RU2780506C1 - Apparatus for removing a rigid protective cap for a needle with an appliance for impact load testing for a pre-filled syringe - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: unit for preventing unintentional triggering of the drug delivery apparatus comprises a body, a cap, and a shifting needle cover with a flanged distal end. The needle cover is placed in the body and is configured to have a before-use position wherein the needle cover extends from the body and a use position wherein said needle cover is shifted into the body; wherein the shifting of the needle cover into the body actuates the drug delivery apparatus by interacting with the drive mechanism. The cap assembly comprises a cap removal apparatus configured to be gripped by the user; and a fastener placed inside the cap removal apparatus. The fastener comprises an inverted protrusion located radially outward relative to the flange and configured to engage with the flange of the needle cover of the drug delivery apparatus. The location of the inverted protrusion relative to the flange is configured to prevent the needle cover from being shifted to the use position. The fastener comprises a protrusion extending in the radial direction, and the cap removal apparatus comprises a side wall hole. The protrusion extending in the radial direction is configured to divert radially outward when the protrusion extending in the radial direction is aligned with the hole in the cap removal apparatus. Disclosed is a drug delivery apparatus.

EFFECT: prevented unintentional triggering.

6 cl, 12 dwg

Description

BACKGROUND OF THE INVENTION

TECHNICAL FIELD OF THE INVENTION

[0001] The present disclosure relates generally to pens and methods for assembling the same, and more particularly to devices for removing protective caps for needles of pens, devices for preventing inadvertent actuation of pens, and methods for assembling pens containing such devices.

Description of the Prior Art

[0002] Automated drug delivery devices, such as pens, have removable safety caps to maintain needle sterility and prevent inadvertent user contact with said needle. Many of these needle shields are made from an elastomeric material and it can be difficult to ensure accurate placement and a firm grip between said needle shield and caps or other removable devices, resulting in additional force being required to remove said needle shield or said needle shield. The protective cap slips and cannot be removed at all. Thus, there is a need in the art for a needle cap removal device that can be securely mounted to quickly and easily remove said needle shield when using said pen.

[0003] In addition, automatic drug delivery devices may have the disadvantage of being prone to inadvertent operation when force is applied to said device. In particular, devices that are actuated by pressing may unintentionally be activated when the device is dropped. Accordingly, there is a need in the art for a device that can prevent the inadvertent actuation of a pen.

SUMMARY OF THE INVENTION

[0004] Provided herein is a block for a drug delivery device, comprising a housing; a displaceable needle cover having a distal end with a flange, wherein said needle cover is housed within said body and configured to have a position prior to use in which said needle cover protrudes from said body, and a use position in which said cover for the needle is at least partially displaced within said housing, wherein displacement of said needle cover within said housing actuates said drug delivery device by interacting with a drive mechanism; and a cap assembly including a cap removal device configured to be gripped by a user and a latch placed inside said cap removal device and configured to engage with said needle cap flange of said drug delivery device, wherein the location of the latch with respect to said flange is configured to prevent said needle cover from moving to said use position.

[0005] Also provided herein is a drug delivery device, including: a housing; a syringe having a needle and at least partially housed within said housing; a needle cover, comprising a flange at its distal end and having a position before use, in which the specified needle is located inside the specified needle cover, and the position of use, in which the specified needle is located at least partially outside the specified needle cover, in which in the position in use, said needle cover is configured to actuate said drug delivery device to deliver a drug; and a cap assembly including a cap removal device and a latch located within said cap removal device, said latch configured to prevent said needle cover from moving from a pre-use position to a use position.

[0006] Additional embodiments and aspects are set forth below:

[0007] A unit for a drug delivery device, including: a body; a displaceable needle cover having a distal end with a flange, wherein said needle cover is housed within said body and configured to have a position prior to use in which said needle cover protrudes from said body, and a use position in which said cover for the needle is at least partially displaced within said housing, wherein displacement of said needle cover within said housing actuates said drug delivery device by interacting with a drive mechanism; and a cap assembly including: a cap remover configured to be gripped by a user; and a latch positioned within said cap removal device and configured to engage with said needle cap flange of said drug delivery device, wherein the position of the latch relative to said flange is configured to prevent said needle cap from moving to said use position.

[0008] The block described above, wherein said retainer comprises at least one protrusion configured to engage with said needle cover flange.

