Tamper-evident closures

Abstract

The disclosed tamper-evident closure (100) encloses a medical access device, such as a vascular access device (200), such that if the medical access device contained in the tamper-evident closure is exposed, it will be apparent. The tamper-evident closure cannot be reapplied to the medical access device in a manner that appears the same as before the medical access device was exposed. The tamper-evident closure includes a retaining cavity (110), a securing mechanism (160), and an apparent peeling device. The disclosed tamper-evident closure is well suited for securing a medical access device having an access point for delivering fluid to or removing fluid from a patient.

Description

Technical Field

[0001] The present disclosure relates to a tamper-evident closure. In particular, the present disclosure relates to a tamper-evident closure for a medical access device such as an intravenous access point. Background Art

[0002] Patients receiving medical care often have a medical access device, such as a vascular access device, inserted to help the healthcare provider deliver medication to the patient. Some medical access devices are used to allow fluids to be removed from the patient, such as a urinary catheter or surgical drain. When a person is under the care of a healthcare provider, it is important to control the medication delivered to the patient. Psychiatric patients, mentally retarded patients, pediatric patients, or intravenous drug users may tamper with intravenous access points or intentionally deliver drugs or medications to a vascular access device. Over-the-counter medications that go into a vascular access device can cause medical problems, drug interactions, and bloodstream infections. Summary of the invention

[0003] The disclosed tamper-evident closure encloses a medical access device. If the medical access device contained in the tamper-evident closure is accessed, it is apparent that the tamper-evident closure has been modified. The tamper-evident closure cannot be reapplied to the medical access device in a manner that appears the same as it did before the medical access device was exposed.

[0004] In some embodiments, the tamper-evident closure also serves as a tamper-evident closure, depending on the choice of materials used.Without a peel mechanism, using a tamper-evident closure, the medical access device is inaccessible and cannot be exposed.

[0005] Various tamper-evident closures are disclosed. The tamper-evident closures include a retaining cavity, a securing mechanism, and an apparent peeling device. The disclosed tamper-evident closures are well suited for securing a medical access device having an access point for delivering fluids to or removing fluids from a patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1a is a perspective view of one embodiment of the front side of a tamper-evident closure showing an outer cover opened to expose a contained vascular access device;

[0007] FIG. 1 b is a perspective view of the rear side of the tamper-evident closure of FIG. 1 a ;

[0008] FIG. 1c is a perspective view of the tamper-evident closure of FIG. 1a showing the outer cover closed to contain a vascular access device;

[0009] FIG2 a is a perspective view of another embodiment of a tamper-evident closure for a vascular access device showing the slide cover retracted, thereby exposing the contained vascular access device;

[0010] FIG2 b is a perspective view of the tamper-evident closure of FIG2 a showing the slide closed to contain a vascular access device;

[0011] FIG3a is a perspective view of another embodiment of a tamper-evident closure including a two-piece locking device in an open position;

[0012] FIG3 b is a perspective view of the tamper-evident closure of FIG3 a with the two-piece locking device locked in a closed position and containing a vascular access device;

[0013] FIG3c is a perspective view of another embodiment of a tamper-evident closure for a sliding door having a covering access point;

[0014] FIG3d is a perspective view of the tamper-evident closure of FIG3c in a closed position with the sliding door open to provide an opening to the access point;

[0015] Figure 4 is a perspective view of another embodiment of a tamper-evident closure including a removable door;

[0016] FIG5a is a perspective view of another embodiment of a tamper-evident closure comprising a two-piece rotatably connected device having a vascular access device in a first component;

[0017] FIG5b is a perspective view of the tamper-evident closure of FIG5a rotated into a closed position and a security label applied to an aligned area of ​​the two-piece rotatably connected device;

[0018] Figure 6 is a perspective view of another embodiment of a tamper-evident closure including a bag with a securing mechanism that is tightened to irreversibly close the opening of the bag;

[0019] FIG. 7a is a perspective view of another embodiment of a tamper-evident closure including a conformable adhesive film with a set of perforations;

