[go: up one dir, main page]

WO2017070155A1 - Dispositifs pour l'émission de lumière thérapeutique réglée de manière répétée et dispositifs pour le traitement de l'empoisonnement au monoxyde de carbone - Google Patents

Dispositifs pour l'émission de lumière thérapeutique réglée de manière répétée et dispositifs pour le traitement de l'empoisonnement au monoxyde de carbone Download PDF

Info

Publication number
WO2017070155A1
WO2017070155A1 PCT/US2016/057614 US2016057614W WO2017070155A1 WO 2017070155 A1 WO2017070155 A1 WO 2017070155A1 US 2016057614 W US2016057614 W US 2016057614W WO 2017070155 A1 WO2017070155 A1 WO 2017070155A1
Authority
WO
WIPO (PCT)
Prior art keywords
light
light delivery
delivered
sensor
delivery device
Prior art date
Application number
PCT/US2016/057614
Other languages
English (en)
Inventor
Christoph Scharf
Gunter SCHARF
J. Christopher Flaherty
Original Assignee
Christoph Scharf
Scharf Guenter
Flaherty J Christopher
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Christoph Scharf, Scharf Guenter, Flaherty J Christopher filed Critical Christoph Scharf
Publication of WO2017070155A1 publication Critical patent/WO2017070155A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/002—Magnetotherapy in combination with another treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/06—Magnetotherapy using magnetic fields produced by permanent magnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/02—Radiation therapy using microwaves
    • A61N5/04—Radiators for near-field treatment
    • A61N5/045—Radiators for near-field treatment specially adapted for treatment inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N2005/0602—Apparatus for use inside the body for treatment of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/061—Bladder and/or urethra
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0626—Monitoring, verifying, controlling systems and methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0662—Visible light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0662—Visible light
    • A61N2005/0663—Coloured light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0664—Details
    • A61N2005/0665—Reflectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0664—Details
    • A61N2005/0667—Filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0624—Apparatus adapted for a specific treatment for eliminating microbes, germs, bacteria on or in the body

