Injection needle cap removal tool and injection testing system

Abstract

To provide cap removal tools and injector testing systems.SOLUTION: Disclosed example cap removal tools comprise: a cap removal adapter having a cap removal aperture; and a base. The base comprises: first alignment features configured to align the cap removal tool with an actuator of the autoinjector testing system; and second alignment features configured to removably attach the cap removal adapter to the base and align the cap removal adapter with the actuator.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] Related Application This application claims the benefit of U.S. Provisional Patent Application No. 63 / 564,223, filed March 12, 2024, entitled "INJECTION NEEDLE CAP REMOVAL TOOLS AND INJECTION TESTING SYSTEMS". The entire content of U.S. Provisional Patent Application No. 63 / 564,223 is expressly incorporated herein by reference.

[0002] The present disclosure relates generally to testing of injection devices, and more specifically to injection needle cap removal tools and injection testing systems. Background Art

[0003] Injection testing systems can test one or more aspects of injection devices, including auto-injectors, for aspects such as cap removal force, plunger actuation force, injection depth, injection time, needle retraction, and / or dosage. Summary of the Invention

[0004] Injection needle cap removal tools and injection testing systems are disclosed, as more fully set forth in the claims, substantially as shown and described in connection with at least one of the drawings.

[0005] These and other features, aspects, and advantages of the present disclosure will be better understood when the following detailed description is read with reference to the accompanying drawings, in which like reference characters refer to like parts throughout the drawings. Brief Description of the Drawings

[0006] [Figure 1] FIG. 1 is a diagram of an example injection testing system for performing testing on an injection device, in accordance with aspects of the present disclosure.

[0007] [Figure 2]This is a block diagram of an exemplary injection test system comprising a needle cap removal tool according to an aspect of the present disclosure.

[0008] [Figure 3A] Figure 2 is a perspective view of an example embodiment of the positioning plate and cap removal tool.

[0009] [Figure 3B] Figure 2 is an exploded view of the positioning plate and cap removal tool.

[0010] [Figure 4A] Figures 3A and 3B are perspective views of the base of the example cap removal tool. [Figure 4B] Figures 3A and 3B are perspective views of the base of the example cap removal tool.

[0011] [Figure 5A] Figures 3A and 3B show perspective views of the example cap removal tool with the cap removal adapter attached. [Figure 5B] Figures 3A and 3B show perspective views of the example cap removal tool with the cap removal adapter attached.

[0012] [Figure 6] Figures 3A and 3B are front views of an illustrative positioning plate and cap removal tool, further including an alignment tool inserted into the cap removal tool to position the cap removal tool relative to the positioning plate.

[0013] [Figure 7] Figure 6 is a perspective view of an example alignment tool.

[0014] [Figure 8A] Figures 3A and 3B show exploded views of the cap removal tool illustrated in the example, with the syringe alignment plate attached.

[0015] [Figure 8B] It is a perspective view of the exemplary cap removal tool and syringe alignment plate of FIG. 8A, holding an exemplary syringe in a proper position for actuation.

[0016] [Figure 9] It is a flowchart illustrating an exemplary method of aligning the cap removal tool of FIGS. 3A and 3B and performing cap removal force measurement.

[0017] [Figure 10] It is a flowchart illustrating an exemplary method of aligning the cap removal tool of FIGS. 3A and 3B using a syringe alignment plate and performing injection measurement. MODE FOR CARRYING OUT THE INVENTION

[0018] The drawings are not necessarily to scale. Where appropriate, similar or identical reference numerals are used to refer to similar or identical components.

[0019] Some syringes, for example auto-injectors, are provided with a safety cap or similar cover to prevent accidental exposure of the syringe needle during actuation of the syringe. The force associated with removing the cap may need to satisfy certain requirements, such as an upper limit and / or a lower limit for the removal force. In conventional syringe testing systems, after a grip is used to grasp the cap, the cap removal force is measured by moving the grip to separate the cap from the body of the syringe. Some conventional syringe testing systems hold the cap during cap removal force measurement using a customized block that conforms to the overall contour of the cap. However, distortion of the cap caused by the gripping force applied by conventional syringe testing systems changes the force required to remove the cap. The disclosed exemplary syringe testing system includes a cap removal tool that improves the accuracy and repeatability of cap removal force measurements. In some examples, the cap removal tool includes a cap removal surface that holds the cap while reducing or eliminating distortion when the cap is separated from the body of the syringe. Some disclosed examples further include alignment tools and procedures for accurately aligning the cap removal tool with a load cell.

