System for testing and image acquisition of medical injection devices
Patent Information
- Application Number
- CN202580023706.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-01-26
- Filing Date
- 2025-01-17
- Publication Date
- 2026-10-30
Smart Images
Figure CN123022449A_ABST
Abstract
Description
Cross-references to related applications
[0001] This application claims priority to European Patent Application No. 24305141.4, filed on January 26, 2024, entitled “System for Testing and Image Acquisition of a Medical Injection Device,” the disclosure of which is incorporated herein by reference in its entirety.
[0002] Background of the Invention Field of the Invention This disclosure generally relates to syringes, and more specifically to syringe systems used in manufacturing syringe barrels having a baked silicone coating thereon, the system supporting the syringe barrel to prevent or minimize syringe barrel tip weakening that may occur during the baking process at the syringe barrel tip.
[0003] Description of related technologies Syringes are used to administer fluids, such as drugs or other medications, to patients in various settings. Syringes typically include a glass (or plastic) syringe barrel and a plunger assembly, the syringe barrel having an opening at its distal end through which the plunger assembly is inserted. The distal end of the syringe barrel may include an end through which the opening is formed. In some embodiments, the end may be configured as a Luer connection allowing fluid to flow out of or into the syringe barrel, while in other embodiments, the end may be configured as a hub to retain a needle for use with the syringe. The plunger assembly typically includes an elongated plunger rod extending from the barrel and a plunger head or stop disposed at the distal end of the plunger rod. The stop is typically made of an elastomeric material and is adapted to ensure the container closure integrity of the syringe when the stop is inserted into the syringe.
[0004] The plunger assembly is movable within the syringe barrel to force fluid out of and / or draw fluid into the internal volume of the syringe barrel—when the plunger assembly is actuated by the user, a stop slides through the barrel. To improve the sliding of the stop within the barrel, it is known in the art to lubricate the barrel with a lubricant coating, such as a silicone coating as a primary example. This coating can be deposited on the inner wall of the barrel by spraying, immersion, or other suitable application techniques. Siliconization of the inner wall of the syringe barrel allows the stop to move or slide smoothly within the cavity.
[0005] As is known in the art, syringes typically include a rigid end cap or needle shield to maintain the sterility of the syringe tip and, where the tip includes a needle, to provide protection against accidental needlesticking. The end cap can be removed from the syringe by applying a pulling force (i.e., a “pull-out force”), and it is desirable that the end cap be removed in a predictable and consistent manner. In some known syringes, the end cap is designed to include a brittle feature that can break during removal, providing evidence of syringe tampering or previous use.
[0006] Regarding the syringe described above, it is desirable to provide tests for such syringes, and in particular, tests regarding the interaction of the various components of the syringe during their use. As a primary example, it is desirable to test and analyze how the stop moves within the syringe barrel during actuation / movement of the plunger assembly (e.g., deformation of the stop, characteristics / reaction of the lubricant layer, etc.) and / or how the end cap reacts when pulled away from the syringe (e.g., deformation of the end cap and / or breakage of its brittle features). Such testing of the syringe may include acquiring a series of images of the syringe during component movement and / or actuation, which may include capturing video images and / or X-ray images (or images at other wavelengths) of the syringe.
[0007] The testing and associated image capture of the syringe, as described above, can be achieved using specialized tools. These tools can be designed to ensure the stability of the syringe during testing (which could otherwise interfere with / distort the captured image) and allow image acquisition of the syringe without interference from the tool's features / components. However, it should be recognized that certain constraints can be imposed on the tool depending on the tests and analyses being performed. For example, in cases where it is desired to perform syringe testing and acquire associated X-ray images of the syringe during testing, constraints can be imposed on the tool regarding the materials used therein and the protection provided with them, allowing the use of X-ray imaging devices during testing. Such constraints can raise challenges regarding how to design and operate the tool.
[0008] Therefore, there is a need in the art to provide tools for acquiring images of syringes during testing, including X-ray images and / or other video images. The tool should provide its remote operation, such as potentially involving actuating the syringe during testing. The tool should be multifunctional to enable testing of various types / sizes of syringes and to be used to test different components of the syringe, for example, it may be desirable to use it for tests associated with the movement of the plunger assembly and / or the removal of the end cap.
