Patent Publication Number: US-2020282155-A1

Title: Tamper-evident closure assembly

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent App. No. 62/568,917, filed Oct. 6, 2017, the disclosure of which is hereby incorporated by reference herein. 
    
    
     TECHNICAL FIELD 
     The present disclosure generally relates to tamper detection devices, and, more particularly, to tamper-evident closure assemblies for medical devices. 
     BACKGROUND 
     Many industrial applications require mechanisms that prevent tampering with a particular product. This is especially the case in the medical profession, where it is important for medical staff and patients to be aware of any tampering to a medical device or substance. Existing technology for detecting and preventing tampering is often cumbersome, difficult to use, increases risks of injury to the user, and increase chance of contamination of the patient or the medical environment. Therefore, there is a need for improved systems and devices for detecting tampering with a device in a safe and efficient manner. 
     SUMMARY 
     Devices and methods for tamper-evident closure assemblies are disclosed. In one embodiment, a tamper-evident closure assembly for use with a medical device includes a connector, a cap, and a locking mechanism. The connector has a receptacle defined by an outer surface of the connector. The receptacle has a depression and a wall adjacent the depression. The cap is configured to attach to the connector and to rotate around the connector. The locking mechanism is disposed on the cap and has a locked configuration and an unlocked configuration. The locking mechanism includes a tab movable between the locked configuration and the unlocked configuration and a plug disposed on the tab. When the locking mechanism is in the unlocked configuration, the plug is disposed outside of the receptacle on the connector, and when the locking mechanism is in the locked configuration, the plug is disposed at least partly within the receptacle, such that the cap is prevented from rotating around the connector. 
     In another embodiment, a system for medicinal delivery includes a medical device configured to receive a medicinal substance and a tamper-evident closure assembly. The closure assembly includes a connector, a cap, and a locking mechanism. The connector has a retaining mechanism configured to releasably affix the connector to the medical device and a receptacle defined by an outer surface of the connector. The receptacle has a depression and a wall adjacent the depression. The cap is configured to attach to the connector and to rotate around the connector. The locking mechanism is disposed on the cap and has a locked configuration and an unlocked configuration. The locking mechanism includes a tab movable between the locked configuration and the unlocked configuration and a plug disposed on the tab. When the locking mechanism is in the unlocked configuration, the plug is disposed outside of the receptacle on the connector, and when the locking mechanism is in the locked configuration, the plug is disposed at least partly within the receptacle, such that the cap is prevented from rotating around the connector. 
     In yet another embodiment, a method of removing a tamper-evident closure assembly from a medical device includes the steps of moving the closure assembly from an unlocked configuration to a locked configuration and rotating the closure assembly in the locked configuration until the closure assembly is disconnected from the medical device. The closure assembly includes a locking mechanism having a plug and a connector defining a receptacle thereon. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present application is further understood when read in conjunction with the appended drawings. For the purpose of illustrating the subject matter, there are shown in the drawings exemplary embodiments of the subject matter; however, the presently disclosed subject matter is not limited to the specific methods, devices, and systems disclosed. In the drawings: 
         FIG. 1  illustrates an isometric view of a closure assembly in accordance with an embodiment; 
         FIG. 2  illustrates a front perspective view of a connector in accordance with an embodiment; 
         FIG. 3  illustrates a cross-sectional view of the closure assembly shown in  FIG. 1  in an unlocked configuration; 
         FIG. 4  illustrates a cross-sectional view of the closure assembly shown in  FIGS. 1 and 3  in a locked configuration; 
         FIG. 5  illustrates an isometric view of a portion of a locking mechanism according to an embodiment; 
         FIG. 6  illustrates an isometric view of a portion of a locking mechanism according to another embodiment; 
         FIG. 7  illustrates an isometric view of a closure assembly in an unlocked configuration according to another embodiment; 
         FIG. 8  illustrates an isometric view of the closure assembly shown in  FIG. 7  in a locked configuration; 
         FIG. 9  illustrates a cross-sectional view of the closure assembly shown in  FIG. 7 ; 
         FIG. 10  illustrates a cross-sectional view of the closure assembly shown in  FIG. 8 ; and 
         FIG. 11  illustrates an isometric view of a system with a closure assembly according to an embodiment. 
