Disinfecting Cap for Medical Connectors

[0001] The present application claims priority to provisional application no. 62/083,817, filed Nov. 24, 2014. This application is incorporated herein by reference in its entirety.

[0002] The present invention relates to caps for medical connectors, and more particularly to caps that can be used to protect the sterility of unconnected medical connectors, such as connectors that may be used for fluid flow or for fluid delivery systems.

[0003] Luer Access Valves (LAV), often referred to as Needless Injection Sites (NIS), are intended to be compliant with the ISO luer thread standard (ISO 594-2), but vary dimensionally, even within the standard. The ISO standard does not anticipate mating caps which lack a luer post—such as disinfecting caps. The problem is providing a secure fit which will not become loose with time and use. In a standard luer connection, the securement is provided by the locking taper fit of the male luer post in the female luer. In a disinfecting cap for an NIS, there is no luer post, and the securement must be provided by other features. In the design presented herein, the securement is provided by a compression fit of the inner diameter of the cap, and the major thread diameter of the NIS, as discussed in more detail below.

[0004] In accordance with one embodiment of the invention, a disinfecting cap is provided for accepting a needleless injection site and applying an antiseptic agent to the needleless injection site. The cap includes a cap body defining a chamber having an opening at a proximal end for accepting the needleless injection site, the chamber having a proximal portion and a distal portion. The cap also includes an antiseptic agent disposed in the distal portion of the chamber, and a breakable seal located in the chamber between the proximal and distal portions so as to be spaced away from the opening. The breakable seal prevents evaporation of the antiseptic agent until a needleless injection site is accepted into the cap. In one variation of this embodiment, the cap body includes a compliant wall about the proximal portion, and the compliant wall deforms when a needleless injection site is inserted into the opening so that the compliant wall engages threading elements on the outer diameter of the needleless injection site to removably hold the cap on the needleless injection site.

[0005] In one embodiment, the breakable seal is oriented transverse to, but not perpendicular to, a longitudinal axis of the cap. In an alternative embodiment, the breakable seal is oriented perpendicular to a longitudinal axis of the cap. In some embodiments, the cap also includes an absorbent material for holding the antiseptic agent, the absorbent material being disposed in the distal portion of the chamber. In some embodiments, the cap body includes a compliant wall about the proximal portion. The compliant wall deforms when a needleless injection site is inserted into the opening so that the compliant wall engages threading elements on the outer diameter of the needleless injection site to removably hold the cap on the needleless injection site. In some embodiments, the compliant wall is made of a thermoplastic elastomer. In alternative embodiments, the compliant wall is made of silicone.

[0006] In an alternative embodiment, a disinfecting cap is provided for accepting a needleless injection site and applying an antiseptic agent to the needleless injection site, wherein the cap body includes a compliant wall about the proximal portion, the compliant wall deforming when a needleless injection site is inserted into the opening so that the compliant wall engages threading elements on the outer diameter of the needleless injection site to removably hold the cap on the needleless injection site. The cap includes a chamber having an opening at the proximal end for accepting the needleless injection site, and an antiseptic agent disposed in the distal portion the chamber. The cap also includes a seal preventing evaporation of the antiseptic agent until a needleless injection site is accepted into the cap. In one variation of this embodiment, an absorbent material is included for holding the antiseptic agent, the absorbent material being disposed in the distal portion of the chamber.

[0007] In an alternative embodiment, a disinfecting cap is provided for accepting a needleless injection site and applying an antiseptic agent to the needleless injection site, wherein a flexible skirt extends from the cap body into the proximal portion, so that when a needleless injection site is inserted into the opening, the flexible skirt engages the outer diameter of the needleless injection site to removably hold the cap on the needleless injection site. The cap also include a cap body defining a chamber having an opening at the proximal end for accepting the needleless injection site, as well as an antiseptic agent disposed in the distal portion the chamber, and a seal preventing evaporation of the antiseptic agent until a needleless injection site is accepted into the cap. This embodiment may further include an absorbent material for holding the antiseptic agent, the absorbent material being disposed in the distal portion of the chamber.

