WO2015126701A1 - Iv access port cap for providing antimicrobial protection - Google Patents

Iv access port cap for providing antimicrobial protection Download PDF

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Publication number
WO2015126701A1
WO2015126701A1 PCT/US2015/015482 US2015015482W WO2015126701A1 WO 2015126701 A1 WO2015126701 A1 WO 2015126701A1 US 2015015482 W US2015015482 W US 2015015482W WO 2015126701 A1 WO2015126701 A1 WO 2015126701A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
actuator
port
lumen
antimicrobial solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2015/015482
Other languages
English (en)
French (fr)
Inventor
Yiping Ma
Siddarth Shevgoor
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to ES15706126T priority Critical patent/ES2780899T3/es
Priority to AU2015219311A priority patent/AU2015219311B2/en
Priority to EP19218266.5A priority patent/EP3659662A1/en
Priority to BR112016018935-3A priority patent/BR112016018935B1/pt
Priority to SG11201606244WA priority patent/SG11201606244WA/en
Priority to CN201580009385.0A priority patent/CN106029151B/zh
Priority to EP15706126.8A priority patent/EP3107611B1/en
Priority to JP2016553507A priority patent/JP6574430B2/ja
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to CA2938604A priority patent/CA2938604C/en
Priority to MX2016010233A priority patent/MX374890B/es
Publication of WO2015126701A1 publication Critical patent/WO2015126701A1/en
Anticipated expiration legal-status Critical
Priority to AU2019210572A priority patent/AU2019210572B2/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/165—Shrouds or protectors for aseptically enclosing the connector

Definitions

  • the present invention relates generally to caps for providing antimicrobial protection to an IV access port or other type of device having a female luer connection.
  • the caps of the present invention can be used to distribute an antimicrobial solution within the intraluminal space of a female luer device.
  • FIG. 1 generally illustrates a port 100 that is configured as a female luer lock connector
  • Figure 2 generally illustrates a port 200 that is configured as a needleless female luer connector
  • a needleless connector employs a valve that seals the lumen of the device from the exterior environment and which is pierced or otherwise separated by a male connector to obtain access to the lumen.
  • a female luer connector should be interpreted as any connector having an internal lumen that is tapered to conform to a corresponding male connector having the same or similar degree of tapering.
  • These female luer connectors can include luer lock and luer slip (or non-lock luer) connectors.
  • Intravenous devices can employ ports to provide quick access to a patient's vasculature. These ports also enable the device to remain within the patient's vasculature even when no access to the vasculature is needed.
  • a port of an intravenous device is not in use, it is desirable to maintain the port clean and free from bacteria and other microbes. If the port becomes contaminated with microbes while not in use, it is possible that the microbes will be flushed into the patient's vasculature once the port is again used for accessing the patient's vasculature. Accordingly, maintaining a sterile port is essential to minimize the risk of infection.
  • caps typically contain an antimicrobial solution that is applied to the exterior surfaces of the port when a cap is attached to the port.
  • some caps employ an alcohol- soaked material that is disposed within the cavity of the cap so that the material scrubs the exterior surfaces of the port when the cap is screwed on. Once screwed on, these caps can retain an amount of the antimicrobial solution around the exterior surface of the port to ensure that the exterior surface remains sterile until the cap is removed.
  • some ports are configured to have antimicrobial coatings on the intraluminal surfaces. With such coatings, the intraluminal surfaces can remain sterile even if microbes come in contact with the surfaces. These coatings can also dissolve into the fluid within the lumen to effectively spread antimicrobial agents throughout the lumen.
  • antimicrobial coatings on the intraluminal surfaces of ports. For example, ports that employ antimicrobial coatings are significantly more expensive to produce. As a result many facilities choose not to use them. Also, for a coating to be effective, it must retain its antimicrobial properties for at least the amount of time that the port could possibly be used (e.g. up to 7 days). To accomplish this, relatively thick coatings or highly concentrated coatings are used. This causes the concentration of antimicrobial agents to be very high during the initial usage time which poses a toxicity risk.
