Assisted injection device for injecting a composition contained in a medical container with reduced effort - Patents.com

JP7645853B2Active Publication Date: 2025-03-14BECTON DICKINSON FRANCE SAS
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Patent Information

Application Number
JP2022178795
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2017-07-21
Filing Date
2022-11-08
Publication Date
2025-03-14
Estimated Expiration
2038-07-20

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Abstract

An assisted injection device is provided for injecting a pharmaceutical composition contained within a medical container. [Solution] An assisted injection device (1) comprising a main body (10), a piston rod (30), and a blocking system comprising locking members (50, 60, 70), the locking member being movable between a locked position that holds the piston rod (30) in a proximal resting position and a released position that allows the piston rod (30) to be moved from the proximal resting position to a distal operating position, the piston rod (30) having a proximal end (32) extending outside the main body (10), configured to be pushed distally by a user to accelerate movement of the piston rod (30) to the distal operating position when the locking members (50, 60, 70) are in the released position, and to be pulled back proximally by the user to move the piston rod (30) to the proximal resting position.
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Description

[Technical field]

[0001] The present invention relates to an assisted injection device for injecting a composition contained in a medical container, which makes the injection of the composition easier for the user who needs to exert less effort to inject the composition, especially when the composition has a high viscosity, and controls the injection flow rate during the injection. [Background technology]

[0002] Pre-filled injection devices are common containers for delivering drugs or vaccines to patients and include syringes, cartridges, auto-injectors, etc. They usually include a sealing stopper that slidingly engages within the container, which is filled with a pharmaceutical composition, thereby providing the practitioner with an injection device that is ready for use with the patient.

[0003] The container has a substantially cylindrical shape, with a proximal end that can be sealed by a sealing stopper, a distal end where the pharmaceutical composition is expelled from the container, and a peripheral wall extending between the proximal and distal ends of the container, in fact the sealing stopper is intended to slide from the proximal end of the container body towards the distal end of the container body when pressure is exerted by the piston rod, thereby expelling the drug contained in the container body.

[0004] Compared to empty injection devices that are filled with a pharmaceutical composition stored in a vial immediately prior to injection into the patient's body, the use of pre-filled injection devices leads to several advantages. In particular, by limiting the preparation before injection, pre-filled injection devices reduce medical dosing errors, minimize the risk of pathogen contamination, and increase the convenience of use for the practitioner. Furthermore, such pre-filled containers can encourage and simplify self-administration by the patient, which can reduce the cost of treatment and increase patient adherence. Finally, pre-filled injection devices reduce the loss of valuable pharmaceutical composition that usually occurs when the pharmaceutical composition is transferred from a vial to a non-pre-filled injection device. This results in a higher number of possible injections per given production batch of pharmaceutical composition, thus reducing purchasing and supply chain costs.

[0005] In certain cases, injection of the pharmaceutical composition contained in the container by a manual injection device such as a syringe can be difficult due to the force that needs to be exerted on the plunger rod to expel the composition. This occurs, for example, when the pharmaceutical composition has high viscosity and / or when the injection is performed manually by a user who cannot press the plunger rod with their fingers hard enough, for example, when suffering from rheumatoid arthritis or any type of disease that affects the user's hands or fingers. The injection can be self-administered or can be performed by the user on another person, such as a health care professional. When a health care professional performs repeated injections of a viscous drug on a patient, the repeated use of the same posture, which requires a large force to be exerted on the plunger rod to perform the injection, can cause repetitive strain injury.

[0006] Auto-injectors can assist a user in performing an automatic injection of a pharmaceutical composition. They typically include an injection button that the user must press to initiate the injection.

[0007] However, the user cannot change the injection flow rate (or injection speed) while performing an injection with an auto-injector, in other words, it is not possible to increase or decrease the injection flow rate while performing an injection.

[0008] This lack of control over the injection flow rate can cause pain and anxiety to the user and can lead to the user failing to perform the injection correctly.

