Syringe parts

Abstract

Keep needles sterile even when syringes are used at home. A syringe component is described. The component includes a container containing a medicament and having a cap. The container is sealed by a septum. A sealing element contacts an outer surface of the container cap. A needle is for penetrating the septum. A needle hub is attached to the needle. The sealing element is disposed between the outer surface of the container cap and the inner surface of the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and a free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. A seal by the sealing element is maintained during transition of the component from the first state to the second state and while the component is in the second state.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 174,694, filed April 14, 2021, the disclosure of which is incorporated herein by reference.

[0002] This application relates to certain components of a medication syringe and methods of making the same. [Background technology]

[0003] Syringes are known in which the medication container is sealed by a pierceable septum. The septum so positioned is generally configured to provide a hygienic seal for the medication container. The needle configured to pierce the septum should also be properly sterilized, thereby ensuring a sterile flow path from the medication container to the patient.

[0004] Ensuring that the septum exterior and needle remain sterile throughout the syringe's lifespan, for example, during its manufacture, storage, and use, is challenging. Without proper care, there is a risk that either or both of the septum exterior and needle may become contaminated, potentially introducing contaminants into the patient during injection. This risk is heightened when injection systems are used at home, where contamination is likely to occur even when the injection system is not operated by a healthcare professional. Furthermore, users may store the syringe and vial in a drawer or cupboard at home where contamination is likely to occur. These challenges are particularly pronounced when auto-injectors are used at home, where auto-injectors are typically used by patients (rather than healthcare professionals), increasing the risk of misuse. Therefore, an improved system for maintaining syringe septum sterility is needed. Summary of the Invention

[0005] In one embodiment of the invention, a syringe component is provided, the component comprising: - A container containing a medicine, fitted with a cap and sealed by a septum. - A sealing element in contact with the outer surface of the container cap. - A needle for piercing the septum. - The needle hub that is attached to the needle. The sealing element is positioned between the outer surface of the container cap and the inner surface of the needle hub. The components are configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the components are in the first state, the sealing element forms a seal between the outer surface of the cap and the inner surface of the needle hub. This seal is maintained both during transition of the components from the first state to the second state and when the components are in the second state.

[0006] In this manner, the component is stored while the free end of the needle remains within the sterile cavity until an injection is to be performed, and the cavity remains sealed during the injection (i.e., during the transition from the first state to the second state), thereby maintaining the sterility of the needle and septum.

[0007] Conventional syringes rely on the user to attach the needle hub to the medication container. The component disclosed herein provides a sterile cavity, reducing user effort and reducing the risk of needle sticks and needle contamination. In these respects, the component is an improvement over conventional syringes.

[0008] Other known syringes require the patient to embed the needle in an elastomer to prevent needle leakage and maintain a container seal integrity (CCI). This can dull the needle, potentially causing increased pain for the patient. Additionally, during shipping or storage of the syringe, medication can flow from the medication container into the needle, causing the medication inside the needle to dry out. This can cause the solidified medication to form a plug inside the needle, restricting flow when the user administers the medication. These problems are addressed by the components described herein.

[0009] The cap of the medication container may be directly on the medication container itself (ie, directly attached to the body of the container), or there may be another cap between the medication container and its cap.

[0010] The above components may further comprise: - a housing configured to receive a container containing a medication, the housing having a longitudinal axis and a hole at its distal end for receiving a portion of a needle; a safety shield surrounding at least a distal portion of the housing and configured to advance distally relative to the housing from a retracted position to an advanced position that protects the needle; an advancement spring disposed between the housing and the safety shield and configured to advance the safety shield from the retracted position to the advanced position; This makes it easier to protect the needle, improving the safety of the part.

[0011] The component may further include a releasable locking mechanism configured to lock the safety shield in the retracted position when engaged with the safety shield.

[0012] The needle hub may be movable relative to the housing between a first position away from the bore in the housing and a second position extending through the bore in the housing, and may be further configured to disengage from the locking mechanism to release the safety shield in the second position.

[0013] The locking mechanism may include a latch surface connected to the safety shield and a flexible latch arm connected to the housing. The latch arm is configured to engage the latch surface to lock the safety shield in the retracted position. The needle hub may be configured to disengage the latch arm from the latch surface in the second position.

[0014] Alternatively, the locations of the latch arm and latch surface may be reversed. That is, the locking mechanism may include a latch surface connected to the housing and a flexible latch arm connected to the safety shield. In other words, one of the latch surface and latch arm is connected to the housing and the other is connected to the safety shield. In either case, the locking mechanism operates as described above.

[0015] The advancement spring may be configured to lock the safety shield to the housing when the safety shield is in the advanced position, thereby preventing the safety shield from returning to the retracted position. Thus, with the above-described components, once the safety shield is advanced, the advancement spring prevents it from returning to the retracted position (and therefore prevents the needle from being exposed). Because the advancement spring functions not only as a means for advancing the safety shield but also as a locking means for the safety shield, the syringe is mechanically simple. Therefore, the syringe is inexpensive to manufacture and easy to assemble. Furthermore, the advancement means and locking means have a small number of parts, reducing the possibility of malfunction of the syringe. The advancement spring may be a coil spring.

[0016] The sealing element may be chemically bonded to the exterior surface of the cap. For example, the sealing element may be overmolded onto the exterior surface of the cap or may be bonded to the cap using bi-injection molding. Chemically bonding the sealing element to the cap has many advantages. Broadly speaking, it reduces the number of parts and simplifies the overall system while ensuring a reliable sterile seal between the cap and the needle hub. The use of chemical bonding has many additional advantages, including: - The use of chemical bonding improves sterility of parts as only a single part is required (as opposed to separate cap and sealing element), thus reducing the chance of contamination during assembly. Additionally, only one part must be sterilized before assembly instead of two. - A more functional and reliable seal is obtained. In particular, parts utilizing sealing elements that chemically bond to the cap are preferable to parts that use O-rings, for example, because the sealing element remains firmly attached to the cap and does not twist during the transition of the part from the first state to the second state (i.e., during the administration of an injection). - The use of chemical bonding eliminates the need for locating features, such as recesses, on either the cap or the needle hub. This not only simplifies the machining of each part, but also reduces the complexity of assembling the two parts. In this sense, the cap and needle hub are easier to manufacture. The absence of locating features means that the risk of contamination of the seal and damage to the sealing element is reduced. For example, when moving the sealing element relative to the needle hub in a part, as will be explained later, if there is no locating feature on the needle hub, the sealing element does not have to be moved over it, and therefore there is no possibility of the sealing element being damaged by that feature.

[0017] It will be appreciated that rather than being bonded to the cap, the sealing element may be attached to the inner surface of the needle hub by chemical bonding (e.g., overmolding or bi-injection molding), etc., which would provide similar advantages and the components would operate in the same manner as described above. The sealing element may contact a proximal projection extending inwardly from the needle hub, and the cap may have a distal annular ridge, which would allow the sealing element to bond to the inner surface of the needle hub and be located between the proximal projection on the needle hub and the distal ridge on the cap. It will be appreciated that the ridge on the cap and / or the proximal projection on the needle hub may be omitted.

[0018] Instead of chemically bonding the sealing element to the outer surface of the cap or the inner surface of the needle hub, the sealing element may be an O-ring. The O-ring may be placed in a groove (or locating recess) on the outer surface of the cap and / or between two annular ribs on the outer surface of the cap. The needle hub may include a similar recess or other feature that aligns with the locating recess on the cap when the components are in the first (pre-injection) state. These features compress the O-ring, thereby forming a tight seal. This helps maintain the sterility of the cavity in which the free end of the needle is located when the components are in the first state.

[0019] Regardless of the type of sealing element used, the cap may include a first locating recess into which the sealing element is seated (which may be bounded, for example, by two annular ribs). The cap may also include a second locating recess configured to receive a locating protrusion on the needle hub when the component is in the second position. In this case, the second recess on the cap locks onto the protrusion on the needle hub when the component is in the second position, thereby limiting the possibility of longitudinal movement of the cap relative to the needle hub.

[0020] When the components are in the first condition, a surface of the locating projection on the needle hub may contact the sealing element, which projection may also provide an advantage by helping to compress the sealing element to form a tight seal when the components are in the first condition.

[0021] The sealing element may comprise a first material and the cap may comprise a second material different from the first material, with the sealing element and the cap being formed as a single unit by double injection molding. Alternatively, the sealing element may comprise a first material and the needle hub may comprise a second material different from the first material, with the sealing element and the needle hub being formed as a single unit by double injection molding.

[0022] Turning to a discussion of the shape of the needle hub, the needle hub may include: - The first inner surface extends perpendicular to the needle and faces the cap. - A proximal projection extending inward toward the needle, especially toward the inner circumference. - A second inner surface extending parallel to the needle from the first inner surface to the proximal projection. The second inner surface may be configured to engage the sealing element when the component is in the first state, during transition of the component from the first state to the second state, and when the component is in the second state.

[0023] In other words, the needle hub may be cylindrical and include at one end a first inner surface facing the cap and at the other end an annular proximal projection (i.e., a ring extending inwardly). The needle hub further includes a cylindrical curved surface connecting the first inner surface and the proximal projection. The sealing element contacts the inner surface of the curved surface of the needle hub (thereby forming a seal between the cap and the inner surface of the curved surface of the needle hub) when the parts are in the first state (pre-injection state), the second state (post-injection state), and during the transition from the first state to the second state. As mentioned above, this shape of the needle hub is particularly easy to manufacture, since no positioning features, such as recesses, are required, allowing the inner surface of the needle hub extending parallel to the needle to be smooth. The absence of positioning features also means that the sealing element will not be damaged or deformed by the positioning features of the needle hub as it moves along the inner surface of the needle hub.

[0024] The cap may include a first rib and a second rib, and a sealing element may be disposed between the first rib and the second rib. In this case, the sealing element may be sandwiched and crushed between the two ribs. This helps to form a tight seal between the cap and the needle hub. When the needle hub is in the pre-injection state, the distance between the first rib and the free end of the needle may be closer than the distance between the second rib and the free end of the needle. In other words, when the needle hub is in the pre-injection state, the first rib is the rib closer to the free end of the needle, and the second rib is the rib further away. When the component is in the first state, the proximal projection of the needle hub may engage with the second rib of the cap, and when the component is in the second state, the first inner surface of the needle hub may engage with the first rib of the cap. In other words, when the component is in the pre-injection state (first state), the proximal surface of the proximal rib engages with the proximal end of the needle hub. During the transition of the component from the first state to the second state, the cap moves distally relative to the needle hub. When the part is in the second state (post-injection state), the distal surface of the distal rib fits onto the distal end of the needle hub.

[0025] In another embodiment of the invention, a method of manufacturing a component of a medication syringe is provided, the method comprising the steps of providing: - A container with a cap and sealed by a septum. - A sealing element in contact with the outer surface of the container cap. - A needle for piercing the septum. - Needle hub. A sealing element is positioned between the exterior surface of the container cap and the interior surface of the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is positioned within a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing element forms a seal between the outer surface of the cap and the inner surface of the needle hub. The seal is maintained during transition of the component from the first state to the second state and while the component is in the second state.

[0026] In this manner, while the syringe is stored, the free end of the needle is held within a sterile cavity until an injection is to be performed. This cavity remains sealed during the injection (i.e., during the transition of the component from the first state to the second state), thus maintaining the sterility of the needle. This manner also provides the other advantages described above for the component itself.

[0027] The method may comprise the following steps: - Providing a housing having a longitudinal axis. - providing a safety shield surrounding at least the distal portion of the housing and advanceable from a retracted position distal to the housing to an advanced position protecting the needle; - disposing an advancement spring between the housing and the safety shield to advance the safety shield;

[0028] The method may further include providing a releasable locking mechanism configured to engage with the safety shield to lock the safety shield in the retracted position. The needle hub may be movable relative to the housing between a first position spaced apart from the bore in the housing and a second position extending through the bore in the housing. In the second position, the needle hub may be configured to disengage from the locking mechanism to release the safety shield.

[0029] The locking mechanism may include a latch surface connected to one of the safety shield and the housing, and a flexible latch arm connected to the other. The latch arm may be configured to engage with the latch surface to lock the safety shield in the retracted position. The needle hub may be configured to disengage the latch arm from the latch surface in the second position. The advancement spring may be configured to lock to the housing and the safety shield when the safety shield is in the advanced position, thereby preventing the safety shield from returning to the retracted position.

[0030] The step of providing the sealing element may include chemically bonding the sealing element to the outer surface of the cap.The step of providing the sealing element may include overmolding the sealing element to the outer surface of the cap.

[0031] The sealing element may comprise a first material and the cap may comprise a second material different from the first material. The chemical bonding step may include bi-injection molding. For example, the sealing element may be made of Santoprene® or a similar material and the cap may be made of a hard resin such as polypropylene. The sealing element may be an O-ring.

[0032] The manufacturing method may include providing any of the components described herein, and the advantages already described for the components are also achieved by the manufacturing method.

[0033] In the above-described component, a sealing element is disposed between the outer surface of the cap and the inner surface of the needle hub. Thus, at least a portion of the cap is disposed within the needle hub. However, the above-described component can be similarly configured if, instead, at least a portion of the needle hub is disposed within the cap of the container. In the latter case, a sealing element is disposed between the inner surface of the cap and the outer surface of the needle hub.

[0034] Thus, a part of a syringe for administering medicine is provided, which comprises: - A container containing a medicine, fitted with a cap and sealed by a septum. - A sealing element that is in contact with the surface of the container cap. - A needle for piercing the septum. - The needle hub that is attached to the needle. The sealing element is positioned between a surface of the container cap and a surface of the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is away from the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing element forms a seal between the surface of the cap and the surface of the needle hub. This seal is maintained both during transition of the component from the first state to the second state and when the component is in the second state.

[0035] A sealing element may be located between the outer surface of the cap and the inner surface of the needle hub (as described for the first embodiment), or alternatively, a sealing element may be located between the inner surface of the cap and the outer surface of the needle hub.

[0036] When the sealing element is disposed between the inner surface of the cap and the outer surface of the needle hub, the sealing element may be chemically bonded to the inner surface of the cap or the outer surface of the needle hub. Examples of chemical bonding include overmolding the sealing element to the inner surface of the cap or the outer surface of the needle hub, and using dual injection molding to bond the sealing element to the inner surface of the cap or the outer surface of the needle hub. The use of chemical bonding offers many advantages, as described above. Alternatively, the sealing element may be an O-ring, as described above.

[0037] The sealing element may comprise a first material and the cap may comprise a second material different from the first material, with the sealing element and the cap being formed as a single piece by double injection molding. Similarly, the sealing element may comprise a first material and the needle hub may comprise a second material different from the first material, with the sealing element and the needle hub being formed as a single piece by double injection molding.

[0038] In any of the above configurations, the sealing element may be part of the septum. In other words, the sealing element may not be a separate part of the septum, but may be formed from a portion of the septum. For example, the septum may include a first portion for sealing against the medication container and an annular ridge or protrusion extending from the first portion. The ridge may function as one or more of the above sealing elements. The ridge may extend distally and be located between the surface of the cap and the surface of the needle hub.

[0039] The partition may have a longitudinal hole through which one end of the needle passes when the component is in the first state and through which a portion of the needle hub passes when the component is in the second state, such that a portion of the needle hub moves through the longitudinal hole in the partition during transition of the component from the first state to the second state. The longitudinal hole may be bounded by the ridge.

[0040] The septum is configured to seal a container, such as a medication container, suitable for use in a component of a medication syringe. The septum is configured to form a seal between two elements of the component, which may be, for example, a needle hub attached to a needle and a cap of a container, such as a medication container, as described above.

[0041] In a configuration in which the sealing element is located between the inner surface of the cap and the outer surface of the needle hub, the cap is shaped such that: the width of the cap is narrower at the distal end than at the proximal end; the cap has one or more shoulders; and the radius of the cap increases sharply at the shoulders. In other words, the cap has a distal end and a proximal end, and the distal end is narrower (i.e., has a smaller radius) than the proximal end. The distal end may be separated from the proximal end by a shoulder.

[0042] It will be appreciated that the cap may include multiple shoulders, thereby dividing it into more than two sections, with any two adjacent sections being separated by a shoulder that forms an abrupt change in radius.

[0043] Advantageously, the cap has such a shape, since the components can be configured such that a sealing element is located between the shoulder of the cap and the outer surface of the needle hub, so that the seal is formed at a fixed point along the cap (i.e., at the shoulder), but the part of the cap that is further from the injection site is wider than the tip, so that the container and cap cannot move relative to the needle hub.

[0044] A method of manufacturing a component of a medication syringe includes the steps of providing: - A container containing a medicine, fitted with a cap and sealed by a septum. - A sealing element that is in contact with the surface of the container cap. - A needle for piercing the septum. - The needle hub that is attached to the needle. The sealing element is positioned between a surface of the container cap and a surface of the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is away from the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing element forms a seal between the surface of the cap and the surface of the needle hub. This seal is maintained both during transition of the component from the first state to the second state and when the component is in the second state.

[0045] Thus, the manufacturing method described above maintains the free end of the needle in a sterile cavity while the syringe is stored and before an injection is performed. The cavity remains sealed during the injection (i.e., during the transition of the part from the first state to the second state), thereby maintaining the sterility of the needle. Other advantages described above are also achieved.

[0046] The manufacturing method may include providing any of the components described herein. The manufacturing method may include chemically bonding the sealing element to a surface (interior or exterior) of the cap. The manufacturing method may include overmolding the sealing element to a surface (interior or exterior) of the cap, or bonding using bi-injection molding.

[0047] As above, the sealing element may comprise a first material and the cap may comprise a second material different from the first material.The manufacturing method may comprise performing bi-injection molding.

[0048] It will be appreciated that any of the above features may be combined in an arrangement (and method of manufacture) in which a sealing element is located between the inner surface of the cap and the outer surface of the needle hub. For example, possible combinations of features include one or more of the following: - Housing - Safety Shield - Forward spring - Releasable locking mechanism - Needle hub and locking mechanism combination - Flexible latch arms and latching surfaces - Needle hub shape - Ribs on the cap - Positioning components The manufacturing method may include sterilizing one or more of these components.

[0049] The following components are also disclosed: (1) A part of a medication syringe that includes: - A container containing a medicine, fitted with a cap and sealed by a septum. - A flexible sealing sleeve placed around the exterior of the container cap. - A retaining ring to hold the sealing sleeve in place. - A needle for piercing the septum. - A needle hub attached to the tip of the needle and sealing sleeve. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is positioned within a cavity sealed by the sealing sleeve. In the second state, the needle penetrates the septum. When the component is in the first state, a seal is formed between the sealing sleeve and the outer surface of the cap and between the sealing sleeve and the needle hub. The seal between the sealing sleeve and the needle hub is maintained during transition of the component from the first state to the second state and when the component is in the second state. The sealing sleeve is configured to collapse and detach from the cap when the component transitions from the first state to the second state.

[0050] The needle hub may be tubular, have a closed distal end (excluding the needle eye) and an open proximal end, and may move proximally while the components transition from the first state to the second state, and may cover the container cap when the components are in the second state.

[0051] The retaining ring may be located at the proximal end of the sealing sleeve. Alternatively, the sealing sleeve may be fitted over the proximal end of the cap instead of the retaining ring. In other words, the sealing sleeve may be fixed to the cap by expanding inward at the proximal end of the cap.

[0052] The sealing sleeve may have a first thickness at a portion that contacts the outer surface of the cap, and a second thickness at a portion that contacts the needle hub. In this case, when the components are in a first state (pre-injection state), the sealing sleeve may have a third thickness at a portion that is located between the needle hub and the cap. The third thickness is thinner than the first thickness and / or the second thickness. This controls the portion of the sealing sleeve that collapses outward when the components transition from the first state to the second state. That is, the thinner portion of the sealing sleeve is more likely to collapse.

[0053] The sealing sleeve may have a lip at its distal end. When the component is in the first position, the lip extends proximally. When the component transitions from the first position to the second position, the lip inverts as the needle hub moves proximally, and when the component is in the second position, the lip extends distally. In this manner, the lip helps guide the needle hub, thereby helping to keep it centered relative to the container. The needle hub may be coupled to the distal end of the sealing sleeve.

[0054] (2) A part of a medication syringe that includes: - A container containing a medicine, fitted with a cap and sealed by a septum. - A flexible sealing sleeve placed around the exterior of the container cap. - A needle for piercing the septum. - The needle hub that is attached to the needle. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is positioned within a cavity sealed by the sealing sleeve. In the second state, the needle penetrates the septum. When the component is in the first state, a seal is formed between the sealing sleeve and the outer surface of the cap, and between the sealing sleeve and the needle hub. These seals are maintained both during transition of the component from the first state to the second state and when the component is in the second state. The sealing sleeve is configured to translate relative to the needle hub when the component transitions from the first state to the second state, i.e., the sealing sleeve moves radially outwardly over the needle hub.

[0055] The sealing sleeve may be fitted over the proximal end of the cap, in other words, the sealing sleeve may be fixed to the cap by expanding inward at the proximal end of the cap.

[0056] The sealing sleeve may have a ridge or notch at its distal end. When the components are in the first (pre-injection) state, the ridge or notch on the sealing sleeve locks into a ridge or notch on the proximal end of the needle hub. This helps to keep the needle hub stationary relative to the sealing sleeve and cap while the components are stored. It also helps to prevent the needle hub from disengaging from the sealing sleeve.

[0057] (3) A part of a medication syringe that includes: - A container containing a medicine, fitted with a cap and sealed by a septum. - A sealing element that is in contact with the surface of the container cap. - A needle for piercing the septum. - The needle hub that is attached to the needle. The sealing element is positioned between the container cap and the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is away from the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, a seal is formed between the sealing element and the cap and between the sealing element and the needle hub. Each seal is maintained during transition of the component from the first state to the second state and when the component is in the second state.

[0058] The component may be configured such that a portion of the needle hub fits inside the sealing element. The sealing element may move circumferentially over the needle hub as the component transitions from the first state to the second state. The sealing element may be flexible and function as a stopper. The proximal end of the stopper may be located in the cap and the distal end of the stopper may be located in the needle hub. The stopper may be crushed between the cap and the needle hub to form a compressible seal with the cap. The sealing element may define a longitudinal hole through which a portion of the needle hub moves as the component transitions from the first state to the second state. The needle hub may have an indentation into which a ridge on the distal end of the sealing element locks when the component is in the second state. The combination of the indentation and the ridge reduces the risk of distal movement of the needle hub relative to the sealing element after the component is in the second state.

[0059] The needle hub may include wings that contact the sealing element when the component is in the second state and prevent the needle hub from moving too far proximally relative to the sealing element. The wings also prevent the needle hub from rotating (about an axis defined by the needle) relative to the component while the component is transitioning from the first state to the second state. The component may include an outer cap that is disposed around the sealing element and the container cap and around at least a portion of the needle hub. The outer cap acts to press the sealing element against the needle hub. The outer cap may include one or more longitudinal holes configured to lock the wings of the needle hub when the component is transitioning from the first state to the second state. This prevents the needle hub from twisting relative to the sealing element while the component is transitioning from the first state to the second state. The needle hub may be rigid.

[0060] (4) A part of a medication syringe that includes: - A medication container that contains a medication, has a cap, and is sealed by a septum. - a first sealing element in contact with the outer surface of the cap of the medicine container; - A needle for piercing the septum. - The needle hub that is attached to the needle. - A second sealing element in contact with the outer surface of the needle hub. - An entire container containing the medicine container cap and needle hub. A first sealing element is disposed between the outer surface of the cap of the medicine container and the inner surface of the entire container. A second sealing element is disposed between the outer surface of the needle hub and the inner surface of the entire container. The components are configured to transition from a first state to a second state. In the first state, the needle is clear of the septum, with the free end of the needle positioned within a cavity sealed by the first and second sealing elements. In the second state, the needle penetrates the septum. When the components are in the first state, a seal is formed between the outer surface of the cap and the inner surface of the entire container by the first sealing element, and a seal is formed between the outer surface of the needle hub and the inner surface of the entire container by the second sealing element. Each seal is maintained during transition of the components from the first state to the second state and when the components are in the second state. Both the first and second sealing elements are flexible, while the entire container is rigid.

[0061] The entire container may be tubular and open at one or both ends. The entire container may have a protrusion at its distal end. The protrusion is locked into a recess in the needle hub when the components are in the first state, thereby preventing the needle hub from moving distally relative to the entire container.

[0062] (5) A part of a medication syringe that includes: - A container containing a medicine, fitted with a cap and sealed by a septum. - A flexible sealing sleeve placed around the exterior of the container cap. - A needle for piercing the septum. - The needle hub that is attached to the needle. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is located in a cavity sealed by the sealing sleeve. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing sleeve forms a seal between the outer surface of the cap and the inner surface of the needle hub. This seal is maintained both during transition of the component from the first state to the second state and when the component is in the second state. The needle hub is configured to translate relative to the cap when the component transitions from the first state to the second state, i.e., the needle hub moves radially outwardly of the sealing sleeve and overlies it. The needle hub may be rigid.

[0063] The sealing sleeve may be made of a flexible material and may have one or more positioning features on its outer surface that hold the needle hub in place when the components are in the first state. The features may have one or more annular ridges, and the needle hub may ride over at least one of the ridges during transition of the components from the first state to the second state.

[0064] (6) A part of a medication syringe that includes: - A container containing a medicine, fitted with a cap and sealed by a septum. - A sealing element that is in contact with the outer surface of the container cap and includes a thread on the outer surface. - A needle for piercing the septum. - A needle hub that is attached to the needle and contains threads on its internal surface. The sealing element is positioned between the outer surface of the container cap and the inner surface of the needle hub. The threads of the needle hub engage with the threads of the sealing element to form a seal. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing element forms a seal between the inner surface of the needle hub and the outer surface of the cap. This seal is maintained both during transition of the component from the first state to the second state and when the component is in the second state. The threads of the needle hub and the sealing element override each other during transition of the component from the first state to the second state.

[0065] The threads of the sealing element and the needle hub may be square threads. The sealing element may be made of a flexible material and the needle hub may be made of a hard material.

[0066] (7) A part of a syringe for administering medicine, comprising: - A container containing a medicine, fitted with a cap and sealed by a septum. - A needle for piercing the septum. - The needle hub that is attached to the needle. - a sealing element made of a flexible material, connecting the container cap and the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing element forms a seal between the needle hub and the container cap. This seal is maintained both during transition of the component from the first state to the second state and when the component is in the second state. The sealing element collapses during transition of the component from the first state to the second state.

[0067] The sealing element may be described as an annular or tubular member. The distal end of the sealing element is connected to the needle hub and the proximal end is connected to the container cap. In this way, the free end of the needle is surrounded by the sealing element, thereby maintaining its sterility. The needle hub may be rigid.

[0068] Any of the mechanisms described herein can be used with any cartridge-type medication container and with a variety of medication delivery systems, including auto-injectors and manual systems.

[0069] The vial cap and needle hub may be injection molded from a thermoplastic resin. The cap may be formed from a hard resin such as polypropylene. The needle hub may be formed from polypropylene or another injection-moldable thermoplastic resin that is unbreakable and moderately impact resistant. The needle may have an anti-coring bevel on the end that penetrates the medication vial septum and a tip suitable for injection, such as a B-bevel lancet, on the end that faces the patient. The needle may be made of medical-grade stainless steel, such as grade 304 or 316. The medication vial septum may be formed from a thermoplastic or highly malleable resin to achieve a tight seal.

[0070] A syringe part that includes: - A container with a cap and sealed by a septum. - A sealing element that is in contact with the surface of the container cap. - A needle for piercing the septum. - Needle hub. The sealing element is positioned between a surface of the container cap and a surface of the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is away from the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing element forms a seal between the surface of the cap and the surface of the needle hub. This seal is maintained during transition of the component from the first state to the second state.

[0071] The component may be a component of a medication syringe, and the container may contain a medication. A needle hub may be attached to the needle. The seal between the surface of the cap and the surface of the needle hub by the sealing element may be maintained when the component is in the second state. The sealing element may be located between the outer surface of the cap and the inner surface of the needle hub, or alternatively, between the inner surface of the cap and the outer surface of the needle hub.