[0009] The above-described block, wherein the engagement of said at least one protrusion of said latch with said needle cover flange prevents said needle cover from moving to a use position.

[0010] The block described above, wherein said flange is disposed on an outer surface of said needle cover and said protrusion is an inwardly facing protrusion disposed radially outward from said flange.

[0011] The block described above, wherein said protrusion abuts said flange at its proximal end.

[0012] The block described above, wherein said retainer comprises at least one protrusion extending in a radial direction, and said cap removal device comprises at least one opening in its side wall.

[0013] The block described above, in which said at least one protrusion extending in the radial direction, is configured to deviate radially outward when the specified at least one protrusion extending in the radial direction aligns with the specified at least one hole in specified device to remove the cap.

[0014] The block described above, in which said latch is operable relative to said cap removal device from a first position in which said at least one protrusion extending in the radial direction is not aligned with at least one opening in said cap removal device and cannot deviate radially outward to a second position in which said at least one protrusion extending in the radial direction aligns with at least one opening in said cap removal device such that said at least one the protrusion extending in the radial direction is able to deviate radially outward.

[0015] A drug delivery device, including: a body; a syringe having a needle and at least partially housed within said housing; a needle cover, comprising a flange at its distal end and having a position before use, in which the specified needle is located inside the specified needle cover, and the position of use, in which the specified needle is located at least partially outside the specified needle cover, in which in the position in use, said needle cover is configured to actuate said drug delivery device to deliver a drug; and a cap assembly including a cap removal device and a latch located within said cap removal device, said latch configured to prevent said needle cover from moving from a pre-use position to a use position.

[0016] The above-described drug delivery device, wherein said retainer comprises at least one protrusion configured to engage with said needle cap flange.

[0017] The above-described drug delivery device, wherein the engagement of said at least one protrusion of said retainer with said needle cap flange prevents said needle cap from moving into a use position.

[0018] A drug delivery device as described above, wherein said retainer comprises at least one protrusion extending in a radial direction and said cap removal device comprises at least one opening in its side wall.

[0019] The above-described drug delivery device, wherein said at least one radially extending protrusion is configured to deflect radially outward when said at least one radially extending protrusion aligns with said at least at least one hole in said cap removal device.

[0020] The above-described drug delivery device, wherein said lock is switchable relative to said cap removal device from a first position in which said at least one radially extending protrusion is not aligned with at least one opening in said cap removal device and cannot deviate radially outward to a second position in which said at least one protrusion extending in the radial direction aligns with at least one opening in said cap removal device such that said at least one protrusion extending in the radial direction is able to deviate radially outward.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1A illustrates a side view of a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0022] FIG. 1B illustrates a bottom view of a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0023] In FIG. 2A shows an exploded cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0024] FIG. 2B illustrates a perspective view of the cap assembly as shown in FIG. 2A;

[0025] In FIG. 3 is a cross-sectional view of a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0026] FIG. 4A illustrates a perspective view of a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0027] FIG. 4B illustrates a perspective view of a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0028] In FIG. 5A is an exploded perspective view of a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0029] FIG. 5B illustrates a perspective view of a protective cap cap remover assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0030] FIG. 5C illustrates a perspective view of a cap retainer assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0031] In FIG. 6 is a cross-sectional perspective view of a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0032] FIG. 7 illustrates a cross-sectional view of a pen including a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0033] FIG. 8 illustrates a cross-sectional view of a pen including a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0034] In FIG. 9 is a cross-sectional view of a pen including a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0035] FIG. 10 illustrates a cross-sectional view of a block containing a cap assembly, in accordance with one non-limiting embodiment or aspect described herein;

[0036] In FIG. 11A-11J depict steps for assembling a block, in accordance with one non-limiting embodiment or aspect described herein; and

[0037] FIG. 12 illustrates a side view of a pen, in accordance with one non-limiting embodiment or aspect described herein.

DESCRIPTION OF THE INVENTION

[0038] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for implementing the present invention. However, various modifications, equivalents, changes and alternatives remain apparent to those skilled in the art. Any possible such modifications, variations, equivalents and alternatives are intended to be included within the scope and spirit of the present invention.

[0039] In the context of the following description, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives will refer to this invention with regard to its orientation in the drawings. However, it is to be understood that the present invention may be capable of various alternatives, except where expressly stated to the contrary. It is also to be understood that the specific devices depicted in the accompanying drawings and described hereinafter are only exemplary embodiments of the present invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be construed as limiting.