[0008] In an alternative embodiment, a system is provided for disinfecting needleless injection sites, wherein the system includes a plurality of caps for accepting a needleless injection site and applying an antiseptic agent to the needleless injection site. Each cap includes a cap body defining a chamber having an opening at a proximal end for accepting the needleless injection site, the chamber having a proximal portion and a distal portion, an antiseptic agent disposed in the distal portion of the chamber, and a breakable seal located in the cavity between the proximal and distal portions so as to be spaced away from the opening, the breakable seal preventing evaporation of the antiseptic agent until a needleless injection site is accepted into the cap. The system also includes a carrier strip, wherein each of the plurality of disinfecting caps is removably attached at its proximal end to the carrier strip, so that the opening in each of the disinfecting caps is covered by the carrier strip. In a preferred embodiment, this carrier strip may further include projections, each projection shaped to engage the opening of a cap so that the cap is removably attached to the projection. In some embodiments, each cap is also removably attached to the carrier strip by adhesive.

[0033] Definitions. As used in this description and the accompanying claims, the following terms shall have the meanings indicated, unless the context otherwise requires:

[0034] “NIS”—Needleless Injection Site (sometimes called LAV).

[0035] “LAV”—Luer Access Valve (also called NIS). A “LAV” is supposed to be made in conformity with industry standards for a luer. A NIS may be made in conformance with industry standards for a luer, but may not be; instead the NIS may be made in conformance with a manufacturer-specific, non-industry-standard specification.

[0036] The terms “proximal” and “distal,” when used herein relative to a cap, are such that an NIS or LAV is inserted into a proximal end of the cap and advanced toward a distal end of the cap.

[0037] “Elastomer” or “Elastomeric”—Materials that are highly elastic. When deformed, they are able to return to near their original shape. Deformations are not permanent. Rubber and silicones are examples of elastomers.

[0038] “Malleable”—Materials which are easily deformed, and once deformed hold much of the deformed shape. Malleable materials do not return to near their original shape.

[0039] “Compliant”—An elastomeric or malleable material that, when pressed against a contoured or shaped surface, conforms substantially to that surface.

[0040] “Flexible”—A material that easily bends. A flexible material need not be elastomeric or malleable.

[0041] “Breakable”—A breakable seal may be pierced, punctured, torn, ruptured or the like so as to permit fluid communication from one side of the seal to the other.

[0042] “Absorbent”—a material capable of holding or storing an antiseptic agent.

[0043] “Reservoir”—a volume capable of receiving and holding/storing an antiseptic agent.

[0044] Preferred embodiments of the invention provide a disinfecting cap for an NIS/LAV include the following features:

• • [0045] A threadless flexible portion (the engagement region), near the proximal end of the cap, for engaging the threads of the NIS/LAV and securing the cap to the NIS/LAV. Alternatively, a malleable portion for engaging the threads is provided as the engagement region. In another alternative embodiment, a flexible skirt is provided at or near the cap's opening at the proximal end of the cap for securing the NIS/LAV.
  • [0046] A reservoir of liquid, gel, or paste disinfectant, such as isopropyl alcohol (IPA). The reservoir, located in a distal portion of the cap's interior chamber, may include an absorbent material for holding the disinfectant, and in some embodiments, scrubbing the face of the NIS/LAV.
  • [0047] A breakable or frangible seal for the reservoir which is broken or unsealed upon installation of the cap on the NIS/LAV. In one embodiment, the seal is located in the cap's interior chamber away recess from the cap's opening.

[0048] Mating features may be provided on opposing ends of the caps for joining the caps into a stack or chain prior to use. The mating engagement may be used to provide sterility of the engagement portion of the caps.

[0049] A number of illustrative embodiments are presented herein. FIGS. 1-6 show views of one embodiment of a cap according to the invention.

