Removable dust cap and tamper evident mechanism for syringes

Abstract

A fluid pathway connector assembly for a medical fluid delivery system includes a connector element having a body, a lumen extending through the body, and a pair of flexible legs connected to the body, each of the flexible legs having a flange. The connector assembly further includes a dust cap removably connected to the connector element. The dust cap includes a dust cap body positioned between the flexible legs and surrounding the lumen, and an engagement element at a distal end of the dust cap body. The engagement element contacts the flanges of the flexible legs to prevent the dust cap from becoming dislodged from the connector element while allowing easy removal of the dust cap by a medical practitioner. A removable / disconnectable tamper-resistant and / or tamper-evident mechanism connecting the dust cap to the connector element is also disclosed.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 336,284, filed April 28, 2022, and U.S. Provisional Application No. 63 / 415,488, filed October 12, 2022, the disclosures of which are incorporated by reference in their entireties herein.

[0002] The present disclosure relates to dust caps, connectors, syringes, and syringe and connector systems for use in fluid delivery systems, and in particular to dust caps and tamper evident mechanisms for connector systems on syringes for use in medical fluid delivery systems in which one or more fluids are delivered to a patient. [Background technology]

[0003] In many medical procedures, such as drug delivery, it is desirable to inject a liquid into a patient. During diagnostic and therapeutic procedures, numerous types of liquids, such as contrast media (often simply referred to as "contrast") and / or saline, may be injected into a patient. Some medical procedures, such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), nuclear medicine, and positron emission tomography (PET), require the timed delivery of liquids, such as contrast media, under high pressures, such as up to 1200 psi. Injectors suitable for these applications may use relatively large volume syringes and are capable of generating relatively large flow rates. Summary of the Invention [Problem to be solved by the invention]

[0004] For medical syringes and related disposable mechanisms, it is important that the various components of the fluid pathway to the patient, such as the syringe, connectors, fluid lines, and other components for delivering fluid to the patient, are kept sterile prior to connection to the patient. Inadvertent contamination of the fluid pathway during manufacturing, shipping, unpacking, and / or set-up can pose a risk to the patient. New designs and configurations of the syringe's cap, such as dust caps, are required to ensure that the fluid pathway, such as the internal volume of the syringe, is kept sterile. Additionally, it is important for the user to ensure that the various components are sterile and have not been contaminated by prior use or tampering (e.g., opening the packaging and / or contaminating the sterile surfaces of the components), etc.

[0005] Because healthcare professionals must connect and / or disconnect fluid delivery systems under stress and / or emergency conditions in a relatively short amount of time, it is important that the various components of the fluid pathway are easy and intuitive to use. It is therefore desirable to develop a syringe dust cap that is configured for immediate use, but that ensures that the fluid pathway is kept sterile prior to connection to a patient.

[0006] To ensure the sterility of the fluid pathway to the patient, it is important that the various components of the fluid pathway are unused or tamper-evident prior to first use. It is therefore desirable to develop a syringe dust cap that includes one or more tamper-evident mechanisms such that the sterility of the fluid pathway components can be maintained. [Means for solving the problem]

[0007] In one example of the present disclosure, an embodiment of a dust cap is described. Various embodiments of the dust cap are configured to ensure that the area of ​​the syringe that contacts the fluid to be injected into the patient remains sterile during shipping, unpacking, and set-up to avoid inadvertent contamination of the fluid path and potentially endangering the patient. The dust cap may engage with a feature associated with the syringe, such as a feature of a connector system at the nozzle of the syringe, to ensure that the dust cap protects and preserves the sterility of the internal volume of the syringe and associated connector features that may contact the medical fluid. In addition, the dust cap configuration may be configured to be easily removed from the connector by medical personnel prior to connection of the fluid path components for a medical injection procedure. In certain embodiments, the dust cap may also include one or more tamper-evident features that allow medical personnel to determine whether the dust cap seal has been tampered with, the syringe has been used previously, or has been otherwise damaged, such that the sterility of the fluid path components may be compromised, for example, during shipping. Various embodiments and features of a dust cap for use with a syringe, for example, a high pressure angiography syringe, a CT syringe, or an MRI syringe for use with a fluid injector system, are described.

[0008] In some embodiments, a fluid pathway connector assembly for a medical fluid delivery system is provided. The fluid pathway connector assembly may include a connector element having a body with a peripheral skirt surrounding the connector element and a lumen extending through the body. The connector element may further include a first flexible leg connected to the body, the first flexible leg having a first flange, and a second flexible leg connected to the body, the second flexible leg having a second flange. The fluid pathway connector assembly may further include a dust cap removably connected to the connector element. The dust cap may include a dust cap body positioned between the first and second flexible legs and surrounding the body of the connector element to enclose the lumen. The dust cap body may have proximal and distal ends and an engagement element at the distal end of the dust cap body. The engagement element may include an angled member defined by a distal edge of the dust cap body. The engaging element may contact a first flange of the first flexible leg and a second flange of the second flexible leg of the connector element to prevent disengagement of the dust cap from the connector element. The first flange of the first flexible leg and the second flange of the second flexible leg of the connector element may be configured to contact the ramp member when the dust cap moves distally relative to the connector element such that the first and second flexible legs expand radially outward to allow removal of the dust cap from the connector element.

[0009] In some embodiments, the ramped member may extend around at least a portion of a circumference of the distal edge of the dust cap body. The ramped member may be a rounded or chamfered periphery. The engagement element may include a ledge configured to contact the first flange of the first flexible leg and the second flange of the second flexible leg of the connector element.

[0010] In some embodiments, a gripping tab may be connected to the distal end of the dust cap body. The gripping tab may include one or more gripping elements configured to facilitate removal of the dust cap from the connector element.

[0011] In some embodiments, the dust cap body may be rotatable relative to the body of the connector element about a longitudinal axis of the dust cap. When the dust cap is connected to the connector element, air pressure within the lumen of the connector element may equalize with external atmospheric pressure while maintaining sterility of the connector element. In some embodiments, a tortuous fluid path is defined between the dust cap body and a circumferential skirt of the body of the connector element to allow equalization of pressure within the lumen of the connector element while preventing passage of contaminants into the lumen of the connector element. The connector element may be configured to fluidly connect to at least one component selected from the group consisting of a syringe, a spike, a fluid tubing set, and a bulk fluid container.

[0012] In some embodiments, the fluid pathway connector assembly may include a removable / disconnectable tamper-resistant and / or tamper-evident mechanism connecting the dust cap to the connector element. If present, the tamper-resistant and / or tamper-evident mechanism may be configured to prevent removal of the dust cap from the connector element, to indicate that the connection between the connector element and the dust cap has previously been tampered with, and / or to prevent or indicate reinstallation of the dust cap on the connector element after the dust cap has been removed from the connector element.

[0013] In some embodiments, the fluid pathway connector assembly may include a connector element having a body with a peripheral skirt surrounding the connector element and a lumen extending through the body. The connector element may further include a first flexible leg connected to the body and a second flexible leg connected to the body. The fluid pathway connector assembly may further include a dust cap removably connected to the connector element. The dust cap may include a dust cap body positioned between the first and second flexible legs and surrounding the body of the connector element to enclose the lumen. The fluid pathway connector assembly may further include a removable / disconnectable tamper-resistant and / or tamper-evident mechanism connecting the dust cap to the connector element. If present, the tamper-resistant and / or tamper-evident feature may be configured to prevent removal of the dust cap from the connector element, to indicate that the connection between the connector element and the dust cap has previously been tampered with, and / or to prevent or indicate reinstallation of the dust cap on the connector element after the dust cap has been removed from the connector element.

[0014] In some embodiments, the tamper-resistant and / or tamper-evident feature may include a polymeric shrink wrap or paper wrap at least partially surrounding the connector element and the dust cap. The polymeric shrink wrap or paper wrap may have at least one removal mechanism for removing the shrink wrap from the fluid pathway connector assembly. The removal mechanism may include a tearable pre-cut, grippable tab, or piercing mechanism for removing the tamper-resistant and / or tamper-evident feature.

[0015] In some embodiments, the tamper-resistant and / or tamper-evident feature may include a cap at least partially surrounding the connector element and the dust cap. The cap may be secured to the syringe via a tearable strip.

[0016] In some embodiments, the tamper-resistant and / or tamper-evident feature may include a first portion connected to the connector element and a second portion connected to the first portion and the dust cap. The first portion may include a pull tab configured to remove the first portion from the connector element. The second portion may be configured to break off from the first portion or the dust cap when the dust cap is rotated about the longitudinal axis.

[0017] In some embodiments, the tamper-resistant and / or tamper-evident mechanism may be a removable band that encircles the first and second flexible legs, the band limiting movement of the first and second flexible legs to prevent removal of the dust cap when the removable band is attached to the fluid pathway connector assembly.

[0018] In some embodiments, the tamper-resistant and / or tamper-evident feature may have a first end connected to the connector element and a second end connected to the dust cap, and the first end may be configured to break or separate from the connector element when the dust cap is rotated about the longitudinal axis.

[0019] In some embodiments, the tamper-resistant and / or tamper-evident feature may include a tearable pull tab integrally formed with the dust cap. The dust cap may include a first flexible arm connected to the dust cap body and configured to removably engage a first flexible leg of the connector element, and a second flexible arm connected to the dust cap body and configured to removably engage a second flexible leg of the connector element. The first and second flexible arms of the dust cap may prevent the dust cap from being reinstalled on the connector element after the dust cap is removed from the connector element.

[0020] In some embodiments, the dust cap body may include a first portion and a second portion connected to one another and separable from one another along a separation line substantially parallel to a longitudinal axis of the dust cap, and the first portion and the second portion may have at least one anti-reinsertion element to prevent the dust cap from being reinstalled on the connector element after the dust cap has been removed from the connector element.

[0021] In some embodiments, the dust cap body may include a first groove configured to receive at least a portion of the first flexible leg and a second groove configured to receive at least a portion of the second flexible leg.

[0022] In some embodiments, when the dust cap and the tamper-resistant and / or tamper-evident feature are connected to the connector element, air pressure within the lumen of the connector element may equalize with external atmospheric pressure while maintaining sterility of the connector element. A tortuous fluid path may be defined between the tamper-resistant and / or tamper-evident feature, the dust cap body, and the body of the connector element to allow equalization of pressure within the lumen of the connector element while preventing passage of contaminants into the lumen of the connector element. The connector element may be configured to fluidly connect to a component selected from the group consisting of a syringe, a spike, a fluid tubing set, and a bulk fluid container.

[0023] In some embodiments, the fluid pathway connector assembly may further include an engagement element at a distal end of the dust cap body. The engagement element may include a ramped member defined by a distal edge of the dust cap body. The engagement element may contact a first flange of the first flexible leg and a second flange of the second flexible leg of the connector element to prevent disengagement of the dust cap from the connector element. The first flange of the first flexible leg and the second flange of the second flexible leg of the connector element may be configured to contact the ramped member when the dust cap moves distally relative to the connector element such that the first and second flexible legs expand radially outward to allow removal of the dust cap from the connector element.

