Device for delivering an antimicrobial composition into a medical device
Inventors
Ziebol, Robert J. • Beilke, Matthew David
Assignees
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Abstract
The present disclosure is directed to a device for delivering an antimicrobial composition into a medical device. Some embodiments disclosed herein provide a method for preventing infection and microbial ingress in medical device connections. The device includes a male connector with a distal tip and a recess at the distal tip. The surface of the recess includes an antimicrobial composition. In certain implementations a male luer comprises a tapered sealing member further comprising a recess containing chlorhexidine acetate.
Core Innovation
The connector device comprises a male luer having a male tapered surface, a fluid flow channel, and recesses extending proximally from the distal end of the male luer. A water-soluble antimicrobial composition is positioned on the recess surfaces. In one configuration, a shroud with an inner thread surrounds at least a portion of the male luer to engage female connector threads, creating liquid-receiving spaces between the recess surfaces and the female tapered surface upon coupling.
In another configuration, the male tapered surface engages a female tapered surface to form a fluid-tight seal with a medical device connector. The recesses extend radially inward of the male tapered surface, defining at least one cavity between the recess surfaces and the female tapered surface upon insertion. This configuration delivers the antimicrobial composition into the medical device as fluid enters or partially fills the cavity.
The antimicrobial composition is positioned in a proximal trap or distributed along a blade-and-channel geometry, with chlorhexidine identified as a component. The recesses retain fluid and antimicrobial composition near contamination pathways, exposing microbes to an effective concentration while limiting total antimicrobial dose and washout. Figure descriptions depict alternative recess profiles, fluid pathways, and connector and tubing configurations, while background problems remain not explicitly described in the patent.
Claims Coverage
The claims include two independent claims, claims 1 and 16, covering two inventive features directed to recessed male connectors carrying a water-soluble antimicrobial composition.
Male connector device with threaded shroud and antimicrobial recesses
Claim 1 recites a male connector device comprising a male luer with a male tapered surface, a fluid flow channel, and a shroud with an inner thread configured to engage female connector threads. Recesses extending proximally from the distal end create liquid-receiving spaces between their surfaces and the female tapered surface upon coupling, and carry a water-soluble antimicrobial composition positioned on each recess surface.
Connector device forming a cavity for antimicrobial delivery
Claim 16 recites a connector device for delivering an antimicrobial composition into a medical device, comprising a fluid flow channel and a male tapered surface configured to engage a female tapered surface to form a fluid-tight seal. Recess surfaces extending radially inward of the male tapered surface carry a water-soluble antimicrobial composition, forming at least one cavity between the recess surfaces and the female tapered surface upon insertion.
Together, the independent claims cover connector configurations featuring fluid flow channels and recessed male surfaces carrying a water-soluble antimicrobial composition that form liquid-receiving spaces or cavities upon engagement with a female connector, where claim 1 specifies a threaded shroud and claim 16 specifies a fluid-tight seal.
Stated Advantages
The recesses retain fluid and antimicrobial near contamination pathways, exposing microbes to an effective antimicrobial concentration while limiting total antimicrobial dose and washout.
The blade-and-channel geometry is stated to accelerate antimicrobial diffusion and microbial killing during brief syringe connections.
Thicker antimicrobial coating in channel troughs provides a reservoir and capillary-guided delivery near the connector septum.
Proximal traps retain antimicrobial agent and limit washout while concentrating it in the cavity formed upon coupling.
Modeling indicates recirculation can maintain chlorhexidine at a concentration associated with at least a 4-log microbial reduction.
Time-release coatings reduce premature antimicrobial loss during insertion.
The male and female tapered surfaces engage to form a fluid-tight seal.
The connector recesses form spaces or a cavity that can receive liquid when the male connector is coupled with or inserted into the female connector.
The connector is configured to deliver antimicrobial composition into a medical device, with antimicrobial composition dispersing into fluid in the cavity.
Documented Applications
A connector device for delivering an antimicrobial composition into a medical device and coupling a male connector to a female connector.
Infusion devices and connector variants including catheters, needleless connectors, transfer sets, peritoneal dialysis transfer sets, caps, couplers, tubing sets, zero-clearance or spiral-blade connectors, and syringes.
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