[0020] FIG7 b is a perspective view of the tamper-evident closure of FIG8 a with the vascular access device within the folded membrane to irreversibly contain the vascular access device;

[0021] FIG8a is a perspective view of another embodiment of a tamper-evident closure including a housing that opens to receive a vascular access device;

[0022] FIG8b is a perspective view of the tamper-evident closure of FIG8a closed and containing a vascular access device;

[0023] Fig. 9 is a perspective view of another embodiment of a tamper-evident closure including a housing that opens to receive a vascular access device;

[0024] Fig.10 is a perspective view of another embodiment of a tamper-evident closure including a housing that opens to receive a vascular access device;

[0025] Fig.11 is a perspective view of another embodiment of a tamper-evident closure including a housing that opens to receive a vascular access device;

[0026] FIG12a is a perspective view of another embodiment of a tamper-evident closure including a base and a strip;

[0027] FIG12b is a perspective view of the tamper-evident closure of FIG12a with a vascular access device coupled to the base of the tamper-evident closure;

[0028] FIG12c is a perspective view of the tamper-evident closure of FIG12b with the strip forming the securing mechanism tightened to irreversibly contain the vascular access device;

[0029] Fig.13 is a perspective view of another embodiment of a tamper-evident closure including a base and a strip;

[0030] Fig.14 is a perspective view of another embodiment of a tamper-evident closure including a base and a strip;

[0031] Fig.15 is a perspective view of another embodiment of a tamper-evident closure including a base and a strip.

[0032] Although the above-mentioned figures and drawings illustrate embodiments of the present invention, other embodiments are also conceivable as noted in the discussion. In all cases, this disclosure describes the present invention by way of example and not limitation. Numerous other modifications and embodiments may be devised by those skilled in the art, which are also within the scope and spirit of the present invention. The accompanying drawings may not be drawn to scale. DETAILED DESCRIPTION

[0033] Various designs for tamper-evident closures are disclosed. The disclosed tamper-evident closure 100 includes a retaining cavity 110, a securing mechanism 160, such that upon tampering or removal of the securing mechanism, there is a visually evident indication that the retaining cavity 110 has been opened or the securing mechanism 160 has been peeled off. The disclosed tamper-evident closure is well suited for securing a medical access device 200 having an access point 210 for delivering fluids to a patient, removing fluids from a patient, or connecting to other devices via a tube 220. In some embodiments, a cap 230, such as a 3M TM Curos TM A sterile cover is secured over access point 210 .

[0034] The holding cavity 110 generally has a perimeter 111 that surrounds at least a portion of a central region 112, wherein an access point 113 opens into the central region 112. Generally, the tamper-evident closure 100 can be opened to all access devices 200 to be placed in the holding cavity 110, and closed to secure the access devices 200 within the holding cavity 110. The securing mechanism 160 160 holds the tamper-evident closure 100 closed. Various designs of the holding cavity 110 and securing mechanism 160 are contemplated and disclosed herein.

[0035] The retaining cavity 110 of the tamper-evident closure 100 contains a medical access device 200. The medical access device 200 can be any site on a catheter or intravenous tubing where medication can be administered and / or fluid can be removed. The medical access device 200 can be a vascular access device, which is a connector that connects to the patient's vascular system for the administration of medication or removal of blood. The medical access device 200 can be any part of an infusion line, catheter, tube, or other medical device. This can be any site on a catheter, intravenous catheter, or other topical or transcutaneous medical device. This can be a Luer active device ("LAD") on the y-site, a LAD on the end of a line, or a male / female connector in the middle of a line or any other connector for a topical or transcutaneous medical device. The Luer activated device can be capped or uncapped.

[0036] When the retaining cavity 110 is closed by the securing mechanism 160, the fluid access point 210 for the medical access device 200 is not accessible. Only when the apparent peeling device is actuated, the fluid access point of the medical access device 200 (covered by the cover 230) becomes accessible, but when the apparent peeling device is actuated, it may be apparent that the tamper-evident closure 100 has been opened.