[0024] In some embodiments, the ramped member may extend around at least a portion of a circumference of the distal edge of the dust cap body. The ramped member may be a rounded or chamfered periphery. The engagement element may include a ledge configured to contact the first flange of the first flexible leg and the second flange of the second flexible leg of the connector element. [Brief description of the drawings]

[0025] [Figure 1] FIG. 1 is a perspective view of a fluid pathway connector assembly associated with a syringe in a disconnected position according to one example of the present disclosure. [Diagram 2] FIG. 2 is a side view of the fluid pathway connector assembly of FIG. 1 in a disconnected position. [Diagram 3] 2 is a perspective view of the fluid pathway connector assembly of FIG. 1 in a connected position. [Figure 4] FIG. 2 is a side view of the fluid pathway connector assembly of FIG. 1 in the connected position. [Diagram 5] 2 is a cross-sectional view of a connector element of the fluid pathway connector assembly of FIG. 1. [Figure 6] 1 is an exploded cross-sectional view of a fluid pathway connector assembly having a dust cap shown in a disconnected position; [Figure 7] FIG. 1 is a perspective view of a fluid pathway connector assembly having a dust cap associated with a syringe in a connected position according to one example of the present disclosure. [Figure 8] 7 is a cross-sectional view of the fluid pathway connector assembly of FIG. 6 with a dust cap shown in the connected position. [Figure 9] FIG. 1 is a perspective view of a fluid pathway connector assembly and a tamper-resistant and / or tamper-evident mechanism according to an example of the present disclosure. [Figure 10] FIG. 1 is a perspective view of a fluid pathway connector assembly and a tamper-resistant and / or tamper-evident mechanism according to an example of the present disclosure. [Figure 11] FIG. 1 is a perspective view of a fluid pathway connector assembly and a tamper-resistant and / or tamper-evident mechanism according to an example of the present disclosure. [Figure 12A] FIG. 1 is a perspective view of a fluid pathway connector assembly and a tamper-resistant and / or tamper-evident mechanism according to an example of the present disclosure. [Figure 12B] FIG. 12B is a perspective view of a dust cap and tamper-resistant or tamper-evident seal of the fluid pathway connector assembly of FIG. 12A. [Figure 13A] FIG. 1 is a perspective view of a fluid pathway connector assembly and a tamper-resistant and / or tamper-evident mechanism according to an example of the present disclosure. [Figure 13B] FIG. 13B is a detailed perspective view of an attachment point between a dust cap and a connector element of the fluid pathway connector assembly of FIG. 13A. [Figure 13C] FIG. 13B is a perspective view of the fluid pathway connector assembly of FIG. 13A installed on a syringe. [Figure 14A] FIG. 2 is an exploded perspective view of a dust cap of a tamper-resistant and / or tamper-evident fluid pathway connector assembly according to one example of the present disclosure. [Figure 14B] FIG. 14B is a perspective view of the dust cap of FIG. 14A in an assembled state. [Figure 14C] FIG. 14B is a side view of the dust cap of FIG. 14A installed on a syringe. [Figure 14D]FIG. 14B is another side view of the dust cap of FIG. 14A installed on a syringe. [Figure 14E] FIG. 14B is yet another side view of the dust cap of FIG. 14A installed on a syringe. [Figure 15A] FIG. 2 is an exploded perspective view of a dust cap of a tamper-resistant and / or tamper-evident fluid pathway connector assembly according to one example of the present disclosure. [Figure 15B] FIG. 15B is a perspective view of the dust cap of FIG. 15A during installation onto a syringe. [Figure 16A] FIG. 2 is an exploded perspective view of a dust cap of a tamper-resistant and / or tamper-evident fluid pathway connector assembly according to one example of the present disclosure. [Figure 16B] FIG. 16B is a perspective view of the dust cap of FIG. 16A during assembly onto a syringe. [Figure 16C] FIG. 16B shows the dust cap of FIG. 16A installed on a syringe. [Figure 16D] FIG. 16B is another view showing the dust cap of FIG. 16A installed on a syringe. [Figure 16E] FIG. 16B is yet another view showing the dust cap of FIG. 16A installed on a syringe. [Figure 17A] FIG. 1 is a perspective view of a dust cap of a fluid pathway connector assembly having a tamper-resistant and / or tamper-evident feature in one example of the present disclosure. [Figure 17B] FIG. 17B is a perspective view of the dust cap of FIG. 17A installed on a syringe. [Figure 17C] FIG. 17B is a side cross-sectional view of the dust cap of FIG. 17A on a syringe. [Figure 18A] FIG. 1 is a perspective view of a dust cap of a fluid pathway connector assembly having a tamper-resistant and / or tamper-evident feature in one example of the present disclosure. [Figure 18B] FIG. 18B is a perspective view of the dust cap of FIG. 18A installed on a syringe. [Figure 19A]FIG. 13 illustrates a bottom perspective view of a dust cap of a fluid pathway connector assembly having a tamper-resistant and / or tamper-evident feature according to an example of the present disclosure. [Figure 19B] FIG. 19B is a top perspective view of the dust cap shown in FIG. 19A. [Figure 19C] FIG. 13 illustrates a bottom perspective view of a dust cap of a fluid pathway connector assembly having a tamper-resistant and / or tamper-evident feature according to an example of the present disclosure. [Figure 19D] FIG. 19D is a top perspective view of the dust cap shown in FIG. 19C. [Figure 20A] 19A-19B installed on a fluid pathway connector assembly and a syringe. FIG. [Figure 20B] 19A-19B installed on a fluid pathway connector assembly and a syringe. FIG. [Figure 20C] 19A-19B installed on a fluid pathway connector assembly and a syringe. FIG. [Figure 20D] 19A-19B installed on a fluid pathway connector assembly and a syringe. FIG. [Figure 21A] FIG. 1 illustrates a top perspective view of a dust cap for a tamper-resistant and / or tamper-evident fluid pathway connector assembly in one example of the present disclosure. [Figure 21B] FIG. 21B is a bottom perspective view of the dust cap shown in FIG. 21A. [Figure 21C] FIG. 21B is a perspective view of the dust cap shown in FIG. 21A having a connector element. [Figure 21D] FIG. 21D is a side perspective view showing the dust cap and connector element of FIG. 21C installed on a syringe. [Figure 21E] FIG. 21D is a top view showing the dust cap and connector element of FIG. 21C installed on a syringe. [Figure 22A] FIG. 2 illustrates a top view of a tamper-resistant and / or tamper-evident mechanism according to an example of the present disclosure. [Figure 22B] FIG. 2 illustrates another top view of a tamper-resistant and / or tamper-evident mechanism according to an example of the present disclosure. [Diagram 23] FIG. 1 is a perspective view of a dust cap of an example tamper-resistant and / or tamper-evident fluid pathway connector assembly of the present disclosure. [Figure 24] FIG. 1 is a perspective view of a dust cap of an example tamper-resistant and / or tamper-evident fluid pathway connector assembly of the present disclosure. [Diagram 25] FIG. 1 is a perspective view of a dust cap of an example tamper-resistant and / or tamper-evident fluid pathway connector assembly of the present disclosure. [Figure 26] FIG. 1 is a perspective view of a dust cap of an example tamper-resistant and / or tamper-evident fluid pathway connector assembly of the present disclosure. [Figure 27] FIG. 1 is a perspective view of a dust cap of an example tamper-resistant and / or tamper-evident fluid pathway connector assembly of the present disclosure. [Figure 28] FIG. 1 is a perspective view of a dust cap of an example tamper-resistant and / or tamper-evident fluid pathway connector assembly of the present disclosure. [Figure 29A] FIG. 2 is a top view of a dust cap of a tamper-resistant and / or tamper-evident fluid pathway connector assembly according to an example of the present disclosure, in a first or unlocked position. [Figure 29B] FIG. 29B is a top view of the dust cap of FIG. 29A in a second or locked position. [Figure 30A] FIG. 2 is a side view of a dust cap of a fluid pathway connector assembly having a tamper-resistant and / or tamper-evident feature according to an example of the present disclosure, in a first or unlocked engagement position. [Figure 30B] FIG. 30B is a side view of the dust cap of FIG. 30A in a second or locked removal position. [Diagram 31] FIG. 1 is a perspective view of a dust cap of an example tamper-resistant and / or tamper-evident fluid pathway connector assembly of the present disclosure. [Figure 32A] FIG. 2 is a top view of a dust cap of a fluid pathway connector assembly having a tamper-resistant and / or tamper-evident feature according to an example of the present disclosure, in a first or unlocked position. [Figure 32B] FIG. 32B is a top view of the dust cap of FIG. 32A in a second or locked position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] In Figures 1-32B, like numbers refer to the same components and elements unless otherwise specified.

[0027] The drawings generally show preferred, non-limiting aspects of the systems and methods of the present disclosure. The description presents various aspects of the device, but should not be construed as limiting the present disclosure in any way. Furthermore, modifications, concepts, and applications of the aspects of the present disclosure should be construed by those skilled in the art as being included, but not limited to, the examples and descriptions provided herein.

[0028] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for implementing the present disclosure. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0029] As used herein, the singular forms "a", "an" and "the" include plural referents unless otherwise indicated. Spatial or directional terms such as "left", "right", "inner", "outer", "above", "below" and the like relate to the embodiments and aspects as shown in the drawings and should not be considered limiting since the embodiments and aspects can assume various alternative orientations. All numbers used in this specification and claims should be understood to be modified in all cases by the term "about". "About" means plus or minus 25% of the stated value, for example plus or minus 10% of the stated value. However, this should not be considered as limiting the analysis of values ​​under the doctrine of equivalents.

[0030] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to include the starting and ending values ​​and any and all subranges or subratios subsumed therein. For example, a range or ratio described as "1 to 10" should be considered to include any and all subranges or subratios between (and including) the minimum value of 1 and the maximum value of 10. That is, all subranges or subratios beginning with a minimum value of 1 or greater and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent average values ​​across the specified ranges and / or ratios.

[0031] The terms "first," "second," and the like do not refer to a particular order or chronology, but rather to different conditions, characteristics, or elements. All documents mentioned herein are "incorporated by reference" in their entirety. The term "at least" is synonymous with "greater than or equal to." The term "not greater than" is synonymous with "less than or equal to." The term "includes" is synonymous with "comprises."

[0032] Some non-limiting embodiments or aspects are described herein in relation to a threshold value. As used herein, meeting a threshold may refer to a value greater than the threshold, greater than or equal to the threshold, less than the threshold, less than or equal to the threshold, equal to the threshold, etc.

[0033] As used herein, "at least one of" is synonymous with "one or more of." For example, the phrase "at least one of A, B, or C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, or C" includes only A, or only B, or only C, or A and B, or A and C, or B and C, or all of A, B, and C.

[0034] When used with respect to a component of a fluid delivery system, such as a fluid reservoir, a syringe, a connector, a dust cap, or a fluid line, the term "distal" refers to the portion of said component closest to the patient. When used with respect to a component of an injector system, such as a fluid reservoir, a syringe, a connector, a dust cap, or a fluid line, the term "proximal" refers to the portion of said component closest to the injector of the injector system (i.e., the portion of said component furthest from the patient). When used with respect to a component of a fluid delivery system, such as a fluid reservoir, a syringe, a connector, a dust cap, or a fluid line, the term "upstream" refers to the direction away from the patient toward the injector with respect to the normal flow of fluid in the injector system. When used with respect to a component of a fluid delivery system, such as a fluid reservoir, a syringe, a connector, a dust cap, or a fluid line, the term "downstream" refers to the direction away from the injector toward the patient with respect to the normal flow of fluid in the fluid delivery system.

[0035] The term "radial" and related terms generally refer to a direction perpendicular to the longitudinal axis of a syringe, connector, dust cap, or other component of an injector system. However, it should be understood that the present disclosure may contemplate various alternative variations and step sequences unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described below are merely exemplary aspects of the present disclosure. Hence, specific dimensions and other physical characteristics relating to the aspects disclosed herein are not to be considered as limiting.

[0036] 1-4 show a fluid pathway connector assembly 10 associated with a syringe 16 according to one example of the present disclosure. The fluid pathway connector assembly 10 may include a connector element 12 and a dust cap 14 configured to connect to one another. In one example of the present disclosure, the connector element 12 may be operably connected to a syringe 16. In a further example of the present disclosure, the connector element 12 may be configured to fluidly connect to a spike, a fluid tubing set, or a bulk fluid container. Various examples of the fluid pathway connector assembly 10 are described in PCT Publication WO 2021 / 168076, the disclosure of which is incorporated herein by reference.

[0037] Various embodiments of the present disclosure may include a dust cap 14 configured to cover the nozzle of the syringe 16, for example, as described herein with reference to Figures 6-8. The dust cap 14 may be configured to maintain the sterility of the sterile fluid pathway associated with the syringe 16 and the connector element 12. As used herein, the term "sterile fluid pathway" refers to components, portions, or surfaces of the syringe 16 and / or associated fluid pathway elements, such as the connector element 14, that may come into contact with medical fluids that are injected into a patient and that are required to be sterile for patient safety. The sterile fluid pathway may be sterilized by conventional sterilization procedures, such as e-beam or ethylene oxide exposure, during the manufacturing or packaging process, and the various components and portions of the sterile fluid pathway may remain sterile even when other portions of the syringe 16, such as the exterior surface of the barrel, are exposed to a non-sterile environment. Thus, the sterile fluid pathway approach does not require a packaging mechanism that is impermeable to environmental and microbial contaminants, but the various sterile surfaces of the sterile fluid pathway are not exposed to environmental or microbial contaminants.

[0038] 1-4, the syringe 16 has a barrel 17 having a proximal end 19 and a distal end 21 having an outlet nozzle 23. In some examples of the present disclosure, the fluid pathway connector assembly 10, such as its connector element 12, is configured to removably connect to the outlet nozzle 23 of the syringe 16. In further examples, a first portion of the fluid pathway connector assembly 10, such as the connector element 14, may be permanently connected to the outlet nozzle 23 of the syringe 16, and the dust cap 14 is removably connected to the connector element 14. The syringe 16 may be any syringe known in the art, for example, a bottle or rolling diaphragm syringe as disclosed in WO 2016 / 172467, WO 2015 / 164783, and WO 2016 / 069711, which are incorporated herein by reference. In other embodiments, the dust caps described herein may be used at the outlet of a peristaltic pump.