[0009] Summary of the Invention This document provides a system for testing a medical injection device. The system includes a testing apparatus configured to hold the medical injection device for testing. The testing apparatus includes an open frame comprising a bottom base, a top support vertically spaced from the bottom base and configured to secure a first portion of the medical injection device, and a side rail member extending between the top support and the bottom base. The testing apparatus also includes a guide rail extending vertically between the top support and the bottom base, a retainer movable relative to the frame along the guide rail and the side rail member and configured to secure a second portion of the medical injection device, and an actuator coupled to the frame and configured to move the retainer along the guide rail in an upward and downward direction, the movement of the retainer causing relative movement between the second and first portions of the medical injection device. The system also includes an x-ray imaging system configured to acquire x-ray images of the medical injection device to capture the relative movement between the second and first portions of the medical injection device.
[0010] In some configurations, the system also includes an X-ray shielding enclosure positioned around the test equipment and the X-ray imaging system.
[0011] In some configurations, the system also includes a loading device configured to provide the medical injection device to the test equipment and transfer the medical injection device to the retainer.
[0012] In some configurations, the system also includes a remote controller configured to control the operation of the actuator.
[0013] In some configurations, the remote controller includes: a first control input for controlling the movement of the retainer in the upward and downward directions; and a second control input for controlling the speed of the retainer as it moves along the guide rail.
[0014] In some configurations, the actuator includes: an outer sleeve; an extension rod movable within the outer sleeve, the bottom end of the extension rod engaging the retainer; and a servo motor configured to linearly move the extension rod into and out of the outer sleeve to move the retainer in the upward and downward directions.
[0015] In some configurations, the test equipment includes a pair of stops positioned on the side rail member and configured to limit the range of movement of the retainer along the side rail member in the upward and downward directions.
[0016] In some configurations, the top support includes a retaining groove formed therein, through which the first portion of the medical injection device is secured to the top support.
[0017] In some configurations, the test apparatus includes a fluid collector positioned on the bottom base, the fluid collector being configured to collect fluid discharged from the medical injection device during testing.
[0018] In some configurations, the medical injection device includes a syringe, wherein the first part is a plunger assembly and the second part is a syringe barrel.
[0019] In some configurations, the test apparatus includes a cap retainer configured to receive and hold the end cap of the syringe therein, the cap retainer being fixed to the bottom base of the frame.
[0020] In some configurations, the cap retainer includes a consumable insert with a cavity formed therein, the cavity being sized to receive the end cap, and wherein an adhesive is provided in the cavity to bond the end cap to the cap retainer when the end cap is positioned within the cavity.
[0021] In some configurations, the x-ray imaging system is configured to capture two-dimensional dynamic x-ray video of the medical injection device during testing.
[0022] This document also provides a method for testing a medical injection device, the method using a system as previously described, including a testing device and an X-ray imaging system. The method includes supplying the medical injection device to the testing device, performing a test on the medical injection device by operating the actuator to move the retainer and thus move the second portion of the medical injection device, and acquiring an X-ray image of the syringe during the movement of the second portion of the medical injection device.
[0023] In some configurations, the medical injection device includes a syringe, and performing the test includes performing a sliding test in which the syringe barrel of the syringe moves relative to the plunger assembly of the syringe, causing a stop of the plunger assembly to slide within the syringe barrel, and an X-ray image of the interaction between the stop and the syringe barrel is acquired.
[0024] In some configurations, the medical injection device includes a syringe, and performing the test includes performing a pull-out test in which the end cap of the syringe is pulled away from the syringe barrel, and an X-ray image of the end cap being removed from the syringe barrel is acquired.
[0025] Brief description of the attached figures Figure 1 This is a perspective view of a syringe that can be used with embodiments of the present disclosure; Figure 2 yes Figure 1 An exploded view of the syringe; Figure 3 This is for testing medical injection devices (e.g., according to the non-limiting embodiments described herein). Figure 1 A block diagram of a system (containing a syringe); Figure 4 The inclusion of the non-limiting embodiments described herein is a subset of the embodiments described herein. Figure 3 A front-view stereoscopic view of the test equipment in the system; Figure 5 yes Figure 3 A rear-view stereoscopic view of the testing equipment; Figure 6 yes Figure 3 Front elevation view of the testing equipment; Figure 7 yes Figure 3 Rear elevation view of the testing equipment; Figure 8 It is included according to another non-limiting embodiment described herein. Figure 3 A front-view stereoscopic view of the test equipment in the system; and Figure 9 yes Figure 8 Detailed view of area A.
[0026] Specific embodiments of the present invention The following description is provided to enable those skilled in the art to produce and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.
[0027] In the following text, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the present invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may take various alternative variations unless explicitly stated otherwise. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical features associated with the embodiments disclosed herein should not be considered limiting.
