Injection device

Abstract

An injection device for delivering an injection, the injection device comprising a housing having a longitudinal axis, a proximal end and a distal end, the housing being arranged such that the injection is delivered from the distal end of the housing; and a release mechanism comprising an obstruction, the release mechanism being movable between a first position in which the obstruction is in an obstructing position to obstruct the delivery of the injection and a second position in which the obstruction is in a non-obstructing position so as not to obstruct the delivery of the injection, wherein the injection device produces an audible signal when the release mechanism is moved from the first position to the second position.

Description

[0001] This application is a divisional application of PCT / EP2014 / 062166, which was filed internationally on June 11, 2014 and entered the Chinese national phase on December 10, 2015. The invention title of the parent application is "Injection Device" and the Chinese application number is 201480033327.7; the invention title of the divisional application is "Injection Device" and the Chinese application number is 202010080071.2. Technical Field

[0002] This invention relates to an injection device for delivering injectables, as well as an injection kit and a method for operating the injection device. Background Technology

[0003] Some conventional injection devices incorporate some form of barrier to selectively obstruct or prevent the delivery of an injection from the device. In such devices, injection can only be performed after the user has moved the barrier out of its obstructing position. This reduces the likelihood of unintentional delivery of the injection from the device, as any attempt to deliver the injection will fail when the barrier is in its obstructing position. In other words, the injection device can be locked. To successfully deliver the injection, the user must move the barrier, thereby unlocking the injection device, and then perform the actions required to deliver the injection.

[0004] Such an injection device is described in WO2006 / 106294. When in its obstructed position, the injection device has a protruding obstruction that restricts the movement of the trigger required to initiate delivery of the injection. This obstruction can be moved to a position where it no longer restricts the movement of the trigger by moving a sliding sleeve into the housing of the injection device.

[0005] It has been found that users of injection devices (such as those described in WO2006 / 106294) often struggle to discern when an obstacle has sufficiently moved to activate the device. This is extremely frustrating for users, as they are unsure whether the obstacle is still in its obstructive position, potentially leading to multiple failed attempts to initiate the injection. Furthermore, frustrated users may attempt to force the injection device by applying excessive pressure to the trigger, thereby damaging the injection mechanism.

[0006] Therefore, there is a need to provide an injection device that can offer intuitive feedback to the user, indicating the process of the injection device transitioning from a locked state to an injection-ready state. This invention solves this problem. Summary of the Invention

[0007] One aspect of the present invention provides an injection device for delivering an injectable, the injection device comprising: a housing having a longitudinal axis, a proximal end, and a distal end, the housing being arranged such that an injectable is delivered from the distal end of the housing; and a release mechanism including an obstruction movable between a first position and a second position, wherein in the first position the obstruction is in an obstructive position to obstruct delivery of the injectable, and in the second position the obstruction is in a non-obstructive position to not obstruct delivery of the injectable, wherein the force required to move the release mechanism from the first position to the second position varies with the distance the release mechanism moves, the variation of the required force with distance being represented by a force distribution curve, which is non-linear.

[0008] In a second aspect, the present invention provides an injection device for delivering an injectable, the injection device comprising: a housing having a longitudinal axis, a proximal end, and a distal end, the housing being arranged such that an injectable is delivered from the distal end of the housing; and a release mechanism including an obstruction, the release mechanism being movable between a first position and a second position, wherein in the first position the obstruction is in an obstructive position to obstruct the delivery of the injectable, and in the second position the obstruction is in a non-obstructive position to not obstruct the delivery of the injectable, wherein the injection device generates an audible signal when the release mechanism moves from the first position to the second position.

[0009] Therefore, the injection device can be selectively locked, in which obstacles impede or prevent the delivery of the injection from the injection device, thereby reducing the risk of unintentional delivery of the injection. The injection device can also be selectively unlocked, in which obstacles no longer impede or prevent the delivery of the injection from the injection device, allowing the injection to be administered.

[0010] The injection device is preferably an autoinjector. Autoinjectors improve the convenience of injection for the user because many injection steps can be completed automatically.

[0011] The injection device of the present invention can use a needle to administer an injection. In such a case, it is preferable that the needle remains covered within the injection device before the injection is administered, and that the injection device is in its locked state at the same time. This reduces the possibility of accidental needle pricks. When the injection device is in its unlocked state, by moving the release mechanism from its first position to its second position, the needle can be moved to the uncovered position as part of the injection process.

[0012] The housing contains the fluid to be injected along the mechanism of the injection device. The housing has a longitudinal axis along its length. Furthermore, the housing has a proximal end and a distal end.

[0013] As used herein, the terms "proximal" and "distal" are relative to the person administering the injection. For example, when a user administers an injection to a patient, the proximal end is the end closest to the user, while the distal end is the end furthest from the user but closest to the patient to whom the injection will be received. Accordingly, the casing is arranged such that the injection is delivered from the distal end of the casing. It should be noted that the use of the terms "proximal" and "distal" does not imply that the injection device cannot be used for self-administration of injections. In this case, the distal end will still be defined as the end of the injection device closest to the target injection site before delivery of the injection.