[0050] FIG. 1 is a perspective view of a disinfecting cap. The cap has a proximal end 10 and a distal end 12. An opening 14 accepts a NIS to be disinfected. The cap includes a cap body 16 that extends from the proximal end 10 to the distal end 12. Near its distal end 12, the cap body 16 includes a gripping area 18, which may be formed by a ring of scallops around the circumference of the cap body 16, as shown in FIG. 1.

[0051] FIG. 2 shows a proximal end view of the cap of FIG. 1. The opening 14 and the proximal edge of the cap body 16 are shown in FIG. 2. Also shown in FIG. 2 is the proximal edge of compliant wall 20, which surrounds the opening 14. FIG. 3 is a sectional view of the FIG. 1 cap taken along line C-C in FIG. 2.

[0052] As shown in FIG. 3, the cap body 16 defines a chamber 30, which has only a single opening 14 to the exterior of the cap. The chamber 30 has a proximal portion 32 and a distal portion 34. Between these two portions is a breakable seal 25. The breakable seal 25 keeps antiseptic liquid in the distal portion 34 and keeps the antiseptic liquid from evaporating until the seal 25 is broken, which occurs when an NIS is fully inserted into the cap. This distal portion 34 may be referred to as a reservoir; this reservoir is enclosed by the side walls of the cap body 16, by the closed end of the cap body, and by the breakable seal 25.

[0053] The breakable seal 25 is preferably disposed at an angle from the perpendicular to the longitudinal axis of the cap. This angle makes it easier for the NIS to break through the seal 25. The seal 25 may be of any one of a variety of materials capable of suitably inhibiting the loss of disinfectant over the shelf life of the cap. Materials envisioned for the breakable seal 25 may include, but are not limited to, metal foils and polymer sheets. Sheet and foil materials may be bonded through adhesives or welding to the cap.

[0054] The breakable seal 25 is broken—releasing the stored disinfectant—when the NIS is installed sufficiently far into the cap. The disinfectant then disinfects the exterior surface of the NIS. Foils and sheets may be chosen such that they are weak enough to break when forced by the NIS. Foils and sheets may also be scored or otherwise selectively weakened so as to improve their ability to break. The bond or weld of the foil or sheet to the cap body may also be configured to break under the force of the NIS.

[0055] Also, as shown in FIG. 3, the compliant wall 20 has a beveled inner edge 21 at the opening 14, which helps guide the NIS into the chamber 30. The region of the compliant wall 20 may be referred to as a thread-engagement region. This thread-engagement region may be made of an elastomeric or malleable material. This region is designed to engage the threads of the NIS. This thread-engagement region may be smooth inside having no threads. Upon engagement with the NIS, this thread-engagement region may deform to accommodate the thread of the NIS. The fit is similar to that of an elastomeric hose or tube on a pipe nipple or hose barb.

[0056] FIGS. 4 and 5 show alternative side views of the cap, and FIG. 6 shows a distal end view of the cap.

[0057] FIG. 7 is a sectional view of an alternative embodiment that is similar to the embodiment of FIGS. 1-6 but has a breakable seal 26 that is oriented perpendicular to the longitudinal axis of the cap, instead of the angled seal 25 shown in FIG. 3. Like the embodiments of FIGS. 1-6, the FIG. 7 embodiment includes a cap body 16 that defines a chamber 30 having an opening 14 at a proximal end 10 for accepting the needleless injection site. The FIG. 7 chamber 30 also has a proximal portion 32 and a distal portion 34, with an antiseptic agent disposed in the distal portion 34. The breakable seal 26 is located in the chamber 30 between the proximal and distal portions. The breakable seal 26 prevents evaporation of the antiseptic agent until a NIS is accepted into the cap and breaks through the seal 26. Also, like the embodiment of FIGS. 1-6, the FIG. 7 embodiment includes a compliant wall 20 near the opening 14. This compliant wall 20 deforms when a NIS is inserted into the opening 14 so that the compliant wall 20 engages threading elements on the outer diameter of the NIS. This arrangement allows the cap to be removably held on the NIS. In the FIG. 7 embodiment, the distal end 12 of the cap body 16 is closed off, so that the cap has only a single opening 14. The FIG. 7 cap body 16 also includes a gripping portion 18.

