1. Field of the Disclosure
The present invention relates to disinfectant caps for medical devices. More specifically, the present invention relates to disinfectant caps for luer access devices that provide direct contact with antiseptic fluid stored therein.
2. Background
Intravenous (IV) devices are widely used to administer fluids to patients, such as through the use of a catheter inserted into a patient. Usually, the catheter is connected to an injection site, such as a luer access device, which provides fluid communication from a fluid source (e.g., IV bag, syringe, etc.) to the patient. The connectors are frequently separated from each other (e.g., when a patient needs to use the bathroom), which exposes the connectors to the environment, which can result in contamination.
To reduce the risk of contamination, the connectors are usually disinfected between uses. Current procedures include swabbing the connectors with a disinfecting pad, which is prone to human error and not often implemented. Alternatively, antiseptic caps are used to clean and cover the connectors. However, many antiseptic caps require a presoaked absorbent material (e.g., absorbent pad, absorbent sponge, etc.) inserted therein to store and subsequently release the antiseptic fluid onto the connector (or any other medical device). Furthermore, the injection sites typically utilize a male luer thread geometry to facilitate connection of syringes and IV tubing for fluid communication. Existing antiseptic caps utilize the corresponding female luer thread geometry to secure the cap to the injection site. However without the additional tapered luer tip geometry, which secures these types of connections between syringes and injection sites, the antiseptic caps do not securely fit on the injection site, and are prone to falling off inadvertently.
The present invention relates to disinfectant caps and packaging for use with a medical device (e.g., connector, luer access device, etc.). The disinfectant caps apply the antiseptic fluid (e.g., disinfectant) directly onto the surface of the medical device. The disinfectant caps incorporate specific thread geometry to provide a secure fit to threaded access sites.
The foregoing features of the disclosure will be apparent from the following Detailed Description, taken in connection with the accompanying drawings, in which:
a-2c illustrate steps for manufacturing the disinfectant cap of
a-3b illustrate steps for applying the disinfectant cap of
The present disclosure relates to disinfectant caps for disinfecting a luer access device (LAD) or any other medical device. More specifically, the disclosure relates to disinfectant caps with antiseptic fluid (e.g., alcohol, isopropyl alcohol, etc.) to disinfect a surface of an LAD. Many of the disinfectant caps of the present disclosure do not require an absorbent material (e.g., an absorbent sponge or pad). The disinfectant caps described below could be manufactured using any suitable technique (e.g., blow molding, injection molding, etc.), and using one or more of a variety of materials (e.g., polypropylene, polyethylene, etc.). The disinfectant cap could be applied to the medical device regardless of the orientation of the medical device. The features described with respect to a particular embodiment could be used with other embodiments described herein.
a-2c illustrate steps for manufacturing the disinfectant cap of
In
The cover 114 can include a planar circular top portion 138 with a depending rim 140 extending downwardly from a peripheral edge of the planar circular top portion 138. The depending rim 140 can include a lip 142 extending (e.g., perpendicularly) from a bottom thereof. The lip 142 could include an annular rounded edge 144 (or taper) to facilitate application of the cover 114 to the cap body 112. The lip 142 of the rim 140 engages the flange 130 of the neck 126 of the cap body 112 to secure the cover 114 to the cap body 112. However, any form of attachment could be used (e.g., friction fit, adhesion, welding, overmolding, etc.).
The cover 114 can include an inner wall 146 extending downwardly from the top portion 138 of the cover 114 and defining a central aperture 148. The inner wall 146 can include a portion of reducing size 150 (e.g., tapered, conical, etc.) extending downwardly to a frangible tip 154 that extends into the interior of the cap body 112. The inner walls 146 can be made of a hard (e.g., rigid, semi-rigid, etc.) plastic and the frangible tip 154 forms a breakable nozzle. Alternatively, the inner walls 146 can be made of a soft material (e.g., rubber, low durometer material, silicone or thermoplastic) and the tip 154 can be slit or manufactured with a small opening (e.g., hole or slit). The inner walls 146 and the tapered portion 150 are sized and shaped to engage a medical implement that requires disinfecting, such as a luer access device (not shown). When the cover 114 is attached to the cap body 112, the frangible tip 154 may be submerged in the antiseptic fluid 118 contained in the cap body 112. A removable film 156 (e.g., paper peel, peelable sterile barrier, foil lidstock, etc.) could be adhered (or otherwise attached) to the top surface of the cover 114, such as over the central aperture 148.
