Apparatus and method for holder adapter assembly

Abstract

An adapter assembly includes 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 holding element; and a second groove formed along the inner wall of the channel and configured to at least partially receive a second retaining element. The first retaining element is configured to extend outwardly from the first groove and the second retaining element is configured to extend outwardly from the second groove such that the first retaining element and the second retaining element abut the medical device received through the channel.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 316,814, filed on March 4, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Various aspects of the present disclosure relate to apparatus and methods for positioning, controlling and retaining medical devices during testing procedures. More specifically, embodiments of the present disclosure relate to apparatus and methods for holding, suspending, aligning and / or maintaining the position of a medical device (e.g., a syringe) relative to an instrument for testing various characteristics of the medical device. Background Art

[0004] Medical devices used to store drug products, such as syringes that store fluid substances, may need to undergo various testing procedures to ensure proper and safe functionality. Testing instruments may be utilized to facilitate such testing, including but not limited to compression and tension testing. In some cases, loads (e.g., forces) may be inadvertently applied to the syringe by the test instrument and / or other devices (e.g., during setup), resulting in inaccuracies in test results or premature failures. In other cases, human error in handling, controlling, or positioning the syringe relative to the test instrument prior to administering the test may similarly affect the results.

[0005] Inadvertently applying a load (referred to herein as "pre-loading") to a syringe prior to administering a test may cause additional complications to the automated testing process of the syringe. For example, pre-loading a syringe may cause misalignment of the syringe relative to the test site and / or the test instrument, thereby causing erroneous results or sample corruption during the testing process. Summary of the invention

[0006] Disclosed herein is an adapter assembly, and in particular an adapter for attaching, holding, aligning and / or controlling the position and / or orientation of a syringe relative to a test instrument and / or a test site. In an embodiment of the present disclosure, the adapter assembly includes a housing, the housing including a channel formed in the housing. The channel is defined by a pair of openings positioned on opposite 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 the inner wall of the channel, the first groove being configured to at least partially receive a first retaining element. The adapter assembly may include a second groove formed along the inner wall of the channel, the second groove being configured to at least partially receive a second retaining element. The first retaining element is configured to extend outwardly from the first groove (e.g., radially inwardly relative to the inner wall), and the second retaining element is configured to extend outwardly from the second groove (e.g., radially inwardly relative to the inner wall), so that each of the first retaining element and the second retaining element is close to (and in contact with) the body of the medical device received by the channel. The first retaining element and the second retaining element are configured to align the body of the medical device relative to the central longitudinal axis of the channel and to bias the proximal end of the medical device from the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate various exemplary embodiments and, together with this description, are used to explain the principles of the disclosed embodiments. The accompanying drawings illustrate different aspects of the present disclosure, and where appropriate, reference numerals that similarly designate similar structures, components, materials, and / or elements in different figures are similarly indicated. It is understood that various combinations of structures, components, and / or elements in the various embodiments are contemplated and within the scope of the present disclosure in addition to those specifically shown.

[0008] Figure 1 A perspective view of an example adapter assembly is depicted that receives an example syringe barrel therein in accordance with aspects of the present disclosure.

[0009] Figure 2 Describe the various aspects of the present disclosure Figure 1 A cross-sectional side view of the adapter assembly and syringe depicted in FIG.

[0010] Figure 3 Describe various aspects of the present disclosure Figure 1 A cross-sectional side view of an adapter assembly.

[0011] Figure 4 Describing additional aspects of the present disclosure, receiving Figure 1 A perspective view of an exemplary test instrument of the adapter assembly and syringe described in FIG.

[0012] Figure 5Describing additional aspects of the present disclosure Figure 4 Side view of the test apparatus.

[0013] Figure 6 A perspective view of another exemplary adapter assembly in a first position is depicted according to aspects of the present disclosure.

[0014] Figure 7 Describe various aspects of the present disclosure Figure 6 A perspective view of the adapter assembly in a second position.

[0015] Figure 8 Describe various aspects of the present disclosure Figure 6 A cross-sectional side view of an adapter assembly.

[0016] Many embodiments are described and illustrated herein. The present disclosure is neither limited to any single aspect or embodiment thereof, nor to any combination and / or permutation of these aspects and / or embodiments. Each aspect and / or its embodiment of the present disclosure can be adopted individually or in combination with one or more other aspects and / or its embodiments of the present disclosure. For the sake of brevity, many of those combinations and permutations are not discussed separately herein. DETAILED DESCRIPTION

[0017] As used herein, the terms "comprises," "comprising," "includes," "including," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may include 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." It is noteworthy that the embodiments or implementations described herein as "examples" or "exemplary" should not be understood as being preferred or advantageous, for example, preferred or advantageous relative to other embodiments or implementations; on the contrary, it is intended to reflect or indicate that the implementation is an "example" rather than "ideal." In addition, the terms "first," "second," and the like do not indicate any order, quantity, or importance herein, but are used to distinguish an element, structure, step, or process from another element, structure, step, or process. In addition, the terms "a" and "an" herein do not indicate a limitation of quantity, but rather indicate the presence of one or more referenced items. Furthermore, the terms "about," "approximately," "substantially," etc., when used to describe a numerical value, mean a variation of + / - 10% of the stated value unless otherwise specified.

[0018] Embodiments of the present disclosure can be used with any type of fluid-containing products, such as liquid drug substances, liquid placebos or other liquids (or liquid solutions) that can be distributed in dosage form. As used herein, the term "substance" can mean a prepared substance including one or more active ingredients. In some embodiments, the device and aspects of the present disclosure can be used with any therapy using the immune system to combat disease, such as including vaccines, allergy treatments, cancer treatments and more treatments of immunotherapy. Specifically, the device and aspects of the present disclosure can be used to treat cancer patients (e.g., immune-oncology). However, it is also considered that the embodiments of the present disclosure can be applicable to any therapy, liquid products and / or any other situation in which different substances can be stored separately in most vials. Although medical indications are described herein, it is contemplated that non-medical liquids packaged together in different vials can be used in combination with vial adapters described herein. It should be understood that embodiments of the present disclosure can be used with fluid-containing products (e.g., syringes), which are empty and do not contain any liquid substances such as for component identification purposes.

