Apparatus and method for retainer adapter assembly

Abstract

An adapter assembly including a housing, a channel formed within the housing and configured to receive a medical device, a first groove formed along an inner wall of the channel and configured to at least partially receive a first retaining element, and a second groove formed along an inner wall of the channel and configured to at least partially receive a second retaining element, wherein the first retaining element and the second retaining element are configured to extend outwardly from the first groove and the second retaining element are configured to extend outwardly from the second groove to abut a medical device received through the channel.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 316,814, filed March 4, 2022, which is incorporated by reference in its entirety herein.

[0002] Technical Field Aspects of the present disclosure relate to devices and methods for positioning, controlling, and retaining medical devices during testing procedures. More particularly, embodiments of the present disclosure relate to devices and methods for holding, suspending, aligning, and / or maintaining the position of a medical device (e.g., a syringe) relative to instrumentation for testing various characteristics of the medical device. [Background technology]

[0003] preface Medical devices for storing pharmaceuticals, such as syringes for storing fluid substances, may be required to undergo various testing procedures to ensure proper and safe functionality. Testing instrumentation may be utilized to facilitate such testing, including, but not limited to, compression and tensile testing. In some cases (e.g., during set-up), the syringe may be inadvertently loaded (e.g., forced) by the testing instrumentation and / or other equipment, which may result in inaccuracies in the test results or premature failure. In other instances, human error in handling, controlling, or positioning the syringe relative to the testing instrumentation prior to performing the test may similarly affect the results.

[0004] Inadvertent loading of a syringe prior to performing a test (hereinafter referred to as "preloading") can introduce additional complications into the automation of the syringe testing process. For example, preloading of a syringe can result in misalignment of the syringe relative to the test site and / or testing instrument, which can damage test results or test specimens during the testing process. Summary of the Invention

[0005] Disclosed herein is an adapter assembly, particularly for mounting, holding, aligning, and / or controlling the position and / or orientation of a syringe relative to testing instrumentation and / or a testing site. In one embodiment of the present disclosure, the adapter assembly includes a housing including a channel formed therein. The channel is defined by a pair of openings disposed on opposing surfaces of the housing and is configured to at least partially receive a portion of a medical device, such as a barrel portion of a syringe body. The adapter assembly includes a first groove formed along an inner wall of the channel, the first groove configured to at least partially receive a first retaining element. The adapter assembly includes a second groove formed along an inner wall of the channel, the second groove configured to at least partially receive a second retaining element. The first retaining element and the second retaining element are each configured to extend outwardly (e.g., radially inwardly relative to the inner wall) from the first groove and the second retaining element is configured to extend outwardly (e.g., radially inwardly relative to the inner wall) from the second groove to abut (and contact) the body of a medical device received through the channel. The first retaining element and the second retaining element are configured to align the body of the medical device with respect to a central longitudinal axis of the channel to offset a proximal end of the medical device from the housing.

[0006] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. The drawings depict different aspects of the disclosure, and where appropriate, reference numerals designating like structures, components, materials, and / or elements in different figures are labeled similarly. It is understood that various combinations of structures, components, and / or elements in the various embodiments other than those specifically shown are contemplated and are within the scope of the disclosure. [Brief description of the drawings]

[0007] [Figure 1] 1 illustrates a perspective view of an exemplary adapter assembly receiving an exemplary syringe barrel therein, according to an aspect of the present disclosure. [Diagram 2] 2 illustrates a cross-sectional side view of the adapter assembly and syringe shown in FIG. 1 according to an embodiment of the present disclosure. [Diagram 3] 2 illustrates a cross-sectional side view of the adapter assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 4] 2 shows a perspective view of an exemplary testing instrument that receives the adapter assembly and syringe shown in FIG. 1 according to a further embodiment of the present disclosure. [Diagram 5] 5 shows a side view of the inspection instrument of FIG. 4 according to a further embodiment of the present disclosure. [Figure 6] 1 illustrates a perspective view of another exemplary adapter assembly in a first position according to an embodiment of the present disclosure. [Figure 7] 7 illustrates a perspective view of the adapter assembly of FIG. 6 in a second position according to an embodiment of the present disclosure. [Figure 8] 7 illustrates a cross-sectional side view of the adapter assembly of FIG. 6 according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] 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. Each aspect and / or embodiment of the present disclosure may 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, many of these combinations and permutations are not described individually herein.

[0009] As used herein, the terms "comprises," "comprising," "includes," "including," or similar terms are intended to include a non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of components may include not only those components, 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 particular, an embodiment or implementation described herein as "example" or "exemplary" should not be construed as being preferred or advantageous over other embodiments or implementations, for example, and is intended to reflect or suggest that the embodiment(s) is / are an "example" rather than an "ideal." Furthermore, terms such as "first," "second," and the like, used herein do not denote an order, quantity, or importance, but rather are used to distinguish one element, structure, step, or process from another. Additionally, the terms "a" and "an" as used herein do not denote a limitation of quantity, but rather denote the presence of one or more of the referenced item. Additionally, the terms "about," "approximately," and "substantially," when used in describing a numerical value, indicate a + / - 10% variance of that value, unless otherwise specified.

[0010] The embodiments of the present disclosure may be used with any type of fluid-containing product, such as a liquid drug substance, a liquid placebo, or other liquid (or liquid solution) that may be administered in a dosage form. As used herein, the term "substance" may refer to a compounded substance that includes an active ingredient or ingredient(s). In some embodiments, the devices and aspects of the present disclosure may be used with any therapy that uses the immune system to fight disease, such as immunotherapy, including vaccines, allergy treatments, cancer treatments, and the like. Specifically, the devices and aspects of the present disclosure may be used in the treatment of cancer patients (e.g., immuno-oncology). However, it is also contemplated that the embodiments of the present disclosure may be applicable to any therapy, liquid product, and / or any other situation in which different substances may be stored separately in multiple vials. Although medical applications are described herein, it is contemplated that non-medical liquids packaged together in different vials may be used in combination with the vial adapters described herein. It is understood that the embodiments of the present disclosure may be used with fluid-containing products (e.g., syringes) that are empty and do not contain any liquid substance, such as for purposes of component testing.