Definitions

  • the present invention relates generally to devices that deliver energy to reduce infection risk or provide a therapeutic benefit to a patient such as to treat carbon monoxide poisoning.
  • Medical devices such as those introduced into an internal body location, can be associated with a risk of infection.
  • the vast majority (over 95%) of hospital acquired urinary tract infections are catheter associated.
  • the majority (over 80%) of blood stream infections are associated with intravenous catheters.
  • Any foreign body, either temporarily or permanently inserted into the body carries the risk of bacterial colonization and subsequent infection.
  • the development of a biofilm containing different species of bacteria, yeasts and other pathogens is an ideal niche for exchange for bacterial resistance genes among species, and thus the biofilm is an ideal niche for exchange of antibiotic resistance among bacteria.
  • the emergence of bacteria resistant to multiple pharmaceutical agents is a growing health care problem and some hospital bacteria have become resistant to almost every available antibiotic treatment. Care and treatment of the infection is expensive and burdensome. There is a need for devices and methods to reduce or prevent device related infections.
  • a light delivery device for insertion into a mammalian patient comprises a shaft comprising a proximal and a distal end.
  • the light delivery device further comprises a light delivery element positioned proximate the distal end of the shaft and configured to deliver light, and the device is configured to repeatedly adjust the light delivered by the light delivery element.
  • the light delivered by the light delivery element is configured to perform a function selected from the group consisting of: prevent infection; reduce infection; cause a physiologic effect; and combinations thereof.
  • the physiologic effect can comprise a physiologic effect selected from the group consisting of: a blood temperature increase; vasodilation; an increase in local nitric oxide; an increase in synthesis of nitric oxide; enhanced nitric oxide release from the vascular endothelium and/or smooth muscle cells;
  • nitric oxide effects an alteration in the function of erythrocytes; a modification in oxygen release from hemoglobin; a facilitation of release of carbon monoxide from hemoglobin; a modification in pH of blood; a modulation in the immune response of blood leucocytes; a modulation of the coagulation and/or thrombocyte function a modification in the function of heme catalyst enzymes in the blood; a modification in hormonal action of a peptide and/or non-peptide hormone; a modification in the binding capacity of one or more antibodies; a decrease in blood glucose level; an effect to circulating tumor cells by selective heating, photocoagulation and/or photolysis; and combinations thereof.
  • the light delivered by the light delivery element is configured to treat a patient disease or disorder selected from the group consisting of: pulmonary hypertension; organ failure; high blood glucose in arterial blood; transplant rejection;
  • autoimmune disease an immunologic disorder; and combinations thereof.
  • the shaft distal end is configured to be advanced into a bladder of a patient.
  • the shaft distal end is configured to be advanced into a patient location selected from the group consisting of: a pulmonary artery; a caval vein; the right atrium; the right ventricle; and combinations thereof, for example, to treat CO poisoning.
  • the shaft distal end is configured to be advanced into a patient location selected from the group consisting of: a carotid artery; a coronary artery; a renal artery; a hepatic artery; a mesenteric artery; and combinations thereof, such as to treat one or more patient diseases or disorders, such as a disease or disorder selected from the group consisting of: organ failure (e.g. by facilitating a release of nitric oxide); pulmonary
  • transplant rejection e.g. by providing an immune therapy including delivering light into one or more arteries supplying blood to the transplanted organ); autoimmune disease; an immunologic disorder; and combinations thereof.
  • the light delivery element is configured to deliver the light at an energy density of approximately 10mW/cm 2 .
  • the light delivery element is configured to deliver a single frequency of light.
  • the light delivery element is configured to delivery multiple wavelengths of light.
  • the light delivery element can be configured to simultaneously deliver light at a first wavelength and light at a second wavelength.
  • the light delivery element can be configured to sequentially deliver light at a first wavelength and light at a second wavelength (e.g. via alternating pulses).
  • the light delivery device can further comprise a sensor configured to produce a signal, and the light delivery element can change from delivering light at the first wavelength to delivering light at the second wavelength based on the sensor signal.
  • the light delivery element is configured to deliver light to blood within a location selected from the group consisting of: a pulmonary artery; a caval vein; the right atrium; the right ventricle; and combinations thereof, such as to treat Carbon Monoxide poisoning.
  • the light delivery element is configured to deliver light to blood within a location selected from the group consisting of: a carotid artery; a coronary artery; a renal artery; a hepatic artery; a mesenteric artery; and combinations thereof, such as to treat a patient disease or disorder selected from the group consisting of: pulmonary hypertension; organ failure; high blood glucose in arterial blood; transplant rejection; autoimmune disease; an immunologic disorder; and combinations thereof.
  • the repeated adjustment of delivered light comprises adjusting a delivered light parameter selected from the group consisting of: frequency;
  • wavelength intensity; proportion of a first frequency relative to a second frequency; a pulse- width modulation parameter; a duty cycle parameter; and combinations thereof.
  • the repeated adjustment of delivered light comprises adjusting the intensity of light delivered.
  • the adjusting of the intensity of light delivered can comprise adjusting the intensity of light delivered to a level in which no light is delivered by the light delivery element.
  • the adjusting of the intensity of light delivered can comprise decreasing the intensity of light delivered to prevent growth of bacteria.
  • the light delivery device can further comprise a sensor configured to produce a signal based on oxygen saturation level, and the adjusting of the intensity of light delivered can be based on the sensor signal. The intensity can be increased when the oxygen saturation level is above and/or below a threshold.
  • the repeated adjustment of delivered light comprises adjusting at least one wavelength of the delivered light.
  • the repeated adjustment of delivered light can comprise adjusting the at least one wavelength of the delivered light at least every 2 days.
  • the repeated adjustment of delivered light can comprise adjusting the at least one wavelength of the delivered light at least every 12 hours.
  • the repeated adjustment of delivered light can comprise adjusting the at least one wavelength of the delivered light at least every 1 hour.
  • the repeated adjustment of delivered light can comprise adjusting the at least one wavelength of the delivered light at least every 15 minutes.
  • the repeated adjustment of delivered light can comprise adjusting the at least one wavelength of the delivered light at least every 1 minute.
  • the delivered light can be configured to reduce or prevent a yeast infection.
  • the device further comprises a sensor configured to measure a parameter and provide a signal based on the measured parameter, and the repeated adjustment of delivered light is based on the sensor signal.
  • the sensor can comprise a sensor selected from the group consisting of: temperature sensor; thermistor; thermocouple; radiometric sensor; infrared sensor; pH sensor; photodiode; pressure sensor; flow sensor; physiologic sensor; blood flow sensor; blood gas sensor; blood conductivity sensor; oxygen sensor; glucose sensor; optical glucose sensor; and combinations thereof.
  • the measured parameter can comprise a parameter selected from the group consisting of: temperature; temperature of tissue and/or fluid proximate the light delivery element; intensity of light delivered by the light delivery element; intensity of light delivered to the light delivery element; wavelength of light delivered to the light delivery element; wavelength of light delivered by the light delivery element; wavelength of light received by the sensor; intensity of light received by sensor; wavelength of light reflected by tissue; intensity of light reflected by tissue; pH of tissue and/or fluid; and combinations thereof.
  • the sensor can comprise an infrared sensor (e.g. for radiometric temperature measurements).
  • the measured parameter can comprise the temperature of tissue proximate the light delivery element.
  • the sensor can comprise a photodiode.
  • the light delivery element can comprise the sensor.
  • the light delivery element can be configured to deliver light to a portion of tissue, and the sensor can be configured to measure light reflected from the portion of tissue; and the repeated adjustment of light delivered is based on the measured reflected light.
  • the measured parameter can comprise the quantity of blood in tissue, and the repeated adjustment of light delivered by the light delivery element is based on the quantity of blood in tissue.
  • the tissue can comprise tissue selected from the group consisting of: mucosal tissue of the bladder; venous blood; arterial blood; pulmonary artery blood; blood of an atrium of the heart; and combinations thereof.
  • the repeated adjustment of light delivered by the light delivery element can comprise a reduction in light delivered if the quantity of blood exceeds a threshold.
  • the repeated adjustment of light delivered can comprise adjusting the intensity of light delivered to a level in which no light is delivered by the light delivery element.
  • the sensor can comprise an oxygen sensor.
  • the measured parameter can comprise the oxygen content in tissue proximate the light delivery element.
  • the tissue can comprise mucosal tissue of the bladder.
  • the repeated adjustment of light delivered by the light delivery element can comprise an increase in light delivered if the quantity of oxygen exceeds a threshold.
  • the threshold can comprise an oxygen content of at least 60%.
  • the threshold can comprise an oxygen content of at least 65%.
  • the threshold can comprise an oxygen content of at least 70%.
  • the sensor can comprise a blood flow sensor.
  • the measured parameter can comprise blood flow in tissue proximate the light delivery element.
  • the tissue can comprise mucosal tissue of the bladder.
  • the repeated adjustment of light delivered by the light delivery element can comprise a modification in the intensity of light delivered (e.g.
  • the sensor can comprise a pH sensor.
  • the measured parameter can comprise pH of urine, blood and/or tissue proximate the light delivery element.
  • the repeated adjustment of light delivered by the light delivery element can comprise a decrease in light delivered if the pH is below a threshold.
  • the repeated adjustment of light delivered can comprise adjusting the intensity of light delivered to a level in which no light is delivered by the light delivery element.
  • the sensor can be configured to provide a signal related to a level of treatment provided by the light delivery device.
  • the light delivery device can be configured to detect an undesired level of treatment, such as to detect an undesired decrease in treatment and/or an undesired level of treatment efficacy.
  • the light delivery device can further comprise a sensor measurement assembly configured to at least one of receive or analyze the signal provided by the sensor.
  • the sensor measurement assembly can comprise an algorithm configured to mathematically process the sensor signal and determine the repeated adjustment of delivered light based on the mathematical processing.
  • the sensor measurement assembly can comprise an alert element (e.g. an audible, visual and/or tactile transducer to alert the patient or a healthcare provider of an undesired condition and/or completion of use).
  • the device further comprises an energy source configured to deliver energy to the light delivery element.
  • the energy source can comprise a battery.
  • the device further comprises a light source.
  • the light delivery element can comprise the light source.
  • the light source can be positioned proximate the light delivery element.
  • the device can further comprise a housing positioned on the proximal end of the shaft, and the light source can be positioned in the housing.
  • the device can further comprise an optical fiber optically connecting the light source to the light delivery element.
  • the device further comprises an anchor positioned proximate the shaft distal end.
  • the anchor can comprise mechanical anchor configured to engage a blood vessel wall and/or a balloon.
  • the light delivery element can be positioned within the anchor.
  • the CO poisoning treatment device comprises one or more of the light delivery devices described herein.
  • the shaft distal end is configured to be advanced into a pulmonary artery of the patient.
  • the shaft distal end is configured to be advanced into a patient location selected from the group consisting of: a pulmonary artery; a caval vein; the right atrium; the right ventricle; and combinations thereof.
  • the light delivery element is configured to deliver light comprising at least one wavelength between 300nm and 700nm (such as between 400nm and 700nm, between 500nm and 700nm, or between 530nm and 590nm).
  • the light delivery element can be configured to deliver light comprising at least one wavelength of approximately 678nm.
  • the light delivery element delivers light at an intensity of at least lOOmW.
  • the light delivery element delivers light at an intensity of up to 5W.
  • the CO poisoning treatment device can further comprise a cooling element configured to cool the light delivery element.
  • the light delivery element delivers light to blood with a radiant exposure of at least 0.05 joules/cm 2 , or at least 0.15 joules/cm 2 .
  • the CO poisoning treatment device further comprises a sensor configured to produce a signal, and the light delivery element delivers light at an intensity determined by the sensor signal.
  • the sensor signal can be related to a parameter selected from the group consisting of: a patient physiologic parameter; a parameter of the CO poisomng treatment device; patient temperature; temperature of at least a portion of the CO poisoning treatment device; electrical conductivity; oxygen saturation; and combinations thereof.
  • the light delivery element delivers light comprising multiple wavelengths.
  • the light delivery element delivers pulsed light.
  • the pulsed light can comprise light with a pulse frequency between 0.5Hz and 100Hz.
  • the pulsed light can comprise light with an on-time between 1msec and 150msec, such as pulsed light with an on- time between 1msec and 100msec, between 50msec and 150msec or between 50msec and 550msec.
  • the delivered light is configured to unbind carbon monoxide from hemoglobin.
  • the light delivery element is configured to deliver light to blood (e.g. venous blood) within a patient location selected from the group consisting of: a pulmonary artery; a caval vein; the right atrium; the right ventricle; and combinations thereof.
  • the light delivery element comprises an element selected from the group consisting of: a light emitting diode; an optical fiber; the distal surface of an optical fiber; a lens; a prism; a mirror; and combinations thereof.
  • the light delivery element comprises at least a portion that is positioned proximate the distal end of the shaft.
  • the light delivery element comprises at least a portion that is positioned proximate to the proximal end of the shaft.
  • the at least a portion of the light delivery element can comprise a user-attachable portion (e.g. a portion operably attached to the proximal end of the shaft or to a housing positioned on the proximal end of the shaft).
  • the CO poisoning treatment device further comprises a sensor configured to measure a parameter and provide a signal based on the measured parameter, and the light delivered by the light delivery element is adjusted based on the sensor signal.
  • the sensor can comprise an oxygen sensor.
  • the CO poisoning treatment device can further comprise an alert assembly configured to provide an alert based on the sensor signal.
  • the alert assembly can be configured to detect an undesired level of treatment based on the sensor signal and to activate the alert when the undesired level of treatment is detected.
  • the CO poisoning treatment device further comprises a light source.
  • the light delivery element can comprise the light source.
  • the device comprises the light delivery device or CO poisoning treatment device described herein.
  • the device is configured to deliver selective phototherapy comprising delivering light with one or more wavelengths between 550nm and 625nm.
  • the device can be configured to exclude delivery of light between 630nm and 700nm.
  • the device can comprise a filter configured to exclude one or more wavelengths of light from being delivered by the device.
  • the filter can be configured to exclude wavelengths between 630nm and 700nm.
  • the device comprises at least two sensors, each configured to produce a signal, and the device is configured to adjust the delivery of light based on the two sensors signals.
  • the at least two sensors can be configured to measure oxygen saturation.
  • the at least two sensors can comprise a first sensor positioned proximate a light delivery element of the device, and a second sensor configured to be positioned at a location distant from the light delivery element of the device.
  • the second sensor can be configured to be positioned at a location proximate the right atrium of the heart.
  • the device is configured to increase nitric oxide production from mitochondria and/or to decrease oxidative stress.
  • the device is configured to deliver light at one or more wavelengths between 575nm and 600nm.
  • the device is configured to deliver light at a power level between 1 joules/cm 2 to 20 joules/cm 2 .
  • the device comprises a sensor configured to measure blood flow selected from the group consisting of: venous blood flow; arterial blood flow; pulmonary artery blood flow; blood flow in an atrium of the heart; and combinations thereof.
  • the device is configured to deliver therapeutic light to blood, and the device comprises a sensor configured to prevent coagulation of blood.
  • the device is configured to deliver therapeutic light to blood, and the device further comprises one or more anti-coagulant agents that are delivered to the patient prior to, during and/or after the delivery of the light to the patient.
  • the device further comprises a therapy enhancing agent.
  • the therapy enhancing agent can comprise a material selected from the group consisting of: a coating on the shaft of the device; an agent delivered by the device; an agent configured to restore and/or cause the release of nitric oxide; an agent configured to increase synthesis of nitric oxide; an agent configured to increase activity of nitric oxide; an agent configured to alter oxygen binding to hemoglobin; N-acetylcysteine; a photosensitizer; a photocatalyst; and combinations thereof.
  • the device is configured to perform a function selected from the group consisting of: deliver pacing energy to the heart; deliver defibrillating energy to the heart; deliver electrical energy to the spine; deliver electrical energy to the brain such as to treat Parkinson's Disease, epilepsy or depression; deliver electrical energy to bone such as to stimulate bone growth; modify immune response so at to treat autoimmune disease; enhance oxygen delivery and/or perfusion of tissue; and combinations thereof.
  • the device is configured to treat: heart failure; kidney failure; liver failure; transplanted organ failure; cancer; autoimmune disease; an immunologic disorder; inflammatory reactions; and/or cerebral disease, and combinations thereof.
  • the device comprises at least one sensor configured to produce a signal, and the device is configured to adjust delivered light based on the signal.
  • the at least one sensor can comprise one or more sensors selected from the group consisting of: physiologic sensor; oxygen sensor; temperature sensor; blood pressure sensor; impedance sensor; electrical sensor; and combinations thereof.
  • the device can be configured to perform the adjustment in order to optimize effect on blood circulation and/or oxygen unloading.
  • the device comprises a light scattering element surrounding the light delivery element, and the light scattering element can be configured to enhance the distribution of light from the light delivery element.
  • the light scattering element can comprise a roughened and/or otherwise modified surface that is created with a surface treatment selected from the group consisting of: etching; cutting; scratching; gouging; treating with a file or sandpaper; covering with roughened material such as silicon; covering with reflective particles; and combinations thereof.
  • the light delivery element can comprise an optical fiber, the light scattering element can comprise a modified surface of the optical fiber.
  • the device comprises a functional element configured to deliver an electromagnetic field, and wherein the electromagnetic field is configured to perform a function selected from the group consisting of: prevent an infection; reduce an infection; provide an antibacterial effect; restore and/or cause the release of nitric oxide; increase synthesis of nitric oxide; increase activity of nitric oxide; alter oxygen binding to hemoglobin; and combinations thereof.
  • the electromagnetic field can comprise at least one of: a dynamic electromagnetic field; a static electromagnetic field; a dynamic magnetic field; a static magnetic field; a dynamic electrical field: and/or a static electrical field.
  • the electromagnetic field delivery element can comprise at least one permanent magnet.
  • the at least one permanent magnet comprises multiple permanent magnets.
  • the multiple permanent magnets can be dispersed relatively uniformly along the length of the shaft.
  • the electromagnetic field can comprise a magnetic field with a field strength between lmT and 500mT.
  • the electromagnetic field can be configured to prevent adversely effecting at least one of a muscle or a nerve.
  • the device comprises a functional element including an electric current and/or electric potential delivery element, and wherein the electric current and/or electric potential delivered is configured to perform a function selected from the group consisting of: prevent an infection; reduce an infection; provide an antibacterial effect; restore and/or cause the release of nitric oxide; increase synthesis of nitric oxide; increase activity of nitric oxide; alter oxygen binding to hemoglobin; and combinations thereof.
  • the electric current and/or electric potential delivered is configured to cause electrolysis.
  • the device comprises a functional element including an ultrasound transducer that produces ultrasound waves configured to perform a function selected from the group consisting of: prevent an infection; reduce an infection; provide an antibacterial effect; restore and/or cause the release of nitric oxide; increase synthesis of nitric oxide; increase activity of nitric oxide; alter oxygen binding to hemoglobin; and combinations thereof.
  • the light delivery element comprises one or more light delivery elements each optically attached to one or more optical fibers.
  • the at least one light delivery element can be configured to deliver light to blood.
  • Fig. 1 is a side sectional view of a device including multiple light delivery elements, consistent with the present inventive concepts.
  • Fig. 1A is a cross sectional view of the shaft of the device of Fig. 1, consistent with the present inventive concepts.
  • Fig. 2 is a side sectional view of a device including light delivery elements comprising light scattering material, consistent with the present inventive concepts.
  • Fig. 2A is a sectional view of the shaft of the device of Fig. 2 at a location entering the patient's body, consistent with the present inventive concepts.
  • Fig. 3 is a side sectional view of a device including a light delivery element comprising light scattering material and a light deliver ⁇ ' element comprising a lens, consistent with the present inventive concepts.
  • Fig. 4 is a side sectional view of an infusion pump including a transcutaneous cannula with a light delivery element, consistent with the present inventive concepts.
  • Fig. 4A is a magnified view of a portion of the shaft of the device of Fig. 4, consistent with the present inventive concepts.
  • Fig. 5 is a side sectional view of an implanted device including a light delivery element, consistent with the present inventive concepts.
  • Fig. 5A is a magnified view of a portion of the shaft of the device of Fig. 5, consistent with the present inventive concepts.
  • Fig. 6 is a side sectional view of a device including a rotating light delivery element, consistent with the present inventive concepts.
  • Fig. 7 is a side sectional view of a device for delivering phototherapy, consistent with the present inventive concepts.
  • Fig. 7A is a cross sectional view of the device of Fig. 7, consistent with the present inventive concepts
  • Fig. 8 is a chart depicting a hemoglobin dissociation curve, consistent with the present inventive concepts.
  • Fig. 9 is a series of charts and molecular structure drawings comparing chlorophyll and heme, consistent with the present inventive concepts.
  • Fig. 10 is a schematic view of an energy delivery device comprising multiple shafts and multiple energy delivery elements, consistent with the present inventive concepts,
  • FIG. 11 is a schematic view of an implantable energy delivery device comprising at least one energy delivery element.
  • Fig. 12 is a side sectional view of a device including a light delivery element positioned in a balloon, consistent with the present inventive concepts.
  • Fig. 13 is a schematic view of a device comprising an external portion including a power converter and a first connector and a catheter portion including a light delivery element and a mating, second connector, consistent with the present inventive concepts.
  • Fig. 14 is a flow chart of a method of delivering and adjusting the delivery of light, consistent with the present inventive concepts.
  • Fig. 15 is an anatomical sectional view of a device including a light delivery element positioned in a pulmonary artery and configured to treat carbon monoxide poisoning, consistent with the present inventive concepts.
  • spatially relative terms such as “beneath,” “below,” “lower,” “above,” “upper” and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as “below” and/or “beneath” other elements or features would then be oriented “above” the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the devices of the present inventive concepts are constructed and arranged to be inserted into a mammalian body, such as through an incision in the skin or through a natural body orifice.
  • the devices can include one or more light delivery elements configured to provide a therapeutic benefit to a patient.
  • light can be delivered to reduce or prevent infection, such as by delivering light that has a bactericidal effect and/or prevents colonization by bacteria.
  • the light delivery elements can be configured to treat at least one of: virus; fungi; or one or more parasites.
  • Direction of delivered light may be shown by arrows included in the drawings.
  • the devices further include a functional element constructed and arranged to further prevent and/or reduce an infection.
  • the functional element can comprise one or more of: an electromagnetic field delivery element; an electric current and/or electric potential delivery element; or an ultrasound transducer.
  • the functional element comprises a filter, such as a light filter configured to block and/or pass one or more wavelengths of light.
  • Device 100 includes shaft 110 comprising proximal end 111 and distal end 112 , as well as outer surface 113.
  • Proximal end 111 is attached to housing 120.
  • Shaft 110 can be flexible or rigid, or it can contain both flexible and rigid portions.
  • Shaft 110 can include one or more lumens, such as central lumen 115.
  • Central lumen 115 is defined by inner surface 114 of shaft 1 0.
  • a wall 117 of shaft 1 10 is positioned between inner surface 114 and outer surface 113.
  • shaft 110 includes multiple lumens, such as when device 100 comprises a multi -lumen catheter for insertion into a blood vessel or other body location.
  • Shaft 110 can include a generally smooth outer surface 113, and can include a relatively uniform outer profile (at least in the distal portion) between 3mm and 9mm in diameter.
  • Device 10 can be configured to be introduced into an artery and/or a vein (e.g. via a puncture site), such as when shaft 110 is advanced through a delivery sheath.
  • Shaft 110 can include one or more light delivery elements, such as one or more of light delivery elements 155a and 155b as shown, configured to deliver light (e.g. single frequency or multiple frequencies of light from one or more light sources as described herein) such as to prevent and/or reduce infection.
  • light delivery elements such as one or more of light delivery elements 155a and 155b as shown, configured to deliver light (e.g. single frequency or multiple frequencies of light from one or more light sources as described herein) such as to prevent and/or reduce infection.
  • device 100 and/or light delivery elements 155a and/or 155b can be constructed and arranged to cause a physiologic effect selected from the group consisting of: a blood temperature increase; vasodilation; an ' increase in local nitric oxide; an increase in synthesis of nitric oxide; enhanced nitric oxide release from the vascular endothelium and/or smooth muscle cells; prolonged local nitric oxide effects; an alteration in the function of erythrocytes; modification in oxygen release from hemoglobin; a facilitation of release of carbon monoxide from hemoglobin; a modification in pH of blood; a modulation in the immune response of blood leucocytes; a modulation of the coagulation and/or thrombocyte function; a modification in the function of heme catalyst enzymes in the blood; a modification in hormonal action of a peptide and/or non-peptide hormone; a modification in the binding capacity of one or more antibodies; a decrease in blood glucose level; an physiologic effect
  • one or more of light delivery elements 155a and 155b are constructed and arranged to deliver phototherapy, such as is described herebelow in reference to Figs. 7 - 15.
  • light delivery element 155 is configured to deliver light providing a radiant exposure between 1 joules/cm 2 to 20 joules/cm 2 .
  • one or more light delivery elements 155 comprises one or more filters, such as one or more filters configured to pass and/or block one or more wavelengths of light.
  • light delivery element 155 comprises multiple light delivery elements, each attached to at least one optical fiber (e.g. each attached to one, two or more optical fibers), and configured to deliver light (e.g. therapeutic light) to blood.
  • the light delivery elements of the present inventive concepts can comprise an element that both produces and delivers light (e.g. a light emitting diode or other light generating element) and/or these elements can simply deliver the light (e.g. a segment of exposed optical fiber or other optical element attached to a light source as described herein).
  • the light delivery elements of the present inventive concepts can include one or more optical components, such as optical elements 157 described herein.
  • An optical element can be constructed and arranged to couple light into a light delivery element, such as a lens or other optical element positioned to couple light from an optical fiber 151 (e.g. optical fiber 151a and/or 151b shown in Fig. 1, singly or collectively fiber 151) into a light delivery element 155.
  • an optical element can be configured to distribute light from a light delivery element, such as a lens, prism or other optical element configured to distribute light in one or more desired patterns.
  • Optical elements of the present inventive concepts can comprise an optical element selected from the group consisting of: lens; ball lens; prism; light diffraction element (diffractor); filter; mirror; optical fiber; and combinations of these.
  • one or more light delivery and/or other energy delivery elements are positioned in a distal balloon, such as is described herebelow in reference to Fig. 12.
  • FIG. 1 The cross section of Fig. 1 illustrates multiple light delivery elements 155 positioned within an axial segment of shaft 110, such as to deliver light radially out from and/or radially into shaft 110 (e.g. into a lumen 115 of shaft 110), as shown by the arrows emanating from each light delivery element 155a.
  • Shaft 110 can include an anchoring and/or expanding element, such as balloon 125.
  • An anchor, such as balloon 125 or other expandable element can be used to anchor shaft 110 at an internal body location such as the bladder and/or a blood vessel (e.g. mechanical anchor constructed and arranged to engage a blood vessel wall).
  • One or more light delivery elements 155b (one shown in Fig.
  • Light delivery elements 155a and 155b are operably connected to one or more sources of light, such as is described herebelow.
  • Device 100 can include one or more optical fibers, such as optical fibers 151a positioned within wall 117 of shaft 110.
  • One or more fibers 151a can each be embedded in wall 117 of shaft 110.
  • one or more fibers 151a can be insertable into (e.g. slidingly received by) a lumen, such as lumens 118 positioned within wall 117 (lumens 118 are omitted from Fig. 1 for illustrative clarity but shown in Fig. 1 A and described herebelow).
  • one or more fibers 151a can be positioned within central lumen 115.
  • central lumen 115 comprises multiple separate lumens and one or more optical fibers 151a can be positioned within and/or insertable into one or more of the multiple lumens of central lumen 115.
  • Fibers 151a include an axial portion covered by an opaque covering, cladding 152a, such as the covered proximal portions of each fiber 151a shown in Fig. 1.
  • Each light delivery element 155a comprises an axial portion of a fiber 151a that is not surrounded by an opaque material (e.g. the uncovered distal segments of each fiber 151a with length Dl shown in Fig. 1).
  • each fiber 151a Light introduced into the proximal end of each fiber 151a is conducted along the cladded optical fiber with minimal losses of light, as is known to those of skill in the art. However when reaching the uncladded portion defined by light delivery element 155a, the conducted light emanates radially out from the associated light delivery element 155a (e.g. a portion of fiber 151 that is not surrounded by cladding and can be modified to enhance the distribution of light), as shown by the arrows emanating from light delivery element 155a shown in Fig. 1.
  • light delivery element 155a can be positioned in an area of the patient to be treated (e.g. infection reduced or prevented), such as within a segment of the urethra.
  • Each light delivery element 155a and/or a component of device 100 surrounding a light delivery element 1 5a can comprise a modified surface, such as a roughened surface and/or a surface otherwise modified to enhance the distribution of light from a light delivery element 155a.
  • a light scattering element comprises a roughened and/or otherwise modified surface that is created with a surface treatment selected from the group consisting of: etching; cutting; scratching; gouging; treating with a file or sandpaper; covering with roughened material such as silicon; covering with reflective particles; and combinations of one or more of these.
  • one or more light delivery elements 155a can comprise a segment of optical fiber 151 that comprises a roughened surface.
  • light delivery element 155a comprises a segment of optical fiber 151 including at least a portion that is surrounded by a transparent covering.
  • the transparent covering can include one or more reflective particles constructed and arranged to diverge the radiated light, such as one or more particles selected from the group consisting of: alumina particles; silica particles; titania particles; titanium oxide particles; and combinations of these.
  • Device 100 can include one or more optical fibers 151b extending from housing 120 to a distal portion of shaft 1 10, such as to a location within balloon 125.
  • One or more optical fibers 151b can be positioned within lumen 115 and/or within wall 117 of shaft 110.
  • Light delivery element 155b can comprise one or more optical elements (as described hereabove) positioned on the distal end of the one or more optical fibers 151b.
  • light delivery element 155b comprises a ball lens that is attached to the distal end of a fiber 15 lb or a ball lens that is formed from the distal end of fiber 151b.
  • a ball lens can be created by melting the end of fiber 151b with applied heat.
  • light delivery element 155b can comprise an uncovered distal portion (e.g. not covered by cladding 152b) as described hereabove in reference to light delivery element 155a.
  • Optical fibers 151a and/or 151b can comprise one or more materials configured to propagate the light for preventing and/or reducing infection.
  • fibers 151a and/or 151b comprise a material selected from the group consisting of: glass; plexiglass; plastic; polymethylmethacrylate (PMMA); one or more polymers (e.g. one or more polymers configured as a microstructured polymer optical fiber); photonic crystal; polycarbonate; polystyrene; and combinations of these.
  • Fibers 151a and/or 1 1b can comprise flexible fibers which allow movement within the patient without breaking or other issues.
  • fibers 151a and/or 151b comprise a fiber with a diameter between 0.1mm and 0.21mm.
  • each fiber 151a is attached and/or attachable to a light source, such as light source 150a shown.
  • the proximal end of each fiber 151b is attached and/or attachable to a light source, such as light source 150b shown.
  • Device 100 further includes a battery, capacitor or other power source, such as power supply 153 shown positioned in housing 120 and operably connected to light sources 150a and 150b.