[0014] An obstruction can prevent the operation required for injection from being performed from the injection device. For example, in the case of an autoinjector, the obstruction can restrict the movement of a trigger used to initiate an injection cycle. Alternatively, the obstruction can function as a barrier to block the delivery of the injectable from the distal end of the housing of the injection device, i.e., the obstruction can restrict the movement of the injection needle out of the housing, thereby preventing the injection cycle from being performed.

[0015] The obstacle may be in the form of a protrusion that obstructs delivery of the injection by preventing one of the movements required to administer the injection from the injection device. Such movements include movement of a trigger for activating the autoinjector, movement of the needle toward the recipient's skin outside the injection device, movement of the autoinjector's actuator, movement of the syringe within the injection device, and movement of components, such as a syringe carrier that moves the syringe within the injection device.

[0016] The release mechanism can be in the form of a switch, such as a rocker switch or a slide switch, wherein movement of the switch will move the obstacle from its obstructing position to its unobstructing position, and preferably, vice versa.

[0017] Alternatively, the release mechanism may include a movable sleeve that is at least partially located within the housing and protrudes from a distal end of the housing. When the release mechanism moves from a first position to a second position, the movable sleeve moves proximally along the longitudinal axis of the housing. The sleeve may be in the form of a cylindrical element. Furthermore, the longitudinal axis of the cylindrical sleeve may be aligned parallel to or coincide with the longitudinal axis of the housing. This form of movable sleeve ensures that the force required for the movement of the sleeve is distributed over a larger area, i.e., within the circumference of the protruding end of the movable sleeve, without interrupting the delivery of the injection through the hollow center and along the longitudinal axis of the cylinder.

[0018] The release mechanism, in the form of a movable sleeve protruding from the distal end of the housing, can be moved by pushing the protruding sleeve against the skin of the intended recipient of the injection. This results in the desired movement of the movable sleeve, placing the injection device in its unlocked state. This is a straightforward method for moving the release mechanism from its first position to its second position as part of the injection procedure.

[0019] Preferably, when in the first position, the movable sleeve protrudes from the distal end, while in the second position, the movable sleeve is flush with the distal end of the housing. This maximizes the range of motion of the movable sleeve at a given protrusion distance and provides further visual indication of whether the release mechanism has been fully moved to the second position before attempting to deliver the injection.

[0020] A force needs to be applied to the release mechanism to move it from its first position to its second position. This force can vary as the release mechanism moves from its first position to its second position. The variation in the force required to move the release mechanism can be represented by a force distribution curve, which shows the change in force as the release mechanism moves a distance. The direction of movement of the release mechanism is typically towards the injection device (i.e., proximal). In this invention, the force distribution curve can be non-linear. In other words, the force required to move the release mechanism is not proportional to the distance the release mechanism moves. This differs from prior art injection devices, which are based on linear elastic behavior.

[0021] The use of non-linear variation generates tactile feedback, allowing the user to visually assess the progress of the release mechanism from its first position to its second position. Therefore, the user can perceive the force distribution curve associated with moving the release mechanism from its first position to its second position. The user can then use this perceived feedback to assess whether the release mechanism has successfully moved from its first position to its second position, thereby assessing whether the injection device is ready to administer the injection. This reduces the likelihood that the user will attempt to administer the injection while the device is still in its locked state.

[0022] Alternatively or otherwise, the injection device may generate auditory feedback in the form of an audible signal as the release mechanism moves from the first position to the second position. The user can then use this auditory feedback to assess when the injection device is ready to administer the injection. Specifically, the audible signal may be audible when the release mechanism reaches the second position and the obstruction is in an unobstructed position. Auditory feedback can be generated using non-linear changes in the force distribution curve, which helps the user assess the progress of the release mechanism from its first position to its second position. This will be described further below. Alternatively or otherwise, the audible signal may be executed in other ways, such as by generating an audible signal through contact between certain parts of the injection device. The contact of these parts can form a circuit, resulting in the generation of an electronic audible signal, such as an electronic tone or a buzzer. The contact of these parts can trigger a mechanical mechanism that generates the audible signal, such as the striking of a hammer on a bell.

[0023] A nonlinear force distribution curve can be provided by a release mechanism having an elastic member along a cam surface, wherein the combination of the elastic member and the cam surface is configured to produce the desired force distribution curve. For example, the cam surface can be configured to have one or more undulations present in the form of lugs or notches, which cause the force distribution curve to change specifically as the elastic member travels along this feature of the cam surface. Lugs and notches on the cam surface can also provide audible signals indicating the progress of the elastic member along the cam surface. The cam surface can have one lug / notch, or two lugs / notches, or three lugs / notches, or four or more lugs / notches. The cam surface can have a combination of lugs and notches. The cam surface can be curved, and this curvature can provide a nonlinear force distribution curve.