[0058] In an alternative embodiment, a moveable seal may be used instead of the breakable seal. For example, the seal may be a disk having some thickness such that it behaves like a stopper or piston sealing against the sidewalls of the cap body. In the case of a disk/piston/stopper style of seal, it is preferable that at least one of the components—the moveable seal or the interior sidewall of the cap be elastomeric to better inhibit disinfectant loss. Disk/piston/stopper designs may be configured such that the disk is held in place by friction (increased by elastomeric fits). The force of installation of the NIS is sufficient to overcome the friction of the disk, thereby moving the disk to a position where the fluid communication with the distal portion is established. Adhesives or welds may also be used to augment a disk/piston/stopper design.

[0059] In alternative embodiments, the openings 14 of the caps shown in FIGS. 1-7 are closed to maintain sterility prior to use. This may be achieved, for example, by: (i) placing the cap in additional packaging, (ii) adding an adhesive or welded lid of a material such as foil, polymer, paper, “Tyvek®”-type material, etc., i.e., a secondary seal, or (iii) creating a stopper-like mating fitment between caps, as discussed below. A male member may be configured on the closed distal end 12 of each cap which mates with the opening 14 of another cap. A chain or column of caps may then be formed, each subsequent cap assuring sterility of the mated cap. A dedicated or dummy cap must be provided to close the opening 14 of the last cap in the chain. The last cap in the chain could also be closed by any of the other closure means discussed above.

[0060] FIG. 8 shows a disinfecting cap with a secondary seal 46. FIG. 9 shows a sectional view of the FIG. 8 embodiment. Like the FIG. 7 embodiment, the embodiment of FIGS. 8 and 9 includes a cap body 16 with an opening 14 at the proximal end 10, a chamber 30 defined by the cap body 16. The chamber is divided into a proximal portion 32 and a distal portion 34 by a breakable (primary) seal. A secondary seal 46 covers the opening. The secondary seal 46 prevents contaminants from entering the proximal portion 32 of the chamber 30 during shipment and storage. Just before use, the secondary seal 46 is removed from the cap, and then the cap is placed on an NIS causing the breakable seal 26 to be ruptured and releasing the antiseptic liquid to disinfect exterior surfaces of the NIS. The cap is left on the NIS long enough to allow the antiseptic liquid to disinfect the NIS or until the NIS is ready for use.

[0061] FIG. 10 is a sectional view of a stacked arrangement of three caps 42. The distal end 12 of one cap fits into the opening 14 in the proximal end 10 of the next cap, the compliant wall 20 of which holds the first cap. In the FIG. 10 embodiment, the caps 42 have breakable seals 25 that are oriented at an angle to the perpendicular to the longitudinal axis of the caps. FIG. 11 is a sectional view of a stacked arrangement of similar caps 43. In the FIG. 11 embodiment, the caps 43 have breakable seals 26 that are oriented perpendicular to the longitudinal axis of the caps.

[0062] FIG. 12 is a sectional view of alternative embodiment of a stacked arrangement of caps 44. As in the embodiments of FIGS. 10 and 11, the cap bodies 56 are shaped so that the distal end 12 of one cap is received into the proximal end 10 of the next cap. A stopper 52 is used to cover the open proximal end 10 of the first cap. In these caps 44, the breakable seal 26 is oriented perpendicular to the longitudinal axis of the cap 44. FIG. 13 is a side view of the caps 44 and the stopper 52 of the embodiment of FIG. 12.

