sup.XII in accordance with the invention. The needle tip 100.sup.XII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XII has a body portion 10.sup.XII, e.g., one-piece or integrally formed body, and a safety shield 20.sup.XII. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.XII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.XII is installed, the protective cap can be removed and even discarded. The needle shield 20.sup.XII includes oppositely arranged guiding projections (not shown but similar to that of the previous embodiment) which engage with one or more guiding recesses (not shown but similar to those of FIG. 35, 36, 39 or 40) arranged on the body 10.sup.XII. The arrangement of the one or more guiding recesses arranged on the body 10.sup.XII is can function well with the recesses shown in FIGS. 35 and 36, but can also be similar to that of the previous embodiment it that it can utilize the two deflectable guide members DGM-1 and DGM-2 shown in FIGS. 39 and 40. With such an arrangement, at least one projection GP.sup.IV extends into a guide recess comprising at least one locking mechanism, i.e., deflectable guide member DGM-2 (see FIG. 39 or 40), and one of these, i.e., deflectable guide member DGM-2, is utilized to retain the safety shield 20.sup.XII in the post use locking position (creating a double, back-up, or redundant locking system). In this embodiment, the inner cylindrical wall can also participate in locking the safety shield 20.sup.XII in the post use locking position. Furthermore, the safety shield 20.sup.XII can be formed of two main components attachable via a snap connection between one or more projections and one or more recesses similar to that shown in FIG. 43.
(62) FIGS. 45 and 46 show another non-limiting embodiment of the pen needle or needle tip 100.sup.XIII in accordance with the invention. The needle tip 100.sup.XIII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XIII has a body portion 10.sup.XIII, e.g., one-piece or integrally formed body, and a safety shield 20.sup.XIII, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.XIII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.XIII is installed, the protective cap can be removed and even discarded. Although similar to that of FIG. 1, this embodiment also utilizes a support ring 30 which functions as a mechanism for preventing a locking of the safety shield 20.sup.XIII when the shield 20.sup.XIII in not in the post use locking position, i.e., such as when the shield 20.sup.XIII is in the initial position. In the position shown in FIG. 45, the ring 30 prevents inward deflection of the tapered projections. As is evident from FIG. 46, during injection the support ring 30 is moved or slid forward relative to its original position (and slight frictional engagement with) inside the safety shield 20.sup.XIII. In this position, it no longer can prevent a locking of the safety shield 20.sup.XIII so that when the shield 20.sup.XIII is allowed to move to the extended position under the action of the spring S1, it becomes locked in the post use locking position.
(63) FIG. 47 shows another non-limiting embodiment of the pen needle or needle tip 100.sup.XIV in accordance with the invention. The needle tip 100.sup.XIV has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XIV has a body portion 10.sup.XIV, e.g., one-piece or integrally formed body, and a safety shield 20.sup.XIV, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.XIV can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.XIV is installed, the protective cap can be removed and even discarded. Although similar to that of FIG. 1, this embodiment also utilizes a support ring 30 (like the embodiment of FIG. 45) which functions as a mechanism for preventing a locking of the safety shield 20.sup.XIV when the shield 20.sup.XIV in not in the post use locking position, i.e., such as when the shield 20.sup.XIV is in the initial position. The ring 30 prevents inward deflection of the tapered projections and also, by having a predefined axial length, provides a predetermined depth of penetration. As should be evident from FIG. 47, during injection the support ring 30 is moved or slid forward relative to its original position (and slight frictional engagement with) inside the safety shield 20.sup.XIV until in abuts the wall having the needle opening. This limits injection depth of penetration. Although not shown, the tip 100.sup.XIV can include indicia (or other indicators such as color of the body or needle shield) informing the user of the depth of penetration provided by the tip. The indicia or indicator feature can be determined by which of a number of different axial length rings are utilized. For example, a red body may provide an indication for one depth of penetration (determined by how much the puncturing end of the needle N projects out past the shin contact surface of the shield) while a blue body may provide an indication for another depth of penetration, and a green one being different from both the red and blue, etc. When the ring 30 is moved, the ring 30 also no longer can prevent a locking of the safety shield 20.sup.XIV so that when the shield 20.sup.XIV is allowed to move to the extended position under the action of the spring S1, it becomes locked in the post use locking position. As such, this embodiment provides for a mechanism for preventing a locking of the safety shield when the shield in not in the post use locking position and includes a predetermined depth setting mechanism.
(64) FIG. 48 shows another non-limiting embodiment of the pen needle or needle tip 100.sup.XV in accordance with the invention. The needle tip 100.sup.XV has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XV has a body portion 10.sup.XV, e.g., one-piece or integrally formed body, and a safety shield 20.sup.XV, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100.sup.XV can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100.sup.XV is installed, the protective cap can be removed and even discarded. Although similar to that of FIG. 1, this embodiment also utilizes a support ring 30 (like the embodiments of FIG. 45-47) which functions as a mechanism for preventing a locking of the safety shield 20.sup.XV when the shield 20.sup.XV in not in the post use locking position, i.e., such as when the shield 20.sup.XV is in the initial position. The ring 30 prevents inward deflection of the tapered projections and also, by having a predefined axial length, provides a predetermined depth of penetration. Furthermore, the ring projections RP can provide a visual and/or tactile indicator that the tip 100.sup.XV has been used. As should be evident from FIG. 48, during injection the support ring 30 is moved or slid forward relative to its original position (and slight frictional engagement with) inside the safety shield 20.sup.XV until in abuts the wall having the needle opening. This limits injection depth of penetration. Although not shown, the tip 100.sup.XV can include indicia (or other indicators such as color of the body or needle shield) informing the user of the depth of penetration provided by the tip. The indicia or indicator feature can be determined by which of a number of different axial length rings are utilized. For example, a red body may provide an indication for one depth of penetration (determined by how much the puncturing end of the needle N projects out past the shin contact surface of the shield) while a blue body may provide an indication for another depth of penetration, and a green one being different from both the red and blue, etc. When the ring 30 is moved, the ring 30 also no longer can prevent a locking of the safety shield 20.sup.XV so that when the shield 20.sup.XV is allowed to move to the extended position under the action of the spring S1, it becomes locked in the post use locking position. As such, this embodiment provides for a mechanism for preventing a locking of the safety shield when the shield in not in the post use locking position and includes a predetermined depth setting mechanism, and also provides includes at least one mechanism for providing a visual and/or tactile indication to the user that the needle tip has been used.