  • the present invention extends to caps for providing antimicrobial protection to a female luer port of an intravenous device.
  • the caps of the present invention are designed to distribute an antimicrobial solution within the intraluminal surfaces of the port. Additionally, in some embodiments, the caps are designed to also distribute an antimicrobial solution around the exterior surfaces of the port. Accordingly, the caps of the present invention provide a complete solution for disinfecting a port of an intravenous device.
  • the present invention is implemented as a cap for a port of an intravenous device.
  • the cap can comprise a body having a cavity; an actuator positioned within the cavity; and an absorbent material containing an antimicrobial solution.
  • the absorbent material is contained within the cavity between the actuator and an inner surface of the body.
  • the actuator comprises a lumen through which the antimicrobial solution flows to reach a lumen of the port.
  • the actuator comprises a male luer in which the lumen is formed.
  • the antimicrobial solution flows through a gap between the body and an exterior surface of the actuator and onto an exterior surface of the port.
  • the body includes a seal that the actuator contacts when the cap is connected to the port thereby forming a seal between the actuator and the body.
  • the concentration of an antimicrobial agent within the antimicrobial solution is selected such that when the antimicrobial solution mixes with fluid contained within the lumen of the port, the concentration of the antimicrobial agent remains higher than the minimum inhibitory concentration of the antimicrobial agent.
  • the port is a female luer into which the actuator inserts.
  • the port is a needleless connector into which the actuator inserts.
  • the actuator includes a protrusion that is positioned within a lumen in the body, the protrusion having a lumen through which the antimicrobial solution flows.
  • the actuator includes a plurality of prongs that extend through corresponding openings in the body.
  • the antimicrobial solution flows through the openings when the actuator is forced into the cavity.
  • the actuator includes a lumen that has an antimicrobial coating.
  • the present invention is implemented as a cap for a port of an intravenous device.
  • the cap can comprise a body having a cavity; an actuator positioned within the cavity, the actuator having a lumen; and an absorbent material containing an antimicrobial solution, the absorbent material being contained within the cavity between the actuator and an inner surface of the body.
  • the absorbent material Prior to the cap being connected to a port of an intravenous device, the absorbent material remains uncompressed. Then, when the cap is connected to a port of an intravenous device, the actuator compresses the absorbent material causing the antimicrobial solution to flow through the lumen of the actuator and into a lumen of the port.
  • the actuator is sized such that a gap exists between an outer edge of the actuator and a wall of the cavity, the antimicrobial solution also flowing through the gap onto an exterior surface of the port.
  • the actuator includes a plurality of prongs which extend through corresponding openings in the body. The antimicrobial solution flows through the openings onto the exterior surface of the port
  • the body includes a seal for sealing the lumen of the actuator.
  • the actuator comprises a male luer.
  • the present invention is implemented as a cap for a needleless connector of an intravenous device.
  • the cap can comprise a body having a cavity; an absorbent material positioned within the cavity, the absorbent material containing an antimicrobial solution; and an actuator positioned within the cavity against the absorbent material.
  • the actuator is moveable within the cavity to compress the absorbent material such that upon the cap being connected to a needleless connector, the needleless connector causes the actuator to compress the absorbent material releasing the antimicrobial solution onto an intraluminal surface of the needleless connector.
  • the actuator comprises a lumen.
  • the antimicrobial solution flows through the lumen of the actuator onto the intraluminal surface of the needleless connector.
  • the antimicrobial solution also flows around an exterior surface of the actuator onto an exterior surface of the needleless connector.
  • Figure 1 illustrates a perspective view of an example of a prior art port that is configured as a female luer lock connector.
  • Figure 2 illustrates a perspective view of an example of a prior art port that is configured as a needleless female luer connector.
  • Figure 3 illustrates a perspective view of a cap in accordance with one or more embodiments of the invention that may be used to apply an antimicrobial solution to the intraluminal surfaces of a port.