[0009] Furthermore, like manual injection devices, auto-injectors can encounter difficulties in injecting highly viscous pharmaceutical compositions, primarily due to insufficient force exerted on the piston by the injection mechanism, such that the pharmaceutical composition is not expelled from the container, or is expelled very slowly.

[0010] In view of the foregoing, there is a strong need for an injection device for injecting a pharmaceutical composition contained in a medical container, which allows easier injection of the composition compared to existing injection devices, especially when the pharmaceutical composition has a high viscosity and / or when the user has reduced strength. There is also a need for such an injection device that allows the user to control the injection, especially to adjust the injection flow rate while performing the injection. Summary of the Invention [Problem to be solved by the invention]

[0011] It is therefore an object of the present invention to provide an assisted injection device for injecting a pharmaceutical composition contained in a medical container, which overcomes the drawbacks of known devices. [Means for solving the problem]

[0012] One object of the present invention is to provide an assisted injection device for injecting a composition contained in a medical container, comprising: a body adapted to receive a medical container in a fixed position relative to the body and configured to be held in a user's hand; a spring-loaded piston rod translationally movable inside the body between a proximal rest position and a distal operating position in which the piston rod engages a stopper of the medical container and pushes the stopper into the medical container; - a blocking system comprising a locking member configured to engage with a piston rod, the locking member being movable between a locked position in which the locking member holds the piston rod in a proximal rest position and a released position in which the locking member allows the piston rod to move from the proximal rest position to a distal operating position under the force of a spring; Equipped with The piston rod is an assisted injection device that includes a proximal end extending outside the body and configured to be pushed distally by a user when the locking member is in a released position to accelerate movement of the piston rod to a distal operating position.

[0013] In the present application, "distal direction" shall be understood as meaning the direction of injection relative to the medical container in which the device of the invention is mounted. The distal direction corresponds to the direction of advancement of the piston rod during injection, in which the medical composition initially contained in the medical container is expelled from the medical container. "Proximal direction" shall be understood as meaning the opposite direction of injection.

[0014] According to other optional features of the device of the present invention: the proximal rest position of the piston rod allows for the insertion of the medical container into the body; a locking member is mounted on the body, in a locked position the locking member cooperates with the body to hold the piston rod in a proximal rest position and in a released position the locking member cooperates with the body to allow the piston rod to be moved under the force of a spring from the proximal rest position to a distal operating position; the piston rod is provided with a transverse bore, the locking member being an insert that is radially inserted into the transverse bore of the piston rod in the locked position and that is removed from the transverse bore in the released position; the insert is slidable on a proximal wall of the body opposite the medical container; the proximal wall of the body comprises a cutout adapted to slidably receive an insert therein, the cutout extending radially to the piston rod and aligned with a bore in the piston rod when the piston rod is in a proximal rest position; - the peripheral wall of the body of the device is provided with a transverse opening forming a transverse passage through said body, and in the locked position the insert is inserted radially into the transverse opening of the body across a bore in the piston rod aligned with said opening, and in the released position the insert is removed from the transverse opening; - the peripheral wall of the body of the device is provided with a transverse opening forming a transverse passage through said body, and in the locked position the insert is inserted radially into the transverse opening of the body distal from the piston rod, whereby the piston rod abuts the insert, and in the released position the insert is removed from the transverse through hole; the piston rod is provided with a narrowed section, the locking member is a latch provided with at least a first hole and a second hole communicating with each other, the diameter of the first hole being smaller than the diameter of the piston rod and the diameter of the second hole being larger than the diameter of the piston rod, the latch being radially slidable between a locked position in which the first hole is aligned with the piston rod and accommodates the narrowed section of the piston rod, and an released position in which the second hole is aligned with the piston rod and is traversed by said piston rod, the latch is slidable on the proximal wall of the body opposite the medical container (40); the piston rod is provided with a toothed rack, the blocking system comprising a button mounted on the body of the device and coupled to a locking member, the wing being pivotally mounted on a structure fixed to the body, the wing being pivotally movable between a locked position, in which the button is released and the wing engages the toothed rack to block the piston rod, and a released position, in which the button is pressed and the wing disengages from the toothed rack to allow the piston rod to move, the button is advantageously a spring-loaded button, the body comprises a container holder system configured to receive at least a portion of a medical container and to hold the medical container in alignment with a direction of movement of the piston rod such that, when moving from a proximal rest position to a distal operating position, the piston rod engages a stopper of the medical container and pushes the stopper into the medical container to inject the composition; -The vessel holder system: a slot provided in a peripheral wall of the body leading to the housing configured to receive at least a portion of the medical container and maintain the medical container in a fixed position aligned with the direction of movement of the piston rod; a through groove provided in a distal wall of the body, the through groove being continuous with the slot and extending from the slot into the distal wall, the through groove being configured to guide a medical container inserted into the housing through the slot; Equipped with.