[0037] In some embodiments shown in the figures, the fluid access point includes a cap 230 for covering the fluid access point prior to use. The cap 230 may include a disinfectant to keep the fluid access point 210 clean prior to use. Exemplary caps 230 are described in U.S. Patents 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 provided as 3M for needleless connectors. TM CUROS TM Sterilization caps are sold and available from 3M Company.

[0038] In some embodiments, materials that are highly resistant to cut or impact damage, such as plastics, films, metals, or ceramics, may be used to make the tamper-evident closure a tamper-resistant or even tamper-proof closure.

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

[0040] FIG. 1a is a perspective view of one embodiment of a front side of a tamper-evident closure 100 in an open position to expose a contained vascular access device 200. FIG. 1b is a perspective view of a rear side of the tamper-evident closure 100 of FIG. 1a. FIG. 1c is a perspective view of the tamper-evident closure 100 of FIG. 1a in a closed position to contain a vascular access device 200.

[0041] In this embodiment, the holding cavity 110 of the tamper-evident closure 100 is a box 120 and includes a first component 125 and a second component 126 connected together at a pivot 126 so that the first component 125 can be moved relative to the second component 126 to open the tamper-evident closure 100 to expose the holding cavity 110. There is an access point 113 in the tamper-evident closure 100 to allow the vascular access device tube 220 to exit the holding cavity 110 while the vascular access device 200 is contained within the holding cavity 110. The access point 113 can be slightly narrower than a standard flexible tube 220 to hold the tube 220 in place so that the vascular access device 200 remains securely positioned when the first component 125 is pivoted relative to the second component 126. In this embodiment, the access point 113 is on both the first component 125 and the second component 126 so that when secured together, the user can use one hand to access the tube 220 while keeping the vascular access device secured.

[0042] As can be seen in Fig. 1b, there is a through hole 161 in the first component 125 and a through hole 162 in the second component 126 so that these through holes can be aligned to form a continuous channel. A fixing mechanism 160, such as a one-way tether, passes through the continuous channel to prevent the first component 125 from moving relative to the second component 126 to keep the holding cavity 110 closed. When the entire tamper-evident closure 100 is damaged or the fixing mechanism 160 is destroyed, the holding cavity 110 will be exposed. Either way, tampering will be obvious. To destroy the fixing mechanism 160, hand pressure can break the line, the device can include a cutting tool or the healthcare provider can use a cutting tool, such as scissors.

[0043] In this embodiment, the rigid materials used for the first and second components 125, 126 and the securing mechanism 160 can be used to make it a tamper-resistant or tamper-proof retention cavity for the vascular access device.

[0044] Figure 2a is a perspective view of another embodiment of a tamper-evident closure 100 for a vascular access device 200 showing the slide cover retracted, thereby exposing the contained vascular access device 200. Figure 2b is a perspective view of the tamper-evident closure 100 of Figure 2a showing the closed slide cover 121 and the securing mechanism 160 holding the slide cover closed.

[0045] This embodiment is similar to the embodiment in Fig. 1a to Fig. 1c, except that the first component 125 and the second component 126 forming the holding cavity 110 are connected in a slidable manner. The second component 126 is similar to a door and slides from an open position (Fig. 2a) to a closed position (Fig. 2b) when it is wrapped around the cylindrical body of the first component 125. This allows a holding cavity 110 of the minimum size with a sliding door 121 because the door is "wrapped" around the first component. The first component 125 has rounded corners to eliminate any sharp edges, thereby improving patient comfort. The first through hole 161 in the first component 125 and the second through hole 162 in the second component 126 are aligned to form a continuous channel. In this embodiment, the continuous channel is a thin longitudinally extending channel. The fixing mechanism 160 shown in Fig. 2b is an adhesive tape that passes through the continuous channel to prevent the second component from opening. When the entire tamper-evident closure is damaged or the fixing mechanism 160 is destroyed, the holding cavity 110 will be exposed.

[0046] As shown, the retaining cavity 110 of the tamper-evident housing 100 can have various sizes and include access points 113 at various locations to accommodate various configurations of the vascular access device 200. The continuous channel can have various sizes and shapes to accommodate a securing mechanism 160 that connects one side of the continuous channel on the first component to the other side of the continuous channel on the second component.

