巴西专利BR112013023840B1 medicine injection pen

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专利摘要:
END OF INJECTION INDICATOR FOR INJECTION PEN This is a medication injection pen (50) that includes a housing (1) and a dose determination handle (2) rotatably connected to the housing (1) to set a dose . An indicating member (200) is movable between a visible position indicating a zero position of the dose determining handle (2) and a non-visible position indicating a non-zero position of the dose determining handle (2). The indicator member is visible to the user in the visible position and not visible to the user in the non-visible position. The dose determination handle is in the zero position when a determined dose has been completely delivered. Consequently, a visible indication is provided to the user when a given dose has been completely administered.
公开号:BR112013023840B1
申请号:R112013023840-2
申请日:2012-03-16
公开日:2021-05-04
发明作者:Michael Quinn；Richard Cronenberg；Gautam Shetty
申请人:Becton, Dikinson And Company；
IPC主号:

专利说明:

field of invention
[001] This application claims benefit under U.S.C. 35 § 119(e) of U.S. Provisional Patent Application No. 61/457,403, filed March 18, 2011, the contents of which are incorporated herein by reference in their entirety. field of invention
[002] The invention relates to a pen-type injection device with an end of injection indicator to signal to a user that a certain dose has been completely injected. Background of the invention
[003] Various medication injection pen devices are known in the prior art. Many injection pen devices require a user to determine a desired dose, as a result of which a dose selector, a drive mechanism or some other element moves a distance away from a main pen body corresponding to the determined dose. To inject the dose into such injection pens, the user then presses a button or some other component that generally returns the dose selector or trigger mechanism to its initial position in the main body of the pen while injecting the determined dose. On many of these pens, the user needs to keep pressing the pressure button until the prescribed dose is complete. However, a problem with many of these pens is that there is no indication to the user that the given dose has been completely administered. Thus, the user can prematurely release the button thinking that the injection process is complete without being informed in some way. In some situations this could expose the user to a risk as the prescribed dose was not fully injected. Therefore, there is a need to offer one or more of a visible, tactile or audible indication to the user when the determined dose has been completely administered. Invention Summary
[004] The exemplary embodiments of the present invention address at least the problems and/or disadvantages and above and offer at least the advantages described below.
[005] According to an exemplary embodiment of the present invention, a medication injection pen includes a housing and a dose determining handle rotatably connected to the housing for determining a dose. An indicating member is movable between a visible position indicating a zero position of the dose setting handle and a non-visible position indicating a non-zero position of the dose setting handle. The indicator member is visible to the user in the visible position and is not visible in the non-visible position. The dose determination handle is in the zero position when a determined dose has been completely delivered. Hence, a visible indication is provided to the user when a given dose has been completely administered.
[006] According to another exemplary embodiment of the present invention, a medication injection pen includes a housing and a dose determining handle rotatably connected to the housing for determining a dose. A window is arranged in the housing such that a portion of the outer surface of the dose setting handle is visible in the window to indicate a zero position of the dose setting handle and the outer surface portion of the dose setting handle is not visible in the window to indicate the non-zero position. The dose determination handle is in the zero position when a determined dose has been completely delivered.
[007] Other objectives, advantages and important features of the exemplary embodiments of the present invention will become clear to those skilled in the art from the following detailed description, which, considered in conjunction with the appended drawings, discloses exemplary embodiments of the present invention. Brief description of the drawings
The foregoing, and other exemplary aspects and advantages of certain exemplary embodiments of the present invention will become clearer in the following description of certain exemplary embodiments thereof when considered in conjunction with the accompanying drawings, in which: Fig. 1 is a elevation view of an injection pen according to an exemplary embodiment of the present invention; Fig. 2 is a perspective view of an end of injection indicator when the indicator is visible according to a first exemplary embodiment of the present invention; Fig. 3 is a perspective view of the end of injection indicator of Fig. 2 when the indicator is not visible; Fig. 4 is a perspective view of an end of injection indicator when the indicator is visible in accordance with a second exemplary embodiment of the present invention; Fig. 5 is a perspective view of the injection end of Fig. 3 when the indicator is not visible; Fig. 6 is a perspective view of a dose determining handle in the embodiments of Figs. 2 to 5; Fig. 7 is a perspective view of an end of injection indicator when an indicator member is visible in accordance with a third exemplary embodiment of the present invention; Fig. 8 is a perspective view of the end of injection indicator of Fig. 7 when the indicator member is not visible; Fig. 9 is a cross-sectional elevation view of the end of injection indicator of Figs. 7 and 8; Fig. 10 is a perspective view of the end of injection indicator of Fig. 7 with the indicator member in a visible part; Fig. 11 is a perspective view of the end of injection indicator of Fig. 7 in which a fin of a dose determining handle engages with the indicating member to retract the indicating member; Fig. 12 is a perspective view of the end of injection indicator of Fig. 11 in which the indicator member is fully retracted and disengaged from the fin in the non-visible position; Fig. 13 is a perspective view of the end of injection indicator of Fig. 12 in which the indicator member is engaged by a thread of a dose determining handle to release the indicator member into the visible position; Fig. 14 is a perspective view of an end of injection indicator according to a fourth exemplary embodiment of the present invention