Sterile cap

Abstract

An apparatus for cleaning a medical device, specifically an apparatus for cleaning a vascular or other fluid access site is disclosed. The apparatus includes a cap having an opening for receiving the access site. The cap can be used in the following manner: a health care worker can open the cap package with gloved hands and place the cap over the medical device port to be cleaned. The health care worker can wipe the site by or with a twisting motion or by simply pushing the cap onto the port. The cap can then be held in place by threads or other mechanisms. The cap in place on the medical device can be a positive indication that the desired site on the medical device is clean. The cap can include a disinfecting substance.

Description

[0001] This application is a divisional application of the patent application filed on August 19, 2016, with application number 201680060068.6 (international application number PCT / US2016 / 047863) and entitled "Disinfection Cap".

[0002] Cross-references to related applications

[0003] This application claims priority and interest in the following U.S. provisional applications: No. 62 / 208,243, filed August 21, 2015, entitled “Disinfecting Cap”; No. 62 / 208,213, filed August 21, 2015, entitled “Disinfecting Cap”; and No. 62 / 216,650, filed September 10, 2015, entitled “Disinfecting Cap with Fluid Reservoir”. The contents of each of these applications are incorporated herein by reference in their entirety. Background Technology

[0004] In the medical field, and specifically in areas where fluids are injected into or aspirated from a patient, there is a need to prevent the transmission of pathogens from potentially contaminated surfaces of medical devices to or onto the patient. These pathogens include microorganisms such as bacteria and viruses. Transmission of pathogens to a patient can lead to potentially fatal infections. Common sites of transmission are found at the entry “site” or injection port of medical devices such as Luer ports, vials, needle-free valves, tubing, or catheters. Even non-invasive medical devices such as stethoscopes or otoscopes can transmit pathogens to the patient.

[0005] Therefore, there is a need for devices and techniques for cleaning parts of medical devices before they come into contact with patients. Attached Figure Description

[0006] The advantages of the present invention will become apparent from the following detailed description and with reference to the accompanying drawings.

[0007] Figure 1 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0008] Figure 2 Show Figure 1 End view of the sterilization cap.

[0009] Figure 3 Show along Figures 1-2 A sectional view of the sterilization cap along line AA.

[0010] Figure 4 Showing the threaded female port attached to the Y part. Figures 1-3 A 3D image of a disinfection cap.

[0011] Figure 5 Show Figure 4 Side view of the cap and Y-section.

[0012] Figure 6 A side view of the cap and Y-section according to an embodiment of the present invention is shown.

[0013] Figure 7 A perspective view of a cap according to an embodiment of the present invention is shown.

[0014] Figure 8 Show Figure 7 Side view of the hat.

[0015] Figure 9 Showing the threaded female port attached to the Y part. Figures 7-8 A 3D image of a disinfection cap.

[0016] Figure 10 A perspective view of a cap according to an embodiment of the present invention is shown.

[0017] Figure 11 Show Figure 10 Another three-dimensional view of the hat.

[0018] Figure 12 Show Figures 10-11 Side view of the hat.

[0019] Figure 13 Show Figures 10-11 A view of the near end of the hat.

[0020] Figure 14 A perspective view of a cap according to an embodiment of the present invention is shown.

[0021] Figure 15 Show Figure 14 Side view of the hat.

[0022] Figure 16 A cross-sectional view of a cap according to an embodiment of the present invention is shown.

[0023] Figure 17 Show Figure 16 A 3D image of the hat.

[0024] Figure 18 A perspective view of a cap with a retaining mechanism according to an embodiment of the present invention is shown.

[0025] Figure 19 Show Figure 18 A view of the near end of the hat.

[0026] Figure 20 A perspective view of a cap having another retaining mechanism according to an embodiment of the present invention is shown.

[0027] Figure 21 Show Figure 20 A view of the near end of the hat.

[0028] Figure 22 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0029] Figure 23 Show Figure 22 The second perspective view of the disinfection cap.

[0030] Figure 24 Show Figure 22 A view of the near end of the hat.

[0031] Figure 25 Show Figure 22 A cross-sectional view of the sterilization cap along line BB.

[0032] Figure 26 Show Figure 22 Side view of the hat.

[0033] Figure 27 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0034] Figure 28 Show Figure 22 A view of the near end of the hat.

[0035] Figure 29 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0036] Figure 30 Show Figure 29 The second perspective view of the disinfection cap.

[0037] Figure 31 Show Figure 29 A view of the near end of the hat.

[0038] Figure 32 Show Figure 29 Side view of the sterilization cap.

[0039] Figure 33 Showing the threaded female port attached to the Y part. Figure 29 Side view of the sterilization cap.

[0040] Figure 34 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0041] Figure 35 Show Figure 34 A view of the near end of the hat.

[0042] Figure 36 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0043] Figure 37 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0044] Figure 38 Show Figure 37 A top view of the sterilization cap.

[0045] Figure 39 Show Figure 37 Side view of the sterilization cap.

[0046] Figure 40 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0047] Figure 41 Show Figure 40 A view of the near end of the hat.

[0048] Figure 42 Show Figure 40 Side view of the hat.

[0049] Figure 43 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0050] Figure 44 Show Figure 43 A bottom view of the disinfection cap.

[0051] Figure 45 Show Figure 43 A cross-sectional view of a sterilization cap.

[0052] Figure 46 A side view of a sterilization cap according to an embodiment of the present invention is shown.

[0053] Figure 47 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0054] Figure 48 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0055] Figure 49 Show Figure 48 Side view of the sterilization cap.

[0056] Figure 50 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0057] Figure 51 Show Figure 50 The second perspective view of the disinfection cap.

[0058] Figure 52Show Figure 50 A view of the near end of the hat.

[0059] Figure 53 Show Figure 50 A cross-sectional view of the disinfection cap along line CC.

[0060] Figure 54 Show Figure 50 Side view of the hat.

[0061] Figure 55 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0062] Figure 56 Show Figure 55 A view of the near end of the hat.

[0063] Figure 57 Show Figure 55 End view of the hat.

[0064] Figure 58 A perspective view of a disinfection cap according to an embodiment of the present invention is shown.

[0065] Figure 59 Show Figure 58 A view of the near end of the hat.

[0066] Figure 60 Show Figure 58 A cross-sectional view of the disinfection cap along line DD and a cross-sectional view of the Y portion with the spiral female port.

