Tamper-evident closure

Abstract

The tamper-evident closure (100) of the present disclosure surrounds a medical access device, such as a vascular access device (200), in a manner that makes it visibly apparent if the medical access device contained within the tamper-evident closure is exposed. The tamper-evident closure cannot be reapplied to the medical access device so that it appears the same as it did prior to the exposure of the medical access device. The tamper-evident closure includes a retention cavity (110), a locking mechanism (160), and an obvious release. The disclosed tamper-evident closure is well suited for securing medical access devices having access points for delivering or removing fluids to or from a patient.

Description

Technical Field

[0001] The present disclosure relates to tamper-evident closures. In particular, the present disclosure relates to tamper-evident closures for medical access devices such as access points for intravenous drips.

Background Art

[0002] Patients receiving medical treatment generally wear medical access devices, such as vascular access devices, that are inserted to assist medical providers in delivering medications to the patient. Some medical access devices are for removing fluids from the patient, such as urinary catheters or surgical drain lines. When a person is under the care of a medical provider, it is important to control the medications delivered to the patient. Patients with mental illnesses, patients with intellectual disabilities, pediatric patients, or intravenous drug users may illicitly open the access point for an intravenous drip or intentionally deliver drugs or medications to a vascular access device. The entry of an unprescribed drug into a vascular access device can cause medical problems, drug interactions, and bloodstream infections.

Summary of the Invention

[0003] The disclosed tamper-evident closure surrounds a medical access device. When the medical access device housed within the tamper-evident closure is accessed, it becomes visibly apparent that the tamper-evident closure has been altered. The tamper-evident closure cannot be reapplied to the medical access device so as to appear the same as it did prior to exposing the medical access device.

[0004] In some embodiments, depending on the choice of material used, the tamper-evident closure also functions as a tamper-proof closure. A tamper-proof closure without a release mechanism prevents access to medical access devices and prevents them from being exposed.

[0005] Various tamper-evident closures are disclosed. The tamper-evident closures include a retaining cavity, a fixation mechanism, and an apparent release. The disclosed tamper-evident closures are particularly well suited for fixing medical access devices having access points for delivering fluid to or removing fluid from a patient. [Brief explanation of the drawing]

[0006] [Figure 1A] This is a perspective view of the front side of one embodiment of a tamper-evident closure, showing that the outer cover is open and the housed vascular access device is exposed.

[0007] [Figure 1B] Figure 1A is a perspective view of the rear of the tamper-evident closure.

[0008] [Figure 1C] Figure 1A is a perspective view of the tamper-evident closure, showing that the outer cover is closed and the vascular access device is housed within it.

[0009] [Figure 2A] A perspective view of another embodiment of a tamper-evident closure for a vascular access device, showing the slide cover retracted and the housed vascular access device exposed.

[0010] [Figure 2B] Figure 2A is a perspective view of the tamper-evident closure, showing the slide cover closed and the vascular access device housed within it.

[0011] [Figure 3A] This is a perspective view of another embodiment of a tamper-evident closure, which includes a two-part locking device in the open position.

[0012] [Figure 3B] Figure 3A is a perspective view of the tamper-evident closure with the two-part locking device locked in the closed position, housing the vascular access device.

[0013] [Figure 3C] A perspective view of another embodiment of a tamper-evident closure having a sliding door covering an access point.

[0014] [Figure 3D] Figure 3C is a perspective view of the tamper evident closure in the closed position with the sliding door open, providing an opening to the access point.

[0015] [Figure 4] A perspective view of another embodiment of a tamper-evident closure with a removable door.

[0016] [Figure 5A] A perspective view of another embodiment of a tamper-evident closure comprising a rotatably connected device of two parts, with a vascular access device located within the first part.

[0017] [Figure 5B] Figure 5A is a perspective view of the tamper-evident closure, rotated to the closed position, with a security sticker affixed to the aligned area of ​​the rotatably connected two-part device.

[0018] [Figure 6] This is a perspective view of another embodiment of a tamper-evident closure, which includes a bag having a fastening mechanism that tightens the opening of the bag to irreversibly close.

[0019] [Figure 7A] Perspective view of another embodiment of a tamper-evident closure comprising a shape-conforming adhesive film having a set of perforations.

[0020] [Figure 7B] Perspective view of the tamper-evident closure of FIG. 8A in a state where a vascular access device is within the folded film and the vascular access device is irreversibly accommodated.

[0021] [Figure 8A] Perspective view of another embodiment of a tamper-evident closure comprising an envelope open to receive a vascular access device.

[0022] [Figure 8B] Perspective view of the tamper-evident closure of FIG. 8A in a closed state accommodating a vascular access device.

[0023] [Figure 9] Perspective view of another embodiment of a tamper-evident closure comprising an envelope open to receive a vascular access device.

[0024] [Figure 10] Perspective view of another embodiment of a tamper-evident closure comprising an envelope open to receive a vascular access device.