[0015] Another object of the invention is an assisted injection device assembly comprising an assisted injection device as described above and a medical container mounted thereon.

[0016] The assisted injection device assembly optionally comprises a spacer configured to be fixed to the stopper, the spacer configured to be contacted by the piston rod and pushed together with the stopper when the piston rod moves from a proximal rest position to a distal operating position. [Brief description of the drawings]

[0017] Further features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 shows an overall perspective view of an embodiment of an injection device of the invention according to a first embodiment of a blocking system. [Diagram 2] FIG. 2 is an exploded perspective view of the injection device shown in FIG. 1. [Figure 3A] FIG. 13 is a side cross-sectional view of the device, in which the blocking system blocks the piston rod in a proximal resting position. [Figure 3B] FIG. 13 is a side cross-sectional view of the device with the blocking system released and the piston rod moved to an operating position. [Figure 4] FIG. 13 is a side cross-sectional view of the device at the end of the injection. [Diagram 5] FIG. 13 is a cross-sectional perspective view of a device according to an alternative of the first embodiment of the blocking system. [Figure 6] FIG. 13 is a cross-sectional perspective view of a device according to a second embodiment of a blocking system. [Figure 7] FIG. 13 is an exploded perspective view of a device according to a third embodiment of a blocking system. [Figure 8] FIG. 8 is a perspective view of the device shown in FIG. 7, in which the blocking system blocks the piston rod in a proximal rest position. [Figure 9A] FIG. 8 is a cross-sectional view of the device shown in FIG. 7, where the blocking system blocks the piston rod in a proximal resting position. [Figure 9B] FIG. 8 is a cross-sectional view of the device shown in FIG. 7 with the blocking system released and the piston rod moved to an operating position. [Figure 10] FIG. 13 is a perspective view of a device according to a fourth embodiment of a blocking system, in which the blocking system blocks the piston rod in a proximal rest position. [Figure 11] FIG. 11 is a side cross-sectional view of the device shown in FIG. [Figure 12] 1 is a perspective view of a device according to an embodiment of a vessel holder system. [Figure 13] FIG. 13 is a side cross-sectional view of the device shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The present invention proposes an assisted injection device for injecting a composition contained in a medical container.

[0019] Prior to injection, the medical container 40 is filled with the composition intended to be injected and is stoppered with a stopper 44 inserted therein. The stoppered medical container 40 can then be mounted onto the device to form an injection device assembly to effect injection of the composition.

[0020] With reference to Figures 1 and 2, the injection device 1 comprises a body 10 extending along a longitudinal axis (A). The body 10 comprises a peripheral wall 11 including a grip surface 12 limited proximally and distally by a first flange 13 and a second flange 14, respectively, extending radially outward from the longitudinal axis (A). Thus, when moving or using the device, a user can easily grasp the body between the flanges 13, 14. The palm of the user's hand contacts the grip surface 12, and the upper and lower ends of the user's hand abut against the flanges 13, 14, thereby stabilizing the running of the device. Alternatively, the user can hold the grip surface 12 between the index and middle fingers, with both fingers abutting against the flanges 13, as one would normally hold a standard syringe. The device is thus handheld, and the dimensions and weight of the device are advantageously adapted for this purpose.