(65) Indeed, in the embodiment of FIG. 49, the ring 30 has ring projections RP which extend to or can be slightly behind the skin contact surface SCS of the shieldthereby providing a visual indicator that the tip 100.sup.XV has been used. This can be made more evident, if the one-piece ring 30 is one color, e., red, and the shield is another color, e.g., white. Although not shown, the frictional engagement between ring projections RP and the openings in the wall having the skin contact surface SCS can be significant so that once inserted therein, they cannot be moved back out without easily.
(66) In the embodiment of FIG. 50, the ring 30 has ring projections RP which extend out past the skin contact surface SCS of the shieldthereby providing a visual and tactile indicator that the tip 100.sup.XVI has been used. This can also be made more evident, if the one-piece ring 30 is one color, e., red, and the shield is another color, e.g., white. Although not shown, the frictional engagement between ring projections RP and the openings in the wall having the skin contact surface SCS can be significant (or non-releasable) so that once inserted therein, they cannot be moved back out without easily.
(67) In the additional embodiment of FIG. 51, which is a modified version of that of FIG. 1 and can be used on any of the herein disclosed embodiments, the skin contact surface includes a concave surface CSthereby providing a more comfortable contact surface for the tip 100.sup.XVII. The needle tip 100.sup.XVII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XVII has a body portion 10.sup.XVII, e.g., one-piece or integrally formed body, and a safety shield 20.sup.XVII, e.g., a one-piece or integrally formed safety shield.
(68) In the additional embodiment of FIG. 52, which is a modified version of that of FIG. 1 and can be used on any of the herein disclosed embodiments, the skin contact wall includes self-sealing puncturable member 40thereby providing a safe covering for the needle N of the tip 100.sup.XVIII The needle tip 100.sup.XVIII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XVIII has a body portion 10.sup.XVIII, e.g., one-piece or integrally formed body, and a safety shield 20.sup.XVIII, e.g., a one-piece or integrally formed safety shield. This embodiment thus provides for a pierceable member that is pierced during injection and/or a pierceable and resealable member that is pierced during injection.
(69) In the additional embodiment of FIG. 53, which is a modified version of that of FIG. 1 and can be used on any of the herein disclosed embodiments, the body is made as a two-piece arrangement that is, e.g., threadably connected. The needle tip 100.sup.XIX has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100.sup.XIX has a two-piece body 10.sup.XIX, e.g., both parts 10.sup.XIXA and 10.sup.XIXB can be one-piece or integrally formed members. A safety shield 20.sup.XIX, e.g., a one-piece or integrally formed safety shield, is also utilized. Furthermore, by providing a threaded connection between the body parts, this embodiment thus provides a depth adjustment mechanism DAM for controlling a depth of injection and that is limited at least between two stop or axial positions. In the position shown in FIG. 53, the needle N would provide for one injection depth. However, by unthreading the part 10.sup.XIXB from the part 10.sup.XIXA, the depth of injection would be reduced. These user determined adjustments occur when the depth of penetration is determined by contact between movable stop surface MSS and the set stop surface SSS. Although not shown, indicia can be provided to indicate to the user which depth setting the tip is current set to.
(70) In the additional embodiment of FIG. 54, which is a modified version of that of FIG. 37 and can be used on any of the herein disclosed embodiments, the shield is made as a two-piece arrangement that is, e.g., threadably connected. The needle tip has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip has a two-piece shield 20.sup.XX, e.g., both parts 20.sup.XXA and 20.sup.XXB can be one-piece or integrally formed members. Furthermore, by providing a threaded connection between the shield parts, this embodiment thus provides a depth adjustment mechanism for controlling a depth of injection and that is limited at least between two stop or axial positions. By threading on or unthreading the part 20.sup.XXB from the part 20.sup.XXA, the depth of injection can be changed. Although not shown, indicia can be provided to indicate to the user which depth setting the tip is current set to.
(71) The devices described herein can preferably be single-use and can also utilize one or more features disclosed in prior art documents expressly incorporated by reference in pending U.S. patent application Ser. No. 11/616,195 (Publication No. 2008/0154192). Moreover, the invention specifically contemplates and recognizes using any one or more features or elements of one embodiment on any one or more of the other herein disclosed embodiments. This application and the documents expressly incorporated therein are hereby expressly incorporated by reference in the instant application. Furthermore, one or more of the various parts of each device or embodiment 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, blood collection devices, 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.
(72) It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.
LIST OF MAIN REFERENCE NUMBERS
(73) Pen needle injection device 100-100.sup.XX;
(74) Body 10-10.sup.XX;
(75) Safety Shield 20-20.sup.XX;
(76) Retaining ring or member 30;
(77) Pierceable and/or resealable member 40;
(78) Spring S1;
(79) Double-ended hollow needle N;
(80) Protective cover PC, PC;
(81) Non-planar or concave surface CS;
(82) Depth Adjustment Mechanism DAM;
(83) Pre-filed syringe 1; and
(84) Threaded section 2.
