Disposable fiber optic introducer component of a light delivery system for preventing, reducing and/or eliminating infections during institutional or in-home use
Inventors
Long, Curtis D. • Hitchcock, Robert W • Lackey, John
Assignees
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Publication Number
US-12527945-B2
Publication Date
2026-01-20
Expiration Date
Abstract
An electromagnetic radiation (EMR) delivery system for delivering EMR at wavelengths, intensities, exposures, and durations to locations inside and/or outside a patient's body in, on, and surrounding a tubular structure such as a tube, catheter, and/or a catheter extension to prevent, reduce, and/or eliminate infectious agents in, on, or surrounding the tubular structure. A smart light engine box generates the therapeutic EMR, controls treatments, and monitors the health of the system. A fiber optic disposable, introduced and positioned by an introducer assembly, makes at-home use of the EMR delivery system possible. Specific embodiments of the EMR delivery system for use with peritoneal dialysis catheters, dialysis accesses, and hemodialysis accesses are also disclosed.
Core Innovation
The invention relates to an electromagnetic radiation delivery system that delivers non-ultraviolet, therapeutic EMR at wavelengths, intensities, exposures, and durations to locations inside and/or outside a patient's body in, on, and surrounding a tubular structure. The tubular structure comprises a tube, a catheter, and/or an extension set, and the therapeutic EMR is used to prevent, reduce, and/or eliminate infectious agents in, on, or surrounding the tubular structure and/or to enhance healthy cell growth.
Each light engine box comprises at least one laser assembly that receives power and generates therapeutic EMR having a range of radiant exposures from 0.1 J/cm2 to 5 kJ/cm2, a range of powers from 0.005 mW to 10 W, and a power density range from 1 mW/cm2 to 5 W/cm2. The light engine box is connected through at least one cable adapter to a light transmission cable, including an umbilical light transmission cable, that propagates the therapeutic EMR to the distal end for delivery to the tubular structure.
The optical element includes a fiber optic for disposition within the lumen of the tubular structure, wherein the fiber optic further comprises at least one radial emission portion disposed between a coupling end and a distal end to provide radial emission relative to the tubular structure. The introducer assembly includes a ready mode, an introduced mode, and a detached mode, with a guide tube having a proximal body and a rotatably connected distal portion, and proximal and distal connector assemblies that are detachably nested and rotatably connected during delivery into the connected tubular structure.
The introducer system architecture is further defined in terms of mode transitions in which the introduced mode is achieved when distal connector elements are connected to a tubular-receiving structure or adapter connected between the distal connector assembly and the tubular structure. In these conditions, the distal connector assembly guides the fiber optic into the connected structure as the fiber optic is advanced by advancing movement of the slide collar, and the guide tube is moved into a detached mode where connector assemblies detach from their nested structures.
Claims Coverage
The partial content provides three independent claims (clm-00001, clm-00011, clm-00018). Across these claims, the inventive coverage centers on an EMR delivery system using non-ultraviolet therapeutic EMR from laser assemblies, delivery via a light transmission cable and fiber optic with radial emission portions, and an introducer assembly/system with ready, introduced, and detached modes including rotatable, detachably nested connector assemblies.
Non-ultraviolet therapeutic EMR delivery for infectious agent prevention or healthy cell growth
An EMR delivery system for delivering therapeutic non-ultraviolet EMR to locations in, on, and surrounding a tubular structure to prevent, reduce, and/or eliminate infectious agents and/or enhance healthy cell growth, connected to a power supply and including a light engine box and an introducer assembly.
Laser-generated therapeutic intensity ranges for inactivation and enhancement
At least one laser assembly disposed within the light engine box generates non-ultraviolet therapeutic EMR having radiant exposures from 0.1 J/cm2 to 5 kJ/cm2, powers from 0.005 mW to 10 W, and a power density range from 1 mW/cm2 to 5 W/cm2, sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth.
Fiber optic with radial emission portion within a tubular lumen
An optical element connected to the light transmission cable comprises a fiber optic for disposition within the lumen of the tubular structure, the fiber optic further comprising at least one radial emission portion disposed between a coupling end and a distal end for radial emission relative to the tubular structure.
Introducer assembly with ready, introduced, and detached modes and rotatable distal portion
An introducer assembly introduces the optical element into the tubular structure, the introducer assembly having a ready mode, an introduced mode, and a detached mode, including a guide tube with a proximal body and a distal portion rotatably connected about a longitudinal axis, a slide collar and slide post for advancing a centered capture structure, and proximal and distal connector assemblies that are detachably nested and rotatably connected during introduced mode.
CPU-controlled smart light engine box features
A CPU controls features provided by the smart light engine box, the CPU being pre-programmed and/or programmable and connected to the power supply, where the smart light engine box generates the therapeutic non-ultraviolet EMR within the stated radiant exposure, power, and power density ranges.
Umbilical light transmission cable facilitating data and electricity transmission
An umbilical light transmission cable includes a proximate end and a distal end, and comprises at least one transmission wire to facilitate transmission of at least one of data and electricity from the proximal end toward the distal delivery.
Introducer system introduced-to-detached mode transitions via guide tube detachment
An introducer system comprises an adapter and an introducer assembly with ready, introduced, and detached modes, where the introducer assembly is movable from ready to introduced, and the introduced mode is defined by connection conditions among distal connector assembly, the adapter, and the tubular structure, including guidance of the fiber optic through connector elements as the slide collar is advanced.
Connector architecture using SMA fiber connector with ferrous ring and distal luer
An introducer assembly includes a proximal connector assembly comprising an SMA fiber connector and a ferrous ring, detachably nested within a centered annular cylinder and connected to the fiber optic, and a distal connector assembly comprising a distal luer and a luer attachment ring, detachably nested within the distal portion of the guide tube and connectable to the tubular-receiving structure.
Introduced mode guidance through distal luer passageway with rotatable connection
The introducer assembly is disposed in the introduced mode when the distal luer is connected to the tubular-receiving structure, the distal luer has a longitudinal passageway through which the fiber optic is guided into the connected tubular-receiving structure as the fiber optic is advanced by advancing movement of the slide collar toward the distal portion, and the distal connector assembly rotates together with the distal portion to rotatably connect to the proximal connector assembly.
The independent claims collectively cover delivering non-ultraviolet therapeutic EMR from laser assemblies through a light transmission cable to a fiber optic with radial emission portions, using an introducer assembly/system with ready, introduced, and detached modes. They further specify rotatable, detachably nested connector assemblies, including proximal SMA/proximal connector architecture and distal luer/distal connector architecture, and in one claim a CPU and an umbilical cable facilitating transmission of data and electricity.
Stated Advantages
inactivating one or more infectious agents
enhancing healthy cell growth
Documented Applications
dialysis systems using peritoneal dialysis (PD) catheters, including radial EMR emission to locations such as a connector hub/cuffs/extension set/into dialysis solution, and hemodialysis systems including dialysis access and inbound/outbound blood flow tubing
sterilization targets including saline line, dialysate line, and vascular access tubing
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