Cassette with nested needle shield for auto-injector - Patent application

Abstract

The present invention relates to a cassette having a telescoping needle shield, the cassette being adapted to be received within an auto-injector.

Description

[Technical Field]

[0001] The present invention relates to a cassette having a telescoping needle shield, the cassette being adapted to be received within an auto-injector. [Background technology]

[0002] Auto-injectors for delivering medication to patients come in many varieties depending on the type of medication to be delivered to the patient. When the auto-injector is a reusable syringe component into which a disposable cassette is inserted, there are several key requirements that must be met for each of the two components. The cassette needs to be mechanically stable, but at the same time, it is often desirable to minimize the use of materials in the disposable cassette to keep manufacturing costs and environmental impact low. WO 2021 / 069106 A1 discloses an example of a system comprising a reusable auto-injector and a disposable cassette, where the disposable cassette is free of major electronic components and spring systems. Summary of the Invention

[0003] Different types of medications set different requirements regarding storage conditions. Some types of medications can degrade or be otherwise damaged when in contact with metal over an extended period of time. This poses some challenges regarding the storage of cassettes with syringes containing this type of medication, as the connection between the injection needle and the syringe compartment containing the medication can have undesirable consequences. Other cassette systems may easily allow the syringe to include a needle that is already connected and has a fluid connection to the medication in the syringe compartment.

[0004] The autoinjector used in combination with the cassette is typically customized to fit the dimensions of the different functional components within the cassette, with the goal of minimizing the number of components within the cassette to maximize system stability. Nevertheless, reusable autoinjectors offer a significant level of flexibility, as they can be easily programmed by software to be optimized for the delivery of different medications. Programmable variations can include injection delivery duration, maximum plunger force, etc. However, optimizing the autoinjector places a limit on the design of the cassette.

[0005] Thus, in a first aspect, a cassette for use in an automatic injector for administering a medication is disclosed herein, the cassette extending in a longitudinal direction (L) from a proximal end to a distal end. The cassette includes a syringe holder configured to receive a syringe containing the medication. The syringe can include a seal at the proximal end of the syringe, the seal configured to be pierced by a needle to establish fluid communication between the medication in the syringe and the needle. The syringe holder includes a needle assembly fixation portion at the proximal end of the syringe holder, the needle assembly fixation portion configured to fix a needle assembly including a needle to the syringe holder after the cassette is installed in the automatic injector.

[0006] The cassette also ●The first needle safety cover, a second needle safety cover, wherein the first needle safety cover is displaceable relative to the second needle safety cover along the longitudinal direction; and one or more release arms, the one or more release arms being movable between at least two positions relative to the syringe holder, the at least two positions being: an initial position (PraIN) in which the first needle safety cover and the second needle safety cover are separated by at most a first separation distance; one or more release arms, including a release position (PraR) in which the first needle safety cover and the second needle safety cover are allowed to move relative to each other to a second separation distance that is greater than the first separation.

[0007] The cassette according to the first aspect allows an auto-injector originally designed and optimized to accept a cassette system with a syringe having a pre-attached needle to be used to deliver medication from a cassette system with a syringe that requires the user to connect the needle to the syringe compartment. This reduces the flexibility of the auto-injector, which is typically limited to cassettes provided in a specific physical format. This reduces the manufacturing cost of the reusable auto-injector, as cassette modifications allow the same reusable syringe to support medication delivery processes using different cassette types. For example, in the absence of a pre-attached needle, the cassette according to the first aspect can ensure that a needle safety cover can both attach the needle and cover it after medication delivery using the same auto-injector used to deliver medication from a cassette with a pre-attached needle. The cassette described above avoids the need for modifications to the auto-injector. Making changes to the software control process of an electronic, reusable auto-injector is typically fairly easy, as modifications can be made without affecting the mechanical structure of such systems. However, adapting an alternative cassette often requires mechanical modifications to the auto-injector, which the cassette avoids. Thus, the cassette as described above allows for the specific requirements and needs of medication delivery from a particular cassette to be captured and addressed without modifying the reusable auto-injector, which reduces the cost of purchasing complex and durable reusable auto-injectors.

[0008] The telescoping feature of the needle safety cover system can also be reliably extended to allow the needle safety cover to both secure the injection needle to the cassette and cover the needle after drug delivery is complete.

[0009] The one or more release arms may be part of the second needle safety cover or the first needle safety cover. The one or more release arms may be replaced by release fingers, release protrusions, or any other release means to control the relative movement of the first and second needle safety covers between the initial position and the released position. The second separation distance may be an extended position. The relative movement between the two needle safety cover parts may be considered a telescopic movement.

[0010] Proximal movement of the first needle safety cover may allow the two needle safety covers to extend telescopically, thereby increasing the distance between the first and second needle safety covers.

[0011] Disclosed herein in a second aspect is a cassette for use in an auto-injector for administering a medicament, the cassette extending in a longitudinal direction (L) from a proximal end to a distal end. Needle safety cover and an index ring rotatable relative to the needle safety cover between a plurality of rotational positions, the plurality of rotational positions including at least: a first rotational position (R1) that prevents the needle safety cover from moving in a distal direction; an index ring between a plurality of rotational positions, including a second rotational position (R2) in which the needle safety cover is longitudinally movable; - A syringe holder configured to receive a syringe containing a medication, the syringe including a seal at a proximal end of the syringe, the seal configured to be pierced by a needle to obtain fluid communication between the medication in the syringe and the needle.

[0012] The syringe holder according to the second aspect may include a needle assembly fixation portion at a proximal end of the syringe holder, the needle assembly fixation portion being configured to fix a needle assembly including a needle to the syringe holder after the cassette is installed in the automatic injector.

[0013] The cassette according to the second aspect may further comprise one or more index ring release tabs movable between at least two positions relative to the index ring, the at least two positions being: an initial position (PraIN) in which the index ring is prevented from rotating from the first rotational position (R1) to the second rotational position (R2); a release position (PraR) in which the index ring is rotatable from a first rotational position (R1) to a second rotational position (R2), When the cassette is secured within the auto-injector, movement of one or more release members of the auto-injector to a first release member position within the cassette causes one or more index ring release tabs to move from an initial position (PraIN) to a release position (PraR).

[0014] The cassette according to the second aspect allows an auto-injector originally designed and optimized to accept a cassette system with a syringe having a pre-attached needle to deliver medication from a cassette system with a syringe that requires the user to connect the needle to the syringe compartment. This reduces the flexibility of the auto-injector, which is typically limited to cassettes provided in a specific physical format. This reduces the manufacturing cost of the reusable auto-injector, since cassette modifications allow the same reusable syringe to support medication delivery processes using different cassette types. For example, in the absence of a pre-attached needle, the cassette according to the second aspect can ensure that a needle safety cover can both attach the needle and cover it after medication delivery using the same auto-injector used to deliver medication from a cassette with a pre-attached needle. The cassette described above avoids the need for modifications to the auto-injector. Making changes to the software control process of an electronic, reusable auto-injector is typically fairly easy, as modifications can be made without affecting the mechanical structure of such systems. However, adapting an alternative cassette often requires mechanical modifications to the auto-injector, which the cassette avoids. Thus, the cassette as described above allows for the specific requirements and needs of medication delivery from a particular cassette to be captured and addressed without modifying the reusable auto-injector, which reduces the cost of purchasing complex and durable reusable auto-injectors.

[0015] Further disclosed herein, in a third aspect, is a cassette for use in an automatic injector for administering a medication, the cassette extending in a longitudinal direction (L) from a proximal end to a distal end. The cassette includes a syringe holder configured to receive a syringe containing the medication. The syringe can include a seal at the proximal end of the syringe, the seal configured to be pierced by a needle to establish fluid communication between the needle in the syringe and the medication. The syringe holder includes a needle assembly fixation portion at the proximal end of the syringe holder, the needle assembly fixation portion configured to fix a needle assembly including a needle to the syringe holder after the cassette is installed in the automatic injector. The cassette further includes a needle attachment prevention system, the proximal end of the needle attachment prevention system configured to move between a plurality of longitudinal positions relative to the syringe holder. The plurality of longitudinal positions include at least: ○ Lock position (PnsL) to prevent needle puncture of the seal, A needle assembly connection location (PnsC) that allows for piercing of the seal by a needle.

[0016] Movement of the proximal end of the needle attachment blocking system is configured to be controlled by the auto-injector after the cassette is secured within the auto-injector.

[0017] "Controlled by the auto-injector after the cassette is secured within the auto-injector" means that movement of the needle attachment blocking system is prevented until the auto-injector changes some configuration of the cassette, allowing the needle attachment blocking system to move in a distal direction.

[0018] Thus, with the cassette according to the third aspect, any premature contact between the medication in the syringe compartment and the injection needle can be prevented. It is simply not possible for a user to secure the needle to the syringe and bring the needle into fluid contact with the medication before the user secures the cassette to the auto-injector. This prevents a situation in which a user connects a needle assembly to the cassette in preparation for a rapid injection at a later time. With the cassette according to the third aspect, it is possible to use an auto-injector originally designed and optimized to accept a cassette system having a syringe with a pre-attached needle to deliver medication from a cassette system having a syringe that requires the user to connect the needle to the syringe compartment. This reduces the flexibility of the auto-injector, which is typically limited to cassettes provided in a specific physical format. This reduces the manufacturing costs of reusable auto-injectors, as cassette modifications allow the same reusable syringe to support medication delivery processes using different cassette types. For example, in the absence of a pre-attached needle, the cassette according to the first and / or second aspects can ensure that a needle safety cover can both attach a needle and cover the needle after medication delivery using the same auto-injector used for medication delivery from a cassette with a pre-attached needle. The cassette described above avoids the need for modifications to the auto-injector. Making changes to the electronic and software control processes of a reusable auto-injector is typically fairly easy, as modifications can be made without affecting the mechanical structure of such systems. However, adapting an alternative cassette often requires mechanical modifications to the auto-injector, which is avoided by the cassette described above. Thus, the cassette described above allows the specific requirements and needs of medication delivery from a particular cassette to be captured and addressed without modifying the reusable auto-injector. This reduces the cost of purchasing complex and durable reusable auto-injectors.

[0019] A syringe configured to be received in a cassette according to the first aspect or the second aspect or the third aspect may include a syringe compartment containing the medicament. The compartment may be a one-chamber compartment.

[0020] Alternatively, the syringe compartment may be a two-chamber compartment including a first sub-compartment containing a first drug component and a second sub-compartment containing a second drug component, with a second stopper separating the two sub-compartments. a first sub-compartment containing a first pharmaceutical component; a second sub-compartment containing a second pharmaceutical component; and a bypass region located between the first sub-section and the second sub-section; a first stopper positioned distally within the first subcompartment prior to use; and a second stopper positioned between the first sub-compartment and the second sub-compartment prior to use; Moving the first stopper proximally moves the first drug component proximally, moving the second stopper proximally, allowing the first drug component to pass through the bypass region into the second subcompartment, and mixing of the first drug component with the second drug component.

[0021] The first drug component and the drug in the second sub-compartment may be mixed prior to drug delivery by proximal movement of the second stopper.

[0022] Alternatively, the two-chamber compartment of the syringe may be designed to hold two liquid substances that are subsequently injected, for example, through the same injection needle.

[0023] In one or more examples, the needle assembly fixation portion secures the needle assembly to the proximal end of the syringe holder by a threaded connection, a press-fit connection, a snap-fit ​​connection, a bayonet connection, or a combination thereof. Alternative connection options may be envisioned. The defined options are merely examples.

[0024] The needle assembly connection position (PnsC) is normally distal to the locked position (PnsL).

[0025] In one or more examples, the needle assembly is pre-attached to the proximal end of the needle attachment blocking system prior to use, and fluid communication between the syringe and the needle is achieved by distal movement of the needle assembly and the needle attachment blocking system relative to the syringe, optionally in combination with rotational movement of the needle assembly relative to the syringe. Alternatively, or in combination, the needle assembly may be pre-attached to the first needle safety cover prior to use, and fluid communication between the syringe and the needle is achieved by distal movement of the needle assembly, the second needle safety cover, and the first needle safety cover relative to the syringe, optionally in combination with rotational movement of the needle assembly relative to the syringe. Having the needle assembly pre-attached to the proximal end of the needle attachment blocking system and / or the first needle safety cover means that the needle assembly can be placed on and supported by the proximal end of the needle attachment blocking system and / or the first needle safety cover. This allows the user to have a pre-prepared system and the user does not have to keep track of where the needle assembly is. Alternatively, the needle assembly and cassette may be stored together as a unit, with the seal still being protected against needle penetration until the cassette and needle assembly system is secured within the auto-injector.

[0026] In one or more examples, the proximal end of the needle attachment blocking system is configured as a needle safety cover that covers the needle after drug delivery, thereby providing dual functionality to the needle attachment blocking system.

[0027] In one or more examples, the needle attachment prevention system includes: ●The first needle safety cover, a second needle safety cover, wherein the first needle safety cover is displaceable relative to the second needle safety cover along the longitudinal direction; and one or more release arms, the one or more release arms being movable between at least two positions relative to the syringe holder, the at least two positions being: an initial position (PraIN) in which the first needle safety cover and the second needle safety cover are separated by at most a first separation distance; one or more release arms, including a release position (PraR) in which the first needle safety cover and the second needle safety cover are allowed to move relative to each other to a second separation distance that is greater than the first separation.

[0028] The one or more release arms may be part of the second needle safety cover or the first needle safety cover. The one or more release arms may be replaced by release fingers, release protrusions, or any other release means to control the relative movement of the first and second needle safety covers between the initial position and the released position. The second separation distance may be an extended position. The relative movement between the two needle safety cover parts may be considered a telescopic movement.

[0029] In one or more examples, the proximal end of the needle attachment prevention system is contained within the second needle safety cover. Configurations in which the first needle safety cover contains the proximal end of the needle attachment prevention system are also contemplated. Which of the two cover parts prevents attachment of the needle assembly is typically not important, as long as one of the parts contains the function.

[0030] In one or more examples, after securing the cassette within the auto-injector, the second needle safety cover is configured to be longitudinally unlocked, and the second needle safety cover is movable distally relative to the syringe holder to move the proximal end of the needle attachment blocking system and / or the second needle safety cover to the needle assembly connection position (PnsC) to enable securing of the needle assembly to the syringe holder. Unlocking the needle attachment blocking system and / or the second needle safety cover enables attachment of the needle assembly to the cassette.

[0031] In one or more examples, after securing the cassette within the automatic injector, the first needle safety cover and the one or more cover springs are configured to be unlocked in the longitudinal direction, and the first needle safety cover and the one or more cover springs are movable distally relative to the syringe holder.

[0032] In one or more examples, the cassette, e.g., the needle attachment prevention system, further includes one or more cover springs biased between the first and second needle safety covers. The cover springs may be replaced by a spring system inside the auto-injector that acts on the first needle safety cover relative to the second needle safety cover after the cassette is attached to the auto-injector. Thus, after relative release of the two needle safety cover parts, movement from the initial position (PraIN) to the released position (PraR) may be assisted by one or more cover springs in the cassette or by a spring system in the auto-injector.

[0033] In one or more examples, when the proximal end of the needle attachment blocking system is in a locked position (PnsL) that prevents puncture of the seal by a needle, the second needle safety cover is longitudinally locked to the syringe holder. The second needle safety cover may prevent puncture of the seal by a needle. In configurations in which the first needle safety cover includes the proximal end of the needle attachment blocking system, the first needle safety cover is typically the cover portion that is longitudinally locked to the syringe holder in the locked position (PnsL).

[0034] In one or more examples, the plurality of longitudinal positions between which the proximal end of the needle attachment blocking system can be moved further include a drug delivery position (PnsD) in which the needle is exposed and a final locking position (PnsFL) in which further longitudinal movement of the needle attachment blocking system is prevented, the final locking position (PnsFL) being proximal to the drug delivery position (PnsD). The extended locking position of the needle attachment blocking system can enable the needle attachment blocking system to also be utilized as a needle shielding system, where the injection needle can be blocked after drug delivery.

[0035] In one or more examples, the plurality of longitudinal positions between which the proximal end of the needle attachment blocking system can be moved further includes a ready-to-use position (PnsR) in which the proximal end of the needle attachment blocking system covers the needle, and the needle attachment blocking system is in the ready-to-use position (PnsR) before moving to the medication delivery position (PnsD), which protects a user and / or healthcare worker delivering medication to a patient from accidental contact with the needle prior to initiating medication delivery.

[0036] In one or more examples, the cassette according to the first aspect further includes an index ring rotatable relative to the first needle safety cover between a plurality of rotational positions, the plurality of rotational positions including at least: a first rotational position (R1) that prevents the second needle safety cover from moving in a distal direction; a second rotational position (R2) in which the second needle safety cover is longitudinally movable between a plurality of rotational positions, including Movement of one or more release members within the auto-injector when the cassette is secured within the auto-injector rotates an indexing ring that can provide easy lock-release of the cassette portions, the rotation of the indexing ring being controlled by longitudinal movement of one or more release members of the auto-injector into / out of the cassette.

[0037] Similarly, in one or more examples, the cassette according to the third aspect further includes an index ring rotatable relative to the needle attachment blocking system between a plurality of rotational positions, the plurality of rotational positions including at least: a first rotational position (R1) that prevents the needle attachment blocking system from moving in a distal direction; a second rotational position (R2) in which the needle attachment blocking system is movable between a locked position (PnsL) and a needle assembly connected position (PnsC); Rotation of the indexing ring is controlled by movement of one or more release members within the auto-injector when the cassette is secured within the auto-injector. The indexing ring can provide easy lock release of the needle attachment blocking system, and rotation of the indexing ring is controlled by longitudinal movement of one or more release members of the auto-injector into / out of the cassette.

[0038] The index ring according to all embodiments of the cassette may include a track extending from a first corner to a second corner of the surface area of ​​the index ring.

[0039] In one or more examples, the indexing ring according to any embodiment is configured to rotate from a first rotational position (R1) to a second rotational position (R2) when the cassette is inserted into the auto-injector and one or more release members included in the auto-injector move proximally within the track. The introduction of a ramp into the track allows for easy rotation of the indexing ring. Typically, the indexing ring is prevented from moving longitudinally relative to the syringe holder.

[0040] In one or more examples, the track extends in an angular direction from a first corner to a second corner, the angular direction being 20 to 70 degrees, e.g., 30 to 60 degrees, e.g., 35 to 55 degrees, e.g., 40 to 50 degrees, e.g., approximately 45 degrees, relative to the longitudinal direction of the cassette. The track may be a single track having a uniform angular orientation along the entire track. Alternatively, the angular orientation need not extend across the entire track portion or have the same angle across the entire track portion. Instead, there may be separate track portions having different angular orientations.

[0041] In one or more examples, the track includes a first track section and a second track section; the first track section extends in a first angular direction from a first corner towards a first intermediate point; the second track section extends in a second angular direction along the length of the cassette from the first midpoint to a second midpoint;

[0042] The first angular direction may be 20 to 70 degrees, such as 30 to 60 degrees, such as 35 to 55 degrees, such as 40 to 50 degrees, for example, approximately 45 degrees relative to the longitudinal direction of the cassette.

[0043] The second angular direction may be −20 to 20 degrees, for example, −10 to 10 degrees, for example, approximately 0 degrees, relative to the longitudinal direction of the cassette.

[0044] This creates two track portions, and proximal movement of one or more release members into and along the first track portion rotates the indexing ring from a first rotational position R1 to a second rotational position R2. When the one or more release members move distally, the indexing ring rotates back to the first rotational position. When the one or more release members move in and along the second track portion, the indexing ring does not rotate further if the second angular orientation is about 0 degrees.

[0045] In one or more examples, the track further includes a third track section extending from the second midpoint toward the second corner in a third angular direction. The third angular direction can be 20 to 70 degrees, e.g., 30 to 60 degrees, e.g., 35 to 55 degrees, e.g., 40 to 50 degrees, or approximately 45 degrees, relative to the longitudinal direction of the cassette. The inclusion of the third track section allows for further rotation of the indexing ring from the second rotational position to a third rotational position, which provides the opportunity to further release and / or secure the cassette portion relative to the indexing ring.

[0046] In one or more examples, the cassette further includes one or more indexing ring release tabs movable relative to the indexing ring, such that when the cassette is secured within the automatic injector, movement of one or more release members of the automatic injector to a first release member position inside the cassette moves the one or more indexing ring release tabs from an initial position (PraIN) to a released position (PraR). The one or more indexing ring release tabs can be part of the syringe holder.

[0047] In one or more examples, the one or more indexing ring release tabs include a protruding surface that engages a blocking surface on the indexing ring in the initial position (PraIN), preventing the indexing ring from rotating from the first rotational position (R1) to the second rotational position (R2). The one or more indexing ring release tabs may be configured to deflect radially inward by proximal movement of the one or more release members when the cassette is secured within the auto-injector. When the one or more indexing ring release tabs deflect radially inward, the protruding surface no longer normally engages the blocking surface on the indexing ring, and the indexing ring is rotatable from the first rotational position (R1) to the second rotational position (R2).