[0072] The part may comprise: a housing having an elongated axis, the housing being configured to receive a container containing a medication and having a hole at its tip through which a portion of the needle passes; a safety shield surrounding at least a distal portion of the housing, the safety shield configured to be advanced distally relative to the housing from a retracted position to an advanced position that protects the needle; an advancement spring disposed between the housing and the safety shield and configured to advance the safety shield from the retracted position to the advanced position;

[0073] The component may further include a releasable locking mechanism configured to engage with the safety shield to lock the safety shield in the retracted position. The needle hub may be movable relative to the housing between a first position and a second position. In the first position, the needle hub is free from the hole in the housing and in the second position, the needle hub is through the hole. When in the second position, the needle hub may be configured to release the locking mechanism, thereby releasing the safety shield.

[0074] The locking mechanism may further comprise: - A latch surface connected to one of the safety shield and the housing, and a flexible latch arm connected to the other. The latch arm is configured to lock the safety shield in the retracted position when engaged with the latch surface, and the needle hub may be configured to disengage the latch arm from the latch surface when in the second position.

[0075] The advancement spring may be configured to lock with the housing and the safety shield when the safety shield is in the advanced position, thereby preventing the safety shield from returning to the retracted position.

[0076] The sealing element may be part of a septum, and the septum may have a longitudinal bore that receives one end of the needle when the part is in the first position and a portion of the needle hub when the part is in the second position.

[0077] The sealing element may be chemically bonded to a surface (exterior or interior) of the cap. For example, the sealing element may be overmolded onto the exterior or interior surface of the cap. The sealing element may be an O-ring.

[0078] The cap may include one or more positioning members and the sealing element may be located therein. The needle hub may include one or more positioning members. The sealing element may be aligned with one of the positioning members of the needle hub when the components are in the first state.

[0079] The seal between the surface of the cap and the surface of the needle hub may be maintained while the components transition from the first state to the second state, or may be maintained when the components are in the second state.

[0080] The sealing element may comprise a first material and the cap may comprise a second material different from the first material, the sealing element and the cap being formed as a single piece by double injection molding.

[0081] The needle hub may include a first inner surface, a proximal protrusion, and a second inner surface. The first inner surface extends perpendicular to the needle and faces the cap. The proximal protrusion extends inward toward the needle. The second inner surface extends parallel to the needle from the first inner surface to the proximal protrusion. The second inner surface is configured to engage the sealing element when the component is in the first state, during transition of the component from the first state to the second state, and when the component is in the second state.

[0082] The cap may include a first rib and a second rib. The sealing element is disposed between the first rib and the second rib. When the component is in the first state, the distance between the first rib and the free end of the needle is shorter than the distance between the second rib and the free end of the needle. When the component is in the first state, the proximal projection of the needle hub may fit into the second rib of the cap, and when the component is in the second state, the first inner surface of the needle hub may fit into the first rib of the cap.

[0083] The cap may include a first locating recess and a second locating recess, the first recess having a sealing element disposed therein, the second recess configured to optionally receive a locating projection on the needle hub when the component is in the second state, and a surface of the locating projection on the needle hub may contact the sealing element when the component is in the first state.

[0084] A method of manufacturing a syringe component includes the steps of providing: - A container with a cap and sealed by a septum. - A sealing element that is in contact with the surface of the container cap. - A needle for piercing the septum. - Needle hub. The sealing element is disposed between a surface of the container cap and a surface of the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is away from the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. When the component is in the first state, the sealing element forms a seal between the surface of the cap and the surface of the needle hub. This seal is maintained during transition of the component from the first state to the second state. The method may be a method for manufacturing a component for a medication syringe.

[0085] A sealing element may be located between the outer surface of the cap and the inner surface of the needle hub. Alternatively, a sealing element may be located between the inner surface of the cap and the outer surface of the needle hub.

[0086] The method may comprise the following steps: - Providing a housing having a longitudinal axis. - providing a safety shield surrounding at least the distal portion of the housing, the safety shield being advanceable from a retracted position distally relative to the housing to an advanced position that protects the needle; - disposing an advancement spring between the housing and the safety shield to advance the safety shield;

[0087] The method may include providing a releasable locking mechanism configured to engage with the safety shield to lock the safety shield in the retracted position. The needle hub may be movable relative to the housing between a first position and a second position. In the first position, the needle hub is free from the bore in the housing and in the second position, the needle hub extends through the bore in the housing. In the second position, the needle hub may be configured to disengage from the locking mechanism to release the safety shield.

[0088] The locking mechanism may further comprise: - A latch surface connected to one of the safety shield and the housing, and a flexible latch arm connected to the other. The latch arm may be configured to lock the safety shield in the retracted position when engaged with the latch surface, and the needle hub may be configured to disengage the latch arm from the latch surface when in the second position.

[0089] The advancement spring may be configured to lock with the housing and the safety shield when the safety shield is in the advanced position, thereby preventing the safety shield from returning to the retracted position.

[0090] The sealing element may be part of a septum, and the septum may have a longitudinal bore that receives one end of the needle when the part is in the first position and a portion of the needle hub when the part is in the second position.

[0091] The sealing element may be chemically bonded to the outer surface of the cap. The sealing element may be overmolded to the outer surface of the cap. The sealing element may comprise a first material and the cap may comprise a second material different from the first material. The chemical bonding may be bi-injection molding. The sealing element may be an O-ring.

[0092] The cap may include one or more positioning members and the sealing element may be located therein. The needle hub may include one or more positioning members. The sealing element may be aligned with one of the positioning members of the needle hub when the components are in the first state.

[0093] The seal between the surface of the cap and the surface of the needle hub may be maintained by a sealing element while the components transition from the first state to the second state, or while the components are in the second state. The method may comprise sterilizing one or more of the components. [Brief explanation of the drawings]

[0094] The invention will now be explained in more detail with reference to a number of example embodiments shown in the following drawings, to which the invention is not, however, limited.

[0095] [Figure 1] 1 is a cross-sectional view of a syringe according to the invention disclosed in this specification. [Figure 2] FIG. 2 is a side view of the syringe of FIG. 1 in a pre-injection state. [Figure 3A] 1 illustrates a storage state of a syringe according to the invention disclosed in this specification. [Figure 3B] The syringe of FIG. 3A is shown rotated 45° about its longitudinal axis L. [Figure 4] 3B shows the syringe in a ready state in FIG. 3A. [Figure 5] 3B shows the syringe of FIG. 3A in an activated state. [Figure 6] 3B shows the syringe of FIG. 3A in an activated state but before dispensing. [Figure 7] 3B shows the syringe of FIG. 3A immediately after administration. [Figure 8] This shows the state when the syringe in FIG. 3A has finished driving and the needle has been removed. [Figure 9] FIG. 1 is an exploded view of a power pack according to the invention disclosed herein. [Figure 10A] 1 is an enlarged perspective view of a latch according to an embodiment of the invention disclosed herein; FIG. [Figure 10B] 1 is an enlarged perspective view of another latch in accordance with the invention disclosed herein; [Figure 10C] FIG. 2 is an enlarged perspective view of a protrusion of the latch mechanism according to the invention disclosed in this specification. [Figure 11A] 1 is a close-up view of the proximal end of a driver according to the invention disclosed herein, with the proximal housing in the unactuated position; [Figure 11B] 11B is a close-up view of the proximal end of the driver shown in FIG. 11A with the proximal housing in an actuated position. [Figure 12] 1 shows a syringe according to another embodiment of the invention disclosed herein; [Figure 13] 1 shows a syringe according to another embodiment of the invention disclosed herein; [Figure 14] The following describes how to assemble a syringe equipped with the power pack shown below. [Figure 15] FIG. 2 is a cross-sectional view of a portion of the syringe of FIG. 1. [Figure 16a] FIG. 16 is an isometric view of the damper of FIG. [Figure 16b] FIG. 16b is an exploded view of the damper of FIG. 16a. [Figure 16c] 16b shows a cross section through a plane along the long axis of the damper of FIG. 16a. [Figure 17a] FIG. 16 is an isometric view of the first drive component of FIG. 15. [Figure 17b] 17b shows a cross section through a plane along the longitudinal axis of the first drive part of FIG. 17a; [Figure 18a] 10A-10C are cross-sectional views of the first drive part and the damper taken along a plane along the longitudinal axis L. FIG. 10B shows various states of extension and contraction of the first drive part within the syringe. [Figure 18b] 10A-10C are cross-sectional views of the first drive part and the damper taken along a plane along the longitudinal axis L. FIG. 10B shows various states of extension and contraction of the first drive part within the syringe. [Figure 18c] 10A-10C are cross-sectional views of the first drive part and the damper taken along a plane along the longitudinal axis L. FIG. 10B shows various states of extension and contraction of the first drive part within the syringe. [Figure 18d] 10A-10C are cross-sectional views of the first drive part and the damper taken along a plane along the longitudinal axis L. FIG. 10B shows various states of extension and contraction of the first drive part within the syringe. [Figure 18e] 10A-10C are cross-sectional views of the first drive part and the damper taken along a plane along the longitudinal axis L. FIG. 10B shows various states of extension and contraction of the first drive part within the syringe. [Figure 19] FIG. 2 is a cross-sectional view of another embodiment of the invention disclosed herein. [Figure 20] FIG. 1 is an isometric cross-sectional view of another embodiment of the invention disclosed herein. [Figure 21] FIG. 10 is a cross-sectional view of a first drive component according to another embodiment of the invention disclosed herein. [Figure 22a] 22A-22D are isometric cross-sectional views of the first drive component of FIG. 21 taken along various longitudinally spaced planes. [Figure 22b] 22A-22D are isometric cross-sectional views of the first drive component of FIG. 21 taken along various longitudinally spaced planes. [Figure 22c] 22A-22D are isometric cross-sectional views of the first drive component of FIG. 21 taken along various longitudinally spaced planes. [Figure 22d] 22A-22D are isometric cross-sectional views of the first drive component of FIG. 21 taken along various longitudinally spaced planes. [Figure 23] FIG. 1 is an isometric cross-sectional view of another embodiment of the invention disclosed herein. [Figure 24a] FIG. 24 is an isometric view of an embodiment of the damper of FIG. 23. [Figure 24b] FIG. 24 is an isometric view of another embodiment of the damper of FIG. 23. [Figure 25] FIG. 1 is an isometric cutaway view of another embodiment of the invention disclosed herein. [Figure 26a] FIG. 26 is an end view of the first drive component of FIG. 25. [Figure 26b] FIG. 26 is a side view of the first drive component of FIG. 25. [Figure 26b] FIG. 26 is a cross-sectional view of the first drive component of FIG. 25. [Figure 27] 1 is a cross-sectional view of a damper according to an embodiment of the invention disclosed herein. [Figure 28a] 1 is a cross-sectional view of one of four embodiments of the invention disclosed in this specification. [Figure 28b] 1 is a cross-sectional view of one of four embodiments of the invention disclosed in this specification. [Figure 28c] 1 is a cross-sectional view of one of four embodiments of the invention disclosed in this specification. [Figure 28d] 1 is a cross-sectional view of one of four embodiments of the invention disclosed in this specification. [Figure 29] 1A and 1B are schematic diagrams illustrating a method for assembling a syringe according to the invention disclosed in this specification. [Figure 30a] 2 is a cross-sectional view of a portion of the syringe of FIG. 1, the syringe in a pre-injection state (storage state). [Figure 30b] 30a shows the syringe of FIG. 30a after (or during) injection. [Figure 31a] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 31b] The state after (or during) injection of the combination of Figure 31a is shown. [Figure 32a] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 32b] The state after (or during) injection of the combination of Figure 32a is shown. [Figure 32c] FIG. 32B is another view of the combination of FIGS. 32a and 32b. [Figure 33] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 34] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 35] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 36] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 37] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 38] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 39] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 40]10 shows another syringe combination according to the invention disclosed in this specification. [Figure 41] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 42] 1 is a cross-sectional view of another syringe combination according to the invention disclosed herein, the combination being in a storage state. [Figure 43] 1 is a flow chart of a method according to the invention disclosed herein. [Figure 44a] FIG. 2 is a first cross-sectional view of the tip of the syringe of FIG. 1. [Figure 44b] FIG. 2 is a second cross-sectional view of the tip of the syringe of FIG. 1. [Figure 44c] FIG. 2 is a side view of the tip of the syringe of FIG. 1. [Figure 45a] FIG. 2 is a first perspective view of a safety shield of the syringe of FIG. 1; [Figure 45b] FIG. 45b is a second perspective view of the safety shield of FIG. 45a. [Figure 45c] FIG. 2 is a perspective view of the housing of the syringe of FIG. 1. [Figure 46] 2 shows the advancement spring of the syringe of FIG. 1; [Figure 47a] The storage state of the syringe in Figure 1 is shown. [Figure 47b] 2 shows the syringe of FIG. 1 in a pre-injection state. [Figure 47c] 2 shows the syringe of FIG. 1 in a first state during injection; [Figure 47D] 2 shows the syringe of FIG. 1 in a first state after injection; [Figure 47E] 2 shows the syringe of FIG. 1 in a second state during injection; [Figure 47F] 2 shows the syringe of FIG. 1 in a second state after injection; [Figure 48A] 47A and 47B are external views of the syringe of Fig. 1 in a first state after injection as shown in Fig. 47D. [Figure 48B] 47A and 47B are external views of the syringe of Fig. 1 in a second state during injection as shown in Fig. 47E. [Figure 48C] 47A is an external view of the syringe of FIG. 1 in a second state after injection as shown in FIG. 47F. [Figure 49] 2 shows how to assemble the syringe of FIG. 1.

[0096] Throughout this description, like reference numerals are used to refer to like parts and elements. DETAILED DESCRIPTION OF THE INVENTION

[0097] The invention disclosed herein is generally directed to syringes, components for syringes, and methods of assembling or manufacturing the same. In a first aspect, the invention provides a power pack, which may form part of a drive unit. In a second aspect, the invention provides a braking mechanism for a syringe that dampens power available from the power pack. In a third aspect, the invention provides a connecting device for a syringe that connects a needle hub to a drug cartridge. In a fourth aspect, the invention provides a passive safety shield for a syringe that protects a user from the exposed tip of the syringe needle.

[0098] Each aspect of the invention will be described in turn below. These aspects can be implemented independently of one another or in combination, as will become apparent from the detailed description below. For example, any of the power pack embodiments described below can be combined with any of the braking mechanisms described herein. The power pack may also be used without a braking mechanism.

[0099] Similarly, the damping mechanism described below may be used with a power pack other than that described herein. While the power pack and damper can be used independently, additional benefits may be realized when the power pack described herein is installed in a syringe in combination with the damping mechanism described below. In particular, the power pack according to the invention disclosed herein can be equipped with a larger drive spring than conventional syringes. The power of the larger drive spring may be damped, if necessary, using the damping mechanism described herein.

[0100] The power pack and / or braking mechanism described herein provides additional advantages when incorporated into a syringe equipped with a passive safety shield as disclosed herein. Alternatively, a safety shield provision may be provided separately from other aspects of the invention disclosed herein. The safety shield provision according to the invention disclosed herein may be utilized, as needed, in syringes of the type configured to extend the needle from the housing during injection, administer a dose of medication through the needle, and then retract the needle after use.

[0101] Finally, it will be understood that the connection devices described herein may be utilized independently of the syringes described herein. The connection devices described herein may be utilized with any device or component in which a medication container includes a septum configured to be pierced by a needle. While the connection devices described herein may be utilized independently of other aspects described below, it will be understood that additional advantages may be achieved when combined with one or more of the other aspects disclosed herein. In particular, the connection devices described herein may provide additional advantages when combined with the provision of a passive safety shield described below.

[0102] Below, embodiments according to each of the above aspects are described, namely, syringes including an example power pack, an example braking mechanism, an example connection device, and an example safety shield mechanism.

[0103] FIG. 1 is a cross-sectional view of a syringe 1001 according to the invention disclosed herein. The syringe 1001 includes a handle 1003 at its proximal end and a cover 1006 at its distal end. The handle 1003 houses a driver 1016 (including a driver spring 1017) and a plunger rod 1015. The distal direction is toward the needle end of the syringe, as indicated by arrow A. The proximal direction is opposite the distal direction and is indicated by arrow B.

[0104] FIG. 1 shows syringe 1001 in a storage state. In this state, cover 1006 conceals the tip of syringe 1001. Cover 1006 is removable from syringe 1001 along with needle cap 1005 and needle shield 1004, thereby exposing the tip of syringe 1001. The tip of syringe 1001 contains a medication reservoir 1007. Medication reservoir 1007 is sealed at its proximal end by plunger 1013 and at its distal end by septum 1008. Medication reservoir 1007 contains medication M. A needle hub 1011 is coupled to the distal end of medication reservoir 1007, and a hypodermic needle 1009 is attached to needle hub 1011. Needle hub 1011 is translatable relative to medication reservoir 1007. Thus, when syringe 1001 is in use, septum 1008 can be pierced by hypodermic needle 1009 to establish a fluid path between medication container 1007 and hypodermic needle 1009 to administer an injection. Although the embodiments disclosed herein are described with syringes having a medication container that is a cartridge sealed by a septum, it will be understood that in some embodiments the container sealed by a septum can be replaced by a syringe barrel with a needle.

[0105] 1, in the syringe shown, the tip of the hypodermic needle 1009 is recessed from the leading edge of the housing 1023. A safety shield 1019 is also provided around the tip of the housing 1023. The safety shield 1019 can optionally be advanced relative to the housing 1023 after injection.

[0106] 1, the housing 1023 may be detachable from the handle 1003. In this case, the housing 1023 and its contents (i.e., the tip of the syringe 1001) may be disposable.

[0107] To perform an injection, a user first removes the cover 1006 (along with the needle cap 1005 and needle shield 1004) from the syringe 1001. The user then places the distal end of the safety shield 1019 at the desired injection site and activates the driver 1016. When the driver 1016 is activated, the driver spring 101 drives the plunger rod 1015 distally. This advances the needle hub 1011 and medication reservoir 1007, thereby penetrating the hypodermic needle 1009 at the injection site. As the plunger rod 1015 continues to advance, the medication reservoir 1007 further advances, until the septum 1008 is pierced by the hypodermic needle 1009. Eventually, the plunger 1013 advances within the medication reservoir 1007 toward the septum 1008, expelling the medication from the medication reservoir 1007 through the hypodermic needle 1009. This completes the injection. When the plunger rod 1015 reaches its terminal end, the drive spring 1017 disengages from the plunger rod 1015, allowing the return spring 1021 to operate to proximally retract the medication container 1007, needle hub 1011, and hypodermic needle 1009. This retracts the hypodermic needle 1009 back into the housing 1023, ensuring the safety of the syringe 1001 after the injection is completed. Optionally, the advancement spring 1025 also advances the safety shield 1019 relative to the housing 1023, thereby providing an additional layer of protection.

[0108] FIG. 2 is an external view of the syringe 1001 of FIG. 1 , showing the syringe in a pre-injection state with the cover 1006 removed in preparation for use. In this state, the housing 1023 and safety shield 1019 are exposed and ready for use. As shown in FIG. 2 , the syringe 1001 includes a proximal end 1 a and a distal end 1 b. The distal end 1 b may be detachable from the proximal end 1 a. In some embodiments, the distal end 1 b may be disposable and the proximal end 1 a may be reusable. That is, the distal end of the syringe (including the needle) may be configured for single use, while the proximal end of the syringe (including the driver) may be reusable multiple times by connecting a new tip to the syringe for each subsequent use. Alternatively, both the proximal and distal ends of the syringe may be disposable or reusable.

[0109] [Power Pack] The power pack according to the first aspect of the invention disclosed in this specification will now be described.

[0110] The driver 1016 shown in Figures 1 and 2 includes a power pack configured to move the medication container 1007 and plunger rod 1015 distally under the action of a drive spring 1017.

[0111] Generally, the power pack includes a drive spring 1017 disposed within a housing 1023 and configured to power distal movement of the plunger rod 1015 and medicament reservoir 1007 to effect an injection. The drive spring 1017 is coupled to the plunger rod 1015 through a releasable inhibiting mechanism (discussed in more detail below). The inhibiting mechanism is configured to maintain the drive spring 1017 engaged with the plunger rod 1015 during injection (which allows distal movement of the medicament reservoir 1007 and / or plunger rod 1015 under the influence of the drive spring 1017). The inhibiting mechanism is further configured to release the plunger rod 1015 from the action of the drive spring after a dose of medicament has been dispensed from the medicament reservoir 1007.

[0112] The power pack will be described below with reference to the syringe 1001 shown in FIG. 1, but it will be understood that the power pack described herein can be used with any syringe in which it is desirable to separate the plunger rod 1015 from the drive spring 1017.

[0113] Figure 1 shows the drive spring 1017 in a syringe in a stored state. As shown in Figure 1, before the syringe is used, the drive spring 1017 is compressed and in a state (loaded state) in which it stores elastic potential energy for driving the syringe 1001. The drive spring 1017 may be kept in the loaded state until the syringe 1001 is activated. When the syringe 1001 is activated, the drive spring 1017 can transition to an extended state, moving the plunger rod 1015 of the syringe 1001 in the process.

[0114] The power transmitted by the drive spring 1017 extending within the syringe 1001 is generally inversely proportional to the extension of the spring 1017. To ensure that the drive spring 1017 transmits power over the entire length of the plunger rod 1015's path, the drive spring 1017 should complete its travel while still somewhat compressed. Thus, during injection, the drive spring 1017 will hold the medication container 1007 in a distal position within the housing 1023 until the medication container 1007 and / or plunger rod 1015 are released from the action of the drive spring 1017. This may be undesirable in many cases, as it may make it difficult to retract the medication container 1007 within the housing 1023 after the injection is complete.

[0115] As will be appreciated from a more detailed description below, the inventive power pack disclosed herein reliably transmits power to plunger rod 1015 during injection to administer a dose of medication, and subsequently disengages drive spring 1017 from plunger rod 1015 at the end of its trajectory, thereby preventing plunger rod 1015 (and medication reservoir 1007) from remaining at the tip of syringe 1001 once the injection is complete.

[0116] Power pack embodiments are described in more detail below with reference to Figures 3A-13.

[0117] 3A-11B show a first embodiment of a syringe 1001 including a power pack 1030 in accordance with the invention disclosed herein. FIG. 3A is a cross-sectional view along the longitudinal axis of the syringe 1001. FIG. 3B is another cross-sectional view of the syringe 1001, rotated 45° about the longitudinal axis L of the syringe 1001 from the position shown in FIG. 3A. FIGS. 3A and 3B show the syringe 1001 in a storage position prior to injection. FIGS. 4-8 show the syringe 1001 of FIGS. 3A and 3B in the following position: the power pack 1030 advances the plunger rod 1015 and medication reservoir 1007 distally within the housing 1023, releasing the plunger rod 1015 from the action of the drive spring 1017 and allowing the medication reservoir 1007 to retract relative to the housing 1023.

[0118] Referring first to Figure 3A, the power pack 1030 includes a drive spring 1017 and a travel blocking mechanism 1036. The travel blocking mechanism 1036 is configured to engage the drive spring 1017 with the plunger rod 1015. The power pack 1030 is disposed within a proximal housing 1032. The proximal housing 1032 is movably mounted within a handle 1003 of the syringe 1001. The handle 1003 also houses an actuator 1034, further details of which are described with reference to Figures 3B, 12, and 13.

[0119] A spiral coil spring is used as the drive spring 1017. This coil spring is arranged coaxially with the plunger rod 1015 and the movement prohibition mechanism 1036. The movement prohibition mechanism 1036 includes a latch mechanism 1038 and a storage tube 1044. The latch mechanism 1038 includes a latch 1040 and a protrusion 1042.

[0120] As shown in Figure 3A, the plunger rod 1015 may be a composite member made up of multiple distinct components. Alternatively, the plunger rod 1015 may be a single piece. As shown in Figure 3A, the proximal portion of the body of the plunger rod 1015 may be hollow. However, this does not prevent the plunger rod 1015 from being substantially solid.

[0121] The latch mechanism 1038 is configured to engage the plunger rod 1015 with the drive spring 1017 and to maintain the drive spring 1017 in a charged state until the syringe 1001 is ready for use. The latch mechanism 1038 is at least partially contained within a cavity within the drive spring 1017. Because the latch mechanism 1038 is located within the drive spring 1017, the diameter of the drive spring 1017 can be larger than if the drive spring 1017 were located inside the travel inhibiting mechanism 1036. The larger the drive spring 1017 used, the more force can be transmitted to the plunger rod 1015, and therefore, the more force can be transmitted to the plunger rod 1015 throughout the entire injection, i.e., until the drive spring 1017 is fully extended.

[0122] 3A, latch mechanism 1038 includes a latch 1040 that is fixed to a protruding portion 1042. Therefore, latch 1040 and protruding portion 1042 can move together due to the action of drive spring 1017. Latch mechanism 1038 may be formed as a single piece (including both the latch and the protruding portion), or may be formed by fitting separate parts, latch 1040 and protruding portion 1042, together.

[0123] The latch 1040 includes a mating portion 1046. The mating portion 1046 is configured to fit the latch 1040 onto the plunger rod 1015. The mating portion 1046 is in the form of an arm (or arms) that includes a latch surface (as shown in FIGS. 10A and 10B). The latch surface is configured to engage with a latch surface 1050 on the plunger rod 1015. The arm of the mating portion 1046 is clearly shown in FIG. 10A and is designated by the reference numeral 1052.

[0124] The arms 1052 of the mating portion 1046 are able to bend outward from a position where they engage the latching surface 1050 of the plunger rod 1015 (as shown in FIG. 3A) to a position where they no longer engage the latching surface 1050. However, when the latch mechanism 1038 is in the locked position as shown in FIG. 3B, the housing barrel 1044 prevents the mating portion 1046 from bending outward, as will be explained further below.

[0125] As shown in FIGS. 3A and 3B, the storage tube 1044 is received between the mating portion 1046 and the protruding portion 1042. The storage tube 1044 includes a generally cylindrical body. At least a portion of the body forms a locking sleeve 1054. The locking sleeve 1054 is configured to surround the arm 1052 of the mating portion 1046 when the latch mechanism 1038 is in the position shown in FIGS. 3A and 3B. This prevents (or limits) bending of the arm 1052 in an outward direction, thereby maintaining the mating portion 1046 engaged with the plunger rod 1015. This position of the latch mechanism 1038 (i.e., the position where the arm of the mating portion 1046 cannot disengage from the plunger rod 1015) is the locked position. This engagement causes the latch mechanism 1038 to releasably couple the drive spring 1017 to the plunger rod 1015, allowing power from the drive spring 1017 to be transmitted to the plunger rod 1015.

[0126] The housing barrel 1044 also has one or more recesses 1064. These recesses 1064 may be through-holes or recesses with a base, and the arms 1052 of the fitting portion 1046 can bend into the space formed by them to disengage from the plunger rod 1015. The latch 1040 is slidably attached to the housing barrel 1044. When the housing barrel 1044 reaches a predetermined position, the locking sleeve 1054 and the arms 1052 of the fitting portion 1046 can move relative to each other. In this position, the one or more recesses 1064 in the housing barrel 1044 are assigned to the free ends of the arms 1052 of the fitting portion 1046, allowing the arms 1052 to bend outward. This position of the latch mechanism 1038 is the movement-permitting position.

[0127] The operation of the travel inhibiting mechanism 1036 during the injection process is described in further detail below with reference to Figures 4-8.

[0128] 3B, the latch mechanism 1038 may also hook onto the activation device 1034 to hold the drive spring 1017 in a charged state until the syringe 1001 is activated. The latch 1040 of the latch mechanism 1038 includes at least one catch element 1056. The catch element 1056 is releasably secured within the handle 1003 to hold the drive spring 1017 in a charged state.

[0129] The catch element 1056 can include a plurality of arms 1058 extending proximally from their free ends. The arms 1058 can include latching surfaces configured to catch on the latching surfaces of the actuation device 1034. The arms 1058 can be held in position by the proximal housing 1032 to catch on the latching surfaces of the actuation device 1034.

[0130] When the tip of the drive spring 1017 presses against the tip flange 1072 of the protruding portion 1042 of the latch mechanism 1038, the latch mechanism 1038 is fixed to the base end of the base housing 1032. This prevents the tip of the drive spring 1017 from extending prematurely.

