JP2016511111A - Disinfection end cap - Google Patents

Abstract

The disinfection termination cap includes a base having a first side and a second side, a first annular wall extending from the first side of the base, and a cylindrical center plug extending from the first side of the base. And a second annular wall extending from the second side of the base. The first annular wall has an outer surface and an inner surface. The cylindrical center plug has an outer surface and an inner surface and is positioned within the first annular wall to form an annular chamber. The second annular wall has an outer surface and an inner surface and defines a second chamber having an open end. The second chamber is further defined by the inner surface of the cylindrical center plug. There is a disinfectant material on at least one of the first annular wall inner surface, the second annular wall inner surface, the second annular wall outer surface, and the cylindrical center plug outer surface.

Description

The present invention relates to a disinfecting cap, particularly a disinfecting end cap for a medical connector.

Background of the Invention Catheters are widely used to treat patients in need of various medical procedures. The catheter may be for acute disease treatment for short-term use, i.e. temporary or chronic for long-term treatment. The catheter is generally introduced from a peripheral vein site into a central vein (such as the vena cava) to gain access to the patient's vasculature.

  In an infusion system, a luer connector, such as a male luer connector, can have a first end and a second end. The first end of the male luer connector can be connected to a fluid line that is connected to a fluid source, such as a drip bag filled with fluid. The second end of the male luer connector can be removably attached to the first end of the female needleless luer connector. The second end of the female needleless luer connector can be attached to a catheter introduced to the patient.

  When the male luer connector and the female needleless luer connector are attached to each other, fluid from the infusion bag can flow into the patient. These connectors are often separated from each other at various times, such as when a patient needs to use a toilet. When the connectors are separated from each other, the connectors are exposed and susceptible to contamination. Current treatments that reduce connector contamination include wiping the connector by disinfection. These procedures are prone to human error and are often not performed. Furthermore, once the male luer connector is separated from the female needleless connector, there is no standard way to store and protect the male luer connector until it is reattached to the female connector.

SUMMARY OF THE INVENTION The present invention comprises a base having a first side and a second side, a first annular wall extending from the first side of the base, and a cylindrical center extending from the first side of the base. A disinfecting termination cap for use with a connector that includes a plug and a second annular wall extending from a second side of the base. The first annular wall has an outer surface and an inner surface. The cylindrical center plug has an outer surface and an inner surface and is positioned within the first annular wall to form an annular chamber. The second annular wall has an outer surface and an inner surface and defines a second chamber having an open end. Disinfecting material is on at least one of the inner surface of the first annular wall, the inner surface of the second annular wall, the outer surface of the second annular wall, and the outer surface of the cylindrical center plug.

  The present invention further includes a base having a first side and a second side, a male connector portion extending from the first side of the base and configured to be connectable to a female luer, And a female connector portion configured to be connectable to a male luer and to a sanitizing end cap for use with a connector. There is disinfectant material on a portion of the male connector portion or the female connector portion.

  In some aspects, the male connector portion includes a first annular wall extending from the first side of the base and having an outer surface and an inner surface and a cylindrical center plug extending from the first side of the base. . The cylindrical center plug has an outer surface and an inner surface and is positioned within the first annular wall to form an annular chamber. In such an aspect, the female connector portion includes a second annular wall extending from the second side of the base, has an outer surface and an inner surface, and defines a second chamber having an open end.

  In some aspects, the disinfecting material is a metal, and in other aspects, the disinfecting material can be an alcohol.

  In other aspects, the first annular wall includes one or more threads. In yet another aspect, the second annular wall includes one or more threads.

  In yet another aspect, the disinfecting material is formed on at least one of the inner surface of the first annular wall, the inner surface of the second annular wall, the outer surface of the second annular wall, and the outer surface of the cylindrical center plug.

BRIEF DESCRIPTION OF THE DRAWINGS For a more complete understanding of the present invention, reference is made to the following detailed description of the invention considered in conjunction with the accompanying drawings.

FIG. 3 is a cross-sectional view of a disinfecting cap assembly engaged with a luer connector according to the present invention. FIG. 6 is a perspective view of a sealed sterilization cap assembly. FIG. 2 is an exploded perspective view showing the disinfection cap assembly and luer connector of FIG. 1. FIG. 2 is a perspective view of the sterilization cap assembly of FIG. 1 engaged with a luer connector. FIG. 3 is a cross-sectional view of a disinfecting cap assembly where the cap has an outer wall. FIG. 6 is a cross-sectional view of a disinfecting cap assembly where the cap includes a central insert. FIG. 7 is a cross-sectional view of a disinfecting cap assembly where the cap includes a center plug. FIG. 7 is a cross-sectional view of a disinfecting cap assembly where the cap holder includes an inward flange. FIG. 6 is a cross-sectional view showing a disinfection cap assembly provided with a center plug and the cap holder including an inward flange. FIG. 3 is a cross-sectional view of a disinfecting cap assembly where the cap includes an unthreaded annular portion. FIG. 3 is a cross-sectional view showing a sterilization cap assembly including a sterilization chamber. FIG. 12 is a perspective view of the disinfecting cap assembly shown in FIG. 11. FIG. 6 is a perspective view showing a disinfection cap assembly in which the cap holder includes a retainer. FIG. 14 is a cross-sectional view of the sterilization cap assembly shown in FIG. 13 taken along section line 14-14 and viewed in the direction of the arrows. FIG. 15 is a cross-sectional view of the sterilization cap assembly shown in FIG. 13 taken along section line 15-15. FIG. 6 is a cross-sectional view showing a disinfecting cap assembly including a ratchet assembly. FIG. 17 is an exploded view of the sterilization cap assembly and luer connector shown in FIG. 16. FIG. 17 is a partial cutaway perspective view of the disinfecting cap assembly shown in FIG. 16 showing the ratchet assembly. FIG. 6 is a perspective view showing a disinfecting cap assembly without a cap holder. FIG. 20 is a cross-sectional view of the disinfection cap assembly of FIG. 19 having a hydrophobic section and a hydrophilic section. FIG. 6 is a perspective view of a sterilization cap assembly having a cap holder with a flange having a recess for receiving a line. FIG. 6 is a cross-sectional view of a sterilization cap assembly in which a plug is supported by an arm. FIG. 6 is a perspective view of a disinfecting cap assembly having various fastening mechanisms. FIG. 6 is a perspective view of a disinfecting cap assembly having various fastening mechanisms. FIG. 6 is a perspective view of a disinfecting cap assembly having various fastening mechanisms. FIG. 6 is a perspective view of a disinfecting cap assembly having various fastening mechanisms. FIG. 6 is a perspective view of a disinfecting cap assembly having various fastening mechanisms. It is a perspective view of a disinfection terminal cap. It is a front view of a disinfection terminal cap. It is a side view of a disinfection terminal cap. It is another perspective view of a disinfection terminal cap. It is another perspective view of a disinfection terminal cap. FIG. 29 is a cross-sectional view of the disinfection termination cap of FIG. 28 taken along line 33-33.