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

[0048] In this embodiment, the tamper-evident closure 100 includes a first component 125 and a second component 126 connected together to form a holding cavity 110. The vascular access device 200 is placed in the first component 125, and then the second component 126 is covered on the first component 125 and pressed to lock with the first component 125, as shown in Figure 3b. The first component 125 and the second component 126 can be two separate components, or can be connected to each other by a hinge. There is an access point 113 in the tamper-evident closure 100 to allow the vascular access device tube 220 to exit from the holding cavity 110, while the vascular access device 200 is contained in the holding cavity 110.

[0049] The securing mechanism 160 includes a channel lock fitting 164 extending around at least a portion of the perimeter of the tamper-evident closure 100 connecting the first component 125 and the second component 126 together. The channel lock fitting 164 has a line of weakness 167 and a tab 168 adjacent to the channel lock fitting 164. The channel lock fitting 164 includes a longitudinally extending protruding portion 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 interlocks with the protruding portion 165. In this embodiment, the channel lock fitting 164 is a zigzag line, which can provide additional strength to the device and limit the user from prying the device open with a tool. For example, the shorter length makes it less likely that the edge of a tool such as a screwdriver or a knife will be pressed between the two and separate. Also along the securing mechanism 160, on the side of the securing mechanism 160 opposite the channel lock fitting 164, is a line of weakness 167, which may be a thin or perforated portion connecting the securing mechanism 160 to the first or second component 125, 126. Extending from the securing mechanism 160 is a tab 168 for detaching the channel lock fitting 164.

[0050] For example, in this embodiment, the securing mechanism 160 is connected to the second component 126 by a line of weakness 167. On the side of the securing mechanism 160 opposite the line of weakness 167 is a longitudinally extending protrusion 165. On the first component 125 is a longitudinally extending receiving portion 166. A channel locking fitting 164 interlocks the first component 125 to the second component 126, as shown in FIG. 3b.

[0051] To remove the securing mechanism 160, the tab 168 is pulled to break the line of weakness 167. This alone is sufficient to disengage the locking connection between the first component 125 and the second component 126. When the entire tamper-evident closure 110 is damaged, or when the tab 168 is at least partially removed from the tamper-evident closure 100 and the line of weakness 167 is broken, the retaining cavity 110 will be exposed. Either way, tampering will be apparent.

[0052] FIG. 3c is a perspective view of another embodiment of a tamper-evident closure 100 in an open position showing an inner sliding door 127, and FIG. 3d is the tamper-evident closure 100 of FIG. 3c in a closed position. The tamper-evident closure 100 is substantially similar to the tamper-evident closure of FIG. 3a, FIG. 3b. In both FIG. 3c and FIG. 3d, the inner sliding door 127 is open to expose the access point 113 to the holding cavity. The sliding door 127 is within the first component 125 and can be slidably actuated to open or close the access point 113 if the vascular access device has a "Y" line.

[0053] Figure 4is a perspective view of another embodiment of a tamper-evident closure 100 including a removable door 127. The removable door 127 includes a thin portion connecting the removable door 127 to the first member 125 so that it can be easily removed to open the access point 113 if the vascular access device has a "Y" wire.

[0054] exist Figure 4 In the illustrated embodiment, front tabs 128 are included. These front tabs 128 are spaced apart from one another on each side of the access point 113. In this embodiment, the front tabs 128 are located on the exterior of the tamper-evident closure 100 to fit against the protruding wings of the vascular access device to prevent rotation of the vascular access device. Rotation may allow tampering of the contained vascular access device, possibly by unscrewing or disconnecting the device.

[0055] Sliding doors, removable doors, or front tabs may be used with any number of the disclosed tamper-evident housings.

[0056] Fig. 5a is a perspective view of another embodiment of a tamper-evident closure 100 including a box 120 having a first component 125 and a second component 126 rotatably connected to form a retaining cavity 110. Fig. 5b is a perspective view of the tamper-evident closure 100 of Fig. 5a wherein the first component 125 and the second component 126 rotate to close the retaining cavity 110 and having a securing mechanism 160 including a security label 169 to hold the tamper-evident closure 100 closed.