[0020] The disclosed exemplary cap removal tool can be used with an auto-injector testing system, and includes a cap removal adapter having a cap removal opening, and a base, wherein the base includes: a first alignment mechanism configured to align the cap removal tool with an actuator of the auto-injector testing system; and a second alignment mechanism configured to removably attach the cap removal adapter to the base and align the cap removal adapter with the actuator.

[0021] In some exemplary cap removal tools, the base comprises a seat and a flange, and the cap removal adapter is configured to abut against the flange such that the cap removal adapter is separated from the seat. In some exemplary cap removal tools, the flange has a first width, and the cap removal opening has a second width smaller than the first width. Some exemplary cap removal tools further comprise an alignment tool that mates with the base and is configured to transmit force from an actuator to the base. In some exemplary cap removal tools, the base comprises an alignment slot configured to receive a projection of the alignment tool.

[0022] The illustrated syringe testing system disclosed comprises a positioning plate having a first section configured to contact a syringe; a cap removal tool coupled to a second section of the positioning plate, the cap removal tool having a cap removal surface facing the positioning plate; a grip configured to grasp the body of a syringe when the syringe is positioned so that the cap of the syringe abuts the cap removal surface; and a syringe positioner configured to move the grip to separate the body of the syringe from the cap.

[0023] In some exemplary syringe testing systems, the cap removal tool remains stationary while the syringe positioner moves its grip to separate the syringe body from the cap. Some exemplary syringe testing systems further include a force sensor coupled to the syringe positioner and configured to measure the load generated by removing the cap from the body. In some exemplary syringe testing systems, the force sensor is configured to measure the actuation force applied by the syringe actuator to release fluid from the syringe.

[0024] In some exemplary syringe testing systems, the cap removal tool comprises a base having a first alignment mechanism configured to connect the cap removal tool to a positioning plate. In some exemplary syringe testing systems, the cap removal surface is removable from the base. In some exemplary syringe testing systems, the first alignment mechanism comprises a slot configured to allow adjustment of the base relative to the positioning plate. In some exemplary syringe testing systems, the base comprises an alignment slot configured to receive a projection of an alignment tool, the alignment tool extending from the alignment slot to a grip and configured to apply force from the grip to adjust the base relative to the positioning plate.

[0025] Some exemplary syringe testing systems further include a positioning plate actuator configured to move a positioning plate from a first position in which a cap removal tool is aligned with the grip to a second position in which a first section is aligned with the grip. Some exemplary syringe testing systems further include a syringe actuator configured to actuate the syringe while the syringe is in contact with the first section of the positioning plate, causing the contents of the syringe to be released through the syringe needle. In some exemplary syringe testing systems, the cap removal surface is removable and replaceable with a syringe alignment tool configured to be coupled to a cap removal tool, and includes a syringe alignment opening configured to hold the syringe in alignment with the injection opening in the first section of the positioning plate.

[0026] Figure 1 shows an exemplary injection test system 100 for performing tests on injection devices such as an automatic syringe 102. The exemplary injection test system 100 can be configured to perform some or all of the tests required to evaluate the requirements of the ISO 11608-5 standard, for example. The exemplary injection test system 100 can be, for example, a general-purpose test system configured for injection testing.

[0027] The illustrated injection test system 100 in Figure 1 comprises one or more positioning devices (for example, positioning the auto-injector 102 to one or more positions and / or orientations for automated testing), one or more actuators (for example, operating components of the auto-injector 102, operating one or more positioning devices, positioning and / or orienting the test apparatus, etc.), and / or sensors for measuring the state of the auto-injector 102 during testing (for example, load sensors for measuring operating force(s), auditory sensors for detecting audible events, mass scales for measuring discharge volume, displacement and / or position sensors for initiating test steps and / or measuring the displacement of components of the auto-injector 102, etc.). The illustrated injection test system 100 further comprises one or more user interface devices such as a display 104 and an input device 106.

[0028] Figure 2 is a block diagram of an exemplary injection test system 200 equipped with a cap removal tool 242. The exemplary injection test system 200 can be used to implement some or all of the components of the injection test system 100 in Figure 1.

[0029] The exemplary injection test system 200 comprises a syringe positioner 202, a syringe actuator 204, an injection collector 206, and a control circuit unit 208. The syringe positioner 202 positions and / or orients a syringe 210 (e.g., an automatic syringe) for one or more tests in the injection test system 200. For example, the syringe positioner 202 can grip the syringe 210 and move and / or rotate the syringe 210 for testing. The position of the syringe positioner 202 and / or the syringe 210 can be measured by one or more displacement sensors 212 that provide displacement and / or position information to the control circuit unit 208.