[0011] As used herein, the terms "proximal" and "proximally" refer to a location (or part of an instrument) relatively closer to or toward the user end opposite the distal location / portion of the instrument, and the terms "distal" and "distally" refer to a location (or part of an instrument) relatively closer to or toward the access point. As used herein, the term "body" when used with respect to a portion of an instrument may refer to a component of an instrument suitable for receiving a quantity of active pharmaceutical ingredient. The body includes, for example, a barrel (such as a syringe barrel), a tube, a cylinder, or other containing portion of an instrument. In some embodiments, the body may also include a distal end having a nozzle, a needle, a needle attachment site, and / or a distal cap.

[0012] Various embodiments of adapter assemblies are described herein, and in particular, adapter assemblies for holding a syringe to an instrument or device for testing a particular characteristic of the syringe. In some cases, the embodiments or aspects of the embodiments disclosed herein may be used in combination with syringes of various shapes and / or sizes. In other examples, the embodiments or aspects of the embodiments disclosed herein may be used with other types of fluid-containing products, including, but not limited to, vials, cartridges, and / or other suitable medical devices. Such adapter assemblies may be intended to reduce human error and / or improve accuracy in performing tests of the characteristics or functionality of medical devices.

[0013] 1, an exemplary adapter assembly 100 is shown. The adapter assembly 100 may be configured and operable to retain and suspend a medical device relative to an examination instrument or examination site. The adapter assembly 100 may include a housing 101 defined by a proximal body 102 and a distal body 104. The proximal body 102 may have a larger cross-sectional profile than the distal body 104. As described herein, each of the proximal body 102 and the distal body 104 may be sized, shaped, and configured to form a frictional fit with a corresponding portion of an examination instrument. The housing 101 may include a handle 106 extending laterally outward from the proximal body 102. The handle 106 may have an ergonomic profile configured to facilitate a user's manual manipulation of the housing 101, such as inserting and / or removing the adapter assembly 100 from an examination instrument.

[0014] The housing 101 may include opposing exterior surfaces, such as a proximal (upper) surface of the proximal body 102 and a distal (lower) surface of the distal body 104. The adapter assembly 100 may include one or more alignment features 105 disposed on the housing 101. In this example, the adapter assembly 100 may include at least a pair of alignment features 105 extending proximally from the proximal (upper) surface of the proximal body 102. The pair of alignment features 105 may be configured to facilitate positioning, alignment, and / or orientation of a medical instrument relative to the adapter assembly 100, and in particular, the proximal (upper) surface of the proximal body 102. As described herein, the alignment features 105 may serve as visual reference points for positioning a medical instrument coupled to the adapter assembly 100.

[0015] As shown in FIG. 1, the medical device may include a syringe 10 having a body 12 for storing a substance 11. The body 12 has a longitudinal length defined between a distal end 14 and a proximal end 16, with a stopper 18 (e.g., a plunger) disposed within a cavity in the body 12. In some embodiments, the syringe 10 may not include the substance 11 and / or may not include the stopper 18. The syringe 10 may include a needle 15 (see FIG. 5) extending distally from the distal end 14. The needle 15 may be in fluid communication with a cavity in the body 12 that contains the substance 11 stored within the body 12. In some examples, the syringe 10 may include a removable cap 20 (e.g., a rigid or soft needle shield) selectively coupled to the distal end 14 for covering the needle 15 when the syringe 10 is not in use. In other examples, the cap 20 may be omitted entirely. It should be noted that a variety of other suitable medical devices can be used in combination with the adapter assembly 100.

[0016] The proximal end 16 defines a flange of the syringe 10 such that a pair of alignment features 105 can be configured to facilitate alignment of the flange relative to a proximal (top) surface of the proximal body 102. In this embodiment, the pair of alignment features 105 may include protrusions that define visual landmarks for inspection and reference by a user of the adapter assembly 100, such as when coupling the syringe 10 to the housing 101. For example, a user may determine a desired position of the body 12 relative to the housing 101 by referencing the corresponding distances between the flange of the proximal end 16 and the pair of alignment features 105.

[0017] Although a pair of alignment features 105 are shown and described herein, adapter assembly 100 may include additional and / or fewer alignment features 105 without departing from the scope of the present disclosure. Additionally and / or alternatively, alignment features 105 may be disposed along various other surfaces and / or walls of housing 101 other than the proximal (top) surface of proximal body 102. It should be understood that alignment features 105 can have a variety of suitable sizes, shapes, and / or configurations other than those shown and described herein.

[0018] 2, the adapter assembly 100 may include a housing 101 and a channel 108 extending through each of the proximal body 102 and the distal body 104 specifically. The channel 108 may have a longitudinal length defined between opposing outer surfaces of the housing 101, such as between a proximal (upper) surface of the proximal body 102 and a distal (lower) surface of the distal body 104. The housing 101 may include a first opening 108A along the proximal (upper) surface of the proximal body 102 and a second opening 108B along the distal (lower) surface of the distal body 104. The channel 108 may extend between the first opening 108A and the second opening 108B and be configured to receive the syringe 10 into the housing 101 through the first opening 108A and the second opening 108B. The channel 108 may have a generally uniform cross-sectional configuration. In some embodiments, a portion of the channel 108 may have a different cross-sectional configuration than another portion of the channel 108 .

[0019] The housing 101 may further include one or more slots and / or grooves formed in the channel 108, such as along an interior wall defining the channel 108. Each of the one or more grooves may be sized and shaped to receive a retention element. In this example, the housing 101 may include a first groove 109A and a second groove 109B. The first groove 109A may be disposed adjacent a proximal (upper) surface of the proximal body 102 relative to the second groove 109B, and the second groove 109B may be disposed adjacent a distal (lower) surface of the distal body 104 relative to the first groove 109A.