[0028] In this disclosure, the distal end of a component or device refers to the end furthest from the user's hand when the component or device is in the use position (i.e., when the user is holding the syringe during preparation or use), and the proximal end refers to the end closest to the user's hand when the component or device is in the use position (i.e., when the user is holding the syringe during preparation or use). Similarly, in this application, the terms "in the distal direction" and "towards the distal end" refer to a direction toward the distal end of the syringe, while the terms "in the proximal direction" and "towards the proximal end" refer to a direction opposite to the direction of the distal end of the syringe.
[0029] refer to Figure 1 and Figure 2 This illustration shows a non-limiting embodiment of a medical injection device 10, which may be, for example, a syringe or pre-filled syringe implemented with aspects or embodiments of this disclosure. Although the medical injection device is shown and described below as syringe 10, it should be recognized that other medical injection devices (e.g., those that may be incorporated into aspects of this disclosure, as detailed below) are also possible.
[0030] like Figure 1 and Figure 2 As shown, the syringe 10 generally includes a syringe barrel 12 and a plunger assembly 14. The plunger assembly 14 is movable within the syringe barrel 12 along a longitudinal axis to an advance position to facilitate, for example, administration of an injectable fluid (e.g., a drug) to a patient. The syringe barrel 12 is formed by a generally cylindrical outer wall 16 and an end member 18, which together define a cavity 20 for retaining fluid therein. The syringe barrel 12 includes an open proximal end 22 and a distal end 24, the proximal end being configured to receive the plunger assembly 14 therein, and the end member 18 being positioned at the distal end. The proximal end 22 of the syringe barrel 12 may include a flange 26 to facilitate manipulation and positioning of the syringe 10 and to maintain the relative position of the syringe barrel 12 with respect to the plunger assembly 14 during drug administration. At the distal end 24, the end member 18 may include a shoulder 28 that narrows relative to the cylindrical outer wall 16, and a hub 30 extending distally from the shoulder 28. The hub 30 is formed as a partially hollow member that defines a channel 32 through which it is in fluid communication with the cavity 20. In some embodiments, the needle 34 is attached to the hub 30 within the channel 32, for example, by adhesive or other means. In other embodiments, it should be appreciated that the syringe 10 may alternatively include a Luer connection formed at the distal end 24 of the syringe barrel 12—instead of the needle 34—that allows the syringe 10 to be directly coupled to a Luer connection of an associated medical device or component to provide direct fluid transfer between the syringe and the associated medical device.
[0031] The plunger assembly 14 of the syringe 10 is formed by an elongated plunger rod 36 (more generally, "plunger 36", as used below) and a plunger head or stop 38. The plunger 36 may include a body 40 extending between a proximal plunger end 42 and a distal plunger end 44. In some embodiments, the body 40 may include a plurality of elongated blades or walls 46 extending axially along the length of the body between the proximal plunger end 42 and the distal plunger end 44. A thumb press 48 is positioned at the proximal plunger end 42, which can be engaged by a user's thumb (or other finger) to apply a distally directed force to the plunger assembly 14 to move the plunger 36 relative to the syringe barrel 12. In some embodiments, a flange extension 50 (e.g., a disc-shaped flange) is positioned at the distal plunger end 44, the flange extension being configured to engage with the stop 38. In other embodiments, the distal end 44 of the plunger may include a concave receiving portion formed therein, the concave receiving portion being configured to receive and connect to a protrusion (e.g., a pin) extending proximally from the stop, the protrusion and the receiving portion being engaged, for example, via a threaded connection.
[0032] A stop 38 of the plunger assembly 14 is positioned at the distal end 44 of the plunger so as to be movable together with the plunger 36 within the cavity 20 of the syringe barrel 12. The stop 38 may be made of a material different from that of the plunger 36, and is capable of forming a tight seal with the syringe barrel 12 when the stop is advanced through it. In some embodiments, the stop 38 includes a receiver (not shown) formed therein, the receiver being sized and configured to receive a flange extension 50 of the plunger 36, the flange extension 50 being coupled to the receiver via, for example, a press-fit connection to secure the stop 38 to the plunger 36; however, it is understood that the stop 38 and the distal end 44 of the plunger can be secured using other techniques known in the art.