in which an indicator member is in a visible position; Fig. 15 is a perspective view of the end of injection indicator of Fig. 14 in which a fin of a dose determining handle engages with a drive mechanism to move the indicator member to a non-visible position; Fig. 16 is a perspective view of the flap of the dose determining handle disengaged from the drive mechanism; Fig. 17 is a perspective view of a thread of a dose setting handle engaging the drive mechanism to move the indicating member into the visible position; Fig. 18 is a perspective view of an end of injection indicator according to a fifth exemplary embodiment of the present invention in which an indicator member is in a visible position; Fig. 19 is a perspective view of the end of injection indicator of Fig. 18 with the indicator member in a non-visible part; Fig. 20 is a perspective view of an injection pen containing an injection indicator in accordance with a sixth exemplary embodiment of the present invention with the illustrated indicator member in the visible position; Fig. 21 is a perspective view of the injection pen of Fig. 20 with the indicator member illustrated in a non-visible position; Fig. 22 is a perspective view of the indicating member of Fig. 20 in the visible position; Fig. 23 is a perspective view of the indicating member of Fig. 20 in the non-visible position; Fig. 24 is a perspective view of an injection indicator according to a seventh exemplary embodiment of the present invention with the illustrated indicator in a visible position; Fig. 25 is another perspective view of the injection indicator of Fig. 24 with the indicator member shown in the visible position; Fig. 26 is a perspective view of the injection indicator of Fig. 24 with the indicator member shown in the non-visible position; Fig. 27 is another perspective view of the injection indicator of Fig. 24 with the indicator member shown in the non-visible position; Fig. 28 is a perspective view of the injection indicator of Fig. 24 with the member moving from the non-visible position to the visible position; Fig. 29 is a perspective view of the injection indicator of Fig. 24 with the indicator member being engaged by a thread of the dose setting handle; Fig. 30 is a partial cross-sectional elevation view of an injection pen including the injection indicator of FIG. 24 in the non-visible position; and Fig. 31 is a partial cross-sectional elevation view of the injection pen of Fig. 30 with the indicating member in the visible position.
[009] Throughout the drawings, similar reference numerals will be understood to refer to similar elements, features and structures. Detailed description of exemplary embodiments
[010] The matters exemplified in this description are presented to assist in a broad understanding of the exemplary embodiments of the invention with reference to the accompanying figures of the drawings. Therefore, those skilled in the art will recognize that various changes and modifications to the illustrative embodiments described herein can be made without departing from the scope and spirit of the disclosed embodiments. Also, well-known job descriptions and constructs are omitted for clarity and brevity.
[011] Fig. 1 represents a view of an injection pen 50 according to an exemplary embodiment of the present invention. As illustrated, the injection pen 50 includes an upper pen body 1 that houses a plurality of dose determining and injection components. The upper body 1 is connected to a cartridge housing 15, which houses a medication cartridge 14. The cartridge housing 15 is preferably transparent or translucent. As illustrated, the injection pen includes a dose determining handle 2 which includes a handle portion 51 which is rotated by a user to determine a desired dose. The dose determining handle 2 also includes a plurality of numerals corresponding to a series of dosage units which is visible through a window 13 provided in the upper body 1. A user turns the dose determining handle 2 until the desired dose is visible in window 13. Body 1 may include an arrow or other indicator 52 to accurately indicate the determined dose. Once the desired dose is determined, the user presses button 3 until the determined dosage amount is completely injected.
[012] To set a dose using the injection pen device 50, the user rotates the handle-shaped portion 51 of the dose setting handle 2 relative to the upper body of the pen 1. The outer surface 53 of the setting handle dose knob 2 includes a thread 21, as shown in Fig. 6, which is in threaded engagement with a plurality of threads (not shown) provided on an inner surface of the pen body 1. The dose setting 2 is rotated relative to the pen body 1, the dose determining handle 2 is threaded or advanced a distance away from the pen body 1 as shown in Fig. 21. Once a desired dose is determined, the user presses pushbutton 3 to start the injection. As the user continues to press button 3, dose setting handle 2 is forced to rotate and thread back into the body by threaded engagement between external thread 21 on dose setting handle 2 and the internal threads in the upper body 1. The rotation of the dose setting handle 2 can then be transferred to a drive mechanism or other element that causes a piston rod or lead screw 6 to move into the cartridge 14 to inject the dose determined, as illustrated in Fig. 2. A more detailed description of the operation of an illustrative injection pen device can be found in Provisional US Patent Application No. 61/457,391, filed March 16, 2011, and in the Application Related International Patent No. PCT/US2012/029308, filed March 15, 2012, both applications entitled “Multiple Use Disposable Injection Pen”, and incorporated herein by reference in their entirety.
[013] The injection process is completed when dose determination handle 2 returns to its initial dose position or "0" within pen body 1, such as when it is locked for further rotation and/or axial movement in the injection direction, i.e., towards a distal end 54 of the injection pen 50, as shown in Fig. 1. According to the first exemplary embodiment illustrated in Fig. 2, the upper body of the pen 1 may include one or more windows 17, through which a portion of dose setting handle 2 is visible only when dose setting handle 2 is in a dose position "0", such as at the injection end, when dose setting handle 2 dose 2 returns to its starting position. Window 17 is disposed on the upper body of pen 1 adjacent to a distal end 55 of the upper body of pen 1. Therefore, the user can be assured that the injection process is complete only when a portion of the dose determining handle is visible through window 17. Preferably, an elongated side 18 of window 17 is substantially perpendicular to a longitudinal axis of the upper pen body 1.
