Fixture and associated method for testing the elasticity of drug delivery devices

Abstract

A fixture and associated method for testing the resilience of a drug delivery device is disclosed. According to one example, a method for testing the resilience of a cannula (108) of a drug delivery device includes securing the barrel of the drug delivery device in a fixture (100) such that the cannula (108) secured to the distal end of the barrel extends outward from the fixture (100). The method includes applying a lateral force to the distal end (189) of the cannula (108) using a striking member (170) to move the distal end (189) of the cannula a threshold distance. The method includes removing the force from the cannula (108). The method includes determining a final position of the distal end (189) of the cannula (108) after the force is removed.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 014006, filed April 22, 2020, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to testing drug delivery devices, and more particularly to testing the resilience of drug delivery members such as cannulas and / or needles. [Background technology]

[0003] Conventional drug delivery can be achieved, for example, through the use of a syringe having a drug delivery member in the form of a rigid hollow cannula and / or needle. To ensure reliability and effectiveness, certain standards and / or regulations may be established that require such cannulas / needles to maintain a certain elasticity or resistance to deformation under some form of lateral injection. Manufacturers are therefore benefited from testing their cannulas / needles to ensure compliance with such standards and / or regulations. Summary of the Invention [Means for solving the problem]

[0004] According to a first example, a fixture assembly for testing the resilience of a cannula of a drug delivery device includes a fixture block and a movable striking member. The fixture block defines a barrel container and has a distal end face. The barrel container is adapted to house the drug delivery device. The drug delivery device has a barrel, and a cannula extends from a distal end of the barrel such that when the drug delivery device is housed in the barrel container, the cannula extends out of the fixture block and beyond the distal end face, thereby defining the cannula as having a fulcrum at the distal end face spaced from the distal end of the barrel. The movable striking member is configured to selectively apply a load to the distal end of the cannula spaced from the fulcrum.

[0005] According to a second example, a method for testing the resilience of a cannula of a drug delivery device includes the steps of: securing the barrel of the drug delivery device in a fixture such that the cannula secured to the distal end of the barrel extends outward from the fixture; applying a lateral force to the distal end of the cannula using a striking member to move the distal end of the cannula a threshold distance; removing the force from the cannula; and determining a final position of the distal end of the cannula after the force is removed.

[0006] Further according to the first and / or second examples above, the apparatus and / or method may further include one or more of the following:

[0007] According to one example, the drug delivery device is disposed within a barrel container.

[0008] According to another example, the striking member is positioned a predetermined distance from the distal end face of the cannula and the fulcrum.

[0009] According to another example, the predetermined distance is about 25 * D 2 where D is the outer diameter of the cannula in millimeters.

[0010] According to another example, the fixture assembly also includes a plurality of gauge blocks that establish a predetermined distance between the striking member and the distal end face, each gauge block having a distinct length dimension corresponding to one of a plurality of predetermined cannula gauges.

[0011] According to another example, each gauge block corresponds to a cannula gauge from about 10 gauge to about 34 gauge.

[0012] According to another example, the illustrated blocks include a first fixture block and a second fixture block.

[0013] According to another example, the first fixture block and the second fixture block are coupled in a clamshell configuration.

[0014] According to another example, each tooling block has a first end, a second end, and defines a barrel groove extending between the first end and the second end, and the first and second tooling blocks are adapted to be mated together such that the barrel grooves are aligned with each other to form corresponding barrel containers.

[0015] According to another example, the fixture assembly also includes a latch that secures the first fixture block and the second fixture block together.

[0016] According to another example, the fixture assembly also includes a first end plate and a second end plate coupled to the second ends of the first and second fixture blocks, respectively, each end plate defining a plunger groove that collectively defines a plunger receptacle that receives a plunger rod of the drug delivery device when the drug delivery device is disposed within the barrel receptacle.

[0017] According to another example, the fixture block includes a support block having a top support surface and a distal end surface, and when the drug delivery device is housed within the barrel container, the cannula extends across the top support surface of the support block.

[0018] According to another example, the fixture block is formed of a first material and the support block is formed of a second material different from the first material.