The present invention relates to a disinfecting cap assembly that engages a male end of a luer connector. However, it should be understood that the teachings herein can be used with other types of medical connectors.

  FIG. 1 is a cross-sectional view of a sterilization cap assembly 10 engaged with a luer connector 12. The proximal end 14 of the luer connector 12 is attached to a fluid line 16 that connects to a fluid source (not shown) such as an infusion bag filled with fluid. Luer connector 12 includes an annular threaded portion 18 having an internal thread 20 and a frustoconical male luer 22 positioned for insertion into a female luer connector (not shown). The male luer 22 includes a tip 26 having an opening 24 in fluid communication with the fluid line 16. The male luer 22 is disposed substantially concentrically within the threaded portion 18. As a result of their generally coaxial arrangement, male luer 22 and threaded portion 18 cooperate to form an annular space therebetween.

  The sterilization cap assembly 10 includes a cap holder 28 and a cap 30 sized to be positioned within the cap holder 28. The cap 30 includes a base 32 and an annular threaded portion 34 extending from the base 32. Base 32 may include a substantially flat surface 36 and an outer flange 38.

  The threaded portion 34 of the cap 30 includes a rim 40 that defines an open end 42 (see FIG. 3). The base 32 closes the opposite end of the threaded portion 34. The threaded portion 34 may be formed with a tapered inner surface 46 that complements the male luer 22 of the luer connector 12. In particular, the tapered inner surface 46 tapers from the rim 40 toward the base 32. The threaded portion 34 defines a chamber 48 (see FIG. 3) sized to receive the male luer 22. The threaded portion 34 includes a male thread 50 for engaging the thread 20 of the luer connector 12. Male thread 50 and thread 20 of luer connector 12 allow cap 30 to be securely threaded with luer connector 12 and cap 30 and luer connector as cap 30 is rotated relative to luer connector 12. Cooperate with each other to allow relative movement between them. The male screw 50 extends between the base 32 and the rim 40.

  The configuration of the cap 30 is shown in the perspective view of FIG. Note that this configuration is exemplary. For example, as described below, the cap 30 can be configured without threads and sized to engage the luer connector 12 with a push-fit friction fit.

  The cap 30 can be made from an absorbent material. Cap 30 may be formed from a porous plastic, for example, a medical grade sintered porous plastic material available from Porex, based in Fairburn, Georgia. Other suitable manufacturers of porous plastic materials include Filtrona, Genpore, and Thermopore. It is desirable for the material to be able to absorb and retain fluids such as disinfecting fluids. It is also desirable that the material be sufficiently rigid to maintain its structure. It is also desirable that the material is compressible and that the absorbed fluid is released after compression. The porous plastic material can comprise any suitable polymer such as polyethylene, polypropylene, nylon, and the like.

  The use of porous plastic material is only exemplary. It will be appreciated that the cap 30 can be made of any other suitable material such as bonded fiber, cotton, silicone, urethane, polyester, cellulose, and the like. The material can be natural or synthetic.

  The threaded portion 34 of the cap 30 may be coated with an antiseptic fluid, an anticoagulant fluid, and / or an antimicrobial fluid, or may be impregnated with an antiseptic fluid, an anticoagulant fluid, and / or an antimicrobial fluid. An example of a suitable disinfecting fluid is isopropyl alcohol. The concentration of isopropyl alcohol can vary and is preferably 70% v / v. The concentration of alcohol can range from 20% to 100%. It will be appreciated that other alcohols including ethanol, propanol, and / or butanol, or other materials such as iodine, hydrogen peroxide, chlorhexidine gluconate, chlorhexidine acetate, and the like may be used. Disinfectants, anticoagulants, and / or antimicrobial agents can be in liquid or solid form.

  Cap holder 28 includes a cylindrical side wall 52 that receives cap 30 and defines a chamber 54 that is sized to receive male luer 22. The cap holder 28 may include an outer flange 56 that projects radially outward from the distal end 58 of the side wall 52. The outer flange 56 defines an open end 60. Cap holder 28 may include a substantially flat surface 62 that defines opposing closed ends. Cap holder 28 may be made from a thermoplastic elastomer, such as the thermoplastic elastomer sold by ExxonMobil, Inc. under the trademark SANTOPRENE®, or any other suitable material. The cap holder 28 can be made from a harder material, such as high density polyethylene. Cap holder 28 and cap 30 may be joined together or attached to each other by any suitable method, such as by adhesive or by molding.

  A gap 64 may exist between the flange 38 of the cap 30 and the cap holder 28 and between the threaded portion 34 of the cap 30 and the cap holder 28 when the cap 30 is attached to the cap holder 28. The cap 30 is attached to the cap holder 28 so that the cap 30 rotates together with the cap holder 28.