  • Light sources 150a and 150b can comprise similar or dissimilar light sources (e.g. light sources that deliver light of similar or dissimilar wavelengths or amplitudes).
  • light source 150a and 150b (collectively light source 150) comprise a single light source 150 attached to one or more power supplies 153.
  • Power supply 153 can comprise a replaceable or rechargeable power source, such as a rechargeable power source included when an implanted housing 120 surrounds power supply 153, such as is described herebelow. In some embodiments, power supply 153 is positioned outside of housing 120, such as to prevent applying unnecessary forces to shaft 110 that might be uncomfortable to the patient. In some embodiments, light source 150 comprises one or more filters, such as one or more filters configured to pass and/or block one or more wavelengths of light.
  • Light source 150 can be positioned within housing 120 (as shown in Fig. 1), on and/or within shaft 110 or balloon 125, or at an external location (as shown in Fig. 2). In some embodiments, one or more portions of light source 150 are positioned outside the patient, and one or more portions of light source 150 are positioned within the patient. Light source 150 can be constructed and arranged to provide light at a single wavelength or multiple wavelengths of light simultaneously or pulsed to one or more light delivery elements 155, such as via one or more optical fibers 151 or other light carrying conduit. Light source 150 can comprise an LED, such as an organic LED.
  • a light delivery element 155 and light source 150 are positioned proximate each other, are attached to each other, and/or comprise the same component.
  • light delivery element 155b comprises light source 150 which can comprise an LED, lamp, laser, or other light source positioned within balloon 125.
  • Light source 150 can comprise a laser, such as a diode laser or other laser configured to provide one or more wavelengths of light.
  • Light source 150 can be constructed and arranged to deliver pulsed light, such as light delivered at a duty cycle between 0.1% and 50%.
  • Light source 150 can provide light at a power of less than 100 Watts, or less than 50 Watts. In some embodiments, light source 150 provides light at a power of less than 10 Watts, such as light delivered at approximately 1 Watt. In some embodiments, light source 150 provides light at less than or equal to 100 Watts that is pulse- width modulated to deliver light at less than 50 Watts rms, or less than 20 Watts rms, to one or more light delivery elements 155. In some
  • light source 150 provides light at a power of at least 0.1 Watts, such as at a power between 2 Watts and 10 Watts. In some embodiments, light source 150 is configured to deliver light at a power of between 1.OmW and lOOmW. In some embodiments, the light delivered by one or more light delivery elements 155 is delivered at a power between l.OmW and lOOmW. [0103] Light source 150 can be constructed and arranged to provide one or more wavelengths of light between 300 nanometers and 900 nanometers, such as between 400 nanometers and 750 nanometers, or between 400 and 430 nanometers. Alternatively or additionally, light source 150 can be constructed and arranged to provide visible light and/or ultraviolet light.
  • Light source 150 can be constructed and arranged to deliver light at varying wavelengths, such as light provided at continuously varying wavelengths or light alternating between at least a first wavelength and a second wavelength.
  • Light source 150 can be constructed and arranged to provide light at multiple wavelengths simultaneously or sequentially (e.g. a sequence of first delivering light at a first wavelength and then delivering light at a second wavelength, where the change in wavelengths is based on a signal produced by a sensor of the present inventive concepts).
  • multiple wavelengths are provided by light source 150 to enhance the bactericidal effects of device 100, such as to effect multiple forms of bacteria, such as to reduce or eliminate one or more of: Escherichia coli; Klebsiella;
  • multiple wavelengths are produced or otherwise provided by light source 150 to reduce or prevent an infection resulting from one or more of: a virus; a fungus; or a parasite (e.g. malaria).
  • one or more wavelengths delivered by light delivery elements 155 are based on the absorption spectra of one or more
  • a wavelength of approximately 405nm can be delivered to treat E Coli; a wavelength of 470nm can be delivered to treat staphylococcus; and/or a wavelength of 670nm can be delivered to treat oral Candida.
  • Light source 1 0 and/or one or more light delivery elements 1 5 can be constructed and arranged to provide light to an area (e.g. an area of tissue or urine) at a power density less than 500 mW/cm 2 , such as at a power density less than 250 mW/cm 2 , less than 100 mW/cm 2 , or less than 10 mW/cm 2 .
  • light source 150 and/or one or more light delivery elements 155 are constructed and arranged to deliver light at approximately 100 mW/cm 2 .
  • device 100 is constructed and arranged to deliver light to tissue at a power density of between 1.OmW/cm 2 and 1 OmW/cm 2 .
  • light source 150 and/or one or more light delivery elements 155 are constructed and arranged to deliver light at a level to prevent mucosal dehydration, such as pulse-width modulated light delivery configured to prevent mucosal dehydration.
  • Device 100 can comprise one or more sensors, such as sensor 119a and/or sensor 119b shown in Fig. 1 (singly or collectively sensor 119).
  • Sensor 119 comprises one or more sensors configured to measure a parameter and to produce a signal related to the measured parameter.
  • Sensor 119 can be configured to produce a signal that can be correlated (e.g. as determined by one or more algorithms of sensor measurement assembly 200 described herebelow) to detect an undesired decrease in treatment, an undesired level of treatment efficacy and/or any sub-optimal level of treatment (hereinafter “undesired level of treatment”) provided by device 100.
  • undesired level of treatment any sub-optimal level of treatment
  • detection of an undesired level of treatment results in a modification of the light delivered by light delivery element 155 (e.g. an increase or decrease in intensity of light delivered and/or a change in one or more wavelengths of light delivered).
  • determination of an undesired level of treatment can result in device 100 entering an alert condition (e.g. an audible, tactile or other alert produced by an alert element 201 of sensor measurement assembly 200, described herebelow).
  • Sensor 119 can be operably attached to, or operably attachable to, sensor measurement assembly 200, such as via one or more conduits, not shown but typically including one or more wires or optical fibers.
  • Sensor measurement assembly 200 can be positioned within housing 120 or at location outside of housing 120 (e.g. when sensor measurement assembly 200 is attached or attachable to housing 120).
  • Sensor measurement assembly 200 can comprise one or more algorithms, such as one or more algorithms configured to analyze (e.g. mathematically process) one or more signals produced by sensor 119, such as an analysis to determine the presence or level of an infection (e.g. a bladder infection), and/or a level of treatment (e.g. to detect an undesired level of treatment).
  • sensor measurement assembly 200 can mathematically process or otherwise analyze one or more signals produced by sensor 119 and perform a repeated adjustment of light delivered by light delivery element 155.
  • sensor measurement assembly 200 comprises an alert element 201 (e.g. an audible element such as a buzzer or speaker, visual element such as a light or LED and/or tactile alert element such as vibrating transducer) which is activated to indicate the presence of infection and/or an undesired level of treatment provided by device 100, as described in detail herebelow.
  • alert element 201 e.g. an audible element such as a buzzer or speaker, visual element such as a light or LED and/or tactile alert element such as vibrating transducer
  • Device 100 can be configured to adjust (e.g. repeatedly adjust) the light delivered by light delivery element 155 based on the signal produced by sensor 119.
  • Sensor 119 can be positioned in or otherwise proximate balloon 125 (e.g. sensor 119a shown); on, in and/or within shaft 110; on, in and/or within housing 120 (e.g. sensor 119b as shown) or at another device 100 location.
  • one or more sensors 119 are positioned on, in and/or within sensor measurement assembly 200.
  • Sensor 119 can comprise a sensor selected from the group consisting of: temperature sensor; thermistor; thermocouple; radiometric sensor; infrared sensor; pH sensor; photodiode; pressure sensor; flow sensor; physiologic sensor; blood flow sensor; blood gas sensor; blood conductivity sensor; oxygen sensor; glucose sensor; optical glucose sensor; and combinations of one or more of these.
  • Sensor 119 can be positioned to measure a parameter selected from the group consisting of: temperature; temperature of tissue and/or fluid proximate the light delivery element; intensity of light delivered by the light delivery element; intensity of light delivered to the light delivery element; wavelength of light delivered to the light delivery element; wavelength of light delivered by the light deliver ⁇ ' element; wavelength of light received by the sensor; intensity of light received by sensor; wavelength of light reflected by tissue; intensity of light reflected by tissue; pH of tissue and/or fluid; and combinations of one or more of these.
  • light delivery element 155 comprises sensor 1 19, such as when light delivery element 155 comprises a diode or other functional element configured to both deliver light and measure a parameter (e.g. measure reflected light).
  • sensor 119 comprises two sensors, a first sensor 119 which is in proximity to light delivered by light delivery element 155, and a second sensor 119 which measures a physiologic parameter of the patient at a location distant from light delivery element 155.
  • the signal from each sensor can be processed (e.g. compared) to determine how light delivery by device 100 should be adjusted.
  • the two sensors 119 can be configured to measure oxygen saturation and device 100 can adjust the delivered light based on a comparison of two oxygen saturation levels (e.g. when the second sensor 119 is positioned at a location proximate the right atrium of the heart).
  • sensor 119 e.g. a temperature sensor
  • sensor 1 19 comprises a thermocouple, thermistor, and/or radiometric sensor attached to assembly 200 with one or more wires such that sensor measurement assembly 200 can produce a temperature measurement used to regulate the light provided by light source 150.
  • Sensor 119 can comprise an infrared temperature sensor configured to produce a signal related to the temperature of tissue (e.g. tissue receiving light from light delivery element 155).
  • sensor 119 comprises a photodiode (e.g.
  • a photodiode positioned in balloon 125, in shaft 110 or in housing 120 configured to measure frequency, intensity or another parameter of light (e.g. intensity of one or more wavelengths of infrared light and/or other light) received from tissue.
  • the photodiode can be configured to measure the light delivered by light delivery element 155 (e.g. measure the intensity and/or a wavelength parameter of the light delivered by light delivery element 155).
  • sensor 119 comprises one or more optical fibers (e.g. one or more optical fibers 151), which collect infrared light (e.g. from their distal end), such as infrared light received from tissue (e.g. tissue receiving light from light delivery element 155).
  • sensor measurement assembly 200 comprises an infrared sensor configured to correlate the received light to a temperature (e.g. infrared light received from bladder mucosal tissue, blood and/or other tissue).
  • the temperature determined by assembly 200 e.g. via thermocouple signal, thermistor signal, radiometric sensor signal, infrared signal or otherwise
  • the temperature determined by assembly 200 can be used to regulate (e.g. repeatedly adjust when the signal produced by the sensor exceeds a threshold) the light delivered by light source 150 in a closed loop fashion, such as to prevent or reduce mucosal dehydration and/or prevent damage to blood or other tissue (e.g. turn off or at least reduce intensity of light delivered to prevent overheating of the tissue).
  • Measurement assembly 200 can include a microprocessor and/or other electronic circuitry to receive one or more signals from sensor 119 to determine a measured temperature or other measured parameter.
  • Sensor 119 can comprise one or more sensors that are positioned at a location relatively proximate to light delivery element 1 5 as shown in Fig. 1, such that light emitted by light delivery element 155 can be measured and/or alterations in light emitted by light delivery element 155 can be assessed.
  • sensor 119 comprises one or more light- detecting sensors configured to measure the absorption of light by hemoglobin (dependent on the oxygen saturation), such as when sensor 119 comprises an oxygen sensor.
  • sensor 119 can comprise an infrared light-detecting sensor, such as to determine a temperature of one or more locations of the patient (e.g. a location proximate the distal portion of device 100).
  • Sensor 119 can comprise one or more light-detecting sensors positioned in a distal portion of device 100, such as sensor 119a shown, such that sensor 119a directly detects light proximate the distal portion of device 100.
  • sensor 119 can comprise one or more light-detecting or other sensors positioned in a proximal portion of device 100 (e.g. in, on and/or within housing 120), such as sensor 119b shown.
  • Sensor 119b can be optically connected, via conduit 199 comprising one or more optical fibers, to light collecting element 198 positioned in a distal portion of device 100.
  • Light collecting element 198 can comprise a lens, prism and/or other optical component configured to collect light surrounding a distal portion of device 100, the collected light transmitted to proximally located sensor 119b via conduit 199.
  • sensor 119b and/or one or more portions of housing 120 are attachable to shaft 110, such that sensor 1 19b can be re-used (e.g. reattached to a separate shaft 110).
  • sensor 119b is included in a reusable sensor measurement assembly 200 (e.g. conduit 199 is attachable to sensor measurement assembly 200).
  • sensor 119a and/or 119b is configured to measure a radiometric signal of blood or other tissue, in order to determine the temperature of the blood or other tissue.
  • sensor 119 comprises a non-temperature measurement device, such as when measurement assembly 200 is configured to record and/or interpret non-temperature measurement signals from sensor 119. This non-temperature measurement signal can be used to repeatedly adjust the light delivered by light delivery element 155.
  • sensor 119 comprises a temperature-based or non-temperature-based sensor selected from the group consisting of: thermistor; thermocouple; radiometric sensor; infrared sensor; pH sensor; photodiode; pressure sensor; flow sensor; physiologic sensor; blood flow sensor; blood gas sensor; blood conductivity sensor; oxygen sensor; glucose sensor; optical glucose sensor; and combinations thereof.
  • sensor 119 is configured to measure the color of tissue (e.g. tissue receiving light from light delivery element 155).
  • tissue e.g. tissue receiving light from light delivery element 155
  • sensor 119 and/or light delivery element 155 can deliver light to tissue, and sensor 119 can measure the reflected light.
  • color of tissue can be correlated to the amount of blood in the tissue (e.g. a measure of the redness of the tissue), where the delivered light can be adjusted (e.g. turned off or at least decreased) if the color level (e.g. redness level) is above a threshold, such as to prevent or at least reduce hemorrhagic hyperemia in the tissue.
  • alert element 201 is activated if the signal produced by sensor 119 is indicative of (i.e. correlates to) an undesired level of treatment is determined by sensor measurement assembly 200.
  • sensor 119 is configured to measure blood flow in tissue proximate light delivery element 155 (e.g. bladder mucosal tissue or other tissue receiving light from light delivery element 155). In some embodiments, sensor 119 is configured to measure blood flow selected from the group consisting of: venous blood flow; arterial blood flow;
  • the blood flow-based signal produced by sensor 119 can be used to assess an infection (e.g. a bladder or other urinary tract infection), and adjust the light delivered by light delivery element 155 accordingly, such as to increase the intensity and/or modify one or more wavelengths of light delivered if the onset of an infection and/or if an increase of severity of an infection is detected.
  • the delivered light is adjusted (e.g. intensity increased) if the measured blood flow is above a threshold.
  • the delivered light can be adjusted (e.g. intensity increased) if the measured blood flow is below a threshold.
  • the intensity of light is decreased (e.g.
  • alert element 201 is activated if the signal produced by sensor 119 is indicative of an undesired level of treatment is determined by sensor measurement assembly 200.
  • sensor 1 19 is configured to measure oxygen content (e.g. oxygen saturation) in tissue proximate light delivery element 155 (e.g. bladder mucosal tissue or other tissue receiving light from light delivery element 155).
  • the oxygen- based signal produced by sensor 119 can be used to assess an infection (e.g. a urinary tract infection), and adjust the light delivered by light delivery element 155 accordingly, such as to increase the intensity and/or modify one or more wavelengths of light delivered if the onset of an infection and/or if an increase of severity of an infection is detected.
  • sensor 1 19 produces a signal related to an oxygen saturation level.
  • the light delivered by light delivery element 155 can be modified (e.g.
  • the delivered light is adjusted (e.g. intensity increased) if the measured oxygen saturation is above a threshold.
  • the delivered light can be adjusted (e.g. intensity increased) if the measured oxygen saturation is below a threshold.
  • the intensity of light is decreased (e.g. shut off) if the onset of an infection and/or if an increase of severity of an infection is detected (e.g. if the infection is due to light-resistant bacteria).
  • Sensor 119 can be configured to measure oxygen content by determining the light absorption of oxygenated hemoglobin and/or deoxygenated hemoglobin (e.g. as is performed in commercial finger pulse oximeters).
  • the light delivered by light delivery element 155 is adjusted if the measured oxygen content exceeds 60%, 65% or 70%.
  • alert element 201 is activated if the signal produced by sensor 119 is indicative of an undesired level of treatment is determined by sensor measurement assembly 200.
  • sensor 119 is configured to produce a signal related to the turbidity of urine (e.g. clarity or other optical assessment of urine in the bladder or other body location). For example, increased turbidity can be correlated to the presence of an infection, such as increased turbidity associated with particles of bacteria and/or leucocytes in the urine. Sensor 119 can be configured to detect reduced light delivered to tissue by light delivery element 155 (e.g. due to the increased turbidity). In some embodiments, the decrease in light delivered to tissue by light delivery element 155 and/or the increased turbidity of the urine, each as detected by sensor 119, can be correlated to treatment efficacy of device 100. In some embodiments, alert element 201 is activated if the signal produced by sensor 119 is indicative of an undesired level of treatment is determined by sensor measurement assembly 200.
  • a signal related to the turbidity of urine e.g. clarity or other optical assessment of urine in the bladder or other body location.
  • increased turbidity can be correlated to the
  • sensor 119 is configured to measure pH of one or more fluids (e.g, blood or urine) proximate light delivery element 155.
  • the pH- based signal produced by sensor 119 can be used to assess an infection (e.g. a urinary tract infection detected by a decrease in measured pH), and to adjust the light delivered by light delivery element 155 accordingly, such as to increase the intensity and/or modify one or more wavelengths of light delivered if the onset of an infection and/or if an increase of severity of an infection is detected.
  • the intensity of light is decreased (e.g. shut off) if the onset of an infection and/or if an increase of severity of an infection is detected (e.g. if the infection is due to light-resistant bacteria).
  • alert element 201 is activated if the signal produced by sensor 119 is indicative of an undesired level of treatment is determined by sensor measurement assembly 200.
  • sensor 119 comprises a visual sensor, such as a camera, CCD and/or an optical element (e.g. a lens connected via at least one optical fiber to a proximally positioned image-capturing assembly such as a CCD) that is configured to provide a signal correlating to an image of tissue or other objects proximate light delivery element 155 (e.g. tissue receiving light from light delivery element 155 such as bladder wall tissue).
  • an optical fiber, wire or other information carrying conduit travels proximally through shaft 110 and operably attaches to sensor measurement assembly 200 (e.g. a sensor measurement assembly 200 positioned within housing 120 and/or attached or attachable to housing 120).
  • sensor measurement assembly 200 can comprise a user interface 205, such as a screen configured to display the image captured by sensor 119.
  • the image produced by sensor 119 can be analyzed (e.g. automatically by an algorithm of sensor measurement assembly 200 and/or manually by the patient, a clinician or other user of device 100). Analysis of the captured image can be used to verify adequate delivery of light by light delivery element 155 (e.g. by measuring brightness). Alternatively or additionally, analysis of the captured image can correlate to presence of an infection (e.g. an infection that increases the turbidity of urine in the bladder and/or an infection that results in reddened tissue such as reddened bladder mucosal tissue due to hyperemia).
  • an infection e.g. an infection that increases the turbidity of urine in the bladder and/or an infection that results in reddened tissue such as reddened bladder mucosal tissue due to hyperemia.
  • Detection and/or quantification of an infection via a camera-based sensor 119 can be used to adjust light delivered by light delivery element 155 (e.g. adjust the intensity and/or one or more wavelengths of delivered light) and/or to provide an alert via alert element 201.
  • light delivery element 155 can comprise one or more light delivery elements configured to deliver multiple frequencies of light, the multiple frequencies delivered sequentially or simultaneously.
  • sensor 119 is configured to produce a signal and sensor measurement assembly 200 is configured to change at least one wavelength of light delivered by light delivery element 155 to a different wavelength based on the sensor 119 signal.
  • the light delivery elements 155 of the present inventive concepts can be constructed and arranged to deliver infection reducing and/or preventing (e.g. bactericidal) light to tissue and/or body fluids, such as tissue and/or body fluids selected from the group consisting of: blood; bladder wall tissue; urethral wall tissue; urine; esophageal tissue; airway tissue;
  • tissue and/or body fluids selected from the group consisting of: blood; bladder wall tissue; urethral wall tissue; urine; esophageal tissue; airway tissue;
  • the light delivery elements 155 can direct light toward a skin incision, such as a skin incision through which shaft 110 passes.
  • the light delivery elements 155 can directly light toward a body fluid such as urine.
  • Device 100 can be constructed and arranged such that the light delivered by one or more light delivery elements 155 prevent, ehminate and/or reduces colonization of foreign material by bacteria, such as to prevent, ehminate and/or reduce a biofilm of bacteria.
  • the light delivered by one or more light delivery elements can be configured to treat at least one of: a virus; a fungus or a parasite.
  • the devices 100 of the present inventive concepts can be constructed for short- term clinical use with the patient (e.g. use for less than 16 hours, less than 24 hours, less than 3 days or less than 7 days), or for long-term clinical use (e.g. use for at least 1 week, at least 1 month, at least 3 months or at least 6 months).
  • the light delivery elements 155 of the present inventive concepts can be constructed and arranged to deliver light (e.g. in a continuous or pulsed, intermittent manner) to reduce and/or prevent infection for short durations of time (e.g. less than 30 minutes, less than 1 hour, less than 4 hours, less than 16 hours, less than 24 hours, less than 3 days or less than 7 days), or for long-term use (e.g.
  • one or more light delivery elements 155 are constructed and arranged to deliver light for or at least 6 months, such as when the one or more light delivery elements 155 are implanted in the patient.
  • the light delivery elements 155 of the present inventive concepts can be constructed and arranged to be implanted within the patient, remain outside the patient's skin, or pass through the patient's skin via an incision or natural body orifice.
  • Light delivery elements 155a can be constructed and arranged to deliver light radially out from all or a portion of outer surface 113 of shaft 110, such as a majority portion and/or distal portion of the outer surface 113. Alternatively or additionally, light delivery elements 155a can be constructed and arranged to deliver light radially inward from all or a portion of inner surface 114 of shaft 110, such as a majority portion and/or distal portion of the inner surface 114. In some embodiments, a light delivery element 155 is positioned to direct light toward a skin surface such as a skin surface surrounding a natural opening such as the skin surface surrounding the urethral orifice, or to a skin surface surrounding a skin incision and/or skin penetration site.
  • a light delivery element 155 comprises one or more optical components (e.g. a lens) configured to distribute light to a skin surface, not shown but such as is described in reference to Fig. 2 herebelow in reference to light delivery element 155d.
  • optical components e.g. a lens
  • the light delivery elements 155 of the present inventive concepts can comprise one or more optical elements.
  • a light delivery element 155 can comprise an optical element selected from the group consisting of: optical fiber; lens; ball lens; prism; diffractor; filter; mirror; and combinations of these.
  • An optical element can be positioned at the end of an optical fiber, such as a light delivery element 155b comprising a ball lens positioned at the end of fiber 151b, as described hereabove.
  • one or more light delivery elements 155 comprise light scattering material, not shown but such as is described in detail in reference to Fig. 2 herebelow.
  • the light scattering material can comprise a material distributed relatively evenly throughout a silicone or other polymer material, such as a light scattering material selected from the group consisting of: alumina particles; silica particles; titania particles; titanium oxide particles; and combinations of these.
  • device 100 can be constructed and arranged to rotate one or more light delivery elements 155 (or a portion of a light delivery element 155), such as to distribute light over a larger area, rotating assembly not shown but described in detail in reference to Fig. 6 herebelow.
  • One or more light delivery elements 155 can be constructed and arranged to deliver light to a majority of a cavity and/or the majority of an internal portion of a blood vessel.
  • light delivery element 155 can comprise a lens, prism, diffractor and/or mirror configured to direct light toward the majority of the surface of the bladder and/or the majority of a segment of a blood vessel (e.g. to deliver light to blood and/or to the blood vessel wall of that segment).
  • device 100 is configured to deliver light to at least blood, and sensor 119 (e.g. sensor 119a and/or sensor 119b shown) provide a signal used to prevent coagulation of the neighboring blood.
  • a signal provided by sensor 119 is used such that device 100 can provide a warning indicative of imminent blood coagulation.
  • light therapy is delivered by device 100 with concomitant use of anticoagulation agents (e.g. an anti-coagulant agent delivered prior to, during and/or after the delivery of the light by device 100, to prevent thrombosis or embolism).
  • anticoagulation agents e.g. an anti-coagulant agent delivered prior to, during and/or after the delivery of the light by device 100, to prevent thrombos
  • one or more fibers 151 terminate within wall 117 of shaft 110, such as when the material of shaft 1 10 has a similar refraction index as fiber 151.
  • shaft 1 10 comprises light scattering material (e.g. titanium dioxide, T1O2 particles) as described herein.
  • balloon 125 is filled with light scattering material (e.g. titanium dioxide particles) in water or other fluid, such that light delivered by one or more fibers 151 can be reflected in all directions relatively equally.
  • one or more portions of device 100 e.g. one or more portions of the outer surface of shaft 110
  • comprise a light dispersing coating e.g.
  • Titanium dioxide and/or another light dispersing component can be constructed and arranged to enhance hydrolysis, such as to generate oxygen radicals that enhance the bactericidal effects of the light delivered by device 100.
  • device 100 includes vanadium pentoxide as a photocatalyst.
  • the light delivery elements 1 5, shaft 1 10 and/or another component of device 100 can comprise a fluorescent material, such as a material constructed and arranged to increase light dispersion.
  • the fluorescent material can be positioned at least on the outer surface 113 and/or inner surface 1 14 of shaft 1 10, such as a fluorescent coating placed upon surfaces 1 13 and/or 114 of shaft 110.
  • Other coatings can be included on one or more components of device 100, such as a photosensitizer constructed and arranged to be activated by light (e.g. light delivered by a light delivery element 155) to cause a bactericidal reaction.
  • Shaft 110 can include one or more portions that are transparent or at least translucent (hereinafter "translucent") to one or more wavelengths of light transmitted by a light delivery element 155.
  • Shaft 1 10 can include a translucent portion surrounding a light delivery element 155a comprising an unclad portion of an optical fiber 151a.
  • device 100 can include an anchoring element or an expandable element, such as balloon 125.
  • Balloon 125 can be constructed and arranged to anchor shaft 110 in an internal body location such as the bladder of the patient. Balloon 125 can be fluidly attached to inflation lumen 126 which travels proximally within shaft 110 and through housing 120 to terminate at inflation port 127.
  • Inflation port 127 can comprise a luer or other attachment element configured to fluidly attach to a fluid delivery device such as a syringe or fluid pump, such that balloon 125 can be expanded and/or contracted such as by a user such as a clinician, nurse, patient family member or the patient.
  • a fluid delivery device such as a syringe or fluid pump
  • Housing 120 can be configured as a handle for a user, such as a clinician or patient, to hold while using device 100.
  • Housing 120 can be implantable or include an implantable portion.
  • Housing 120 can comprise a first housing and a second housing separated from the first housing.
  • Housing 120 can surround one or more components including but not limited to: power supplies such as batteries; agent reservoirs such as pharmaceutical agent reservoirs; pumping mechanisms; energy delivery circuitry such as cardiac pacing or
  • defibrillating circuitry electronic processing circuitry; electronic memory circuitry; and combinations of these.
  • device 100 comprises a device selected from the group consisting of: urine removal catheter; vascular access device; central venous catheter;
  • peripherally inserted central catheter such as a peripherally inserted venous catheter
  • cerebrospinal fluid catheter ventriculoperitoneal shunt, insulin pump; implanted device;
  • implanted drug or other agent delivery pump pacemaker; drive shaft assembly for a cardiac assist device; inflow and/or outflow cannula for a cardiac assist device; neurostimulator; artificial heart; drainage catheter; colostomy tube; and combinations of these.
  • shaft 110 is constructed and arranged for insertion through an incision of the skin, such as when shaft 110 is further inserted into a blood vessel, organ, and/or a subcutaneous tissue tunnel.
  • distal end 112 of shaft 110 is inserted into a blood vessel such that blood can be removed via lumen 115 and/or one or more agents can be delivered to an internal body location (e.g. into the cardiovascular system of the patient) via lumen 115.
  • housing 120 can include a luer or other attachment element configured to add or remove fluids via lumen 115, such as when device 100 comprises a central venous catheter or peripherally inserted central catheter.
  • shaft 110 is inserted through an incision in the skin and into the bladder, such as when device 100 is configured as a suprapubic bladder catheter. In some embodiments, shaft 110 is inserted through the skin and into an organ such as the kidney or into the ureter, such as when device 100 is configured as a urethral and/or nephrostomy catheter. In some embodiments, device 100 is configured as a colostomy tube inserted through the abdomen, such as to provide access to the intestine or colon. Alternatively, device 100 can comprise an external (i.e. non- implanted) drug delivery pump, such as a skin-attached or other external drug delivery device in which shaft 110 comprises a transcutaneous conduit (e.g.
  • housing 120 can include a pumping mechanism, not shown but described in reference to Figs. 4 and 4A herebelow.
  • the agent delivered comprises an agent selected from the group consisting of: insulin; a chemotherapeutic agent; a nutritional material; a pain control agent such as mo hine; and combinations thereof.
  • shaft 110 is constructed and arranged for insertion into a natural body orifice, such as urethra; mouth; anus; vagina; nostril; ear hole; eye socket; and combinations of these.
  • Device 100 can be constructed and arranged to prevent urinary tract infections.
  • Shaft 110 can be constructed and arranged for insertion into the urethra and/or for insertion in the bladder, such as to support evacuation of urine from the patient.
  • one or more light delivery elements 155 are constructed and arranged to deliver light to a bladder, such as to a majority of the cavity of the bladder, such as to deliver light to the majority of urine in the bladder.
  • one or more light delivery elements 155 can be constructed and arranged to deliver light to all or a portion of the urethra, such as to deliver light to all or a portion of the urine present in the urethra during light delivery.
  • light delivery element 155b is constructed and arranged to deliver light to a majority of the cavity of the bladder
  • one or more light delivery elements 155a is constructed and arranged to deliver light to at least a distal portion of the urethra.
  • the one or more light delivery elements 155a can be configured to deliver light to a segment of urethra of length Dl as shown.
  • Dl (the unclad portion of fiber 151a) is
  • the total light delivered to the bladder is more than the total light delivered to the urethra.
  • the light delivered per area of the bladder and the urethra is approximately equal, such as at an amount less than or equal to 500 mW/cm 2 , or less than or equal to 250 mW/cm 2 , or less than or equal to 100 mW/cm 2 .
  • device 100 is constructed and arranged to deliver light to tissue at a power density of between 1.OmW/cm 2 and 10mW/cm 2 .
  • the light provided by light source 150 and delivered by light delivery elements 155 can be constructed and arranged to have a bactericidal effect, such as to reduce or prevent bacterial colonization, such as to reduce and/or prevent infection.
  • the light provided by light source 150 and delivered by light delivery elements 155 can be constructed and arranged to treat one or more of: a virus; a fungus or a parasite.
  • shaft 110 and housing 120 are constructed and arranged for implantation into the patient, such that light delivery elements 155a and/or 155b can deliver light to an internal location within the patient to prevent and/or reduce infection at one or more locations surrounding shaft 110.
  • Shaft 110 can be constructed and arranged for insertion through a subcutaneous tissue tunnel or other internal body location.
  • Distal end 112 can be constructed and arranged for insertion into a blood vessel, a ventricle of the brain, a portion of the cerebrospinal fluid space, a joint capsule, a chamber of the heart, or other location, such as to provide a fluid conduit and/or to provide an electrical wire or optical fiber for a therapeutic application.
  • Device 100 can comprise an implanted portion configured to deliver energy to one or more internal locations of a patient, such as to deliver energy to an organ such as a heart or brain.
  • shaft 110 can include one or more conductors (e.g. within lumen 115) attached to an energy dehvery unit within housing 120, conductors and energy delivery unit not shown but described in reference to Figs. 5 and 5A herebelow.
  • device 100 can comprise an implanted portion configured to deliver a
  • an implanted housing 120 can surround a drug reservoir and pumping means which deliver an agent to lumen 115 of shaft 110 (drug reservoir and pumping means not shown but described in detail in reference to Figs. 5 and 5A herebelow).
  • distal end 112 of shaft 110 is constructed and arranged to be inserted to a patient location selected from the group consisting of: a pulmonary artery; a caval vein; the right atrium; the right ventricle; and combinations of one or more of these.
  • device 100 can be configured to treat one or more patient diseases or disorders, such as to treat carbon monoxide poisoning as described herebelow in reference to Fig. 15.
  • distal end 112 of shaft 110 is constructed and arranged to be inserted into a patient location selected from the group consisting of: a carotid artery; a coronary artery; a renal artery; a hepatic artery; a mesenteric artery; and combinations thereof.
  • device 100 can be configured to treat one or more patient diseases or disorders, such as a disease or disorder selected from the group consisting of: pulmonary hypertension; organ failure; high blood glucose in arterial blood; transplant rejection;