[0040] Provided herein is a cap assembly for a drug delivery device comprising a needle. In non-limiting embodiments or aspects, said drug delivery device is a pen or similar device for automatically or manually delivering a substance to a user's body. With reference to FIG. 1-6 depict a cap assembly (100) which, in non-limiting embodiments or aspects, is a cap assembly removal device including a retainer (110) and a cap removal device (150). The latch (110) is inserted inside the device (150) to remove the cap. In non-limiting embodiments or aspects, the cap remover (150) has an extension at its distal end to form an ergonomic grip surface so that the user can firmly grasp said cap remover. The retainer (110) and cap remover (150) may be made from any rigid material, such as, but not limited to, plastics and the like.

[0041] In FIG. 2A, 2B, and 5A-5C depict one non-limiting embodiment or aspect of the cap assembly described herein, exploded. The device (150) for removing the cap includes a proximal end (155), which is configured to be located closest to the body, and a distal end (160). In non-limiting embodiments or aspects, the proximal end (155) of the cap removal device (150) includes two or more legs that engage with the body (not shown) of the pen. In such non-limiting embodiments or aspects, said legs of the cap remover (150) include at least one protrusion or shoulder to securely releasably engage with said pen body. The distal end (160) of the device (150) for removing the cap contains at least one hole (162). In non-limiting embodiments or aspects, the cap remover (150) includes at least one opening (170) in its side wall. In non-limiting embodiments or aspects, the cap remover (150) includes two holes (170). In non-limiting embodiments or aspects, the cap removal device (150) comprises two holes (170) that are located on opposite sides of said cap removal device (150).

[0042] Further, with respect to FIG. 1, 2A, 2B, 4, 5A, and 5B, the retainer (110) includes proximal (115, closest to the body) and distal (120) ends. In non-limiting embodiments or aspects, the proximal end (115) of the retainer (110) includes two or more legs that engage with a needle shield (not shown) of the pen. In such non-limiting embodiments or aspects, said latch legs (110) comprise at least one lug to securely engage said needle shield. The specified distal end (120) of the latch (110) has at least one hole (122). In non-limiting embodiments, said distal end (120) of retainer (110) is configured to fit against said distal end (160) of said cap removal device (150). In non-limiting embodiments or aspects, said hole (162) in said distal end (160) of said cap removal device (150) has a larger diameter than said hole (122) in said distal end (120) of said retainer (110). In non-limiting embodiments or aspects, this difference in diameter allows said retainer (110) to be inserted inside said cap removal device (150) through said opening (162) in said distal end (160) of said cap removal device (150).

[0043] As previously described, the proximal end (115) of the retainer (110) may include at least one gripping element, such as a protrusion, to securely engage the needle shield. With reference to FIG. 3 and 6 depicts a cap assembly, in accordance with one non-limiting embodiment or aspect, wherein said retainer (110) includes at least one gripping element (125) at its proximal end (115). Said at least one gripping element may be at least one protrusion (125) and may be configured to grip the needle shield by its flange.

[0044] In non-limiting embodiments or aspects, said retainer (110) and device (150) for removing the cap of said cap (100) assembly are configured or positioned such that the needle cap and/or syringe pen (not shown) can be displaced relative to said retainer by inserting a device such as a working tool through said holes (122, 162) in the distal ends (120, 160) of said retainer (110) and cap removal device (150), respectively . Insertion of the operating instrument through said openings in said cap remover and retainer allows said needle shield and syringe to be displaced proximally and thus adjust the position of said projections (125) relative to said needle shield to ensure a secure grip. between the indicated retainer (110) and the protective cap for the needle.

[0045] Further with respect to FIG. 3 and 6, as described above in non-limiting embodiments or aspects, said cap removal device (150) comprises at least one opening (170) in its side wall. The specified at least one hole (170) is made with the ability to allow at least one radially outgoing protrusion (135) on the latch (110) to pass through it. In a non-limiting embodiment or aspect depicted in FIG. 3 and 6, at least one radially extending protrusion (135) extends from a stem that extends proximally from said distal end (120) of said retainer (110). In other non-limiting embodiments or aspects (not shown), said at least one radially extending protrusion (135) is located on the main part of said latch (110).