[0057] In this embodiment, the holding cavity 110 is formed by a first component 125 and a second component 126 that are connected together in a rotatable manner. As shown, extending from the end is an access point 113 for a tube 220. When the first component 125 and the second component 126 are rotated as shown in FIG. 5a, an opening portion 129 is formed so that the vascular access device 200 can be inserted into the holding cavity 110. Then, the first component 125 and the second component 126 are rotated to break the misaligned opening portion 129 and fix the vascular access device 200 in the holding cavity 110. Once rotated, the opening portion on the second component 126 serves as an access point to allow the tube 220 to leave the side of the holding cavity. Once rotated so that the open portions are no longer aligned, the safety label 169 is fixed to span the first component 125 and the second component 126, as shown in FIG. 5b.

[0058] Security label 169 may be formed of a permanent adhesive or other security label such that removal of the label will permanently damage or destroy security label 169. Additionally, attempting to rotate first member 125 relative to second member 126 to achieve alignment of fully open portion 129 to access vascular access device 200 may damage or tear label 169. Either way, tampering will be apparent.

[0059] Figure 6 is a perspective view of another embodiment of a tamper-evident closure 100 in which a retaining cavity 110 includes a pocket 130 having an opening 132 and a securing mechanism 160 that is fastened to irrevocably close the retaining cavity 110 .

[0060] In this embodiment, the holding cavity 110 is formed by a bag 130 having an opening 132. When opened, the vascular access device 200 is inserted into the holding cavity 110 of the bag 130. The bag 130 can advantageously accommodate vascular access devices 200 of various sizes and shapes, and easily allow the tube 220 to exit through the opening 132. The fixing mechanism 160 is fastened at the opening 132 of the bag 130 to close the opening 132. There is a series of rivets 133 at the opening 132, and the fixing mechanism 160 is threaded through the rivets 133. Alternatively, a slit or cutout of the bag or a channel of the folded material of the bag can also hold the fixing mechanism. The fixing mechanism 160 allows a one-way tightening of the opening, such as a ligature with a locking receiver as shown. In this embodiment, the tightening mechanism has two strips passing through the one-way locking unit. In addition, one end of the fixing mechanism 160 may include a breaking device, a cutting end, or a tool for helping to break the fixing mechanism 160. When the bag 130 is broken open or the securing mechanism 160 is broken, the holding cavity 110 will be exposed. Either way, tampering will be obvious.

[0061] When the holding cavity can be composed of Figure 6 When the film is formed as shown, the bag can be made of puncture-resistant material such as Kevlar TM Then, if a locking securing mechanism is used, such as a locking wire, the tamper-evident closure may be tamper-resistant or tamper-evident.

[0062] 7a is a perspective view of another embodiment of a tamper-evident closure 100 comprising a conformable adhesive film that forms a pocket 130 when formed around an access device 220. FIG7b is a perspective view of the tamper-evident closure 100 of FIG7a with the conformable adhesive film folded to irreversibly contain a vascular access device 200.

[0063] In this embodiment, retention cavity 110 is formed by the film of bag 130, wherein first adhesive surface 141 is folded to second adhesive surface 142. As shown in FIG7a, vascular access device 200 is applied to bag 130 and then folded around vascular access device 200 to form retention cavity 110 in bag 130 around vascular access device 200. Fixing mechanism 160 is opposite first surface 141 and second surface 142, which are fixed together in an adhesive manner, which will seal bag 130 around vascular access device 200, as shown in FIG7b.

[0064] Adhesive should be permanent adhesive, makes it impossible to open the relative adhesive face. In some embodiments, permanent adhesive is a touch pressure adhesive. Before use, can cover and protect adhesive surface with removable release liner. When bag 130 is broken and opened, keep cavity 110 and will be exposed. In some cases, can use stripping material, make two adhesive surfaces adhere, but after separation, one of adhesive preferentially attracts another adhesive surface, thereby does not leave adhesive on the surface that comprises release agent. In this case, two surfaces cannot be fixed together.

