US20180043108A1 - Automatic injector with needle cover - Google Patents

Abstract

An auto-injector automatically dispenses a predetermined dose of medicament upon activation. The auto-injector includes a needle cover operative to engage an injection site and activate the injector. The needle cover is configured to move from a locked retracted position prior to a medicament dispensing operation to a locked extended position after the medicament dispensing operation. The non-removable needle cover prevents contact with the needle both before and after the medicament dispensing operation.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This is a continuation of U.S. patent application Ser. No. 12/258,754, filed Oct. 27, 2008, now U.S. Pat. No. 8,048,035, which is a continuation-in-part of U.S. patent application Ser. No. 11/095,664, filed Apr. 1, 2005, now U.S. Pat. No. 7,449,012, which claims the benefit of U.S. Provisional Application No. 60/599,054, filed Aug. 6, 2004, the entire contents of each are expressly incorporated herein by reference thereto.
FIELD OF THE INVENTION
• The invention relates to an automatic injector or auto-injector for delivering medicament to an injection site. In particular, the invention is directed to an auto-injector having a needle cover mechanism to prevent a user from coming into contact with the needle of the auto-injector after use. The needle cover mechanism is held in a locked position prior to activation of the auto-injector. After injection, the needle cover mechanism is held in a locked deployed position such that the user cannot access the needle.
• The invention is also directed to an auto-injector having a power pack containing a one-piece molded collet. The molded collet reduces the overall number of manufactured components while increasing versatility. The molded collet can be used with cartridges of varying sizes, different sized needles and can be used to vary the amount of the delivered dosage of medicament.
BACKGROUND OF THE INVENTION
• An automatic injector or auto-injector is a device designed to allow a user to self-administer a pre-measured dose of a medicament composition subcutaneously or intramuscularly, usually in an emergency situation. Automatic injectors are used, for example, to treat anaphylactic (severe allergic) reactions and to administer antidotes for certain poisons, such as chemical nerve agents and various drug compositions such as diazepan.
• A typical auto-injector has a housing, inside of which is a cartridge. The cartridge has one or several chambers containing medicament compositions or components thereof and is adapted to be attached to a needle assembly. The cartridge can hold either a pre-mixed liquid medicament or a solid medicament and a liquid that are mixed prior to injection. The housing carries an actuation assembly with a stored energy source, for example, a compressed spring. Activation of the actuation assembly causes a sequence of movements, whereby the needle extends from the auto-injector into the user so that the medicament compound is then forced through the needle and into the user. After delivery of the dose of medicament into the injection site, the needle remains in an extended position. If the auto-injector is of the type designed to carry plural components of the medicament composition in separate, sealed compartments, structure may be included that forces the components to mix when the actuation assembly is activated.
• There is a need for an auto-injector having a cover that provides adequate protection from the needle both prior to and after operation of the auto-injector. U.S. Pat. No. 5,295,965 to Wilmot et al. discloses an external cover member providing sharps protection for an auto-injector after use. The cover member is deployed after actuation of the auto-injector such that the user does not view the needle after use. The position of the cover member with respect to the auto-injector body is offset after use such that the needle cannot be redeployed through an opening in the needle cover.
• U.S. Pat. No. 6,767,336 to Kaplan discloses a cover for an auto-injector. In an effort to reduce components, Kaplan eliminates an outer housing for the auto-injector. The cover is secured to the exterior of the cartridge holder sleeve. The cartridge holder sleeve includes several Mots, which are sized to receive a latch on the cover. When the auto-injector is actuated, the cartridge within the cartridge holder sleeve causes the latch to be released from the reams such that the cover is free to travel under the bias of the spring. Since the cover disclosed by Kaplan is located on the exterior of the cartridge holder sleeve, it is possible for the user to grip the cover during operation of the auto-injector. As such, the user may prevent the latches from being released from the respective slots, which could prevent the cover from being properly deployed. This could impede the movement of the cartridge within the cartridge holder sleeve, which could result in the medicament being dispensed through the needle prior to the needle reaching the injection site. To overcome these deficiencies, higher trigger forces would be necessary. When the latches are released during the deployment of the cover, the latches are biased outwardly. It is possible for the user to be, pinched or otherwise injured by this deployment.
• If the cover deploys prior to delivery of the drug, a potentially life threatening event may arise because the user may not receive the proper dose of medicament. There is a need for a secured cover such that it cannot be displaced prior to use of the auto-injector. There, is also a need for a cover that does not impede or adversely impact the operation of the auto-injector in the event it is contacted by the user. It is also desirable that the cover be locked in an extended position after use of the auto-injector so that the needle is not exposed such that a person cannot be accidentally pricked by the needle. It is also desirable to, have a cover member having locking and deployment mechanisms that are protected against contact from the operator to prevent improper deployment of the cover.
SUMMARY OF THE INVENTION
• One aspect of the present invention relates t an auto-injector for dispensing a predetermined dosage of a medicament. The medicament may be either self administered or administered by a caregiver. The auto-injector includes a housing. The housing is preferably oval or elliptical in shape such that it is more ergonomic. The oval shape prevents the auto-injector from rolling off a table or flat surface, while providing a larger surface area for printing user instructions. A cartridge container is disposed within the housing. A cartridge is received within the cartridge container. The cartridge has at least one opening therein and contains a medicament. The medicament is rearwardly confined by a plunger. The cartridge includes a needle assembly to dispense the medicament therethrough. The cartridge is advanced within the cartridge container from a stored position to an operation position where the needle extends from the cartridge container such that the dose of medicament can be administered. An actuation assembly or power pack provides a stored energy source that is capable of being released to drive the plunger within the cartridge to dispense the medicament through the needle assembly into the user and, allowing the needle to be accessible on activation.
• Another aspect of the auto-injector is the provision of a needle cover received within the housing. The needle cover shields the user from inadvertent exposure to the needle after use of the auto-injector providing sharps protection, Theoretically, the operation of the needle cover is fail safe because the cover will not deploy until after the needle penetrates the user. During operation, the needle of the cartridge extends through an opening in the needle cover to permit the dispensing of a dose of medicament. After use of the auto-injector, the needle cover is held in a locked position to prevent the cover from being retracted to expose the needle. According to another aspect of the invention, the needle cover has a locked retracted position prior to activation of the auto-injector, thus maintaining a compact configuration of the device prior to use. According to another aspect of the invention, the actuation forces associated with the auto-injector are not imparted on the needle cover.
• In accordance with another aspect of the present invention, the auto-injector has a first locking assembly that holds the needle cover in the first locked position. The first locking assembly may be located on the cartridge co tamer. The first locking assembly may include at least one locking tooth pivotally connected to the cartridge container or the needle cover. Each locking tooth release engages the needle cover and includes a locking surface constructed and arranged to co taco a surface on the needle cover or the cartridge container. Each locking tooth may be formed as a separate component that is connected to the container or cover. It is contemplated that the locking teeth may be formed as integral parts of the needle cover or cartridge. A spring force of the locking tooth biases the locking surface into contact with the needle cover. The spring force may be provided by a spring portion of the locking tooth. The spring forte may also be provided by a separate spring assembly biasing the locking surface into contact with the needle cover. Each locking tooth is preferably pivotally connected to the cartridge container. Each locking tooth pivots in response to movement of the cartridge within the cartridge container. It is also contemplated that the locking teeth can pivot m response to movement of the collet or the power pack. Typically, the locking surface pivots out of contact with the needle cover when the locking tooth pivots in response to the movement of the cartridge. The spring force and the force exerted by the locking teeth on the cartridge are controlled such that they negligibly or minimally impede the motion of the cartridge during the injection operation to avoid any premature rupturing of the diaphragm within the cartridge and premature administering of the medicament.
