# US 11,992,700 B2 · Light delivery system with a fiber optic disposable for preventing, reducing and/or eliminating infections during institutional or in-home use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,992,700 B2 - Document ID: US11992700B2 - Status: Granted - Kind: B2 - Application number: 17/947,868 - Filed: 2022-09-19 - Published: 2023-03-09 - Granted: 2024-05-28 - Earliest claimed: 2012-04-05 - Assignees: Light Line Medical, Inc. - Applicants: Light Line Medical, Inc. - Inventors: Curtis D. Long; Perry Croll - Web page: https://patentgrep.com/patent/US11992700B2 ## CPC - A61N 5/0624: {for eliminating microbes, germs, bacteria on or in the body} - A61B 90/98: using electromagnetic means, e.g. transponders - A61M 1/285: {Catheters therefor} - A61M 1/3661: {for haemodialysis} - A61M 39/105: {Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes (multi-channel connectors in general F16L37/56)} - A61N 5/0601: {Apparatus for use inside the body} - A61N 5/067: using laser light - A61L 2/084: Visible light - A61M 1/168: {Sterilisation or cleaning before or after use} - A61N 2005/0626: {Monitoring, verifying, controlling systems and methods} - A61N 2005/063: {comprising light transmitting means, e.g. optical fibres} - A61N 2005/0659: {infrared} - A61N 2005/0662: {Visible light} - A61N 2005/0663: {Coloured light} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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)} - 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) ## 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 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. ## Claims ### Claim 1 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 having a lumen and comprising a tube, a catheter, and/or a catheter extension, to prevent, reduce, and/or eliminate infectious agents in, on, or surrounding the tubular structure and/or to enhance healthy cell growth, the EMR delivery system being connected to a power supply and comprising: at least one light engine box for connection to the power supply and for generating therapeutic EMR, each light engine box comprising: at least one laser assembly disposed within the light engine box that receives power from the power supply and generates a non-ultraviolet, therapeutic EMR having an intensity comprising a range of radiant exposures from 0.1 J/cm2 to 5 kJ/cm2, and a range of powers from 0.005 mW to 5 W, and a power density range from 1 mW/cm2 and 2 W/cm2, 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 at least one cable adapter, each cable adapter being connected to one laser assembly; a light transmission cable having a proximate end and a distal end, the proximate end being connected with the cable adapter, the cable adapter for receiving therapeutic EMR from the laser assembly and facilitating the propagation of the therapeutic EMR from the laser assembly to and through the light transmission cable to the distal end of the light transmission cable for delivery to the tubular structure; and an optical element connected to the light transmission cable, the optical element comprising a fiber optic for disposition within the lumen of the tubular structure, the fiber optic being conducive to the axial propagation of the therapeutic EMR relative to the tubular structure, the fiber optic further comprises at least one radial emission portion disposed between a coupling end of the fiber optic and a distal end of the fiber optic. ### Claim 2 (depends on 1) The EMR delivery system of claim 1 wherein the light engine box is a smart light engine box and further comprises a central processing unit (CPU) that controls features provided by the smart light engine box, the CPU being connected to the power supply and being at least one of pre-programmed and programmable. ### Claim 3 (depends on 2) The EMR delivery system of claim 2 wherein the smart light engine box further comprises a test module and a subminiature version A (SMA) optical fiber connector, the SMA optical fiber connector facilitates the connection of the test module to the distal end of the light transmission cable such that therapeutic EMR is delivered to the test module from the distal end of the light transmission cable and the delivered therapeutic EMR is tested by the test module, the test module sends test results to the CPU to be analyzed against predetermined EMR parameters and the CPU determines the health of the laser assembly and any degradation in the therapeutic EMR delivered to the test module. ### Claim 4 (depends on 3) The EMR delivery system of claim 3 wherein the smart light engine box further comprises an alarm alert that activates when the CPU indicates to the alarm alert that the therapeutic EMR fails to meet the predetermined therapeutic EMR parameters, indicating that one of the health of the laser assembly is compromised or the light transmission cable has degraded and requires