Drug delivery device fixture for testing system and method therefor - Patents.com

Abstract

A syringe fixator for holding a syringe in a test system includes a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber, the first chamber including a plurality of first walls having a first length and a plurality of second walls having a second length, the second length being less than the first length, the plurality of first walls and the plurality of second walls forming a housing for at least a needle of the syringe, the second chamber configured to hold at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe, and a base having a support, the base configured to receive a portion of a plunger rod of the syringe, the base including at least one geometric feature configured to enable or impart rotational movement to a portion of the plunger rod received within the base.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 287,500, filed December 8, 2021, which is incorporated by reference herein in its entirety.

[0002] The present disclosure is directed to a drug delivery device (eg, syringe) fixator for a testing system and methods of use thereof. [Background technology]

[0003] Mechanical testing systems, such as tension and compression testing systems, are used in laboratories to perform real-time analysis. Examples of such devices are the Instron® “Low Force Universal Testing Systems” and the Instron® “High Force Universal Testing Systems” (Instron, www.instron.com / en-us / products / testing-systems / universal-testing-systems, incorporated herein by reference). While such mechanical testing systems offer many beneficial applications, they are large and expensive pieces of equipment that are not easily adaptable to analyze a wide variety of devices. Additional components for the testing system need to be acquired to properly hold the device of interest (e.g., a syringe, auto-injector, or other suitable drug delivery device) so that the testing system can accurately analyze the functional forces of such devices. Depending on the device's components, size, and / or configuration, it can be difficult to properly secure the device within the testing system so that accurate tests and measurements can be obtained. Even slight disturbances can affect the results generated from the testing system. For example, imprecise alignment of the device within the testing system can affect the results. The test system should be configured to properly hold and support the device of interest to ensure accurate testing and analysis. Summary of the Invention

[0004] In one aspect, the present disclosure describes a syringe fixator for holding a syringe in a test system, the fixator comprising: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber, the first chamber including a plurality of first walls having a first length and a plurality of second walls having a second length, the second length being less than the first length, the plurality of first walls and the plurality of second walls forming a housing for at least a needle of the syringe, the second chamber configured to hold at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe; and a base having a support, the base configured to receive a portion of a plunger rod of the syringe, the base including at least one geometric feature configured to enable or impart rotational movement to a portion of the plunger rod received within the base.

[0005] Various embodiments of the syringe fixator may include one or more of the following aspects: The base may include a holder for a plunger rod of the syringe and a casing, the casing and holder may be configured to be secured together with a fastener to support the plunger rod. The base may include a lug configured to receive the plunger rod of the syringe and a connector, the lug and connector may be secured together to support the plunger rod. The second chamber may be removable from the main housing. The second chamber may have a first configuration and may be interchangeable with a different second chamber having a second configuration, the second configuration being different from the first configuration. The plurality of second walls may include a top wall and a bottom wall, the top wall including a fastener for securing the main housing to a test system. The support of the base may include a plurality of threaded holes for securing the base to a test system. The cover may be attached to the second chamber with a plurality of hinges and a closure, the closure configured to allow the cover to be opened and closed. The second chamber may include a chamber extension extending from a bottom of the second chamber and the cover may include a cover extension extending from a bottom of the cover, each portion may have a height of about 4.80 mm to about 5.20 mm. The chamber extension of the second chamber and the cover extension of the cover may each have a length of about 13.22 mm to about 13.62 mm. The spacing between the chamber extension of the second chamber and the cover extension of the cover may be about 12.95 mm to about 13.35 mm. The first chamber of the main housing may be configured to be secured to a movable portion of a test system and the support of the base may be configured to be secured to a stationary portion of a test system. The first chamber of the main housing may be configured to be secured to a stationary portion of a test system and the support of the base may be configured to be secured to a movable portion of a test system.

[0006] In another aspect, the present disclosure describes a syringe fixator for holding a syringe in a test system, the fixator comprising: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber, the first chamber including a housing for at least a needle of the syringe, the second chamber configured to receive at least a flange portion of the syringe, and the second chamber including a cover for enclosing at least the flange portion of the syringe; and a base having a support, the base including a lug configured to receive a plunger rod of the syringe and a connector, the lug and connector being fixed together to support the plunger rod.

[0007] Various embodiments of the syringe fixator may include one or more of the following aspects: The base may include a thumb nut for securing and stabilizing the lug and connector to the test system; The lug may include an opening for receiving a portion of the plunger rod, the opening may include a plurality of ridges configured to engage the portion of the plunger rod; The lug may include a first end having a first diameter and a second end having a second diameter, the second diameter being larger than the first diameter, and the lug may include a sidewall extending from the first end to the second end, the sidewall flaring outwardly from the first end to the second end.

[0008] In another aspect, the present disclosure describes a method for testing a syringe, the method comprising: fixing a syringe fixator to a test system, the fixator comprising a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber, the first chamber including a housing for at least a needle and a needle cap of the syringe, the second chamber configured to hold at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe, and a base having a support; and inserting the syringe into the syringe fixator. Various methods of the present disclosure may further comprise fixing the first chamber of the main housing to a movable part of the test system and fixing the support of the base to a stationary part of the test system, or may further comprise fixing the first chamber of the main housing to a stationary part of the test system and fixing the support of the base to a movable part of the test system. [Brief description of the drawings]

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various examples and, together with the description, serve to explain the principles of the disclosed examples and embodiments. Aspects of the present disclosure may be implemented in conjunction with the embodiments illustrated in the accompanying drawings, which depict different aspects of the disclosure, and where appropriate, reference numerals designating like structures, components, materials, and / or elements in different drawings are similarly labeled. It is understood that various combinations of structures, components, and / or elements other than those specifically shown are contemplated and are within the scope of the present disclosure.

[0010] Moreover, many embodiments are described and illustrated herein. The present disclosure is not limited to any single aspect or embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Moreover, each of the aspects of the present disclosure and / or its embodiments can be used alone or in combination with one or more of the other aspects and / or embodiments of the present disclosure. For the sake of brevity, certain permutations and combinations are not separately described and / or illustrated herein. In particular, an embodiment or implementation described herein as "exemplary" should not be construed as being preferred or advantageous over other embodiments or implementations, for example, but rather is intended to reflect or indicate that the embodiment(s) are "example" embodiment(s). [Figure 1A-1C] FIG. 1A is a front view of a syringe fixator according to an embodiment of the present disclosure, FIG. 1B is a side view of the main housing of the syringe fixator, and FIG. 1C is an exemplary syringe that may be utilized with the syringe fixator. [Diagram 2] FIG. 2 is a side view of a syringe fixator according to an embodiment of the present disclosure. [Diagram 3] FIG. 3 is a perspective view of a syringe fixator according to an embodiment of the present disclosure. [Figure 4A-4D] FIG. 4A is a perspective view of the main housing, FIGS. 4B and 4C are front views of the main housing, and FIG. 4D is a detailed view of the second chamber of the main housing, according to an embodiment of the present disclosure. [Figure 5A-5D] 5A-5D are front views of a syringe fixator including detailed views of the interior of the first chamber, according to an embodiment of the present disclosure. [Figures 6A-6D] FIG. 6A is a perspective view of the main housing, and FIGS. 6B-6D are bottom views of the second chamber, according to an embodiment of the present disclosure. [Figure 7A-7D] FIG. 7A is a perspective view of a cover for a second chamber, and FIGS. 7B-7D are detailed views of the interior of the cover, according to an embodiment of the present disclosure. [Figure 8A-8C]FIG. 8A is a perspective view of a cover for a second chamber, and FIGS. 8B and 8C are bottom views of the cover, according to an embodiment of the present disclosure. [Figure 9A-9D] FIG. 9A is a perspective view of a base holder, and FIGS. 9B-9D are top views of the holder, according to an embodiment of the present disclosure. [Figure 10A-10D] 10A-10D are front views of a base holder, the holder enclosing a syringe, according to an embodiment of the present disclosure. [Figures 11A-11F] FIG. 11A is a perspective view of a syringe fixator according to an embodiment of the present disclosure, FIG. 11B is a perspective view of a base casing of the syringe fixator, FIGS. 11C and 11D are top views of the casing, and FIGS. 11E and 11F are front views of the casing. [Figures 12A-12E] FIG. 12A is a perspective view of a syringe fixator according to an embodiment of the present disclosure, FIG. 12B is a perspective view of a base of the syringe fixator, the base including a lug and a connector, FIG. 12C is a side view of the base, and FIGS. 12D and 12E are top views of the lug. [Figure 13A-13B] FIG. 13A is a side view of the base lug of FIG. 12A, and FIG. 13B is a cutaway view of the lug along line EE of FIG. 12E. [Figure 14] FIG. 14 is an isometric view of how the syringe fits inside the base, according to an embodiment of the present disclosure. [Figure 15] FIG. 15 is a diagram of a syringe fixator in an inverted position according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] As used herein, the terms "comprises," "comprising," "includes," "including," or other similar terms are intended to include a non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements can include not only those elements, but also other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." In addition, terms such as "first," "second," and the like are used herein not to denote any order, quantity, or importance, but rather to distinguish one element or structure from another. Furthermore, the terms "a" and "an" are used herein not to denote a limitation of quantity, but rather to denote the presence of one or more of the referenced items.