[0033] like Figure 1 and Figure 2 As shown, and still as Figure 3 As shown, the syringe 10 also includes an end cap 60, which can be coupled to the hub 30 of the syringe barrel 12. Although in Figure 1 and Figure 2The diagram shows a needle shield for protecting the needle 34, but the end cap 60 can alternatively be configured as a cap covering the Luer connection. In embodiments where the end cap 60 is configured as a needle shield, the end cap 60 may consist of a rigid outer shell 62 providing the structure of the end cap 60 and a compliant inner shell 64 surrounding the needle 34 (when the needle shield 60 is coupled to the syringe barrel 12). In various embodiments, the outer shell 62 may be made of a rigid material, while the inner shell 64 may be made of a deformable material (e.g., rubber). As is known in the art, the end cap 60 can be removed from the hub 30 of the syringe barrel 12 by applying a pull-out force to the end cap 60 in a direction away from the syringe barrel 12—this pull-out force is the force required to remove the needle shield from the hub 30 and from the needle 34. According to embodiments, the formulation of the soft parts of the needle shield and / or the amount and location of contact between the soft parts and the syringe barrel may affect the amount of pull-out force required to remove the needle shield.
[0034] According to several aspects of this disclosure, a system is provided that allows for the performance of tests on medical injection devices (e.g., syringe 10). This system allows for testing of the syringe involving the interaction of syringe components during syringe use. As an example, tests can be performed on the movement of a stop within the syringe barrel during actuation / movement of the plunger assembly to analyze deformation of the stop, characteristics / reaction of the lubricant layer, etc. As another example, tests can be performed on the reaction to removal of the end cap from the syringe to analyze deformation of the end cap, breakage of brittle features on the end cap, or pull-out force required to remove the end cap. Testing of the syringe may include acquiring a series of images of the syringe during movement and / or actuation of syringe components, which may include capturing video images and / or X-ray images of the syringe.
[0035] Now for reference Figure 3 A block diagram of a system 70 according to a non-limiting embodiment is provided, by which testing of a syringe 10 can be performed. System 70 includes: a test device 72 by which testing of the syringe 10 can be performed; a closure 74 in which the test device 72 is housed; a loading device 76 for providing / loading the syringe 10 into the test device 72; and a control device 78 providing remote operation of the test device 72 (“remote controller 78”). The test device 72 may further include a tool 80 providing holding and actuation / movement of the syringe 10; together with an imaging device 82, which allows capturing images or videos of the syringe 10 during testing.
[0036] According to one aspect of this disclosure, the imaging device 82 included in the test apparatus 72 is an x-ray imaging device that provides the capture of a two-dimensional dynamic x-ray video of the syringe 10 during testing. The x-ray imaging device 82 may include an arrangement of an x-ray source 84 and an x-ray detector 86 that provides the capture of such a two-dimensional dynamic x-ray video, the x-ray source 84 and the x-ray detector 86 being suitably positioned relative to the tool 80 to enable the capture of such x-ray video during testing. The x-ray imaging device 82 (together with the tool 80) is housed within a closure 74, which, according to embodiments, may include a lead-containing closure to prevent exposure of the user of the system 70 to x-ray radiation. In some embodiments, the imaging device 82 may be configured to acquire other types of images or videos (besides x-ray images / videos); a high-resolution video recorder is a non-limiting example.
[0037] In some embodiments, the syringe loading device 76 may include a robotic arm or device that provides automated loading of the syringe 10 into the test device 72. The loading device 76 operates to provide the syringe 10 through an opening in the closure 74 to the test device 72 (i.e., to the tool 80) to enable testing of the syringe 10.
[0038] Now for reference Figures 4 to 7 The tool 80 of the test apparatus 72 according to an embodiment of the present disclosure is shown in more detail. The tool 80 includes a frame 88 having a bottom base 90, a top support 92 vertically spaced from the bottom base 90, and a side rail member 94 extending between the top support 92 and the bottom base 90. The tool 80 also includes a guide rail 96 extending vertically between the top support 92 and the bottom base 90, a (syringe) retainer 98 mounted on and movable along the guide rail relative to the frame 88, and an actuator 100 coupled to the frame 88 and configured to move the retainer 98 along the guide rail 96. According to one aspect of the present disclosure, components of the tool 80 are formed of a non-metallic material suitable for use with the imaging device 82 of the test apparatus 72 (i.e., compatible with an X-ray imaging device). Therefore, in some embodiments, the tool 80 may be formed of a polymeric material or other suitable composite material that does not interfere with the acquisition of X-ray images of the syringe 10 during testing.