• The needle cover is spring biased so that the cover is biased outwardly from the housing to cover the exposed needle after the first locking assembly is released. In accordance with another aspect of the present invention, the auto-injector has a second locking assembly that holds the needle cover in the second locked position. The second locking assembly may be located on the cartridge container, the outer body or the cover member. The second locking assembly may include at least one locking arm or wing preferably connected to the cartridge container. Each locking arm is spaced from the cartridge container such that the locking arm can be temporarily compressed against the cartridge container as the needle cover moves from the first locked position to the second locked position. Each locking arm has a locking surface to engage the needle cover when the needle cover is in the locked extended position. Each locking arm has a thick strut portion and a thin strut portion, wherein the thick strut portion is outwardly curved and the thin strut portion is inwardly curved. This construction maintains the locking arm in a normal uncompressed state to reduce stress on the cartridge container. This also permits a smooth deployment of the cover member. Furthermore, this arrangement ensures that the thick strut portion will buckle into a stable condition. This creates a stronger lock to prevent the cover member from being moved rearwardly to a retracted position. The inwardly curved nature of the thin strut portion allows the thick portion to buckle in a controlled manner to a stable condition. Additionally, the outwardly curved shape of the thick strut portion provides for fail safe locking of the cover member in the extended position. In the event that the thin strut breaks, the thick strut portion will still engage the cover member to maintain it in an extended locked position.
• The cartridge container may further include at least one ledge extending outwardly therefrom. Each ledge is constructed and arranged to engage an edge of an opening in the needle cover to limit the travel of the needle cover with the respect to the cartridge container when the needle cover is in the extended position. When the ledge on the cartridge container engages the edge of the opening, the outward travel of the needle cover is limited. The second locking assembly limits the inward travel of the needle cover. The needle cover and the cartridge container contain openings formed therein. When the openings are aligned prior to activation of the auto-injector, user can view the contents of the cartridge through the housing and the openings. The housing may be transparent or opaque. When opaque, the housing may contain an opening that can be aligned with the openings in the needle cover and cartridge container so that the color of the medicament may be checked to determine whether or not the medicament is suitable for injection. If the medicament is discolored, the user will know not to administer the medicament. When the openings are not aligned after operation of the auto-injector, the user is no longer able to view the contents of the cartridge through the openings providing a visual indication to the user that the auto-injector has been used.
• Another aspect of the present invention is the construction and arrangement of the actuation assembly or power pack, which is mounted within the housing adjacent to an open end. A release pin or safe pin is removably attached to the actuation assembly to prevent inadvertent actuation of the auto-injector when the release pin is in place. A pin or stem on the release pin is received within an opening in the actuation assembly to prevent actuation of the auto-injector. This opening in the power pack is spaced from the open end of the housing such that the opening is less visible to a user prior to administering the drug. This arrangement is provided so that user will not orient the incorrect end of the auto-injector against the injection surface of the user. The power pack is recessed or spaced from the end of the housing, which provides an indication to the user that pressing the power pack will not operate the auto-injector. The recessed nature of the power pack serves to hide the release pin hole in the power pack when the user is viewing the instructions on the outer body such that the user does not confuse the release pin hole with the opening through which the needle passes for administering the medicament. The release pin includes at least one tab extending therefrom. The tab is compression fit into a complimentary recess formed in the actuation assembly to prevent the inadvertent removal of the release pin. The tabs also prevent rotation of the release pin such that the user easily recognizes that the release pin must be pulled in order to be removed.
• The actuation assembly includes an outer body, which is configured to engage the release pin. The outer body is constructed to be connected to the housing. An inner body is operatively coupled to the outer body. At least one retention tab on the inner body secures the inner body to the outer body. The inner body is capable of limited movement with respect to the outer body. A collet is operatively coupled to the inner body. An energy source is operatively connected to the inner body and the collet. Unlike conventional collets, the collet in the present invention is molded as a single piece, No spacers or other components are provided between the collet and the plunger in the cartridge. This arrangement simplifies construction. Different sized collets can be produced and installed into the actuation assembly, such that only the collet needs to altered when different sized cartridges are used or a different sized dosage of medicament is to be administered.
BRIEF DESCRIPTION OF THE DRAWINGS
• An understanding of the various embodiments of the invention may be gained by virtue of the following figures, of which like elements in various figures will have common reference numbers, and wherein:
• FIG. 1 is a side cross sectional view of the auto-injector according to an embodiment of the present invention;
• FIG. 2 is a side cross sectional view of the auto-injector ofFIG. 1 in an unactivated state having the release pin in place;
• FIG. 3 is a side schematic view of the auto-injector in the unactivated state ofFIG. 2;
• FIG. 4 is a side cross sectional view of the auto-injector ofFIG. 1 having the release pin removed in preparation for activation;
• FIG. 5 is a side cross sectional view of the auto-injector ofFIG. 1 wherein the needle cover spring is in a compressed state;
• FIG. 6 is a side schematic view of the auto-injector ofFIG. 5;
• FIG. 7 is a side cross sectional view of the auto-injector in an actuated state with the needle in a drug delivery position;
• FIG. 8 is a side schematic view of the auto-injector ofFIG. 7;
• FIG. 9 is a side cross sectional view of the auto-injector following delivery of the drug wherein the needle cover is in an extended protective state;
• FIG. 10 is an enlarged view of the locking wings of the cartridge container when the needle cover is in the extended protective state, as shown inFIGS. 9 and 11;
• FIG. 11 is a side schematic view of the auto-injector ofFIG. 9;
• FIG. 12 is a left front schematic view of the auto-injector ofFIG. 1 having the outer body removed wherein the needle cover is located in a retracted position prior to activation of the auto-injector;
• FIG. 13 is an enlarged view ofFIG. 12 illustrating the position of the locking wings of the cartridge container and the locking teeth;
• FIG. 14 is a left front schematic view of the auto-injector ofFIG. 1 having the outer body removed when the needle cover is located in an extended protective position after use of the auto-injector;
• FIG. 15 is an enlarged view ofFIG. 14 illustrating the position of the locking wings of the cartridge container and the locking teeth;
• FIG. 16 is an enlarged cross sectional view illustrating the position of the locking teeth when the needle cover is in the extended protective position;
• FIG. 17 is a left rear perspective view of the power pack outer body for the power pack for the auto-injector according to the present invention;
• FIG. 18 is a side perspective view of the collet for the power pack for the auto-injector according to the present invention;
• FIG. 19 is a right front perspective view of the power pack inner body for the power pack for the auto-injector according to the present invention;
• FIG. 20 is a side perspective view of the spring assembly for the power pack for the auto-injector according to the present invention;