[0131] 3A and 3B, the proximal end of drive spring 1017 presses against adjacent surface 1073 of proximal housing 1032. Thus, drive spring 1017 in a stored state is compressed between distal flange 1072 of projection 1042 and proximal adjacent surface 1073 of proximal housing 1032.

[0132] The proximal housing 1032 may be configured to move between an unactivated position and an activated position relative to the actuation device 1034. The arm 1058 of the catch element 1056 may be configured to release from its constrained state between the proximal housing 1032 and the actuation device 1034 upon relative movement between the proximal housing 1032 and the actuation device 1034, causing the drive spring 1017 to extend distally and move the latch mechanism 1038 distally. The syringe 1001 may include a spring 1075 disposed between the proximal housing 1032 and the actuation device 1034. The spring 1075 is configured to exert a force on the proximal housing 1032 in the distal direction (i.e., toward the unactivated position). Initially, the user's force applied to the syringe 1001 (as described below) must overcome the force of the spring 1075 and move the proximal housing 1032 proximally relative to the actuator 1034, releasing the arm 1058 from the engagement between the proximal housing 1032 and the actuator 1034. The interaction between the catch element 1056 and the actuator 1034 is described in more detail below with reference to Figures 10A-10C.

[0133] It will be appreciated that the latch mechanism 1038 may be configured in a variety of different ways. For example, the mating portion 1046 of the latch 1040 may include a single arm 1052 configured to couple the latch mechanism 1038 to the plunger rod 1015, or multiple arms 1052 as shown. The multiple arms 1052 may be arranged in diametrically opposed pairs across the syringe 1001, or may be circumferentially spaced apart about the longitudinal axis L of the syringe 1001.

[0134] Similarly, the catch element 1056 of the latch 1040 may include a single arm 1058 configured to catch the actuator 1034, or multiple arms 1058 as shown. The multiple arms 1058 may be arranged in diametrically opposed pairs across the syringe 1001 or may be circumferentially spaced apart about the longitudinal axis L of the syringe 1001. The latch mechanism 1038 may be formed from a resiliently deformable material, such as a metallic material or a resiliently deformable polymer.

[0135] The operation of the latch mechanism 1038 during the course of an injection will now be described in more detail.

[0136] First, the cover 1006 (shown in Figure 1) is removed from the syringe 1001 shown in Figures 3A and 3B, as in the syringe 1001 shown in Figure 4. The syringe 1001 is placed at the injection site in the pre-injection state shown in Figure 4, and the safety shield 1019 is pressed against the injection site.

[0137] As shown in FIGURE 5, the action of pressing the safety shield 1019 against the injection site causes the housing 1023 and driver 1016 (including the power pack 1030 and proximal housing 1032) to move proximally within the handle 1003 relative to the handle 1003 (compressing the spring 1075). It will be appreciated that proximal movement of the housing 1023 relative to the handle 1003 is equivalent to distal movement of the handle 1003 relative to the housing 1023. In other words, because the actuator 1034 is fixed relative to the handle 1003, retraction of the proximal housing 1032 relative to the handle 1003 moves the actuator 1034 distally relative to the proximal housing 1032 from the unactuated position to the actuated position. This releases the catch element 1056 from its constrained position between the proximal housing 1032 and the actuator 1034.

[0138] Retraction of the proximal housing 1032 in the illustrated embodiment occurs when the user presses the syringe 1001 against the injection site. This action moves the housing 1023 proximally relative to the handle 1003. Retraction of the housing 1023 also moves the proximal housing 1032 through the intermediate housing 1084. However, one skilled in the art will appreciate that other configurations are possible. For example, the proximal and intermediate housings may be formed as a single piece. Alternatively, the proximal and / or intermediate housings may each be formed from multiple pieces.

[0139] As shown in Figure 6, when the syringe 1001 is activated, the drive spring 1017 expands and moves the plunger rod 1015 toward the distal end. As the plunger rod 1015 moves toward the distal end, the medicine container 1007 also moves toward the distal end, piercing the needle 1009 into the injection site. Even after the medicine container 1007 has completely moved toward the distal end, the plunger rod 1015 continues to move forward (moving toward the distal end relative to the medicine container 1007), so that one dose of medicine is expelled from the medicine container 1007 through the needle 1009.

[0140] As can be seen from Figures 4-6, at this stage of the injection, the housing barrel 1044 moves with the latch mechanism 1038, so that the locking sleeve 1054 holds the arm 1052 of the mating portion 1046 in a position where the latch surface 1050 is engaged with the plunger rod 1015.

[0141] After the housing barrel 1044 has traveled its full distal distance, it comes to rest against an abutment surface 1062 on the housing 1023 (see FIG. 7). In the embodiment shown, the abutment surface 1062 is on the intermediate housing 1084, which is configured to mate with the proximal housing 1032. However, one skilled in the art will appreciate that the abutment surface 1062 may be on another component, such as the housing 1023 or the handle 1003.

[0142] After the barrel 1044 reaches the abutment surface 1062, the latch mechanism 1038 continues to advance distally relative to the barrel 1044 (as shown in FIG. 7). This advancement causes the arms 1052 of the mating portion 1046 to move out of contact with the locking sleeve 1054 and into recesses 1064, or holes, in the barrel 1044. In this position, the locking sleeve 1054 no longer holds the arms 1052 of the mating portion 1046 against the latching surface of the plunger rod 1015, causing the arms 1052 to flex outward, releasing the plunger rod 1015. As a result, the travel inhibiting mechanism 1036 (shown in FIG. 3A and consisting of the barrel 1044 and the latch mechanism 1038) moves from the inhibited position to the permitted position, separating the plunger rod 1015 from the latch mechanism 1038 and removing it from the action of the drive spring 1017.

[0143] 7, because the latch surfaces of both the plunger rod 1015 and the arm 1052 of the fitting portion 1046 are inclined, the force (in the distal direction) of the latch 1040 pressing against the plunger rod 1015 pushes the arm 1052 outward. The only thing that prevents the arm 1052 from bending due to this force is the locking sleeve 1054 of the housing tube 1044. Therefore, after the arm 1052 is fitted into the recess 1064, the force of the drive spring 1017 disengages the arm 1052 from the plunger rod 1015, and the plunger rod 1015 is released from the action of the drive spring 1017.

[0144] Finally, as shown in Figure 8, when the plunger rod 1015 is released from the action of the drive spring 1017, the medication container 1007 may be retracted into the syringe 1001 after use, for example by the action of a return spring 1021. The mechanism by which the medication container 1007 can be retracted into the housing 1023 will be described in more detail with reference to Figures 47a-47F.

[0145] The power pack according to the invention disclosed in this specification allows the drive spring to transmit power to the plunger rod through the travel-restricting mechanism by the above-described method. The travel-restricting mechanism is configured to allow the physical connection between the drive spring and the plunger rod to be released. In the initial travel-restricted state, the drive spring expands, causing the plunger rod to move with its force. In the next travel-permitted state, the travel-restricting mechanism releases the force of the drive spring from the plunger rod, allowing the plunger rod to move freely without being fixed by the power of the drive spring.

[0146] Turning to FIG. 9, the components of the power pack 1030 described with reference to FIGS. 3A-8 are shown in more detail in an exploded view. As shown in FIG. 9, the proximal housing 1032 is coaxially mateable with the drive spring 1017, the latch mechanism 1038 (including the latch 1040 and the ledge 1042), the housing barrel 1044, and the plunger rod 1015. The drive spring 1017 is sized to be equal to or smaller than the inner diameter of the proximal housing 1032. The ledge 1042 is sized to be equal to or smaller than the inner diameter of the coiled drive spring 1017. The latch 1040 is sized to fit within the ledge 1042 with the housing barrel 1044 positioned between the latch 1040 and the ledge 1042. Finally, the plunger rod 1015 is sized to be equal to or smaller than the inner diameter of the latch 1040.

[0147] The proximal housing 1032 is movably mounted relative to the actuation tool 1034. The spring 1075 is configured to exert a force on the proximal housing 1032 in a distal direction (towards the unactuated position). In other words, the spring 1075 is positioned between the proximal housing 1032 and the actuation tool 1034, and therefore exerts a force on the proximal housing 1032 and the actuation tool 1034 to move them away from each other.

[0148] The barrel 1044 is slidably fitted into the latch mechanism 1038 between the latch 1040 and the protruding portion 1042. However, because the latch 1040 and the protruding portion 1042 are radially pressed against and hooked onto the barrel 1044, friction between the latch mechanism 1038 and the barrel 1044 prevents the latch mechanism 1038 from sliding relative to the barrel 1044 in the direction of the longitudinal axis of the housing 1023. This tight fit between the barrel 1044 and the latch mechanism 1038 provides sufficient friction to prevent the latch mechanism 1038 and the barrel 1044 from sliding relative to each other in the direction of the longitudinal axis of the housing 1023 when the proximal housing 1032 moves distally during storage of the syringe 1001 or during initial use. However, this friction is weak enough to allow the latch mechanism 1038 to slide relative to the housing barrel 1044 when the housing barrel 1044 contacts an adjacent surface (indicated by reference numeral 1062 in FIG. 7).

[0149] In this exploded view ( FIG. 9 ), the arms forming the mating portion 1046 of the latch 1040 are clearly visible. The arms forming the catch element 1056 of the latch 1040 are also clearly visible. For clarity, the arms of the mating portion 1046 are labeled with the reference numeral 1052 in FIG. 10A , and the arms of the catch element 1056 are labeled with the reference numeral 1058. Also visible in FIG. 9 are the latch surfaces at the free ends of these arms, as well as the associated latch surfaces of the plunger rod 1015. However, for clarity, the reference numerals for the latch surfaces are labeled in FIG. 10A because FIG. 10A more clearly shows the latch surfaces of the arms. In the illustrated embodiment, the latch surface of the plunger rod 1015 is formed as an annular rib 1060 extending circumferentially around the plunger rod 1015. However, one skilled in the art will understand that the circumferentially continuous rib 1060 may be replaced by multiple discrete latch surfaces.

[0150] The force exerted on the plunger by the drive spring is removed when the plunger reaches the end of its trajectory, but this force may be more precisely controlled using a braking mechanism, which is shown in Figures 15-29 and will be described in more detail below with reference to those figures.

[0151] Turning to Figures 10A and 10B, two example latch configurations are shown. Figure 10A shows an example latch 1040 similar to that shown in Figure 9. Latch 1040 includes four arms 1058 forming a catch element 1056 and four arms 1052 forming a mating portion 1046.

[0152] The arms 1058 that make up the catch element 1056 each have a free end that extends proximally from the main body 1066 of the latch 1040. A locking hook 1068 is provided at or midway to the free end of each arm 1058. The locking hook 1068 is the portion of the latch 1040 that is restrained between the proximal housing 1032 and the actuator 1034. The restraint of the locking hook 1068 by these factors will be described in more detail with reference to Figures 11A and 11B.

[0153] The arms 1052 that make up the mating portion 1046 extend at their free ends distally from the body 1066 of the latch 1040. A shoulder 1070 is formed at or on the way to the free end of each arm 1052, and a latch surface 1051 is disposed thereon.

[0154] 10A, the catch element 1056 includes four arms 1058, and the mating portion 1046 includes four arms 1052. These arms 1058, 1052 are alternately spaced apart around the body 1066, with the arms 1058 of the catch element 1056 offset 45° from the arms 1052 of the mating portion 1046 in the circumferential direction.

[0155] The arms 1052, 1058 are configured to bend during an injection to disengage their respective latching surfaces. In particular, the arms 1052, 1058 may be formed from a resiliently deformable material.

[0156] FIG. 10B illustrates a variation of the latch 1040 shown in FIG. 10A. The latch 1040' of FIG. 10B includes two arms 1058' of the catch element 1056 and two arms 1052' of the mating portion 1046. The arms 1058' of the catch element 1056 face each other across the diameter of the latch 1040. The arms 1052' of the mating portion 1046 face each other across the diameter of the latch 1040. The arms 1058', 1052' are staggered in the circumferential direction. Any number and combination of arms 1058', 1052' may be used and is not limited to the specific example shown in the drawings. For example, there may be six arms 1058', 1052', and the catch element may have two arms and the mating portion may have four arms.

[0157] FIG. 10C shows the extension 1042 of the latch 1040 in isolation. The extension 1042 includes a distal flange 1072. The distal flange 1072 extends radially outward, and its surface engages and contacts the drive spring 1017, transmitting the force of the drive spring 1017 to the latch mechanism 1038. The extension 1042 includes a sleeve 1074. The sleeve 1074 extends proximally from the distal flange 1072 to a castellated flange 1076. The castellated flange 1076 includes at least one wall 1078 extending radially inward from the sleeve 1074. When the latch 1040 is engaged with the extension 1042, the arm 1058 of the catch element 1056 of the latch 1040 passes between the walls 1078, causing the wall 1078 to compress against the body 1066 of the latch 1040. As a result, the force of the drive spring 1017 is transmitted to the latch 104 , and further transmitted to the rib 1060 of the plunger rod 1015 through the arm 1052 of the fitting portion 1046 .

[0158] In the embodiment shown in Figure 10C, the rampart flange 1076 has four walls 1078 with four spaces between them through which the four arms 1058 of the catch element 1056 can pass. It will be appreciated that the number of walls 1078 (and the number of spaces between them) can be adjusted to accommodate the number of arms 1058 of the catch element 1056 on the latch 1040. Those skilled in the art will also appreciate that the number of arms does not necessarily have to equal the number of spaces, and that there can be more spaces than arms.

[0159] 11A and 11B, the operation of actuator 1034 to release latch 1040 will be described in more detail.

[0160] 11A is a cross-sectional view of the proximal end of actuator 1016. When syringe 1001 is in a storage position, mating portion 1046 of latch 1040 is captured between proximal housing 1032 and actuator 1034 in the unactuated position.

[0161] 11A, arms 1058 of catch element 1056 extend through holes in the proximal end of proximal housing 1032. Locking hooks 1068 of arms 1058 are prevented from moving outward by a retaining cap 1080. Retaining cap 1080 fits over the proximal end of proximal housing 1032. However, it will be appreciated that the body of proximal housing 1032 itself may be sized to prevent outward bending of arms 1058.

[0162] When the actuator 1034 is in the unactuated position shown in Figure 11A, the cover surface 1082 of the actuator 1034 prevents the arm 1058 from bending inward. The shape of the locking hook 1068 prevents the arm 1058 from sliding along its longitudinal axis relative to the proximal housing 1032. Thus, when the actuator 1034 is in the unactuated position shown in Figure 11A, the arm 1058 is captured between the proximal housing 1032 and the actuator 1034, preventing the latch mechanism 1038 from advancing and maintaining the drive spring 1017 in a compressed state.

[0163] Proximal housing 1032 is maintained in a distal (non-actuated) position relative to activation device 1034 by spring 1075 (shown schematically in FIGS. 11A and 11B). When the user presses syringe 1001 against an injection site to activate syringe 1001, housing 1023 moves proximally relative to handle 1003. This in turn causes proximal housing 1032 to move proximally within handle 1003, compressing spring 1075.

[0164] 11B shows the proximal housing 1032 in the actuated position. (In the actuated position, the proximal housing 1032 is moved proximally relative to the actuating device 1034 as a result of the syringe 1001 being pressed against the injection site.) In this position, the cap surface 1082 of the actuating device 1034 is moved distally relative to the proximal housing 1032 (compressing the spring 1075), and the locking hook 1068 of the arm 1058 faces the hole 1083, or recess, in the actuating device 1034. With the actuating device 1034 in this position, the arm 1058 is free to flex inward (into the recess), disengaging the locking hook 1068 from the retaining cap 1080 (or proximal housing 1032), allowing the latch mechanism 1038 to advance under the action of the drive spring 1017.

[0165] The travel blocking mechanism is releasable as described above and is configured to release the plunger rod 1015 from the action of the drive spring 1017. It will be appreciated that the travel blocking mechanism may take different forms. Another embodiment, shown in FIG. 12, illustrates the syringe 2001 in a pre-injection state. The syringe 2001 includes a handle 2003, a housing 2023, and a safety shield 2019, similar to those described above. The syringe 2001 also includes a driver 2016. The driver 2016 includes a power pack disposed within the proximal housing 2032. The power pack includes a drive spring 2017, which is configured to be releasably coupled to the plunger rod 2015 by a travel blocking mechanism 2036.

[0166] 12 includes a housing barrel 2044 and a latch mechanism 2038. The latch mechanism 2038 is configured to releasably couple the plunger rod 2015 and the drive spring 2017.

[0167] Similar to the previous embodiment, the latch mechanism 2038 includes a latch 2040 and a protrusion 2042. The latch 2040 is configured to hook onto a latching surface of the plunger rod 2015. The protrusion 2042 includes a flange that bears against the drive spring 2017.

[0168] The latch mechanism configuration shown in Figure 12 differs from that described with reference to Figures 3A-11B, but operates in a similar manner as will be described below.

[0169] Latch mechanism 2038 includes a mating portion 2046 that is configured to releasably engage plunger rod 2015 with a bendable arm that is configured to hook onto a latching surface of plunger rod 2015. Latch mechanism 2038 also includes a catch element 2056 that is configured to interact with an actuator to releasably retain latch mechanism 2038 to the proximal end of syringe 2001 while maintaining drive spring 2017 in a charged state.

[0170] The travel preventing mechanism 2036 also includes a storage tube 2044. The storage tube 2044 prevents the arm of the mating portion 2046 from bending outward, thereby holding the arm against the latching surface of the plunger rod 2015. Unlike storage tubes that include a cylindrical body with a recess (into which the arm of the mating portion can bend), the storage tube 2044 shown in FIG. 12 includes a locking sleeve 2054. The locking sleeve 2054 is a portion of the first inner diameter that keeps the arm of the mating portion 2046 hooked onto the plunger rod 2015. The inner diameter of the storage tube 2044 expands (relative to the locking sleeve 2054) distal to the locking sleeve 2054, providing space for the arm of the mating portion 2046 to bend outward. The storage tube 2044 also includes a compression surface 2092 distal to the locking sleeve 2054. The compression surface 2092 acts to move the arm of the mating portion 2046 out of contact with the plunger rod 2015 when the housing barrel 2044 is moved proximally relative to the latch mechanism 2038 .

[0171] As will be explained below, syringe 2001 operates similarly to syringe 1001.

[0172] At the start of an injection, the syringe 2001 is placed at the injection site and the safety shield 2019 is pressed against the skin. The act of pressing the safety shield 2019 against the injection site retracts the housing 2023 and driver 2016 within the handle 2003, actuating the syringe 2001 by compressing an actuator (not shown) between the driver 2016 and the handle 2003. That is, the actuator releases the drive spring 2017 from its charged state, thereby actuating the syringe 2001. When the syringe 2001 is actuated, the drive spring 2017 expands, moving the plunger rod 2015 distally.

[0173] Syringe 2001 includes an inhibiting mechanism 2036, which includes a latch mechanism 2038 and a housing barrel 2044. The inhibiting mechanism 2036 shown in Figure 12 operates in a similar manner to the inhibiting mechanism 1036 described with reference to Figure 3A.

[0174] During the first stage of injection (when the travel-blocking mechanism is in the "blocked" state), a locking sleeve 2054 with a relatively narrow inner diameter keeps the mating portion 2046 of the latch 2040 hooked onto the plunger rod 2015. However, unlike the embodiment described above with reference to FIGS. 3-10 , which has a generally cylindrical body including recesses into which the arms of the mating portion 2046 bend, the syringe barrel 2044 of the syringe 2001 shown in FIG. 12 includes a compression surface 2092. The compression surface 2092 is configured to bend the arms of the mating portion 2046 toward the inside of a portion of the barrel 2044 that is larger in diameter than the locking sleeve 2054, thereby exerting a force in the circumferential direction on the mating portion 2046 and actively disengaging the mating portion 2046 from the plunger rod 2015. The compression surface 2092 may be configured as multiple arms or as a conical slope. When the storage barrel 2044 reaches the adjacent surface 2062 of the housing (as the latch mechanism 2038 continues to advance), it slides against the latch mechanism 2038, displacing the mating portion 2046 from the plunger rod 2015. The mating portion 2046 may be configured to initially remain engaged with the plunger rod 2015, and then be actively disengaged from the plunger rod 2015, such that it remains locked or securely engaged with the plunger rod 2015 until it is disengaged from the plunger rod 2015. In this way, the latch mechanism 2038 can be securely engaged with and disengaged from the plunger rod 2015.

[0175] Thus, in one aspect of the invention disclosed herein, the housing barrel includes a compression surface configured to circumferentially push the arms of the mating portion off the plunger rod. In another aspect of the invention, the compression surface may include multiple arms or a conical slope. It will also be appreciated that these features may be combined with the locking sleeve described above.

[0176] FIG. 13 shows another syringe 3001. The syringe 3001 includes a handle 3003 disposed at the proximal end, a housing 3023, and a cover 3006 disposed at the distal end. The handle 3003 houses a driver 3016, which includes a drive spring 3017 and an advancement spring 3099. The drive spring 3017 provides power to expel the medication from the medication container 3007. However, it does not provide power to move the medication container 3007 toward the distal end, i.e., to pierce the needle into the skin; this power is provided by a separate advancement spring 3099. When the syringe 3001 is actuated, the drive spring 3017 remains compressed, while the advancement spring 3099 is released from its compressed state.

[0177] The syringe 3001 can be activated by pressing the safety shield 3019 against the injection site, i.e., the skin. The act of pressing the safety shield 3019 against the injection site causes the housing 3023 and driver 3016 to retract within the handle 3003, releasing the advancement spring 3099 from its compressed state and thereby activating the syringe 3001.

[0178] When the syringe 3001 is actuated, the advancement spring 3099 expands, moving the plunger rod 3015 distally. The action of the advancement spring 3099 causes the plunger rod 3015 to move distally along with the drive spring 3017. The drive spring 3017 is maintained in a compressed state, as shown in FIG. 13, between the (spaced apart) distal abutment surface 3097 and the proximal abutment surface 3095. Once the advancement spring 3099 has moved a predetermined distance (enough to fully advance the medication container 3007, but not enough to expel the medication), the distal abutment surface 3097 is released from its position relative to the proximal abutment surface 3095, and the drive spring 3017 is no longer constrained in its compressed state. When the distal abutment surface 3097 is released from the proximal abutment surface 3095, the drive spring 3017 compresses against the distal abutment surface 3097, moving it distally, which in turn moves the plunger rod 3015 distally. Thus, after the advancement spring 3099 has advanced the medication container 3007 to the injection position, the drive spring 3017 is allowed to extend, thereby powering the plunger rod 3015 to move through the travel restricting mechanism 3036. Upon or before full extension, the drive spring 3017 is disengaged from the plunger rod 3015 by the releasable travel restricting mechanism 3036. The travel restricting mechanism 3036 may be similar to mechanisms 1036, 2036 described above, or may be otherwise.

[0179] When the plunger rod 3015 moves distally to the end of its trajectory (ie, when all the medication has been dispensed), the travel inhibiting mechanism 3036 can release the plunger rod 3015 from the power of the drive spring 3017 .

[0180] The distance that the advancement spring 3099 extends before the drive spring 3017 can extend may be determined as the distance required to move the medication container 3007 and needle from a stored position to a fully usable position, which in some cases may be between 10 mm and 20 mm distally, for example 18 mm.

[0181] Separate advancement spring 3099 and drive spring 3017 reduce the force required to advance the needle, but this is not a limited purpose. For example, using a strong drive spring to both move the needle distally to pierce the injection site and to deliver the medication may be uncomfortable for the user in some circumstances. Utilizing an advancement spring 3099 that is weaker than drive spring 3017 allows the syringe to advance the needle more slowly while delivering the medication more quickly.

[0182] Accordingly, in one aspect of the invention, a syringe comprises: a housing having a longitudinal axis; a drive spring disposed within the housing; the drive spring having a distal end, a proximal end opposite the distal end along the longitudinal axis of the housing, and a cavity formed therein; a plunger disposed at least partially within the medication container; a plunger rod attached to the plunger; an advancement spring having a distal end, and a proximal end opposite the distal end along the longitudinal axis of the housing; and an actuation mechanism configured to maintain both the drive spring and the advancement spring in a compressed state. The actuation mechanism is also configured to: after actuation of the syringe, first release the advancement spring from its compressed state, causing the advancement spring to move the medication container to a distal position, and then release the drive spring from its compressed state, causing the drive spring to move the plunger within the medication container, expelling the medication from the syringe barrel.

[0183] In another aspect of the invention, a syringe is provided with a movement inhibiting mechanism, which includes: a latch mechanism at least partially received within a cavity within the drive spring, the latch mechanism including at least one fitting configured to releasably engage with the plunger rod and configured to move toward the distal end of the syringe under the action of the drive spring; ○ Storage tube fitted into the latch mechanism. The latch mechanism is configured to move from a movement-prohibited position to a movement-permitted position relative to the storage tube. In the locked position, the storage barrel keeps the latch mechanism's engaging portion engaged with the plunger, so that the extension of the drive spring moves the latch mechanism and storage barrel, expelling the medicine from the syringe barrel. - In the movement permission position, the housing tube does not keep the fitting portion engaged with the plunger.

[0184] In another aspect of the invention, the forward spring is at least partially contained within the cavity within the drive spring. In yet another aspect of the invention, the forward spring is entirely contained within the cavity within the drive spring when in a compressed state.

[0185] In another aspect of the invention, the actuation mechanism is configured to release the drive spring after the advancement spring has extended a predetermined distance in the distal direction, optionally between 10 mm and 20 mm, e.g., 18 mm.

[0186] Figure 14 shows how to assemble the syringe with the power pack, as will now be described.

[0187] In step 101, a housing having a longitudinal axis is provided. In step 103, a drive spring is placed within the housing. The drive spring has a distal end and a proximal end opposite the distal end along the longitudinal axis of the housing. The drive spring forms a cavity therein. In steps 105 and 107, at least a portion of a plunger is placed within the medication container, and a plunger rod is fitted onto the plunger. In step 109, a latch mechanism is fitted onto the syringe barrel to form a movement-restricting mechanism. The latch mechanism has at least one fitting portion. In step 111, at least a portion of the latch mechanism is placed into the cavity of the drive spring, and the fitting portion is releasably fitted onto the plunger. In step 113, the syringe barrel is disposed within the movement-restricting mechanism, thereby maintaining the fitting portion fitted onto the plunger. Expansion of the drive spring moves the latch mechanism and syringe barrel toward the distal end, expelling the medication from the syringe barrel. The syringe barrel is configured to move from a restricted position to a permitted position. In the movement permitting position, the housing barrel does not keep the fitting portion engaged with the plunger. Optionally, in step 115, the distal and proximal ends of the drive spring may be compressed to place the drive spring in a compressed state, and a latch mechanism may be configured to keep the drive spring in a compressed state. The reader will understand that the above steps may be performed in any order.

[0188] While the syringe according to the first aspect of the invention disclosed herein has been described above, embodiments of the invention may also relate to a power pack for a syringe or a power pack for a syringe driver. The power pack according to the invention disclosed herein may be incorporated into a syringe configured to automatically advance a medicine container with a needle to an injection position and automatically expel a dose of medicine. In particular, the power pack may be used in the following types of automatic injectors: an automatic injector that advances a medicine container to expel a dose of medicine and automatically retracts the medicine container relative to the housing after use.

[0189] The power packs described herein may be combined with one or more braking mechanisms, connecting devices, and passive safety shields, each of which is described in more detail below.

[0190] [Brake mechanism] The invention disclosed herein also provides an example of a braking mechanism configured to attenuate the force of a syringe driver. The braking mechanism according to the invention will be described below in conjunction with the example driver described above. However, it will be understood that the braking mechanism does not have to be used with the driver described above. Rather, the braking mechanism described below can be incorporated into other syringes that have different drivers than the driver described above, but where at least a portion of the power must be attenuated or would be advantageous.

[0191] The syringe of Figures 1 and 2 may be equipped with a damping mechanism configured to dampen at least a portion of the initial force of the drive spring when the syringe is actuated to perform an injection.

[0192] Generally speaking, the damping mechanism includes a damper configured to be interference-fitted to a first component of a driver. The driver is configured to transmit power from the driver spring to a plunger located within the medication container, thereby causing the driver spring to inject the user. As will be described in more detail below with reference to Figures 15-28, the damper and the component of the driver to which it is fitted (collectively referred to as the "first driver component") can take a variety of different forms. While the damper is described in connection with many example syringes described herein, it will be understood that the damper may be incorporated into other syringes.