[0030] The syringe actuator 204 acts on one or more aspects of the syringe 210, such as the plunger or other injection mechanism of the syringe 210. The force applied by the syringe actuator 204 and / or the syringe positioner 202 can be measured by a force sensor 214 that provides force measurements to the control circuit unit 208. The force sensor 214 can measure, for example, the force associated with the operation of the syringe 210 (e.g., for releasing fluid from the syringe 210), the force associated with removing the cap from the syringe 210, and / or any other resistive force during operation and / or strain on the syringe 210. The force sensor 214 can be a load cell or other type of force sensor.

[0031] The syringe collector 206 comprises a loading surface (e.g., a positioning plate 216), a blowing nozzle 218, and a collection container 220. The collection container 220 and the syringe 210 are positioned so that when the syringe 210 is activated and the fluid contained in the syringe 210 is released, the fluid is released into the collection container 220. A collection sensor 222 measures the mass and / or volume collected in the collection container 220 and provides the mass or volume measurement to the control circuit unit 208.

[0032] The positioning plate 216 extends the needle 224 of the syringe 210 toward the collection container 220 through the positioning plate 216. The positioning plate 216 can prevent the body 225 of the syringe 210 from penetrating the positioning plate 216 by using an opening appropriately sized for the needle 224 and the body 225 of the syringe 210. To test the discharge of the contained fluid, the syringe positioner 202 can position the syringe 210 so that it is in contact with or abuts against the positioning plate 216 so that the needle 224 penetrates the opening in the positioning plate 216. Once the syringe 210 is positioned, the syringe 210 can be actuated (for example, manually or automatically via the syringe actuator 204) to discharge the contents of the syringe 210 into the collection container 220.

[0033] In the examples disclosed herein, a positioning plate 216 is used as the loading surface, but in other examples, a different type of loading surface may be used, such that the syringe 210 can be operated to expose the needle 224 to the loading surface and / or discharge the contents of the syringe 210 to the loading surface. For example, a rod or other structural member may be used that contacts the body of the syringe 210 at the top (upper) side of the loading surface and is positioned so as not to obstruct the needle 224. In some such examples, the blow nozzle 218 may be coupled to or otherwise adjustablely supported on another surface adjacent to the bottom (lower) side of the loading surface and / or adjacent to the position of the needle 224 within the syringe collector 206.

[0034] Upon completion of the syringe 210's operation, the blow nozzle 218 is controlled to blow the last droplet of fluid into the collection container 220 from the tip of the needle or its vicinity. A gas supply source 226 supplies a gas, such as nitrogen or air, to the blow nozzle 218. The gas supply source 226 may be, for example, a compressed gas source, a pneumatic pump, or a blower. The blow nozzle 218 can be positioned and / or directed to adjust the position where the blow gas strikes the needle 224, and / or to direct the blow gas to strike the needle 224 over the length of the needle.

[0035] Some syringes are equipped with a safety cap or similar cover to prevent the needle 224 of the syringe 210 from being accidentally exposed when the syringe 210 is in operation. The force required to remove the cap may need to meet certain requirements, such as upper and / or lower limits on the removal force. To assist in measuring the cap removal force, the exemplary test system 200 further comprises a cap removal tool 242 that can be attached to a positioning plate 216. In contrast to conventional cap removal methods, such as gripping the cap with a grip, the exemplary cap removal tool 242 reduces or eliminates strain forces on the cap that may affect the removal force being measured.

[0036] The grip 244 is coupled to the syringe positioner 202 for positioning the syringe 210. The grip 244 can be electrically, pneumatically, and / or hydraulically operated and actuated by the syringe positioner 202. The grip 244 may include one or more sets or pairs of grips. Exemplary grips on which the grip 244 may be implemented are disclosed in U.S. Provisional Patent Application No. 63 / 558,971, filed on 28 February 2024, entitled "GRIPS FOR INJECTOR TESTING SYSTEMS," and in U.S. Provisional Patent Application No. 63 / 588,550, filed on 6 October 2023, entitled "GRIPS FOR INJECTOR TESTING SYSTEMS." The entire contents of U.S. Provisional Patent Applications No. 63 / 558,971 and No. 63 / 588,550 constitute part of this application by reference.