[0021] The medical container 40 comprises a body 46 including a proximal end 41 and a distal end from which extends a tip 42 and a needle 43. The needle 43 may be covered by a cap (not shown) to prevent any injury when handled prior to use.

[0022] The main body 10 includes a container holder system 20 .

[0023] According to the embodiment shown in FIG. 1 , the container holder system 20 includes a slot 21 provided in the peripheral wall 11 of the body, advantageously in the second flange 14, which leads to a housing 22 adapted to receive the proximal end 41 of the medical container 40.

[0024] The container holder system 20 further includes a through groove 23 provided in the distal wall 16 of the body, contiguous with the slot 21 and extending from the slot into the distal wall. In a practical manner, the proximal end of the medical container 40 is inserted through the slot 21 and moved radially along the groove 23 until the container 40 is in a fixed position within the housing 22 relative to the body 10. The groove separates two projections 24 against which the proximal end 41 of the medical container 40 abuts, thereby preventing the medical container 40 from falling out of the device.

[0025] To this end, the inner surface of the groove 23 contacts the body of the container 40. In particular, the groove 23 can be configured to prevent radial movement of a container 40 inserted therein unless the container is moved by a user. The groove is made of a rigid and lubricious material, for example a rigid plastic or metal (aluminum, stainless steel), to make it easier to insert the container therein and to contribute to maintaining the container in a fixed position within the housing 22 during injection.

[0026] The structure of both the slot 21 and the groove 23 may be adapted according to the type of container 40 that is intended to be plugged by the device 1 .

[0027] This embodiment is particularly useful where the medical container 40 is a syringe or the like, since the proximal end 41 of the container 40 is a flange that abuts the projection 24 .

[0028] Alternatively, if the container 40 is a cylinder or the like (without a proximal flange), the configuration of the container holder system 20 can be adapted accordingly. According to the embodiment shown in Figures 12 and 13, the dimensions of the slot 21 and the housing 22 are adapted to receive the entire body 46 of the medical container 40 inserted therein, and the tip 42 of the container 40 is moved radially along the groove 23 until it is positioned in the housing 22 where the medical container 40 is maintained in a fixed position relative to the body 10. When the container 40 is positioned in the housing 22, the shoulder 47 (between the body 46 and the tip 42) abuts the protrusion 24, thereby preventing the medical container 40 from falling out of the device 1. Advantageously, in this situation, only the tip 42 and the needle 43 of the medical container 40 protrude distally from the body 10 of the device. Of course, this embodiment can also be suitable if the medical container 40 is a syringe or the like, and the housing 22 is adapted to accommodate the flange of the medical container accordingly.

[0029] Of course, other embodiments of the container holder system are possible without departing from the scope of the present invention. For example, the medical container 40 can be inserted longitudinally through an opening provided in the distal wall of the body 10 and secured by an insert inserted radially into a slot provided in the peripheral wall 11 of the body 10.

[0030] The device 1 comprises a piston rod 30 extending within the interior volume 17 of the body 10 along an axis A. A spring 31 is disposed within the interior volume 17 in coaxial contact with the piston rod 30. In this way, the spring-loaded piston rod 30 is translationally movable inside the body 10 along the axis (A) under the force of the spring 31 between a proximal rest position and a distal operating position in which the piston rod 30 engages a stopper 44 of the medical container 40 and pushes the stopper into the medical container.

[0031] 2 and 3, the piston rod 30 advantageously comprises a radially enlarged proximal end 32 which serves as a pushing surface enabling the user to push the piston rod 30 distally with his thumb and as a handle enabling the user to pull the piston rod 30 back proximally by grasping the radially enlarged proximal end 32, e.g. to perform another injection with another container.

[0032] The injection device 1 further comprises a blocking system for holding the piston rod 30 in a proximal rest position. The blocking system comprises a locking member 50 configured to engage with the piston rod. The locking member is movable between a locked position, in which the locking member holds the piston rod 30 in the proximal rest position, and a released position, in which the locking member allows the piston rod 30 to be moved under the force of the spring 31 from the proximal rest position to a distal working position in order to perform an injection of the composition contained in the medical container 40. The blocking system is described by several embodiments in the presented documents below.