[0020] 2, each of the first groove 109A and the second groove 109B may extend around the inner wall and / or inner surface defining the channel 108 such that the length of each groove may be perpendicular (e.g., perpendicular) to the central longitudinal axis A of the channel 108. The first groove 109A and the second groove 109B may be positioned around the outer periphery of the body 12 when the syringe 10 is received within the channel 108. The first groove 109A and the second groove 109B may extend around the entire outer edge of the channel 108, or may extend only a portion thereof. Additionally, portions of the first groove 109A and the second groove 109B may overlap one another, while other portions of the first groove 109A and the second groove 109B may not overlap one another. Furthermore, although the present disclosure illustrates first groove 109A and second groove 109B as extending in a plane substantially perpendicular to the central longitudinal axis A of channel 108, one of ordinary skill in the art will readily appreciate that such grooves may extend in a plane parallel to central longitudinal axis A. Additionally, while two circumferential grooves 109A, 109B are shown in Figure 2, more or fewer grooves may be provided in accordance with the principles of the present disclosure.

[0021] The first groove 109A may be configured to receive the first retaining element 110A, and the second groove 109B may be configured to receive the second retaining element 110B. The first retaining element 110A and the second retaining element 110B may extend to the entire outer edge of the channel 108, or only a portion thereof, depending on the corresponding configuration of each groove. Furthermore, portions of the first retaining element 110A and the second retaining element 110B may overlap one another, while other portions of the first retaining element 110A and the second retaining element 110B may not overlap one another. Although the first retaining element 110A and the second retaining element 110B are shown in this disclosure as extending in a plane substantially perpendicular to the central longitudinal axis A, one skilled in the art will understand that such retaining elements may also extend in a plane parallel to the central longitudinal axis A. Although only two circumferential retaining elements 110A, 110B are shown and described herein, it should be understood that additional and / or fewer retaining elements may be provided depending on the number of corresponding grooves.

[0022] As best shown in FIG. 3, each of the first retaining element 110A and the second retaining element 110B may be sized and / or shaped to extend at least partially outward from a corresponding groove. In other words, the retaining elements 110A, 110B may extend radially inward from and / or relative to an inner wall of the housing 101. Thus, the first retaining element 110A and the second retaining element 110B may extend into the channel 108 and toward the central longitudinal axis A. In some embodiments, one or more of the first groove 109A and the second groove 109B may be oversized to allow more clearance and / or space for the respective retaining element to contract therein.

[0023] As described below, the first retaining element 110A and the second retaining element 110B can be configured to contact an exterior surface of the body 12 when the syringe 10 is received in the channel 108. The first retaining element 110A and the second retaining element 110B can be configured to retain the syringe 10 in a constant position, orientation, and / or alignment relative to the housing 101 and the test site upon engaging the body 12 within the channel 108.

[0024] The first groove 109A and the second groove 109B may be spaced apart from each other in a longitudinal direction (parallel to the central longitudinal axis A of the channel 108) by a minimum predetermined distance to facilitate optimal retention of the syringe 10 relative to the housing 101. In other words, the offset between the first groove 109A and the second groove 109B and the corresponding separation distance between the retention elements received in each groove may be configured to improve engagement between the housing 101 and the syringe 10. Additionally, the offset distance between the first groove 109A and the second groove 109B may improve alignment (e.g., alignment relative to the central longitudinal axis A) of the body 12 within the channel 108 when the syringe 10 is received in the housing 101. As described herein, the adapter assembly 100 may be configured to suspend (e.g., retain) the syringe 10 within the housing 101 and align the needle 15 or needle shield 20 relative to the examination site. In some embodiments, the syringe 10 may omit the needle shield 20 entirely, allowing the needle 15 to be exposed at the distal end 14. The adapter assembly 100 may be configured to retain the syringe 10 therein until an appropriate force is applied to the syringe 10 via the retaining elements 110A, 110B.

[0025] 3, the relative positions of first groove 109A and second groove 109B define two concentric contact points for adapter assembly 100. Although a pair of grooves and a corresponding pair of retaining elements are shown and described herein, it should be understood that additional and / or fewer grooves and retaining elements may be included in adapter assembly 100 without departing from the scope of the present disclosure. The cross-sectional dimensions of channel 108, first retaining element 110A, and / or second retaining element 110B may at least partially define a gripping diameter for adapter assembly 100.

[0026] In some embodiments, the first groove 109A and the second groove 109B may have a similar size and / or shape, while in other embodiments, the grooves may have different sizes and / or shapes relative to one another. Similarly, the first retaining element 110A and the second retaining element 110B may have similar sizes and / or shapes to one another, or different sizes and / or shapes to one another. The material composition of the retaining elements 110A, 110B may further adjust the gripping diameter of the adapter assembly 100, such as based on the relative elasticity and / or flexibility of the materials. Thus, the gripping diameter of the adapter assembly 100 may be substantially constant or may vary along the central longitudinal axis A of the channel 108.

[0027] In one example, the first retaining element 110A and the second retaining element 110B can be formed of a flexibly deformable elastomeric material, and the pair of retaining elements 110A, 110B can thus be configured to contract and / or deform when the syringe 10 is received in the channel 108, thereby exerting a radially inward force against the body 12 to retain the syringe 10 within the housing 101.

[0028] In some examples, the retaining elements 110A, 110B may include rubber O-rings made of Viton® having a Shore hardness ranging from about 80A to about 90A, e.g., 85A. In other examples, the retaining elements 110A, 110B may include various suitable seals, gaskets, inserts, and other similar devices. Those skilled in the art will readily appreciate that the retaining elements 110A, 110B may be made of any suitable material, such as, for example, rubber or a suitable fluoroelastomer. The housing 101, including the proximal body 102, the distal body 104, and the handle 106, may be formed of a variety of materials, such as carbon fiber nylon, polyetheretherketone (PEEK) carbon fiber, and other similar materials.

[0029] In an exemplary use, the adapter assembly 100 may be operable to facilitate testing of a medical device, such as a syringe 10, with a testing instrument. It should be appreciated that the adapter assembly 100 may facilitate testing of a syringe 10 with or without a substance 11 or stopper 18 disposed within the body 12, and / or with or without a needle shield 20 coupled to the needle 15. As shown in FIG. 1 , the syringe 10 (or other medical device) may be coupled to the adapter assembly 100 by inserting the body 12 into the channel 108. When the syringe 10 is received in the first opening 108A, passes through the channel 108, and exits the housing 101 through the second opening 108B, the first retaining element 110A and the second retaining element 110B may interact with the exterior of the body 12.

