Methods and apparatus to inactivate infectious agents on a drainage catheter residing in a body cavity
Inventors
Rhodes, Nathaniel L. R. • Bracken, Adam E. • de la Presa, Martin • Poursaid, Ahrash E. • Coil, Ryan R. • Barneck, Mitchell D. • Allen, James P.
Assignees
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Publication Number
US-11529530-B2
Publication Date
2022-12-20
Expiration Date
Abstract
Methods and apparatus for the inactivation of infectious agents in, on or around a catheter residing in a patient's body cavity. The method comprises a coupling adapter for facilitating the transmission of non-ultraviolet sterilizing electromagnetic radiation (EMR) substantially axially along an optical element into the catheter body. Through delivery of the sterilizing EMR to particular areas of highest infection, the present disclosure is able to inactivate the major sources of infection in catheters.
Core Innovation
The invention provides catheter-based medical device assemblies and methods for delivering non-ultraviolet, sterilizing electromagnetic radiation into a cavity of a patient's body while the catheter is used for drainage of fluid. The device includes a catheter having an elongate catheter body with at least one internal lumen, a coupling end, a distal end tip, and an inflatable balloon disposed proximate the distal end tip.
An optical element is applied within the catheter body, where the optical element is conducive to axial propagation of a sterilizing electromagnetic radiation through the catheter. An electromagnetic radiation source is coupled to the catheter body to provide non-ultraviolet sterilizing electromagnetic radiation that propagates axially and irradiates outwardly into the patient's body along at least a portion of the catheter.
The optical element is terminated or discontinuous near the distal tip or insertion site to irradiate outward into surrounding tissue, including irradiation at insertion sites and transcutaneous portions associated with infection hotspots. In some implementations, the device architecture includes a convergence chamber with an optical feature to combine or redirect sterilizing electromagnetic radiation toward fluid-path lumens so that sterilizing electromagnetic radiation is directed into the convergence chamber, fluid lines, and any fluid in the fluid line.
The electromagnetic radiation intensity delivered by the electromagnetic radiation source includes a radiant exposure of at least 0.1 J/cm2 and up to 100 J/cm2 and power of at least 0.005 mW and up to 1 Watt, and such intensity is sufficient to inactivate one or more infectious agents. The described implementations also include adjustable duty cycle and timing, including emission immediately after insertion for inhibiting biofilm growth.
Claims Coverage
The independent claims provide coverage for catheter-based delivery of non-ultraviolet sterilizing electromagnetic radiation into a patient's body cavity for fluid drainage, with sterilizing intensity parameters sufficient to inactivate one or more infectious agents. The coverage is grounded in the use of an optical element for axial propagation within a catheter and an electromagnetic radiation source coupled to the catheter, with dependent refinements adding convergence chamber embodiments, optical features, adjustable duty cycle and timing, and biofilm inhibition.
Catheter with axial optical propagation for non-ultraviolet sterilizing electromagnetic radiation
providing a catheter having an elongate catheter body with at least one internal lumen, a coupling end, a distal end tip and an inflatable balloon, the distal end tip being insertable into the cavity of the patient's body, the inflatable balloon being disposed proximate the distal end tip and being inflatable by delivering an inflation fluid to the balloon; applying an optical element within the catheter body, the optical element being conducive to the axial propagation of a sterilizing electromagnetic radiation through the catheter; and coupling an electromagnetic radiation source to the catheter body
Non-ultraviolet sterilizing electromagnetic radiation intensity for inactivating infectious agents
coupling an electromagnetic radiation source to the catheter body, the electromagnetic radiation source for providing non-ultraviolet, sterilizing electromagnetic radiation that propagates axially and irradiates outwardly into the patient's body along at least a portion of the catheter, the non-ultraviolet, sterilizing electromagnetic radiation having an intensity comprising a radiant exposure of at least 0.1 J/cm2 and up to 100 J/cm2 and power of at least 0.005 mW and up to 1 Watt, such intensity being sufficient to inactivate one or more infectious agents.
Inflatable balloon disposed proximate distal end tip for cavity insertion
providing a catheter having an elongate catheter body with at least one internal lumen, a coupling end, a distal end tip and an inflatable balloon, the distal end tip being insertable into the cavity of the patient's body, the inflatable balloon being disposed proximate the distal end tip and being inflatable by delivering an inflation fluid to the balloon;
Convergence chamber with optical feature directing sterilizing electromagnetic radiation to fluid-path components
providing a medical device convergence chamber with at least one fluid line, connecting it between the catheter coupling end and the electromagnetic radiation source, and applying an optical feature to direct sterilizing electromagnetic radiation to sterilize the convergence chamber, its fluid line, and any fluid therein.
Optical feature comprising reflective surface, lens, or fiber optic
the optical feature includes at least one of a reflective surface, a lens, or a fiber optic.
Adjustable duty cycle for emitting non-ultraviolet sterilizing electromagnetic radiation
The method further includes a medical device assembly configured to drain fluid from the patient's body comprising the steps of: [and], setting an adjustable duty cycle to deliver electromagnetic radiation at predetermined times and for predetermined time periods within that duty cycle.
Immediately after insertion emission sufficient to inhibit biofilm growth
immediately after inserting a medical device assembly into the patient's body cavity, an electromagnetic radiation source emits non-ultraviolet sterilizing electromagnetic radiation at an intensity sufficient to inactivate infectious agents to inhibit biofilm growth.
Overall, the independent claims focus on catheter-based delivery of non-ultraviolet sterilizing electromagnetic radiation using an optical element that enables axial propagation within the catheter and an electromagnetic radiation source configured to irradiate outwardly into the body cavity, with sterilizing intensity defined by radiant exposure and power sufficient to inactivate one or more infectious agents. Dependent coverage further refines the system by adding convergence chamber embodiments with an optical feature, specifying optical feature types, and narrowing operation via adjustable duty cycle, timing, and biofilm inhibition.
Stated Advantages
inactivate one or more infectious agents
inhibit biofilm growth
sterilize the convergence chamber, its fluid line, and any fluid therein
Documented Applications
No documented applications found
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