Method and apparatus for removable catheter visual light therapeutic system
Inventors
Long, Curtis D. • Barneck, Mitchell D. • Rhodes, Nathaniel L. • Allen, James P. • de la Presa, Martin
Assignees
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Publication Number
US-11241585-B2
Publication Date
2022-02-08
Expiration Date
Abstract
A medical device assembly is provided for removable insertion into a catheter with a lumen. The medical device assembly comprises an electromagnetic radiation (EMR) source for providing non-ultraviolet, therapeutic EMR having an intensity sufficient to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect, and a removable EMR conduction system at least partially insertable into and removable from the lumen of the catheter. The EMR conduction system has at least one optical element providing axial propagation of the therapeutic EMR through an insertable elongate body. The elongate body may have an exterior surface between a coupling end and a distal end tip that has at least one modified portion permitting the radial emission of therapeutic EMR from the elongate body proximate the modified portion. Such modified portion may be gradient along the exterior surface.
Core Innovation
The invention relates to a removable catheter visual light therapeutic system that delivers non-ultraviolet, therapeutic electromagnetic radiation (EMR) into, onto, and around an indwelling catheter within a patient's body. A medical device assembly includes an EMR source and an EMR conduction system having an optical element with an elongate body and a distal end tip, where at least a portion of the optical element is insertable into and removable from the catheter lumen while the catheter resides within the patient's body. The optical element exterior surface includes at least one radial emission portion between a proximal coupling end and the distal end tip that allows emission of non-ultraviolet therapeutic EMR radially from the elongate body into the lumen of the catheter and through the catheter.
The therapeutic effect is produced by an intensity delivered as at least one of radiant exposure, power, and power density, where such intensity causes at least one of inactivating one or more infectious agents and promoting healing. The EMR conduction system delivers the non-ultraviolet therapeutic EMR according to a duty cycle comprising at least one of a single, multiple, variable, continuous, increasing-intensity lead-in, decreasing-intensity phase-out, and any combination thereof on-and-off periods. The system therefore provides a duty cycle of non-ultraviolet therapeutic EMR into, onto, and around the catheter while the optical element resides in the disposition and the catheter resides within the patient's body.
The medical device assembly further includes a coupling that connects the EMR source to an optical element connector of the EMR conduction system to deliver non-ultraviolet therapeutic EMR for axial propagation through the elongate body and for radial emission into and through the catheter. The disclosed approach supports delivering non-ultraviolet therapeutic EMR with a wavelength range above 380 nm to 904 nm and specifies that the duty cycle structure can include lead-in and phase-out on-and-off periods. The disclosed embodiments also describe an optical element formed to provide radial emission through modified exterior surfaces and exterior portions adapted for emission into and through the catheter.
Claims Coverage
The independent claims include three inventive categories: a medical device assembly, a medical system, and a method. Across the claims, the core inventive features total about three per claim: non-ultraviolet therapeutic EMR intensity for inactivating infectious agents and/or promoting healing, a luminally insertable/removable optical conduction element with axial propagation and radial emission, and a duty cycle delivering on-and-off phases into, onto, and around the catheter while the catheter remains indwelling.
Non-ultraviolet therapeutic EMR intensity for therapeutic effect
An EMR source for providing non-ultraviolet, therapeutic EMR having an intensity comprising at least one of a radiant exposure of at least 0.5 J/cm2 and up to 1 kJ/cm2, power of at least 0.005 mW and up to 1 W, and power density of at least 0.1 mW/cm2 and up to 1 W/cm2, whereby such intensity causes a therapeutic effect of at least one of inactivating one or more infectious agents and promoting healing.
Removably insertable optical conduction element with axial propagation and radial emission
An EMR conduction system comprising an optical element connector and an optical element having an elongate body and a distal end tip, at least a portion of the optical element being insertable into a disposition within and removable from the lumen of the catheter while the catheter resides within the patient's body, the elongate body being conducive to the axial propagation of the non-ultraviolet, therapeutic EMR through the elongate body, the exterior surface having at least one radial emission portion between the proximal coupling end and the distal end tip allowing the emission of non-ultraviolet, therapeutic EMR radially from the elongate body into the lumen of the catheter and through the catheter.
Duty cycle delivery with lead-in and phase-out on-and-off periods
Delivering a duty cycle of the non-ultraviolet, therapeutic EMR into, onto, and around the catheter while the optical element resides in the disposition and the catheter resides within the patient's body, the duty cycle comprising at least one of a single, multiple, variable, continuous, increasing-intensity lead-in, decreasing-intensity phase-out, and any combination thereof on-and-off periods.
Method of removably inserting an optical element into an indwelling catheter lumen
Inserting an optical element of an EMR conduction system into a disposition within the lumen of the catheter, the optical element having an exterior surface dimension which is less than the interior surface dimension of the lumen such that the optical element is removably insertable into the lumen of the catheter.
Transmitting a duty-cycle exposure of non-ultraviolet therapeutic EMR intensity for therapeutic effect
Transmitting a duty cycle of non-ultraviolet, therapeutic EMR from an EMR source into the optical element of the EMR conduction system for an amount of time and at an intensity comprising at least one of a radiant exposure of at least 0.5 J/cm2 and up to 1 kJ/cm2, power of at least 0.005 mW and up to 1 W, and power density of at least 0.1 mW/cm2 and up to 1 W/cm2, whereby such intensity causes a therapeutic effect of at least one of inactivating one or more infectious agents and promoting healing.
Emitting the duty cycle radially into the lumen and delivering into, onto, and around the indwelling catheter
Emitting the duty cycle of non-ultraviolet, therapeutic EMR radially into the lumen of the catheter and through the catheter, delivering the duty cycle of the non-ultraviolet, therapeutic EMR into, onto, and around the catheter while the optical element resides in the disposition and the catheter resides within the patient's body, and removing the optical element of the EMR conduction system from the lumen of the catheter, the catheter remaining indwelling within the patient's body.
Across the independent claims, the claimed invention is anchored on providing non-ultraviolet therapeutic EMR intensity that causes inactivation of infectious agents and/or promoting healing, delivering the EMR via a luminally insertable/removable optical conduction element that enables axial propagation and radial emission through the catheter, and applying that radial emission according to a duty cycle with configurable on-and-off phases while the catheter remains indwelling.
Stated Advantages
Inactivating one or more infectious agents.
Promoting healing.
Inactivating infectious agents by inhibiting device-related biofilm growth [as part of the claimed therapeutic effect].
Documented Applications
Delivering non-ultraviolet, therapeutic EMR into, onto, and around an indwelling catheter within a patient's body.
Inactivating infectious agents and/or promoting healing associated with a catheter indwelling in a patient's body.
Inhibiting device-related biofilm growth associated with a catheter.
Sterilizing part of the medical device assembly outside the patient's body [dependent claim refinement].
Method of effectively delivering non-ultraviolet, therapeutic EMR into a catheter while the catheter remains indwelling in a patient's body, including inserting an optical element into the catheter lumen and removing the optical element while leaving the catheter indwelling.
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