[0012] Among other things, for simplicity and clarity of description, certain aspects of the drawings show schematic structures and / or methods of construction of various embodiments. Descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring other features. Elements in the drawings are not necessarily drawn to scale, and dimensions of some features may be exaggerated relative to other elements to improve understanding of the illustrative embodiments. For example, those skilled in the art will appreciate that side views are not drawn to scale and should not be viewed as depicting proportional relationships between separate components. Side views are provided to help illustrate various components of the depicted assemblies and to show their relative positional relationships.

[0013] Reference will now be made in detail to examples of the present disclosure, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. In the following description, relative terms such as "about," "substantially," and "approximately" are used to indicate possible variations in the numerical range of the values ​​set forth below, as specified below.

[0014] As disclosed on the Instron® website, www.instron.com / en-us / products / testing-systems / universal-testing-systems, Instron® systems are large mechanical testing instruments that can be used to perform a variety of mechanical tests, such as tension, compression, bending, peeling, and tearing. Syringes are an example of a category of devices that can be analyzed using a test system such as an Instron®. As discussed above and as disclosed on the Instron® system website, existing mechanical testing systems may require additional specific components in addition to the large and expensive test system itself to securely hold the device in the test and analysis. For example, multiple syringes may have varying dimensions, configurations, and / or components such that a fixture for holding a first type of syringe in a test system may not be capable of holding a second type of syringe in the same test system. Additionally, a universal fixture sold by a test system manufacturer may not adequately and securely hold the syringe being tested. During functional force testing, e.g., release and / or glide force testing, the plunger rod of the syringe can be pushed to mimic the dosing and injection steps. For torque force testing, the plunger rod can be twisted to mimic the priming step. If the syringe is not properly secured within the test system, pushing or twisting the syringe may cause it to move within the test system. In addition, if the fixture does not properly secure the syringe within the test system, the force on the syringe components, e.g., the plunger rod, may cause the syringe to slip out of the fixture used in the test system. As previously mentioned, during some mechanical tests, e.g., to analyze torque force, the syringe components can be twisted to initiate the injection step.If the syringe is not coaxially aligned with the fixture, it will create additional torque from any misalignment between the syringe and the test system. It is therefore important that the syringe, syringe fixture, and test system components are coaxially aligned. Any of the above situations, such as misalignment or instability of the device being tested by the system, will cause the test system to provide inaccurate measurements and / or require the user to perform multiple tests, hindering efficiency.

[0015] Although this disclosure makes reference to an Instron® testing mechanism, one of ordinary skill in the art will readily recognize that the concepts of the present disclosure may be utilized with any suitable or equivalent testing mechanism or machine (e.g., ZWICKROELL, ADMET, MECMESIN, TEST RESOURCES, etc.). Additionally, although this disclosure makes reference to testing the force applied to a syringe, one of ordinary skill in the art will readily recognize that the reference to a syringe is exemplary only and that the concepts of the present disclosure may be used with any suitable drug delivery device, including, but not limited to, autoinjectors and syringes (both plastic and glass).

[0016] Thus, the present disclosure is directed to various embodiments of a syringe fixture that holds the syringe with sufficient stability and in proper alignment with the test system throughout the test period. In some examples, the syringe is a precision dose delivery system as described in International Publication Nos. WO 2019 / 118588 and WO 2020 / 247686, and U.S. Design Application Nos. 29 / 760,798 and 29 / 760,796, which are incorporated herein by reference in their entireties.

[0017] SUMMARY OF THE DISCLOSURE Embodiments of the present disclosure relate to a syringe fixator, and in particular to a syringe fixator for holding a syringe in a test system (e.g., a mechanical test system such as an Instron® test device). FIG. 1A shows a front view of a syringe fixator 100 for a test system. The syringe fixator 100 may be designed to hold any commercially known syringe (or other suitable drug delivery device). The syringe fixator 100 may be formed of any suitable material having sufficient weight and components to aid in the stability of the test fixator and / or having any properties suitable for use in a laboratory environment. For example, the syringe fixator 100 may be made from a plastic material and / or other chemically resistant material. In some embodiments, the syringe fixator 100 may be made from a metal machined into a desired configuration.

[0018] Syringe fixator 100 may include a main housing 120 and a base 130. Main housing 120 may include a first chamber 122, a second chamber 124, and an opening 134 extending from first chamber 122 to second chamber 124.

[0019] The first chamber 122 may include a plurality of first walls 150a, 150b and a plurality of second walls 152a, 152b (FIGS. 5A-5D). The plurality of first walls 150a, 150b and the plurality of second walls 152a, 152b may define an upper opening 134a (FIG. 4B). The first chamber 122 and the upper opening 134a may be of any suitable size and / or shape to accommodate a portion of the syringe 105, as described in detail below. In some variations, the upper opening 134a may not be open, but may be a solid wall coupled to the walls 150a, 150b, 152a, and 152b to provide additional structure and support to the testing fixture.

[0020] The second chamber 124 may include a plurality of first walls 160a, 160b and a plurality of second walls 162a, 162b (FIG. 4A). The plurality of first walls 160a, 160b and the plurality of second walls 162a, 162b may define a bottom opening 134b (FIG. 4B). In some variations, the bottom opening 134b may not be open, but may be a solid wall coupled to the walls 160a, 160b, 162a, 162b to provide additional structure and support to the test fixture. The second chamber 124 may also include a cover 106. The cover 106 may be attached to the second chamber 124 using any suitable attachment means. For example, the cover 106 may be attached to the second chamber 124 using a hinge 107. In some embodiments, the cover 106 may be attached to the second chamber 124 using a pair of hinges 107. The cover 106 may be solid (FIG. 5A) or may include a window 108 that allows a user to view the second chamber 124 and / or the interior of the body of the syringe 105 as well as the contents of the syringe (FIG. 5C). The window 108 may be an opening or may be made of a translucent material. The cover 106 may be moved and / or secured with any suitable closure 113, e.g., a handle or knob, to allow a user to properly insert the syringe 105 into the second chamber 124. The cover 106 may include a receiving feature 113b for securing the closure 113 to the cover 106. For example, the cover 106 can be opened and closed using the closure 113. The closure 113 may also be used to lock the cover 106 to the second chamber 124 by attaching to the receiving feature 113b to securely hold the syringe 105. With reference to FIG. 1A, the portion of the syringe fixator 100 including the first chamber 122 and the second chamber 124 relative to the cover 106 may be referred to as the case 104.