replacement. ### Claim 5 (depends on 2) The EMR delivery system of claim 2 wherein the smart light engine box further comprises a treatment actuator to initiate a pre-programmed dosing treatment of therapeutic EMR meeting the predetermined therapeutic EMR parameters, the treatment actuator being manually activated. ### Claim 6 (depends on 5) The EMR delivery system of claim 5 wherein the smart light engine box further comprises an alarm alert that activates when the CPU indicates to the alarm alert that the smart light engine box is in a failure mode, the treatment actuator being manually deactivated when the failure mode is indicated. ### Claim 7 (depends on 2) The EMR delivery system of claim 2 wherein the light transmission cable is an umbilical light transmission cable comprising at least one transmission wire to facilitate the transmission of at least one of data and electricity. ### Claim 8 (depends on 7) The EMR delivery system of claim 7 wherein the smart light engine box further comprises an alarm alert that activates when the CPU indicates to the alarm alert that any transmission within any transmission wire has been disrupted. ### Claim 9 (depends on 2) The EMR delivery system of claim 2 wherein the optical element comprises a fiber optic disposable, the fiber optic disposable has an elongate structure, a retracted mode, and a fiber-advanced mode and comprises the fiber optic, a proximal end for connection to the distal end of the light transmission cable, a distal end for advancing into the tubular structure, the fiber optic is maintained in a sterile environment when the fiber optic disposable is in the retracted mode, when the fiber optic is advanced into the lumen of the tubular structure the fiber optic disposable is in the fiber-advanced mode. ### Claim 10 (depends on 9) The EMR delivery system of claim 9 wherein the fiber optic further comprises at least one radial emission portion disposed between the proximal end of the fiber optic and the distal end of the fiber optic. ### Claim 11 An 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 having a lumen and comprising a tube, a catheter, and/or a catheter extension, to prevent, reduce, and/or eliminate infectious agents in, on, or surrounding the tubular structure and/or to enhance healthy cell growth, the EMR delivery system being connected to a power supply and comprising: a CPU that controls features provided by the smart light engine box, the CPU being connected to the power supply and being at least one of pre-programmed and programmable, at least one smart light engine box for connection to the power supply and for generating therapeutic EMR, each smart light engine box comprising: at least one laser assembly disposed within the light engine box that receives power from the power supply and generates a non-ultraviolet, therapeutic EMR having an intensity comprising a range of radiant exposures from 0.1 J/cm2 to 5 kJ/cm2, and a range of powers from 0.005 mW to 5 W, and a power density range from 1 mW/cm2 and 2 W/cm2, 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 at least one cable adapter, each cable adapter being connected to one laser assembly via an SMA optical fiber connector; an umbilical light transmission cable having a proximate end and a distal end, the proximate end being connected with the cable adapter, the cable adapter for receiving therapeutic EMR from the laser assembly and facilitating the propagation of the therapeutic EMR from the laser assembly to and through the umbilical light transmission cable to the distal end of the umbilical light transmission cable for delivery to the tubular structure, the umbilical light transmission cable comprising at least one transmission wire to facilitate the transmission of at least one of data and electricity; and a fiber optic disposable, the fiber optic disposable having an elongate structure, a retracted mode, and a fiber-advanced mode and comprises a fiber optic, a proximal end for connection with the distal end of the umbilical light transmission cable, a distal end for advancing into the lumen of the tubular structure, the fiber optic is maintained in a sterile environment when the fiber optic disposable is in the retracted mode, when the fiber optic is advanced into the lumen of the tubular structure the fiber optic disposable is in the fiber-advanced mode, the fiber optic being conducive to the axial propagation of the therapeutic EMR relative to the tubular structure when in the fiber-advanced mode, the fiber optic further comprises at least one radial emission portion disposed between proximal end of the fiber optic and a distal end of the fiber optic. ### Claim 12 (depends on 11) The EMR delivery system of claim 11 wherein the CPU blocks actuation of the laser assembly when the monitoring of usage of the fiber optic disposable is unable to complete another treatment before the