[0048] In one or more examples, the index ring is rotatable from a first rotational position (R1) to a second rotational position (R2) by distal movement of the needle safety cover.

[0049] In one or more examples, the index ring is configured to rotate from the first rotational position (R1) to the second rotational position (R2) by distal movement of the first needle safety cover when the protruding surface no longer engages the blocking surface on the index ring.

[0050] In one or more examples, the index ring is configured to rotate from a first rotational position (R1) to a second rotational position (R2) by a second index ring engagement finger on the second needle safety cover moving inside a first secondary track section on the index ring.

[0051] In one or more examples, when the one or more release members are in a first release member position inside the cassette, further rotation of the index ring from the second rotational position (R2) to the third rotational position (R3) is prevented by the one or more release members engaging a first track in the index ring.

[0052] In one or more examples, the indexing ring is rotatable from a second rotational position (R2) to a third rotational position (R3) upon proximal movement of one or more release members of the automatic injector from a first release member position within the cassette to a second release member position within the cassette.

[0053] In one or more examples, the index ring is rotatable from a second rotational position (R2) to a third rotational position (R3) upon further proximal movement of one or more release members of the automatic injector from a first release member position within the cassette to a second release member position within the cassette, the second release member position being proximal to the first release member position.

[0054] In one or more examples, the index ring is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) by distal movement of the first needle safety cover following proximal movement of one or more release members of the automatic injector from a first release member position inside the cassette to a second release member position inside the cassette.

[0055] In one or more examples, the index ring is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) by a second index ring engagement finger on the second needle safety cover moving inside a third secondary track section on the index ring.

[0056] In one or more examples, when the index ring is in the third secondary rotational position (R3), the second index ring engagement finger no longer abuts at least one of the one or more release arms on the index ring, allowing proximal movement of the first needle safety cover and the second needle safety cover relative to the index ring to their final locked positions.

[0057] In one or more examples, when the one or more release members are in a first release member position inside the cassette, further rotation of the index ring from the second rotational position (R2) to the third rotational position (R3) is prevented by the one or more release members engaging a first track in the index ring.

[0058] In one or more examples, when a dual-chamber syringe is used, the indexing ring is in the second rotational position (R2) when the first and second drug components are mixed.

[0059] The one or more release arms may be separate items. Alternatively, in one or more examples, the release arms are part of the index ring. The release arms may be positioned at a proximal end of the index ring.

[0060] In one or more examples, the first needle safety cover includes a first index ring engagement finger and the second needle safety cover includes a second index ring engagement finger. When the index ring is in the first rotational position (R1), the first index ring engagement finger and the second index ring engagement finger can abut at least one of the one or more release arms on the index ring to prevent proximal movement of the first needle safety cover and the second needle safety cover relative to the index ring.

[0061] When the index ring is in the second rotational position (R2), the first index ring engagement finger may no longer abut at least one of the one or more release arms on the index ring, and the one or more cover springs are configured to move the first needle safety cover proximally relative to the second needle safety cover and move the first needle safety cover to a locked cover position in which further relative longitudinal movement between the first needle safety cover and the second needle safety cover is prevented.

[0062] Typically, there are two index ring engagement fingers on both the first and second needle safety covers, which are symmetrically positioned on opposite sides.

[0063] In one or more examples, the first and second needle safety covers, in the locked cover position, include a first locking pair that prevents proximal movement of the first needle safety cover relative to the second needle safety cover and a second locking pair that prevents distal movement of the first needle safety cover relative to the second needle safety cover. The proximal lock may be obtained by the first locking pair comprising a proximal first needle safety cover interface on the first needle safety cover and a distal second needle safety cover locking tab on the second needle safety cover. The distal lock may be obtained by the second locking pair comprising a distal first needle safety cover locking surface on the first needle safety cover and a proximal second needle safety cover locking tab on the second needle safety cover. Surfaces / components on the first and second needle safety covers abut each other to create the locking pair.

[0064] In one or more examples, the index ring includes a second track extending from a first secondary corner to a second secondary corner of a surface area of ​​the index ring, and the index ring is configured to rotate from a first rotational position (R1) to a second rotational position (R2) by distal movement of the needle safety cover, and at least one protrusion on the needle safety cover moves inside the second track to rotate the index ring.

[0065] In one or more examples, the index ring includes a second track extending from a first secondary corner to a second secondary corner of a surface area of ​​the index ring, and the index ring is configured to rotate from a first rotational position (R1) to a second rotational position (R2) by distal movement of the second needle safety cover, and a second index ring engagement finger on the second needle safety cover moves inside the second track to rotate the index ring.

[0066] In one or more examples, the second track includes a first secondary track section and a second secondary track section; the first secondary track section extends in a first secondary angular direction from the first secondary corner towards a first secondary midpoint; the second secondary track section extends in a second secondary angular direction along the length of the cassette from the first secondary midpoint to a second secondary midpoint;

[0067] The first secondary angular orientation may be 20 to 70 degrees, such as 30 to 60 degrees, such as 35 to 55 degrees, such as 40 to 50 degrees, for example approximately 45 degrees relative to the longitudinal direction of the cassette.

[0068] The second secondary angular orientation may be between −20 and 20 degrees, for example between −10 and 10 degrees, for example approximately 0 degrees, relative to the longitudinal direction of the cassette.

[0069] In one or more examples, the second track further includes a third secondary track section extending from the second secondary midpoint toward the second secondary corner in a third secondary angular direction. The third secondary angular direction can be 20 to 70 degrees, for example, 30 to 60 degrees, for example, 35 to 55 degrees, for example, 40 to 50 degrees, or approximately 45 degrees, relative to the longitudinal direction of the cassette.

[0070] In one or more examples, the second track further includes a fourth secondary track section. The fourth secondary track section typically extends distally from the second secondary corner. The fourth secondary track section can be a plateau track section having a fourth angular orientation between -20 and 20 degrees, e.g., between -10 and 10 degrees, e.g., approximately 0 degrees, relative to the longitudinal direction of the cassette.

[0071] In one or more examples, the indexing ring is configured to rotate from a first rotational position (R1) to a second rotational position (R2) when the cassette is inserted into the automatic injector and one or more release members included in the automatic injector move proximally within the track.

[0072] In one or more examples, the indexing ring is rotatable from a second rotational position (R2) to a third rotational position (R3) upon proximal movement of one or more release members of the automatic injector from a first release member position within the cassette to a second release member position within the cassette.

[0073] In one or more examples, the index ring is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) by distal movement of the first needle safety cover following proximal movement of one or more release members of the automatic injector from a first release member position inside the cassette to a second release member position inside the cassette.

[0074] In one or more examples, when the index ring is in the third secondary rotational position (R3), the second index ring engagement finger no longer abuts at least one of the one or more release arms on the index ring, allowing proximal movement of the first needle safety cover and the second needle safety cover relative to the index ring to their final locked positions.

[0075] In one or more examples, in the initial position (PraIN), the first needle safety cover is prevented from moving proximally relative to the second needle safety cover. Similarly, in the released position (PraR), the first needle safety cover may be allowed to move proximally relative to the second needle safety cover. Proximal movement of the first needle safety cover may allow the needle attachment blocking system / needle safety cover portion to telescope. Telescopic extension by moving the first needle safety cover proximally relative to the second needle safety cover typically increases the distance between the proximal end of the first needle safety cover and the proximal end of the second needle safety cover when the first needle safety cover is positioned proximal to the second needle safety cover prior to telescopic extension.

[0076] Prior to securing the cassette within the auto-injector, the first and second needle safety covers may be permitted to move toward one another by compression of one or more cover springs, which may facilitate attachment of the needle assembly to the cassette.

[0077] In one or more examples, the first needle safety cover includes one or more cover locking tabs that lock the first needle safety cover in a final locked position by preventing distal movement of the first needle safety cover relative to the cassette housing.

[0078] In one or more examples, the second needle safety cover includes at least one flexible arm, the first needle safety cover includes a first locking tab, and the one or more release arms each include a protruding surface release portion that limits proximal movement of the first needle safety cover relative to the second needle safety cover in the initial position (PraIN) by preventing the at least one flexible arm from deflecting when it abuts the first locking tab. In this manner, telescopic movement of the two needle safety cover portions is limited by the one or more release arms.

[0079] In one or more examples, the second needle safety cover, the first needle safety cover, and the one or more release arms are configured to move distally relative to the syringe holder upon securing the needle assembly to the syringe holder. The needle safety cover portion / needle attachment blocking system may be configured to be pushed distally when a user secures the needle assembly to the cassette.

[0080] In one or more examples, the second needle safety cover, the first needle safety cover, and the one or more release arms each move different distances distally relative to the syringe holder when the needle assembly is secured to the syringe holder. The second needle safety cover, the first needle safety cover, and the one or more release arms each may move relative to one another when pressed distally to secure the needle assembly to the cassette. Alternatively, the two parts may move longitudinally the same distance.

[0081] In one or more examples, the needle assembly further includes a removable needle cap that covers and protects the needle prior to use, and after securing the needle assembly to the syringe holder and removing the needle cap, the one or more cover springs are adapted to urge the first needle safety cover proximally relative to the second needle safety cover, so that the first needle safety cover covers the needle in the ready-to-use position (PnsR). Thus, the proximal end of the needle attachment prevention system is in the ready-to-use position (PnsR). The one or more cover springs may alternatively be replaced by a spring system inside the auto-injector that acts on the first needle safety cover relative to the second needle safety cover after the cassette is attached to the auto-injector, as described above.

[0082] In one or more examples, after securing the needle assembly to the syringe holder, the one or more release arms are locked relative to the syringe holder.

[0083] In one or more examples, after securing the needle assembly to the syringe holder and removing the needle cap, when the one or more release arms are in the release position (PraR), the second needle safety cover is adapted to be moved proximally by the automatic injector while the one or more release arms are locked relative to the syringe holder. Proximal movement of the second needle safety cover relative to the one or more release arms can push the first needle safety cover and the second needle safety cover into a position where telescopic movement between the second needle safety cover portions is possible. Proximal movement of the second needle safety cover can cause the first needle safety cover to follow. Alternatively, proximal movement of the first needle safety cover can cause the second needle safety cover to follow.

[0084] In one or more examples, when the one or more release arms are in the released position (PraR) after securing the needle assembly to the syringe holder and removing the needle cap, the one or more cover springs are adapted to urge the first needle safety cover proximally relative to the second needle safety cover, moving the at least one flexible arm proximally, past the protruding surface release, to a position in which the at least one flexible arm is deflected, and allowing a first locking tab of the first needle safety cover to pass through the at least one flexible arm and, using the one or more cover springs, to urge the first needle safety cover to an extended position relative to the second needle safety cover. The proximal movement of the first needle safety cover in the above examples results in the second needle safety cover following.

[0085] In one or more examples, when the cassette is in the ready-to-use position (PnsR), the one or more locking arms are in the released position (PraR) and the needle safety cover portion / needle attachment blocking system is in a locked-cover position in which further relative longitudinal movement of the first needle safety cover relative to the second needle safety cover is prevented. The position in which the first needle safety cover is locked relative to the second needle safety cover does not prevent the two parts from moving together as one combined needle safety cover.

[0086] In one or more examples, the first needle safety cover includes a second locking tab positioned distally of the first locking tab, the second needle safety cover including a stop surface positioned proximally of the flexible arm, and in the locked cover position, the second locking tab abuts the flexible arm to prevent distal movement of the first needle safety cover relative to the second needle safety cover, and the first locking tab abuts the stop surface to prevent proximal movement of the first needle safety cover relative to the second needle safety cover, thereby locking the first needle safety cover relative to the second needle safety cover.

[0087] In one or more examples, the first needle safety cover is movable between a plurality of longitudinal positions relative to the syringe holder, the plurality of longitudinal positions comprising: ●Ready-to-use position (PnsR) and a drug delivery position (PnsD) where the needle is exposed, the drug delivery position (PnsD) being distal to the ready-to-use position (PnsR); ●A final locking position (PnsFL) in which further longitudinal movement of the first needle safety cover is prevented, the final locking position (PnsFL) being proximal to the drug delivery position (PnsD).

[0088] The ready-to-use position protects the user and / or healthcare professional delivering the medication to the patient from accidental contact with the needle before medication delivery begins, while the final locked position allows the injection needle to be covered after medication delivery, preventing unintentional contact with the needle after medication delivery.

[0089] In one or more examples, the first needle safety cover covers the needle in a ready-to-use position (PnsR).

[0090] In one or more examples, the final locked position (PnsFL) is proximal to the ready-to-use position (PnsR).

[0091] In one or more examples, distal movement of the one or more release members after medicament delivery rotates the indexing ring back to the first rotated position (R1), and the proximal end of the needle attachment blocking system and / or first needle safety cover is longitudinally locked in the final locked position (PnsFL), whereby the indexing ring can help secure the needle attachment blocking system and / or first needle safety cover in the final locked position after medicament delivery.

[0092] In one or more examples, the second needle safety cover further functions as a needle attachment blocking system, the needle attachment blocking system comprising: a locked position (PnsL) that prevents the needle from puncturing the seal before the cassette is secured to the auto-injector; a needle assembly connected position (PnsC) that allows piercing of the seal by the needle after securing the cassette within the auto-injector;

[0093] The movement of the second needle safety cover can be configured to be controlled by the auto-injector after the cassette is secured in the auto-injector. Therefore, any premature contact between the medication in the syringe compartment and the injection needle can be prevented. It is simply not possible for a user to secure the needle to the syringe and bring the needle into fluid contact with the medication before securing the cassette to the auto-injector. This prevents a situation in which a user would most likely connect a needle assembly to the cassette and puncture the seal in preparation for a quick injection at a later point in time.

[0094] In one or more examples, the needle assembly includes a removable needle cap, and removal of the needle cap when the proximal end of the needle attachment blocking system is in the drug delivery position (PnsD) allows the proximal end of the needle attachment blocking system to move proximally.

[0095] In one or more examples, the plurality of longitudinal positions between which the proximal end of the needle attachment prevention system can be moved further includes: the drug delivery position (PnsD) where the needle is exposed; a final locked position (PnsFL) in which further longitudinal movement of the needle attachment blocking system is prevented; The drug delivery position (PnsD) and the final locked position (PnsFL) are at the same longitudinal position, so that the needle attachment blocking system remains in the drug delivery position when locked after use.

[0096] In one or more examples, after medication delivery, distal movement of one or more release members of the automatic injector is configured to rotate the index ring back to the first rotational position (R1), and the proximal end of the needle attachment prevention system is longitudinally locked in the final locking position (PnsFL).

[0097] In one or more examples, when the index ring is in the second rotational position (R2), the one or more cover springs move the first needle safety cover proximally relative to the second needle safety cover to a locked cover position, in which further relative longitudinal movement between the first needle safety cover and the second needle safety cover is prevented by the one or more locking means.

[0098] In one or more examples, the one or more locking means include a first locking pair, and the first needle safety cover and the second needle safety cover include a first locking pair that prevents proximal movement of the first needle safety cover relative to the second needle safety cover.

[0099] In one or more examples, the one or more locking means includes a second locking pair, and the first needle safety cover and the second needle safety cover include a second locking pair that prevents distal movement of the first needle safety cover relative to the second needle safety cover.

[0100] In one or more examples, the needle safety cover may include: a locked position (PnsL) that prevents the needle from puncturing the seal before the cassette is secured to the auto-injector; a needle assembly connected position (PnsC) that allows piercing of the seal by the needle after securing the cassette within the auto-injector;

[0101] When the index ring is in the first rotational position (R1), the needle safety cover may be in a locked position (PnsL), and when the index ring is in the second rotational position (R2), the needle safety cover may be movable to a needle assembly connected position (PnsC) by distal movement of the needle safety cover.

[0102] In one or more examples, a needle safety cover according to the third aspect may include: Needle safety cover and - a second needle safety cover, wherein the first needle safety cover is displaceable relative to the second needle safety cover along the longitudinal direction.

[0103] In the initial position (PraIN), the first and second needle safety covers may be separated by up to a first separation distance, and in the released position (PraR), the first and second needle safety covers may be allowed to move relative to each other a second separation distance that is greater than the first separation.

[0104] In one or more examples, the cassette according to any of the embodiments having a two-part safety further includes one or more cover springs biased between the first needle safety cover and the second needle safety cover. The first needle safety cover may include a first index ring engagement finger, and the second needle safety cover includes a second index ring engagement finger. When the index ring is in the first rotational position (R1), the first index ring engagement finger and the second index ring engagement finger on the second needle safety cover normally abut against at least one of the one or more release arms on the index ring to prevent proximal movement of the first needle safety cover and the second needle safety cover relative to the index ring. When the index ring is in the second rotational position (R2), the first index ring engagement finger normally no longer abuts at least one of the one or more release arms on the index ring, and the one or more cover springs move the first needle safety cover proximally relative to the second needle safety cover to a locked cover position in which the first needle safety cover is configured to be prevented from further relative longitudinal movement between the first needle safety cover and the second needle safety cover.

[0105] In one or more examples, the first needle safety cover and the second needle safety cover include, in the locked cover position, a first locking pair that prevents proximal movement of the first needle safety cover relative to the second needle safety cover and a second locking pair that prevents distal movement of the first needle safety cover relative to the second needle safety cover.

[0106] In one or more examples, the first needle safety cover includes one or more housing locks that lock the first needle safety cover in a final locked position by preventing distal movement of the first needle safety cover relative to the cassette housing.

[0107] In one or more examples, the first needle safety cover includes one or more housing locks that lock the first needle safety cover in a final locked position by preventing distal movement of the first needle safety cover relative to the cassette housing.

[0108] In one or more examples, the one or more release arms are separate parts that do not form part of the indexing ring, the second needle safety cover, and the first needle safety cover.

[0109] A fourth aspect of the present disclosure further discloses a system for use with an automatic injector for administering a medication. The system includes a cassette according to the first, second, or third aspect and a syringe containing the medication. The syringe can include a seal at a proximal end of the syringe, the seal configured to be pierced by a distal end of a needle to establish fluid communication between the medication in the syringe and the needle. Prior to securing the cassette in the automatic injector, a first needle safety cover prevents the distal end of the needle from piercing the seal. The proximal end of the needle is configured to pierce the seal of the syringe, and the proximal end of the needle is configured to pierce an injection site.

[0110] The system may further include a needle assembly including a needle, a needle assembly adapter for securing the needle assembly to the syringe holder, and a removable needle cap for covering and protecting the needle.

[0111] The syringe may include a syringe compartment containing a drug. The compartment may be a one-chamber compartment. Alternatively, the syringe compartment may be a two-chamber compartment including a first sub-compartment containing a first drug component and a second sub-compartment containing a second drug component, with a second stopper separating the two sub-compartments. The first drug component and the drug in the second sub-compartment may be mixed prior to drug delivery by proximal movement of the second stopper.

[0112] The syringe can be a 1-3 mL syringe, e.g., a 1 mL, 2.25 mL, or 3 mL syringe. Examples include a 3 mL liquid single-chamber cartridge and a 1 mL dual-chamber cartridge. When referring to a 1 mL dual-chamber cartridge, the 1 mL may refer to the resulting reconstituted liquid drug to be injected, i.e., the total amount of drug after mixing. The syringe may further have a sleeve at the distal end of the syringe for easy attachment to a syringe holder.

[0113] In one or more examples, the system further includes an auto-injector, the auto-injector configured to receive the cassette.

[0114] The auto-injector may include one or more release members configured to move into the cassette when the cassette is received within the auto-injector.

[0115] In one or more examples, the needle assembly further includes a needle assembly shield configured to have a plurality of positions, the plurality of positions including: an initial delivery position of the needle assembly in which a needle assembly shield covers the needle; a drug delivery location where the needle is exposed; and a final locked position in which the needle assembly shield covers the needle.

[0116] In a fifth aspect of the present specification, an automatic injector for administering a drug is disclosed, the automatic injector being configured to receive either a cassette according to the first aspect, the second aspect, or the third aspect, and / or configured to receive a system according to the fourth aspect without requiring modification. This allows the automatic injector to be used with different types of cassettes without the need to change the automatic injector. Any necessary modifications depending on the requirements of the type of drug, differences in needle assembly design, etc., are included as modifications to the individual cassette. For example, alternative minor modifications to the electronic components of the automatic injector may be envisioned.

[0117] In a sixth aspect of the present specification, disclosed herein is a system including an automatic injector for administering a medication and a cassette according to the first, second, or third aspect. The system may further include a needle assembly including a needle, a needle assembly adapter for securing the needle assembly to a syringe holder, and a removable needle cap for covering and protecting the needle, and the needle attachment prevention system prevents the distal end of the needle from piercing the seal before securing the cassette to the automatic injector. The distal end of the needle is for penetrating the septum. The proximal end of the needle is for penetrating the injection site during medication delivery.