[0067] Figure 61 The basis for indicating the subsequent use phase is shown. Figure 58 A perspective view of a sterilization cap, an embodiment of the cap shown.

[0068] Figure 62 Show Figure 61 A cross-sectional view of the disinfection cap along line DD and a cross-sectional view of the Y portion with the spiral female port.

[0069] Figure 63 The basis for indicating the subsequent use phase is shown. Figure 61 A perspective view of a sterilization cap, an embodiment of the cap shown.

[0070] Figure 64 Show Figure 63 A cross-sectional view of the disinfection cap along line DD and a cross-sectional view of the Y portion with the spiral female port.

[0071] Figure 65 The basis for indicating the subsequent use phase is shown. Figure 63 A perspective view of a sterilization cap, an embodiment of the cap shown.

[0072] Figure 66 Show Figure 65 A cross-sectional view of the disinfection cap along line DD and a cross-sectional view of the Y portion with the spiral female port.

[0073] While the invention is readily adaptable to various modifications and alternatives, specific embodiments have been illustrated by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that the invention is not intended to be limited to the specific forms disclosed. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Detailed Implementation

[0074] Embodiments of the invention will now be described in detail. Referring to the accompanying drawings, the same reference numerals denote the same parts in all views. As used herein and throughout the claims, the following terms explicitly take on their meaning in connection with the text unless the context clearly indicates otherwise: “a,” “an,” and “the” have the meaning of a plural, and “in” has the meaning of both “in” and “on”. Terms such as first and second, top and bottom, forward and backward, and similar relational terms may be used only to distinguish one entity or action from another, without necessarily requiring or implying any actual such relationship, direction, or order between such entities or actions.

[0075] In describing the various embodiments, the terms “near” and “far” are used throughout this application. These terms are not intended to be limiting and are set forth only for the convenience of maintaining a consistent orientation in describing the various embodiments. As used herein, near refers to a direction that is generally closer to the patient and / or the medical device to be cleaned, while far refers to a direction that is generally farther away from the patient and / or the medical device to be cleaned.

[0076] This application provides a description of various embodiments and examples of a device for cleaning medical devices, specifically a device for cleaning entry points to blood vessels or other fluids. Various embodiments of the invention include a cap having an opening for receiving the entry point. In this application, illustrative embodiments refer to the use of a cap engaging with a "port" as an example of such an entry point. Those skilled in the art will understand that the invention can also be used in combination with other entry points or other medical devices that do not have entry points.

[0077] The following are non-limiting examples of how healthcare workers can use this cap: A healthcare worker can open the cap packaging with gloved hands and place the cap over the port of the medical device to be cleaned. In some embodiments, the healthcare worker can wipe the area either by applying a rotational motion or simply by pushing the cap onto the port. The cap can then be held in place by threaded connections to other mechanisms described herein. The cap's placement on the medical device can be a positive indication that the desired area of ​​the medical device is clean. Bright colors or other markings can be used to allow the cap's presence to be immediately visible from a doorway or hallway.

[0078] The embodiments of the cap described herein may include a disinfectant substance, such as a solution of a suitable microbial or bactericidal agent. The disinfectant substance may include any suitable type and amount of antimicrobial disinfectant depending on the size and construction of the cap. For example, in some embodiments, the disinfectant substance may be an aqueous solution comprising about two percent (2%) of chlorhexidine gluconate (chlorhexidine gluconate solution, “CHG”). In other embodiments, the disinfectant substance comprises a solution of about 70 percent (70%) of isopropanol (“IPA”) in an aqueous solution. In yet another embodiment, the disinfectant substance comprises a solution of about 70 percent (70%) of isopropanol and about 2 percent (2%) of CHG in an aqueous solution. In the latter solution, it is noted that in one embodiment, the concentration of IPA may vary from about 60 percent (60%) to about 90 percent (90%), while the concentration of CHG may vary from about one percent (1%) to about five percent (5%).

[0079] Other suitable solution compositions and concentrations are also possible. For example, other disinfectant substances may include povidone-iodine, polyhexamethylene biguanide (“PHMB”), benzalkonium chloride (“BAC”), p-chloro-m-xylenol (“PCMX”), or hydrogen peroxide solution. Throughout this disclosure, references to one or more of these disinfectant substances in the cap embodiments should be understood as disclosures of the use of any other suitable disinfectant substances as described herein or as would be understood by those skilled in the art. Furthermore, embodiments of the disinfectant substances may be in liquid or gel form.

[0080] In various embodiments of the invention described herein, the port comes into contact with a disinfectant substance in liquid or gel form, or with an absorbent material infused with the disinfectant substance. However, the surface of the port may not necessarily come into contact with the liquid or gel disinfectant substance. For example, if IPA is used as part of a disinfectant solution, the IPA vapor trapped within the cap can act as a disinfectant for the port without requiring contact between the liquid solution and the area to be cleaned.

[0081] Various materials can be used to manufacture the cap embodiments described herein. Suitable materials may include polyurethane (“PU”), polypropylene (“PP”), thermoplastic elastomer (“TPE”), Sanoprene, or other materials that will be understood by those skilled in the art. While the various embodiments described herein record the use of specific materials, those skilled in the art will understand that other suitable materials may be used in place of the disclosed materials.

[0082] Various embodiments also describe the use of foam materials. Such foam may be formed from polyurethane (“PU”) or other suitable absorbent materials. Alternatively, other absorbent materials may be used to replace the foam, including, for example, felted nonwoven fabrics or other fibrous materials.

[0083] Figures 1-3 An illustrative sterilization cap according to an embodiment of the present invention is shown. The cap 1002 is molded from PP. The cap includes an opening 1004 having an outer peripheral flange 1006. The opening 1004 provides access to a first cavity 1008, while a second cavity 1010 having a smaller diameter extends from the base 1012 of the first cavity 1008. The cap may include ribs 1022 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers.

[0084] A foam ring 1014 is positioned within a first cavity 1008. The foam ring 1014 has a central hole 1016 extending through it. The central hole 1016 has a diameter smaller than that of the second cavity 1010. The foam ring 1014 includes slots 1024 formed at intervals around its perimeter, and the ring is capable of being filled with a disinfectant solution. The second cavity 1010 includes threads 1020 formed on the inner diameter of the cavity.