It is noted that the cap body 112 does not require a neck 126 (e.g., the sidewall 122 defines a top opening of the cap body 112), and that any shape or type of cap body 112 and/or cover 114 could be used. The cover 114 could include threads (or other mating feature such as protrusions, recesses, and/or snap fits) molded into the inner walls 146 (such as in the tapered portion 150) to mate with and retain the LAD. Alternatively, the inner walls 146 could be sized to form an interference fit with the LAD. The inner walls 146 could be made of a material of sufficient softness to allow threads on the LAD to penetrate into the surface of the inner walls 146 so as to create mating female threads on the smooth surface.
In
a-3b illustrate steps for applying the disinfectant cap 110 of
The inner circumference of the neck 226 is smaller than the circumference of the sidewall 222. The neck 226 defines a top opening 228 providing access to the interior of the cap body 212. A cover 214 (e.g., breakable seal insert) is inserted into the neck 226 to seal the interior of the disinfectant cap 210.
The bottom wall 220 of the cap body 212 includes a bulb 268 integrally formed with (or attached to) the cap body by a stem 270. The circumference of the bulb 268 could be sized similarly to, or smaller than, the circumference of the cap body 212. The bulb 268 defines an interior, which is in fluid communication with the interior of the cap body 212 via a channel within the stem 270.
The bottom surface 272 (and/or top surface 274) of the bulb 268 could be invertible to decrease the volume of the disinfectant cap 210 and increase the pressure of the antiseptic fluid and any gas contained therein. The bulb 268 could be deformed before or after engagement with an LAD, such as by squeezing the bulb 268 to direct disinfecting fluid through the stem 270 and onto an LAD or other medical device. The bulb 268 can be designed such that it retains its deformed shape to maintain internal pressure. For example, the bottom surface 272 (e.g., bottom wall) of the bulb 268 could be designed with a slight outward bow so that as pressure is exerted the bottom surface 272 eventually reaches a point of inflection where it flexes and inverts, and then remains nested in the top surface 274 (e.g., similar to a locking bellow).
The elastomeric dome cover 314 includes a generally planar outer periphery 338 with a centrally located dome portion 339. A depending rim 340 extends downwardly from the outer periphery 338 a peripheral edge of the outer periphery 338. The rim 340 include a lip 342 extending from a bottom of the rim 340. As described above, the lip 342 of the rim 340 engages the flange 330 of the neck 326 of the cap body 312 to secure the elastomeric dome cover 314 to the cap body 312. However, any form of attachment could be used (e.g., friction fit, adhesion, etc.).
The elastomeric dome cover 314 includes a dome portion 339 (e.g., hemispherical wall) having one or more partial slits 341 formed through (or near) the apex thereof. The elastomeric dome cover 314 is attached to the top of the cap body 312, thereby retaining antiseptic fluid 318 and gas 336, if any, therein. Alternatively, the disinfectant cap 310 could be filled with antiseptic fluid 318 through the partial slits 341. Further, instead of partial slits 341, the elastomeric dome cover 314 could have a weakened area made by other means (e.g., a thin wall that separates when pressure is applied to the cover or when the cover is inverted). Instead of partial slits 341, the elastomeric dome cover 314 could have a small hole which retains the disinfectant in the cavity through the surface tension of the liquid. The elastomeric dome cover 314 (e.g., and partial slits 341 or small hole) could be sealed with a lidstock.