[0039] like Figures 4 to 7As shown, the frame 88 of the tool 80 is configured as a generally open frame 88, which provides visibility of the syringe 10 when positioned in / on the tool 80. The bottom base 90 may include a generally flat or planar base, side rail members 94 positioned on opposite sides of the base 90, and a top support 92 positioned above these side rail members 94—the frame 88 thus forms a window-type opening 102 in which guide rails 96 and retainers 98 are arranged. The window-type opening 102 defined by the frame 88 allows images of the syringe 10 to be acquired during testing (by the imaging device 82) without the frame 88 interfering with such image acquisition, for example, by enabling the x-ray source 84 and x-ray detector 86 to be positioned on opposite front and rear sides of the tool 80, without any part of the tool 88 being positioned between the syringe 10 and the source 84 and / or detector 86.
[0040] In some embodiments, the top support 92 of the frame 88 may be configured as a triangular member having a bottom leg 104 and side legs 106. The bottom leg 104 of the top support 92 engages with the top of the side rail member 94 and is arranged parallel to the bottom base 90 of the frame 88, and the side legs 106 extend upward from the bottom leg 104 at an angle and intersect at the upper end or point 108 of the top support 92. The side legs 106 of the top support 92 may enable connection to the tool 80, for example, by including a power plug 110 on one of these side legs 106, through which power can be supplied to the tool 80 (i.e., to the actuator 100). The bottom leg 104 of the top support 92 may be configured to include a groove or receiving portion 112 on its front surface, the groove or receiving portion being configured to receive and retain a portion of the syringe 10. Specifically, the thumb press 48 at the proximal end 42 of the plunger rod 36 can be positioned within a groove 112 in the bottom leg 104, so that the plunger rod 36 can remain stationary during actuation and testing of the syringe 10.
[0041] like Figure 5 and Figure 7As best illustrated, actuator 100 is fixed to the top support 92 of frame 88 and also to retainer 98. Actuator 100 can be any suitable actuator of any type that can perform linear movement of retainer 98; as a non-limiting example, actuator 100 is configured as an electric or hydraulic actuator. In an exemplary embodiment, actuator 100 includes servo motor 114 that provides precise control of the linear position of retainer 98, and (optionally) precise control of the speed and acceleration of retainer 98—servo motor 114 controls the positioning / length of extension rod 116 coupled between the motor and retainer 98. Servo motor 114 is a closed-loop servo mechanism that uses position feedback to control its movement and the positioning of retainer 98. In one example, servo motor 114 is paired with a position encoder, such as potentiometer 118, to provide position (and optionally, speed) feedback for controlling the operation of servo motor. Servo motor 114 can be attached to frame 88 at the upper end or point 108 of top support 92. Extension rod 116 is positioned below servo motor 114, within sleeve 120, and moves vertically in and out of sleeve 120. The bottom end of extension rod 116 is coupled to retainer 98, such that extension rod 116 extending from and / or retracting from sleeve 120 causes vertical movement of retainer 98 and the portion of syringe 10 held by retainer.
[0042] As previously stated, the retainer 98 of the test apparatus 72 is movable along the guide rail 96 in response to the operation of the actuator 100. The retainer 98 includes a body 122, a protrusion 124 extending upward from the body 122 (to which the extension rod 116 of the actuator 100 is fixed), and a pair of rollers 126 positioned at opposite ends of the body 122. Figure 6 Roller 126 is configured to engage the side track member 94 of frame 88 to provide movement of retainer 98 along side track member 94. In some embodiments, roller 126 may include circumferential grooves or protrusions formed thereon that engage and cooperate with corresponding tracks formed on side track member 94 to provide smooth translation of retainer 98 along side track member 94. In some embodiments, upper and lower stops 128 may be provided on side track member 94 to limit the range of movement of retainer 98 relative to frame 88. Stops 128 may be fixed to side track member 94 at desired locations and are used to contact roller 126 of retainer 98 and prevent further movement of roller along side track member 94. The stop 128 can be fixed to the side rail member 94 at a desired position on the side rail member to set the range of movement of the retainer 98. It is understood that the positioning of the stop 128 (and the desired range of movement of the retainer 98) can be determined by the type / size of the syringe 10 being tested and / or the type of test being performed by the system 70.
[0043] The body 122 of the retainer 98 includes a pair of channels 130 formed therein, extending from the top end of the body through the body 122 to the bottom end of the body, the channels 130 being positioned to receive the guide rail 96 of the tool 80 therein. In some embodiments, a bushing 132 may be included within the channels 130 to limit wear / friction between the retainer 98 and the guide rail 96. The channels 130 (and bushing 132) are configured to allow the body 122 to slide along the guide rail 96 with minimal friction, while providing stability of the retainer 98 on the guide rail 96 and preventing wobbling or other horizontal movement of the body 122 relative to the guide rail 96.