  As shown in FIG. 2, the cap holder 28 can be attached to the flange 56 by any suitable method, such as by adhesive or by conductive or inductive heat sealing techniques, foil material or It can be sealed with a material such as a lid stock material. A pull tab 68 may be provided to facilitate removal of the membrane 66 and access to the sterilization cap 10.

  In general, the cap 30 may be hydrophobic. However, it may be desirable to make at least a portion of cap 30 hydrophilic, since hydrophobic materials can act to prevent or minimize disinfection fluids such as isopropyl alcohol from passing through cap 30. is there. For example, it may be desirable to treat at least a portion of the cap 30 with a hydrophilic surfactant. Thus, the hydrophilic portion may allow alcohol to pass through it, while the hydrophobic portion acts to prevent or minimize disinfecting fluids such as isopropyl alcohol from passing through it. obtain. In one embodiment, the threaded portion 34 may be treated with a hydrophilic surfactant, but the base 32 may remain hydrophobic so that it is resistant to disinfecting fluids such as alcohol. The hydrophobic section can also serve as a plug to prevent infusion fluid from leaking through the tubing and past the cap 30.

  Referring to FIG. 1, the threaded portion 34 of the cap 30 engages the thread 20 of the luer connector 12 and is attached to the luer connector 12 such that the base 32 is positioned adjacent the opening 24 of the male luer 22. A disinfection cap assembly 10 is shown. Also in this position, the inner surface 46 of the threaded portion 34 is adjacent to the male luer 22, which compresses the cap 30 and releases at least a portion of the disinfecting fluid to disinfect the luer connector 12. The sterilization cap assembly 10 can remain attached to the luer connector 12 for any suitable period. As shown in the perspective view of FIG. 4, when the sterilization cap assembly 10 is attached to the luer connector 12, the luer connector 12 is exposed to the sterilization fluid.

  The cap holder 28 may be configured to remain on the cap 30 after the sterilization cap assembly 10 is engaged with the luer connector 12. Alternatively, the cap holder 28 can be configured to be removably attached to the cap 30. For example, the cap holder 28 can be removed from the cap 30 after the sterilization cap assembly 10 engages the luer connector 12.

  FIG. 5 shows a disinfection cap assembly, generally indicated as 110, that is sized to engage and disinfect the male luer 22. The sterilization cap assembly 110 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 110 includes a cap holder 128 and a cap 130 sized to be positioned within the cap holder 128.

  The cap 130 includes an annular side wall 111 that extends from the outer flange 138 and substantially concentric with the threaded portion 134. When the cap holder 128 is used, the annular side wall 111 is positioned proximate to the outer surface of the cap holder 12. When the sterilization cap assembly 110 is attached to the luer connector 12, the annular side wall 111 abuts the outer surface of the threaded portion 18 of the luer connector 12. The annular side wall 111 can be made from porous plastic, such as the remainder of the cap 130, or any other suitable material. The annular side wall 111 covers and protects the outer surface of the threaded portion 18 of the luer connector 12. The annular side wall 111 contains a disinfecting fluid and may release at least a portion of the disinfecting fluid.

  FIG. 6 shows a disinfection cap assembly, generally designated 210, that is dimensioned to engage and disinfect the male luer 22. The sterilization cap assembly 210 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 210 includes a cap holder 228 and a cap 230 sized to be positioned within the cap holder 228.

  The cap 230 includes a central insert 211 that is integrally connected thereto. Alternatively, the cap 230 and the central insert 211 can be separate components. The central insert 211 may be made of porous plastic, such as the rest of the cap 230, or any other suitable material, containing a disinfecting fluid and releasing at least a portion of the disinfecting fluid. Also good. The central insert 211 can be treated with a hydrophilic surfactant or otherwise made hydrophilic.

  The central insert 211 projects from the base 232 of the cap 230 and is positioned within the threaded portion 234 of the cap 230. The central insert 211 has a distal end 213 that may have a cornered edge 215, thereby giving the central insert 211 a generally trapezoidal shape. The central insert 211 may define other shapes such as conical, square, rectangular, etc.

  When the cap 230 is attached to the luer connector 12, the center insert 211 is positioned within the opening 24 formed in the male luer 22, allowing disinfecting fluid to enter the male luer 22 and disinfecting fluid at the inner tip 26 of the male luer 22. Makes it possible to apply.

  FIG. 7 shows a disinfection cap assembly, generally designated 310, that is dimensioned to engage and disinfect the male luer 22. The sterilization cap assembly 310 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-3 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 310 includes a cap holder 328 and a cap 330 sized to be positioned within the cap holder 328.

  A sealing mechanism, such as the center plug 311, is dimensioned to extend from the base 332 of the cap 330 and dimensioned to be positioned within the threaded portion 334 of the cap 330. Cap 330 and center plug 311 may be separate components as shown, or alternatively, cap 330 and center plug 311 may be integrally formed. Alternatively, the central plug 311 can be an extension of the cap holder 328 molded therein.

  The center plug 311 has a distal end 313 that may have a cornered edge 315, thereby giving the center plug 311 a generally trapezoidal shape. Center plug 311 may define other shapes such as conical, square, rectangular, and the like.

  The center plug 311 contacts the opening 24 formed in the male luer 22 and prevents the disinfecting fluid from entering the male luer 22. The central plug 311 extends from the base 332 a distance sufficient to engage the opening 24 in the male luer 22 before the threaded portion 334 of the cap 330 is compressed by the male luer 22 to open the opening in the male luer 22. The part 24 is sealed.