[0019] As used herein, the terms "proximal" and "proximally" mean a position (or a portion of a device) that is relatively closer to a client or in the direction of a client relative to a distal position / portion of a device, and the terms "distal" and "distally" mean a position (or a portion of a device) that is relatively closer to an access point or in the direction of an access point. As used herein, the term "body" when used with respect to a portion of a device may mean a device component that is suitable for containing a volume of a drug substance. The body may include, for example, a barrel (e.g., a syringe barrel), a tube, a cylinder, or another containing portion of the device. In some embodiments, the body may also include a distal end portion having a nozzle, a needle, a needle attachment site, and / or a distal cap.

[0020] In the various embodiments of the adapter assembly described herein, and especially for holding a syringe relative to an instrument or device, this instrument or device is used to test some characteristics of a syringe. In some cases, the embodiments disclosed herein or various aspects of the embodiments can be used in combination with syringes of various shapes and / or sizes. In other cases, the embodiments disclosed herein or various aspects of the embodiments can be used together with other types of fluid-containing products, including but not limited to vials, cassettes and / or other suitable medical devices. Such an adapter assembly can be intended to reduce human error and / or raise the accuracy of the test of the characteristics or functionality of a management medical device.

[0021] Reference now Figure 1, describing an exemplary adapter assembly 100. The adapter assembly 100 may be configured and operable to hold and suspend a medical device relative to a test instrument or a test 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, the size, shape, and configuration of each of the proximal body 102 and the distal body 104 may be designed to form a friction fit with a corresponding portion of the test 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 that is configured to facilitate a user to manually manipulate the housing 101, such as inserting the adapter assembly 100 and / or removing the adapter assembly 100 from the test instrument.

[0022] The housing 101 may include opposing exterior surfaces, such as a proximal (top) surface of the proximal body 102 and a distal (bottom) surface of the distal body 104. The adapter assembly 100 may include one or more alignment mechanisms 105 positioned on the housing 101. In an example, the adapter assembly 100 may include at least one pair of alignment mechanisms 105 extending proximally from the proximal (top) surface of the proximal body 102. The pair of alignment mechanisms 105 may be configured to facilitate positioning, alignment, and / or orientation of a medical device relative to the adapter assembly 100, and in particular, the proximal (top) surface of the proximal body 102. As described herein, the alignment mechanisms 105 may serve as visual reference points for positioning a medical device coupled to the adapter assembly 100.

[0023] like Figure 1 As seen in FIG. 1 , the medical device may include a syringe 10 having a body 12 for storing a substance 11. The body 12 may have 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 of the body 12. In some embodiments, the syringe 10 may omit the substance 11 and / or may not include the stopper 18. The syringe 10 may include a needle 15 extending distally from the distal end 14 (see FIG. 1 ). Figure 5 ). The needle 15 can be in fluid communication with the cavity of the body 12, including the substance 11 stored in the body 12. In some examples, the syringe 10 can include a removable cap 20 (e.g., a rigid needle shield or a soft needle shield) selectively coupled to the distal end 14 to cover the needle 15 when the syringe 10 is not in use. In other examples, the cap 20 can be omitted entirely. It should be understood that various other suitable medical devices can be used in conjunction with the adapter assembly 100.

[0024] The proximal end 16 can define a flange of the syringe 10, such that the pair of alignment mechanisms 105 can be configured to facilitate positioning of the flange relative to the proximal (top) surface of the proximal body 102. In this embodiment, the pair of alignment mechanisms 105 can include raised portions that define a line of sight 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, the user can refer to the corresponding distances between the flange of the proximal end 16 and the pair of alignment mechanisms 105 to determine the desired position of the body 12 relative to the housing 101.

[0025] Although a pair of alignment mechanisms 105 are shown and described herein, the adapter assembly 100 may include additional and / or fewer alignment mechanisms 105 without departing from the scope of the present disclosure. Additionally and / or alternatively, the alignment mechanisms 105 may be positioned along various other surfaces and / or walls of the housing 101 rather than the proximal (top) surface of the proximal body 102. It should be understood that the alignment mechanisms 105 may have various other suitable sizes, shapes, and / or configurations in addition to those shown and described herein.

[0026] refer to Figure 2 , the adapter assembly 100 may include a channel 108 extending through the housing 101, and in particular through each of the proximal body 102 and the distal body 104. The channel 108 may have a longitudinal length defined between opposite outer surfaces of the housing 101, for example, between the proximal (top) surface of the proximal body 102 and the distal (bottom) surface of the distal body 104. The housing 101 may include a first opening 108A along the proximal (top) surface of the proximal body 102 and a second opening 108B along the distal (bottom) surface of the distal body 104. The channel 108 may extend between the first opening 108A and the second opening 108B, and may be configured to receive the syringe 10 through the housing 101 via the first opening 108A and the second opening 108B. The channel 108 may have a substantially 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.

[0027] The housing 101 may also include one or more grooves and / or channels formed within the channel 108, such as along an inner wall defining the channel 108. Each of the one or more grooves may be sized and shaped to receive a retaining element. In an example, the housing 101 may include a first groove 109A and a second groove 109B. The first groove 109A may be positioned adjacent to the proximal (top) surface of the proximal body 102 relative to the second groove 109B, and the second groove 109B may be positioned adjacent to the distal (bottom) surface of the distal body 104 relative to the first groove 109A.

