WO2008076986A1 - Procédés et dispositifs permettant une photothérapie contrôlable - Google Patents

Procédés et dispositifs permettant une photothérapie contrôlable Download PDF

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Publication number
WO2008076986A1
WO2008076986A1 PCT/US2007/087803 US2007087803W WO2008076986A1 WO 2008076986 A1 WO2008076986 A1 WO 2008076986A1 US 2007087803 W US2007087803 W US 2007087803W WO 2008076986 A1 WO2008076986 A1 WO 2008076986A1
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WIPO (PCT)
Prior art keywords
photo
radiation
sensor
radiation source
site
Prior art date
Application number
PCT/US2007/087803
Other languages
English (en)
Inventor
James R. Flom
Norbert H. Leclerc
Jonathan L. Podmore
Paul Lingane
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Allux Medical, Inc.
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.)
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Publication date
Application filed by Allux Medical, Inc. filed Critical Allux Medical, Inc.
Publication of WO2008076986A1 publication Critical patent/WO2008076986A1/fr

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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00057—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
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0607—Nose
    • 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
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0644—Handheld applicators

Definitions

  • the invention relates to devices and methods for delivering photo-radiation to a target site within a human or animal subject, such as a body cavity.
  • the photo-radiation delivery includes the controllable emission and propagation of energy in the form of rays or waves, including ultraviolet, infrared and visible light.
  • the invention also relates to controllable photo-radiation delivery which can result in a more effective distribution of photo- radiation onto the site.
  • UV ultraviolet
  • UV light has been used for medical applications, such as the treatment of psoriasis and vitiligo.
  • Ultraviolet lasers and lamps have also been designed to illuminate more localized regions of the skin for treatment of lesions and marks. These devices benefit from delivering the light therapy onto a relatively flat surface; consequently, the applied dose is relatively uniform.
  • Recent work has included delivering light into the nasal cavity to treat allergic rhinitis.
  • Kemeny and Koreck include placing a probe tip into the anterior portion of the nose and directing the therapeutic light into the nasal cavity. Due to the irregular shape of the nasal cavity, this method results in a relatively high variability of delivered dose to the nasal tissue. As a result, some targeted portions of the nasal tissue may not receive enough dosage, while other targeted regions of nasal tissue may receive too much dosage. As a result, the safety and/or effectiveness of the treatment are impacted.
  • the aim of the present invention is to provide methods and devices that facilitate controlling the application of therapeutic photo-radiation to a target site, thus improving overall delivered dosage, safety and effectiveness of photo- radiation therapy.
  • An aspect of the invention is directed to a device comprising: a body having a distal end and a proximal end wherein the distal end is adapted to internally engage a site within a human or animal subject; a photo-radiation source which emits photo-radiation therapy; a sensor in communication with the distal end of the body, wherein the sensor detects a spatial environment of the site; and a controller that controls therapy delivery from the photo-radiation source in response to feedback from the sensor.
  • the photo-radiation source and sensors can be adapted to communicate with the distal end of the device to permit the device to emit photo-radiation therapy either by delivering photo-radiation to the distal end of the device and sensing a parameter received at a distal end of the device; or by being positioned in or on the distal end.
  • the device is adapted and configured to treat a body cavity of a subject, including, for example, the nasal cavity, the sinus cavity, the stomach, the ear, etc.
  • the device may also be adapted and configured to access a target or desired treatment site through intracavitary, interstitial, minimally-invasive, or non-invasive techniques known to those skilled in the art.
  • photo-radiation sources can be used for these devices, including, for example, a xenon chloride laser, a xenon fluoride laser, a nitrogen laser, a solid state laser, a laser diode, an incandescent bulb, a dye laser, a gas discharge lamp, a high intensity discharge lamp, an arc lamp, a fluorescent lamp, and a light emitting diode, or combinations thereof.
  • the photo-radiation sources can be visible light sources, ultra-violet light sources, infrared light sources, or combinations thereof.
  • Sensors include, for example, photodetectors, infrared detectors, reflectometers, capacitive sensors, microwave detectors, acoustic sensors, temperature sensors, and combinations thereof.
  • imaging devices may be used, either as part of the sensor, or separately. Suitable imaging devices include, for example, CMOS sensors, CCD, triangulation systems, structured photo- radiation systems and a stereoscopic imaging devices.