[0046] With respect to FIG. 2A and 2B, between said cap remover (150) and retainer (110), during removal of said cap (100) assembly, a lag circuit is provided. The retainer (110) is inserted inside said cap removal device (150) such that at least one protrusion (112) is positioned proximal to at least one arm (152) of the cap removal device (150). In non-limiting embodiments or aspects, said at least one protrusion (112) prevents displacement of said retainer (110) distally from said cap removal device (150) by engaging with the proximal surface of said at least one shoulder (152 ). In non-limiting embodiments or aspects, said retainer (110) further includes at least one flange (114) disposed distally with respect to said at least one shoulder (152) of said cap removal device (150). Thus, proximal displacement of said retainer (110) from said cap removal device (150) is prevented by engagement of the proximal surface of said at least one flange (114) with the distal surface of said at least one shoulder (152). The longitudinal space between said at least one protrusion (112) and at least one flange (114) on said latch (110) results in a predetermined gap between these components. Accordingly, in non-limiting embodiments or aspects, when said cap removal device (150) is pulled distally to remove said cap (100) assembly from the drug delivery device to which it is attached, the cap removal device (150) the cap is pulled a certain distance before said at least one shoulder (152) engages with said at least one protrusion (112) of said retainer (110). This results in a delay between the start of movement of said cap removal device (150) and the start of movement of said retainer (110). When the cap removal device (150) is displaced enough for said at least one shoulder (152) to engage with said at least one projection (112), said retainer (110) begins to disengage from said drug delivery device, and, due to the location of said at least one protrusion (125) relative to the needle shield, said needle shield begins to detach from said syringe and needle.

[0047] Also provided herein is a pen including a body, a syringe having a barrel, a needle and a needle cap, and a cap assembly. With reference to FIG. 7-9, a pen is shown having a body, a syringe (200) with a barrel (210) and a needle (220) attached thereto, a removable protective cap (230) for the needle, configured to at least partially wrap around said needle. (220), and cap (100) assembly. The pen body (lower body (310) is shown, although it should be understood that the pen may include an upper body as described below) includes a proximal end and a distal end, where said distal end is open to said needle (220 ) was able to pass through it to deliver the substance to the user's body.

[0048] The removable protective cap (230) for the needle may include proximal (232) and distal (234) ends. In non-limiting embodiments or aspects, the removable needle shield (230) is a two-part needle shield including an elastomer inner and a rigid outer. In non-limiting embodiments or aspects, said rigid outer portion at least partially wraps said elastomeric inner portion of said needle shield (230). In non-limiting embodiments or aspects, the needle shield (230) includes at least one flange or shoulder (235). In non-limiting embodiments or aspects, said at least one flange or shoulder (235) is positioned on said elastomeric inner to engage said rigid outer. In non-limiting embodiments or aspects, the needle shield (230) comprises at least one gripping accessory (233) at said proximal end (232). In non-limiting embodiments or aspects, said at least one complementary gripping element (233) is configured to complement said at least one gripping element (125) of said retainer and be able to engage with it. In non-limiting embodiments or aspects, said at least one complementary grip element (233) is the proximal edge of said needle shield (230).

[0049] In non-limiting embodiments or aspects, said elastomeric portion of the needle shield (230) is formed from one or more natural or synthetic rubbers and/or thermoplastic elastomer, or combinations thereof. In non-limiting embodiments or aspects, said rigid outer portion of the needle shield (230) is formed from a rigid plastic. In non-limiting embodiments or aspects, said rigid outer portion is formed from polypropylene.

[0050] The cap (100) assembly includes, as previously described, a cap remover (150) and a retainer (110). In non-limiting embodiments or aspects, said cap removal device (150) and/or retainer (110) comprise one or more of the elements described above. In non-limiting embodiments or aspects, the cap remover (150) at least partially wraps around said open distal end of the housing. In non-limiting embodiments or aspects, the cap remover (150) does not have the ability to rotate relative to said housing. The body of the pen and/or the device (150) for removing the cap may contain appropriate elements to prevent rotation of the device (150) for removing the cap and, thus, the retainer (110) and the protective cap (230) for the needle relative to the specified body and specified needle (220) while removing the needle protection cap (230). In non-limiting embodiments or aspects, appropriate anti-rotation features include one or more protrusions, guide channels, and/or shoulders on the cap remover (150) and/or body.