The elastomeric dome cover 314 and the cap body 312 define an interior having a first volume and the antiseptic fluid 318 and gas 336 (e.g., air or atmosphere), if any, is stored therein at a first pressure (e.g., atmospheric pressure). A removable film could be applied (e.g., adhered) to the top surface of the elastomeric dome cover 314.
The ribs 443 could extend vertically or horizontally or radially from the dome 439. The ribs 443 are non-continuous with aligned opposite ends 445 such that each rib 443 is composed of two rib segments (e.g., a first rib segment 443a and a second rib segment 443b). The breaks 447 between the rib segments 443 facilitate inversion of the elastomeric dome cover 414 by allowing the dome 439 to bend/flex. Although two rib segments 443 are shown, any number of rib segments 443 could be used, or a single non-continuous rib (e.g., with only one break).
As shown, the disinfectant cap 610 includes a cap body 612 with a sidewall 616 and a bottom wall 618 defining an interior. The top of the sidewall 616 defines a top opening 620. Although not shown, a removable film could be provided over the top opening 620. The sidewall 616 includes an upper portion 622 and a lower portion 624, with a shoulder (e.g., ledge) 626 therebetween, such that the wall of the upper portion 622 has a smaller thickness than the wall of the lower portion 624. The annular disc 634 rests on the shoulder (e.g., ledge) 626 of the cap body 612 when positioned therein.
The upper portion 622 of the sidewall 616 of the cap body 612 and the top surface of the elastomeric dome insert 614 define a second chamber 642 for receiving and engaging an LAD (not shown). The inner surface of the upper portion 622 of the sidewall 616 could be threaded and/or elastically deformable to engage the LAD. Alternate engagement features or mechanisms could be employed such as press fits, snap fits, grooves, recesses, etc.
It may be desirable to design the cap to allow evaporation of the disinfectant after application of the cap to the LAD. A significant residual pool of disinfectant can remain on the access site and increase the risk of infusing the disinfectant into the patient (in the example of disinfecting an LAD). Without any absorbent material present to remove residual disinfectant, it may be beneficial to allow excess disinfectant to evaporate. This can be accomplished by designing channels, slits, holes, gaps in the threading, or other means through which the disinfectant can evaporate to the external atmosphere.
Antiseptic fluid 722 is inserted into and contained within the cap body 712. A movable plug 714 (e.g., wall, divider, etc.) is positioned within the interior of the cap body 712 at or above the antiseptic fluid 722. The movable plug 714 includes a cylindrical bottom end 724 which has approximately the same size as the interior diameter of the cap body 712, and could form a friction fit with the cap body 712, or an o-ring could be added around the periphery of the bottom end 724 to prevent the antiseptic fluid 722 from seeping past the movable plug 714. The bottom surface of the bottom end 724 of the movable plug 714, the sidewalls 716, and the bottom wall 718 define a first chamber 726. The top surface of the movable plug 714 and the sidewalls 716 of the cap body 712 define a second chamber 728.
The movable plug further comprises a recessed section 730 extending from the bottom end 724. The upper portion of the movable plug 714 includes an annular rim 732, which defines a recess 734 therein and the annular rim 732 could be continuous or non-continuous (e.g., could include one or more breaks), and/or have one or more scallops in a top surface thereof. The recessed section 730 has a diameter that is smaller than that of the bottom end 724, to facilitate movement of the plug 714 does not interfere with the threads. Alternatively, instead of the recessed section 730, the rim 732 could simply extend from the top of the bottom end 724 (so that the entire plug 714 has one continuous sidewall of a substantially consistent diameter).
The recessed section 730 defines a vertical channel 736 extending from a top of the recessed section 730 through (or nearly through) a bottom of the bottom end 724. At the bottom of the channel 736 there could be an access point 738 (e.g., small hole, fluid seal, valve, or a frangible element built into (or attached to) the bottom end 724 of the plug 714 that prevents fluid from seeping into the channel 736. For example, the movable plug 714 may be made of a rigid material (e.g., polypropylene, polyethylene, etc.) with an access point 738 being a weaker area molded into the bottom end 724 of the plug 714, or the movable plug 714 could be an elastomer (e.g., silicone) with the access point 738 being a valve (e.g., check valve, duck-bill valve, thin slit valve, etc.) or small hole molded into the bottom end 724 of the plug 714.