[0044] The body 122 of the retainer 98 also includes a syringe retaining region 132, which is centered on the body 122 and aligned with the extension rod 116 of the actuator 100. The retaining region 132 is formed in the front surface 134 of the body 122 and includes a central receiving portion 136 extending vertically through the body 122 and an upper groove 138 arranged generally orthogonally to the central receiving portion 136. The central receiving portion 136 is configured to provide positioning of the syringe barrel 12 therein, which extends from the bottom of the body 122 when positioned within the central receiving portion 136. The upper groove 138 formed in the body 122 is configured to receive a removable retainer 140 of the retainer 98 that holds the syringe barrel 12 therein, and recesses on opposite sides of the upper groove 138 are configured to retain flanges of the retainer 140 therein to secure the retainer 140 to the body 122. The retainer 140 includes an opening 142 formed therethrough, aligned with a central receiving portion 136, the opening 142 having a diameter approximately equal to the diameter of the barrel 12 of the syringe 10—allowing the barrel 12 to be received snugly within the opening 142. The retainer 140 also includes a seat 144 formed around the opening 142 on its upper surface, the seat 144 being sized to receive a flange 26 formed at the proximal end 22 of the syringe barrel 12. It will be appreciated that the removable retainer 140 can be customized to receive a syringe (barrel) of a specific size to be tested by the testing device 72, the dimensions of the opening 142 and the seat 144 varying depending on the syringe 10 being tested (e.g., a 10 mL syringe versus a 1 mL to 3 mL syringe). When testing of a syringe 10 of another size is desired, the retainer 140 can be selectively replaced with another retainer 140 to provide flexibility / adaptability within the testing device 72 for testing a variety of syringes and other medical injection devices. To facilitate the removal of the retainer 140, a front flange 146 may be provided on the front end / edge of the retainer 140—the front flange 146 allows the retainer 140 to be gripped and pulled out from the upper slot 138 of the body 122.
[0045] According to several aspects of this disclosure, the test apparatus 72 can be used to perform activation and sliding tests, wherein the plunger assembly 14 is moved relative to the syringe barrel 12 such that the stop 38 slides within the syringe barrel 12, and the interaction between the stop and the syringe barrel can be tested and observed. With the retainer 98 and frame 88 configured as described above, the syringe 10 positioned in the test apparatus 72 will have its barrel 12 secured within the retainer 98 (where the retainer 140 receives the syringe barrel 12) and its plunger assembly 14 secured to the frame 88 (where a groove 112 in the top support 92 receives the thumb press 48 of the plunger rod 36). By operation of the actuator 100, the syringe barrel 12 and plunger assembly 14 can be moved relative to each other, for example, by repositioning / moving the syringe barrel 12 upwards or downwards while the plunger rod 36 remains in a fixed position. During the movement of the syringe barrel 12 relative to the plunger assembly 14 (and the stop 38), the imaging device 82 can acquire multiple images or dynamic videos of the movement, such as a two-dimensional dynamic X-ray video of the syringe 10 as the stop 38 moves within the syringe barrel 12.
[0046] In some embodiments, where the syringe 10 being tested is configured as a pre-filled syringe containing a drug or other fluid within a cavity 20 of the syringe barrel 12, a fluid collector 148 may be provided as part of the test device 72 to capture / collect fluid dispensed from the syringe 10 during testing. The fluid collector 148 may have a bowl-shaped configuration and may be positioned on the top surface of the bottom base 90—the fluid collector 148 is centered on the bottom base 90 and extends generally between the guide rails 96 of the test device 72. As the plunger assembly 14 and the stop 38 move further into the cavity of the syringe barrel 12 during testing (in response to movement via the retainer 98 of the actuator 100), fluid is dispensed from the cavity 20 of the syringe barrel 12, and the fluid is captured and retained by the fluid collector 148, thereby preventing fluid spillage into other areas of the test device 72 and / or the closure 74.