[0051] Also provided herein is a method for assembling a pen containing a cap assembly, comprising the steps of providing a lower pen assembly, inserting a syringe inside said lower housing assembly, and placing the upper housing assembly on said lower housing. assembled. In the first step, a lower housing (300) assembly is provided, containing a cap (100) assembly engaged therewith. Said lower housing (300) assembly includes the lower housing (310). In non-limiting embodiments or aspects, the lower housing (300) assembly includes a ring (320) at its proximal end. Said lower housing (300) assembly comprises a proximal end and a distal end, wherein said distal end is open to allow the syringe needle to pass through it, and said proximal end of said lower housing (310) is open to allow insertion of the syringe into specified body. The housing may be formed from any suitable material, including, for example and without limitation, rigid plastic. The lower housing (300) assembly also includes a cap (100) assembly. The cap (100) assembly comprises, as previously described, a cap remover (150) and a retainer (110), each having distal ends (160, 120) with a hole (162, 122) passing through them. In non-limiting embodiments or aspects, said cap removal device (150) and/or retainer (110) comprise one or more of the elements described above. In the initial configuration (for example, when the cap (100) assembly is located on the lower body (310)) the specified distal end (120) of the retainer (110) is at a distance from the specified distal end (160) of the cap removal device (150).

[0052] Considering FIG. 7, in non-limiting embodiments or aspects, in the second step of said method, the syringe (200) is inserted into said lower housing (310). Said syringe (200) may include a cylinder (210) for containing a drug or other substance, a needle (220) located at the distal end of said cylinder (210), and a removable protective cap (230) for the needle. The syringe (200), barrel (210), needle (220) and protective cap (230) for the needle may contain one or more of the elements described above. The syringe barrel (210) may be of any useful size and may be formed from any useful material such as glass or plastic. In non-limiting embodiments or aspects, the syringe (200) is a one-piece syringe and said needle (220) is formed together with said syringe barrel (210). In non-limiting embodiments or aspects, the syringe barrel (210) is not formed with the needle (220) therein, but instead, a needle cannula (not shown) holds the needle (220). The needle (220) of the syringe may be formed from any useful material and may be of any suitable gauge. The needle shield (230) may be a one-piece needle shield formed from an elastomeric material or a two-piece needle shield having an inner portion formed from an elastomeric material and an outer portion formed from from hard material. Said protective cap (230) at least partially wraps around said needle (220). In non-limiting embodiments or aspects, the syringe (200) includes a flange (240) at its proximal end. At the conclusion of the second stage, the said distal end (120) of the latch (110) remains located at a distance in the longitudinal direction from the distal end (160) of the said cap removal device (150).

[0053] In non-limiting embodiments or aspects, said step of introducing the syringe (200) includes moving said syringe (200) towards said distal end of the body (310), preferably such that said at least one member (125) ) to be gripped was at a distance in the longitudinal direction from the specified proximal end of the specified protective cap for the needle. In other words, said at least one gripping element (125) is located more proximally than in its final position (shown in Fig. 9). In this position, said distal end (234) of said syringe flange rests against said ring (320). In this position, the specified proximal end (115) of the retainer (110) is in contact with the specified barrel (210) of the syringe.

[0054] As described above, at the end of this step, said distal end (120) of retainer (110) is supported proximal to said distal end (160) of cap removal device (150), such that said distal end (120) of retainer (110) located at a distance in the longitudinal direction from the specified distal end (160) of the device (150) to remove the cap. In non-limiting embodiments or aspects, a working tool (not shown) is inserted into the specified hole (162) of the device (150) to remove the cap. This working tool can be used to push the said latch (110) in the proximal direction, so that the specified distal end (120) of the latch (110) is located at a distance in the longitudinal direction from the specified distal end (160) of the cap removal device (150).

[0055] In non-limiting embodiments or aspects, said proximal end (115) of the latch (110) comprises at least one gripping element, such as protrusions (125), and said protrusions (125) contact the syringe barrel (210) proximally relative to said distal end of the syringe barrel (210). Thus, said latch (110) is in the "overtravel" position when said at least one gripping element (125) is too far proximal from said needle shield (230) (FIG. 7). In non-limiting embodiments or aspects, the specified protective cap (230) for the needle contains at least one flange or shoulder (235), and the specified proximal end (115) of the latch (110) contains at least one element (125) for gripping, and said at least one gripping element (125) contacts said syringe barrel (210) proximally with respect to said at least one flange or shoulder (235).