[0019] According to another example, the method also includes determining an initial position of the distal end of the cannula before applying a force to the distal end of the cannula by moving the striking member into contact with the distal end of the cannula.

[0020] According to another example, the method also includes determining a change between the final position and the initial position by moving the striking member into contact with the distal end of the cannula.

[0021] According to another example, the method also includes determining a change in angle of the cannula between the final position and the initial position.

[0022] According to another example, the method includes defining a fulcrum for the cannula spaced from the distal end of the barrel.

[0023] According to another example, the step of defining the fulcrum includes providing a jig with a pair of jig blocks and support blocks extending from the jig blocks, the support blocks defining a top support surface that supports the cannula and a distal end face that is spaced from the distal end of the barrel of the drug delivery device and from which the distal end of the cannula extends further, such that the fulcrum of the cannula is located at the distal end faces of the support blocks.

[0024] According to another example, the method includes positioning the striking member a predetermined distance from a fulcrum of the cannula before applying a lateral force to the distal end of the cannula.

[0025] According to another example, the striking member may be positioned such that the striking member is approximately 25° from the fulcrum of the cannula. * D 2 where D is the outer diameter of the cannula in millimeters.

[0026] According to another example, positioning the striking member includes selecting one gauge block from a plurality of gauge blocks based on the outer diameter of the cannula, placing the selected gauge block in a fixture adjacent to the cannula, and moving the striking member into contact with the selected gauge block.

[0027] The present disclosure will be better understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements for the purpose of more clearly showing other elements. Such omission of elements in some of the drawings does not necessarily represent the presence or absence of the particular element in any of the illustrative embodiments, unless expressly expressed in the corresponding description. Additionally, none of the drawings are necessarily drawn to scale. [Brief explanation of the drawings]

[0028] [Figure 1] 1 is a schematic diagram of one embodiment of a jig assembly constructed in accordance with a first example of the present disclosure. [Figure 2] FIG. 2 is an enlarged view of the jig assembly of FIG. 1. [Figure 3] FIG. 2 is an isometric view of the fixture assembly of FIG. 1 secured to the base plate of a compression testing machine including a striking member. [Figure 4] FIG. 10 is an isometric side view of a jig assembly that secures the barrel of the drug delivery device and a portion of a striking member that engages the cannula so that the initial position of the cannula can be determined. [Figure 5] FIG. 5 is an isometric side view of the portion of the jig assembly shown in FIG. 4 together with a striking member that applies a force to the cannula to move it a threshold distance. [Figure 6] 5 is an isometric view of the portion of the fixture assembly shown in FIG. 4 with the force removed from the striking member. [Figure 7] FIG. 5 is an isometric view of the portion of the jig assembly shown in FIG. 4 in which the striking member determines the final position of the cannula after the force is removed. DETAILED DESCRIPTION OF THE INVENTION

[0029] The present disclosure generally relates to a test fixture for use in determining the resilience of drug delivery members, such as cannulas and / or needles (hereinafter referred to as "cannulas"). During exemplary resilience tests, the cannula can be bent a threshold distance for a threshold time and then released. The exemplary fixture can be used to repeatedly secure a drug delivery device while performing these resilience tests. By placing the cannula in approximately the same position during each test, the striking member used to move the cannula can contact approximately the same portion of the cannula. As a result, the tests can be performed in a substantially similar manner regardless of who performs the test and where.

[0030] Each of the above-mentioned components of the drug delivery device is described in more detail below.

[0031] FIG. 1 is a schematic diagram of one embodiment of a fixture assembly 100 constructed in accordance with a first example of the present disclosure. The fixture assembly 100 is used to test a drug delivery device 102, such as a syringe, as shown. However, the fixture assembly 100 may alternatively be configured to test a flexible cannula. The drug delivery device 102 includes a barrel 104, a flange 106, and a drug delivery member, such as a cannula 108, coupled to the barrel 104. The drug delivery device 102 also includes a plunger rod 110 movably disposed within the barrel 104. A plunger (not shown) may be coupled to the plunger rod 110 and slidably disposed within the barrel 104. However, the tests disclosed herein may be performed using a fixture assembly 100 having a plunger rod 110 that is not disposed within the barrel 104. The cannula 108 may be a rigid cannula, such as a hollow needle, or the cannula may be a flexible cannula in some versions. Generally, during elasticity testing, the drug delivery device 102 may be clamped or otherwise housed within and / or secured to the fixture assembly 100, and a force is applied to and then removed from the cannula 108. The cannula 108 is then measured to determine whether the cannula 108 has plastically deformed as a result of the applied force.