  • autoimmune disease an immunologic disorder; and combinations of one or more of these.
  • device 100 further comprises one or more therapy- enhancing materials, agent 160, such as a light-enhancing material (e.g. photosensitizer and/or a photocatalyst); an agent configured to restore and/or cause the release of nitric oxide (e.g. N- acetylcysteine); an agent configured to increase synthesis of nitric oxide; an agent configured to increase activity of nitric oxide; and/or an agent configured to alter oxygen binding to hemoglobin.
  • agent 160 can be included in one or more components of device 100, such as a coating applied to all or a portion of shaft 110 and/or balloon 125. The coating can be configured to dissolve or otherwise migrate from shaft 110 and/or balloon 125.
  • Agent 160 can be delivered by one or more components of device 100, such as through balloon 125 when balloon 125 comprises a porous balloon, from one or more openings in shaft 110 (e.g. lumen 115 at distal end 112) and/or from an outlet in another component of shaft 110.
  • agent 160 comprises a light-enhancing material selected from the group consisting of: toluidine blue O; methylene blue; and combinations thereof.
  • agent 160 is constructed and arranged to be activated by light delivered by device 100, such as light delivered by one or more light delivery elements 155.
  • One or more components of device 100 can be provided sterile, such as a sterile shaft 110.
  • One or more components of device 100 can be reusable and/or re-sterilizable.
  • shaft 110 is used in a single use on a single patient, while light source 150 and/or one or more light delivery elements 155 (e.g. fibers 151) are reused in multiple uses with one or more patients (e.g. when light source 150 is operably attachable to fiber 151 and/or when fiber 151 is insertable into shaft 110).
  • device 100 in addition to one or more light delivery elements 155, includes one or more additional components constructed and arranged to further prevent and/or further reduce infection, and/or to perform another function, such as functional element 195 shown in Fig. 1.
  • Functional element 195 can be constructed and arranged to improve upon the infection prevention and/or reduction than that which is achieved with the light delivered by the one or more light delivery elements 155 alone.
  • functional element 195 is configured to improve therapy delivered by device 100.
  • functional element 195 comprises a light filter, such as a filter configured to pass and/or block (i.e. exclude) one or more wavelengths of light from being delivered by device 100.
  • functional element 195 includes a functional element configured to deliver an electromagnetic field, and wherein the electromagnetic field is configured to perform a function selected from the group consisting of: prevent an infection; reduce an infection; provide an antibacterial effect; restore and/or cause the release of nitric oxide; increase synthesis of nitric oxide; increase activity of nitric oxide; alter oxygen binding to hemoglobin; and combinations thereof.
  • the electromagnetic field can comprise at least one of: a dynamic electromagnetic field; a static electromagnetic field; a dynamic magnetic field; a static magnetic field; a dynamic electrical field: and/or a static electrical field.
  • the electromagnetic field delivery element can comprise at least one permanent magnet (e.g. two or more permanent magnets).
  • functional element 195 comprises multiple permanent magnets dispersed relatively uniformly along the length of shaft 110.
  • the electromagnetic field can comprise a magnetic field with a field strength between lmT and 500mT.
  • the functional elements 195 can be positioned and/or powered to deliver an electromagnetic field that is configured to prevent adversely effecting at least one of a muscle or a nerve.
  • functional element 195 includes an electric current and/or electric potential delivery element.
  • the electric current and/or electric potential delivered can be configured to perform a function selected from the group consisting of: prevent an infection; reduce an infection; provide an antibacterial effect; restore and/or cause the release of nitric oxide; increase synthesis of nitric oxide; increase activity of nitric oxide; alter oxygen binding to hemoglobin; and combinations thereof.
  • the electric current and/or electric potential delivered is configured to cause electrolysis.
  • functional element 195 includes an ultrasound transducer that produces ultrasound waves configured to perform a function selected from the group consisting of: prevent an infection; reduce an infection; provide an antibacterial effect; restore and/or cause the release of nitric oxide; increase synthesis of nitric oxide; increase activity of nitric oxide; alter oxygen binding to hemoglobin; and combinations thereof.
  • Functional element 195 can be connected to conduit 196, which can comprise one or more wires, optical fibers, or other energy carrying conduits.
  • Conduit 196 travels proximally through shaft 110, and connects to a supply of energy, such as energy delivery unit 197.
  • Energy delivery unit 197 can be contained within housing 120 (as shown), or at a location external to housing 120.
  • Energy delivery unit 197 can be attached to power supply 153 or another supply of power via conduit 196.
  • Conduit 196 can comprise at least two wires, such as two wires constructed and arranged to provide power to functional element 195 to create an
  • electromagnetic field and/or an electric current e.g. an electromagnetic field and/or electrical field provided to tissue and/or body fluid.
  • functional element 195 comprises an element configured to deliver an electromagnetic field.
  • Functional element 195 can produce one or more of: a dynamic electromagnetic field; a static electromagnetic field; a dynamic magnetic field; a static magnetic field; a dynamic electrical field; and/or a static electrical field.
  • Functional element 195 can produce a magnetic field with a field strength between 1 milliTesla (mT) and 500 mT.
  • Functional element 195 can produce a magnetic field constructed and arranged to prevent adversely effecting one or more muscles and/or nerves.
  • functional element 195 can comprise an element configured to deliver an electric current and/or electric potential.
  • the delivered electric current and/or electric potential can be configured to cause electrolysis.
  • functional element 195 can comprise an ultrasound transducer, and the produced ultrasound waves can be configured to further prevent or further reduce an infection.
  • Energy delivery unit 197 provides electrical power, ultrasound signals, or other energy used to energize functional element 195.
  • Functional element 195 can be positioned on and/or in shaft 110, and/or within a location including balloon 125.
  • functional element 195 comprises one or more elements positioned on and/or within balloon 125, such that functional element 195 traverses radially from shaft 110 as balloon 125 is expanded, such as when balloon 125 is expanded within a bladder to anchor shaft 110 in the bladder.
  • functional element 195 is positioned along a majority of the length of shaft 110, or along a majority of the length of a portion of shaft 110 positioned under the patient's skin.
  • functional element 195 delivers an anti-infection effect (e.g.
  • functional element 195 comprises multiple functional elements, such as multiple functional elements selected from the group consisting of: one or more electromagnetic field generating elements; one or more electric current and/or electric potential delivering elements; one or more ultrasound transducers; and combinations thereof.
  • the multiple functional elements 195 can be, singly or in combination, constructed and arranged to at least one of further prevent or further reduce infection.
  • One or more functional elements 195 comprise one or more permanent magnets.
  • functional element 195 comprises multiple permanent magnets, such as multiple permanent magnets positioned on or in shaft 110.
  • the multiple permanent magnets can be dispersed relatively uniformly along one or more portions of the length of shaft 110, such as along a full or partial circumferential portion of shaft 110, along a majority of the length of shaft 110 and/or along a majority of the length of shaft 110 which is inserted into the patient.
  • functional element 195 comprises multiple permanent magnets that are dispersed non-uniformly, such as when a higher density of magnets are positioned proximate to balloon 125 than along a more proximal portion of shaft 110.
  • one or more functional elements 195 of device 100 are constructed and arranged to at least one of prevent or reduce infection, with or without the inclusion of one or more light delivery elements 155.
  • one or more light delivery elements 155 can be included to at least one of further prevent or further reduce infection.
  • device 100 is configured such that light delivered by light delivery element 155 is adjusted (e.g. repeatedly adjusted), as described herebelow in reference to Fig. 14.
  • the delivered light can be adjusted based on a signal provided by sensor 119 and/or it can be automatically adjusted (e.g. temporally adjusted at one or more regular time intervals).
  • device 100 is configured to treat carbon monoxide poisoning, such as is described herebelow in reference to device lOOco of Fig. 15.
  • device 100 e.g. light delivery element 155) can be configured to deliver light comprising at least one wavelength between 300nm and 700nm, between 400nm and 700nm, between 500nm and 700nm, or between 530nm and 590nm.
  • device 100 e.g. light delivery element 155) is configured to deliver light comprising at least one wavelength of approximately 678nm.
  • light therapy e.g. light therapy to treat carbon monoxide poisoning as described herebelow in reference to Fig.
  • FIG. 1 A a cross sectional view of device 100 of Fig. 1 at line A-A is illustrated, consistent with the present inventive concepts.
  • Shaft 1 10 includes wall 117 and central lumen 115. Positioned within wall 117 are an array of multiple optical fibers 151 (sixteen fibers 151 shown), such as optical fibers 151a or l51b of Fig. 1. Surrounding optical fibers 151 at section A-A is cladding 152. Cladding 152 is not included in the more distal portion of fibers 151 as described above.
  • Wall 117 can include multiple lumens 118 configured to slidingly receive optical fibers 151. Also positioned within wall 117 is conduit 196 and inflation lumen 126, as described hereabove. In alternative embodiments, inflation lumen 126 comprises a lumen within an inflation tube positioned within lumen 115, such as an inflation tube well known to those of skill in the art.
  • Device 100 can be constructed and arranged to deliver light to one or more patient locations prior to any significant bacterial presence, such as to prevent initial biofilm formation and/or bacterial adhesion.
  • Device 100 can be constructed and arranged to prevent emergence of drug resistant bacteria by avoiding biofilm creation (a known location for exchange of plasmids for drug resistance).
  • Device 100 of Fig. 2 can include numerous components of similar construction, arrangement and function as similar reference numbered components of Fig. 1 , such as shaft 110, central lumen 1 15, housing 120, balloon 125, inflation lumen 126 and inflation port 127.
  • Device 100 includes multiple light delivery elements, 155a-e (collectively light delivery elements 155).
  • Each of light delivering elements 155 can comprise a light scattering material 158 (depicted for light delivery element 155c only, for illustrative clarity but typically included in each of elements 155a ⁇ e).
  • Light scattering material 158 can comprise a light scanning material embedded in a translucent material (e.g. a translucent polymer), and configured to relatively evenly distribute light delivered to each light delivery element 155.
  • the light scattering material 158 comprises a material selected from the group consisting of: alumina particles; silica particles; titania particles; and combinations of these.
  • each light delivery element 155 Optically connected to each light delivery element 155 are one or more optical fibers 151 which collectively form optical fiber bundle 154a.
  • Device 100 is configured such that light delivered by light source 150 travels into the one or more optical fibers 151 connected at their distal end to each light delivery element 155.
  • Device 100 can include one or more optical fiber bundles and user attachable optical connectors configured to transmit light from light source 150 to optical fibers 151 , such as fiber bundles 154a and 154b and connectors 159a and 159b shown in Fig. 2.
  • one or more of fiber bundles 154a and/or 154b can comprise one or more optical fibers, one or more wires and/or one or more other conduits.
  • Light source 150 can include a user attachable connector 159b which can allow attachment of the proximal end of fiber bundle 154b to light source 150.
  • fiber bundle 154b can be permanently attached to light source 150.
  • Optical fibers 151 can collectively form fiber bundle 154a as shown.
  • the proximal end of fiber bundle 154a can be configured to be operably attached to the distal end of fiber bundle 154b via a user attachable connector 159a, which can be attached to housing 120 (e.g.
  • fiber bundle 154a can be permanently attached to fiber bundle 154b or fiber bundle 154a and 154b can comprise a single, continuous fiber bundle without need of a connector.
  • Light delivered by light source 150 travels through connector 159b, into fiber bundle 154b, through connector 159a and into fiber bundle 154a, and then into the individual optical fibers 151.
  • light source 150 is integral to housing 120 and fiber bundle 154a attaches directly to light source 150 without the need of connectors or additional wire bundles.
  • light delivered by light source 150 travels through connector 159b, into fiber bundle 154b, through connector 159a and into fiber bundle 154a and then into the individual optical fibers 151 and eventually their attached light delivery elements 155.
  • Light source 150 can be constructed and arranged similar to light source 150 of Fig. 1, such as a light source configured to provide one or more wavelengths of light at one or more power levels as described hereabove.
  • light source 150 comprises one or more light emitting diodes, LED 156.
  • light source 150 comprises a laser.
  • Device 100 can include light delivery element 1 5a, which comprises the outer portion of an axial segment of shaft 110, such as a full circumferential outer segment of shaft 110 as shown.
  • Light delivery element 155a is optically connected to one or more optical fibers 151.
  • optical element 157a e.g. a lens or other optical component as described hereabove
  • Light provided by light source 150 is distributed radially out from shaft 110 (as shown by the arrows), at the location of light delivery element 155a, to prevent or reduce infection as described hereabove in reference to Fig. 1.
  • Device 100 can include light delivery element 155b, which comprises the inner portion of an axial segment of shaft 1 10, such as a full circumferential inner segment of shaft 110 as shown.
  • Light delivery element 155b is optically connected to one or more optical fibers 151.
  • optical element 157b e.g. a lens or other optical component as described hereabove
  • Light provided by light source 150 is distributed radially inward from shaft 110 (e.g. into lumen 1 15 as shown by the arrows), at the location of light delivery element 155b, to prevent or reduce infection as described hereabove in reference to Fig. 1.
  • Device 100 can include light delivery element 155c, which comprises the distal tip portion of 110 as shown.
  • Light delivery element 155c is optical! ⁇ ' connected to one or more optical fibers 151.
  • optical element 157c e.g. a lens or other optical component as described hereabove
  • Light provided by light source 150 is distributed radially out from the distal tip of shaft 110 (as shown by the arrows), at the location of light delivery element 155c, to prevent or reduce infection as described hereabove in reference to Fig. 1.
  • Device 100 can include light delivery element 155d, which comprises an element positioned within balloon 125 as shown.
  • Light delivery element 155d is optically connected to one or more optical fibers 151.
  • optical element 1 7d e.g. a lens or other optical component as described hereabove
  • Light provided by light source 150 is distributed radially out from balloon 125 (as shown by the arrows), to prevent or reduce infection as described hereabove in reference to Fig. 1.
  • Device 100 can include light delivery element 155e, which comprises a light delivery element positioned on a circumferential outer segment of shaft 110 as shown.
  • Light delivery element 155e is positioned at an axial location that is proximal to a typical insertion depth of device 100, such as a depth for insertion into a natural body orifice such as the urethra or a skin incision point.
  • Light delivery element 155e is optically connected to one or more optical fibers 151.
  • optical element 157e e.g. a lens or other optical component as described hereabove
  • optical element 157e is included to optically connect a fiber 151 to light delivery element 155c.
  • device 100 includes one or more additional components constructed and arranged to further prevent and/or further reduce infection, not shown but such as functional element 195 described in reference to Fig. 1 hereabove.
  • FIG. 3 a side sectional view of a device with a light delivery element comprising light scattering material and a light delivery element comprising a lens is illustrated, consistent with the present inventive concepts.
  • Device 100 of Fig. 3 can include numerous components of similar construction, arrangement and function as similar reference numbered components of Fig. 1, such as shaft 110, central lumen 115, housing 120, balloon 125, inflation lumen 126 and inflation port 127. In some embodiments, device 100 does not include balloon 125.
  • central lumen 115 comprises multiple separate lumens, such as two separate lumens used to deliver two different agents to the patient's cardiovascular system (e.g. a different agent in each lumen).
  • Device 100 can include multiple light delivery elements, such as 155a and 155d shown (singly or collectively light delivery elements 155).
  • Light delivery element 155a comprises a light scattering material 158.
  • Light scattering material 158 can comprise a light scanning material embedded in a translucent material (e.g. a translucent silicone or other polymer), and configured to relatively evenly distribute light delivered to each light delivery element 155.
  • the light scattering material 158 comprises a material selected from the group consisting of: alumina particles; silica particles; titania particles; and combinations of these.
  • each light deliver ⁇ ' element 155 Optically connected to each light deliver ⁇ ' element 155 are one or more optical fibers 151 which collectively form optical fiber bundle 154. Bundle 154 terminates in optical connector 159 which attaches to a separately housed light source 150.
  • light source 150 can be integral to housing 120.
  • Light source 150 can be constructed and arranged similar to light source 150 of Fig. 1, such as a light source configured to provide one or more wavelengths of light at one or more power levels as described hereabove.
  • light source 150 comprises one or more light emitting diodes.
  • light source 150 comprises a laser.
  • Device 100 can include light delivery element 155a, which comprises the outer portion of shaft 110, such as a full circumferential outer segment of all (as shown) or a portion of shaft 110.
  • Light delivery element 155a is optically connected to one or more optical fibers 151 a.
  • optical element 157a e.g. a lens or other optical component as described hereabove
  • Light provided by light source 150 is distributed both radially out from shaft 110 (as shown by the arrows) and radially inward toward lumen 115 (arrows not included for illustrative clarity), at the location of light delivery element 155a, to prevent or reduce infection as described hereabove in reference to Fig. 1.
  • Device 100 can include light delivery element 155d, which comprises an element positioned within balloon 125 as shown, such as an element comprising an optical element such as a ball lens or other lens, a prism, a diffractor, a mirror, and the like.
  • Light delivery element 155d is optically connected to one or more optical fibers 151.
  • optical element 157d e.g. a lens or other optical component as described hereabove
  • Light provided by light source 150 is distributed radially out from balloon 125 (as shown by the arrows) to prevent or reduce infection as described hereabove in reference to Fig. 1.
  • optical element 157d comprises a light source, such as an LED, and optical fiber 151d can be replaced with a wire providing power to the LED.
  • device 100 includes one or more additional components constructed and arranged to further prevent and/or further reduce infection, such as functional element 195.
  • Functional element 195 can be constructed and arranged similar to functional element 195 described in reference to Fig. 1 hereabove, and device 100 can include conduit 196 and energy delivery unit 197, not shown in Fig. 3.
  • light source 150 comprises energy deliver ⁇ 7 unit 197.
  • Functional element 195 can be positioned on and/or within one or more locations of shaft 1 10.
  • Functional element 195 can be sized and positioned to deliver an anti-infection effect to similar locations of tissue and/or body fluid to that receiving light from the one or more light delivery elements 155a and/or 155d.
  • Device 100 comprises housing 120 surrounding an agent delivery reservoir 182 fluidly attached to a pumping assembly 181 .
  • Device 100 includes a shaft 110 comprising a transcutaneous cannula 183 fluidly attached to pumping assembly 181 such that one or more agents contained with agent delivery reservoir 182 is propelled through cannula 183 by pumping assembly 181.
  • Pumping assembly 181 can receive power from power supply 1 3 through the connection shown.
  • Pumping assembly 181 can comprise a syringe pump, a peristaltic pump, a displacement pump, and the like.
  • Cannula 183 can be constructed and arranged to be inserted through the patient's skin such that its distal tip is in an internal body location such as a blood vessel or in subcutaneous tissue. In some embodiments, cannula 183 is part of an attachable infusion set. In some embodiments, cannula 183 is injected into the skin via an injection mechanism internal to housing 120, injection mechanism not shown but such as known to those of skill in the art. Cannula 183 is constructed and arranged to prevent or reduce infection at locations proximate cannula 183.
  • Device 100 of Fig. 4 further includes a light source 150 and a power supply 153. such as have been described hereabove.
  • a magnified sectional view of cannula 183, cannula 183 comprises lumen 184.
  • One or more optical fibers 151 optically couple light source 150 to a light delivery element 155 positioned on the outer surface of at least a portion of the length of the transcutaneous conduit, cannula 183.
  • Light delivery element 155 can comprise an exposed (e.g. not covered by cladding material) portion of optical fiber 151.
  • light delivery element 155 can be attached to optical fiber 151 as shown in Fig. 4A, such as via optical element 157 as has been described hereabove.
  • Light delivery element 155 can comprise a translucent material, such as a translucent polymer, that is filled with light scattering material 158, also as has been described hereabove.
  • a reflecting element 186 can be positioned on the inner surface of light delivery element 155 such as to prevent light from being delivered toward lumen 184 of cannula 183.
  • Reflecting element 186 can comprise a flexible reflecting surface or membrane, such as an element comprising a metallic or other reflecting material.
  • Light emanating radially out from cannula 183 can be configured to prevent or reduce infection at locations proximate cannula 183, such as to prevent or reduce infection at a location proximate a skin penetration site through which cannula 183 is inserted.
  • device 100 includes one or more additional components constructed and arranged to further prevent and/or further reduce infection, such as functional element 195.
  • Functional element 195 can be constructed and arranged similar to functional element 195 described in reference to Fig. 1 hereabove, and device 100 can include conduit 196 and energy delivery unit 197, not shown in Fig. 4.
  • light source 150 and/or pumping assembly 181 comprise energy delivery unit 197.
  • Functional element 195 can be positioned on and/or within one or more locations of shaft 110 (i.e. one or more locations along cannula 183).
  • Functional element 195 can be sized and positioned to deliver an anti-infection effect to similar locations of tissue and/or body fluid to that receiving light from the one or more light delivery elements 155a.
  • Device 100 includes an implanted portion 190 including housing 120. Housing 120 can surround a power supply 153, such as a rechargeable battery or capacitor, or other power supply element. Power supply 153 is operably attached to delivery unit 192 which in turn is operably attached to conduit 194. Device 100 further includes conduit 194, a flexible or rigid conduit which can include one or more electrical conductors, one or more optical fibers, and/or one or more lumens (e.g. for agent delivery).
  • a power supply 153 such as a rechargeable battery or capacitor, or other power supply element.
  • Power supply 153 is operably attached to delivery unit 192 which in turn is operably attached to conduit 194.
  • Device 100 further includes conduit 194, a flexible or rigid conduit which can include one or more electrical conductors, one or more optical fibers, and/or one or more lumens (e.g. for agent delivery).
  • Conduit 194 is operably attached to shaft 110, such as an attachment to one or more conductors within shaft 110, to one or more optical fibers within shaft 110, and/or to one or more lumens with shaft 110.
  • Delivery unit 192 and conduit 194 are constructed and arranged to deliver one or more agents and/or one or more forms of energy to shaft 110 to subsequently be delivered to an internal location of the patient.
  • delivery unit 192 and conduit 194 deliver tissue stimulating electrical and/or light energy to the patient.
  • device 100 can be configured to perform a function selected from the group consisting of: deliver pacing energy to the heart; delivery defibrillating energy to the heart; deliver electrical energy to the spine; deliver electrical energy to the brain such as to treat Parkinson's Disease, epilepsy or depression; deliver electrical energy to bone such as to stimulate bone growth; modify immune response such as to treat autoimmune disease; enhance oxygen delivery and/or perfusion of tissue; and combinations of these.
  • delivery unit 192 and conduit 194 can delivery one or more agents, such as one or more pharmaceutical agents.
  • device 100 can be configured to perform a function selected from the group consisting of: deliver a pain control agent such as morphine; deliver an agent to the patient's spine such as to treat chronic pain; deliver a chemotherapeutic agent; deliver an agent to the patient's brain such as a neurological agent delivered to a ventricle of the brain; deliver one or more hormones to provide hormonal therapy to the patient; deliver insulin such as insulin delivered to the patient's cardiovascular system and/or subcutaneous tissue; and combinations of these.
  • a pain control agent such as morphine
  • agent to the patient's spine such as to treat chronic pain
  • a chemotherapeutic agent deliver an agent to the patient's brain such as a neurological agent delivered to a ventricle of the brain
  • deliver one or more hormones to provide hormonal therapy to the patient deliver insulin such as insulin delivered to the patient's cardiovascular system and/or subcutaneous tissue; and combinations of these.
  • Device 100 can include an external controller 191, such as a controller with a user interface used to transmit information to implanted portion 190 and/or receive information from implanted portion 190.
  • External controller 191 can communicate with implanted portion 190 via one or more wireless communication means including radiofrequency telemetry; Bluetooth; infrared transmissions; and combinations of these.
  • controller 191 can be constructed and arranged to recharge a power supply of implanted portion 190, such as power supply 153, such as via inductive coupling of electromagnetic energy waves.
  • controller 191 can be configured to wirelessly transfer power to implanted portion 190.
  • device 100 further includes a light delivery element 155 along at least a portion of shaft 110, such as along at least a distal portion of shaft 110.
  • light delivery element 155 comprises a full circumferential segment of wall 117 of shaft 110.
  • Light delivery element 155 can include light scattering material 158.
  • light delivery element 155 can include one or more exposed (e.g. not covered by cladding) segments of one or more optical fibers, such as one or more optical fibers 151.
  • Positioned without housing 120 is light source 150, which is optically connected to at least one fiber 151.
  • Fiber 151 is optically connected to light delivery element 155 directly, or through one or more optical elements, not shown but described hereabove in reference to component 157.
  • Light delivered to light delivery element 155 travels through at least one fiber 151 and transmits at least radially out as shown by the arrows of Fig. 5 A. In some embodiments, light is also transmitted radially inward (e.g. toward a lumen of shaft 110).
  • light delivery element 155 can include a reflective element on its inner surface to prevent light being transmitted radially inward, such as reflecting element 186 described hereabove.
  • shaft 110 surrounds conductor 193, such as an electrical conductor or optical conductor constructed and arranged to deliver energy to tissue as described above (e.g. energy provided by delivery unit 192 and delivered via conduit 194).
  • conductor 193 can include one or more lumens, such as one or more lumens constructed and arranged to deliver one or more agents to tissue, also as described above and delivered by delivery unit 192 via conduit 194.
  • device 100 includes one or more additional components constructed and arranged to further prevent and/or further reduce infection, such as functional element 195.
  • Functional element 195 can be constructed and arranged similar to functional element 195 described in reference to Fig. 1 hereabove, and device 100 can include conduit 196 (shown) and energy delivery unit 197 (not shown in Fig. 5).
  • light source 150 and/or delivery unit 192 comprise energy delivery unit 197.
  • Functional element 195 can be positioned on and/or within one or more locations of shaft 110 (i.e. one or more locations along cannula 183).
  • Functional element 195 can be sized and positioned to deliver an anti-infection effect to similar locations of tissue and/or body fluid to that receiving light from the one or more light delivery elements 1 5a.
  • Device 100 of Fig. 6 can include numerous components of similar construction, arrangement and function as similar reference numbered components of Fig. 1, such as shaft 110, proximal end 111, lumen 115, housing 120, optical fiber 151, cladding 152, and light source 150.
  • device 100 of Fig. 6 comprises an expandable element or anchor, not shown but similar to balloon 125 of Fig. 1.
  • Lumen 115 is fluidly attached to port 116, such as a luer connector, such that blood withdrawals and/or agent deliveries can be accomplished via lumen 1 15 when shaft 110 is inserted into a blood vessel or other internal body location as has been described in detail hereabove.
  • lumen 115 comprises two or more separate lumens, such as two or more lumens used to deliver two or more pharmaceutical or other agents while preventing mixing within device 100.
  • Shaft 110 includes lumen 1 18, which terminates within shaft 110 and can be configured to slidingly receive optical fiber 151 (e.g. when optical fiber 151 is inserted into a patient by a clinician, the patient or other user of device 100). The proximal portion of optical fiber 151 is surrounded by cladding 152.
  • Light delivery element 155a comprises the distal, exposed portion of shaft 151, as shown.
  • Light delivery element 155a can comprise a treated portion of optical fiber 151, such as an optical fiber 151 segment that has received a surface treatment as described hereabove.
  • light delivery element 155b can be included, comprising optical element 157 shown positioned at the distal end of fiber 151.
  • cladding can cover the full length of fiber 151, such that light is delivered radially out solely by light delivery element 155b (i.e. by optical element 157).
  • shaft 110 comprises a disposable (i.e. single patient use) component and optical fiber 151, optical component 157 (if included) and light source 150 are reusable, such as to be reused with multiple shafts 110 after each has been inserted into an internal body location of the patient.
  • shaft 110, optical fiber 151 and optical component 157 (if included) can be disposable and light source 150 can be reused with multiple optical fibers 151.
  • device 100 further comprises rotating assembly 300 which frictionally engages fiber 151 to cause full or partial rotations of fiber 151.
  • Rotating assembly 300 can be configured to continuously rotate optical fiber 151, such as continuous uni-directional 360° rotations, or to rotate optical fiber 151 in discrete or reciprocating (back and forth) motions.
  • Rotation of fiber 151 can be used to rotate optical element 1 7, such as to circumferentially distribute light delivered by optical element 157.
  • light delivery element 155a comprises a segment of optical fiber 151 that delivers light in an asymmetric pattern (e.g. due to an asymmetric coating or surface treatment), and rotation of fiber 151 can be used to deliver light in an even circumferential pattern.
  • device 100 includes one or more additional components constructed and arranged to further prevent and/or further reduce infection, such as functional element 195.
  • Functional element 195 can be constructed and arranged similar to functional element 195 described in reference to Fig. 1 hereabove, and device 100 can include conduit 196 and energy delivery unit 197 (neither shown in Fig. 6).
  • light source 150 comprises energy delivery unit 197.
  • Functional element 195 can be positioned on and/or within one or more locations of shaft 1 10, such as when light delivery element 155b comprises functional element 195 as shown in Fig. 6.
  • Functional element 195 can be sized and positioned to deliver an anti-infection effect to similar locations of tissue and/or body fluid to that receiving light from the one or more light delivery elements 155a.
  • Figs. 7 through 11 illustrate devices and methods for delivery of light or other electromagnetic energy to provide a therapeutic benefit, such as to treat: heart failure; kidney failure; liver failure; transplanted organ failure; cancer; autoimmune disease; an immunologic disorder; inflammatory reactions; and/or cerebral disease.
  • Devices 500a, 500b and 500c of Figs. 7, 10 and 11, respectively, collectively devices 500 each include one or more energy delivery elements 555.
  • Energy delivery elements 555 can be constructed and arranged to deliver one or more forms of energy, such as electromagnetic energy or other energy.
  • one or more energy delivery elements 555 are configured to deliver energy selected from the group consisting of: light energy; electrostatic field energy; magnetic field energy; varying field energy; microwave energy; ultrasound energy; and combinations of these.
  • one or more energy delivery elements 555 are constructed and arranged to deliver light energy and a second form of energy, such as electrostatic field energy; magnetic field energy; and/or electromagnetic field energy.
  • one or more energy delivery elements 555 are constructed and arranged to deliver at least light energy, such as light energy comprising one or more wavelengths, such as one or more wavelengths between 300nm and 900nm, such as between 250nm and 730nm (e.g. to affect nitric oxide), between 410 nm and 580 nm, between 410nm and 420nm, between 540nm and 550nm, or between 570nm and 580nm.
  • energy delivery elements 555 are constructed and arranged to deliver visible light, ultraviolet light and/or infrared light.
  • energy delivery elements 555 deliver one or more wavelengths of light constructed and arranged to cause immunomodulation.
  • Device 500 and/or energy delivery elements 555 can be constructed and arranged to deliver phototherapy and/or thermal therapy, such as be delivering electromagnetic waves to blood or other tissue.
  • the delivered electromagnetic waves can be configured to alter the function of heme proteins and/or enzymes to effect metabolic, vascular and/or immunomodulative function.
  • One or more energy delivery elements 555 can comprise an LED constructed of an organic material.
  • Energy delivery elements 555 can each comprise a phosphorescent material, such as one or more polymers such as poly(n-vinylcarbazole) used as a host to which an organometallic complex (e.g. an iridium complex) is added as a dopant (e.g. to increase energy efficiency).
  • a phosphorescent material such as one or more polymers such as poly(n-vinylcarbazole) used as a host to which an organometallic complex (e.g. an iridium complex) is added as a dopant (e.g. to increase energy efficiency).
  • Energy delivery elements 555 can be constructed and arranged to warm the patient's blood, such as via the delivery of microwave or ultrasound energy, such as to modify oxygen unloading as seen in the dissociation curve of Fig. 8. In some embodiments, energy delivery elements 555 are constructed and arranged to both warm blood and deliver light energy to blood.
  • One or more energy delivery elements 55 can be constructed and arranged to deliver energy in a continuous manner, and/or in a pulsed, intermittent manner.
  • Device 500 and one or more energy delivery elements 555 can be constructed and arranged to deliver energy in a closed-loop fashion, such as in response to a signal provided by a sensor, such as sensor 619, 719 and 819 of Figs. 7, 10 and 11, respectively, each described herebelow.
  • Energy delivery can comprise light energy or other electromagnetic energy that is adjusted based on a sensor signal.
  • an electromagnetic field strength is adjusted based on the sensor signal.
  • pulse-width modulation parameter e.g. ratio of on time to off time