[0118] Various embodiments will now be described with reference to the drawings. Like reference numerals refer to like elements throughout. Therefore, like elements will not be described in detail with respect to the description of each figure. It should also be noted that the drawings are intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the claimed invention or as limiting the scope of the claimed invention. In addition, an illustrated example need not have all aspects or advantages shown. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and may be implemented in any other embodiment, even if not so illustrated. [Brief explanation of the drawings]

[0119] [Figure 1] 1 shows an exploded view of the different parts of a first example of a cassette. [Figure 2A] 1 shows the separate parts of the first cassette. [Figure 2B] 1 shows the separate parts of the first cassette. [Figure 2C] 1 shows the separate parts of the first cassette. [Figure 2D] 1 shows the separate parts of the first cassette. [Figure 2E] 1 shows the separate parts of the first cassette. [Figure 2F] 1 shows the separate parts of the first cassette. [Figure 2G]1 shows the separate parts of the first cassette. [Figure 2H] 1 shows the separate parts of the first cassette. [Figure 2I] 1 shows the separate parts of the first cassette. [Figure 3A] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3B] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3C] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3D] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3E] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3F] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3G] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3H] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3I] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3J] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3K] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 3L] 1 shows a partially cutaway perspective view of the first cassette during needle assembly attachment and drug delivery. [Figure 4A]The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4B] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4C] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4D] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4E] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4F] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4G] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4H] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4I] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4J] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4K] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 4L] The first cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 6A] 10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 6B] 10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 6C] 10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 6D] 10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 6E]10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 6F] 10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 6G] 10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 6H] 10 shows the second cassette during needle assembly attachment and drug delivery. [Figure 7] 6A-H show exploded views of the different parts of a second example of the cassette shown in FIGS. [Figure 8A] 10 shows the third cassette before connection to the needle assembly, while connection to the needle assembly, and after removal of the needle assembly. [Figure 8B] 10 shows the third cassette before connection to the needle assembly, while connection to the needle assembly, and after removal of the needle assembly. [Figure 8C] 10 shows the third cassette before connection to the needle assembly, while connection to the needle assembly, and after removal of the needle assembly. [Figure 8D] 10 shows the third cassette before connection to the needle assembly, while connection to the needle assembly, and after removal of the needle assembly. [Figure 8E] 10 shows the third cassette before connection to the needle assembly, while connection to the needle assembly, and after removal of the needle assembly. [Figure 8F] 10 shows the third cassette before connection to the needle assembly, while connection to the needle assembly, and after removal of the needle assembly. [Figure 9A] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 9B] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 9C] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 9D] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 9E] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 9F] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 9G] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 9H] 10 shows the third cassette during needle assembly attachment and drug delivery. [Figure 10A] 10 shows a dual chamber syringe for use with any of the shown examples of cassettes. [Figure 10B] 10 shows a dual chamber syringe for use with any of the shown examples of cassettes. [Figure 10C] 10 shows a dual chamber syringe for use with any of the shown examples of cassettes. [Figure 11] 10 shows an exploded view of the different parts of a fourth example of a cassette; [Figure 12A] 4 shows the separate parts of the first cassette. [Figure 12B] 4 shows the separate parts of the first cassette. [Figure 12C] 4 shows the separate parts of the first cassette. [Figure 12D] 4 shows the separate parts of the first cassette. [Figure 12E] 4 shows the separate parts of the first cassette. [Figure 12F] 4 shows the separate parts of the first cassette. [Figure 12G] 4 shows the separate parts of the first cassette. [Figure 13A] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13B] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13C] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13D]The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13E] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13F] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13G] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13H] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13I] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13J] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 13K] The fourth cassette is shown in cutaway view during needle assembly attachment and drug delivery. [Figure 14A] 10 shows a close-up view of the interaction between the first needle safety cover, the second needle safety cover, the index ring, and the syringe holder during the process of attaching the needle assembly to the syringe holder. [Figure 14B] 10 shows a close-up view of the interaction between the first needle safety cover, the second needle safety cover, the index ring, and the syringe holder during the process of attaching the needle assembly to the syringe holder. [Figure 14C] 10 shows a close-up view of the interaction between the first needle safety cover, the second needle safety cover, the index ring, and the syringe holder during the process of attaching the needle assembly to the syringe holder. [Figure 14D] 10 shows a close-up view of the interaction between the first needle safety cover, the second needle safety cover, the index ring, and the syringe holder during the process of attaching the needle assembly to the syringe holder. [Figure 14E]10 shows a close-up view of the interaction between the first needle safety cover, the second needle safety cover, the index ring, and the syringe holder during the process of attaching the needle assembly to the syringe holder. [Figure 14F] 10 shows a close-up view of the interaction between the first needle safety cover, the second needle safety cover, the index ring, and the syringe holder during the process of attaching the needle assembly to the syringe holder. [Figure 14G] 10 shows a close-up view of the interaction between the first needle safety cover, the second needle safety cover, the index ring, and the syringe holder during the process of attaching the needle assembly to the syringe holder. [Figure 15A] 1 shows an auto-injector configured to receive a cassette according to the first or second example, and shows the injector assembled. [Figure 15B] 1 shows an auto-injector configured to receive a cassette according to the first or second example, showing a view of the surface of the auto-injector in contact with the cassette; [Figure 16] 15A-B show exploded views of the auto-injector of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0120] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. In this regard, the embodiments may have different forms and should not be construed as limited to the description set forth herein. Accordingly, the embodiments are simply described below with reference to the drawings to illustrate aspects. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. Expressions such as "at least one," when preceding a list of elements, modify the entire list of elements, and not individual elements of the list.

[0121] In the drawings, the thicknesses of several layers and regions are shown in an exaggerated format for clarity and ease of illustration. When a layer, region, element, or plate is referred to as being "on" another layer, region, element, or plate, it may be directly on the other layer, region, element, or plate, or there may be intervening layers, regions, elements, or plates therebetween. Conversely, when a layer, region, element, or plate is referred to as being "directly on" another layer, region, element, or plate, there are no intervening layers, regions, elements, or plates therebetween. Furthermore, when a layer, region, element, or plate is referred to as being "under" another layer, region, element, or plate, it may be directly under the other layer, region, element, or plate, or there may be intervening layers, regions, elements, or plates therebetween. Conversely, when a layer, region, element, or plate is referred to as being "directly beneath" another layer, region, element, or plate, there are no intervening layers, regions, elements, or plates present.

[0122] The spatially relative terms "lower" or "bottom" and "upper" or "top," "below," "beneath," "less," "above," and the like may be used for ease of description to describe the relationship between one element or component and another element or component as shown in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if a device shown in the figures is rotated, an element described as being on the "lower" side of other elements, or another element "below" or "lower," would be oriented on the "upper" side of, or "above," the other element. Thus, the exemplary terms "lower" or "lower" can encompass both "lower" and "upper" orientations, depending on the particular orientation of the figure. Similarly, if the device in one of the figures were turned over, elements described as "below" or "lower" of other elements would be oriented "above" the other elements. Thus, the exemplary terms "below" or "lower" can encompass both an orientation of above and below, and thus, spatially relative terms may be interpreted differently depending on the orientation described.

[0123] Throughout this specification, when an element is said to be "connected" to another element, the element may be "directly connected" to the other element or "electrically connected" to the other element with one or more intervening elements therebetween.

[0124] The terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" may also be intended to include "at least one," unless the context clearly indicates otherwise. "At least one" should not be interpreted as limiting "a" or "an." It will be further understood that the terms "comprises," "comprising," "includes," and / or "including" specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0125] It will be understood that the terms "first," "second," "third," etc. may be used herein to describe various elements, but these elements should not be limited by these terms. These terms are used only to distinguish one element from another. Thus, a "first element" described below may be referred to as a "second element" or a "third element," and "second element" and "third element" may be similarly referred to without departing from the teachings of this specification.

[0126] As used herein, "about" or "approximately" encompasses stated values ​​and means within an acceptable range of deviation for a particular value as determined by one of ordinary skill in the art, and encompasses the error associated with the measurement and measurement of the particular quantity (i.e., the limitations of the measurement system). For example, "about" can mean within one or more standard deviations, or within ±30%, 20%, 10%, 5% of the stated value.

[0127] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0128] Illustrative examples are described herein with reference to cross-sectional illustrations that are schematic illustrations of idealized embodiments, where like reference numerals refer to like elements throughout. As such, variations from the shapes of the illustrations are to be expected as a result, for example, of manufacturing techniques and / or tolerances. Accordingly, the embodiments described herein should not be construed as limited to the particular shapes of regions as illustrated herein but are to include, for example, deviations in shapes that result from manufacturing. For example, a region illustrated or described as flat may have rough and / or non-linear features. Furthermore, sharp angles shown may be rounded. Accordingly, regions illustrated in the figures are schematic in nature, and their shapes are not intended to illustrate the precise shape of the regions and are not intended to limit the scope of the claims. To specifically illustrate illustrative embodiments of the present disclosure, some components not associated with the description may not be provided.

[0129] Proximal end / proximal face means the end / surface that points towards the needle, i.e., the end of the cassette that is closest to the injection site during drug delivery. Distal end / distal face means the end / surface that points away from the needle, i.e., the opposite end from the end of the cassette that is closest to the injection site during drug delivery.

[0130] FIG. 1 shows an exploded view of the different parts of a first example of a cassette 100, and FIGS. 2A-I show the separate parts of the cassette shown in FIG. 1 enlarged for a clearer view. The cassette 100 includes a syringe holder 300 for receiving a syringe 200, a first needle safety cover 410, a second needle safety cover 440, a release arm 480, a cover spring 470, and an index ring 500. The first needle safety cover 410, the second needle safety cover 440, the release arm 480, and the cover spring 470 are part of a needle safety cover assembly 400. The needle safety cover assembly 400 is a nested assembly, and the distance between the two needle safety cover parts 410, 440 can vary. The first needle safety cover 410 and the second needle safety cover 440 extend around the syringe holder 300.

[0131] 2A and 10A , the syringe 200 extends from a proximal end 202 to a distal end 204. The medication is contained within syringe compartments 206, 206d that extend between the proximal and distal ends 204 of the syringe 200. The proximal end of the syringe 200 includes a seal / septum 208 that, when pierced by a needle 222 in a needle assembly 220, defines a syringe outlet 209 for the medication to exit the syringe compartments 206, 206d. Inside the syringe compartments 206, 206d is a first stopper 212 that, when moved proximally, pushes the medication out of the syringe outlet 209. Typically, the first stopper 212 is pushed proximally by a plunger rod 1018 included in an auto-injector 1000 to which the cassette 100 having the syringe 200 is attached.

[0132] A single chamber syringe 200 as shown in Figure 2A may be used. Alternatively, a dual chamber syringe 200d as shown in Figures 10A-C may be used.

[0133] In the dual-chamber syringe 200d, the syringe compartment 206d includes two subcompartments 214, 216. One subcompartment 216 may contain a liquid pharmaceutical component, and the other may contain a solid / powder component 214. Such a cartridge may be referred to as a liquid-powder two-compartment cartridge. Alternatively, two different liquid components may be found in each subcompartment 214, 216, one liquid. Such a syringe 200d may be referred to as a liquid-liquid two-compartment cartridge. The two subcompartments 214, 216 may be separated by a second stopper 218. The liquid pharmaceutical component is typically located between the two stoppers 212, 218. When the first stopper 212 is moved proximally, the second stopper 218 is typically moved to a bypass region 217, allowing the two pharmaceutical components to contact and mix with each other. In the bypass region 217, liquid components found in the sub-compartment 216 between the two stoppers 212, 218 can pass proximal to the second stopper 218 and enter the most proximal sub-compartment 214, where they are mixed with the solid / powder / liquid components within this sub-compartment 214. Further movement of the first stopper 212 pushes the second stopper 218 and the mixed drug proximally for drug delivery.

[0134] As an alternative to the bypass region and mixing of the two drug components, sequential delivery may also be envisioned. In such a scenario, the cartridge is typically a liquid-liquid two-compartment cartridge, with the drug in the most proximally positioned sub-compartment being delivered first and the drug in the most distally positioned sub-compartment being delivered second. The cartridge may include one or more internal needles for piercing a second stopper to provide access to the drug in the most distally positioned sub-compartment.

[0135] The needle assembly 220 shown in FIG. 2B includes a needle 222 and a needle hub 224 through which the needle 222 extends. The needle 222 protrudes from both ends of the needle hub 224. A proximal end 232 of the needle 222 is inserted into an injection site, i.e., a patient, during drug delivery. When the needle assembly 220 is secured to the syringe 200, a distal end 234 (see FIG. 4A ) of the needle 222 penetrates a septum 208 in the syringe 200, 200d, establishing a syringe outlet 209. The needle assembly 220 further includes a needle assembly adapter 226 that can secure the needle assembly 220 to a syringe holder 300. Prior to use, the needle 222 is protected by a needle cap 228, e.g., a rigid needle shield.

[0136] The syringe holder 300 shown in FIG. 2C extends between a proximal end 302 and a distal end 304. Typically, the syringe holder 300 is longitudinally locked to the cassette housing 600 shown in FIG. 2I. The proximal end 302 of the syringe holder 300 includes a needle assembly locking portion 306 for connecting the needle assembly 220 to the syringe holder 300. The needle assembly locking portion 306 on the syringe holder 300 connects to the needle assembly adapter 226 on the needle assembly 220 via a threaded connection. The connection between the two components may be any other type of connection that allows the needle assembly 220 to be secured to the syringe holder 300. A press-fit connection is one such example. Furthermore, a press-fit connection may be the result of a specialized needle being combined with a threaded interface such that the specialized needle effectively slides over the threads without the user having to induce rotation. At the end of the sliding movement, the interface in the thread and the needle hub can ensure that the special needle cannot be easily withdrawn again. Alternatively, a bayonet locking principle can also be envisaged. In the case of the bayonet locking principle, the user typically performs a combination of pressing the needle assembly against the syringe holder and possibly slightly rotating the needle assembly relative to the syringe holder.

[0137] Syringe holder 300 includes an elongated tubular portion 308 within which syringe 200, 200d is viewed when syringe 200, 200d is installed within syringe holder 300. Elongated tubular portion 308 has multiple openings, including two windows 312 for inspection of syringe 200, 200d. Elongated tubular portion 308 also has two release arm receiving channels 314, each for receiving a release arm 480 (see FIG. 2G for release arms). Release arm receiving channels 314 are closed at their distal ends to provide release arm blocking surfaces 315 that prevent further distal movement of release arm 480 when distal end 484 of release arm 480 abuts release arm blocking surfaces 315.

[0138] The distal end 304 of the syringe holder 300 has a distal ring portion 316. The distal ring portion 316 includes a plunger opening 318 through which a plunger rod 1018 from the auto-injector 1000 can pass. The plunger opening 318 also allows a syringe 200, 200d to be inserted into the syringe holder 300. The distal ring portion 316 also has two release member openings 319 through which the release member 1006 of the auto-injector can pass after the cassette 100 is assembled into the auto-injector 1000.

[0139] Along the elongated tubular portion 308 is a further index ring receiving opening 310 for receiving at least a portion of the index ring locking protrusion 506 of the index ring 500. The index ring locking protrusion 506 is capable of rotating within the index ring receiving opening 310.

[0140] 2D extends between a proximal end 412 and a distal end 414 and has a tubular shape. The proximal end 412 has an opening 426 in a proximally positioned face plate 424, through which the needle assembly 220 can be attached to the syringe holder 300. When connecting the needle assembly 220 to the syringe holder 300, the needle cap 228 in the needle assembly 220 abuts the proximal surface of the face plate 424 of the first needle safety cover 410. When the first needle safety cover 410 is in the unlocked initial position Pns1IN, a user can therefore push the first needle safety cover 410 distally relative to the syringe holder 300 by pushing the needle assembly 220 distally. The first needle safety cover 410 extends at least partially around the second needle safety cover 440. Thereby, the distal surface of the face plate 424 of the first needle safety cover 410 contacts the proximal end 442 of the second needle safety cover 440 when the first needle safety cover 410 is pushed distally before the two needle safety cover parts are in the extended lock position Pns12L.

[0141] The face plate 424 is positioned a short distance distal to the proximal end 412 of the first needle safety cover 410. A narrow inner support surface 428 is created proximal to the face plate 424 on the inner surface of the tubular first needle safety cover 410. The inner support surface 428 can be used to support the needle assembly 220 prior to connecting the needle assembly 220 to the syringe holder 300. In this way, the needle assembly 220 and the cassette 100 can be delivered as a combined kit, with the needle 222 not yet piercing the septum 208.

[0142] The first needle safety cover 410 includes a first locking tab 416. The first locking tab 416 has a proximal sloped surface 417. The first needle safety cover 410 further includes a second locking tab 420. Both locking tabs 416, 420 are positioned on the inside surface of the first needle safety cover 410. The first locking tab 416 is proximal to the second locking tab 420. The second locking tab 417 similarly has a proximal sloped surface 421. The sloped surfaces 417, 421 allow a flexible arm 446 on the second needle safety cover 440 to move along and pass through the first sloped surface 417 and the second sloped surface 421, facilitating proximal movement of the first needle safety cover 410 relative to the second needle safety cover 440. The distal surface 418 of the first locking tab 416 and the distal surface 422 of the second locking tab 420 prevent distal movement of the first needle safety cover 410 relative to the second needle safety cover 440 once the flexible arm 446 moves past either of the two locking tabs 416, 420. The distal locking tab surfaces 418, 422 are typically approximately perpendicular to the longitudinal axis of the cassette 100 or are angled in a direction that prevents proximal movement of the flexible arm when the flexible arm 446 is positioned to abut the distal locking tab surfaces 418, 422.

[0143] The first needle safety cover 410 includes two cover lock tabs 430 that protrude distally and radially outward from the tubular cover. The distal end 431 of each cover lock tab 430 rests against a housing lock protrusion 606 inside the cassette housing 600 (see cassette housing in FIG. 2I). The cover lock tabs 430 are flexible, allowing the two distal ends 431 to flex radially inward toward each other. This allows the first needle safety cover 410 to be pushed proximally relative to the cassette housing 600 to its extended position after medication injection. The cover lock tabs 430 move along inclined surfaces 608 on the housing lock protrusions 606 when the first needle safety cover 410 moves relative to the cassette housing 600 to its extended position. The proximal surface 610 of the housing locking protrusion 606 prevents the cover locking tab 430 from moving distally when the cover locking tab 430 is moved to a position proximal to the housing locking protrusion 606. This locks the first needle safety cover 410 in an extended position where the needle 222 is covered by the first needle safety cover 410 after drug delivery.

[0144] Further visible at the distal end 414 of the first needle safety cover 410 are two distally extending pins 432. Surrounding each pin 432 is the proximal end 472 of a cover spring 470 (see close-up of the cover springs in FIG. 2E). The distal end 474 of each cover spring 470 extends around a proximally extending pin 454 on the second needle safety cover 440. Each pin 432, 454 supports the cover spring 470, although other support means, such as inwardly projecting channels or exterior surfaces on the cover portions 410, 440, can be used instead of pins for support. Furthermore, although two sets of pins / springs are shown, the cassette can also be constructed using only one set of pins / springs or a single spring.

[0145] The second needle safety cover 440 is shown in an enlarged view in Figure 2F. The second needle safety cover 440 extends between a proximal end 442 and a distal end 444. The second needle safety cover 440 has a tubular portion 452. The first needle safety cover 410 extends at least partially around the tubular portion 452 of the second needle safety cover 440. A flexible arm 446 extends distally from the proximal end 442 of the needle safety cover 440. A distal end 447 of the flexible arm 446 has an angled surface 448 that contacts the angled surfaces 417, 421 on the locking tabs 416, 420 of the first needle safety cover 410 when the two needle safety cover portions 410, 440 are moved away from each other. When either locking tab 416, 420 moves proximally beyond flexible arm 446, distal rearward movement of locking tab 416, 420 is prevented by proximal stop surface 449 on flexible arm 446. When both second locking tabs 420 move to a position proximal to distal end 447 of flexible arm 446, stop surface 450 prevents further telescoping separation of the two needle safety cover portions 410, 440 when first locking tab 416 abuts stop surface 450.

[0146] When the release arm 480 is in the initial position PraIN relative to the syringe holder 300, telescopic movement of the two needle safety cover parts 410, 440 away from each other is prevented by the release arm 480. In the initial position PraIN, the release arm 480 prevents the flexible arm 446 from deflecting and prevents the locking tabs 416, 420 of the first needle safety cover 410 from being able to move proximally beyond the angled surface 448 of the flexible arm 446.

[0147] The tubular portion 452 has an inspection opening 458 for inspecting the syringe 200, 200d. The flexible arm 446 is positioned inside the inspection opening 458. Extending distally from the tubular portion 452 is a distally extending pin 456. A proximally extending pin 454, about which a cover spring 470 is positioned, extends from a proximal end face of the distally extending pin 456. The second needle safety cover 440 has distally extending pins 456, typically symmetrically on both sides of the second needle safety cover 440, and similarly has inspection openings 458 on both sides.