  • Figure 4 illustrates a cross-sectional view of a cap in accordance with one or more embodiments of the invention in which an actuator is movable within the body of the cap to cause an antimicrobial solution to be squeezed from an absorbent material contained within the body and distributed through the actuator into the intraluminal space of a port.
  • Figure 5 illustrates a cross-sectional view of a cap having a body that is comprised of two pieces in accordance with one or more embodiments of the invention.
  • Figure 6 illustrates a cross-sectional view of a cap that is configured to be connected to a port that is configured as a luer slip connector in accordance with one or more embodiments of the invention.
  • Figures 7A-7C illustrate a sequence of how the cap depicted in Figure 4 is connected to a port of an intravenous device.
  • Figure 7A illustrates the cap prior to contacting the port.
  • Figure 7B illustrates that, as the cap is being forced onto the port, the actuator is forced into the absorbent material causing antimicrobial solution to flow towards the port through the gaps formed by the movement of the actuator and through the lumen of the actuator.
  • Figure 7C illustrates that, once the cap is fully connected to the port, the actuator is forced against a seal to seal the lumen of the port.
  • Figure 8 illustrates a cross-sectional view of the cap depicted in Figure 4 when connected to a port that does not include a ridge against which the actuator presses.
  • Figures 9A and 9B illustrate a sequence of how the cap depicted in Figure 4 can be used on a port that employs a septum.
  • Figure 10A illustrates a cross-sectional view of an alternate embodiment of a cap which employs prongs to facilitate the flow of antimicrobial solution to the exterior surfaces of the port.
  • Figure 10B illustrates an exploded view of the cap of Figure 10A.
  • Figures 11A-11C illustrate a sequence of how the cap depicted in Figure 10A is connected to a port of an intravenous device.
  • Figure 11A illustrates the cap upon contacting the port.
  • Figure 11B illustrates that, as the cap is being forced onto the port, the actuator is forced into the absorbent material causing antimicrobial solution to flow towards the port through the gaps formed by the movement of the actuator and through the lumen of the actuator.
  • Figure 11C illustrates that, once the cap is fully connected to the port, the actuator is forced against a seal to cause further flow of the antimicrobial solution to be only through the lumen of the actuator.
  • the present invention extends to caps for providing antimicrobial protection to a female luer port of an intravenous device.
  • the caps of the present invention are designed to distribute an antimicrobial solution within the intraluminal surfaces of the port. Additionally, in some embodiments, the caps are designed to also distribute an antimicrobial solution around the exterior surfaces of the port. Accordingly, the caps of the present invention provide a complete solution for disinfecting a port of an intravenous device.
  • the present invention is implemented as a cap for a port of an intravenous device.
  • the cap can comprise a body having a cavity; an actuator positioned within the cavity; and an absorbent material containing an antimicrobial solution.
  • the absorbent material is contained within the cavity between the actuator and an inner surface of the body.
  • the actuator comprises a lumen through which the antimicrobial solution flows to reach a lumen of the port.
  • the actuator comprises a male luer in which the lumen is formed.
  • the antimicrobial solution flows through a gap between the body and an exterior surface of the actuator and onto an exterior surface of the port.
  • the body includes a seal that the actuator contacts when the cap is connected to the port thereby forming a seal between the actuator and the body.
  • the concentration of an antimicrobial agent within the antimicrobial solution is selected such that when the antimicrobial solution mixes with fluid contained within the lumen of the port, the concentration of the antimicrobial agent remains higher than the minimum inhibitory concentration of the antimicrobial agent.
  • the port is a female luer into which the actuator inserts.
  • the port is a needleless connector into which the actuator inserts.
  • the actuator includes a protrusion that is positioned within a lumen in the body, the protrusion having a lumen through which the antimicrobial solution flows.
  • the actuator includes a plurality of prongs that extend through corresponding openings in the body.
  • the antimicrobial solution flows through the openings when the actuator is forced into the cavity.