[0085] like Figures 4-5 As shown, the cap 1002 can be attached to the threaded female port of the Y portion 1026. The female port is inserted through the hole 1016 of the foam ring 1014. The foam ring thereby wipes the outer surface of the port and applies a disinfecting solution. The thread 1028 formed on the outer diameter of the female port 1026 engages with the internal thread 1020 of the second cavity 1010, securing the cap to the port.

[0086] like Figure 5 As shown, the second cavity 1010 may have a depth such that the female port or its threads are bottomed out within the cavity before the cap 1002 contacts other parts of the Y portion. Alternatively, as Figure 6 As shown, the second cavity 1010 can be deeper, such that the cap contacts the second port 1030 of the Y portion, or that the shoulder 1032 of the female port contacts the base 1012 of the first cavity surrounding the diameter of the second cavity.

[0087] Figures 7-9 An illustrative sterilization cap according to an embodiment of the invention is shown. The cap 1102 may be molded from PP or other suitable materials. The cap includes an open proximal end 1104 and a closed distal end 1106. The cap 1102 may include ribs 1126 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0088] The proximal end has an opening 1108 providing access to the cavity 1110. The cavity 1110 has a proximal section 1112 and a distal section 1114. The distal section 1114 may include threads 1116 formed on its inner diameter. A foam ring 1118 is inserted into the proximal cavity section 1112. The foam ring 1118 has a central hole 1120 extending through the ring. The ring 1118 extends a distance into the cavity 1110 but stops before the threads 1116. The ring may be filled with a disinfectant solution.

[0089] like Figure 9 As shown, the cap 1102 can be attached to the threaded female port of the Y-section 1122. The female port of the Y-section is inserted through the hole 1120 of the foam ring 1118. The foam ring thereby wipes the outer surface of the port and applies a disinfecting solution. The thread 1124 formed on the outer diameter of the female port 1122 engages with the internal thread 1116 of the distal cavity 1114, securing the cap to the port.

[0090] Figures 10-13 An illustrative sterilization cap according to an embodiment of the present invention is shown. The cap 1202 may be molded from PP or other suitable materials. The cap includes an open proximal end 1204 and a closed distal end 1206. The cap 1202 may include ribs 1226 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0091] The proximal end has an opening 1208 providing access to the cavity 1210. The cavity 1210 includes a generally cylindrical internal surface 1212. However, the internal surface may also be a tapered segment, such that the diameter adjacent to the opening 1208 is larger than the diameter located at the closed distal end 1214 of the cavity. The internal surface 1212 is divided into segments, each segment surrounding at least a portion of the cylindrical surface. Each segment includes one or more foam segments 1216 and one or more threaded segments 1218. A slot 1228 is formed in the foam segment 1218. The slot 1228 may extend generally parallel to the central axis of the cap.

[0092] Foam member 1230 is inserted into cavity 1208 along foam section 1216 on its inner surface. The foam member extends along the foam section around the periphery of the cavity, thereby forming a discontinuous ring extending around at least a portion of the inner periphery of the cavity. Finger-like members 1232 formed on the outer surface of each foam member engage slots 1228 and serve to hold the foam member in place. The foam member may be formed in a pre-bent manner or may adopt a curved shape resulting from installation against the curved periphery of the cavity. The foam member may be filled with a disinfectant solution.

[0093] Thread 1234 is formed on the inner periphery of the threaded section 1218. Cap 1202 can be attached to the threaded female port (not shown) at the Y-section. The female port at the Y-section is inserted into the cavity 1208, and the thread formed on the outer diameter of the female port engages with the internal thread 1234 of the distal cavity, securing the cap to the port. When the port is screwed into the cavity, the surface of the port passes over the foam, thereby wiping the outer surface of the port and applying a disinfectant solution.

[0094] Figures 14-15 An illustrative sterilization cap according to an embodiment of the invention is shown. The cap 1302 may be molded from PP or other suitable materials. The cap includes an open proximal end 1304 and a closed distal end 1306. The cap 1302 may include ribs 1326 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0095] The proximal end has an opening 1310 providing access to the cavity 1308. The cavity 1310 includes a generally cylindrical inner surface 1312. However, the inner surface may be a tapered section such that the diameter adjacent to the opening 1308 is larger than the diameter located at the closed distal end 1306 of the cavity. A thread 1316 is formed on the inner surface 1312 of the cavity and spaced some distance from the distal end 1306 of the cap.

[0096] The seal 1318 is positioned across the opening 1308 of the cavity 1310. The seal may be positioned adjacent to the proximal end 1304 of the cavity, or spaced apart within the cavity, leaving a space 1320 between the seal and the cap end. The space 1322 within the cavity enclosed by the seal 1318 may be at least partially filled with IPA. The seal may include a perforation 1324, a scribe line, or other features that facilitate seal rupture.

[0097] The cap 1302 can be attached to the threaded female port (not shown) at the Y-section. The female port at the Y-section is inserted into the cavity 1308, and the thread formed on the outer diameter of the female port engages with the internal thread 1316 of the cavity, securing the cap to the port. Due to the force applied to the cap to engage the port, the perforated seal cracks under the pressure from the port. The port surface is thus exposed to the IPA of liquid or vapor.

[0098] Figures 16-17 An illustrative sterilization cap according to an embodiment of the invention is shown. The cap 1402 may be formed of PP or other plastics. The cap includes generally cylindrical sidewalls 1404. The cap includes an open proximal end 1406 and a closed distal end 1408, and surrounds a cavity 1410. The cap 1402 may include ribs (not shown) formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown in other embodiments, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0099] The cap also includes a diaphragm valve 1414 covering the open end 1406 of the cavity 1410. The valve covers the proximal end 1418 of the sidewall 1404 and the open end 1406 of the cavity 1410. A portion 1422 of the diaphragm valve 1414 may extend an opening along the outer surface 1420 of the sidewall 1404. The valve may be molded over the side and open end of the cap. The diaphragm valve includes a slit 1424. A female port or other access portion is pushed through the slit 1424 into the cavity 1410. Once the port has passed through the slit, the diaphragm valve secures the end of the port within the cavity.

[0100] A portion of the cavity 1410 may be filled with IPA or another disinfectant in liquid or gel form. Alternatively, at least a portion of the cavity may be filled with foam such as open-cell PU foam 1426. The foam may be infused with a disinfectant.