[0056] Considering FIG. 8, in non-limiting embodiments or aspects, the third step of said syringe assembly method includes, after inserting said syringe (200) into said lower housing (310), moving said syringe (200) in a proximal direction. In non-limiting embodiments or aspects, movement of said syringe (200) in the proximal direction within said lower housing (310) is achieved by inserting the device through said at least one opening (162, 122) in said distal ends (160, 120) of said device (150) to remove the cap and cap retainer (110) and apply pressure to push said syringe (200) proximally. In non-limiting embodiments or aspects, and as depicted in FIGS. 8, when said syringe (200) is pushed in a proximal direction, said at least one retainer (110) engaging member (125) engages said needle shield at its most proximal edge. In non-limiting embodiments or aspects, said at least one gripping element (125) engages with at least one corresponding complementary gripping element (233) on said needle shield (230). In non-limiting embodiments or aspects, after said syringe (200) is pushed proximally, said syringe flange (240) is spaced longitudinally from said ring (320) of the lower body (300) assembly. At the end of this step, said at least one gripping element (125) is engaged with said at least one supplementary element (233) for gripping said protective cap (230) for the needle, said distal end (120) of the latch (110) is on a distance in the longitudinal direction from the specified distal end (160) of the device (150) for removing the cap, and the specified flange (240) of the syringe is at a distance in the longitudinal direction from the specified ring (320).

[0057] In non-limiting embodiments or aspects, said method includes a fourth step of placing an upper housing assembly (not shown) comprising an upper housing on said lower housing assembly. As with the lower case and lower case assembly, the upper case and upper case assembly may be formed from any suitable material, including, but not limited to, rigid plastic. In non-limiting embodiments or aspects, the step of placing said upper body assembly on said lower body assembly causes said syringe to move distally such that said syringe flange (240) rests against said ring (320).

[0058] Considering FIG. 9, after assembly, the distal end (120) of the retainer (110) falls or is otherwise displaced towards said distal end (160) of the cap removal device (150) such that said distal end (120) of the retainer (110) is adjacent to said distal end (120) of the retainer (110). end (160) of the device (150) for removing the cap.

[0059] Desiring to remove said needle shield, the end user pulls on the cap remover. As described above, the gap between said at least one protrusion (112) of the latch (110) and at least one arm (152) of the device (150) for removing the cap causes a delay between the start of the longitudinal movement of the device (150) for removing cap away from the specified lower housing (300) assembly and the beginning of the longitudinal movement of the specified retainer (110) away from the specified lower housing (300) assembly.

[0060] With reference to FIG. 10, in non-limiting embodiments or aspects, said cap (100) assembly serves to prevent actuation of a drug delivery device, such as a pen, to which said cap (100) assembly is attached. Considering FIG. 12 depicts one non-limiting embodiment or aspect of a pen with which the present device can be used. The pen (500) includes a lower housing assembly or lower housing assembly (300) as previously described, an upper housing assembly (400), a cap remover (150), and a latch (110). Said lower housing unit includes a housing (310) and a cover (330) for the needle. In non-limiting embodiments or aspects depicted in FIG. 10-12, the needle cover (330) is configured to shield said needle (220) of the syringe (200) from the user when, for example, the removable needle shield (230) has been removed. Needle cover (330) is movable from an extended position (pre-use position) to a retracted position (use position) when said needle cover (330) proximally passes into the lower housing (300) assembly, and into a second extended position (position after use). In both extended positions (before and after use), said needle cover (330) at least partially encloses said needle (220). In the position of use, said needle cover (330) does not enclose said needle that can be inserted into the user's skin.