[0065] In some embodiments, such as shown in FIG. 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 having to seal all edges. In addition, the tear strip 167 makes it easy to open the formed bag 130 to remove the vascular access device 130. When it is necessary to open the bag 130, the tear strip 167 is removed from the bag 130 to expose the vascular access device 200. The bag 130 cannot then be reclosed.

[0066] The adhesive should be a permanent adhesive so that the opposing surfaces cannot be separated. In some embodiments, the permanent adhesive is a contact adhesive, which is an adhesive that strongly adheres to itself but generally does not adhere to other substrates. Contact adhesives work well so that exposed adhesive does not adhere to the vascular access device or transfer adhesive to the surface of the vascular access device, making the device sticky and dirty. In addition, medical providers often wear gloves, and the contact adhesive will not strongly adhere to the worker's gloves, but will strongly adhere to another surface containing the contact adhesive. An example of a suitable film with a contact adhesive is 3M VISION(R) available from 3M Company. TM SCOTCH TM Flex&Seal shipping rolls. Can be covered and protected with a removable release liner prior to use.

[0067] Figure 8a is a perspective view of another embodiment of a tamper-evident closure 100 including a retaining cavity 110 as an enclosure 140. Figure 8b is a perspective view of the tamper-evident closure 100 of Figure 8a closed and containing a vascular access device 200.

[0068] These constructions described as enclosures are similar in structure to bag constructions, but as shown, these enclosure constructions are slightly more rigid and have greater structural integrity than film bag constructions. The structurally rigid tamper-evident closures can be formed from plastic in a molding, printing, or thermoforming process. The more structurally rigid tamper-evident closures have more form for receiving the access device into the correct position within the holding cavity and can be easily closed. Any of these enclosure constructions can alternatively be formed from a film.

[0069] The enclosure 140 includes a first component 125 and a second component 126 connected along a fold line 143. As shown, the access point 113 can be molded into the tamper-evident closure 110 in one or both of the first component 125 or the second component 126 to more easily accommodate the discharge tube 220. On the first component 125 is a first adhesive surface 141 and on the second component 126 is a second adhesive surface 142. The access device 200 is inserted into the retaining cavity 110 and the first component 125 is hinged toward the second component 126. The first adhesive surface 141 contacts the second adhesive surface, as shown in FIG. 8b, to close the tamper-evident closure 100. When it is necessary to open the enclosure 140, the sealed adhesive surfaces 141, 142 are removed from the enclosure 140 at the tear strip 167 located between the retaining cavity 110 and the sealed adhesive surfaces 141, 142. The enclosure cannot then be reclosed and tampering will be obvious.

[0070] Fig. 9 8a-8b. However, in this embodiment, the fold line 142 between the first component 125 and the second component 126 is a tear strip 167. After the vascular access device 200 is inserted, the tamper-evident closure 100 is hinged closed so that the adhesive surfaces 141, 142 contact each other to seal the tamper-evident closure 100. When it is desired to open the housing 140, the tear strip 167 is removed and the first component 125 is disconnected from the second component 126 to expose the vascular access device 200. The housing 140 cannot then be reclosed.

[0071] Fig.10 8a, 8b and 8c are perspective views of another embodiment of a tamper-evident closure 100 including a retaining cavity 110 in the form of an enclosure 140. This embodiment is similar to that of FIGS. 8a, 8b and 8c. Fig. 91, because the tamper-evident closure 100 is formed of a structurally rigid material that forms a housing 140 for receiving a vascular access device 200. In this embodiment, the tamper-evident closure 100 has a first component 125 having a first adhesive surface 141 and a second component 126 having a second surface 142. The second component 126 is hinged over the first component 125 to close the retention cavity 110 so that the first surface 141 and the second surface 142 are adhesively sealed together. The tear strip 167 is adjacent to the retention cavity 110 so that when it is necessary to open the housing 140, the tear strip 167 is removed to expose the vascular access device 200. Then, the housing 140 cannot be reclosed.