• FIG. 21 is a left bottom perspective view of the release pin for the auto-injector according to the present invention;
• FIG. 22 is a right bottom perspective view of the power pack of the auto-injector in an assembled state;
• FIG. 23 is a side cross sectional view of the power pack ofFIG. 22;
• FIG. 24 is a top left perspective view of the power pack ofFIG. 22 having the top portion of the release pin and a peripheral rib of the power pack outer body removed;
• FIG. 25 is a top left perspective view of the power pack ofFIG. 22;
• FIG. 26 is a top left perspective view of the power pack positioned within the outer body having the safe pin removed;
• FIG. 27 is left side perspective view of the power pack outer body
• FIG. 28 is a partial cross sectional perspective view illustrating the interior of the power pack outer body;
• FIG. 29 is a partial cross sectional perspective view illustrating the interior of the power pack inner body;
• FIG. 30 is side perspective view of the power pack inner body;
• FIG. 31 is a bottom perspective view of the power pack inner body;
• FIG. 32 is a side view of the release pin;
• FIG. 33 is another side view of the release pin ofFIG. 32 rotated 900 about an axis;
• FIG. 34 is a bottom perspective view of the safe pin ofFIG. 32;
• FIG. 35 is a side view of the collet of the power pack;
• FIG. 36 is another side view of the collet ofFIG. 35 rotated 90° about an axis;
• FIG. 37 is an enlarged end view of the collet illustrating the stabilizing arch;
• FIG. 38 is side perspective view of the needle cover located within the outer body of the auto-injector;
• FIG. 39 is a cross sectional view of the cartridge container and needle cover located within the outer body with the power pack removed prior to final assembly of the auto-injector;
• FIG. 40 is a cross sectional view of the cartridge container and needle cover located within the outer body ofFIG. 39 rotated 90° about an axis with the power pack removed prior to final assembly of the auto-injector;
• FIG. 41 is a front left side perspective view of the cartridge container of the auto-injector;
• FIG. 42 is a perspective view of the needle cover spring;
• FIG. 43 is a front left side perspective view of the needle cover of the auto-injector;
• FIG. 44 is a front left side perspective view of the outer body of the auto-injector;
• FIG. 45 is another left side perspective view of the outer body ofFIG. 44;
• FIG. 46 is a partial cross sectional perspective view illustrating the interior of the outer body;
• FIG. 47 is a side view of the outer body;
• FIG. 48 is another side view of the outer body ofFIG. 47 rotated 90° about an axis;
• FIG. 49 is a right rear side perspective view of the cartridge container of the auto-injector;
• FIG. 50 is a side view of the cartridge container;
• FIG. 51 is another side view of the cartridge container ofFIG. 51 rotated 90° about an axis;
• FIG. 52 is an enlarged side view of the cartridge container illustrated inFIG. 51, wherein the dotted lines illustrate the deflection path of the locking wings;
• FIG. 53 is a right rear perspective view of the needle cover of the auto-injector;
• FIG. 54 is a side view of the needle cover ofFIG. 53;
• FIG. 55 is a perspective view of the needle cover spring;
• FIG. 56 is a right top perspective view of a locking tooth of the auto-injector according to the invention;
• FIG. 57 is a left bottom perspective view of the locking tooth ofFIG. 55;
• FIG. 58 is a side view of the locking tooth;
• FIG. 59 is a top view of the locking tooth;
• FIG. 60 is a side view of an auto-injector prior to use with user-friendly labeling according to the invention; and
• FIG. 61 is a side view of the auto-injector ofFIG. 60 after use.
DETAILED DESCRIPTION OF THE INVENTION
• It should be appreciated that some of the components described herein are conventionally known in the broader aspects, as described in U.S. Pat. No. 4,031,893 (“the '893 patent”) hereby incorporated by reference in its entirety, and thus not described in unnecessary detail here. It should also be appreciated that known modifications or variations to the '893 patent can apply equally to the auto-injector of the present invention as will be described below. These modifications or variations include embodiments described in U.S. Pat. Nos. 4,226,235; 4,329,988; 4,394,863; 4,723,937; and U.S. Ser. Nos. 09/985,466; 10/285,692, each of which is incorporated by reference in its entirety for the full teachings therein.
• An auto-injector100 of the present invention will now be described in greater detail in connection withFIGS. 1-59. The auto-injector100 includes anouter body110, arelease pin120, apower pack130, acartridge container140, aneedle cover150 and acartridge160 housing a dose of medicament. The dose can be stored in liquid or solid form or as a combination of a liquid and a solid that is mixed prior to injection.
• The auto-injector100 includes anouter body110 shown inFIGS. 38 and 44-48. Theouter body110 has a generally oval or elliptical shape, which is more ergonomic sized to permit easy grasping and use by the user or caregiver in comparison with a cylindrical body. The generally oval shape of theouter body110 prevents the auto-injector100 from inadvertently rolling or sliding off a flat surface. Furthermore, the oval shape provides a larger print surface for labeling the auto-injector100 with instructions. Theouter body110 is preferably formed from a synthetic material such that it can be easily molded. Theouter body110 can be transparent such that the interior components can be easily viewed through theouter body110. With such a construction, the user can view the contents of thecartridge160 throughwindows141aand141bin thecartridge container140 and theneedle cover150 at predetermined times. It is also contemplated that theouter body110 can be opaque such that the interior components are not visible through theouter body110. It is also contemplated that theouter body110 has a window or windows that permit viewing of the components within theouter body110, Theouter body110 has anopening111 formed in one end that is sized to receive arelease pin120. When in place, therelease pin120 prevents inadvertent use or activation of the auto-injector100. Therelease pin120 is illustrated inFIGS. 32-34. It is contemplated that operating instructions may be printed directly onto theouter body110. It is also contemplated that a label may be affixed to theouter body110, which may increase the rigidity of theouter body110. When theouter body110 includes one or more apertures, the provision of a label increases the strength of theouter body110, which makes the provision of additional structural reinforcements unnecessary.
• Theopening111 includes side recesses111aand111b, which extend downwardly along opposing sides of theouter body110, shown inFIGS. 45, 46 and 48. While two recesses are shown, it is contemplated that a single recess may be provided or more than two may be provided. The number of recesses will correspond to the number of tabs. Therecesses111aand111bare sized so that they may receive downwardly extendingtabs121aand121bon therelease pin120. Thetabs121aand121bprevent rotation of therelease pin120 such that the user easily recognizes that therelease pin120 is to be pulled rather than rotated to permit removal of therelease pin120 in order to actuate the auto-injector100. Thetabs121aand121bare primarily received in retention recesses235 located on opposing sides of thepower pack130, described in greater detail below. Therecesses111aand111bprovide access to the tabs121 in therecesses235. Thetabs121aand121bare compression fit onto thepower pack130 to prevent inadvertent removal. To release thepin120, the operator compresses or pinches the tabs121 to dislodge the edges of the tabs121 from therecesses235 such that thepin120 can then be pulled/removed from thepower pack130. As shown, the tabs121 have a curvature which creates a chamfered edge that engages the edges of therecesses235. The shape of the tabs121 and therecesses235 are full complimentary, which creates the friction or compressive retaining force between thepin120 andpower pack130. Therelease pin120 also includes downwardly projectingribs122aand122b, which are adapted to be received on the top surface of thepower pack130. Theribs122aand122bincrease the stability and rigidity of therelease pin120. It is contemplated that additional ribs may be provided. Therelease pin120 includes an outwardly facingflat end123 having aperipheral ledge124. Theperipheral ledge124 permits grasping of therelease pin120 by the user. Theledge124 is sized to rest on the end surface of theouter body110adjacent opening111. Therelease pin120 includes a downwardly extendingpin125, which engages thecollet430 of thepower pack130. When secured in place (i.e., prior to removal of therelease pin120 and prior to actuation of the auto-injector100), thepin125 prevents the end of thecollet430 from compressing, which prevents actuation of the auto-injector100. Theend123 has a shape corresponding to the oval/elliptical shape of theouter body110.