[0037] In some examples, the test system 200 includes a positioning plate actuator 246 that controls the positioning of the positioning plate 216 relative to a tool chain (e.g., syringe positioner 202, grip 244, etc.). For example, the positioning plate actuator 246 can position various sections of the positioning plate 216 in alignment with the syringe positioner 202 for various operations or parts of the syringe test. For example, a first section of the positioning plate 216 can be used for cap removal (e.g., by a cap removal tool 242), and a second section of the positioning plate 216 can be used for operating the syringe 210 and collecting fluid.

[0038] The syringe positioner 202, syringe actuator 204, and positioning plate actuator 246 can be implemented using any number of motors or actuators (e.g., electric motors, pneumatic actuators, or hydraulic actuators) and / or transmission devices (e.g., transmitting force from one actuator to one or more types of motion).

[0039] The exemplary control circuit unit 208 can be any other type of processing system configured to communicate with a general-purpose computer, laptop computer, tablet computer, and / or sensors and actuators of the injection test system 200. For example, the control circuit unit 208 comprises a processor 228, memory 230, and storage device 232. The exemplary processor 228 can be any general-purpose central processing unit (CPU) from any manufacturer. In some other examples, the processor 228 may include one or more dedicated processing units such as a RISC processor with an ARM core, a graphics processing unit, a digital signal processor, and / or a system on a chip (SoC). The processor 228 executes machine-readable instructions 234 which can be stored locally in the processor (e.g., in a provided cache or SoC), in memory (e.g., random access memory or other volatile memory, read-only memory or other non-volatile memory such as flash memory), and / or in storage device 232. The exemplary storage device 232 can be a hard drive, a solid-state storage drive, a hybrid drive, a RAID array, and / or any other mass data storage device.

[0040] Figure 3A is a perspective view of an illustrative embodiment of the positioning plate 216 and cap removal tool 242 of Figure 2. Figure 3B is an exploded view of the positioning plate 216 and cap removal tool 242 of Figure 2. The illustrative cap removal tool 242 is coupled to a first section 302 of the positioning plate 216, and a second section 304 of the positioning plate is provided with an injection opening 306 for a needle 224 to pass through the positioning plate for the operation of a syringe.

[0041] Figures 4A and 4B are perspective views of the base of the exemplary cap removal tool shown in Figures 3A and 3B. The exemplary cap removal tool 242 comprises a base 308, the base 308 having a seat 310 and a flange 312 surrounding the seat 310 and rising from the seat 310. The cap removal tool 242 may be machined from a single block of material (e.g., steel, plastic) and / or constructed using multiple components (e.g., separate pieces for the base 308 and flange 312 may be welded to each other or otherwise attached).

[0042] As shown in Figure 4B, the second end 402 of the base 308 includes a first alignment mechanism 404. The exemplary first alignment mechanism 404 includes an alignment slot 406 that allows relative movement between the base 308 and the projection 314 of the positioning plate 216 (Figure 3B). The exemplary first alignment mechanism 404 further includes a threaded hole 408, which can be used to fix the base 308 to the positioning plate 216 in a desired alignment position via bolts or other threaded fasteners.

[0043] The flange 312 includes a second alignment mechanism 316 that can be used to mount a cap removal adapter. The exemplary second alignment mechanism 316 includes an alignment hole 318 (e.g., a non-threaded hole) and a mounting hole 320 (a threaded hole for fastening by bolts). Although the exemplary second alignment mechanism 316 is shown, there may be more or fewer alignment holes 318 and mounting holes 320, and / or the mounting hole 320 may be non-threaded for use with clamps, bolts and nuts, and / or other clamping or mounting techniques.

[0044] Figures 5A and 5B are perspective views of the cap removal tool 242 illustrated in Figures 3A and 3B, with the cap removal adapter 502 attached. The cap removal adapter 502 is attached to a second alignment mechanism 316 on the flange 312, while contacting the surface of the flange 312. The cap removal adapter 502 includes a cap removal surface 504 defined by its inner circumference. The width 506 of the cap removal surface 504 is smaller than the width 508 of the seat portion 310. The separation of the cap removal surface 504 and the seat portion 310 allows a portion of the cap 510 of the syringe 210 to be inserted between the seat portion 310 and the cap removal surface 504.

[0045] The cap removal adapter 502 is removable and / or replaceable for use with various types of syringes and syringe caps. For example, various cap removal adapters 502 with different widths 506 and / or different degrees of separation between the cap removal surface 504 and the seat 310 can be attached. In addition or alternatively, other types of adapters may be attached to the base 308 to provide other functions, such as syringe alignment and / or stabilization (as shown in Figures 8A and 8B).