[0024] Alternatively or otherwise, the nonlinear force distribution curve can be provided by an elastic member that experiences varying amounts of frictional force as it travels along the cam surface. For example, the elastic member can experience increased and / or decreased amounts of frictional force, thereby providing increased and / or decreased forces to the force distribution curve as the release mechanism moves from a first position to a second position. Variations in frictional force can be achieved by changing the roughness of the portion of the cam surface traversed by the elastic member and / or changing the material of that portion.

[0025] Changes in friction can result in a nonlinear force distribution curve, or changes in friction can be combined with other methods that alter the force distribution curve, such as the undulations mentioned above.

[0026] The injection device may have more than one set of elastic members and cam surfaces; that is, it may have two elastic members and corresponding cam surfaces, or three or four elastic members and corresponding cam surfaces. When there are more than one set of elastic members and cam surfaces, each set may independently have any of the features described herein.

[0027] Further details regarding the possible forms of the force distribution curve are given below. Other methods for modifying the force distribution curve are within the scope of this invention.

[0028] The release mechanism can be resiliently biased toward a first position. In this way, any obstruction coupled to the release mechanism is biased toward its obstructive position. This ensures that forced operation must occur so that the injection can be administered from the injection device of the present invention, further reducing the possibility of accidental delivery of the injection.

[0029] The elastic bias towards the first position can be provided by the elastic member of the release mechanism, which undergoes increased deformation as the release mechanism moves from the first position to the second position. In other words, the deformation of the elastic member of the release mechanism can increase as the sleeve moves from the first position to the second position. The elastic bias is then driven by the reduction of this deformation. Preferably, this elastic member is also used to provide the nonlinear force distribution curve detailed herein.

[0030] When the release mechanism moves from the first position to the second position, the force distribution curve associated with the injection device of the present invention can show an increased force. Two examples of such force distribution curves are shown in... Figure 1 The force distribution curve is given in [reference]. Alternatively or otherwise, when the release mechanism moves from the first position to the second position, the force distribution curve may show an increasing force. This force may continuously increase or continuously decrease as the release mechanism moves from the first position to the second position. Specifically, the force may continuously change as the release mechanism moves throughout its entire range of motion, i.e., from being fully in its first position to being fully in its second position. Examples of force distribution curves showing increasing and decreasing forces as the release mechanism moves from the first position to the second position are shown in [reference]. Figure 2 middle.

[0031] Using force distribution curves that combine increasing and decreasing forces, such as Figure 2 As shown, this provides users with particularly distinct tactile and auditory feedback because the force required by the motion release mechanism changes periodically. Users will be able to easily discern the various increases and decreases in the required force, and through experience, will be able to use tactile and auditory cues to determine when the release mechanism has been sufficiently moved to its second position.

[0032] In its simplest form, as the release mechanism moves from the first position to the second position, the force distribution curve will have a force that first increases and then decreases. Therefore, the technician will be able to feel the completion of the desired movement and thus know that the injection device has been placed in the unlocked state.

[0033] about Figure 2 The force distribution curve shown indicates that after three such cycles, the injection device will be in its unlocked state and ready to deliver the injection.

[0034] A similar effect can be achieved using a force distribution curve that always increases (or decreases), but the rate of force increase varies with distance (i.e., the gradient of the force distribution curve changes). Such a curve is shown in... Figure 3 In this mechanism, the rate of force increase varies periodically with distance. It first increases, then decreases, then increases and decreases three more times. This variation can provide tactile and auditory feedback to inform the user of the release mechanism's progress toward its second position and unlocked state.

[0035] In its simplest form, as the release mechanism moves from the first position to the second position, the force distribution curve will have a gradient that first increases and then decreases. After sensing one increase and decrease, the user will know that the release mechanism has moved enough distance to reach its second position and that the injection can be administered.

[0036] about Figure 3 The force distribution curve shown indicates that after four such cycles, the injection device will be in its unlocked state and ready to deliver the injection.

[0037] Such forces and force gradients are both periodic variations of force distribution curves that can be used with the present invention: the force changes from increasing with the increase of the distance the release mechanism moves to decreasing with the increase of the distance the release mechanism moves (or vice versa), and the force gradient changes from increasing with the increase of the distance the release mechanism moves to decreasing with the increase of the distance the release mechanism moves (or vice versa).

[0038] The force distribution curve can exhibit any number of periodic variations. As mentioned above, in its simplest form, there will be only one increase and one decrease. Alternatively, there may be two increases and one decrease, or three increases and decreases (e.g., Figure 2 (as shown), or four or more increases and decreases (such as...) Figure 3 (As shown).

[0039] The use of multiple periodic variations results in a ratchet-like effect, where the force varies with distance, thus providing a repetitive nature of tactile and / or auditory feedback. This helps the user assess the progress of the release mechanism from a first position to a second position.

[0040] All the force distribution curves described herein allow the user to perceive the progress of the release mechanism from the first position to the second position. Therefore, before attempting to administer the injection, the user can be aware of this sensation and subsequently ensure the release mechanism moves from the first position to the second position.

[0041] The injection device may also include an initiation device for initiating the injection, wherein when the obstacle is in an obstructive position, the obstacle interacts with a component of the initiation device to obstruct the initiation device and thereby obstruct the delivery of the injectable.