  • the controller can be adapted to control the processes that are output from the sensor. For example, the controller can control processes that result in controlling, for example, treatment duration and radiation fluence of photo-radiation from the photo-radiation source.
  • optics can be provided which, for example, direct or condition the photo-radiation emitted from the photo-radiation source of the device.
  • Suitable optics include, for example, an aperture, a shutter device, a scanning mirror, a digital micromirror device, an LCD, a lens, a filter, a diffuser, a mirror, a fiber optic, a liquid lightguide, or combinations thereof. In some instances, it may be desirable to provide a dichroic mirror to direct photo-radiation to the sensor.
  • the devices can be configured to include a second, or more, photo-radiation source. Where additional photo-radiation sources are provided, it is possible that those sources will be independently controlled.
  • Another aspect of the invention is directed to methods of delivering phototherapy to a target site in a subject.
  • the method comprises the steps of : delivering, for example by inserting, a device comprising a body having a distal end and a proximal end wherein the distal end is adapted to internally engage a site within a subject; a photo-radiation source in communication with the distal end of the body; a sensor in communication with the distal end of the body, wherein the sensor detects a spatial environment of the site, to a site within a subject; emitting photo-radiation from the device at the distal end; and modulating the emitted photo-radiation in response to a feedback about the site from the sensor.
  • the photo-radiation sources can be selected from a xenon chloride laser, a xenon fluoride laser, a nitro ⁇ en laser, a solid state laser, a laser diode, an incandescent bulb, a dye laser, a gas discharge lamp, a high intensity discharge lamp, an arc lamp, a fluorescent lamp, and a light emitting diode, or a combination thereof.
  • the photo-radiation source can be a visible light source, an ultraviolet light source, an infrared light source, or combinations thereof.
  • Sensors include, for example, photodetectors, infrared detectors, reflectometers, capacitive sensors, microwave detectors, acoustic sensors, temperature sensors, and combinations thereof.
  • imaging devices may be used, either as part of the sensor, or separately. Suitable imaging devices include, for example, CMOS sensors, CCD, triangulation systems, structured photo-radiation systems and a stereoscopic imaging devices.
  • the controller can be adapted to control the processes that are output from the sensor. For example, the controller can control,directly or indirectly, treatment duration and radiation fluence of photo-radiation from the photo-radiation source. Additionally, optics can be provided which are, for example, direct or condition the photo-radiation emitted from the photo-radiation source of the device.
  • Suitable optics include, for example, an aperture, a shutter device, a scanning mirror, a digital micromirror device, an LCD, a lens, a filter, a diffuser, a mirror, a fiber optic, a liquid lightguide, or combinations thereof. In some instances, it may be desirable to provide a dichroic mirror to direct photo-radiation to the sensor.
  • the devices can be configured to include a second, or more, photo-radiation source. Where additional photo-radiation sources are provided, it is possible that those sources will be independently controlled.
  • the method can further comprise the step of monitoring the position of the device, for example, where the position is processed by the controller and effects therapy delivery.
  • Another aspect of the invention is directed to a method of delivering phototherapy to a target site in a subject comprising: delivering a device comprising a body having a distal end and a proximal end wherein the distal end is adapted to internally engage a site within a subject; a photo-radiation source in communication with the distal end of the body; imaging the site, wherein the imaging detects a spatial environment; emitting photo-radiation from the device at the distal end; and modulating the emitted photo-radiation in response to a feedback about the site from the imaging.
  • kits comprising: a device for modulating photo-radiation therapy comprising a body having a distal end and a proximal end wherein the distal end is adapted to internally engage a site within a subject; a photo-radiation source which emits photo-radiation; a sensor in communication with the distal end of the body, wherein the sensor detects a spatial environment of the site; a central processing unit for processing input and output to and from the device; and a power source for powering the device and the central processing unit.
  • Kits can be adapted for use with a body cavity, such as a nasal cavity or sinus cavity. Additionally, the kit can be adapted to position the device for controlling modulation of therapy delivery. Kits can also include changeable tips adapted and configured to engage the distal end of the device. Additionally, the kits can include sheaths.
  • Yet another aspect of the invention is directed to a device comprising: a body adapted to internally engage a site within a subject; a photo-radiation source which emits photo-radiation therapy from the device; a sensor which detects a spatial environment of the site; and a controller that controls therapy delivery from the photo-radiation source in response to feedback from the sensor.