  • the actuator includes a lumen that has an antimicrobial coating.
  • the present invention is implemented as a cap for a port of an intravenous device.
  • the cap can comprise a body having a cavity; an actuator positioned within the cavity, the actuator having a lumen; and an absorbent material containing an antimicrobial solution, the absorbent material being contained within the cavity between the actuator and an inner surface of the body.
  • the absorbent material Prior to the cap being connected to a port of an intravenous device, the absorbent material remains uncompressed. Then, when the cap is connected to a port of an intravenous device, the actuator compresses the absorbent material causing the antimicrobial solution to flow through the lumen of the actuator and into a lumen of the port.
  • the actuator is sized such that a gap exists between an outer edge of the actuator and a wall of the cavity, the antimicrobial solution also flowing through the gap onto an exterior surface of the port.
  • the actuator includes a plurality of prongs which extend through corresponding openings in the body.
  • the antimicrobial solution flows through the openings onto the exterior surface of the port
  • the body includes a seal for sealing the lumen of the actuator.
  • the actuator comprises a male luer.
  • the present invention is implemented as a cap for a needleless connector of an intravenous device.
  • the cap can comprise a body having a cavity; an absorbent material positioned within the cavity, the absorbent material containing an antimicrobial solution; and an actuator positioned within the cavity against the absorbent material.
  • the actuator is moveable within the cavity to compress the absorbent material such that upon the cap being connected to a needleless connector, the needleless connector causes the actuator to compress the absorbent material releasing the antimicrobial solution onto an intraluminal surface of the needleless connector.
  • the actuator comprises a lumen.
  • the antimicrobial solution flows through the lumen of the actuator onto the intraluminal surface of the needleless connector.
  • the antimicrobial solution also flows around an exterior surface of the actuator onto an exterior surface of the needleless connector.
  • FIG. 3 illustrates a perspective view of a cap 300 in accordance with one or more embodiments of the invention.
  • cap 300 comprises a body 301 and an actuator 302.
  • Body 301 is generally shaped to allow cap 300 to be connected to a female luer connector such as port 100. If the cap is designed to connect to a female luer lock connector, the inside surface of the body can include threads (e.g. as shown in Figure 4). In contrast, if the cap is designed to connect to a female luer slip connector, the inside surface of the body may or may not include threads.
  • actuator 302 can be configured as a male luer connector to allow actuator 302 to be inserted into the female luer port 100.
  • Figure 4 illustrates a cross-section view of cap 300.
  • cap 300 includes body 301, actuator 302, and absorbent material 303 positioned between body 301 and actuator 302.
  • Cap 300 includes threads 310 and is therefore an example of a cap designed for a female luer lock connector.
  • Actuator 302 has a tip that is designed as a male luer connector to allow the tip to be inserted into the lumen of a female luer connector.
  • Figure 4 depicts cap 300 prior to being connected to a port.
  • actuator 302 Before connection, actuator 302 is positioned against the interior surface of body 301 and does not compress absorbent material 303. In some embodiments, actuator 302 can be held in this position by an adhesive, welding, or other physical force between body 301 and actuator 302. In other embodiments, actuator 302 can be held in this position by absorbent material 303. In other words, absorbent material 303 may be sufficiently rigid to retain the position of actuator 302 until a substantial force is applied against actuator 302. In any case, actuator 302 is designed to not compress absorbent material 303 until cap 300 is connected to a port. A seal (not shown) can be applied overtop of actuator 302 and possibly the opening of body 301 to seal absorbent material 303 from the exterior environment until cap 300 is to be used.
  • Figure 5 illustrates a cross-sectional view of an alternate embodiment of cap 300.
  • body 301 comprises two pieces, a top piece 301a and a bottom piece 301b.
  • This two piece design can be used to facilitate manufacturing (e.g. to facilitate positioning actuator 302 within body 301).
  • cap 300 will function the same as will be described below.
  • Figure 6 illustrates a cross-sectional view of another alternate embodiment of cap 300.