[0039] Referring to FIG. 5, in one example of the present disclosure, the inner surface of the distal end 21 of the syringe 16 may include a plurality of ribs 25 that form a contour within the syringe 16 that utilizes the Coanda effect of the fluid passing through the syringe 16. As used herein, the Coanda effect is the tendency of a liquid flow to be attracted to a nearby curved or inclined surface as the liquid flows along the surface. Thus, as the fluid enters the syringe 16 through the connector element 14, the fluid is redirected toward the inner wall of the discharge nozzle 23 of the syringe 16 and comes into contact with the plurality of ribs 25. As the fluid flows along the ribs 25, the fluid is naturally attracted to the inner surface of the conical distal end 21 of the syringe 16. The fluid then flows down the inner surface 27 of the tubular sidewall 29 of the syringe 16, eventually accumulating at the bottom of the syringe 16, filling the syringe 16 from the bottom up as air escapes the syringe 16 through the distal end 21. This flow along the inner surface of the syringe 16 helps to reduce turbulence as the fluid fills the syringe 16, which helps to reduce the formation of air bubbles as the syringe 16 is filled. Additionally, the ribs 25 allow for more rapid filling of the syringe 16, thereby shortening the duration of the fluid injection process. Further features and advantages of this Coanda effect are described in WO 2017 / 091643, the disclosure of which is incorporated by reference in its entirety.

[0040] 1-5, connector element 12 may be operatively connected to a distal end 21 of syringe 16. In one example of the present disclosure, connector element 12 may be welded (e.g., laser welded), chemically welded, or otherwise adhered to distal end 21 of syringe 16.

[0041] 1-5, in some examples of the present disclosure, connector element 12 may include a body 18, a lumen 15 (shown in FIG. 5) extending through body 18, a first flexible leg 20 (hereinafter referred to as the "first flexible leg" or "first leg"), and a second flexible leg 22 (hereinafter referred to as the "second flexible leg" or "second leg"), each of first flexible leg 20 and second flexible leg 22 having a connecting beam 31 (shown in FIG. 5) connecting first flexible leg 20 and second flexible leg 22 to body 18. First flexible leg 20 and second flexible leg 22 may be integrally formed with body 18. The first and second flexible legs 20 and 22 may extend from the body 18 in a distal direction relative to the distal end 23 of the syringe 16, as shown in Figures 1-5. In one example of the present disclosure, the first and second flexible legs 20 and 22 are made of a material that allows the flexible legs 20, 22 to pivot where they meet the connecting beam 31 to allow the distal ends of the first and second flexible legs 20 and 22 to move radially outward in a direction relative to the longitudinal axis 24 of the connector element 12. In one example of the present disclosure, the first and second flexible legs 20 and 22 may be made of a rigid material with a flexible pivot point to allow the first and second flexible legs 20 and 22 to move radially outward relative to the longitudinal axis 24 of the connector element 12 (shown in Figure 5).

[0042] In some examples of the present disclosure, the connector element 12 may also include a first actuation arm 26 and a second actuation arm 28 extending from the body 18 in a direction opposite to the first flexible leg 20 and the second flexible leg 22. The first actuation arm 26 and the second actuation arm 28 may be integrally formed with the body 18 and the first flexible leg 20 and the second flexible leg 22. In some examples, the first flexible leg 20 and the second flexible leg 22 and the first actuation arm 26 and the second actuation arm 28 may be connected to the body 18 of the connector element 12 via a connecting beam 31. During operation of the fluid pathway connector assembly 10, the first actuation arm 26 and the second actuation arm 28 are configured to be pushed radially inward toward one another by an operator to move the first flexible leg 20 and the second flexible leg 22 radially outward from one another. Pressure on the first and second actuation arms 26, 28 causes the first and second flexible legs 20, 22 to move away from each other. In one embodiment of the present disclosure, at least one of the first and second actuation arms 26, 28 may include a plurality of gripping ribs 30 to aid in gripping the first and second actuation arms 26, 28 when handling the connector element 12. In some examples of the present disclosure, the connector element 12 may also include a support portion 32 that extends from the body 18 in the same direction as the first and second actuation arms 26, 28, i.e., toward the body of the syringe 16, as shown in FIGS. 1-6. The support portion 32 may be integrally formed with the body 18 and may define a channel configured to receive the distal end 23 of the syringe 16. The support portion 32 may be connected to the distal end of the syringe 16 by, for example, a threaded fit, adhesive, or welding. The support portion 32 provides a stabilizing effect to the connector element 12 when the connector element 12 is operably connected to the syringe 16 and when the first actuation arm 26 and the second actuation arm 28 are pressed inwardly toward each other to actuate the connector element 12.

[0043] According to various examples of the present disclosure, each of the first and second flexible legs 20 and 22 may include a first and second flange 34 and 36, respectively, configured to engage a portion of the dust cap 14 described herein to facilitate connecting the connector element 12 to the dust cap 14. In some examples of the present disclosure, at least a portion 38, 40 of each flange 34, 36, respectively, may be angled inwardly relative to the longitudinal axis 24 of the connector element 12. In one example of the present disclosure, the portions 38, 40 of the flanges 34, 36 may be oriented toward the distal end 21 of the syringe 16 such that the portions 38, 40 of the flanges 34, 36 extend toward the proximal end of the syringe 16. Under fluid injection pressure, the angled portions 38, 40 of the flanges 34, 36 may force the first leg 20 and the second leg 22 radially inward, thereby increasing the strength of the connection between the connector element 12 and the dust cap 14 during pressure injection and making the connection less likely to become disconnected. The distal-most surfaces 42, 44 of the flanges 34, 36 may be angled or chamfered to aid in receiving the dust cap 14, as described below. The surfaces 42, 44 may be angled inwardly toward the longitudinal axis 24 of the connector element 12. In one example of the present disclosure, the outer edge of each surface 42, 44 may be angled inwardly toward the actuation arms 26, 28 while angling inwardly to the inner edge of each surface 42, 44. The chamfered or angled surfaces 42, 44 cause the first and second flexible legs 20, 22 to bend radially outward during insertion of the dust cap 14 into the connector element 12, and then, once the body 46 of the dust cap 14 passes the flanges 34, 36, the first and second flexible legs 20, 22 snap back radially inward, thereby engaging the connector element 12 with the dust cap 14. The snap back action may produce an audible click to confirm that the dust cap 14 is properly connected to the connector element 12.

[0044] According to various examples of the present disclosure, each of the legs 20, 22 may also include at least one reinforcing member 45a, 45b. According to various examples, the reinforcing member 45a, 45b may be provided along at least a portion of the outer surface of the leg 20, 22. In certain examples, the reinforcing member 45a, 45b may extend the entire length of the leg 20, 22. The reinforcing member 45a, 45b may be integrally formed with the leg 20, 22, for example, on the outer surface of the leg 20 or 22. The reinforcing member 45a, 45b may be made of a similar material as the leg 20, 22 and the connector element 12, for example, by co-molding the leg 20, 22 with the respective reinforcing member 45a, 45b. In other examples, the reinforcing member 45a, 45b may be made of a different material than the leg 20, 22 and the connector element 12 to increase the strength of the leg 20, 22. The reinforcing members 45a, 45b may be provided on the legs 20, 22 to add rigidity to the legs 20, 22 while allowing the legs 20, 22 to remain flexible enough to move inwardly and outwardly during connection and disconnection between the connector element 12 and the dust cap 14. In one example of the present disclosure, the reinforcing members 45a, 45b may be strips of material that extend along at least a portion of the length of the legs 20, 22 and extend outwardly from the outer surface of the legs 20, 22, e.g., substantially perpendicular to the outer surface of the legs 20, 22. After the dust cap 14 is connected to the connector element 12, the reinforcing members 45a, 45b may be configured to help maintain the connection of the legs 20, 22 to the dust cap 14, e.g., by further reducing outward bending or stretching of the legs 20, 22.

[0045] 6-8, a dust cap 14 for ensuring non-contamination through the discharge nozzle 23 of the syringe 16 will be described in detail, according to some examples of the present disclosure. The dust cap 14 may be configured to easily engage the distal end 21 of the syringe 16 and be removably retained on the discharge nozzle 23 by the connector element 12 to maintain sterility of the lumen of the connector element 12 and the interior volume of the syringe 16. According to various embodiments, the dust cap 14 may be configured to be easily removed from the distal end 21 of the syringe 16 prior to connection of one or more fluid path elements with the connector element 12. During the setup of one or more fluid delivery procedures prior to injection of contrast and / or saline, it is important to perform the setup quickly and accurately so that the overall time of the imaging procedure can be reduced, thereby allowing for an increased number of imaging procedures to be performed per day. This allows for more patients to be treated. It is also important that the setup procedure is performed accurately to ensure that the fluid injector is ready to deliver fluid to the patient. One step in the fluid injector setup process is to remove the dust cap and attach the fluid lines to fill the syringe with fluid and / or deliver the fluid to the patient while maintaining the sterility of the fluid pathway. Various embodiments of the present disclosure provide a dust cap mechanism that allows for quick removal while maintaining the sterility of the fluid pathway. Additionally, the dust cap designs herein may further include one or more tamper-resistant or tamper-evident mechanisms to prevent tampering of the dust cap, ensure sterility of the fluid pathway, and / or notify medical personnel that the syringe / dust cap assembly may have been tampered with or a previously used syringe, thereby affecting the sterility of the system and potential danger to the patient.

[0046] In certain embodiments, the dust cap 14 may be configured to be easily removed by a medical practitioner by grasping a tab element 58 extending distally from the dust cap 14, e.g., by simply pulling the dust cap 14 distally to remove the dust cap 14 from the distal connector element 12. For example, the dust cap 14 may be configured to engage the connector element 12 and the flexible legs 20, 22 while maintaining sterility of the fluid path of the syringe 16, but may be removed without the medical practitioner radially displacing the flexible legs 20, 22 to release the dust cap. In some examples, the dust cap 14 is configured to be removed from the connector element 12 with one hand, e.g., after the syringe 16 is installed in the fluid injector. The dust cap 14 may be made from a rigid medical grade material that substantially resists bending or deformation. In some examples, the dust cap 14 is made from a flexible material that is amenable to bending.

[0047] The dust cap 14 may include a body 46 configured to connect to the connector element 12, for example, by a peripheral skirt 47. In some examples of the present disclosure, the peripheral skirt 47 of the body 46 may be configured to substantially surround an outer surface of the body of the connector element 12 to surround the lumen 15. In other embodiments, the peripheral skirt 47 of the body 46 may have a smaller diameter than the body 18 of the connector element 12 and be configured to substantially fit and engage an inner surface of the body 18 of the connector element 12 to surround the lumen 15. The body 46 may be substantially cylindrical in shape. Upon connecting the dust cap 14 with the connector element 12, the body 46 may be configured to be removably retained between the legs 20, 22 of the connector element 12. The body 46 may assist in maintaining the sterility of the fluid pathway, for example, by preventing inadvertent contact and contamination of the body of the connector element 12 during operation of the syringe 16 and the fluid pathway connector assembly 10, and / or by preventing the ingress of contaminants into the sterile fluid pathway of the syringe 16. In some examples, the dust cap body 46 may be rotatable relative to the body 18 of the connector element 12 about the longitudinal axis 24. In further examples, the dust cap body 46 may be fixed from rotation relative to the body 18 of the connector element 12 about the longitudinal axis 24.

[0048] 6, the dust cap body 46 has a proximal end 48 opposite a distal end 50 with a sidewall 52 extending between the proximal end 48 and the distal end 50. The sidewall 52 may be substantially cylindrical. The dust cap body 46 is configured to extend from the connecting beam 31 at the proximal end 48 and engage the distal end 50 of the dust cap 14 with the flange portions 38, 40 of the flexible legs 20, 22 when connected to the connector element 12. The proximal end 48 may be open or may be configured to extend over at least a portion of the body 18 of the connector element 12 to surround the lumen 15 (shown in FIG. 5). The distal end 50 is closed to prevent ingress of contaminants into the interior of the dust cap body 46. As shown in FIG. 8, when the dust cap 14 is connected to the connector element 12, a tortuous fluid path 56 is defined between the dust cap body 46 and the body 18 of the connector element 12, allowing equalization of air pressure with the internal volume of the syringe 16 through the lumen 15 of the connector element 12 while preventing the passage of contaminants within the lumen 15 of the connector element 12 and into the interior of the syringe 16. In this manner, air can freely pass through the lumen 15 of the connector element 12 and cannot build up pressure inside the syringe 16 due to changes in temperature or atmospheric pressure during shipping and storage. For example, during shipping (e.g., by air) or during storage (at different temperatures), the syringe may be subject to changes in atmospheric pressure that create a pressure gradient between the internal volume of the syringe 16 and the outside, which may result in the dust cap 14 or the syringe plunger (not shown) being ejected from the syringe 16. By equalizing the pressure to eliminate the pressure gradient, ejection of the dust cap 14 or the plunger may be avoided.