[0072] Fig.11 8a, 8b, and 8c are perspective views of another embodiment of a tamper-evident closure 100 including a retaining cavity 110 in the form of an enclosure. Fig. 9 and Fig.10 1, because the tamper-evident closure 100 is formed of a structurally rigid material that forms a housing 140 for receiving a vascular access device. The tamper-evident closure 100 is clamped to open the holding cavity 110. The holding cavity 110 has a first component 125 including a first surface 141 and a second component 126 including a second surface 142, which are hinged and, when in contact with each other, are adhesively secured to close and seal the holding cavity 110 after the vascular access device is inserted. In this embodiment, the tear strip 167 overlaps the first component 125 so that when it is necessary to open the housing, the tear strip can be removed to expose the vascular access device. Then, the housing 140 cannot be reclosed.

[0073] Fig. 12a is a perspective view of another embodiment of a tamper-evident closure 100, wherein a retaining cavity 110 includes a base 150 and extending from the base 150 are a first strip 153 and a second strip 154. Fig. 12b is a perspective view of the tamper-evident closure 100 of Fig. 12a, wherein a vascular access device 200 is coupled to the base 150 of the tamper-evident closure 200. Fig. 12c is a perspective view of the tamper-evident closure 100 of Fig. 12b, wherein the strips 153, 154 are secured together with a securing mechanism 160 to form the retaining cavity 110.

[0074] In this embodiment, the holding chamber 110 has a base 150 and opposing first and second strips 153, 154, wherein the vascular access device 200 is positioned adjacent to the base 150 and the opposing strips 153, 154. The holding chamber 110, such as that shown in FIG. 12c, is well suited for engagement with a cover 230 covering a needleless connector on the vascular access device 200. In this embodiment, the base 150 includes a protrusion 151 that engages integrally into the cover 230, and in particular engages into a recessed portion of the cover 230. The securing mechanism 160 is a ratchet mechanism that engages with matching openings of the first and second strips 153, 154, as best shown in FIG. 12c. When the securing mechanism 160 is engaged, the first and second strips 153, 154 fit tightly around the access device 200. The first and second strips 153, 154 are long enough so that when the securing mechanism 160 is tightened, the strips 153, 154 are adjacent to the outwardly extending portion of the access device 200. Thus, the tamper-evident closure 100 cannot be pulled down to disengage from the connection with the cap 230. When the base 150 is engaged and the first and second strips 153, 154 are closed, the vascular access device 200 cannot be accessed unless the securing mechanism 160 is irreversibly damaged. To assist in the intentional destruction of the strips, a tear strip 167 may be included on one or both strips. Pulling the tear strip 167 destroys the strip so it can be disconnected without the use of tools.

[0075] Fig.13 12a to 12c. In this embodiment, the base 150 is enclosed around the disinfection cover, wherein the strips 153, 154 are fixed to the top part of the base 150. Therefore, there is a greater vertical tolerance for movement before the base 150 may completely disengage the covering cover. In this embodiment, the base 150 can be a cover to engage with a needleless connector on a vascular access device. The cover can include an internal fixing mechanism for engaging with the needleless connector. The cover can include an antiseptic to keep the needleless connector clean and ready for use when the cover is removed. This will allow the disinfection process and the tamper protection process to be integrated into a single step.

[0076] Fig.14 FIG. 1 is a perspective view of another embodiment of a tamper-evident closure including a base 150 and strips 153, 154. This embodiment is substantially similar to the embodiment in FIGS. 12a to 12c. This embodiment is similar to Fig. 9 a to Fig. 9c. However, in this embodiment, the securing mechanism 160 is a set of recesses at the first strip 153 that interlock with a protrusion at the second strip 154. To aid in intentionally breaking the strips 153, 154 secured together, a perforation line 167 may be included on one or both of the strips 153, 154. In this embodiment, the cut line at one of the protrusions / recesses can be twisted from the tamper-evident closure 100 to irreversibly open the retention cavity.