     
    
    
     DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS 
     Systems and methods are disclosed for providing tamper-evident closure assemblies for medical devices. The closure assembly includes a connector with which the assembly connects to a medical device and a tamper-evidence mechanism that informs the user of tampering. Once tampering has been identified, the user may take appropriate steps to remedy the problem. 
     Referring to  FIGS. 1-4 , a closure assembly  100  includes a connector  104 , a cap  130 , and a locking mechanism  150 . As shown in the illustrative embodiment of  FIG. 2 , the connector  104  may be substantially cylindrical. However, it will be appreciated that the connector  104  may alternatively comprise a different shape, for example, prismatic, and that the present disclosure is not limited to the shape of the connector  104 . The connector  104  may include a retaining mechanism  120  disposed thereon and configured to fixedly attach the connector  104  to a separate component, for example a medical device. The retaining mechanism  120  may be a friction fit connector, a threaded connector, or another suitable connector. In some embodiments, the connector  104  may be configured to attach to standardized medical connectors, for example, Luer lock interfaces. 
     A receptacle  108  is disposed on the connector  104  and is defined by the outer surface  128  of the connector  104 . The receptacle  108  is further defined by a depression  116  and at least one wall  112  that extends from the depression  116  toward the outer surface  128 . The receptacle  108  may be defined by multiple walls  112  extending from the depression  116 . In some embodiments, the connector  104  includes multiple receptacles  108 , for example, 2, 3, 4, or another suitable number of receptacles. 
     The cap  130  is attached to the connector  104  and is configured to rotate around the centerline of the connector  104  depicted by axis A. It will be understood that the cap  130  may attach to the connector  104  in a variety of ways, for example, via a snap-fitting, and this disclosure is not limited to any specific connection interface between the cap  130  and the connector  104 . In some embodiments, the cap  130  may freely rotate around the connector  104  between 0 and 360 degrees, inclusive. In alternative embodiments, the range of rotation may be limited, for example between 0 and 45 degrees, between 0 and 90 degrees, between 0 and 180 degrees, and between 0 and 360 non-inclusive. In some embodiments, the cap  130  may be larger than the connector  104  such that the cap  130  covers the connector  104 . Referring to the illustrative embodiment of  FIGS. 1-4 , the cap  130  encloses the entirety of the connector  104  within itself. In further embodiments, the cap  130  may also enclose at least a portion of a medical device connected to the connector  104  with the retaining mechanism  120 . By covering the connection portion of the connector  104 , the cap  130  may prevent undesirable access to the retaining mechanism  120 . In some embodiments, it may be advantageous to have the cap  130  encompass the connector  104  and the retaining mechanism  120  to prevent tampering with the connector  104  or any components attached to thereto. 
     The closure assembly  100  further includes a locking mechanism  150  configured to engage with the cap  130 , the connector  104 , or both. Referring again to  FIGS. 1-4 , the locking mechanism  150  is disposed on the cap  130  and radially surrounds at least a portion of the cap  130 . The locking mechanism  150  can be actuated to lock the rotation of the cap  130  around the connector  104 . In an unlocked configuration, the locking mechanism  150  does not obstruct rotation of the cap  130 , permitting the cap  130  to rotate around the connector  104  up to its full range of rotation. In a locked configuration, the locking mechanism  150  impedes the full range of rotation of the cap  130 . In some embodiments, the locked configuration may permit the cap  130  to rotate at a decreased range of rotation that is smaller than the range of rotation when the device is in the unlocked configuration. In another embodiment, when the locking mechanism  150  is in the locked configuration, the cap  130  is substantially prevented from rotating at all. 