[0025] [Figure 11] Perspective view of another embodiment of a tamper-evident closure comprising an envelope open to receive a vascular access device.

[0026] [Figure 12A] Perspective view of another embodiment of a tamper-evident closure comprising a base and a strap.

[0027] [Figure 12B] Figure 12A is a perspective view of the tamper-evident closure with the vascular access device connected to the base of the tamper-evident closure.

[0028] [Figure 12C] Figure 12B is a perspective view of the tamper-evident closure in which the straps forming the fixation mechanism are tightened, irreversibly housing the vascular access device.

[0029] [Figure 13] A perspective view of another embodiment of a tamper-evident closure comprising a base and a strap.

[0030] [Figure 14] A perspective view of another embodiment of a tamper-evident closure comprising a base and a strap.

[0031] [Figure 15] A perspective view of another embodiment of a tamper-evident closure comprising a base and a strap.

[0032] The drawings and figures above illustrate embodiments of the present invention, but other embodiments are also conceivable, as described in the description. In all cases, this disclosure presents the invention by providing representative examples rather than limitations. Numerous other modifications and embodiments that fall within the scope and spirit of the present invention can be conceived by those skilled in the art. The drawings may not be drawn to scale. [Modes for carrying out the invention]

[0033] Various designs of tamper-evident closures are disclosed. Disclosed tamper-evident closure 100 comprises a retaining cavity 110 and a fixing mechanism 160, thereby visually indicating that the retaining cavity 110 is open or the fixing mechanism 160 is released in the event of tampering with or removal of the fixing mechanism. The tamper-evident closures of this disclosure are well suited for securing a medical access device 200 having an access point 210 for delivering fluid to a patient, removing fluid from a patient, or connecting to another device through a tube 220. In some embodiments, a cap 230 containing a disinfectant, such as 3M® Curos® Disinfecting Cap, is fixed onto the access point 210.

[0034] The retaining cavity 110 typically has a peripheral portion 111 that surrounds at least a portion of the central region 112, which has access points 113 within the central region 112. Typically, a tamper-evident closure 100 can be opened to accommodate all access devices 200 within the retaining cavity 110 and closed to secure the access devices 200 within the retaining cavity 110. A fixing mechanism 160 holds the tamper-evident closure 100 in a closed position. Various designs of the retaining cavity 110 and the fixing mechanism 160 are contemplated and disclosed herein.

[0035] The retaining cavity 110 of the tamper-evident closure 100 includes a medical access device 200. The medical access device 200 may be any site in a catheter or intravenous tubing capable of administering a drug and / or removing a fluid. The medical access device 200 may be a vascular access device that is a connection to the patient's vascular system for administering a drug or removing blood. The medical access device 200 may be any site in an intravenous tubing, catheter, tube, or other medical device. This may be any site in a catheter, intravenous tubing, or other topical or percutaneous medical device. This may be a Luer-activated device ("LAD") on site y, an LAD at the end of a line, a male / female connector in the middle of a line, or any other connector used in a topical or percutaneous medical device. The Luer-activated device may be capped or uncapped.

[0036] When the retaining cavity 110 is closed by the fixing mechanism 160, the fluid access point 210 for the medical access device 200 is inaccessible. The fluid access point of the medical access device 200 (covered by the cap 230) becomes accessible only when an obvious release occurs, but when an obvious release occurs, it is clearly evident that the tamper-evident closure 100 has been opened.

[0037] In some embodiments as shown in the figures, the fluid access point includes a cap 230 for covering the fluid access point before use. The cap 230 may contain a disinfectant to keep the fluid access point 210 clean until use. Exemplary caps 230 are described in U.S. Patents No. 7,282,186, 7,780,794, 9,907,617, and 9,259,284, the disclosures of which are incorporated herein by reference. Exemplary caps 230 are available from 3M Company and marketed as 3M® CUROS® Disinfecting Caps for Needleless Connectors.

[0038] In some embodiments, tamper-evident closures, tamper-resistant closures, or even tamper-proof closures can be fabricated using materials that have high resistance to breakage by cutting or impact, such as plastics, films, metals, or ceramics.

[0039] In the embodiments shown in Figures 1 to 15, the medical access device 200 is a vascular access device. It is understood that other medical access devices may be used in the tamper-evident closure 100.

[0040] Figure 1A is a perspective view of the front side of one embodiment of the tamper-evident closure 100 in the open position, exposing the vascular access device 200 that is housed inside. Figure 1B is a rear perspective view of the tamper-evident closure 100 of Figure 1A. Figure 1C is a perspective view of the tamper-evident closure 100 of Figure 1A in the closed position, housing the vascular access device 200 inside.