[0101] Figures 18-19An illustrative sterilization cap with a retaining mechanism is shown, according to an embodiment of the invention. Various embodiments of the invention described herein utilize threads formed on the outside of the area to be sterilized, thereby securing the cap to that area. However, the invention also contemplates, for example, in… Figures 18-19 The alternative fixation mechanism is shown. The cap 1502 includes an open proximal end 1504 and a closed distal end 1506. The cap 1502 may include ribs 1526 or other gripping elements. The proximal end has an opening 1508 providing access to the cavity 1510. The cavity 1510 includes a generally cylindrical inner surface 1512. However, the inner surface may also be a tapered segment, such that the diameter adjacent to the opening 1508 is larger than the diameter located at the closed distal end 1504 of the cavity.

[0102] Adjacent to opening 1508, the internal surface includes a series of stepped countersunk holes 1514, 1516, and 1518. Each successive countersunk hole has a smaller diameter than the preceding one. Therefore, as... Figure 18 As shown, the proximal countersunk hole 1514 adjacent to the opening has a first diameter, followed by the countersunk hole 1516 with a second smaller diameter, and so on, until the diameter of the inner surface 1512 is reached. The illustrative embodiment shows three different countersunk holes, but more or fewer countersunk holes can be used.

[0103] The countersunk holes 1514, 1516, and 1518 are designed to engage the threads, shoulders, or other parts of the portion by means of friction fit. Alternatively, the countersunk holes may provide clearance for the shoulders of the portion, allowing the inner surface 1512 to have a suitable diameter to engage the threads of the port by means of friction fit.

[0104] Figures 20-21 An illustrative sterilization cap with an alternative holding mechanism according to an embodiment of the invention is shown. The cap 1602 includes an open proximal end 1604 and a closed distal end 1606. The cap 1602 may include ribs 1626 or other gripping elements. The proximal end has an opening 1608 providing access to a cavity 1610. The cavity 1610 includes a generally cylindrical inner surface 1612. However, the inner surface may also be a tapered segment such that the diameter adjacent to the opening 1608 is larger than the diameter located at the closed distal end 1604 of the cavity.

[0105] The retaining element 1614 extends from the inner surface 1612. For example... Figures 20-21As shown, these elements are arranged in three rows 1616a, 1616b, and 1616c, evenly spaced around the inner surface. However, more or fewer may be used. Within each row, a series of retaining elements 1614, 1614b, and 1614c extend longitudinally along the inner surface 1612 into the cavity 1610. Arranged in this way, the retaining elements engage with the threads or other features of the port to be cleaned and hold the cap on the port.

[0106] In various embodiments, the retaining elements can be formed in a resilient manner, such that the cap can be pushed onto the port. As the threads of the port are pushed past each retaining element, the element allows the threads to pass through and then springs back to a position in which the retaining element engages the threads and retains the cap. Alternatively, the cap can be screwed onto the port such that the retaining element engages the threads.

[0107] The exemplary embodiments discussed herein envision holding elements 1614 arranged in a particular type, particularly in columns of equal holding elements. However, those skilled in the art will understand that holding elements can be arranged in any other possible type, including primarily in a spiral type or in a spaced matrix.

[0108] Figures 22-25 An illustrative disinfection cap according to an embodiment of the invention is shown. The cap 1702 is molded from PU and is formed by reactive injection molding of PU foam into its final shape. The molded foam 1740 may include a skin 1742 resistant to IPA or other disinfectant solutions. The cap includes an open proximal end 1704 and a closed distal end 1706. The cap 1702 may include ribs 1726 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0109] The proximal end has an opening 1708 providing access to the main cavity 1710. The cavity 1710 has generally cylindrical sidewalls 1712 and a distal or bottom surface 1714. Threads 1716 may be formed on the sidewalls to engage with the threads of the area to be cleaned and to retain the cap in that area. The cylindrical sidewalls may have a constant diameter along the longitudinal axis of the cap, or the diameter may increase along the longitudinal axis such that, in one embodiment, the diameter of the sidewall at the distal end is larger than the diameter of the sidewall at the proximal end or near the bottom surface 1714. In another embodiment, the diameter may decrease along the longitudinal axis such that the diameter of the sidewall at the distal end is smaller than the diameter of the sidewall at the proximal end or near the bottom surface 1714.

[0110] One or more recesses, cavities, or holes 1718 are formed extending from the distal surface 1714 of the cavity 1710 into the cap. These holes 1718 are at least partially filled with a disinfectant solution such as a liquid or gel ISA and serve as reservoirs for holding the disinfectant solution. When inserted into the cap, the end surface of the portion may contact the distal surface 1714 of the cavity 1710, thereby wetting the portion with the disinfectant solution, or the surface of the portion may remain spaced apart from the distal surface, thereby providing disinfection by the vapor of the disinfectant solution contained within the cap.

[0111] The cap 1702 may include a peelable cap 1720 that seals to the cap skin 1742 to retain the disinfectant solution within the cap cavity 1710, thereby preventing the disinfectant solution from leaking or evaporating from the cap 1702.

[0112] Hole 1718 can be generally cylindrical and can be set in any suitable manner. Alternatively, the holes can be formed in other shapes. For example, Figures 27-28 Showing with Figures 22-26 A similar embodiment of the cap 1802, wherein the holes 1818 are spaced further away from the sidewalls 1812 and are generally rectangular in shape. Each hole can be as follows... Figures 24-25 and Figure 28 The holes are formed to have a uniform cross-section, or each hole may have a different cross-section. For example, each hole may be conical or pyramidal, such that the opening 1728 adjacent to the distal surfaces 1714, 1814 of the cavities 1710, 1810 has a larger cross-sectional area than the bottom 1724 of the hole 1718. Alternatively, each hole may be undercut, such that the opening adjacent to the distal surfaces 1714, 1814 of the cavities 1710, 1810 has a smaller cross-sectional area than the bottom 1724 of the hole 1718. The shape or geometry of the holes may be such that the surface tension (cohesion and adhesion) of the disinfectant solution is retained within the holes below the distal surfaces 1714, 1814 without the need for a cover or other retaining mechanism.

[0113] In one embodiment, the disinfectant solution in the cap fills at least a portion of each individual cavity 1718 and the main cavity 1710. The applicant was surprised to find that the cap having this construction—that is, multiple cavities in the bottom surface combined with the main cavity—allows it to retain a significantly larger volume of solution, particularly when flipped, compared to that achieved by means of a single main cavity portion. This allows the cap to be flipped when mounted on a port while still retaining a sufficient volume of solution. Even when the cap is shaken, it retains sufficient solution. This result is found in both caps using internal threads and caps without threads that use cylindrical sidewalls of a constant diameter that engage with the port through frictional fit.