• As shown inFIG. 46, the inner surface of theouter body110 is contoured to receive thepower pack130, acartridge container140 and a needle cover therein150. Unlike many prior art needle covers, theneedle cover150 is positioned between thecontainer140 and theouter body110 such that the user does not contact thecover150 during the operation, which could impede the deployment of the cover or cause a diaphragm within the cartridge to rupture prematurely. Additionally, the mechanisms for locking and deploying the cover member are located within theouter body110 and are thus protected against tampering and dirt ingress. Theouter body110 includes a cartridgecontainer retention step112 formed on the inner surface near the end of theouter body110 adjacent theopening111. Aledge142 of thecartridge container140 abuts theretention step112 to limit the downward movement of thecartridge container140 within theouter body110 once the auto-injector100 has been assembled such that the container can not be moved out ofopening114. A plurality of powerpack retention openings113a,113band113care formed on at least one side of theouter body110. Projections orteeth238 on thepower pack130 are snap fit into theopenings113. This snap fit prevents the removal of thepower pack130 from theouter body110 once installed in theouter body110. The power packouter body230 is not movable with respect to theouter body110. Theledge142 of thecartridge container140 is sandwiched between theretention step112 and thepower pack130.
• Anopening114 is formed in theouter body110 on an end opposite theopening111. Theopening114 is configured such that a portion of thecartridge container140, a portion of theneedle cover150 can extend therefrom. Thestep112 limits the travel of thecontainer140 throughopening114. The end of theouter body110 is intended to be orientated adjacent the injection surface of the user such that end portion of thecover100 contacts the injection surface.
• Thepower pack130 will now be described in greater detail in connection withFIGS. 17-20, 22-31 and 35-37. Thepower pack130 includes a power packouter body230, a power packinner body330, acollet430, and a powerpack spring assembly530. The activation force necessary to release the energy stored in the power pack is between 4 to 8 pounds. The activation force is the force required to release thecollet430 from theinner body330 when the auto-injector100 is pressed against the injection surface. The injection force provided by thespring assembly530 is approximately 30 pounds. The injection force must be sufficient such that thecartridge160 is advanced within thecartridge container140 to drive the needle such that it pierces the sheath to permit injection of the medicament into the user. The power packouter body230 is a generally cylindrical elongatedhollow body231. A plurality of outerperipheral ribs232a,232band232cextend outwardly from an outer surface of thehollow body231. While these ribs232 are shown, it is contemplated additional ribs may be provided. The ribs232 are provided to prevent distortion of theouter body110 of the auto-injector100. A plurality of outerlongitudinal ribs233a,233bare spaced about the outer surface of thehollow body231, The ribs233 cooperate with the ribs232 to further strengthen the auto-injector100 and prevent distortion of theouter body110 when gripped and used by a user.
• One of theperipheral ribs232aforms atop end surface237 of the power packouter body230. Ahole234 is provided in end surface which is sized to receive the downwardly extendingpin125 of therelease pin120. Retention recesses235aand235bare formed on opposing sides of thehollow body231 adjacent the top end surface. Therecesses235aand235bare formed bywalls236aand236bwhich extend outwardly from thehollow body231 and upwardly from thetop end surface237 of theperipheral rib232a. Therecesses235aand235bare aligned with the side recesses111aand111bof theouter body110 such that when therelease pin120 is secured to the auto-injector100, thetabs121aand121bare received in bothrecesses235aand235b. Therecesses235aand235bare sized to apply a compressive force on thetabs121aand121bto secure therelease pin120 in place to prevent inadvertent removal.
• As shown inFIGS. 17, 26 and 27, thewalls236aand236bextend upwardly from theend surface237 of theperipheral rib232a. With such an arrangement, theend surface237 is spaced or recessed below the end surface of theouter body110, as shown inFIG. 26, forming arecess115. Therecess115 reduces and/or avoids the visual effect of a push button. As such, the user will not be inclined to press theend surface237 to administer the medicament. Additionally, it provides a visual indication to the user that therecess115 is located at the inoperative end of the auto-injector100 such that the user is inclined to place thecover150 against the injector surface not the opposite end of the auto-injector. Therecess115 also serves to space thehole234 from the end of the auto-injector100 to deemphasize the presence of thehole234 such that it is hidden when the user reads the label on theouter body110. As such, the user is disinclined to position thehole234 adjacent the injection site. This arrangement is just one countermeasure provided to insure against improper use of the auto-injector100. Theribs122aand122bof therelease pin120 are received within therecess115.
• A plurality of projections orteeth233a,238b,238care formed on the outer surface of thehollow body231. Theteeth238,238b,238care sized to be snap fit into theopenings113a,113b,113cto secure thepower pack130 within theouter body110. This construction permits thesecomponents110 and130 to be secured together without the need of an adhesive of other form of bonding, A corresponding set ofteeth238 may be provided on the opposite side of thehollow body230 to match the corresponding openings in theouter body110.
• The interior of thehollow body231 includes arecess231a, which is sized to receive aretention tab334 on the power packinner body330, Therecess231amay be a groove, which extends about the inner periphery of thehollow body231. Therecess231ais positioned in thehollow body231 near an end opposite theend surface237. As seen inFIGS. 1 and 28, acollet activation structure239 extends into the interior of thehollow body231 from the inner side of theend surface237, Thecollet activation structure239 has a generally cylindrical shape with a slopedcollet activation surface239alocated on a free end. Theactivation surface239ais provided such that when thepin120 is removed and the front end of the injector is forced into an injection site so thatcartridge container140 rearwarwardly moves to engageinner body330, this will rearwardly force the arrowheads434 and particularlyrearward surface489 thereof (seeFIG. 35) into engagement withsurface239ato force the arrowheads434 of thecollet430 together to release thespring assembly530 and thus release the necessary energy to inject the medicament into the user.Ribs239bmay be provided to reinforce thecollet activation structure239. It is contemplated that other means of releasing thecollet430 may be employed. A push button type actuation arrangement may be employed, which is described in greater detail in U.S. Pat. No. 4,031,893 and hereby incorporated in its entirety by reference.
• The power packinner body330 is a generally cylindrical hollowinner body331. The hollowinner body331 has anopening332 formed in one end. Theopening332 has a collet assembly lead-insurface332awhich is used to compress a portion of thecollet assembly430 during assembly of the auto-injector100 such that is can be properly mounted within the power packinner body330. Theopening332 also has acollet retention surface332blocated on an opposite edge which support the opposing arrowheads434 of thecollet430 prior to activation. The hollowinner body331 has anopening333 formed on an opposing end. Spaced from theopening333 are a plurality ofretention tabs334 which are sized to be snapped into theretention recess231a. Therecess231 andtabs334 permit limited movement between the power packinner body330 and the power packouter body230. The arrangement is also beneficial for purposes of assembling the auto-injector100. Theinner body330 and theouter body230 can be preassembled. Therecess231 andtabs334 maintain theinner body330 and theouter body230 in proper alignment for assembly. Furthermore, this arrangement prevents the subassembly of theinner body330 and theouter body230 from separating prior to the final assembly in the auto-injector100. It is also contemplated that other means which permit limited movement between the outer power pack and the inner power pack, which secure the components together may be employed. Aledge335 at least partially extends about the periphery of theopening333. Theledge335 is sized to engage thecartridge container140 and the power packouter body230 at certain times during the operation of the auto-injector100, described in greater detail below. A spacing exists between theinner power pack330 and thecartridge container140 after assembly and prior to activation of the auto-injector100 to create a gap, which avoids permanently putting forces on the power pack and thespring530.
• Acollet430 is received within the hollow interior of the power packinner body330. Thecollet430 preferably is a molded one piece construction. The collect430 has anelongated body431 having anopening432 formed therein which forms a pair ofside arms433aand433b. Eachside arm433aand433bincludes anarrowhead detail434aand434brespectively. One side of eacharrowhead434aand434bis configured to contact and engage thecollet retention surface332b. An opposite side of eacharrowhead434aand434bis configured to engage the collet assembly lead-insurface332a, which permits theside arms433aand433bto be deflected inwardly to permit operation of the auto-injector100. Theend435 of thecollet430 adjacent thearrowheads434aand434bincludes anopening435asized to receive thepin125 of therelease pin120. Thepin125 prevents the side arms433 from being deflected inwardly towards each other. When secured in place, thepin125 prevents activation of the auto-injector100. Theopening432 has an arch432aformed on one end, as shown inFIG. 37. The arch432ahelps stabilize the side arms433 and assist them in springing apart when the arms have been compressed together. The arch432areduces the amount of stress on the collet.