[0046] The cap removal adapter 502 is coupled to the flange 312 via a slot 512, which aligns with each of the second alignment mechanisms 316 (e.g., threaded holes 320) of the flange 312. For example, to secure the cap removal adapter 502 to the flange 312, a bolt can be inserted into the slot 512 and screwed into the flange 312. The illustrated slot 512 is elongated so that the cap removal adapter 502 can be adjusted relative to the flange 312 and the seat 310. The cap removal adapter 502 may have additional holes or slots for alignment with the alignment holes 318.

[0047] The exemplary cap removal tool 242 further comprises an alignment slot 322 for receiving a corresponding projection of an alignment tool. Figure 6 is a front view of the exemplary positioning plate 216 and cap removal tool 242 of Figures 3A and 3B, further including an alignment tool 602 inserted into the cap removal tool 242 to position the cap removal tool 242 relative to the positioning plate 216. Figure 7 is a perspective view of the exemplary alignment tool 602 of Figure 6. As shown in Figure 7, the alignment tool 602 comprises a projection 702 that fits into the alignment slot 322. The alignment tool 602 further comprises a body 704 extending from the seat 310 to be engaged by exemplary grips 706a, 706b, 708a, 708b. The grips 706a-708b may be those of the grip 244 of Figure 2.

[0048] The cap removal tool 242 and grips can be aligned with grips 706a, 706b, 708a, and 708b using the alignment tool 602 and the alignment process. The alignment slot 322 is elongated in a first direction and fits the projection 702 with almost no tolerance in a second direction, so that the alignment tool 602 can bias the cap removal tool 242 to align with grips 706a, 706b, 708a, and 708b during the alignment process. In the illustrated example, the alignment process includes: 1) loosening the connection between the cap removal tool 242 and the positioning plate 216 and loosening the attachment of the grips 706a, 706b, 708a, and 708b; 2) closing the grips 706a, 706b, 708a, and 708b toward the alignment tool 602 to shift the grips 706a, 706b, 708a, and / or the cap removal tool 242 into an aligned position; and 3) tightening the cap removal tool 242 toward the positioning plate 216 to secure the attachment of the grips 706a, 706b, 708a, and 708b. The grips 706a–708b may be designed to shift forward, backward, upward, and / or downward when force is applied to the alignment tool 602 by the grips 706a–708b to compensate for misalignment (e.g., due to tolerances) while loosened. As a result of the shift, the grips 706a–708b and the cap removal tool 242 are aligned with the same test axis (e.g., the load string axis). A flowchart illustrating an exemplary method of performing the alignment is disclosed below with reference to Figure 9.

[0049] One or both pairs of grips 706a, 706b, 708a, and 708b can be used to grip the syringe 210 during measurement, depending on the type of syringe 210 and / or the type of measurement or test being performed.

[0050] Figure 8A is an exploded view of the exemplary cap removal tool 242 shown in Figures 3A and 3B with the syringe alignment plate 800 attached. Figure 8B is a perspective view of the exemplary cap removal tool 242 and syringe alignment plate 800 shown in Figure 8A, holding an exemplary syringe 802 in the appropriate position for operation. The exemplary syringe alignment plate 800 can be attached to the second alignment mechanism 316 of the flange 312 in the same manner as the cap removal adapter 502.

[0051] The syringe alignment plate 800 includes a syringe alignment opening 804, which has a cross-section configured to support a syringe 802 having a corresponding cross-section. For example, the syringe alignment opening 804 can hold the syringe 802 upright and / or aligned with the grip 244 while the needle of the syringe 802 penetrates the injection opening 306. The syringe alignment plate 800 can be replaced with various syringe alignment plates 800 having different cross-sections for the syringe alignment opening 804.

[0052] Figure 9 is a flowchart illustrating one example of a method 900 for measuring the cap removal force by aligning the cap removal tools shown in Figures 3A and 3B.

[0053] In block 902, the cap removal tool 242 is positioned on the alignment tab (e.g., projection 314) of the positioning plate 216. In block 902, the cap removal tool 242 is not fixed to the positioning plate 216 and can move relative to the positioning plate 216 (e.g., the alignment slot 406 can slide over the projection 314).

[0054] In block 904, the alignment tool 602 (for example, the protruding part 702) is inserted into the alignment slot 322 of the cap removal tool 242.

[0055] In block 906, the fixing devices (fixing hardware) for grips 706a to 708b can be loosened, thereby allowing relative movement between each of the grips 706a to 708b and the mount or actuator supporting them. By loosening them, the grips 706a to 708b can be shifted in the same direction as the relative movement of the cap removal tool 242.