[0032] Referring now to fixture assembly 100, fixture assembly 100 includes fixture block 111, which includes first fixture block 112, second fixture block 114, and support 116. First fixture block 112 may be referred to as the upper fixture block, and second fixture block 114 may be referred to as the lower fixture block. Fixture blocks 112, 114 each have first and second ends 118, 120 and define a barrel groove 122 (more clearly shown in FIG. 2 ) extending between ends 118, 120. Barrel groove 122 is adapted to mate to form a barrel container 124.

[0033] The support 116 is coupled to and extends from a first end 118 of the second fixture block 114. The barrel groove 122 is adapted to receive the barrel 104 so that the cannula 108 fits over the support 116 and spaces a fulcrum 126 (see FIG. 5 ) of the cannula 108 from a distal end 127 of the barrel 104 when the cannula 108 is bent during elasticity testing. The fulcrum 126 may be located adjacent a distal end face 128 of the support 116. The distal end face 128 is spaced from the first end 118 of the second fixture block 114 and forms a fulcrum for the cannula 108. In another example, the fixture block 111 can define the barrel receptacle 124 without including the first and second fixture blocks 112, 114 and includes the support 116. In such an example, the drug delivery device 102 may be mounted into the fixture block 111 from the second end 120 such that the cannula 108 extends beyond the distal end face 128. An end cap may be included that is used to secure the drug delivery device 102 within the fixture block 111.

[0034] Because fulcrum 126 is spaced from distal end 127 of barrel 104, cannula 108 itself is deflected or bent during elasticity testing. However, if fulcrum 126 were located at the bond between cannula 108 and barrel 104, the bond or bond between barrel 104 and cannula 108 could be deflected / bent instead. Deflecting the bonded bond could result in inaccurate test results and / or the elasticity of cannula 108 itself may not be tested.

[0035] 1 , the support 116 is a support block 130. The support block 130 has a top support surface 132 that is generally planar with an upwardly facing surface 134 of the second fixture block 114. The cannula 108 overlies the top support surface 132 when the drug delivery device 102 is secured within the fixture assembly 100.

[0036] The first fixture block 112 and the second fixture block 114 may be coupled in a clamshell configuration as shown, and thus the fixture blocks 112, 114 may be rotatably coupled.

[0037] A latch 135 is used to secure the first fixture block 112 and the second fixture block 114 together. The latch 135 may also be referred to as a clamp. The latch 135 includes a male portion 136 that is rotatably coupled to the second fixture block 114 and a female portion 138 that is coupled to the first fixture block 112. The male portion 136 and the female portion 138 are shown coupled to the fixture blocks 112, 114 using fasteners (e.g., bolts). However, the male and / or female portions 136, 138 may be coupled to the fixture blocks 112, 114 in different manners. For example, the male and / or female portions 136, 138 may be brazed to the corresponding fixture blocks 112, 114 and / or may be adhesively attached.

[0038] In the illustrated example, the male portion 136 includes an elongated threaded fastener 140 that extends through a groove 142 in the female portion 138. A nut 144 is placed on the male portion 136 and threaded onto a front surface 146 of the female portion 138 to secure the fixture blocks 112, 114 together. However, in other examples, the fixture blocks 112, 114 may be connected in a different manner. For example, multiple fasteners may be used to connect the first fixture block 112 and the second fixture block 114 together. It will be appreciated that other methods may also be suitable.