[0028] Still reference Figure 2, each of the first groove 109A and the second groove 109B may extend around the inner wall and / or surface defining the channel 108, so that each groove may have a length that is transverse (e.g., perpendicular) to the central longitudinal axis A of the channel 108. When the syringe 10 is received in the channel 108, the first groove 109A and the second groove 109B may be positioned around the periphery of the body 12. The first groove 109A and the second groove 109B may extend completely around the periphery of the channel 108 or only a portion thereof. In addition, portions of the first groove 109A and the second groove 109B may overlap with each other, while other portions of the first groove 109A and the second groove 109B may not overlap with each other. Further, although the present disclosure describes the first groove 109A and the second groove 109B as extending in a plane that is substantially perpendicular to the central longitudinal axis A of the channel 108, a person of ordinary skill in the art will readily recognize that the grooves may extend in a plane parallel to the central longitudinal axis A. In addition, although Figure 2 Two circumferential grooves 109A, 109B are depicted, but more or fewer grooves may be provided in accordance with the principles of the present disclosure.

[0029] The first groove 109A may be configured to receive a first retaining element 110A, and the second groove 109B may be configured to receive a second retaining element 110B. According to the corresponding configuration of the respective grooves, the first retaining element 110A and the second retaining element 110B may extend completely around the periphery of the channel 108 or only a portion thereof. In addition, portions of the first and retaining elements 110A, 110B may overlap each other, while other portions of the first and second retaining elements 110A, 110B may not overlap each other. Although the present disclosure describes the first retaining element 110A and the second retaining element 110B extending in a plane substantially perpendicular to the central longitudinal axis A, a person of ordinary skill in the art will recognize that these retaining elements may 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 according to a corresponding number of grooves.

[0030] like Figure 3 As best seen in , each of the first retaining element 110A and the second retaining element 110B can be sized and / or shaped to extend at least partially outwardly from the corresponding groove. In other words, the retaining elements 110A, 110B can extend radially inwardly from and / or relative to the inner wall of the housing 101. Accordingly, the first retaining element 110A and the second retaining element 110B can 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 can be oversized to allow for greater clearance and / or space for the respective retaining element to flex therein.

[0031] As described below, the first retaining element 110A and the second retaining element 110B can be configured to contact an outer surface of the body 12 when the syringe 10 is received through the passage 108. The first retaining element 110A and the second retaining element 110B can be configured to hold the syringe 10 in a fixed position, orientation, and / or alignment relative to the housing 101 and the test site when the body 12 is engaged within the passage 108.

[0032] The first groove 109A and the second groove 109B can be longitudinally spaced apart from each other (in a direction parallel to the central longitudinal axis A of the passage 108) by a minimum predetermined distance to promote 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 between the retention elements received in each groove can be configured to improve engagement between the housing 101 and the syringe 10. In addition, when the syringe 10 is received by the housing 101, the offset distance between the first groove 109A and the second groove 109B can improve alignment of the body 12 within the passage 108, for example, relative to the central longitudinal axis A. As described herein, the adapter assembly 100 can be configured to suspend (e.g., retain) the syringe 10 within the housing 101 and align the needle 15 or the needle shield 20 relative to the test site. In some embodiments, the syringe 10 can omit the needle shield 20 entirely, so that the needle 15 can be exposed at the distal end 14. Via the retaining elements 110A, 110B, the adapter assembly 100 may be configured to retain the syringe 10 therein until an appropriate force is applied to the syringe 10 .

[0033] Still reference Figure 3 , the relative positions of the first groove 109A and the second groove 109B define two concentric contact points for the adapter assembly 100. Although a pair of grooves and a pair of corresponding retaining elements are shown and described herein, it should be understood that additional and / or fewer grooves and retaining elements may be included in the adapter assembly 100 without departing from the scope of the present disclosure. The cross-sectional dimensions of the channel 108, the first retaining element 110A, and / or the second retaining element 110B may at least partially define a gripping diameter of the adapter assembly 100.

[0034] In some embodiments, the first groove 109A and the second groove 109B can have similar sizes and / or shapes, while in other embodiments, the grooves can have varying sizes and / or shapes relative to each other. Similarly, the first retaining element 110A and the second retaining element 110B can have similar or varying sizes and / or shapes relative to each other. The material composition of the retaining elements 110A, 110B can further adjust the gripping diameter of the adapter assembly 100, for example, based on the relative elasticity and / or flexibility of the materials. Accordingly, the gripping diameter of the adapter assembly 100 can be substantially constant and / or can vary along the central longitudinal axis A of the channel 108.

[0035] In one example, the first retaining element 110A and the second retaining element 110B can be formed of a flexibly deformable elastic material. Accordingly, when the syringe 10 is received through the passage 108, the retaining elements 110A, 110B can be configured to bend and / or deform, thereby applying a radially inward force to the body 12 to retain the syringe 10 in the housing 101.

[0036] In some examples, the retaining elements 110A, 110B may include The rubber O-ring formed has a Shore hardness range of about 80A to about 90A, for example, 85A. In other examples, the retaining elements 110A, 110B may include various suitable seals, washers, plug-ins and other similar devices. Those of ordinary skill in the art will readily recognize that the retaining elements 110A, 110B may be, for example, made of any suitable material, such as rubber or a suitable fluororubber. The housing 101 including the proximal body 102, the distal body 104 and the handle 106 may be formed of various materials such as carbon fiber nylon, polyetheretherketone (PEEK) carbon fiber and other similar materials.

[0037] In an exemplary use, the adapter assembly 100 may be operable to facilitate testing of a medical device, such as the syringe 10, with a test instrument. It should be appreciated that the adapter assembly 100 may facilitate testing of the syringe 10 with or without the substance 11 or the stopper 18 disposed within the body 12 and / or the needle shield 20 coupled to the needle 15. Figure 1 , the syringe 10 (or another medical device) can be coupled to the adapter assembly 100 by inserting the body 12 through the passage 108. When the syringe 10 is received in the first opening 108A, passes through the passage 108, and exits the housing 101 from the second opening 108B, the first retaining element 110A and the second retaining element 110B can interface with the exterior of the body 12.