[0041] In this embodiment, the retaining cavity 110 of the tamper-evident closure 100 is a box 120 comprising a first part 125 and a second part 126 connected at a pivot 126, thereby allowing the first part 125 to move relative to the second part 126, opening the tamper-evident closure 100 and exposing the retaining cavity 110. The tamper-evident closure 100 has an access point 113 that allows the vascular access device tube 220 to exit the retaining cavity 110 while the vascular access device 200 is housed within the retaining cavity 110. The access point 113 can be slightly narrower than a standard flexible tube 220 to hold the tube 220 in place, thereby keeping the vascular access device 200 firmly in place while the first part 125 pivots relative to the second part 126. In this embodiment, the access point 113 is present in both the first component 125 and the second component 126, so that when fixed together, the user can access the tube 220 with one hand while firmly holding the vascular access device.

[0042] As can be seen in Figure 1B, the first component 125 has a through hole 161 and the second component 126 has a through hole 162, so that the through holes can be aligned to form a continuous channel. A fastening mechanism 160, such as a one-way tie-down, passes through the continuous channel and prevents the first component 125 from moving relative to the second component 126, keeping the retaining cavity 110 closed. The retaining cavity 110 is exposed when either the entire tamper-evident closure 100 is destroyed or the fastening mechanism 160 is damaged. In either case, unauthorized opening would be obvious. To destroy the fastening mechanism 160, the line can be destroyed by manual pressure, the device may include a cutting tool, or the healthcare provider may use a cutting tool such as scissors.

[0043] In this embodiment, the first component 125 and the second component 126, as well as the fixing mechanism 160, are made of rigid material, and this can be fabricated as a tamper-resistant or tamper-proof retaining cavity for a vascular access device.

[0044] Figure 2A is a perspective view of another embodiment of the tamper-evident closure 100 for the vascular access device 200, showing the slide cover retracted and the housed vascular access device 200 exposed. Figure 2B is a perspective view of the tamper-evident closure 100 of Figure 2A, showing the closed slide cover 121 and a fixing mechanism 160 for keeping the slide cover closed.

[0045] This embodiment is similar to the embodiments in Figures 1A to 1C, except that the first part 125 and the second part 126, which form the retaining cavity 110, are slidably connected. The second part 126 functions like a door, wrapping around the cylindrical body of the first part 125 and sliding from an open position (Figure 2A) to a closed position (Figure 2B). This allows the door to "wrap around" the first part, enabling the smallest possible retaining cavity 110 in the sliding door 121. The first part 125 is rounded to eliminate any sharp edges in order to improve patient comfort. The first through-hole 161 in the first part 125 and the second through-hole 162 in the second part 126 are aligned to form a continuous channel. In this embodiment, the continuous channel is a narrow passage extending in the longitudinal direction. The fixing mechanism 160 shown in 2B is a through-adhesive tape that passes through a continuous channel to prevent the second component from opening. The retaining cavity 110 is exposed when the entire tamper-evident closure is destroyed or when the fixing mechanism 160 is damaged.

[0046] As shown, the retaining cavity 110 of the tamper-evident enclosure 100 may be of various sizes and may include access points 113 in various positions to accommodate vascular access devices 200 of various configurations. The continuous channel may have various sizes and shapes to accommodate a fixing mechanism 160 connecting from one side of the continuous channel of the first component to the other side of the continuous channel of the second component.

[0047] Figure 3A is a perspective view of another embodiment of the tamper-evident closure, which includes a retaining cavity having a first and a second component. Figure 3B is a perspective view of the tamper-evident closure of Figure 3A in the closed position, locked, and housing a vascular access device.

[0048] In this embodiment, the tamper-evident closure 100 comprises a first component 125 and a second component 126 that are connected to each other and form a retaining cavity 110. The vascular access device 200 is placed within the first component 125, and then, as shown in Figure 3B, the second component 126 is placed on top of the first component 125 and pressed to lock into place with the first component 125. The first component 125 and the second component 126 may be two separate components or may be connected to each other by a hinge. The tamper-evident closure 100 has an access point 113 that allows the vascular access device tube 220 to be brought out of the retaining cavity 110 while the vascular access device 200 is housed within the retaining cavity 110.

[0049] The locking mechanism 160 includes a channel lock fit 164 that extends around at least a portion of the periphery of the tamper-evident closure 100 and connects the first component 125 and the second component 126. The channel lock fit 164 has a fragile line 167 and a tab 168 adjacent to the channel lock fit 164. The channel lock fit 164 includes a longitudinally extending projection 165 on one of the first component 125 or the second component 126, and a longitudinally extending receiving portion 166 on the other of the first component 125 or the second component 126 that engages with the projection 165. In this embodiment, the channel lock fit 164 is a zigzag line, which provides additional strength to the device and can restrict a user from prying the device open with a tool. For example, its short length makes it difficult to push the edge of a tool such as a screwdriver or knife between them and separate them. Additionally, along the fastening mechanism 160, on the side of the fastening mechanism 160 opposite to the channel lockfit 164, there is a weak line 167, which may be a thin or perforated portion connecting the fastening mechanism 160 to the first component 125 or the second component 126. A tab 168 for separating the channel lockfit 164 extends from the fastening mechanism 160.