[0039] An upper end plate 152 and a lower end plate 154 may be included coupled to the second ends 120 of the corresponding fixture blocks 112, 114. The end plates 152, 154 are shown coupled to the fixture blocks 112, 114 using fasteners. It will be appreciated that other methods of coupling the end plates 152, 154 to the fixture blocks 112, 114 are suitable. In the illustrated example, each end plate 152, 154 defines a plunger groove 156 that mates to form a plunger receptacle 158. When the drug delivery device 102 is secured within the fixture assembly 100, the plunger rod 110 of the drug delivery device 102 can extend through the plunger receptacle 158.

[0040] The fixture blocks 112, 114 may be formed from a first material, and the support 116 may be formed from a second material. In one example, the fixture blocks 112, 114 are formed from a metal such as aluminum, and the support 116 is formed from a plastic such as polyetheretherketone (PEEK). Using PEEK for the support 116 may reduce wear on the cannula 108. However, other materials may be found suitable for forming the fixture blocks 112, 114, and / or the support 116, and the fixture blocks 112, 114, and / or the support 116 may be formed from the same or different materials.

[0041] Figure 2 is an expanded view of the fixture assembly 100 of Figure 1. Fixture blocks 112, 114 include sides 159, 160 and, in the illustrated example, are rotatably coupled at side 159 by hinge 162. Although two hinges 162 are shown, any number of hinges may alternatively be included. A latch 135 is used to selectively couple fixture blocks 112, 114 at second side 160.

[0042] In the illustrated example, the support 116 includes a barrel seat 164 adapted to receive the terminal end of the barrel 104 of the drug delivery device 102. During elasticity testing, the distal end 127 of the barrel 104 can press against the barrel seat 164. The barrel seat 164 may be referred to as a notch. The barrel seat 164 may be formed by a semicircular groove or have a cross-section that corresponds to at least a portion of the cross-section of the drug delivery device 102. In other implementations, and based on the length of the drug delivery device 102 (e.g., the length of the barrel 104) under test, the shape, dimensions, etc. of the barrel seat 164 may be modified and / or omitted. Furthermore, additional or alternative modifications may be made to the fixture assembly 100 to accommodate different styles and / or brands of drug delivery devices manufactured by the same or different manufacturers. For example, in some implementations, centering features (e.g., strips, O-rings, or other structures) can be used with fixture blocks 112, 114 to accommodate, for example, syringe barrels having different physical shapes and / or dimensions. In one contemplated version, for example, fixture blocks 112, 114 can define opposing grooves connected to and extending outwardly from corresponding barrel grooves 122, perpendicular to the longitudinal dimension of the barrel grooves 122. These opposing grooves can contain elastomeric material, for example, in the form of rubber strips, used to center and / or secure drug delivery device 102, barrel 104, and / or cannula 108 relative to fixture assembly 100. Other configurations are possible.

[0043] The fixture blocks 112, 114 also each define a flange groove 165 adjacent the second end 120. The flange groove 165 is adapted to mate and receive the flange 106 of the drug delivery device 102. The flange groove 165 allows the drug delivery device 102 to be positioned in a substantially uniform, fixed position while performing elasticity tests on different drug delivery devices. The end plates 152, 154 also form part of the flange groove 165 when coupled to the fixture blocks 112, 114.

[0044] 3-6 illustrate the process of using fixture assembly 100 during elasticity testing.

[0045] Figure 3 is an isometric view of the fixture assembly 100 of Figure 1 secured to a base plate 166 of a compression tester 168. The compression tester 168 includes a striking member 170, shown as a striking pin. The compression tester 168 may be a force tester.

[0046] In the illustrated example, the gauge 172 is disposed on the support 116. The gauge 172 may also be referred to as a gauge block. The gauge 172 is L-shaped and includes an upper leg 174 and a lower leg 176.

[0047] In practice, the gauge 172 is used to define a distance 178 between the surface 180 of the support 116 (see FIG. 1) and the striking member 170. In some examples, the distance 178 is defined by Equation 1, where D corresponds to the distance 178 and the diameter corresponds to the outer diameter of the cannula 108. The diameter of the cannula 108 may be in millimeters, and the distance 178 may be in millimeters. Note that the distance D is a measure of length, even though the square of the diameter is a measure of area. In one example, the outer diameter of the cannula 108 is approximately 1.0 millimeter. Formula 1: D=25(diameter 2 )

[0048] The terminal end 182 of the striking member 170 is adapted to engage and move the distal end 171 of the cannula 108 during, for example, elasticity testing. The distal end 171 of the cannula 108 extends from the jig assembly 100. The striking member 170 may have a pointed or blunt tip.