[014] When the dose determining handle 2 is in the home position, a distal end 56 (Fig. 6) of the dose determining handle 2 is substantially adjacent to the distal end 55 of the upper body of the pen 1 so that a portion of dose determination handle 2 is visible through window 17 on the pen upper body 1. When a dose is being determined, dose determination handle 2 is advanced in a distal direction from the pen's upper body as shown in Fig. 21, so that the distal end 56 of the dose determining handle 2 is advanced proximally to the window 17 in the upper body of the pen 1. Thus, the dose determining handle 2 is not visible through the window 17, as shows Fig. 3. As illustrated, dose determination handle 2 is not in a “0” dose position, so either a dose has been determined, or the injection process is not complete. When the dose is completed, the dose determining handle 2 is again visible through the window 17 in the upper body of the pen 1 as the distal end 56 of the dose determining handle 2 is returned to its initial position substantially adjacent to the distal end. 55 of the upper body of the pen 1.
[015] An end of injection indicator according to a second exemplary embodiment is illustrated in Figs. 4 and 5, which illustrate an injection pen substantially similar to that of Figs. 2 and 3. A window 19 is arranged in the upper body of the pen 1 as illustrated in Figs. 4 and 5. Window 19 has a different orientation than window 17 of Figs. 2 and 3. Window 19 has an elongated dimension 20 that is substantially parallel to a longitudinal axis of pen upper body 1, as opposed to elongated dimension 188 of window 17 being substantially perpendicular to the longitudinal axis of pen upper body 1, as show Figs. 2 and 3.
[016] The end of injection indicator of Figs. 4 and 5 operates substantially similar to that of Figs. 2 and 3. When dose determination handle 2 is not visible through window 19, as shown in Fig. 5, dose determination handle 2 is not in an initial dose or “0” position, ie, a dose is being determined or has not yet been completed. When dose determination handle 2 is visible through window 19 as shown in Fig. 4, dose determination handle 2 is in the initial dose or “0” position.
[017] The dose determination handle 2 illustrated in Fig. 6 can be used with the exemplary embodiments described above in relation to Figs. 2 to 5. As illustrated, dose determining handle 2 is generally cylindrical in shape. To ensure that no part of dose determination handle 2 is visible through window 17 or 19 until dose determination handle 2 is in the initial dose position or "0", dose determination handle 2 may include a cut-off part 23. As shown in Fig. 6, cut-off part 23 is formed by a substantially V-shaped inverted cut made at the distal end 56 of the dose setting handle 2. dose 2 rotate to return to the dose position "0" during an injection, the cut portion 23 is preferably removed from a portion of the outer surface, as illustrated. Thus, even when dose determination handle 2 is very close to returning to its initial dose position or "0", no part of dose determination handle 2 is visible through window 17 or 19 until the determination handle The dose setting 2 is fully rotated back to the pen upper body 1. Alternatively, instead of providing a cut-out portion 23 of the dose setting handle 2, a line or printed block may be provided on a portion of the outer surface 53 of dose setting handle 2 which would only be visible when dose setting handle 2 is in dose position “0”. Additionally, although the exemplary embodiments illustrated in Figs. 2 to 5 illustrate only a single window near the distal end 55 of the pen upper body 1, a plurality of windows can be used at various positions in the pen upper body 1.
[018] An end of the injection indicator according to a third exemplary embodiment of the present invention is illustrated in Figs. 7 and 8. An indicator member 200 is in the visible or exposed position and is only visible when the dose setting handle 2 is in the “0” or initial dose position, as illustrated in Fig. 7. Therefore, as shown in Fig . 8, when dose determination handle 2 is not in its initial position, as is evident by the gap "a" between dose determination handle 2 and the upper body of pen 1, indicator member 200 is no longer in the visible position. The exposed indicator member 200 is more readily visible to the user when the dose determining handle 2 is in its initial or end of injection position due to the larger size of the indicator member 200. The cartridge housing 15 is preferably transparent or translucent to facilitate visibility of indicator member 200 in visible position.
[019] The energy used to activate the indicating member 200 of Figs. 7 and 8 is stored during the dose determination action performed by the user. To facilitate the injection process, the force required to release the indicator member 200 into the visible position is preferably minimal and imperceptible to the user. A cross section of an injection end mechanism for exposing the indicator member 200 of Figs. 7 and 8 is illustrated in Fig. 9. The operation of the injection mechanism is illustrated in Figs. 10 to 13, in which the pen body 1 and cartridge holder 15 are removed to more clearly illustrate the operation thereof.
[020] As shown in Fig. 10, indicating member 200 has a substantially cylindrical shape and coaxially surrounds an insert 300. Insert 300 is axially retained and rotatably secured with respect to an upper pen body or housing 1, as shown in Fig. 9. Figs. 9 and 10 depict indicating member 200 in the visible or exposed position, visible to a user. As such, dose determination handle 2 is in the initial or dose “0” position. As shown in Fig. 9, a portion of the indicating element 200, represented by a length "b", is visible between the pen body 1 and the cartridge housing 15 when the indicating member 200 is in the visible position. Cartridge housing 15 is preferably transparent or translucent to facilitate visibility of indicator member 200. A compression spring element 400 is provided coaxially surrounding insert 300 between a protrusion 307 of insert member 300 and a protrusion 207 of indicator member 200. In this position, spring member 400 is biasing indicator member 200 away from dose determining handle 2 to expose indicator member 200 to the user. Indicator member 200 is connected to insert member 300 via engagement between a boss 302 on insert member 300 and a rail 204 of indicator member 200. Indicator member 200 is rotatable relative to insert member 300. rotational movement of indicator member 200 is determined by the configuration of rail 204 on indicator member 200.