[0021] 2, the second chamber 124 may include a chamber extension 202 extending from a bottom of the second chamber 124. The cover 106 may include a cover extension 204 extending from a bottom of the cover 106. The chamber extension 202 is also shown in FIG. 6A, and the cover extension 204 is also shown in FIG. 7A. The chamber extension 202 and the cover extension 204 may provide additional stability to the second chamber 124 and the main housing 120. In another example, the chamber extension 202 and the cover extension 204 may provide a view of the plunger 128, also referred to herein as the plunger rod 128, as the plunger 128 approaches the flange body 118. The height of these extensions may be selected so as not to interfere with components of the syringe 105, such as the plunger end 109 of the syringe. Each of these extensions, shown as A in FIG. 2, may have a height of about 4.00 mm to about 6.00 mm. For example, the height of each extension can be about 4.20 mm to about 5.80 mm, about 4.40 mm to about 5.60 mm, about 4.60 mm to about 5.40 mm, about 4.80 mm to about 5.20 mm, about 4.90 mm to about 5.10 mm, or about 5.00 mm. In some examples, each extension can have a height that is about 4.80 mm to about 5.20 mm or about 5.00 mm ± 0.20 mm. As shown in FIG. 1A, when syringe 105 is inserted into second chamber 124, a portion of syringe 105, e.g., plunger end 109 and plunger 128, can extend between and beyond chamber extension 202 and cover extension 204. 2, the spacing (clearance) 206 between the chamber extension 202 and the cover extension 204 can be configured to allow sufficient space for the plunger end 109 and plunger 128 so that the main housing 120 can fit well into the base 130. The spacing 206 has a width, designated as B in FIG. 2, of about 12.00 mm to about 14.00 mm, about 12.35 mm to about 13.95, about 12.55 mm to about 13.75 mm, about 12.75 mm to about 13.55 mm, about 12.95 mm to about 13.35 mm, about 13.05 mm to about 13.25 mm, or about 13.15 mm.In some examples, the spacing 206 has a width of 12.95 mm to about 13.35 mm or about 13.15 mm ±0.20 mm.

[0022] Second chamber 124 may be of any suitable size and / or shape to accommodate a portion of syringe 105. For example, flange 117 and flange body 118 may fit within second chamber 124 such that syringe 105 is stably secured thereto. With reference to FIGS. 4B-4D, second chamber 124 may include various cavities configured to securely hold flange 117 and flange body 118 such that there is limited or no space between flange 117 and the cavity of second chamber 124.

[0023] The second chamber 124 may include a first cavity 402, a second cavity 404, and a third cavity 408. The first cavity 402 may be of any suitable size and / or shape to accommodate a portion of the syringe body 116 distal from the flange 117. As shown in FIG. 4D, the first cavity 402 may have a diameter, indicated as F, of about 9.00 mm to about 12.00 mm, 10.00 mm to about 11.00 mm, about 10.10 mm to about 10.90 mm, about 10.20 mm to about 10.80 mm, about 10.30 mm to about 10.80 mm, about 10.40 mm to about 10.80 mm, about 10.50 mm to about 10.70 mm, or about 10.60 mm. In some examples, the first cavity 402 has a diameter of about 9.60 mm to about 10.40 mm or about 10.80 mm ±0.20 mm.

[0024] The second cavity 404 may be of any suitable size and / or shape to accommodate the flange 117. The second cavity 404 may include arm cavities 406a, 406b. The arm cavities 406a, 406b may have a height, shown as D in FIG. 4D, of about 2.00 mm to about 2.50 mm, about 2.05 mm to about 2.45 mm, about 2.10 mm to about 2.40 mm, about 2.15 mm to about 2.40 mm, about 2.20 mm to about 2.40 mm, or about 2.30 mm. In some examples, the arm cavities 406a, 406b have a height of about 2.22 mm to about 2.38 mm or about 2.30 mm ±0.08 mm.

[0025] The third cavity 408 may be of any suitable size and / or shape to accommodate the flange body 118. As shown in FIG. 4D, the third cavity 408 may include an extension 202 that extends beyond the bottom of the second chamber 124, as described in detail above. The third cavity 408 and extension 202 may have a diameter, shown as E in FIG. 4D, of about 13.00 mm to about 14.00 mm, about 13.10 mm to about 13.90 mm, about 13.15 mm to about 13.80 mm, about 13.20 mm to about 13.70 mm, about 13.22 mm to about 13.62 mm, about 13.32 mm to about 13.52 mm, or about 13.42 mm. In some examples, the diameter is in the range of about 13.22 mm to about 13.62 mm or 13.42 ± 0.20 mm.

[0026] 6A-6D, the third cavity 408 may be of any suitable size and / or shape to accommodate the flange body 118. In a bottom view (FIG. 6B) of the second chamber 124, the third cavity 408 may include a rim 604 and shoulders 602a, 602b. As shown in FIG. 6D, the distance shown as G between the inner curve of shoulder 602a and the inner curve of shoulder 602b may be about 13.00 mm to about 14.00 mm, about 13.05 mm to about 13.90 mm, about 13.10 mm to about 13.80 mm, about 13.15 mm to about 13.70 mm, about 13.20 mm to about 13.65 mm, about 13.22 mm to about 13.62 mm, about 13.32 mm to about 13.52 mm, or about 13.42 mm. In some examples, the distance between the inner curve of shoulder 602a and the inner curve of shoulder 602b is between about 13.22 mm and about 13.62 mm or 13.42±0.20 mm.

[0027] In some examples, the distance shown as H in FIG. 6D from the inner curve of the rim 604 to the bottom of either of the shoulders 602a, 602b can be about 6.00 mm to about 7.50 mm, about 6.10 mm to about 7.40 mm, about 6.20 mm to about 7.30 mm, about 6.30 mm to about 7.20 mm, about 6.40 mm to about 7.10 mm, about 6.50 mm to about 7.00 mm, about 6.52 mm to about 6.92 mm, about 6.62 mm to about 6.82 mm, or about 6.72 mm. In some examples, this distance from the inner curve of the rim 604 to the bottom of either of the shoulders 602a, 602b is about 6.52 mm to about 6.92 mm or about 6.72 ± 0.20 mm.

[0028] The cover 106 is attached to the second chamber 124 to enclose and securely hold portions of the syringe 105, such as the flange 117 and the flange body 118, and the cover 106 may be of any suitable size and / or shape. For example, when the flange 117 and the flange body 118 are inserted into the second chamber 124, the cover 106 may be disposed over the second chamber 124 to enclose such portions of the syringe 105. With reference to FIGS. 7A-7D, the cover 106 may include a number of cavities corresponding to the cavities 402, 404, 408 of the second chamber 124. The cavities of the cover 106 may be configured to securely hold the flange 117 and the flange body 118 such that there is limited or no space between the flange 117 and the corresponding cavity walls of the cover 106. For example, a portion of the syringe 105 and the cover 106 may fit together such that there is limited or no space between the portion of the syringe 105 and the interior of the cover 106 .

[0029] The cover 106 may include a first cavity 702, a second cavity 704, and a third cavity 708. The first cavity 702 may be of any suitable size and / or shape to accommodate a portion of the syringe body 116 distal to the flange 117. As shown in FIG. 7D, the first cavity 702 may have a diameter of about 10.00 mm to about 11.00 mm, about 10.10 mm to about 10.90 mm, about 10.20 mm to about 10.80 mm, about 10.30 mm to about 10.80 mm, about 10.40 mm to about 10.80 mm, about 10.50 mm to about 10.70 mm, or about 10.60 mm. In some examples, the first cavity 702 has a diameter of about 9.60 mm to about 10.40 mm or about 10.80 mm ±0.20 mm.

[0030] The second cavity 704 may be of any suitable size and / or shape to accommodate the flange 117. The second cavity 704 may include arm cavities 706a, 706b. The arm cavities 706a, 706b may have a height, shown as I in FIG. 7D, of about 2.00 mm to about 2.50 mm, about 2.05 mm to about 2.45 mm, about 2.10 mm to about 2.40 mm, about 2.15 mm to about 2.40 mm, about 2.20 mm to about 2.40 mm, or about 2.30 mm. In some examples, the arm cavities 706a, 706b have a height of about 2.22 mm to about 2.38 mm or about 2.30 mm ±0.08 mm.