[0038] The first retaining element 110A and the second retaining element 110B can be configured to flex when engaged with the body 12. Specifically, when the body 12 is received by the passage 108, the pair of retaining elements 110A, 110B can be compressed radially outward (e.g., away from the central longitudinal axis A of the passage 108) to form a friction fit against the exterior of the syringe 10 (see Figure 2 The friction fit can 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 can be configured to automatically align the syringe 10 with the central longitudinal axis A when the syringe 10 is inserted through the housing 101. As described herein, by aligning the syringe 10 within the channel 108, the adapter assembly 100 can be configured to improve the alignment of the needle 15 and / or the needle shield 20 relative to the test site when the assembly of the syringe 10 and the adapter assembly 100 is coupled to a test instrument (see Figure 4-5 ).

[0039] It should be understood that while the pair of retaining elements 110A, 110B engage the body 12 within the passage 108, the syringe 10 can be moved relative to the housing 101 such that a user of the adapter assembly 100 can 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 inhibit movement of the syringe 10 relative to the housing 101 in the absence of force applied to the body 12 (e.g., by a user of the adapter assembly 100). Accordingly, the pair of retaining elements 110A, 110B can be configured to maintain the position and / or orientation of the syringe 10 relative to the housing 101, such as from natural gravity, but do not prevent the user from applying proximal and / or distal force to the body 12 to move the syringe 10 to a desired position and / or orientation relative to the adapter assembly 100.

[0040] Still reference Figure 1 and 2 , a user may utilize the pair of alignment mechanisms 105 as a visual reference for aligning and moving the syringe 10 through the housing 101. For example, the syringe 10 may be moved (e.g., translated, rotated, etc.) relative to the housing 101 to position the flange (at the proximal end 16) of the syringe 10 in a desired position and / or orientation relative to the pair of alignment mechanisms 105. In an example, the pair of alignment mechanisms 105 are spaced from the first opening 108A such that the alignment mechanisms 105 are not positioned within the path of travel of the body 12 (and / or the flange at the proximal end 16) when the syringe 10 is moved through the passage 108.

[0041] In another example, one or more of the pair of alignment mechanisms 105 can be movable relative to the housing 101, and in particular, the proximal body 102. For example, at least one of the alignment mechanisms 105 can include a movable arm coupled to a hinge, such that the alignment mechanism 105 can be configured to move (e.g., pivot) relative to the proximal (top) surface of the proximal body 102. In this case, the movable arm of the alignment mechanism 105 can be at least partially positioned above the first opening 108A, such that the alignment mechanism 105 can be within the path of travel of the body 12 as the syringe 10 moves through the passage 108. The swingable arm of the alignment mechanism 105 can engage a portion of the body 12, such as at a flange at the proximal end 16, to fix the relative position and / or orientation of the body 12 relative to the housing 101 until the swingable arm is moved away from the first opening 108A and out of the path of travel of the body 12. In a further example, the adapter assembly may include an alignment mechanism movably (e.g., slidably) coupled to a groove on the housing of the adapter assembly, and the alignment mechanism may be movable between a plurality of positions in the groove to selectively block and allow movement of the flange toward the first opening 108A (e.g., see Figure 6-8 ).

[0042] Reference now Figure 4 , the assembled syringe 10 and adapter assembly 100 (referred to herein as the "assembly") can be received within a fastening component 50 of a test instrument. The fastening component 50 can include a cavity 52 and a bottom wall 54 having an opening 56. With the assembly of the syringe 10 and the adapter assembly 100 received within the cavity 52 of the fastening component 50, a portion of the syringe 10 can 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 fastening component 50, the assembly can be suspended within the fastening component 50.

[0043] In other words, the adapter assembly 100 can be configured to engage the fastening component 50 to securely secure the syringe 10 thereto. One or more portions of the housing 101 can form a friction fit with one or more surfaces of the fastening component 50. For example, at least one portion of the housing 101 can be sized and / or shaped according to the cross-sectional dimensions of each of the cavity 52 and the opening 56 on the bottom wall 54 to form a friction fit with a majority of the surfaces of the fastening component 50.

[0044] The size and / or shape of the distal body 104 can be designed according to the diameter of the opening 56, so that the adapter assembly 100 can be configured to couple the syringe 10 to the fastening component 50 in response to the distal body 104 being received in the opening 56. In addition, the size and / or shape of the proximal body 102 can be designed to be larger than the diameter of the opening 56 and consistent with the diameter of the cavity 52, so that the adapter assembly 100 can be configured to couple the syringe 10 to the fastening component 50 in response to receiving the proximal body 102 in the cavity 52. ​​The adapter assembly 100 can be selectively decoupled from the fastening component 50, such as by grasping the handle 106, when the housing 101 is manually removed from the cavity 52 and the opening 56.

[0045] Still reference Figure 4 , the handle 106 can rest against the top surface of the bottom wall 54, and a user of the adapter assembly 100 can access the components of the syringe 10 and the adapter assembly 100 by grasping the handle 106, for example, to remove such components from the fastening component 50 when a testing procedure is completed. With the syringe 10 received by the adapter assembly 100, the syringe 10 can be securely coupled to the fastening component 50, and at least a portion of the body 12 can extend outwardly (i.e., distally) from the fastening component 50 through the opening 56. As described herein, the adapter assembly 100 can be configured to suspend the syringe 10 by the fastening component 50 and relative to a test site positioned adjacent to the fastening component 50.