[0056] In block 908, the grips 706a to 708b are actuated (for example, by the syringe positioner 202 in Figure 2, which can be controlled manually and / or by the control circuit unit 208) to ensure contact with the alignment tool 602. For example, when the grips 706a to 708b are closed, the grips 706a to 708b move along the length of the alignment tool 602 to ensure sufficient contact between the grips 706a to 708b and the alignment tool 602.

[0057] In block 910, grips 706a-708b are actuated (for example, by the syringe positioner 202 in Figure 2, which can be controlled manually and / or by the control circuit unit 208) to close toward the alignment tool 602. By closing grips 706a-708b, grips 706a-708b and / or the cap removal tool 242 are shifted as necessary along the parallel direction to align the cap removal tool 242 with the load string of the test system 200.

[0058] In block 912, the cap removal tool 242 is fixed to the positioning plate 216 to prevent further relative movement. In block 914, the grips 706a to 708b are fixed to prevent further movement relative to the support and / or actuator. After block 914, the cap removal tool 242 is aligned with the operating direction of the load string and grips 706a to 708b.

[0059] In block 916, the alignment tool is removed from the cap removal tool 242. In block 918, the cap removal adapter 502 is fixed or replaced on the base 308 (for example, on the flange 312 via a fixing device). The cap removal adapter 502 can be selected to fit a specific type of syringe 210 and / or syringe cap.

[0060] In block 920, the syringe cap 510 is placed inside the cap removal tool 242. The cap 510 can be seated on the seat portion 310 and at least partially below the cap removal surface 504 of the fixed cap removal adapter 502.

[0061] In block 922, the control circuit 208 controls the syringe positioner 202 to move the grips 708a and 708b to grasp the body of the syringe 210. In some cases, the lower grips 706a and 706b are activated first to help align the syringe 210 (for example, to adjust the tilt), and then the upper grips 708a and 708b are activated to grasp the syringe 210. When the upper grips 708a and 708b are closed, the lower grips 706a and 706b are opened, allowing the upper grips 708a and 708b to be activated for cap removal. In block 924, the control circuit 208 controls the syringe positioner 202 to move the grips 708a and 708b to separate the body of the syringe 210 from the cap 510. For example, the syringe positioner 202 can be operated to move the grips away from the seat 310 (while the grips 708a and 708b are gripping the body of the syringe 210). The body of the syringe 210 moves with the grips, while the cap 510 is prevented from moving away from the body by the cap removal surface 504. While the syringe positioner 202 is operating the grips 708a and 708b, the control circuit 208 measures or monitors the force applied to the grips 708a and 708b using the force sensor 214 and determines the removal force required to remove the cap 510 from the body of the syringe 210. The exemplary method 900 is then completed.

[0062] Figure 10 is a flowchart illustrating an exemplary method 1000 for performing injection measurements by aligning the cap removal tool shown in Figures 3A and 3B using a syringe alignment plate (e.g., syringe alignment plate 800 in Figures 8A and 8B).

[0063] In block 1002, the cap removal tool 242 is positioned on the alignment tab (e.g., projection 314) of the positioning plate 216. In block 1002, the cap removal tool 242 is not fixed to the positioning plate 216 and can move relative to the positioning plate 216 (e.g., the alignment slot 406 can slide over the projection 314).

[0064] In block 1004, the alignment tool 602 (for example, the protruding part 702) is inserted into the alignment slot 322 of the cap removal tool 242.

[0065] In block 1006, the fixing devices for grips 706a to 708b can be loosened, thereby allowing relative movement between each of the grips 706a to 708b and the mount or actuator supporting them. By loosening them, the grips 706a to 708b can be shifted in the same direction as the relative movement of the cap removal tool 242.

[0066] In block 1008, grips 706a to 708b are actuated (for example, by the syringe positioner 202 in Figure 2, which can be controlled manually and / or by the control circuit unit 208) to ensure contact with the alignment tool 602. For example, when grips 706a to 708b are closed, grips 706a to 708b move along the length of the alignment tool 602 to ensure sufficient contact between grips 706a to 708b and the alignment tool 602.

[0067] In block 1010, grips 706a-708b are actuated (for example, by the syringe positioner 202 in Figure 2, which can be controlled manually and / or by the control circuit unit 208) to close toward the alignment tool 602. By closing grips 706a-708b, grips 706a-708b and / or the cap removal tool 242 are shifted as necessary along the parallel direction to align the cap removal tool 242 with the load string of the test system 200.