[0031] The third cavity 708 may be of any suitable size and / or shape to accommodate a portion of the flange body 118. As shown in FIG. 7D, the third cavity 708 may include an extension 204 as described in detail above that extends beyond the bottom of the cover 106. The third cavity 708 and extension 204 may have a diameter, shown as J in FIG. 7D, of about 13.00 mm to about 14.00 mm, about 13.10 mm to about 13.90 mm, about 13.15 mm to about 13.80 mm, about 13.20 mm to about 13.70 mm, about 13.22 mm to about 13.62 mm, about 13.32 mm to about 13.52 mm, or about 13.42 mm. In some examples, the diameter is about 13.22 mm to about 13.62 mm or 13.42 ± 0.20 mm.

[0032] 8A-8C, the third cavity 708 can be of any suitable size and / or shape to accommodate the plunger body 118. In a bottom view of the cover 106 (FIG. 8B), the third cavity 708 can include a rim 804 and shoulders 802a, 802b. As shown in FIG. 8C, the distance, indicated as K, between the inner curve of shoulder 802a and the inner curve of shoulder 802b can be about 13.00 mm to about 14.00 mm, about 13.05 mm to about 13.90 mm, about 13.10 mm to about 13.80 mm, about 13.15 mm to about 13.70 mm, about 13.20 mm to about 13.65 mm, about 13.22 mm to about 13.62 mm, about 13.32 mm to about 13.52 mm, or about 13.42 mm. In some examples, the distance between the inner curve of shoulder 802a and the inner curve of shoulder 802b is between about 13.22 mm and about 13.62 mm or 13.42±0.20 mm.

[0033] 8C from the inner curve of the rim 804 to the bottom of either of the shoulders 802a, 802b can be about 6.00 mm to about 7.50 mm, about 6.10 mm to about 7.40 mm, about 6.20 mm to about 7.30 mm, about 6.30 mm to about 7.20 mm, about 6.40 mm to about 7.10 mm, about 6.50 mm to about 7.00 mm, about 6.52 mm to about 6.92 mm, about 6.62 mm to about 6.82 mm, or about 6.72 mm. In some examples, the distance from the inner curve of the rim 804 to the bottom of either of the shoulders 802a, 802b is about 6.52 mm to about 6.92 mm or about 6.72 ± 0.20 mm.

[0034] One or more of the cavities 402, 404, 408 of the second chamber 124 and one or more of the cavities 702, 704, 708 of the cover 106 may include features to aid in gripping the syringe 105 within the cavities of the second chamber 124 and the cover 106. For example, one or more of the cavities may include a polished coating, a silicone coating, or an elastic coating to provide a closer and / or tighter hold between the portions of the syringe 105 and the cavities of the second chamber 124 and the cover 106. In other examples, the dimensions of the cavities can be tailored to be rectangular geometric shapes to aid in gripping the syringe 105. In still other examples, support structures, geometric features, or textures, such as ribs, bumps, or protrusions, may be included to aid in gripping the syringe 105.

[0035] In an embodiment of the present disclosure, the second chamber 124 may be removable from the main housing 120, as shown by the dashed lines in FIG. 5C. As detailed above, the second chamber 124 and the cavities 402, 404, 408 may have various sizes and / or shapes to properly receive and securely hold a portion of the syringe 105, such as the flange 117 and the flange body 118. It is understood that different syringes may have different sizes and / or configurations. To adapt the syringe fixator 100 so that a variety of commercially available syringes can be used with the syringe fixator 100, it may be useful to have different configurations of the second chamber 124 that can be interchanged within the main housing 120. For example, the second chamber 124 having a first configuration may be removed from the main housing 120 in order to insert a different second chamber having a different configuration into the interior of the main housing 120. In some embodiments, the syringe fixator 100 may be sold or provided in a kit with multiple second chambers, each second chamber having a different configuration for use with a different syringe.

[0036] The base 130 may include a casing 110, a holder 111, and a support 112. The holder 111 may be configured to securely hold a plunger top 119 of the syringe 105. With reference to FIGS. 1C, 2, 3, and 9A-9D, the plunger top 119 may be inserted into the holder 111. The holder 111 may have any suitable configuration for holding the plunger top 119 in a stable position between the first ring 129a and the second ring 129b and in coaxial alignment with the remainder of the syringe fixator 100. For example, the holder 111 may have a first plurality of side walls 910a, 910b and a second plurality of side walls 912a, 912b, the plurality of side walls extending between a bottom 914 and a top 916 to form a cavity 918. 9A , the bottom portion 914 may have a length that is greater than the length of the top portion 916. The side walls may have various configurations to provide stable support for the syringe 105. For example, one or more of the second plurality of side walls 912a, 912b may be angled or curved inwardly toward the cavity 918.

[0037] The plunger top 119 of the syringe 105 may fit into the top 916 of the holder 111 (see FIGS. 9A-9D). The top 916 may include a retaining portion 921 configured to receive the plunger top 119 between the first ring 129a and the second ring 129b. The top 916 may also include a notch 924. A portion of the plunger top 119, such as the protrusion 131, may fit into the notch 924 to securely retain the plunger top 119. The top 916 may also include an opening 920 for holding a portion of the syringe 105, such as a trigger or injection button. The bottom 914 may include an opening 922 configured to receive a fastener, such as a screw, for securing the bottom 914 to the support 112.

[0038] 9D illustrates various dimensions of the upper portion 916. For example, the notch 924 can have a width, shown as M, of about 2.50 mm to about 3.50 mm, about 2.70 mm to about 3.30 mm, about 2.70 mm to about 3.10 mm, about 2.80 mm to about 3.00 mm, or about 2.90 mm. In some examples, the notch 924 has a width of about 2.70 mm to about 3.10 mm or 2.90±0.20 mm. Additional measurements of the upper portion 916 can be made with reference to the inner circumference 926. The upper portion 916 may include a number of shoulders 928a, 928b, where the distance, designated as P, from the outer edge of either of the shoulders 928a, 928b to the inner periphery 926 is about 2.00 mm to about 3.00 mm, about 2.14 mm to about 2.94 mm, about 2.24 mm to about 2.84 mm, about 2.34 mm to about 2.54 mm, or about 2.44 mm. In some examples, this distance from the outer edge of either of the shoulders 928a, 928b to the inner periphery 926 is about 2.34 mm to about 2.54 mm or 2.44 mm ±0.10 mm. The distance, designated as O, from the upper edge of either of the shoulders 928a, 928b to the central axis of the inner circumference 926 is about 1.00 mm to about 2.00 mm, about 1.15 mm to about 1.85 mm, about 1.25 mm to about 1.65 mm, about 1.35 mm to about 1.55 mm, or about 1.45 mm. In some examples, the distance from the upper edge of either of the shoulders 928a, 928b to the central axis of the inner circumference 926 is about 1.25 mm to about 1.65 mm or 1.45 mm ± 0.20 mm. The upper edge of the notch 924 relative to the inner circumference 926, designated as N, is in the range of about 2.00 mm to about 3.00 mm, about 2.20 mm to about 2.80 mm, about 2.30 mm to about 2.60 mm, about 2.37 mm to about 2.57 mm, or about 2.47 mm. In some examples, this distance from the upper edge of the notch 924 to the inner periphery 926 is between about 2.37 mm and about 2.57 mm or 2.47 mm ±0.10 mm.

[0039] The shoulders 928a, 928b can be configured to receive protrusions on the plunger top 119. In some embodiments, the plunger top 119 can include multiple protrusions that can be received in any combination of the notch 924 and the shoulders 928a, 928b. For example, if the protrusions on the plunger top 119 are equidistant from each other (e.g., FIG. 1C), the syringe may be able to be rotated and still be received within the holder 111.

[0040] 10A-10D show the holder 111 with the plunger top 119 inserted. FIG. 10D shows various dimensions with reference to the plunger top 119 inserted within the holder 111. The maximum diameter 1102 of the holder 111 corresponds to the maximum diameter 1010 of the casing 110 and can be about 16.50 mm to about 17.50 mm, about 16.55 mm to about 17.40 mm, about 16.60 mm to about 17.30 mm, about 16.60 mm to about 17.20 mm, about 16.60 mm to about 17.10 mm, about 16.62 mm to about 17.02 mm, about 16.72 mm to about 16.92 mm, or about 16.82 mm. In some examples, this diameter is about 16.62 mm to about 17.02 mm or 16.82 mm ±0.20 mm.