[0049] 6-8, the dust cap 14 may include a gripping tab 58 connected to the distal end 50 of the dust cap body 46. In some examples, the gripping tab 58 has one or more gripping elements 60 configured to facilitate gripping and removal of the dust cap 14 from the connector element 12. For example, the one or more gripping elements 60 may be arranged in an X-shaped configuration shown in FIG. 7. In other embodiments, the gripping elements 60 may include one or more lateral bumps along a surface of the gripping tab 58.

[0050] 7, the dust cap 14 further includes an engagement element, such as a ledge 68, at the distal end 50 (shown in FIG. 6) of the dust cap body 46. When the dust cap 14 is connected to the connector element 12, the engagement element 62 is configured to contact a portion 38 of the first flange 34 of the first flexible leg 20 and a portion 40 of the second flange 36 of the second flexible leg 22 of the connector element 12 (shown in FIG. 8) to prevent the dust cap 14 from dislodging from the connector element 12. In this manner, the dust cap 14 may be maintained on the connector element 12 to ensure sterility of the fluid path of the syringe 16. In various embodiments herein, the dust cap 14 may be quickly removed by a medical practitioner during a fluid path assembly step without the need to apply pressure to radially displace the flexible legs 20, 22. For example, according to various embodiments, a medical professional can remove the dust cap 14 from the connector element 12 by simply grasping the gripping tab 58 and pulling the dust cap 14 in a distal direction, saving additional time during the set-up process. During the manufacturing, shipping, and unpackaging processes, the dust cap 14 is retained by one or more of a friction fit with at least a portion of the connector element 12 and a retention force between the distal end 50 of the dust cap 14 and the flanges 34, 36 of the flexible legs 20, 22.

[0051] According to various examples, the engagement element 62 has a ramped member 64 defined by a distal edge 66 of the dust cap body 46. The ramped member 64 extends around at least a portion of the circumference of the distal edge 66 of the dust cap body 46. In some examples of the present disclosure, the ramped member 64 is a rounded or chamfered periphery. When the dust cap 14 is connected to the connector element 12 and being removed by a medical professional, the first flange 34 of the first flexible leg 20 and the second flange 36 of the second flexible leg 22 of the connector element 12 are configured to contact the ramped member 64 as the dust cap 14 moves distally relative to the connector element 14 in the direction of arrow A in FIG. 7 such that the first flexible leg 20 and the second flexible leg 22 expand radially outward in the direction of arrow B in FIG. 7 to enable removal of the dust cap 14 from the connector element 12. The engaging element 62 further includes a ledge 68 configured to contact the first flange 34 of the first flexible leg 20 and the second flange 36 of the second flexible leg 22 of the connector element 14 when the dust cap 14 is connected to the connector element 12 to retain the dust cap 14 on the connector element 12 when not required for removal. The ledge 68 may be oriented in a direction substantially perpendicular to the direction of the longitudinal axis 24.

[0052] The dust cap 14 according to any of the various configurations described herein may further include a tamper-resistant and / or tamper-evident mechanism 70 to inform a medical professional or user that the sterility of the sterile fluid pathway may be compromised, for example, due to damage during manufacturing, packaging, shipping, or unpacking, or that the syringe 16 has been previously used or tampered with and may no longer be sterile. Because the syringe 16 is being used to deliver medical fluids to a patient's arterial or venous system, it is important for the patient's safety that the interior surfaces of the syringe 16 and associated fluid pathways in contact with the medical fluids are sterile and free from microbial contamination, inadvertent or intentional contact with hazardous compounds, or contamination with bodily fluids from a previous patient.

[0053] The tamper-resistant and / or tamper-resistant mechanism 70 may be removed or disengaged upon unpacking or after the syringe 16 is installed in the injector. The tamper-resistant and / or tamper-resistant mechanism 70 according to various embodiments may be configured to work in conjunction with the dust cap 14 to ensure sterility of the fluid path of the syringe 16 and associated fluid path components. Once the tamper-resistant and / or tamper-resistant mechanism 70 is removed, a medical practitioner may grasp the grip tab 58 of the dust cap 14, remove the dust cap 14 from the connector element 12, and attach one or more fluid path components to the connector element 12, such as tubing for delivering fluid from the syringe 16 to a patient. According to various examples, damage or alteration of the tamper-resistant and / or tamper-resistant mechanism 70 informs the medical practitioner that the syringe 16 is no longer sterile or safe to use and should be replaced with a new sterile syringe. When present, the tamper-resistant and / or tamper-evident feature 70 is configured to prevent premature removal of the dust cap 14 from the connector element 12 and to help maintain engagement between the dust cap 14 and the syringe 16 during manufacturing, shipping, storage, and setup. Removal of the tamper-resistant and / or tamper-evident feature 70 is configured to allow the dust cap 14 to be removed from the connector element 12.

[0054] Referring to FIG. 9, according to one example, the tamper-resistant and / or tamper-evident mechanism 70 is a seal 72 that covers at least a portion of the connector element 12 and the dust cap 14, at least partially encloses the connector element 12 and the dust cap 14, and keeps the dust cap 14 engaged with the connector element 12. In some examples, the seal 72 may be a shrink-wrap seal made from a heat-shrinkable plastic material or other shrinkable plastic material (e.g., solvent-shrinkable) that at least partially conforms to the shape of the connector element 12 and the dust cap 14. If present, the seal 72 is configured to prevent the dust cap 14 from being removed from the connector element 12 and to indicate that the dust cap 14 has not been previously removed from the syringe 16, thus ensuring sterility of the components. The seal 72 may have one or more removal tabs 74 that allow for easy removal of the seal 72 from the connector element 12 and the dust cap 14. The removal tab 74 may be connected to the seal 72 by at least one tearable perforation strip 76 such that pulling the removal tab 74 away from the seal 72 tears the at least one tearable perforation strip 76. In some examples, the multiple tearable perforation strips 76 may be radially spaced around the connector element 12 and the dust cap 14. The multiple tearable perforation strips 76 may be equally or unequally spaced from one another. In other embodiments, the seal 72 may include at least one tearable perforation strip 76 having one or more starter notches at an edge of the seal 72 that initiate the tearing of the tearable strip. In certain embodiments, the at least one tearable strip may include a reinforced non-tearable portion embedded within or otherwise attached along the strip to ensure complete tearing along the longitudinal axis of the strip 76. Removal tab 74 may be provided on either the proximal or distal portion of seal 72 and may be removed by a pulling motion in the distal or proximal direction, respectively.In a further example, a pair of removal tabs 74 may be provided such that the tearable perforated strip 76 can be removed by pulling in either a proximal or distal direction. In some examples, the tearable perforated strip 76 may be straight, as shown in FIG. 9. In a further example, the removal tab 74 may extend diagonally relative to the longitudinal axis 24 (shown in FIG. 5) or in a helical direction about the longitudinal axis 24, such that the removal tab 74 is removed by a rotational movement about the longitudinal axis 24.

[0055] 10, one example of a tamper-resistant and / or tamper-evident mechanism 70 may include a cap 78, such as a plastic cap, that at least partially encloses the connector element 12 and the dust cap 14. In certain embodiments, the cap 78 may cover the entire distal end 21 of the syringe 16, including the entire connector element 12 and the dust cap 14. Alternatively, the cap 78 may cover only a portion of the distal end 21 of the syringe 16, including a portion of the connector element 12 and the dust cap 14. For example, the protective cap may include one or more portions that extend over the distal gripping tabs 58 of the dust cap 14 and retain the dust cap 14 connected to the connector element 12. The cap 78 may be attached to the distal end of the syringe 16 by a snap fit or a friction fit.

[0056] The cap 78 may be at least partially transparent to allow the connector element 12 and / or dust cap 14 to be visually observed through a sidewall of the cap 78, allowing a medical professional to see the connector element 12 and dust cap 14 to ensure they remain engaged. In some examples, the cap 78 may be opaque. In some examples, the cap 78 is made from a medical grade plastic material. Alternatively, the cap 78 may be made from another medical grade material that prevents access to and / or removal of the dust cap 14 prior to use. For example, in certain examples, the cap 78 may be made from paper, card stock, cardboard, or other readily recyclable materials.

[0057] With continued reference to FIG. 10, the cap 78 may have at least one vent 82 to allow air exchange and pressure equalization between the interior of the cap (and ultimately the interior of the syringe via the dust cap 14) and the external atmosphere to prevent air pressure gradients or temperature-related pressure buildup within the syringe 16 during shipping and storage, as described herein.

[0058] The cap 78 may be secured to the syringe 16, such as to the distal end 21 of the syringe 16, via a connecting element, such as a tearable strip or adhesive 80. In certain examples, the tearable strip 80 may seal the proximal end of the cap 78 with a distal lip of the circumferential barrel of the syringe. In some examples, the cap 78 may be configured for a push-fit or snap-fit ​​connection with a periphery 84 (shown in FIGS. 1-4 ) of the distal end 21 of the syringe 16.

[0059] To prepare the syringe 16 for use, the medical practitioner may remove the tearable or adhesive strip 80 from the cap 78 by pulling the cap 78 distally or by applying a torque to the cap 78, and remove the cap 78 from the syringe 16. In some examples, an inner portion of the cap 78 may be connected to the dust cap 14, such as the grip tab 58. In this manner, removing the cap 78 from the syringe 16 also removes the dust cap 14 from the connector 12. Once removed, the cap 78 may be discarded or recycled. In some examples, the removed cap 78 may be used to collect a quantity of priming fluid during a priming operation of the fluid injector. In some examples, the cap 78 may be made from a breakable plastic material configured to break when the cap 78 is removed from the syringe 16, preventing reconnection and reuse of the cap 78 and the syringe 16, and ensuring that the syringe 16 and the cap 78 are not reused.

[0060] Referring to FIG. 11 , according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include a stiffening band 86 that surrounds the periphery of at least a portion of the first and second flexible legs 20, 22. The stiffening band 86 may be made of paper, other textile materials, and / or plastic, or combinations thereof. While plastic and / or paper are suitable materials for the stiffening band 86, other materials that can be wrapped around the flexible legs 20, 22 are contemplated. The presence of the stiffening band 86 around the first and second flexible legs 20, 22 prevents the flexible legs 20, 22 from moving radially outward. Thus, if an attempt is made to remove the dust cap 14 with the stiffening band 86 connected, the stiffening band 86 prevents the first and second flexible legs 20, 22 from deflecting, thereby preventing removal of the dust cap 14. In a further example, removal of the dust cap 14 may break the stiffening band 86, thereby indicating that the connector element 12 may have been tampered with or previously used. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by the absence or damage of the stiffening band 86.

[0061] In some examples, the ends of the stiffening band 86 may be glued, heat sealed, or otherwise secured to one another so as to encircle at least a portion of the first and second flexible legs 20, 22. At the connection site 88 between the ends, the stiffening band 86 may include a pull tab 90 that a medical professional can easily grasp and pull to disconnect the ends and remove the stiffening band 86. Once the stiffening band is removed, the flexible legs 20, 22 may be free to move radially outward once the dust cap 14 is removed from the connector element 12, as described herein.

[0062] 12A-12B, according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include a band 92 connected to the connector element 12 and a breakable connection tie 94 having a first end connected to the band 92 and a second end connected to the dust cap 14. In some examples, the band 92 and the breakable connection tie 94 may be integrally formed with the dust cap 14, for example, molded with the dust cap.

[0063] In some examples, such as shown in FIG. 12B , the band 92 may be a zip tie having a first free end 96 connectable with a connector 98 at the second end 100. The zip tie may be configured to wrap around the connector element 12, e.g., proximal to a connecting beam 31 connecting the flexible legs 20, 22 to the body 18 of the connector element 12, such that the first free end 96 can be inserted through the connector 98 at the second end 100 to secure the zip tie to the connector element 12. In this manner, the dust cap 14 may be securely connected with the connector element 12, and the band 92 and the breakable connecting tie 94 prevent removal of the dust cap 14 without disconnecting the tamper-resistant and / or tamper-evident mechanism 70, e.g., by breaking the breakable connecting tie 94 from the dust cap 14. In further examples, the band 92 may be integrally formed with the connector element 12, or the band 92 may be connected to the connector element 12 during manufacturing, such as by welding.