[021] As shown in Fig. 10, the rail 204 has a first portion or slanted portion 205 extending in a distal direction at an angle to the longitudinal axis of the pen upper body 1. A second portion or horizontal portion 206 of the track 204 extends substantially along the longitudinal axis of the upper pen body 1 from an end 208 of the first portion 205 of track 204.
[022] Indicator member 200 includes at least one arm 202 extending from a cylindrical portion of indicator member 200 toward dose determining handle 2. A cut-off portion 210 is formed at a proximal end of arm 202 to form a flexible arm 209 at a proximal end thereof. Arm 202 of indicating member 200 engages with a fin 25 provided adjacent the distal end 56 of the dose determining handle 2, as shown in Fig. 10. During determination of a dose, as the dose determining handle 2 is rotated, the fin 25 on the dose determining handle 2 engages with a portion of the arm 202 to cause the indicator member 200 to rotate, as shown in Fig. 11. As the indicator member 200 rotates, the rail portion The slant 205 of the indicator member 200 performs a cam function with the boss 302 on the insert 300 so that the indicator member 200 retracts into the body 1 as the boss 302 traverses the slanted rail portion 205. indicator member 200 retracts, compression spring 400 is compressed between indicator member 200 and insert member 300, which is fixed and does not move axially or in rotation. When the boss 302 reaches an end 208 of the sloped rail portion 205, the indicator member 200 is fully retracted into the pen body 1 and is not visible to the user, as shown in Fig. 11. The indicator member 200 can additionally rotate with rotating the dose setting handle 2 until the boss 302 reaches an end of the horizontal rail portion 206. As the dose setting handle 2 continues to rotate, the fin 25 on the dose setting handle 2 moves out of engagement with arm 202 of indicator member 200. Consequently, fin 25 on dose determining handle 2 will move a sufficient distance so that it no longer engages arm 202 of indicator 200, as shown. Fig. 12. At this point, indicator 200 no longer rotates and dose determination handle 2 rotates and threads or advances outward from the upper body of pen 1 for a distance that corresponds to a given dose, as shown in Fig. 8. The bossa 302 is posic mounted at one end 212 of the horizontal portion 206 of the rail 204, as shown in FIG. 12. The boss 302 being disposed on the horizontal portion 206 of the rail 204 prevents movement of the indicator member 200 in the distal direction so that the spring 400 (Fig. 9) remains compressed between the indicator member 200 and the insert 300.
[023] During an injection, dose determination handle 2 is threaded back down towards upper body 1 when the user presses button 3 (Figs. 7 and 8). As dose determination handle 2 approaches the end of the injection position or dose position “0”, dose determination handle 2 may reach a position where fin 25 on dose determination handle 2 engages the top of arm 202 of indicating member 200, as shown in Fig. 12. If fin 25 were to hit the top of arm 202 instead of passing over the top, it is possible that the pen would jam and the determined dose would be prevented from be completed. Thus, the arm 202 in the insert member 200 may include the cutting portion 210 near the top of the arm 202 forming the flexible arm 209. Thus, when the fin 25 contacts the upper surface of the arm 202, the arm flexible 209 flexes out of the way of fin 25 so that dose determination handle 2 can continue to its home position or dose position "0".
[024] After the fin 25 passes the arm 202, a thread 21 on the dose determination handle 2 contacts a side edge of the arm 202, thus causing the rotation of the index member 200, as shown in Fig. 13. This interaction preferably occurs just before dose determination handle 2 reaches dose position “0”. As indicator member 200 rotates, horizontal rail portion 206 of rail 204 moves over boss 302 on insert member 300, as illustrated. Once the rail 204 moves so that the boss 302 is positioned on the slanted rail portion 205, the spring 400 (Fig. 9) is released. Spring 400 actuates indicator member 200 in a distal direction away from insert 300, until boss 302 is positioned at one end 213 of slanted rail portion 205 of rail 205, as shown in Fig. 10. End 213 of rail contacting the boss 302 results in a clicking or popping sound at the end of the stroke, thus providing an audible indication that the injection is complete. The critical point when the boss 302 is positioned on the slanted rail portion 205 of the rail 204 is when the dose determining handle 2 has returned to the "0" dose position so that the injection is completed. Axial movement of indicator member 200 as inclined rail portion 205 moves over boss 302 moves indicator member portion 200 into the externally visible position of pen upper body 1, thereby providing the user with a visible indication of that the injection is complete.
[025] In a fourth exemplary embodiment illustrated in Figs. 14-17, a drive mechanism 500 is added to supplement the movement of the indicator member 251. The indicator member 251 can move an axial distance in and out of the body so that a portion of the indicator member 251 can be visible. or exposed to the user in a home or dose “0” position, but hidden when dose determination handle 2 is not in the home or dose “0” position, as shown in Figs. 7 and 8. Indicator member 251 does not rotate, and is limited to axial movement. An insert 271 is fixed to the upper pen body 1, thereby preventing the rotational and axial movement of the insert 271. The drive mechanism 500 is provided so that it rotates with respect to the upper pen body 1, but does not move. axially in and out of the pen's upper body 1.