[0193] Figure 15 is an enlarged cross-sectional view of the proximal end of the syringe 1001 shown in Figures 1 and 2. In this enlarged view, the driver 1016 of Figure 1 is shown with the handle 1003, but separated from the remainder of the syringe 1001 shown in Figure 1.

[0194] The actuator 1016 (see FIG. 1) includes a power pack 1030, a housing (previously referred to as the proximal housing 1032), and an actuator 1034. The structure and operation of these components are described in more detail with reference to FIGS. 3A-14, but generally, the power pack 1030 includes a drive spring 1017 and a travel blocking mechanism 1036 (described above with reference to FIGS. 3-10). The travel blocking mechanism 1036 is configured to couple the drive spring 1017 to the plunger rod 1015. The travel blocking mechanism 1036 includes a latch 1040 configured to mate with the plunger rod 1015 and the actuator 1034, and a protrusion 1042 configured to mate with the drive spring 1017. The protrusion 1042 couples to the latch 1040, which in turn couples to the plunger rod 1015. Thus, the drive spring 1017 is configured to transmit power to the plunger rod 1015 through the latch 1040 and the protrusion 1042 .

[0195] As shown in Figure 15, the driver 1016 also includes a damping mechanism configured to dampen the initial force of the driver spring 1017 when the driver spring 1017 is released from the charged state shown in Figure 15.

[0196] The damping mechanism according to the invention disclosed herein includes a damper 1200. The damper 1200 is fixed relative to the housing 1032 and configured to be interference fitted onto a surface of the first drive component. The first drive component is configured to move longitudinally relative to the proximal housing 1032 during injection. In the embodiment described below, the first drive component is configured as a hollow plunger rod 1015.

[0197] Damper 1200 can be secured within housing 1032 of syringe 1001 by pin 1202. Throughout this disclosure, the housing to which the damper is secured is the interior housing of the syringe, such as proximal housing 1032 of syringe 1001. Alternatively, damper 1200 can be secured to an exterior housing of the syringe, such as handle 1003. Securement of damper 1200 within the syringe housing ensures that the drive component moves relative to damper 1200 when drive spring 1017 is released at the start of an injection.

[0198] The pin 1202 extends along the longitudinal axis L of the housing and includes a head and a shaft. The shaft extends through a bore 1204 in the proximal housing 1032. The head of the pin 1202 contacts a shoulder surrounding the edge of the bore 1204 in the proximal housing 1032, forming a stop. This stop secures the pin 1202 against longitudinal movement relative to the proximal housing 1032. The pin 1202 includes threads on the shaft. The threads are configured to mate with a threaded bore (see FIG. 16c) at the proximal end of the damper 1200, securing the pin 1202 to the damper 1200, thereby securing the damper 1200 within the housing of the syringe 1001. The pin 1202 may be manufactured from plastite® or another suitably stiff material to secure the damper 1200 in place.

[0199] While the embodiments described below show a pin securing the damper in place, it will be understood that the retainer may take the form of something other than a pin. For example, the retainer may be a flange on the housing that plugs against a corresponding portion of the damper, adhesive that attaches the damper to the housing, and / or a mechanical locking mechanism disposed between a portion of the damper and a portion of the housing. Mechanical locking mechanisms include, for example, a turn lock or a snap lock. Alternatively, the damper may be integrally formed with the proximal housing (or handle), in which case a retainer is not required.

[0200] Damper 1200 is coaxially disposed with the first drive component within proximal housing 1032. Damper 1200 is also coaxially disposed about longitudinal axis L with latch 1040, ledge 1042, and pin 1202.

[0201] When syringe 1001 is in a storage state (as shown in FIG. 15 ), damper 1200 is located within a well 1206 formed in plunger rod 1015. Plunger rod 1015 is a generally tubular structure with a substantially cylindrical enclosure. The hollow portion of this enclosure serves as well 1206, which contains damper 1200. Well 1206 is bounded by an interior wall 1208 and is configured (in size, shape, and position) to receive at least a portion of damper 1200 through opening 1210.

[0202] Only the proximal end of plunger rod 1015 is shown in Figure 15. At the distal end of the portion shown is visible connector 1212. Connector 1212 is configured to connect to the distal end of plunger rod 1015 (see Figure 1). While plunger rod 1015 as shown herein includes multiple parts, it will be understood that plunger rod 1015 may be a single piece that includes a hollow portion at the proximal end.

[0203] 15, damper 1200 includes a damping member 1214. Damping member 1214 is configured to be interference-fit with inner wall 1208 of plunger rod 1015 during movement of plunger rod 1015 relative to damper 1200. Damping member 1214 has a maximum outer diameter that is wider than the maximum outer diameter of the body of damper 1200.

[0204] The damping member 1214 is shaped as a band or ring of elastically deformable material and is configured to contact at least a portion of the inner wall 1208 of the well 1206 during injection. The maximum outer diameter of the damping member 1214 is greater than the minimum inner diameter of the well 1206. It will be appreciated that the inner diameter of the well 1206 may be constant along its length (wherein the inner diameter of the well 1206 is always less than the outer diameter of the damping member 1214 before deformation) or may vary (wherein the inner diameter of the well 1206 is less than the outer diameter of the damping member 1214 along only a portion of the length of the well 1206).

[0205] By ensuring that the inner diameter of at least a portion of the bore 1206 is narrower than the outer diameter of the damping member 1214, the deformable material of the damping member 1214 is compressed against the inner wall 1208 of the bore 1206 during at least a portion of the injection. This compression creates an interference fit between the damper 1200 and the plunger rod 1015, which makes it difficult (but not impossible) for the plunger rod 1015 to move proximally relative to the damper 1200 even when actuated by the drive spring 1017.

[0206] Due to the tight fit between the damper 1200 and the first drive component (here the plunger rod 1015), the frictional force between the damper 1200 and the plunger rod 1015 resists the force of the drive spring 1017, thereby weakening the force of the drive spring 1017 in at least a portion of the stretched section of the drive spring 1017.

[0207] The damper 1200 will be described in more detail below with reference to Figures 16a-16c, and the plunger rod 1015 with reference to Figures 17a and 17b.

[0208] The interaction between the damper 1200 and the plunger rod 1015 along the trajectory of the plunger rod 1015 will be explained in more detail with reference to FIGS. 18a-18e and 19.

[0209] Figure 16a is an isometric view of the damper 1200 of Figure 15, and Figure 16b is an enlarged view thereof. Figure 16c shows a cross section of the damper 1200 through a plane along the longitudinal axis L shown in Figure 15.

[0210] As shown in Figures 16a and 16b, the damper 1200 includes an elongated body 1200a and a deformable damping member 1214. The damping member 1214 surrounds the head 1200b of the damper 1200. In this sense, the damper 1200 can also be referred to as a mandrel. The body 1200a can be made from nylon resin or other suitably rigid material. The damping member 1214 can be made from silicone or other elastomer or elastically deformable material.

[0211] As shown in FIGS. 16a and 16b, the body 1200a of the damper 1200 includes a locating feature 1216 at its proximal end. The locating feature 1216 is for locating the proximal end of the damper 1200 within the groove in the proximal housing 1032. In the illustrated embodiment, the locating feature 1216 comprises a hexagonal prism. The prism is for locating one end of the damper 1200 within the hexagonal seat in the proximal housing 1032, as shown in FIG. 15 . The locating feature 1216 includes an annular flange distal to the proximal end of the damper 1200. The flange has a surface that mates with a shoulder that surrounds the seat in the proximal housing 1032. The locating feature 1216 and the flange make it easier to place the damper 1200 within the proximal housing 1032 and align the longitudinal axis L during assembly of the syringe 1001.

[0212] Located at or midway to the tip of damper 1200 is head 1200b. Head 1200b and locating portion 1216 are connected by a shaft extending therebetween. As can be seen in Figure 16b, head 1200b has a larger diameter than both elongated body 1200a of the shaft and locating portion 1216.

[0213] The head 1200b of the damper 1200 supports the damping member 1214. Mounting the damping member 1214 at the tip of the damper 1200 maximizes the distance that the damping member 1214 can travel while seated against the inner wall 1208 of the longitudinal hole 1206 of the plunger rod 1015.

[0214] As previously mentioned, the damping member 1214 may comprise a strip of elastically deformable material that surrounds the head 1200b (or a portion thereof) of the damper 1200. The damping member 1214 may also be overmolded onto the head 1200b of the damper 1200.

[0215] In the configuration shown in Figure 16b, the head 1200b includes two circumferential grooves 1218a, 1218b spaced apart along its length, with a circumferential ridge 1220 formed between the grooves 1218a, 1218b. Although two grooves 1218a, 1218b are shown, the head 1200b may include one, three, four, or any number of grooves.

[0216] As shown in Figures 16a, 16b, and 16c, the damping member 1214 comprises an annular tube. The inner peripheral surface of this tube conforms to the contour of the outer peripheral surface of the head 1200b of the damper 1200, thereby fitting snugly within the circumferential grooves 1218a, 1218b and over the circumferential ridges 1220. The contours of the inner peripheral surface of this tube are supplemented, if necessary, to securely mount the damping member 1214 on and around the head 1200b. This configuration allows the head 1200b to hold the damping member 1214 in place even when frictional shear forces act on the damping member 1214 in any direction parallel to the longitudinal axis L. The interfitting of the damping member 1214 and head 1200b can be more clearly seen in Figure 16c. Figure 16c is a cross-sectional view of the damping member 1214 seated in the grooves 1218a, 1218b of the head 1200b and on the ridges 1220. The inner peripheral surface of the damping member 1214 matches the contours of the grooves 1218a, 1218b and ridges 1220 on the surface of the head 1200b, ensuring a snug fit therewith.

[0217] As shown in Figures 16b and 16c, the damping member 1214 includes a groove 1222 extending along its outer periphery. The groove 1222 defines two bands 1224a and 1224b that extend circumferentially around the outer periphery of the damping member 1214 (see Figure 16a). Because the outer diameter C1 of the bands 1224a and 1224b is greater than the outer diameter C2 of the head 1200b of the damper 1200, the bands 1224a and 1224b protrude furthest from the axis of the damper 1200 and are the portions of the damper 1200 that are configured to fit within the inner wall 1208 of the bore 1206 of the plunger rod 1015. The only portions of the damper 1200 that can fit within the inner wall 1208 of the bore 1206 are the damping member 1214 and the head 1200b. This allows for better control of the friction between the damper 1200 and the plunger rod 1015, as the damper 1200 only fits onto a portion of the inner wall 1208 wherever the plunger rod 1015 is located within the syringe 1001.

[0218] FIG. 16c is a cross-sectional view of the damper 1200. As shown in FIG. 16c, the damper 1200 includes a bore 1226, which will be described in more detail below. The bore 1226 is configured to receive the pin 1202 (shown in FIG. 15) that secures the damper 1200 within the housing. The damper 1200 also includes a socket 1228. The socket 1228 may be hexagonal in shape, if desired, and configured to receive the head of a tool (e.g., an Allen wrench) used to install the pin 1202 in the damper 1200. While the pin may be secured in the damper without a socket configured to accept a tool, such an arrangement may be more convenient. This is because the location of the damping member 1214 and the location of the damper 1200 within the elongated proximal housing 1032 may make it difficult to grasp the exterior surface of the damper 1200.

[0219] In manufacturing the damper 1200 of Figures 16a, 16b, and 16c, the damping member 1214 can be overmolded onto the head 1200b. This helps to more securely attach the damping member 1214 to the body 1200a of the damper 1200, as it provides a stronger mechanical bond between the damping member 1214 and the body 1200a of the damper 1200 than other means (e.g., installing an O-ring in a groove). This can reduce variability in damper performance and can reduce manufacturing and / or assembly costs, for example, by reducing or simplifying the need for quality control.

[0220] In the configuration shown in Figures 16a-16c, the grooves 1218a, 1218b and ridges 1220 of the damper 1200 extend circumferentially around the head 1200b, forming an unbroken annulus. The damping member 1214 therefore comprises a continuous annulus whose inner circumferential contour matches the outer circumferential contour of the head 1200b of the damper 1200. However, it will be appreciated that this configuration may be modified so that the annulus formed by the grooves 1218a, 1218b and / or ridges 1220 includes a break, and the inner circumferential contour of the damping member 1214 is modified accordingly.

[0221] Furthermore, in the illustrated embodiment, the damper 1200 includes two circumferential grooves with one circumferential ridge formed therebetween. However, one skilled in the art will appreciate that other configurations are possible. For example, three circumferential grooves may be provided with a circumferential ridge separating every two adjacent grooves. Furthermore, only one circumferential groove may be provided in which a portion of the damping member is mounted.

[0222] As will be appreciated, the interference fit between plunger rod 1015 and damper 1200 secures damper 1200 within the housing of syringe 1001, allowing damper 1200 to act as a brake when drive spring 1017 moves other components relative to the housing. To that end, a fastener is positioned to prevent relative movement between damper 1200 and the housing, at least in a direction parallel to the longitudinal axis of the housing.

[0223] The plunger rod 1015 shown in FIG. 15 will now be described in more detail with reference to FIGS. 17a and 17b. FIG. 17a is an isometric view of the proximal end of the plunger rod 1015 of FIG. 15. (The complete plunger rod 1015, including the proximal and distal ends, is shown in FIG. 1.) FIG. 17b is a cross-sectional view of the proximal end of the plunger rod 1015 taken along a plane along the longitudinal axis L. As shown in FIG. 17a, the inner wall 1208 defines a longitudinal bore 1206. The longitudinal bore 1206 extends the entire length of the proximal end of the plunger rod 1015. The proximal end of the plunger rod 1015 includes a distal snap-fit ​​connector 1230. This connector 1230, together with a distal snap-fit ​​connector on the distal end of the plunger rod 1015 (shown in FIG. 1), connects the proximal and distal ends of the plunger rod 1015.

[0224] As shown in Figure 17b, the longitudinal bore 1206 has five sections with different inner diameters. Broadly speaking, these five sections include a distal section 1232 with a first inner diameter dl, an intermediate section 1234 with a second inner diameter d2, and a proximal section 1236 with a third inner diameter d3. Transition sections 1238 and 1240 are provided between these sections. The first transition section 1238 connects the distal section 1232 to the intermediate section 1234, and the second transition section 1240 connects the intermediate section 1234 to the proximal section 1236.

[0225] As can be seen from FIG. 17b, the inner diameter of the longitudinal bore 1206 varies along its length, so that the damping force provided by the damper 1200 during injection can be varied by varying the amount of compression of the damping member 1214 as the plunger rod 1015 advances relative to the damping member 1214.

[0226] The distal section 1232 is where the head 1200b of the damper 1200 is located when the drive spring 1017 is in a charged state (as shown in FIG. 15). As the plunger rod 1015 advances relative to the damper 1200, the damping member 1214 moves from the distal section 1232, through the intermediate section 1234, and to the proximal section 1236.

[0227] The inner diameter d2 of the intermediate section 1234 is smaller than both the inner diameter d1 of the tip section 1232 and the inner diameter d3 of the base section 1236. When the head 1200b of the damper 1200 is positioned within the intermediate section 1234, the damping member 1214 is compressed. This increases the amount of compression of the damping member 1214 by the inner wall 1208 of the vertical hole 1206, thereby strengthening the normal force between the damping member 1214 and the inner wall 1208. Therefore, when the drive spring 1017 moves the plunger rod 1015 relative to the damper 1200, friction between the inner wall 1208 and the damping member 1214 increases. When the damping member 1214 is located in the distal section 1232 of the well 1206 (e.g., while the syringe 1001 is stored) or in the proximal section 1236 of the well 1206 (e.g., when the plunger rod 1015 is advanced to advance the medication container to the injection position), the damping member 1214 is located in a wider portion of the well 1206 and is not compressed (or is compressed to a reduced extent) by the inner wall 1208 of the well 1206. In this way, the damping force provided by the damping mechanism can be removed (or reduced) when the plunger rod 1015 begins and ends its movement relative to the damper 1200. Furthermore, the distal section 1232 provides a space in which the damping member 1214 can remain uncompressed during storage of the syringe 1001 and before use. Therefore, compared to syringes in which the braking member remains compressed even during storage, the braking function and reliability of syringe 1001 can be improved.

[0228] By varying the diameter of each section of the vertical bore 1206 relative to the outer diameter of the damping member 1214, the damping force of the damper 1200 can be varied as the plunger rod 1015 advances relative to the damper 1200. Furthermore, by varying the length and / or diameter of each of these sections, the distance over which the force is reduced as the drive spring 1017 extends can also be varied.

[0229] In the above embodiment, the minimum inner diameter of the vertical bore 1206 is wider than the outer diameter of the rigid head 1200b of the damper 1200. However, the inner diameter of at least one section of the vertical bore 1206 (here, the intermediate section 1234) is equal to or smaller than the outer diameter of the damping member 1214 before deformation. By making the inner diameter of at least a portion of the plunger rod 1015 smaller than the outer diameter of the damping member 1214 before deformation, a frictional force is created that counteracts the force of the drive spring 1017.

[0230] It will be understood that the sections of the well 1206 shown in FIG. 17b may be modified. For example, in the embodiment of FIG. 17b, there is only one section (the middle section 1234) whose inner diameter is narrower than the outer diameter of the damping member 1214. However, multiple sections of the well 1206 may have an inner diameter narrower than the outer diameter of the damping member 1214. Furthermore, while the above embodiment shows the well 1206 divided into five sections, there may be more or fewer sections. For example, the inner diameter of the well 1206 may be substantially constant along its length, so that the damping force of the damper 1200 remains substantially constant as the plunger rod 1015 advances relative to the damper 1200. The transition sections 1238 and 1240 may be omitted, and instead, steps may be provided between sections of different diameters. The plunger rod may have a well that tapers smoothly from one end to the other. These and other modifications will be apparent to those skilled in the art in light of the disclosure herein.

[0231] In an embodiment of the invention, damper 1200 dampens the force of drive spring 1017 early in the movement of plunger rod 1015. However, damper 1200 may dampen the force of drive spring 1017 during the period before and / or during needle insertion, or during the period of plunger rod 1015 movement before a large amount of medication is flushed from medication container 1007 through the needle. Note that damping of drive spring 1017 by damper 1200 may be unnecessary during the administration of medication through the needle bore because a restricted flow of medication through the needle creates a pressure to push back the flow. Therefore, damper 1200 may not be required to dampen the force of drive spring 1017 as early as it is during the initial movement of the syringe (e.g., after needle insertion).

[0232] The interaction between the damper 1200 and the plunger rod 1015 shown in FIG. 15 as the plunger rod 1015 advances relative to the damper 1200 will now be described in more detail with reference to FIGS. 18a-18e.

[0233] Figures 18a-18e are cross-sectional views of the plunger rod 1015 and damper 1200 taken along a plane along the longitudinal axis L. Figure 18a shows the damper 1200 with the head 1200b positioned in the distal section 1232 of the well 1206. Figures 18b-18e show the damper 1200 as the plunger rod 1015 advances to its distal-most position relative to the damper 1200 during an injection.

[0234] As shown in FIG. 18a, until injection is initiated (by release of the drive spring 1017), the head 1200b of the damper 1200, along with the damping member 1214, is positioned in the distal section 1232 of the well 1206. As noted above, the inner diameter of this section 1232 is wider than the outer diameter of the damping member 1214, so that the damping member 1214 does not contact (i.e., is not compressed by) the inner wall 1208 of the well 1206 (see FIGS. 17a and 17b). This arrangement results in limited (or no) engagement of the damping member 1214 against the inner wall 1208 of the well 1206, thereby reducing (or eliminating) frictional forces between the plunger rod 1015 and the damper 1200.

[0235] 18b shows the position of the plunger rod 1015 relative to the damper 1200 when the head 1200b of the damper 1200 has straddled the first transition section 1238 of the bore 1206 and is at least partially within the intermediate section 1234. In this position, the inner diameter of the bore 1206 is narrower than the outer diameter of the damping member 1214 (before deformation), so the proximal end of the damping member 1214 is compressed by the inner wall 1208 of the bore 1206. Meanwhile, the distal end of the damping member 1214 is still located in the distal section 1232 of the bore 1206, so it is not compressed by the inner wall 1208 of the bore 1206 (or is compressed to a lesser extent than the proximal end). As a result, the damping member 1214 is more tightly gripped by the inner wall 1208 of the bore 1206, and the frictional force between the plunger rod 1015 and the damping member 1214 is moderate.

[0236] 18c shows the relative position of the damper 1200 and plunger rod 1015 of FIG. 15 when the plunger rod 1015 has advanced further relative to the damper 1200 and the head 1200b of the damper 1200 is positioned in the intermediate section 1234 of the well 1206. In this position, the damping member 1214 is compressed over its entire length by the inner wall 1208 of the well 1206. As a result, there is a strong frictional force between the plunger rod 1015 and the damping member 1214 as the damping member 1214 catches against the inner wall 1208 of the well 1206.

[0237] As shown in FIG. 18d, as the plunger rod 1015 continues to move distally relative to the damper 1200, a portion of the head 1200b of the damper 1200 is positioned in the intermediate section 1234 of the well 1206 (where the damping member is compressed), and another portion is positioned across the second transition section 1240 in the proximal section 1236 (where the damping member is not compressed, or is only slightly compressed). In this position, similar to the position shown in FIG. 18b, only the distal end of the damping member 1214 still remains within the narrower intermediate section 1234, so that only a portion of the damping member 1214 is compressed. As a result, the frictional force between the plunger rod 1015 and the damping member 1214, due to the partial engagement of the damping member 1214 with the inner wall 1208 of the well 1206, returns to a moderate strength.

[0238] 18e, when the plunger rod 1015 reaches its distal-most position relative to the damper 1200, the head 1200b of the damper 1200 is positioned at the proximal section 1236 of the well 1206. Because the inner diameter of the proximal section 1236 of the well 1206 is wider than the outer diameter of the damping member 1214, the damping member 1214 is not compressed by the inner wall 1208 of the well 1206. As a result, there is limited (or no) engagement of the damping member 1214 against the inner wall 1208 of the well 1206, and therefore, frictional forces between the plunger rod 1015 and the damper 1200 are reduced (or eliminated).

[0239] With these considerations in mind, the distal end section 1232 of the bore 1206 may be referred to as the "damper storage area." When positioned in this area, the damping member 1214 is in an uncompressed state (see FIG. 18a). This position of the damper 1200 relative to the plunger rod 1015 corresponds to the syringe's storage state, in which the syringe 1001 is not yet activated and the drive spring 1017 is compressed. The distal end section 1232 of the bore 1206 is configured to receive the head 1200b of the damper 1200 so that there is little or no binding between the damper 1200 and the plunger rod 1015. This configuration may be convenient because, during assembly of the syringe 1001, inserting the damper 1200 into the distal end of the plunger rod 1015 to assemble the damping mechanism does not require overcoming the strong friction associated with binding between the damping member 1214 and the plunger rod 1015.

[0240] The intermediate section 1234 may be referred to as the "damper compression region." When located in this region, the damping member 1214 is in a compressed state. At this stage, the damping member 1214 is maximally compressed, thereby reducing the force of the drive spring 1017 immediately after activation of the syringe. This minimizes the impact of the medication container on components within the syringe. Alternatively or additionally, this can avoid strong shocks that could startle the user or vibrations that could lead to unexpected user errors.

[0241] The proximal section 1236 may be referred to as the "non-damping region." When positioned in this region, the damping member 1214 is mostly or completely released from its compressed state. Providing the non-damping region at the proximal end of the longitudinal bore 1206 may be convenient because the force of the drive spring 1017 is strongest only in the section of its trajectory that advances the medication container 1007 toward the injection position (e.g., the initial section of movement). Furthermore, the proximal section may be widened (with a tapered transition section between the proximal section 1236 and the intermediate section 1234, if necessary) to facilitate retracting the plunger rod 1015 relative to the damper 1200 after the injection is completed.

[0242] Although the plunger rod 1015 shown in Figures 15-18e includes a longitudinal bore 1206 with a varying inner diameter, it will be understood that the inner diameter of the longitudinal bore may be substantially constant, with the damping member 1214 engaging the inner wall of the longitudinal bore for substantially the entire length of the plunger rod 1015's travel relative to the damper 1200. While an example of such an embodiment is not shown in the drawings, it will be understood that the plunger rod 1015 shown in Figures 18a-18e may simply be replaced with a plunger rod having a substantially cylindrical bore with a constant inner diameter.

[0243] As will be described below with reference to FIG. 19, an alternative configuration is disclosed in which the damper is housed within a hollow plunger rod.

[0244] Figure 19 is a cross-sectional view of a further embodiment of the invention disclosed herein. The embodiment shown in Figure 19 is similar to the embodiments described above. As can be seen in Figure 19, the syringe 4001 includes a driver 4016. The driver 4016 includes a proximal housing 4032, which houses a driver spring 4017, a latch 4040, a protrusion 4042, and an actuator 4034. As in the embodiments described above, the latch 4040 and protrusion 4042 together transfer power from the driver spring 4017 to the plunger rod 4015. The plunger rod 4015 includes a longitudinal bore 4206, i.e., a hollow portion, at its proximal end.

[0245] Unlike the embodiment described with reference to Figure 15, the first drive component 4015 in the embodiment of Figure 19 has two sections with different inner diameters, a distal section 4232 and a proximal section 4236, which are configured to accommodate the damper 2400 depending on the extension state of the plunger rod 4015. The second inner diameter of the proximal section 4236 is wider than the first inner diameter of the distal section 4232.

[0246] Damper 4200 of FIG. 19 also differs from damper 1200 of FIG. 15. Damper 1200 of FIG. 15 includes only one damping member 1214 configured to match the inner peripheral contour of head 1200b. In contrast, damper 4200 of FIG. 19 includes multiple annular grooves in head 4200b, each configured to receive an O-ring therein. Damper 4200 also includes a body portion 4200a that supports head 4200b.

[0247] 19 shows a damper 4200 having a head 4200b with three circumferential grooves 4218a, 4218b, and 4218c. Three damping members 4214a, 4214b, and 4214c (each formed as an O-ring) are individually mounted in the circumferential grooves 4218a, 4218b, and 4218c. When the head 4200b is properly positioned, the outer diameters of the damping members 4214a, 4214b, and 4214c are wider than the outer diameter of the head 4200b.

[0248] Damper 4200 of Fig. 19 operates in the same manner as damper 1200 of Fig. 15. In the position shown in Fig. 19, the inner diameter of tip portion 4232 of vertical hole 4206 is narrower than the outer diameter of damping members 4214a, 4214b, and 4214c of damper 4200, so that damping members 4214a, 4214b, and 4214c are compressed by inner wall 4208 of vertical hole 4206. As a result, strong frictional force is generated between plunger rod 4015 and damper 4200 as damping members 4214a, 4214b, and 4214c catch on inner wall 4208 of vertical hole 4206.

[0249] When the damping members 4214a, 4214b, 4214c are installed in the proximal portion 4236 of the well 4206, the wider diameter of the proximal portion 4236 no longer compresses (or compresses) the damping members 4214a, 4214b, 4214c. As a result, there is limited (or no) engagement of the damping members 4214a, 4214b, 4214c against the inner wall 4208 of the well 4206, and therefore the frictional force between the plunger rod 4015 and the damper 4200 is reduced (or eliminated).

[0250] A feature of the plunger rod 4015 of FIG. 19 that is not found in the embodiment of FIG. 15 is the bung 4242. The bung 4242 is in the form of a cap that closes the bore 4206 at the tip of the distal end portion 4232 of the bore 4206. The bung 4242 forms a surface that the end of the head 4200b of the damper 4200 abuts during assembly of the syringe, preventing the first drive component 4015 from retracting too far when the first drive component 4015 returns to its original position after an injection dose is completed. It will be understood that the bung 4242 may be omitted from this embodiment or added to the embodiment of FIG. 15 if desired. The bung 4242 also helps prevent the damper 4200 from interfering with other components of the syringe, such as a PCB that may be located between the damper and the plunger.

[0251] It will be understood that the damper and plunger rod are not limited to the types shown in Figures 15 and 19, i.e., where the damper is hooked to the inner wall of the vertical hole in the plunger rod. According to the invention disclosed in this specification, the damper can also be configured to hook to other drive components.