[0047] As described above, system 70 includes a control device 78 (i.e., a remote controller 78) that provides remote operation of test equipment 72. The remote controller 78 can be configured to send commands to actuator 100 to control its operation, for example, by controlling the operation of servo motor 114 to achieve linear translation of retainer 98 and thereby actuate syringe 10. Figure 3As shown, the remote controller 78 may include a plurality of input devices 150, 152 thereon, which can be used to control the operation of the actuator 100 and / or other components of the system 70 (e.g., the syringe loading device 76). In one embodiment, the input devices 150, 152 may include a toggle switch 150 and a rotatable knob 152 for controlling the actuator 100. The toggle switch 150 can control the upward and downward movement of the retainer 98 to selectively actuate the syringe 10. Movement of the toggle switch 150 in a first direction causes the actuator 100 to move the retainer 98 of the test device 72 in a downward direction, and movement of the toggle switch 150 in a second direction causes the actuator 100 to move the retainer 98 of the test device 72 in an upward direction. The rotatable knob 152 can control the speed at which the actuator 100 moves the retainer 98 in the upward and downward directions. Rotation of the knob in the first direction causes the actuator 100 to increase the translational speed of the retainer 98, and rotation of the knob in the second direction causes the actuator 100 to decrease the translational speed of the retainer 98.
[0048] Now for reference Figure 8 and Figure 9 This illustrates a tool 154 for testing apparatus 72 according to another embodiment of the present disclosure. Tool 154 and Figures 4 to 7 The tool 80 is substantially similar, except that tool 154 is specifically configured to perform a pullout force (POF) test required to remove the end cap 60 from the syringe 10. To enable the POF test on the syringe 10, tool 154 also includes a cap retainer 156 capable of securing the end cap 60 of the syringe 10 therein—then the actuator 100 and retainer 98 are used to pull the syringe barrel 12 away from the end cap while the end cap 60 is secured in the cap retainer 156, thereby detaching the end cap 60 from the syringe barrel 12.
[0049] like Figure 8 and Figure 9 As shown, the cap retaining device 156 may include a retaining fastener 158 secured to the bottom base 90 of the frame 88, for example, via suitable fasteners. In some embodiments, the retaining fastener 158 may be positioned within a fluid collector 148, which may remain in place on the bottom base 90, while in other embodiments, the retaining fastener 158 may be secured directly or indirectly (via another fastener plate) to the bottom base 90. The retaining fastener 158 may include a generally cylindrical member including a groove 160 formed toward its upper end, the groove 160 being formed through / around a portion of the circumference of the cylindrical member.
[0050] According to various aspects of this disclosure, the retainer 158 (i.e., the groove 160 formed therein) receives a consumable insert 162, which is configured to secure the end cap 60 therein. Figure 9 As best shown, the consumable insert 162 may include a cylindrical top portion 164 together with a bottom portion 168, the cylindrical top portion having an opening or cavity 166 formed in its top surface, the bottom portion being in the form of an annular flange vertically separated from the cylindrical top portion 164 by a gap. The bottom annular flange 168 is sized and configured to engage a groove 160 formed in the upper end of the retainer 158, such that the consumable insert 162 can be secured to the retainer 158 and to the entire frame 88 of the tool 154. The cavity 166 formed in the cylindrical top portion 164 is sized and configured to receive the end cap 60 of the syringe 10 therein—the cavity 166 thus having a diameter similar to that of the end cap 60. The cavity 166 includes an adhesive that can be used to secure the end cap 60 to the cap retainer 156 when the end cap 60 is positioned in the cavity 166. The adhesive may be a fast-drying or fast-bonding adhesive that can bond with the end cap 60 when it is placed in the cavity 166, thereby securing the end cap 60 to the consumable insert 162.
[0051] During POF testing, the test apparatus 72 can be initially operated such that the actuator 100 causes the retainer 98 to move downward, thereby moving the syringe barrel 12 and the end cap 60 downward until the end cap 60 engages the cap retainer 156. Specifically, the syringe barrel 12 and the end cap 60 move downward until the end cap 60 is positioned within the cavity 166 of the consumable insert 162. When the adhesive within the cavity 166 binds to the end cap 60 to secure it to the consumable insert 162, the test apparatus 72 can be operated such that the actuator 100 causes the retainer 98 to move upward, thereby applying a pulling force to the syringe barrel 12 in a direction away from the cap retainer 156. As the syringe barrel 12 is pulled away from the cap retainer 156 (and the end cap 60 held therein), the end cap 60 is detached from the syringe barrel 12. During the separation of the syringe barrel 12 from the end cap 60, the imaging device 82 can acquire multiple images or dynamic videos of this movement, such as a two-dimensional dynamic X-ray video of the syringe as the end cap 60 is removed from the syringe barrel 12. Therefore, POF testing can be performed via... Figure 8 and Figure 9 The tool shown, 154, is executed.