[0050] For example, in this embodiment, the fixing mechanism 160 is connected to the second component 126 by a weak line 167. On the side of the fixing mechanism 160 opposite to the weak line 167, there is a longitudinally extending projection 165. A longitudinally extending receiving portion 166 is located on the first component 125. The channel lock fit 164 engages the first component 125 with the second component 126, as shown in Figure 3B.

[0051] To remove the locking mechanism 160, pull the tab 168 to break the fragile wire 167. This alone should be sufficient to disengage the locking connection between the first part 125 and the second part 126. The retaining cavity 110 is exposed when the entire tamper-evident closure 110 is destroyed, or when the tab 168 is at least partially removed from the tamper-evident closure 100 and the fragile wire 167 is broken. In either case, the tampering would be obvious.

[0052] Figure 3C is a perspective view of another embodiment of the tamper-evident closure 100 in the open position, showing the internal sliding door 127, and Figure 3D is the tamper-evident closure 100 of Figure 3C in the closed position. The tamper-evident closure 100 is substantially similar to the tamper-evident closures of Figures 3A and 3B. In both Figures 3C and 3D, the internal sliding door 127 is open, exposing the access point 113 to the retaining cavity. The sliding door 127 is located within the first component 125 and can be slidably operated to open or close the access point 113 if the vascular access device has a "Y" line.

[0053] Figure 4 is a perspective view of another embodiment of the tamper-evident closure 100, which includes a removable door 127. The removable door 127 includes a thin section that connects to the first component 125, so that the removable door can be easily removed to open the access point 113 if the vascular access device has a "Y" line.

[0054] In the embodiment shown in Figure 4, front tabs 128 are included. These front tabs 128 are spaced apart from each other and located on each side of the access point 113. In this embodiment, the front tabs 128 are located outside the tamper-evident closure 100 to fit onto the wings of the protruding vascular access device and prevent the vascular access device from rotating. Rotation and unscrewing or disconnecting the device could allow unauthorized opening of the housed vascular access device.

[0055] Sliding doors, removable doors, or front tabs may be used in any number of tamper-evident enclosures of this disclosure.

[0056] Figure 5A is a perspective view of another embodiment of the tamper-evident closure 100, comprising a box 120 having a first part 125 and a second part 126 that are rotatably connected to form a retaining cavity 110. Figure 5B is a perspective view of the tamper-evident closure 100 of Figure 5A, comprising a fixing mechanism 160 with a security sticker 169 for the first part 125 and the second part 126 to rotate to close the retaining cavity 110 and hold the tamper-evident closure 100 in a closed position.

[0057] In this embodiment, the retaining cavity 110 is formed from a first part 125 and a second part 126 that are rotatably connected. As shown in the figure, an access point 113 for the tube 220 extends from the end. When the first part 125 and the second part 126 are rotated as shown in Figure 5A, an opening 129 is formed, as a result allowing the vascular access device 200 to be inserted into the retaining cavity 110. The first part 125 and the second part 126 are then rotated to disconnect the unaligned opening 129 and secure the vascular access device 200 within the retaining cavity 110. Once rotated, the opening of the second part 126 functions as an access point, allowing the tube 220 to exit from the side of the retaining cavity. Once rotated so that the openings are no longer aligned, the security sticker 169 is secured to span the first part 125 and the second part 126, as shown in Figure 5B.

[0058] The security sticker 169 may be formed from permanent adhesive or another security label so that removing the label would permanently damage or destroy the security sticker 169. Also, attempting to rotate the first component 125 relative to the second component 126 to align it with the fully open portion 129 in order to access the vascular access device 200 would destroy or tear the sticker 169. In either case, tampering would be obvious.

[0059] Figure 6 is a perspective view of another embodiment of the tamper-evident closure 100, in which the retaining cavity 110 comprises a bag 130 having an opening 132 and a fixing mechanism 160 that tightens to permanently close the retaining cavity 110.

[0060] In this embodiment, the retaining cavity 110 is formed from a bag 130 having an opening 132. When open, the vascular access device 200 is inserted into the retaining cavity 110 of the bag 130. The bag 130 can advantageously accommodate vascular access devices 200 of a wide range of sizes and shapes and facilitate the passage of the tube 220 through the opening 132. The fastening mechanism 160 fastens and closes the opening 132 of the bag 130. The opening 132 has a series of rivets 133 through which the fastening mechanism 160 passes. Alternatively, a slit or notch in the bag, or a channel in the folded material of the bag, can also hold the fastening mechanism. The fastening mechanism 160 allows the opening to be fastened in one direction, such as a zip tie with a lock receiver as shown. In this embodiment, the cinch mechanism has two strips passing through a one-way locking unit. Furthermore, one end of the fixing mechanism 160 may include a breaking device, cutting end, or tool to assist in destroying the fixing mechanism 160. The retaining cavity 110 is exposed when the bag 130 is broken and opened, or when the fixing mechanism 160 is damaged. In either case, tampering would be obvious.