[0148] The distal end 457 of the distally extending pin 456 interacts with the automatic injector 1000, possibly by activating a sensor that notifies the automatic injector 1000 that the cassette 100 is secured within the automatic injector 1000.

[0149] The distally extending pin 456 includes a first locking recess 460 and a safety cover locking protrusion 462. The safety cover locking protrusion 462 is positioned distal to the first locking recess 460. The first locking recess 460 and the safety cover locking protrusion 462 interact with and mate with an indexing ring 500. The indexing ring 500 (see FIG. 2H) includes an indexing ring locking protrusion 506 and is secured inside the first locking recess 460 prior to securing the cassette 100 within the auto-injector. When the indexing ring locking protrusion 506 is fully positioned within the first locking recess 460, the second needle safety cover 440 is longitudinally locked to the indexing ring 500. Since the index ring 500 is normally longitudinally locked to the syringe holder 300, the second needle safety cover 440 is longitudinally locked to the syringe holder 300 when the index ring locking protrusion 506 is fully positioned within the first locking recess 460.

[0150] The indexing ring 500 is rotatable relative to the second needle safety cover 440. Rotation of the indexing ring 500 is controlled by the movement of one or more release members 1006 in the automatic injector 1000 into and out of the cassette 100. As the indexing ring 500 is rotated from an initial first rotational position R1 to a second rotational position R2, the indexing ring locking protrusion 506 moves to a position where it no longer prevents the second needle safety cover 440 from moving distally. In the second rotational position R2, the second needle safety cover 440 is still prevented from moving proximally by the safety cover locking protrusion 462. The safety cover locking protrusion 462 extends radially further than the surface 464 of the distally extending pin 456 found proximal to the first locking recess 460. In some instances, there is no difference between the first locking recess 460 and the surface 464. In the second rotational position R2, the second needle safety cover 440 can be pushed distally, thereby securing the needle assembly 220 to the syringe holder 300.

[0151] Further rotational movement of the indexing ring 500 from the second rotational position R2 to a third rotational position R3 completely removes the indexing ring locking protrusion 506 from contact with the safety cover locking protrusion 462 and the first locking recess 460. In the third position R3, the second needle safety cover 440 is permitted to move proximally relative to the syringe holder 300. Typically, the auto-injector 1000 rotates the indexing ring 500 to the third rotational position R3 when medication delivery is initiated by proximal movement of the plunger rod 1018 within the auto-injector.

[0152] When the user removes the cassette 100 and auto-injector 1000 system from the injection site, the needle safety cover spring system 1026 within the auto-injector 1000 pushes the second needle safety cover 440 proximally to the extended position. After medication delivery, the auto-injector 1000 retracts the one or more release members 1006. Retraction of the one or more release members 1006 rotates the indexing ring 500 from the third rotational position R3 to the first rotational position R1. When the indexing ring 500 has rotated to the first rotational position R1, the cassette is in the final locked position PnsFL, where the two needle safety cover portions 410, 440 are prevented from moving distally. This is because the safety cover locking protrusion 462 is now proximal to the indexing ring locking protrusion 506 and prevents distal movement of the second needle safety cover 440.

[0153] The second needle safety cover 440 further includes a proximal end surface 465 against which the first needle safety cover 410 abuts when the needle assembly 220 is secured to the syringe holder 300 .

[0154] 2G each extend between a proximal end 482 and a distal end 484. The distal end 484 of each release arm 480 has two flexible fingers 490 that can bend toward each other. The release arms 480 are positioned within release arm receiving channels 341 in the syringe holder 300. As the release arms 480 move distally inside the release arm receiving channels 341 from an initial position PraIN to a released position PraR, the flexible fingers 490 on each release arm 480 are urged toward each other by the constriction of the release arm receiving channels 341. The release arm receiving channels 314 are closed at their distal ends and provide release arm blocking surfaces 315 that prevent further distal movement of the flexible fingers 490 when they abut against the release arm blocking surfaces 315. At the proximal end 482 of the release arm 480, the release arm 480 bends toward the center of the cassette 100, as seen when the release arm 480 is positioned within the release arm receiving channel 341. Instead of two separate release arms 480, a release ring with a tubular ring portion connecting the release arms may also be envisioned. Using only one release arm is also an option.

[0155] The protruding surface release 486 on the release arm 480 is found on the outward-facing surface when the release arm 480 is positioned within the release arm receiving channel 341. In the initial position PraIN, the protruding surface release 486 is located more distally than when in the released position PraR. In the initial position PraIN, the protruding surface release 486 prevents proximal movement of the first needle safety cover 410 because the flexible arm 446 on the second needle safety cover 440 cannot deflect to allow passage of the first locking tab 416 on the first needle safety cover 410. When the release arm 480 is moved to the released position PraR, the flexible arm 446 on the second needle safety cover 440 can deflect, allowing the first needle safety cover 410 to be pushed into an extended position relative to the second needle safety cover 440 by pressure from the cover spring 470 between the two needle safety covers 410, 440.

[0156] The indexing ring 500 extends from a proximal end 502 to a distal end 504, as shown in FIG. 2H. The indexing ring 500 is positioned around the syringe holder 300 and is typically longitudinally locked to the syringe holder 300. The indexing ring 500 is rotatably movable relative to the syringe holder 300 between a plurality of rotational positions, including at least a first rotational position R1, in which the second needle safety cover 440 is prevented from moving distally, and a second rotational position R2, in which the second needle safety cover 440 is movable distally. The rotational positions are shown in FIGS. 3A-L and 4A-L.

[0157] Indexing ring 500 has two indexing ring locking protrusions 506 each positioned at the distal end of an indexing ring arm 508. The release function of indexing ring locking protrusions 506 is described above.

[0158] Indexing ring 500 further includes a tubular indexing ring portion 510 that extends around syringe holder 300. Indexing ring 500 further includes a surface region 512 that partially forms part of tubular indexing ring portion 510. Surface region 512 includes a track 514 that extends from a first corner 516 of surface region 512 to a second corner 518 of surface region 512. Track 514 extends in an angular direction from first corner 516 to second corner 518. The angular direction is typically 20 to 70 degrees, for example, 30 to 60 degrees, for example, 35 to 55 degrees, for example, 40 to 50 degrees, or approximately 45 degrees, relative to the longitudinal direction of the cassette.

[0159] 2H, the track 514 includes a first track section 520, a second track section 522, and a third track section 524. The first track section 520 extends from a first corner 516 in a first angular direction toward a first midpoint 526, the second track section 522 extends from the first midpoint 526 to a second midpoint 528 in a second angular direction along the longitudinal direction of the cassette, and the third track section 524 extends from the second midpoint 528 in a third angular direction toward the second corner 518. The first angular direction and / or the third angular direction are typically inclined directions and have an angle of 20 to 70 degrees, for example, 30 to 60 degrees, for example, 35 to 55 degrees, for example, 40 to 50 degrees, or approximately 45 degrees, with respect to the longitudinal direction of the cassette. The second track section 522 is typically a plateau track section having a second angular orientation of -20 to 20 degrees, for example -10 to 10 degrees, for example approximately 0 degrees, relative to the longitudinal direction of the cassette.

[0160] The rotational position of the indexing ring locking protrusion 506, and therefore the rotational position of the indexing ring 500 relative to the second needle safety cover 440, is controlled by one or more release members 1006 within the auto-injector 1000 when the cassette 100 is secured within the auto-injector 1000. More specifically, the indexing ring 500 is configured to rotate from a first rotational position R1 to a second rotational position R2 to a third rotational position R3 when the cassette 100 is inserted into the auto-injector 1000 and the track guide protrusions 1008 of the one or more release members 1006 move proximally within the tracks 514. When the track guide protrusions 1008 again move distally, the indexing ring 500 rotates from the third rotational position R3 to the second rotational position R2 and then back to the first rotational position R1. Thus, by withdrawing the release member 1006 with the track guide protrusion 1008 back into the auto-injector, the indexing ring is rotated back to its initial rotational position R1.

[0161] 2I, cassette housing 600 extends from proximal end 602 to distal end 604 and has an opening 612 at distal end 604 through which indexing ring 500, needle safety cover portions 410, 440, and syringe holder 300 are attached. When cassette 100 is assembled, cassette housing 600 at least partially, if not completely, encloses syringe holder 300, syringes 200, 200d when positioned within syringe holder 300, needle safety cover portions 410, 440, and indexing ring 500. Syringe holder 300 will typically be longitudinally and rotationally locked to cassette housing 600. The cassette housing 600 has an inspection window 614 on at least one surface side, which allows a user to inspect the syringe compartments 206, 206d containing the medication when the syringes 200, 200d are installed in the cassette 100. The cassette 100 may be symmetrically configured so that it can be installed in the auto-injector 1000 in different orientations. A cassette locking tab 616 is located on the distal end 604 of the cassette housing 600. The cassette locking tab 616 is flexible and is used to secure the cassette 100 in the auto-injector 1000.

[0162] Housing locking protrusions 606 on the inside of cassette housing 600 interact with cover locking tabs 430 on first needle safety cover 410 as described above.

[0163] 3A-L show a partially cutaway perspective view of the cassette 100 during needle assembly 220 attachment and drug delivery, and FIGS. 4A-L show a central cross-sectional view of the cassette 100. As shown in FIGS. 3A and 4A, the cassette 100 extends from the proximal end 102 to the distal end 104. In FIGS. 3A and 4A, the cassette 100 is in a delivery state prior to attachment of the needle assembly 220. The proximal end 412 of the first needle safety cover 410 protrudes slightly outside the cassette housing 600. The first needle safety cover 410 is pushed proximally by the cover spring 470. However, further proximal movement of the first needle safety cover 410 to the fully extended position Pns12L, in which the two needle safety cover portions 410, 440 are locked relative to each other, is prevented by the release arm 480.

[0164] 3B and 4B, the needle assembly 220 rests against the inner support surface 428 and the proximally positioned face plate 424. In FIGS. 3C and 4C, the needle assembly 220 and first needle safety cover 410 have been pushed distally, bringing the proximally positioned face plate 424 of the first needle safety cover 410 into contact with the proximal end 442 of the second needle safety cover 440. Further distal movement of the two needle safety cover parts 410, 440 is prevented by the indexing ring 500, which longitudinally locks the second needle safety cover 440. In this position, the needle assembly 220 cannot be connected to the syringe holder 300, and the needle safety cover parts 410, 440 function as a needle assembly blocking system.

[0165] In Figures 3D and 4D, the indexing ring 500 has been rotated from a first rotational position R1, as shown in Figures 3A-C, to a second rotational position R2 by a release member 1006 (not shown) of the auto-injector 1000, which moves within the cassette 100 and rotates the indexing ring 500. As shown in Figures 3E and 4E, securing the needle assembly 220 to the syringe holder 300 allows distal movement of the two needle safety cover portions 410, 440. Securing the needle assembly 220 to the syringe holder 300 pushes the release arm 480 distally from its initial position PraIN (shown in Figures 3A and 4A-D) to its released position PraR. When the needle cap 228 is removed from the needle assembly 220, the cover spring 470 pushes the first needle safety cover 410 proximally, forcing the second needle safety cover 440 to follow suit. This is shown in Figures 3F and 4F. Depending on the strength of the cover springs 470, the movement pattern of the two needle safety covers 410, 440 may vary. If the two cover springs 470 have a higher spring force than the needle safety cover spring system 1026 in the auto-injector 1000 acting on the second needle safety cover 440, the two cover springs 470 will expand first, and the second needle safety cover 440 will initially stay behind. Alternatively, if the two cover springs 470 have a lower spring force than the needle safety cover spring system 1026 in the auto-injector 1000 acting on the second needle safety cover 440, the two needle safety covers 410, 440 will initially move simultaneously to the end stops for the needle safety cover spring system 1026, after which the cover springs 470 will expand for their respective end positions of the first needle safety cover, as shown in FIG. 3F.

[0166] When the safety cover locking protrusion 462 of the second needle safety cover 440 contacts the indexing ring locking protrusion 506, the second needle safety cover 440 is prevented from further proximal movement, as shown in FIGS. 3G and 4G. However, because the release arm 480 is in the release position PraR, the first needle safety cover 410 is allowed to continue proximal movement, bringing the first needle safety cover 410 to the extended position, as shown in FIGS. 3H and 4H. In this fully extended position Pns12L, the first needle safety cover 410 and the second needle safety cover 440 form a single combined needle safety cover 408 that is locked relative to one another and allowed to move distally as a single item. Distal movement of the combined needle safety cover 408, shown in FIGS. 3I and 4I, is initiated when the user presses the cassette against the injection site for medication delivery.

[0167] The auto-injector can detect that the combined needle safety cover 408 has been pushed distally, for example, by a switch that is activated when the distal end 457 of the distally extending pin 456 contacts the needle safety cover pin 1024 to activate drug delivery. Alternatively, the user can manually press a button on the auto-injector 1000 to activate drug delivery. During activation of drug delivery, the indexing ring 500 is rotated by the release member 1006, which moves further into the cassette 100 and further rotates the indexing ring 500. This is shown in FIGS. 3J and 4J.

[0168] The needle safety cover spring system 1026 within the automatic injector 1000 pushes the syringe needle safety cover pin 1024 proximally. The syringe needle safety cover pin 1024 then contacts the distal end 457 of one of the distally extending pins 456 on the second needle safety cover 440. During medication delivery, the syringe needle safety cover pin 1024 moves proximally and the needle safety cover spring system 1026 is biased. When the user removes the cassette from the injection site after medication delivery is complete, the combined needle safety cover 408 is pushed proximally by the needle safety cover spring system 1026. With the indexing ring 500 in the third rotational position R3, the combined needle safety cover 408 is now allowed to move onto the syringe over the needle 222. This is shown in FIGS. 3K and 4K. The first needle safety cover 410 is locked into position inside the cassette housing 600, as seen most clearly in FIG. 4K. When the release member 1006 is retracted distally again into the auto-injector 1000, the indexing ring 500 rotates back to the first rotational position R1, where it prevents distal movement of the combined needle safety cover 408, as shown in FIGS. 3L and 4L. The cassette 100 is now locked in a position where the needle 222 is protected and can be removed from the auto-injector 1000.

[0169] FIG. 5A shows an alternative example of a second needle safety cover 440′ in which there is no difference between the first locking recess 460 and the surface 464. This means that the second needle safety cover 440′ can be pushed distally, thereby securing the needle assembly 220 to the syringe holder 300 in both the first rotational position R1 and the second rotational position R2 of the indexing ring 500. This can be seen by comparing FIGS. 5B and 5C. Further rotational movement of the indexing ring 500 from the second rotational position R2 to the third rotational position R3 completely removes the indexing ring locking protrusion 506 from contact with the safety cover locking protrusion 462 and the first locking recess 460. Typically, the auto-injector 1000 rotates the indexing ring 500 to the third rotational position R3 when medication delivery is initiated by proximal movement of the plunger rod 1018 within the auto-injector. The drug delivery position is shown in Figure 5D, and the final locked position after drug delivery is shown in Figure 5E.

[0170] Figures 6A-H show a second cassette 100b during attachment of needle assembly 220b and during drug delivery. Figure 7 shows an exploded view of the different parts of a second example of cassette 100b and a second example of needle assembly 220b. The same reference numbers are used for similar parts, although similar parts are marked with a "b." Cassette 100b extends from a proximal end 102b to a distal end 104b, as shown in Figure 6A.

[0171] 1, 2A-I, 3A-L, and 4A-L, needle assembly 220b configured to be connected to second cassette 100b includes a needle assembly shield 235b that is deflectable distally to expose needle 222b. A needle assembly shield spring (not shown) pushes needle assembly shield 235b proximally after use to protect needle 222b. Other components of needle assembly 220b also include a needle hub 224b, a needle assembly adapter 226b, and a needle cap 228b. Needle cap 228b is removable from needle assembly 220b after securing needle assembly 200b to syringe holder 300 by securing needle assembly adapter 226b to needle assembly lock 306 of syringe holder 300.

[0172] In comparison to cassette 100 shown and described in Figures 1, 2A-I, 3A-L, and 4A-L, cassette 100b, shown in an exploded view in Figure 7, lacks a telescoping assembly but instead includes an integrated needle attachment blocking system 400b. Needle attachment blocking system 400b includes components similar to second needle safety cover 440 as shown and described in Figures 1, 2A-I, 3A-L, and 4A-L. Needle attachment blocking system 400b extends from a proximal end 402b to a distal end 404b.

[0173] Needle attachment blocking system 400b has a tubular portion 452b. Extending distally from tubular portion 452b is a distally extending pin 456b. Needle attachment blocking system 400b is generally symmetrical, including a distally extending pin 456b on each side of needle attachment blocking system 400b.

[0174] The distal end 457b of the distally extending pin 456b interacts with the auto-injector 1000, possibly by activating a sensor that notifies the auto-injector 1000 that the cassette 100b has been secured within the auto-injector 1000. Alternatively, the cassette insertion detection sensor system may be located at a different location within the auto-injector 1000.

[0175] The distally extending pin 456b includes a first locking recess 460b and a blocking system locking protrusion 462b. The blocking system locking protrusion 462b is positioned distal to the first locking recess 460b. The first locking recess 460b and the blocking system locking protrusion 462b interact with and mate with the indexing ring 500. The indexing ring 500 (see FIG. 2H) includes an indexing ring locking protrusion 506 and is secured inside the first locking recess 460b prior to securing the cassette 100b within the auto-injector 1000. When the indexing ring locking protrusion 506 is fully positioned within the first locking recess 460b, the needle attachment blocking system 400b is longitudinally locked to the indexing ring 500. Since the index ring 500 is normally longitudinally locked to the syringe holder 300, the needle attachment prevention system 400b is longitudinally locked to the syringe holder 300 when the index ring locking protrusion 506 is fully positioned within the first locking recess 460b.

[0176] The indexing ring 500 is rotatable relative to the needle attachment blocking system 400b. Rotation of the indexing ring 500 is controlled by the movement of one or more release members 1006 in and out of the cassette 100b within the automatic injector 1000. As the indexing ring 500 is rotated from an initial first rotational position R1 to a second rotational position R2, the indexing ring locking protrusion 506 moves to a position where it no longer prevents the needle attachment blocking system 400b from moving distally. This can be seen by comparing FIGS. 6A-C. In the second rotational position R2, the needle attachment blocking system 400b is prevented from moving proximally by the blocking system locking protrusion 462b. The blocking system locking protrusion 462b extends radially further than the surface 464b of the distally extending pin 456b found proximal to the first locking recess 460b. In some instances, there is no difference between the first locking recess 460b and the surface 464b. In the second rotational position R2, the needle attachment blocking system 400b can be pushed distally, thereby securing the needle assembly 220b to the syringe holder 300. In Figure 6C, the needle attachment blocking system 400b is pushed distally and the needle assembly 220b is attached.

[0177] 6A-H illustrate the second cassette 1000 during needle assembly 220b installation and drug delivery, as well as its interaction with the auto-injector 1000 during the process. The rotation of the indexing ring 500 by the release member 1006 within the injector 1000 can be seen by comparing FIGS. 6A-H. In FIG. 6A, the cassette 100b has just been installed within the auto-injector 1000. In FIG. 6B, the auto-injector 1000 detects the presence of the cassette 100b, locks the cassette 100b to the auto-injector 1000, and moves the release member 1006 proximally, rotating the indexing ring 500 to a second rotational position R2. As shown in FIG. 6C, pushing the needle assembly 220b distally to secure it to the cassette 100b activates the switch 1032. This causes the release member 1006 to move further proximally, rotating the indexing ring 500 to a third rotational position R3, as shown in FIG. 6D. When the needle cap 228b is removed, the needle attachment blocking system 400b moves proximally, as shown in FIG. 6E. To deliver a medication, the auto-injector 1000 and cassette 100b system is pressed against the patient's skin, pushing the needle assembly shield 235b of the needle assembly 220b distally. This is seen in FIG. 6F. After medication delivery, the release member 1006 within the injector 1000 retracts distally, rotating the indexing ring 500 to the first rotational position R1, as shown in FIG. 6G. When the cassette 100b is removed from the patient's skin, the needle assembly shield spring inside the needle assembly 220b pushes the needle assembly shield 235b of the needle assembly 220b proximally to cover the needle 222b, as shown in FIG. 6H.

[0178] Figures 8A-F show the third cassette 100c extending from the proximal end 102c to the distal end 104c prior to connection to the needle assembly 220b, during attachment of the needle assembly 220b, and during drug delivery. The same reference numerals are used for similar parts compared to the first and second examples of cassettes 100, 100b described above, although similar parts are indicated with a "c." Figures 9A-H show the third cassette 100c, in views similar to Figures 6A-H, during attachment of the needle assembly 220b of the second example and during drug delivery.