Antiseptic fluid 822 is inserted into and contained within the cap body 812. A threadable insert 814 is positioned within the interior of the cap body 812 at, or above, the antiseptic fluid 822 (thereby retaining the antiseptic fluid 822 in the cap body 812). The threadable insert 814 includes a sidewall 824 and a bottom wall 826 defining an interior. The threadable insert 814 includes outer threads 828 defined by an exterior surface of the sidewall 824, which engage the threads 819 of the sidewall 816 of the cap body 812, and could provide a seal therebetween. The threadable insert 814 also includes inner threads 830 defined by an interior surface of the sidewall 824, which engage the threads of the LAD (not shown). Alternatively, the threadable insert 814 could utilize a friction fit (instead of the outer threads 828 and/or inner threads 830).
The sidewall 824 of the threadable insert 814 includes an upper portion 832 and a lower portion 834, where the sidewall 824 of the upper portion 832 is thinner than that of the lower portion 834, thereby defining an annular ledge 836. The bottom wall 826 includes an access point 838 (e.g., frangible element and/or fluid seal) in the center of the bottom wall 818. Further, the access point 838 could define a conical recess 840 in the exterior surface thereof, where the conical recess 840 is positioned directly in line with (and could be correspondingly shaped to) the spike 817.
To apply the disinfectant cap 810 to the LAD, the disinfectant cap 810 is threaded onto the LAD, so that the threadable insert 814 moves relative to the LAD. Once the LAD bottoms out and contacts the ledge 836 of the threadable insert 814 (e.g., the LAD cannot engage the threadable insert any more), the threadable insert 814 stops moving relative to the LAD, and instead moves relative to the cap body 812. The disinfectant cap 810 is continued to be threaded and move laterally into the interior of the cap body 812, pressure could build by the decreased volume between the bottom wall 826 of the threadable insert 814 and the bottom wall 818 of the cap body 812. The cap 810 continues to move inwardly until the spike 817 of the cap body 812 punctures the access point 838 of the bottom wall 826 of the threadable insert 814. Once punctured, the pressurized antiseptic fluid 822 flows onto the surface of the LAD and pools in the lower portion 834 of the threadable insert 814 so that the antiseptic fluid 822 makes continuous contact with the LAD. The conical recess 840 of the bottom wall 826 of the threadable insert 814 delays the puncturing of the access point 838, which further decreases the volume (increasing the pressure) of the antiseptic fluid 822 and gas, if any.
Notably, the spike 817 of the disinfectant cap of
The disinfectant cap 910 includes a cap body 912 with a sidewall 914 and a bottom wall 916 defining an interior. The top of the sidewall 914 defines a top opening 918. Although not shown, a removable film could be provided over the top opening 918. The outer surface of the sidewall 916 could include a plurality of annularly spaced vertical ribs 920 oriented along the axis of the disinfectant cap 910. The vertical ribs 920 facilitate gripping and twisting of the disinfectant cap 910 by a user. The inner surface of the sidewall 914 includes one or more variable threads 921. The disinfectant cap 910 can be stored in a second component, which can serve as an applicator and/or as packaging. The vertical ribs 920 can provide rotational lock between the disinfectant cap 910 and the second component (e.g., applicator). Lidstock can be applied to the second component (e.g., applicator) to provide a fully sterile packaging for the disinfectant cap 910. In applications where the cap 910 is stored within a second component, the lidstock can be adhered to both the cap 910 and the second component to provide two distinct chambers. Alternately, the cap can 910 be detached from the lidstock such that it is open within the chamber that is formed by the second component and the lidstock.