[0114] In tests conducted using a cap with a honeycomb structure of 2.5 mm depth, initial tests showed that, upon flipping, the honeycomb structure retained 50% more IPA than caps without a honeycomb structure or certain other fluid retention mechanisms. Furthermore, the honeycomb structure retained 70% of its flipped IPA after vigorous shaking.

[0115] Figures 29-32 An illustrative sterilization cap according to an embodiment of the invention is shown. The cap includes an open proximal end 1904 and a closed distal end 1906. The cap 1902 may include ribs 1926 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0116] The proximal end has an opening 1908 providing access to the cavity 1910. The cavity 1910 has generally cylindrical sidewalls 1912 and a distal or bottom surface 1914. Threads 1916 may be formed on the sidewalls to engage with the threads of the area to be cleaned and retain the cap in that area. The threads may extend completely around the inner periphery of the internal cavity, they may extend partially around the inner periphery, or they may extend more than around the entire inner periphery.

[0117] One or more recesses, cavities, or holes 1918 are formed extending from the distal surface 1914 of the cavity 1910 into the cap. These holes 1918 are at least partially filled with a sterilizing solution of ISA, such as a liquid or gel, and serve as reservoirs for holding the sterilizing solution. The holes 1918 may be generally cylindrical and may be arranged in any suitable manner. Alternatively, the holes may be formed in other shapes.

[0118] Each hole can be as follows Figures 31-32 The holes are formed to have a uniform cross-section, or each hole may have a different cross-section. For example, each hole may be conical or pyramidal, such that the opening 1928 adjacent to the distal surface 1914 of the cavity 1910 has a larger cross-sectional area than the bottom 1924 of the hole 1918. Alternatively, each hole may be undercut, such that the opening 1928 adjacent to the distal surface 1914 of the cavity 1910 has a smaller cross-sectional area than the bottom 1924 of the hole 1918. The shape or geometry of the holes may be such that the surface tension (cohesion and adhesion) of the disinfectant solution is held within the holes below the distal surface 1914, eliminating the need for a cover or other retaining mechanism when using a cap.

[0119] However, as Figure 36As shown, the cap may include a peelable cap 1950 or other packaging. A portion 1952 of the cap 1950 extends into the cavity 1910 of the cap 1902. The inner surface of the extension 1952 of the cap seals the bottom surface of the cavity 1910 to retain the disinfectant solution in the orifices until the cap is used.

[0120] like Figure 33 As shown, cap 1902 can be attached to the threaded female port of Y portion 1930. The female port of Y portion is inserted into the cavity 1910 of cap. Thread 1932 formed on the outer diameter of female port 1930 engages with internal thread 1916 to secure cap to port.

[0121] When inserted into the cap, the end surface 1934 of this portion can contact the distal surface 1914 of the cavity 1910, causing the portion to be wetted by the disinfectant solution. When the connector face 1934 engages with the bottom surface 1914 of the cavity 1910, the bottom surface 1914 and the opening 1928 twist, and as the opening deforms and loses its full volume, the disinfectant solution is released from the opening 1918. The material of the entire cap, or only the section surrounding the opening 1918 at the bottom of the cavity 1910, can be a soft or hard plastic, such as polypropylene (PP) or savantine or other thermoplastic elastomers (TPE). Alternatively, the surface of this portion can remain spaced apart from the distal surface, thereby providing disinfection by the disinfectant solution vapor contained within the cap.

[0122] Figures 34-35 An illustrative embodiment of a cap 2002 is shown, which is related to Figures 29-33 Similar to the embodiments, in which the holes 2018 are formed as honeycomb structures 2048 instead of individual cavities.

[0123] Figures 40-42 Another illustrative embodiment of the cap 2802 is shown, which is similar to... Figures 34-35 The embodiments are similar. In this exemplary embodiment, the cap includes an open proximal end 2804 and a closed distal end 2806. The cap 2802 may include ribs 2826 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0124] The proximal end has an opening 2808 providing access to the cavity 2810. The cavity 2810 has generally cylindrical sidewalls 2812 and a distal or bottom surface 2814. Threads 2816 may be formed on the sidewalls to engage with the threads of the area to be cleaned and to retain the cap in place. The threads may extend completely around the inner periphery of the internal cavity, they may extend partially around the inner periphery, or they may extend around the entire inner periphery more than once. In the illustrative embodiment, the threads are shown as extending upwards to the surface of the proximal end 2804 of the cap.

[0125] Hexagonal cavities or holes 2818, similar to a honeycomb structure, are formed extending from the distal surface 2814 of the cavity 2810 into the cap. These holes 2818 are at least partially filled with a disinfectant solution such as a liquid or gel ISA and serve as a reservoir for holding the disinfectant solution.

[0126] Each hole can be as follows Figures 40-42 The holes are formed to have a uniform cross-section, or the holes may have varying cross-sections. For example, each hole may be conical or hexagonal pyramidal, such that the opening 2828 adjacent to the distal surface 2814 of the cavity 2810 has a larger cross-sectional area than the bottom 2824 of the hole 2818. Alternatively, each hole may be undercut, such that the opening 2828 adjacent to the distal surface 2814 of the cavity 2810 has a smaller cross-sectional area than the bottom 2824 of the hole 2818. The shape or geometry of the holes may be such that the surface tension (cohesion and adhesion) of the disinfectant solution is held within the holes below the distal surface 2814, eliminating the need for a cover or other retaining mechanism when using a cap.

[0127] Figures 37-39 An illustrative sterilization cap according to an embodiment of the invention is shown. The cap 2102 includes a lanyard 2104 for suspending or otherwise attaching the cap to a port or entry point to be cleaned. The lanyard has a loop 2106 through which the port can be inserted. The cap may include two cap portions 2108, 2110, such that the cap can be used twice. Each cap portion has a generally cylindrical sidewall 2112 and an open end 2114 and a closed end 2116. The caps are positioned back-to-back such that the closed end 2116 is common. The cap 2102 is removed from any package, and the first cap portion 2108 is applied to the port to be cleaned. Even when removed from the initial package, the second cap portion 2110 includes a sealed cap 2118. When a healthcare worker uses the cap a second time, the cap 2118 is removed, and the second cap portion 2110 is applied to the port to be cleaned.