[0179] In Figure 8A, cassette 100c is in a pre-use position, with needle attachment blocking system 400b in an unlocked initial position Pns1IN. In Figures 8B-D, cassette 100c is in a position in which needle assembly 220b is secured to cassette 100c, with needle attachment blocking system 400b in a needle assembly connected position PnsC. In Figures 8E-F, cassette 100c is in a post-use position, with needle attachment blocking system 400b in a final locked position PnsFL. Figures 8D and 8F are identical to Figures 8C and 8E, respectively, except that cassette housing 600 has been removed from cassette 100c in Figures 8D and 8F.

[0180] In FIG. 9A, the cassette 100c is inserted into the automatic injector 1000 but is not yet secured. Therefore, the indexing ring 500 has not yet rotated from its initial first rotational position R1 to its second rotational position R2. Therefore, needle assembly 220b cannot yet be attached. In FIG. 9B, the cassette 100c is locked into the automatic injector 1000, the indexing ring 500 has been rotated to its first rotational position R1, and the indexing ring locking protrusion 506 has been moved to a position where it no longer prevents distal movement of the needle attachment blocking system 400b. In the second rotational position R2, the needle attachment blocking system 400b can be pushed distally, thereby securing the needle assembly 220b to the syringe holder 300. In FIG. 9C, the needle attachment blocking system 400b has been pushed distally, and the needle assembly 220b has been attached. In FIG. 9D, the needle cap 228b has been removed. To deliver the medication, the auto-injector 1000 and cassette 100c system is pressed against the patient's skin, pushing the needle assembly shield 235b of the needle assembly 220b distally. This is seen in FIG. 9E. The plunger rod 1018 moves proximally, expelling the medication from the syringe 200, 200d. This is seen in FIG. 9F. After medication delivery, the release member 1006 within the injector 1000 retracts distally, rotating the indexing ring 500 to the first rotational position R1, as shown in FIG. 9G. When the cassette 100c is removed from the patient's skin, the needle assembly shield spring inside the needle assembly 220b pushes the needle assembly shield 235b of the needle assembly 220b proximally, covering the needle 222b, as shown in FIG. 9H. When the indexing ring 500 has rotated to the first rotational position R1, the cassette 100c is in a final locked position PnsFL where the needle attachment blocking system 400b is prevented from moving distally or proximally. This is achieved by the indexing ring locking protrusion 506 engaging the second locking recess 461b of the distally extending pin 456b. When the cassette 100c is used for drug delivery, the needle attachment blocking system 400b is therefore in the final locked position PnsFL, which is distal to the locking position PnsL.Therefore, the final locking position PnsFL is the same as the needle assembly connecting position PnsC and the drug delivery position PnsD.

[0181] The indexing ring may differ from that shown in FIGS. 9A-H in that it does not rotate to the third rotational position R3. The indexing ring 500 used in the cassette 100c may lack the equivalent of the third track section 524 of the first example of the indexing ring 500. During medication delivery, the indexing ring 500 may be in the second rotational position R2. The needle safety cover spring system 1026 in the automatic injector 1000 does not need to push the needle attachment blocking system 400b to the proximally extended position if the distally extending pin 456b does not extend distally enough for the needle safety cover spring system 1026 to exert a proximal pushing force on the distally extending pin 456b. After medication delivery, when the automatic injector 1000 retracts the one or more release members 1006, the indexing ring 500 rotates from the second rotational position R2 to the first rotational position R1.

[0182] 10A-C show a dual-chamber syringe 200d having a first sub-compartment 214 and a second sub-compartment 216, as previously described.

[0183] FIG. 11 shows a fourth cassette 100d in an exploded view. The fourth cassette 100d includes a syringe holder 300d, a first needle safety cover 410d, a second needle safety cover 440d, a cover spring 470, an index ring 500d, and a cassette housing 600d. With the exception of the cover spring 470, the other cassette components 410d, 440d, 500d, and 600d are slightly alternatives to those previously described in the first example of cassette 100. While similar components are indicated with a "d," the same reference numerals are used for similar components compared to the first, second, and third examples of cassettes 100, 100b, and 100c. Compared to the first example of cassette 100, the fourth example of cassette 100d lacks a separate release arm. Instead, the release arm 580 in the fourth example of cassette 100d is positioned as part of index ring 500d, as shown in FIG. 12E.

[0184] FIG. 12A shows a cassette housing 600d. In addition to the components already described for the first version of the cassette housing 600, the cassette housing 600d shown in FIG. 12A includes a first needle safety cover stop surface 618 that prevents the first needle safety cover 410d from being pushed proximally out of the cassette housing 600d in the final locked position by abutting the distal end cover locking tab 431 against the first needle safety cover 410d. The cassette housing 600d further includes at least one first needle safety cover channel 620 through which a cassette housing guide tab 429 travels. The pair of channel 620 and guide tab 429 rotatably locks the cassette housing 600d and first needle safety cover 410d together.

[0185] 12B-C show the first needle safety cover 410d from two different directions. In addition to the cassette housing stop surface 438 and cassette housing guide tab 429 described above, as well as the components already described for the first version of the first needle safety cover 410, the first needle safety cover 410d shown in FIGS. 12B-C includes a cover locking tab 430 having a distal cover locking tab 431d, which prevents the first needle safety cover 410d from being pushed proximally out of the cassette housing 600d in the final, locked position. The first needle safety cover 410d further includes a distal first needle safety cover locking surface 436 and a proximal first needle safety cover locking surface 437. In the Pns12L position, the distal first needle safety cover locking surface 436 abuts the proximal second needle safety cover locking tab 466 on the second needle safety cover 440d, preventing distal movement of the first needle safety cover 410d relative to the second needle safety cover 440d. Similarly, in the Pns12L position, the first needle safety cover interface 435 abuts the distal second needle safety cover locking tab 467 on the second needle safety cover 440d, preventing proximal movement of the first needle safety cover 410d relative to the second needle safety cover 440d. In this manner, the two needle safety cover parts 410d, 440d are locked relative to each other in the Pns12L position.

[0186] The first needle safety cover 410d further includes a first needle safety cover arm 434 having a first indexing ring engagement finger 433 and a first needle safety cover interface 435. When the indexing ring 500d is in the first rotational position R1, the first indexing ring engagement finger 433 on the first safety cover 410d abuts at least one of the one or more release arms 580 on the indexing ring 500d, preventing proximal movement of the first needle safety cover 410d relative to the indexing ring 500d. When the first needle safety cover 410d and the second needle safety cover 440d are in the extended, locked position, the first needle safety cover interface 435 abuts the distal second needle safety cover locking tab 467, preventing further proximal movement of the first needle safety cover 410d relative to the second needle safety cover 440d.

[0187] 12D shows the second needle safety cover 440d. In addition to the proximal and distal second needle safety cover locking tabs 466, 467, and the components already described for the first version of the second needle safety cover 440, the second needle safety cover 440d includes a second indexing ring engagement finger 469 and a second needle safety cover interface 468. The second needle safety cover interface 468 holds the two needle safety cover portions 410d, 440d together when assembled with the indexing ring 500d. The second needle safety cover interface 468 abuts the release arm 580 prior to positioning the cassette 100d within the auto-injector 1000. A cover spring 470 positioned around the proximally extending pin 454 on the second needle safety cover 440d and the distally extending pin 432 on the first needle safety cover 410d attempts to urge the needle safety cover portions 410d, 440d away from each other. However, prior to the relative release of the needle safety cover portions 410d, 440d by the release arm 580 on the index ring 500d, the release arm 580 locks the needle safety cover portions 410d, 440d together in the unlocked initial position Pns1IN.

[0188] Figures 12F-G show syringe holder 300d from two different directions. In addition to indexing ring release arm 330 with protruding surface 332 and the components already described for the first version of syringe holder 300, syringe holder 300d includes cassette detection tab 320 (also present in the first version of syringe holder 300 as shown in Figure 2C) that abuts against cassette detection pin 1080 inside auto-injector 1000 for cassette detection. Syringe holder 300d shown in Figures 12F-G further includes syringe support surface 322 and syringe locking hook 324 for supporting and securing syringe 200, 200d within syringe holder 300d. These components may be omitted.

[0189] FIG. 12E illustrates an index ring 500d. In addition to the components already described for the first version of index ring 500, the index ring 500d illustrated in FIG. 12E includes a second track 544 located on an index ring arm 508. The second track 544 includes a first secondary track section 550, a second secondary track section 552, a third secondary track section 554, and a fourth secondary track section 555. The first secondary track section 550 extends in a first angular direction from a first secondary corner 546 to a first secondary midpoint 556. The second secondary track section 552 extends in a second angular direction along the length of the cassette 100d from the first secondary midpoint 556 to a second secondary midpoint 558. The third secondary track section 554 extends in a third angular direction from the second secondary midpoint 558 toward the second secondary corner 548. The fourth secondary track section 555 extends distally from the second secondary corner 548. The first angular direction and / or the third angular direction are typically oblique directions and have an angle of 20 to 70 degrees, for example, 30 to 60 degrees, for example, 35 to 55 degrees, for example, 40 to 50 degrees, or approximately 45 degrees, relative to the longitudinal direction of the cassette. The second secondary track section 522 is typically a plateau track section having a second angular direction of -20 to 20 degrees, for example, -10 to 10 degrees, or approximately 0 degrees, relative to the longitudinal direction of the cassette. The fourth secondary track section 555 is also typically a plateau track section having a fourth angular orientation between −20 and 20 degrees, such as between −10 and 10 degrees, such as approximately 0 degrees, relative to the longitudinal direction of the cassette.

[0190] Prior to inserting cassette 100d into auto-injector 1000, indexing ring 500d is locked relative to needle safety cover 410d, 440d by blocking surface 540 on indexing ring 500d abutting protruding surface 332 on indexing ring release tab 330 on syringe holder 300d. When cassette 100d is positioned within auto-injector 1000, one or more release members 1006 within auto-injector 1000 move proximally into cassette 100d, contacting indexing ring release tab 330 and deflecting it radially inward. In doing so, blocking surface 540 on indexing ring 500d no longer abuts protruding surface 332. This allows indexing ring 500d to rotate from first rotational position R1 to second rotational position R2.

[0191] Rotation of indexing ring 500d from first rotational position R1 toward second rotational position R2 is controlled by a user pushing needle safety cover portions 410d, 440d distally to attach needle assembly 220 to needle assembly lock portion 306 on syringe holder 300d. Second indexing ring engagement finger 469 on second needle safety cover 440d abuts first secondary track 550 of second track 544, thus rotating indexing ring 500d toward second rotational position R2 when a user pushes needle safety cover portions 410d, 440d distally.

[0192] Rotation of the index ring 500d disengages the release arm 580 from the first index ring engagement finger 433, which allows the cover spring 470 to move the first needle safety cover 410d proximally relative to the second needle safety cover 440d after installation of the needle assembly 220. The proximal movement of the first needle safety cover 410d relative to the second needle safety cover 440d by the cover spring 470 urges the needle safety covers 410d, 440d into a locked-cover position, preventing further relative longitudinal movement between the first needle safety cover 410d and the second needle safety cover 440d. The proximal lock is obtained by the first locking pair comprising the proximal first needle safety cover interface 435 and the distal second needle safety cover locking tab 467, as described above. Distal locking is achieved by a second locking pair comprising a distal first needle safety cover locking surface 436 and a proximal second needle safety cover locking tab 466 as described above.

[0193] In the second rotational position R2 of index ring 500d, second index ring engagement finger 469 on second needle safety cover 440d abuts release arm 580, preventing further proximal movement of needle safety covers 410d, 440d, as seen in FIG. 14G.

[0194] The indexing ring 500d is rotatable from the second rotational position R2 to the third rotational position R3 following proximal movement of one or more release members 1006 of the automatic injector from a first release member position inside the cassette 100d to a second release member position inside the cassette 100d. Following proximal movement of one or more release members 1006 of the automatic injector 1000, the indexing ring 500d can be rotated from the second rotational position R2 to the third secondary rotational position R3 by distally moving the first needle safety cover 410d. This occurs when a user presses the first needle safety cover 410d against the injection site for needle insertion. See FIGS. 13H-I for further details.

[0195] When the index ring 500d is rotated from the second rotational position R2 to the third secondary rotational position R3 by moving the first needle safety cover 410d distally for needle insertion and drug delivery, the second index ring engagement finger 469 no longer abuts the release arm 580 proximally. This allows the needle safety covers 410d, 440d to move proximally relative to the index ring 500d to the final locking position PnsFL after drug delivery is completed. Therefore, the second index ring engagement finger 469 is allowed to move proximally to the release arm 580 to the final locking position PnsFL, as shown in FIGS. 13J-K.

[0196] FIGS. 13A-K illustrate a sequence similar to that shown in FIGS. 3A-L, showing in cutaway views a fourth cassette during needle assembly attachment and subsequent drug delivery. In FIG. 13A, cassette 100d has not yet been inserted into the auto-injector, and needle assembly 220 has not yet been attached to cassette 100d. In FIG. 13B, cassette 100d is positioned inside the auto-injector, and release member 1006 has been moved proximally to lock cassette 100d into the auto-injector. Indexing ring 500d has not yet been rotated, but can now be rotated from a first rotational position R1 to a second rotational position R2 by a user installing needle assembly 220. In FIG. 13C, first needle safety cover 410d has been moved distally relative to second needle safety cover 440d. This causes a slight rotation of indexing ring 500d (see FIG. 14C), further compressing cover spring 470 compared to that shown in FIG. 13B.

[0197] In FIG. 13D, needle assembly 220 is secured to syringe holder 300d, and indexing ring 500d has been rotated to second rotational position R2 by second indexing ring engagement finger 469 moving along first and second secondary tracks 550, 552 of second track 544 (see enlarged views in FIGS. 14D-F). In this position, first needle safety cover 410d is unlocked relative to second needle safety cover 440d. In FIG. 13E, needle cap 228 has been removed, and first needle safety cover 410d is pushed to a proximally extending position over needle 208 by the spring force of cover spring 470. Release arm 580, by abutting second indexing ring engagement finger 469, prevents movement of needle safety covers 410d, 440d to their outermost proximal positions. However, in this position, the needle safety covers 410d, 440d are locked relative to one another. In Figure 13F, the needle safety covers 410d, 440d are pushed distally to remove the rigid needle shield 236. After removal of the rigid needle shield 236, the needle safety covers 410d, 440d are again moved to the position of Figure 13E by the needle safety cover spring system 1026 of the auto-injector.

[0198] 13H shows the movement of the plunger rod 1018 and release member 1006 to mix the medicaments in the two sub-compartments 214, 216 when a dual-chamber syringe 200d is used. If a single-chamber syringe 200 is used, this step may be omitted.

[0199] In Figure 13I, the needle 208 is inserted into the injection site by pressing the first needle safety cover 410d against the injection site, and the medication is delivered. Pressing the first needle safety cover 410d against the injection site also causes the second indexing ring engagement finger 469, which travels along the third secondary track section 554, to rotate the indexing ring 500d from the second rotational position R2 to the third rotational position R3. After traveling along the third secondary track section 554, the second indexing ring engagement finger 469 travels along the fourth secondary track section 555, as shown in Figure 13I.

[0200] Rotation of the indexing ring 500d to the third rotational position R3 allows the second indexing ring engagement finger 469 to pass the release arm 580 proximally after removal of the device from the injection site. This is shown in FIG. 13J. The distal end of the cover lock tab 431 now locks the first needle safety cover 410d in the extended proximal position, i.e., the final locked position PnsFL. Distal movement of the release member 1006, as shown in FIG. 13K, rotates the indexing ring 500d back to the first rotational position R1, and the cassette 100d is now removed from the auto-injector.

[0201] 14A-G show close-up views of the interaction between the first needle safety cover 410d, the second needle safety cover 440d, the indexing ring 500d, and the syringe holder 300d during the process of attaching the needle assembly 220 to the syringe holder 300d. In FIGS. 14A-B (shown from different angles), the cassette 100d is in its original position prior to attaching the cassette 100d to the auto-injector. The release arm 580 is positioned within the indexing ring receiving opening 310 between the first indexing ring engagement finger 433 and the ramp 439 on the first needle safety cover arm 434. The second needle safety cover interface 468 on the second needle safety cover 440d is also visible in FIG. 14A, positioned relative to the release arm 580. The first needle safety cover interface 435 and the distal second needle safety cover locking tab 467 are visible in FIG. 14B.

[0202] Once the cassette 100d is locked into the auto-injector 1000 and the indexing ring 500d is rotated free from the syringe holder 300d by proximal movement of the release member 1006 in the auto-injector, as shown in FIG. 13B, the first needle safety cover 410d can move distally relative to the second needle safety cover 440d. This causes the ramp 439 on the first needle safety cover arm 434 to abut against the release arm 580 on the indexing ring 500d, causing the indexing ring 500d to rotate slightly. This moves the system to the position shown in FIG. 14C, which is a close-up of the position shown in FIG. 13C. The needle assembly 220 can now be installed.

[0203] 14D-F (viewed from different directions), the needle assembly is installed. In doing so, the first needle safety cover 410d and the second needle safety cover 440d are moved further distally, causing the second indexing ring engagement finger 469 to move within the second track 544 relative to the first and second secondary tracks 550, 552 of the second track 544, thereby rotating the indexing ring 500d to a second rotational position R2. This moves the system to the position shown in FIG. 13D, where the needle assembly 220 is installed.

[0204] As the second indexing ring engagement finger 469 moves within the secondary track 552 of the second track 544, the indexing ring 500d rotates to a second rotational position R2. Rotation of the indexing ring 500d moves the release arm 580 out of engagement with the first indexing ring engagement finger 433. When the needle cap 228 is removed, the first needle safety cover 410d moves proximally relative to the second needle safety cover 440d as the cover spring 470 pushes the two cover portions away from each other. The two needle safety covers 410d, 440d are now locked in the extended position, as shown in FIG. 13E. Proximal locking of the two needle safety covers 410d, 440d is achieved by the first needle safety cover interface 435 and the distal second needle safety cover locking tab 467.

[0205] 15A-B show the auto-injector 1000 in an assembled view, and FIG. 16 shows an exploded view of the auto-injector 1000 configured to receive cassettes 100, 100b, 100c, and 100d. All of the examples of cassettes 100, 100b, 100c, and 100d described above can be received within the auto-injector 1000. Different cassette versions can also be received within the auto-injector 1000. The auto-injector 1000 extends along a longitudinal axis L from a proximal end 1002 to a distal end 1004 and includes a syringe housing 1040 and multiple internal syringe components positioned within the syringe housing 1040.

[0206] The cassettes 100, 100b, 100c, and 100d are removably received within the auto-injector 1000 along a longitudinal direction L. Typically, the cassettes 100, 100b, 100c, and 100d are received at the proximal end 1002 of the auto-injector 1000, resulting in a front-loading auto-injector. In FIG. 15B, a view of the inside of the injector 1000 shows the cassette abutment surface 1042 against which the cassettes 100, 100b, 100c, and 100d rest upon installation within the injector 1000. Also shown is an opening in the cassette abutment surface 1042 through which internal syringe components extend during drug delivery and during preparation steps leading to drug delivery. The opening includes a cassette detector pin opening 1081 through which a cassette detector pin 1080 extends. The opening further includes a needle safety cover pin opening 1028 through which the syringe needle safety cover pin 1024 extends. A release member opening 1043 through which the release member 1006 extends is also provided in the cassette abutment surface 1042. A cassette locking tab 1086 on the inside of the syringe housing 1040 for securing the cassette 100 inside the auto-injector 1000 can also be seen in FIG. 15B.

[0207] 16 , the inner syringe component includes a plunger rod 1018 configured to move proximally for delivery of a medicament. The plunger rod 1018 has an internal threaded surface that threadingly engages an external threaded surface of a threaded rod 1014 positioned inside the plunger rod 1018. Rotation of the threaded rod 1014 inside the plunger rod 1018 causes the plunger rod 1018 to move proximally or distally along the longitudinal axis L, depending on which direction the threaded rod 1014 is rotated.

[0208] The auto-injector 1000 includes a release member 1006 having two release member pins 1007, each with a track guide protrusion 1008. When the auto-injector 1000 is activated after a cassette 100, 100b, 100c, 100d is installed within the auto-injector 1000, the release member 1006 travels inside the indexing ring track 514, rotating the indexing ring 500. The release member pin 1007 is connected by a release member bridge 1010 to a plunger rod opening 1012 that allows a plunger rod 1018 to pass through for medication delivery.

[0209] The release member 1006 and plunger rod 1018 are connected to a clutch 1030, which is configured to move between a first clutch position in which the plunger rod 1018 and one or more release members 1006 are longitudinally coupled so as to move proximally together, and a second clutch position in which the plunger rod 1018 is decoupled from the one or more release members 1006 and the plunger rod 1018 is able to move longitudinally while the one or more release members 1006 are longitudinally stationary.