[0064] In other embodiments, the band 92 may include an adhesive connection connecting the first free end 96 to the second end 100, which may be easily broken during removal of the dust cap 14. According to these embodiments, the band 92 may be made from a polymeric plastic material that is integrally formed with the dust cap 14. Alternatively, the band 92 may be made from a paper-and-fabric type material that may be glued to the dust cap 14, for example, at the second end 100 of the breakable connection tie 94. Securing the band 92 around the connector element 12 prevents the dust cap 14 from being inadvertently removed from the connector element 12 unless the band 92 is first disengaged.

[0065] The breakable connection tie 94 may be broken by grasping the gripping tab 54 of the dust cap 14 and pulling the gripping tab 58 in the distal direction A along the longitudinal axis 24 (shown in FIG. 7 ) and / or rotating the gripping tab 58 about the longitudinal axis 24 to break the connection between the breakable connection tie 94 and the dust cap body 46. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by absence or damage of the breakable connection tie 94. In certain embodiments, the band 92 may be disengaged by disconnecting the first end 96 from the second end 100, for example, when the first end 96 is adhesively connected to the second end 100, to allow removal of the dust cap 14.

[0066] 13A-13C by way of another example, a breakable connection tie 94 has a first end 102 connected to the dust cap 14 and a second end 104 in the form of a point attachment integrally formed and connected with the connector element 12. In some examples, the breakable connection tie 94 may be integrally formed with the connector element 12 and the dust cap 14, such as by an injection molding process. The second end 104 may have a weakened portion 106 (shown in FIG. 13B), such as a point attachment, configured to break, disconnect, or tear when the grip tab 54 of the dust cap 14 is pulled distally along and / or rotated about the longitudinal axis 24 (FIG. 8).

[0067] As shown in FIG. 13C, when the connector element 12 is connected to the syringe 16, the dust cap body 46 is positioned to fit sealingly within the discharge nozzle 23 at the distal end 21 of the syringe 16. In some examples, the dust cap body 46 may surround the discharge nozzle 23 of the syringe 16. In this manner, a sterile fluid pathway within the syringe may be maintained while the dust cap 14 is in place. The dust cap 14 may be removed when the gripping tab 54 of the dust cap 14 is pulled distally along and / or rotated about the longitudinal axis 24 (shown in FIG. 8), thereby breaking the breakable connection tie 94 at the weakened portion 106. Once the dust cap 14 is removed, the syringe 16 may be attached to various fluid pathway elements during setup for a fluid injection procedure. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by disconnection of the breakable connection tie 94 from the connector element 12 .

[0068] 14A-14E, according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may be embodied as a two-piece dust cap 14. Referring to FIGS. 14A-14B, the dust cap 14 has a first portion 110 that is removably connectable to a second portion 112. In some examples, the first portion 110 and the second portion 112 may be joined to one another on a plane that is substantially parallel to the direction of the longitudinal axis 24 (shown in FIG. 14C). The first portion 110 and the second portion 112 may have one or more alignment bosses 114 and corresponding one or more alignment recesses 116 that serve to align the first portion 110 with the second portion 112 during connection to form the dust cap 14. The one or more alignment bosses 114 are configured to align and engage, for example by a snap fit, with one or more opposing alignment recesses 116 to precisely orient the first and second portions 110, 112 of the two-piece dust cap 14. In some examples, the one or more alignment bosses 114 and the corresponding one or more alignment recesses 116 may be formed on inner surfaces of the first and second portions 110, 112 that face each other along the grip tab 58. The one or more alignment bosses 114 may be one or more protrusions on one of the first and second portions 110, 112 that are configured to connect with one or more alignment recesses 116 on the other of the first and second portions 110, 112.

[0069] In one configuration, the first portion 110 and the second portion 112 may be identical such that one or more alignment bosses 114 on one side of the gripping tab piece of the first portion 110 engage with corresponding one or more alignment recesses 116 on the other side of the gripping tab piece of the second portion 112. In another configuration, the first portion 110 may include only one or more alignment bosses 114 and the second portion 112 may include only one or more alignment recesses 116. Other arrangements and configurations of the one or more alignment bosses 114 and the one or more alignment recesses 116 are also contemplated.

[0070] The one or more alignment bosses 114 and corresponding one or more alignment recesses 116 may be formed, for example, on the grip tab 58 of the dust cap 14. The first portion 110 and the second portion 112 may be joined to one another by friction or a snap fit between the one or more alignment bosses 114 and the corresponding one or more alignment recesses 116 and / or by other means, such as using an adhesive or plastic welding.

[0071] 14A , the dust cap 14 may further include at least one tongue 118 and at least one corresponding groove 120 configured to connect with the at least one tongue 118. In some examples, the at least one tongue 118 and the at least one groove 120 may be provided on the dust cap body 46 and configured to hold the first and second parts 110, 112 of the two-piece dust cap 14 aligned in an engagement orientation. The at least one tongue 118 and the at least one groove 120 may be provided on both sides of the first part 110 and on both sides of the second part 112 in a configuration such that the tongue 118 of the first part 110 engages the corresponding groove 120 of the second part 112 and the tongue 118 of the second part 110 engages the corresponding groove 120 of the first part 112. In other embodiments, the first portion 110 may include at least one tongue 118 and the second portion 112 may include at least one groove 120 in a configuration such that the tongue 118 of the first portion 110 engages a corresponding groove 120 of the second portion 112.

[0072] 14A-14B, the proximal end 48 on each side of the first and second portions 110, 112 of the two-piece dust cap 14 may include an undercut 122 that extends through the sidewall of the dust cap body 46. In some examples, the undercut 122 may be configured to aid in separation of the first portion 110 from the second portion 112 upon removal of the dust cap 14 from the connector element 12 (shown in FIGS. 14C-14E). The undercut 122 may include at least one tapered or angled side 124 configured to interact with at least a portion of the connector element 12, such as the connecting beam 31 that connects the body 18 of the connector element 12 to the first and second flexible legs 20, 22. In this manner, during a removal process, such as by pulling the gripping tab 58 distally, the at least one angled side 124 acts as a wedge to separate the first and second portions 110, 112 of the dust cap 14. In particular, the at least one angled side 124 of the undercut 122 is configured to slide along the connecting beam 31 of the connector element 12 (shown in FIG. 14D ) as the dust cap 14 moves in the direction of arrow C in FIG. 14C , which forces the proximal end 48 of the two-piece dust cap 14 radially outward, thereby disengaging the at least one tongue 118 and the at least one groove 120 and / or the one or more alignment bosses 114 and one or more alignment recesses 116 of the first and second portions 110, 112 of the dust cap 14 during removal.

[0073] The two-piece dust cap 14 may be assembled onto the connector element 12 and aligned such that one or more alignment bosses and tongue-and-groove alignment features on one of the first and second portions 110 and 112 engage with complementary features on the other of the first and second portions 110 and 112. The first and second portions 110 and 112 may then be adhesively connected, for example, using a UV process or other adhesive process, or by a snap fit. Once adhered together, the first and second portions 110 and 112 are breakably connected to one another, such as by engagement of the angled side 124 of the undercut 122 with the connecting beam 31 of the connector element 12 when the dust cap 14 is moved in the direction of arrow C in FIG. 14C. Once removed, the dust cap 14 breaks down into two pieces (i.e., the first and second portions 110 and 112) that are configured to prevent reassembly. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by observation of at least partial disconnection of the first and second parts 110, 112 of the two-piece dust cap 14, or the absence of the dust cap 14 from the connector element 12.

[0074] 15A-15B, another embodiment of a two-piece dust cap 14 is shown. According to the illustrated embodiment, the two-piece dust cap 14 operates similarly to the dust cap 14 shown in FIGS. 14A-14E, but may be assembled to the connector element 12 in a different manner. With reference to FIG. 15A, the first and second portions 110, 112 of the two-piece dust cap 14 may include one or more alignment bosses 114, one or more alignment recesses 116, and at least one tongue 118 and at least one groove 120 features described herein and / or described with reference to the various embodiments shown in FIGS. 14A-14E. Additionally, each of the first portion 110 and the second portion 112 may include one or both of one or more male snap features 126 and one or more female snap features 128, with the one or more male and female snap features 126, 128 on one of the first portion 110 and the second portion 112 mated with one or more complementary female and male snap features 128, 126 on the other of the first portion 110 and the second portion 112. In this manner, the first portion 110 and the second portion 112 of the dust cap 14 may come together during engagement and be held together by engagement of the one or more male snap features 126 on the first portion 110 of the dust cap 14 with the one or more corresponding female snap features 128 on the second portion 112 of the dust cap 14. First portion 110 and second portion 112 may be identical, such as may be manufactured using a single mold as described herein, or may be different, and / or first portion 110 may include one or more male snap features 126 and second portion 112 may include corresponding one or more female snap features 128 positioned and configured to engage with one or more male snap features 126 on first portion 110.

[0075] During assembly, the first and second portions 110, 112 of the two-piece dust cap 14 may be engaged with the connector element 12 by sliding each of the first and second portions 110, 112 laterally between the opposing flexible legs 20, 22 of the connector element 12, as shown in FIG. 15B. As the first and second portions 110, 112 approach laterally, one or more male snap features 126 on one of the first and second portions 110, 112 snap into one or more corresponding female snap features 128 on the other of the first and second portions 110, 112 to releasably engage the first and second portions 110, 112 of the two-piece dust cap 14. Removal of the dust cap similarly involves pulling the gripping tab 58 in a distal direction, thereby disengaging the first portion 110 from the second portion 112 via interaction of the tapered or angled sides 124 on the undercuts 122 of the first and second portions 110, 112 with the connector element 12, as described herein with reference to Figures 14A-14E. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by observation of at least partial disconnection of the first and second portions 110, 112 of the two-piece dust cap 14, or the absence of the dust cap 14 from the connector element 12.

[0076] 16A-16E, another embodiment of the dust cap 14 having a tamper-resistant and / or tamper-evident feature 70 is shown. The tamper-resistant and / or tamper-evident feature 70 may include at least one slot 130 extending through the side wall 52 and ledge 68 of the dust cap body 46. The at least one slot 130 includes a first portion 132 that extends through the side wall 52 of the dust cap body 46 in a direction along a longitudinal axis 134 of the body 46 and a second portion 136 that extends through the ledge 68 in a direction substantially perpendicular to the longitudinal axis 134. The at least one slot 130 may be a pair of slots 130 positioned opposite each other on either side of the grip tab 58.

[0077] The slots 130 may be configured to releasably engage the distal surfaces 42, 44 of the flexible legs 20, 22 of the connector element 12. The second portion 136 of each slot 130 is configured to receive at least a portion of the distal surface 42 of the first leg 20 and the distal surface 44 of the second leg 22 when the dust cap 14 is installed on the connector element 12. The first portion 132 of each slot 130 is configured to receive the reinforcing member 45a of the first leg 20 and the reinforcing member 45b of the second leg 22, respectively. As shown in FIG. 16B, during installation of the dust cap 14 on the connector element 12, the flexible legs 20, 22 are pressed radially inward in the direction of arrow D to allow the flange portions 34, 36 of the flexible legs 20, 22 to be received within the second portion 136 of the slots 130. As the dust cap 14 moves in the proximal direction of arrow E in FIG. 16B, the reinforcing members 45a, 45b of each of the flexible legs 20, 22 slide within the first portion 132 of the corresponding slot 130. As the dust cap 14 is pushed proximally toward the connector element 12 such that the dust cap body 46 engages the connecting beam 31 of the connector element 12, the distal faces 42, 44 of the flange portions 38, 40 of the flexible legs 20, 22 protrude from the second portion 136 of the slot 130, thereby providing a clearance space for the flexible legs 20, 22 to resiliently return radially outward to their original positions. The dust cap 14 may be retained at the distal end 21 of the syringe 16 by the radially outward engagement between the flange portions 38, 40 of the flexible legs 20, 22 and the inner surface of the sidewall 52 (shown in FIG. 16A) of the dust cap body 46.

[0078] In certain embodiments, the distal faces 42, 44 of the flexible legs 20, 22 may each include an angled capture surface 138 at an end surface of the flanges 34, 36. The capture surface 138 is configured to engage and capture the ledge 68 of the dust cap body 46 onto the connector element 12. During removal of the dust cap 14 from the connector element 12, such as by pulling the gripping tab 58 of the dust cap 14 distally in the direction of arrow F in FIG. 16D, the portion of the sidewall 52 defining the second portion 136 of the slot 130 extends along a proximal surface of the angled capture surface 138, thereby allowing the flexible legs 20, 22 to move radially inwardly and slidably remove the dust cap 14 from the connector element 12. Reinstallation of the dust cap 14 onto the connector element 18 is prevented because significant manipulation of the flexible legs 20, 22 and dust cap 14 is required. In this manner, tampering, potential contamination, or previous use of the syringe 16 may be indicated by the absence or dislocation of the dust cap 14 from the connector element 18 .