  The center plug 311 can be made of a non-porous material such as rubber, or any other suitable material. The central plug 311 is made of a porous plastic and can remain in a hydrophobic state, i.e. not treated with a surfactant, like the threaded portion 334 of the cap 330, whereby disinfecting fluid passes through the male luer 22. Can be prevented or minimized from passing into the opening 24 formed in the. As such, the central plug 311 acts to limit or prevent alcohol from entering the fluid line 316 of the luer connector 312. Further, the center plug 311 can function as a plug for preventing drip fluid from dripping from the line.

  The configuration of the sealing mechanism is merely exemplary. It will be appreciated that the present invention may employ other sealing mechanisms. For example, the sealing mechanism can be a center pin (not shown) that is dimensioned to extend further into the opening 24 formed in the male luer 22 than the center plug 311. Center plug 311 extends beyond the threads on threaded portion 324 and can be inserted prior to thread engagement.

  FIG. 8 shows a disinfection cap assembly, generally designated 410, that is sized to engage and disinfect the male luer 22. The sterilization cap assembly 410 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 410 includes a cap holder 428 and a cap 430 dimensioned to be positioned within the cap holder 428.

  The cap holder 428 includes an inward flange 411 that can form a protective seal that closes the interior of the cap holder 428 when the sterilization cap assembly 410 is engaged with the luer connector 12. The inner flange 411 extends radially inward from the distal end 458 of the side wall 452 of the cap holder 428. When the sterilization cap assembly 410 is engaged with the luer connector 12, the inward flange 411 of the cap holder 428 may contact the threaded portion 18 of the luer connector 12 to seal the interior of the cap holder 428.

  The inward flange 411 of the cap holder 428 may provide a physical barrier against the entry of pathogens, dust or other contaminants into the cap holder 428. The inward flange 411 may act to hold at least a portion of the disinfecting fluid from the disinfecting cap assembly 410 from leaking out. The inward flange 411 may prevent evaporation of at least a portion of the retained disinfecting fluid.

  The configuration of the cap holder 428 can vary. For example, the cap holder 428 includes an outer flange (not shown) such as an outer flange 56 (FIG. 1) that projects radially outward from the distal end 458 of the side wall 452 and a radial direction from the distal end 458 of the side wall 452. An inwardly projecting inward flange 411.

  FIG. 9 shows a disinfection cap assembly, shown generally as 510, that is dimensioned to engage and disinfect the male luer 22. The sterilization cap assembly 510 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 510 includes a cap holder 528 and a cap 530 sized to be positioned within the cap holder 528.

  The sterilization cap assembly 510 includes a center plug 511, such as the center plug 311 shown in FIG. In addition, the cap holder includes an inward flange 513 such as the flange 411 shown in FIG.

  It should be understood that various features of the various embodiments disclosed herein can be used together without departing from the spirit or scope of the present invention.

  FIG. 10 shows a disinfection cap assembly, generally designated as 610, that is dimensioned to engage and disinfect male luer 22. The sterilization cap assembly 610 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 610 includes a cap holder 628 and a cap 630 sized to be positioned within the cap holder 628.

  Cap 630 includes an annular portion 611 extending from base 632. The annular portion 611 is configured without threads, but is sized to engage the luer connector 12 by a push friction fit. The sterilization cap assembly 610 can be removed by pulling from the luer connector 12.

  The annular portion 611 of the cap 630 can be configured such that when the cap 630 is pressed against the male luer 22, the inner surface contacts the male luer 22 and is compressed by the male luer 22 to release the sanitizing fluid. The outer surface of the annular portion 611 can also contact the internal thread 18 of the threaded portion 18 of the male luer 22 and can also release disinfecting fluid on this side. Alternatively, the annular portion 611 can be configured to avoid contact with the threads 20 of the luer connector 12. The annular portion 611 need not be tapered as shown.

  FIGS. 11 and 12 show a disinfection cap assembly, generally designated as 710, that is sized to engage and disinfect the male luer 22. The sterilization cap assembly 710 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-3 unless otherwise specified. The sterilization cap assembly 710 includes a sterilization chamber 715 and a cap 730.

  Cap 730 includes an annular portion 711 extending from base 732. The annular portion 711 is configured and dimensioned to engage the luer connector 12 by a push friction fit.

  The disinfection chamber 715 is attached to the base 732 of the cap 730 and is formed by continuous side walls 713 and end walls 723. The side wall 713 includes an inner flange 717 that extends radially inward from the side wall 713. The flange 717 defines an open end 721.

  The base 732 of the cap 730 is aligned with the disinfection chamber 715. The base 732 of the cap 730 is positioned in the disinfection chamber 715 such that the outer flange 738 of the base 732 is taken into the disinfection chamber 715 by the inner flange 717 of the disinfection chamber 715 extending over the base 732. The base 732 closes the disinfectant chamber 715 and the annular portion 711 of the cap 730 contacts the inner flange 717 of the disinfecting chamber 715. Cap 730 may be attached to sterilization chamber 715 such that cap 730 rotates in conjunction with sterilization chamber 715. In one embodiment, the base 732 of the cap 730 need not be aligned with the disinfection chamber 715 in the push-in design.

  The disinfection chamber 715 can include an absorbent material 725 such as a pad, sponge, or elastic foam configured to hold a disinfecting fluid. The absorbent material 725 can be moistened with a disinfecting fluid or can be immersed in the disinfecting fluid. The absorbent material 725 can be deformable. Cap 730 may be made from a porous plastic material that acts as a carrier for disinfecting disinfecting fluid from disinfectant chamber 715. As the cap holder 728 is compressed, the absorbent material 725 releases at least a portion of the disinfecting fluid. The fluid can then flow through the base 732 along the annular portion 711 and be delivered to the male luer 22. FIG. 12 shows a perspective view of the sterilization cap assembly 710.

  It will be appreciated that the present invention may employ other mechanisms that involve pushing on the components of the sterilization cap assembly to activate or release the sterilization fluid.