  • body 301 does not include threads but is configured to form a friction fit with the exterior surface of a port. Accordingly, a cap in accordance with this alternate embodiment could be used on a non-lock female luer connector.
  • body 301 it is desirable to secure body 301 to the port (e.g. via threads or a friction fit) to allow a seal to be formed between actuator 302 and body 301 once the cap is connected. The role of this seal will be further described below with reference to Figure 7C.
  • absorbent material 303 is saturated with an antimicrobial solution which remains within absorbent material 303 until absorbent material 303 is compressed.
  • Actuator 302 is designed to provide a fluid pathway to distribute the antimicrobial solution to a port when cap 300 is connected to the port.
  • the primary fluid pathway is through lumen 320.
  • a secondary fluid pathway is also provided around the exterior of actuator 302. The distribution of the antimicrobial solution is illustrated in Figures 7A-7C.
  • Figures 7A-7C illustrate a sequence that occurs when cap 300 is connected to a port. Although Figures 7A-7C illustrate the design of cap 300 as shown in Figure 4, the same sequence would occur when a cap designed as shown in Figures 5 or 6 is connected. Also, for simplicity of illustration, cap 300 is shown as being connected to port 100. However, the same sequence would occur when cap 300 is connected to any port that is configured as a female luer connector.
  • ports on which cap 300 can be used include the BD Q- Syte® (manufactured by Becton, Dickinson and Company), the CareFusion MaxPlus® Clear (manufactured by CareFusion Corp), and the LifeShield MicroClave® (manufactured by Hospira, Inc.) among many others.
  • Figure 7A shows the state of cap 300 prior to contacting port 100.
  • cap 300 is as shown in Figure 4.
  • Port 100 is shown as including an internal ridge 111 against which the tip of actuator 302 presses when cap 300 is connected to the port.
  • Port 100 is also shown as including threads 110 and is therefore an example of a luer lock connector. Accordingly, cap 300 is connected to port 100 by threading the cap onto the port.
  • the primary pathway along which the antimicrobial solution flows is through lumen 320 of actuator 302. Because lumen 320 aligns with lumen 120 of port 100, the antimicrobial solution flowing through lumen 320 will ultimately be distributed along the surfaces of lumen 120 and into any fluid contained within lumen 120. In this way, the intraluminal surfaces of port 100 can be disinfected.
  • the secondary pathway is around actuator 302 as depicted by the outer arrows in Figure 7B.
  • the antimicrobial solution will flow along the secondary pathway until the top surface of actuator 302 contacts seal 304 formed along the interior surface of body 301 as is shown in Figure 7C.
  • the contact between actuator 302 and seal 304 limits the antimicrobial solution from flowing around actuator 302 and therefore forces further flow through lumen 320. In this way, an adequate amount of antimicrobial solution will flow into the intraluminal space of port 100.
  • antimicrobial solution will be contained within lumen 320 and lumen 120 as well as in the spaces between the outer surface of actuator 302, and the inner surface of body 301.
  • This antimicrobial solution outside of actuator 302 can disinfect the top and outer surfaces of port 100.
  • the connection between port 100 and cap 300 may not be fluid tight, the antimicrobial solution may be allowed to seep between threads 110 and 310 and onto the exterior surfaces of port 100.
  • this antimicrobial solution can flow into the opening of port 100 between the exterior surface of actuator 302 and the interior surface of port 100. In this way, the intraluminal surfaces that may otherwise not be reached by antimicrobial solution that has flowed through lumen 320 may still be disinfected.
  • cap 300 allows the intraluminal surfaces of a port to be disinfected. Because the lumen of port 100 may typically contain a fluid (e.g. a saline solution or other solution that was infused into the patient), the antimicrobial solution can mix with the fluid to enhance the distribution of the antimicrobial agents throughout lumen 120.
  • a fluid e.g. a saline solution or other solution that was infused into the patient
  • a seal can be formed between actuator 302 and seal 304 as shown in Figure 7C.