[0033] According to a first embodiment, the locking member is an insert 50 adapted to be removably inserted into a transverse bore 34 provided in the piston rod 30. The transverse bore 34 extends perpendicular to the axis (A) and is preferably a through bore extending across the piston rod. The insert 50 is represented in a non-limiting embodiment as a pin in Figures 1-5, but may be of another form, provided that the insert is able to perform its function as described.

[0034] According to a first alternative of the first embodiment shown in figures 1 to 4, the insert 50 is adapted to be slid on the proximal wall 15 of the body 10, opposite the medical container 40. Preferably, the insert 34 is adapted to be slid towards or away from the piston rod 30, in a notch 51 arranged on the proximal wall 15 of the body 10, which extends radially to the piston rod 30. In other words, the longitudinal axis (B) of the notch 51 is perpendicular to the axis (A) of the piston rod 30. If the piston rod hole 34 is a through hole, the notch 51 preferably extends on both sides of the piston rod 30 through the proximal wall 15 of the body 10 from one point to another around the proximal wall. The notch can alternatively extend only on one side of the piston rod 30 and through only a portion of the proximal wall 15 of the body 10.

[0035] 3A, when the piston rod 30 is in the proximal rest position, the transverse bore 34 of the piston rod 30 is substantially radially aligned with the proximal wall 15 of the body, and the notch 51 is radially aligned with the transverse bore 34, thus allowing the insert 50 to be inserted therein. In this position, the spring 31 is compressed and the distal end of the piston rod 30 is moved away from the stopper 44.

[0036] To perform an injection, the insert 50 is removed from the transverse hole 34 of the piston rod 30 and slid back away from the piston rod, as shown in FIG. 3B. As a result, the spring 31 translates the piston rod 30 distally from a proximal rest position to an operating position, where the piston rod 30 engages the stopper 44 and the composition is expelled from the syringe 40 via the needle 43. This movement of the piston rod 30 is due to the spring force of the spring 31, which returns the spring to a relaxed state, where it is released. Thus, the piston rod 30 can be moved without user input, thereby making the injection easier.

[0037] At the end of the injection shown in Fig. 4, the entire composition has been injected. The stopper 44 abuts the distal end 42 of the medical container 40 and the piston rod 30 cannot move any further distally. The spring 31 is at least partially in a relaxed state and a proximal portion of the piston rod 30 near its proximal end 32 remains outside the body 10, thereby allowing the user to pull the piston rod 30 back to a proximal rest position to perform a subsequent injection. The piston rod 30 is then blocked by the insert 50 and the empty medical container 40 can be removed from the container holder system and replaced by another pre-filled medical container to perform another injection.

[0038] In the following, features of the device other than the blocking system will not be described again since these features and functions are similar to those described above taking into account the structural differences of the devices according to different embodiments.

[0039] According to a second alternative of the first embodiment, shown in figure 5, the insert 50 is adapted to be slid towards or away from the piston rod 30 in a transverse opening 18 provided in the peripheral wall 11 of the body 10 forming a passage extending radially to the piston rod 30, preferably from one side of the peripheral wall 11 to the other. In other words, the longitudinal axis (B) of the transverse opening is perpendicular to the axis (A) of the piston rod 30.

[0040] When the piston rod 30 is in the proximal rest position, the transverse opening 18 is aligned with the bore 34 of the piston rod 30. The insert 50 is radially inserted into the transverse opening 18 of the body 10 and into the bore 34 of the piston rod 30, thereby maintaining the piston rod in the proximal rest position. The transverse opening 18 can be positioned in different places in the peripheral wall 11. For example, the transverse opening can be positioned between the first flange 13 and the internal volume 17 of the body 10. Alternatively, the transverse opening can be positioned in radial alignment with the internal volume 17 of the body 10 and lead to this internal volume. In this latter case, the coils of the spring are advantageously adapted to allow the insert 50 to pass through the piston rod 30 via the transverse bore 34. For example, the distance between adjacent coils of the spring is greater than the diameter of the insert 50.