[0030] The first retaining element 110A and the second retaining element 110B may be configured to contract when engaged with the body 12. Specifically, the pair of retaining elements 110A, 110B are compressed radially outward (e.g., away from the central longitudinal axis A of the channel 108) when the body 12 is received through the channel 108, thereby forming a frictional fit against the exterior of the syringe 10 (see FIG. 2). The frictional fit may be configured to retain the syringe 10 within the adapter assembly 100 until an appropriate force is applied to the syringe 10, as described in more detail below. The first retaining element 110A and the second retaining element 110B may be configured to automatically align the syringe 10 with the central longitudinal axis A when the syringe 10 is inserted into the housing 101. As described herein, by aligning the syringe 10 within the channel 108, the adapter assembly 100 can be configured to improve alignment of the needle 15 and / or needle shield 20 relative to the testing site when the assembly of the syringe 10 and adapter assembly 100 is coupled to the testing instrument (see Figures 4-5).

[0031] It should be appreciated that despite the pair of retaining elements 110A, 110B engaging the body 12 within the channel 108, the syringe 10 can be movable relative to the housing 101 to allow a user of the adapter assembly 100 to position the syringe 10 at a desired depth relative to the housing 101. The first retaining element 110A and the second retaining element 110B can be configured to partially restrain movement of the syringe 10 relative to the housing 101 when no force is applied to the body 12 (e.g., by a user of the adapter assembly 100). Thus, the pair of retaining elements 110A, 110B can be configured to maintain a position and / or orientation of the syringe 10 relative to the housing 101, such as against natural gravity, but do not prevent a user from applying proximal and / or distal forces to the body 12 to move the syringe 10 to a desired position and / or orientation relative to the adapter assembly 100.

[0032] 1 and 2, a user can utilize the pair of alignment features 105 as a visual reference for aligning and moving the syringe 10 through the housing 101. For example, the syringe 10 can be moved (e.g., translated, rotated, etc.) relative to the housing 101 to position a flange (proximal end 16) of the syringe 10 in a desired location and / or orientation relative to the pair of alignment features 105. In this example, the pair of alignment features 105 are spaced apart from the first opening 108A such that the alignment features 105 are not positioned in the path of movement of the body 12 (and / or the flange of the proximal end 16) as the syringe 10 is moved through the channel 108.

[0033] In another example, one or more of the pair of alignment mechanisms 105 may be movable relative to the housing 101, specifically the proximal body 102. For example, at least one alignment mechanism 105 may include a movable arm coupled to a hinge such that the alignment mechanism 105 may be configured to move (e.g., pivot) relative to a proximal (top) surface of the proximal body 102. In this case, the movable arm of the alignment mechanism 105 may be positioned at least partially above the first opening 108A such that the alignment mechanism 105 may be within the path of movement of the body 12 when the syringe 10 is moved through the channel 108. The pivotable arm of the alignment mechanism 105 may engage a portion of the body 12, such as a flange at the proximal end 16, to fix the relative position and / or orientation of the body 12 with respect to the housing 101, until the pivotable arm moves away from the first opening 108A and out of the path of movement of the body 12. In a further example, the adapter assembly can include a movable (e.g., slidable) alignment mechanism coupled to a slot in the housing of the adapter assembly, and the alignment mechanism can be movable between a plurality of positions within the slot to selectively block and allow movement of the flange toward the first opening 108A (see, e.g., Figures 6-8).

[0034] 4, the assembled syringe 10 and adapter assembly 100 (referred to herein as the "assembly") may be received within a fixture component 50 of an inspection instrument. The fixture component 50 may include a cavity 52 and a bottom wall 54 having an opening 56. When the assembly of the syringe 10 and adapter assembly 100 is received within the cavity 52 of the fixture component 50, a portion of the syringe 10 may extend through the bottom wall 54 via the opening 56. In response to the adapter assembly 100 forming a frictional engagement with one or more portions of the fixture component 50, the assembly may be suspended within the fixture component 50.

[0035] In other words, the adapter assembly 100 may be configured to engage the fixture component 50 to securely secure the syringe 10 to the fixture component 50. One or more portions of the housing 101 may form a frictional fit with one or more surfaces of the fixture component 50. For example, at least a portion of the housing 101 may be sized and / or shaped according to respective cross-sectional dimensions of the cavity 52 and the opening 56 on the bottom wall 54 to form a frictional fit with multiple surfaces of the fixture component 50.

[0036] The distal body 104 can be sized and / or shaped according to a diameter of the opening 56 such that the adapter assembly 100 can be configured to couple the syringe 10 to the fastener component 50 in response to the distal body 104 being received within the opening 56. Additionally, the proximal body 102 can be sized and / or shaped to be larger than the diameter of the opening 56 and to match a diameter of the cavity 52 such that the adapter assembly 100 can be configured to couple the syringe 10 to the fastener component 50 in response to the proximal body 102 being received within the cavity 52. ​​The adapter assembly 100 can be selectively separated from the fastener component 50 upon manually removing the housing 101 from within the cavity 52 and opening 56, such as by squeezing the handle 106.

[0037] 4 , a handle 106 may rest against an upper surface of the bottom wall 54, allowing a user of the adapter assembly 100 to access the syringe 10 and adapter assembly 100 assembly by grasping the handle 106, such as when removing the assembly from the fixture component 50 upon completion of a testing procedure. Upon receiving the syringe 10 through the adapter assembly 100, the syringe 10 is securely coupled to the fixture component 50, and at least a portion of the body 12 may extend outwardly (i.e., distally) from the fixture component 50 through the opening 56. As described herein, the adapter assembly 100 may be configured to suspend the syringe 10 from the fixture component 50 and relative to a testing site positioned adjacent the fixture component 50.

[0038] The adapter assembly 100 may be configured to counteract and / or minimize loads (e.g., forces) applied to the syringe 10 (e.g., by the fixture component 50 and / or the housing 101) by maintaining one or more portions of the syringe 10 in a suspended position relative to the fixture component 50 and / or the housing 101. For example, with the first and second retaining elements 110A, 110B abutting the body 12 within the channel 108 (see FIG. 2 ), the adapter assembly 100 may be configured to separate a flange of the syringe 10 (at the proximal end 16) from one or more adjacent surfaces when the assembly of the syringe 10 and the adapter assembly 100 is received within the fixture component 50.