[0061] If the retaining cavity can be formed from a film as shown in Figure 6, the bag may be constructed from a puncture-resistant material such as Kevlar® film. Then, if a locking mechanism such as a wire with a lock is used, the tamper-evident closure may be tamper-resistant or tamper-proof.

[0062] Figure 7A is a perspective view of another embodiment of the tamper-evident closure 100, which includes a shape-conforming adhesive film that forms a bag 130 when formed around the access device 220. Figure 7B is a perspective view of the tamper-evident closure 100 of Figure 7A with the shape-conforming adhesive film folded in, irreversibly housing the vascular access device 200.

[0063] In this embodiment, the retaining cavity 110 is formed from the film of the bag 130 with the first adhesive surface 141 folded over the second adhesive surface 142. As shown in Figure 7A, the vascular access device 200 is applied to the bag 130, and the bag is then folded around the vascular access device 200 to form a retaining cavity 110 within the bag 130 that surrounds the vascular access device 200. The fixing mechanism 160 is an adhesively fixed, opposing first surface 141 and second surface 142 that seals the bag 130 around the vascular access device 200, as shown in Figure 7B.

[0064] The adhesive must be a permanent adhesive so that the opposing bonding surfaces cannot be separated. In some embodiments, the permanent adhesive is a contact adhesive. Before use, the bonding surfaces can be covered and protected with a removable release liner. The retaining cavity 110 is exposed when the bag 130 is broken open. In some cases, the two bonding surfaces adhere, but a release material may be used so that after separation, one of the adhesives preferentially attracts to the other bonding surface, leaving no adhesive residue on the surface containing the release material. In this case, the two surfaces cannot be fixed together.

[0065] In some embodiments, as shown in Figure 8C, a tear strip 167 is included. In this embodiment, the tear strip 167 is located in the center of the bag 130, which allows the film to be easily applied around the vascular access device 200 without the need to seal all edges. The tear strip 167 also allows the formed bag 130 to be easily opened and the vascular access device 130 to be removed. If it is desired to open the bag 130, the tear strip 167 is removed from the bag 130, exposing the vascular access device 200. The bag 130 cannot then be closed again.

[0066] The adhesive must be a permanent adhesive so that the opposing surfaces cannot be separated. In some embodiments, the permanent adhesive is a contact adhesive, which adheres strongly to itself but typically not to other substrates. Contact adhesives work well to prevent exposed adhesive from sticking to the vascular access device and to prevent the adhesive from transferring to the surface of the vascular access device, causing the device to become sticky and contaminated. Also, healthcare providers often wear gloves, and contact adhesives do not adhere strongly to the worker's gloves but adhere strongly to another surface containing the contact adhesive. An example of a suitable film having a contact adhesive is the 3M® SCOTCH® Flex & Seal Shipping Roll, available from 3M Company. Before use, the adhesive surface can be covered and protected with a removable release liner.

[0067] Figure 8A is a perspective view of another embodiment of the tamper-evident closure 100, which includes a retaining cavity 110 that is an envelope 140. Figure 8B is a perspective view of the tamper-evident closure 100 of Figure 8A, which is closed and houses a vascular access device 200.

[0068] These structures, described as envelopes, are structurally similar to bag structures, but as illustrated, these envelope structures have slightly higher rigidity and greater structural integrity compared to thin-film bag structures. Structurally rigid tamper-evident closures can be formed from plastic by molding, printing, or thermoforming processes. Structurally higher rigid tamper-evident closures have more morphology for receiving access devices in the correct position within the retaining cavity and can be easily closed. Any of these envelope structures can instead be formed from film.

[0069] The envelope 140 includes a first part 125 and a second part 126 connected along a fold 143. As shown in the figure, the access point 113 can be molded to a tamper-evident closure 110 on either the first part 125 or the second part 126 or both, to more easily accommodate the outlet tube 220. The first part 125 has a first bonding surface 141, and the second part 126 has a second bonding surface 142. The access device 200 is inserted into the retaining cavity 110, with the first part 125 hinged toward the second part 126. The first bonding surface 141 contacts the second bonding surface to close the tamper-evident closure 100, as shown in Figure 8B. If the envelope 140 is to be opened, the sealed adhesive surfaces 141 and 142 are removed from the envelope 140 by the tear strip 167 located between the retaining cavity 110 and the sealed adhesive surfaces 141 and 142. The envelope cannot then be closed again, and tampering would be obvious.

[0070] Figure 9 is a perspective view of another embodiment of a tamper-evident closure 100, which includes an envelope 130 that is open to receive a vascular access device 200. This embodiment is substantially similar to the embodiments shown in Figures 8A-8B. However, in this embodiment, the fold 142 between the first part 125 and the second part 126 is a tear strip 167. After the vascular access device 200 is inserted, the tamper-evident closure 100 is then closed in a hinge manner, so that the adhesive surfaces 141, 142 come into contact with each other and seal the tamper-evident closure 100. If it is desired to open the envelope 140, the tear strip 167 is removed, the first part 125 is disconnected from the second part 126, and the vascular access device 200 is exposed. The envelope 140 cannot then be closed again.