  • the tight fit between the male luer actuator 302 and the female luer port 100 can also form a seal between these two connectors.
  • lumens 120 and 320 can be substantially sealed from the external environment thereby limiting the amount of antimicrobial solution within lumen 120 that evaporates after cap 300 has been connected.
  • the antimicrobial solution can therefore remain active until the cap is removed for attachment of another device.
  • the antimicrobial solution that remains within lumen 120 can disinfect the tip of the device.
  • cap 300 not only disinfects port 100 when not in use, but can also disinfect other devices that are connected to the port after cap 300 has been removed.
  • Figure 8 illustrates a cross-sectional view of an alternate embodiment in which a port 100a does not include a ledge against which the tip of actuator 302 presses.
  • the frictional force created when actuator 302 has been inserted into lumen 120 can be sufficient to force actuator 302 upward into absorbent material 303. This frictional force can also be sufficient to form a seal between actuator 302 and port 100.
  • FIGs 9A and 9B illustrate a cross-sectional view of another alternate embodiment in which cap 300 is connected to a port 200 that is configured as a needleless connector that includes a split septum 230.
  • a port 200 that is configured as a needleless connector that includes a split septum 230.
  • actuator 302 As shown in Figure 9A, as the tip of actuator 302 initially contacts septum 230 and is forced through septum 230, actuator 302 is forced upwardly to initiate the flow of antimicrobial solution. Actuator 302 will pass through septum 230 and ultimately contact a ledge within lumen 220 of port 200 (or if port 200 does not contain a ledge, may contact the tapered sides of the port).
  • cap 300 when fully connected, cap 300 is positioned in a similar manner on port 200 as cap 300 is positioned on port 100. Accordingly, cap 300 can be used to disinfect the intraluminal surfaces of ports of various designs and configurations.
  • FIG. 10A illustrates a cross-sectional view of another embodiment of a cap 1000.
  • Cap 1000 like cap 300, includes a body 1001, an actuator 1002, and absorbent material 1003.
  • actuator 1002 and the bottom surface of body 1001 have a different configuration to enhance the flow of absorbent material to the exterior surfaces of a port.
  • Figure 10B illustrates a cross-sectional exploded view of cap 1000 in which actuator 1002 is shown removed from body 1001.
  • actuator 1002 includes a central protrusion 1053 that forms lumen 1020.
  • Actuator 1002 also includes prongs 1052 that extend from the bottom surface of actuator 1002.
  • the bottom of body 1001 is configured to accommodate actuator 1002.
  • body 1001 includes a lumen 1050 within which protrusion 1053 is contained and openings 1051 through which prongs 1052 extend.
  • Figures 11A-11C illustrate how this configuration of cap 1000 enhances the flow of antimicrobial solution to the exterior surfaces of a port while still distributing sufficient antimicrobial solution to the lumen of the port.
  • Figure 11A illustrates cap 1000 upon actuator 1002 contacted the top surface of port 1100.
  • the design of actuator 1002 causes prongs 1052 to first contact port 1100.
  • the upward force on prongs 1052 causes actuator 1002 to compress absorbent material 1003 resulting in antimicrobial solution flowing through lumen 1020 and around the exterior of actuator 1002 in much the same manner as described with reference to Figures 7B.
  • FIG 11C illustrates cap 1000 once fully connected to port 1100. As shown, in this position, port 1100 has forced actuator 1002 upward until it contacts seal 1004. At this point, antimicrobial solution will be forced to flow through lumen 1020. However, the antimicrobial solution that flowed around actuator 1002 and is contained within the internal spaces of body 1001 will be allowed to flow out through openings 1051 onto the exterior surfaces of port 1100.
  • Figure 11C shows that a gap exists between protrusion 1053 and the internal surfaces of lumen 1050 when cap 1000 is fully connected
  • the dimensions of protrusion 1053 and lumen 1050 can be configured so that protrusion 1053 forms a tight seal within lumen 1050 when actuator 1002 is in the upward position. Forming a seal between protrusion 1053 and lumen 1050 may be desired when a tight seal is not formed between port 1100 and body 1001.