[0039] Thus, the adapter assembly 100 can reduce the application of a preload to the syringe 10, such as at the proximal end 16, prior to initiating a testing procedure with a testing instrument, by maintaining the syringe 10 in a floating state with the flange elevated (e.g., in a proximal direction) relative to the proximal body 102. By reducing undesirable loads on the syringe 10 prior to testing, the adapter assembly 100 can allow a user to set and / or adjust the total preload experienced by the syringe 10 (e.g., as measured by load cells of the testing instrument communicatively coupled to grippers attached to the fixture component 50 and / or clamps 58A, 58B) for testing control purposes.

[0040] As shown in FIG. 5, when the cap 20 is removed from the distal end 14 to expose the needle 15, the needle 15 is positioned between a pair of clamps 58A, 58B of the testing instrument. Prior to administering a test sample of the substance 11 from the syringe 10, the pair of clamps 58A, 58B may be actuated (e.g., moved) toward the needle 15 to securely engage the syringe 10. In this case, engagement of the clamps 58A, 58B with the needle 15 may exert a force on the syringe 10 in an axial direction parallel to the longitudinal length of the syringe 10. The adapter assembly 100 may be configured to minimize the axial load endured by the syringe 10 at the proximal end 16 in response to the pair of clamps 58A, 58b engaging the needle 15.

[0041] Specifically, by maintaining the flange (proximal end 16) of the syringe 10 in a suspended position relative to the housing 101, the adapter assembly 100 may be configured to separate the flange from one or more adjacent surfaces that may inadvertently load the syringe 10 when the pair of clamps 58A, 58B engage the needle 15. The first and second retaining elements 110A, 110B may at least partially prevent movement (e.g., translation) of the syringe 10 relative to the housing 101 by abutting the exterior of the body 12 (FIG. 2) when the clamps 58A, 58B engage the needle 15. Thus, the adapter assembly 100 may maintain the flange of the proximal end 16 in a floating condition and separated from contact with the housing 101, thereby minimizing preload on the syringe 10 prior to performing a testing procedure.

[0042] The fixture component 50 of the testing instrument, and specifically the opening 56, may be positioned over a testing site suitable for receiving a sample from the syringe 10. With the syringe 10 received within the fixture component 50 and suspended above the testing site by the adapter assembly 100, a sample of the substance 11 (stored within the body 12) may be precisely administered to the testing site, for example, in response to clamps 58A, 58B removing the needle 15 from the syringe 10. In other embodiments, the substance 11 may not be stored within the body 12 of the syringe 10 during the testing procedure.

[0043] The retaining elements 110A, 110B may abut the body 12 at spaced intervals within the channel 108 to align the syringe 10, and specifically the needle 15, with the testing site and maintain the syringe 10 in a linear configuration parallel and / or collinear with the central longitudinal axis A of the channel 108 (FIGS. 2-3). The distal body 104 may be received in and centered within the opening 56 in the bottom wall 54 to align the central longitudinal axis A of the channel 108 with the testing site. Thus, the adapter assembly 100 may be configured to maintain the needle 15 in parallel alignment with the testing site during a testing test that requires removal of the needle 15 from the syringe 10.

[0044] 6, another exemplary adapter assembly 200 is shown. The adapter assembly 200 may include similar structure as the adapter assembly 100 shown and described above, and similar reference numbers are used to identify similar components. The adapter assembly 200 may be configured and operable similarly to the adapter assembly 100, except for the differences expressly described herein. For example, the adapter assembly 200 includes a housing 201 defined by a proximal body 102 and a distal body 104, where the proximal body 102 may have a larger cross-sectional profile than the distal body 104. The housing 201 may include a handle 106 extending laterally outwardly from the proximal body 102 and a slot 205 formed along a proximal (top) surface of the handle 106.

[0045] The slot 205 may be recessed relative to a proximal (top) surface of the handle 106 and may extend along at least a portion of the longitudinal length of the housing 201. In other words, the slot 205 may have a longitudinal length parallel to the longitudinal length of the housing 201. For example, the slot 205 may extend from a first end adjacent the proximal body 102 to a second (opposite) end adjacent the handle 106. The slot 205 may be further defined by a pair of opposing sidewalls 207 and a lip 206 extending across each of the pair of opposing sidewalls 207. As shown, the slot 205 may include a substantially inverted T-shaped configuration.

[0046] The width of the slot 205 may be defined by a pair of opposing sidewalls 207, and a lip 206 may extend on each sidewall 207, thereby forming a track along the sidewalls 207 below the overhang of the lip 206. As described herein, the housing 201 may be configured to receive an alignment feature 250 within the slot 205, and the pair of opposing sidewalls 207 may be configured to interact with the alignment feature 250 to guide the alignment feature 250 to a plurality of positions along the slot 205.

[0047] 6, the housing 201 may include an opening 209 at the second end of the slot 205. The opening 209 may be sized and shaped to receive a portion of the alignment feature 250, thereby facilitating receipt and / or removal of the alignment feature 250 from within the slot 205. The alignment feature 250 may include a movable body 252 having a longitudinal length defined between a first end 252A and a second end 252B.

[0048] The movable body 252 may include one or more legs 254 at a first end 252A and a shelf 256 at a second end 252B. The alignment mechanism 250 may include one or more openings along a proximal (top) surface of the movable body 252 to receive one or more fastening mechanisms (e.g., fasteners). In the example shown in FIG. 6, the alignment mechanism 250 includes at least a first opening 258A and at least a second opening 258B. As described in more detail below, the first opening 258A may be configured to receive a first fastener (e.g., a screw, not shown) and the second opening 258B may be configured to receive a second fastener (e.g., a screw, not shown), each fastener may facilitate securing the movable body 252 in a fixed position relative to the connector 260 and / or the housing 201 of the alignment mechanism 250. Although two openings 258A, 258B are shown in this example, alignment mechanism 250 may include additional and / or fewer openings without departing from the scope of the present disclosure. Additionally, although the figures and description depict one or more fasteners being used to secure moveable body 252 to connector 260, one skilled in the art will appreciate that any suitable fastening or locking mechanism may be used to couple moveable body 252 to connector 260.