[0041] The height of the top 916 of the holder 111, indicated by 1104 in FIG. 10D, which secures the plunger top 119, can be about 4.50 mm to about 5.50 mm, about 4.60 mm to about 5.40 mm, about 4.70 mm to about 5.30 mm, about 4.80 mm to about 5.20 mm, about 4.90 mm to about 5.20 mm, about 4.92 mm to about 5.12 mm, or about 5.02 mm. In some examples, the height is about 4.92 mm to about 5.12 mm or 5.02 mm ±0.10 mm.

[0042] When the syringe 105 is attached to the holder 111, the retaining portion 921 fits between the first ring 129a and the second ring 129b of the plunger top 129. The height of the first ring 129a housed within the holder 111 is shown as 1106 in FIG. 10D and can be about 2.00 mm to about 3.00 mm, about 2.05 mm to about 2.50 mm, about 2.10 mm to about 2.45 mm, about 2.15 mm to about 2.40 mm, about 2.17 mm to about 2.37 mm, or about 2.27 mm. In some examples, the height is about 2.17 mm to about 2.37 mm or 2.27±0.10 mm. In addition, the height of the second ring 129b housed within the holder 111 is shown as 1108 in FIG. 10D and can be about 2.00 mm to about 3.00 mm, about 2.10 mm to about 2.90 mm, about 2.20 mm to about 2.80 mm, about 2.30 mm to about 2.60 mm, about 2.36 mm to about 2.56 mm, or about 2.46 mm. In some examples, the height can be 2.36 mm to about 2.56 mm, or about 2.46 mm ±0.10 mm.

[0043] The casing 110 may be positioned over or aligned with and receive a portion of the holder 111. A fastener 114 may be inserted into one or both of the casing 110 and the holder 111 to receive and securely hold the plunger top 119. The fastener 114 may be a key, rod, pin, or any suitable means for locking the casing 110 and holder 111 together.

[0044] 11A-11F, the casing 110 may have a plurality of side walls 1002a, 1002b, 1002c, a top wall 1004, and a second retention area 1001 configured to surround a portion of the plunger top 119. When the casing 110 is attached to the holder 111 using the fastener 114, the retention portion 921 of the holder 111 and the second retention area 1001 of the casing 110 may securely hold the plunger top 119 within the base 130. One or more of the plurality of side walls 1002a, 1002b, 1002c may include a through hole configured to receive the fastener 114. The top wall 1004 may have a configuration corresponding to the holder 111 such that the casing 110 and the holder 111 together may form a secure hold of the plunger top 119. In some examples, the top wall 1004 may include a notch 1006. A portion of the plunger top 119, such as protrusion 131, may fit within notch 1006 to securely retain the plunger top 119. The configuration of notch 1006 may be complementary to notch 924 such that notch 1006 and notch 924 together may securely retain the plunger top 119. In other examples, the casing 110 and holder 111 may include any number of notches or protrusions that allow for rotation of the syringe 105.

[0045] 11D illustrates various dimensions of the top wall 1004. For example, the notch 1006 can have a width, shown as Q, of about 2.50 mm to about 3.50 mm, about 2.70 mm to about 3.30 mm, about 2.70 mm to about 3.10 mm, about 2.80 mm to about 3.00 mm, or about 2.90 mm. In some examples, the notch 1006 has a width of about 2.70 mm to about 3.10 mm or 2.90±0.20 mm. Additional measurements of the top wall 1004 can be made with reference to the inner circumference 1008. The top wall 1004 may include a number of shoulders 1007a, 1007b, where the distance, designated as T, from the outer edge of either of the shoulders 1007a, 1007b to the inner periphery 1008 is about 2.00 mm to about 3.00 mm, about 2.14 mm to about 2.94 mm, about 2.24 mm to about 2.84 mm, about 2.34 mm to about 2.54 mm, or about 2.44 mm. In some examples, the distance from the outer edge of either of the shoulders 1007a, 1007b to the inner periphery 1008 is about 2.34 mm to about 2.54 mm or 2.44 mm ±0.10 mm. The distance, designated S, from the upper edge of either shoulder 1007a, 1007b to the central axis of inner circumference 1008 is about 1.00 mm to about 2.00 mm, about 1.15 mm to about 1.85 mm, about 1.25 mm to about 1.65 mm, about 1.35 mm to about 1.55 mm, or about 1.45 mm. In some examples, this distance from the upper edge of either shoulder 1007a, 1007b to the central axis of inner circumference 1008 is about 1.25 mm to about 1.65 mm or 1.45 mm ± 0.20 mm. The upper edge of notch 1006 relative to inner circumference 1008, designated R, is in the range of about 2.00 mm to about 3.00 mm, about 2.20 mm to about 2.80 mm, about 2.30 mm to about 2.60 mm, about 2.37 mm to about 2.57 mm, or about 2.47 mm. In some examples, this distance from the upper edge of the notch 1006 to the inner periphery 1008 is between about 2.37 mm and about 2.57 mm, or 2.47 mm ±0.10 mm.

[0046] 11F illustrates various dimensions for the plunger top 119 inserted inside the casing 110. For example, the thickness, shown as 1009, of the top wall 1004 is about 3.50 mm to about 4.00 mm, about 3.55 mm to about 3.95 mm, about 3.60 mm to about 3.90 mm, about 3.65 mm to about 3.85 mm, or about 3.75 mm. In some examples, the height of the top wall 1004 is about 3.65 mm to about 3.85 mm or 3.75±0.10 mm. In some examples, the portion of the top wall 1004 configured to hold the plunger top 119 can have a diameter 1010 of about 16.50 mm to about 17.50 mm, about 16.55 mm to about 17.40 mm, about 16.60 mm to about 17.30 mm, about 16.60 mm to about 17.20 mm, about 16.60 mm to about 17.10 mm, about 16.62 mm to about 17.02 mm, about 16.72 mm to about 16.92 mm, or about 16.82 mm. In some examples, this diameter can be about 16.62 mm to about 17.02 mm or 16.82 mm ±0.20 mm.

[0047] When the casing 110 is placed on the holder 111 and houses the plunger top 119, the second holding area 1001 fits between the first ring 129a and the second ring 119b of the plunger top 129. The height of the first ring 129a housed within the casing 110 is shown as 1011 in FIG. 11F and can be about 1.00 mm to about 3.00 mm, about 2.00 mm to about 3.00 mm, about 2.12 mm to about 2.32 mm, or about 2.22 mm. In some examples, the height 1011 is about 2.12 mm to about 2.32 mm or 2.22 mm ±0.10 mm. In addition, the height of second ring 129b housed within casing 110 is shown as 1012 in FIG. 11F and can be about 1.00 mm to about 2.00 mm, about 1.10 mm to about 1.30 mm, about 1.15 mm to about 1.25 mm, or about 1.252 mm. In some examples, this height 1012 is about 1.15 mm to about 1.35 mm or 1.25 mm ±0.10 mm.

[0048] When the flange 117 and plunger top 119 are properly secured within the base 130 through the second chamber 124, respectively, the syringe 105 can extend from the base 130, through the second chamber 124, and into the first chamber 122. In some examples, at least the needle and the plurality of needle cap portions 115 of the syringe 105 can be received within the first chamber 122 and the top opening 134a. The top opening 134a can have a height, shown as C in FIG. 4C, of ​​about 60 mm to about 70 mm. For example, the height of the top opening 134a can be about 60 mm to about 68 mm, about 60 mm to about 66 mm, about 62 mm to about 70 mm, about 62 mm to about 68 mm, about 62 mm to about 66 mm, about 64 mm to about 66 mm, or about 65.00 mm. In some examples, the height of the top opening 134a is about 64.00 mm to about 66.00 mm or 65.00 mm ± 1.00 mm. The height of the top opening 134a may be selected to provide sufficient clearance, i.e., space, so that a user may prime the syringe, for example, by removing a needle cap and / or inserting a needle into the syringe, without disturbing the alignment of the syringe while the syringe is held within the syringe fixator 100. In some examples, the height of the top opening 134a may be selected to provide sufficient space so that a fully assembled syringe with needle can be loaded into the fixator.