     A tab  154  may communicate with the cap  130  and/or the connector  104  to decrease the range of rotation or to completely prevent rotation of the cap  130 . The tab  154  may transition between the unlocked configuration where the cap  130  can rotate and the locked configuration where the rotation is limited. Referring to  FIGS. 3-4 , a plug  158  may be disposed on the tab  154  to interact with the cap  130  and/or the connector  104 . The closure assembly  100  may include a plurality of plugs  158 , for example 2, 3, 4, or another suitable number. In the illustrative embodiment of  FIGS. 1-11 , the closure assembly  100  includes two plugs  158 . 
     In some embodiments, when the tab  154  transitions from the unlocked configuration to the locked configuration, the plug  158  engages with a corresponding component of the closure assembly  100 . The plug  158  may be dimensioned such that it can pass into the receptacle  108  of the connector  104 . As shown in  FIG. 3 , when the locking mechanism  150  is in the unlocked configuration, the plug  158  is outside the receptacle  108 . Referring now to  FIG. 4 , showing the locking mechanism  150  in the locked configuration, the plug  158  is disposed at least partially within the receptacle  108 . 
     In the locked configuration, the interaction of the plug  158  within the receptacle  108  obstructs rotation of the one or more components. As rotational force is applied to the locking mechanism  150 , the cap  130 , and/or the connector  104 , the plug  158  may contact the wall  112 . This contact prevents continued relative rotation between the cap  130  and the connector  104 . In some embodiments, the cap  130  may be configured to rotate in multiple directions, for example, clockwise and counterclockwise around the axis A. In such embodiments, the receptacle  108  may include two walls  112  such that, in the locked configuration, the plug  158  may be disposed within the receptacle  108  between the two walls  112 . Thus, as rotational force is applied between the cap  130  and the connector  104  in the clockwise direction, the plug  158  contacts one of the two walls  112 ; conversely, if rotational force is applied in the counterclockwise direction, the plug  158  contacts the other of the two walls  112 . Each wall  112  prevents the plug  158  from moving radially out of the receptacle  108 . The plug  158 , being fixedly connected to the tab  154 , thus prevents radial rotation of the locking mechanism  150  around the connector  104 . 
     The plug  158  may have a plug body  164  and a plug head  166 . The plug body  164  may be substantially cylindrical, or it may have another suitable shape. In some embodiments, the plug head  166  may be wider than the plug body  164 . The plug head  166  may be tapered such that the plug head  166  is widest adjacent the plug body  164  and is most narrow at the point farthest away from the plug body  164 . Various plug shapes may be used. Referring to  FIGS. 5 and 6 , two exemplary embodiments of plugs  158  are depicted. Plug  158   a  shows a plug body  164  that is narrower than the plug head  166 . As shown in  FIG. 5 , the plug head  166  may taper to a flat distal end at the farthest point from the plug body  164 . In an alternative embodiment illustrated in  FIG. 6 , plug  158   b  may have a plug head  166  that tapers to an angled distal end instead. It will be understood that the plug  158  may have different dimensions, and that this disclosure is not limited to the specific embodiments illustrated in the figures. In some embodiments, the wall  112  may be beveled or sloped in the direction of the depression  116 . Thus, wherever the plug  158  contacts the wall  112 , the plug  158  may slide along the beveled wall  112  into the receptacle  108 . The beveled wall  112  may serve as a guide for the plug  158  to direct it into the receptacle  108 . 
     In some embodiments, the cap  130  may further define an opening  138  extending therethrough. The opening  138  may be adjacent the plug  158 . When the locking mechanism  150  moves from the unlocked configuration to the locked configuration, the plug  158  may pass through the opening  138 . The opening  138  may be dimensioned such that a plug  158  can pass through it in a first direction toward the connector  104  but not in a second direction opposite the first direction. In some embodiments, the plug  158 , having the plug head  166  larger than the plug body  164 , may be forced through the opening  138  until a portion of the plug  158  passes through. The plug head  166  may be configured to flex upon contacting the portion of the cap  130  that defines the opening  138 , such that the plug head  166  temporarily decreases in size in order to pass through the opening  138 . Once the plug head  166  passes through the opening  138 , it reverts to its original size. In some embodiments, the plug head  166  is dimensioned with a one-way taper towards the distal end of the plug head  166  that is farthest from the plug body  164 . In such embodiments, the plug head  166  may pass through the opening  138  only in one direction towards the connector  104  but is then prevented from passing back through the opening  138  in the opposite direction. This ensures that once the locking mechanism is in the locked configuration and the plug  158  is in the receptacle  108 , the plug  158  cannot leave the receptacle  108 , and the locking mechanism cannot revert to the unlocked configuration without application of excessive force and/or risking damage to one or more components of the closure assembly  100 . 