[0049] 6, the first end 252A of the movable body 252 may be U-shaped with a pair of legs 254 defining the terminus of the first end 252A. The pair of legs 254 may be spaced apart from one another by a predetermined distance, such as a distance corresponding to the diameter of the first opening 108A. Alternatively, the spacing between the legs 254 may be sized to correspond to the outer diameter of the syringe barrel (e.g., body 12) for testing. The shelf 256 may define an elevated surface of the second end 252B of the movable body 252 elevated relative to the proximal (top) surface of the movable body 252. The shelf 256 may have an ergonomic profile configured to facilitate a user manually grasping the shelf 256 to actuate the alignment mechanism 250, for example, to move the movable body 252 between one or more positions relative to the housing 201.

[0050] In some embodiments, the movable body 252 may be configured to move relative to the housing 201 between at least a first position, shown in FIG. 6, and at least a second position, shown in FIG. 7. In the first position, the legs 254 may be positioned adjacent the first opening 108A and in a path of travel of the proximal end 16 when the syringe 10 is received through the first opening 108A. The legs 254 may be configured to engage a portion of the syringe 10, such as a flange on the proximal end 16, when the body 12 moves distally through the channel 108. The legs 254 may be sized and / or shaped to form an obstacle and / or obstruction in a path of travel of the body 12 when the syringe 10 is moved through the housing 201 while the alignment mechanism 250 is in the first position.

[0051] Thus, the alignment mechanism 250 can be configured to prevent the flange of the proximal end 16 from moving distally toward the proximal body 102 when the legs 254 are disposed between the flange and the proximal body 102. In this case, the legs 254 can be an obstruction that prevents the flange from contacting the proximal (top) surface of the proximal body 102. Thus, when the alignment mechanism 250 is in the first position, the position and / or orientation of the body 12 relative to the housing 201 can be fixed. Given the U-shape of the first end 252A of the movable body 252 and the separation distance between the legs 254, the alignment mechanism 250 can still allow the body 12 to be received in the channel 108 through the first opening 108A, as the legs 254 prevent the proximal end 16 from contacting the proximal body 102.

[0052] The alignment feature 250 may provide assistance in aligning the body 12 relative to the housing 201 when the pair of legs 254 are disposed adjacent the first opening 108A and prevent the flange from contacting the proximal body 102. For example, in the first position shown in FIG. 6, the alignment feature 250 may serve as a visual reference for positioning the syringe 10 relative to the adapter assembly 200. Additionally, the alignment feature 250 may provide a physical stop for the syringe 10, thereby providing an additional reference for positioning the syringe 10 relative to the adapter assembly 200. The size (e.g., height) and / or shape of the legs 254 may at least partially define the permissible range of distal movement of the body 12 relative to the housing 201 while the alignment feature 250 is in the first position.

[0053] 7, the alignment mechanism 250 can be configured to move to a second position relative to the housing 201. Specifically, when the movable body 252 moves to the second position, it can translate on the handle 106 through the slot 205 and toward the opening 209. The pair of legs 254 can move away from the first opening 108A, thereby clearing an obstruction from the path of movement of the body 12 and the corresponding flange. Once the legs 254 are no longer disposed adjacent the first opening 108A, the flange of the proximal end 16 can move distally toward the housing 201 until it encounters the proximal body 102.

[0054] While alignment mechanism 250 is shown and described herein in relation to two positions, it should be understood that adapter assembly 200 can be configured to enable alignment mechanism 250 to include additional and / or fewer positions relative to housing 201. In some embodiments, adapter assembly 200 may be configured to enable alignment mechanism 250 to be fully removed from housing 201, such as by translating moveable body 252 out of slot 205 through opening 209. Thus, adapter assembly 200 can be configured to separate alignment mechanism 250 from housing 201 by translating moveable body 252 out of slot 205 through opening 209. In some cases, the second position of alignment mechanism 250 may correspond to fully removing moveable body 252 from slot 205.

[0055] 8, the alignment mechanism 250 may include a connector 260 disposed within the slot 205 and at least partially received within the movable body 252, such as within the first opening 258A and the second opening 258B. The connector 260 may be disposed distally (e.g., below) the movable body 252 and coupled to the movable body 252 along a distal (bottom) surface of the movable body 252. As described herein, the movable body 252 may be coupled to the connector 260 by receiving a first fastener in the first opening 258A for engagement with a first screw channel 266A of the connector 260 and a second fastener in the second opening 258B for engagement with a second screw channel 266B of the connector 260. The connector 260 may be configured to move through the slot 205 in response to corresponding movement of the movable body 252 along a proximal (top) surface of the housing 201 when coupled together. As described herein, the connector 260 may interact with the slot 205 to couple the moveable body 252 to the housing 201 .

[0056] In this example, the connector 260 may include a linear bearing having a body 262 sized and shaped to be received within the slot 205. The body 262 may include a pair of outer edges and / or rails 264 extending along opposing sidewalls of the body 262. The pair of rails 264 are sized and shaped to fit the pair of sidewalls 207 of the slot 205 such that the rails 264 may be received beneath an overhang defined by the lip 206. The pair of rails 264 may thus be movable along a track defined by the sidewalls 207 to facilitate movement of the alignment mechanism 250 through the slot 205. With the rails 264 received along the sidewalls 207 and beneath the lip 206, the connector 260 may be securely coupled to the slot 205, thereby connecting the alignment mechanism 250 to the adapter assembly 200.

[0057] 8, the connector 260 can include at least one screw channel for each opening of the movable body 252. In this example, the connector 260 can include a first screw channel 266A extending proximally outward from the body 262 for reception into the first opening 258A, such as from the proximal direction. The connector 260 can include a second screw channel 266B extending proximally outward from the body 262 for reception into the second opening 258B, such as from the proximal direction. The screw channels 266A, 266B can extend into and be received into corresponding openings 258A, 258B, such that the body 262 can be securely coupled to the movable body 252 via one or more fasteners. Thus, movement (e.g., translation) of the movable body 252 along the outer surface of the housing 201 can simultaneously move the body 262 within the slot 205.