[0049] In some examples, portions of the syringe 105 within the first chamber 122 and the top opening 134a may not be attached to any component of the syringe fixator 100. In such a configuration, the syringe 105 may be securely held in the syringe fixator 100 using the second chamber 124 and the base 130.

[0050] 12A-12E, the base 130 may include a lug 1200, a thumb nut 1210, a connector 1220, and a support 112. As shown in FIG. 12A, the lug 1200 may be configured to hold a portion of the plunger rod 128, and the connector 1220 may be configured to be attached to the support 112. With specific reference to FIG. 12B, the lug 1200 may include a first end 1201 and a second end 1202, and a circumferential sidewall 1204 that extends from the first end 1201 to the second end 1202. In some embodiments, the sidewall 1204 may flare outwardly away from the first end 1201. 12B, sidewall 1204 may form a rounded or circular shape, with sidewall 1204 extending from first end 1201 and flaring outwardly away from first end 1201. Sidewall 1204 may flare away from first end 1201 at an angle of about 90° to about 102°, about 91° to about 101°, about 92° to about 100°, about 93° to about 99°, about 94° to about 98°, or about 95° to about 97°. The sidewall 1204 may flare outwardly away from the first end 1201 at an angle of about 90°, about 91°, about 92°, about 93°, about 94°, about 95°, about 96°, about 97°, about 98°, about 99°, about 100°, about 101°, or about 102°.

[0051] As shown in FIG. 12B, the lug 1200 may include a plurality of ridges 1206 extending inwardly from the sidewall 1204 toward the center of the lug 1200. The ridges 1206 may have any shape and configuration suitable for engaging a portion of the plunger rod 128 (FIG. 14). In some examples, the plurality of ridges 1206 may each have a substantially rectangular cross-sectional shape, as shown in FIGS. 12B, 12D, 12E, 13B, and 14. As shown in FIG. 12B, the lug 1200 may include an inner wall 1203. The inner wall 1203 may include a fastening hole 1207 that receives a fastening means 1208, such as a screw. The lug 1200 may be attached to other portions of the base 130 by any suitable fastening means 1208 (e.g., a screw).

[0052] 12B, the connector 1220 can be attached to the lug 1200 such that the connector 1220 extends from the first end 1201 of the lug 1200. The connector 1220 can have a substantially cylindrical shape, and the connector 1220 extends from the first end 1201 of the lug 1200 and connects to the support 112. As shown in FIGS. 12A-12C, the connector 1220 can include an opening 1222 for receiving a connector fastener 1224, e.g., a screw or pin. In some embodiments, the connector 1220 can include multiple openings 1222 and multiple connector fasteners 1224. As shown in FIG. 12C, the thumb nut 1210 can surround a portion of the lug 1200 and / or a portion of the connector 1220 to couple and / or secure the lug 1200 and / or connector 1220 to a mechanical testing system. The thumb nut 1210 can include a recess 1212. In some embodiments, the thumb nut 1210 may include a plurality of recesses 1212. In some embodiments, the plurality of recesses 1212 may be configured to receive a fastening means, such as a fastening bar or screw, to tighten the thumb nut 1210.

[0053] 12E, each ridge 1206a, 1206b, 1206c, and 1206d may be configured within lug 1200 such that each lug is equidistant from another ridge. The distance, designated M1, between ridges 1206a and 1206b may be between about 14.10 mm and about 15.10 mm, between about 14.20 mm and about 15.10 mm, between about 14.30 mm and about 14.90 mm, between about 14.40 mm and about 14.80 mm, or between about 14.50 mm and about 14.70 mm. In some examples, the distance between ridges 1206a and 1206b can be about 14.10 mm, about 14.20 mm, about 14.30 mm, about 14.40 mm, about 14.50 mm, about 14.60 mm, about 14.70 mm, about 14.80 mm, about 14.90 mm, about 15.00 mm, or about 15.10 mm. The inner radius of curvature of lug 1200, shown as R1 in FIG. 12E, can be R8, R9, R10, R11, or R12.

[0054] 12E and 13B, the fastener holes 1207 may have a diameter of about 7.93 mm to about 8.93 mm, about 8.03 mm to about 8.83 mm, about 8.13 mm to about 8.73 mm, about 8.23 ​​mm to about 8.63 mm, or about 8.33 mm to about 8.53 mm. In some examples, the diameter of the fastener holes 1207 may be about 7.93 mm, about 8.03 mm, about 8.13 mm, about 8.23 ​​mm, about 8.33 mm, about 8.43 mm, about 8.53 mm, about 8.63 mm, about 8.73 mm, about 8.83 mm, or about 8.93 mm. In some examples, the countersink angle (not shown) of the fastener holes 1207 may be about 80° to about 120° or about 90° to about 110°. The countersink angle can be about 80°, about 82°, about 90°, about 100°, about 110°, or about 120°.

[0055] 12E, the fastening means 1208 can have a diameter of about 4.00 mm to about 5.00 mm, about 4.10 mm to about 4.90 mm, about 4.20 mm to about 4.80 mm, about 4.30 mm to about 4.70 mm, or about 4.40 mm to about 4.60 mm. In some examples, the diameter of the fastening means 1208 can be about 4.00 mm, about 4.10 mm, about 4.20 mm, about 4.30 mm, about 4.40 mm, about 4.50 mm, about 4.60 mm, about 4.70 mm, about 4.80 mm, about 4.90 mm, or about 5.00 mm.

[0056] 13A, the distance indicated by M4 between the first end 1201 and the second end 1202 of the lug 1200 can be about 13.5 mm to about 14.5 mm, about 13.6 mm to about 14.4 mm, about 13.7 mm to about 14.3 mm, about 13.8 mm to about 14.2 mm, or about 13.9 mm to about 14.1 mm. In some examples, this distance between the first end 1201 and the second end 1202 can be about 13.5 mm, about 13.6 mm, about 13.7 mm, about 13.8 mm, about 13.9 mm, about 14 mm, about 14.1 mm, about 14.2 mm, about 14.3 mm, about 14.4 mm, or about 14.5 mm.

[0057] The diameter, designated M2, of the lug 1200 at the first end 1201 can be about 23.71 mm to about 24.71 mm, about 23.81 mm to about 24.61 mm, about 23.91 mm to about 24.51 mm, about 24.01 mm to about 24.41 mm, or about 24.11 mm to about 24.31 mm. In some examples, the diameter of the lug 1200 at the first end 1201 can be about 23.71 mm, about 23.81 mm, about 23.91 mm, about 24.01 mm, about 24.41 mm, about 24.11 mm, about 24.21 mm, about 24.31 mm, about 24.41 mm, about 24.51 mm, about 24.61 mm, or about 24.71 mm. The diameter, designated M3, of the lug 1200 at the second end 1202 can be about 26.65 mm to about 27.65 mm, about 26.75 mm to about 27.55 mm, about 26.85 mm to about 27.45 mm, about 26.95 mm to about 27.35 mm, or about 27.05 mm to about 27.25 mm. In some examples, the diameter of the lug 1200 at the second end 1202 can be about 26.65 mm, about 26.75 mm, about 26.85 mm, about 26.95 mm, about 27.05 mm, about 27.15 mm, about 27.25 mm, about 27.35 mm, about 27.45 mm, about 27.55 mm, or about 27.65 mm. In some embodiments, the diameter of the second end 1202 can be greater than the diameter of the first end 1201. In some examples, the lug 1200 can have a radius of curvature of R0.10, R0.20, R0.30, R0.40, or R0.50, shown as R2 in FIG. 13A.