[0046] The adapter assembly 100 can be configured to compensate for and / or minimize loads (e.g., forces) applied to the syringe 10 (e.g., via the fastening member 50 and / or the housing 101) by maintaining one or more portions of the syringe 10 in a suspended position relative to the fastening member 50 and / or the housing 101. For example, the first retaining element 110A and the second retaining element 110B are positioned against the body 12 within the passage 108 (see Figure 2 ), when the assembly of the syringe 10 and the adapter assembly 100 are received within the fastening component 50, the adapter assembly 100 can be configured to separate the flange (at the proximal end 16) of the syringe 10 from one or more abutting surfaces.

[0047] Accordingly, the adapter assembly 100 can be maintained by the syringe 10 in a floating condition with the flange raised (e.g., proximally) relative to the proximal body 102, reducing the preload applied, for example, at the proximal end 16 to the syringe 10 prior to initiating a testing procedure with the test instrument. By reducing the undesirable load applied to 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 for test control purposes (e.g., as measured by a load cell of a test instrument communicatively coupled to the fastening component 50 and / or attached to the clamping device of the clamps 58A, 58B).

[0048] like Figure 5 As seen in the , the cap 20 is removed from the distal end 14 to expose the needle 15, which can be positioned between a pair of jaws 58A, 58B of the test instrument. Prior to administering a test sample of the substance 11 from the syringe 10, the pair of jaws 58A, 58B can be actuated (e.g., moved) toward the needle 15 to securely engage the syringe 10. In this case, a force can be applied to the syringe 10 from the engagement of the jaws 58A, 58B with the needle 15 in an axial direction parallel to the longitudinal length of the syringe 10. The adapter assembly 100 can be configured to minimize the axial load supported by the syringe 10 at the proximal end 16 in response to the engagement of the pair of jaws 58A, 58b with the needle 15.

[0049] Specifically, by maintaining the flange of the syringe 10 (at the proximal end 16) in a suspended position relative to the housing 101, the adapter assembly 100 can be configured to separate the flange from one or more abutment surfaces that may apply unintentional loads to the syringe 10 when the pair of clamps 58A, 58B engage the needle 15. The first retaining element 110A and the second retaining element 110B can be abutted against the exterior ( Figure 2 ) at least partially inhibits movement (e.g., translation) of the syringe 10 relative to the housing 101. Thus, the adapter assembly 100 can maintain the flange in a floating state at the proximal end 16 and separate from the contact housing 101, thereby minimizing the preload applied to the syringe 10 before implementing the test procedure.

[0050] The fastening member 50 of the test instrument, and in particular the opening 56, can be positioned above a test site suitable for receiving a sample from the syringe 10. When the syringe 10 is received in the fastening member 50 and suspended above the test site by the adapter assembly 100, a sample of the substance 11 (stored in the body 12) can be accurately applied to the test site, for example, in response to the clamps 58A, 58B removing the needle 15 from the syringe 10. In other embodiments, the syringe 10 may not have any substance 11 stored in the body 12 during the testing procedure.

[0051] The retaining elements 110A, 110B can align the syringe 10 and, in particular, the needle 15 with the test site by abutting the body 12 at spaced intervals within the passage 108 to maintain the syringe 10 in a linear configuration parallel to and / or co-linear with the central longitudinal axis A of the passage 108 ( Figure 2-3). With the distal body 104 received through and centrally positioned within the opening 56 of the bottom wall 54, the central longitudinal axis A of the passage 108 can be aligned with the test site. Accordingly, the adapter assembly 100 can be configured to maintain the needle 15 in parallel alignment with the test site during a test experiment involving removal of the needle 15 from the syringe 10.

[0052] Reference now Figure 6 , describing another exemplary adapter assembly 200. The adapter assembly 200 may include similar structure to the adapter assembly 100 shown and described above, such that similar reference numbers are used to identify similar components. The adapter assembly 200 may be configured and operated like the adapter assembly 100, except for the differences explicitly noted herein. For example, the adapter assembly 200 may include a housing 201 defined by a proximal body 102 and a distal body 104, such that the proximal body 102 has a larger cross-sectional profile than the distal body 104. The housing 201 may include a handle 106 extending laterally outward from the proximal body 102 and a groove 205 formed along a proximal (top) surface of the handle 106.

[0053] The groove 205 can be recessed relative to the proximal (top) surface of the handle 106 and can extend along at least a portion of the longitudinal length of the housing 201. In other words, the groove 205 can have a longitudinal length that is parallel to the longitudinal length of the housing 201. For example, the groove 205 can extend from a first end positioned adjacent the proximal body 102 to a second (opposite) end positioned adjacent the handle 106. The groove 205 can be further defined by a pair of opposing side walls 207 and a lip 206 extending above each of the pair of opposing side walls 207. As depicted in these figures, the groove 205 can include a substantially inverted T-shaped configuration.

[0054] The width of the groove 205 can be defined by the pair of opposing side walls 207, and the lip 206 can extend over each side wall 207, thereby forming a guide along the side walls 207 and under the overhang of the lip 206. As described herein, the housing 201 can be configured to receive the alignment mechanism 250 within the groove 205, and the pair of opposing side walls 207 can be configured to interface with the alignment mechanism 250 and guide the alignment mechanism 250 at multiple locations along the groove 205.

[0055] Still reference Figure 6 , the housing 201 may include an opening 209 at the second end of the recess 205. The opening 209 may be sized and shaped to receive a portion of the alignment mechanism 250, thereby facilitating receiving and / or removing the alignment mechanism 250 from the recess 205. The alignment mechanism 250 may include a movable body 252 having a longitudinal length defined between a first end 252A and a second end 252B.

