Methods and apparatus to deliver therapeutic, non-ultraviolet electromagnetic radiation to inactivate infectious agents and/or to enhance healthy cell growth via a catheter residing in a body cavity

Inventors

Barneck, Mitchell D. • Rhodes, Nathaniel L. R. • Allen, James P. • Long, Curtis D.

Assignees

Light Line Medical Inc

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Publication Number

US-10307612-B2

Patent

Publication Date

2019-06-04

Expiration Date


Abstract

Methods and apparatus provide therapeutic electromagnetic radiation (EMR) for inactivating infectious agents in, on or around a catheter residing in a patient's body cavity and/or for enhancing healthy cell growth. The method comprises transmitting non-ultraviolet therapeutic EMR substantially axially along an optical element in a lumen of the catheter body and/or the catheter body. Through delivery of the therapeutic EMR to particular infected areas and/or areas requiring tissue healing. The methods and apparatus of the present disclosure inactivate the major sources of infection in, on, and around catheters and/or enhance healthy cell growth around catheters.

Core Innovation

A medical device assembly is provided for insertion into a cavity of a patient’s body to deliver a fluid to and/or retrieve fluid from the patient’s body while simultaneously providing non-ultraviolet, therapeutic electromagnetic radiation (EMR). The EMR source provides therapeutic EMR having an intensity defined by radiant exposure of at least 0.1 J/cm² and up to 1.0 kJ/cm² and power of at least 0.005 mW and up to 1.0 Watt, and the intensity is sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth.

The assembly includes an elongate catheter having at least one internal lumen with a coupling end and a distal end insertable into the cavity. The catheter body directs both the fluid and the therapeutic EMR axially relative to the catheter body, and axial flow of the fluid within the catheter body facilitates at least one of delivery of fluid and retrieval of fluid. An optical element conducive to axial propagation of the therapeutic EMR is positioned with respect to the catheter body to be at least one of in, on, or within a wall of the catheter body and within at least one internal lumen, and at least one coupling connects the EMR source to the catheter body.

In embodiments and dependent refinements, the catheter and optical arrangement enable therapeutic EMR to be propagated axially and also configured to emit radially into a catheter lumen through a radial emission portion. The therapeutic EMR can be constrained to a wavelength range above 380 nm to 904 nm and can be emitted as selected wavelengths, with structures and surface characteristics including an ablated surface with gradient ablation to provide a desired radial emission intensity and configurable emission patterns and source control such as an adjustable duty cycle length.

Claims Coverage

The document provides three independent claims: a medical device assembly for insertion and simultaneous therapeutic EMR and fluid delivery/retrieval, a further medical device assembly with selected EMR source types and wavelength/intensity constraints, and a method for delivering therapeutic EMR via an internal lumen of a catheter. Across the independent claims, the coverage centers on at least one therapeutic function and an EMR delivery architecture that positions an optical element within or relative to a catheter body to achieve axial propagation, with optional refinements that further define radial emission and source wavelength control.

Non-ultraviolet therapeutic EMR intensity for therapeutic effect

A non-ultraviolet, therapeutic electromagnetic radiation (EMR) source providing therapeutic EMR having an intensity comprising a radiant exposure of at least 0.1 J/cm² and up to 1.0 kJ/cm² and power of at least 0.005 mW and up to 1 Watt, wherein such intensity is sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth.

Catheter axially directs fluid and therapeutic EMR

An elongate catheter with at least one internal lumen, a coupling end and a distal end insertable into the cavity of the patient’s body, wherein the catheter body directs both the fluid and the therapeutic EMR axially relative to the catheter body and axial flow of the fluid within the catheter body facilitates at least one of delivery of fluid into the patient’s body and retrieval of fluid from the patient’s body.

Optical element for axial propagation positioned with respect to catheter

An optical element conducive to the axial propagation of the therapeutic EMR relative to the catheter body, the optical element having a position with respect to the catheter body of being at least one of in, on, or within a wall of the catheter body and within at least one internal lumen of the catheter body.

EMR source coupled to catheter

At least one coupling to connect the EMR source to the catheter body.

Selected non-ultraviolet therapeutic EMR source types

An electromagnetic radiation (EMR) source selected from a group including a solid state laser, a semiconductor laser, a diode laser, and a light emitting diode, for providing non-ultraviolet, therapeutic EMR having a wavelength in a range of above 380 nm to 904 nm and having an intensity comprising a radiant exposure of at least 0.1 J/cm² and up to 1.0 kJ/cm² and power of at least 0.005 mW and up to 1.0 Watt, wherein such intensity is sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth.

Position optical element in catheter lumen for axial propagation

Positioning at least a portion of an optical element within the internal lumen of a catheter having an elongate catheter body, the optical element being conducive to the axial propagation of the therapeutic EMR relative to the catheter body.

Connect EMR source to optical element for therapeutic intensity

Connecting an EMR source to the optical element, the EMR source for providing non-ultraviolet, therapeutic EMR having an intensity comprising a radiant exposure of at least 0.1 J/cm² and up to 1.0 kJ/cm² and power of at least 0.005 mW and up to 1.0 Watt, wherein such intensity is sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth.

Activate EMR source to produce therapeutic effect in cavity

Activating the EMR source to produce the therapeutic effect within the cavity of the patient’s body.

Across the independent claims, the core claim coverage is directed to a catheter-based medical device assembly and method that couples a non-ultraviolet therapeutic EMR source to an optical element positioned within and/or relative to a catheter lumen or wall to achieve axial EMR propagation, while enabling therapeutic effect at least one of inactivating infectious agents and enhancing healthy cell growth, and optionally refining aspects such as selected EMR source types, wavelength constraints, and catheter-integrated axial fluid delivery/retrieval.

Stated Advantages

Inactivating one or more infectious agents.

Enhancing healthy cell growth.

Documented Applications

Delivering therapeutic EMR and fluid and/or retrieving fluid from a cavity of a patient’s body using a catheter disposed within the cavity.

Treating therapeutic effects within the cavity of a patient’s body, including inactivating one or more infectious agents and enhancing healthy cell growth.

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