[0049] The fixture assembly 100 and gauge 172 may be moved toward the striking member 170 to adjust the position of the striking member 170 to engage the gauge 172 and define a distance 178. After the gauge 172 engages the striking member 170, the gauge 172 and fixture assembly 100 cannot be moved further toward the striking member 170, and the fixture assembly 100 is fixed to the base plate 166. In the illustrated example, the fixture assembly 100 includes a slot 184 through which a fastener 186 extends to couple the fixture assembly 100 to a compression tester 168. The interaction of the fastener 186 and the slot 184 allows the fixture assembly 100 to be moved in the direction generally indicated by the arrow 188.

[0050] Although gauge 172 is shown in FIG. 3, different gauge blocks may be used. For example, multiple gauge blocks may be provided, each having a distinct length dimension (e.g., width) associated with a different cannula gauge (e.g., needle gauge). Gauge blocks including gauge 172 may be used with cannula gauges ranging from about 10 gauge to about 34 gauge. In one example, gauge 172 is associated with cannulas having a 20 gauge, 21 gauge, 22 gauge, 23 gauge, 25 gauge, 29 gauge, 30 gauge, or 31 gauge.

[0051] Prior to determining the resilience of the cannula 108, the striking member 170 may also be zeroed by contacting the striking member 170 with the fixture assembly 100 and / or support 116 until a force of approximately 1 Newton (N) to 5 N is registered. Axial height may be defined as "zero." At the start of and / or prior to the start of the resilience test, the striking member 170 may be moved above the fixture assembly 100 to secure the drug delivery device 102 within the fixture assembly 100.

[0052] 4 is an isometric side view of a portion of a jig assembly 100 that secures the barrel 104 of a drug delivery device 102 and a striking member 170 that engages a cannula 108, allowing the initial position of the cannula 108 to be determined. With the drug delivery device 102 secured within the jig assembly 100, the cannula 108 inserted into the barrel 104 can be extended from the jig assembly 100. The cannula 108 is shown extending over the support block 116 and beyond the distal end face 128 of the support block 116. In the illustrated example, the striking member 170 is shown contacting the cannula 108 so that the compression tester 168 can determine the initial position of the cannula 108 before the striking member 170 bends / moves the cannula 108 during elasticity testing.

[0053] In one example, when striking member 170 initially contacts cannula 108, striking member 170 approaches cannula 108 at a rate of approximately 5 millimeters (mm) per minute. However, striking member 170 can approach cannula 108 at a rate of approximately 0.1 mm / minute to approximately 500 mm / minute, or another rate. Striking member 170 can contact cannula 108 at portion 189 of cannula 108 defined by distance 178 set by gauge 172. Striking member 170 can stop moving for approximately 1 second after a force of approximately 0.15 N is recorded. The axial distance of striking member 170 is recorded as the initial position of cannula 108. i It can be expressed as:

[0054] 5 is an isometric side view of the portion of the jig assembly 100 shown in FIG. 4 with the striking member 170 applying a force to the cannula 108 to move the cannula 108 a threshold distance 190. The threshold distance 190 may be referred to as the test condition or threshold amount. During the elasticity test, the striking member 170 may bend the cannula 108 a given bend angle (in degrees), a given axial distance, and / or a given amount of force for a threshold time. A fulcrum 126 is shown formed on the support 116 a distance 192 away from the distal end 127 of the barrel 104 of the drug delivery device 102.

[0055] In one example, during resilience testing, striking member 170 applies a lateral force to cannula 108 toward base plate 166 in the direction indicated by arrow 193 at a rate of approximately 5 mm / min. In another example, striking member 170 may be moved toward base plate 166 at a rate of approximately 0.1 mm / min to approximately 500 mm / min until a threshold distance is reached. As an example, some resilience tests require cannula 108 to bend to a 12-degree angle from an initial position and hold at 12 degrees for 60 seconds. However, resilience tests in different countries may have different requirements.