[0071] Figure 10 is a perspective view of another embodiment of a tamper-evident closure 100 having a retaining cavity 110 in the form of an envelope 140. This embodiment is similar to the embodiments described in Figures 8A, 8B, and 9, as the tamper-evident closure 100 is formed from a structurally rigid material that forms an envelope 140 for receiving a vascular access device 200. In this embodiment, the tamper-evident closure 100 has a first component 125 having a first bonding surface 141 and a second component 126 having a second surface 142. The second component 126 hinges over the first component 125 to close the retaining cavity 110, thereby bonding and sealing the first surface 141 and the second surface 142. If it is desired to open the envelope 140, the tear strip 167 is adjacent to the retaining cavity 110 so that it can be removed and the vascular access device 200 can be exposed. The envelope 140 cannot then be closed again.

[0072] Figure 11 is a perspective view of another embodiment of a tamper-evident closure 100 having a retaining cavity 110 in the form of an envelope. This embodiment is similar to the embodiments described in Figures 8A, 8B, 9, and 10, as the tamper-evident closure 100 is formed from a structurally rigid material that forms an envelope 140 for receiving a vascular access device. The tamper-evident closure 100 is clamped to open the retaining cavity 110. The retaining cavity 110 has a first part 125 having a first surface 141 and a second part 126 having a second surface 142 that are hinged together and, after the vascular access device is inserted, are bonded together when in contact with each other to close and seal the retaining cavity 110. In this embodiment, a tear strip 167 overlaps with the first part 125 so that, if it is desired to open the envelope, the tear strip can be removed to expose the vascular access device. After that, it is not possible to close envelope 140 again.

[0073] Figure 12a is a perspective view of another embodiment of the tamper-evident closure 100, in which the retaining cavity 110 comprises a base 150 from which a first strap 153 and a second strap 154 ​​extend. Figure 12B is a perspective view of the tamper-evident closure 100 of Figure 12A, in which a vascular access device 200 is connected to the base 150 of the tamper-evident closure 200. Figure 12C is a perspective view of the tamper-evident closure 100 of Figure 12B, in which the straps 153 and 154 are fixed to each other by a fixing mechanism 160 to form the retaining cavity 110.

[0074] In this embodiment, the retaining cavity 110 has a base 150 and a first strap 153 and a second strap 154 ​​opposite to each other, and the vascular access device 200 is positioned adjacent to the base 150 and the straps 153 and 154 opposite to each other. The retaining cavity 110, as shown in Figure 12C, is well suited to engaging with a cap 230 that covers the needleless connector of the vascular access device 200. In this embodiment, the base 150 includes a protruding portion 151 that engages integrally with the cap 230, in particular into a recess of the cap 230. The locking mechanism 160 is a ratchet mechanism that engages with the fitting openings of the first strap 153 and the second strap 154, as best seen in Figure 12C. When the locking mechanism 160 is engaged, the first strap 153 and the second strap 154 ​​tighten around the access device 200. The first strap 153 and the second strap 154 ​​are long enough so that when the fastening mechanism 160 is tightened, the straps 153 and 154 are adjacent to the outwardly extending portion of the access device 200. Therefore, the tamper-evident closure 100 cannot be pulled down to disengage it from the connection with the cap 230. Once the base 150 is engaged and the first strap 153 and the second strap 154 ​​are closed, the vascular access device 200 cannot be accessed unless the fastening mechanism 160 is irreversibly destroyed. A tear strip 167 may be included in one or both straps to assist in intentionally destroying the straps. By pulling the tear strip 167, the straps are destroyed, allowing them to be disengaged without the use of tools.

[0075] Figure 13 is a bottom perspective view of another embodiment of the tamper-evident closure 100, similar to the embodiments in Figures 12A-12C, comprising a base 150 and first straps 153 and second straps 154 on opposite sides. In this embodiment, the base 150 surrounds the disinfectant cap with the straps 153 and 154 fixed to the top of the base 150. Thus, there is more tolerance for vertical movement before the base 150 is completely removed from covering the cap. In this embodiment, the base 150 may be a cap that engages with a needleless connector on a vascular access device. The cap may include an internal retaining mechanism for engaging with the needleless connector. The cap may contain a disinfectant to keep the needleless connector clean and ready for use when the cap is removed. This makes it possible to integrate the disinfection process and the tamper-evident process into a single step.

[0076] Figure 14 is a perspective view of another embodiment of a tamper-evident closure comprising a base 150 and straps 153, 154. This embodiment is substantially similar to the embodiments in Figures 12A-12C. This embodiment is similar to the embodiments described in Figures 9A-9C. However, in this embodiment, the fastening mechanism 160 is a set of protrusions in the second strap 154 ​​and recesses in the first strap 153 that engage with it. Perforations 167 may be included in one or both of the straps 153, 154 to help intentionally break the straps 153, 154 that are fastened together. In this embodiment, a cutting line in one of the protrusions / recesses can be twisted away from the tamper-evident closure 100 to irreversibly open the retaining cavity.