• Thecollet430 is positioned within the powerpack spring assembly530. One end of thespring assembly530 is supported on aflange436 formed on thecollet430. Theflange436 extends outwardly from theelongated body431. While theflange436 supports one end of thespring assembly530, the location of theflange436 on thebody431 can also serve to define the delivered dose volume of medicament injected into the user. In certain applications it is desirable to control the amount of medicament delivered through the needle such that a portion of the medicament remains incartridge160. Theflange436 may limit the distance that thecollet430 can travel into thecartridge160, which contains the liquid medicament. As such, the amount of medicament delivered is controlled. In this arrangement, theflange436 is sized to contact the end of thecartridge160. For larger diameter cartridges and for larger doses of medicament, it is contemplated that theflange436 can travel within thecartridge160. Thecollet430 further includes aprojection437, which receives aplunger438. Theplunger438 is slidably received within thecartridge160. In other applications, it is desirable to dispense all of the medicament from thecontainer160. A small residual amount of medicament remains in theneedle162 and the neck of thecartridge160 adjacent theneedle162. In these applications, theflange436 travels within the interior of thecartridge160 so that theplunger438 travels the length of the interior of thecartridge160 to dispense all of the medicament (except for the residual amounts mentioned above) through theneedle162. It is contemplated that differentsized collets430 may be used in the present auto-injector100. As such, thecollet430 can be changed based upon cartridge size and desired dose.
• Thecollet430 is preferably formed as a single piece from a suitable plastic material. The onepiece collet430 simplifies manufacturing and lowers costs by reducing the number of components needed to form a collet. In conventional collets, multiple brass components may be used. In addition in other auto-injectors, a spacer has been required for use in conjunction with thecollet430 to accommodate different amounts of medicament for different auto-injectors. Thecollet430 in accordance with the present invention eliminates the multi component construction and also advantageously eliminates the need for a spacer. The length of the collet can be selected based upon the desired dosage. This construction further permits the elimination of a metal insert typically found in the plunger and a firing seat above the power pack inner body. It is contemplated that the size and shape of thecollet430 itself may be varied to accommodate differentsized cartridges160. When theflange436 does not contact thecartridge160, it is possible to dispense the entire contents of thecartridge160 except for any residual amounts remaining in the needle or in the neck of thecartridge160. It is contemplated that a nipple plunger, as disclosed in U.S. Pat. No. 5,713,866 to Wilmot, the disclosure of which is hereby incorporated specifically herein by reference, may be employed to prevent any buildup of residual amounts of medicament in the neck of thecartridge160. The position of theflange436 can be varied to control the amount of dosage injected into the user when the flange is positioned such that the collet and theplunger438 travel a greater distance within thecartridge160 before theflange436 contacts thecartridge160, a larger dose is dispensed. The length of thecollet430 and the diameter of thecartridge160 can be selected to control the flow of fluid through theneedle162 of thecartridge160 so that a desired flow rate is obtained. The auto-injector100 in accordance with the present invention is configured such thatcollets430 of varying sizes can be used within the sameouter body110 and thepower pack430.
• An opposite end of thespring assembly530 rests against an inner surface of the power packinner body330 againstopening332.
• Thecartridge container140 will now be described in greater detail in connection withFIGS. 41 and 49-52. Thecartridge container140 has a generally elongatedhollow body141 sized to be received within theouter body110. Aledge142 is formed on one end of theelongated body141. Theledge142 contacts theretention step112 formed on the inner surface of theouter body110. Theledge142 limits the downward movement of thecartridge container140 within theouter body110 such that it cannot be removed throughopening114. Theledge142 is formed byperipheral ribs142 and142b, which extend outwardly similar to theribs232a,232band232con the power packouter body230, Theribs142aand142balso prevent distortion of theouter body110.
• The elongatedhollow body141 has a hollow interior sized to receive thecartridge160 therein. The hollow body has anopening143 such that thecartridge160 can be located in the hollow interior and to permit thecollet430 to be slidably received within thecartridge160. Thecartridge container140 and the lockingteeth340 thereof are designed to accommodate varioussized cartridges160, while maintaining full needle cover functionality. As such, a common design needle cover assembly (including the cartridge container and locking teeth) can be used for various different volumes of drugs and different sized needles. For longer and larger cartridges, it is desirable to provide additional support to prevent axial and radial movement, which could damage or fracture thecartridge160. A pair oftabs600 are formed on thehollow body141 to apply a compressive force on thecartridge160 to hold and align thecartridge160 in a proper orientation to prevent such axial and radial movement. Thetabs600 provide friction to prevent movement of thecartridge160 within thehollow body141 during shock loading to prevent the cartridge from being dislodged or moved forward with thecartridge holder140 prior to the medicament dispensing sequence, Typically, the smaller cartridges do not contact thetabs600. Thecollet430 and the needle and needle sheath provide sufficient support for the cartridge. The end ofhollow body141 has a tapered construction with anopening144 sized to permit the passage therethrough of theneedle162 andprotective sheath165 of thecartridge160. A plurality ofribs145 are formed on the outer surface of thehollow body141 on the tapered end. Theribs145 help stabilize theneedle cover spring153 of theneedle cover150. Theribs145 also serve as guides to aid in the assembly of the auto-injector100.
• The elongatedhollow body141 has at least oneviewing window141aand141bformed therein. Theviewing windows141aand141bpermit the user to view the contents of thecartridge160 before activation of the auto-injector100 to insure that the medicament has not become contaminated or expired.
• A pair of locking arms orwings240 extend from theledge142 and are connected to a mid-portion of thehollow body141, as shown inFIG. 52. Each lockingwing240 has a thickenedstrut241 having a generally curved shape, as shown inFIG. 52. The thickenedstrut241 is curved such that when a compressive load is applied to the locking wing240 (e.g., when a user is attempted to push theneedle cover150 back into theouter body110 after use of the auto-injector100) the thickenedstrut241 bends in the manner illustrated by the dashed lines inFIG. 52. With such a construction, the lockingwings240 are supported by thebody141 of thecartridge container140, which increases the compressive strength of the lockingwings240. While not preferred, it is contemplated that asingle locking wing240 can be provided.
• Athinner strut242 extends from the free end of thestrut241 and is connected to thebody141 of thecartridge container140. A lockingsurface243 is formed at the intersection ofstruts241 and242. The lockingsurface243 engages a surface on thecover150 to limit the inward travel of thecover150 after operation of the auto-injector100, as shown inFIGS. 9 and 10. Thethinner strut242 provides a spring force to keep thethicker strut241 biased in an outwardly direction. Thethinner strut242 also provides tensile strength under extreme loads and helps prevent thestrut241 from collapsing in a sideways direction because thethinner strut242 remained retained in a guide groove in theneedle cover150 after thecover member150 has moved to an extended position. The curved shape of thestrut242 permits thestrut242 to bend inwardly as shown in the dashed lines inFIG. 52. This prevents theentire wing240 from forming a rigid arch. Thus allowing thethicker strut241 to flex inwardly towards thebody141 without causing excessive compressive leads along thewing240. It is contemplated that thelocking arm240 may be located on theouter body110.