[0056] 6 is an isometric view of the portion of the jig assembly 100 shown in FIG. 4 with the force removed from the striking member 170. Thus, the cannula 108 is allowed to move to its natural and / or final position after being moved by the striking member 170. In one example, after reaching the threshold distance 190, the striking member 170 may be moved away from the cannula 108 at a rate of approximately 500 mm / min. In another example, the striking member 170 may be moved away from the cannula 108 at any rate between approximately 0.1 mm / min and approximately 2000 mm / min. It will be appreciated that other speeds for moving the striking member 170 are also suitable.

[0057] 7 is an isometric view of the portion of the jig assembly 100 shown in FIG. 4 with the striking member 170 determining the final position of the cannula 108 after the force is removed. The cannula 108 can be inspected to determine whether the cannula 108 has returned to its initial position or whether plastic deformation occurred while the cannula 108 was under load. Thus, using the disclosed examples, plastic deformation of the cannula 108, if any, can be quantified by measuring the change between the initial position of the cannula 108 and the final position of the cannula 108. The change between the initial position and the final position can be defined in terms of deflection angle in millimeters or degrees.

[0058] Elasticity test result output can be generated by the compressible testing machine 108. The results can be displayed using different methods, such as displaying the results in a user interface, making the results accessible on different devices, or printing the results.

[0059] In one example, to determine the final position of the cannula 108, the striking member 170 can approach the cannula 108 at a rate of about 5 mm / min. In another example, the striking member 170 can move toward the cannula 108 at a rate of about 0.1 mm / min to about 500 mm / min. The striking member 170 can stop moving for about 1 second after contacting the cannula 108 at portion 189 of the cannula 108 and recording a force of about 0.15 N. The axial distance of the striking member 170 is recorded as the final position of the cannula 108, P. f It can be expressed as:

[0060] The change in position (bend) of the cannula 108 can be determined using Equation 2, where Pi is the initial position of the cannula 108 in millimeters, Pf is the final position of the cannula 108 in millimeters, D is the nominal outer diameter of the cannula 108 in millimeters, and the deflection angle is the angle formed by the initial position of the cannula 108 and the final position of the cannula 108 after applying a force to portion 189 of the cannula 108. Formula 2:

number

[0061] The deflection is also the distance P f -P i is calculated as follows.

[0062] While the present disclosure has been described in connection with various embodiments, it will be understood that the present disclosure is capable of further modifications. This disclosure is intended to cover any variations, uses, or adaptations of the disclosed subject matter that generally conform to the principles of the disclosure and to include such departures from the disclosure as come within known and customary practice in the art to which the disclosure pertains.

[0063] It should be noted that the structure and configuration of the drug delivery device, and the various elements and assemblies, as shown in the various exemplary embodiments are for illustrative purposes only. While this disclosure has detailed only a few embodiments of the subject matter of interest, those skilled in the art upon reviewing this disclosure will readily appreciate that numerous modifications (e.g., variations in the size, dimensions, structure, shape, and proportions of the various elements, parameter values, mounting arrangements, use of materials, color, orientation, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter disclosed herein. For example, elements shown as integrally formed may be composed of multiple parts or elements, or vice versa. Additionally, the positions of elements may be reversed or otherwise changed, and the nature, number, or location of separate elements may be modified or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure, as defined by the appended claims. Furthermore, the order or sequence of any process or method steps may be changed or rearranged in accordance with alternative embodiments. Other substitutions, modifications, variations, and omissions may be made in the design, operating conditions, and arrangements of the various exemplary embodiments without departing from the scope of the present disclosure.

Claims

1. 1. A fixture assembly for testing the resilience of a cannula of a drug delivery device, comprising: A tooling block defining a barrel container and having a distal end surface, a fixture block adapted to house the drug delivery device, the drug delivery device having a barrel, the cannula extending from a distal end of the barrel such that when the drug delivery device is housed within the barrel, the cannula extends out of the fixture block beyond the distal end face, thereby defining the cannula as having a fulcrum located on the distal end face and spaced from the distal end of the barrel; A fixture assembly including a movable striking member configured to selectively apply a load to a distal end of the cannula spaced from the fulcrum.