[0252] The power pack is also not limited to that shown in Figures 15 and 19, and a member similar to the latch projection may transmit the force of the drive spring directly to the first drive component without the use of a latch. This and other modifications will become apparent from the following discussion of Figures 20-28d.

[0253] Figure 20 is a cross-sectional view of an embodiment of the invention. In this embodiment, damper 5200 is configured to hook directly onto a component of the driver (other than the plunger rod). Figure 20 shows a configuration similar to that shown in Figures 15 and 19. In this configuration, the driver includes a drive spring 5017 and a damper 5200. Damper 5200 is configured to dampen at least the initial extension of drive spring 5017.

[0254] Unlike the embodiment described with reference to Figure 15, the damper 5200 of the embodiment of Figure 20 does not have a flared head. More specifically, the body of the damper 5200 shown in Figure 20 is a rod with a substantially uniform diameter along most of its length. However, there are two circumferential grooves 5218a, 5218b around the tip of the damper 5200. Grooves 5218a, 5218b each house one of the damping members 5214a, 5214b. The two damping members 5214a, 5214b have the same shape as the O-rings described with reference to Figure 19.

[0255] 15, the drive component in which damper 5200 is fitted is sleeve 5015. Sleeve 5015 is coupled to drive spring 5017 and therefore functions as the first drive component moved by drive spring 5017. Sleeve 5015 may form part of the plunger rod of a syringe.

[0256] The sleeve 5015 has a longitudinal bore, somewhat similar to the longitudinal bore of the plunger rod described above, that is configured to receive the damper 5200. The inner wall of the longitudinal bore is configured to allow the damper 5200 to be an interference fit.

[0257] As can be seen in FIG. 20 , the bore of the sleeve 5015 has three sections: a distal section 5232 having a first diameter; a proximal section 5236 having a second diameter wider than the first diameter; and a tapered transition section 5238 sandwiched between the distal section 5232 and the proximal section 5236. As with the previous embodiment, the sleeve 5015 has at least one section whose inner diameter is narrower than the outer diameter of the damping members 5214 a, 5214 b. In the embodiment shown, the distal section 5232 can be referred to as a damper storage area because the inner diameter of the distal section 5232 is wider than the outer diameter of the damping members 5214 a, 5214 b. The proximal section 5236 can be referred to as a damper compression area because the inner diameter of the proximal section 5236 is narrower than the outer diameter of the damping members 5214 a, 5214 b.

[0258] Unlike the first drive component shown in Figures 15 and 19, the drive component (sleeve 5015 in this embodiment) is not coupled to the drive spring 5017 via a latch mechanism. Instead, the first drive component is fitted within a drive sleeve 5042, which has a shape similar to the protrusion 1042 of the latch mechanism described above. The drive sleeve 5042 (which has a shape similar to the protrusion 1042) has a distal flange 5072 that is pressed against the drive spring 5017. Because the sleeve 5015 is fitted within the drive sleeve 5042, when the drive sleeve 5042 moves distally due to the action of the drive spring 5017, the sleeve 5015 moves distally together with the drive sleeve 5042.

[0259] The sleeve 5015 and / or the driving sleeve 5042 may be configured to transmit power to a plunger rod (not shown) that is configured to move the plunger distally within the medication container to expel a dose of medication. Accordingly, the distal end of the sleeve 5015 may include a positioning member (e.g., a raised annular flange) that fits over a corresponding member on the proximal end of the plunger rod.

[0260] The above-described embodiments include a longitudinal bore with a varying inner diameter along its length, which allows the amount of compression of the damping member (and therefore the damping force) to vary as the drive spring expands. However, it will be appreciated that the longitudinal bore may have a constant inner diameter along its length, which allows the damping force to remain approximately constant as the longitudinal bore moves distally relative to the damper.

[0261] Turning now to FIG. 21 , yet another embodiment of the invention disclosed herein will be described. FIG. 21 illustrates a plunger rod 6015. The plunger rod 6015 includes a plurality of grooves 6250a, 6250b, and 6250c extending generally along the longitudinal axis. These grooves 6250a, 6250b, and 6250c may be aligned with, or parallel to, the longitudinal axis. As will be explained in more detail below, the grooves 6250a, 6250b, and 6250c reduce the surface area of ​​the wall of the well that contacts the damping member. This creates a space within which the damping member can deform to reduce the compressive force it receives from the wall of the well. Therefore, the frictional force between the damper and the first drive component is reduced in the surface area of ​​the first drive component where the damper is fitted.

[0262] Figure 21 is a cross-sectional view of a variation of the plunger rod 7015 of Figures 17a and 17b. Figure 22a is a cross-sectional view taken along line A-A' in Figure 21. Figure 22b is a cross-sectional view taken along line B-B' in Figure 21. Figure 22c is a cross-sectional view taken along line C-C' in Figure 21. Figure 22d is a cross-sectional view taken along line D-D' in Figure 21.

[0263] Figure 21 shows essentially the same first drive component as shown in Figures 17a and 17b, but differs in the following respects. As shown in Figure 21, the intermediate section 6234 of the longitudinal bore 6206 (located between the distal section 6232 and the proximal section 6236) includes a plurality of grooves 6250a, 6250b, and 6250c on its inner surface. The grooves 6250a, 6250b, and 6250c extend parallel to the longitudinal axis L of the plunger rod 6015. Each of the grooves 6250a, 6250b, and 6250c extends in the direction of the longitudinal axis L from the proximal end of the intermediate section 6234 to the distal end. The first groove 6250a extends along almost the entire intermediate section 6234 and terminates just short of the distal end of the intermediate section 6234. The second groove 6250b is circumferentially spaced from the first groove 6250a and has a length that is approximately two-thirds the length of the intermediate section 6234. The third groove 6250c is circumferentially spaced from both the first groove 6250a and the second groove 6250b and has a length that is approximately one-half the length of the intermediate section 6234. The first groove 6250a, the second groove 6250b, and the third groove 6250c are arranged around the circumference of the intermediate section 6234 in the following order: first groove, second groove, third groove, second groove, first groove, first groove, second groove, third groove, second groove, first groove.

[0264] As shown in FIG. 22a, a first cross-section A-A' of the plunger rod 6015 of FIG. 21 is between the tip of the intermediate section 6234 and the end of the first groove 6250a and does not include any of grooves 6250a, 6250b, or 6250c. As shown in FIG. 22b, a second cross-section B-B' of the plunger rod 6015 of FIG. 21 is between the end of the first groove 6250a and the end of the second groove 6250b and includes only the first groove 6250a. As shown in FIG. 22c, a third cross-section C-C' of the plunger rod 6015 of FIG. 21 is between the end of the second groove 6250b and the end of the third groove 6250c and includes only the first groove 6250a and the second groove 6250b. As shown in FIG. 22d, the fourth cross section D-D' of the plunger rod 6015 in FIG. 21 is located between the end of the third groove 6250c and the base end of the intermediate section 6234 and includes all of the first groove 6250a, the second groove 6250b, and the third groove 6250c.

[0265] Thus, as the distance from the distal end to the proximal end of the intermediate section 6234 increases, the number of grooves 6250a, 6250b, and 6250c per unit circumference of the intermediate section 6234 increases. Therefore, within the intermediate section 6234, as the plunger rod 6015 advances, the surface area of ​​the plunger rod 6015 that contacts the damping member decreases as the damper moves from the distal end to the proximal end of the intermediate section 6234. This reduces the contact area between the damper and the inner wall of the plunger rod 6015 as the plunger rod 6015 advances. In other words, the ratio of the inner wall to the grooves decreases toward the proximal end. Therefore, as the plunger rod 6015 advances, the friction force between the damper and the plunger rod 6015 weakens in a stepped manner.

[0266] In the embodiment shown in Figure 21, there are ten grooves in the midsection. However, it will be understood that the total number of grooves, as well as the number of grooves at different lengths, can vary. Furthermore, while this embodiment describes the grooves being provided on a drive component that has a varying inner diameter along its length, the grooves may be provided elsewhere.

[0267] While this embodiment is described with respect to a plunger rod, it will be understood that the grooves described above may be incorporated into the sleeve 5015 of FIG. 20 or into other drive components configured to move relative to the damper. Additionally, while the above description shows the grooves on the inner wall of the plunger rod, the embodiment is not so limited. For example, as described below in this specification, if the damper is annular (see, e.g., FIG. 27) and a first drive component is positioned inside the damper, the grooves may be formed on the outer periphery of the first drive component that is positioned to engage with the damper. Alternatively, or in addition, the grooves may be on the portion of the damper that is positioned to engage with the first drive component.

[0268] Turning now to Figures 23-24b, a damping mechanism according to the presently disclosed invention may include a damper having a plurality of deformable, elongated, plate-like members (splines or ridges). The splines extend longitudinally of the damper (i.e., substantially parallel to the longitudinal axis of the syringe) and are positioned to be compressed by a first drive component, such as a plunger rod, or other component of the drive device. The first drive component may include a compression ring configured to compress the splines. As will be appreciated from the present disclosure, splines on a portion of the damper that is adapted to fit onto the first drive component can be used to control the amount of friction between the damper and the first drive component. Similar to the grooves described above, varying the length, width, or thickness of the splines, or varying the number of splines per unit circumference, may increase or decrease the friction between the damper and the first drive component.

[0269] More specifically, as shown in FIG. 23, some embodiments include a damper 7200 that is coaxially disposed with a first drive component. In this embodiment, the first drive component is in the form of a sleeve 7015 similar to sleeve 5015 of FIG. 19. As in the embodiment shown in FIG. 19, sleeve 7015 is coupled to a drive sleeve 7252. Drive sleeve 7252 has a distal flange 7072 against which a drive spring 7017 can compress. As in the embodiment shown in FIG. 20, damper 7200 is secured within the housing by a pin 7202 that is fastened to damper 7200.

[0270] 23, sleeve 7015 includes a longitudinal bore 7206. Longitudinal bore 7206 is configured to receive at least a portion of damper 7200. Sleeve 7015 also includes a compression ring 7254 at or near the proximal end of longitudinal bore 7206. Compression ring 7254 is made of a material (e.g., metal) that is resistant to deformation due to forces exerted by damper 7200 as sleeve 7015 advances relative to damper 7200 during injection. Compression ring 7254 is located at the proximal end of sleeve 7015 and occupies only a portion of the longitudinal length of sleeve 7015.

[0271] Damper 7200 has a plurality of splines 7256 on its exterior surface extending in the direction of its longitudinal axis. Splines 7256 extend from the tip of damper 7200 along a portion of its body in the direction of its longitudinal axis. Splines 7256 project radially from the outer periphery of the body of damper 7200 and are spaced apart around the body. The radial extension of splines 7256 increases the diameter of damper 7200 beyond the diameter of the cylindrical rod at the tip of damper 7200. This diameter (the "spline diameter") is also greater than the minimum inner diameter of compression ring 7254.

[0272] Splines 7256 have a substantially constant height in the longitudinal direction except for the base end, and taper toward the body of damper 7200 as they approach the base end. The outer diameter of splines 7256 is wider than the minimum inner diameter of compression ring 7254. Because at least splines 7256 of damper 7200 are formed from an elastically deformable material, splines 7256 can be compressed by the inner surface of compression ring 7254. Splines 7256 may be formed from an elastomer, such as a thermoplastic elastomer.

[0273] As shown in FIG. 23, compression ring 7254 tapers at one end from a diameter wider than the spline diameter to a diameter narrower than the spline diameter. Compression ring 7254 thereby divides bore 7206 into a damper storage area distal to compression ring 7254, a damper compression area formed by compression ring 7254, and a non-damping area proximal to compression ring 7254. The inner diameter of bore 7206 (regardless of its position relative to compression ring 7254) may be consistently wider than the outer diameter of splines 7256 running along the body of damper 7200. The splines 7256 of FIG. 23 are clearly visible in FIG. 24a, which is a perspective view of the damper of FIG. 23.

[0274] 23, when the syringe is in the storage position (drive spring fully compressed), sleeve 7015 is fully retracted relative to damper 7200, and the damper storage area at the tip accommodates the portion of damper 7200, including spline 7256. Because the outer diameter of spline 7256 is narrower than the inner diameter of sleeve 7015 and the outer diameter of the body of damper 7200 is narrower than the smallest inner diameter of compression ring 7254, damper 7200 does not catch on the inner wall of first drive component 7015.

[0275] During operation of the syringe, the force of drive spring 7017 moves first drive element 7015 forward relative to damper 7200, forcing splines 7256 into compression ring 7254. Because the outer diameter of splines 7256 is wider than the minimum inner diameter of compression ring 7254 and splines 7256 are elastically deformable, splines 7256 engage with and compress compression ring 7254. A normal force associated with the deformation of splines 7256 is applied to compression ring 7254. This creates a frictional force between damper 7200 and sleeve 7015. As with the other embodiments, this frictional force acts to counteract the force applied by drive spring 7017 against the plunger rod and / or medication container.

[0276] The splines may have different shapes, as will be described below with reference to Figures 24a and 24b. As previously mentioned, Figure 24a is a perspective view of the damper 7200 of Figure 23. As can be seen in this figure, the splines 7256 of the damper 7200 are of constant length, begin and end longitudinally in the same place, and are distributed circumferentially around the body of the damper 7200. This arrangement provides a substantially constant damping force when the portion of the damper 7200 containing the splines 7256 passes through the compression ring 7254.

[0277] Figure 24b shows another embodiment of a damper 7200'. The damper 7200' includes splines 7256a, 7256b, and 7256c of different lengths. As Figure 24b shows, the different lengths of the splines 7256a, 7256b, and 7256c allow for varying the damping force provided by the damping mechanism as the sleeve 7015 with compression ring 7254 advances relative to the damper 7200'.

[0278] Each of the splines 7256 shown in FIG. 24a extends approximately the same distance from the distal end to the proximal end of the damper 7200. Therefore, the frictional force between the compression ring 7254 and the damper 7200 remains approximately constant throughout the movement of the drive element 7015 relative to the damper 7200. In contrast, in the embodiment shown in FIG. 24b, the different lengths of the splines 7256a, 7256b, 7256c vary the frictional force between the first drive element 7015 and the damper 7200′ as the first drive element 7015 advances relative to the damper 7200′, similar to how the different groove lengths are used to vary the frictional force between the plunger rod 6015 and the damper in the embodiment of FIG. 21.

[0279] Figure 24b particularly shows that: the first spline 7256a of the damper 7200' extends the entire length of the tip of the damper 7200'; the second spline 7256b is approximately ¾ of the length of the tip of the damper 7200' and therefore terminates approximately ¼ of the length of the tip from the tip of the damper 7200'; and the third spline 7256c is approximately ⅓ of the length of the tip of the damper 7200' and therefore terminates approximately ⅔ of the length of the tip from the tip of the damper 7200'.

[0280] In summary, splines 7256a, 7256b, 7256c are positioned such that the contact area between splines 7256a, 7256b, 7256c and compression ring 7015 varies as damper 7200′ passes through compression ring 7015. In embodiments, the plurality of splines includes at least one first spline 7256a and one second spline 7256b. First spline 7256a and second spline 7256b each extend over only a portion of damper 7200′. First spline 7256a and second spline 7256b have different lengths (i.e., the dimension measured along the major axis L of damper 7200′ and syringe 1001). Alternatively or additionally, at least one spline may have a varying width along its length. Alternatively or additionally, the "spline diameter" may vary with position along the length of the damper.

[0281] The different lengths of splines 7256a, 7256b, and 7256c result in different spline densities over distance along the longitudinal axis of damper 7200′, resulting in different contact areas per unit length. This results in different damping forces as first actuation element 7015 moves forward from its fully retracted position to its extended position. At any given position of damper 7200′, the denser the splines, the greater the contact area between damper 7200′ and first actuation element 7015, resulting in stronger damping forces. In other words, the proportion of the damper's outer surface that is occupied by splines decreases toward the tip of the damper, resulting in weaker damping forces. Conversely, splines of the same length would provide a uniform damping force along the length of the damper.

[0282] In any of the dampers described above, the splines have a constant width (measured around the circumference of the damper around the longitudinal axis of the syringe). Alternatively, one or more splines may vary in width along their length. The width may vary gradually, with the splines tapering along their length. Alternatively, the width may vary in a stepped manner along their length. This also results in a change in the contact area between the damper and the first drive component along the length of the damper.

[0283] The spline diameter may be uniform along the length of the damper. Alternatively, the spline diameter may vary along the length of the damper. The change in spline diameter may be gradual, with the spline tapering along the length of the damper. Alternatively, the spline diameter may vary in a stepped manner along the length of the spline. The change in spline diameter changes the normal force between the damper and the first drive component as the spline passes through the compression ring. Therefore, as the first drive component advances, the frictional force changes, which in turn changes the degree to which the drive spring is damped.

[0284] While the splines and grooves described above are arranged parallel to the longitudinal direction of the damper, the invention disclosed herein is not so limited. For example, the grooves may be arranged in a spiral pattern on the damper, or the splines on the first drive component. As with the arrangement described above, the attributes of the splines or grooves (i.e., width, length, radial position, or density) may vary as a function of longitudinal position. The spiral splines or grooves may vary the contact area and / or normal force between the damper and the first drive component, thereby producing a desired change in friction. However, providing splines on the first drive component that extend along its longitudinal axis is easier to manufacture.

[0285] Furthermore, while the above embodiments include a splined damper configured to interact with a sleeve that is part of the driver, it will be appreciated that a compression ring may be provided on a portion of the plunger rod, such as plunger rod 1015 in FIG. 15.

[0286] In yet another embodiment of the invention disclosed herein, the braking mechanism may be configured as follows to vary the frictional force between the first drive component and the damper. A compressive force is applied to a fixed damper by a tube, and the compressive force is varied by varying the wall thickness of the tube along its length. While the structure of this embodiment differs somewhat from the above-described embodiments, the underlying principle (i.e., varying the compressive force applied by the damper and drive component) is the same, as explained below. In summary, in these embodiments, the first drive component may be configured as an attached drive member including a compression sleeve. The compression sleeve has a constant inner diameter along its length but a varying wall thickness. The compression sleeve may be integral with the drive component, which is configured to advance distally under the action of a drive spring, or may be a separate component coupled to the drive component. A damper is disposed inside the compression sleeve and fits onto the inner surface of the compression sleeve.

[0287] 25 is an isometric cross-sectional view of a braking mechanism comprising a first drive part 8015. The first drive part 8015 is formed from a body 8015a, a compression ring 8015b, a damper 8200, and a pin 8202.

[0288] The damper 8200 includes a body 8200a and a ferrule 8200b. The body 8200a is tapered so that the outer diameter narrows toward both ends and includes a threaded hole for accommodating the pin 8202. A portion with a maximum outer diameter is formed between both ends of the body 8200a, and the outer diameter is wider than the outer diameter of the pin 8202. The ferrule 8200b is an annular member formed on the outside of the body 8200a. The ferrule 8200b plastically deforms when inserted into the compression sleeve 8015b, thereby weakening the force of the drive spring. The ferrule 8200b may be formed from metal, injection-molded resin, or other plastically deformable (i.e., substantially incapable of elastic deformation) material. The ferrule 8200b may have greater hardness and strength than the compression sleeve 8015b.

[0289] The ferrule 8200b surrounds the body 8200a and has a wider outer diameter than the body 8200a, so as to provide a surface that contacts the inner wall of the drive component in a manner similar to the brake member embodiments disclosed herein. In the embodiment shown, the ferrule 8200b is mounted on the body 8200a, but it will be understood that if the outer diameter of the ferrule is wider than the outer diameter of the pin 8202, the body may be omitted and the ferrule may be mounted directly on the pin 8202.

[0290] 25, the first drive component 8015 includes a body 8015a and a compression sleeve 8015b. The body 8015a is a generally cylindrical member and includes an annular ring 8260. The annular ring 8260 defines a distally facing shoulder that bears against a shoulder 8262 on the compression sleeve 8015b. The abutment of these shoulders prevents distal movement of the body 8015a relative to the compression sleeve 8015b. Thus, the action of the drive spring ensures that the body 8015a and the compression sleeve 8015b move together (at least distally).

[0291] The compression sleeve 8015b is an elongated tube extending proximally from the shoulder, within which the ferrule 8200b can be placed. The compression sleeve 8015b is described in more detail below with reference to Figures 26a-26c.

[0292] Figure 26a is an end view of the compression sleeve 8015b. As shown in Figure 26a, the cross section of the compression sleeve 8015b is substantially circular.

[0293] Figure 26b is a side view of compression sleeve 8015b. As shown in this figure, compression sleeve 8015b includes a storage portion 8264 (having a proximal-facing shoulder 8262 formed at its proximal end) and a compression portion 8266 (extending from storage portion 8264 toward an open proximal end). As can be seen in Figure 26b, compression portion 8266 has an outer diameter that gradually decreases from a maximum at its distal end to a minimum at its proximal end.

[0294] 26c is a cross-sectional view taken along the plane F-F' shown in FIG. 26a. As shown in FIG. 26c, the inner diameter d c The outer diameter of the compression portion 8266 is constant. The outer diameter of the compression portion 8266 is the first outer diameter d d to the second outer diameter d of the base end (the end farther from the storage section 8264) p8266. The thickness of the wall 8268 of the compression section 8266 decreases gradually along its length from a maximum at the distal end to a minimum at the proximal end.

[0295] Varying the wall thickness of the compression sleeve 8015b changes the hoop stress between the damper and the first drive component as a function of the position of the first drive component relative to the damper. The change in hoop stress changes the normal force between the first drive component and the damper. This changes the degree of interference fit between the compression sleeve 8015b and the damper, which in turn changes the degree of damping of the drive spring force against the plunger and / or medication container.

[0296] Although the embodiment describes the damper being disposed inside the first drive component, the invention disclosed in this specification is not limited to this arrangement. For example, damping of the drive spring may be achieved using a damper such as the following: This damper is annular and surrounds the first drive component, generating frictional forces to reduce the force of the drive spring at various stages of the forward movement of the first drive component.

[0297] Figure 27 is a cross-sectional view of an example syringe 2001 (described with reference to Figure 12), in which an annular damper 2200 is disposed around the first drive component and fits onto the outer periphery of the first drive component. Figure 27 shows the proximal end of the syringe 2001 described with reference to Figure 12.

[0298] 27 is formed as an O-ring, is installed in a vertical hole in the proximal housing 2032, and is coupled to the proximal housing 2032 so as to prevent movement in the longitudinal direction of the proximal housing 2032. The annular damper 2200 surrounds and fits into the outer wall of a first drive component formed as a latch 2040. When the annular damper 2200 is not under force, its inner diameter is slightly narrower than the outer diameter of the outer wall of the first drive component (latch 2040). The first drive component (latch 2040) is coupled to the drive spring 2017 by a drive sleeve formed as a protrusion 2042. Therefore, when the annular damper 2200 surrounds the first drive component (latch 2040), a normal force is applied to the outer peripheral surface of the first drive component (latch 2040), resulting in a frictional force between the annular damper 2200 and the first drive component (latch 2040), which resists the force of the drive spring 2017.

[0299] In FIG. 27 , the latch 2040 is positioned to maintain contact with the toroidal damper 2200 throughout the operation of the syringe. That is, because the outer diameter of the latch 2040 is substantially uniform, the damping force is independent of the position of the first drive component. However, this is not a limiting embodiment of the invention. For example, the outer diameter of the latch 2040 may vary such that the toroidal damper 2200 applies different magnitudes of normal force to the first drive component 2015 at various stages during the extension of the drive spring 2017. Alternatively, or in addition, the outer diameter of the latch 2040 may vary such that the toroidal damper 2200 and the latch 2040 are in contact at some stages during the extension of the drive spring 2017 and not at other stages. Varying the outer diameter of the sleeve in this way can vary the frictional force in various patterns, including, but not limited to, any of those described herein.

[0300] While embodiments of the invention are described as having a fixed damper that applies a frictional force against the part moved by the drive spring, the inventors recognize that other means of damping the drive spring's force are possible. For example, Figures 28a-28d show various configurations of elastomers in direct contact with the drive spring in its compressed state. Each elastomer is positioned to resist extension of the drive spring, i.e., to allow only one coil of the spring to advance at a time.

[0301] FIG. 28a shows an elastomer formed as an elastomeric sheath 18a surrounding a fully compressed drive spring 17a. In its unstressed state, the elastomeric sheath 18a has an inner diameter that is narrower than the outer diameter of the drive spring 17a. The elastomeric sheath 18a is also longer than the fully compressed drive spring 17a. Therefore, when the elastomeric sheath 18a expands to surround the drive spring 17a, and the ends of the elastomeric sheath 18a, which extend beyond the ends of the drive spring 17a, compress and apply a compressive force to the drive spring 17a, the elastomeric sheath 18a effectively encases the drive spring 17a. Therefore, an axial force (i.e., a force parallel to the axis of the drive spring 17a) is applied to one turn at each end of the drive spring 17a. This force exerted by the elastomeric sheath 18a prevents all turns of the drive spring 17a from expanding at once. Only one turn at a time is released from the end of the elastomeric sheath 18a. As one turn is released, the axial force of the elastomeric sheath 18a is applied to the next turn, resisting its elongation, and so on.

[0302] Figure 28b shows an elastomeric inner tube 18b, which functions substantially similarly to the elastomeric sheath 18a of Figure 28a. The elastomeric inner tube 18b is also coaxial with the drive spring 17b. However, the elastomeric inner tube 18b is formed inside the drive spring 17b. Because the outer diameter of the elastomeric inner tube 18b is wider than the inner diameter of the drive spring 17b and it is longer than the compressed drive spring 17b, both ends of the elastomeric inner tube 18b apply an axial force to both ends of the drive spring 17b. This achieves the same effect as described with reference to Figure 28a.

[0303] FIG. 28c shows a rigid support tube 18c coaxially positioned around and surrounding drive spring 17c. Support tube 18c supports an elastomeric ridge 188c on the inner surface of one end of support tube 18c. Elastomer ridge 188c extends circumferentially around the inner surface of support tube 18c. Because the inner diameter of elastomeric ridge 188c is narrower than the outer diameter of drive spring 17c, elastomeric ridge 188c applies an axial force against the end of drive spring 17c, resisting the elongation of the first turn. As the first turn is released from the end of support tube 18c, elastomeric ridge 188c applies an axial force against the next turn, and so on.

[0304] Figure 28d shows a configuration similar to Figure 28c. However, this configuration includes a support tube 18d disposed inside the drive spring 17d, and an elastomer ridge 188d extending circumferentially around one end of the support tube 18d. Because the outer diameter of the elastomer ridge 188d is wider than the inner diameter of the drive spring 17d, each turn of the drive spring 17d receives an axial force from the elastomer ridge 188d as it is sequentially released from the end of the support tube 18d. Therefore, this configuration also achieves the aforementioned effect of releasing the turns of the drive spring 17d one by one.

[0305] FIG. 29 illustrates a method for manufacturing a syringe according to the invention disclosed herein. In step 201, a housing having a longitudinal axis is provided. In step 203, a damper is attached to the housing so as to prevent translation along the longitudinal axis relative to the housing. In step 205, a drive spring is installed within the housing. In step 207, a first drive component is installed within the housing, such that the damper is coaxially disposed within the first drive component and is configured to have an interference fit therebetween such that the drive spring moves the first drive component along the longitudinal axis relative to the damper. As an additional step, in step 209, a deformable damping member may be overmolded onto the elongated member (e.g., a mandrel) that forms the damper.

[0306] As the reader will appreciate, the above steps can be performed in any order, and the method may further include providing any of the features previously described for the embodiment shown in Figures 15-28d.

[0307] In accordance with the device description disclosed herein, a method for damping a drive spring in a syringe is provided, which method includes the following steps: - advancing the medication container relative to the syringe housing from a retracted position to an extended position using a drive spring, the drive spring transmitting power to the medication container through a first drive component; - moving the first drive component relative to the damper, the damper being coaxially disposed relative to the first drive component; - creating an interference fit between a surface of the first drive part and the damper while the first drive part moves relative to the damper.

[0308] As can be understood from the description of the above embodiments, the frictional force between the damper and the first drive component is adjusted by adjusting the normal force and / or the coefficient of dynamic friction between these components. The normal force depends on the fit between the damper and the first drive component, and / or the elasticity or rigidity of either component, and / or the amount of partial displacement of either component (which is usually proportional to the restoring force in the case of an elastomer). The coefficient of dynamic friction depends on the contact area between the damper and the first drive component and / or the coefficient of dynamic friction per unit contact area.