• As shown inFIGS. 39, 41, 49, 50 and 52, theelongated body141 of thecartridge container140 includes arecess244 located between thethinner strut242. If the lockingarms240 are located on theouter body110, therecess244 could be formed in theouter body110. Alternatively, an opening in theouter body110 could also be provided. Thisrecess244 increases the distance that thethinner strut242 travels inwardly toward thebody141, which increases the spring force provided to thethicker strut241 to maintain thestrut241 in an outwardly biased position. The lockingwings240 are normally maintained in unstressed states. The lockingwings240 are compressed temporarily as theneedle cover150 passes over them. The lockingwings240 spring out such that the lockingsurface243 engages thecover member150 to prevent theneedle cover150 from being pushed backwards as shown inFIG. 10.
• Anelongated slot146 is formed on each side of theelongated body141. Theslot146 extends from the ends of thestrut242, as shown inFIGS. 49 and 51. Eachslot146 is sized to receive a lockingtooth340. As shown inFIGS. 1,2, 4, 5, 7, 9, 16, 39 and 41, the lockingteeth340 are locked on opposing sides of thecartridge container140. The lockingteeth340 are provided to hold back theneedle cover150 from deploying until after operation of the auto-injector100, A pair of lockingteeth340 are provided. While not preferred, it is contemplated that asingle locking tooth340 can be employed.
• Each lockingtooth340 is capable of pivoting about the bearingaxle341 within theaxle slot147. Multiple axle slots may be provided such that the position of thetooth340 may be adjusted. As shown inFIGS. 56-59, each lockingtooth340 has atab342 having a bearingsurface342a. Thetab342 is positioned within theslot146 such that it extends into the interior of theelongated body141 and is capable of contacting thecartridge160. As thecartridge160 is advanced within thebody141 during operation of the auto-injector100, the contact between thecartridge160 and thebearing surface342acauses the lockingtooth340 to rotate about theaxle341, While thesurface342acontacts thecartridge160, the lockingteeth340 have minimal or negligible impact on the movement of thecartridge160 within thecontainer140 during the injection operation. The low or minimal force applied by the locking teeth to the cartridge is advantageous in that it does not build pressure within the cartridge that could prematurely burst the diaphragm before the needle is fully extended. Furthermore, the movement of thecartridge160 within thecontainer140 is not impeded or negligibly impeded by the lockingteeth340. Thetab342 extends from one side of theaxle341. Aspring tail343 extends from an opposing side of theaxle341. Thespring tail343 is positioned within theslot146 and is designed to slide along thecartridge container140. Thespring tail343 serves to bias the lockingtooth340 into a locked position such that theneedle cover150 is retained or locked in a retracted position prior to operation of the auto-injector100. It is contemplated that thespring tail343 may be replaced with a spring assembly. A bearingsurface344 is provided on one end of thetail343 to permit thespring tail343 to slide smoothly along thecartridge container140 withinslot146. The bearingsurface344 andcentral body345 provide a flat area for an ejector pin.
• Formed below thespring tail343 is a v-shapednotch347. Thenotch347 has a lockingsurface347aon one side which holds theneedle cover150 before activation of the auto-injector100. Anothersurface347blimits the travel of thetooth340 within thecartridge container140 to limit its rotation. Thenotch347 is formed as part of atab348, which extends on either side of thespring tail343. The lockingteeth340 increase the flexibility of the auto-injector100. Numerous cartridges of various lengths and diameters can be used without modifying the auto-injector100. The spring action of thetails343 adjust the position of the lockingteeth340 such that thesurface342acontacts thecartridge160.
• Thecartridge container140 further includes a pair ofopenings141aand141b, which are formed on opposing sides of thebody141. Theopenings141aand14bpermit viewing of the contents of thecartridge160 such that the user can visually inspect the medicament prior to operation of the auto-injector100. Prior to use theopenings141aand141bare aligned with corresponding openings in theneedle cover150 such that the user can view the contents ofcartridge160 through theouter body110. Aledge149 having a plurality of reinforcingribs149ais formed adjacent one end of theopening141. Theledge149 contacts theedge154aof theopening154 in theneedle cover150 to prevent theneedle cover150 from moving any further forward relative to thecartridge container140 so that theneedle cover150 cannot be pulled out of theouter body110. When in this position, the lockingsurface243 of the lockingwings240 engages the end ofneedle cover150 to prevent theneedle cover150 from being inserted back into theouter body110, When theledge149 is in contact with the edge of the opening in theneedle cover150, the openings in the cartridge container and the needle cover are no longer aligned such that the user cannot view thecartridge160 through theouter body110. This provides a visual guide indicator to the user that the auto-injector100 has been used.
• Theneedle cover150 will now be described in greater detail in connection withFIGS. 12-15,38,42,43 and 53-54. Theneedle cover150 has a generally elongatedhollow body151 having a shape that is complementary to the shape ofouter body110. Theelongated body151 is slidably received within theouter body100. One end of thehollow body151 is tapered having anenclosed end surface152.End surface152 prevents a human finger (e.g., a child's finger) from entering the needle cover and contacting the needle.End surface152 has anopening152asized to permit the passage of the needle of thecartridge160 there through during an injection operation, as shown inFIGS. 7 and 8. Theend surface152 is intended to be placed on the injection surface of the user during operation of the auto-injector100 Aneedle cover spring153 is compressed between theend surface152 of theneedle cover150 and thecartridge container140, as shown inFIGS. 1, 2, 4, 5, 7, and 9. The auto-injector100 withneedle cover150 in accordance with the present invention is designed to function like auto-injectors without needle covers in that a similar activation force is required to operate the auto-injector. As such, thespring153 has a very low load. The biasing force for thecover150 is less than the activating force of the auto-injector100. The maximum load for thespring153 is preferably 1.5 pounds. The load is lower than the activation force (1.5 versus 4-8) necessary to actuate the auto-injector100 such that theneedle cover150 does not impact the operation of the auto-injector100 when compared to injectors without covers such as disclosed in the '893 patent. Theribs145 on thecartridge container140 act to stabilize thespring153 within thecover150. Thehollow body151 may includeindents151a, shown inFIGS. 53 and 54. Theindents151areduce the thickness of the plastic to conserve materials.
• Thehollow body151 further includes a pair ofopenings154 formed thereon. As discusses above, theopenings154 align with theopenings141aand141bin thecartridge container140 prior to activation to allow visibility of the medicament within thecartridge160.Edge surface154aof theopening154 is designed to contactledge149 to prohibit further advancement of theneedle cover150.
• Slots155 are provided on opposing sides of theneedle cover150. Theslots155 are positioned to be aligned with the lockingwings240 and the lockingteeth340. Theslots155 guide and support the lockingwings240 prior to deployment of theneedle cover150. A cross slot155amay be provided to aid in the assembly of the auto-injector100 such that the lockingteeth340 can be inserted in place on thecartridge container140 throughslot155 in theneedle cover150.Bearing surface344 can be placed through the slot155a. Lockingprojections156 extend inwardly into theslot155. The lockingprojections156 are configured to engage thelocking surface347aon the lockingteeth340.Multiple projections156 are provided to correspond to themultiple axle slots147 in thecartridge container140 for the bearingaxle341.
• Aninterior groove157 is provided within the interior of thehollow body151. Theinterior groove157 is axially aligned with theslots155. A portion of thestrut241 is aligned in thegroove157 when thecover member150 is in the position shown inFIGS. 12 and13. The grooves are aligned with the lockingwings240 to provide support and prevent sideways collapsing of the lockingwings240.
• Thecartridge160 includes a generally elongated glass tube having anopening161 at one end sized to receive theplunger438 andcollet430. Theflange436 on thecollet430 is designed to contact the end of thecartridge160 to limit the inward travel of the plunger and collet into thecartridge160 to control the dosage dispensed through theneedle162. Theneedle162 is attached to ahub assembly163 which is secured to another end of thecartridge160. Thehub assembly163 may include adiaphragm164 to prevent the passage of liquid medicament through theneedle162 prior to activation of the auto-injector. Theneedle162 is encased in aprotective sheath165. Thesheath165 is secured to thehub assembly163. Theneedle162 pierces thesheath165 during operation, when theneedle162 projects through theneedle cover150. Thecartridge160, as illustrated, provides a container for a dose of liquid medicament. It is not intended that the auto-injector100 be limited solely to the use of a single liquid, rather, it is contemplated that one or more liquids may be stored incartridge160 that mix upon activation of the auto-injector100, Furthermore, a solid medicament and a liquid can be separately stored in thecartridge160 whereby the solid is dissolved in the liquid prior to dispensing.