[0063] FIG. 14 shows an embodiment of a carrier strip 50 for holding a plurality of caps 43, and FIG. 15 is a sectional view of the FIG. 14 embodiment. In this embodiment, the carrier strip 50 includes a plurality of button-shaped protrusions 55, each of which is adapted to retain a cap 43. As can be seen in FIG. 15, the buttons 55 are shaped and sized to fit snugly into the proximal portion 32 of the cap's chamber 30. Preferably, the button 55 interferes sufficiently with the cap's compliant wall 20 so that the cap 43 is friction fitted to the button 55. In this way, a plurality of caps 43 may be held on a single strip 50, so that each cap 43 may be easily removed and used by a healthcare professional. This friction fit of the cap 43 to the strip 50 may be supplemented by adhesive that helps hold the cap more securely to the strip, but nevertheless permits the easy removal of the cap from the stip. Alternatively, adhesive may be used in lieu of the buttons altogether to removably hold the caps 43 to the strip 50. The carrier strip 50 may also be provided with a hole or holes 57 to permit the carrier strip 50 to be hung from an IV pole or the like, so that the caps 43 may be readily accessible near where they are to be used. In addition to holding the cap 43 to the strip 50, the projections 55 also keep possible contaminants out of the proximal portion 32 of the chamber 30. The antiseptic liquid is kept in the distal portion 34 until the cap 43 is placed on an NIS, causing the NIS to break through the seal 26, resulting in the surface of the NIS being disinfected by the antiseptic liquid.

[0064] FIGS. 16-18 are side views of a cap 60 being installed on a needleless access site 70, and FIGS. 19-21 are sectional views of the same process. In FIGS. 16 and 19, the cap 60 and the NIS 70 are brought near each other; in FIGS. 17 and 20, the NIS 70 has started being inserted into the cap 60; and in FIGS. 18 and 21, the cap 60 is fully installed on the NIS 70. When the cap 60 is fully on the NIS 70, the seal 26 is broken and the antiseptic liquid disinfects the exposed surfaces of the NIS 70. The white arrows shown in FIG. 21 show how the antiseptic liquid can flow from the distal portion around the edge of the NIS 70 so as to disinfect the sides as well as the face of the NIS.

[0065] FIGS. 19 and 20 show an absorbent pad 63 for holding the antiseptic liquid. In a preferred embodiment, the NIS 70 comes into contact with the absorbent pad 63 when fully inserted into the cap 60. The absorbent pad is not included in FIG. 21, so that the broken seal 26 can be more easily seen.

[0066] In this embodiment, the entire cap is monolithically formed as a single part, a compliant material. As can be seen in FIGS. 16-21, the threads 72 on the NIS 70 are accommodated by a compliant wall 61, which is in the thread engagement region of the cap body 16. The cap body 16, including the compliant wall 61, may be made of a silicone or a thermosplastic elastomer (for example, Santoprene). The compliant wall 61 bulges out where the threads 72 of the NIS come into contact with inner surface of the compliant wall. In FIGS. 17 and 20, the threads 72 have begun to engage the compliant wall 61, but the NIS has not yet come into contact with the breakable seal 26. In FIGS. 18 and 21, the threads 72 are more fully engaged by the compliant wall 61, and the NIS has broken through the seal 26.

[0067] FIGS. 22-24 are side views of an alternative cap 60 being installed on a needleless access site 70, and FIGS. 19-21 are sectional views of the same process. In this embodiment, a reservoir 76 for holding the antiseptic liquid—preferably with an absorbent material 63 as shown in FIGS. 25-27—is a separate part which is inserted into the cap 60. In some embodiments, the cap 60 is made of an elastomeric material. The material of the cap body 16 also forms the thread engagement region or compliant wall 61. In this embodiment, the materials of the reservoir 76 and the thread engagement region may be selected separately.

[0068] Selecting the reservoir and thread engagement region materials separately allows the materials to be optimized for the requirements of each region or component. For example, an IPA impermeable material may be chosen for the reservoir (such as polypropylene), while an elastomer might be chosen for the thread engagement region (such as a thermoplastic polyurethane, for example, Tecothane® or Pellethane®). The elastomer of the thread engagement region may have less resistance to IPA, but the elastomeric properties are more suitable to the requirements of the thread engagement region. Additionally, this construction allows a soft feel or grip to the outside of the cap while providing structure or support to the body of the cap by the reservoir, which may be constructed of a more rigid material. The separate reservoir might be filled and closed prior to assembly with the cap.