[0128] Figures 43-45An illustrative sterilization cap according to an embodiment of the present invention is shown. The cap 2402 may be molded from PP or other suitable plastics or other materials. The cap includes an opening 2404 having an outer peripheral surface 2406 surrounding the opening. The opening 2404 provides access to a cavity 2408.

[0129] The cap 2402 may have a generally square cross-section or may include ribs formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0130] Cavity 2408 has generally cylindrical sidewalls 2412 and a distal or bottom surface 2414. Retaining elements 2410 extend from the inner surface 2412. In various embodiments, the retaining elements may be formed resiliently such that a cap can be pushed onto the port. As the threads of the port are pushed past each retaining element, the element allows the threads to pass through and then springs back to a position in which the retaining element engages the threads and retains the cap. Alternatively, the cap may be screwed onto the port such that the retaining element engages the threads.

[0131] Those skilled in the art will understand that the retaining element 2410 can be configured in any number of possible forms, including primarily in column, row, or spaced matrix configurations. Alternatively, threads may be formed on the sidewalls to engage with the threads of the area to be cleaned and retain the cap on the area.

[0132] The cylindrical sidewalls may have a constant diameter along the longitudinal axis of the cap, or the diameter may increase along the longitudinal axis such that, in one embodiment, the diameter of the sidewall at the proximal end is larger than the diameter of the sidewall at the distal end or near the bottom surface 2414. In another embodiment, the diameter may decrease along the longitudinal axis such that the diameter of the sidewall at the proximal end is smaller than the diameter at the distal end or near the bottom surface 2414.

[0133] The cap 2402 may include an aperture 2416 adjacent to the bottom or distal end of the cap. The aperture may be sized to receive a thumb pad 2418 attached to a plunger actuation shaft 2420 of a syringe (not shown). The bottom surface 2424 surrounding the aperture 2416 may include a slot 2422 having suitable dimensions to receive a rib 2426 of the syringe plunger shaft 2420.

[0134] Absorbent material 2430 may be positioned within cavity 2408. This absorbent material may be filled with a disinfectant solution. Alternatively, the disinfectant solution may be present within the cavity without the use of absorbent material. Cap 2402 may include a peelable cap 2428 that seals to the top surface 2406 of the cap, thereby retaining the disinfectant solution within the cap cavity 2408 and preventing leakage or evaporation of the disinfectant solution from cap 2402.

[0135] Figure 46 An illustrative sterilization cap according to an embodiment of the invention is shown. In this embodiment, the cap 2502 includes resilient fingers 2516 extending from a bottom surface 2524 of the cap. One or more slots 2522 may extend vertically between the resilient fingers 2516, such that the fingers can flex outward to receive a push pad 2518 attached to a plunger actuation shaft 2520 of a syringe 2532. The fingers 2516 may include notches or grooves 2534 in which the push pad is disposed when the cap is installed. In the illustrated embodiment, the opening 2504 of the cap is located on the distal end 2536 of the cap, away from the syringe 2532.

[0136] Figure 47 An illustrative disinfection cap according to an embodiment of the invention is shown. In this embodiment, the cap 2602 may be formed of a soft or flexible material. The cap includes a flange 2616, which is stretched to extend around at least a portion of the diameter of a push pad 2618 attached to a plunger actuation shaft 2620 of a syringe (not shown). The cap 2602 includes a cavity 2608 having an opening 2604 and a closed end 2614. In the illustrated embodiment, the top surface 2606 of the cap surrounding the opening 2604 is positioned adjacent to the surface of the push pad 2618. Thus, the push pad can act to seal the cavity 2608, thereby retaining the disinfectant solution within the cap cavity.

[0137] In such Figures 48-49 In the alternative embodiment shown, cap 2702 may include clamping member 2716. Clamping member may include resilient arm 2718, which is sized to releasably engage the barrel 2734 of syringe 2732.

[0138] Absorbent material 2730 may be positioned within cavity 2408. This absorbent material may be filled with a disinfectant solution. Alternatively, the disinfectant solution may be present in the cavity without the use of absorbent material. Cap 2702 may include a peelable cap 2728 that seals to the top surface 2706 of the cap, thereby retaining the disinfectant solution within the cap cavity 2708 and preventing leakage or evaporation of the disinfectant solution from cap 2702.

[0139] Figures 50-53An illustrative disinfection cap according to an embodiment of the invention is shown. The cap 2202 is molded from PU and is formed by reactive injection molding of PU foam into its final shape. The molded foam 2240 may include a skin 2242 resistant to IPA or other disinfectant solutions. The cap includes an open proximal end 2204 and a closed distal end 2206. The cap 2202 may include ribs 2226 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0140] The proximal end has an opening 2208 providing access to the cavity 2210. The cavity 2210 has generally cylindrical sidewalls 2212 and a distal or bottom surface 2214. The cylindrical sidewalls 2212 may have a constant diameter along the longitudinal axis of the cap, or the diameter may increase along the longitudinal axis such that, in one embodiment, the diameter of the sidewall at the distal end is larger than the diameter of the sidewall at the proximal end or near the bottom surface 2214. In another embodiment, the diameter may decrease along the longitudinal axis such that the diameter of the sidewall at the distal end is smaller than the diameter at the proximal end or near the bottom surface 2214.

[0141] Various embodiments of the cap may include a valve 2230. The valve may be a duckbill-type diaphragm or other type of self-sealing valve. As shown in the illustrative embodiment, the valve 2230 includes a flange 2232 extending above the top surface 2234 of a cavity sidewall 2236. The sidewall 2236 may include a countersunk hole 2238 or recess that receives the flange 2232, such that the proximal surface of the flange is flush with the proximal surface of the cap. A portion 2244 of the valve 2230 extends distally from the flange 2232 along the inner diameter 2212 of the cavity 2210. Starting below the proximal surface of the cap, two generally planar portions 2246 of the valve extend distally at relative angles (inclined towards each other), meeting at an acute angle 2248. A slit 2250 is formed at the intersection of the two planar portions 2246.

[0142] When a healthcare worker inserts the port to be cleaned into the cap, the end of the port passes through the valve and is exposed to the disinfectant solution. Once the port has passed through slit 2250, the valve secures the end of the port within the cavity. A portion of the cavity 2210 may be filled with IPA or other disinfectant substances in liquid or gel form. Alternatively, at least a portion of the cavity may be filled with foam such as open-cell PU foam. The foam may be infused with disinfectant. The valve may operate to secure the cap to the port and also to prevent or reduce leakage of disinfectant solution from the cap.