• The operation of the auto-injector100 will now be described in greater detail. The auto-injector100 is shown in an unactivated state inFIGS. 1, 2 and 3, Therelease pin120 is secured in place such that thepin125 is received within thehole234 and thehole435ain thecollet430 such that the side arms433 can not be inwardly deflected. In this position, theneedle cover150 is held in a locked retracted position by the lockingteeth340. The locking surfaces347aare biased by thespring tails343 into alignment with the lockingprojections156 on theneedle cover member150. In this position, the auto-injector100 cannot be operated and theneedle162 is not exposed.
• When operation of the auto-injector100 is desired, therelease pin120 is grasped by theperipheral ledge124 and pulled to remove therelease pin120 from the end of the auto-injector100. This readies the auto-injector100 for operation, as shown inFIG. 4. Thearrowheads434aand434bandside arms433aand433bare now capable of being compressed together when the auto-injector100 is activated. The lockingwings240 are not compressed or stressed at this time.
• As shown inFIGS. 5 and 6, the user presses theend surface152 of theneedle cover150 against the injection site. This causes thepre-compressed spring153 to be slightly further compressed until theneedle cover150 moves and contacts thefront end145aof the cartridge container140 (seeFIG. 51), thus moving theledge142 of thecartridge container140 reawardly. The force ofspring153 is less that the force ofspring530. Theneedle cover150, thecartridge container140 and the cartridge60 are then moved rearwardly into theouter body110. Thecartridge container140 moves upward into theouter body110 until theledge142 thereof contacts theledge335 of the power packinner body330. The power packinner body330, and thecollet430 and thespring assembly530 are then pushed rearwardly into the auto-injector100 into the power packouter body230. Thecollet430 moves upwardly until it contacts thecollet activation structure239, shown inFIG. 28. Thearrowheads434aand434bcontact the slopedactivation surface239a. Thearrowheads434aand434bare compressed together by the slopedsurface239 as thecollet430 moves rearwardly, such that thearrowheads434aand434bare released from thecollet retention surface332b. During this loading operation, the needle cover150) is rearwardly pushed a small amount intoouter body110. When this occurs, the preload on the lockingteeth340 provided by thespring153 is temporarily removed. As such, the v-shapednotch347 temporarily disengagesprojection156 formed on theneedle cover150. During this operation, theprojection156 no longer contacts eithersurface347aor347b, but remains in a space provided between the surfaces. As such when pressure from theneedle cover150 is removed, theprojection156 will return into contact with thesurfaces347aor347b. The lockingteeth340 will completely release theneedle cover150 only in response to movement of thecartridge160 as it travels forwardly within thecartridge container140. Accordingly, theneedle cover150 cannot deploy until thecartridge160 moves.
• Thespring530 andcollet430 simultaneously force thecartridge160 and thecartridge container140 forward toward the open front end of theouter body110. Once theneedle162 has been extended through theneedle cover150, pressure of the medicament within thecartridge160 causes thediaphragm164 to burst permitting the flow of medicament into the user. The drug is forced through theneedle162 allowing theplunger438 andcollet430 to more further into thecartridge160. Thecartridge container140 retains thesheath165 and also prevents the spring force of thespring530 from being transferred through thecartridge140 onto theneedle cover150 and the injection site. That is, the force fromspring530 that drives thecartridge160 froward is opposed by the front end of thecartridge container140, with thesheath165 compressed there between, rather than force being received directly by theneedle cover150. In addition, the needle cover spring force is less than the activation force required to collapse the collet to release the collet during actuation. Preferably, the needle cover spring force is about 0.25 to 0.75 of the minimum activation force. The power pack residual spring force after activation is contained within thecartridge container140,cartridge160, theouter body110 and the power packouter body230. This arrangement advantageously prevents a kickback effect from occurring. As such, the auto-injector is not pushed away from the injection site during activation to ensure that the proper dose of medicament is administered and the proper needle extended length or proper needle penetration is maintained. This effect would occur if the spring force from thespring530 were transferred to theneedle cover150 and the injection site, whereby the auto-injector100 could be pushed away from the injection site and alter the location of theneedle162 within the injection site. This has several negative impacts including startling the patient; changing the injection from an intramuscular to subcutaneous injection, which will affect pk levels. At the same time, thecartridge160 is advanced within cartridge container140 (i.e., when theneedle160 goes from a retracted position to extended position), The advancement of thecartridge160 causes the lockingtooth340 to pivot about the axle34. This is in response tocartridge160 contactingbearing surface342aand pushing the bearingsurface342aaway from the main longitudinal axis of theneedle162. This rotation of the lockingtooth340 causes thelocking surface347ato disengage the lockingprojections156. Thesurface347blimits the rotation of the lockingtooth340. At this point, theneedle cover150 is in an unlocked position such that it can move with respect to thecartridge container140. The release of thecollet430 from thecollet retention surface332bforces the end of the power packinner body330 into contact with the power packouter body230.
• Once the dose has been injected into the user, the user removes the auto-injector100 from the injection surface, Since theneedle cover150 is not locked with respect to thecartridge container140, thespring153 forces theneedle cover150 out of theouter body110 to cover the exposedneedle162, as shown inFIGS. 9 and 11. Since theslot155 is aligned withgroove157 and a portion of thestrut241 is retained in theslot157, the portion of thestrut241 moves into thegroove157 when thecover150 moves outwardly. As theneedle cover150 slides outwardly, the lockingwings240 are temporarily compressed by theneedle cover150 as thethicker strut241 slides through thegroove157. This compression occurs when the bottom surface of thegroove157 contacts the top surface of thestrut241. Thewings240 compress in the manner shown in the dashed lines inFIG. 52. Once thethicker strut241 clears thegroove157 such that thewings240 andneedle cover150 are in the position illustrated inFIGS. 10, 14 and 15, the lockingsurface243 contacts the end of theneedle cover150 to prevent the needle cover from being reinserted intoouter body110. In the event that inward force is applied, thestruts241 and242 compress such that the lockingwing240 is pressed against thebody141 of thecartridge container140 such that thesurface243 remains engaged with theneedle cover150. This arrangement limits the inward travel of theneedle cover150. Theledge149 engages theedge154aof theopening154 in theneedle cover150. The auto-injector100 is now in an inoperable stored position.
• Safe user operation of the auto-injector is of paramount importance. Various features were tested and studied in user trials to improve safety and usability. One feature in particular, color coding of some injector parts with certain colors, was shown to minimize, if not eliminate, the potential for accidental injection caused by incorrectly orienting the auto-injector. That is, after removingrelease pin120, some users mistakenly placed the auto-injector upside down against an injection site, which would have likely resulted in the accidental injection of a thumb or other finger. The user trials indicated that, surprisingly, ablue release pin120 and an orange needle cover150 (as opposed to other colors, such as, for example, a green release pin and a red needle cover) best reduced the number of incorrect injector orientations and accidental injections. User trials also indicated that labeling of the needle cover improved injector handling, safety, and usability. For example, needle covers with “NEEDLE END” printed near the tip of the cover, as shown inFIG. 60, and “USED” printed farther up on the needle cover that only became visible after the auto-injector was used, as shown inFIG. 61, prevented incorrect injector orientation, accidental injection, and attempted use of a discharged auto-injector.
• The invention having been disclosed in connection with the foregoing embodiment and examples, additional variations will now be apparent to persons skilled in the art. Various modifications and variations to the above described auto-injector can be made without departing from the scope of the invention. The invention is not intended to be limited to the embodiment specifically mentioned and accordingly reference should be made to the appended claims rather than the foregoing discussion of preferred embodiments and examples to assess the spirit and scope of the invention in which exclusive rights are claimed.