[0042] The actuation device may include a trigger configured to move to an actuation position to perform delivery of an injectable substance from the injection device. The trigger may be in the form of a rocker switch or a slide switch, or any equivalent.

[0043] The actuation device may include a driver capable of providing the force required to deliver the injection. This driver may be in the form of a spring. Before delivery of the injection, the spring may be held in a compressed state. During injection delivery, the spring is allowed to extend to apply a force that performs the delivery of the injection from the injection device.

[0044] As described above, in order to impede the delivery of the injection, the obstacle of the injection device of the present invention can interact with a component of the actuation device. For example, the obstacle can interact with a trigger. Thus, when the obstacle is in the obstructing position, it can cause the trigger to stop moving to its actuation position. When the obstacle moves to its non-obstructing position, the trigger can move to the actuation position and initiate the injection.

[0045] Alternatively, the obstacle may interact with a actuator that provides the force required to deliver the injection. For example, the obstacle may cause a spring-type actuator to stop extending, thereby stopping the delivery of the injection.

[0046] As described above, the release mechanism may include an elastic member and a cam surface on which the elastic member is configured to travel along with the release mechanism as it moves from a first position to a second position. In this way, the travel of the elastic member on the cam surface forms a force distribution curve, and therefore the cam surface and the elastic member can be configured to provide any desired force distribution curve. For example, the cam surface can be adjusted such that as the elastic member travels along the cam surface, it will experience varying amounts of deformation and thus receive varying amounts of force resisting its movement, thereby forming a force distribution curve. Possible structural features on the cam surface include at least one lug and / or at least one notch.

[0047] As the release mechanism moves from its first position to its second position, the elastic member can travel discontinuously along the cam surface. For example, when the release mechanism is initially moved from being fully in its first position but will engage the cam surface and move along the cam surface to being fully in its second position, the elastic member may not travel along the cam surface, but may engage the cam surface for the first time somewhere between the first and second positions. This discontinuous travel of the elastic member on the cam surface contributes to the non-linear nature of the force distribution curve. Alternatively, the elastic member may initially engage the cam surface, but disengage as the release mechanism moves from its first position to its second position.

[0048] The elastic member can be in the form of an elastic arm, which acts as a cantilever, with its free end traveling along the cam surface. Therefore, various structural features on the cam surface can cause varying degrees of bending in the cantilever, and these different degrees of deformation can result in specific force distribution curves. The elastic member / arm is part of the release mechanism, and thus moves when the release mechanism moves. The elastic member / arm can be integrally formed with the release mechanism. This simplifies the manufacturing process of the injection device.

[0049] The cam surface and the elastic arm can be configured such that the elastic arm deforms in a two-dimensional plane. Specifically, when the release mechanism moves in the proximal and distal directions of the injection device, respectively, the elastic arm can be configured to travel along the cam surface in the proximal and distal directions of the injection device. An example of this configuration has a cam surface on the inside of the housing, and it is inclined generally toward the longitudinal axis of the housing, with the inclination increasing along the longitudinal direction of the housing. As the elastic arm travels along the cam surface, the general inclination causes the elastic member to deform radially toward the central longitudinal axis.

[0050] Alternatively, the cam surface may be arranged on the inner surface of the housing in a generally circumferentially inclined manner, preferably around the longitudinal axis of the housing. When the release mechanism moves in the proximal and distal directions of the injection device, the elastic arm travels along the generally circumferentially inclined cam surface in a generally circumferential direction. If the rotational movement of the release mechanism is constrained, the deformation of the elastic arm in the generally circumferential direction is maximized. This generally circumferential configuration reduces the diameter space requirement of the cam surface / elastic arm mechanism because the elastic arm does not need to bend towards the center of the housing, but rather travels around the inner surface of the housing.

[0051] When the elastic arm moves along the cam surface, the shape of the cam surface may have undulations or exhibit varying amounts of friction, thus affecting the observed force distribution curve.

[0052] Even if the aforementioned cam surface has undulations or exhibits friction along a varying amount of friction, the general inclination of the surface means that the elastic member will deform more when the release mechanism is in its second position compared to when it is in its first position. In other words, there is an overall trend of increased deformation in the elastic member as the release mechanism moves from its first position to its second position.

[0053] The injection device can be configured to accommodate a syringe. Specifically, the injection device can be configured to accommodate a hypodermic syringe. For this purpose, the injection device may also include a syringe carrier that holds the syringe within the injection device and carries the syringe during delivery of the injection.

[0054] When the injection device is configured to accommodate a syringe, an obstruction can act on the syringe to impede the delivery of the injectable when the obstruction is in its obstructive position. When the injection device includes a syringe carrier, an obstruction can act on the syringe to impede injection when the obstruction is in its obstructive position.

[0055] A third aspect of the invention provides an injection kit comprising the injection device and syringe of the present invention. Specifically, the syringe may be a hypodermic syringe. The injection device in the injection kit is configured to accommodate the syringe present in the injection kit. The injection device forming part of the injection kit may have any of the above-described features.