[0077] Figure 15 is a perspective view of another embodiment of the tamper-evident closure 100, which has a base 150 and straps 153, 154 substantially similar to those shown in Figures 12A, 12B, 12C, 13, and 13, but the straps 153, 154 are adhesively connected. The fastening mechanism 160 is the opposing adhesive surfaces on the straps 153, 154, which are sealed together. Because many different connector manufacturers exist, this fastening mechanism allows for a flexible fastening system that compensates for mechanical variations. The adhesive must be a permanent adhesive so that the opposing adhesive surfaces cannot be opened. In some embodiments, the permanent adhesive is a contact adhesive. Before use, the adhesive surfaces can be covered and protected with a removable release liner. Perforations 167 can be included on one or both straps to help intentionally break the straps.

[0078] Tamper-evident closures, such as those disclosed in this application, are designed to be removed without the need for additional removal tools. For example, perforations, destructible fixing straps, twistable or tearable structures or films may be used to facilitate removal of the tamper-evident closure if a healthcare provider wishes to intentionally access a vascular access device. Furthermore, when the tamper-evident closure is intentionally removed, it is desirable that the retaining cavity opens cleanly with only a few separating parts. For example, in the embodiments shown in Figures 12A–15, the base may be twisted off the strap for clean separation.

[0079] In embodiments where a film may be used to form all or part of a tamper-evident closure, an attempt at tampering may be made, resulting in the film itself being torn, ripped, pulled open, or the two joined or closed film surfaces being separated. It may be desirable to include a film that has properties indicating tampering. For example, a film may be able to produce selective tearing in one or more directions. Weak areas, the manufacturing direction of the film, and embossing are all ways in which a film may produce selective tearing. In such cases, when an attempt at tampering is made, the film will produce a clean tear in a certain direction, indicating obvious tampering.

[0080] In another embodiment where the film has properties indicating tampering, the film may undergo a physical change when stress, stretching, or tension is applied. For example, the film may be transparent or translucent, and when stretched in any direction, the film may become opaque. This visually indicates that the film has been tampered with or an attempt has been made to tamper with.

[0081] As described and as will be obvious to those skilled in the art, a rigid structure, a locking mechanism. For example, a healthcare provider would have access to the lock to release the locking mechanism.