[0068] In block 1012, the cap removal tool 242 is fixed to the positioning plate 216 to prevent further relative movement. In block 1014, the grips 706a to 708b are fixed to prevent further movement relative to the support and / or actuator. After block 1014, the cap removal tool 242 is aligned with the operating direction of the load string and grips 706a to 708b.

[0069] In block 1016, the alignment tool is removed from the cap removal tool 242. In block 1018, the syringe alignment plate 800 is fixed or replaced on the base 308 (for example, on the flange 312 via a fixing device). The syringe alignment plate 800 can be selected to match a specific type of syringe 802.

[0070] In block 1020, the syringe 802 is placed in the syringe alignment opening 804 of the syringe alignment plate 800. Furthermore, the syringe 802 can be brought into contact with the positioning plate 216 so that the needle 224 of the syringe 802 penetrates the injection opening 306.

[0071] In block 1022, the control circuit unit 208 controls the syringe positioner 202 to move the grips 706a to 708b to activate the syringe 802 positioned within the syringe alignment plate 800. While the syringe 802 is being activated, the example force sensor 214 can detect the force applied to the grips to activate the syringe 802.

[0072] In some examples, after the syringe 802 has been positioned in the alignment opening 804 (block 1020) but before the syringe 802 is activated (block 1022), the grips 706a to 708b can perform cap removal from the syringe 802. For example, after the syringe is inserted into the opening 804, the top grips 708a and 708b close toward the syringe 802, moving it a predetermined distance and positioning the cap of the syringe 802 for the lower grips 706a and 706b to grasp. Once the lower grips 706a and 706b grasp the cap of the syringe 802, the top grips 708a and 708b move upward to perform cap removal. In some examples, the positioning plate actuator 246 moves the positioning plate 216 to position the base 308 below the cap, and the lower grips 706a and 706b release the cap, thereby positioning the cap within the base. The positioning plate actuator 246 then moves the positioning plate 216 to position the injection opening 306 below the syringe 802, allowing the injection measurement to continue.

[0073] After that, the example method 1000 is completed.

[0074] The method and system can be implemented in hardware, software, and / or a combination of hardware and software. The method and / or system can be implemented centrally in at least one computing system, or distributedly, with different elements distributed across several interconnected computing systems. Any type of computing system or other device adapted to perform the method described herein is suitable. A typical combination of hardware and software may include a general-purpose computing system, along with a program or other code that, once loaded and executed, controls the computing system to perform the method described herein. Another typical embodiment may include an application-specific integrated circuit or chip. Some embodiments may include a non-temporary machine-readable (e.g., computer-readable) medium (e.g., flash drive, optical disk, magnetic storage disk, etc.) which stores one or more lines of machine-executable code, thereby causing a machine to perform a process such as that described herein. As used herein, the term “non-temporary machine-readable medium” includes all types of machine-readable storage media and is defined as being free from propagated signals.

[0075] As used in this application, the terms “circuit” and “circuit section” refer to physical electronic components (i.e., hardware) and any software and / or firmware ("code") that can constitute the hardware, can be executed by the hardware, and / or can be otherwise associated with the hardware. As used in this application, for example, a particular processor and memory may include a first “circuit” when executing one or more first lines of the code, and a second “circuit” when executing one or more second lines of the code. As used in this application, “and / or” means any one or more items in the list linked by “and / or”. For example, “x and / or y” means any element of the set of three elements {(x), (y), (x,y)}. In other words, “x and / or y” means “one or both of x and y”. As another example, “x, y and / or z” means any element of the seven-element set {(x), (y), (z), (x,y), (x,z), (y,z), (x,y,z)}. In other words, “x, y and / or z” means “one or more of x, y and z.” As used in this application, the term “exemplary” means to serve as an unrestricted example, case, or illustration. As used in this application, the term “for example” means to begin a list of one or more unrestricted examples, cases, or illustrations. As used in this application, whenever a circuit section includes the hardware and code (if any of which are required) necessary to perform a certain function, the circuit section is “operable” to perform that function, regardless of whether the performance of that function is disabled or not (e.g., by user-configurable settings, factory trim, etc.).