[0056] A fourth aspect of the invention provides a method of operating the injection device of the invention, the method comprising the steps of: moving a release mechanism from a first position toward a second position; and delivering an injection agent upon detection of an auditory signal. The injection device employing this method may have any of the above-described structural features.

[0057] A fifth aspect of the invention provides a method of operating the injection device of the invention, the method comprising the steps of: moving a release mechanism from a first position toward a second position; and delivering an injection agent after detecting a nonlinear nature of the force distribution curve. The injection device employing this method may have any of the above-described structural features.

[0058] The method of this invention allows the user to perceive, through tactile and / or auditory feedback caused by the nonlinear nature of the force distribution curve, that the release mechanism has fully moved from its first position to its second position, indicating that the injection can be successfully delivered. Therefore, the user can ensure that the release mechanism has fully moved to its second position, thus avoiding the problems associated with prior art devices.

[0059] The injection device or injection kit of any of the above embodiments may contain a substance selected from the group consisting of: golimumab, hormones, antitoxins, substances for controlling pain, substances for controlling thrombosis, substances for controlling or eliminating infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, antibodies, oligonucleotides, anti-allergy agents, antihistamines, anti-inflammatory agents, corticosteroids, disease-modifying antirheumatic drugs, erythropoietin, or vaccines for use in the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes, diabetic retinopathy, acute coronary syndrome, angina pectoris, myocardial infarction, atherosclerosis, cancer, macular degeneration, allergies, hay fever, inflammation, anemia, or spinal dysplasia, or for the expression of protective immunity.

[0060] The phrase "an injection device or injection kit may contain a substance" means that the substance can be contained in a suitable drug container, such as in a vial or syringe, within an injection device, or in the syringe of an injection kit. This drug container may contain other substances, such as additional active or inactive ingredients.

[0061] In another aspect of the invention, a substance is provided, selected from the group consisting of: golimumab, hormones, antitoxins, substances for controlling pain, substances for controlling thrombosis, substances for controlling or eliminating infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, antibodies, oligonucleotides, anti-allergic agents, antihistamines, anti-inflammatory agents, corticosteroids, disease-modifying antirheumatic drugs, erythropoietin, or vaccines, for use in the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes, diabetic retinopathy, acute coronary syndrome, angina pectoris, myocardial infarction, atherosclerosis, cancer, macular degeneration, allergies, hay fever, inflammation, anemia, or spinal dysplasia, or in the expression of protective immunity, by using an injection device or injection kit according to any one of the above embodiments.

[0062] In another aspect of the invention, an injection device is provided for delivering a substance to a human subject for use in the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes, diabetic retinopathy, acute coronary syndrome, angina pectoris, myocardial infarction, atherosclerosis, cancer, macular degeneration, allergies, hay fever, inflammation, anemia, or spinal dysplasia, or for the expression of protective immunity, said substance being selected from the group consisting of: golimumab, hormones, antitoxins, substances for controlling pain, substances for controlling thrombosis, substances for controlling or eliminating infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, antibodies, oligonucleotides, anti-allergic agents, antihistamines, anti-inflammatory agents, corticosteroids, disease-modifying antirheumatic drugs, erythropoietin, or vaccines, wherein the injection device is the injection device or injection kit described in any of the above embodiments.

[0063] The term "substance delivery" refers to the injection of the substance into a human subject using an injection device, such as via subcutaneous, intradermal, or intramuscular injection. The substance may be administered in combination with other substances, such as additional active or inactive ingredients. Attached Figure Description

[0064] The invention will now be described by way of example with reference to the accompanying drawings, in which: Figure 1 Examples of two types of force distribution curves are shown, one with an increasing gradient and the other with a decreasing gradient; Figure 2 The force distribution curve is shown, which shows that the force first increases and then decreases, and then the force increases and decreases twice more. Figure 3 The force distribution curve is shown, in which the rate of force increase first increases and then decreases, and then increases and decreases three more times; Figure 4 The injection device of the present invention is shown, illustrating the mechanism within the housing; Figure 5 A plan view of the injection device of the present invention is shown; Figure 6 Details of the release mechanism of the injection device of the present invention are shown; Figure 7 A detailed view of a portion of the release mechanism of the injection device of the present invention is shown; Figure 8 Details of the lugs on the cam surface of the injection device of the present invention are shown. Figure 9 It shows Figure 8The force distribution curve shown is generated by the combination of the elastic arm and the cam surface. Figure 10 Details of the plurality of lugs on the cam surface of the injection device of the present invention are shown. Figure 11 It shows Figure 10 The force distribution curve shown is generated by the combination of the elastic arm and the cam surface. Figure 12 Details of the curved cam surface of the injection device of the present invention are shown. Figure 13 It shows Figure 12 The force distribution curve shown is generated by the combination of the elastic arm and the cam surface. Figure 14 This illustrates another possible configuration for the cam surface and the elastic arm; Figure 15 It shows the result of Figure 14 Force distribution curve generated by the structure Figure 16 The possible configuration of the cam surface and the elastic arm is shown, wherein the frictional force exerted by the cam surface varies along its length. Figure 17 It shows the result of Figure 16 The force distribution curve generated by the structure; Figure 18a , Figure 18b and Figure 18c The movement of the elastic arm relative to a cam surface inclined toward the longitudinal axis of the injection device is shown. Figure 19a , Figure 19b and Figure 19c The movement of the elastic arm relative to a cam surface arranged in a circumferentially inclined manner is shown; Figure 20 Details of the spring structure of the injection device of the present invention are shown; and Figure 21 It shows the result of Figure 16 The force distribution curve generated by the spring structure. Detailed Implementation