[026] The drive mechanism 500 includes a first horizontal rail portion 510 that is engaged with a boss 272 on the insert 271 to axially secure the drive mechanism 500 to the insert 271 while allowing rotation with respect thereto. Hence, the rotation distance through which the dose determining handle 2 and an arm 502 of the drive mechanism 500 are engaged at the beginning of the dose determination and towards the end of the injection is reduced. As such, any potential for the injection mechanism to stick or fail due to such engagement can be reduced or minimized.
[027] As shown in Fig. 14, dose determination handle 2 is in the initial or dose “0” position, thus, an indicator member 251 is visible or exposed to the user. As in the third exemplary embodiment illustrated in Figs. 9 to 13, a spring member (not shown) is provided between insert 271 and indicator 251 and is provided to urge indicator member 251 away from dose setting handle 2. As before, when the user adjusts the dose setting handle 2 to set a desired dose, the dose setting handle 2 is rotated and a flap 25 on the dose setting handle 2 engages an axially extending arm 502 from a drive mechanism 500. Due to this engagement, the drive mechanism 500 is forced to rotate. The drive mechanism 500 includes an inclined rail portion 504 that engages a boss 257 provided on the indicator member 251. As the drive mechanism 500 rotates, the boss 257 is forced to slide into and onto the shoulder portion. slanted rail 504 of drive mechanism 504, thus causing indicator member 251 to move upwardly into pen upper body 1 against bias of spring member 400 (Fig. 9). Indicator member 251 continues to retract into pen upper body 1 until boss 257 reaches horizontal rail portion 505 of drive mechanism 500. At this point, as shown in Fig. 15, indicator member 251 is fully retracted and arm 502 is no longer engaged with fin 25 on dose determining handle 2. Since arm 502 on drive mechanism 500 does not retract into the pen body upon retraction of indicator member 251 as in the embodiment above, the arm 502 and the dose determining handle 2 are engaged for a shorter period of time and for a shorter rotation distance. The boss 257 being positioned on the horizontal rail portion 505 holds the spring member in the compressed position.
[028] During injection, dose determination handle 2 moves back towards its home position or dose “0” towards arm 502 of trigger element 500. When a fin 25 engages an upper edge of arm 502 during the return of dose determining handle 2, a flexible arm 509 of trigger arm 502 flexes downward so that fin 25 can move past arm 502 of trigger mechanism 500. The trigger mechanism 500 rotates after engagement of a thread 21 on the dose setting handle 2 with a side edge of the arm 502, as shown in fig. 16. As the drive mechanism 500 rotates, the boss 257 moves along the horizontal portion of the rail 505, as shown in Fig. 17, until it reaches the slanted rail portion 504. At this point, the spring element 400 (Fig. 9) disposed between insert 271 and indicating member 251 is released and pushes indicating member 251 away from the dose determining handle 2 and away from the upper body of the pen 1 so that it is visible to the user. Again, when the boss 257 reaches an end 515 of the sloped rail portion 504, as shown in Fig. 14, an audible and/or tactile click or snap is generated.
[029] Figs. 18 and 19 illustrate a fifth exemplary embodiment of an end of injection indicator. A generally cylindrical indicating member 600 surrounds an insert member 700 to provide an indication that the dose determining handle 620 has returned to its home or dose "0" position in a manner similar to the exemplary embodiments above. Indicator member 600 includes at least one elongated arm 602 that engages with dose determining handle 620. Dose determination handle 620, in this exemplary embodiment, includes an angled fin 625 that engages with a corresponding angled portion 603 on the surface. internal of arm 602 to lift indicator member 600 upon rotation of dose setting handle 620. As dose setting handle 620 is rotated to set a dose, indicating member 600 is raised or pulled into the body. upper body of pen 1, against bias of a spring member 400 (Fig. 9) disposed between insert 700 and indicator member 600. Indicator member 600 is moved axially into pen upper body 1 by a distance corresponding to length of a vertical rail portion 604 of the indicator member. Indicator member 600 is lifted by engagement with fin 625 on dose setting handle 620 enough for a boss 702 on insert member 700 to span the length of vertical rail portion 604 and move into horizontal portion 605 , as shown in Fig. 19, which holds indicator member 600 in the retracted position until dose determination handle 620 returns to the initial or dose “0” position. Spring member 400 (Fig. 9) remains compressed when boss 702 is disposed on horizontal track portion 605 and prevents axial movement of indicator member 600.
[030] Figure 19 illustrates the indicating member 600 just before the dose determination handle 620 returns to the starting or dose “0” position. As illustrated, just before dose determination handle 620 reaches the home or dose position "0", a thread 621 on dose determination handle 620 engages an edge of arm 602 to cause arm 602 to rotate by a slight amount that will release the boss 702 disposed on insert 700 from the horizontal rail portion 605 into the vertical rail portion 604. Once the boss 702 is aligned with the vertical rail portion 604, the spring member 400 (Fig. 9) releases and urges indicating member 600 away from dose determining handle 620 so that a portion of indicating member 600 is exposed outside the upper body of pen 1 in similar fashion to the above exemplary embodiments to be visible to the user. As before, when the boss 702 reaches an end 606 of the vertical rail portion 604, an audible and/or tactile click or snap is generated.