[0052] Advantageously, embodiments of the invention thus provide a system for testing medical injection devices (e.g., syringes). The system includes a testing device and associated tools that provide image acquisition of the syringe during testing, including X-ray images and / or other video images. The tools are versatile to enable testing of syringes of various types / sizes and for testing different components of the syringe, such as tests potentially associated with movement of the plunger assembly and / or removal of the end cap. The system provides remote operation of the testing device, potentially involving actuation of the syringe during testing.
[0053] While this disclosure has been described in detail for illustrative purposes, based on embodiments or aspects currently considered to be most practical and preferred, it should be understood that such detail is for this purpose only, and that this disclosure is not limited to the disclosed embodiments or aspects. Rather, this disclosure is intended to cover modifications and equivalent arrangements falling within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.
Claims
1. A system for testing medical injection devices, the system comprising: Testing equipment, configured to hold the medical injection device for testing the medical injection device, the testing equipment comprising: An open frame, the frame comprising: Bottom base; A top support member, vertically spaced from the bottom base, configured to secure a first portion of the medical injection device; and A side track member extending between the top support and the bottom base; A guide rail that extends vertically between the top support and the bottom base; A retainer, movable relative to the frame along the guide rail and the side rail member, the retainer being configured to secure a second portion of the medical injection device; and An actuator, coupled to the frame and configured to move the retainer along the guide rail in an upward and downward direction, the movement of the retainer causing relative movement between the second and first portions of the medical injection device; and An x-ray imaging system configured to acquire x-ray images of the medical injection device in order to capture the relative movement between the second and first portions of the medical injection device.
2. The system of claim 1 further includes an X-ray shielding enclosure positioned around the test equipment and the X-ray imaging system.
3. The system of claim 2 further includes a loading device configured to provide the medical injection device to the test equipment and to transfer the medical injection device to the retainer.
4. The system of claim 1 further includes a remote controller configured to control the operation of the actuator.
5. The system according to claim 4, wherein, The remote controller includes: A first control input terminal is used to control the movement of the retainer in the upward and downward directions; and The second control input is used to control the speed of the retainer as it moves along the guide rail.
6. The system according to claim 3, wherein, The actuator includes: Outerwear; An extension rod, movable within the outer sleeve, the bottom end of the extension rod engaging with the retainer; and A servo motor configured to linearly move the extension rod into and out of the outer sleeve to move the retainer in the upward and downward directions.
7. The system according to claim 1, wherein, The testing equipment also includes a pair of stops positioned on the side rail member and configured to limit the range of movement of the retainer along the side rail member in the upward and downward directions.
8. The system according to claim 1, wherein, The top support includes a retaining groove formed therein, through which the first portion of the medical injection device is secured to the top support.
9. The system according to claim 1, wherein, The testing equipment also includes a fluid collector positioned on the bottom base, the fluid collector being configured to collect fluid discharged from the medical injection device during testing of the medical injection device.
10. The system according to claim 1, wherein, The medical injection device includes a syringe, wherein the first part is a plunger assembly and the second part is a syringe barrel.
11. The system according to claim 10, wherein, The testing equipment also includes a cap retainer configured to receive and retain the end cap of the syringe therein, the cap retainer being fixed to the bottom base of the frame.
12. The system according to claim 11, wherein, The cap retaining device includes a consumable insert having a cavity formed therein, the cavity being sized to receive the end cap, and wherein an adhesive is provided in the cavity, the adhesive binding the end cap to the cap retaining device when the end cap is positioned within the cavity.
13. The system according to claim 1, wherein, The x-ray imaging system is configured to capture two-dimensional dynamic x-ray video of the medical injection device during testing of the medical injection device.
14. A method for testing a medical injection device, the method using the system according to claim 1, the method comprising: Supply the medical injection device to the test equipment; as well as The medical injection device was tested by performing the following: Operate the actuator to move the retainer, and subsequently move the second part of the medical injection device; as well as Acquire an X-ray image of the medical injection device during movement of the second part of the syringe.
15. The method according to claim 14, wherein, The medical injection device includes a syringe, and wherein performing the test includes performing a sliding test in which the syringe barrel of the syringe moves relative to the plunger assembly of the syringe such that a stop of the plunger assembly slides within the syringe barrel, and an X-ray image of the interaction between the stop and the syringe barrel is acquired.
16. The method of claim 14, wherein, The medical injection device includes a syringe, and wherein performing the test includes performing a pull-out test in which the end cap of the syringe is pulled away from the syringe barrel of the syringe, and an X-ray image of the end cap being removed from the syringe barrel is acquired.