[0309] As will be understood by those skilled in the art from the illustrated embodiments, the cross section of the damper or braking member is uniform. However, the invention disclosed herein is not so limited. For example, the cross section of the damper may vary so that the normal force between the damper and the first drive component varies depending on the position of the damper relative to the compression region of the first drive component. This approach also allows for varying degrees of damping of the drive spring force depending on the relative positions of the damper and the first drive component.

[0310] The above detailed description describes a system and method for reducing power in a syringe having a particular mechanism for inserting and removing a needle. However, those skilled in the art will understand that the invention is not limited to use with the example syringe described herein. Rather, other medication delivery devices may also achieve one or more of the benefits of the invention. This will be apparent to those skilled in the art in light of the above detailed description.

[0311] Although drive springs have been described, the inventors recognize that embodiments of the invention can also be described with respect to more general elastic members, of which drive springs are but one example.

[0312] Although the description has been given of a case in which one damper is used, the syringe may be provided with a damping mechanism including two or more dampers. These dampers can act together to weaken the force of the drive spring. Furthermore, although the description has been given of a syringe, the embodiments of the invention may also be said to relate to a damping mechanism for a syringe or a damping mechanism for a drive unit of a syringe.

[0313] The braking mechanism according to the invention disclosed herein may be implemented in an injector configured to automatically dispense a dose of medication, particularly in an auto-injector of the type that advances a medication container to dispense a dose of medication and then automatically retracts the medication container relative to the housing after use.

[0314] The braking mechanism described herein may be combined with a power pack according to the above aspects of the invention and / or may be combined with one or more of the connection device and passive safety shield described in more detail below.

[0315] [Connection device] The invention disclosed herein also provides an example of a connection device configured to connect a needle to the interior of a sealed medication container.

[0316] FIG. 30a is a cross-sectional view of a connecting device 1500 for a syringe. The syringe is for administering medication according to the invention disclosed herein, such as the one shown in FIG. 1. The connecting device 1500 shown in FIG. 30a is in a storage state. The connecting device 1500 includes a medication container 1007. The medication container 1007 is filled with medication M and has a cap 1502 attached. The medication container 1007 is sealed with a septum 1008. The cap 1502 has a first rib 1504 and a second rib 1506. The ribs 1504, 1506 surround the periphery of the cap 1502 and form a first positioning recess 1508 therebetween. A sealing element 1510 contacts an outer surface 1524 of the cap 1502 and is sandwiched between the first rib 1504 and the second rib 1506 within the first recess 1508. The sealing element 1510 surrounds the periphery of the cap 1502 and is chemically bonded to, in particular overmolded with, the cap 1502, thereby forming a single unit between the cap 1502 and the sealing element 1510. The sealing element 1510 is made of a flexible material and (while chemically bonded to the cap 1502) is crushed between the two ribs 1504, 1506.

[0317] The distal end of the cap 1502 (including the first rib 1504 and the second rib 1506) and the sealing element 1510 are mounted within the needle hub 1011. The needle hub 1011 includes a body 1512 and an elongated portion 1514 extending from the body 1512. Within the body 1512 of the needle hub 1011, the surfaces of the needle hub 1011, the cap 1502, and the sealing element 1510 define a cavity 1516 within which the free end 1518 of the needle 1009 is located. Looking at the interior surface of the needle hub 1011, the needle hub 1011 includes a first interior surface 1520. The first interior surface 1520 is circular, extends perpendicular to the needle 1009, and faces the cap 1502. The needle hub 1011 also includes a proximal projection 1522 extending circumferentially inward toward the needle 1009. The proximal projection 1522 is annular and extends around and is contactable with the outer periphery of the cap 1502. The proximal projection 1522 also optionally contacts the second rib 1506, particularly its proximal surface. Thus, the needle hub 1011 covers the distal end of the cap 1502 (including the first rib 1504, the second rib 1506, and the sealing element 1510).

[0318] The needle hub 1011 also includes a second inner surface 1528. The second inner surface 1528 is tubular, extends parallel to the needle 1009, and is connected to the first inner surface 1520 and the proximal projection 1522. Because the needle hub 1011 is made of a rigid material, the soft sealing element 1510 is compressed between the first rib 1504 and the second rib 1506 of the cap 1502, and also against the second inner surface 1528 of the needle hub 1011. Thus, a seal is formed between the outer surface 1524 of the cap 1502 and the second inner surface 1528 of the needle hub 1011. This seal is formed by the sealing element 1510.

[0319] The needle 1009 penetrates the first inner surface 1520 and the long portion 1514 of the needle hub 1011. The needle 1009 then reaches the tip of the connecting device 1500 and contacts the needle shield (corresponding to the needle seal 1004 shown in FIG. 1).

[0320] The needle hub 1011 is provided with an annular projection 1526 at the distal end of its body 1512. The purpose of this projection will be explained below with reference to Figure 30b.

[0321] Figure 30a shows the first state (pre-injection state) of the connection device 1500. In the first state, the free end 1518 of the needle 1009 is held away from the septum 1008. Figure 30b shows the second state of the connection device 1500. In the second state, the needle 1009 penetrates the septum 1008. The transition of the connection device 1500 from the first state shown in Figure 30a to the second state shown in Figure 30b is described below.

[0322] The process for performing an injection was described with reference to FIG. 1 , and the reader will understand that the same description applies to this embodiment. As described, during an injection, the needle hub 1011 and medication container 1007 advance distally, causing the hypodermic needle 1009 to pierce the injection site. As the plunger rod 1015 continues to advance (see FIG. 1 ), the medication container 1007 further advances, moving relative to the needle hub 1011 to maintain a seal between the needle hub 1011, particularly its second inner surface 1528, and the outer surface 1524 of the cap 1502. The needle 1009 then pierces the septum 1008, allowing the medication M to be expelled from the medication container 1007 through the hypodermic needle 1009. The plunger 1013 moves through the medication container 1007 toward the septum 1008, expelling the medication M from the medication container 1007 through the hypodermic needle 1009. The injection is then performed.

[0323] As the needle hub 1011 advances distally during an injection, the annular projections 1526 on the needle hub 1011 engage the soft latch arms 1402 (see Figures 47a-47c and their description below) and push them outward, disengaging them from the latch surfaces 1404. As a result, the safety shield 1019 is no longer locked in the retracted position.

[0324] Another connecting device for use with a medication syringe will now be described with reference to Figures 31a and 31b. The connecting device shown in Figure 31a is similar to the one shown in Figures 30a and 30b, but differs in the following respects: First, the sealing element 9510 is an O-ring. As with the previous device, the sealing element 9510 is made of a flexible material. The sealing element 9510 is installed in a positioning recess 9508 in the cap 9502 (made of a rigid material). The needle hub 9011 (also made of a rigid material) has a similar recess 9530. When the connecting device 9500 is in the first state, i.e., the state in which the free end of the needle 9009 is held in a position away from the septum 9008, the recess 9530 in the needle hub 9011 is aligned with the sealing element 9510, thereby helping to press the sealing element 9510 into the positioning recess 9508 in the cap 9502. Thus, the sealing element 9510 forms a seal between the cap 9502 and the needle hub 9011 , forming a cavity 9516 .

[0325] As described above, during injection, the medication container 9007 advances (distally) relative to the needle hub 9011, thereby maintaining a seal between the needle hub 9011 and the cap 9502.

[0326] Figure 31b shows the connecting device 9500 of Figure 31a in a second state, i.e., when the needle 9009 has penetrated the septum 9008. The sealing element 9510 is crushed against the inner surface of the needle hub 9011 within the first recess 9508 of the cap 9508. The locating protrusion 9532 of the needle hub 9011 is aligned with and locked into the second locating recess 9534 of the cap 9502. The second recess 9534 is located adjacent to the first recess 9530. When the connecting device 9500 is in the second state, the locking of the protrusion 9532 into the second recess 9534 prevents proximal movement of the needle hub 9011 relative to the cap 9502 (and therefore prevents the needle 9009 from being removed from the medication container 9007).

[0327] Figure 32a shows a third connection device 10500. The third connection device 10500 includes elements common to the two connection devices (shown in Figures 30a, 30b, 31a, and 31b), but differs in the following ways: First, the third connection device 10500 is configured so that the needle hub 10011 is located inside the cap 10502 (as opposed to the connection devices shown in Figures 30a, 30b, 31a, and 31b, in which the cap is located inside the needle hub). When the third connection device 10500 is in the first state (pre-injection state), a portion of the needle hub 10011 is located inside the cap 10502.

[0328] The septum 10008 also differs in shape and function from the septum shown in Figures 30a, 30b, 31a, and 31b. The septum 10008 includes a main portion 10008a and an elongated portion 10008b. The elongated portion 10008b is an annular ridge that defines a cavity 10516. The needle hub 10011 also includes an elongated portion 10550.

[0329] A sealing element 10510 is formed by a portion of the septum 10008, specifically the distal end of the elongated portion 10008b, and is sandwiched between the inner surface of the cap 10502 and the outer surface of the needle hub 10011. Both the cap 10502 and the needle hub 10011 are made of a rigid material (which may or may not be the same material), while the septum 10008 is made of a flexible material. Thus, the annular ridge 10008b of the septum 10008 is compressed between the cap 10502 and the needle hub 10011 to form a seal. This forms a flow path or cavity 10516.

[0330] The cap 10502 includes a first shoulder 10538 and a second shoulder 10540. At each shoulder 10538, 10540, the radius of the cap 10502 increases rapidly (from the distal end to the proximal end of the cap 10502). The sealing element (i.e., the distal end of the septum 10008) is crushed between the first shoulder 10538 and the needle hub 10011. In this manner, the sealing element is forced against a defined portion of the cap 10502, ensuring a tight seal. The portion of the cap 10502 proximal to the first shoulder 10538 has a larger radius than the distal end of the cap 10502, thereby not unduly restricting movement of the medication container 10007 and the septum 10008 relative to the needle hub 10011. The second shoulder 10540 of the cap 10502 crushes the septum 10008 to form a seal.

[0331] The cap 10502 surrounds the tip of the medicine container 10007. The tip of the medicine container 10007 includes a first cylindrical portion 10542 with a first radius and a second cylindrical portion 10544 with a second radius smaller than the first radius. The second cylindrical portion 10544 is farther from the partition wall 10008 than the first cylindrical portion 10542. The cap 10502 is in contact with the first cylindrical portion 10542 of the medicine container 10007 and includes a rib 10055 (having a smaller radius than the first cylindrical portion 10542) that is locked by the second cylindrical portion 10544. This makes it easier for the cap 10502 to be fixed to the medicine container 10007.

[0332] The cap 10502 has a hole at its tip that accommodates a portion of the needle hub 10011. The cap 10502 includes a protrusion 10546 that protrudes inwardly into this hole. The needle hub 10011 has a protrusion 10566 that hooks onto the protrusion 10546 on the cap 10502, preventing the needle hub 10011 from moving distally relative to the cap 10502 and becoming detached from the cap 10502. The protrusion 10546 on the cap 10502 has a sloped surface, and the tip is thinner than the base end. The needle hub 10011 also has a sloped surface 10562 that hooks onto the sloped surface of the protrusion 10546 on the cap 10502 when the third connecting device 10500 transitions from the first state to the second state, as described below. The needle hub 10011 also has a recess 10554. When the third connecting device 10500 is in the second state, the protrusion 10546 of the cap 10502 is locked in the recess 10554, so that the needle hub 10011 cannot move distally relative to the cap 10502 after the third connecting device 10500 reaches the second state.

[0333] The needle hub 10011 also has a circumferentially extending disc 10556. The disc 10556 has three holes that are equally spaced around the circumference of the needle hub 10011. These holes are visible in FIG. 32c. The holes have three wings 10558 that separate the holes. The holes receive the tip of the cap 10502 when the third connecting device 10500 is in the first state and prevent twisting of the needle hub 10011 relative to the cap 10502 when the third connecting device 10500 transitions from the first state to the second state, as will be explained in more detail below.

[0334] The cap 10502 has three recesses 10560 configured to receive the three wings 10558 of the needle hub 10011 as the needle hub 10011 moves proximally relative to the cap 10502.

[0335] As the third connecting device 10500 transitions from the first state to the second state, the medication container 10007 moves distally relative to the needle hub 10011, causing the elongated portion 10550 of the needle hub 10011 to be received inside the longitudinal hole or cavity 10516 of the septum 10008. The sealing element 10510 is pressed against the continuous surface of the elongated portion 10550 of the needle hub 10011 by the cap 10502. Thus, as the third connecting device 10500 transitions from the first state (shown in FIG. 32a) to the second state (shown in FIG. 32b), the sealing element 10510 continues to be crushed between the inner surface of the cap 10502 and the outer surface of the needle hub 10011. This smooth surface of the needle hub 10011 means that the needle hub 10011 is easy to manufacture. The absence of a positioning device also means that the sealing element 10510 is less likely to be damaged as it moves over the needle hub 10011.

[0336] As the needle hub 10011 moves further, the bevel 10564 of the protrusion 10546 of the cap 10502 rides up onto the bevel 10562 of the needle hub 10011, forcing the tip of the cap 10502 apart by the width of the needle hub 10011. As the needle hub 10011 continues to move proximally relative to the cap 10502, the needle 10009 eventually pierces the septum 10008. A flow path is opened between the medication container 10007 and the needle 10009, and the medication M is discharged. When the protrusion 10546 of the cap 10502 reaches a position where it fits into the recess 10554 of the needle hub 10011 (as shown in FIG. 32b), the needle hub 10011 cannot move distally from that position relative to the cap 10502.

[0337] 32c is another view of the third connecting device 10500 when the syringe is in a first (pre-injection) state. As shown, the distal end of the cap 10502 is received within a hole in the disc 10556 of the needle hub 10011. The cap 10502 includes a recess 10560 that receives the wings 10558 of the disc 10556 when the needle hub 10011 is moved proximally relative to the cap 10502.

[0338] 33 shows a fourth connection device 11500. The fourth connection device 11500 includes a sealing sleeve 11568 surrounding a cap 11502. The proximal end of the sealing sleeve 11568 contacts the exterior surface of the medication container 11007 and is held in place by a retaining ring 11572 surrounding the medication container 11007. The fourth connection device 11500 also includes a rigid needle hub 11011. The needle 11009 passes through the needle hub 11011. The needle hub 11011 contacts the interior surface of the sealing sleeve 11568 at its distal end. Seals are formed between the cap 11502 and the sealing sleeve 11568 and between the needle hub 11011 and the sealing sleeve 11568. The cavity 11570 is bounded by the needle hub 11011, the sealing sleeve 11568, the cap 11502, and the septum 11008. The free end 11518 of the needle 11009 is located within the cavity 11570 when the fourth connecting device 11500 is in the first state (storage state).

[0339] When a distal force is applied to the medication container 11007, the medication container 11007 moves distally relative to the needle 11009 and needle hub 11011. As the medication container 11007 advances, the sealing sleeve 11568 collapses and bends outward, causing the needle 11009 to pierce the septum 11008. As a result, the medication M is expelled through the needle 11009.

[0340] FIG. 34 illustrates a fifth connecting device 12500. Like the fourth connecting device 11500 illustrated in FIG. 33, the fifth connecting device 12500 utilizes a sealing sleeve 12568. The sealing sleeve 12568 surrounds the cap 12502 and flares inward at the proximal end of the cap 12502, thereby securing the sealing sleeve 12568 to the cap 12502. A seal is formed between the inner surface of the sealing sleeve 12568 and the outer surface 12574 of the cap 12502.

[0341] The tip of the sealing sleeve 12568 is locked to a rigid needle hub 12011. The needle hub 12011 is pierced by the needle 12009. A seal is formed between the needle hub 12011 and the tip of the sealing sleeve 12568.

[0342] The sealing sleeve 12568 has a lip 12576 at its distal end. The lip 12576 extends around the distal end of the sealing sleeve 12568. When the syringe is in the first condition, the lip 12576 extends proximally.

[0343] When a force is applied to the medicine container 12007 in the distal direction, the medicine container 12007 moves relative to the needle hub 12011 and the needle 12009. As the medicine container 12007 moves forward, the sealing sleeve 12568 (particularly the portion not in contact with the outer surface of the cap 12502) collapses outward, causing the lip 12576 to invert and extend distally, surrounding the tip of the needle hub 12011. This guides the needle hub 12011, ensuring that it is drawn toward the center of the medicine container 12007. Eventually, the needle 12009 pierces the septum 12508, and the medicine M is expelled through the needle 12009.

[0344] 35 shows a sixth connecting device 13500. The sixth connecting device 13500 also uses a sealing sleeve 13568. In this configuration, the sealing sleeve 13568 surrounds the cap 13502 and flares inward at the proximal end of the cap 13502, thereby securing the sealing sleeve 13568 to the cap 13502. The sealing sleeve 13568 has a ridge at its distal end that locks into a ridge at the proximal end of the needle hub 13011, thereby forming a seal between the sealing sleeve 13568 and the needle hub 13011. The needle hub 13011 is made of a hard material, and the sealing sleeve 13568 is made of a soft material.

[0345] A seal is also formed between the sealing sleeve 13568 and the outer surface 13574 of the cap 13502. A cavity 13578 is defined by the inner walls of the needle hub 13011 and the cap 13502 and the septum 13008. When the sixth connecting device 13500 is in the first state, the free end 13518 of the needle 13009 is located within the cavity 13578.

[0346] When a distal force is applied to the medication container 13007, it moves distally relative to the needle 13009 and needle hub 13011. As the medication container 13007 moves forward, the wall 13580 of the needle hub 13011 moves inside (particularly, along the inner periphery) of the sealing sleeve 13568. During this movement, a seal is maintained between the sealing sleeve 13568 and the outer surface of the needle hub 13011. Eventually, the needle 13009 pierces the septum 13008, causing the medication M to be expelled through the needle 13009.

[0347] FIG. 36 shows a seventh connecting device 14500. The connecting device 14500 of FIG. 36 includes a sealing element in the form of a stopper 14582 that contacts the cap 14502 of the medication container 14007. Alternatively, the stopper 14582 may contact a first outer cap (not shown) that surrounds the cap 14502. The advantage of using an outer cap in this manner is that the medication container 14007 and its cap 14502 do not need to be modified in any way, nor do they need to have a specific shape or be equipped with specific devices, in order to be used with the seventh connecting device 14500. The stopper 14582 is made of a soft material.

[0348] The needle hub 14011 contacts the bung 14582. When the seventh connecting device 14500 is in the first position, a portion of the needle hub 14011 is located inside (i.e., on the inner periphery of) the bung 14582. The needle hub 14011 is made of a rigid material and includes wings 14586 for stability. The cap 14502, the bung 14582, and a portion of the needle hub 14011 are surrounded by a second outer cap 14588. The second outer cap 14588 has a plurality of vertical holes through which the wings 14586 move when the seventh connecting device 14500 transitions from the first position to the second position. In this manner, the wings 14586 are locked into the vertical holes of the second outer cap 14588, preventing the needle hub 14011 from rotating relative to the bung 14582 when the seventh connecting device 14500 transitions to the second position. The longitudinal bore of the second outer cap 14588 is not shown in Figure 36 but is similar to the longitudinal bore of the cap 10502 shown in Figure 32c. The wings 14586 also prevent the needle hub 14011 from overtraveling proximally, as described below.

[0349] Adjacent to the wings 14586 of the needle hub 14011 is a recess 14590. A ridge 14592 located on the tip of the bung 14582 locks into the recess 14590 when the syringe is in the second position.

[0350] In the first state (shown in FIG. 36 ), a seal is formed between the outer surface of the needle hub 14011 and the inner surface of the bung 14582. The bung 14582, the needle hub 14011, the tip of the cap 14502, and the septum 14008 define a cavity 14578. When the seventh connecting device 14500 is in the first state, the free end 14518 of the needle 14009 is located within the cavity 14578.

[0351] When a distal force is applied to the medication container 14007, the medication container 14007 (together with the second outer cap 14588 and the bung 14582) moves distally relative to the needle 14009 and needle hub 14011. As the medication container 14007 advances, the proximal end of the needle hub 14011 moves inside (particularly, along the inner periphery of) the wall 14594 of the bung 14582. During this movement, a seal is maintained between the bung 14582 and the outer surface of the needle hub 14011. As the needle hub 14011 moves relative to the bung 14582, the needle 14009 eventually pierces the septum 14008 and the medication M is expelled through the needle 14009. As described above, the wing portion 14586 of the needle hub 14011 fits into the vertical hole in the second outer cap 14588 and eventually becomes adjacent to the distal end of the bung 14582. Thus, the needle hub 14011 is prevented from moving further proximally relative to the bung 14582. Furthermore, the needle hub 14011 is also prevented from moving distally relative to the bung 14582 because the recess 14590 of the needle hub 14011 locks into the ridge 14592 of the bung 14582.

[0352] FIG. 37 shows an eighth connecting device 15500. The eighth connecting device 15500 includes a container 15596. The container 15596 surrounds and houses the proximal end of the needle 15009, the proximal end of the needle hub 15011, a first sealing element 15598a, and a second sealing element 15598b. The sealing elements 15598a and 15598b are formed as two flexible rings. The rings 15598a and 15598b are made of a soft material, while the container 15596 is made of a rigid material. The first ring 15598a is sandwiched between the inner surface of the container 15596 and the outer surface 15574 of the cap 15502. The first ring 15598a forms a seal between the inner surface of the container 15596 and the outer surface 15574 of the cap 15502. The second ring 15598b is sandwiched between the inner surface of the container 15596 and the outer surface of the needle hub 15011. The second ring 15598b forms a seal between the inner surface of the container 15596 and the outer surface of the needle hub 15011. A cavity 15578 is defined by the inner surfaces of the container 15596, the proximal end of the needle hub 15011, and the distal end of the cap 15502 and is sealed by the rings 15598a, 15598b. When the eighth connecting device 15500 is in the first condition (shown in FIG. 37 ), the free end 15518 of the needle 15009 is located within the cavity 15578.

[0353] When a distal force is applied to the medication container 15007, it moves distally relative to the needle 15009 and needle hub 15011. As the medication container 15007 moves forward, the distal end of the container 15596 bends open and moves toward the outer periphery of the distal end of the eighth connecting device 15500. As the medication container 15007 moves forward, a seal is maintained between the needle hub 15011 and the container 15596 (by the second ring 15598b), and a seal is maintained between the cap 15502 and the container 15596 (by the first ring 15598a). Eventually, the needle 15009 pierces the septum 15008 and the medication M is expelled through the needle 15009.

[0354] FIG. 38 illustrates a ninth connecting device 16500. The ninth connecting device 16500, similar to that shown in FIG. 35, uses, for example, a sealing sleeve 16568. The sealing sleeve 16568 is made of a soft material. In this embodiment, the sealing sleeve 16568 surrounds the cap 16502 and flares inward at its proximal end, thereby securing the sealing sleeve 16568 to the cap 16502. The distal end of the sealing sleeve 16568 is sandwiched between the inner surface 16600 of the needle hub 16011 and the outer surface 16574 of the cap 16502. The sealing sleeve 16568 forms a seal between the cap 16502 and the inner surface 16600 of the needle hub 16011. A cavity 16578 is defined by the needle hub 16011, the cap 16502, and the inner surface of the septum 16008 and is sealed by the sealing sleeve 16568. When the eighth connecting device 16500 is in the first state, the free end 16518 of the needle 16009 is located within the cavity 16578 .

[0355] The outer surface of the sealing sleeve 16568 is provided with a positioning feature. When the ninth connecting device 16500 is in the first state, the positioning feature continues to hold the proximal end of the needle hub 16011. In this case, the positioning feature is ridges 16602a, 16602b. When the ninth connecting device 16500 is in the first state, ridge 16604, located at the proximal end of the needle hub 16011, is positioned between ridges 16602a, 16602b, thereby holding the needle hub 16011 against the medication container 16007.

[0356] When a distal force is applied to the medication reservoir 16007, the medication reservoir 16007 moves distally relative to the needle 16009 and needle hub 16011, causing the ridge 16604 on the needle hub 16011 to overcome the ridge 16602a on the sealing sleeve 16568. As the medication reservoir 16007 advances, a seal is maintained between the cap 16502 and the inner surface 16600 of the needle hub 16011. Eventually, the needle 16009 pierces the septum 16008 and the medication M is expelled through the needle 16009.

[0357] FIG. 39 illustrates a tenth connecting device 17500. The tenth connecting device 17500 is largely similar to that shown in FIG. 34, with the following differences: The connecting device 17500 of FIG. 39 does not include the lip 12576 shown in FIG. 34. (However, it will be understood that a lip could be incorporated into this embodiment.) Like the connecting device of FIG. 34, the connecting device 17500 of FIG. 39 includes a sealing sleeve 17568. In the case of the connecting device 17500 of FIG. 39, the area of ​​the sealing sleeve 17568 that is not in contact with the outer surface of the cap 17502 (i.e., the area sandwiched between the needle hub 17011 and the cap 17502) has a reduced thickness compared to the areas that are in contact with the cap 17502 and the needle hub 17011, respectively. This provides for better control of the components of the tenth connecting device 17500, as the sealing sleeve 17568 is more likely to collapse in this position (i.e., the position of reduced thickness).

[0358] 40 shows an eleventh connecting device 18500. In the eleventh connecting device 18500, the needle hub 18011 has an internal square thread 18606. The internal thread 18606 is configured to mate with an external thread formed on a sleeve 18608 that surrounds the cap 18502 of the medicine container 18007. The sleeve 18608 is made of a soft material. When the eleventh connecting device 18500 is in the first state, i.e., before the needle 18009 pierces the septum (not shown) of the cap 18502, the external thread of the sleeve 18608 forms a seal with the internal thread 18606 of the needle hub 18011.

[0359] When a distal force is applied to the medication reservoir (not shown), the external threads of the sleeve 18608 and the internal threads 18606 of the needle hub 18011 overcome each other, causing the medication reservoir to move distally relative to the needle 18009 and needle hub 18011. As the medication reservoir advances, the needle 18009 pierces the septum and the medication is expelled through the needle 18009.

[0360] Figure 41 shows a twelfth connection device 19500. The twelfth connection device 19500 is similar to that shown in Figure 30a, except that in this case the sealing element 19510 is bonded to the inner surface of the needle hub 19011 rather than to the outer surface of the cap 19502. In addition, there is only one rib 19610 on the outer surface of the cap 19502 (corresponding to rib 1504 in Figure 30a). The sealing element 19510 is crushed between the rib 19610 and the proximal end 19612 of the needle hub 19011. Otherwise, the operation of the twelfth connection device 19500 is the same as that described with reference to Figures 30a and 30b.

[0361] It will be appreciated that the rib 19610 may not be present, and instead friction between the sealing element and the cap may prevent proximal movement of the sealing element relative to the needle hub.

[0362] Figure 42 shows the thirteenth connecting device 20500. The thirteenth connecting device 20500 is similar to that shown in Figures 30a and 30b, with the following exception: Instead of a sealing element surrounding the cap 20502 to form a seal between the cap 20502 and the inner surface of the needle hub 20011, there is a sealing element in the form of a sleeve 20614 surrounding the needle 20009. The sleeve 20614 extends from the inner wall of the needle hub 20011 (which is perpendicular to the needle 20009 and located at the tip of the needle hub 20011) to the tip of the cap 20502, facing the needle 20009. In this way, the sleeve 20614 surrounds the needle 20009, keeping both the needle 20009 and the area of ​​the septum that is pierced by the needle 20009 sterile at all times.

[0363] When a distal force is applied to the medicine container 20007, the medicine container 20007 moves distally relative to the needle 20009 and the needle hub 20011. As the medicine container 20007 moves forward, the sleeve 20614 collapses toward the outer periphery. Eventually, the needle 20009 pierces the septum and the medicine M is expelled through the needle 20009.

[0364] In any of the above embodiments, the sealing element may be formed from a malleable elastomer such as Santroprene, particularly Santroprene 101-73.

[0365] In any of the above embodiments, the cap and needle hub may be formed from a hard polymer such as polypropylene.

[0366] The needle in any of the above embodiments may be formed from a metal such as stainless steel (eg, grade 304 or 316).