[031] According to a sixth illustrative embodiment shown in Figs. 20 to 23, instead of placing an indicator out of the pen's upper body 1 so that it is exposed or visible to a user, an indicator 800 is configured to rotate so that a portion of the indicator 800 is visible to the user. As shown in Fig. 22, an indicator member 800 includes a plurality of legs 804 that are circumferentially spaced apart. Thus, as the indicating member 800 rotates relative to the upper body of the pen 1, one of the legs 804 rotates to the user's view, as illustrated in Fig. 20. Fig. 22 illustrates this embodiment when the determining handle de dose 2 is rotated by a certain amount to determine a dose so that dose determination handle 2 is no longer in the initial or dose “0” position. As illustrated, none of the legs 804 of indicating member 800 is visible to the user. Instead, a portion of the cartridge holder 15 may be visible.
[032] A difference between the embodiment of Figs. 20 to 23 and the above embodiments is that a torsion spring is provided between an insert 900 and the indicator member 800 instead of a compression spring. As shown in Fig. 22, indicator member 800 includes a rail 805 that engages with a boss 902 provided on insert member 900. dose 820 and hooks up to it. The dose determining handle 820 is provided with an angled fin 825, as shown in Fig. 23, which engages a similar angled member 808 provided on the inner surface of the arm 802. rotated to set a desired dose, engagement between angled portions 825 and 808 causes indicator member 800 to lift or move into pen upper body 1 in small amount and rotate against the bias of the torsion spring to move boss 902 disposed on insert 902 to a secure position, not shown, within rail 805. boss 902 is held in secure position against torsion spring bias until arm 802 is engaged near the start or dose position "0 ” by dose setting handle 820. After dose setting handle 820 engages arm 802 during its return, indicator member 800 is rotated by an amount that releases boss 902 so that the torsion spring makes the limb indicator 80 0 spin back. After the indicator member 800 rotates back under the force of the torsion spring, one of the legs 804 is visible to the user to indicate that the dose determination handle 820 is in the home or dose “0” position. The return of the boss 902 on the rail 805 under the force of the spring member results in an audible and/or tactile click or snap that is perceptible to the user.
[033] An end of injection indicator according to a seventh exemplary embodiment of the present invention is illustrated in Figs. 24 to 31. An indicator member 1021 is in the visible or exposed position and is only visible when the dose determining handle 1002 is in the initial or "0" dose position as illustrated in Figs. 24 and 25. Therefore, as shown in Figs. 26 to 29, when dose determination handle 1002 is not in its initial position (for example, as illustrated by the gap “a” between dose determination handle 2 and the upper body of pen 1 in Fig. 8), indicator member 1021 is no longer in the visible position. Exposed indicator member 1021 is more readily visible to the user when dose determination handle 1002 is in its start or end of injection position due to the fact that indicating member 200 extends beyond a distal end 1004 of a pen upper body 1003 as shown in Fig. 31. Cartridge housing 15 (Figs. 7 and 8, for example) is preferably transparent or translucent to facilitate visibility of indicating member 1021 in the visible position.
[034] The energy used to activate the indicating member 1021 of Figs. 24 to 31 is stored during the dose determination action performed by the user. To facilitate the injection process, the force required to release indicator member 1021 into the visible position is preferably minimal and imperceptible to the user. A cross section of one end of the injection mechanism to expose indicator member 1021 is illustrated in Figs. 30 and 31. The operation of the injection mechanism is illustrated in Figs. 24 to 29, in which pen body 1003 and cartridge holder 15 (Figs. 7 and 8) are removed to more clearly illustrate the operation thereof.
[035] As shown in Figs. 24 to 29, indicator member 1021 is substantially cylindrical in shape and is coaxially encircled by an insert 1031. Insert 1031 is prevented from moving axially in the distal direction by the externally extending flange 1005 of the brake tower 1005 receiving an internally extended shoulder 1033 of insert 1031. Axial movement in the proximal direction and rotational movement relative to the upper body of pen 1003 is substantially impeded by a boss 1023 of indicator member 1021 received in a rail 1035 of insert 1031. A spring member 1041 is disposed. between flange 1005 of brake turret 1005 and a proximal end 1025 of indicator member 1021, as shown in Figs. 30 and 31. Spring member 1041 biases indicator member 1021 into the visible position illustrated in Figs. 24 and 25, and prevents movement of indicator member 1021 and insert 1031 due to the connection of boss 1023 and rail therebetween.
[036] Figs. 24 and 25 depict indicating member 1021 in the visible or exposed position such that a portion of indicating member 1021 is visible to the user through the transparent or translucent cartridge housing 15 (Figs. 7 and 8). As such, dose determination handle 1002 is in the initial or dose “0” position. A portion of indicating member 1031 at a distal end 1027 thereof is visible beyond distal end 1004 of pen upper body 1003 when indicating member 1021 is in the visible position.
[037] As shown in Figs. 24 to 29, rail 1035 has a first portion or slanted portion 1036 extending in a distal direction at an angle to the longitudinal axis of pen upper body 1003 (Figs. 30 and 31). A second or horizontal portion 1037 of rail 1035 extends substantially along the longitudinal axis of pen upper body 1003 (Figs. 30 and 31) from one end of first portion 1036 of rail 1035. A ramp 1038 is formed thereon. transition from second part 1037 to first part 1036 of track 1035 to maintain boss 1023 in second part 1037 of track 1035 when dose determining handle 1002 is in a non-zero position, as shown in Figs. 26 and 27.