     The locking mechanism  150  may further include an actuator  162  that is used to toggle the locking mechanism  150  from the unlocked configuration to the locked configuration. As shown in the illustrative embodiment of  FIG. 1 , the actuator  162  may be a button. To transition from the unlocked configuration to the locked configuration, a user may apply suitable force to the button in the direction toward the center of the closure assembly  100  (e.g., toward the connector  104 ). In some embodiments, the suitable force may be a threshold force required to move the plug  158  through the opening  138 . Although depicted as a button, it will be understood that the actuator  162  may comprise another structure, for example, a handle, a knob, a switch, or another suitable component that is configured to move the locking mechanism  150  from an unlocked to a locked configuration. In some embodiments, as illustrated in  FIGS. 7 and 8 , the actuator  162  may be a ridge disposed on the tab  154 . In further embodiments, the tab  154  may itself serve as the actuator  162  without an additional structural component. 
     In some embodiments, the transition from the unlocked configuration to the locked configuration may be designed such that it is irreversible. Once a closure assembly  100  is in the locked configuration, this may be indicative of prior tampering or attempted tampering with the assembly or with a connected component or device. In such embodiments, it may be advantageous to prevent transition from the locked configuration back to the unlocked configuration, as this would result in uncertainty of the existence of previous tampering. 
     When the locking mechanism  150  is in the locked configuration, it may be further advantageous to notify the user of the transition. In some embodiments, the closure assembly  100  may include an indicator  142  that provides a signal to the user that the assembly is in the locked configuration. When used in the medical field, for example, this signal may alert the user to previous tampering of the closure assembly  100  and/or the medical device associated with it. 
     Referring to  FIGS. 7-10 , the indicator  142  may include a protrusion configured to extend from the cap  130 . When the locking mechanism  150  is in the unlocked configuration, the indicator  142  is not plainly visible to the user. But, when the locking mechanism  150  is moved into the locked configuration, the indicator  142  becomes visible to notify the user of the transition. In some embodiments, the locking mechanism  150  may include an indicator channel  146  that is dimensioned to receive the indicator  142 . As shown in  FIG. 7 , when the locking mechanism  150  is in the unlocked configuration, the indicator channel  146  is empty and does not house the indicator  142 . Referring now to  FIG. 8 , when the locking mechanism  150  is in the locked configuration, the indicator  142  is disposed at least partly within the indicator channel  146 , such that it is plainly visible to the user external the closure assembly  100 . 
     The closure assembly  100  may be used with various devices, for example medical devices. Suitable medical devices may include, but are not limited to, syringes, bottles, tubes, or other medical devices that may benefit from a closure assembly that indicates prior tampering with the assembly or the medical device. Referring to the illustrative embodiment of  FIG. 11 , the closure assembly  100  is fixedly attached to a syringe  10 . 
     The closure assembly  100  may be manufactured, sold, and distributed as a stand-alone component that can be adapted to a desired use or device. Alternatively, the closure assembly  100  may be manufactured, sold, and distributed affixed to a desired device and intended for a specific use. Referring again to  FIG. 11 , the exemplary system  200  includes the closure assembly  100  fixedly attached to a syringe  10 . The syringe  10  may be prefilled with a desired medicinal substance before distribution. 