[0065] The injection device 110 according to the invention is shown in Figure 4 and Figure 5 The injection device 110 has an injection device housing 112 and a longitudinal axis 101. Figure 4 and Figure 5 Only the lower half of the housing 112 is shown. The upper half of the housing 112 is omitted so that the internal mechanisms can be clearly seen.

[0066] A syringe (not shown) is housed in a housing 112. The injection device 110 includes a trigger 114 as part of an actuation mechanism. The trigger 114 is responsive about a pivot 115 from a rest position (e.g., Figure 4 (As shown) Rotate to the start position. The proximal end 114b of the trigger 114 is connected to the drive coupling 121, which is actuated by the drive spring 120. The drive coupling 121 is connected to the syringe. Both the drive coupling 121 and the drive spring 120 form part of an actuation device that allows for the delivery of the injection by acting on the syringe.

[0067] The injection device 110 includes a release mechanism 126, which is in the form of a cylindrical sleeve protruding from the distal end of the injection device 110.

[0068] In order to deliver the injection, the trigger 114 rotates about the pivot 115 in the direction R (i.e., downward into the housing 112 at its first end 114a). This causes the second end 114b of the trigger 114 to disengage from the drive coupling 121, thereby causing the drive spring 120 to drive the syringe (via the drive coupling 121) along the longitudinal axis 101 and out of the hole 118 in the housing 112.

[0069] However, when the release mechanism 126 is in its obstructed position, that is, corresponding to the release mechanism protruding from the distal end of the housing 112, the obstruction is in the form of a protrusion 154 (as shown in the image). Figure 6 The protrusion 154 (shown) is positioned to abut the lower surface of portion 150 of trigger 114. In this way, the protrusion 154 impedes rotation of the trigger, thereby impeding delivery of the injectable. For injection, the release mechanism moves to a second position, which corresponds to the release mechanism 126 moving into the housing 112 along the longitudinal axis 101. When the release mechanism is in its second position, the protrusion 154 is aligned with a notch 152 in the trigger 114. The protrusion 154 can be accommodated in the notch 152, and thus the trigger can rotate about the pivot 115 and perform delivery of the injectable.

[0070] As in Figure 6 and Figure 7 As can be seen, the release mechanism 126 is provided with a pair of cantilevered, integrally formed elastic arms 201. The elastic arms 201 are configured to be able to bend elastically toward the housing 112 and away from the housing 112.

[0071] The housing 112 includes a pair of cam surfaces 210, along which the resilient arm 201 travels when the release mechanism 126 moves from its first position to its second position. In the first position, a protrusion 154 abuts a portion 150 of the trigger 114, and in the second position, the protrusion 154 is accommodated in a cutout portion 152 of the trigger 114. (The last sentence appears to be incomplete and possibly refers to a different context.) Figure 7 As can be seen, as the release mechanism 126 moves from its first position to its second position, that is, as the release mechanism 126 moves along the longitudinal axis 101 of the injection device 110 into the housing 112, the deformation of the elastic arm 201 increases. This provides an elastic bias on the release mechanism 126 toward its first position.

[0072] Details of the possible forms of the cam surface are shown in Figure 8 In the middle. It can be seen here that the cam surface 210 includes lugs 212. These lugs 212 introduce non-linear force changes through the distance traveled by the release mechanism 126. Specifically, the lugs 212 will generate a force distribution curve in which the rate of force increase first increases and then decreases, such as... Figure 9 As shown. This nonlinear force distribution curve provides tactile feedback to the user, indicating that the release mechanism 126 has moved completely from its first position to its second position and that the injection cycle may be initiated.

[0073] Alternative forms of the cam surface are shown in Figure 10 In the middle. It can be seen here that each cam surface 210 includes three lugs 212. These three lugs 212 produce a force distribution curve with periodic ratchet-like characteristics, where the rate of force increase first increases and then decreases, then increases and decreases twice more, as shown in the figure. Figure 11 As shown.

[0074] Another possible form of the cam surface is shown in Figure 12 In this example, the cam surface does not have any lugs, but rather a continuous curved surface, which increases the rate of deformation of the elastic arm 201 as the release mechanism 126 moves from its first position to its second position. This results in... Figure 13 The force distribution curve shown depicts a force that continuously increases with distance, and the rate of increase in force also continuously increases with distance. Like other force distribution curves, this provides tactile feedback to help the user assess the progress of the release mechanism 126 from its first position to its second position.