The inner surface of the upper portion 924 of the disinfectant cap 910 includes variable pitch threads 921. For the disinfectant cap 910, the threads 921 (e.g., double threads) start out at a constant pitch (e.g., starting pitch), such as for an approximate ¼-¾ of a turn, and then change pitch thereafter. The starting pitch is that of a standard luer lock design to assist the user with applying the disinfectant cap 910 to an LAD (e.g., relatively low torque). By varying the pitch (e.g., by reducing or increasing the pitch), as the disinfectant cap 910 is threaded onto the LAD (or other medical device), the consistent standard threads of the medical device wedge with the mismatched variable pitch threads 921 of the disinfectant cap 910.
Wedging the threads together in this fashion provides a more secured connection (e.g., from unthreading or loosening from incidental handling or contact) because a higher removal torque is needed to disengage the disinfectant cap 910 from the LAD. This design allows for engagement of the disinfectant cap 910 onto a threaded medical device (e.g., luer threads), with no other engagement mechanism (e.g., luer taper). Without a luer taper, the proposed reducing pitch threads 921 provide a secure fit than traditional luer threads alone. To create and maintain the wedge, the disinfectant cap 910 could be made of a variety of materials, such as a hard plastic (e.g., high-density polyethylene (HDPE)). LADs usually have ACME profiled threads or modified ACME profiled threads (e.g., stub ACME threads), which are known for power transmission applications due to the flat sides which distribute stress well over the faces of the thread. As a result, the ACME type threads transmit high torques while minimizing stress, which translates to better wedging action and higher removal torques.
Further, the inner diameter of the side wall 914 of the disinfectant cap 910 (e.g., major and/or minor inner diameters of the threads) can reduce in diameter further into the disinfectant cap 910. This can provide an interference fit with the outer diameter (e.g., the threads) on the medical implement. Additionally, the start of the threads 912 could be offset from the top opening 918. This could require partial insertion of the luer access device into the disinfectant cap 910, which provides alignment of the disinfectant cap 910 and luer access device before threading and facilitates threading of the disinfectant cap 910 onto the luer access device.
The lower portion 926 of the inner surface of the sidewall 914 includes retaining rings or threads 930, which is discussed in more detail below with respect to
The disinfectant cap 1010 includes a cap body 1012 with a sidewall 1014 and a bottom wall 1016 defining an interior. The top of the sidewall 1014 defines a top opening 1018. Although not shown, a removable film could be provided over the top opening 1018. The outer surface of the sidewall 1014 includes a plurality of annularly spaced vertical ribs 1020 oriented along the axis of the disinfectant cap 1010. The vertical ribs 1020 facilitate gripping and twisting of the cap 1010 by a user. The inner surface of the sidewall 1014 includes one or more variable thread segments 1021.
The inner surface of the upper portion 1024 of the disinfectant cap includes variable pitch thread segments 1021 (e.g., helical threads with one or more breaks or interruptions). The variable thread segments 1021 operate similarly to the threads of the disinfectant cap of
The lower portion 1026 of the inner surface of the sidewall 1014 includes retaining rings 1030, which is discussed in more detail below with respect to
A film 1156 could be provided over the top opening 1118 to seal antiseptic material (e.g., antiseptic liquid, antiseptic fluid, etc.) within the antiseptic cap 1110. The film 1156 could have an outer base 1157 and an inner flap 1159, which are separable from one another by a scored area 1161 but remain connected to one another by an attached area 1163. The scored area 1161 could be perforated or otherwise weakened (e.g., in a generally circular shape) to facilitate separating the inner flap 1159 from the outer base 1157, except at the attached area 1163 (e.g., the gap in the generally circular shape of the scored area 1161). At the attached area 1163, the inner flap 1159 remains attached to the outer base 1157. Accordingly, the scored area 1161 is in a “C” shape and is not cut at a full 360 degrees in order to retain a point of attachment between the outer base 1157 and the inner flap 1159 (e.g., the attached area 1163).