  • Sensors of the present inventive concepts can comprise a sensor selected from the group consisting of: temperature sensor such as a thermocouple or thermistor; radiometric sensor; oxygen sensor; glucose sensor such as an optical glucose sensor; pH sensor; physiologic sensor; pressure sensor; blood gas sensor; blood conductivity sensor; impedance sensor; motion sensor; accelerometer; and combinations of these.
  • energy delivery is modified based on the conductivity and/or impedance of blood.
  • energy delivery is modified based on a measured blood glucose level, such as a blood glucose level measured by an optical glucose sensor.
  • Devices 500 of the present inventive concepts can be constructed for short-term clinical use with the patient (e.g. use for less than 16 hours, less than 24 hours, less than 3 days or less than 7 days), or for long-term clinical use (e.g. use for at least 1 week, at least 1 month, at least 3 months or at least 6 months).
  • the energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver light (e.g. in a continuous or pulsed, intermittent manner) to provide phototherapy and/or thermal therapy for short durations of time (e.g. less than 30 minutes, less than 1 hour, less than 4 hours, less than 16 hours, less than 24 hours, less than 3 days or less than 7 days), or for long-term use (e.g.
  • one or more energy delivery elements 555 are constructed and arranged to deliver light for or at least 6 months, such as when the one or more energy delivery elements 555 are implanted in the patient.
  • the energy delivery elements 555 of the present inventive concepts can be constructed and arranged to be implanted within the patient, remain outside the patient's skin, or pass through the patient's skin via an incision or natural body orifice.
  • Devices 500 of Figs. 7, 10 and 11 can include a photo sensitizer or other agent, such as agent 660 of Fig. 7.
  • Agent 660 can be patient ingested or otherwise delivered to the patient (e.g. via intravenous or intraarterial delivery) and can enhance the effect of the phototherapy, such as to enhance or otherwise modify the absorption of light by blood or other tissue of the patient.
  • Agent 660 can be given to the patient to enhance target enzyme effects, such as when agent 660 comprises a nitric oxide donor medication, tetrahydrofolate, and/or other substrates for heme enzymes (e.g. L-arginine).
  • Device 500a of Fig. 7 includes a shaft, shaft 610, configured to be inserted into the patient, such as through a natural orifice or percutaneous incision to access a blood vessel.
  • Device 500b of Fig. 10 includes multiple shafts, shafts 710, that can be positioned at multiple locations, such as in multiple blood vessels, such as in multiple pulmonary arteries.
  • Device 500c of Fig. 11 comprises an implantable device from which one or more shafts 810 are attached and can be placed to one or more internal body locations.
  • One or more energy delivery element 5 5 can be positioned on, in and/or within one or more shafts such as shafts 610, 710 and 810, such as one or more energy delivery elements 555 positioned on the distal end of the shaft, in the distal portion of the shaft, or along a majority of the length of the shaft.
  • one or more energy delivery elements 555 can be advanceable from a shaft, such as an energy delivery element 555 mounted to a control rod, not shown but configured to advance one or more energy delivery elements 555 from the side of a shaft or from the distal end of a shaft.
  • one or more shafts include a coating, such as an anti-thrombogenic coating such as a surface comprising nanoparticles configured to carry a negative electrical charge.
  • Heart failure is a condition, where the pumping function of the heart is insufficient to deliver an adequate amount of blood for oxygen delivery to vital organs.
  • Oxygen transport is the main function of cardiovascular circulation.
  • the circulation to target organs and other body tissue locations depends critically on the degree of vascular resistance.
  • tissue underperfusion e.g. shock
  • vascular resistance is increased by vasoconstriction in order to increase blood pressure and thereby perfusion pressure. Further decrease of tissue perfusion by vasoconstriction can lead to a vicious circle aggravating oxygen depth.
  • tissue underperfusion e.g. shock
  • vasoconstriction vascular resistance is increased by vasoconstriction in order to increase blood pressure and thereby perfusion pressure. Further decrease of tissue perfusion by vasoconstriction can lead to a vicious circle aggravating oxygen depth.
  • one or more treatments can be implemented.
  • An increase in cardiac output can be attempted, such as by administering one or more
  • a therapy to decrease in peripheral vascular resistance can be employed.
  • ACE inhibitors, angiotensin blockers and/or other cardiac medications have improved cardiac output and survival.
  • nitric oxide has been shown to act as an endogenous vasodilator improving perfusion, especially in the pulmonary circulation.
  • hypoxemia local vasoconstriction, which is a physiologic response to decreased perfusion of poorly ventilated regions, increases the afterload for the right ventricle considerably in diseases such as: shock; pulmonary disease; scleroderma; primary pulmonary hypertension; and/or intracardiac shunt.
  • nitric oxide has been proven a potent vasodilator with great therapeutic potential, it is expensive and difficult to deliver. Therefore a method to locally increase availability of nitric oxide provides an attractive alternative.
  • Another method of increasing oxygen delivery to tissue can include improving oxygen unloading.
  • Animals living at high altitude e.g. birds and other mammals living in the Himalayan mountains
  • mutations in their hemoglobin which has led to facilitated oxygen unloading and thereby improving tissue oxygenation.
  • several humoral factors associated with metabolic demand such as increased temperature, decreased pH and increased metabolites such as 2,3DPG facilitate oxygen unloading and thereby local oxygen delivery to tissues, as described herebelow.
  • oxygen consumption cardiac output x arteriovenous oxygen difference
  • oxygen delivery can be improved by widening the arterio-venous difference of oxygen content.
  • Better oxygen unloading from hemoglobin improves organ and other tissue oxygen availability and leads to lower venous oxygen content.
  • the characteristics of hemoglobin oxygen unloading are summarized in the hemoglobin dissociation curve shown in Fig. 8.
  • the devices and methods of the present inventive concepts can be constructed and arranged to shift the hemoglobin dissociation curve to the right, such as to improve oxygen unloading and thereby improve tissue oxygen availability. These improvements can decrease the symptoms and consequences of heart failure such as impaired renal and other organ function.
  • the devices and methods of the present inventive concepts are constructed and arranged to cause a temporary, reversible, right shift of the hemoglobin dissociation curve in the precapillary lung, such as to treat pulmonary hypertension.
  • the devices and methods of the present inventive concepts can be constructed and arranged to enhance or otherwise modify one or more functions of blood, such as by delivering light, electrical current and/or other electromagnetic energy, such as to modify one or more of the blood functions described immediately herebelow.
  • the function of blood is to transport oxygen from the lungs to the tissue, which is accomplished by the red blood cells. Hemoglobin binds to oxygen. If the oxygen binding is decreased by shifting the oxygen dissociation curve to the right, increased amounts of oxygen are released to the tissue. This release occurs in cases of decreasing H, increasing temperature, and in the presence of metabolites of glycolysis, such as DPG. Any artificial right shift of the oxygen dissociation curve by the alteration of blood pH, blood temperature and/or direct photochemical or electrochemical interaction with hemoglobin might improve oxygen availability in the tissue and thereby alleviate the symptoms and consequences of heart failure.
  • Another function of the blood is transport of hormones, cytokines, antibodies and other messenger molecules between the organs or the site of production to the site of action. Any artificial modification of the chemical structure, conformation or electrical binding affinity of those messenger molecules can be used for therapeutic action, such as an increase or decrease of hormone effects (e.g. insulin, adrenalin) and/or inactivation or activation of circulating antibodies, cytokines, etc.
  • hormones e.g. insulin, adrenalin
  • Another function of the blood is the immunologic function of the white blood cells, which is important for defense against infectious agents but is also responsible for a variety of unwanted reactions, for instance in autoimmune diseases, inflammatory diseases (e.g. arthritis) and inflammatory processes due to transplantation.
  • Extracorporeal light therapy of blood alters its immune function after reinfusion.
  • Device 500 can cause similar therapeutic effects to extracorporeal light therapy (which may also be modified by nitric oxide).
  • device 500 can be placed in an artery supplying a transplanted organ (e.g. kidney, liver, heart, lung, intestine, pancreas, and the like) and activated if rejection by the hose is anticipated.
  • Device 500 can be placed in a central vessel such as the right atrium in order to modulate the circulating white blood cells and immune system, such as to treat graft versus host disease, autoimmune disease, chronic inflammatory diseases, allergic reactions and/or leukemia.
  • coagulation Another function of the blood is coagulation, which prevents bleeding.
  • a cascade of clotting factors circulates in the blood and is activated readily in case of trauma and/or contact with an artificial surface or chemical agents.
  • clot formation can lead to embolus or undesired vascular occlusion.
  • Clots can be dissolved by fibrinolysis, but the balance of the coagulation and fibrinolysis is very delicate.
  • a therapeutic intervention with light therapy via device 500 can offer unique opportunities to treat disseminated intravascular coagulation disorders (DIC), as they occur in the setting of acute disease (bacteremia, cancer) and coagulation associated with the implantation of foreign bodies such as stents. Thrombosis is a major complication of stent implantation.
  • DIC disseminated intravascular coagulation disorders
  • Electromagnetic waves as light are absorbed by solid particles of the blood. However, if the wavelength of the electromagnetic wave delivered by device 500 is similar to the diameter of the erythrocytes (7-10 micrometer), then the penetration of the wave is sufficient for reaching the entire volume inside the blood vessel.
  • the wavelength delivered by device 500 can range from visible light up to microwaves. The delivered wavelength can range up to
  • the wavelengths delivered by device 500 can be used in the circulatory system to view a vessel wall and/or treat the vessel wall by photodynamic therapy.
  • the energy of the light can be deposited at the vessel wall and not within the blood.
  • device 500 can be constructed and/or arranged to deliver light and electric current, such as an electric current constructed and arranged to cause electrolysis.
  • light and electric current such as an electric current constructed and arranged to cause electrolysis.
  • the electromagnetic energy emission and the application of current has a profound impact on pH of the blood and the electrochemical equilibrium. Electrolysis of water results in H 2 and 0 2 , however electrolysis in the presence of physiologic NaCl, as in blood, results in chloride, hydrogen and caustic soda lye (2NaCl + 2 H 2 0 —» CL2 + H2 + 2 NaOH).
  • device 500 can include an ion exchange membrane around a location generating one or more toxic substances, membrane not shown for illustrative clarity, but positioned and configured to prevent any toxic materials from entering the blood stream.
  • Device 500 can be constructed and arranged to alter blood pH, oxygen availability and other electrochemical reactions, depending on the location of the two or more electrodes providing electrolysis (e.g. an anode and a cathode).
  • Device 500 can be configured such that reactions take place at an electrode configured as an anode (e.g. electrons absorbed to generate H+ ions) and an electrode configured as a cathode (electrons emitted for example to generate H 2 ).
  • electrolysis can be achieved from photoactivation by device 500 of a catalyst such as titanium oxide.
  • Device 500 can be constructed and arranged to alter electromagnetic fields within the blood to change the conformation of proteins, such as coagulation factors, hormones and other messenger proteins and the entire spectrum of actions described hereabove.
  • proteins such as coagulation factors, hormones and other messenger proteins and the entire spectrum of actions described hereabove.
  • One or more portions of device 500 may be treated with a biocompatible coating such as parylene.
  • Hematogenetic spread of cancer involves transport of cancer cells from the primary site to other organs by blood transport.
  • the insertion of device 500 within one or multiple veins draining the area of a primary tumor might prevent the formation of hematogenous metastasis by electrochemically and/or photodynamically inactivating circulating cancer cells.
  • microwaves with a wavelength which is larger than the diameter of an erythrocyte and leucocyte, but smaller than the cancer cell will be absorbed by the cancer cell while it goes through the blood cells.
  • a selective heating is possible which can be used to selectively inactivate cancer cells while preserving the blood cells.
  • the use of a photosensitizer and/or ferromagnetic particles can enhance the therapeutic effect of the energy delivered by device 500.
  • the use of optomagnetic particles containing Fe, Co, Ni or other magnetizable elements can enhance the therapeutic effect of phototherapy delivered by device 500.
  • the magnetization and/or demagnetization of hemoglobin ferrous ions can change oxygen affinity and can be used to improve tissue oxygenation. Hemoglobin occurs in three types, oxyhemoglobin (not magnetic), deoxj ⁇ hemoglobin (magnetic) and methemoglobin (not magnetic).
  • At least a portion of device 500 can be placed temporarily around and/or in a blood vessel such as a vein or an artery.
  • a blood vessel such as a vein or an artery.
  • at least a portion of device 500 can be implanted within the patient, such as an implanted portion comprising a power supply such as a battery or capacitor and recharging circuitry such as an inductive coupling recharging circuit.
  • Device 500 can be constructed and arranged to deliver light, electromagnetic waves (e.g. microwaves), electrical currents (e.g. electrical currents for electrolysis), and/or electromagnetic fields, each of which, singly and/or in combination, can be delivered
  • electromagnetic waves e.g. microwaves
  • electrical currents e.g. electrical currents for electrolysis
  • electromagnetic fields each of which, singly and/or in combination, can be delivered
  • Light emitted by device 500 can comprise one or more wavelengths of light delivered simultaneously and/or sequentially, such as multiple wavelengths delivered to provide different therapeutic effects to the patient.
  • the molecule for oxygen transport is heme, a protoporphyrin ring molecule coupled to four different protein chains, which alter the chemical affinity of the heme.
  • the heme molecule which is one of the most constant chemical structures across different animal species, has also a high similarity with chlorophyll, the molecule responsible for photosynthesis in plants (see Fig. 9). Chlorophyll is activated by sunlight and acts as a chemical catalyst for
  • Heme is a molecule not only prevalent in hemoglobin, but also in various enzymes such as the nitric oxygen synthase (e.g. eNOS) as well at least 30 other heme enzymes (e.g.
  • Cytochrom C prostacyclin synthase, Methyltetrahydro protoberberin 14-monoxygenase, Leukotriene-monoxygenase, Hydroxjdsamine oxidase and Heme oxidase).
  • the devices and methods of the present inventive concepts can be constructed and arranged to deliver light to induce the catalytic function of one or more of these heme enzymes.
  • Peng et al. (201 1) showed beneficial effects of phototherapy on atherosclerotic plaques in rabbits, which can have been effected by elevated levels of nitric oxide.
  • pulmonary hypertension a disease in which elevated vascular resistance in the lungs often leads to right heart failure and premature death. Therapy using endothelin receptor antagonist has raised hope for clinicians and patients.
  • a major pathophysiologic mechanism for pulmonary hypertension is the lack of nitric oxide in the pulmonary vascular bed, which as of yet has not been substantially improved with pharmacologic therapy.
  • Evans et al. (2011) described pulmonary vasoconstriction being triggered by heme-oxygenase 2, which acts as a physiologic 0 2 sensor leading to profound vasoconstriction at the pulmonary vascular bed during hypoxia.
  • the light or other energy delivered by energy delivery elements 555 of the present inventive concepts can be constructed and arranged to provide phototherapy and/or thermal therapy to treat one or more patient diseases or disorders.
  • the light or other energy delivered by energy delivery elements 555 can be constructed and arranged to cause one or more physiologic effects.
  • one or more energy delivery elements 555 are constructed and arranged to heat blood.
  • one or more energy delivery elements 555 are constructed and arranged to alter the oxygen dissociation curve.
  • one or more energy delivery elements 55 are constructed and arranged to cause vasodilation.
  • one or more energy delivery elements 555 are constructed and arranged to increase nitric oxide, such as a local increase in nitric oxide.
  • one or more energy delivery elements 555 are constructed and arranged to enhance nitric oxide release from the vascular endothelium and/or smooth muscle cells.
  • one or more energy delivery elements 555 are constructed and arranged to prolong local nitric oxide effects. [0209] In some embodiments, one or more energy delivery elements 555 are constructed and arranged to cause an alteration in the function of erj'throcytes.
  • one or more energy delivery elements 555 are constructed and arranged to cause a modification in oxygen release from hemoglobin.
  • the modification can be due to an interference with the heme-heme interaction.
  • the modification can be caused by an electrostatic stabilization of deoxyhemoglobin in the T-form.
  • the modification can be caused by an increase in blood temperature due to heating of the blood by the energy delivery elements 555.
  • one or more energy delivery elements 555 are constructed and arranged to facilitate the release of carbon monoxide from hemoglobin (e.g. as described herebelow in reference device lOOco to Fig. 15).
  • one or more energy delivery elements 555 are constructed and arranged to cause a modification in the pH of blood, such as an increase and/or a decrease in blood pH.
  • one or more energy delivery elements 555 are constructed and arranged to cause a modulation in the immune response of blood leucocytes.
  • the modulation can be caused to prevent: organ rejection; graft versus host disease; and/or an autoimmune disease.
  • one or more energy delivery elements 555 are constructed and arranged to cause a modulation of the coagulation and/or thrombocyte function.
  • the modulation can be caused in order to increase coagulability and/or to inhibit blood coagulation.
  • one or more energy deliver ⁇ ' elements 555 are constructed and arranged to cause a modification in the function of heme catalyst enzymes in the blood.
  • the enzymes can include but are not limited to: catalase; endothelial nitric oxide synthase (ENOS); heme oxidase; cytochrome; and/or myoglobin.
  • one or more energy delivery elements 555 are constructed and arranged to cause a modification of hormonal action of one or more peptide and/or non- peptide hormone.
  • one or more energy delivery elements 555 are constructed and arranged to cause a modification in the binding capacity of one or more antibodies.
  • one or more energy delivery elements 555 are constructed and arranged to cause a decrease in blood glucose level.
  • the glucose decrease can be caused by an electrochemical action that results due to the energy delivered by one or more energy delivery elements 555.
  • Device 500 can include the delivery of one or more reagents configured to cause the glucose reduction. In some embodiments, no reagents are delivered by device 500.
  • one or more energy delivery elements 555 are constructed and arranged to affect circulating tumor cells by selective heating, photocoagulation and/or photolysis.
  • the device is constructed and arranged to causes electrolysis of blood, such as to prevent blood clotting proximate the device.
  • device 500 is constructed and arranged to heat blood to a temperature of approximately 40°C such as to facilitate hemoglobin oxygen unloading.
  • Device 500 can deliver phototherapeutic light as well as energy configured to heat blood, such as phototherapeutic light plus infrared light in the absorption spectrum of oxy-Hb and/or radiofrequency energy configured to warm blood.
  • the radiofrequency energy can comprise energy at a frequency of 200kHz to 2000MHz, such as energy at a frequency between 500MHz and 2000MHz, or between 200kHz and 1000kHz, to facilitate the oxygen unloading by heating the blood.
  • Device 500a can be constructed and arranged to deliver phototherapy and/or thermal therapy as has been described hereabove.
  • Device 500a includes energy delivery elements 555a and 555b, collectively energy delivery elements 555.
  • Energy delivery elements 555 can be constructed and arranged to deliver one or more forms of electromagnetic energy such as light energy selected from the group consisting of: visible light energy; infrared light energy; and combinations thereof.
  • Device 500a and energy delivery elements 555 can be constructed and arranged to deliver electromagnetic energy into blood proximate a target organ such as an organ selected from the group consisting of: lung; heart; brain; kidney; liver; a transplanted organ; and combinations of these.
  • the energy delivery elements 555 can be constructed and arranged to cause an effect selected from the group consisting of: improved perfusion; improved oxygen delivery by better oxygen unloading;
  • the treatment delivered by device 500a can be performed alone or in conjunction with one or more agents 660, such as an agent selected from the group consisting of: a nitric oxide donor; a photo sensitizer; a photocatalyst; an enzyme substrate; and combinations of these.
  • Agent 660 can comprise a photosensitizer and/or a photocatalyst.
  • Agent 660 can comprise an agent configured to enhance the photodynamic effects of the phototherapy provided by one or more energy delivery elements 555.
  • Agent 660 can comprise an agent selected from the group consisting of: metal; protein; carbohydrate; fatty acid; nucleic acid; synthetic medication;
  • antibody ionic solution; heme group; flavin group; aminolaevulin; phenol; polycarbon;
  • Agent 660 can comprise a reagent, such as a reagent delivered by device 500a, such as to cause a reduction in blood glucose level.
  • Agent 660 can comprise a photosensitizer or other agent that can be delivered from shaft 610 of device 500, such as via a pump element, not shown.
  • Agent 660 can be stored in a reservoir within housing 620 or shaft 610. Alternatively or additionally, agent 660 can be injected intravenously, inhaled and/or administered as an oral pill.
  • Device 500a can be constructed and arranged for use in intensive care units, heart catheterization laboratories and/or other clinical care locations.
  • the intravascular phototherapy for heme compounds delivered by device 500a can increase precapillary levels of nitric oxide and can provide vasodilation thereby, such as to improve perfusion in a target organ.
  • Device 500a can be constructed and arranged to treat pulmonary hypertension.
  • Device 500a can be constructed and arranged to deliver intravascular phototherapy to modify oxygen sensors and/or to cause a right shift of the hemoglobin dissociation curve of Fig. 8 as described hereabove. The shift can be accomplished by a photodynamic effect and/or by a thermal effect caused by the energy delivered by energy delivery elements 555 (e.g.
  • infrared waves, microwaves, etc. that results in increased blood temperature.
  • Increasing the temperature by 1°C can improve oxygen unloading by approximately 6% or more, analogous to the body's fever response.
  • an increase of 3°C can result in an improvement in oxygen delivery of approximately 18% or more.
  • device 500a and energy delivery elements 555 are constructed and arranged to deliver energy to treat non-cardiac organs, such as the kidneys in renal failure; the liver in acute hepatic failure; the brain during and/or after a stroke; and/or a transplanted organ in acute rejection.
  • non-cardiac organs such as the kidneys in renal failure; the liver in acute hepatic failure; the brain during and/or after a stroke; and/or a transplanted organ in acute rejection.
  • one or more energy delivery elements 555 comprise a light emitting diode.
  • a target blood volume e.g. a maximum blood volume
  • multiple light emitting diodes can be mounted along one or more shafts 610 and positioned in two or three dimensional orientations.
  • the one or more shafts 610 can be constructed and arranged to be placed in an artery, vein, or other blood conducting conduit or chamber, including but not limited to: a pulmonary artery; a chamber of the heart; and/or the hepatic artery.
  • the light or other energy delivered by device 500a can be titrated to a clinical response.
  • the light or other energy delivered by device 500a can be pulsed (e.g. turned on and off), or simply turned off after a sufficient clinical improvement is achieved and/or pre-determined dose is delivered.
  • energy delivery elements 555 are positioned to deliver energy to a site specific (i.e. non-systemic) location, such as a volume of blood proximate a target organ (e.g. blood within an artery proximal to the target organ).
  • device 500a is configured for insertion into a natural body orifice or a blood vessel (e.g. via percutaneous access of the blood vessel).
  • Device 500a includes shaft 610 comprising proximal end 611 and distal end 612, as well as outer surface 613.
  • Proximal end 611 is attached to housing 620.
  • Shaft 610 can be flexible or rigid, or it can contain both flexible and rigid portions.
  • Shaft 610 can include one or more lumens, such as central lumen 615. Central lumen 615 is defined by inner surface 614 of shaft 610.
  • device 500a is configured for insertion over a guidewire, such as a guidewire inserted through central lumen 615, or a guidewire inserted in a distal sidecar, not shown but known to those of skill in the art to permit rapid exchange insertion of device 500a over a guidewire.
  • a wall 617 of shaft 610 is positioned between inner surface 614 and outer surface 613.
  • shaft 610 includes multiple lumens, such as when device 500a comprises a multi-lumen catheter for insertion into a blood vessel or other body location.
  • Shaft 610 can include a generally smooth outer surface 613, and can include a relatively uniform outer profile (at least in the distal portion), such as an outer profile between 2mm and 9mm in diameter.
  • Shaft 610 can include one or more energy deliver ⁇ ' elements, such as one or more of energy delivery elements 555a and 555b as shown, configured to deliver light or other energy such as to provide phototherapy and/or thermal therapy as described hereabove.
  • the energy delivery elements of the present inventive concepts can comprise an element that both produces and delivers light (e.g. a light emitting diode or other light generating element) and/or these elements can simply deliver light (e.g. a segment of exposed optical fiber or other optical element attached to a light source as described herein).
  • the energy delivery elements of the present inventive concepts can include one or more optical components, such as one or more of the optical elements described herein.
  • An optical element can be constructed and arranged to couple light into an energy delivery element 555, such as optical element 657 described herebelow.
  • an optical element can be configured to distribute light from an energy delivery element, such as a lens, prism or other optical element configured to distribute light in one or more desired patterns.
  • Optical elements of the present inventive concepts can comprise an optical element selected from the group consisting of: lens; ball lens; prism;
  • diffractor filter; mirror; optical fiber; and combinations thereof.
  • FIG. 7 The cross section of Fig. 7 illustrates multiple energy delivery elements 555 positioned within an axial segment of shaft 610, such as to deliver light or other energy radially out from and/or radially into shaft 610 (e.g. into a lumen 615 of shaft 610), as shown by the arrows emanating from each energy delivery element 555a.
  • One or more energy delivery elements 555b (one shown in Fig. 1) can be positioned within a distal portion of shaft 610, such as to transmit light radially out from shaft 610, as shown by the arrows emanating from energy delivery element 555b.
  • energy delivery element 555b is constructed and arranged to be positioned within a chamber of the heart, or other site specific location.
  • Energy delivery elements 555a and 555b are operably connected to one or more sources of light, such as is described herebelow.
  • device 500a includes one or more energy delivery elements 555a (e.g. positioned along the majority of the length of shaft 610) and no energy delivery element 555b.
  • device 500a includes energy delivery element 555b (e.g. positioned in a distal portion of shaft 610) and no energy delivery elements 555a.
  • Device 500a can include one or more optical fibers, such as optical fibers 651a positioned within wall 617 of shaft 610.
  • One or more fibers 651a can each be embedded in wall 617 of shaft 610.
  • one or more fibers 651a can be insertable into (e.g. slidingly received by) a lumen, such as lumens 618 positioned within wall 617 (lumens 618 are omitted from Fig. 7 for illustrative clarity but shown in Fig. 7A and described herebelow).
  • one or more fibers 651a can be positioned within central lumen 615.
  • central lumen 615 comprises multiple separate lumens and one or more optical fibers 651a can be positioned within and/or insertable into one or more of the multiple lumens of central lumen 615.
  • Fibers 651 include an axial portion covered by an opaque covering, cladding 652a, such as the covered proximal portions of each fiber 651a shown in Fig. 7.
  • Each energy delivery element 555a comprises an axial portion of a fiber 651a that is not surrounded by an opaque material (e.g. the uncovered distal segments of each fiber 651a with length Dl shown in Fig. 7).
  • each fiber 651 a Light introduced into the proximal end of each fiber 651 a is conducted along the cladded optical fiber with minimal losses of light, as is known to those of skill in the art.
  • the conducted light or other energy emanates radially out from the associated energy delivery element 555a (e.g. a portion of fiber 651 that is not surrounded by cladding and can be modified to enhance the distribution of light or other energy), as shown by the arrows emanating from energy delivery element 555a shown in Fig. 7.
  • energy delivery element 555a can be positioned in an area of the patient to be treated (e.g. phototherapy or thermal therapy delivered), such as within a segment of a blood vessel.
  • Each energy delivery element 555a can comprise a modified surface of fiber 651, such as a roughened surface and/or a surface otherwise modified to enhance the distribution of light or other energy.
  • one or more energy delivery elements 555a can comprise a segment of optical fiber 651 that has received a surface treatment selected from the group consisting of: etching; cutting; covering with roughened material such as silicon; and combinations thereof.
  • energy delivery element 555a comprises a segment of optical fiber 651 including at least a portion that is surrounded by a transparent covering.
  • the transparent covering can include one or more reflective particles constructed and arranged to diverge radiated light, such as one or more particles selected from the group consisting of:
  • light delivery element 555a is surrounded by a material configured to enhance the distribution of light, as described herein.
  • Device 500a can include one or more optical fibers 651b extending from housing 620 to a distal portion of shaft 610.
  • One or more optical fibers 651b can be positioned within lumen 615 and/or within wall 617 of shaft 610.
  • Energy delivery element 555b can comprise one or more optical elements (as described hereabove) positioned on the distal end of the one or more optical fibers 651b, such as optical element 657 shown, which couples light from fiber 651b into energy delivery element 555b.
  • energy delivery element 555b comprises a ball lens that is attached to the distal end of a fiber 65 lb or a ball lens that is formed from the distal end of fiber 651b.
  • a ball lens can be created by melting the end of fiber 651b with applied heat.
  • energy delivery element 555b can comprise an uncovered distal portion (e.g. not covered by cladding 652b) as described hereabove in reference to energy delivery element 555a.
  • optical fiber 651b and energy delivery element 555 are configured to translate through lumen 615, such as to exit the distal end 612 of shaft 610.
  • energy delivery element 555 can exit a side hole in an exterior portion of shaft 610.
  • Optical fibers 651a and/or 651b can comprise one or more materials configured to propagate the light for delivering phototherapy and/or thermal therapy.
  • optical fibers 651a and/or 651b can comprise one or more wires or other conduits configured to conduct non-light energy.
  • fibers 651a and/or 651b comprise a material selected from the group consisting of: glass; plexiglass; plastic; polymethylmethacrylate (PMMA); one or more polymers (e.g. one or more polymers configured as a micro structured polymer optical fiber); photonic crystal; polycarbonate; polystyrene; and combinations of these.
  • Fibers 651a and/or 65 lb can comprise flexible fibers which allow movement within the patient without breaking or other issues.
  • fibers 651a and/or 651b comprise a diameter between 0.1mm and 0.2mm.
  • each fiber 651a is attached and/or attachable to a light and/or other energy source, such as energy source 650a shown.
  • the proximal end of each fiber 651b is attached and/or attachable to a light and/or other energy source, such as energy source 650b shown.
  • Device 500a further includes a battery, capacitor or other power source, such as power supply 653 shown positioned in housing 620 and operably connected to energy sources 650a and 650b.
  • energy sources 650a and 650b (collectively energy source 650) comprise a single energy source 650 attached to one or more power supplies 653.
  • Power supply 653 can comprise a replaceable or rechargeable power source, such as a rechargeable power source included when an implanted housing 620 surrounds power supply 653, such as implantable housing 820 and power supply 853 of Fig. 11 described herebelow.
  • one or more energy sources 650 comprises a non-light energy source, such as when optical fibers 651a and/or 651b comprise a wire or other conduit configured to transmit non-light energy to one or more energy delivery elements 555, such as when one or more energy delivery elements 555 comprise an LED or other electrically powered light source, or when one or more energy delivery elements 555 comprise a non-light energy delivery element.
  • Energy source 650 can be positioned within housing 620 (as shown in Fig. 7), on and/or within shaft 610, or at an external location (as shown in Fig. 2). Energy source 650 can be constructed and arranged to provide light at a single wavelength. Alternatively or additionally, energy source 650 can be constructed and arranged to provide light at multiple wavelengths, simultaneously or pulsed. The light can be provided to one or more energy delivery elements 555, such as via one or more optical fibers 651 or other light or other energy carrying conduit. Energy source 650 can comprise an LED, such as an organic LED, described hereabove. In some embodiments, an energy delivery element 555 and energy source 650 are positioned proximate each other, are attached to each other, and/or comprise the same component. In some embodiments, energy delivery element 555b comprises energy source 650 which can comprise an LED, lamp, laser, or other light source positioned within a distal portion of shaft 610.
  • Energy source 650 can comprise a laser, such as a diode laser or other laser configured to provide one or more wavelengths of light.
  • Energy source 650 can be constructed and arranged to deliver pulsed light, such as light delivered at a duty cycle between 0.1% and 50%.
  • Energy source 650 can provide light at a power of less than 100 Watts, or less than 50 Watts.
  • energy source 650 provides light at less than or equal to 100 Watts that is pulse-width modulated to deliver light at less than 50 Watts rms, or less than 20 Watts rms, to one or more energy delivery elements 555.
  • energy source 650 provides light at a power of at least 0.1 Watts, such as at a power between 2 Watts and 10 Watts, or such as between 0.3 Watts and 0.6 Watts. Energy source 650 can provide one or more energy wavelengths.
  • light source 150 is configured to deliver light at a power of between l.OmW and lOOmW. In some embodiments, the light delivered by one or more light delivery elements 155 is delivered at a power between 1.OmW and 1 OOmW. In some
  • light delivery element 155 delivers light to tissue at a power density between l .OmW/cm 2 and lO.OmW/cm 2 .
  • Energy source 650 can be constructed and arranged to provide one or more wavelengths, such as one or more wavelengths between 410 nm and 580 nm, between 410nm and 420nm, between 540nm and 550nm, and/or between 570nm and 580nm.
  • Energy source 650 can be constructed and arranged to provide visible light and/or ultraviolet light.
  • Energy source 650 can be constructed and arranged to deliver light at varying wavelengths, such as light provided at continuously varying wavelengths or light alternative between at least a first wavelength and a second wavelength.
  • Energy source 650 can be constructed and arranged to provide light at multiple wavelengths simultaneously. In some embodiments, multiple wavelengths are provided by energy source 650 to enhance the phototherapeutic effects of device 500a.