Claims (30)

We claim:

1. An auto-injector comprising:

a housing;

a cartridge container disposed within the housing;

a cartridge received within the cartridge container, the cartridge having at least one opening therein and containing a medicament, the medicament rearwardly confined by a plunger, the cartridge including a needle assembly to dispense the medicament there through, the needle assembly having a needle;

an actuation assembly having a stored energy source capable of being released to drive the plunger within the cartridge to dispense the medicament through the needle assembly; and

a needle cover received within the housing, the needle cover having an opening formed therein to permit passage of the needle there through during a medicament dispensing operation, the needle cover having a first locked position wherein the needle cover is in a locked retracted position prior to activation of the auto-injector, the needle cover having a second locked position wherein the needle cover is in a locked extended position after the medicament dispensing operation, the needle cover surrounding the needle on all sides outside of the housing to prevent contact with the needle before activation of the auto-injector and after the medicament dispensing operation.

2. The auto-injector ofclaim 1 wherein the cartridge further comprises a needle sheath disposed about the needle, the needle sheath being compressed between the cartridge container and the cartridge during the medicament dispensing operation.

3. The auto-injector ofclaim 1 further comprising a locking mechanism for holding the needle cover in the first locked position and in the second locked position, the locking mechanism located within the housing to protect against tampering and dirt ingress.

4. The auto-injector ofclaim 1, wherein the cartridge container is constructed such that needles of varying lengths and cartridges of varying lengths and diameters can be accommodated within the cartridge container.

5. The auto-injector ofclaim 1 wherein the needle cover is operable to be pressed against the injection site to start the medicament dispensing operation.

6. The auto-injector ofclaim 1 wherein the needle cover is colored orange.

7. The auto-injector ofclaim 1 wherein the needle cover has indicia printed thereon to indicate the location of the opening formed in the needle cover.

8. The auto-injector ofclaim 7 wherein the indicia comprises the words “needle end.”

9. The auto-injector ofclaim 1 wherein the needle cover has indicia printed thereon to indicate that the auto-injector has been used.

10. The auto-injector ofclaim 9 wherein the indicia comprises the word “used.”

11. The auto-injector ofclaim 9 wherein the indicia is not visible to a user until immediately after the medicament dispensing operation.

12. An auto-injector comprising:

a housing having a needle end and an opposite open end, the housing having a longitudinal axis extending from the needle end to the opposite open end;

a cartridge container disposed within the housing;

a cartridge received within the cartridge container, the cartridge having at least one opening therein and containing a medicament, the medicament rearwardly confined by a plunger, the cartridge including a needle assembly to dispense the medicament there through, the needle assembly having a needle;

an actuation assembly having a stored energy source capable of being released to drive the plunger within the cartridge to dispense the medicament through the needle assembly, the actuation assembly positioned in the housing and recessed from the open end;

a release pin removably attached to the actuation assembly at the open end of the housing to prevent inadvertent activation of the auto-injector while the release pin is attached to the actuation assembly, removal of the release pin allowing the auto-injector to be activated from the needle end of the housing; and

a non-removable needle cover received within the housing, the needle cover having an end surface extending transversely to the longitudinal axis, the end surface having a hole formed therein sized to permit passage of the needle there through during a medicament dispensing operation, the end surface preventing a human finger from entering the needle cover and contacting the needle before and after the medicament dispensing operation, the needle cover having a first locked position wherein the needle cover is in a locked retracted position prior to activation of the auto-injector, the needle cover having a second locked position wherein the needle cover is in a locked extended position after the medicament dispensing operation.

13. The auto-injector ofclaim 12 further comprising:

a first locking assembly that holds the needle cover in the first locked position, the first locking assembly connected to the cartridge container or the housing and including at least one locking tooth that releasably engages the needle cover; and

a second locking assembly that holds the needle cover in the second locked position; wherein:

each locking tooth is pivotally connected to the cartridge container;

each locking tooth includes a locking surface constructed and arranged to contact a surface on the needle cover;

the locking surface contacts the surface on the needle cover to prevent movement of the needle cover such that the needle cover is maintained in the first locked position prior to activation of the auto-injector; and

each locking tooth further includes a spring assembly constructed and arranged to bias the locking surface into contact with the surface on the needle cover.

14. The auto-injector ofclaim 12 wherein the end surface is operable to be pressed against the injection site to start the medicament dispensing operation.

15. The auto-injector ofclaim 12 wherein the cartridge further comprises a needle sheath disposed about the needle, the needle sheath being compressed between the cartridge container and the cartridge during the medicament dispensing operation.

16. The auto-injector ofclaim 12 wherein the stored energy source is a spring.

17. The auto-injector ofclaim 12 wherein the needle cover is of a first color and the release pin is of a second color different than the first color.

18. The auto-injector ofclaim 12 wherein the needle cover is colored orange.

19. The auto-injector ofclaim 12 wherein the release pin is colored blue.

20. The auto-injector ofclaim 12 wherein the needle cover has indicia printed thereon to indicate the location of the needle end.

21. An auto-injector comprising:

a housing having a needle end and an opposite open end;

a cartridge container disposed within the housing;

a cartridge received within the cartridge container, the cartridge having at least one opening therein and containing a medicament, the medicament rearwardly confined by a plunger, the cartridge including a needle assembly to dispense the medicament there through, the needle assembly having a needle;

an actuation assembly having a stored energy source capable of being released to drive the plunger within the cartridge to dispense the medicament through the needle, the actuation assembly positioned in the housing and recessed from the open end;

a release pin removably attached to the actuation assembly at the open end of the housing to prevent inadvertent activation of the auto-injector while the release pin is attached to the actuation assembly, removal of the release pin allowing the auto-injector to be activated, the release pin blue in color; and

a needle cover received within the housing, the needle cover having an enclosed end surface for placement against an injection site prior to activation of the auto-injector, the end surface having a hole formed therein to permit passage of the needle there through during a medicament dispensing operation, the needle cover having a locked retracted position prior to activation of the auto-injector and a locked extended position after the medicament dispensing operation, the needle cover orange in color.

22. The auto-injector ofclaim 21 wherein the needle cover has indicia printed thereon to indicate the location of the needle end.

23. The auto-injector ofclaim 22 wherein the indicia comprises the words “needle end.”

24. The auto-injector ofclaim 21 wherein the needle cover has indicia printed thereon to indicate that the auto-injector has been used.

25. The auto-injector ofclaim 24 wherein the indicia comprises the word “used.”

26. The auto-injector ofclaim 24 wherein the indicia is not visible to a user until immediately after the medicament dispensing operation.

27. The auto-injector ofclaim 21 wherein the cartridge further comprises a needle sheath disposed about the needle, the needle sheath being compressed between the cartridge container and the cartridge during the medicament dispensing operation.

28. The auto-injector ofclaim 21 wherein the hole in the end surface is sized to prevent a human finger from entering the needle cover and contacting the needle before and after the medicament dispensing operation.

29. The auto-injector ofclaim 21 wherein the needle cover surrounds the needle on all sides outside of the housing to prevent contact with the needle before and after the medicament dispensing operation.

30. The auto-injector ofclaim 21 wherein the end surface is operable to be pressed against the injection site to start the medicament dispensing operation.

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