[0082] While specific embodiments have been described and illustrated in this specification, it will be understood that these embodiments are merely illustrative of the many specific configurations that may be conceived in application of the principles of the present invention. Those skilled in the art will be able to devise numerous and diverse other configurations in accordance with these principles without departing from the spirit and scope of the present invention. The scope of the present invention should not be limited to the structures described in this application, but only to the structures described in the language of the claims and their equivalents. In addition to the embodiments described above, the following embodiments are also noted. (Note 1) A tamper-evident closure for a medical access device, A first component and a second component that form a retaining cavity, wherein the first component is connected to the second component such that the operation of the first component relative to the second component opens or closes access to the retaining cavity. A fixing mechanism extending from the first component to the second component, maintaining closed access to the retaining cavity, A tamper-evident closure equipped with [a specific feature]. (Note 2) The tamper-evident closure described in Appendix 1, wherein the first component is pivotably connected to the second component. (Note 3) The tamper-evident closure described in Appendix 1, wherein the second component is slidably connected along the periphery of the first component. (Note 4) The tamper-evident closure according to Appendix 1, wherein the first component is rotatably connected to the second component, and an opening for accessing the retaining cavity is formed at a first alignment position of the first component relative to the second component. (Note 5) A tamper-evident closure according to any one of the appendices 1 to 4, wherein the first component comprises a first through hole, the second component comprises a second through hole, and the fixing mechanism maintains closed access to the retaining cavity through the first and second through holes. (Note 6) The fixing mechanism is a sticker extending from the first part to the second part, as described in Appendix 4, which is a tamper-evident closure. (Note 7) A protruding channel extending along a portion of the peripheral part of the first component, A receptive channel extending along a portion of the peripheral part of the second component, (i) a tear strip between the protruding channel and the first component, or (ii) between the receiving channel and the second component, A tab connected to the tear strip, A tamper-evident closure further comprising: The protruding channel engages with the receiving channel in alignment with it. The actuation of the tab disengages the tear strip from the corresponding first or second component. The tamper-evident closure described in Appendix 1. (Note 8) A tamper-evident closure according to any one of the appendices 1 to 7, further comprising an access point to the retaining cavity through the tamper-evident closure. (Note 9) The tamper-evident closure described in Appendix 8 further comprises a removable door to the aforementioned access point. (Note 10) The door is a tamper-evident closure as described in Appendix 9, which can slide to cover or expose the access point. (Note 11) The tamper-evident closure according to any one of the appendices 1 to 10, further comprising front tabs on each side of the access point. (Note 12) A tamper-evident closure for a medical access device, An envelope comprising a retaining cavity and an opening to the retaining cavity, The first surface in the opening, The second surface in the opening, A fixing mechanism comprising an adhesive on at least one of the first surface or the second surface, A tear strip adjacent to the retaining cavity, A tamper-evident closure equipped with [a specific feature]. (Note 13) The tamper-evident closure according to Appendix 12, wherein the first surface and the second surface are provided with an adhesive. (Note 14) The adhesive is a contact adhesive, as described in Appendix 12 or 13, for the tamper-evident closure. (Note 15) The tear strip is located between the retaining cavity and the first surface or the second surface, which is provided with an adhesive, in the tamper-evident closure according to any one of the appendices 12 to 14. (Note 16) The tear strip is a tamper-evident closure as described in any one of appendices 12 to 15, located between the first surface and the second surface. (Note 17) A tamper-evident closure according to any one of the appendices 12 to 16, further comprising an access point on one of the first surface or the second surface. (Note 18) A tamper-evident closure according to any one of the appendices 12 to 17, wherein the first surface is hinged to the second surface. (Note 19) The envelope comprises a film, and is a tamper-evident closure as described in any one of appendices 12 to 18. (Note 20) The tamper-evident closure described in any one of the appendices 12 to 19, wherein the film (i) changes color when stretched, or (ii) selectively binds in one direction. (Note 21) The envelope is a tamper-evident closure as described in any one of the appendices 12 to 18, comprising a rigid or semi-rigid material. (Note 22) A tamper-evident closure for a medical access device, A base that mechanically engages with the aforementioned medical access device, A first strap extending from the base, A second strap extending from the aforementioned base, A fixing mechanism for connecting the first strap and the second strap around the medical access device, A tamper-evident closure equipped with [a specific feature]. (Note 23) The tamper-evident closure according to Appendix 22, wherein the base comprises a projection for entering into a recess on the medical access device. (Note 24) The tamper-evident closure according to Appendix 22, wherein the base comprises a projection extending around the medical access device. (Note 25) The tamper-evident closure according to Appendix 24, wherein the base comprises a disinfectant and a connector for locking onto the medical access device. (Note 26) The tamper-evident closure according to any one of appendices 22 to 25, wherein the fastening mechanism comprises a cinch strap on the first strap that engages with an opening on the second strap to lock the first strap to the second strap. (Note 27) The tamper-evident closure according to any one of appendices 22 to 25, wherein the fixing mechanism comprises a projection on the first strap that engages with a recess on the second strap for locking the first strap to the second strap. (Note 28) The fixing mechanism is a tamper-evident closure as described in Appendix 22, wherein the first strap has an adhesive on it for locking the first strap to the second strap. (Note 29) The tamper-evident closure according to any one of the appendices 22 to 28, further comprising a tear strip for removing the first strap from the base.

Claims

1. A tamper-evident closure for a medical access device, A first component and a second component that form a retaining cavity, A protruding channel extending along a portion of the peripheral part of the first component, A receptive channel extending along a portion of the peripheral part of the second component, (i) a tear strip connecting the protruding channel and the first component, or (ii) the receiving channel and the second component, Equipped with, The protruding channel engages with the receiving channel in alignment with it. The tear strip is disengaged from one of the first or second parts. The aforementioned protruding channel includes multiple teeth, The receiving channel defines a plurality of cavities configured to receive the plurality of teeth, A tamper-evident closure in which the engagement between the protruding channel and the receiving channel forms a zigzag, linear channel lockfit.

2. A tamper-evident closure for a medical access device, A first component and a second component that form a retaining cavity, A protruding channel extending along a portion of the peripheral part of the first component, A receptive channel extending along a portion of the peripheral part of the second component, A tear strip connecting the protruding channel and the first component, Equipped with, The protruding channel engages with the receiving channel in alignment with it. The tear strip is disengaged from the first component. The aforementioned protruding channel includes multiple teeth, The receiving channel defines a plurality of cavities configured to receive the plurality of teeth, The engagement between the protruding channel and the receiving channel forms a zigzag, linear channel lock fit. A tamper-evident closure wherein the tear strip is located between the protruding channel and the first component, and removal of the tear strip disengages the tear strip from the first component and disengages the protruding channel from the receiving channel.

3. Further comprising a tab connected to the tear strip, The tamper-evident closure according to claim 1, wherein the operation of the tab disengages the tear strip from the first or second component.

4. Further comprising an access point to the retaining cavity through the tamper-evident closure, The tamper-evident closure according to claim 1, wherein the medical access device comprises a fluid delivery tube passing through the access point.

5. The tamper-evident closure according to claim 4, further comprising a door covering the access point, the door having (i) a vulnerable area for connecting the door to the first component, or (ii) slidably connected to the first component to cover or expose the access point.

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