  • one or more wavelengths delivered by energy source 650 are based on the absorption spectra of one or more microorganisms to be treated. For example, a wavelength of approximately 405nm can be delivered to treat E Coli; a wavelength of 470nm can be delivered to treat staphylococcus; and/or a wavelength of 670nm can be delivered to treat oral Candida. Alternatively or additionally, one or more wavelengths may be delivered to cause a vascular effect (e.g. to mediate nitric oxide), such as one or more wavelengths approximating 350nm and/or 430nm.
  • a vascular effect e.g. to mediate nitric oxide
  • energy source 650 can be configured to deliver selective phototherapy with a relatively narrow band of one or more wavelengths, such as when energy source 650 delivers light at one or more wavelengths between 550nm and 620nm (e.g. without delivering any wavelengths outside of that band).
  • energy source 650 comprises one or more filters, such as to prevent delivery of light within one or more ranges of wavelengths, such as a filter configured to prevent delivery of wavelengths between 630nm and 700nm.
  • energy source 650 is configured to deliver light at one or more wavelengths between 575nm and 600nm, such as when device 100 is configured to improve mitochondrial nitric oxide production and/or decrease oxidative stress.
  • Energy source 650 and/or one or more energy delivery elements 555 can be constructed and arranged to provide light to an area (e.g. an area or volume of blood, or an area of tissue) at a power density less than 50 mW/cm 2 , such as at a power density less than 25 mW/cm 2 , or at a power density approximately equal to or less than 10 mW/cm 2 .
  • energy source 650 and/or one or more energy delivery elements 555 are constructed and arranged to deliver light or other energy at approximately 1.OmW/cm 2 to 10 mW/cm 2 .
  • energy source 650 and/or one or more energy delivery elements 555 are constructed and arranged to deliver between O.lmW/cm 2 and lOOmW/cm 2 , between 2mW/cm 2 and 10mW/cm 2 , between 2mW/cm 2 and 8mW/cm 2 , or between 50mW/cm 2 and 300mW/cm 2 .
  • energy source 650 and/or one or more energy delivery elements 555 are constructed and arranged to deliver light or other energy at a level to prevent tissue dehydration or other adverse tissue effect, such as pulse-width modulated light delivery configured to prevent tissue dehydration or cell damage.
  • Heating of the surrounding blood or other tissue can be monitored by one or more sensors of device 500a, such as a sensor 619 when sensor 619 comprises a thermocouple, thermistor, radiometric sensor and/or other temperature sensor.
  • Sensor 619 can be positioned on shaft 610, such as in a distal portion of shaft 610 as shown, or at another device 500a location.
  • Sensor 619 can be operably attached to, or operably attachable to, sensor measurement assembly 200, such as via one or more conduits, not shown but typically including one or more wires or optical fibers.
  • sensor 619 comprises a temperature sensor attached to assembly 200 with one or more wires such that sensor measurement assembly 200 can produce a temperature measurement used to regulate the light and/or other energy provided by energy source 650.
  • sensor 619 can comprise one or more optical fibers (e.g. one or more optical fibers 651), which collect infrared light (e.g. from their distal end).
  • sensor measurement assembly 200 comprises an infrared sensor configured to correlate the received light to a temperature.
  • the temperature determined by assembly 200 e.g. via thermocouple signal, thermistor signal, radiometric sensor signal, infrared signal or otherwise, can be used to regulate the light delivered by energy source 650 in a closed loop fashion, such as to prevent damage to tissue and/or to optimize the phototherapy and/or thermal therapy being delivered by device 500a.
  • Measurement assembly 200 can include a
  • sensor 619 comprises an oxygen sensor, such as an oxygen saturation sensor used to titrate the effect of oxygen unloading.
  • sensor 619 can comprise a sensor constructed and arranged to determine the difference in absorption spectrum red (650nm to 750nm) for deoxy-Hb and infrared 860-lOOOnm for oxy-Hb.
  • Energy delivery elements 555a can be constructed and arranged to deliver light radially out from all or a portion of outer surface 613 of shaft 610, such as a majority portion and/or distal portion of the outer surface 613. Alternatively or additionally, energy delivery elements 555a can be constructed and arranged to deliver light radially inward from all or a portion of inner surface 614 of shaft 610, such as a majority portion and/or distal portion of the inner surface 614. In some embodiments, an energy delivery element 555 is positioned to direct light toward a skin surface such as a skin surface surrounding a natural opening such as the skin surface surrounding the urethral orifice, or to a skin surface surrounding a skin incision and/or skin penetration site. In some embodiments, an energy delivery element 555 comprises one or more optical components (e.g. a lens) configured to distribute light to a skin surface, not shown but such as is described in reference to Fig. 2 hereabove.
  • optical components e.g. a lens
  • the energy delivery elements 555 of the present inventive concepts can comprise one or more optical elements.
  • an energy delivery element 555 can comprise an optical element selected from the group consisting of: optical fiber; lens; ball lens; prism; diffractor; filter; mirror; and combinations of these.
  • An optical element can be positioned at the end of an optical fiber, such as an energy delivery element 55b comprising a ball lens positioned at the end of fiber 651b, as described hereabove.
  • one or more energy delivery elements 555 comprise light scattering material, not shown but such as is described in detail in reference to Fig. 2 hereabove.
  • the light scattering material can comprise a material distributed relatively evenly throughout a silicone or other polymer material, such as a light scattering material selected from the group consisting of: alumina particles; silica particles; titania particles; titanium oxide particles; and combinations of these.
  • device 500a can be constructed and arranged to rotate one or more energy delivery elements 555 (or a portion of an energy delivery element 555), such as to distribute light and/or other energy over a larger area, rotating assembly not shown but described in detail in reference to Fig. 6 hereabove.
  • One or more energy delivery elements 555 can be constructed and arranged to deliver light to a majority of a cavity, such as a lens, prism, diffractor and/or mirror configured to direct light toward the majority of the surface of a heart chamber or other organ surface and/or the majority of a segment of a blood vessel wall.
  • a cavity such as a lens, prism, diffractor and/or mirror configured to direct light toward the majority of the surface of a heart chamber or other organ surface and/or the majority of a segment of a blood vessel wall.
  • the energy delivery elements 555, shaft 610 and/or another component of device 500a can comprise a fluorescent material, such as a material constructed and arranged to increase light dispersion.
  • the fluorescent material can be positioned at least on the outer surface 613 and/or inner surface 614 of shaft 610, such as a fluorescent coating placed upon surfaces 613 and/or 614 of shaft 610.
  • Other coatings can be included on one or more components of device 500a, such as a photo sensitizer constructed and arranged to be activated by light (e.g. light delivered by an energy delivery element 555) to cause a phototherapeutic and/or thermal therapeutic effect.
  • Shaft 610 can include one or more portions that are transparent or at least translucent (hereinafter "translucent") to one or more wavelengths of light transmitted by an energy delivery element 555.
  • Shaft 610 can include a translucent portion surrounding an energy delivery element 555a comprising an unclad portion of an optical fiber 651a.
  • device 500a can include an anchoring element or an expandable element, such as balloon, such as balloon 125 of Fig. 1 described hereabove.
  • Housing 620 can be configured as a handle for a user, such as a clinician or patient, to hold while inserting, rotating and/or otherwise using device 500a.
  • Housing 620 can be implantable or include an implantable portion, such as is described in reference to Fig. 11 herebelow.
  • Housing 620 can comprise a first housing and a second housing separated from the first housing. Housing 620 can surround one or more components including but not limited to: power supplies such as batteries; agent reservoirs such as pharmaceutical agent reservoirs;
  • Device 500a can be constructed and arranged to perform numerous functions in addition to the deliver ⁇ ' of phototherapy and/or thermal therapy.
  • device 500a comprises a device selected from the group consisting of: vascular access device; central venous catheter; peripherally inserted central catheter such as a peripherally inserted venous catheter; drug or other agent delivery pump; implanted device; implanted drug or other agent delivery pump; pacemaker; drive shaft assembly for a cardiac assist device; inflow and/or outflow cannula for a cardiac assist device; artificial heart; and combinations of these.
  • shaft 610 is constructed and arranged for insertion through an incision of the skin, such as when shaft 610 is further inserted into a blood vessel, organ, and/or a subcutaneous tissue tunnel.
  • distal end 612 of shaft 610 is inserted into a blood vessel such that blood can be removed via lumen 615 and/or one or more agents can be delivered to an internal body location (e.g. into the cardiovascular system of the patient) via lumen 615.
  • housing 620 can include a luer or other attachment element configured to add or remove fluids via lumen 615, such as when device 500a comprises a central venous catheter or peripherally inserted central catheter.
  • shaft 610 is inserted through the skin and into a blood vessel supplying blood to an organ such as the kidney, liver or heart.
  • device 500a can comprise an external (i.e. non-implanted) drug delivery pump, such as a skin-attached or other external drug delivery device in which shaft 610 comprises a transcutaneous conduit (e.g. a rigid needle or flexible catheter passing through the skin surface into a blood vessel) for agent delivery.
  • housing 620 can include a pumping mechanism, not shown but described in reference to Figs. 4 and 4A herebelow.
  • the agent delivered comprises an agent selected from the group consisting of: insulin; a chemotherapeutic agent; a nutritional material; a pain control agent such as morphine; and combinations thereof.
  • the energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver a minimum amount of light and/or other energy to blood and/or other tissue. Alternatively or additionally, the energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver a maximum of light and/or other energy to blood and/or other tissue.
  • shaft 610 and housing 620 are constructed and arranged for implantation into the patient, such that energy delivery elements 555a and/or 555b can deliver light or other energy to blood surrounding at least a portion of shaft 610.
  • Shaft 610 can be constructed and arranged for insertion through a subcutaneous tissue tunnel or through another internal body location.
  • Distal end 612 can be constructed and arranged for insertion into a blood vessel, heart chamber, or other internal body location.
  • Device 500a can comprise an implanted portion configured to deliver a pharmaceutical agent or other agent systemically and/or locally to an internal location of the patient, such as to deliver an agent systemically or locally within the patient.
  • the delivered agent can be configured to improve the phototherapeutic effect of light delivered by one or more energy delivery elements 555.
  • an implanted housing 620 can surround a drug reservoir and pumping means which deliver an agent to lumen 615 of shaft 610, drag reservoir and pumping means not shown but described in detail in reference to Figs. 5 and 5A hereabove.
  • device 500a further comprises a therapy-enhancing material, agent 660, such as a light-enhancing material (e.g. a photosensitizer and/or a photocatalyst); an agent configured to restore and/or cause the release of nitric oxide (e.g. N- acetylcysteine); an agent configured to increase synthesis of nitric oxide; an agent configured to increase activity of nitric oxide; and/or an agent configured to alter oxygen binding to hemoglobin.
  • agent 660 can be included in one or more components of device 500a, such as a coating applied to all or a portion of shaft 610. The coating can be configured to dissolve or otherwise migrate from shaft 610.
  • Agent 660 can be delivered by one or more components of device 500a, such as from one or more openings in shaft 610 (e.g. lumen 615 at distal end 612) and/or from an outlet in another component of shaft 10.
  • agent 660 is constructed and arranged to enhance the photodynamic effect of device 500a, such as when agent 660 is a material selected from the group consisting of: metal; protein; carbohydrate; fatty acid; a nucleic acid; a synthetic medication; antibody; ionic solution; heme group; flavin group; L- arginine; aminolaevulin; phenol; a polycarbon; and combinations of these.
  • agent 660 is a material selected from the group consisting of: metal; protein; carbohydrate; fatty acid; a nucleic acid; a synthetic medication; antibody; ionic solution; heme group; flavin group; L- arginine; aminolaevulin; phenol; a polycarbon; and combinations of these.
  • agent 660 comprises a light-enhancing material selected from the group consisting of: toluidine blue O; methylene blue; and combinations thereof.
  • the agent 660 is constructed and arranged to be activated by light delivered by device 500a, such as light delivered by one or more energy delivery elements 555.
  • One or more components of device 500a can be provided sterile, such as a sterile shaft 610.
  • One or more components of device 500a can be reusable and/or re-sterilizable.
  • shaft 610 is used in a single use on a single patient, while energy source 650 and/or one or more energy delivery elements 555 (e.g. fibers 651) are reused in multiple uses with one or more patients (e.g. when energy source 650 is operably attachable to fiber 651 and/or when fiber 651 is insertable into shaft 610).
  • device 500a in addition to one or more energy delivery elements 555, includes one or more additional components constructed and arranged to further provide phototherapy and/or thermal therapy, such as functional element 695 shown in Fig. 7.
  • Functional element 695 can be constructed and arranged to improve upon the phototherapy and/or thermal therapy that is achieved with the energy delivered by the one or more energy delivery elements 555 alone.
  • Functional element 695 is connected to conduit 696, which can comprise one or more wires, optical fibers, or other energy carrying conduits.
  • Conduit 696 travels proximally through shaft 610, and connects to a supply of energy, such as energy delivery unit 697.
  • Energy delivery unit 697 can be contained within housing 620 (as shown), or at a location external to housing 620.
  • Energy delivery unit 697 can be attached to power supply 653 or another supply of power via conduit 696.
  • Conduit 696 can comprise at least two wires, such as two wires constructed and arranged to provide power to functional element 695 to create an electromagnetic field and/or an electric current (e.g. an electromagnetic field and/or electrical field provided to tissue and/or body fluid).
  • functional element 695 comprises an element configured to deliver an electromagnetic field.
  • Functional element 695 can produce one or more of: a dynamic electromagnetic field; a static electromagnetic field; a dynamic magnetic field; a static magnetic field; a dynamic electrical field; and/or a static electrical field.
  • Functional element 695 can produce a magnetic field with a field strength between 1 milliTesla (mT) and 500 mT.
  • Functional element 695 can produce a magnetic field constructed and arranged to prevent adversely effecting one or more muscles and/or nerves.
  • functional element 695 can comprise an element configured to deliver an electric current and/or electric potential.
  • the delivered electric current and/or electric potential can be configured to cause electrolysis.
  • functional element 695 can comprise an ultrasound transducer, and the produced ultrasound waves can be configured to enhance the phototherapy and/or thermal therapy provided by device 500a.
  • Energy delivery unit 697 can provide electrical power, ultrasound signals, or other energy used to energize functional element 695.
  • Functional element 695 can be positioned on and/or in shaft 610, such as on and/or in a distal portion of shaft 610 or at distal end 612 of shaft 610.
  • functional element 695 comprises one or more elements positioned on and/or within a balloon (not shown but such as balloon 125 of Fig. 1), such that functional element 695 traverses radially from shaft 610 as the balloon is expanded.
  • functional element 695 is positioned along a majority of the length of shaft 610, or along a majority of the length of a portion of shaft 610 positioned in the patient's blood.
  • functional element 695 delivers a phototherapeutic or thermal therapeutic effect (e.g.
  • functional element 695 comprises multiple functional elements, such as multiple functional elements selected from the group consisting of: one or more electromagnetic field generating elements; one or more electric current and/or electric potential delivering elements; one or more ultrasound transducers; and combinations thereof.
  • the multiple functional elements 695 can be, singly or in combination, constructed and arranged to enhance the phototherapeutic effect and/or thermal therapeutic effect of device 500a.
  • One or more functional elements 695 comprise one or more permanent magnets.
  • functional element 695 comprises multiple permanent magnets, such as multiple permanent magnets positioned on or in shaft 610.
  • the multiple permanent magnets can be dispersed relatively uniformly along one or more portions of the length of shaft 610, such as along a full or partial circumferential portion of shaft 610, along a majority of the length of shaft 610 and/or along a majority of the length of shaft 610 which is positioned in the blood of the patient.
  • functional element 695 comprises multiple permanent magnets that are dispersed non-uniformly, such as along a distal, mid or proximal portion of shaft 610.
  • Shaft 610 includes wall 617 and central lumen 615. Positioned within wall 617 are an array of multiple optical fibers 651 (sixteen fibers 651 shown), such as optical fibers 651a or 651b of Fig. 1. Surrounding optical fibers 651 at section A-A is cladding 652. Cladding 652 is not included in the more distal portion of fibers 651 as described above. Wall 617 can include multiple lumens 618 configured to slidingly receive optical fibers 651. Also positioned within wall 617 is conduit 696 described hereabove.
  • Device 500b can be constructed and arranged to deliver phototherapy and/or thermal therapy as has been described hereabove.
  • Device 500b comprises shafts 710a-d (collectively shafts 710) with energy delivery elements 555a-d, respectively.
  • Each energy delivery element 555a-d can comprise one or more energy delivery elements, as shown, such as multiple energy delivery elements positioned along the majority of the length of each shaft 710a-d, respectively.
  • Energy delivery elements 555a-d (collectively energy delivery elements 555) can be constructed and arranged to deliver one or more various forms of energy, such as has been described hereabove.
  • Energy delivery elements 555 are operably attached to one or more energy carrying conduits, not shown but such as one or more wires or optical fibers that deliver energy to energy delivery elements 555 from energy source 750.
  • energy is delivered by energy source 750 to distribution element 761, from which energy is individually distributed to the energy delivery elements 555.
  • energy delivery elements 555 comprise light energy delivery elements.
  • energy delivery elements 555 can comprise a light source such as an LED that is attached to one or more wires that travel proximally connecting to distribution element 761 and/or energy source 750.
  • energy delivery elements 555 can comprise an optical fiber, lens or other optical component as has been described hereabove to deliver light energy.
  • the optical component can be attached to one or more optical fibers which optically attach to distribution element 761 and/or energy source 750 (e.g. a laser or other light energy source).
  • shafts 710 comprise an optical fiber that comprises one or more energy delivery elements 555 (e.g. one or more unclad portions of an optical fiber as described hereabove).
  • Control 728 comprises a user interface component that can be configured to initiate energy delivery by the multiple energy delivery elements 555 and/or modify the energy delivery provided.
  • Shafts 710a-d can be configured to be inserted individually or in multiple into one or more blood vessels of the patient, such as one or more pulmonary arteries of the patient. Shafts 710a-d can be configured to deliver phototherapy and/or thermal therapy to the blood passing through the one or more pulmonary arteries as has been described hereabove.
  • Device 500c can be constmcted and arranged to deliver phototherapy and/or thermal therapy as has been described hereabove.
  • Device 500c includes an implantable housing 820 surrounding a power supply 853.
  • power supply 853 is a rechargeable battery, such as when device 500c is configured to allow recharging of power supply 853 via a transcutaneous transfer of energy selected from the group consisting of: inductive coupling of electromagnetic waves; transmission of microwaves; transmission of ultrasound waves; and combinations of these.
  • device 500c comprises an expandable scaffold 861 configured in a stent-like configuration and inserted into blood vessel BV as shown.
  • Expandable scaffold 861 includes multiple energy delivery elements 555 configured to deliver light or other electromagnetic energy to blood passing within expandable scaffold 861.
  • expandable scaffold 861 can be positioned on the outside of blood vessel BV, and energy delivery elements 555 can be configured to deliver light or other energy through the walls of blood vessel BV to be received by the blood passing therein.
  • Energy delivery elements 555 are connected to energy source 850 via one or more cables 851, such as one or more fiber optic cables.
  • energy source 850 transmits light energy, ultrasound energy and/or mechanical energy over cable 851 to energy delivery elements 555.
  • energy source 850 comprises a light energy source, such as a light energy source delivering light of one or more wavelengths, such as one or more wavelengths between 250nm and 730nm, as has been described hereabove.
  • a light energy source delivering light of one or more wavelengths, such as one or more wavelengths between 250nm and 730nm, as has been described hereabove.
  • one or more wavelengths in the infrared and/or microwave spectrum can be applied (e.g. one or more wavelengths between 730nm and 10 cm).
  • Device 100 can be constructed and arranged to deliver one or more wavelengths of electromagnetic energy as well as modify the blood's pH (e.g. via electrolysis), such as to improve or at least alter the absorption of hemoglobin by altering the pH of hemoglobin.
  • Device 500c includes external controller 891 which includes user interface 898 and electronics module 899a.
  • Electronics module 899a comprises a wireless transmitter and one or more other electronic components for providing a user interface and controlling one or more implanted components of device 500c.
  • Implanted housing 820 surrounds electronics module 899b which comprises a wireless receiver which receives communications from external controller 891.
  • electronics module 899a and electronics module 899b are each configured as transceivers to allow two way communications between the implanted portion of device 500c and external controller 891.
  • Controller 891 can be configured to allow adjustment of energy delivered by energy source 850 to one or more energy delivery elements 555 as has been described hereabove.
  • electronics module 899a and electronics module 899b are constructed and arranged for wireless transfer of power from controller 891 to power supply 853, such as power transferred through inductive coupling and/or transcutaneous delivery of light.
  • Device 100 includes shaft 110 comprising proximal end 111 and distal end 112, as well as outer surface 113.
  • Proximal end 111 is attached to housing 120.
  • Shaft 110 can be flexible or rigid, or it can contain both flexible and rigid portions.
  • Shaft 110 can include one or more lumens, such as central lumen 115.
  • Central lumen 115 is defined by inner surface 114 of shaft 110 and is operably attachable at its proximal end to an evacuation device such as a urine bag or other fluid evacuation assembly.
  • a wall 117 of shaft 110 is positioned between inner surface 114 and outer surface 113.
  • shaft 110 includes multiple lumens, such as when device 100 comprises a multi-lumen catheter for insertion into a blood vessel (e.g. via a vascular introducer) or other body location.
  • Shaft 110 can include a generally smooth outer surface 113, and can include a relatively uniform outer profile (at least in the distal portion) between 3mm and 9mm in diameter.
  • Shaft 110 can include an anchoring and/or expanding element, such as balloon 125 positioned on a distal portion of shaft 110.
  • An anchor such as balloon 125 or other expandable element can be used to anchor shaft 110 at an internal body location such as the bladder.
  • inflation of balloon 125 can be configured to provide a function selected from the group consisting of: cooling one or more light delivery elements 155 as described herebelow; position one or more light delivery elements 155 at a minimum or target distance from tissue receiving light from the one or more light delivery elements 155.
  • Balloon 125 is typically in a radially compacted (e.g. deflated) state during insertion shaft 110 into a body lumen such as the urethra. In its deflated state, balloon 125 provides a relatively smooth outer surface preventing any trauma to the patient from light delivery element 1 5 and/or bundle 154.
  • Light delivery elements 155 can comprise one or more light delivery elements that are positioned within balloon 125 such as to transmit light radially out from balloon 125, as shown by the arrows emanating from light balloon 125. Alternatively or additionally, light delivery elements 155 can comprise one or more light delivery elements positioned on, in or within shaft 110. In some embodiments, light delivery element 155 comprises a circumferential array of LEDs or other light delivery elements. In some embodiments, light delivery element 155 comprises an LED and a lens configured to near spherically distribute light (e.g. through the majority of the surface of balloon 125). During use, light delivery element 155 can be positioned in an area of the patient to be treated (e.g.
  • Light delivery elements 155 are operably connected to the distal end of one or more energy carrying conduits, bundle 154, such as a flexible bundle of one or more optical fibers and/or electrical wires.
  • Bundle 154 can comprise one or more optical fibers including a surrounding cladding layer (as described hereabove) and/or one or more electrically conductive wires surrounded by an insulating layer.
  • Bundle 154 can comprise one or more energy carrying conduits positioned within a lumen of shaft 110, within the wall of shaft 110, and/or on the outer surface of shaft 1 10.
  • Bundle 154 can be operably connected on its proximal end to a source of power, power supply 153 such as a battery and/or capacitor electrically connected to light delivery element 155 via bundle 154.
  • Power supply 153 can be positioned outside of shaft 110 and/or housing 120 to avoid applying a load to shaft 110, such as to prevent undesired forces on shaft 110 that may lead to patient discomfort.
  • power supply 153 may be attachable to a piece of patient's clothing (e.g. a belt) and/or furniture of the patient (e.g. a bed or a chair). In some embodiments, power supply 153 is positioned within housing 120.
  • Power supply 153 can comprise a replaceable or rechargeable power supply, such as a replaceable battery or a rechargeable energy source, respectively. Power supply 153 can be attached to one or more switches or other controls, not shown but configured to allow an operator to selectively apply energy to light delivery element 155.
  • Light delivery element 155 can be configured to deliver light such as to prevent and/or reduce infection.
  • device 100 and/or light delivery element 155 can be constructed and arranged to cause a physiologic effect selected from the group consisting of: a blood temperature increase; vasodilation; an increase in local nitric oxide;
  • one or more light delivery elements 155 are constructed and arranged to deliver phototherapy, such as is described herein.
  • the light delivery elements of the present inventive concepts can comprise an element that both produces and delivers light (e.g. a light emitting diode or other light generating element) and/or these elements can simply deliver the light (e.g. a segment of exposed optical fiber or other optical element attached to a light source as described herein).
  • the light delivery elements of the present inventive concepts can include one or more optical components, such as the optical elements 157 described hereabove in reference to Fig. 1.
  • An optical element can be constructed and arranged to couple light into a light delivery element, such as a lens or other optical element positioned to couple light from bundle 154 into a light delivery element 155.
  • an optical element can be configured to distribute light from a light delivery element, such as a lens, prism or other optical element configured to distribute light in one or more desired patterns.
  • Optical elements of the present inventive concepts can comprise an optical element selected from the group consisting of: lens; ball lens; prism; diffractor; filter; mirror; optical fiber; and combinations of these.
  • light delivery element 1 5 comprises a light source constructed and arranged to deliver light through the walls of balloon 125 via power delivered by one or more electrical wires of bundle 1 4.
  • Light delivery element 155 can comprise a light source selected from the group consisting of: LED; lamp; laser; and combinations thereof.
  • Light delivery element 155 can comprise one or more organic LEDs.
  • Light delivery element 155 can comprise a ball lens or other lens configured to deliver light in any or all directions from balloon 125.
  • Light delivery element 155 can comprise one or more LEDs comprising at least one dimension (e.g. length, width and/or diameter) less than or equal to 1mm.
  • One or more light delivery elements 155 can be mounted to balloon 125 and/or shaft 110.
  • One or more light delivery elements 155 can be constructed and arranged to deliver blue light.
  • One or more light delivery elements 155 can be constructed and arranged to deliver multiple wavelengths of light.
  • Light delivery element 155 can comprise a diode or other light source configured to provide one or more wavelengths of light. Light delivery element 155 can be constructed and arranged to deliver pulsed light, such as light delivered at a duty cycle between 0.1% and 50%. Light delivery element 155 can provide light at a power of less than 100 Watts, or less than 50 Watts. In some embodiments, light delivery element 155 provides light at less than or equal to 100 Watts that is pulse- width modulated to deliver light at less than 50 Watts rms, or less than 20 Watts rms. In some embodiments, light delivery element 155 provides light at a power of at least 0.1 Watts, such as at a power between 2 Watts and 10 Watts.
  • light source 150 is configured to deliver light at a power of between l.OmW and lOOmW. In some embodiments, the light delivered by one or more light delivery elements 155 is delivered at a power between 1.0 mW and 100 mW. In some embodiments, light delivery element 155 delivers light to tissue at a power density between 1.OmW/cm 2 and 10.0mW/cm 2 .
  • Light delivery element 155 can be constructed and arranged to provide one or more wavelengths of light between 300 nanometers and 900 nanometers, such as between 400 nanometers and 750 nanometers, or between 400 and 430 nanometers. Alternatively or additionally, light delivery element 155 can be constructed and arranged to provide visible light and/or ultraviolet light. Light delivery element 155 can be constructed and arranged to deliver light at varying wavelengths, such as light provided at continuously varying wavelengths or light alternative between at least a first wavelength and a second wavelength. Light delivery element 155 can be constructed and arranged to provide light at multiple wavelengths simultaneously.
  • multiple wavelengths are provided by light delivery element 155 to enhance the bactericidal effects of device 100, such as to effect multiple forms of bacteria, such as to reduce or eliminate one or more of: Escherichia coli; Klebsiella; Pseudomonas and other gram negative intestinal bacteria; Staphylococcus aureus; Streptococcus; skin bacteria; Pneumococcus; Hamophilus; respiratory tract bacteria; or anaerobic bacteria.
  • multiple wavelengths are produced or otherwise provided by light delivery element 155 to reduce or prevent an infection resulting from one or more of: a virus; a fungus; or a parasite (e.g. malaria).
  • one or more wavelengths delivered by light delivery element 155 are based on the absorption spectra of one or more microorganisms to be treated. For example, a wavelength of approximately 405nm can be delivered to treat E Coli; a wavelength of 470nm can be delivered to treat staphylococcus; and/or a wavelength of 670nm can be delivered to treat oral Candida.
  • Light delivery element 155 can be constructed and arranged to provide light to an area (e.g. an area of urine, blood and/or other tissue) at a power density less than 500 mW/cm 2 , such as at a power density less than 250 mW/cm 2 , less than 100 mW/cm 2 , or less than 10 mW/cm 2 .
  • light delivery element 155 is constructed and arranged to deliver light at approximately 100 mW/cm 2 .
  • device 100 is constructed and arranged to deliver light to tissue at a power density of between 1.0m W/cm 2 and 10mW/cm 2 .
  • light delivery element 155 is constructed and arranged to deliver light at a level to prevent mucosal dehydration, such as pulse-width modulated light delivery configured to prevent mucosal dehydration.
  • Heating of the surrounding tissue and/or fluids can be monitored by one or more sensors of device 100, such as functional element 195 configured as a temperature sensor.
  • Functional element 195 can be positioned in or proximate balloon 125 as shown, on or in shaft 110, or at another device 100 location.
  • Functional element 195 can be operably attached to, or operably attachable to, a sensor measurement assembly (e.g. sensor measurement assembly 200 of Fig. 1), such as via one or more conduits, not shown but typically including one or more wires or optical fibers.
  • functional element 195 comprises a temperature sensor attached to a sensor measurement assembly with one or more wires such that the sensor measurement assembly can produce a temperature measurement used to regulate the light provided by light delivery element 155.
  • functional element 195 comprises one or more optical fibers which collect infrared light (e.g. from their distal end).
  • a sensor measurement assembly can comprise an infrared sensor configured to correlate the received light to a temperature. The temperature determined by the sensor measurement assembly (e.g.
  • thermocouple signal via thermocouple signal, thermistor signal, radiometric sensor signal, infrared signal or otherwise
  • thermocouple signal can be used to regulate the light delivered by light delivery element 155 in a closed loop fashion, such as to prevent or reduce mucosal dehydration and/or prevent other tissue damage as described hereabove in reference to Fig. 1.
  • the light delivery elements 155 of the present inventive concepts can be constructed and arranged to deliver infection reducing and/or preventing (e.g. bactericidal) light to tissue and/or body fluids, such as tissue and/or body fluids selected from the group consisting of: blood; bladder wall tissue; urethral wall tissue; urine; esophageal tissue; airway tissue;
  • tissue and/or body fluids selected from the group consisting of: blood; bladder wall tissue; urethral wall tissue; urine; esophageal tissue; airway tissue;
  • the light delivery elements 155 can direct light toward a skin incision, such as a skin incision through which shaft 110 passes.
  • the light delivery elements 155 can directly light toward a body fluid such as urine.
  • Device 100 can be constructed and arranged such that the light delivered by one or more light delivery elements 155 prevent, eliminate and/or reduces colonization of foreign material by bacteria, such as to prevent, eliminate and/or reduce a biofilm of bacteria.
  • the light delivered by one or more light delivery elements can be configured to treat at least one of: a virus; a fungus or a parasite.
  • Light delivery element 155 can be constructed and arranged to deliver light radially out from all or a portion of balloon 125 and/or outer surface 113 of shaft 110, such as a majority portion and/or distal portion of the outer surface 113 and/or a majority portion of balloon 125.
  • light delivery element 155 can be constructed and arranged to deliver light radially inward from all or a portion of inner surface 1 14 of shaft 110, such as a majority portion and/or distal portion of the inner surface 114.
  • a light delivery element 155 is positioned to direct light toward a skin surface, such as is described hereabove in reference to light delivery element 155d of Fig. 2.
  • bundle 154 comprises one or more optical fibers that terminate within the wall of shaft 110, such as when the material of shaft 110 has a similar refraction index as an optical fiber of bundle 154.
  • shaft 110 comprises light scattering material (e.g. titanium dioxide particles) as described herein.
  • balloon 125 is filled with fluid comprising light scattering material 158 (e.g. titanium dioxide particles) in water or other fluid, such that light delivered by bundle 154 and/or light delivery element 155 can be reflected in all directions relatively equally.
  • one or more portions of device 100 (e.g. one or more portions of the outer surface of shaft 110) comprise a light dispersing coating (e.g.