predetermined useful life of the fiber optic disposable is exhausted. ### Claim 13 (depends on 11) The EMR delivery system of claim 11 wherein the smart light engine box further comprises a treatment actuator to initiate a pre-programmed dosing treatment of therapeutic EMR meeting the predetermined therapeutic EMR parameters, the treatment actuator being manually activated. ### Claim 14 (depends on 13) The EMR delivery system of claim 13 wherein the smart light engine box further comprises an alarm alert that activates when the CPU indicates to the alarm alert that the smart light engine box is in a failure mode, the treatment actuator being manually deactivated when the failure mode is indicated. ### Claim 15 An EMR delivery fiber optic disposable 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 having a lumen to prevent, reduce, and/or eliminate infectious agents in, on, or surrounding the tubular structure, the EMR delivery fiber optic disposable being connected to an EMR delivery system connected to a power supply, the EMR delivery system comprising a CPU that controls features of the EMR delivery system, at least one laser assembly that receives power from the power supply and generates a non-ultraviolet, therapeutic EMR having an intensity sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing healthy cell growth, a light transmission cable having a proximate end and a distal end, the proximate end being connected the laser assembly for receiving therapeutic EMR from the laser assembly and facilitating the propagation of the therapeutic EMR from the laser assembly to and through the light transmission cable to the distal end of the light transmission cable, the EMR delivery fiber optic disposable comprising: a fiber optic disposable, the fiber optic disposable having an elongate structure, a retracted mode, and a fiber-advanced mode and comprises a fiber optic, a proximal end for connection to the distal end of the light transmission cable, a distal end for advancing into the lumen of the tubular structure, the fiber optic is maintained in a sterile environment when the fiber optic disposable is in the retracted mode, when the fiber optic is advanced into the lumen of the tubular structure the fiber optic disposable is in the fiber-advanced mode, the fiber optic being conducive to the axial propagation of the therapeutic EMR relative to the tubular structure, the fiber optic further comprises at least one radial emission portion disposed between the proximal end of the fiber optic and a distal end of the fiber optic. ### Claim 16 (depends on 15) The EMR delivery fiber optic disposable of claim 15 wherein the EMR delivery system further comprises a fiber optic introducer for disposition intermediate of the fiber optic disposable and the tubular structure, the fiber optic introducer comprising a main line, an entry port, an exit port, a branching line, and a side port. ### Claim 17 (depends on 16) The EMR delivery fiber optic disposable of claim 16 wherein the main line is tubular and has the entry port and the exit port disposed at opposite ends of the mainline and the branching line communicates with the main line and has the side port forming a Y-connector, the entry port is connected to the distal end of the fiber optic disposable, the exit port is connected to the tubular structure, the side port is connected to a second tubular structure, the fiber optic passes through the entry port into the main line and through the exit port into the tubular structure when the fiber optic disposable is in the fiber-advanced mode, fluid flows through the exit port, the main line, the branching line, the side port, into and out of the second tubular structure. ### Claim 18 (depends on 17) The EMR delivery fiber optic disposable of claim 17 wherein the fiber optic has at least one radial emission portion disposed within the main line. ### Claim 19 (depends on 17) The EMR delivery fiber optic disposable of claim 17 wherein the fiber optic has at least one radial emission portion disposed within the tubular structure. ### Claim 20 (depends on 16) The EMR delivery fiber optic disposable of claim 16 wherein the main line is tubular and has the entry port and the exit port disposed at opposite ends of the mainline and the branching line communicates with the main line and has the side port forming a Y-connector, the entry port is connected to the distal end of the fiber optic disposable, the exit port is connected to the tubular structure, the side port is connected to a second tubular structure, the fiber optic passes through the entry port into the main line and through the branching line and side port into the second tubular structure when the fiber optic disposable is in the fiber-advanced mode, fluid dialysate flows through the exit port, the main line, the branching line, the side port, into and out of the second tubular structure.