[0058] To couple the body 262 to the movable body 252, the first screw channel 266A can be configured to engage a first fastener received from the first opening 258A, and the second screw channel 266B can be configured to engage a second fastener received from the second opening 258B. In one example, the fastener may include a screw configured to mate with a threaded portion of each of the first screw channel 266A and the second screw channel 266B. In some examples, the fastener may be further configured to securely fix a position (e.g., one or more of a first position, a second position, etc.) of the alignment feature 250 relative to the housing 201 by engaging the slot 205 when received through the corresponding openings 258A, 258B and screw channels 266A, 266B.

[0059] A fastener may be inserted into openings 258A, 258B and the outer threads of the fastener may be mated with the inner threads of thread channels 266A, 266B such that the distal end of the fastener may translate distally through body 262 to engage a surface of slot 205. In this case, a frictional engagement may be formed between alignment feature 250 and housing 201. The frictional engagement between the fastener and slot 205 may be configured to prevent movement of alignment feature 250 relative to housing 201 until the distal force exerted by the fastener on slot 205 is minimized and / or removed.

[0060] The features listed above are described within the context of certain embodiments and / or examples. However, as will be appreciated by those skilled in the art, the features and aspects of each embodiment or example can be combined, added to, or subtracted from other embodiments or examples in any manner suitable to aid in the controlled preparation and / or delivery of drugs. Although numerous embodiments and / or examples are presented herein, it is contemplated that multiple variations of such embodiments and combinations of elements from one or more embodiments are possible and are within the scope of the present disclosure. Moreover, those skilled in the art will appreciate that the concepts on which the present disclosure is based can be readily used as a basis for designing other devices, methods, and systems that embody some of the objectives of the present disclosure.

[0061] The present disclosure is further illustrated by the following non-limiting clauses.

[0062] Clause 1. Housing: a channel formed within the housing and configured to receive a medical device; a first groove formed along an inner wall of the channel and configured to at least partially receive a first retention element; a second groove formed along the inner wall of the channel and configured to at least partially receive a second retention element; and the housing comprising: 1. An adapter assembly comprising: an adapter assembly, wherein the first retaining element and the second retaining element are configured to extend outwardly from the first groove and the second retaining element are configured to extend outwardly from the second groove to abut a body of the medical device received through the channel.

[0063] Clause 2. The adapter assembly of clause 1, wherein the first retaining element and the second retaining element are configured to align the body of the medical device with respect to a central longitudinal axis of the channel.

[0064] Clause 3. The adapter assembly of clause 1, wherein the first retaining element and the second retaining element are configured to maintain the body of the medical device in a suspended position relative to the housing.

[0065] Clause 4. The adapter assembly of clause 3, wherein the first retaining element and the second retaining element are configured to offset a proximal end of the body from a proximal surface of the housing when the medical device is in the suspended position.

[0066] Clause 5. An adapter assembly as described in Clause 4, wherein the first retaining element and the second retaining element are configured to minimize load applied to the medical device by the housing when the proximal end of the body is separated from the proximal face of the housing.

[0067] Clause 6. The adapter assembly of clause 4, further comprising an alignment mechanism disposed on a proximal surface of the housing, the alignment mechanism configured to position the proximal end of the medical device relative to the housing.

[0068] Clause 7. The adapter assembly of clause 6, wherein the housing includes a slot on the proximal surface, the slot configured to slidably receive the alignment mechanism between a plurality of positions within the slot.

[0069] Clause 8. The adapter assembly of clause 7, wherein the alignment mechanism is movable between a first position and a second position relative to the slot, and in the first position, the alignment mechanism is configured to limit movement of the proximal end of the medical device relative to the housing, and in the second position, the alignment mechanism is configured to permit movement of the proximal end of the medical device relative to the housing.

[0070] Clause 9. The adapter assembly of clause 1, wherein the housing includes a handle configured to removably couple the adapter assembly to an inspection instrument, and the medical device includes a syringe having a needle.

[0071] Clause 10. The adapter assembly of clause 9, configured to align the needle with respect to the testing instrument when the syringe is received within the housing and the adapter assembly is coupled to the testing instrument.

[0072] Clause 11. The adapter assembly of clause 9, configured to suspend the syringe within the testing instrument such that the body of the syringe is separated from one or more surfaces of the testing instrument.

[0073] Clause 12. The adapter assembly of clause 11, wherein the first retaining element and the second retaining element are configured to minimize load applied to the syringe by the inspection instrument by isolating a proximal flange of the syringe from the housing and the one or more surfaces of the inspection instrument.

[0074] Clause 13. The adapter assembly of clause 1, wherein the cross-sectional dimensions of the channel, the first retaining element, and the second retaining element define a gripping portion diameter of the adapter assembly, the gripping portion diameter of the adapter assembly varying along the longitudinal length of the housing.

[0075] Clause 14. The adapter assembly of clause 1, wherein each of the first retaining element and the second retaining element is formed from a flexibly deformable elastomeric material.

[0076] Article 15. Housing: a channel configured to receive a portion of a medical device; a pair of grooves formed along an inner wall of the channel, each of the pair of grooves being longitudinally offset from one another along the inner wall; a pair of retaining elements, each of the pair of retaining elements at least partially received within at least one of the pair of grooves; the housing comprising: 1. An adapter assembly comprising: An adapter assembly, wherein the pair of retaining elements are configured to extend outwardly from and into the pair of channels to thereby interact with the portion of the medical device received through the channels.

[0077] Clause 16. The adapter assembly of clause 15, wherein the housing includes an alignment mechanism and a slot formed along a proximal surface of the housing, the alignment mechanism configured to move through the slot to a plurality of positions relative to the proximal surface of the housing.

[0078] Clause 17. The adapter assembly of clause 16, wherein in a first position of the alignment mechanism relative to the slot, the alignment mechanism is configured to engage a portion of the medical device, thereby preventing movement of the medical device relative to the adapter assembly, and in a second position of the alignment mechanism relative to the slot, the alignment mechanism is configured to disengage from the portion of the medical device, thereby allowing movement of the medical device relative to the adapter assembly.