[0076] While the Method and / or System has been described with reference to certain specific embodiments, those skilled in the art will understand that various modifications and substitutions can be made without departing from the scope of the Method and / or System. For example, blocks and / or components of the disclosed examples can be combined, divided, rearranged, and / or otherwise modified. In addition, many modifications can be made without departing from the scope of the Disclosure to adapt the teachings of the Disclosure to specific circumstances or materials. Therefore, the Method and / or System is not limited to the specific embodiments disclosed. Instead, the Method and / or System includes all embodiments that fall within the scope of the appended claims, either literally or under the doctrine of equivalents. [Configuration 1] A cap removal tool for an automatic syringe testing system, A cap removal adapter having a cap removal opening, The base, A first alignment mechanism is configured to align the cap removal tool with the actuator of the automatic syringe testing system, A second alignment mechanism is configured to removably attach the cap removal adapter to the base and to align the cap removal adapter with the actuator, A base equipped with, A cap removal tool equipped with [features / equipment]. [Configuration 2] The cap removal tool according to configuration 1, wherein the base comprises a seat and a flange, and the cap removal adapter is configured to contact the flange so that the cap removal adapter is separated from the seat. [Configuration 3] The cap removal tool according to configuration 2, wherein the flange has a first width, and the cap removal opening has a second width smaller than the first width. [Structure 4] The cap removal tool according to configuration 1, further comprising an alignment tool configured to engage with the base and to transmit force from the actuator to the base. [Composition 5] The cap removal tool according to configuration 4, wherein the base comprises an alignment slot configured to receive the protrusion of the alignment tool. [Composition 6] This is a syringe testing system, A positioning plate having a first section configured to contact a syringe, A cap removal tool coupled to a second section of the positioning plate, the cap removal tool having a cap removal surface facing the positioning plate, Multiple grips are configured to hold the body of the syringe when the syringe is positioned so that the cap of the syringe contacts the cap removal surface, A syringe positioner configured to move the grip in order to separate the body of the syringe from the cap, A syringe testing system equipped with the following features. [Composition 7] The syringe testing system according to configuration 6, wherein the cap removal tool remains stationary while the syringe positioner moves the grip to separate the body of the syringe from the cap. [Structure 8] The syringe testing system according to configuration 6, further comprising a force sensor coupled to the syringe positioner, the force sensor configured to measure the load generated by the removal of the cap from the main body. [Composition 9] The syringe testing system according to configuration 8, wherein the force sensor is configured to measure the operating force applied by the syringe actuator to release fluid from the syringe. [Configuration 10] The syringe testing system according to configuration 6, wherein the cap removal tool comprises a base, the base having a first alignment mechanism configured to connect the cap removal tool to the positioning plate. [Composition 11] The syringe testing system according to configuration 10, wherein the cap removal surface is removable from the base. [Composition 12] The syringe testing system according to configuration 10, wherein the first alignment mechanism includes a slot configured to allow adjustment of the base relative to the positioning plate. [Composition 13] The syringe testing system according to configuration 12, wherein the base comprises an alignment slot configured to receive a projection of an alignment tool, and the alignment tool is configured to extend from the alignment slot to the grip and to apply force from the grip to adjust the base relative to the positioning plate. [Composition 14] The syringe testing system according to configuration 6, further comprising a positioning plate actuator, the positioning plate actuator configured to move the positioning plate from a first position in which the cap removal tool is aligned with the grip to a second position in which the first section is aligned with the grip. [Composition 15] The syringe testing system according to configuration 14, further comprising a syringe actuator, the syringe actuator configured to actuate the syringe to release the contents of the syringe through the needle of the syringe while the syringe is in contact with the first section of the positioning plate. [Composition 16] The syringe testing system according to configuration 6, wherein the cap removal surface is removable and replaceable with a syringe alignment tool, the syringe alignment tool is configured to be coupled to the cap removal tool and has a syringe alignment opening configured to hold the syringe in alignment with the injection opening in the first section of the positioning plate.

Claims

1. A cap removal tool for an automatic syringe testing system, A cap removal adapter having a cap removal opening, The base, A first alignment mechanism is configured to align the cap removal tool with the actuator of the automatic syringe testing system, A second alignment mechanism is configured to removably attach the cap removal adapter to the base and to align the cap removal adapter with the actuator, A base equipped with, A cap removal tool equipped with [features / equipment].

2. The cap removal tool according to claim 1, wherein the base comprises a seat and a flange, and the cap removal adapter is configured to contact the flange so that the cap removal adapter is separated from the seat.

3. The cap removal tool according to claim 2, wherein the flange has a first width, and the cap removal opening has a second width smaller than the first width.

4. The cap removal tool according to claim 1, further comprising an alignment tool configured to engage with the base and to transmit force from the actuator to the base.

5. The cap removal tool according to claim 4, wherein the base comprises an alignment slot configured to receive a protrusion of the alignment tool.

Images