[0056] The movable body 252 may include one or more legs 254 at the first end 252A and a protrusion 256 at the second end 252B. The alignment mechanism 250 may include one or more apertures along the proximal (top) surface of the movable body 252 for receiving one or more locking mechanisms (e.g., fasteners). Figure 6 In the example shown, the alignment mechanism 250 includes at least one first aperture 258A and at least one second aperture 258B. As described in detail below, the first aperture 258A can be configured to receive a first fastener (e.g., a screw, not shown), and the second aperture 258B can be configured to receive a second fastener (e.g., a screw, not shown), and each fastener can facilitate locking the movable body 252 to the connector 260 of the alignment mechanism 250 and / or relative to the housing 201 to a fixed position. Although two apertures 258A, 258B are shown in the example, the alignment mechanism 250 may include additional and / or fewer apertures without departing from the scope of the present disclosure. In addition, although the figures and description describe the use of one or more fasteners to lock the movable body 252 to the connector 260, a person of ordinary skill in the art will recognize that any suitable locking or locking mechanism can be used to couple the movable body 252 to the connector 260.

[0057] Still reference Figure 6 , the first end 252A of the movable body 252 can be U-shaped, with a pair of legs 254 defining a terminal end of the first end 252A. The pair of legs 254 can be separated from each other by a predetermined distance, such as a distance corresponding to the diameter of the first opening 108A. Alternatively, the spacing between the legs 254 can be sized to correspond to the outer diameter of the syringe barrel (e.g., body 12) intended for testing. The protrusion 256 can define a raised surface at the second end 252B of the movable body 252 that is raised relative to the proximal (top) surface of the movable body 252. The protrusion 256 can have an ergonomic profile that is configured to facilitate a user to manually grasp the protrusion 256 to actuate the alignment mechanism 250, such as to move the movable body 252 between one or more positions relative to the housing 201.

[0058] In some embodiments, the movable body 252 can be configured to move in a Figure 6 At least the first position seen in Figure 7108A and the alignment mechanism 250 are in the first position. In the first position, the leg 254 can be positioned adjacent the first opening 108A and positioned in the path of travel of the proximal end 16 when the syringe 10 is received through the first opening 108A. The leg 254 can be configured to engage a portion of the syringe 10, such as a flange, at the proximal end 16 when the body 12 moves distally through the passage 108. The leg 254 can be sized and / or shaped to form an obstruction and / or impediment in the 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.

[0059] Accordingly, the alignment mechanism 250 can be configured to inhibit the flange at the proximal end 16 from moving distally toward the proximal body 102 when the legs 254 are positioned between the flange and the proximal body 102. In this case, the legs 254 can provide a barrier for the flange to contact the proximal (top) surface of the proximal body 102. Accordingly, 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 separation distance between the U-shape of the first end 252A of the movable body 252 and the legs 254, the alignment mechanism 250 can still allow the body 12 to be received through the first opening 108A and enter the channel 108 when the legs 254 inhibit the proximal end 16 from contacting the proximal end body 102.

[0060] When the pair of legs 254 are positioned adjacent to the first opening 108A and the blocking flange contacts the proximal body 102, an alignment mechanism 250 may be provided to assist in aligning the body 12 relative to the housing 201. Figure 6 , the alignment mechanism 250 can act as a visual reference for positioning the syringe 10 relative to the adapter assembly 200. In addition, the alignment mechanism 250 can provide a physical stop for the syringe 10, thereby providing a further reference for positioning the syringe 10 relative to the adapter assembly 200. When the alignment mechanism 250 is in the first position, the size (e.g., height) and / or shape of the legs 254 can at least partially define the allowable range of distal movement of the body 12 relative to the housing 201.

[0061] Reference now Figure 7 , the alignment mechanism 250 can be configured to move to a second position relative to the housing 201. Specifically, when moving to the second position, the movable body 252 can translate over the handle 106, through the groove 205, and toward the opening 209. The pair of legs 254 can move away from the first opening 108A, thereby removing an obstruction from the path of travel of the body 12 and its corresponding flange. With the legs 254 no longer positioned adjacent to the first opening 108A, the flange at the proximal end 16 can move distally toward the housing 201 until it encounters the proximal body 102.

[0062] Although the alignment mechanism 250 is shown and described herein with respect to two positions, it should be understood that the adapter assembly 200 can be configured such that the alignment mechanism 250 can include additional and / or fewer positions relative to the housing 201. In some embodiments, the adapter assembly 200 can be configured such that the alignment mechanism 250 can be completely removed from the housing 201, such as by translating the movable body 252 through the opening 209 and out of the recess 205. Accordingly, the adapter assembly 200 can be configured to decouple the alignment mechanism 250 from the housing 201 by moving the movable body 252 out of the recess 205 via the opening 209. In some cases, the second position of the alignment mechanism 250 can correspond to completely removing the movable body 252 from the recess 205.

[0063] Reference now Figure 8 , the alignment mechanism 250 may include a connector 260 disposed within the groove 205 and at least partially received within the movable body 252, for example, within the first aperture 258A and the second aperture 258B. The connector 260 may be located distally from the movable body 252 (e.g., below it) 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 aperture 258A to engage with a first threaded channel 266A of the connector 260 and receiving a second fastener in the second aperture 258B to engage with a second threaded channel 266B of the connector 260. When coupled together, the connector 260 may be configured to move through the groove 205 in response to a corresponding movement of the movable body 252 along the proximal (top) surface of the housing 201. As described herein, the connector 260 can interface with the recess 205 and couple the movable body 252 to the housing 201 .

[0064] In an example, the connector 260 can include a linear bearing having a body 262 that is sized and shaped to be received within the groove 205. The body 262 can include a pair of outer edges and / or rails 264 that extend along opposing sidewalls of the body 262. The pair of rails 264 can be sized and shaped to conform to the pair of sidewalls 207 of the groove 205 so that the rails 264 can be received under the overhang defined by the lip 206. As such, the pair of rails 264 can move along the rails defined by the sidewalls 207 to facilitate movement of the alignment mechanism 250 through the groove 205. With the rails 264 received along the sidewalls 207 and under the lip 206, the connector 260 can be securely coupled to the groove 205, thereby connecting the alignment mechanism 250 to the adapter assembly 200.