[0041] To perform an injection, the insert 50 is removed from the bore 34 and the transverse opening 18 of the piston rod, allowing the piston rod 30 to be moved to a distal operating position.

[0042] According to a second embodiment shown in FIG. 6, the piston rod 30 does not comprise a transverse hole as explained above. The locking member is an insert 50 as explained in the first embodiment. The insert 50 is adapted to be slid in a transverse opening 18 provided in the peripheral wall 11 of the body 10. The transverse opening 18 has a structure similar to that of the first embodiment. This transverse opening 18 is radially aligned with and leads to the internal volume 17 of the body 10 and is positioned distally from the piston rod 30 when the piston rod 30 is in the proximal rest position. In particular, the transverse opening 18 may be provided between the second flange 14 of the body 10 and the piston rod 30 when the piston rod 30 is in the proximal rest position. When the insert 50 is inserted into the transverse opening of the body 10, the piston rod 30 is in a proximal rest position so that the insert 50 extends across the interior volume of the body 10 and the distal end 33 of the piston rod 30 abuts the insert 50, thereby maintaining the piston rod in a proximal rest position.

[0043] To perform an injection, the insert 50 is removed from the transverse opening 18. Thus, the distal end 33 of the piston rod 30 no longer abuts the insert 50 and the piston rod moves to its distal operating position.

[0044] According to a third embodiment, shown in figures 7 and 8, the piston rod 30 is provided with a narrowed section 35 having a reduced diameter compared to that of the piston rod 30. The locking member is a latch 60 provided with a first hole 61 and a second hole 62 communicating with each other. The diameter of the first hole 61 is smaller than the diameter of the piston rod 30 and is configured to accommodate only the narrowed section 35 of the piston rod. The diameter of the second hole 62 is larger than the diameter of the piston rod 30 and is configured to accommodate the piston rod.

[0045] The latch 60 is preferably radially slidable relative to the body 10 and the piston rod 30 on the proximal wall 15 of the body 10 by pushing or pulling the actuation zone 63 .

[0046] 9A, when the piston rod 30 is in the proximal rest position, the first bore 61 is aligned with the piston rod 30 and receives the narrowed section 35 of the piston rod. The piston rod abuts the latch 60, thereby maintaining it in the proximal rest position.

[0047] To perform an injection, the latch 60 is slid radially inward by pressing on the actuation zone 63, as shown in Figure 9B, thereby aligning the second hole 62 with the piston rod 30. The piston rod 30 passes through the second hole 62 and is thus moved from a proximal rest position to an operating position.

[0048] The advantage of this embodiment is that the latch remains attached to the device throughout its use and therefore cannot be lost even after the piston rod is released.

[0049] According to a fourth embodiment, shown in figures 10 and 11, the piston rod 30 is provided with a toothed rack 36. The blocking system comprises a button 71, preferably a spring-loaded button, mounted on the body 10 of the device 1 and coupled to a locking member, which is a wing 70. The wing 70 is pivotally mounted on a structure fixed to the body 10, in the form of two advantageously curved branches 72, joining the first flange 13 and the peripheral wall 11 of the body 10. The body 10 of the device is provided with a housing 73 adapted to receive the wing.

[0050] The button is released and the wings engage the toothed rack, as shown in Figure 10. The piston rod 30 is in the proximal rest position.

[0051] To perform an injection, the button 71 is pressed radially inward (as represented by the arrows) causing the wings 70 to pivot about the curved branches 72 away from the piston rod 30 and disengage from the toothed rack 36, thereby allowing the piston rod to move from a proximal resting position to an operating position.

[0052] Regardless of the embodiment of the blocking system, at the end of an injection, the device can be manually reset by the user to proceed with another injection. To do so, the piston rod 30 is pulled proximally by the user back to the proximal rest position, preferably by gripping the radially enlarged proximal end 32, and the locking member is moved to the locked position. The empty medical container 40 can then be removed from the container holder system 20 and a new filled medical container 40 can be positioned in the container holder system 20.