  FIGS. 13-15 show a disinfection cap assembly, generally designated as 810, that is dimensioned to engage and disinfect male luer 22. The sterilization cap assembly 810 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-3 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 810 includes a cap holder 828 and a cap 830 dimensioned to be positioned within the cap holder 828.

  Cap 830 includes an annular portion 811 that extends from base 832. The annular portion 811 is configured without threads and is sized to engage the luer connector 12 by a push-fit friction fit. The sterilization cap assembly 810 can be removed by pulling from the luer connector 12.

  The cap holder 828 includes a retainer 813 that acts to hold or secure the cap 830 on the luer connector 12. The retainer 813 includes a pair of shoulders 815 and 817 extending vertically from opposite sides of the outer flange 856 of the cap holder 828 and a pair of arms extending radially inward from the shoulders 815 and 817. 823,825.

  When the sterilization cap assembly 810 is engaged with the luer connector 12, the arms 823 and 825 of the retainer 813 extend over the male luer 22 to hold the cap 830. The cage 813 can be made from a thermoplastic elastomer, such as SANTOPRENE (R), or any other suitable material. The cage 813 can be made from a flexible material.

  The cap holder 828 may include a gripping region defined by a recessed portion 827 (FIGS. 13 and 15) and a recessed portion 829 (FIGS. 13 and 15) on opposite sides of the outer sidewall 852. The recessed portions 827, 829 are configured to grip the cap 830 and attach the cap 830 to the male luer 22.

  FIGS. 16-18 illustrate a disinfection cap assembly, generally designated 910, that is dimensioned to engage and disinfect male luer 22. The sterilization cap assembly 910 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 910 includes a cap holder 928 and a cap 930 inserted into the cap holder 928. This embodiment includes a mechanism for preventing excessive tightening of the cap 930 onto the male luer 22 that can damage the male luer 22. This is addressed by the ratchet assembly.

  Cap 930 includes a base 932 and an annular threaded portion 934 extending from base 932. The base 932 includes an outer flange 938 having a plurality of teeth 911 (see FIGS. 17 and 18) along the outer periphery, and can rotate in only one direction. Alternatively, it can be configured to allow rotation in both directions by angling both sides of the tooth. The teeth 911 have a cornered surface 912 and a generally vertical surface 914.

  The cap holder 928 includes a holding mechanism for holding the cap 930 on the cap holder 928. The retention mechanism may include a first protrusion 913 that extends from one section of the side wall 952 of the cap holder 928 and a second protrusion 915 that extends from an opposing section of the side wall 952 of the cap holder 928. The first and second protrusions 913, 915 are configured to extend on the base 932 of the cap 930. Alternatively, the retention mechanism may include a single ring around the interior of the cap holder 928.

  The cap holder 928 includes a plurality of teeth 917 that mesh with the teeth 911 to form a ratchet mechanism. The teeth 917 interact with the teeth 911 to allow the cap 930 to rotate in only one direction within the cap holder 928 and, like the teeth 911 of the base 932, are generally perpendicular to the angled surface 916. Surface 918. Alternatively, it can be configured to allow rotation in both directions.

  The ratchet mechanism provides audible or tactile feedback indicating that the sterilization cap assembly 910 is properly secured. The ratchet mechanism also limits torque to prevent damage to the luer connector 12 or cap 930. Cap 930 is mounted on male luer 22 according to another embodiment of cap 930. If the cap 930 is turned beyond the thread limit, instead of damaging the male luer 22, the cap 930 will slide relative to the cap holder 928, and the angular teeth 911, 917 of the base 932 of the cap 930 will be shown. And the cap holder 930 each slide past each other to prevent further fastening of the cap 930 on the male luer 22. When the cap 930 is removed from the male luer 22, the generally vertical surfaces 914, 918 engage and do not allow sliding.

  FIG. 19 shows a sterilization cap assembly, generally designated 1010, that is dimensioned to engage and disinfect male luer 22. The sterilization cap assembly 1010 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified.

  The cap 1030 is used without a cap holder. Cap 1030 includes a base 1032 and an annular threaded portion 1034 extending from base 1032. The disinfecting fluid can be associated with the inner surface of the annular screw portion 1034.

  The configuration of the cap 1030 is merely exemplary. For example, the cap 1030 can be configured without threads and sized to engage the luer connector 12 with a push-fit friction fit. Similarly, cap 1030 may also include a sidewall as shown in FIG.

  FIG. 20 shows a sterilization cap assembly, generally designated 1110, that is sized to engage and disinfect a male luer. The sterilization cap assembly 1110 operates and is configured in a manner consistent with the sterilization cap assembly 1010 shown in FIG. 18 unless otherwise specified.

  At least a portion of cap 1130 can be treated with a hydrophilic surfactant or otherwise rendered hydrophilic. While the threaded portion 1134 can be treated with a hydrophilic surfactant, the base 1132 can remain hydrophobic to be resistant and non-absorbable to the disinfecting fluid.

  The center plug 1111 can abut an opening 24 formed in the male luer 22 to prevent disinfecting fluid from entering the male luer 22. The central plug 1111 is made of porous plastic and may remain in a hydrophobic state, thereby preventing or minimizing the passage of disinfecting fluid therethrough to the opening 24 formed in the male luer 22. Can be The hydrophobic section may also act as a plug in the infusion line to prevent the disinfection fluid from entering or stop the infusion fluid from leaking.

  FIG. 21 shows a sterilization cap assembly, generally designated 1210, that is sized to engage and disinfect the male luer 22. The sterilization cap assembly 1210 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-4 unless otherwise specified.

  The cap holder 1228 has a notch 1211 in an outer flange 1256 that is configured to attach to a support surface, such as a fluid line 1213. As shown, the cap holder 1228 has a plurality of ribs 1215 that extend along the side wall 1252 from one end 1217 of the cap holder 1228 to the opposite end 1219 of the cap holder 1228. The ribs 1215 facilitate the gripping of the cap holder 1228.