  • the caps of the present invention also provide the advantage of minimizing the concentrations of antimicrobial solution that must be used to ensure that the port is adequately disinfected.
  • concentrations of antimicrobial solution may be minimized.
  • the caps of the present invention will only remain on the port in between uses.
  • the concentration of the antimicrobial solution can be employed in the caps of the present invention while still providing adequate antimicrobial protection.
  • the concentration of the antimicrobial solution (or the concentration once mixed with fluid already present within the lumen of the port) can be just higher than the minimum inhibitory concentration of the antimicrobial agent in the solution.
  • antimicrobial solutions may be used in caps of the present invention.
  • any antimicrobial agent that is soluable in alcohol, saline, or saline/heparin solutions can be employed.
  • the concentration of the antimicrobial agent within the antimicrobial solution can be selected so that the resulting concentration of the agent once the antimicrobial solution is mixed with the fluid in the lumen of the port is above the minimum inhibitory concentration of the antimicrobial agent.
  • Suitable antimicrobial agents include CHA and CHG among others.
  • the lumen of the actuator can be coated with an antimicrobial coating.
  • the cap may or may not also include the absorbent material containing the antimicrobial solution.
  • the antimicrobial protection can be provided when the fluid within the lumen of the port contacts the antimicrobial coating within the lumen of the actuator.
  • the dry antimicrobial coating can dissolve into the fluid to thereby disinfect the lumen of the port.
  • the flow of the antimicrobial solution from the absorbent material may be partially or completely directed around the exterior of the actuator to ensure distribution on the exterior surfaces of the port.
  • Some antimicrobial solution may be designed to flow through the lumen in the actuator to assist in distributing the antimicrobial coating throughout the lumen of the port. In this way, an antimicrobial solution can still be directed to both the intraluminal and the exterior surfaces of the port.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Urology & Nephrology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • External Artificial Organs (AREA)
PCT/US2015/015482 2014-02-20 2015-02-11 Iv access port cap for providing antimicrobial protection Ceased WO2015126701A1 (en)

Priority Applications (11)

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EP15706126.8A EP3107611B1 (en) 2014-02-20 2015-02-11 Iv access port cap for providing antimicrobial protection
EP19218266.5A EP3659662A1 (en) 2014-02-20 2015-02-11 Iv access port cap for providing antimicrobial protection
BR112016018935-3A BR112016018935B1 (pt) 2014-02-20 2015-02-11 Tampa para uma abertura de um dispositivo intravenoso
SG11201606244WA SG11201606244WA (en) 2014-02-20 2015-02-11 Iv access port cap for providing antimicrobial protection
CN201580009385.0A CN106029151B (zh) 2014-02-20 2015-02-11 用于提供抗菌防护的静脉注射装置进出端口盖
ES15706126T ES2780899T3 (es) 2014-02-20 2015-02-11 Tapa de puerto de acceso intravenoso para proporcionar protección antimicrobiana
MX2016010233A MX374890B (es) 2014-02-20 2015-02-11 Tapa de orificio de acceso intravenoso (iv) para proporcionar protección antimicrobiana.
JP2016553507A JP6574430B2 (ja) 2014-02-20 2015-02-11 抗菌保護を提供するためのｉｖアクセスポートキャップ
CA2938604A CA2938604C (en) 2014-02-20 2015-02-11 Iv access port cap for providing antimicrobial protection
AU2015219311A AU2015219311B2 (en) 2014-02-20 2015-02-11 IV access port cap for providing antimicrobial protection
AU2019210572A AU2019210572B2 (en) 2014-02-20 2019-07-31 IV access port cap for providing antimicrobial protection

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US14/185,827 2014-02-20
US14/185,827 US9283369B2 (en) 2014-02-20 2014-02-20 IV access port cap for providing antimicrobial protection

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