     It will be understood that the closure assembly  100  may be attached to a desired device in a variety of ways, and this disclosure is not limited to a particular method of connecting the closure assembly  100  to a device. Referring once more to  FIGS. 1-4 , the cap  130  may be designed to communicate with the connector  104  in such a manner that the cap  130  and the connector  104  are rotated to engage the retaining mechanism  120  with a corresponding connector on the device. The connector  104  may include a ramp  124  that is configured to contact a corresponding ramp  134  on the cap  130 . When the cap  130  is rotated in a first direction (e.g., clockwise around the axis A), the ramp  134  disposed on the cap  130  also moves and forcibly contacts the ramp  124 . As force is exerted on the ramp  124  that is fixedly disposed on the connector  104 , the connector  104  also rotates in the same first direction (e.g., clockwise), and the retaining mechanism  120  engages with the device. When the cap  130  is rotated in a second direction opposite the first direction (e.g., counterclockwise around the axis A), the ramp  134  contacts the ramp  124  and slides along it, such that even when the cap  130  rotates, the rotational force transferred to the ramp  124  is insufficient to rotate the connector  104 . 
     In some embodiments, the cap  130  may have a first position relative to the connector  104  and a second position that is axially displaced from the first position. In the first position, the ramp  134  is at least partially located in the same plane as the ramp  124  such that the two ramps can contact each other upon rotation of the cap  130 . In the second position, the cap  130  is axially displaced a sufficient distance such that the plane in which the ramp  134  lies no longer overlaps the plane of the ramp  124 . When the cap  130  is in the second position, neither rotation in the first direction nor rotation in the second direction results in contact between the ramps  124 ,  134 . 
     When the closure assembly  100  is in the locked configuration, rotation of the cap  130  around the connector  104  is limited or prevented. This allows the entire closure assembly  100  to be removed from the device. As the cap  130 , the locking mechanism  150 , and the connector  104  are “locked” together such that there is limited or no relative movement between the components, the closure assembly  100  may be twisted in a removing direction (e.g., counterclockwise) to disengage the retaining mechanism  120  of the connector  104  from the device or component to which it is connected. The closure assembly  100  can then be discarded. 
     The embodiments disclosed herein offer a number of advantages. The closure assembly  100  allows a user to quickly and accurately detect any tampering of the assembly or the device to which it is connected. In the medical field, this decreases the risk of inadvertently administering an incorrect medicinal substance to a patient. Furthermore, once the user moves the closure assembly  100  into the locked configuration, in some embodiments it cannot be moved back to the unlocked configuration. This serves to alert another user at a later time that the medical device with the locked closure assembly has already been used, thus decreasing risk of infection from reusing certain medical devices, for example, syringes. 
     The present disclosure offers various advantages over existing anti-tamper technology. Many current options require removal of a portion of the device to indicate tampering. For example, some existing assemblies require breaching or breaking a ring surrounding the assembly. This approach results in extraneous pieces of the assembly that need to be removed. In a medical scenario, loose pieces may not be desirable because they may cause contamination of tools and/or infection in the patient. Additionally, breaking or removing a portion of the assembly exposes sharp edges, the locations and angles of which are often difficult to predict. This may result in direct injury to the user and/or the patient, or in indirect risk of contamination or infection due to ripped gloves or the loose edges catching on tools or materials. 
     Furthermore, existing technology often requires application of greater force by the user. Some people, especially the young, the elderly, or those suffering from debilitating diseases, may not have the strength to operate these assemblies. The presently disclosed closure assembly is more ergonomic and requires less effort to toggle between the unlocked and the locked configuration. Moreover, the disclosed ergonomic assembly avoids excessive force and direct contact with dangerous portions of medical devices. Existing technology often requires direct access to the connecting interfaces of the devices, which may expose users to greater risk of injury, for example, contacting sharp edges, needles, or dangerous substances within the device. 
     While systems and methods have been described in connection with the various embodiments of the various figures, it will be appreciated by those skilled in the art that changes could be made to the embodiments without departing from the broad inventive concept thereof. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, and it is intended to cover modifications within the spirit and scope of the present disclosure as defined by the claims.