[0075] Another possible configuration of the cam surface and the elastic arm is shown in Figure 14 In this example, when the release mechanism 126 is fully in its first position (e.g., ... Figure 14As shown), the elastic arm 201 does not contact the cam surface 210. Therefore, the initial portion of the force distribution curve represents a relatively constant force, formed by the frictional force associated with the motion release mechanism 126. Then, as the release mechanism 126 moves further toward its second position, and the elastic wall 201 engages with and travels along the cam surface 210, the force distribution curve exhibits an increasing force. The resulting force distribution curve is shown in... Figure 15 middle.

[0076] Another possible configuration of the cam surface and the elastic arm is shown in Figure 16 In this context, the elastic arm 201 remains in contact with the cam surface 210, but there is a step change in frictional force along the path of the elastic arm's movement between the elastic arm 201 and the cam surface 210. This will result in a step change in the obtained force distribution curve, such as... Figure 17 As shown.

[0077] The injection device may have a cam surface 201 inclined toward the longitudinal axis of the injection device housing, such as Figure 18a As shown. The tilt increases along the longitudinal direction of the housing. This causes the arm to move in the proximal direction along the cam surface 201, as... Figure 18b As shown, the elastic arm 210 bends toward the longitudinal axis of the housing in a two-dimensional plane. A cross-sectional view of the housing perpendicular to the longitudinal axis of the housing shows the radial direction of movement of the elastic arm 210.

[0078] Alternative forms of the cam surface are shown in Figure 19a In the middle, the cam surface 201a is arranged circumferentially inclined around the longitudinal axis of the housing and extends inward from the inner surface of the housing. Therefore, the cam surface 201a is inclined such that as the elastic arm 210 is moved into the housing, it will travel along the circumferential cam surface 201a. This causes the elastic arm 210 to deform in the circumferential direction as it moves along the cam surface, such as... Figure 19b As shown. A cross-sectional view of the outer casing perpendicular to its longitudinal axis ( Figure 19c The diagram shows the circumferential direction of movement of the elastic arm 210.

[0079] As described above, various force distribution curves can be achieved using elastic arms 201 and cam surfaces 210 with different configurations. Furthermore, force distribution curves can also be achieved through other means, such as the construction of a spring.

[0080] An example of this spring construction is shown in Figure 20The release mechanism 126 has a first pair of springs 214 and a second pair of springs 216. When the release mechanism 126 is in its first position, only the ends of the first pair of springs 214 are restricted, and thus a force can be applied against the movement of the release mechanism 126 from its first position to its second position. However, as the release mechanism 126 moves from its first position to its second position, the second pair of springs 216 engage, causing the rate of increase in force to suddenly increase as the release mechanism 126 continues to move toward its second position. This results in a non-linear force distribution curve, such as... Figure 21 As shown.

[0081] In use, the injection device described above can be used to deliver substances such as: golimumab, hormones, antitoxins, substances for pain control, substances for controlling thrombosis, substances for controlling or eliminating infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, antibodies, oligonucleotides, anti-allergy agents, antihistamines, anti-inflammatory agents, corticosteroids, disease-modifying antirheumatic drugs, erythropoietin, or vaccines for the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes, diabetic retinopathy, acute coronary syndrome, angina pectoris, myocardial infarction, atherosclerosis, cancer, macular degeneration, allergies, hay fever, inflammation, anemia, or spinal dysplasia, or for the expression of protective immunity. As those skilled in the art will appreciate, in addition to the substances described above, any medicine contained within the injection device may also contain other substances, such as inactive ingredients.

[0082] Of course, those skilled in the art will understand that certain substances are effective in treating or preventing certain conditions, as is well known in the art. For example, antihistamines are known to be effective in treating or preventing allergies; antihistamines are known to be effective in treating or preventing hay fever; anti-inflammatory agents are known to be effective in treating or preventing inflammation; and so on. Therefore, any selection of one or more substances listed herein or described in the claims for the treatment or prevention of one or more conditions is conceivable, provided that the substance is known to be effective for the one or more conditions.

[0083] However, in one specific example, golimumab is known to be effective for the treatment or prevention of one or more types of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis, or any combination of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, or all of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

[0084] Golimumab can be optionally used in combination with one or more inactive ingredients, such as any or all of L-histidine, L-histidine hydrochloride monohydrate, sorbitol, polysorbate 80, and water. Golimumab can be present in the composition, wherein golimumab is the sole active ingredient. For example, golimumab can be SIMPONI. ® Apply.

[0085] It should be understood that the invention has been described above by way of example only, and modifications to the details may be made within the scope of the invention.

Claims

1. An injection device for delivering an injectable agent, comprising: A housing having a longitudinal axis, a proximal end, and a distal end, the housing being arranged such that the injectable is delivered from the distal end of the housing; A starting device for initiating the injection; and A release mechanism including an obstacle is movable between a first position and a second position. In the first position, the obstacle is in an obstructive position to obstruct the delivery of the injection, and in the second position, the obstacle is in a non-obstructive position to not obstruct the delivery of the injection. When the obstacle is in the obstructive position, the obstacle interacts with a component of the actuation device to obstruct the actuation device and thus obstruct the delivery of the injection. When the release mechanism moves from the first position to the second position, the injection device generates an audible signal.