[038] The insert 1031 includes at least one arm 1039 extending from a cylindrical portion of the insert 1031 towards the dose determining handle 1002 as shown in Figs. 24 to 31. A distal end 1032 of arm 1039 slopes downward toward the distal end of pen 1001 (Figs. 30 and 31). Arm 1039 of insert 1031 engages a fin 1011 provided adjacent a distal end 1012 of dose determining handle 1002. During determination of a dose, as dose determining handle 1002 is rotated, fin 1011 in dose determining handle 1002 engages with a portion of arm 1039 to rotate insert 1031 as shown in Figs. 25 and 26. As insert 1031 rotates, slanted rail portion 1036 of insert 1031 performs a cam function with boss 1023 on indicator member 1021 so that indicator member 1021 retracts into body 1003 as that the boss 1023 traverses the slanted rail portion 1036. As the indicator member 1021 retracts, the spring member 1041 is compressed between the indicator member 1021 and the flange 1006 of the brake tower 1005, which is secured to the upper body. of pen 1003 and does not move axially or in rotation. When the boss 1023 reaches an end 1049 of the sloped rail portion 1036, the indicator member 1021 is fully retracted into the pen body 1003 and is not visible to the user, as shown in Figs. 26 and 27. Indicator member 1021 further rotates with rotation of dose determining handle 1002 until boss 1023 reaches an end of horizontal rail portion 1037. As dose determining handle 1002 continues to rotate, the fin 1011 on dose determination handle 1002 moves out of engagement with arm 1039 of insert 1031. Consequently, fin 1011 on dose determination handle 1002 moves a sufficient distance that it no longer engages with the arm 1039 of insert 1031, as shown in Fig. 26. At this point, insert 1031 no longer rotates and dose setting handle 1002 rotates and threads or advances outward from the upper body of pen 1003 for a distance corresponding to one determined dose, as shown in Fig. 8. The boss 1023 is positioned at one end 1034 of the horizontal portion 1037 of the rail 1035, as shown in Figs. 26 and 27. The boss 1023 being disposed on the horizontal portion 1037 of the rail 1035 prevents movement of the indicator member 1021 in the distal direction so that the spring 1041 remains compressed between the indicator member 1021 and the flange 1006 of the brake tower 1005.
[039] During an injection, dose determination handle 1002 is threaded back down or advanced into the upper body of pen 1003 after the user presses button 3 (Figs. 7 and 8). As dose determination handle 1002 approaches the end of the injection position or dose position “0”, dose determination handle 1002 may reach a position where fin 1011 on dose determination handle 1002 engages the top of arm 1039 of insert 1031. If fin 1011 were to hit the top of arm 1039 instead of passing over the top, it is possible that the pen would jam and the determined dose would be prevented from being completed. Thus, arm 1039 on insert 1031 is angled downward toward a distal end 1030 of insert 1031. Thus, when fin 1011 contacts the upper surface of arm 1039, the proximal end of arm 1039 facilitates passage of fin 1011 over arm 1039 so that dose determination handle 1002 can continue to its home position or dose position "0".
[040] After fin 1011 passes arm 1039, a thread 1043 in dose setting handle 2 contacts a side edge of arm 1039, thus causing the insert 1031 to rotate, as shown in Fig. 29. This interaction preferably occurs just before dose setting handle 1002 reaches dose position “0”. As the insect 1031 rotates, the boss 1023 moves on the horizontal rail portion 1037 on the insert 1031. After the insert 1031 rotates so that the boss 1023 is positioned on the ramp 1038 on the rail 1035 and the arm 1039 is positioned on the second end 1063 of recess 1061 in dose setting handle 1002. Continued rotation of dose setting handle 1002 forces boss 1023 to pass over chute 1038 of rail 1035 in insert 1031. When boss 1023 passes chute 1038, 1041 spring is released. Spring 1041 drives indicator member 1021 in a distal direction away from insert 1031, until boss 1023 is positioned at one end 1048 of slanted rail portion 1036 of rail 1035, as shown in Figs. 24 and 25. End 1048 of rail 1035 contacting boss 1023 results in a clicking or popping sound at the end of travel, thus providing an audible indication that injection is complete. The critical point when the boss 1023 is positioned on the slanted rail portion 1036 of the rail 1035 is when the dose determining handle 1002 has returned to the "0" dose position so that the injection is completed. Axial movement of the indicator member 1021 as the boss moves on the slanted rail portion 1036 moves the indicator member portion 1021 to the externally visible position of the upper pen body 1003 as shown in Fig. 31, thus providing the user a visible indication that the injection is complete.
[041] The injection pens described herein may use conventional injection and dose determination mechanisms as disclosed, for example, in US Patent Nos. 5,626,566, 6,235,004 and 7,241,278, all of which are hereby incorporated for reference purposes in their entirety .
[042] Although the present invention has been illustrated and described with reference to particular illustrative embodiments, it should not be restricted to such exemplary embodiments. It should be appreciated that those skilled in the art may alter or modify the exemplary embodiments without departing from the scope and spirit of the present invention as defined in the appended claims and their equivalents.