[0053] The spring 31 is advantageously selected depending on the viscosity of the composition to be injected and, more generally, on the difficulty of performing the injection: for example, for a highly viscous composition, a spring with a high spring force must be preferentially selected.

[0054] While performing an injection, the user can push the proximal end 32 of the piston rod 30 in the distal direction. In this case, the force applied to the piston rod 30 is a combination of the spring force and the force exerted by the user. The movement of the piston rod 30 can thus be accelerated and the injection flow rate is thus increased. When the user stops pushing the piston rod 30, it is again driven only by the spring 31.

[0055] According to the first, second and third embodiments of the device, when the locking members 50, 60, 70 are in the released position, the piston rod 30 moves in a distal direction and continues to move until the injection is completed.

[0056] According to a fourth embodiment of the device, the injection continues as long as the user keeps the button 71 pressed. When the user releases the button, the injection stops. Thus, the user can selectively start and stop the injection by pressing or releasing the button, respectively.

[0057] The injection device assembly is advantageously provided with a spacer 80 which is positioned within the container 40 in contact with the stopper 44 prior to mounting the container 40 on the device 1. The spacer 80 preferably includes a projection 81 on its distal end which is inserted into a corresponding recess 45 on the proximal end of the stopper 44, so that the stopper 44 and the spacer 80 are fixed together and slide together within the container 40 when pushed by the piston rod 30.

[0058] The spacer 80 absorbs part of the mechanical force transmitted by the piston rod 30 to the stopper 44 when the piston rod is in indirect contact with the stopper. Thus, the stopper 44 moves continuously and smoothly when pushed by the piston rod 30 through the spacer 80. To achieve this, the spacer 80 is advantageously made of a rigid material, for example plastic or metal, and its length is adapted relatively to the amount of composition contained in the medical container so as to reduce the space between the proximal end of the medical container and the surface of the composition. The smaller the amount of composition, the longer the spacer.

[0059] The proximal end of the spacer 80 is adapted to contact the distal end of the piston rod 30, and the contact surface between the spacer 80 and the piston rod 30 is preferably a flat surface, so that the mechanical force is distributed over the entire flat surface, thus improving the movement of the spacer 80 with the stopper 44.

Claims

1. An assisted injection device (1) for injecting a composition contained in a medical container (40), comprising: a unitarily constructed body (10) having a peripheral wall (11) including a gripping surface (12) defined proximally and distally by a first flange (13) and a second flange (14) extending radially outwardly from a longitudinal axis (A), the body (10) being adapted to receive a medical container (40) in a radially movable and fixed position relative to the body (10) and configured to be held in a hand of a user; a spring-loaded piston rod (30) translationally movable inside the body (10) between a proximal rest position allowing insertion of the medical container (40) into the body (10) and a distal operating position in which the piston rod (30) engages a stopper (44) of the medical container (40) and pushes the stopper (44) into the medical container (40); a blocking system comprising a locking member (50, 60, 70) mounted on said body (10) and configured to engage said piston rod, said locking member being movable between a locked position in which said locking member cooperates with said body to hold said piston rod (30) in said proximal rest position and a released position in which said locking member cooperates with said body to allow said piston rod (30) to be moved from said proximal rest position to said distal operating position under the force of said spring (31); Equipped with The piston rod (30) includes a proximal end (32) extending outside the body (10) and configured to be pushed distally by the user to accelerate movement of the piston rod (30) to the distal operating position when the locking member (50, 60, 70) is in the released position, and configured to be pulled back proximally by the user to move the piston rod (30) to the proximal rest position.

2. 2. The assisted injection device (1) of claim 1, wherein the piston rod (30) is provided with a transverse hole (34), and the locking member is an insert (50) that is radially inserted into the transverse hole (34) of the piston rod (30) when in the locked position and is removed from the transverse hole (34) when in the released position.

3. The assisted injection device (1) according to claim 2, wherein the insert (50) is slidable on a proximal wall (15) of the body (10) on the opposite side of the longitudinal axis (A) from the medical container (40).