[0210] The auto-injector 1000 further includes a syringe needle safety cover pin 1024 and a needle safety cover spring system 1026 that urges the syringe needle safety cover pin 1024 proximally. When the cassette 100, 100b, 100c, 100d is installed in the auto-injector 1000, the needle safety cover 440 is free to move proximally and will urge the second needle safety cover 440 proximally when the user is not simultaneously urging the needle safety cover 440 distally. Normally, the syringe needle safety cover pin 1024 abuts one of the distally extending pins 454 in the needle safety cover 440.

[0211] Also located inside the automatic injector 1000 is a cassette detection pin 1080 and a cassette detection spring 1082, which detects when a cassette 100, 100b, 100c, 100d is installed in the automatic injector 1000 by contacting another distally extending pin 454 in the needle safety cover 440.

[0212] 15A, the injector housing 1040 has a distal housing section 1044 and a cassette cover section 1046, where the distal housing section 1044 covers the internal injector components and the proximal cassette cover section 1046 at least partially covers the cassette 100, 100b, 100c, 100d when the cassette is installed in the auto-injector 1000. When the cassette is installed in the auto-injector 1000, the distal end 104 of the cassette 100, 100b, 100c, 100d abuts against a cassette abutment surface 1042 on the inside of the auto-injector 1000.

[0213] The internal syringe part further includes a drive module adapted to move the plunger rod 1018 in a proximal direction. The drive module may be constructed in several ways, of which the solution shown in Fig. 16 is just one example. The drive module shown in Fig. 16 includes a motor 1076 and a motor gear wheel 1078 for rotating the threaded rod 1014 inside the plunger rod 1018, a battery 1056 that can be recharged, for example, from a USB charger connected to a printed circuit board 1054, and several chassis parts 1070, 1077, 1090, 1094, 1095 and a screw 1079 for supporting the drive module parts.

[0214] The auto-injector 1000 may further include a processor that controls the drive module, which processor includes a printed circuit board (PCB) 1054. A visual display signal to the user may be included in the form of a light emitting diode (LED) 1064, which may be positioned in a PCB placeholder 1062 or the like. The LED is displayed via the LED window frame 1050, the light box placeholder 1058, and the light guide placeholder 1060.

[0215] The auto-injector can be activated by depressing an activation button 1052 located on the user interface housing portion 1048. A protective foil 1049 is typically included to protect the electronic components inside the injector 1000. See the reference numbers for other internal injector components.

[0216] The present invention is further described in the following clauses. 1. A cassette (100, 100b, 100c, 100d) for use in an automatic injector for administering a medication, the cassette extending in a longitudinal direction (L) from a proximal end (102) to a distal end (104); a syringe holder (300, 300d) configured to receive a syringe (200, 200d) containing a medicament, the syringe (200, 200d) including a seal (208) at a proximal end (202) of the syringe (200, 200d), the seal (208) configured to be pierced by a needle (222, 222b) to provide fluid communication between the medicament in the syringe (200, 200d) and the needle (222, 222b); a syringe holder (300, 300d) including a needle assembly fixation portion (306) at a proximal end (302) of the syringe holder (300, 300d), the needle assembly fixation portion (306) being configured to fix a needle assembly (220, 220b) including a needle (222, 222b) to the syringe holder (300, 300d) after the cassette (100, 100b, 100c, 100d) is installed in the automatic injector (1000); a needle attachment blocking system (400, 400b), wherein a proximal end (402, 402b) of the needle attachment blocking system (400, 400b) is configured to move between a plurality of longitudinal positions relative to the syringe holder (300, 300d), the plurality of longitudinal positions comprising at least: a locked position (PnsL) that prevents the needle (222, 222b) from puncturing the seal (208); a needle assembly connection position (PnsC) that allows piercing of the seal (208) by the needle (222, 222b); A cassette, wherein movement of the proximal end (402, 402b) of the needle-mounted blocking system (400, 400b) is configured to be controlled by the automatic injector (1000) after the cassette (100, 100b, 100c, 100d) is secured within the automatic injector (1000).

[0217] 2. The cassette of clause 1, wherein the needle assembly connection position (PnsC) is distal to the lock position (PnsL).

[0218] 3. A cassette as described in clause 1 or 2, wherein the needle assembly fixing portion (306) fixes the needle assembly (220, 220b) to the proximal end (302) of the syringe holder (300, 300d) by a threaded connection, or a press-fit connection, or a snap-fit ​​connection, or a bayonet connection, or a combination thereof.

[0219] 4. A cassette described in any one of clauses 1 to 3, wherein the needle assembly (220, 220b) is pre-attached to the proximal end of the needle attachment prevention system (400, 400b) prior to use, and fluid connection between the syringe (200, 200d) and the needle (222, 222b) is achieved by distal movement of the needle assembly (220, 220b) and the needle attachment prevention system (400, 400b) relative to the syringe (200, 200d), optionally combined with rotational movement of the needle assembly (220, 220b) relative to the syringe (200, 200d).

[0220] 5. The cassette (100, 100b, 100c, 100d) further includes an index ring (500, 500d) rotatable relative to the needle attachment blocking system (400, 400b) between a plurality of rotational positions, the plurality of rotational positions including at least: a first rotational position (R1) that prevents the needle attachment blocking system (400, 400b) from moving in a distal direction; a second rotational position (R2) in which the needle attachment prevention system (400, 400b) is movable between a locked position (PnsL) and a needle assembly connected position (PnsC); A cassette described in any one of clauses 1 to 4, wherein rotation of the index ring (500, 500d) is configured to be controlled by movement of one or more release members (1006) within the automatic injector (1000) when the cassette (100, 100b, 100c, 100d) is secured within the automatic injector (1000).

[0221] 6. A cassette as described in clause 5, wherein the index ring (500, 500d) includes a track (514) extending from a first corner (516) to a second corner (518) of the surface area of ​​the index ring (500, 500d).

[0222] 7. A cassette as described in clause 6, wherein the track (514) extends in an angular direction from the first corner (516) to the second corner (518), the angular direction being 20 to 70 degrees, for example 30 to 60 degrees, for example 35 to 55 degrees, for example 40 to 50 degrees, for example approximately 45 degrees, relative to the longitudinal direction of the cassette.

[0223] 8. The track (514) includes a first track section (520) and a second track section (522); the first track section (520) extends in a first angular direction from the first corner (516) to a first midpoint (526); the second track section (522) extends in a second angular direction along the length of the cassette from a first midpoint (526) to a second midpoint (528); the first angular direction is 20 to 70 degrees, for example, 30 to 60 degrees, for example, 35 to 55 degrees, for example, 40 to 50 degrees, for example, approximately 45 degrees, relative to the longitudinal direction of the cassette; 8. The cassette of clause 7, wherein the second angular orientation is between -20 and 20 degrees, for example between -10 and 10 degrees, for example approximately 0 degrees, relative to the longitudinal direction of the cassette.

[0224] 9. A cassette as described in clause 8, wherein the track (514) further includes a third track section (524), the third track section (524) extending from the second midpoint (528) toward the second corner (518) in a third angular direction, the third angular direction being 20 to 70 degrees, for example, 30 to 60 degrees, for example, 35 to 55 degrees, for example, 40 to 50 degrees, for example, approximately 45 degrees, relative to the longitudinal direction of the cassette.

[0225] 10. The plurality of longitudinal positions between which the proximal end (402, 402b) of the needle attachment blocking system (400) can be moved further comprises: a drug delivery position (PnsD) where the needles (222, 222b) are exposed; - A cassette as described in any one of clauses 1 to 9, comprising a final locking position (PnsFL) in which further longitudinal movement of the needle attachment prevention system (400, 400b) is prevented, the final locking position (PnsFL) being proximal to the drug delivery position (PnsD).

[0226] 11. A cassette as described in clause 10, wherein distal movement of one or more release members (1006) after drug delivery rotates the index ring (500, 500d) back to the first rotational position (R1), and the proximal end (402, 402b) of the needle attachment prevention system (400, 400b) is longitudinally locked in the final locked position (PnsFL).

[0227] 12. The plurality of longitudinal positions between which the proximal end (402, 402b) of the needle attachment blocking system (400, 400b) can be moved further comprises: a ready-to-use position (PnsR) in which the proximal end (402, 402b) of the needle-mounted blocking system (400, 400b) covers the needle (222, 222b); 12. A cassette according to clause 10 or 11, wherein the needle attachment prevention system (400, 400b) is in a ready-to-use position (PnsR) before being moved to the drug delivery position (PnsD).

[0228] 13. A cassette according to any one of clauses 1 to 12, wherein the proximal end (402, 402b) of the needle attachment blocking system (400, 400b) is further configured as a needle safety cover that covers the needle after drug delivery.

[0229] 14. The needle attachment prevention system (400, 400d) - a first needle safety cover (410, 410d); a second needle safety cover (440, 440d), wherein the first needle safety cover (410, 410d) is displaceable relative to the second needle safety cover (440, 440d) along the longitudinal direction; and one or more release arms (480, 580), the one or more release arms (480, 580) being movable between at least two positions relative to the syringe holder (300, 300d), the at least two positions being: an initial position (PraIN) in which the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d) are separated by at most a first separation distance; ○A cassette described in any one of clauses 1 to 13, comprising one or more release arms, including a release position (PraR) in which the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d) are allowed to move relative to each other to a second separation distance that is greater than the first separation.

[0230] 15. The cassette of clause 14, wherein in the initial position (PraIN), the first needle safety cover (410, 410d) is prevented from moving proximally relative to the second needle safety cover (440, 440d).

[0231] 16. The cassette of clause 14 or 15, wherein in the release position (PraR), the first needle safety cover (410, 410d) is allowed to move proximally relative to the second needle safety cover (440, 440d).

[0232] 17. A cassette described in any one of clauses 14 to 16, wherein the first needle safety cover (410, 410d) includes one or more cover lock tabs (431) that lock the first needle safety cover (410, 410d) in a final locked position (PnsFL) by preventing distal movement of the first needle safety cover (410, 410d) relative to the cassette housing (600, 600d).

[0233] 18. A cassette according to any one of clauses 14 to 17, wherein the proximal end (402, 402d) of the needle attachment blocking system (400) is contained in a second needle safety cover (440, 440d).

[0234] 19. A cassette described in any one of clauses 14 to 18, wherein when the proximal end (402) of the needle attachment prevention system (400) is in a locked position (PnsL) that prevents the needle (222) from puncturing the seal (208), the second needle safety cover (440, 440d) is longitudinally locked to the syringe holder (300, 300d).

[0235] 20. A cassette described in any one of clauses 14 to 19, wherein after the cassette (100, 100d) is secured within the automatic injector (1000), the second needle safety cover (440, 440d) is configured to be unlocked in the longitudinal direction, and the second needle safety cover (440, 440d) is movable distally relative to the syringe holder (300, 300d), moving the proximal end (402) of the needle attachment prevention system (400) to the needle assembly connection position (PnsC) and enabling the needle assembly (220) to be secured to the syringe holder (300, 300d).

[0236] 21. A cassette described in any one of clauses 14 to 20, wherein the needle attachment prevention system (400) further includes one or more cover springs (470) biased between the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d).

[0237] 22. A cassette as described in clause 21, wherein after the cassette (100, 100d) is secured within the automatic injector (1000), the first needle safety cover (410, 410d) and the one or more cover springs (470) are configured to be unlocked in the longitudinal direction, and the first needle safety cover (410, 410d) and the one or more cover springs (470) are movable distally relative to the syringe holder (300, 300d).

[0238] 23. A cassette described in any one of clauses 5 to 22, wherein the cassette (100d) further includes one or more index ring release tabs (330) movable relative to the index ring (500d), and when the cassette (100d) is secured within the automatic injector (1000), movement of one or more release members (1006) of the automatic injector to a first release member position inside the cassette (100d) moves the one or more index ring release tabs (330) from an initial position (PraIN) to a release position (PraR).

[0239] 24. The cassette of clause 23, wherein the one or more indexing ring release tabs (330) are part of the syringe holder (300d).

[0240] 25. one or more index ring release tabs (330) include protruding surfaces (332) that engage blocking surfaces (540) on the index ring (500d) in the initial position (PraIN) to prevent the index ring (500d) from rotating from the first rotational position (R1) to the second rotational position (R2); the one or more indexing ring release tabs (330) are configured to deflect radially inwardly upon proximal movement of the one or more release members (1006) when the cassette (100d) is secured within the auto-injector (1000); A cassette as described in clause 23 or 24, wherein when one or more index ring release tabs (330) are deflected radially inward, the protruding surface (332) no longer engages with the blocking surface (540) on the index ring (500d), and the index ring (500d) is rotatable from the first rotational position (R1) to the second rotational position (R2).

[0241] 26. A cassette described in clause 25, dependent on any one of clauses 14 to 24, wherein the index ring (500d) is configured to rotate from the first rotation position (R1) to the second rotation position (R2) by distal movement of the first needle safety cover (410d) when the protruding surface (332) no longer engages with the blocking surface (540) on the index ring (500d).

[0242] 27. A cassette as described in clause 25 or 26, wherein the index ring (500d) is configured to rotate from a first rotational position (R1) to a second rotational position (R2) by a second index ring engagement finger (469) on the second needle safety cover (440d) moving inside a first secondary track section (550) on the index ring (500d).

[0243] 28. A cassette described in any one of clauses 23 to 27, wherein when the one or more release members (1006) are in a first release member position inside the cassette (100d), further rotation of the index ring (500d) from the second rotational position (R2) to the third rotational position (R3) is prevented by the one or more release members (1006) engaging a first track (514) in the index ring (500d).

[0244] 29. A cassette as described in clause 26, wherein the index ring (500d) is rotatable from a second rotational position (R2) to a third rotational position (R3) upon proximal movement of one or more release members (1006) of the automatic injector from a first release member position inside the cassette (100d) to a second release member position within the cassette (100d).

[0245] 30. A cassette described in any one of clauses 26 to 29, dependent on any one of clauses 14 to 25, wherein the index ring (500d) is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) upon distal movement of the first needle safety cover (410d) following proximal movement of one or more release members (1006) of the automatic injector from a first release member position inside the cassette (100d) to a second release member position inside the cassette (100d).

[0246] 31. A cassette described in any one of clauses 26 to 30, dependent on any one of clauses 14 to 25, wherein the index ring (500d) is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) by the second index ring engagement finger (469) on the second needle safety cover (440d) moving inside the third secondary track section (554) on the index ring (500d).

[0247] 32. A cassette described in any one of clauses 26 to 31, wherein when the index ring (500d) is in the third secondary rotation position (R3), the second index ring engagement finger (469) no longer abuts at least one of the one or more release arms (580) on the index ring (500d), allowing proximal movement of the first needle safety cover (410d) and the second needle safety cover (440d) relative to the index ring (500d) to their final locked positions.

[0248] 33. The cassette of any one of clauses 14 to 32, wherein the release arm (580) is part of the index ring (500d).

[0249] 34. The cassette of clause 33, wherein the release arm (580) is positioned at the proximal end (502) of the indexing ring (500d).

[0250] 35. The first needle safety cover (410d) includes a first index ring engagement finger (433), and the second needle safety cover (440d) includes a second index ring engagement finger (469); when the index ring (500d) is in the first rotational position (R1), the first index ring engagement finger (433) and the second index ring engagement finger (469) abut against at least one of the one or more release arms (580) on the index ring (500d) to prevent proximal movement of the first needle safety cover (410d) and the second needle safety cover (440d) relative to the index ring (500d); A cassette described in any one of clauses 14 to 34, wherein when the index ring (500d) is in the second rotational position (R2), the first index ring engagement finger (433) no longer abuts at least one of the one or more release arms (580) on the index ring (500d), and the one or more cover springs (470) are configured to move the first needle safety cover (410d) proximally relative to the second needle safety cover (440d) and move the first needle safety cover (410d) to a locked cover position in which further relative longitudinal movement between the first needle safety cover (410d) and the second needle safety cover (440d) is prevented.

[0251] 36. A cassette as described in clause 35, wherein the first needle safety cover (410d) and the second needle safety cover (440d) include, in the locked cover position, a first locking pair that prevents proximal movement of the first needle safety cover (410d) relative to the second needle safety cover (440d), and a second locking pair that prevents distal movement of the first needle safety cover (410d) relative to the second needle safety cover (440d).

[0252] 37. A cassette described in any one of clauses 14 to 36, wherein the index ring (500d) includes a second track (544) extending from a first secondary corner (546) to a second secondary corner (548) of the surface area of ​​the index ring (500d), and the index ring (500d) is configured to rotate from a first rotational position (R1) to a second rotational position (R2) by distal movement of the second needle safety cover (440d), and a second index ring engagement finger (469) on the second needle safety cover (440d) moves inside the second track (544) and rotates the index ring (500d).

[0253] 38. The second track (544) includes a first secondary track section (550) and a second secondary track section (552). the first secondary track section (550) extends in a first secondary angular direction from the first secondary corner (546) towards the first secondary midpoint (526); the second secondary track section (552) extends in a second secondary angular direction along the length of the cassette from a first secondary intermediate point (556) to a second secondary intermediate point (558); the first secondary angular direction is 20 to 70 degrees, for example, 30 to 60 degrees, for example, 35 to 55 degrees, for example, 40 to 50 degrees, for example, approximately 45 degrees, relative to the longitudinal direction of the cassette; 38. The cassette of clause 37, wherein the second secondary angular orientation is between -20 and 20 degrees, such as between -10 and 10 degrees, such as approximately 0 degrees, relative to the longitudinal direction of the cassette.

[0254] 39. A cassette as described in clause 38, wherein the second track (544) further includes a third secondary track section (554), the third secondary track section (554) extending in a third secondary angular direction from the second secondary midpoint (558) towards the second secondary corner (548), the third secondary angular direction being 20 to 70 degrees, for example 30 to 60 degrees, for example 35 to 55 degrees, for example 40 to 50 degrees, for example approximately 45 degrees, relative to the longitudinal direction of the cassette.

[0255] 40. A cassette described in any one of clauses 1 to 6, wherein the index ring (500) is configured to rotate from a first rotational position (R1) to a second rotational position (R2) when the cassette (100) is inserted into the automatic injector (1000) and one or more release members (1006) included in the automatic injector (1000) move proximally inside the track (514).

[0256] 41. A cassette described in any one of clauses 14 to 21 and 40, wherein, prior to securing the cassette (100) within the automatic injector (1000), the first needle safety cover (410) and the second needle safety cover (440) are allowed to move toward each other by compression of one or more cover springs (470).

[0257] 42. A cassette described in any one of clauses 14 to 21, 40 and 41, wherein the second needle safety cover (440) includes at least one flexible arm (446), the first needle safety cover (410) includes a first locking tab (416), and the one or more release arms (480) each include a protruding surface release portion (486), which limits proximal movement of the first needle safety cover (410) relative to the second needle safety cover (440) in the initial position (PraIN) by preventing the at least one flexible arm (446) from bending when it abuts the first locking tab (416).

[0258] 43. A cassette described in any one of clauses 14 to 21 and 40 to 42, wherein when the needle assembly (220) is secured to the syringe holder (300), the second needle safety cover (440), the first needle safety cover (410), and one or more release arms (480) are configured to move distally relative to the syringe holder (300).

[0259] 44. A cassette as described in clause 43, wherein each of the second needle safety cover (440), the first needle safety cover (410), and the one or more release arms (480) move different distances distally relative to the syringe holder (300) upon securing the needle assembly (220) to the syringe holder (300).

[0260] 45. A cassette described in any one of clauses 14 to 21 and 40 to 44, wherein the needle assembly (220) further includes a removable needle cap (228) that covers and protects the needle (222) before use, and wherein the needle assembly (220) is secured to the syringe holder (300), and after the needle cap (228) is removed, one or more cover springs (470) are adapted to urge the first needle safety cover (410) proximally against the second needle safety cover (440), so that the first needle safety cover (410) covers the needle (222), and the proximal end (402) of the needle attachment prevention system (400) is in a ready-to-use position (PnsR).

[0261] 46. ​​A cassette described in any one of clauses 14 to 21 and 40 to 45, wherein after securing the needle assembly (220) to the syringe holder (300), one or more release arms (480) are locked relative to the syringe holder (300).

[0262] 47. A cassette as described in clause 46, wherein, after securing the needle assembly (220) to the syringe holder (300) and removing the needle cap (228), when the one or more release arms (480) are in the release position (PraR), the second needle safety cover (440) is adapted to be moved proximally by the automatic injector (1000) while the one or more release arms (480) are locked relative to the syringe holder (300).

[0263] 48. A cassette as described in clause 46 or 47, wherein when the one or more release arms (480) are in the released position (PraR) after securing the needle assembly (220) to the syringe holder (300) and removing the needle cap (228), the one or more cover springs (470) are adapted to urge the first needle safety cover (410) proximally against the second needle safety cover (440), moving the at least one flexible arm (446) proximally, past the protruding surface release portion (486), to a position in which the at least one flexible arm (446) is deflected, and allowing the first locking tab (416) of the first needle safety cover (410) to pass through the at least one flexible arm (446) and use the one or more cover springs (470) to urge the first needle safety cover (410) to an extended position against the second needle safety cover (440).