  • balloon 125 can comprise coating 128, such as a light dispersing (e.g. light scattering) coating such as titanium dioxide.
  • Coating 128 can be positioned on the outer and/or inner surfaces of balloon 125.
  • Titanium dioxide and/or another light dispersing component can be constructed and arranged to enhance hydrolysis, such as to generate oxygen radicals that enhance the bactericidal effects of the light delivered by device 100.
  • device 100 includes vanadium pentoxide as a photocatalyst.
  • Light delivery element 155, shaft 110 and/or another component of device 100 can comprise a fluorescent material, such as a material constructed and arranged to increase light dispersion.
  • the fluorescent material can be positioned at least on the outer surface 113 and/or inner surface 114 of shaft 110, such as a fluorescent coating placed upon surfaces 113 and/or 114 of shaft 110.
  • Other coatings can be included on one or more components of device 100, such as a photosensitizer constructed and arranged to be activated by light (e.g. light delivered by a light delivery element 155) to cause a bactericidal reaction.
  • Shaft 1 10 and/or balloon 125 can include one or more portions that are transparent or at least translucent (hereinafter "translucent") to one or more wavelengths of light transmitted by a light delivery element 155.
  • Shaft 110 can include a translucent portion surrounding a light delivery element 155 comprising an unclad portion of an optical fiber of bundle 1 4.
  • Balloon 125 can be constructed and arranged to be radially expanded through filling with fluid (e.g. fluid including light scattering material 158). Balloon 125 can be fluidly attached to inflation lumen 126 which travels proximally within shaft 110 and through housing 120 to terminate at inflation port 127.
  • Inflation port 127 can comprise a luer or other attachment element configured to fluidly attach to a fluid delivery device such as a syringe or fluid pump, such that balloon 125 can be expanded and/or contracted such as by a user such as a clinician, nurse, patient family member or the patient.
  • inflation port 127 is attached and/or attachable to fluid delivery assembly FDA 400 as shown.
  • Inflation port 127 can comprise one or more valves 129, such as a valve used to maintain one or more fluids in balloon 125 when FDA 400 is detached from port 127.
  • one or more valves 129 can be included within one or more inflation lumens 126 and/or within balloon 125, such as to maintain fluid within balloon 125 and/or controllably release fluid from balloon 125.
  • fluid delivered into balloon 125 e.g. via FDA 400 is used to cool one or more light delivery elements 155 positioned on or within balloon 125 or shaft 110, such as to prevent damage to tissue due to overheating.
  • the cooling fluid can be a recirculating fluid, such as a fluid recirculated into balloon 125 in a constant fashion via two lumens (e.g. a first lumen configured as a fluid delivery lumen and a second lumen configured as a fluid extraction lumen), or via a single lumen where a reciprocating delivery and extraction of fluid is performed.
  • a recirculating fluid such as a fluid recirculated into balloon 125 in a constant fashion via two lumens (e.g. a first lumen configured as a fluid delivery lumen and a second lumen configured as a fluid extraction lumen), or via a single lumen where a reciprocating delivery and extraction of fluid is performed.
  • Housing 120 can be configured as a handle for a user, such as a clinician or patient, to hold while using device 100.
  • Housing 120 can be implantable or include an implantable portion.
  • Housing 120 can comprise a first housing and a second housing separated from the first housing.
  • Housing 120 can surround one or more components including but not limited to: power supplies such as batteries; agent reservoirs such as pharmaceutical agent reservoirs; pumping mechanisms; energy delivery circuitry such as cardiac pacing or
  • defibrillating circuitry electronic processing circuitry; electronic memory circuitry; and combinations of these.
  • device 100 comprises a device selected from the group consisting of: urine removal catheter; vascular access device; central venous catheter;
  • peripherally inserted central catheter such as a peripherally inserted venous catheter
  • cerebrospinal fluid catheter ventriculoperitoneal shunt; insulin pump; implanted device;
  • implanted drug or other agent delivery pump pacemaker; drive shaft assembly for a cardiac assist device; inflow and/or outflow cannula for a cardiac assist device; neurostimulator; artificial heart; drainage catheter; colostomy tube; and combinations of these.
  • shaft 110 is constructed and arranged for insertion through an incision of the skin, such as when shaft 110 is further inserted into a blood vessel, organ, and/or a subcutaneous tissue tunnel.
  • distal end 112 of shaft 110 is inserted into a blood vessel such that blood can be removed via lumen 115 and/or one or more agents can be delivered to an internal body location (e.g. into the cardiovascular system of the patient) via lumen 115.
  • housing 120 can include a luer or other attachment element configured to add or remove fluids via lumen 115, such as when device 100 comprises a central venous catheter or peripherally inserted central catheter.
  • shaft 110 is inserted through an incision in the skin and into the bladder, such as when device 100 is configured as a suprapubic bladder catheter. In some embodiments, shaft 110 is inserted through the skin and into an organ such as the kidney or into the ureter, such as when device 100 is configured as a urethral and/or nephrostomy catheter. In some embodiments, device 100 is configured as a colostomy tube inserted through the abdomen, such as to provide access to the intestine or colon. Alternatively, device 100 can comprise an external (i.e. non- implanted) drug delivery pump, such as a skin-attached or other external drug delivery device in which shaft 110 comprises a transcutaneous conduit (e.g.
  • housing 120 can include a pumping mechanism, not shown but described hereabove in reference to Figs. 4 and 4A.
  • the agent delivered comprises , an agent selected from the group consisting of: insulin; a chemotherapeutic agent; a nutritional material; a pain control agent such as morphine; and combinations thereof.
  • shaft 110 is constructed and arranged for insertion into a natural body orifice, such as urethra; mouth; anus; vagina; nostril; ear hole; eye socket; and combinations of these.
  • Device 100 can be constructed and arranged to prevent urinary tract infections.
  • Shaft 110 can be constructed and arranged for insertion into the urethra and/or for insertion in the bladder, such as to support evacuation of urine from the patient.
  • one or more light delivery elements 155 are constructed and arranged to deliver light to a bladder, such as to a majority of the cavity of the bladder, such as to deliver light to the majority of urine in the bladder.
  • one or more light delivery elements 155 can be constructed and arranged to deliver light to all or a portion of the urethra, such as to deliver light to all or a portion of the urine present in the urethra during light delivery.
  • light delivery element 155 is constructed and arranged to deliver light to a majority of the cavity of the bladder, and one or more light delivery elements 155 is constructed and arranged to deliver light to at least a distal portion of the urethra.
  • the total light delivered to the bladder is more than the total light delivered to the urethra.
  • the light delivered per area of the bladder and the urethra is approximately equal, such as at an amount less than or equal to 500 mW/cm 2 , or less than or equal to 250 mW/cm 2 , or less than or equal to 100 mW/cm 2 .
  • device 100 is constructed and arranged to deliver light to tissue (e.g. the bladder and/or urethra) at a power density of between 1.0m W/cm 2 and 10mW/cm 2 .
  • the light provided by light delivery element 155 can be constructed and arranged to have a bactericidal effect, such as to reduce or prevent bacterial colonization, such as to reduce and/or prevent infection.
  • the light provided light delivery element 155 can be constructed and arranged to treat one or more of: a virus; a fungus or a parasite.
  • shaft 110 and housing 120 are constructed and arranged for implantation into the patient, such that light delivery element 155 can deliver light to an internal location within the patient to prevent and/or reduce infection at one or more locations surrounding shaft 110.
  • Shaft 110 can be constructed and arranged for insertion through a subcutaneous tissue tunnel or other internal body location.
  • Distal end 112 can be constructed and arranged for insertion into a blood vessel, a ventricle of the brain, a portion of the cerebrospinal fluid space, a joint capsule, a chamber of the heart, or other location, such as to provide a fluid conduit and/or to provide an electrical wire or optical fiber for a therapeutic apphcation.
  • Device 100 can comprise an implanted portion configured to deliver energy to one or more internal locations of a patient, such as to deliver energy to an organ such as a heart or brain.
  • shaft 110 can include one or more conductors (e.g. within lumen 115) attached to an energy delivery unit within housing 120, such as the conductors and energy delivery unit described hereabove in reference to Figs. 5 and 5A.
  • device 100 can comprise an implanted portion configured to deliver a pharmaceutical agent or other agent systemically and/or locally to an internal location of the patient, such as to deliver an agent systemically or locally within the patient.
  • the delivered agent can be configured to improve the phototherapeutic effect of light delivered by one or more light delivery elements 155.
  • an implanted housing 120 can surround a drug reservoir and pumping means which deliver an agent to lumen 115 of shaft 110, drug reservoir and pumping means not shown but described in detail hereabove in reference to Figs. 5 and 5A.
  • device 100 further comprises a therapy-enhancing material, agent 160, such as a light-enhancing material (e.g. a photosensitizer and/or a photocatalyst); an agent configured to restore and/or cause the release of nitric oxide (e.g. N- acetylcysteine); an agent configured to increase synthesis of nitric oxide; an agent configured to increase activity of nitric oxide; and/or an agent configured to alter oxygen binding to hemoglobin.
  • a therapy-enhancing material agent 160
  • agent 160 such as a light-enhancing material (e.g. a photosensitizer and/or a photocatalyst)
  • an agent configured to restore and/or cause the release of nitric oxide e.g. N- ace
  • Agent 160 can be included in one or more components of device 100, such as a coating applied to all or a portion of shaft 110 and/or balloon 125.
  • the coating can be configured to dissolve or otherwise migrate from shaft 1 10 and/or balloon 125.
  • Agent 160 can be delivered by one or more components of device 100, such as through balloon 125 when balloon 125 comprises a porous balloon, from one or more openings in shaft 1 10 (e.g. lumen 115 at distal end 112) and/or from an outlet in another component of shaft 110.
  • agent 160 comprises a light-enhancing material selected from the group consisting of: toluidine blue O; methylene blue; and combinations thereof.
  • agent 160 is constructed and arranged to be activated by light delivered by device 100, such as light delivered by one or more light delivery elements 1 5.
  • One or more components of device 100 can be provided sterile, such as a sterile shaft 110.
  • One or more components of device 100 can be reusable and/or re-sterilizable.
  • shaft 110 is used in a single use on a single patient, while light delivery element 155 and/or bundle 154 are reused in multiple uses with one or more patients (e.g. when bundle 154 and/or light delivery element 155 is insertable into shaft 110).
  • device 100 in addition to one or more light delivery elements 155, includes one or more additional components constructed and arranged to further prevent and/or further reduce infection, such as functional element 195 shown in Fig. 12.
  • Functional element 195 can be constructed and arranged to improve upon the infection prevention and/or reduction than that which is achieved with the light delivered by the one or more light delivery elements 155 alone.
  • Functional element 195 is connected to a conduit, not shown but configured similar to conduit 196 described hereabove in reference to Fig. 1.
  • functional element 195 comprises an element configured to deliver an electromagnetic field.
  • Functional element 195 can produce one or more of: a dynamic electromagnetic field; a static electromagnetic field; a dynamic magnetic field; a static magnetic field; a dynamic electrical field; and/or a static electrical field.
  • Functional element 195 can produce a magnetic field with a field strength between 1 milliTesla (mT) and 500 mT.
  • Functional element 195 can produce a magnetic field constructed and arranged to prevent adversely effecting one or more muscles and/or nerves.
  • functional element 195 can comprise an element configured to deliver an electric current and/or electric potential.
  • the delivered electric current and/or electric potential can be configured to cause electrolysis and/or otherwise modify the pH of blood or other body fluid.
  • functional element 195 can comprise an ultrasound transducer, and the produced ultrasound waves can be configured to prevent (e.g. further prevent) or reduce (e.g. further reduce) an infection.
  • Functional element 195 can be attached to an energy delivery unit, such as energy delivery unit 197 described hereabove in reference to Fig. 1. Delivery of ultrasound by functional element 195 can be configured to dissolve a biofilm, such as with a mechanical disruption action. Transmission of ultrasound waves across balloon 125 (and liquid including , light scattering material 158) can improve dispersion of the ultrasound waves, similar to ultrasonic waves used to clean jewelry.
  • Functional element 195 can be positioned on and/or in shaft 110 and/or on or within balloon 125 as shown in Fig. 12.
  • functional element 195 comprises one or more elements positioned on and/or within balloon 125, such that functional element 195 traverses radially from shaft 110 as balloon 125 is expanded, such as when balloon 125 is expanded within a bladder to anchor shaft 1 10 in the bladder.
  • functional element 195 is positioned along a majority of the length of shaft 110, or along a majority of the length of a portion of shaft 110 positioned under the patient's skin.
  • functional element 195 delivers an anti-infection effect (e.g.
  • functional element 195 comprises multiple functional elements, such as multiple functional elements selected from the group consisting of: one or more electromagnetic field generating elements; one or more electric current and/or electric potential delivering elements; one or more ultrasound transducers; one or more electrodes; one or more heating elements such as one or more heating elements configured to raise the temperature of blood; one or more cooling elements such as one or more cooling elements configured to lower the temperature of blood; and combinations thereof.
  • the multiple functional elements 195 can be, singly or in combination, constructed and arranged to at least one of further prevent or further reduce infection.
  • One or more functional elements 195 can comprise one or more permanent magnets.
  • functional element 195 comprises multiple permanent magnets, such as multiple permanent magnets positioned on or in shaft 110 and/or on or in balloon 125.
  • the multiple permanent magnets can be dispersed relatively uniformly along one or more portions of the length of shaft 110, such as along a full or partial circumferential portion of shaft 110, along a majority of the length of shaft 110 and/or along a majority of the length of shaft 110 which is inserted into the patient.
  • functional element 195 comprises multiple permanent magnets that are dispersed non-uniformly, such as when a higher density of magnets are positioned within and/or proximate to balloon 125 than along a more proximal portion of shaft 110.
  • one or more functional elements 195 of device 100 are constructed and arranged to at least one of prevent or reduce infection, with or without the inclusion of one or more light delivery elements 155. In these embodiments, one or more light delivery elements 155 can be included to at least one of further prevent or further reduce infection.
  • Device 100 comprises external portion 901 and catheter 905.
  • External portion 901 can comprise a housing surrounding battery 153 which is electrically connected to power converter 902 via wire 903a.
  • Battery 153 can be of similar construction and arrangement to power supply 153 described hereabove in reference to Fig. 1.
  • Power converter 902 is electrically connected to connector 904 via wire 903b.
  • Power converter 902 can be configured to convert an input voltage to a different output voltage, to limit current and ⁇ or to provide another power delivery function.
  • power converter 902 is configured to provide a constant current and/or a constant voltage to light delivery element 155 and/or another component of catheter 905 and/or device 100. In some embodiments, power converter 902 is configured to limit the voltage supplied to light delivery element 155 and/or to limit the current supplied to light delivery element 155. In some embodiments, power converter 902 is configured to provide constant voltage and/or current to light delivery element 155 while the voltage and/or current provided to power converter 902 by battery 153 varies, such that the energy level of light provided by light delivery element 155 is relatively constant over time. Power converter 902 can be configured to produce an output voltage between 1.5 V and 20V, such as an output voltage of approximately 3.3V.
  • Light energy delivered by light delivery element 155 can represent a portion of the power supplied by power converter 902, such as when the light energy delivered equates to between 1% and 5% of the energy supplied by power converter 902, such as when the remainder of the energy is converted to heat.
  • light deliver)'' element 155 can be cooled by a cooling element 909.
  • Cooling element 909 can comprise fluid surrounding light delivery element 155 (e.g. fluid contained within a balloon such as has been described herein), a silicone member or other flexible material surround light delivery element 155 and/or a metal or other heat sink (e.g. a wire) from which heat can be dissipated away from light delivery element 155.
  • light delivery element 155 delivers between lmW and 200mW of light energy.
  • Battery 153 can comprise a voltage between 1.5V and 30V, and can include multiple batteries connected in series and/or in parallel (e.g. four approximately 1 ,2V batteries connected in series). In some embodiments, battery 153 comprises one or more 9V batteries. Battery 153 can comprise one or more batteries, such as one or more batteries configured to provide approximately between 0.5 Ah and 20 Ah of energy. Battery 153 can comprise one or more rechargeable batteries. Power converter 902 can be configured to provide a maximum amount of current, such as a maximum current of 1000mA.
  • Catheter 905 comprises a light delivery element 155, such as a light delivery element 1 5 positioned within an expandable balloon and configured to prevent arid/or reduce infection, such as is described herein.
  • Light delivery element 155 can be of similar construction and arrangement to light delivery element 155 of Figs. 1, 2, 3, 4, 5A. 6 and/or 12 and/or light delivery element 555 of Figs. 7, 10 and/or 11.
  • Light delivery element 155 electrically attaches to connector 905 via wire 907.
  • Connector 904 can comprise a male and/or female connector (e.g. including one or more male or female connecting portions) configured to electrically attach to a mating connector 906 of catheter 905, such that energy provided by battery 153 and converted by power converter 902 can be delivered to light delivery element 155, through connections made between connector 904 and connector 906.
  • device 100 includes an element configured to alert an operator (e.g. a clinician and/or the patient) that light delivery element 155 is delivering light, such as indicator 908 shown.
  • Indicator 908 can comprise a visible light LED or other visible indicator that changes status (e.g. turns on) when light delivery element 155 begins delivering light.
  • the devices of the present inventive concepts include one or more light or other energy delivery elements constructed and arranged to deliver light or other energy.
  • Energy delivery can be configured to provide phototherapy and/or thermal therapy.
  • Energy delivery can be configured to reduce or prevent infection, such as by delivering light with a bactericidal effect, or by delivering light to treat one or more of: a virus; a fungus; or a parasite (e.g. malaria).
  • the energy delivery elements can include a source of light (e.g. an LED) and/or they can be attached to a source of light (e.g. attached to a laser, LED or other light source via an optical fiber).
  • Light can be delivered from the light source in a continuous or pulsed (e.g. pulse-width modulated) manner.
  • the light source can provide light configured to have bactericidal effects on one or more forms of bacteria, such as bacteria selected from the group consisting of: Escherichia coli; Klebsiella; Pseudomonas and other gram negative intestinal bacteria; Staphylococcus aureus; Streptococcus; a skin bacteria; Pneumococcus; Hemophilus; a respiratory tract bacteria;
  • bacteria selected from the group consisting of: Escherichia coli; Klebsiella; Pseudomonas and other gram negative intestinal bacteria; Staphylococcus aureus; Streptococcus; a skin bacteria; Pneumococcus; Hemophilus; a respiratory tract bacteria;
  • the light source can produce or otherwise provide light configured to reduce or prevent an infection resulting from one or more of: a virus; a fungus; or a parasite (e.g. malaria). Delivery of light from the light source can be performed in a closed-loop fashion, such as when a device of the present inventive concepts includes at least one sensor such as a temperature sensor, and light is delivered based on one or more
  • Light can be delivered from a light delivery element in a symmetric or asymmetric pattern.
  • the light can be delivered to tissue and/or body fluids, such as tissue and/or body fluids selected from the group consisting of: blood; bladder wall tissue; urethral wall tissue; urine; esophageal tissue; airway tissue; subcutaneous tissue; vascular wall tissue; cardiac valve tissue; cerebrospinal fluid; meningeal tissue; synovial fluid; and combinations of these.
  • Light can be delivered to one or more light deliver ⁇ ' elements via an optical fiber, such as via multiple optical fibers that each travel distally from the proximal end of the device to a different light delivery element, or a single optical fiber that travels distally and proximally (i.e.
  • the light delivery elements can comprise one or more optical components, such as an optical component selected from the group consisting of: optical fiber; lens; ball lens; prism; diffractor; filter; mirror; and combinations of these.
  • the light delivery element comprises a ball lens positioned at the end of an optical fiber.
  • one or more light delivery elements include light scattering material configured to scatter light produced by or delivered to the light delivery element.
  • one or more light delivery elements are rotated, such as by rotating an optical fiber.
  • the devices of the present inventive concepts can include one or more shafts configured for insertion into the body of a patient, such as via being implanted within the patient, being inserted through an incision of the patient or being inserted into a natural orifice such as the urethra.
  • the shafts can be flexible, rigid, or include both flexible and rigid portions.
  • the shafts can include one or more lumens, such as one or more lumens comprising an opening constructed and arranged to withdraw blood or other body fluids and/or deliver one or more agents to an internal body location.
  • the lumens can be filled with material, such as one or more conduits comprising one or more wires, optical fibers and/or other conduits.
  • the devices of the present inventive concepts can include one or more additional components constructed and arranged to further prevent and/or further reduce infection, such as a functional element configured to deliver an electric current and/or electric potential, an electromagnetic field and/or ultrasound waves.
  • the devices of the present inventive concepts can include one or more single use components (e.g. a single use shaft) and/or one or more reusable components (e.g. a single use light source).
  • the light and/or energy delivery devices of the present inventive concepts can be constructed for short-term clinical use with the patient (e.g. use for less than 16 hours, less than 24 hours, less than 3 days or less than 7 days), or for long-term clinical use (e.g. use for at least 1 week, at least 1 month, at least 3 months or at least 6 months).
  • the light and/or other energy delivery elements of the present inventive concepts can be constructed and arranged to deliver light (e.g. in a continuous or pulsed, intermittent manner) to reduce and/or prevent infection for short durations of time (e.g.
  • one or more energy delivery elements are constructed and arranged to deliver light for or at least 6 months, such as when the one or more energy delivery elements are implanted in the patient.
  • the energy delivery elements of the present inventive concepts can be constructed and arranged to be implanted within the patient, remain outside the patient's skin, or pass through the patient's skin via an incision or natural body orifice.
  • a device is inserted into a patient, such as a device of similar construction and arrangement as device 100, 500a and/or 500b described herein.
  • the device can include a shaft (e.g. a flexible shaft) that is inserted into a natural body orifice (e.g. via the penis, vagina, ear, nose or mouth).
  • the device can be inserted by the patient, a family member or a caregiver (e.g. a clinician or nurse).
  • the shaft can be inserted through an incision in the skin and into a body conduit (e.g. percutaneously inserted into an artery or vein).
  • the device can be inserted by a clinician.
  • the inserted device comprises a urinary catheter configured to be advanced into the bladder of a male or female patient.
  • Step 1420 light is delivered by a light delivery element positioned on, in and/or within the flexible shaft, as is described herein.
  • Light can be delivered to prevent or at least reduce infection.
  • light can be delivered to cause a physiologic effect selected from the group consisting of: a blood temperature increase; vasodilation; an increase in local nitric oxide; an increase in synthesis of nitric oxide; enhanced nitric oxide release from the vascular endothelium and/or smooth muscle cells; prolonged local nitric oxide effects; an alteration in the function of erythrocytes; a modification in oxygen release from hemoglobin; a facilitation of release of carbon monoxide from hemoglobin; a modification in pH of blood; a modulation in the immune response of blood leucocytes; a modulation of the coagulation and/or thrombocyte function; a modification in the function of heme catalyst enzymes in the blood; a modification in hormonal action of a peptide and
  • Delivered light can comprise a single frequency of light or multiple frequencies of light. Multiple frequencies of light can be delivered simultaneously or sequentially.
  • the light delivered by the light delivery element is adjusted (e.g. repeatedly adjusted), such as an adjustment to one or more delivered light parameters selected from the group consisting of: frequency; wavelength; intensity; proportion of a first frequency relative to a second frequency; a pulse-width modulation parameter; a duty cycle parameter; and combinations of one or more of these.
  • intensity of light delivered is decreased to zero (e.g. turned off such that no light is delivered) or at least reduced, to prevent damage to tissue (e.g. a decrease based on a sensor signal related to tissue damage as described herein).
  • intensity of light delivered is increased, such as to enhance prevention of an infection (e.g.
  • delivered light is adjusted (e.g. intensity reduced and/or wavelengths changed) to prevent growth of bacteria (e.g. light-resistant bacteria or other bacteria whose growth may be enhanced by the delivery of one or more wavelengths of light).
  • the adjustments to light delivered e.g. intensity
  • one or more delivered light parameters are temporally adjusted, such as a temporal adjustment made after similar or dissimilar time periods. Temporal adjustments can be made at least every 2 days, or at least every 12 hours, or at least every 1 hour, or at least every 15 minutes, or at least every 1 minute. Alternatively or additionally, one or more delivered light parameters can be adjusted based on a sensor signal (e.g. a signal produced by sensor 119 described herein), such as in a closed-loop configuration of light delivery.
  • a sensor signal e.g. a signal produced by sensor 119 described herein
  • Delivered light can be adjusted (e.g. repeatedly adjusted) to enhance the prevention of an infection and/or to prevent an undesired effect of the delivered light (e.g. to prevent tissue damage such as to prevent damage to bladder mucosal tissue).
  • Delivery of light by device 100 can be adjusted based on a signal produced by a sensor, such as one or more of the sensors described herein.
  • the signal is provided by one or more sensors selected from the group consisting of: physiologic sensor; oxygen sensor; temperature sensor; blood pressure sensor; impedance sensor; electrical sensor; and combinations thereof.
  • device 100 adjusts the delivery of light (e.g. based on a signal from one or more sensors), in order to optimize effect on blood circulation and/or oxygen unloading. Adjustment of light delivery can include modification of one or more wavelengths of light delivered, modification of amplitude of light delivered and/or modification of pulse- width of light delivered.
  • one or more wavelengths of delivered light are repeatedly modified (e.g. repeated at intervals of minutes, to hours, to days), such as to enhance the bactericidal effect of the delivered light when treating one or more forms of bacteria (e.g. yeast) which are sensitive to multiple wavelengths of light.
  • one or more forms of bacteria e.g. yeast
  • Step 1440 the device is removed from the patient.
  • FIG. 15 an anatomical sectional view of a device including a light delivery element positioned in a pulmonary artery and configured to treat carbon monoxide poisoning is illustrated, consistent with the present inventive concepts.
  • Carbon monoxide poisoning is a serious problem accounting for more than 50,000 emergency room cases annually in the U.S. alone.
  • Current therapy is delivery of oxygen to the patient (e.g. hyperventilation).
  • the devices of the present inventive concepts can be configured to provide an enhanced therapeutic option for patients suffering from carbon monoxide poisoning (e.g. by
  • Device lOOco of Fig. 15 comprises shaft 110 which includes proximal end 111 and distal end 112. A portion of shaft 110, including at least distal end 112, can be constructed and arranged for insertion into a blood vessel or other internal anatomical location of a patient. Proximal end 111 is operably attached to housing 120. Positioned on a distal portion of shaft 110 (i.e. proximate distal end 112) is light delivery element 155.
  • Device lOOco includes source 150 (e.g. a light source or power supply), which can be positioned in housing 120 as shown. Source 150 can be of similar construction and arrangement to light source 150 described hereabove.
  • Source 150 can be operably attached to fiber 151 which extends through shaft 110 to operably (e.g. optically) attach to light delivery element 155.
  • Device lOOco can include sensor 119, which can be of similar construction and arrangement to sensors 1 19a and/or 119b described hereabove in reference to Fig. 1.
  • Sensor 119 can be positioned proximate light delivery element 155 as shown.
  • at least a portion of sensor 119 is positioned at a location of device 100 that is located outside of the patient's body, such as when sensor 119 is connected to a conduit that is optically connected to a light collection element in the distal portion of device 100, as described hereabove in reference to sensor 119b, conduit 199 and light collection element 198 of Fig. 1.
  • Device lOOco of Fig. 15 can be of similar construction and arrangement and can include one or more similar components to one or more devices 100, 500a and/or 500b described hereabove (e.g. device 100 of Fig. 1).
  • Light delivered by device 1 OOco can be configured to enhance the dissociation of hemoglobin and carbon monoxide (photodissociation), and can be more than five times or more than ten times as effective as oxygen therapy (e.g. hyperventilation).
  • device lOOco can be configured to deliver light comprising at least one wavelength between 500nm and 800nm, such as a light comprising at least one wavelength of approximately 678nm.
  • the light can be delivered to blood of the patient (e.g. blood within a pulmonary artery or other cardiovascular location such as an artery, vein and/or chamber of the heart), such as to unbind carbon monoxide from hemoglobin.
  • distal end 112 and light delivery element 155 are constructed and arranged to be advanced into a patient location selected from the group consisting of: a pulmonary artery; a caval vein; the right atrium; the right ventricle; and combinations thereof.
  • light delivery element 155 can deliver light to these locations or locations proximate these locations, such as to treat CO poisoning or another disease or disorder.
  • the light delivered by device 100 is set and/or adjusted based on one or more signals provided by the one or more sensors of sensor 1 19.
  • Device lOOco can include a guidewire (e.g. a standard cardiovascular guidewire), and shaft 110 can be configured to be advanced over guidewire 130 (e.g. via a lumen extending through at least a portion of shaft 1 10),
  • guidewire 130 e.g. via a lumen extending through at least a portion of shaft 1 10
  • shaft 1 10 has been inserted into a patient over guidewire 130 such that light delivery element 155 is positioned within a pulmonary artery of the patient (e.g. shaft 110 and guidewire 130 are positioned within the right atrium, into the right ventricle and then into a pulmonary artery).
  • device 1 OOco can be configured to deliver light to treat carbon monoxide poisoning.
  • Light delivery element 155 can comprise one or more light delivery elements as described herein.
  • light delivery element 155 comprises an optical component (e.g. a surface at the end of an optical fiber, lens, prism and/or mirror) optically connected to source 150 via fiber 151.
  • light delivery element 155 comprises a light emitting device, such as a lamp or light emitting diode, such as when source 150 comprises a power supply and fiber 151 comprises one or more wires electrically coupled to light emitting device 155, such that source 150 can be configured to provide power (e.g.
  • At least a portion of light delivery element 155 can be positioned proximate the distal end 1 12 of shaft 110 (as shown in Fig. 15).
  • at least a portion of light delivery element 155 e.g. an LED, laser or other light source
  • Device 1 OOco can be configured to adjust the light delivered by light delivery element 1 5 (e.g. adjust the light provided by source 150), as described hereabove in reference to Fig. 14.
  • light delivered by light delivery element 1 5 can be periodically adjusted (e.g. periodically turned off or at least reduced in intensity, periodic increased in intensity, periodic changes in wavelengths of light delivered, etc).
  • light delivered by light delivery element 155 can be adjusted (e.g. a modification of duration, pulsing, intensity and/or wavelengths of light delivered) based on a signal provided by sensor 119 (e.g. as determined by an algorithm of sensor measurement assembly 200 described hereabove).
  • carbon monoxide treatment device lOOco comprises an alert element (e.g. alert element 201) described hereabove, and device lOOco is configured to activate the alert element when an undesired level of treatment is determined based on the signal provided by sensor 119.
  • device lOOco is configured to treat carbon monoxide poisoning by having light delivery element 155 deliver light comprising at least one wavelength between 300nm and 700nm, between 400nm and 700nm, between 500nm and 700nm, or between 530nm and 590nm.
  • device lOOco e.g. light delivery element 155
  • intensity of light delivered by light delivery element 155 is optimized (e.g. relatively maximized) based on feedback received from sensor 119, such as a temperature sensor, oxj'gen sensor, electrical conductivity sensor and/or other sensor.
  • sensor 1 19 can produce a signal relating to one or more of: temperature (e.g. temperature of neighboring blood and/or temperature of a portion of device lOOco, to prevent overheating of blood or other tissue); electrical conductivity (e.g. to electrical conductivity of neighboring blood to prevent undesired coagulation of blood); oxygen saturation or other oxygen parameter; another physiologic parameter of the patient; and/or a device lOOco parameter.
  • temperature e.g. temperature of neighboring blood and/or temperature of a portion of device lOOco, to prevent overheating of blood or other tissue
  • electrical conductivity e.g. to electrical conductivity of neighboring blood to prevent undesired coagulation of blood
  • oxygen saturation or other oxygen parameter e.g. to oxygen saturation or other oxygen parameter
  • another physiologic parameter of the patient e.g., a device lOOco parameter.
  • light delivery element 155 delivers light at a power of at least lOOmW. In some embodiments, light delivery element 155 delivers
  • light delivery element 155 is configured to deliver light providing a radiant exposure (e.g. to the blood receiving the delivered light) with a minimum of 0.05 joules/cm 2 to 0.1 joules/cm 2 . In some embodiments, light delivery element 155 is configured to deliver light providing a radiant exposure between 1 joules/cm 2 to 20 joules/cm 2 .
  • the light delivered by light delivery element 155 can comprise one or more wavelengths, and can be delivered in a continuous or pulsed manner (e.g.
  • pulsed light delivered with a pulse frequency between 0.5Hz and 100Hz).
  • pulsed light is delivered with a pulse duration (e.g. "on time") between 1msec and 1000msec, between 50msec and 150msec, or between 50msec and 550msec.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