[0079] Clause 18. An adapter assembly as described in clause 16, wherein the alignment mechanism includes a movable body and a connector coupled to the movable body, the movable body having a pair of openings, each of the pair of openings configured to receive a fastening mechanism for coupling the movable body to the connector.

[0080] Clause 19. An adapter assembly as described in clause 18, wherein the movable body is disposed on the proximal surface of the housing, the connector is disposed within the slot, and the alignment mechanism is configured such that when the movable body moves relative to the proximal surface, the connector makes corresponding movement through the slot.

[0081] Clause 20. A method of holding a medical device using an adapter assembly, comprising: inserting the medical instrument into a channel of the adapter assembly, the channel including a pair of grooves separated from one another along a longitudinal length of the channel and at least one retaining element received within each of the pair of grooves for suspending the medical instrument within the channel; placing an alignment feature of the adapter assembly in a first position to engage a portion of the medical device to prevent movement of the medical device relative to the channel; placing the alignment feature of the adapter assembly in a second position to disengage the portion of the medical instrument thereby allowing the medical instrument to move relative to the channel; A method comprising:

Claims

1. A housing, a channel formed within the housing and configured to receive a medical device; a first groove formed along an inner wall of the channel and configured to at least partially receive a first retention element; a second groove formed along the inner wall of the channel and configured to at least partially receive a second retention element; the housing comprising:

1. An adapter assembly comprising: an adapter assembly, wherein the first retaining element and the second retaining element are configured to extend outwardly from the first groove and the second retaining element are configured to extend outwardly from the second groove to abut a body of the medical device received through the channel.

2. The adapter assembly of claim 1 , wherein the first retaining element and the second retaining element are configured to align the body of the medical device with respect to a central longitudinal axis of the channel.

3. The adapter assembly of claim 1 , wherein the first retaining element and the second retaining element are configured to maintain the body of the medical instrument in a suspended position relative to the housing.

4. The adapter assembly of claim 3 , wherein the first retaining element and the second retaining element are configured to offset a proximal end of the body from a proximal face of the housing when the medical device is in the suspended position.

5. 5. The adapter assembly of claim 4, wherein the first retaining element and the second retaining element are configured to minimize loads applied by the housing to the medical device when the proximal end of the body is separated from the proximal face of the housing.

6. The adapter assembly of claim 4 , further comprising an alignment mechanism disposed on a proximal face of the housing, the alignment mechanism configured to position the proximal end of the medical instrument relative to the housing.

7. The adapter assembly of claim 6 , wherein the housing includes a slot on the proximal surface, the slot configured to slidably receive the alignment feature between a plurality of positions therein.

8. the alignment mechanism is movable between a first position and a second position relative to the slot; 8. The adapter assembly of claim 7, wherein in the first position, the alignment mechanism is configured to limit movement of the proximal end of the medical instrument relative to the housing, and in the second position, the alignment mechanism is configured to permit movement of the proximal end of the medical instrument relative to the housing.

9. The adapter assembly of claim 1 , wherein the housing includes a handle configured to removably couple the adapter assembly to a testing instrument, and the medical instrument includes a syringe having a needle.

10. The adapter assembly of claim 9 , configured to align the needle with respect to the testing instrument when the syringe is received within the housing and the adapter assembly is coupled to the testing instrument.

11. The adapter assembly of claim 9 , configured to suspend the syringe within the testing instrument such that the body of the syringe is separated from one or more surfaces of the testing instrument.

12. 12. The adapter assembly of claim 11, wherein the first retaining element and the second retaining element are configured to minimize loads applied to the syringe by the testing instrument by isolating a proximal flange of the syringe from the housing and the one or more surfaces of the testing instrument.

13. 2. The adapter assembly of claim 1, wherein the cross-sectional dimensions of the channel, the first retaining element, and the second retaining element define a gripping diameter of the adapter assembly, the gripping diameter of the adapter assembly varying along a longitudinal length of the housing.

14. The adapter assembly of claim 1 , wherein each of the first and second retaining elements is formed from a flexibly deformable elastomeric material.

15. A housing, a channel configured to receive a portion of a medical device; a pair of grooves formed along an inner wall of the channel, each of the pair of grooves being longitudinally offset from one another along the inner wall; a pair of retaining elements, each of the pair of retaining elements at least partially received within at least one of the pair of grooves; the housing comprising:

1. An adapter assembly comprising: An adapter assembly, wherein the pair of retaining elements are configured to extend outwardly from and into the pair of channels to thereby interact with the portion of the medical device received through the channels.

16. 16. The adapter assembly of claim 15, wherein the housing includes an alignment feature and a slot formed along a proximal face of the housing, the alignment feature configured to move through the slot to a plurality of positions relative to the proximal face of the housing.

17. in a first position of the alignment mechanism relative to the slot, the alignment mechanism is configured to engage a portion of the medical instrument, thereby preventing movement of the medical instrument relative to the adapter assembly; The adapter assembly of claim 16, wherein in a second position of the alignment mechanism relative to the slot, the alignment mechanism is configured to disengage from the portion of the medical instrument, thereby allowing movement of the medical instrument relative to the adapter assembly.

18. 17. The adapter assembly of claim 16, wherein the alignment mechanism includes a movable body and a connector coupled to the movable body, the movable body having a pair of openings, each of the pair of openings configured to receive a fastening mechanism for coupling the movable body to the connector.

19. the movable body is disposed on the proximal face of the housing and the connector is disposed within the slot; The adapter assembly of claim 18 , wherein the alignment mechanism is configured such that movement of the moveable body relative to the proximal face causes corresponding movement of the connector through the slot.

20. 1. A method of holding a medical instrument using an adapter assembly, comprising: inserting the medical instrument into a channel of the adapter assembly, the channel including a pair of grooves separated from one another along a longitudinal length of the channel and at least one retaining element received within each of the pair of grooves for suspending the medical instrument within the channel; placing an alignment feature of the adapter assembly in a first position to engage a portion of the medical device to prevent movement of the medical device relative to the channel; placing the alignment feature of the adapter assembly in a second position to disengage the portion of the medical instrument thereby allowing the medical instrument to move relative to the channel; A method comprising:

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