[0264] 49. A cassette described in any one of clauses 14 to 21 and 40 to 48, wherein when the cassette is in the ready-to-use position (PnsR), one or more locking arms (440) are in the release position (PraR) and the needle attachment prevention system (400) is in a locking cover position in which further relative longitudinal movement of the first needle safety cover (410) with respect to the second needle safety cover (440) is prevented.

[0265] 50. A cassette as described in clause 49, wherein the first needle safety cover (410) includes a second locking tab (420) positioned distally of the first locking tab (416), and the second needle safety cover (440) includes a stop surface (450) positioned proximal to the flexible arm (446), and in the locked cover position, the second locking tab (420) abuts the flexible arm (446) to prevent distal movement of the first needle safety cover (410) relative to the second needle safety cover (440), and the first locking tab (416) abuts the stop surface (450) to prevent proximal movement of the first needle safety cover (410) relative to the second needle safety cover (440).

[0266] 51. A cassette as described in clause 50, wherein the needle assembly (220) includes a removable needle cap (228), and removal of the needle cap (228) when the proximal end (402) of the needle attachment blocking system (400) is in the drug delivery position (PnsD) allows the proximal end (402) of the needle attachment blocking system (400) to move proximally.

[0267] 52. The plurality of longitudinal positions between which the proximal end (402b) of the needle attachment blocking system (400b) can be moved further comprises: a drug delivery position (PnsD) where the needle (222) is exposed; a final locked position (PnsFL) in which further longitudinal movement of the needle attachment blocking system (400b) is prevented; 9. A cassette according to any one of clauses 1 to 8, wherein the drug delivery position (PnsD) and the final locking position (PnsFL) are at the same longitudinal position.

[0268] 53. A cassette as described in clause 52, wherein after drug delivery, distal movement of one or more release members (1006) within the automatic injector (1000) is configured to rotate the index ring (500) back to the first rotational position (R1), and the proximal end (402b) of the needle attachment prevention system (400b) is longitudinally locked in the final locked position (PnsFL).

[0269] 54. A system for use with an auto-injector for administering a medication, the system comprising: a cassette according to any one of clauses 1 to 53; a syringe including a medicament and a seal (208) at a proximal end (202) of the syringe (200, 200d), the seal (208) configured to be pierced by a distal end of a needle (222) to obtain fluid communication between the medicament in the syringe (200, 200d) and the needle (222, 222b); a needle assembly (220, 220b) including a needle (222, 222b), a needle assembly adapter (226, 226b) for securing the needle assembly (220, 220b) to a syringe holder (300, 300d), and a removable needle cap (228) for covering and protecting the needle (222); Prior to securing the cassette (100, 100d) within the auto-injector (1000), the needle attachment prevention system (400, 400b) prevents the distal end of the needle (222, 222b) from piercing the seal (208).

[0270] 55. The needle assembly (220b) further includes a needle assembly shield (235b) configured to have a plurality of positions, the plurality of positions including: an initial delivery position in which the needle assembly shield (235b) of the needle assembly (220b) covers the needle (222b); a drug delivery location where the needle (222b) is exposed; and a final locked position in which the needle assembly shield (235b) of the needle assembly (220b) covers the needle (222b).

[0271] 56. The system according to clause 54 or 55, further comprising an automatic injector (1000), the automatic injector (1000) being configured to receive the cassette (100, 100d).

[0272] 57. The system of clause 56, wherein the automatic injector (1000) includes one or more release members (1006) configured to move into the cassette (100, 100d) when the cassette is received within the automatic injector (1000).

[0273] 58. An automatic injector (1000) for administering a medication, wherein the automatic injector (1000) is configured to receive any of the cassettes (100, 100d) described in clauses 1 to 53 and / or any of the systems described in clauses 54 or 55 without requiring any modification to the automatic injector (1000).

[0274] 59. A system including an automatic injector (1000) for administering a medication, wherein the automatic injector (1000) is configured to receive, without modification, any of the cassettes (100, 100d) described in clauses 1 to 53.

[0275] 60. The system described in clause 59, further comprising a needle assembly (220, 220b) including a needle (222, 222b), a needle assembly adapter (226) for securing the needle assembly (220, 220b) to the syringe holder (300, 300d), and a removable needle cap (228) covering and protecting the needle (222, 222b), wherein the needle attachment prevention system (400, 400b) prevents the distal end of the needle (222, 222b) from piercing the seal (208) before the cassette (100, 100d) is secured within the automatic injector (1000).

[0276] 61. The needle assembly (220) further includes a needle assembly shield (235b) configured to have a plurality of positions, the plurality of positions being an initial delivery position in which the needle assembly shield (235b) of the needle assembly (220b) covers the needle (222b); a drug delivery location where the needle (222b) is exposed; and a final locked position in which the needle assembly shield (235b) of the needle assembly (220b) covers the needle (222b). [Explanation of symbols]

[0277] 100, 100b, 100c, 100d cassettes 102, 102b, 102c Proximal end of cassette 104, 104b, 104c Distal end of cassette 200, 200d syringe 202 Proximal end of syringe 204 Distal end of syringe 206, 206d syringe compartment 208 Syringe outlet end seal / septum 209 Syringe outlet 212 First Stopper 214 First Subdivision 216 Second Subdivision 217 Bypass Area 218 Second Stopper 220, 220b needle assembly 222, 222b needle 224, 224b needle hub 226, 226b needle assembly adapter 228, 228b Needle Cap / Rigid Needle Shield / RNS 232, 232b proximal end of needle 234, 234b Distal end of needle 235b Needle assembly shield for needle assembly 236 Rigid Needle Shield Holder, RNS 300, 300d Syringe Holder 302 Proximal end of syringe holder 304 Distal end of syringe holder 306 Needle assembly locking part 308 Long, thin tubular part 310 Index ring receiving opening 312 Syringe viewing window 314 Release arm receiving channel 315 Release arm blocking surface 316 Distal ring 318 Plunger opening 319 Release member opening 320 Cassette detection tab 322 Syringe Support Surface 324 Syringe fixing hook 330 Indexing ring release arm on syringe holder 332 Protruding surface 400, 400b Needle Safety Cover Assembly / Needle Attachment Blocking System 402, 402b Proximal end of needle safety cover assembly / needle attachment blocking system 404b Distal end of needle safety cover assembly / needle attachment blocking system 408 Combined and fully extended needle safety cover 410, 410d First needle safety cover 412 proximal end of first needle safety cover 414 the distal end of the first needle safety cover 416 First locking tab on first needle safety cover 417 Proximal ramp of first locking tab 418 Distal surface of first locking tab 420 Second locking tab on first needle safety cover 421 Proximal ramp of second locking tab 422 Distal surface of second locking tab 424 Proximally positioned surface plate 426 opening at the proximal end of the first needle safety cover 428 Inner Support Surface 429 Cassette housing guide tab 430 Cover lock tab 431 Distal end of cover locking tab 432 distally extending pin 433 first index ring engagement finger 434 First needle safety cover arm 435 First needle safety cover interface 436 Distal First Needle Safety Cover Locking Surface 437 Proximal First Needle Safety Cover Locking Surface 438 Cassette housing stop surface 439 Inclined surface on first needle safety cover arm 440, 440', 440b, 440d Secondary needle safety cover 442 proximal end of second needle safety cover 444 Distal end of second needle safety cover 446 Flexible Arm on Second Needle Safety Cover 447 Distal end of flexible arm 448 Inclined surface on flexible arm 449 Proximal Stop Surface on Flexible Arm 450 Stop surface on second needle safety cover 452, 452b tubular part 454 Proximally extending pin 456, 456b distally extending pin 457, 457b distal end of distally extending pin 458 Inspection opening 460, 460b First locking recess 461b Second locking recess 462, 462b Safety cover locking protrusion / blocking system locking protrusion 464, 464b Distally extending pin surface 465 Proximal end face 466 Proximal Second Needle Safety Cover Locking Tab 467 Distal Second Needle Safety Cover Locking Tab 468 Second needle safety cover interface 469 Second index ring engagement finger 470 Cover spring 472 Proximal end of cover spring 474 Distal end of cover spring 480 Release Arm 482 Proximal end of release arm 484 Distal end of release arm 486 Protruding surface release part of release arm 490 Flexible Finger 500, 500d index ring 502 Proximal end of index ring 504 Distal end of index ring 506 Index ring lock protrusion 508 Index Ring Arm 510 Tubular part of index ring 512 index ring surface area 514 Tracks on the surface area of ​​the index ring 516 First corner of the track 518 Second corner of the track First section of the 520 track Second section of the 522 track 524 Third Section of Track 526 First Waypoint of Track 528 Second Waypoint of Track 540 Blocking surface 544 Second Track 546 First secondary corner 548 Second secondary corner 550 Second Track First Secondary Track 552 Secondary Track Secondary Track 554 Secondary Track Third Secondary Track 555 Secondary Track 4 Secondary Track 556 First secondary waypoint of second track 558 Second secondary waypoint of second track 580 Index ring release arm 600, 600d cassette housing 602 Cassette Housing Proximal End 604 Distal end of cassette housing 606 Housing lock protrusion 608 Inclined surface of housing lock protrusion 610 Proximal surface of housing lock protrusion 612 Opening in cassette housing 614 Inspection window 616 Cassette fixing tab 618d First needle safety cover stop surface 620d First needle safety cover channel 1000 auto-injector 1002 Proximal end of auto-injector 1004 Distal end of auto-injector 1006 Release member 1007 Release member pin 1008 Track guide protrusion 1010 Release member bridge 1012 Plunger rod opening 1014 Threaded Rod 1016 Motor and Threaded Rod Connector 1018 Plunger Rod 1019 Stop Clutch Tab 1020 first plunger rod plug portion 1022 second plunger rod plug portion that engages with the stopper 1024 Syringe Needle Safety Cover Pin 1026 Needle Safety Cover Spring System 1028 Needle safety cover spring pin opening at cassette abutment surface 1030 clutch 1032 Switch 1040 Syringe Housing 1042 Cassette contact surface 1043 Release member opening in cassette abutment surface 1044 Distal Housing Section 1046 Cassette Cover Section 1048 first user interface housing portion 1049 Protective foil 1050 LED window frame 1052 Start button 1054 Printed Circuit Board (PCB) 1055 RCT Battery 1056 Battery 1057 Adhesive 1058 Lightbox Placeholders 1060 Light Guide Placeholder 1062 PCB Placeholder LED Placeholder with 1064 LEDs 1066 Content Management System (CMS) 1068 USB Gasket 1070 Proximal chassis 1076 Motor 1077 Motor flange 1078 Motor Gear 1079 Screw 1080 Cassette detection pin 1081 Cassette detection pin opening on cassette contact surface 1082 Cassette detection spring 1084 Cassette detection holder 1086 Cassette locking tab in syringe housing 1088 NFC antenna for detecting RFID chips on cassettes 1090 Distal end that connects to the housing 1092 bearings 1094 Intermediate chassis part 1095 Distal chassis part L Longitudinal direction of cassette and auto-injector Pns12L First needle safety cover and second needle safety cover in locked position Pns1IN Unlocked initial position PnsL Locked position to prevent needle puncture of seal PnsC needle assembly connection position PnsR ready for use position PnsD drug delivery location PnsFL Final lock position PraIN release arm initial position PraR release arm release position R1 First rotation position of the index ring R2 Second rotation position of the index ring R3 Third rotation position of the index ring

Claims

1. A cassette (100, 100d) for use in an automatic injector for administering a medication, the cassette extending in a longitudinal direction (L) from a proximal end (102) to a distal end (104); a syringe holder (300, 300d) configured to receive a syringe (200, 200d) containing the medicament, the syringe (200, 200d) including a seal (208) at a proximal end (202) of the syringe (200, 200d), the seal (208) configured to be pierced by a needle (222) to obtain fluid communication between the medicament in the syringe (200, 200d) and the needle (222); the syringe holder (300, 300d) includes a needle assembly fixation portion (306) at a proximal end (302) of the syringe holder (300, 300d), the needle assembly fixation portion (306) being configured to fix a needle assembly (220) including the needle (222) to the syringe holder (300, 300d) after the cassette (100, 100d) is installed in an automatic injector (1000); a first needle safety cover (410, 410d); a second needle safety cover (440, 440d), wherein said first needle safety cover (410, 410d) is displaceable relative to said second needle safety cover (440, 440d) along said longitudinal direction (L); one or more release arms (480, 580), the one or more release arms (480, 580) being movable between at least two positions relative to said syringe holder (300, 300d), said at least two positions being: an initial position (PrAIN) in which the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d) are separated by at most a first separation distance; A cassette comprising one or more release arms, the release arms including a release position (PraR) in which the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d) are allowed to move relative to each other to a second separation distance that is greater than the first separation.

2. The cassette of claim 1 , wherein in the initial position (PraIN), the first needle safety cover (410, 410d) is prevented from moving proximally relative to the second needle safety cover (440, 440d).

3. 3. The cassette of claim 1 or 2, wherein in the release position (PraR), the first needle safety cover (410, 410d) is allowed to move proximally relative to the second needle safety cover (440, 440d).

4. The cassette (100, 100d) of any one of claims 1 to 3, further comprising one or more cover springs (470) biased between the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d).

5. 5. The cassette of claim 4, wherein the needle assembly (220) further includes a removable needle cap (228) that covers and protects the needle (222) before use, and after securing the needle assembly (220) to the syringe holder (300, 300d) and removing the needle cap (228), the one or more cover springs (470) are adapted to urge the first needle safety cover (410, 410d) proximally against the second needle safety cover (440, 440d), so that the first needle safety cover (410, 410d) covers the needle (222) in a ready-to-use position (PnsR).

6. The first needle safety cover (410, 410d) is movable between a plurality of longitudinal positions relative to the syringe holder (300, 300d), the plurality of longitudinal positions including: ●Ready for use position (PnsR) and a drug delivery position (PnsD) at which the needle (222) is exposed, the drug delivery position (PnsD) being distal to the ready-to-use position (PnsR); A cassette as described in any one of claims 1 to 5, including a final locking position (PnsFL) in which further longitudinal movement of the first needle safety cover (410) is prevented, the final locking position (PnsFL) being proximal to the drug delivery position (PnsD).

7. The cassette of claim 6, wherein the first needle safety cover (410, 410d) covers the needle (222) in the ready-to-use position (PnsR).

8. 8. A cassette according to claim 6 or 7, wherein the final locked position (PnsFL) is proximal to the ready-to-use position (PnsR).

9. The second needle safety cover (440, 440d) further functions as a needle attachment blocking system (400), which includes: a locked position (PnsL) that prevents the needle (222) from piercing the seal (208) before securing the cassette (100, 100d) in the automatic injector (1000); a needle assembly connection position (PnsC) that allows the needle (222) to pierce the seal (208) after the cassette (100, 100d) is secured within the automatic injector (1000); 9. The cassette of claim 1, wherein movement of the second needle safety cover is configured to be controlled by the automatic injector after the cassette is secured within the automatic injector.

10. The cassette of claim 9 , wherein the needle assembly connection position (PnsC) is distal to the locking position (PnsL).

11. 11. The cassette of claim 9 or 10, wherein after the cassette (100, 100d) is secured within the automatic injector (1000), the second needle safety cover (440, 440d) is configured to be unlocked in the longitudinal direction, and the second needle safety cover (440, 440d) is movable distally relative to the syringe holder (300, 300d) to move the second needle safety cover (440, 440d) to the needle assembly connection position (PnsC) and enable securing of the needle assembly (220) to the syringe holder (300, 300d).

12. 12. The cassette of claim 11, wherein after the cassette (100, 100d) is secured within the automatic injector (1000), the first needle safety cover (410, 410d) and the one or more cover springs (470) are configured to be unlocked in the longitudinal direction, and the first needle safety cover (410, 410d) and the one or more cover springs (470) are movable in the distal direction relative to the syringe holder (300, 300d).

13. 13. The cassette of claim 1, wherein the needle assembly fixation portion (306) fixes the needle assembly (220) to the proximal end (302) of the syringe holder (300, 300d) by a threaded connection, or a press-fit connection, or a snap-fit ​​connection, or a bayonet connection, or a combination thereof.

14. The cassette (100, 100d) further includes an index ring (500, 500d) rotatable relative to the first needle safety cover (410, 410d) between a plurality of rotational positions, the plurality of rotational positions including at least: a first rotational position (R1) that prevents the second needle safety cover (440, 440d) from moving in a distal direction; a second rotational position (R2) in which the second needle safety cover (440, 440d) is longitudinally movable; 14. The cassette of claim 1, wherein movement of one or more release members (1006) within the automatic injector (1000) when the cassette (100, 100d) is secured within the automatic injector (1000) enables rotation of the index ring (500, 500d).

15. 15. The cassette of claim 14, wherein the index ring includes a first track extending from a first corner to a second corner of a surface area of ​​the index ring.

16. 16. A cassette according to claim 15, wherein the first track (514) extends from the first corner (516) towards the second corner (518) in an angular direction, the angular direction being 20 to 70 degrees, for example 30 to 60 degrees, for example 35 to 55 degrees, for example 40 to 50 degrees, for example approximately 45 degrees, relative to the longitudinal direction of the cassette.

17. the first track (514) includes a first track section (520) and a second track section (522); said first track section (520) extends in a first angular direction from said first corner (516) towards a first intermediate point (526); said second track section (522) extends in a second angular direction along said longitudinal direction of said cassette from said first midpoint (526) to a second midpoint (528); the first angular orientation is between 20 and 70 degrees, for example between 30 and 60 degrees, for example between 35 and 55 degrees, for example between 40 and 50 degrees, for example around 45 degrees, relative to the longitudinal direction of the cassette; 17. The cassette of claim 16, wherein the second angular orientation is between -20 and 20 degrees, such as between -10 and 10 degrees, such as approximately 0 degrees, relative to the longitudinal direction of the cassette.

18. 18. The cassette of claim 17, wherein the first track (514) further comprises a third track section (524), the third track section (524) extending from the second midpoint (528) towards the second corner (518) in a third angular direction, the third angular direction being 20 to 70 degrees, for example 30 to 60 degrees, for example 35 to 55 degrees, for example 40 to 50 degrees, for example approximately 45 degrees, relative to the longitudinal direction of the cassette.

19. 19. The cassette of claim 14, wherein distal movement of the one or more release members (1006) after drug delivery rotates the index ring (500, 500d) back to the first rotational position (R1) and the first needle safety cover (410, 410d) is longitudinally locked in the final locked position (PnsFL).

20. 20. The cassette of claim 6, wherein the first needle safety cover (410, 410d) includes one or more cover locking tabs (431) that lock the first needle safety cover (410, 410d) in the final locked position (PnsFL) by preventing distal movement of the first needle safety cover (410, 410d) relative to the cassette housing (600, 600d).

21. 21. The cassette of claim 1, wherein the needle assembly (220) is pre-attached to the first needle safety cover (410, 410d) before use, and fluid connection between the syringe (200, 200d) and the needle (222) is achieved by distal movement of the needle assembly (220), the second needle safety cover (440, 440d), and the first needle safety cover (410, 410d) relative to the syringe (200, 200d), optionally in combination with rotational movement of the needle assembly (220) relative to the syringe (200, 200d).

22. A cassette according to any one of claims 14 to 21, wherein said release arm (580) is part of said index ring (500d).

23. 23. The cassette of claim 22, wherein the release arm (580) is positioned at a proximal end (502) of the index ring (500d).

24. the first needle safety cover (410d) includes a first index ring engagement finger (433), and the second needle safety cover (440d) includes a second index ring engagement finger (469); when the index ring (500d) is in the first rotational position (R1), the first index ring engagement finger (433) and the second index ring engagement finger (469) abut against at least one of one or more release arms (580) on the index ring (500d) to prevent proximal movement of the first needle safety cover (410d) and the second needle safety cover (440d) relative to the index ring (500d); 24. The cassette of claim 14, wherein when the index ring (500d) is in the second rotational position (R2), the first index ring engagement finger (433) no longer abuts at least one of one or more release arms (580) on the index ring (500d), and the one or more cover springs (470) are configured to move the first needle safety cover (410d) proximally relative to the second needle safety cover (440d).

25. 25. The cassette of claim 24, wherein when the index ring (500d) is in the second rotational position (R2), one or more cover springs (470) move the first needle safety cover (410d) proximally relative to the second needle safety cover (440d) to a locked cover position, in which further relative longitudinal movement between the first needle safety cover (410d) and the second needle safety cover (440d) is prevented by one or more locking means.

26. 26. The cassette of claim 25, wherein the one or more locking means include a first lock pair (435, 467), and the first needle safety cover (410d) and the second needle safety cover (440d) include the first lock pair (435, 467) that prevents proximal movement of the first needle safety cover (410d) relative to the second needle safety cover (440d).