L'invention concerne un dispositif destiné à être inséré dans le corps d'un patient mammifère, qui comprend une tige et un élément d'émission de lumière. L'arbre comprend une extrémité proximale et une extrémité distale, et l'élément d'émission de lumière est positionné à proximité de l'extrémité distale de l'arbre. Le dispositif est configuré pour régler de manière répétée la lumière émise par les éléments de distribution d'émission de lumière. L'invention concerne également des dispositifs et des procédés pour le traitement de l'empoisonnement au monoxyde de carbone.
PCT/US2016/057614 2015-10-19 2016-10-19 Dispositifs pour l'émission de lumière thérapeutique réglée de manière répétée et dispositifs pour le traitement de l'empoisonnement au monoxyde de carbone WO2017070155A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562243302P 2015-10-19 2015-10-19
US62/243,302 2015-10-19

Publications (1)

Publication Number Publication Date
WO2017070155A1 true WO2017070155A1 (fr) 2017-04-27

Family

ID=58558012

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/057614 WO2017070155A1 (fr) 2015-10-19 2016-10-19 Dispositifs pour l'émission de lumière thérapeutique réglée de manière répétée et dispositifs pour le traitement de l'empoisonnement au monoxyde de carbone

Country Status (1)

Country Link
WO (1) WO2017070155A1 (fr)

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180140863A1 (en) * 2015-05-18 2018-05-24 The General Hospital Corporation System and method for phototherapy for preventing or treating carbon monoxide poisoning
WO2020084199A1 (fr) * 2018-10-26 2020-04-30 Koite Health Oy Procédés de traitement de surfaces biologiques
EP3884998A1 (fr) * 2020-03-26 2021-09-29 Oscor Inc. Système et procédé d'utilisation de la thérapie par lumière ultraviolette endobronchique pour traiter des patients infectés par le coronavirus covid-19, sars-cov-2
US11147984B2 (en) 2020-03-19 2021-10-19 Know Bio, Llc Illumination devices for inducing biological effects
WO2022051394A1 (fr) * 2020-09-04 2022-03-10 Covidien Lp Surveillance d'une insuffisance rénale aiguë
US11524173B2 (en) 2015-07-28 2022-12-13 Know Bio, Llc Systems and methods for phototherapeutic modulation of nitric oxide
US11654294B2 (en) 2021-03-15 2023-05-23 Know Bio, Llc Intranasal illumination devices
EP4223365A1 (fr) * 2022-02-08 2023-08-09 Uvisa Health ApS Dispositif de transmission de lumière dans une cavité corporelle
US11864893B2 (en) 2020-09-04 2024-01-09 Covidien Lp Oxygen sensor calibration
CN117379112A (zh) * 2023-12-12 2024-01-12 南京医科大学 一种尿液厌氧采集培养一体化装置
EP4138997A4 (fr) * 2020-04-20 2024-04-24 Cern Corp. Dispositifs de thérapie vaginale par lumière et procédés d'utilisation correspondants
US11986666B2 (en) 2020-03-19 2024-05-21 Know Bio, Llc Illumination devices for inducing biological effects
US12011611B2 (en) 2020-03-19 2024-06-18 Know Bio, Llc Illumination devices for inducing biological effects
US12029914B2 (en) 2015-07-28 2024-07-09 Know Bio, Llc Phototherapeutic light for treatment of pathogens
US12115384B2 (en) 2021-03-15 2024-10-15 Know Bio, Llc Devices and methods for illuminating tissue to induce biological effects
WO2024243294A1 (fr) * 2023-05-25 2024-11-28 Hollister Incorporated Produit de cathéter luminescent dans l'obscurité

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070129613A1 (en) * 2003-11-18 2007-06-07 Qinetiq Limited Flexible light sources and detectors and applications thereof
US20130101464A1 (en) * 2011-02-12 2013-04-25 Mark S. Smyczynski Extracorporeal photodynamic blood illumination (irradiation) for the treatment of carbon monoxide poisoning
CA2930090A1 (fr) * 2013-11-14 2015-05-21 St. Marianna University School Of Medicine Dispositif de resolution d'un empoisonnement au monoxyde de carbone, gaine pour traitement d'un empoisonnement au monoxyde de carbone dotee dudit dispositif, et catheter pour traitement d'un empoisonnement au monoxyde de carbone

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070129613A1 (en) * 2003-11-18 2007-06-07 Qinetiq Limited Flexible light sources and detectors and applications thereof
US20130101464A1 (en) * 2011-02-12 2013-04-25 Mark S. Smyczynski Extracorporeal photodynamic blood illumination (irradiation) for the treatment of carbon monoxide poisoning
CA2930090A1 (fr) * 2013-11-14 2015-05-21 St. Marianna University School Of Medicine Dispositif de resolution d'un empoisonnement au monoxyde de carbone, gaine pour traitement d'un empoisonnement au monoxyde de carbone dotee dudit dispositif, et catheter pour traitement d'un empoisonnement au monoxyde de carbone

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10953236B2 (en) * 2015-05-18 2021-03-23 The General Hospital Corporation System and method for phototherapy for preventing or treating carbon monoxide poisoning
US11826580B2 (en) 2015-05-18 2023-11-28 The General Hospital Corporation System and method for phototherapy for preventing or treating carbon monoxide poisoning
US20180140863A1 (en) * 2015-05-18 2018-05-24 The General Hospital Corporation System and method for phototherapy for preventing or treating carbon monoxide poisoning
US12029914B2 (en) 2015-07-28 2024-07-09 Know Bio, Llc Phototherapeutic light for treatment of pathogens
US12109429B2 (en) 2015-07-28 2024-10-08 Know Bio, Llc Phototherapeutic light for treatment of pathogens
US11524173B2 (en) 2015-07-28 2022-12-13 Know Bio, Llc Systems and methods for phototherapeutic modulation of nitric oxide
US12179035B2 (en) 2015-07-28 2024-12-31 Know Bio, Llc Phototherapeutic light for treatment of pathogens
US11617895B2 (en) 2015-07-28 2023-04-04 Know Bio, Llc Systems and methods for phototherapeutic modulation of nitric oxide
US12263349B2 (en) 2018-10-26 2025-04-01 Koite Health Oy Method of treatment of biological surfaces
WO2020084199A1 (fr) * 2018-10-26 2020-04-30 Koite Health Oy Procédés de traitement de surfaces biologiques
CN113423464A (zh) * 2018-10-26 2021-09-21 科伊特健康有限公司 处理生物表面的方法
US11752359B2 (en) 2020-03-19 2023-09-12 Know Bio, Llc Illumination devices for inducing biological effects
US11684798B2 (en) 2020-03-19 2023-06-27 Know Bio, Llc Illumination devices for inducing biological effects
US11147984B2 (en) 2020-03-19 2021-10-19 Know Bio, Llc Illumination devices for inducing biological effects
US12011611B2 (en) 2020-03-19 2024-06-18 Know Bio, Llc Illumination devices for inducing biological effects
US11986666B2 (en) 2020-03-19 2024-05-21 Know Bio, Llc Illumination devices for inducing biological effects
US11590358B2 (en) 2020-03-26 2023-02-28 Osypka Technologies Llc System and method of using endobronchial ultraviolet light therapy to treat patients infected with COVID-19 coronavirus, SARS, CoV-2
US20210299467A1 (en) * 2020-03-26 2021-09-30 Oscor Inc. System and method of using endobronchial ultraviolet light therapy to treat patients infected with covid-19 coronavirus, sars, cov-2
EP3884998A1 (fr) * 2020-03-26 2021-09-29 Oscor Inc. Système et procédé d'utilisation de la thérapie par lumière ultraviolette endobronchique pour traiter des patients infectés par le coronavirus covid-19, sars-cov-2
EP4138997A4 (fr) * 2020-04-20 2024-04-24 Cern Corp. Dispositifs de thérapie vaginale par lumière et procédés d'utilisation correspondants
WO2022051394A1 (fr) * 2020-09-04 2022-03-10 Covidien Lp Surveillance d'une insuffisance rénale aiguë
US11864893B2 (en) 2020-09-04 2024-01-09 Covidien Lp Oxygen sensor calibration
US12115384B2 (en) 2021-03-15 2024-10-15 Know Bio, Llc Devices and methods for illuminating tissue to induce biological effects
US11654294B2 (en) 2021-03-15 2023-05-23 Know Bio, Llc Intranasal illumination devices
WO2023152173A1 (fr) * 2022-02-08 2023-08-17 Uvisa Health Aps Dispositif d'émission de lumière à l'intérieur d'une cavité corporelle
EP4223365A1 (fr) * 2022-02-08 2023-08-09 Uvisa Health ApS Dispositif de transmission de lumière dans une cavité corporelle
WO2024243294A1 (fr) * 2023-05-25 2024-11-28 Hollister Incorporated Produit de cathéter luminescent dans l'obscurité
CN117379112B (zh) * 2023-12-12 2024-02-09 南京医科大学 一种尿液厌氧采集培养一体化装置
CN117379112A (zh) * 2023-12-12 2024-01-12 南京医科大学 一种尿液厌氧采集培养一体化装置
US12096919B1 (en) 2023-12-12 2024-09-24 Nanjing Medical University Integrated urine anaerobic collection and culture apparatus

Similar Documents

Publication Publication Date Title
WO2017070155A1 (fr) Dispositifs pour l'émission de lumière thérapeutique réglée de manière répétée et dispositifs pour le traitement de l'empoisonnement au monoxyde de carbone
US20160151639A1 (en) Devices and methods for delivery of therapeutic energy
EP2139539B1 (fr) Procédé et dispositif d'administration de médicament
US20040073278A1 (en) Method of and device for therapeutic illumination of internal organs and tissues
US8622991B2 (en) Method and device for drug delivery
CA2890978C (fr) Procede et dispositif d'administration de medicament
AU725077B2 (en) Intracorporeal light treatment of blood
EP2922476B1 (fr) Système pour la thérapie optogénétique
EP1334748A1 (fr) Appareil de thérapie photodynamique
JP6594332B2 (ja) 咳を治療的に管理するためのシステムおよび方法
CN101466433A (zh) 持续低辐照度光动力学治疗系统和方法
US20130289372A1 (en) Implantable oximetric measurement apparatus and method of use
AU2015274457A1 (en) Optogenetic therapies for movement disorders
CN2907735Y (zh) 一种妇科腔内理疗仪器
US20210370088A1 (en) Devices and related methods for light-based modulation of foreign body responses in living tissue
JP3246227U (ja) 体腔の中に留置するカテーテルを介して可変的に治療用非紫外線電磁放射線を送達するための方法及び装置
US11173321B2 (en) System for its use to treat Leukemia
US20150273221A1 (en) Method and apparatus for inducing endogenous generation of adult stem cells
WO2019088938A1 (fr) Dispositif de source de lumière à led pour thérapie photodynamique
AU2014200298A1 (en) Method and device for drug delivery
JPH07144026A (ja) 光免疫療法による癌治療装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16858095

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16858095

Country of ref document: EP

Kind code of ref document: A1