[0069] In FIGS. 22 and 25, the cap 60 and the NIS 70 are brought near each other; in FIGS. 23 and 26, the NIS 70 has started being inserted into the cap 60; and in FIGS. 24 and 27, the cap 60 is fully installed on the NIS 70. When the cap 60 is fully on the NIS 70, the seal 26 is broken and the antiseptic liquid disinfects the exposed surfaces of the NIS 70. FIGS. 25 and 26 show an absorbent pad 63 for holding the antiseptic liquid. In a preferred embodiment, the NIS 70 comes into contact with the absorbent pad 63 when fully inserted into the cap 60. The absorbent pad is not included in FIG. 27, so that the broken seal 26 can be more easily seen. As can be seen in FIGS. 22-27, the threads 72 on the NIS 70 are accommodated by a compliant wall 61, which is in the thread engagement region of the cap body 16. The compliant wall 61 bulges out where the threads 72 of the NIS come into contact with inner surface of the compliant wall. In FIGS. 23 and 26, the threads 72 have begun to engage the compliant wall 61, but the NIS has not yet come into contact with the breakable seal 26. In FIGS. 24 and 27, the threads 72 are more fully engaged by the compliant wall 61, and the NIS has broken through the seal 26. The white arrows shown in FIG. 27 show how the antiseptic liquid can flow from the distal portion around the edge of the NIS so as to disinfect the sides as well as the face of the NIS.

[0070] FIGS. 28-30 are side views of another cap 60 being installed on a needleless access site 70, and FIGS. 31-33 are sectional views of the same process. In FIGS. 28 and 31, the cap 60 and the NIS 70 are brought near each other; in FIGS. 29 and 32, the NIS 70 has started being inserted into the cap 60; and in FIGS. 30 and 33, the cap 60 is fully installed on the NIS 70. When the cap 60 is fully on the NIS 70, the seal 26 is broken and the antiseptic liquid disinfects the exposed surfaces of the NIS 70. FIGS. 31 and 32 show an absorbent pad 63 for holding the antiseptic liquid. In a preferred embodiment, the NIS 70 comes into contact with the absorbent pad 63 when fully inserted into the cap 60. The absorbent pad is not included in FIG. 33, so that the broken seal 26 can be more easily seen.

[0071] In this embodiment, a separate elastomeric or malleable material is included on the inner surface of the thread engagement region to form the complaint wall 61. This elastomeric or malleable material is a separate component which is inserted into the cap 60 as shown in FIGS. 31-33. The reservoir for holding the antiseptic liquid is formed with the main cap material. As can be seen in FIGS. 28-33, the threads 72 on the NIS 70 are accommodated by a compliant wall 61. In FIGS. 29 and 32, the threads 72 have begun to engage the compliant wall 61, but the NIS has not yet come into contact with the breakable seal 26. The compliant wall 61 may be configured to accept a number of different NIS sizes. In FIGS. 30 and 33, the threads 72 are more fully engaged by the compliant wall 61, and the NIS has broken through the seal 26. The white arrows shown in FIG. 33 show how the antiseptic liquid can flow from the distal portion around the edge of the NIS 70 so as to disinfect the sides as well as the face of the NIS.

[0072] FIGS. 34 and 35 are perspective and sectional views of another cap embodiment. As in the prior embodiments, the cap includes a cap body 16, which defines a chamber 30, which is divided into a proximal portion 32 and a distal portion 34 by a breakable seal. Around the opening 14 at the proximal end 10 of the cap is a flexible skirt 82. This skirt 82 engages the outer diameter of the NIS, including any threads on the NIS, so as to hold the cap on the NIS.

[0073] The embodiments of the invention described above are intended to be merely exemplary; numerous variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to be within the scope of the present invention as defined in any appended claims.