As shown in
A film 1256 could be provided over the top opening 1218, to seal antiseptic material (e.g., antiseptic liquid, antiseptic fluid, etc.) within the antiseptic cap 1210, as discussed in
As shown in
The disinfectant cap 1310 includes a cap body 1312 with a sidewall 1316 and a bottom wall 1318 defining an interior. The top of the sidewall 1316 defines a top opening 1320. The sidewall 1316 includes an upper portion 1322 and a lower portion 1324, with a shoulder (e.g., ledge) 1326 therebetween, such that the wall of the upper portion 1322 has a smaller thickness than the wall of the lower portion 1324. The annular disc 1334 rests on the shoulder (e.g., ledge) 1326 of the cap body 1312 when positioned therein. The lower portion 1324 of the sidewall 1316 of the cap body 1312 and the bottom surface of the elastomeric dome insert 1314 define a first chamber 1336 for containing antiseptic fluid. The upper portion 1322 of the sidewall 1316 of the cap body 1312 and the top surface of the elastomeric dome insert 1314 define a second chamber 1342 for receiving and engaging a medical device (e.g., LAD). The inner surface of the upper portion 1322 of the sidewall 1316 could include threads 1321 (e.g., variable and/or standard threads) and/or be elastically deformable to engage the LAD.
The disinfectant cap assembly 1300 includes the disinfectant cap 1310, elastomeric dome insert 1314, and cap holder 1360. The cap holder 1360 includes a sidewall 1362 and a bottom wall 1364 defining an interior. The top of the sidewall 1362 defines a top opening 1370 and includes an outwardly extending flange 1366. The outer surface of the sidewall 1316 could include a plurality of annularly spaced vertical ribs 1368 oriented along the axis of the cap holder 1360. A lidstock 1356 could be attached to the flange 1366 of the cap holder 1360 to seal the disinfectant cap 1310 therein. The top of the sidewall 1316 of the disinfectant cap 1310 could also be attached to the lidstock 1356 to seal the elastomeric dome insert 1314 and antiseptic fluid within the disinfectant cap 1310.
The disinfectant cap 1410 includes a cap body 1412 with a sidewall 1416 defining an interior. The top of the sidewall 1416 defines a top opening 1420, and the bottom of the sidewall 1416 defines a bottom opening 1423. The bottom opening 1423 could be hexagonally shaped (or otherwise shaped, such as circularly shaped). The sidewall 1416 includes an upper portion 1422 and a lower portion 1424, with a shoulder 1426 therebetween. The disinfectant cap assembly 1400 includes the disinfectant cap 1410, elastomeric dome insert 1414, and cap holder 1460. The cap holder 1460 includes a cap holder body 1461 with a sidewall 1462 and a bottom wall 1464 defining an interior. The top of the sidewall 1462 defines a top opening 1470 and includes an outwardly extending flange 1466. The outer surface of the sidewall 1416 could include a plurality of annularly spaced vertical ribs 1468 oriented along the axis of the cap holder 1460. As described above, a lidstock (not shown) could be attached to the flange 1466 of the cap holder 1460 to seal the disinfectant cap 1410 therein. The top of the sidewall 1416 of the disinfectant cap 1410 could also be attached to the lidstock to seal the elastomeric dome insert 1414 and antiseptic fluid within the disinfectant cap 1412.
The cap holder 1470 could further include an inwardly protruding base 1465 extending from an approximate center of the bottom wall 1464 of the cap holder 1460. The base 1465 includes one or more nubs 1467 extending from a perimeter of the base 1465. The base 1465 is approximately sized to that of the bottom opening 1423 of the disinfectant cap 1410 to be received therein. The sides of the base 1465 and/or the one or more nubs 1467 frictionally engage and/or partially deform the walls forming the bottom opening 1423 to secure the disinfectant cap 1410 to the cap holder 1460.