[0079] 17A-17C, another embodiment of the dust cap 14 having a tamper-resistant and / or tamper-evident feature 70 is shown. According to this embodiment, the tamper-resistant and / or tamper-evident feature 70 may include one or more tearable seams 140 formed in the dust cap body 46. The one or more seams 140 may extend into an exterior surface of the sidewall 52 of the dust cap body 46 and define a breakable or tearable weakened portion to allow removal of the dust cap 14 from the connector element 12. In some examples, the one or more seams 140 may extend in a direction substantially parallel to the direction of the longitudinal axis 134 of the dust cap 14. In other examples, the one or more seams 140 may be inclined at an oblique angle relative to the longitudinal axis 134. The seams 140 may be spaced apart from one another at equal or unequal angular intervals around the circumference of the dust cap body 46.

[0080] 17B-17C, the distal end 50 of the dust cap body 46 may have a flange 142 that projects distally relative to the ledge 68. The flange 142 may be angled radially outward relative to the sidewall 52 of the dust cap body 14. The distal faces 42, 44 of the flexible legs 20, 22 may each include an angled capture surface 139 at an end face of the flanges 34, 36 configured to capture the flange 142 when the dust cap 14 is connected to the connector element 12. In other embodiments, the distal end 50 of the dust cap 14 may include an angled member 64 defined by the distal edge 66 of the dust cap body 46, as described herein.

[0081] When a torsional or lateral force is applied to the dust cap 14, such as twisting the gripping tab 58 about the longitudinal axis 134 or moving the gripping tab 58 in a direction perpendicular or oblique to the longitudinal axis 134, the one or more seams 140 are configured to separate, split, and / or tear along the sidewall 52 of the dust cap body 46, such that the dust cap 14 may be easily removed from the connector element 12, for example, by sliding the dust cap 14 laterally to the side of the connector element 12 or pulling the gripping tab 58 distally in a direction substantially along the longitudinal axis. Now that the material of the dust cap 14 has been torn, the dust cap 14 cannot be reinstalled on the connector element 12. In this manner, tampering, potential contamination, or previous use of the syringe 16 may be indicated by at least one torn seam 140.

[0082] According to another embodiment, as shown in FIGS. 18A-18B, the tamper-resistant and / or tamper-evident mechanism 70 may include a dust cap 14 having two or more tearable seams 140 molded or cut into a sidewall of the dust cap body 46 in a manner similar to that described with reference to FIGS. 17A-17C. The two or more seams 140 extend in a direction substantially parallel to the direction of the longitudinal axis 134 from the proximal end 48 to the distal end 50 of the dust cap body 46. In some examples, the two or more seams 140 may be angled relative to the longitudinal axis 134. The embodiment shown in FIGS. 18A-18B further includes a pull tab 144 extending away from the dust cap body 46 between the two or more seams 140. Pulling the pull tab 144 is configured to separate or tear the seams 140. In this manner, dust cap 14 can be removed from connector element 12 by pulling dust cap 14 laterally between flexible legs 20, 22 or by pulling pull tab 144 across the top of dust cap 14. Now, since the material of dust cap 14 has been torn, this indicates that dust cap 14 has been previously removed and should not be reinstalled on connector element 12. In this manner, tampering, potential contamination, or previous use of syringe 16 can be indicated by torn seam 140.

[0083] According to other embodiments, as shown in FIGS. 19A-19D, the tamper-resistant and / or tamper-evident feature 70 may include a dust cap 14 having two or more seams 140 molded or cut into the exterior (FIGS. 19A, 19B) or interior (FIGS. 19C, 19D) sidewall 52 of the dust cap body 46 in a manner similar to that described with reference to FIGS. 18A-18B. The two or more seams 140 may extend from one side of the body 46 to the opposite side of the body 46, or may extend from one side of the body 46 over a ledge 68 of the dust cap 14. In some examples, as shown in FIGS. 19A-19B, the two or more seams 140 extend partially into the sidewall 52 on an exterior surface 146 of the body 46. In other examples, as shown in FIGS. 19C-19D, the two or more seams 140 extend partially into the sidewall 52 on an interior surface 148 of the body 46. The pull tab 144 may extend away from the dust cap body 14 between two or more seams 140 such that pulling the pull tab 144 is configured to separate or tear the seams 140 and allow removal of the dust cap 46.

[0084] 19A-19D , the tamper-resistant and / or tamper-evident feature 70 may include a retention flange 150 extending proximally from the proximal end 48 of the dust cap body 46. The retention flange 150 has a retention pocket 152 defined by a pair of retention legs 154 spaced apart from the proximal end 48 of the dust cap body 46. In some examples, with reference to FIGS. 20A-20D , the retention pocket 152 is configured to receive at least a portion of the connection beams 31 of the flexible legs 20, 22 when the dust cap 14 is connected to the connector element 12. The retention flange 150 is configured to prevent the dust cap 14 from slipping distally off the connector element 12 during manufacturing, shipping, or storage, and may further require pulling the pull tab 144 and tearing the seam 140 to remove the dust cap 14.

[0085] Pulling the pull tab 144 is configured to separate or tear the seam 140. In this manner, the dust cap 14 can be removed from the connector element 12 by pulling the dust cap 14 sideways or upward between the flexible legs 20, 22 such that the retention mechanism 150 slides against the connecting beam 31. Because the material of the dust cap 14 is now torn, this indicates that the dust cap 14 should not be reinstalled on the connector element 12. In this manner, tampering, potential contamination, or previous use of the syringe 16 can be indicated by a torn seam 140.

[0086] According to another embodiment, as shown in FIGS. 21A-21E, the tamper-resistant and / or tamper-evident mechanism 70 may include a dust cap 14 that may be placed on the connector element 12 before the connector element 12 is attached to the syringe 16. As shown in FIGS. 21A and 21B, the dust cap 14 may have one or more side arms 156 connected to the dust cap body 46 and configured to engage the flexible first leg 20 and second leg 22 of the connector element 12. Each of the one or more side arms 156 has a first end 158 connected to the dust cap body 46 and a second end 160 that projects in a direction substantially perpendicular to the longitudinal axis 134. In some examples, the first end 158 of the one or more side arms 156 may be integrally formed with the dust cap body 46 at the proximal end 48 of the dust cap body 46. The one or more side arms 156 may be made of a material that can pivot or bend at the first end 158 to allow the second end 160 to move radially outward in a direction relative to the longitudinal axis 134. In one example of the present disclosure, the one or more side arms 156 may be made of a rigid material with a flexible pivot point to allow the one or more side arms 156 to move radially outward in a direction relative to the longitudinal axis 134.

[0087] The dust cap 14 is installed on the connector element 12 by sliding the dust cap 14 laterally onto the connector element 12 in the direction of arrow G in FIG. 21C , which allows the second ends 160 of the one or more side arms 156 to flex around and engage the first and second flexible legs 20, 22 of the connector element 12, for example, by bending over the stiffening member 45. For example, as the dust cap 14 is moved towards the connector element 12 in the direction of arrow G, the second ends 160 of the side arms 156 are configured to flex radially outward in the direction of arrow H to allow the side arms 156 to extend around the stiffening member 45 of the first and second flexible legs 20, 22 of the connector element 12. The second ends 160 of the side arms 156 are configured to return to their unbent position after removal of the reinforcing members 45 of the first and second flexible legs 20, 22, where the reinforcing members 45 are retained within the retention notches 162 of the second ends 160 of the one or more side arms 156 (see Figures 21D-21E).

[0088] Each side arm 156 may have a tab 164 connected to the side arm 156 between the first end 158 and the second end 160 (see FIG. 21B). In some examples, the tab 164 may extend in a direction substantially parallel to the side arm 156. The tab 164 may be configured to engage a side of the first leg 20 or the second leg 22 and abut the reinforcing member 45. During removal of the dust cap 14 from the connector element 12, the tab 164 may be configured to bend over the distal ends of the first and second flexible legs 20 and 22 in the direction of arrow I in FIG. 21E. After removal of the dust cap 14 from the connector element 12, the tab 164 is configured to return to its original undeflected position. Tab 164 is configured to prevent dust cap 14 from being reinstalled on connector element 12 after removal, for example, by preventing a user from pushing dust cap 14 proximally back onto connector element 12. In some examples, tab 164 may be positioned such that tab 164 interferes with an outwardly tapered distal end of first leg 20 or second leg 22.

[0089] The dust cap 14 may further include a skirt 166 extending around at least a portion of the dust cap body 46. The skirt 166 may extend radially outward relative to the dust cap body 46. In some examples, the skirt 166 may extend radially outward from the proximal end 48 of the dust cap body 46. In some examples, the skirt 166 may have a first portion 168a separated from the second portion 168b such that the first portion 168a and the second portion 168b extend around a portion of the circumference of the dust cap body 46. In some examples, the first end 158 of the one or more side arms 156 may be connected to the first portion 168a. The first portion 168a and the second portion 168b of the skirt 166 may be separated by one or more gaps 169 (shown in FIG. 21B ) configured to accommodate the first flexible leg 20 and the second flexible leg 22 when the dust cap 14 is installed on the connector element 12.

[0090] Once the dust cap 14 has been installed on the connector element 12 as described herein, the connector assembly 10 may be attached to the syringe 16, for example by laser welding or adhesively adhering, such that the dust cap 14 seals the discharge nozzle 23 of the syringe 16, as shown in Figures 21D and 21E. To remove the dust cap 14 from the connector element 12, a user removes the dust cap by pulling the gripping tab 58 of the dust cap 14 distally along the longitudinal axis 134 of the connector element 12, thereby biasing the side arms 156 and tabs 164 to flex and slide over the outer surfaces and stiffening member 45 of the first and second legs 20 and 22 of the connector element 12. As described, the tab 164 is also configured to bend and pass over the distal ends of the first and second flexible legs 20, 22 during the removal process and then flex or snap back to its original orientation to prevent reinstallation of the dust cap 14 onto the connector element 12.

[0091] According to another embodiment, as shown in FIGS. 22A-B, the tamper-resistant and / or tamper-evident mechanism 70 may include a flexible strip 170 having a first opening 172 configured to receive at least a portion of the dust cap 14 and a second opening 174 configured to receive at least a portion of the connector element 12. In some examples, as shown in FIG. 22A, the first opening 172 and the second opening 174 may have a circular shape. In other examples, at least one of the first opening 172 and the second opening 174 may have a non-circular shape. In some examples, the first opening 172 may be a shape that corresponds to a shape of at least a portion of the dust cap 14, such as the circular portion of the ledge 68 (FIG. 22A) or the grip tab 58 (see FIG. 22B). Similarly, the second opening 174 may be a shape that corresponds to a shape of at least a portion of the connector element 12, such as the body 18 of the connector element 12. Flexible strip 170 is configured to bend or flex such that at least a portion of dust cap 14 is received within first opening 172 and at least a portion of connector element 12 is received within second opening 174. Flexible strip 170 is configured to prevent dust cap 14 from being removed from connector element 12 without first removing flexible strip 170.

[0092] In some examples, the flexible strip 170 may be made from a tearable plastic, paper, or other easily tearable woven material. To remove the flexible strip 170 from the dust cap 14 and the connector element 12, a user may simply pull on the flexible strip 170, thereby breaking or tearing at least a portion of the flexible strip 170. For example, the flexible strip 170 may be configured to tear a portion of the flexible strip 170 surrounding the first opening 172 and the second opening 174 when the flexible strip 170 is pulled in a lateral direction, such as a radial direction, relative to the dust cap 14 and the connector element 12. Alternatively, removing the dust cap 14, for example by grasping and pulling the gripping tab 58 in a longitudinal distal direction, may remove the dust cap 14 while stretching and tearing the flexible strip 170. Once the material of the flexible strip 170 is torn, the dust cap 14 may be removed from the connector element 12. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by a torn flexible strip 170 .

[0093] 23 , according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include a strap 176 connected to the dust cap 14, such as to the grip tab 58 of the dust cap 14. In some examples, the strap 176 may be formed integrally with, such as by molding, the grip tab 58 of the dust cap 14. In other embodiments, the strap 176 may be glued or welded to the grip tab 58 of the dust cap 14. The grip tab 58 may be flexible or bendable such that it can be bent to be positioned proximate the connector element 12 to allow the strap 176 to be connected to the connector element 12.