  • the device would be low-profile and adapted and configured for delivery within a target body cavity by, for example, swallowing, catheter, or other suitable mechanism.
  • the device can be controlled remotely to deliver therapy or sense a target parameter.
  • the device is adapted and configured to treat a body cavity of a subject, including, for example, the nasal cavity, the sinus cavity, the stomach, the ear, etc.
  • the device may also be adapted and configured to access a target or desired treatment site through intracavitary, interstitial, minimally-invasive, or non-invasive techniques known to those skilled in the art.
  • a variety of suitable photo-radiation sources can be used for these devices.
  • the photo-radiation sources can be visible light sources, ultra-violet light sources, infrared light sources, or combinations thereof.
  • Sensors include, for example, photodetectors, infrared detectors, reflectometers, capacitive sensors, microwave detectors, acoustic sensors, temperature sensors, and combinations thereof.
  • imaging devices may be used, either as part of the sensor, or separately.
  • Suitable imaging devices include, for example, CMOS sensors, CCD, triangulation systems, structured photo-radiation systems and a stereoscopic imaging devices.
  • the controller can be adapted to control the processes that are output from the sensor. For example, the controller can control processes that result in controlling, for example, treatment duration and radiation fluence of photo-radiation from the photo-radiation source.
  • optics can be provided which, for example, direct or condition the photo-radiation emitted from the photo-radiation source of the device. Suitable optics include, for example, an aperture, a shutter device, a scanning mirror, a digital micromirror device, an LCD, a lens, a filter, a diffuser, a mirror, a fiber optic, a liquid lightguide, or combinations thereof.
  • the devices can be configured to include a second, or more, photo-radiation source. Where additional photo-radiation sources are provided, it is possible that those sources will be independently controlled.
  • FiG. 1 is a physiological view of the nasal cavity illustrating the anatomy
  • FlG.2 is a physiological view of the ear illustrating the anatomy of the outer, middle, and inner ears; [0017] FlG.3 depicts an overview of a device and feedback method for controlling photo-radiation; [0018] FiG.4A-E depict a photo-radiation therapy device;
  • FlGS.5A-D depicts tips suitable for use with a photo-radiation therapy devices
  • FlG.6A-C illustrates application of a device adapted to control photo-radiation therapy of a nasal cavity
  • FlG.7A-B illustrates application of a device adapted to treat a contoured target surface area with photo- radiation
  • FiG. 8 illustrates controlled photo-radiation treatment from a device to a target section of respiratory epithelium
  • FlG.9 illustrates a method of the invention for detecting sensor waves and controlling photo-radiation therapy
  • FlG. 10 illustrates how photo-radiation therapy of the tympanic cavity might be achieved with use of a photo- radiation device
  • FlG. 11 illustrates photo-radiation therapy of the nasal cavity with use of a photo-radiation device
  • FlG. 12 illustrates photo-radiation therapy of the stomach mucosa layer with use of a photo-radiation device
  • FlGS.13A-B illustrates a photo-radiation therapy device and the device delivering therapy to the stomach mucosa layer.
  • the invention described herein has a wide range of applications for photo-radiation of body cavities and internal sites, as will be appreciated by persons of skill in the art upon reviewing the disclosure.
  • the devices, systems, kits and methods could be used, for example, to apply photo-radiation therapy to the nose and sinuses, the ear, the stomach, the eye, the mouth, the lower airway, the trachea, the esophagus, the rectum, the intestines, the uterus, and the urogenital tract, to name a few.
  • the devices, systems, kits and methods could be used, for example, to apply photo-radiation therapy to treat inflammatory diseases; viral, fungal and bacterial infections; cancerous and precancerous conditions; as well as for aesthetic conditions. Applications to other anatomical locations and to treat other medical conditions are possible as well.
  • the devices, systems, kits and methods, and components thereof are described in relation to the nasal cavity (FIGS. 1 and 11), the ear (FlGS.2 and 10) and the stomach (FlG. 12).
  • FIG.1 a saggital section of the skull and face of a human is depicted with the anatomy of the nasal cavity illustrated.