[0058] Figure 13B is a cross-sectional view taken along line EE of Figure 12E. As shown, the height of ridge 1206, designated M5, can be about 8.5 mm to about 9.5 mm, about 8.6 mm to about 9.4 mm, about 8.7 mm to about 9.3 mm, about 8.8 mm to about 9.2 mm, or about 8.9 mm to about 9.1 mm. In some examples, the height M5 of ridge 1206 can be about 8.5 mm, about 8.6 mm, about 8.7 mm, about 8.8 mm, about 8.9 mm, about 9 mm, about 9.1 mm, about 9.2 mm, about 9.3 mm, about 9.4 mm, or about 9.5 mm. The width, designated M6, of the ridge 1206 can be about 2.32 mm to about 3.32 mm, about 2.42 mm to about 3.22 mm, about 2.52 mm to about 3.12 mm, about 2.62 mm to about 3.02 mm, or about 2.72 mm to about 2.92 mm. In some examples, this width M6 of the ridge 1206 can be about 2.32 mm, about 2.42 mm, about 2.52 mm, about 2.62 mm, about 2.72 mm, about 2.82 mm, about 2.92 mm, about 3.02 mm, about 3.12 mm, about 3.22 mm, or about 3.32 mm.

[0059] As discussed above, FIG. 14 illustrates how a portion of the plunger rod 128, such as the plunger top 119 and / or protrusions 131, may fit within the lug 1200. Referring to the arrows, multiple protrusions 131 of the plunger top 119 may fit between at least two ridges 1206. The at least two ridges 1206 may be spaced apart on either side of the protrusions 131 to ensure capture of the plunger top 119 into the lug 1200. In some embodiments where the plunger top 119 includes more than one protrusion 131, each protrusion 131 may fit between at least two ridges 1206.

[0060] As one skilled in the art will readily recognize, when lug 1200 is rotated (e.g., clockwise or counterclockwise) about its longitudinal axis, the multiple side walls of ridge 1206 move in contact with the multiple side walls of protrusion 131, thereby imparting a similar rotational motion to plunger 109.

[0061] In some embodiments, the syringe fixator 100 can be secured to a mechanical testing system, for example, an Instron® testing system. For attachment to the testing system, one of the second plurality of walls 152a, 152b can include an attachment means. For example, the wall 152a can include a fastener 102, for example, a screw. The fastener 102 can be attached to the wall 152a with a nut or clamp 103. In other examples, the fastener 102 can include a through hole 101 for further attachment to the testing system. For further attachment to the testing system, the support 112 of the base 130 can include a plurality of threaded holes (FIG. 3) configured to receive a plurality of fasteners, for example, screws or bolts, to secure the support 112 of the syringe fixator 100 to the testing system. The mechanical testing system, for example, an Instron® testing system, can include a moving part and a stationary part. In some systems, the moving part can be superior, i.e., above, the stationary part such that the moving part and the stationary part are in a coaxial arrangement.

[0062] As described above, the syringe 105 may include a needle and needle cap portion 115, which may also be referred to herein as the "needle end," and a plunger end 109 of the syringe, which may also be referred to herein as the "plunger end." With reference to the syringe 105, the syringe fixator 100 may be configured, for example, as shown in FIG. 1A, such that the fastener 102 is above the needle end and the base 130 is below the plunger end. The configuration of the syringe fixator 100 of FIG. 1A may be used in a mechanical testing system as described above, such that the fastener 102 is attached to a moving part and the base 130 is attached to a stationary part. In an alternative embodiment, the syringe fixator 100 may be configured, for example, as shown in FIG. 15, such that the base 130 is above the plunger end and the fastener 102 is below the needle end. The configuration of syringe fixator 100 of FIG. 15 may be used in a mechanical testing system such as those described above, such that base 130 is attached to a moving part and fastener 102 is attached to a stationary part.

[0063] For purposes of description herein, the configuration of the syringe fixator 100 in FIG. 1A is referred to as "needle up", i.e., the needle is pointing up, and the configuration of the syringe fixator 100 in FIG. 15 is referred to as "needle down", i.e., the needle is pointing down. Which orientation is used may depend on the mechanical testing system and / or the type of mechanical test being performed. Various mechanical tests that may be performed using the syringe fixator 100 include maximum injection force, application torque, override torque, full injection force, and priming. For example, a maximum injection force test can be performed "needle down" so that gravity is utilized to fully expel the contents of the syringe during the test. A test to measure application torque may be performed "needle down" so that the plunger rod of the syringe can rotate. Tests to measure override torque, i.e., how much force is required to overcome the initial frictional force between the stopper and sidewall of the syringe when expelling the contents of the syringe, can also be performed in the needle-down configuration. To measure the full injection force profile of the syringe, the syringe fixator 100 can be in the "needle-up" position. In addition, tests of syringe priming may also be performed "up the needle". None of the tests described above or that can be performed with the syringe fixator 100 are limited to the "up the needle" or "down the needle" configurations.

[0064] Working Example The following example is provided for illustrative purposes only and is not intended to limit any single aspect or embodiment of the syringe fixator, nor is it limited to any combination and / or variation of such aspects and / or embodiments. This example illustrates how the syringe fixator of the present disclosure can be used with a syringe of the dose precision system described in WO 2019 / 118588 or WO 2020 / 247686. Those skilled in the art will understand that the syringe fixator can be adjusted to fit other types of syringes and other measurements are possible depending on various applications and / or drugs placed in the syringe.

[0065] Representative uses of the embodiments of the syringe fixator as disclosed are provided herein. The syringe fixator was inserted and attached to an Instron® test system with the first chamber on top, as shown in FIG. 1A for example. The needle cap of the syringe of the target dose precision system (as described in WO 2019 / 118588 or WO 2020 / 247686) was removed, and a thin needle with its needle cover was attached to the exposed needle end of the syringe. The needle was rotated on the syringe through the luer connection until resistance was felt and the needle was securely fixed in the luer adaptor of the syringe. The handle of the second chamber was then unlocked so that the cover could be opened. The prepared syringe was placed in the syringe fixator so that the flange and flange body were housed in the second chamber and the syringe body and needle end extended through the second chamber into the first chamber. The cover was then moved to enclose and secure the flange and flange body of the syringe, and the handle was locked. The Instron® test system program was started and all of the steps described above were repeated for the four samples. The injection force profile was analyzed for each of the four samples. The injection force profile results are shown below. The first force was the break force, followed by the snap deflection force when the snap tabs on the plunger rod moved from the windows / slots in the flange. As the snaps deflected, the plunger rod continued to push the piston down, expelling the air in the system, which is referred to as the air glide force. When the piston contacted the liquid, the liquid was expelled, as shown by the fluid priming glide force. The next fluid dosing glide force shows the dosing force after the plunger rod was rotated.

[0066] [Table 1]

[0067] The table below summarizes the means and standard deviations for these forces for all samples, and a histogram graphs the data for maximum injection force.

[0068] [Table 2]

[0069] [Table 3]

[0070] The torque of the plunger rod was measured during a 90 degree rotation of the plunger rod. The maximum torque force occurred at an average rotation of 61.8 degrees. The average maximum torque was 21.28 N*mm with a standard deviation of 1.916 N*mm.

[0071] [Table 4]

[0072] In addition, tests were conducted using syringes with flanges made of polypropylene. The average PP maximum torque was 23.854N*mm, with a standard deviation of 2.173N*mm. The results are shown below.

[0073] [Table 5]

[0074] [Table 6]

[0075] The above description and examples are illustrative and are not intended to be limiting. Numerous modifications and / or alterations may be made by one of ordinary skill in the art without departing from the intended scope of the present invention. For example, as has been referenced, aspects of the above-described embodiments may be used in any suitable combination with one another. In addition, parts of the above-described embodiments may be removed without departing from the scope of the present invention. Furthermore, modifications may be made to adapt a particular situation or aspect to the teachings of the various embodiments without departing from such scope. Many other embodiments will be apparent to those of ordinary skill in the art upon reviewing the above description.

[0076] Implementations of the present disclosure may include the following features. Item 1. A syringe retainer for holding a syringe in a test system, comprising: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber; the first chamber includes a plurality of first walls having a first length and a plurality of second walls having a second length, the second length being less than the first length, the plurality of first walls and the plurality of second walls forming a housing for at least a needle of the syringe; the main housing, the second chamber configured to hold at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe; A syringe fixation device comprising: a base having a support, the base configured to receive a portion of a plunger rod of the syringe, the base including at least one geometric feature configured to enable or impart rotational movement to the portion of the plunger rod received within the base.