[0094] In some examples, the strap 176 may be a zip tie having a first free end 178 connectable with a connector 180 on a second free end 182. The zip tie may be configured to wrap around the connector element 12 such that the first free end 178 may be inserted through the connector 180 of the second free end 182 to secure the zip tie to the connector element 12. In this manner, the dust cap 14 may be securely connected with the connector element 12, and the strap 176 prevents removal of the dust cap 14 without disconnecting the tamper-resistant and / or tamper-evident mechanism 70, for example, by breaking the strap 176 from the connector element 12 and / or the dust cap 14. According to another embodiment, the strap 176 may be substantially circular and configured to encircle the body 18 of the connector element 12 prior to connecting the connector element 12 to the syringe 16. Once the connector element 12 is engaged with the syringe 16, the strap 176 cannot be removed from the body 18 of the connector element 12 without tearing the strap, and the dust cap 14 cannot be removed unless the strap 176 is broken or the gripping tab 58 is broken. The strap 176 may be broken by pulling or rotating the strap 176 to break the connection between the strap 176 and the dust cap 14 and / or the connector element 12. In some embodiments, the strap 176 may be broken by removing the dust cap 14 distally. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by the absence or damage of the strap 176.

[0095] 24 , according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include at least one breakable beam 190 connecting a connector element 12, such as one of the first and second flexible legs 20 and 22, to the dust cap 14. In some examples, the at least one breakable beam 190 has a first end 192 connected to one of the first and second flexible legs 20 and 22, and a second end 194 connected to at least a portion of the dust cap 14, such as the dust cap body 46 or the grip tab 58. When the breakable beam 190 is connected to the connector element 12 and the dust cap 14, the breakable beam 190 prevents distal movement of the dust cap 14 relative to the connector element 12. By rotating the dust cap 14 about the longitudinal axis 134, at least one of the first end 192 and the second end 194 is configured to break away from the first / second flexible legs 20 / 22 and / or the dust cap 14, thereby allowing removal of the dust cap 14 by pulling in a distal direction. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by a broken condition of the breakable beam 190.

[0096] 25, according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include at least one strip 184, such as a pair of strips 184, each having a first end 186 connected to at least a portion of the dust cap 14 and a second end 188 connected to a portion of the connector element 12. In some examples, the first end 186 may be connected to a grip tab 58 of the dust cap 14 and the second end 188 may be connected to a proximal gripping portion of the flexible first and second legs 20 and 22. In other embodiments, the second end 188 may be attached to a flange or ledge (not shown) integrally formed on an outer surface of the flexible first and second legs 20 and 22. In some examples, each of the strips 184 may be integrally formed, such as by molding, with the grip tab 58 of the dust cap 14 or the connector element 12. The dust cap 14 can be securely connected with the connector element 12, and the strip 184 prevents removal of the dust cap 14 without disconnecting the tamper-resistant and / or tamper-evident mechanism 70, for example, by breaking the strip 184 from the connector element 12 and / or the dust cap 14. The strip 184 may be broken by pulling or rotating the strip 184 or by pulling or rotating the dust cap 14 to break the connection between the strip 184 and the dust cap 14 and / or the connector element 12. Tampering, potential contamination, or previous use of the syringe 16 can be indicated by the absence or damage of the strip 184.

[0097] Referring to FIG. 26 , according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include a skirt 196 connected to the proximal end 48 of the dust cap 14. In some examples, the skirt 196 may be an annular skirt. In other examples, the skirt 196 may extend at least partially around the dust cap body 46. The skirt 196 may have a first end 198 connected to the proximal end 48 of the dust cap body 46 and a second free end 200. In some examples, the second free end 200 is folded over such that the skirt 196 extends in a distal direction when the dust cap 14 is installed on the connector element 12. In some examples, the second end 200 of the skirt 196 may be configured to be received within the first flange 38 of the first leg 20 and the second flange 40 of the second leg 22 of the connector element 12. When the dust cap 14 is connected to the connector element 12, the second end 200 of the skirt 196 is disposed within the space between the first flange 38 and the second flange 40, thereby preventing the dust cap 14 from moving distally relative to the connector element 12 without deformation of the second end 200 relative to the first end 198. When the dust cap 14 is pulled distally, such as by pulling the gripping tab 58, the skirt 196 is configured to deploy, for example, by deforming and deploying when the second end 200 abuts the first flange 38 of the first leg 20 and the second flange 40 of the second leg 22, forcing the second end 200 to move proximally relative to the first end 198 as the dust cap 14 continues to move distally, thereby allowing the dust cap 14 to be removed by pulling distally. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by the deployed state of the skirt 196 on the dust cap 14 .

[0098] 27 , according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include at least one loop 202 connected to one of the first and second flexible legs 20 and 22 of the connector element 12. In some examples, the at least one loop 202 may be formed, such as integrally molded, with one of the first and second flexible legs 20 and 22, or the at least one loop 202 may be adhesively connected or welded to one of the first and second flexible legs 20 and 22. In some examples, the at least one loop 202 may be elastic such that it may be stretched from a first of the first and second flexible legs 20 and 22 and looped over the other of the first and second flexible legs 20 and 22 to surround the circumference of at least a portion of the first and second flexible legs 20 and 22. The presence of the at least one loop 202 around the first and second flexible legs 20 and 22 prevents radial outward movement. In this manner, if removal of the dust cap 14 is attempted while the at least one loop 202 is connected, the at least one loop 202 prevents radial deflection of the first and second flexible legs 20 and 22, thereby preventing removal of the dust cap 14. For example, when at least one loop 202 is removed from the loops on the first and second flexible legs 20, 22, such as by a medical professional breaking at least one loop 202 by pulling the material of at least one loop 202 radially outward, the flexible legs 20, 22 may move radially outward when the dust cap 14 is removed from the connector element 12, as described herein. In a further example, removing the dust cap 14 while at least one loop 202 is engaged with the first and second flexible legs 20, 22 may break at least one loop 202, thereby indicating that the connector element 12 may have been used. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by the absence or damage of at least one loop 202.

[0099] 28, the first and second flexible legs 20, 22, or both, may have one or more notches 204 configured to retain a band 203 extending around the first and second flexible legs 20, 22. The one or more notches 204 may be configured as protrusions extending radially outward from an outer surface of the first and second flexible legs 20, 22 to receive the band 203. In some examples, the multiple notches 204 may be axially spaced apart along the longitudinal length of the first and second flexible legs 20, 22. The band 203 may be elastic such that it may be stretched from a first of the first and second flexible legs 20 and 22, looped over the other of the first and second flexible legs 20 and 22, and secured within one or more notches 204 to surround the circumference of at least a portion of the first and second flexible legs 20 and 22. In some examples, the band 203 may be positionable in any of the notches 204 along the longitudinal length of the first and second flexible legs 20 and 22. The presence of the band 203 around the first and second flexible legs 20 and 22 prevents radially outward movement. In this manner, if removal of the dust cap 14 is attempted with the band 203 still connected, the band 203 will prevent radial deflection of the first and second flexible legs 20, 22, thereby preventing removal of the dust cap 14. When the band 203 is removed from the loops on the first and second flexible legs 20, 22, such as by a medical professional breaking the band 203 by pulling the material of the band 203 radially outward, the flexible legs 20, 22 may move in a radially outward direction when the dust cap 14 is removed from the connector element 12, as described herein. In a further example, removing the dust cap 14 while the band 203 is engaged with the first and second flexible legs 20, 22 may break the band 203, thereby indicating that the connector element 12 may have been used.Tampering, potential contamination, or previous use of the syringe 16 may be indicated by the absence or damage of the band 203.

[0100] 29A-29B , according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include at least one flexible locking leg 206 connected to the dust cap 14, such as the body 46 of the dust cap 14. In some examples, the at least one flexible locking leg 206 may be a pair of flexible locking legs 206 extending radially outward from the dust cap body 46. Each flexible locking leg 206 has a first end 208 connected to the dust cap body 46 and a second end 210 projecting radially outward relative to the first end 208. In some examples, the second end 210 may have an engagement hook 212 configured to connect with the connector element 12. For example, the engagement hook 212 may be configured to extend around at least a portion of the first and second flexible legs 20 and 22, for example, by hooking onto a surface of the reinforcing members 45a, 45b on the first and second flexible legs 20 and 22, respectively. The at least one flexible locking leg 206 may be movable between a disengaged position (FIG. 29A) in which the at least one flexible locking leg 206 is not connected to one or both of the first and second flexible legs 20 and 22, and an engaged position (FIG. 29B) in which the at least one flexible locking leg 206 is in hooked engagement with one or both of the first and second flexible legs 20 and 22. The locking leg 206 is movable between the disengaged and engaged positions by rotational movement about the longitudinal axis of the dust cap 14. For example, rotation of the dust cap 14 may deform material associated with the engagement hook 212 such that the second end 210 of the at least one flexible locking leg 206 disengages from at least a portion of the first flexible leg 20 or the second flexible leg 22. Alternatively, a user may manually disengage the engagement hook 212 from at least a portion of the first flexible leg 20 or the second flexible leg 22 prior to removing the dust cap 14. In the engaged position, the locking legs 206 prevent the dust cap 14 from disengaging from the connector element 12. In the disengaged position of the locking legs 206, the dust cap 14 may be removed from the connector element 12.Tampering, potential contamination, or previous use of the syringe 16 may be indicated, for example, by deformation of the engagement hook 212 on the second end 210 of the at least one flexible locking leg 206 of the dust cap 14 .

[0101] 30A-30B, according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include a dust cap 14 having a movable element 218 movable relative to the dust cap body 46. The movable element 218 may include an outer cylindrical skirt 219 configured to surround an inner cylindrical portion 221 of the dust cap body 46 configured to fit within a nozzle of the connector element 12. In some examples, the grip tab 58 may be defined on the movable element 218. The movable element 218 may have a first engagement element 216. At least a portion of the dust cap body 46 is received within the outer cylindrical skirt 219. A distal portion of the dust cap body 46 has a second engagement element 214 configured to engage with the first engagement element 216 of the movable element 218 when the movable element 218 moves to a distal-most position relative to the dust cap body 46.

[0102] The dust cap body 46 may include a post 223 extending through the first engaging element 216 such that in the engaged position, the second engaging element 214 is locked to the first engaging element 216 (FIG. 30B). In this manner, the movable element 218 is freely movable in the direction of arrow F relative to the dust cap body 46 until the first engaging element 216 is locked into engagement with the second engaging element 214. Once the first engaging element 216 and the second engaging element 214 are locked into engagement, continued distal movement of the movable element 218 relative to the dust cap body 46 results in removal of the dust cap body 46 from the connector element 12, such as by radial displacement of the flexible legs 20, 22, as described herein. Once the first engaging element 216 and the second engaging element 214 are engaged, they are configured to remain engaged. In this manner, the locking engagement between the movable element 218 and the dust cap body 46 indicates that the dust cap 14 has been removed.

[0103] In one embodiment, the second engaging element 214 may be in the form of an angled fin extending from the post 223 and the first engaging element 216 is in the form of a hole through which the post 223 passes. When the gripping tab 58 is pulled distally, the angled fin of the second engaging element 214 contacts and locks into the periphery of the hole in the first engaging element 216, locking the dust cap 14 in the extended position. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by a locking engagement between the movable element 218 and the dust cap body 46.

[0104] 31, according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include a dust cap 14 having a movable element 225 movable relative to the dust cap body 46, similar to the movable element 218 described herein with reference to FIGS. 30A-30B. The movable element 225 is surrounded by the dust cap body 46 and received within an opening in the dust cap body 46 such that the movable element 225 is movable relative to the dust cap body 46. In some examples, the grip tab 58 may be defined on the movable element 225. The movable element 225 may have a first engagement element 216, while a distal portion of the dust cap body 46 has a second engagement element 214 in the form of an opening on the dust cap body 46 configured to engage with the first engagement element 216 of the movable element 225 when the movable element 225 moves to a distal-most position relative to the dust cap body 46, as described herein with reference to FIGS. 30A-30B. The tamper-resistant and / or tamper-evident mechanism 70 further includes a disk 208 connected to the gripping tab 58 for engaging the dust cap body 14 with the flexible legs 20, 22 of the connector element 12 which retains the dust cap 46 on the connector element 12 during shipping and storage.