[0143] The cap 2202 may include a peelable cap 2220 that seals to the cap skin 1742 to retain the disinfectant solution within the cap cavity 2210, thereby preventing the disinfectant solution from leaking or evaporating from the cap 2202.

[0144] Figures 55-57 An illustrative sterilizing cap according to an embodiment of the present invention is shown. The cap 2302 includes a first engaging portion 2330 and a second reservoir portion 2370. The engaging portion 2330 includes a generally cylindrical sidewall 2338. The engaging portion includes an open proximal end 2334 and an open distal end 2336, and surrounds a cavity 2342. Threads 2340 may be formed on the sidewall to engage with threads on the portion to be cleaned and to retain the cap in that portion. The cylindrical sidewall may have a constant diameter along the longitudinal axis of the cap, or the diameter may increase along the longitudinal axis such that the diameter of the sidewall at the proximal end 2334 is larger than the diameter of the sidewall at the distal end 2336. In another embodiment, the diameter may decrease along the longitudinal axis such that the diameter of the sidewall at the proximal end 2334 is smaller than the diameter of the sidewall at the distal end 2336.

[0145] The cap 2302 may include ribs (not shown) formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0146] The engagement portion 2330 includes a diaphragm valve 2344 covering the distal end 2336 of the cavity 2342. The valve may cover the distal end 2346 of the sidewall 2338 and the open end 2336 of the cavity 2342. A portion 2348 of the diaphragm valve 2344 may extend beyond the opening along the outer surface 2350 of the sidewall 2338. The valve may be molded over the side and open end of the engagement portion. The diaphragm valve 2344 includes a slit 2352. A female port or other access portion is pushed through the slit 2350 into the cavity 2342, and the threads 2340 of the cavity engage with the threads of the port. Alternatively, once the port has passed through the slit, the diaphragm valve may retain the end of the port within the cavity.

[0147] The cap 2302 also includes a reservoir portion 2370. The reservoir portion includes an open proximal end 2372 and a closed distal end 2374. A generally cylindrical sidewall 2378 surrounds a cavity 2376. The reservoir portion may be acoustically welded to or otherwise attached to the mating portion. A portion of the cavity 2376 may be filled with IPA or other disinfectant substances in liquid or gel form. Alternatively, at least a portion of the cavity may be filled with foam such as open-cell PU foam. The foam may be infused with disinfectant substances. Accordingly, when the female port or other access portion is pushed through the slit 2352 of the mating portion 2330 into the cavity 2370 of the reservoir portion 2370, the port is exposed to the disinfectant substances.

[0148] Figures 58-60 An illustrative disinfection cap according to an embodiment of the invention is shown. The cap 2902 is molded from PP. Alternatively, the cap may be molded from PU and may be reactively injection molded from PU foam into its final shape. The molded foam may include a skin resistant to IPA or other disinfectant solutions. The cap 2902 includes an open proximal end 2904 and a closed distal end 2906. The cap may include ribs 2926 formed on its outer surface to provide easier handling and twisting of the cap by healthcare workers. The ribs may extend parallel to the central axis of the cap as shown, or may have other configurations. Alternatively, other embossed elements, textured elements, finger-shaped elements, or gripping elements may be provided.

[0149] The proximal end has an opening 2908 providing access to the cavity 2910. The cavity 2910 has generally cylindrical sidewalls 2912 and a distal or bottom surface 2914. Threads may be formed on the sidewalls to engage with the threads of the area to be cleaned and to retain the cap in that area. The cylindrical sidewalls may have a constant diameter along the longitudinal axis of the cap, or the diameter may increase along the longitudinal axis such that, in one embodiment, the diameter of the sidewall at the proximal end is larger than the diameter of the sidewall at the distal end or near the bottom surface 2914. In another embodiment, the diameter may decrease along the longitudinal axis such that the diameter of the sidewall at the distal end is smaller than the diameter of the sidewall at the proximal end or near the bottom surface 2914.

[0150] The cap 2902 may also include a separating disc or sieve 2918. The illustrative sieve 291 has a generally cylindrical disc-shaped / flat circular shape with an outer diameter 2920, which corresponds on a portion of its circumference to the sidewall 2912 of the cavity 2910. The sieve 2918 divides the cavity 2910 into two parts, a proximal portion 2922 adjacent to the opening 2908 and a distal portion 2924 adjacent to the bottom surface 2914 of the cavity. The distal cavity 2924 may be at least partially filled with a disinfectant solution.

[0151] The sieve 2918 may have one or more through holes 2928. The holes 2928 may be generally cylindrical and may be arranged in any suitable manner. Alternatively, the holes may be formed in other shapes. The holes may be as follows: Figures 58-60 The holes are formed to have a uniform cross-section, or each hole may have a different cross-section. For example, each hole may have a conical shape or a pyramidal shape.

[0152] The sidewalls 2912 of the cavity 2910 may include one or more slots 2930. Each slot extends parallel to the longitudinal axis of the cap. Ridges or arms 2932 extend from the outer diameter 2920 of the sieve 2918. These arms 2932 engage with the slots 2930 within the cavity diameter and allow the arms 2918 to slide longitudinally within the cavity 2910. The arms 2932 may extend longitudinally over the top surface 2934 of the sieve 2918.

[0153] Figure 58 and Figure 60 The cap is shown before the female port 2036 at the Y-section 2038 is inserted into the cap. The screen is positioned adjacent to the open end 2904 of the cap such that the arm 2932 is parallel to or below the top surface 2903 of the cap.

[0154] Figures 61-62 The cap 2902 is shown when the female port 2934 first contacts the cap. In the illustrative embodiment, the thread 2940 formed on the outer diameter of the female port or the distal surface 2942 of the port 2934 contacts the arm 2932 of the sieve 2918. The top surface 2934 of the sieve is spaced apart from the top surface 2903 of the cap by a first distance 2944. At this moment, the distal portion 2924 of the cavity 2910 is at least partially filled with disinfectant solution, while the proximal portion 2922 of the cavity does not contain any disinfectant solution.

[0155] Figures 63-64 The cap 2902 is shown when the female port 2934 has been partially pushed into the cap. The top surface 2934 of the sieve is spaced a second, larger distance 2946 from the top surface 2903 of the cap. At this moment, the distal portion 2924 of the cavity 2910 remains at least partially filled with disinfectant solution, but at least a portion of the disinfectant solution has been forced through the hole 2928 into the proximal portion 2922 of the cavity. The disinfectant solution wets and disinfects the surface of the female port 2934.