[0367] 43 is a flowchart illustrating a method for manufacturing a connection device for a medication syringe. The method includes the following steps: In step 301, a medicine container with a cap and sealed with a septum is provided; in step 303, a sealing element is provided that contacts the outer surface of the medicine container cap; in step 305, a needle is provided for piercing the septum; the sealing element is placed between the outer surface of the medicine container cap and the inner surface of the needle hub; and in step 307, a needle hub is provided. The connection device is configured to transition from a first state (where the needle is held away from the septum and the free end of the needle is located in a cavity sealed by the sealing element) to a second state (where the needle pierces the septum). When the connection device is in the first state, the sealing element forms a seal between the inner surface of the needle hub and the outer surface of the cap. The seal is maintained throughout the transition of the connection device from the first state to the second state and is maintained while the connection device is in the second state.

[0368] The inventive connection device disclosed herein can be implemented in an injector configured to automatically dispense a dose of medication. However, it will be understood that the connection device described herein may also be implemented in a manual dispensing device or a dispensing device having an electrically driven drive. In some embodiments, at least the inventive connection device and braking mechanism disclosed herein may be used in an automatic injector type that: advances the medication container to dispense a dose of medication, and automatically retracts it into the housing after use;

[0369] The connection devices described herein may be combined with a power pack and / or braking mechanism according to the above aspects of the invention and / or with a passive safety shield, which is described in detail below.

[0370] [Passive needlestick prevention measures] The specification also discloses examples of safety devices that are configured to protect the user from needle stick injuries before, during, and after use of the syringe.

[0371] Figures 44a and 44b are cross-sectional views of the tip 1b of the syringe 1001 in a pre-injection state. The cross-section shown in Figure 44b is perpendicular to the cross-section shown in Figure 44a. Figure 44c is a side view of the syringe of Figures 44a and 44b.

[0372] As shown in Figures 44a and 44b, the safety shield 1019 comprises a round tube that is closed at its distal end except for a hole 1400 through which the hypodermic needle 1009 extends during an injection. The safety shield 1019 surrounds the distal end of the housing 1023. Figures 44a-44c show the safety shield 1019 in a retracted position relative to the housing 1023. The safety shield 1019 is advanceable distally relative to the housing 1023 to an advanced position that protects the hypodermic needle 1009. An advancement spring 1025 applies a force to the safety shield 1019 toward the advanced position. The advancement spring 1025 is positioned between the housing 1023 and the safety shield 1019, with the proximal end of the advancement spring 1025 exerting force against a distal-facing shoulder near the distal end of the housing 1023, and the distal end of the advancement spring 1025 exerting force against the distal end of the safety shield 1019. However, in the pre-injection state shown in FIGS. 44a-44c, the flexible latch arm 1402 of the housing 1023 engages with the latch surface 1404 of the safety shield 1019, preventing the safety shield 1019 from advancing. Therefore, in the pre-injection state, the safety shield 1019 cannot be advanced to the advanced position even when the advancement spring 1025 is in operation. In other words, the flexible latch arm 1402 and the latch surface 1404 form a releasable locking mechanism, which is shown in the locked state in FIGS. 44a-44c.

[0373] The housing 1023 has a bore 1406 at its proximal end for receiving the medication container 1007 and a bore 1408 at its distal end for receiving the hypodermic needle 1009 and the distal end of the needle hub 1011 during an injection. The medication container 1007 is housed within the housing 1023 and is coupled to the needle hub 1011 and the hypodermic needle 1009. In the pre-injection state shown in Figures 44a-44c, the medication container 1007, needle hub 1011, and hypodermic needle 1009 are in a first (retracted) position. They are configured to move distally within the housing 1023 from the first (retracted) position and to move to a second (injection) position during an injection. The medication container 1007, needle hub 1011, and hypodermic needle 1009 are biased toward the first (retracted) position by a return spring 1021. The return spring 1021 is disposed between the housing 1023 and the medication container 1007. The proximal end of the return spring 1021 applies force against a distally facing shoulder of the medication container 1007. The distal end of the return spring 1021 applies force against the distal end of the housing 1023. The medication container 1007 is movable to a second position (injection position) by the action of the plunger rod 1015 (not shown in Figures 44a-44c). That is, when the plunger rod 1015 is actuated, it overcomes the force of the return spring 1021 and advances the medication container 1007 to the second position (injection position). Because the medication container 1007 is coupled to the needle hub 1011, as the medication container 1007 advances toward the second position (injection position), the needle hub 1011 (and the hypodermic needle 1009) also advance toward the second position (injection position), causing the hypodermic needle 1009 to pierce the injection site. As the medication container 1007 advances further toward the second position (injection position), the septum 1008 is pierced by the base end of the hypodermic needle 1009. Note that before injection, the hypodermic needle 1009 does not pierce the septum 1008, so the sterility of the medication in the medication container 1007 is maintained.

[0374] The safety shield 1019 includes a first protrusion 1410 on its inner surface, and the housing 1023 includes a second protrusion 1412 on its outer surface. As shown in FIG. 44a, in the pre-injection state, the first protrusion 1410 and the second protrusion 1412 are adjacent. This prevents the safety shield 1019 from moving further proximally relative to the housing 1023 than the retracted position shown. Furthermore, when the safety shield 1019 advances to the advanced position, the first protrusion 1410 contacts the proximally-facing, steep cliff face 1414a of the one-way receiver 1414. Therefore, the safety shield 1019 cannot advance beyond the advanced position. In other words, the location of the first protrusion 1410, the second protrusion 1412, and the one-way receiver 1414 limits the movement of the safety shield 1019 between the retracted position and the advanced position. Moreover, the bevel 1414b of the one-way receiver 1414 facing the tip side allows the first protrusion 1410 to climb over the one-way receiver 1414 during assembly of the tip portion 1b of the syringe 1001. The one-way receiver 1414 also includes a cantilevered arm 1416, which further facilitates assembly of the tip portion 1b of the syringe 1001. In short, the tip portion 1b of the syringe 1001 is easy to assemble, but is not easy to disassemble or tamper with.

[0375] As shown in Figure 44c, the housing 1023 further includes an assembly tab 1418 on the exterior surface of the proximal end. The assembly tab 1418 is configured to fit over a member of the handle 1003 when the syringe 1001 is assembled, thereby securing the distal end 1b to the proximal end 1a.

[0376] Figure 45a is a first perspective view of the safety shield 1019 shown in Figure 1, showing the inner surface of the safety shield 1019. Figure 45b is a second perspective view of the safety shield 1019 shown in Figure 1, showing the tip of the safety shield 1019. Figure 45c is a perspective view of the housing 1023 shown in Figure 1.

[0377] FIG. 45a shows one of the two first protrusions 1410. The other first protrusion 1410, not visible in FIG. 45a, faces the first protrusion 1410 that is visible. In other words, the safety shield 1019 includes two first protrusions 1410, one located on each of the opposing inner surfaces of the safety shield 1019. As shown in FIG. 45a, the first protrusion 1410 is a protrusion that extends circumferentially along a portion of the inner circumference of the safety shield 1019. One of the two latch surfaces 1404 is also visible at the tip of the safety shield 1019. The other latch surface 1404, not visible in FIG. 45a, faces the visible latch surface 1404. In other words, the safety shield 1019 includes two latch surfaces 1404, one located on each of the opposing edges of the hole 1400. Finally, Figure 45a shows longitudinal ridges 1420 formed on the interior surface of the safety shield 1019. When the safety shield 1019 is in the retracted position as shown in Figures 44a-44c, each of the longitudinal ridges 1420 fits into a longitudinal groove 1422 in the housing 1023.

[0378] As shown in FIG. 45c, the housing 1023 includes a distally facing shoulder 1424. The shoulder 1424 includes a plurality of distally facing first locking surfaces 1426. The first locking surfaces 1426 are located at the distal ends of the grooves 1422. Additionally, each longitudinal ridge 1420 includes a proximally facing second locking surface 1428. That is, each longitudinal ridge 1420 extends distally from the second locking surface 1428. When the safety shield 1019 is in the advanced position, the ridges 1420 are located distally of the grooves 1422, so that the first locking surfaces 1426 and second locking surfaces 1428 face each other.

[0379] Figure 45c shows the two latch arms 1402 and one of two one-way receivers 1414 of the housing 1023. As the reader will appreciate, the other one-way receiver 1414 is located on the opposite side of the housing 1023 from the visible one-way receiver 1414. The two latch arms 1402 are configured to hook onto two latch surfaces 1404. The two one-way receivers 1414 are configured to hook onto two circumferential protrusions 1410. Finally, two of the four assembly tabs 1418 are visible in Figure 45c.

[0380] FIG. 46 is a side view of the advancement spring 1025 in its natural (uncompressed) state. As shown, the advancement spring 1025 includes a proximal end 1430 and a distal end 1432. The proximal end 1430 has a larger diameter than the distal end 1432. When the syringe 1001 is assembled, the advancement spring 1025 is disposed between the housing 1023 and the safety shield 1019. The advancement spring 1025 is further positioned such that the proximal end 1430 contacts the shoulder 1424 of the housing 1023 and the distal end 1432 contacts the distal end of the safety shield 1019. Thus, when the safety shield 1019 is in the retracted position shown in FIGS. 44a-44c, the advancement spring 1025 is in axial compression and exerts a force on the safety shield 1019 toward the advanced position. Additionally, when the safety shield 1019 is in the retracted position, the proximal end 1430 of the advancement spring 1025 is sandwiched between the ridges 1420 and is therefore radially compressed by the ridges 1420. As will be explained in more detail below, when the safety shield 1019 is in the extended position, the proximal end 1430 of the advancement spring 1025 is no longer sandwiched between the ridges 1420 and is therefore not radially compressed. The proximal end 1430 of the advancement spring 1025 expands radially and becomes wedged between the first locking surface 1426 and the second locking surface 1428. Therefore, the safety shield 1019 cannot return to the retracted position after it reaches the extended position. The one-way catch prevents further distal movement of the safety shield 1019 from the advanced position, and the proximal end 1430 of the advancement spring 1025 acts as a wedge between the first locking surface 1426 and the second locking surface 1428, preventing proximal movement of the safety shield 1019. Thus, the safety shield 1019 is stuck in the retracted position.

[0381] Figure 47a shows the storage state of Figure 1, Figure 47b shows the state before injection of Figures 2, 44a, 44b, and 44c, Figure 47c shows a first state during injection, Figure 47D shows a first state after injection, Figure 47E shows a second state during injection, and Figure 47F shows a second state after injection, which, as will be explained later, is the state that occurs before the second state after injection.

[0382] As previously described, in the storage state of FIG. 1 , the cover 1006 encloses the housing 1023 and the safety shield 1019. This state is the storage state shown in FIG. 47a. When a user prepares to inject, the cover 1006 is removed to expose the housing 1023 and the safety shield 1019. This pre-injection state is shown in FIG. 47b. When a user activates the driver 1016 to perform an injection, the medication reservoir 1007 advances distally relative to the needle hub 1011, causing the hypodermic needle 1009 to pierce the septum 1008. The medication reservoir 1007 and needle hub 1011 then move further distally, causing the hypodermic needle 1009 to penetrate the injection site. This mid-injection state, i.e., with the medication reservoir 1007 and needle hub 1011 in the second position (injection position), is shown in FIG. 47c.

[0383] As can be seen in Figures 47a-47c, the advancement spring 1025 is axially compressed, thereby exerting a force on the safety shield 1019 toward the advanced position. However, in Figures 47a and 47b, the flexible latch arm 1402 engages the latch surface 1404, thereby advancing the safety shield 1019 to the advanced position. In other words, while the safety shield 1019 is locked in the retracted position in the storage state and pre-injection state, when the needle hub 1011 moves to the second position (injection position), as in the first state during injection shown in Figure 47c, the flexible latch arm 1402 disengages from the latch surface 1404. Therefore, the safety shield 1019 is no longer locked in the retracted position.

[0384] If the injection is performed correctly, the driver 1016 completes its operation, expelling all of the medication from the medication container 1007. At this time, the driver 1016 disengages from the plunger rod 1015. Thus, the return spring 1021 (which is compressed in the first state during injection shown in FIG. 47c) returns the medication container 1007 to the first (retracted) position, thereby also retracting the hypodermic needle 1009. If the injection is performed correctly by the user, the syringe 1001 is not removed from the injection site until the injection is complete and the medication container 1007 has returned to the first (retracted) position. Therefore, in that case, the latch arm 1402 will re-engage with the latch surface 1404 by the time the syringe 1001 is removed from the injection site. Thus, the safety shield 1019 is re-locked in the retracted position. In other words, if an injection is completed in the first (i.e., correct) post-injection state shown in FIG. 47D , the needle 1009 is retracted into the housing 1023 (and therefore safe), and the safety shield 1019 is not engaged. As shown in FIG. 47D , when the medication container 1007 and the needle hub 1011 move proximally back to the first (retracted) position, the first indicator band 1434 moves proximally with them. The first indicator band 1434 is located between the medication container 1007 and the housing 1023 and may be green. Therefore, when the medication container 1007 and the needle hub 1011 return to the first (retracted) position, the first indicator band 1434 becomes visible through the window 1436 in the housing 1023. This provides a visual indication to the user that the entire dose of medication has been administered through the needle 1009 and that the medication container 1007 and the needle hub 1011 have successfully returned to the first (retracted) position.

[0385] On the other hand, if the syringe should be removed from the injection site earlier than planned or if there is a malfunction in the needle retraction mechanism, the syringe 1001 will transition to the second state during injection shown in FIG. 47E and then to the second state after injection as shown in FIG. 47F.

[0386] In the second state (i.e., abnormal state) after injection, the driver 1016 is incompletely actuated, resulting in incomplete discharge of a dose from the medication container 1007. Alternatively, the driver 1016 does not disengage from the plunger rod 1015. In either case, the needle hub 1011 does not return to the first position (retracted position), so the latch arm 1402 remains in the unlocked position. In other words, the safety shield 1019 never returns to the locked state. Therefore, when the syringe 1001 is removed from the injection site, the safety shield 1019 can advance to the advanced position. The syringe 1001 temporarily enters the second state during injection, shown in FIG. 47E. In this state, the needle 1009 remains in the second position (injection position), but the safety shield 1019 in the advanced position prevents injury from the needle 1009. Furthermore, the proximal end 1430 of the advancement spring 1025 becomes wedged between the first locking surface 1426 and the second locking surface 1428, preventing the safety shield 1019 from returning to the retracted position. In essence, the safety shield 1019 keeps the syringe safe even if the syringe is not being used properly. As can be seen in FIG. 47E, as the safety shield 1019 is advanced, the second indicator band 1438 located on the exterior surface of the distal end of the housing 1023 becomes visible. Because the advancement of the safety shield 1019 is the result of improper syringe use, the visibility of the second indicator band 1438 can easily alert the user to such improper use. The second indicator band 1438 may be red.

[0387] FIG. 47F shows a second (i.e., abnormal) state after injection. In this state, the driver 1016 has completed its operation and all of the medication has been expelled from the medication reservoir 1007. Furthermore, because the driver 1016 has successfully separated from the plunger rod 1015, the return spring 1021 can return the medication reservoir 1007 to the first (retracted) position and retract the needle 1009. However, because the syringe 1001 was removed from the injection site before the medication reservoir 1007 was retracted (as described for the second state during injection shown in FIG. 47E), the safety shield 1019 is locked in the advanced position. Furthermore, even though all of the medication has been expelled through the hypodermic needle 1009, the dose of medication was not fully administered to the injection site because the syringe 1001 was removed from the injection site prematurely. As shown in FIG. 47F, both the first indicator band 1434 and the second indicator band 1438 are visible. This not only indicates that the dose of medication has been completely expelled through the needle 1009 (because the first indicator band 1434 is visible), but also indicates that the syringe 1001 was removed from the injection site prematurely (because the second indicator band 1438 is visible), resulting in the dose not being completely administered to the patient.

[0388] That is, Figures 47D-47F and Figures 48A-48C show the following states.

[0389] First state after injection, indicating that the syringe 1001 has been used correctly. In this state, the needle 1009 is in the first (retracted) position and the safety shield 1019 is in the retracted position. This state is shown in Figure 47D. See also Figure 48A. Figure 48A is an external view of the syringe 1001 in the first state after injection. As shown, the first indicator band 1434 is visible.

[0390] A second state during injection, indicating that the syringe 1001 has been tampered with and that the medication has not been fully dispensed through the needle 1009. In this state, the needle 1009 is in the injection position and the safety shield 1019 is in the advanced position. This state is shown in FIG. 47E. See also FIG. 48B. FIG. 48B is an external view of the syringe 1001 in the second state during injection. As shown, the second indicator band 1438 is visible.

[0391] A second state, post-injection, indicating that the syringe 1001 has been tampered with, resulting in complete delivery of medication through the needle 1009 but incomplete delivery to the injection site. In this state, the needle 1009 is in the first position (retracted position) and the safety shield 1019 is in the advanced position. This state is shown in FIG. 47F. See also FIG. 48C. FIG. 48C is an external view of the syringe 1001 in the second state, post-injection. As shown, both the first indicator band 1434 and the second indicator band 1438 are visible.

[0392] In the unlikely event that the mechanism for retracting the medication container 1007 fails to operate, the second state during injection may become the third state after injection. This is extremely unlikely, but the needle 1009 is still kept safe by the safety shield 1019 in its advanced position.

[0393] FIG. 49 illustrates how the syringe 1001 of FIG. 1 is assembled. In step 401, the advancement spring 1025 is placed within the safety shield 1019 and secured within the longitudinal ridge 1420. The distal end of the housing 1023 is then inserted into the safety shield 1019, and the advancement spring 1025 is placed between the housing 1023 and the safety shield 1019. The housing 1023 is advanced within the safety shield 1019 until the projection 1410 overcomes the one-way catch 1414, thereby preventing the safety shield 1019 from separating from the housing 1023. Further advancement of the housing 1023 within the safety shield 1019 causes the flexible latch arm 1402 to engage the latch surface 1404, thereby locking the safety shield 1019 in the retracted position. During this step, a tool may be inserted into the proximal end of the housing 1023 to spread the flexible latch arms 1402 apart while the housing 1023 and safety shield 1019 are mated. Once the housing 1023 is further advanced through the safety shield 1019, the tool is removed and the flexible latch arms 1402 properly engage the latch surfaces 1404, locking the safety shield 1019 in the retracted position.

[0394] In step 403, the return spring 1021 is inserted into the housing 1023, followed by the medication container 1007. Thus, the return spring 1021 is sandwiched between the housing 1023 and the medication container 1007. When the medication container 1007 is inserted into the housing 1023, the medication container 1007 may already be attached to the needle hub 1011 and the hypodermic needle 1009. Furthermore, the needle 1009 may already be covered by the needle shield 1004 and the needle cap 1005.

[0395] As the reader will appreciate, steps 401 and 403 may be performed in reverse order, i.e., step 403 may be performed before step 401. If step 403 is performed first, no tool may be used to spread flexible latch arms 1402.

[0396] In step 405, the tip 1b assembled in steps 401-403 is attached to the handle 1003, and the syringe 1001 is fully assembled.

[0397] This specification discloses numerous embodiments of the invention, each of which is numbered as follows:

[0398] A1 A housing with a long axis, a drive spring disposed within said housing, said drive spring having a distal end and a proximal end opposite said distal end of said drive spring along said longitudinal axis, said drive spring defining an internal cavity; a plunger located at least partially within the medication container; a plunger rod fitted to the plunger; - Anti-movement mechanism A syringe or part of a syringe, comprising: The movement prohibition mechanism is a latch mechanism, the latch mechanism including at least one fitting portion at least partially received in a cavity of the drive spring and configured to releasably fit onto the plunger rod, the latch mechanism being configured to move toward the distal end of the drive spring under the action of the drive spring; a storage tube fitted into the latch mechanism; Including, The latch mechanism is configured to move from a movement-prohibited position to a movement-permitted position with respect to the storage tube, - in the movement-restricted position, the storage barrel keeps the fitting portion fitted onto the plunger rod, so that the extension of the drive spring moves the latch mechanism and the storage barrel toward the tip of the drive spring, thereby expelling the medicine from the syringe barrel; In the movement permission position, the housing cylinder does not keep the fitting portion fitted to the plunger rod, so that the fitting portion can be released from the plunger. A syringe or part of a syringe characterized by:

[0399] A2. The syringe according to A1, wherein the latch mechanism includes a distal flange that contacts the distal end of the drive spring.

[0400] A3 The syringe according to A1 or A2, wherein the latch mechanism and the storage barrel are configured to move toward the tip of the drive spring while being connected in the direction of the longitudinal axis of the housing when the latch mechanism is in the movement-prohibited position.

[0401] A4 The housing includes an abutment, and the abutment is By preventing the storage tube from moving beyond the adjacent portion toward the tip end side of the drive spring, the latch mechanism is made movable toward the tip end side of the drive spring relative to the storage tube, and is moved from the movement prohibited position to the movement permitted position. The syringe according to A3, configured as follows:

[0402] A5. A syringe as described in any one of A1 to A4, wherein the latch mechanism is configured to move the storage barrel toward the tip of the drive spring by an interference fit between the latch mechanism and the storage barrel in the movement-preventing position.

[0403] A6: The syringe described in A5, wherein the latch mechanism is configured to move from the movement-prohibited position to the movement-permitted position by the force applied by the drive spring overcoming friction between the latch mechanism and the storage barrel.

[0404] A7. The syringe of any one of A1 to A4, wherein the latch mechanism is configured to keep the drive spring compressed prior to activation of the syringe.

[0405] A8 The latch mechanism is a catch element configured to be releasably secured to a portion of the housing to retain the drive spring in the compressed state; A syringe according to A7, comprising at least one of:

[0406] A9 The latch mechanism is a protruding portion configured to fit onto the drive spring; a latch fitted to the protruding portion; The syringe of any one of A1 to A8, comprising:

[0407] A10 The syringe according to A9, wherein the latch includes the mating portion and the protruding portion includes the catch element.

[0408] A11 The syringe according to A10, wherein the latch mechanism is a single-piece molded part.

[0409] A12 the syringe further comprises a handle; the housing is axially movable relative to the handle from an unactuated position to an actuated position; When the housing moves from the non-activated position to the activated position, the drive spring is released from its compressed state. Syringe as described in A7.

[0410] A13 The syringe according to A12, wherein the housing is configured to move from the non-activated position to the activated position when the tip of the syringe is pressed against injectable tissue, thereby releasing the drive spring from the compressed state.

[0411] A14 The syringe further comprises: an actuation spring disposed between the housing and the handle and applying a force to the housing toward the unactuated position; A syringe according to A13, comprising:

[0412] A15. The syringe according to A13, wherein the catch element is fixed between the housing and the activation device when the housing is in the non-activated position.

[0413] A16. The syringe according to A15, wherein the actuation device is entirely located within the handle.

[0414] A17. The syringe according to A16, wherein the actuator is fixed to the handle so as not to move axially.

[0415] A18. The syringe of any one of A1 to A17, wherein the housing barrel includes a sleeve having at least one hole therein.

[0416] A19 When the latch mechanism is in the movement-preventing position, the sleeve of the storage tube is aligned radially with the fitting portion, keeping the fitting portion fitted onto the plunger rod; When the latch mechanism is in the movement permitting position, the hole in the sleeve is radially aligned with the mating portion, allowing the mating portion to flex outward and disengage from the plunger rod. Syringe as described in A18.

[0417] A20 The drive spring is a single spring configured to: 1) axially move a syringe barrel within the housing; and 2) expel medication from the syringe barrel. A syringe according to any one of A1 to A19, comprising:

[0418] A21 A method for manufacturing a syringe or a part of a syringe, - providing a housing having a longitudinal axis; - placing a drive spring having a distal end and a proximal end defining a cavity within the housing such that the proximal end is opposite the distal end of the drive spring along the longitudinal axis; - placing at least a portion of the plunger within the medication container; - fitting a plunger rod onto the plunger; - fitting a latch mechanism including at least one mating portion to the housing tube to form a movement-restricting mechanism; - placing at least a portion of the latch mechanism within a cavity of the drive spring and releasably engaging the mating portion with the plunger rod; - placing the storage barrel in a restricted position where the storage barrel keeps the engaging portion engaged with the plunger rod, thereby allowing the extension of the drive spring to move the latch mechanism and the storage barrel toward the tip of the drive spring and expel the medicine from the syringe barrel; Equipped with The storage cylinder is configured to move from the movement-prohibited position to a movement-permitted position in which the storage cylinder does not keep the fitting portion fitted on the plunger rod. A manufacturing method characterized by:

[0419] A22 compressing the distal and proximal ends of the drive spring to a compressed state and causing the latch mechanism to hold the drive spring in the compressed state. The manufacturing method according to A21, further comprising:

[0420] B1 A housing with a long axis and a drive spring located within the housing; a first drive element configured to transfer power from the drive spring to a plunger located within a medication container; a damper disposed coaxially with the first drive component and fixed to the housing against movement in the direction of the longitudinal axis; A syringe comprising: The first driving component is The actuation of the drive spring causes the damper to move along the longitudinal axis of the housing. It is structured as follows: The damper is an interference fit on a surface of the first drive component while the first drive component moves relative to the damper; It is configured as follows: A syringe or part of a syringe characterized by:

[0421] B2. The syringe of B1, wherein the damper is annular.

[0422] B3. The syringe of any one of B1 and B2, wherein the drive spring is configured to advance the medication container relative to the housing from a retracted position to an extended position.

[0423] B4. The syringe of B3, wherein the damper is attached to the housing by a pin extending in the direction of the longitudinal axis.

[0424] B5 The tip of the damper is a socket configured to receive the head of a tool for securing the damper to the pin; A syringe according to B4, forming

[0425] B6 The damper: an elongated body secured within said housing Equipped with The first drive component is The inner wall that forms the shaft Equipped with The damper is configured to be housed in the vertical hole and fitted to the inner wall. A syringe according to any one of B1 to B5.

[0426] B7. The syringe of any one of B1 to B6, wherein the damper further comprises at least one deformable damping member mounted on the body.

[0427] B8 The body is: A head containing at least one circumferential groove at the tip It is equipped with the groove is configured to receive a complementary shaped portion of the braking member; Syringe as described in B7.

[0428] B9. The syringe of B6 or B7, wherein the diameter of the longitudinal bore varies to at least two different values ​​along the longitudinal axis of the housing, thereby varying the degree of interference fit between the first drive part and the damper as the first drive part moves relative to the damper.

[0429] B10 The syringe of any one of B7 to B9, wherein the damping member comprises an overmolded part.

[0430] B11 The syringe of any one of B6 to B10, wherein the inner wall of the first drive part has a plurality of grooves extending longitudinally of the inner wall or along or parallel to the longitudinal axis of the housing.

[0431] B12 The syringe according to B11, wherein the grooves include at least one groove having a first length and one groove having a second length different from the first length.

[0432] B13 The syringe of B11 or B12, wherein the grooves are circumferentially spaced about the longitudinal axis of the housing.

[0433] B14. The syringe according to any one of B10 to B13, wherein the ratio of the groove to the inner wall of the first drive component decreases toward the tip.

[0434] B15 A method for manufacturing a syringe or part of a syringe, comprising the steps of: Providing a housing having a longitudinal axis. Mounting a damper on the housing and securing it against translational movement relative to the housing along the longitudinal axis. Installing a drive spring within the housing. Installing a first drive component within the housing and coaxially disposing the damper within the first drive component. The first drive component is configured to be moved relative to the damper along the longitudinal axis of the housing by the drive spring while being interference fitted with the damper.

