# US 10,307,612 B2 · 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 > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,612 B2 - Document ID: US10307612B2 - Status: Granted - Kind: B2 - Application number: 15/668,266 - Filed: 2017-08-03 - Published: 2018-01-18 - Granted: 2019-06-04 - Earliest claimed: 2012-04-05 - Assignees: Light Line Medical, Inc. - Applicants: Light Line Medical, Inc. - Inventors: Mitchell D. Barneck; Nathaniel L. R. Rhodes; James P. Allen; Curtis D. Long - Web page: https://patentgrep.com/patent/US10307612B2 ## CPC - A61N 5/0624: {for eliminating microbes, germs, bacteria on or in the body} - A61L 2/084: Visible light - A61L 2/085: Infrared radiation - A61M 25/0009: {Making of catheters or other medical or surgical tubes} - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - A61M 25/0028: {characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves (catheter hubs A61M25/0097)} - A61N 5/0601: {Apparatus for use inside the body} - A61L 2/08: Radiation - A61L 2/10: Ultraviolet [UV] radiation - A61L 2103/05: Living organisms or biological materials - A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps - A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement} - Y10T 29/49002: Electrical device making - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## 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. ## Claims ### Claim 1 A medical device assembly for insertion into a cavity of a patient's body and for delivery of a fluid to and/or retrieval of fluid from the patient's body, comprising: an electromagnetic radiation (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 Watt, such intensity being sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth; a catheter having an elongate catheter body with at least one internal lumen, a coupling end and a distal end, the distal end being 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, 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; 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; and at least one coupling to connect the EMR source to the catheter body. ### Claim 2 (depends on 1) The medical device assembly as in claim 1 wherein the catheter body is configured for access to at least one cavity of the patient's body, such cavity being at least one of a venous, an arterial, a gastrointestinal, an abdominal, a urological, a respiratory, a cranial, and a spinal cavity. ### Claim 3 (depends on 1) The medical device assembly as in claim 1 wherein the at least one internal lumen comprises a propagation lumen for the axial propagation of the therapeutic EMR relative to the catheter body. ### Claim 4 (depends on 1) The medical device assembly as in claim 1 wherein the optical element is selected from a group of optical elements including a reflective surface, a lens, a fiber optic filament, and any combination thereof. ### Claim 5 (depends on 1) The medical device assembly as in claim 1 wherein at least a portion of the optical element comprises a fiber optic filament for disposition within the at least one internal lumen, the fiber optic filament comprises a fiber body having at least a portion configured as at least one of a bare fiber body and a cladding-encased fiber body, the fiber body having an exterior surface, a coupling end, a distal end, and a core, the fiber optic filament being conducive to the axial propagation of therapeutic EMR within the core. ### Claim 6 (depends on 5) The medical device assembly as in claim 5 wherein the fiber optic filament further comprises at least one radial emission portion on the exterior surface disposed between the coupling end of the fiber body and the distal end of the fiber body, the radial emission portion allowing the emission of therapeutic EMR radially from the fiber body into the lumen of the catheter. ### Claim 7 (depends on 6) The medical device assembly as in claim 6 wherein at least one radial emission portion directs therapeutic EMR of a desired intensity radially through and along the length of each radial emission portion into the internal lumen of the catheter. ### Claim 8 (depends on 7) The medical device assembly as in claim 7 wherein the radial emission portion comprises an ablated surface, the ablated surface having a gradient ablation, the gradient ablation having a gradient pattern such that the emission of EMR radially from the radial emission portion has a uniform intensity. ### Claim 9 (depends on 1) The medical device assembly as in claim 1 wherein the therapeutic EMR has a wavelength that ranges from about 380 nm to about 904 nm. ### Claim 10 (depends on 5) The medical device assembly as in claim 5 wherein the internal lumen has an inner diameter and the fiber body has an outer diameter, the inner diameter of the internal lumen being greater that the outer diameter of the fiber body, thereby defining a void within the internal lumen external to the exterior surface of the fiber body. ### Claim 11 (depends on 10) The medical device assembly as in claim 10 wherein the void facilitates the passage of fluid through the void by at least one of delivery of fluid to and retrieval of fluid from the patient's body simultaneously with at least a portion of the fiber body being disposed within the internal lumen. ### Claim 12 (depends on 10) The medical device assembly as in claim 10 wherein at least a portion of the optical element is removably insertable into the internal lumen. ### Claim 13 (depends on 1) The medical device assembly as in claim 1 wherein the catheter is a urinary catheter. ### Claim 14 A medical device assembly for insertion into a cavity of a patient's body and for delivery of fluid to and/or retrieval of fluid from the patient's body, comprising: 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, the EMR source 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, such intensity being sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth; a catheter having an elongate catheter body with at least one internal lumen, a coupling end and an distal end, the distal end being 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 for at least one of delivery of fluid into the patient's body and retrieval of fluid from the patient's body; 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; and at least one coupling to connect the radiation source to the catheter body. ### Claim 15 (depends on 14) The medical device assembly as in claim 14 wherein the wavelength of the therapeutic EMR is selected from a group of wavelengths including wavelengths centered about 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. ### Claim 16 (depends on 15) The medical device assembly as in claim 15 wherein the therapeutic EMR comprises one or more of the selected wavelengths being emitted in at least one of alternating and parallel treatment patterns. ### Claim 17 (depends on 14) The medical device assembly as in claim 14 wherein the EMR source has an adjustable duty cycle length. ### Claim 18 A method for delivering therapeutic electromagnetic radiation (EMR) into an internal lumen of a catheter disposed within a cavity of a patient's body to produce a therapeutic effect within the catheter and/or the patient's body, the method comprising the steps of: positioning at least a portion of an optical element within the internal lumen of the catheter having an elongate catheter body, the optical element being conducive to the axial propagation of the therapeutic EMR relative to the catheter body; 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, such intensity being sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth; and activating the EMR source to produce the therapeutic effect within the cavity of the patient's body. ### Claim 19 (depends on 18) The method as in claim 18 wherein the optical element comprises at least one radial emission portion on an exterior surface of the optical element, the method further comprising the step of emitting radially therapeutic EMR from the radial emission portion of the optical element into the lumen of the catheter. ### Claim 20 (depends on 19) The method as in claim 19 wherein the radial emission portion comprises an ablated surface, the ablated surface having a gradient ablation, the method further comprising the step of creating the gradient ablation by ablating the exterior surface of the optical element in a gradient pattern such that the emission of EMR radially from the radial emission portion has a desired intensity.