[0077] Item 2. The base is a holder for the plunger rod of the syringe; and a casing; Item 1, wherein the casing and the holder are configured to be secured together with a fastener to support the plunger rod.

[0078] Item 3. The base is a lug configured to receive a plunger rod of the syringe; and a connector; Item 1, wherein the lug and the connector are secured together to support the plunger rod.

[0079] Item 4. The syringe lock of item 1, wherein the second chamber is removable from the main housing. Item 5. The syringe fixator of item 4, wherein the second chamber has a first configuration and is interchangeable with a different second chamber having a second configuration, the second configuration being different from the first configuration.

[0080] Item 6. The syringe fixator of item 1, wherein the plurality of second walls include a top wall and a bottom wall, the top wall including a fastener for fixing the main housing to the test system. Item 7. The syringe fixator of item 1, wherein the support of the base includes a plurality of threaded holes for fixing the base to the test system.

[0081] Item 8. The syringe fixator of item 1, wherein the cover is attached to the second chamber with a plurality of hinges and a closure, the closure configured to allow the cover to be opened and closed.

[0082] Item 9. The syringe fixator of item 1, wherein the second chamber includes a chamber extension extending from a bottom of the second chamber, and the cover includes a cover extension extending from a bottom of the cover, each extension having a height of about 4.80 mm to about 5.20 mm.

[0083] Item 10. The syringe fixator according to item 7, wherein the chamber extension of the second chamber and the cover extension of the cover each have a length of about 13.22 mm to about 13.62 mm.

[0084] Item 11. The syringe fixator according to item 7, wherein a distance between the chamber extension of the second chamber and the cover extension of the cover is in the range of about 12.95 mm to about 13.35 mm.

[0085] Item 12. The syringe fixator of item 1, wherein the first chamber of the main housing is configured to be fixed to a movable portion of the test system and the support of the base is configured to be fixed to a stationary portion of the test system.

[0086] Item 13. The syringe fixator of item 1, wherein the first chamber of the main housing is configured to be fixed to a stationary portion of the test system and the support of the base is configured to be fixed to a movable portion of the test system.

[0087] Item 14. A syringe retainer for holding a syringe in a test system, comprising: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber; the first chamber includes a housing for at least a needle of the syringe; the main housing, the second chamber configured to receive at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe; A syringe fixator comprising: a base having a support, the base including a lug configured to receive a plunger rod of the syringe, and a connector, the lug and the connector being fixed together to support the plunger rod.

[0088] Item 15. The syringe lock of item 14, wherein the base includes a thumb nut for securing and stabilizing the lug and the connector to the test system. Item 16. The syringe lock of item 14, wherein the lug includes an opening for receiving a portion of the plunger rod, the opening including a plurality of ridges configured to engage the portion of the plunger rod.

[0089] Item 17. The syringe lock of item 16, wherein the lug includes a first end having a first diameter and a second end having a second diameter, the second diameter being larger than the first diameter, and the lug includes a sidewall extending from the first end to the second end, the sidewall flaring outwardly from the first end to the second end.

[0090] Item 18. A method for testing a syringe, comprising: Securing a syringe fixture to a test system, comprising: The syringe holder includes: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber; the first chamber includes a housing for at least a needle and a needle cap of the syringe; the main housing, the second chamber configured to hold at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe; a base having a support; and and inserting the syringe into the syringe retainer.

[0091] Item 19. Fixing the first chamber of the main housing to a movable portion of the test system; 20. The method of claim 18, further comprising: fixing the support of the base to a stationary part of the test system.

[0092] Item 20. Fixing the first chamber of the main housing to a stationary portion of the test system; 20. The method of claim 18, further comprising fixing the support of the base to a movable part of the test system.

Claims

1. a syringe retainer for retaining a syringe within a test system, comprising: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber; the first chamber includes a plurality of first walls having a first length and a plurality of second walls having a second length, the second length being less than the first length, the plurality of first walls and the plurality of second walls forming a housing for at least a needle of the syringe; the main housing, the second chamber configured to hold at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe; A syringe fixator comprising: a base having a support, the base configured to receive a portion of a plunger rod of the syringe, the base including at least one geometric feature configured to enable or impart rotational movement to the portion of the plunger rod received within the base.

2. The base portion is a holder for the plunger rod of the syringe; and a casing; The syringe lock of claim 1 , wherein the casing and the holder are configured to be secured together with a fastener to support the plunger rod.

3. The base portion is a lug configured to receive a plunger rod of the syringe; and a connector; The syringe lock of claim 1 , wherein the lug and the connector are secured together to support the plunger rod.

4. The syringe fixator of claim 1 , wherein the second chamber is removable from the main housing.

5. 5. The syringe fixator of claim 4, wherein the second chamber has a first configuration and is interchangeable with a different second chamber having a second configuration, the second configuration being different from the first configuration.

6. The syringe fixator of claim 1 , wherein the plurality of second walls include a top wall and a bottom wall, the top wall including a fastener for fixing the main housing to the test system.

7. The syringe fixator of claim 1 , wherein the support of the base includes a plurality of threaded holes for fixing the base to the test system.

8. The syringe lock of claim 1 , wherein the cover is attached to the second chamber using a plurality of hinges and a closure, the closure configured to allow the cover to be opened and closed.

9. 2. The syringe fixator of claim 1, wherein the second chamber includes a chamber extension extending from a bottom of the second chamber, and the cover includes a cover extension extending from a bottom of the cover, each extension having a height of about 4.80 mm to about 5.20 mm.

10. 10. The syringe fixator of claim 9, wherein the chamber extension of the second chamber and the cover extension of the cover each have a length of about 13.22 mm to about 13.62 mm.

11. 10. The syringe fixator of claim 9, wherein the spacing between the chamber extension of the second chamber and the cover extension of the cover ranges from about 12.95 mm to about 13.35 mm.

12. 2. The syringe fixator of claim 1, wherein the first chamber of the main housing is configured to be fixed to a movable portion of the test system and the support of the base is configured to be fixed to a stationary portion of the test system.

13. 2. The syringe fixator of claim 1, wherein the first chamber of the main housing is configured to be fixed to a stationary portion of the test system and the support of the base is configured to be fixed to a movable portion of the test system.

14. 1. A syringe retainer for holding a syringe within a test system, comprising: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber; the first chamber includes a housing for at least a needle of the syringe; the main housing, the second chamber configured to receive at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe; A syringe fixator comprising: a base having a support, the base including a lug configured to receive a plunger rod of the syringe; and a connector, the lug and the connector being fixed together to support the plunger rod.

15. The syringe locker of claim 14 , wherein the base includes a thumb nut for securing and stabilizing the lug and connector to the test system.

16. The syringe lock of claim 14, wherein the lug includes an opening for receiving a portion of the plunger rod, the opening including a plurality of ridges configured to engage the portion of the plunger rod.

17. 17. The syringe lock of claim 16, wherein the lug includes a first end having a first diameter and a second end having a second diameter, the second diameter being larger than the first diameter, and the lug includes a sidewall extending from the first end to the second end, the sidewall flaring outwardly from the first end to the second end.

18. 1. A method for testing a syringe, comprising: Securing a syringe fixture to a test system, comprising: The syringe fixture includes: a main housing including a first chamber, a second chamber, and an opening extending from the first chamber to the second chamber; the first chamber includes a housing for at least a needle and a needle cap of the syringe; the main housing, the second chamber configured to hold at least a flange portion of the syringe, the second chamber including a cover for enclosing at least the flange portion of the syringe; a base having a support; and inserting the syringe into the syringe retainer.

19. securing the first chamber of the main housing to a movable part of the test system; 20. The method of claim 18, further comprising: securing the base support to a stationary portion of the test system.

20. securing the first chamber of the main housing to a stationary portion of the test system; 20. The method of claim 18, further comprising: fixing the base support to a moving part of the test system.

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