[0077] Fig.15 is a method comprising a method substantially similar to FIG. 12a, FIG. 12b, FIG. 12c, Fig.13 and Fig.13 153,154 of the embodiment shown in the perspective view of another embodiment of the tamper-evident closure 100 of the base 150 and strips 153,154, however, wherein the strips 153,154 are connected in an adhesive manner. The fixing mechanism 160 is the relative adhesive face on the strips 153,154 that will be sealed together. Since there are many different connector manufacturers, a flexible fixing system can be used to compensate for mechanical variability. The adhesive should be a permanent adhesive so that the relative adhesive face cannot be opened. In some embodiments, the permanent adhesive is a touch adhesive. Before use, the adhesive surface can be covered and protected with a removable release liner. In order to help intentionally destroy the strips, a perforated line 167 can be included on one or both strips.

[0078] Tamper-evident closures, such as those disclosed in the present application, are designed to be removed without the need for additional removal tools. For example, perforated lines, breakable securing strips, twistable or tearable structures or membranes can be used to make it easy to remove the tamper-evident closure when a healthcare provider intentionally wants to access the vascular access device. In addition, it is desirable to keep the lumen cleanly open with few separate parts when the tamper-evident closure is intentionally removed. For example, in FIGS. 12 a to 12 b, the tamper-evident closure is removed by the healthcare provider. Fig.15 In the embodiment described in , the base can be twisted to be removed from the strip to achieve clean separation.

[0079] In embodiments where the film can be used to form all or part of a tamper-evident closure, tampering may be attempted to tear, rip, pull apart the film itself, or peel apart two film surfaces that have been joined or closed together. It may be desirable to include a film with properties that will indicate tampering. For example, the film may tear preferentially in one or more directions. Weak areas, the orientation of the film in which it is manufactured, embossing are all ways that the film may tear preferentially. In this case, when tampering is attempted, a clean tear will be produced in the film in one direction, thereby indicating obvious tampering.

[0080] In another embodiment, in the case of a film having properties that would indicate tampering, the film may have a physical change when stressed, stretched, or pulled. For example, the film may be transparent or translucent, and when stretched in any direction, the film may turn opaque. This will visually show that the film has been tampered with or attempted tampering.

[0081] As described above, the rigid structure, locking securing mechanism will be obvious to the skilled person. For example, the healthcare provider will have access to the lock to strip the securing mechanism.

[0082] Although specific embodiments have been shown and described herein, it should be understood that these embodiments are merely exemplary of many possible specific arrangements that can be designed when applying the principles of the present invention. Those skilled in the art can design many and different other arrangements based on these principles without departing from the spirit and scope of the present invention. Therefore, the scope of the present invention should not be limited to the structures described in this patent application, but only to the structures described in the text of the claims and their equivalents.

Claims

1. A tamper-evident closure for a medical access device, the tamper-evident closure comprising: first component; a second component coupled to the first component, wherein the first component and the second component are transitionable between an open configuration and a closed configuration, and wherein the first component and the second component form a retention cavity in the closed configuration; a first access point at an end of the tamper-evident closure to the retention cavity; a second access point that opens into the retention cavity on a side of the tamper-evident closure, wherein the second access point is not longitudinally aligned with the first access point; a channel lock fitting coupled to the first component along a line of weakness, wherein the channel lock fitting comprises: a protruding channel extending along a portion of a periphery of the first component; and a plurality of teeth extending along a periphery of the first member; a receiving channel extending along a portion of a perimeter of the second component, wherein the protruding channel aligns with and engages the receiving channel to retain the first component and the second component in the closed configuration; a plurality of recesses defined in the second component, wherein the plurality of teeth are aligned with the plurality of recesses upon positioning the first component and the second component in the closed configuration; and A tab extends from the channel lock fitting, wherein the tab is pullable to break the channel lock fitting from the first component along the line of weakness to allow the first and second components to transition to the open configuration.

2. The tamper-evident closure according to claim 1, wherein the first component is pivotably, slidably or rotatably connected to the second component.

3. The tamper-evident closure of claim 1 further comprising a label extending from the first component to the second component.

4. The tamper-evident closure of claim 1 further comprising a door covering the second access point.

5. The tamper-evident closure of claim 1 further comprising a front tab extending from the first component on each side of the second access point.

6. The tamper-evident closure of claim 1, further comprising a sliding door that is slidably actuatable to open or close the second access point.

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