  FIG. 22 shows a sterilization cap assembly, generally designated 1310, dimensioned to engage and disinfect a male luer. The sterilization cap assembly 1310 operates and is configured in a manner consistent with the sterilization cap assembly 10 shown in FIGS. 1-3, unless otherwise specified. Like the sterilization cap assembly 10, the sterilization cap assembly 1310 includes a cap holder 1328 and a cap 1330 sized to be positioned within the cap holder 1328.

  A sealing mechanism, such as center plug 1311, is sized to extend from cap holder 1328 through base 1332 and sized to be positioned within threaded portion 1334 of cap 1330. As such, the center plug 1311 is made of a non-porous material such as SANTOPRENE (R), or any other suitable material. In particular, center plug 1311 includes an arm 1313 with one end 1315 extending from base 1332 and a sphere 1317 attached to the opposite end 1319 of arm 1313. The sphere 1317 is configured to abut an opening 24 formed in the male luer 22 to limit the distance that the disinfecting fluid can travel into the male luer 22. Alternatively, the central plug 1311 extends from the base 1332 and can be made of another material such as rubber. The sphere 1317 can be replaced with a non-spherical device.

  Any of the disinfecting cap assemblies 10, 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110, 1210, and 1310 disclosed herein is an infusion bag, an infusion pump. Or can be configured to be removably attached to a suitable surface (not shown) such as an infusion pole or the like. For example, in FIG. 23, the substantially flat surface 62 of the cap holder 28 is dimensioned to removably secure the sterilization cap assembly 10 to a support surface (not shown) such as an infusion bag. including. In FIG. 24, a hook 82 may be provided that extends from the substantially flat surface 62 of the cap holder 28 and is dimensioned to removably secure the disinfecting cap assembly 10 to a support surface (not shown). .

  In FIG. 25, there is a horseshoe-shaped clip 84 extending from the substantially flat surface 62 of the cap holder 28 and dimensioned to releasably fasten the sterilization cap assembly 10 to a support surface (not shown). Can be provided. The location of the fastening member can vary. For example, in FIG. 26, the side wall 52 of the cap holder 28 includes a clip 86.

  In FIG. 27, the end surface 62 of the cap holder 28 includes an adhesive 88 that can be covered by the release sheet 89. The adhesive 88 can be used to attach the sterilization cap assembly 10 to a support surface such as an infusion pole. A pull tab 90 may be provided to remove the release sheet 89 and expose the adhesive 88.

  Alternative fastening mechanisms can be provided. For example, the sterilization cap assembly may include a ring (not shown).

  The disinfecting cap assembly can be incorporated into a kit having a cleaning syringe, a cap for handling a catheter or needleless connector, a line access device, and the like. The disinfecting fluid used may include anticoagulant materials and / or antimicrobial materials. Examples of disinfecting fluids that may be used are US Provisional Patent Application No. 11 / 821,190 filed June 22, 2007 and US Provisional Patent Application No. 11 / 821,190 filed June 19, 2008. 12 / 214,526. The entire disclosures of US Provisional Patent Application Nos. 11 / 821,190 and 12 / 214,526 are hereby incorporated by reference in their entirety.

  FIG. 28 is a perspective view of a multifunctional sterilization end cap 1410. The disinfection termination cap 1410 includes a first portion 1412 that connects to a female luer (not shown), such as a male connector portion, and a second portion 1414 that connects to a male luer (not shown), such as a female connector portion. The male luer or female luer may each be attached to a fluid source (not shown) such as an infusion bag filled with fluid. For example, the male luer can be the male luer 22 illustrated in and described in connection with FIG. 1 and FIGS.

  As shown in FIGS. 28-33, the first portion 1412 includes a first annular wall 1416 extending from the base 1418. The first annular wall 1416 includes one or more threads 1420 positioned on the inner wall of the first annular wall 1416. The thread 1420 of the first portion 1412 is configured to engage and cooperate with the thread of the female luer to ensure that the end cap 1410 is threadably connected to the female luer.

  The first annular wall 1416 defines an open end 1422. The base 1418 closes the opposite end of the first annular wall 1416. A cylindrical center plug 1430 extends from the base 1418 in the direction of the first annular wall 1416 and is closed by the end wall 1432. The first annular wall 1416 and the cylindrical center plug 1430 are coaxial with each other, and the cylindrical center plug 1430 is smaller in diameter than the first annular wall 1416. First annular wall 1416, base 1418 and cylindrical center plug 1430 define a first chamber 1424 that is annular and accessible by open end 1422 and dimensioned to receive a female luer. As the female luer is inserted through the open end 1422 of the first portion 1412, the cylindrical center plug 1430 and the end wall 1432 are inserted into a portion of the female luer.

  The second portion 1414 includes a second annular wall 1426 that extends from the base 1418 opposite the direction of the first annular wall 1416 and forms an inner shoulder 1428 with the base 1418. Second annular wall 1426 has an open end 1434 and forms a second chamber 1436, while cylindrical center plug 1430 and end wall 1432 form a third chamber 1438. Second chamber 1436 and third chamber 1438 are in fluid communication, and second chamber 1436 is accessible by open end 1434. The second chamber 1436 is sized to receive a male luer.

  One or more threads 1440 are positioned on the outer wall of the second annular wall 1426. The thread 1440 is configured to engage and cooperate with a thread of a male luer connector, such as the luer connector 12 shown in FIG. The threads 1440 and male luer connector threads cooperate with each other to allow the end cap 1410 to be securely threadedly connected to the male luer connector. End cap 1410 may include a plurality of outer ridges 1442 provided on first portion 1412 to facilitate gripping of end cap 1410 during operation and connection with a connector.