4. 4. The assisted injection device (1) of claim 3, wherein the proximal wall (15) of the body (10) is provided with a notch (51) adapted to slidably receive the insert (50) therein, the notch (51) extending radially to the piston rod (30) and aligned with the transverse hole (34) of the piston rod (30) when the piston rod (30) is in the proximal rest position.

5. The assisted injection device (1) of claim 2, wherein the peripheral wall (11) of the body (10) of the assisted injection device (1) is provided with a transverse opening (18) forming a transverse passage through the body (10), and when in the locked position, the insert (50) is radially inserted into the transverse opening (18) of the body (10) and crosses the transverse hole (34) of the piston rod (30) aligned with the transverse opening, and when in the released position, the insert (50) is removed from the transverse opening (18).

6. 2. The assisted injection device (1) of claim 1, wherein the peripheral wall (11) of the body (10) of the assisted injection device (1) is provided with a transverse opening (18) forming a transverse passage through the body (10), and when in the locked position, the locking member (50) is inserted radially into the transverse opening (18) of the body (10) distal from the piston rod (30) so that a distal end of the piston rod abuts against the locking member (50), and when in the released position, the locking member (50) is removed from the transverse opening (18).

7. 2. The assisted injection device (1) according to claim 1, wherein the piston rod (30) is provided with a narrowed section (35), and the locking member is a latch (60) provided with at least a first hole (61) and a second hole (62) communicating with each other, the diameter of the first hole (61) being smaller than the diameter of the piston rod (30) and the diameter of the second hole (62) being larger than the diameter of the piston rod (30), and the latch (60) is radially slidable between the locked position in which the first hole (61) is aligned with the piston rod (30) and accommodates the narrowed section (35) of the piston rod (30) and the released position in which the second hole (62) is aligned with the piston rod (30) and is traversed by the piston rod.

8. The assisted injection device (1) according to claim 7, wherein the latch (60) is slidable on a proximal wall (15) of the body (10) on the opposite side of the longitudinal axis (A) to the medical container (40).

9. 2. The assisted injection device (1) according to claim 1, wherein the piston rod (30) is provided with a toothed rack (36), and the blocking system comprises a button (71) mounted on the body (10) of the assisted injection device (1) and coupled to the locking member, which is a wing (70), the wing (70) being pivotally mounted on a structure (72) fixed to the body (10), the wing (70) being pivotally movable between a locked position, in which the button (71) is released and the wing (70) engages with the toothed rack (36) to block the piston rod (30), and a released position, in which the button (71) is pressed and the wing (70) disengages from the toothed rack (36) to allow the piston rod (30) to move.

10. 10. The assisted injection device (1) according to claim 9, wherein the button (71) is a spring-loaded button.

11. 11. The assisted injection device (1) of any one of claims 1 to 10, wherein the body (10) comprises a container holder system (20) configured to receive at least a portion of the medical container (40) and to hold the medical container (40) in alignment with a direction of movement of the piston rod (30) such that, when moving from the proximal rest position to the distal operating position, the piston rod (30) engages with a stopper (44) of the medical container (40) and pushes the stopper (44) into the medical container (40) to inject the composition.

12. The container holder system (20) comprises: a slot (21) provided in a peripheral wall (11) of the body (10) leading to a housing (22) configured to receive at least a portion of the medical container (40) and maintain the medical container (40) in a fixed position aligned with the direction of movement of the piston rod (30); a through groove (23) provided in a distal wall (16) of the body (10), continuous with the slot (21) and extending from the slot (21) into the distal wall (16), the through groove (23) configured to guide the medical container (40) inserted into the housing (22) through the slot (21); Assisted injection device (1) according to claim 11, comprising:

13. 13. An assisted injection device assembly comprising an assisted injection device (1) according to any one of claims 1 to 12 and a medical container (40) mounted on the assisted injection device.

14. The assisted injection device assembly of claim 13, further comprising a spacer (80) configured to be fixed to the stopper (44), the spacer (80) being configured to be contacted by the piston rod (30) and pushed together with the stopper (44) when the piston rod (30) moves from the proximal rest position to the distal operating position.

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