The present disclosure generally relates to tamper detection devices, and, more particularly, to tamper-evident closure assemblies for medical devices.
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.
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.
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:
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
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
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
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
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
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
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
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
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
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
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
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.
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.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2018/054067 | 10/3/2018 | WO | 00 |
Number | Date | Country | |
---|---|---|---|
62568917 | Oct 2017 | US |