2. The fixture assembly of claim 1 , further comprising the drug delivery device disposed within the barrel container.

3. The jig assembly of any one of claims 1 to 2, wherein the striking member is positioned a predetermined distance from the distal end face and a fulcrum of the cannula.

4. The predetermined distance is 25 ＊ D ２ 4. The jig assembly of claim 3, wherein D is the outer diameter of the cannula in millimeters.

5. 5. The jig assembly of claim 3, further comprising a plurality of gauge blocks for setting a predetermined distance between the striking member and the distal end face, each gauge block having a distinct length dimension corresponding to one of a plurality of predetermined cannulas.

6. 6. The fixture assembly of claim 5, wherein each gauge block accommodates cannula gauges from 10 gauge to 34 gauge.

7. The jig assembly of any one of claims 1 to 6, wherein the jig blocks include a first jig block and a second jig block.

8. The fixture assembly of claim 7 , wherein the first fixture block and the second fixture block are joined in a clamshell configuration.

9. 9. The fixture assembly of claim 7 or 8, wherein each fixture block has a first end, a second end, and defines a barrel groove extending between the first end and the second end, and the first and second fixture blocks are adapted to be mated together such that the barrel grooves align with one another to form the corresponding barrel container.

10. 10. The jig assembly of claim 7, further comprising a latch that secures the first jig block and the second jig block together.

11. 11. The jig assembly of claim 7, further comprising a first end plate and a second end plate coupled to second ends of the first and second jig blocks, respectively, each end plate defining a plunger groove, the plunger grooves collectively defining a plunger receptacle for accommodating a plunger rod of the drug delivery device when the drug delivery device is disposed within the barrel receptacle.

12. 12. The jig assembly of claim 1, wherein the jig block includes a support block having a top support surface and a distal end surface, and wherein the cannula extends across the top support surface of the support block when the drug delivery device is housed within the barrel container.

13. The fixture assembly of claim 12 , wherein the fixture block is formed of a first material and the support block is formed of a second material different from the first material.

14. 1. A method for testing the resilience of a cannula of a drug delivery device, comprising: securing a barrel of a drug delivery device within a fixture such that the cannula secured to a distal end of the barrel extends outwardly from the fixture; applying a lateral force to the distal end of the cannula with a striking member to move the distal end of the cannula a threshold distance; removing the force from the cannula; determining a final position of the distal end of the cannula after the force is removed; further comprising the step of defining a fulcrum for the cannula spaced from the distal end of the barrel; the step of defining the fulcrum includes providing the jig with a pair of jig blocks and support blocks extending from the jig blocks, the support blocks defining a top support surface that supports the cannula and a distal end surface that is spaced from the distal end of the barrel of the drug delivery device and from which the distal end of the cannula extends further, whereby the fulcrum of the cannula is located at the distal end surface of the support blocks. method.

15. 15. The method of claim 14, further comprising determining an initial position of the distal end of the cannula by moving the striking member into contact with the distal end of the cannula before applying the force to the distal end of the cannula.

16. 16. The method of claim 15, further comprising determining a change between the final position and the initial position by moving the striking member into contact with the distal end of the cannula.

17. 17. The method of claim 15 or 16, further comprising determining the change in angle of the cannula between the final position and the initial position.

18. The method of any one of claims 14-17, further comprising the step of positioning the striking member a predetermined distance from a fulcrum of the cannula before applying a lateral force to the distal end of the cannula.

19. The step of positioning the striking member comprises positioning the striking member 25° from the fulcrum of the cannula. ＊ D ２ 20. The method of claim 18, comprising the step of positioning the cannula at a distance of D from the outer diameter of the cannula in millimeters.

20. 20. The method of claim 18 or 19, wherein the step of positioning the striking member comprises the steps of selecting one gauge block from a plurality of gauge blocks based on an outer diameter of the cannula, placing the selected gauge block in a fixture adjacent to the cannula, and moving the striking member into contact with the selected gauge block.

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