[0435] B16 The damper comprises an elongated body and a deformable damping member; overmolding the damping member onto the body to form the damper. The method of B15, further comprising:

[0436] C1 A mechanism for use in a syringe for administering medication, comprising: a container containing a medication, having a cap and sealed by a septum; a sealing element in contact with an outer surface of the container cap; a needle for piercing the septum; a needle hub attached to the needle; Equipped with the sealing element is disposed between an outer surface of the container cap and an inner surface of the needle hub; the mechanism is configured to transition from a first state to a second state; In the first state, the needle is spaced from the septum and a free end of the needle is located within a cavity sealed by the sealing element; In the second state, the needle penetrates the septum; A seal between the inner surface of the needle hub and the outer surface of the cap is formed by the sealing element in the first state and maintained in the second state during transition from the first state to the second state. A mechanism characterized by:

[0437] C2 a housing having a longitudinal axis and a distal end with a hole for passing a portion of the needle therethrough, the housing being configured to accommodate a container containing a drug; a safety shield surrounding at least a distal portion of the housing and configured to advance distally relative to the housing from a retracted position to an advanced position covering the needle; an advancement spring disposed between the housing and the safety shield and configured to advance the safety shield from the retracted position to the advanced position; The mechanism of claim C1, comprising:

[0438] C3. A releasable locking mechanism configured to engage the safety shield to lock the safety shield in the retracted position. The mechanism of C2, further comprising:

[0439] C4 said needle hub, a first position that is movable relative to the housing away from the bore of the housing and a second position that extends through the bore of the housing; In the second position, the safety shield is configured to be disengaged from the locking mechanism, thereby releasing the safety shield. The mechanism described in C3.

[0440] C5 the locking mechanism includes a latch surface connected to one of the safety shield and the housing and a flexible latch arm connected to the other of the safety shield and the housing; the latch arm is configured to engage the latch surface to lock the safety shield in the retracted position; the needle hub is configured to disengage the latch arm from the latch surface in the second position. The mechanism described in C3 or C4.

[0441] C6. A mechanism as described in any one of C2 to C5, wherein the forward spring is configured to lock to the housing and the safety shield when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position.

[0442] C7. The arrangement of any one of C1 to C6, wherein the sealing element is chemically bonded to the outer surface of the cap.

[0443] C8. The arrangement of any one of C1 to C7, wherein the sealing element is overmolded onto the outer surface of the cap.

[0444] C9. The arrangement of any one of C1 to C6, wherein the sealing element is an O-ring.

[0445] C10 the sealing element comprises a first material; the cap comprises a second material different from the first material; The sealing element and the cap are formed as a single piece by double injection molding. The mechanism of any one of C1 to C7.

[0446] C11 the needle hub, a first inner surface extending perpendicular to the needle and facing the cap; a proximal protrusion extending inward toward the needle; a second inner surface extending parallel to the needle from the first inner surface to the proximal projection; Including, the second inner surface is configured to engage the sealing element in the first state, during a transition from the first state to the second state, and in the second state. The mechanism of any one of C1 to C10.

[0447] C12 The cap includes a first rib and a second rib; The sealing element is disposed between the first rib and the second rib. The mechanism of any one of C1 to C11.

[0448] C13 In the first state, the distance between the first rib and the free end of the needle is shorter than the distance between the second rib and the free end of the needle, and the proximal projection of the needle hub is fitted into the second rib of the cap; In the second state, a first inner surface of the needle hub is fitted into a first rib of the cap. The mechanism described in C12.

[0449] C14 The cap, a first positioning recess in which the sealing element is located; a second positioning recess for selectively receiving a positioning protrusion of the needle hub in the second state; The mechanism of any one of C1 to C13, comprising:

[0450] C15. The mechanism of C14, wherein in the first state, a surface of a positioning projection of the needle hub contacts the sealing element.

[0451] C16 A method of manufacturing a mechanism for use in a syringe for administering medication, comprising the steps of: providing: a container having a cap and sealed by a septum; a sealing element in contact with an outer surface of the container cap; a needle for piercing the septum; A needle hub having the sealing element disposed between the outer surface of the container cap and its inner surface. the mechanism is configured to transition from a first state to a second state; In the first state, the needle is spaced from the septum and a free end of the needle is located within a cavity sealed by the sealing element; In the second state, the needle penetrates the septum; A seal between the inner surface of the needle hub and the outer surface of the cap is formed by the sealing element in the first state and maintained in the second state during transition from the first state to the second state.

[0452] C17 providing a housing having a longitudinal axis; providing a safety shield surrounding at least a distal portion of the housing and advanceable relative to the housing from a retracted position distally to an advanced position protecting the needle; disposing an advancement spring between the housing and the safety shield configured to advance the safety shield; The method of manufacturing a mechanism according to C16, further comprising:

[0453] C18 a releasable locking mechanism configured to lock the safety shield in the retracted position when engaged with the safety shield A method for manufacturing a mechanism according to C16 or C17, comprising the step of providing:

[0454] C19 The needle hub a first position that is movable relative to the housing away from the bore of the housing and a second position that extends through the bore of the housing; In the second position, the safety shield is configured to be disengaged from the locking mechanism, thereby releasing the safety shield. A method for manufacturing the mechanism described in C18.

[0455] C20 the locking mechanism includes a latch surface connected to one of the safety shield and the housing and a flexible latch arm connected to the other of the safety shield and the housing; the latch arm is configured to engage the latch surface to lock the safety shield in the retracted position; the needle hub is configured to disengage the latch arm from the latch surface in the second position. A method for producing the mechanism according to C18 or C19.

[0456] C21 A method for manufacturing a mechanism described in any one of C17 to C20, wherein the forward spring is configured to lock to the housing and the safety shield when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position.

[0457] C22. The method of any one of C16 to C21, wherein the step of providing the sealing element includes chemically bonding the sealing element to an exterior surface of the cap.

[0458] C23. The method of any one of C16 to C22, wherein the step of providing a sealing element comprises overmolding the sealing element onto an outer surface of the cap.

[0459] C24. A method of manufacturing a mechanism according to any one of claims C16 to C23, wherein the sealing element comprises a first material and the cap comprises a second material different from the first material.

[0460] C25. The method of manufacturing the mechanism of C22, wherein the chemical bonding step comprises performing bi-injection molding.

[0461] C26. A method of manufacturing a mechanism according to any one of C16 to C21 or C24, wherein the sealing element is an O-ring.

[0462] D1: A housing configured to accommodate a medication container containing a medication, the housing having a longitudinal axis and a distal end having a hole for passing a portion of a needle operably coupled to the medication container; a safety shield surrounding at least a distal portion of the housing and configured to advance distally relative to the housing from a retracted position to an advanced position that protects the needle; an advancement spring disposed between the housing and the safety shield, the advancement spring configured to advance the safety shield from the retracted position to the advanced position, and configured to lock with the housing and the safety shield when the safety shield is in the advanced position, thereby preventing the safety shield from returning to the retracted position; A syringe or part of a syringe comprising:

[0463] D2 the housing comprises a first locking surface and the safety shield comprises a second locking surface; the second locking surface is positioned to face the first locking surface when the safety shield is in the advanced position; the forward spring is configured to lock with the first locking surface and the second locking surface when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position. Syringe as described in D1.

[0464] D3 the first locking surface includes a shoulder facing the distal end of the housing; the second locking surface includes a shoulder facing the proximal end of the housing, with a ridge extending distally from the shoulder in the direction of the longitudinal axis; the longitudinal ridge is configured to radially compress the advancement spring when the safety shield is in the retracted position; the advancement spring is configured to expand radially when the safety shield passes the second locking surface during advancement. Syringe as described in D2.

[0465] D4 the forward spring has a proximal end with a first diameter and a distal end with a second diameter narrower than the first diameter; the proximal end is configured to be locked to the housing and the safety shield when the safety shield is in the advanced position. A syringe according to any one of D1 to D3.

[0466] D5. When the safety shield is in the retracted position, the proximal end of the advancement spring is compressed to a third diameter narrower than the first diameter; the advancement spring is arranged to expand to the first diameter when the safety shield is in the advanced position. Syringe as described in D4.

[0467] D6: one of the housing and the safety shield includes a retaining tab, and the other includes a one-way receiving portion; the retaining tab is configured to slide over the one-way receiver during assembly of the syringe and to contact the one-way receiver during advancement of the safety shield, thereby preventing separation of the safety shield from the housing. A syringe according to any one of D1 to D3.

[0468] D7 The one-way receiving portion is a ramp conveniently positioned to allow the retention tab to ride over the one-way receiver during assembly of the syringe; a sheer cliff face positioned to prevent the retention tab from climbing over the one-way receiving portion during advancement of the safety shield; Including, Syringe as described in D6.

[0469] D8. The syringe according to D7, wherein the one-way receiving portion further comprises a cantilevered arm.

[0470] D9. The syringe of any one of D6 to D8, wherein the housing includes the one-way receiver and the safety shield includes the retaining tab.

[0471] D10. The syringe of D9, wherein the retaining tab includes a circumferentially extending projection.

[0472] D11 a releasable locking mechanism configured to lock the safety shield in the retracted position when engaged with the safety shield; The syringe of any one of claims D1 to D10, further comprising:

[0473] D12 a needle hub connecting said needle and said drug container Further provided with The needle hub is attached to the housing. a first position spaced from the hole in the housing; a second location extending through the bore of the housing; and It is movable between the needle hub is configured to disengage from the locking mechanism in the second position, thereby releasing the safety shield. Syringe as described in D11.

[0474] D13 the locking mechanism includes a latching surface connected to one of the safety shield and the housing and a flexible latching arm connected to the other; the latch arm is configured to engage the latch surface to lock the safety shield in the retracted position; the needle hub is configured to disengage the latch arm from the latch surface in the second position. Syringe as described in D12.

[0475] D14 a return spring arranged to apply a force to the medication container and the needle hub toward the first position. The syringe of any one of claims D11 to D13, further comprising:

[0476] D15. The syringe according to D14, wherein the return spring comprises a coil spring and is located between the housing and the medication container.

[0477] D16. The syringe of any one of claims D1 to D15, wherein the advancement spring comprises a coil spring.

[0478] D17 A method for manufacturing a syringe, comprising: providing a housing having a longitudinal axis; providing a safety shield surrounding at least a distal portion of the housing and advanceable from a retracted position distally relative to the housing to an advanced position protecting the needle; disposing an advancement spring between the housing and the safety shield and configuring the advancement spring to advance the safety shield; Equipped with The forward spring is The housing and the safety shield are locked together when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position. It is configured as follows: A method characterized by:

[0479] D18: One of the housing and the safety shield includes a retaining tab, and the other includes a one-way receiver; Sliding the safety shield over the housing toward the retracted position and locking the safety shield behind the one-way receiving portion by causing the retaining tab to overcome the one-way receiving portion, thereby preventing the safety shield from separating from the housing. The method of D17, further comprising:

[0480] D19. placing the advancement spring in the safety shield before sliding the safety shield over the housing. The method of D18, further comprising:

[0481] E1: A housing configured to accommodate a medication container containing a medication, the housing having a longitudinal axis and a distal end having a hole for passing a portion of a needle operably coupled to said medication container; a drive spring disposed within the housing, the drive spring having a distal end and a proximal end opposite the distal end along a longitudinal axis of the housing, the drive spring defining an internal cavity; a plunger at least partially disposed within the medication container; a plunger rod fitted to the plunger; A syringe comprising: A movement prohibition mechanism; A braking mechanism; a safety shield mechanism; Medicine container connection device and a) the movement prohibition mechanism is a latch mechanism including at least one fitting portion at least partially received within a cavity of the drive spring and configured to releasably fit onto the plunger rod, the latch mechanism being configured to move distally under the action of the drive spring; a storage tube fitted into the latch mechanism; Including, the latch mechanism is configured to move from a movement-prohibiting position to a movement-allowing position relative to the storage tube; In the movement-prohibited position, the storage barrel holds the fitting portion of the latch mechanism in a state where it is fitted onto the plunger rod, and the latch mechanism and the storage barrel are moved toward the distal end by the extension of a drive spring, thereby discharging the medicine from the syringe barrel; At the movement permission position, the storage cylinder does not hold the fitting portion of the latch mechanism in a state where it is fitted onto the plunger rod, so that the fitting portion can be disengaged from the plunger, b) the braking mechanism a first drive element, optionally provided as the plunger rod, configured to transfer power from the drive spring to the plunger located within the medication container; a damper disposed coaxially with the first drive component and fixed to the housing so as not to move in the longitudinal direction; Including, the first drive component is configured to move along a longitudinal axis of the housing relative to the damper under the action of the drive spring; the damper is configured to be interference fitted onto a surface of the first drive component while the first drive component moves relative to the damper; c) the safety shield mechanism comprises: a safety shield surrounding at least a distal portion of the housing and configured to advance distally relative to the housing from a retracted position to an advanced position that protects the needle; an advancement spring disposed between the housing and the safety shield and configured to advance the safety shield from the retracted position to the extended position; Including, the forward spring is configured to lock with the housing and the safety shield when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position; d) the medicine container connection device, a medicine container containing the medicine, the medicine container having a cap and a septum seal; a sealing element in contact with an outer surface of the cap of the medication container; a needle for piercing the septum; a needle hub having the needle attached thereto and the sealing element disposed between an inner surface and an outer surface of the cap of the medication container; Including, the medication container connection device is configured to transition from a first state to a second state; In the first state, the needle is spaced from the septum with the free end of the needle positioned within a cavity sealed by the sealing element; In the second state, the needle penetrates the septum; a seal between the inner surface of the needle hub and the outer surface of the cap is formed by the sealing element in the first state, maintained during transition from the first state to the second state, and maintained in the second state; A syringe characterized by:

[0482] It will be understood that the terms "proximal" and "distal" are used for convenience in interpreting the drawings and should not be construed as limiting the invention. The term "distal" means toward the injection site (i.e., the end of the needle that contacts the patient at the injection site), and the term "proximal" means away from the injection site. The term "comprising" should be interpreted as meaning "including, but not limited to," and does not exclude the presence of unrecited elements. The term "annular," when used, should not be construed as being limited to a circle, but rather as meaning any shape with an uninterrupted circumference. The term "toward the longitudinal axis" should be construed as meaning along the axis along which the needle is disposed. Similarly, "radial" means perpendicular to the longitudinal axis of the needle. The circumferential direction should be construed as a direction away from the needle, and the inner circumferential direction should be construed as a direction toward the needle.

[0483] The embodiments described above and illustrated in the accompanying drawings are given as examples of how the invention can be implemented, and are not intended to limit the scope of the invention. Changes can be made to the embodiments, components of the embodiments can be replaced with functionally and structurally equivalent components, and configurations of different embodiments can be combined without departing from the invention disclosed in this specification.

[0484] The following embodiments are also disclosed. Embodiment 1: A mechanism for use in a syringe, comprising: A container that has a cap and is sealed by a septum. A sealing element that contacts the surface of the container cap. A needle for piercing the bulkhead. Needle hub. The sealing element is positioned between a surface of the container cap and a surface of the needle hub. The component is configured to transition from a first state to a second state. In the first state, the needle is clear of the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. A seal between the surface of the cap and the surface of the needle hub is formed by the sealing element when the mechanism is in the first state. This seal is maintained during transition of the mechanism from the first state to the second state.

[0485] Embodiment 2: A mechanism according to embodiment 1, wherein the sealing element is located between the inner surface of the needle hub and the outer surface of the cap.

[0486] Embodiment 3: A mechanism according to embodiment 1, wherein the sealing element is located between the inner surface of the cap and the outer surface of the needle hub.

[0487] Embodiment 4: A mechanism according to any of embodiments 1-3, comprising: a housing having a longitudinal axis, the housing being configured to receive a container containing a medication and having a hole at a distal end through which a portion of the needle passes; a safety shield surrounding at least a distal portion of the housing, the safety shield configured to advance from a retracted position distally relative to the housing to an advanced position to protect the needle; An advancement spring disposed between the housing and the safety shield and configured to advance the safety shield from the retracted position to the advanced position.

[0488] Embodiment 5: The mechanism according to embodiment 4, including a releasable locking mechanism configured to lock the safety shield in the retracted position when the locking mechanism engages with the safety shield.

[0489] Embodiment 6: The mechanism according to embodiment 5, characterized in that the needle hub is movable relative to the housing between a first position and a second position. In the first position, the needle hub is free from the bore in the housing and extends through the bore in the housing in the second position. When in the second position, the needle hub is configured to disengage from the locking mechanism, thereby releasing the safety shield.

[0490] Embodiment 7: The mechanism according to embodiment 5 or embodiment 6, characterized in that: the locking mechanism includes: A latch surface connected to one of the safety shield and the housing, and a flexible latch arm connected to the other. The latch arms are configured to engage the latch surfaces to lock the safety shield in the retracted position. The needle hub is configured to disengage the latch arm from the latch surface in the second position.

[0491] Embodiment 8: The mechanism according to any one of embodiments 4-7, characterized in that: the forward spring is configured to lock with the housing and the safety shield when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position.

[0492] Embodiment 9: The arrangement according to any of embodiments 1-8, characterized in that: the sealing element is part of the dividing wall.

[0493] Embodiment 10: The mechanism according to any of embodiments 1-9, characterized in that the septum has a longitudinal hole through which one end of the needle passes when the mechanism is in the first state and through which a portion of the needle hub passes when the mechanism is in the second state.

[0494] Embodiment 11: A device according to any of embodiments 1-10, characterized in that: the sealing element is chemically bonded to the surface of the cap.

[0495] Embodiment 12: A mechanism according to any of embodiments 1-11, characterized in that: the sealing element is overmolded onto the surface of the cap.

[0496] Embodiment 13: A mechanism according to any of embodiments 1-8 or embodiment 10, characterized in that: the sealing element is an O-ring.

[0497] Embodiment 14: A mechanism according to any of embodiments 1-13, characterized in that: the cap comprises one or more positioning members in which the sealing element is placed.

[0498] Embodiment 15: A mechanism according to any of embodiments 1-14, characterized in that: the needle hub includes one or more positioning members; and when the mechanism is in the first state, the sealing element is aligned with one of the positioning members of the needle hub.

[0499] Embodiment 16: A mechanism according to any of embodiments 1-15, characterized in that the seal between the surface of the cap and the surface of the needle hub is maintained during transition of the mechanism from the first state to the second state and while the mechanism is in the second state.

[0500] Embodiment 17: The mechanism according to any of embodiments 1-16, characterized in that the sealing element comprises a first material, the cap comprises a second material different from the first material, and the sealing element and the cap are formed as a single piece by double injection molding.

[0501] Embodiment 18: A mechanism according to any of embodiments 1-17, characterized in that the needle hub includes a first inner surface extending perpendicular to the needle and facing the cap, a proximal protrusion extending inward toward the needle, and a second inner surface extending parallel to the needle from the first inner surface to the proximal protrusion, the second inner surface being configured to engage the sealing element when the mechanism is in the first state, during transition from the first state to the second state, and when in the second state.

[0502] Embodiment 19: The mechanism according to embodiment 6, characterized in that: the cap includes a first rib and a second rib; and the sealing element is disposed between the first rib and the second rib.

[0503] Embodiment 20: The mechanism according to embodiment 19, characterized in that when the mechanism is in the first state, the distance between the first rib and the free end of the needle is shorter than the distance between the second rib and the free end of the needle, when the mechanism is in the first state, the proximal projection of the needle hub engages with the second rib of the cap, and when the mechanism is in the second state, the first inner surface of the needle hub engages with the first rib of the cap.

[0504] Embodiment 21: The mechanism according to any of embodiments 1-20, characterized in that the cap includes a first positioning recess and a second positioning recess, the sealing element is located in the first recess, and the second recess is configured to receive a positioning protrusion of the needle hub when the mechanism is in the second state.

[0505] Embodiment 22: The mechanism according to embodiment 21, characterized in that: when the mechanism is in the first state, the surface of the positioning projection of the needle hub is in contact with the sealing element.

[0506] Embodiment 23: A method of manufacturing a syringe component, comprising the steps of providing: A container that has a cap and is sealed by a septum. A sealing element that contacts the surface of the container cap. A needle for piercing the bulkhead. Needle hub. The sealing element is positioned between a surface of the container cap and a surface of the needle hub. The mechanism is configured to transition from a first state to a second state. In the first state, the needle is away from the septum and the free end of the needle is located in a cavity sealed by the sealing element. In the second state, the needle penetrates the septum. A seal between the surface of the cap and the surface of the needle hub is formed by the sealing element when the mechanism is in the first state and maintained during transition of the mechanism from the first state to the second state and while the mechanism is in the second state.

[0507] Embodiment 24: The method according to embodiment 23, characterized in that: a sealing element is placed between the inner surface of the needle hub and the outer surface of the cap.

[0508] Embodiment 25: The method according to embodiment 23, characterized in that: a sealing element is placed between the inner surface of the cap and the outer surface of the needle hub.

[0509] Embodiment 26: A method according to any of embodiments 23-25, comprising the steps of: Providing a housing having a longitudinal axis. Providing a safety shield surrounding at least the distal portion of the housing, the safety shield being advanceable from a retracted position distally relative to the housing to an advanced position that protects the needle. Disposing an advancement spring between the housing and the safety shield, the advancement spring configured to advance the safety shield.

[0510] Embodiment 27: The method according to embodiment 26, comprising the steps of: providing a releasable locking mechanism configured to engage with the safety shield to lock the safety shield in the retracted position.

[0511] Embodiment 28: The method according to embodiment 27, wherein the needle hub is movable relative to the housing between a first position and a second position. In the first position, the needle hub is free from the bore in the housing and extends through the bore in the housing. In the second position, the needle hub is configured to disengage from the locking mechanism, thereby releasing the safety shield.

[0512] Embodiment 29: The method according to embodiment 27 or embodiment 28, wherein the locking mechanism includes a latch surface connected to one of the safety shield and the housing and a flexible latch arm connected to the other of the safety shield and the housing. The latch arm is configured to engage with the latch surface to lock the safety shield in the retracted position. The needle hub is configured to disengage the latch arm from the latch surface in the second position.

[0513] Embodiment 30: The method according to any of embodiments 26-29, characterized in that: the forward spring is configured to lock to the housing and the safety shield when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position.

[0514] Embodiment 31: The method according to any of embodiments 23-30, characterized in that: the sealing element is part of the septum.

[0515] Embodiment 32: The method according to any of embodiments 23-31, characterized in that: the septum has a longitudinal bore that receives one end of the needle when the mechanism is in the first state and a portion of the needle hub when the mechanism is in the second state.

[0516] Embodiment 33: The method according to any of embodiments 23-32, comprising chemically bonding the sealing element to a surface of the cap.

[0517] Embodiment 34: The method according to any of embodiments 23-33, comprising overmolding the sealing element onto a surface of the cap.

[0518] Embodiment 35: The method according to any of embodiments 23-34, wherein the sealing element is formed from a first material and the cap is formed from a second material different from the first material.

[0519] Embodiment 36: The method according to embodiment 33, wherein the chemically bonding step comprises performing bi-injection molding.

[0520] Embodiment 37: The method according to any of embodiments 23-30 or embodiment 32, characterized in that: the sealing element is an O-ring.

[0521] Embodiment 38: The method according to any of embodiments 23-37, characterized in that: the cap comprises one or more positioning members in which the sealing element is located.

[0522] Embodiment 39: The method according to any of embodiments 23-38, characterized in that: the needle hub includes one or more positioning members; and when the mechanism is in the first state, the sealing element is aligned with one of the positioning members of the needle hub.

[0523] Embodiment 40: The method according to any of embodiments 23-39, characterized in that: the seal between the surface of the cap and the surface of the needle hub is maintained during transition of the mechanism from the first state to the second state and while the mechanism is in the second state.

[0524] Embodiment 41: A method according to any of embodiments 23-40, comprising sterilizing one or more parts of the mechanism.

Claims

1. A component of a medication syringe, comprising: a container containing the medication; a cylindrical cap surrounding the mouth of the container; a septum sealing the mouth of the container; a needle hub having a cylindrical shape including a closed end and an open end surrounding the cap, the closed end being adapted to be brought close to the septum; a needle including a fixed end fixed to the closed end of the needle hub while passing through the closed end, and a free end supported away from the septum, the free end being positioned to pass through the septum when the needle hub moves the closed end closer to the septum; a sealing element positioned between an outer peripheral surface of the cap and an inner peripheral surface of the needle hub to form a seal to seal a cavity within the needle hub; Equipped with the component is configured to transition from a first state to a second state; In the first state, the free end of the needle is spaced from the septum and positioned within the cavity sealed by the sealing element; In the second state, the free end of the needle penetrates the septum; The seal is maintained while the component transitions from the first state to the second state and while the component is in the second state and an injection is being performed. A part characterized by:

2. a housing configured to receive a container containing a medication, the housing having a longitudinal axis and a distal end having a hole through which a portion of the needle passes; a safety shield surrounding at least a distal portion of the housing and configured to advance distally relative to the housing from a retracted position to an advanced position that protects the needle; an advancement spring disposed between the housing and the safety shield and configured to advance the safety shield from the retracted position to the advanced position; The component of claim 1 , comprising:

3. a releasable locking mechanism configured to lock the safety shield in the retracted position when engaged with the safety shield; The component of claim 2 further comprising:

4. the needle hub a first position that is movable relative to the housing away from the bore of the housing and a second position that extends through the bore of the housing; In the second state, the safety shield is configured to be released by disengaging from the locking mechanism.

4. The component of claim 3.

5. the locking mechanism includes a latch surface connected to one of the safety shield and the housing and a flexible latch arm connected to the other of the safety shield and the housing; the latch arm is configured to engage the latch surface to lock the safety shield in the retracted position; the needle hub is configured to disengage the latch arm from the latch surface in the second position.

5. The component of claim 4.

6. 3. The component of claim 2, wherein the forward spring is configured to lock the housing and the safety shield when the safety shield is in the forward position, thereby preventing the safety shield from returning to the retracted position.

7. The component of claim 1 , wherein the sealing element is chemically bonded to the outer periphery of the cap.

8. The component of claim 1 , wherein the sealing element is overmolded onto an outer periphery of the cap.

9. the sealing element comprises a first material; the cap comprises a second material different from the first material; The sealing element and the cap are formed as a single piece by double injection molding. The component of claim 1 .

10. the needle hub a first inner surface extending perpendicular to the needle and facing the cap; a proximal protrusion extending inward toward the needle; a second inner surface extending parallel to the needle from the first inner surface to the proximal projection; Including, the second inner surface is configured to engage the sealing element when the component is in the first state, during transition of the component from the first state to the second state, and when the component is in the second state. The component of claim 1 .

11. the cap includes a first rib and a second rib; The sealing element is disposed between the first rib and the second rib. The component of claim 10.

12. When the part is in the first state, the distance between the first rib and the free end of the needle is closer than the distance between the second rib and the free end of the needle, and the proximal projection of the needle hub fits into the second rib of the cap; When the component is in the second state, a first inner surface of the needle hub fits into a first rib of the cap. The component of claim 11.

13. The cap is a first locating recess in which the sealing element is located; a second locating recess for optionally receiving a locating projection on the needle hub when the component is in the second state; The component of claim 1 , comprising:

14. 1. A method of manufacturing a component for a medication syringe, comprising: the needle hub is configured so that the closed end can be brought close to the septum, the free end of the needle, supported in a state away from the septum, is positioned to penetrate the septum when the needle hub brings the closed end close to the septum, and a sealing element is positioned between an outer peripheral surface of the cap and an inner peripheral surface of the needle hub to form a seal and seal a cavity within the needle hub, the sealing element forms a seal between an outer peripheral surface of the cap and an inner peripheral surface of the needle hub; configuring the component to transition from a first state to a second state; In the first state, the free end of the needle is spaced from the septum and positioned within a cavity in the needle hub that is sealed by the sealing element; In the second state, the free end of the needle penetrates the septum; The seal is maintained while the component transitions from the first state to the second state and while the component is in the second state and an injection is being performed. A method characterized by:

15. providing a housing having a longitudinal axis; providing a safety shield surrounding at least a distal portion of the housing and advanceable from a retracted position distally relative to the housing to an advanced position protecting the needle; disposing an advancement spring between the housing and the safety shield to advance the safety shield; The method of claim 14 further comprising:

16. a releasable locking mechanism configured to lock the safety shield in the retracted position when engaged with the safety shield; 16. The method of claim 15, comprising providing:

17. the needle hub a first retracted position and a second extended position movable relative to the housing; In the second position, the safety shield is configured to be disengaged from the locking mechanism and thereby released.

17. The method of claim 16.

18. The step of disposing the sealing element comprises: Chemically bonding the sealing element to the outer circumferential surface of the cap; or overmolding the sealing element onto the outer periphery of the cap.

15. The method of claim 14, comprising:

19. The method of claim 14 , wherein the sealing element comprises a first material and the cap comprises a second material different from the first material.

20. 20. The method of claim 18, wherein the chemically bonding step comprises performing bi-injection molding.

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