  Using the male luer connector 12 shown in FIG. 1 as an example, when the male luer connector 12 engages the second portion 1414, the male luer 22 of the male luer connector 12 is inserted into the open end 1434 and the second chamber 1436. Is done. As the thread 20 of the male luer connector 12 engages the thread 1440 of the second portion 1414, the male luer 22 may further traverse within the second chamber 1436 and traverse within the third chamber 1428. The second annular wall 1426 may be formed in a tapered shape that complements the male luer 22 of the luer connector 12. In such a configuration, the second annular wall 1426 can narrow from the open end 1434 to the base 1418.

  As described above, the sterilization end cap 1410 has a double operability and is configured to be attached to a male luer connector as well as a male luer connector. In general, female luer connectors can include a peripheral wall defining a chamber and having external threads. When the end cap 1410 is attached to the female luer connector, the peripheral wall of the female luer connector is inserted through the open end 1422 into the first chamber 1424 so that the cylindrical center plug 1420 is inserted into the peripheral wall of the female luer connector. The The end cap 1410 can be twisted such that one or more threads 1420 engage the female luer connector, securing the end cap 1410 with the female luer connector.

  FIG. 33 is a cross section of the multifunctional sanitizing end cap 1410 of FIG. 28 taken along line 33-33. FIG. 33 shows the configuration of the end cap 1410 in more detail. Note that this configuration is exemplary. For example, the end cap 1410 can be configured without the first partial thread 1420 and / or the second partial thread 1440. In such a configuration, the first annular wall 1416 and the cylindrical center plug 1430 may be sized to engage the female luer connector by a push friction fit. Similarly, the second annular wall 1426 may be sized to engage the male luer connector with a push-fit friction fit.

  The end cap 1410 functions to cover over the male luer connector and / or female luer connector so that fluid does not leak from the fluid source. The end cap 1410 may be used for temporary separation of male lures and female lures so as not to guarantee disposal.

  The disinfecting cap disclosed herein includes a male connector portion and a female connector portion, but may be provided with only a male portion or only a female portion. In an arrangement where the sterilization end cap 1420 includes only a male connector portion, the end cap 1420 extends from the base 1418 in the direction of the base 1418, the first annular wall 1416 extending from the base 1418, and the first annular wall 1416. A cylindrical center plug 1430, which is closed by an end wall 1432, and a plurality of threads 1420. The second annular wall 1426 and the female side of the cap can be removed. In an arrangement where the sterilization end cap 1420 includes only a female connector portion, the end cap 1420 may include a base 1418, a second annular wall 1426, and a thread 1440. Base 1418 and second annular wall 1426 define a second chamber 1436. The first annular wall 1416 and the cylindrical center plug 1430 can be removed.

  Parts of the disinfection termination cap 1410 such as the inner surface of the first annular wall 1416, the plurality of threads 1420, the outer surface of the second annular wall 1426, the inner surface of the second annular wall 1426, and the second partial thread 1440 are Can be coated with, or impregnated with, a disinfecting fluid, an anticoagulant fluid and / or an antibacterial fluid. An example of a suitable disinfecting fluid is isopropyl alcohol. The concentration of isopropyl alcohol can vary and is preferably 70%. The alcohol concentration can range from 20% to 100%. It will be appreciated that other alcohols including ethanol, propanol, and / or butanol, or other materials such as iodine, hydrogen peroxide, chlorhexidine gluconate, chlorhexidine acetate, and the like may be used. Disinfectants, anticoagulants and / or antibiotics can be in liquid or solid form.

  The disinfection end cap 1410 may be composed of a material having a durometer hardness value of 40-60 on the Shore A scale. The material can be overlaid for the purpose of engagement with the lure and can be malleable medium to medium hardness rubber.

Disinfectant coating The device described herein can be used to immerse the part in the disinfectant, spray coat the part with disinfectant, mix the disinfectant or material with the polymer material used to manufacture the device, etc. It is contemplated that it can be coated with a disinfectant coating by any suitable technique.

  An amount of physiological antibacterial metal compound is added to the resin for direct molding of the article. Physiological and antibacterial metals are intended to include precious metals such as silver, gold and platinum, and copper and zinc. Physiological and antibacterial metal compounds used herein are preferably silver and gold oxide and salts such as silver acetate, silver benzoate, silver carbonate, silver citrate, silver chloride, silver iodide, silver nitrate, silver oxide , Silver sulfadiazine, silver sulfate, gold chloride, and gold oxide. Platinum compounds such as chloroplatinic acid or salts thereof (eg, sodium chloroplatinate and calcium chloroplatinate) may also be used. Also, copper and zinc compounds such as copper and zinc oxides and salts such as those described above for silver may be used. A single physiological antibacterial metal compound or a combination of physiological antibacterial metal compounds may be used.

  Preferred physiological antibacterial metal compounds used in the present invention are silver acetate, silver oxide, silver sulfate, gold chloride, and a combination of silver oxide and gold chloride. The silver compound particles can be sufficiently extracted to form a zone of inhibition to prevent and extinguish bacteria.

  In another preferred form of the invention, the device herein is impregnated with triclosan and silver compounds or triclosan and chlorhexidine, or chlorhexidine gluconate, or chlorhexidine acetate.

  It will be appreciated that the embodiments described herein are exemplary only, and that many variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. All such variations and modifications are intended to be included within the scope of the invention as defined by the appended claims.