[0065] Still refer to Figure 8, the connector 260 may include at least one threaded channel for each aperture on the movable body 252. In an example, the connector 260 may include a first threaded channel 266A extending outwardly from the body 262 toward the proximal side for receiving in the first aperture 258A, for example, from the proximal direction. The connector 260 may include a second threaded channel 266B extending outwardly proximally from the body 262 for receiving in the second aperture 258B, for example, from the proximal direction. With the threaded channels 266A, 266B extending into the corresponding apertures 258A, 258B and being received therein, the body 262 may be securely coupled to the movable body 252 via one or more fasteners. Accordingly, the movement (e.g., translation) of the movable body 252 along the outer surface of the housing 201 may provide for simultaneously moving the body 262 in the groove 205.

[0066] The first threaded channel 266A can be configured to engage with a first fastener received by the first aperture 258A, and the second threaded channel 266B can be configured to engage with a second fastener received by the second aperture 258B to couple the body 262 to the movable body 252. In one example, the fasteners can include screws configured to engage with respective threaded portions of the first threaded channel 266A and the second threaded channel 266B. In some examples, the fasteners can be further configured to securely fix the position of the alignment mechanism 250 relative to the housing 201 (e.g., at one or more of the first position, the second position, etc.) via the engagement groove 205 when received through the corresponding apertures 258A, 258B and the threaded channels 266A, 266B.

[0067] By inserting the fastener through the apertures 258A, 258B and engaging the outer threaded surface of the fastener with the inner threaded surface of the threaded passage 266A, 266B, the tip (distal end) of the fastener can be translated distally through the body 262 to engage the surface of the groove 205. In this case, a frictional engagement can be formed between the alignment mechanism 250 and the housing 201. The frictional engagement between the fastener and the groove 205 can be configured to inhibit movement of the alignment mechanism 250 relative to the housing 201 until the distally directed force applied to the groove 205 by the fastener is minimized and / or removed.

[0068] The features listed above have been described in the context of specific embodiments and / or examples. However, as will be appreciated by those of ordinary skill in the art, the features and aspects of each embodiment or example may be combined, added to other embodiments or examples, subtracted from the embodiments, etc. in any manner suitable for assisting in the controlled preparation and / or delivery of drugs. Although several embodiments and / or examples are presented herein, most variations of these embodiments and combinations of components from one or more embodiments are possible and are considered to be within the scope of the present disclosure. In addition, those of ordinary skill in the art will recognize that concepts based on the present disclosure may be easily used as a basis for designing other devices, methods, and systems for performing several purposes of the present disclosure.

[0069] The present disclosure is further described by the following non-limiting items:

[0070] Item 1. An adapter assembly comprising:

[0071] A housing, the housing comprising:

[0072] a channel formed in the housing and configured to receive a medical device;

[0073] a first groove formed along an inner wall of the channel and configured to at least partially receive a first retaining element; and

[0074] a second groove formed along an inner wall of the channel and configured to at least partially receive a second retaining element;

[0075] The first retaining element is configured to extend outwardly from the first groove, and the second retaining element is configured to extend outwardly from the second groove, such that each of the first retaining element and the second retaining element abuts a body of a medical device received through the passageway.

[0076] Item 2. An adapter assembly as described in Item 1, wherein the first retaining element and the second retaining element are configured to align the body of the medical device relative to the central longitudinal axis of the channel.

[0077] Item 3. An adapter assembly as described in Item 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.

[0078] Item 4. The adapter assembly of Item 3, wherein the first retaining element and the second retaining element are configured to bias the proximal end of the body away from the proximal surface of the housing when the medical device is in the suspended position.

[0079] Item 5. An adapter assembly as described in Item 4, wherein the first retaining element and the second retaining element are configured to minimize the load applied to the medical device through the housing when the proximal end of the body is separated from the proximal surface of the housing.

[0080] Item 6. The adapter assembly as described in Item 4 further includes an alignment mechanism positioned on the proximal surface of the housing, wherein the alignment mechanism is configured to position the proximal end of the medical device relative to the housing.

[0081] Item 7. An adapter assembly as described in Item 6, wherein the housing includes a groove on the proximal surface, and the groove is configured to slidably receive the alignment mechanism between a plurality of positions within the groove.

[0082] Item 8. An adapter assembly as described in Item 7, wherein the alignment mechanism is movable between a first position and a second position relative to the groove;

[0083] In the first position, the alignment mechanism is configured to restrict movement of the proximal end of the medical device relative to the housing, and in the second position, the alignment mechanism is configured to allow movement of the proximal end of the medical device relative to the housing.

[0084] Item 9. The adapter assembly of Item 1, wherein the housing includes a handle configured to removably couple the adapter assembly to a test instrument, and the medical device includes a syringe having a needle.

[0085] Item 10. The adapter assembly of Item 9, wherein the adapter assembly is configured to align the needle relative to the test instrument when the syringe is received in the housing and the adapter assembly is coupled to the test instrument.

[0086] Item 11. An adapter assembly as described in Item 9, wherein the adapter assembly is configured to suspend the syringe within the test instrument so that the body of the syringe is separated from one or more surfaces of the test instrument.

[0087] Item 12. An adapter assembly as described in Item 11, wherein the first retaining element and the second retaining element are configured to minimize the load applied to the syringe by the test instrument by separating the proximal flange of the syringe from one or more surfaces of the housing and the test instrument.

[0088] Item 13. An adapter assembly as described in Item 1, wherein the cross-sectional dimensions of each of the channel, the first retaining element, and the second retaining element define a gripping diameter of the adapter assembly, and the gripping diameter of the adapter assembly varies along the longitudinal length of the housing.