[0105] The movable element 225 is freely movable in a distal direction relative to the dust cap body 46 until the first engaging element 216 is locked into engagement with the second engaging element 214. Once the first engaging element 216 and the second engaging element 214 are locked into engagement, continued distal movement of the movable element 225 relative to the dust cap body 46 results in removal of the dust cap body 46 from the connector element 12, such as by radial displacement of the flexible legs 20, 22, as described herein. Once the first engaging element 216 and the second engaging element 214 are engaged, they are configured to remain engaged. In this manner, the locking engagement between the grip tab 58 and the dust cap body 46 indicates that the dust cap 14 has been removed. The disk 208 may be configured to prevent re-engagement of the dust cap 14 with the connector element 12 due to interference with the first and second flexible legs 20 and 22 when the first and second engaging elements 216 and 214 are engaged, locking the movable element 225 in a distal-most position and preventing the disk 208 from re-engaging the first and second flexible legs 20 and 22. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by a locking engagement between the first engaging element 216 on the movable element 225 and the second engaging element 214 on the dust cap body 46.

[0106] 32A-32B, according to another example, the tamper-resistant and / or tamper-evident mechanism 70 may include a deformable flange 220 connected to the dust cap body 46 between the proximal end 48 and the distal end 50. In some examples, the deformable flange 220 may be annular in shape. In other examples, the deformable flange 220 may extend at least partially around a portion of the dust cap body 46. The deformable flange 220 may have a first end 222 connected to the dust cap body 46 and a second free end 224. In some examples, the second free end extends radially outward in a distal direction. In some examples, the second end 224 of the deformable flange 220 may be configured to be received within and engage with the first flange 38 of the first leg 20 and the second flange 40 of the second leg 22 of the connector element 12 (shown in FIG. 5 ) when the dust cap 14 is engaged with the connector element 12. When the dust cap 14 is connected to the connector element 12, the disposition of the second end 224 of the deformable flange 220 within the space of the first flange 38 and the second flange 40 retains the dust cap 14 within the connector element 12. The deformable flange 220 is configured to deform by folding in a proximal direction (as shown in FIG. 32B ) when the second end 224 of the deformable flange 220 presses against the first flange 38 of the first leg 20 and the second flange 40 of the second leg 22 of the connector element 12 as the dust cap 14 moves in a distal direction and out of engagement with the first leg 20 and the second leg 22 upon removing the dust cap 14 from the connector element 12, such as by pulling the gripping tab 58. Tampering, potential contamination, or previous use of the syringe 16 may be indicated by a deformed state of the deformable flange 220 on the dust cap 14, shown in FIG. 32B.

[0107] Although various examples of the present disclosure have been provided in the foregoing description, those skilled in the art can make modifications and variations to these examples without departing from the scope and spirit of the present disclosure. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The above disclosure is defined by the claims, and all changes to the disclosure that come within the meaning and range of equivalence of the claims are intended to be embraced within their scope. [Explanation of symbols]

[0108] 10 fluid pathway connector assembly, 12 connector element, 14 dust cap, 15 lumen, 16 syringe, 17 barrel, 18 body, 19 proximal end, 20 first flexible leg, 21 distal end, 22 second flexible leg, 23 distal end, 24 longitudinal axis, 25 rib, 26 first actuation arm, 27 inner surface, 28 second actuation arm, 29 tubular sidewall, 30 gripping rib, 31 connecting beam, 32 support portion, 34 first flange, 36 second flange, 38 flange portion, 40 flange portion, 42 surface, 44 surface, 45 reinforcing member, 45a reinforcing member, 45b reinforcing member, 46 dust cap body, 47 peripheral skirt, 48 proximal end, 50 distal end, 52 sidewall, 54 gripping tab, 56 fluid pathway, 58 gripping tab, 60 gripping element, 62 engagement element, 64 ramped member, 66 distal edge, 68 ledge, 70 tamper-resistant and / or tamper-evident feature, 72 seal, 74 removal tab, 76 perforation strip, 78 cap, 80 tearable strip or adhesive, 82 vent, 84 periphery, 86 reinforcement band, 88 connection site, 90 pull tab, 92 band, 94 frangible connection tie, 96 first free end, 98 connector, 100 second end, 102 first end, 104 second end, 106 weakened portion, 110 first portion, 112 second portion, 114 alignment boss, 116 alignment recess, 118 tongue, 120 groove, 122 undercut, 124 beveled side, 126 male snap feature, 128 female snap feature, 130 slot, 132 first portion, 134 longitudinal axis, 136 second portion, 138 beveled capture surface, 139 capture surface, 140 seam, 142 flange, 144 pull tab, 146 outer surface, 148 inner surface, 150 retention flange, 152 retention pocket, 154 retention leg, 156 side arm, 158 first end, 160 second end, 162 retention notch, 164 tab, 166 skirt, 168a first portion, 168b second portion, 169 gap, 170 flexible strip, 172 first opening, 174 second opening, 176 strap, 178 first free end, 180 connector, 182 second free end, 184 Strip, 186, first end, 188, second end, 190Breakable beam, 192; first end, 194; second end, 196; skirt, 198; first end, 200; second free end, 202; loop, 203; band, 204; notch, 206; flexible locking leg, 208; disk, first end, 210; second end, 212; engagement hook, 214; second engagement element, 216; first engagement element, 218; movable element, 219; outer cylindrical skirt, 220; deformable flange, 221; inner cylindrical portion, 222; first end, 223; post, 224; second end, 225; movable element

Claims

1. A fluid path connector assembly for a medical fluid delivery system, wherein the fluid path connector assembly is A connector element, wherein the connector element is A main body comprising a surrounding skirt that encloses the aforementioned connector element, A tubular lumen extending through the aforementioned body, A first flexible leg connected to the main body, having a first flange, A second flexible leg connected to the main body, the second flexible leg having a second flange, A connector element comprising, A dust cap detachably connected to the connector element, wherein the dust cap is A dust cap body positioned between the first flexible leg and the second flexible leg, surrounding the main body of the connector element so as to enclose the lumen, having a proximal end and a distal end, An engaging element located at the distal end of the dust cap body, comprising an inclined member defined by the distal edge of the dust cap body, A dust cap equipped with, Equipped with, The engaging element contacts the first flange of the first flexible leg and the second flange of the second flexible leg of the connector element in order to prevent the dust cap from being disengaged from the connector element. The first flange of the first flexible leg and the second flange of the second flexible leg of the connector element are configured to contact the inclined member when the dust cap moves distal to the connector element, such that the first and second flexible legs expand radially outward to allow the dust cap to be removed from the connector element. Fluid path connector assembly.

2. The fluid path connector assembly according to claim 1, wherein the inclined member extends around at least a portion of the outer circumference of the distal edge of the dust cap body.

3. The fluid path connector assembly according to claim 1 or 2, wherein the inclined member has a rounded or chamfered edge.

4. The fluid path connector assembly according to any one of claims 1 to 3, wherein the engaging element comprises a ledge configured to contact the first flange of the first flexible leg of the connector element and the second flange of the second flexible leg.

5. The fluid path connector assembly according to any one of claims 1 to 4, further comprising a gripping tab connected to the distal end of the dust cap body.

6. The fluid path connector assembly according to claim 5, wherein the gripping tab comprises one or more gripping elements configured to facilitate the removal of the dust cap from the connector element.

7. The fluid path connector assembly according to any one of claims 1 to 6, wherein the dust cap body is rotatable with respect to the body of the connector element about the longitudinal axis of the dust cap.

8. The fluid path connector assembly according to any one of claims 1 to 7, wherein when the dust cap is connected to the connector element, the air pressure in the lumen of the connector element can become equal to the external atmospheric pressure while maintaining sterility in the lumen of the connector element.

9. A fluid path connector assembly according to any one of claims 1 to 8, wherein a winding fluid path is defined between the dust cap body and the circumferential skirt of the body of the connector element, thereby enabling the equalization of pressure within the lumen of the connector element while preventing the passage of contaminants into the lumen of the connector element.

10. The fluid path connector assembly according to any one of claims 1 to 9, wherein the connector element is configured to fluidly connect to at least one component selected from the group consisting of a syringe, a spike, a fluid tube set, and a bulk fluid container.

11. The fluid path connector assembly according to any one of claims 1 to 10, further comprising a removable / disconnectable tamper-proof or tamper-proof mechanism for connecting the dust cap to the connector element.

12. The fluid path connector assembly according to claim 11, wherein, if present, the tamper-resistant or tamper-proof mechanism is configured to prevent the removal of the dust cap from the connector element, to indicate that the connection between the connector element and the dust cap has been previously tampered with, or to prevent or indicate that the dust cap has been reinstalled on the connector element after it has been removed from the connector element.

13. A fluid path connector assembly for a medical fluid delivery system, wherein the fluid path connector assembly is A connector element comprising: a body having a circumferential skirt surrounding the connector element; a lumen extending through the body; a first flexible leg connected to the body; and a second flexible leg connected to the body. A dust cap detachably connected to the connector element, wherein the dust cap comprises a dust cap body positioned between the first flexible leg and the second flexible leg, and surrounding the body of the connector element so as to enclose the lumen, A removable / disconnectable tamper-proof or tamper-proof mechanism for connecting the dust cap to the connector element, Equipped with, If present, the tamper-resistant or tamper-proof mechanism is configured to prevent the removal of the dust cap from the connector element, to indicate that the connection between the connector element and the dust cap has been previously tampered with, or to prevent or indicate that the dust cap can be reinstalled on the connector element after it has been removed from the connector element. Fluid path connector assembly.

14. The fluid path connector assembly according to claim 13, wherein the tamper-resistant or tamper-proof mechanism comprises a polymer shrink wrap or paper wrap that at least partially surrounds the connector element and the dust cap, and the polymer shrink wrap or paper wrap has at least one removal mechanism for removing the polymer shrink wrap from the fluid path connector assembly.

15. The fluid path connector assembly according to claim 14, wherein the removal mechanism comprises a tearable precut, a grippable tab, or a perforating mechanism for removing the tamper-resistant or tamper-proof mechanism.

16. The fluid path connector assembly according to claim 13, wherein the tamper-proof or tamper-proof mechanism comprises a cap that at least partially surrounds the connector element and the dust cap.

17. The fluid path connector assembly according to claim 16, wherein the cap is secured to the syringe via a tearable strip.

18. The fluid path connector assembly according to claim 13, wherein the tamper-resistant or tamper-proof mechanism comprises a first portion connected to the connector element and a second portion connected to the first portion and the dust cap.

19. The fluid path connector assembly according to claim 18, wherein the first portion comprises a pull tab configured to detach the first portion from the connector element.

20. The fluid path connector assembly according to claim 18 or 19, wherein the second portion is configured to break off from the first portion or the dust cap when the dust cap rotates about its longitudinal axis.

21. The fluid path connector assembly according to claim 13, wherein the tamper-resistant or tamper-proof mechanism is a removable band surrounding the first flexible leg and the second flexible leg, the band restricting the movement of the first flexible leg and the second flexible leg to prevent the removal of the dust cap when the removable band is attached to the fluid path connector assembly.

22. The fluid path connector assembly according to claim 13, wherein the tamper-resistant or tamper-proof mechanism has a first end connected to the connector element and a second end connected to the dust cap, the first end being configured to break or separate from the connector element when the dust cap rotates about its longitudinal axis.

23. The fluid path connector assembly according to claim 13, wherein the tamper-resistant or tamper-proof mechanism comprises a tearable pull tab integrally formed with the dust cap.

24. The fluid path connector assembly according to claim 13, wherein the dust cap body comprises a first part and a second part that are separable from each other and connected along a separation line substantially parallel to the longitudinal axis of the dust cap.

25. The fluid path connector assembly according to claim 24, wherein the first portion and the second portion each have at least one reinsertion prevention element to prevent the dust cap from being reinserted onto the connector element after the dust cap has been removed from the connector element.

26. The fluid path connector assembly according to claim 13, wherein when the dust cap and the tamper-proof or tamper-proof mechanism are connected to the connector element, the air pressure in the lumen of the connector element can become equal to the external atmospheric pressure while maintaining sterility in the lumen of the connector element.

27. The fluid path connector assembly according to claim 13, further comprising an engaging element at the distal end of the dust cap body, wherein the engaging element comprises an inclined member defined by the distal edge of the dust cap body.

28. The engaging element contacts the first flange of the first flexible leg and the second flange of the second flexible leg of the connector element in order to prevent the dust cap from being disengaged from the connector element. The first flange of the first flexible leg and the second flange of the second flexible leg of the connector element are configured to contact the inclined member when the dust cap moves distal to the connector element, such that the first and second flexible legs expand radially outward to allow the dust cap to be removed from the connector element. The fluid path connector assembly according to claim 27.

29. The fluid path connector assembly according to claim 27 or 28, wherein the inclined member extends around at least a portion of the outer circumference of the distal edge of the dust cap body.

30. The fluid path connector assembly according to any one of claims 27 to 29, wherein the inclined member has a rounded or chamfered edge.

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