[0156] Figures 65-66The cap 2902 is shown when the female port 2934 has been fully pushed into the cap. The top surface 2934 of the sieve is spaced a third, larger distance 2948 from the top surface 2903 of the cap. At this moment, the distal portion 2924 of the cavity 2910 can completely collapse as shown in the illustrative embodiment. Alternatively, the distal portion of the cavity can retain at least some volume filled with disinfectant solution, but a considerable portion of the disinfectant solution has been forced through the hole 2928 into the proximal portion 2922 of the cavity. The inner diameter 2912 of the cavity 2910 can retain the cap on the port by means of a friction-fitting engagement of the thread 2940 of the female port 2934.

[0157] When port 2934 is inserted into the cap, it forces sieve 2918 into the distal cavity portion 2924, and the disinfectant solution is forced through orifice 2918 into the proximal cavity portion 2922, where the disinfectant solution wets and disinfects the port. The disinfectant liquid can flow through the orifices, causing it to flow along the sidewall 2912 of the cavity and onto the port. Alternatively, the insertion speed of the port can be such that the disinfectant liquid is forced through orifice 2918 with sufficient force to spray onto and cover the port surface.

[0158] Figures 58-66 The illustrated embodiment provides an example of a sieve 2918 having a certain thickness between its top surface 2934 and bottom surface. In alternative embodiments of the invention, the sieve may have a different thickness, which may be thinner or thicker than that shown in the exemplary embodiment. In view of the disclosure of this application, those skilled in the art will understand that the combination of the sieve thickness and the size and shape of the orifice 2928 will affect the amount of disinfectant liquid flowing onto or sprayed onto the port surface.

[0159] The cap 2902 may include a peelable cap that seals to the top surface 2903 of the cap, thereby retaining the disinfectant solution within the cap cavity 2910 and thus preventing the disinfectant solution from leaking or evaporating from the cap 2902.

[0160] While some embodiments have been described in detail above, other modifications are possible. For example, any of the embodiments described above may be sized and proportioned for use in a particular medical device, such as a stethoscope or otoscope. Other embodiments are within the scope of the following claims.

[0161] This application provides a description of various embodiments and examples of a device for cleaning medical devices. The embodiments have been described as having various features. Those skilled in the art will understand that the features of the embodiments are intended to be interchangeable, and that features described in the context of one embodiment may be implemented in combination with a device having the features and structure of another embodiment.

Claims

1. A sterilization cap, into which a portion of a medical device is insertable, the sterilization cap comprising: A closed distal end and an open proximal end, the proximal end including an opening that provides access to a cavity, the cavity including generally cylindrical sidewalls and a bottom surface; A separating disc divides the cavity into two parts, including a proximal part and a distal part, the proximal part being adjacent to the opening and the distal part being adjacent to the bottom surface, the separating disc including one or more through holes; Before the medical device is inserted, the separation disc is in a first position, adjacent to the open end of the cap and spaced a first distance from the top surface of the cap; Inserting the medical device into the cap will displace the separation disc from the first position to the second position, creating a second distance that is greater than the first distance between the disc and the top surface of the cap.

2. The disinfection cap according to claim 1, characterized in that, The portion of the inserted medical device is a port.

3. The disinfection cap according to claim 2, characterized in that, The port mentioned is the mother port of the Y part.

4. The disinfection cap according to claim 2, characterized in that, The inner surface of the cavity engages with the threads of the port through a friction fit to retain the cap on the port.

5. The disinfection cap according to claim 1, characterized in that, The separating disc includes a sieve.

6. The disinfection cap according to any one of claims 1 to 5, characterized in that, When the separation disc is in the first position, the distal portion of the separated cavity is at least partially filled with disinfectant solution.

7. The disinfection cap according to claim 6, characterized in that, Displacing the separation plate from the first position to the second position forces at least a portion of the disinfectant solution to enter the proximal portion of the cavity from the distal portion of the cavity through the holes in the separation plate.

8. The disinfection cap according to claim 7, characterized in that, The disinfectant solution wets and disinfects the surface of the medical device.

9. The disinfection cap according to claim 7, characterized in that, Inserting the medical device fully into the cap will displace the separation disc from the second position to the third position, which is a third distance from the top surface of the cap that is greater than the second distance.

10. The disinfection cap according to claim 9, characterized in that, Displacing the separation disc from the second position to the third position forces a significant portion of the disinfectant solution to enter the proximal portion of the cavity from the distal portion of the cavity through the holes in the separation disc.

11. The disinfection cap according to claim 9, characterized in that, Displacing the separation disc from the second position to the third position will cause the distal portion of the cavity to collapse.

12. The disinfection cap according to claim 6, characterized in that, The medical device is inserted into the cap at a sufficient speed so that the disinfectant liquid is forced through the hole by sufficient force, so that the disinfectant liquid is sprayed onto and covers the port surface of the medical device.

13. The disinfection cap according to any one of claims 1 to 5, characterized in that, The sidewalls of the cavity include slots.

14. The disinfection cap according to claim 13, characterized in that, The slot extends parallel to the longitudinal axis of the cap.

15. The disinfection cap according to claim 14, characterized in that, The separation disk includes an arm extending from the outer diameter of the separation disk.

16. The disinfection cap according to claim 15, characterized in that, The arm of the separation disc engages with a slot in the sidewall of the cavity.

17. The disinfection cap according to claim 16, characterized in that, The arm extends longitudinally above the top surface of the separation disc.

18. The disinfection cap according to claim 16, characterized in that, Before the medical device is inserted, the separation disc is positioned adjacent to the open end of the cap such that the arm is parallel to or below the top surface of the cap.

19. The disinfection cap according to claim 1, characterized in that, The medical device in question is a stethoscope.

20. The disinfection cap according to claim 1, characterized in that, The medical device is an otoscope.

21. The disinfection cap according to any one of claims 1 to 5, characterized in that, The cap also includes ribs formed on the outer surface of the cap.

22. The disinfection cap according to claim 1, characterized in that, The one or more through holes include cylindrical holes with a consistent cross-section.

23. The disinfection cap according to claim 1, characterized in that, The one or more through holes include a tapered shape.

24. The disinfection cap according to claim 1, characterized in that, The one or more through holes include a pyramidal shape.

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