The lower portion 1424 of the sidewall 1416 of the cap body 1412, the bottom surface of the elastomeric dome insert 1414, and the top surface of the cap holder base 1465 define a first chamber 1436 for containing antiseptic fluid. The upper portion 1422 of the sidewall 1416 of the cap body 1412 and the top surface of the elastomeric dome insert 1414 define a second chamber 1442 for receiving and engaging a medical device (e.g., LAD). The inner surface of the upper portion 1422 of the sidewall 1416 could include threads 1421 (e.g., variable and/or standard threads) and/or be elastically deformable to engage the LAD.
Further, the bottom wall 1464 could include one or more annular cuts 1469 (e.g., or thin webbing, or other weakened area) therein generally surrounding the inwardly protruding base 1465. Accordingly, once a user fully threads the cap 1410 and cap holder 1460 onto a medical device, the user can then continue to twist, and break away the inwardly protruding base 1465 from the rest of the cap holder 1460 along the one or more cuts 1469. This leaves the inwardly protruding base 1465 still fully engaged with the cap 1410, like the cap shown in
As shown in
The embodiment of
The disinfectant cap assembly 1500 includes the disinfectant cap 1510 and cap holder 1560. The cap holder 1560 includes a cap holder body 1561 with a sidewall 1562 and a bottom wall 1564 defining an interior. The top of the sidewall 1562 defines a top opening 1570 and includes an outwardly extending flange 1566. The outer surface of the sidewall 1516 could include a plurality of annularly spaced vertical ribs (not shown). As described above, a lidstock (not shown) could be attached to the flange 1566 of the cap holder 1560 to seal the disinfectant cap 1510 therein. The top of the sidewall 1516 of the disinfectant cap 1510 could also be attached to the lidstock to seal the elastomeric dome barrier 1514 and antiseptic fluid within the disinfectant cap 1512. The cap holder 1570 could further include an inwardly protruding base 1565 extending from an approximate center of the bottom wall 1564 of the cap holder 1560. The base 1565 includes one or more nubs 1567 extending from a perimeter of the base 1565.
In this embodiment, the disinfectant cap 1510 includes an elastomeric dome barrier 1514 integrally formed with and attached to the body 1512 of the disinfectant cap 1510. The elastomeric dome barrier 1514 has a dome 1530 with a hole 1532 at (or proximate to) the apex thereof. The base 1534 of the elastomeric dome barrier 1514 is integrally attached to the interior surface of the sidewalls 1516 of the disinfectant cap 1510. Accordingly, the lower portion 1524 of the sidewall 1516 of the cap body 1512, the bottom surface of the elastomeric dome barrier 1514, and the top surface of the cap holder base 1565 define a first chamber 1536 for containing antiseptic fluid. The upper portion 1522 of the sidewall 1516 of the cap body 1512 and the top surface of the elastomeric dome barrier 1514 define a second chamber 1542 for receiving and engaging a medical device (e.g., LAD).
Further, the bottom wall 1564 could include one or more annular cuts 1569 (e.g., or thin webbing, or other weakened area) therein generally surrounding the inwardly protruding base 1565. Accordingly, once a user fully threads the cap 1510 and cap holder 1560 onto a medical device, the user can then continue to twist, and break away the inwardly protruding base 1565 from the rest of the cap holder 1560 along the one or more cuts 1569. This leaves the inwardly protruding base 1565 still fully engaged with the cap 1510, like the cap shown in
Alternately, the first chamber 1536 could be formed by the bottom surface of the dome barrier 1514, the sidewall 1516 of the cap body 1512, and an additional piece (not shown) that is inserted into the opening 1523. This allows the formation of the first chamber 1536 without using a surface of the cap holder 1560. This also allows the entire cap 1510 to set within the sterile packaging formed by the cap holder 1560 and the lidstock.