Claims (41)

A sanitizing end cap for use with a connector,
A base having a first side and a second side;
A first annular wall extending from the first side of the base and having an outer surface and an inner surface;
A cylindrical central plug extending from the first side of the base and having an outer surface and an inner surface and positioned within the first annular wall to form an annular chamber;
A second annular wall extending from the second side of the base and having an outer surface and an inner surface and defining a second chamber having an open end, the second chamber having a cylindrical center Further defined by the inner surface of the plug;
Disinfecting material on at least one of the inner surface of the first annular wall, the inner surface of the second annular wall, the outer surface of the second annular wall, and the outer surface of the cylindrical center plug; Disinfection end cap.   The disinfection termination cap according to claim 1, wherein the disinfecting material comprises a metal.   The disinfection termination cap according to claim 2, wherein the metal is silver.   The disinfection end cap of claim 1, wherein the disinfecting material comprises alcohol.   5. A disinfection termination cap according to claim 4, wherein the alcohol is isopropyl alcohol.   The disinfecting end cap of claim 1, wherein the disinfecting material comprises chlorhexidine.   The disinfection termination cap of claim 1, wherein the cap is formed of a material having a Shore A hardness in the range of approximately 40-60.   The sterilization termination cap according to claim 1, wherein the first annular wall includes one or more threads.   The disinfection end cap of claim 8, wherein the disinfecting material is on the one or more threads of the first annular wall.   The disinfection termination cap of claim 1, wherein the second annular wall includes one or more threads.   The disinfecting end cap of claim 10, wherein the disinfecting material is on the one or more threads of the second annular wall.   The disinfection termination cap according to claim 1, wherein the second annular wall tapers so as to become thinner from the open end toward the base.   The disinfecting material is obtained by immersing the cap in a disinfecting solution, the inner surface of the first annular wall, the inner surface of the second annular wall, the outer surface of the second annular wall, and the cylindrical center plug. The disinfection termination cap of claim 1, coated on at least one of said outer surfaces.   The disinfecting material disinfects at least one of the inner surface of the first annular wall, the inner surface of the second annular wall, the outer surface of the second annular wall, and the outer surface of the cylindrical center plug. The disinfection termination cap of claim 1, coated on the cap by spray coating with a liquid.   The disinfecting material comprises at least one of the first annular wall, the second annular wall, and the cylindrical center plug by mixing a disinfectant or material into a polymer material and forming the cap therefrom. The disinfection end cap of claim 1, wherein the disinfection end cap is formed.   The disinfection termination cap of claim 1, wherein the cylindrical center plug includes a distal end having an outer surface and an inner surface, the inner surface forming a bottom wall of the second chamber. A sanitizing end cap for use with a connector,
A base having a first side and a second side;
A first annular wall extending from the first side of the base and having an outer surface and an inner surface;
A cylindrical center plug extending from the first side of the base and having an outer surface and positioned within the first annular wall to form an annular chamber;
A disinfection termination cap having a disinfectant material on at least one of the inner surface of the first annular wall and the outer surface of the cylindrical center plug.   The disinfecting end cap of claim 17, wherein the disinfecting material comprises a metal.   The disinfection termination cap of claim 18, wherein the metal is silver.   The disinfection termination cap of claim 17, wherein the disinfecting material comprises alcohol.   21. A disinfection termination cap according to claim 20, wherein the alcohol is isopropyl alcohol.   The disinfecting end cap of claim 17, wherein the disinfecting material comprises chlorhexidine.   The disinfection termination cap according to claim 17, wherein the cap is formed of a material having a Shore A hardness in the range of approximately 40-60.   The disinfection termination cap of claim 17, wherein the first annular wall includes one or more threads on the inner surface.   18. The disinfectant of claim 17, wherein the disinfecting material is coated on at least one of the inner surface of the first annular wall and the outer surface of the cylindrical center plug by immersing the cap in a disinfecting solution. End cap.   The disinfectant material is coated on the cap by spray coating at least one of the inner surface of the first annular wall and / or the outer surface of the cylindrical center plug with a disinfectant solution. Disinfecting end cap as described in.   The disinfecting material comprises at least one of the inner surface of the first annular wall and the outer surface of the cylindrical center plug by mixing a disinfectant or material into a polymer material and forming the cap therefrom. The disinfection end cap of claim 17, formed in A sanitizing end cap for use with a connector,
A base having a first side and a second side;
An annular wall extending from the second side of the base and having an outer surface and an inner surface and defining a chamber having an open end;
A disinfection termination cap, wherein a disinfecting material is on at least one of the outer surface of the annular wall and the inner surface of the annular wall.   29. A disinfection termination cap according to claim 28, comprising a cylindrical center plug extending from the first side of the base and having an outer surface and an inner surface, wherein the chamber is further defined by the inner surface of the cylindrical center plug. .   30. A disinfection termination cap according to claim 29, wherein the cylindrical center plug includes a distal end having an outer surface and an inner surface, the inner surface forming a bottom wall of the chamber.   29. A disinfection termination cap according to claim 28, wherein the disinfecting material comprises a metal.   32. A disinfection termination cap according to claim 31, wherein the metal is silver.   29. A disinfection end cap according to claim 28, wherein the disinfecting material comprises alcohol.   34. A disinfection termination cap according to claim 33, wherein the alcohol is isopropyl alcohol.   29. A disinfection end cap according to claim 28, wherein the disinfecting material comprises chlorhexidine.   29. A disinfection termination cap according to claim 28, wherein the cap is formed of a material having a Shore A hardness in the range of approximately 40-60.   29. A disinfection termination cap according to claim 28, wherein the annular wall includes one or more threads on the outer surface.   29. A disinfection termination cap according to claim 28, wherein the annular wall tapers to taper from the open end toward the base.   29. A disinfection termination cap according to claim 28, wherein the disinfecting material is coated on at least one of the outer surface of the annular wall and the inner surface of the annular wall by dipping the cap in a disinfecting solution.   29. The disinfection termination cap of claim 28, wherein the disinfecting material is coated on the cap by spray coating at least one of the outer surface of the annular wall and the inner surface of the annular wall with a disinfecting liquid.   The disinfecting material is formed on at least one of the outer surface of the annular wall and the inner surface of the annular wall by mixing a disinfectant solution or material into a polymer material and forming the cap therefrom. 28. Disinfection end cap according to 28.

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