权利要求:
Claims (18)
[0001]
1. Medicine injection pen (50) CHARACTERIZED by comprising: a housing (1); a dose determining handle (2) rotatably connected to said housing for determining a dose; and an indicator member (200) movable between a visible position indicating a zero position of said dose determining handle and a non-visible position indicating a non-zero position of said dose determining handle, said dose determining handle being in said zero position when a determined dose has been completely administered, and said dose determining handle (2) being in said non-zero position when at least a part of the determined dose remains in said medicine injection pen (50 ); wherein in said non-visible position, said indicating member is not exposed to an exterior of said medicine injection pen, and in said visible position, said indicating member is exposed to said exterior of said medicine injection pen.
[0002]
2. The medicine injection pen, according to claim 1, characterized in that: a spring member (400) biases said indicator member to said zero position.
[0003]
3. Medicine injection pen, according to claim 1, characterized in that: an arm (202) extends axially from said index member towards said dose determining handle.
[0004]
4. Medicine injection pen according to claim 3, CHARACTERIZED by the fact that: a fin (25) disposed on said dose determination handle engages with said arm when rotating said dose determination handle to determine a dose for moving said indicator member from said visible position to said non-visible position.
[0005]
5. Medicine injection pen according to claim 4, CHARACTERIZED by the fact that: a thread (21) disposed on said dose determining handle engages with said arm when injecting a determined dose to move said indicator member from said non-visible position to said visible position.
[0006]
6. Medicine injection pen, according to claim 5, CHARACTERIZED by the fact that: a flexible arm (209) is disposed at one end of said arm to allow the passage of said fin over said arm when injecting said dose determined.
[0007]
7. Medicine injection pen, according to claim 2, CHARACTERIZED by the fact that: an insert (300) is fixed to said housing and has a boss (302) extending outwardly therefrom; and a rail (204) in said indicator member receives said boss for guiding said indicator member between said visible position and said non-visible position.
[0008]
8. Medicine injection pen, according to claim 7, CHARACTERIZED by the fact that: said rail has a first part (604) and a second part (605) so that the movement of said boss through said the first part provides axial movement of said indicator member and movement of said boss through said second part prevents axial movement of said indicator member.
[0009]
9. Medicine injection pen, according to claim 8, CHARACTERIZED by the fact that: said spring (400) moves said indicator member to said visible position when said boss enters said first part of said track a from the second part.
[0010]
10. Medicine injection pen, according to claim 9, CHARACTERIZED by the fact that: an audible indication is generated when said boss contacts an end (606) of said first part of said rail when said member indicator is returned to that visible position.
[0011]
11. Medicine injection pen, according to claim 2, CHARACTERIZED by the fact that: a first boss (257) extends outside said indicator member; an insert (271) is secured to said housing and has a second boss (272) extending outwardly therefrom; and a drive mechanism (500) has a first track (504) receiving said first boss (257) and a second track (510) receiving said second boss (272) so that movement of said first boss on said first boss rail move said pointing member between said visible and non-visible positions.
[0012]
12. Medicine injection pen, according to claim 11, CHARACTERIZED by the fact that: the movement of said second boss (272) on said second rail (510) of said drive mechanism facilitates the rotation of said drive mechanism. - to in relation to that insert.
[0013]
13. Medicine injection pen according to claim 11, CHARACTERIZED by the fact that: an arm (502) extends axially from said drive mechanism towards said dose determining handle.
[0014]
14. Medicine injection pen according to claim 13, CHARACTERIZED by the fact that: a fin (25) disposed on said dose determining handle engages with said arm when rotating said dose determining handle to determine a dose for moving said indicator member from said visible position to said non-visible position.
[0015]
15. Medicine injection pen according to claim 11, CHARACTERIZED by the fact that: said first rail has a first part (604) and a second part (605) so that the movement of said first boss through of said first part provides axial movement of said indicator member and movement of said first boss through said second part prevents axial movement of said indicator member.
[0016]
16. Medicine injection pen, according to claim 4, CHARACTERIZED by the fact that: said fin (625) has an angled surface; and a protrusion (808) disposed on said arm has an angled surface such that rotation of said dose determining handle in determining said dose engages said angled surfaces to move said indicator member from said visible position to said position. non-visible.
[0017]
17. Medicine injection pen, according to claim 2, CHARACTERIZED by the fact that: said spring comprises a torsion spring.
[0018]
18. Medicine injection pen, according to claim 17, CHARACTERIZED by the fact that: an insert (900) is fixed to said housing and has a boss (902) extending outwardly therefrom; and a track (805) disposed on said indicator member receives said boss so that movement of said boss on said track rotates said indicator member between said visible position and said non-visible position.

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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-08-25| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

2021-02-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-03-16| B09W| Correction of the decision to grant [chapter 9.1.4 patent gazette]|Free format text: RETIFICACAO DA PUBLICACAO DE DEFERIMENTO POR TER SIDO EFETUADA COM INCORRECAO. TAL PUBLICACAO NAO IMPLICA NA ALTERACAO DA DATA DO DEFERIMENTO E NOS PRAZOS DECORRENTES DA MESMA. |

2021-05-04| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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US201161457403P| true| 2011-03-18|2011-03-18|

US61/457,403|2011-03-18|

PCT/US2012/029545|WO2012129120A1|2011-03-18|2012-03-16|End of injection indicator for injection pen|

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