The disinfectant cap 1610 includes a plug 1660. The plug 1660 includes an inwardly protruding base 1665 and outwardly extending flanges 1667. The base 1665 is approximately sized to that of the bottom opening 1623 of the disinfectant cap 1610 to be received therein. The sides of the base 1665 and/or the one or more nubs 1667 frictionally engage and/or partially deform the walls forming the bottom opening 1623 to secure the plug 1660 to the disinfectant cap 1610. The flanges 1667 prevent over insertion of the plug 1660 into the disinfectant cap 1610. Accordingly, the lower portion 1624 of the sidewall 1616 of the cap body 1612, the bottom surface of the elastomeric dome barrier 1614, and the top surface of the plug 1660 define a first chamber 1636 for containing antiseptic fluid. The upper portion 1622 of the sidewall 1616 of the cap body 1612 and the top surface of the elastomeric dome barrier 1614 define a second chamber 1642 for receiving and engaging a medical device 1664 (e.g., LAD).
Extending from the top wall of the disinfectant cap is a neck 1784 which has been crimped (e.g., heat crimped) closed to form a frangible stop 1786. Extending from the neck 1784 is a receptacle 1780 defining a top opening 1788 and conical interior (e.g., tapered interior) to engage a medical device (e.g., LAD). The receptacle 1780 is of a generally inverted cone such that the top of the cone 1780 is wider than the base (e.g., where the receptacle 1780 attaches to the neck 1784). The inner surface of the receptacle 1780 includes one or more threads 1792 (variable and/or standard threads). The exterior surface of the receptacle 1780 could include a plurality of annularly spaced vertical ribs 1790. In this way, the antiseptic cap 1710 could be a one piece construction (e.g., all of the components are integrally connected to one another). A lidstock (not shown) could be attached to the top opening 1788 of the receptacle 1780.
As the medical device is inserted (e.g., threadably inserted) into the receptacle 1780, the taper of the receptacle 1780 forces the head 1780 apart (e.g., the narrowest point of the conical head 1780 closest to the neck 1784 is widened). As a result, the frangible stop 1786 is eventually forced open, and the antiseptic fluid contained within the body 1712 of the disinfectant cap 1710 flows out of the disinfectant cap 1710 through the neck 1786.
The disinfectant cap 1810 includes a cap body 1812 with a sidewall 1816, a bottom wall 1820, and top wall 1824 defining an interior. The bottom wall 1820 of the cap body 1812 can include an invertible wall 1832 (as described in more detail above). Extending from the top wall of the disinfectant cap is a neck 1884 which forms a channel 1886 prior to being crimped close to form a frangible stop. Extending from the neck 1884 is a receptacle 1880 defining a top opening 1888 and generally conical interior to engage a medical device (e.g., LAD). The conical interior is of a generally inverted cone such that the top of the cone 1880 is wider than the base (e.g., where the receptacle 1880 attaches to the neck 1884). The inner surface of the receptacle 1880 includes one or more threads 1892 (variable and/or standard threads). The exterior surface of the receptacle 1880 could include a plurality of annularly spaced vertical ribs 1890. In this way, the antiseptic cap 1810 could be a one piece construction (e.g., all of the components are integrally connected to one another). The receptacle 1880 further includes one or more annularly spaced upwardly angled fingers 1894 extending from a base of the receptacle 1880.
As shown in
As shown, the outermost diameter formed by the angled fingers 1894 could be greater than the inner diameter of the cap holder 1860. As a result, radial forces of the angled fingers 1894 against the cap holder keep the neck 1884 closed (thereby retaining the antiseptic fluid therein). Further, the width of the angled fingers 1894 could be approximately the same width as the spacing between the plurality of vertical ribs 1863.
As shown in
As shown in
A number of the components and features discussed above could be integrally constructed or separately attached. For example, the disinfectant cap and cover of
Having thus described the system and method in detail, it is to be understood that the foregoing description is not intended to limit the spirit or scope thereof. It will be understood that the embodiments of the present disclosure described herein are merely exemplary and that a person skilled in the art may make any variations and modification without departing from the spirit and scope of the disclosure. All such variations and modifications, including those discussed above, are intended to be included within the scope of the disclosure.
This application claims the benefit of U.S. Provisional Application No. 62/036,666 filed on Aug. 13, 2014, the entire disclosure of which is expressly incorporated herein by reference.
Number | Date | Country | |
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62036666 | Aug 2014 | US |