27. 27. A cassette as described in claim 25 or 26, wherein the one or more locking means includes a second locking pair (436, 466), and the first needle safety cover (410d) and the second needle safety cover (440d) include the second locking pair (436, 466) that prevents distal movement of the first needle safety cover (410d) relative to the second needle safety cover (440d).

28. 28. The cassette of claim 14, wherein the index ring (500d) includes a second track (544) extending from a first secondary corner (546) to a second secondary corner (548) of a surface area of ​​the index ring (500d), and wherein the index ring (500d) is configured to rotate from the first rotational position (R1) to the second rotational position (R2) by distal movement of the second needle safety cover (440d), and wherein a second index ring engagement finger (469) on the second needle safety cover (440d) moves inside the second track (544) to rotate the index ring (500d).

29. the second track (544) includes a first secondary track section (550) and a second secondary track section (552); said first secondary track section (550) extends in a first secondary angular direction from said first secondary corner (546) towards a first secondary midpoint (526); said second secondary track section (552) extends in a second secondary angular direction along said longitudinal direction of said cassette from said first secondary midpoint (556) to a second secondary midpoint (558); the first secondary angular orientation is between 20 and 70 degrees, for example between 30 and 60 degrees, for example between 35 and 55 degrees, for example between 40 and 50 degrees, for example around 45 degrees, relative to the longitudinal direction of the cassette; 29. A cassette according to claim 28, wherein the second secondary angular orientation is between -20 and 20 degrees, such as between -10 and 10 degrees, such as approximately 0 degrees, relative to the longitudinal direction of the cassette.

30. 30. The cassette of claim 29, wherein the second track (544) further comprises a third secondary track section (554), the third secondary track section (554) extending from the second secondary midpoint (558) towards the second secondary corner (548) in a third secondary angular direction, the third secondary angular direction being 20 to 70 degrees, for example 30 to 60 degrees, for example 35 to 55 degrees, for example 40 to 50 degrees, for example approximately 45 degrees, relative to the longitudinal direction of the cassette.

31. The cassette of any one of claims 14 to 30, further comprising one or more index ring release tabs (330) movable relative to the index ring (500d), wherein when the cassette (100d) is secured within the automatic injector (1000), movement of one or more release members (1006) of the automatic injector to a first release member position inside the cassette (100d) moves the one or more index ring release tabs (330d) from the initial position (PrAIN) to the release position (PrR).

32. 32. The cassette of claim 31, wherein the one or more indexing ring release tabs (330) are part of the syringe holder (300d).

33. the one or more index ring release tabs (330) include protruding surfaces (332) that engage blocking surfaces (540) on the index ring (500d) in the initial position (PrAIN) to prevent the index ring (500d) from rotating from the first rotational position (R1) to the second rotational position (R2); the one or more indexing ring release tabs (330) are configured to deflect radially inwardly upon proximal movement of the one or more release members (1006) when the cassette (100d) is secured within the automatic injector (1000); 33. The cassette of claim 31 or 32, wherein when the one or more index ring release tabs (330) are deflected radially inward, the protruding surfaces (332) no longer engage the blocking surfaces (540) on the index ring (500d), and the index ring (500d) is rotatable from the first rotational position (R1) to the second rotational position (R2).

34. 34. The cassette of claim 33, wherein the index ring (500d) is configured to rotate from the first rotational position (R1) to the second rotational position (R2) by distal movement of the first needle safety cover (410d) when the protruding surface (332) no longer engages the blocking surface (540) on the index ring (500d).

35. 35. A cassette as described in claim 33 or 34, wherein the index ring (500d) is configured to rotate from the first rotational position (R1) to the second rotational position (R2) by the second index ring engagement finger (469) on the second needle safety cover (440d) moving inside a first secondary track section (550) on the index ring (500d).

36. 36. A cassette according to any one of claims 31 to 35, wherein when the one or more release members (1006) are in the first release member position inside the cassette (100d), further rotation of the index ring (500d) from the second rotational position (R2) to a third rotational position (R3) is prevented by the one or more release members (1006) engaging the first track (514) in the index ring (500d).

37. 35. The cassette of claim 34, wherein the index ring (500d) is rotatable from the second rotational position (R2) to a third rotational position (R3) upon further proximal movement of the one or more release members (1006) of the automatic injector from the first release member position in the cassette (100d) to a second release member position in the cassette (100d), the second release member position being proximal to the first release member position.

38. 38. The cassette of claim 37, wherein the index ring (500d) is configured to rotate from the second rotational position (R2) to a third secondary rotational position (R3) by distal movement of the first needle safety cover (410d) after proximal movement of the one or more release members (1006) of the automatic injector from the first release member position inside the cassette (100d) to the second release member position inside the cassette (100d).

39. 39. A cassette as described in claim 37 or 38, wherein the index ring (500d) is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) by the second index ring engagement finger (469) on the second needle safety cover (440d) moving inside a third secondary track section (554) on the index ring (500d).

40. 40. A cassette as described in any one of claims 34 to 39, wherein when the index ring (500d) is in the third secondary rotational position (R3), the second index ring engagement finger (469) no longer abuts against at least one of the one or more release arms (580) on the index ring (500d), allowing proximal movement of the first needle safety cover (410d) and the second needle safety cover (440d) relative to the index ring (500d) to their final locked positions.

41. 41. The cassette of claim 40, wherein the first needle safety cover (410d) includes one or more housing locks that lock the first needle safety cover (410d) in the final locked position by preventing distal movement of the first needle safety cover (410d) relative to the cassette housing (600d).

42. 20. The cassette of claim 4, wherein, prior to securing the cassette (100) in the automatic injector (1000), the first needle safety cover (410) and the second needle safety cover (440) are allowed to move towards each other by compression of one or more cover springs (470).

43. A cassette as described in any one of claims 4 to 19 and 42, wherein the one or more release arms are separate parts that do not form part of the index ring (500), the second needle safety cover (440), and the first needle safety cover (410).

44. 44. A cassette according to any one of claims 4 to 19, 42 and 43, wherein the second needle safety cover (440) includes at least one flexible arm (446), the first needle safety cover (410) includes a first locking tab (416), and the one or more release arms (480) each include a protruding surface release portion (486) that limits the proximal movement of the first needle safety cover (410) relative to the second needle safety cover (440) in the initial position (PraIN) by preventing the at least one flexible arm (446) from bending when it abuts the first locking tab (416).

45. A cassette as described in any one of claims 4 to 19 and 42 to 44, wherein when the needle assembly (220) is secured to the syringe holder (300), the second needle safety cover (440), the first needle safety cover (410), and the one or more release arms (480) are configured to move distally relative to the syringe holder (300).

46. 46. ​​The cassette of claim 45, wherein each of the second needle safety cover (440), the first needle safety cover (410), and the one or more release arms (480) moves different distances distally relative to the syringe holder (300) when the needle assembly (220) is secured to the syringe holder (300).

47. 47. The cassette of claim 4, wherein after securing the needle assembly to the syringe holder, the one or more release arms are locked relative to the syringe holder.

48. 48. The cassette of claim 47, wherein after securing the needle assembly (220) to the syringe holder (300) and removing the needle cap (228), when the one or more release arms (480) are in the release position (PraR), the second needle safety cover (440) is adapted to be moved proximally by the automatic injector (1000) while the one or more release arms (480) are locked relative to the syringe holder (300).

49. When the one or more release arms (480) are in the release position (PraR) after securing the needle assembly (220) to the syringe holder (300) and removing the needle cap (228), the one or more cover springs (470) urge the first needle safety cover (410) in the proximal direction against the second needle safety cover (440), moving the at least one flexible arm (446) proximally, past the protruding surface release portion (486), and pushing the at least one flexible arm (446) proximally.

49. The cassette of claim 47 or 48 when dependent on any one of claims 44 to 46 when dependent on any one of claims 4 to 19, 42 and 43, wherein the cassette is adapted to move the first locking tab (416) of the first needle safety cover (410) to a deflected position, allowing the first locking tab (416) of the first needle safety cover (410) to pass through the at least one flexible arm (446) and to urge the first needle safety cover (410) into an extended position relative to the second needle safety cover (440) using the one or more cover springs (470).

50. A cassette as described in any one of claims 46 to 49, wherein when the cassette is in the ready-to-use position (PnsR), the one or more release arms (480) are in the release position (PraR) and the needle safety cover parts (410, 440) are in a locked cover position in which further relative longitudinal movement of the first needle safety cover (410) with respect to the second needle safety cover (440) is prevented.

51. 51. The cassette of claim 50, wherein the first needle safety cover (410) includes a second locking tab (420) positioned distally of the first locking tab (416), and the second needle safety cover (440) includes a stop surface (450) positioned proximally of the flexible arm (446), and in the locked cover position, the second locking tab (420) abuts the flexible arm (446) to prevent distal movement of the first needle safety cover (410) relative to the second needle safety cover (440), and the first locking tab (416) abuts the stop surface (450) to prevent proximal movement of the first needle safety cover (410) relative to the second needle safety cover (440).

52. 52. The cassette of any one of claims 4 to 19 and 42 to 51, wherein movement of one or more release members (1006) within the automatic injector (1000) when the cassette (100) is secured within the automatic injector rotates the index ring (500).

53. A cassette according to any one of claims 4 to 19 and 42 to 52, wherein the index ring (500) is configured to rotate from the first rotational position (R1) to the second rotational position (R2) when the cassette (100) is inserted into the automatic injector (1000) and the one or more release members (1006) included in the automatic injector (1000) move proximally inside the track (514).

54. 1. A system for use with an auto-injector for administering a medication, the system comprising: a cassette (100, 100d) according to any one of claims 1 to 53; a syringe (200, 200d) comprising a syringe compartment (206, 206d) containing the medicament and a seal (208) at a proximal end (202) of the syringe (200, 200d), the seal (208) being configured to be pierced by the distal end of a needle (222) to obtain fluid communication between the medicament within the syringe (200, 200d) and the needle (222); The system further comprises a first needle safety cover (410, 100d) that prevents the distal end of the needle (222) from piercing the seal (208) before the cassette (100, 100d) is secured within the automatic injector (1000).

55. The syringe compartment (206d) comprises: a first sub-compartment (214) containing a first pharmaceutical component; a second sub-compartment (216) containing a second pharmaceutical component; a bypass region (217) located between said first sub-compartment (214) and said second sub-compartment (216); a first stopper (212) positioned distally within said first sub-compartment (214) prior to use; a second stopper (218) positioned between said first sub-compartment (214) and said second sub-compartment (216) prior to use; 55. The system of claim 54, wherein moving the first stopper (212) in the proximal direction moves the first pharmaceutical component proximally and moves the second stopper (218) proximally, allowing the first pharmaceutical component to pass through the bypass region (217) and enter the second subcompartment (216), causing the first pharmaceutical component and the second pharmaceutical component to mix.

56. 56. The system of claim 55, wherein the indexing ring (500, 500d) is in the second rotational position (R2) when the first pharmaceutical component and the second pharmaceutical component are mixed.

57. 57. The system of claim 54, further comprising a needle assembly (220) including the needle (222), a needle assembly adapter (226) for securing the needle assembly (220) to the syringe holder (300), and a removable needle cap (228) for covering and protecting the needle (222), wherein a proximal end of the needle (222) is configured to pierce the seal (208) of the syringe (200, 200d), and wherein the proximal end of the needle (222) is configured to pierce an injection site.

58. The system of any one of claims 54 to 57, further comprising the automatic injector (1000), the automatic injector (1000) configured to receive the cassette (100, 100d).

59. An automatic injector (1000) for administering a medication, the automatic injector (1000) being configured to receive, without modification, any of the cassettes (100, 100d) of claims 1 to 53 and / or any of the systems of claims 54 to 57.

60. The automatic injector (1000) of claim 59, wherein the automatic injector (1000) includes one or more release members (1006) configured to move into the cassette (100, 100d) when the cassette is received within the automatic injector (1000).

61. A cassette (100, 100d) for use in an automatic injector for administering a medication, the cassette extending in a longitudinal direction (L) from a proximal end (102) to a distal end (104); Needle safety covers (400, 410, 410d, 440, 440d), an index ring (500, 500d) rotatable relative to said needle safety cover (400, 410, 410d, 440, 440d) between a plurality of rotational positions, said plurality of rotational positions comprising at least: a first rotational position (R1) that prevents the needle safety cover (400, 410, 410d, 440, 440d) from moving in a distal direction; a second rotational position (R2) in which the needle safety cover (400, 410, 410d, 440, 440d) is longitudinally movable; and a syringe holder (300, 300d) configured to receive a syringe (200, 200d) containing the medicament, the syringe (200, 200d) including a seal (208) at a proximal end (202) of the syringe (200, 200d), the seal (208) configured to be pierced by a needle (222) to obtain fluid communication between the medicament in the syringe (200, 200d) and the needle (222); the syringe holder (300, 300d) includes a needle assembly fixation portion (306) at a proximal end (302) of the syringe holder (300, 300d), the needle assembly fixation portion (306) being configured to fix a needle assembly (220) including the needle (222) to the syringe holder (300, 300d) after the cassette (100, 100d) is installed in an automatic injector (1000); one or more index ring release tabs (330, 330d) movable between at least two positions relative to said index ring (500, 500d), said at least two positions being: an initial position (PrAIN) in which the index ring (500, 500d) is prevented from rotating from the first rotational position (R1) to the second rotational position (R2); a release position (PraR) in which the index ring (500, 500d) is rotatable from the first rotational position (R1) to the second rotational position (R2), When the cassette (100, 100d) is secured within the automatic injector (1000), one or more release members (1006) of the automatic injector move to a first release member position within the cassette (100, 100d), thereby moving the one or more index ring release tabs (330) from the initial position (PraIN) to the release position (PraR).

62. 62. The cassette of claim 61, wherein when the one or more release members (1006) are in the first release member position inside the cassette (100, 100d), further rotation of the index ring (500, 500d) from the second rotational position (R2) to a third rotational position (R3) is prevented by the one or more release members (1006) engaging a first track (514) in the index ring (500, 500d).

63. 63. The cassette of claim 61 or 62, wherein the one or more indexing ring release tabs (330) are part of the syringe holder (300, 300d).

64. the one or more index ring release tabs (330) include protruding surfaces (332) that engage blocking surfaces (540) on the index ring (500, 500d) in the initial position (PrAIN) to prevent the index ring (500, 500d) from rotating from the first rotational position (R1) to the second rotational position (R2); the one or more indexing ring release tabs (330) are configured to deflect radially inwardly upon proximal movement of the one or more release members (1006) when the cassette (100, 100d) is secured within the automatic injector (1000); 64. The cassette of claim 61, wherein when the one or more index ring release tabs (330) are deflected radially inward, the protruding surfaces (332) no longer engage the blocking surfaces (540) on the index ring (500, 500d), and the index ring (500, 500d) is rotatable from the first rotational position (R1) to the second rotational position (R2).

65. 65. A cassette according to any one of claims 61 to 64, wherein the index ring (500, 500d) is rotatable from the first rotational position (R1) to the second rotational position (R2) by distal movement of the needle safety cover (400, 410, 410d, 440, 440d).

66. 66. The cassette of claim 61, wherein the index ring includes a second track extending from a first secondary corner to a second secondary corner of a surface area of ​​the index ring, the index ring being configured to rotate from the first rotational position to the second rotational position by distal movement of the needle safety cover, and wherein at least one protrusion on the needle safety cover moves inside the second track to rotate the index ring.

67. The needle safety cover (400, 410, 410d, 440, 440d) a locked position (PnsL) that prevents the needle (222) from piercing the seal (208) before securing the cassette (100, 100d) in the automatic injector (1000); a needle assembly connection position (PnsC) that allows the needle (222) to pierce the seal (208) after securing the cassette (100, 100d) to the automatic injector (1000); When the index ring (500, 500d) is in the first rotation position (R1), the needle safety cover (400, 410, 410d, 440, 440d) is in the locked position (PnsL); 67. A cassette according to any one of claims 61 to 66, wherein when the index ring (500, 500d) is in the second rotational position (R2), the needle safety cover (400, 410, 410d, 440, 440d) is movable to the needle assembly connection position (PnsC) by distal movement of the needle safety cover (400, 410, 410d, 440, 440d).

68. The needle safety cover (400, 410, 410d, 440, 440d) Needle safety covers (410, 410d), a second needle safety cover (440, 440d), wherein the first needle safety cover (410, 410d) is displaceable relative to the second needle safety cover (440, 440d) along the longitudinal direction; A cassette as described in any one of claims 61 to 67, wherein in the initial position (PraIN), the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d) are separated by a maximum first separation distance, and in the released position (PraR), the first needle safety cover (410, 410d) and the second needle safety cover (440, 440d) are allowed to move relative to each other to a second separation distance greater than the first separation.

69. the cassette (100d) further includes one or more cover springs (470) biased between the first needle safety cover (410d) and the second needle safety cover (440d); the first needle safety cover (410d) includes a first index ring engagement finger (433), and the second needle safety cover (440d) includes a second index ring engagement finger (469); when the index ring (500d) is in the first rotational position (R1), the first index ring engagement finger (433) and the second index ring engagement finger (469) on the second needle safety cover (440d) abut against at least one of the one or more release arms (580) on the index ring (500d) to prevent proximal movement of the first needle safety cover (410) and the second needle safety cover (440) relative to the index ring (500d); 69. The cassette of claim 68, wherein when the index ring (500d) is in the second rotational position (R2), the first index ring engagement finger (433) no longer abuts at least one of the one or more release arms (580) on the index ring (500d), and the one or more cover springs (470) are configured to move the first needle safety cover (410d) proximally relative to the second needle safety cover (440d) and move the first needle safety cover (410d) to a locked cover position in which further relative longitudinal movement between the first needle safety cover (410d) and the second needle safety cover (440d) is prevented.

70. 70. The cassette of claim 69, wherein the first needle safety cover (410d) and the second needle safety cover (440d) include, in the locked cover position, a first lock pair (435, 467) that prevents proximal movement of the first needle safety cover (410d) relative to the second needle safety cover (440d), and a second lock pair (436, 466) that prevents distal movement of the first needle safety cover (410d) relative to the second needle safety cover (440d).

71. the second track (544) includes a first secondary track section (550) and a second secondary track section (552); said first secondary track section (550) extends in a first secondary angular direction from said first secondary corner (546) towards a first secondary midpoint (526); said second secondary track section (552) extends in a second secondary angular direction along said longitudinal direction of said cassette from said first secondary midpoint (556) to a second secondary midpoint (558); the first secondary angular orientation is between 20 and 70 degrees, for example between 30 and 60 degrees, for example between 35 and 55 degrees, for example between 40 and 50 degrees, for example around 45 degrees, relative to the longitudinal direction of the cassette; 71. A cassette according to any one of claims 66 to 70, wherein the second secondary angular orientation is between -20 and 20 degrees, for example between -10 and 10 degrees, for example approximately 0 degrees, relative to the longitudinal direction of the cassette.

72. 72. A cassette according to claim 71, wherein the second track (544) further comprises a third secondary track section (554), the third secondary track section (554) extending from the second secondary midpoint (558) towards the second secondary corner (548) in a third secondary angular direction, the third secondary angular direction being 20 to 70 degrees, for example 30 to 60 degrees, for example 35 to 55 degrees, for example 40 to 50 degrees, for example approximately 45 degrees, relative to the longitudinal direction of the cassette.

73. A cassette according to any one of claims 62 to 72, wherein the index ring (500d) is rotatable from the second rotational position (R2) to the third rotational position (R3) upon proximal movement of the one or more release members (1006) of the automatic injector from the first release member position in the cassette (100d) to a second release member position in the cassette (100d).

74. 74. A cassette as described in any one of claims 62 to 73, wherein the index ring (500d) is configured to rotate from the first rotational position (R1) to the second rotational position (R2) by the second index ring engagement finger (469) on the second needle safety cover (440d) moving inside the first secondary track section (550) on the index ring (500d).

75. 75. The cassette of claim 73 or 74, wherein the index ring (500d) is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) by distal movement of the first needle safety cover (410d) after proximal movement of the one or more release members (1006) of the automatic injector from the first release member position inside the cassette (100d) to the second release member position inside the cassette (100d).

76. 76. The cassette of claim 75, wherein the index ring (500d) is configured to rotate from the second rotational position (R2) to the third secondary rotational position (R3) by the second index ring engagement finger (469) on the second needle safety cover (440d) moving inside a third secondary track section (554) on the index ring (500d).

77. 77. A cassette as described in claim 75 or 76, wherein when the index ring (500d) is in the third rotational position (R3), the second index ring engagement finger (469) no longer abuts against at least one of the one or more release arms (580) on the index ring (500d), allowing proximal movement of the first needle safety cover (410d) and the second needle safety cover (440d) relative to the index ring (500d) to their final locked positions.

78. 78. The cassette of claim 77, wherein the first needle safety cover (410d) includes one or more housing locks that lock the first needle safety cover (410d) in the final locked position by preventing distal movement of the first needle safety cover (410d) relative to the cassette housing (600d).

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