[0061] In non-limiting embodiments or aspects depicted in FIG. 10-12, in order to use the pen (500), the user removes said cap (100) assembly as described above (and below) and applies said distal end of the pen (500) to the skin at the intended injection site. . The needle cap (330) is positioned at the distal end of said pen and thus comes into contact with the user's skin. Applying force to said pen (500) towards the skin causes said needle cover (330) to move proximally inside said body (310) of the lower body block. In non-limiting embodiments or aspects, movement of said needle cap (330) in a proximal direction enables drug delivery, for example, through interaction of said needle cap (330) with a container holder (not shown). In particular, in non-limiting embodiments or aspects, proximal movement of said needle cover (330) causes said needle cover (330), from its proximal end (335), to contact a container holder provided in said upper housing block (400). , whereby said container holder is forced to move in the proximal direction. Said container holder may have at least one window (not shown) that allows spring-loaded locking elements (not shown) that hold the syringe plunger (not shown) of the pen (500) in position prior to use due to the preload force of the injection spring ( not shown), to move radially to a non-spring position. Said radial movement of said locking elements releases said syringe plunger, which is forced out of said container holder by said injection spring, which shifts the piston rod (not shown) in the syringe barrel (210), causing drug injection through said needle (220).

[0062] As can be understood from the above embodiment or aspect, proximal movement of said needle cap (330) may cause said pen (500) to unintentionally fire. Accordingly, as shown in FIG. 10 and 11, in non-limiting embodiments or aspects, a block is provided for a drug delivery device such as a pen. The specified block includes a body (310), a cover (330) for a needle and a cap (100) assembly, including a retainer (110) and a device (150) for removing the cap. In non-limiting embodiments or aspects, said latch (110) prevents inadvertent proximal movement of said needle cover (330) and thus inadvertent actuation of the drug delivery device of which said block is a component. In non-limiting embodiments or aspects, said retainer (110) comprises at least one protrusion, such as an inwardly facing protrusion (136). In non-limiting embodiments or aspects, said at least one inwardly extending protrusion (136) is located on the same proximally extending stem as at least one radially extending protrusion (135).

[0063] Further, considering FIG. 10 and 11, in non-limiting embodiments or aspects, said needle cover (330) comprises, at its distal end, a lip or flange (340) projecting outward. In non-limiting embodiments or aspects, an inward-facing lug (136) on the latch (110) is positioned proximal to said edge or flange (340) of the needle cover (330) preventing said needle cover (330) from moving proximal enough to actuation of said pen (500). In non-limiting embodiments or aspects, the inwardly facing projection (136) engages with or abuts said edge or flange (340) of said needle cover (330) substantially or completely preventing said needle cover (330) from proximal movement.

[0064] In FIG. 10 shows a non-limiting embodiment or aspect in which a lip or flange (340) is located on the outer surface of the needle cap (330) and the lip (136) is an inwardly facing lip configured to engage with said lip or flange (340) . In non-limiting embodiments or aspects (not shown), said protrusion is an outward-facing protrusion and is located on a stem that extends proximally from said distal end of said retainer (110) through an interior space defined by a needle cap (330) and is configured to engage with said edge or flange located on the inner surface of said needle cover.

[0065] With reference to FIG. 11 depicts the above assembly process, with particular attention paid to the interaction between said at least one inward-facing protrusion (136) and the edge or flange (340) of said needle cover (330), as well as said at least one a protrusion (135) extending radially and at least one opening (170).

[0066] FIG. 11A and 11B illustrate a needle cover (330) (graphically isolated from the rest of the lower body (300) assembly) having a lip or flange (340) and a cap assembly including a cap remover and retainer prior to placement. of the specified needle cap inside the specified cap assembly.

[0067] In FIG. 11C and 11D depict the initial stage of assembly when said cap assembly is first fitted to the needle cover. Said at least one protrusion (135) extending radially of said latch is configured to deviate outward due to its longitudinal location relative to said at least one hole (170). The edge or flange (340) of said needle cover engages with a proximal-facing surface of said at least one inward-facing protrusion (136).

[0068] FIG. 11E and 11F illustrate the next step in said assembly process. The edge or flange (340) has begun to move distally past said at least one protrusion (136) facing inward. In non-limiting embodiments or aspects, when said at least one inward-facing protrusion (136) is located on at least one leg of said retainer, said leg(s) may flex outward. as said edge or flange (340) passes by said at least one projection (136), allowing said needle cover to move distally past the projection(s) (136).

[0069] Further, considering FIG. 11, Fig. 11G and 11H illustrate the next step of said assembly process when said lip or flange (340) has passed distally past said at least one inwardly facing projection (136). In non-limiting embodiments or aspects in which said at least one inward-facing protrusion (136) can flex outward to allow the lip or flange (340) to pass distally, said leg(s) has returned to a non-spring state. .