2. The injection device according to claim 1, wherein an auditory signal is emitted when the release mechanism reaches the second position and the obstacle is in a non-obstructive position.

3. The injection device according to claim 1, wherein the force required to move the release mechanism from the first position to the second position varies with the distance the release mechanism moves, and the variation of the required force with distance is represented by a force distribution curve, the force distribution curve being non-linear.

4. The injection device according to any one of the preceding claims, wherein the release mechanism is resiliently biased toward the first position.

5. The injection device of claim 1, wherein a component of the actuation device is a trigger configured to move to an actuation position when the obstacle is in its non-obstructive position to perform the delivery of the injection.

6. The injection device according to claim 1 or claim 5, wherein the actuation device includes a driver to provide the force required to deliver the injection.

7. The injection device according to any one of the preceding claims, wherein the release mechanism includes a movable sleeve that protrudes from the distal end of the housing and moves proximally along the longitudinal axis of the housing as the release mechanism moves from the first position to the second position.

8. The injection device of claim 7, wherein the movable sleeve protrudes from the distal end when in the first position and is flush with the housing when in the second position.

9. The injection device of claim 7 or claim 8, wherein the movable sleeve includes an elastic arm, and the housing further includes a cam surface located inside the housing, the elastic arm being configured to travel along the cam surface as the movable sleeve moves from the first position to the second position.

10. The injection device of claim 9, wherein the cam surface is configured such that when the sleeve moves from the first position to the second position, the deformation of the elastic arm increases to provide an elastic bias toward the first position.

11. The injection device of claim 10, wherein the cam surface is substantially inclined toward the longitudinal axis of the housing.

12. The injection device of claim 10, wherein the cam surface is inclined substantially circumferentially along the inner surface of the housing.

13. The injection device of claim 9, wherein the cam surface has undulations in the form of lugs or notches, wherein the undulations provide the auditory signal.

14. The injection device according to any one of the preceding claims, wherein the auditory signal is generated by the components of the injection device contacting each other.

15. The injection device of claim 14, wherein the components contact each other to form a circuit, resulting in the electronic generation of the auditory signal.

16. The injection device of claim 14, wherein the components contact each other to form a mechanical structure for generating the auditory signal.

17. The injection device according to any one of the preceding claims, wherein the injection device is configured to accommodate a syringe.

18. An injection kit comprising: The injection device according to claim 17; and syringe.

19. A method of operating an injection device according to any one of the preceding claims, comprising the following steps: Move the release mechanism from the first position toward the second position; as well as The injection is delivered after the auditory signal is detected.

20. The injection device according to any one of claims 1 to 17 or the injection kit according to claim 18, wherein the injection device or the injection kit comprises a substance selected from the group consisting of: golimumab, hormones, antitoxins, substances for controlling pain, substances for controlling thrombosis, substances for controlling or eliminating infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, antibodies, oligonucleotides, anti-allergic agents, antihistamines, anti-inflammatory agents, corticosteroids, disease-modifying antirheumatic drugs, erythropoietin, or vaccines. It may be used for the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes, diabetic retinopathy, acute coronary syndrome, angina pectoris, myocardial infarction, atherosclerosis, cancer, macular degeneration, allergies, hay fever, inflammation, anemia, or spinal dysplasia, or for the expression of protective immunity.

21. A substance selected from the group consisting of: golimumab, hormones, antitoxins, substances for controlling pain, substances for controlling thrombosis, substances for controlling or eliminating infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, antibodies, oligonucleotides, anti-allergic agents, antihistamines, anti-inflammatory agents, corticosteroids, disease-modifying antirheumatic drugs, erythropoietin, or vaccines. For use in the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes, diabetic retinopathy, acute coronary syndrome, angina pectoris, myocardial infarction, atherosclerosis, cancer, macular degeneration, allergies, hay fever, inflammation, anemia, or spinal dysplasia, or in the expression of protective immunity, by using the injection device according to any one of claims 1 to 17 or the injection kit according to claim 18.

22. An injection device for delivering a substance to a human subject via the injection device in the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes, diabetic retinopathy, acute coronary syndrome, angina pectoris, myocardial infarction, atherosclerosis, cancer, macular degeneration, allergies, hay fever, inflammation, anemia, or spinal dysplasia, or in the expression of protective immunity. The substance is selected from the group consisting of: golimumab, hormones, antitoxins, substances for pain control, substances for controlling thrombosis, substances for controlling or eliminating infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, antibodies, oligonucleotides, anti-allergy agents, antihistamines, anti-inflammatory agents, corticosteroids, disease-modifying antirheumatic drugs, erythropoietin, or vaccines. The injection device is the injection device according to any one of claims 1 to 17 or the injection kit according to claim 18.

Images