[0089] Item 14. The adapter assembly of Item 1, wherein each of the first retaining element and the second retaining element is formed of a flexibly deformable elastic material.

[0090] Item 15. An adapter assembly comprising:

[0091] A housing, the housing comprising:

[0092] a channel configured to receive a portion of a medical device;

[0093] a pair of grooves formed along an inner wall of the channel, wherein each of the pair of grooves are longitudinally offset from one another along the inner wall; and

[0094] a pair of retaining elements, wherein each of the pair of retaining elements is at least partially received within at least one of the pair of grooves; and

[0095] Wherein the pair of retaining elements are configured to extend outwardly from the pair of channels and into the channels to interface with a portion of a medical device received through the channels.

[0096] Item 16. An adapter assembly as described in Item 15, wherein the housing includes an alignment mechanism and a groove formed along a proximal surface of the housing, and the alignment mechanism is configured to move through the groove to a plurality of positions relative to the proximal surface of the housing.

[0097] Item 17. An adapter assembly as described in Item 16, wherein in a first position of the alignment mechanism relative to the groove, the alignment mechanism is configured to engage a portion of the medical device, thereby hindering movement of the medical device relative to the adapter assembly; and wherein, in a second position of the alignment mechanism relative to the groove, the alignment mechanism is configured to disengage the portion of the medical device, thereby allowing movement of the medical device relative to the adapter assembly.

[0098] Item 18. An adapter assembly as described in Item 16, wherein the alignment mechanism includes a movable body and a connector connected to the movable body, the movable body having a pair of openings, each opening being configured to receive a locking mechanism for connecting the movable body to the connector.

[0099] Item 19. An adapter assembly as described in Item 18, wherein the movable body is disposed above the proximal surface of the housing and the connector is disposed in the groove; wherein the alignment mechanism is configured so that movement of the movable body relative to the proximal surface produces corresponding movement of the connector through the groove.

[0100] Item 20. A method for holding a medical device with an adapter assembly, comprising:

[0101] inserting a medical device through a channel of the adapter assembly, the channel comprising a pair of grooves spaced apart 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 device inside the channel;

[0102] positioning an alignment mechanism of the adapter assembly in a first position to impede movement of the medical device relative to the channel by engaging a portion of the medical device; and

[0103] By disengaging the portion of the medical device, the alignment mechanism of the adapter assembly is positioned in a second position to allow movement of the medical device relative to the channel.

Claims

1. An adapter assembly, comprising: A housing, the housing comprising: a channel formed in 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 the inner wall of the passage and configured to at least partially receive a second retaining element; The first retaining element is configured to extend outwardly from the first groove and the second retaining element is configured to extend outwardly from the second groove such that each of the first retaining element and the second retaining element abuts against a body of the medical device received through the passageway.

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 relative 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 device 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 bias the proximal end of the body away from the proximal surface of the housing when the medical device is in the suspended position.

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

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

7. The adapter assembly of claim 6, wherein the housing includes a groove on the proximal surface, the groove being configured to slidably receive the alignment mechanism between a plurality of positions within the groove.

8. The adapter assembly of claim 7, wherein the alignment mechanism is movable between a first position and a second position relative to the groove; Wherein in the first position, the alignment mechanism is configured to limit the movement of the proximal end of the medical device relative to the housing, and in the second position, the alignment mechanism is configured to allow the movement of the proximal end of the medical device 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 test instrument, and the medical device includes a syringe having a needle.

10. The adapter assembly of claim 9, wherein the adapter assembly is configured to align the needle relative to the test instrument when the syringe is received in the housing and the adapter assembly is coupled to the test instrument.

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

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

13. The adapter assembly of claim 1, wherein the cross-sectional dimensions of each 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 retaining element and the second retaining element is formed of a flexibly deformable elastic material.

15. An adapter assembly, comprising: A housing, the housing comprising: a channel configured to receive a portion of a medical device; a pair of grooves formed along an inner wall of the channel, wherein each of the pair of grooves are longitudinally offset from one another along the inner wall; and a pair of retaining elements, wherein each of the pair of retaining elements is at least partially received within at least one of the pair of grooves; and Wherein the pair of retaining elements are configured to extend outwardly from the pair of channels and into the channels to interface with the portion of the medical device received through the channels.

16. The adapter assembly of claim 15, wherein the housing includes an alignment mechanism and a groove formed along a proximal surface of the housing, the alignment mechanism being configured to move through the groove to a plurality of positions relative to the proximal surface of the housing.

17. The adapter assembly of claim 16, wherein in a first position of the alignment mechanism relative to the recess, the alignment mechanism is configured to engage a portion of the medical device to thereby resist movement of the medical device relative to the adapter assembly; and in, In a second position of the alignment mechanism relative to the recess, the alignment mechanism is configured to disengage the portion of the medical device, thereby allowing movement of the medical device relative to the adapter assembly.

18. An adapter assembly as described in claim 16, wherein the alignment mechanism includes a movable body and a connector connected to the movable body, the movable body having a pair of holes, each hole being configured to receive a locking mechanism for connecting the movable body to the connector.

19. The adapter assembly of claim 18, wherein the movable body is disposed above the proximal surface of the housing and the connector is disposed within the recess; Wherein the alignment mechanism is configured such that movement of the movable body relative to the proximal surface produces corresponding movement of the connector through the recess.

20. A method for holding a medical device with an adapter assembly, comprising: inserting the medical device through a channel of the adapter assembly, the channel comprising a pair of grooves spaced apart 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 device inside the channel; as well as positioning an alignment mechanism of the adapter assembly in a first position to impede movement of the medical device relative to the passageway by engaging a portion of the medical device; as well as The alignment mechanism of the adapter assembly is positioned in a second position to allow movement of the medical device relative to the channel by disengaging the portion of the medical device.

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