[0070] As previously described, after said lower housing (310) is assembled on said needle cover and cap assembly, said retainer moves distally (FIGS. 11I and 11J). Considering the design of the assembly of said lower body (310), said protrusions (135) are unable to move so that they align with said holes (170). As a result, said legs, including the protrusions (135), are not allowed to bend outward until the cap (100) assembly is assembled on said lower body (300) assembly. Therefore, said inward-facing projections (136) are held in engagement with said flange (340) of the needle cover (330). This engagement prevents proximal movement of said needle cover (330), which, as described above, prevents said pen from being triggered. In this way, unintentional operation of said device can be avoided.

[0071] In order to be able to use said pen, the user must first remove said cap (100) assembly. To do this, he/she pulls said cap removal device (150) away from said lower body (310). Due to the axial clearance between said retainer (110) and cap remover (150), said cap remover (150) moves relative to said retainer (110) so that said at least one protrusion (135) again aligns with said at least one opening (170), thereby allowing said latch leg (110) to swing outward and disengage said inward-facing lug (136) and said needle cover (330) flange (340). This allows said lock (110) and needle cover (330) to disengage. Then, said needle cover (330) is free to move in the proximal direction to initiate the injection.

[0072] Although the present invention has been described in detail for the purpose of illustration based on what is currently considered the most practical and preferred embodiments, it should be understood that such detailed information is for the stated purpose only and that the present invention is not limited to the disclosed embodiments, rather, it is intended to cover modifications and equivalent solutions that are within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment of the present invention.

Claims (14)

1. A block for preventing unintentional operation of a drug delivery device, comprising: housing (310); a displaceable needle cover (330) having a distal end with a flange (340), wherein said needle cover (330) is placed inside said body (310) and configured to have a position prior to use in which said needle cover (330) extends from said body (310), and a use position in which said needle cover (330) is at least partially offset into said body (310), in which displacement of said needle cover (330) into said body (310) results in actuating said drug delivery device by interacting with the drive mechanism; and cap (100) assembly, containing: a device (150) for removing the cap, made with the possibility of capture by the user; and a retainer (110) placed inside said cap removal device (150), wherein the retainer (110) comprises at least one inward-facing protrusion (136) located radially outward relative to said flange and configured to engage with said flange (340) said cap (330) for the drug delivery device needle, wherein the location of at least one inwardly facing projection (136) relative to said flange (340) is configured to prevent said needle cover (330) from moving to said use position, and in which the specified latch contains at least one protrusion (135) extending in the radial direction, and the specified device (150) for removing the cap contains at least one hole (170) in its side wall, and said at least one protrusion (135) extending in the radial direction is configured to deviate radially outward when said at least one protrusion (135) extending in the radial direction aligns with at least one hole (170) in the specified device (150) to remove the cap. 2. An assembly according to claim 1, wherein said flange (340) is located on the outer surface of said needle cap (330). 3. Block according to any one of paragraphs. 1, 2, wherein said inwardly facing projection (136) abuts said flange (340) at its proximal end. 4. Block according to claim. 1, in which the specified latch (110) is configured to switch relative to the specified device (150) to remove the cap from the first position in which the specified at least one protrusion (135) extending in the radial direction, not is aligned with at least one opening (170) in said cap removal device (150) and cannot deviate radially outward to a second position in which said at least one protrusion (135) extending in the radial direction aligns with by at least one opening (170) in said cap removal device (150), so that said at least one protrusion (135) extending in the radial direction is able to deviate radially outward. 5. Device (500) for drug delivery, including: a block for a device for drug delivery according to claim 1, further including a syringe (200) having a needle (220) and at least partially placed inside the specified housing (310), in which, in the position of use, the specified needle (220) is located at least partially outside the specified cover (330) for the needle, in which, in the position of use, the specified cover (330) for the needle is configured to drive the specified device for drug delivery for drug delivery. 6. The device for drug delivery according to claim 5, in which the specified latch (110) is configured to switch relative to the specified device (150) to remove the cap from the first position, in which the specified at least one protrusion (135) extending into direction, is not aligned with said at least one opening (170) in said cap removal device (150) and cannot deviate radially outward to a second position in which said at least one protrusion (135) extending into in the radial direction, aligns with said at least one opening (170) in said cap removal device (150), so that said at least one protrusion (135) extending in the radial direction is able to deviate radially outward.

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