  • the nasal vestibule anterior vestibule
  • the limen nasi vestibular limen 16 is a ridge of skin, tissue, and mucosa that marks the transition between the squamous epithelium and the respiratory epithelium.
  • the lateral wall 20 of the nasal cavity 10 is a complex structure containing three bony turbinates 22, 24, 26 with overlying mucosa consisting of stratified pseudocolumnar respiratory epithelia as well as muscles (e.g. the nasalis muscle).
  • a physician encounters (in order of appearance): the squamous epithelium of the nasal vestibule, the limen nasi, the transition to respiratory epithelium, and the inferior turbinate 22.
  • the middle and superior turbinates 24, 26 are encountered further back in the nasal cavity.
  • FiG. 2 illustrates the anatomy of the ear in a human. Entering the ear from the outside through the auditory canal 30 provides access to the ear drum, also known as the tympanic membrane 32.
  • the section of the ear before the tympanic membrane is often referred to as the outer ear.
  • the middle ear 40 an air- filled cavity behind tympanic membrane, includes the three ear bones (ossicles): the incus (anvil) 42, malleus (hammer) 44, and stapes (stirrup) 46.
  • the three bones are arranged so that movement of the tympanic membrane causes successive movement of the malleus, then the incus, and then the stapes.
  • the stapes footplate pushes on the oval window, it causes movement of fluid within the cochlea 48.
  • the middle ear In humans and other animal subjects, the middle ear is typically filled with air that is not in direct contact with the atmosphere outside the body.
  • the Eustachian tube 34 connects from the chamber of the middle ear to the back of the pharynx.
  • the middle ear also referred to as the tympanic cavity, is a hollow mucosa-lined cavity in the skull that is ventilated through the nose, similar to a paranasal sinus.
  • FlG. 3 illustrates a system comprising a sensor 302, a controller 304, a photo-radiation source 318, optics 316 and a delivery source 306.
  • the sensor 302 collects spatial information about the site to be treated by the delivery source 306 and confers the information to the controller 304.
  • the controller 304 is a central processing unit. However, as will be appreciated by those skilled in the art, other controller systems can be used without departing from the scope of the invention.
  • the controller 304 controls the delivery of photo-radiation from the delivery source 306 either directly 310 or indirectly 320, 330.
  • An example of an indirect path 320 of control of the delivery source 306 includes controlling a photo-radiation source 318 that sends photo-radiation directly to the delivery source 306 to modulate, or condition, therapy delivery at the target site.
  • Another example of indirect control 330 of delivery source therapy modulation is through control of a photo-radiation source 318 and optics 316 that send modulated photo-radiation to the delivery source 306 for therapy.
  • the delivery source can be an insertion member configured for insertion into the body cavity.
  • the delivery source 306 can be a photo-radiation source, such as a light source, adapted for delivering therapeutic photo-radiation to a target site.
  • the photo-radiation delivered by photo-radiation source 318 and/or delivery source 306 varies depending upon the desired optical properties, such as spectrum, fluence and illumination pattern, and the desired clinical results.
  • the photo-radiation can be coherent or non-coherent light.
  • the photo-radiation may be any of a variety of monochromatic and multi-wavelength light emitting devices.
  • Examples of monochromatic light emitting devices that are incorporated into the invention include, but are not limited to, a xenon chloride laser, a xenon fluoride laser, a nitrogen laser, a solid state laser, a laser diode, or a combination thereof.
  • Examples of multi- wavelength light emitting devices that are incorporated into the invention include, but are not limited to, an incandescent bulb, a dye laser, a gas discharge lamp, an arc lamp, a fluorescent lamp, and a light emitting diode (LED), or a combination thereof,
  • the photo-radiation source 318 and/or delivery source 306 is generally adapted and configured to emit photo- radiation with at least some wavelengths in the ultraviolet spectrum, including the portions of the ultraviolet spectrum known to those of skill in the art as the UVA (or UV-A), UVAi, UVA 2 , the UVB (or UV-B) and the UVC (or UV-C) portions.
  • the photo-radiation source can emit photo-radiation in the visible spectrum (e.g., visible light) in combination with ultraviolet light or by itself.
  • the photo-radiation source can emit photo-radiation within the infrared spectrum, in combination with white light and/or ultraviolet light, or by itself.
  • Optical guidance systems can also be used to pass or communicate therapeutic radiation from the photo- radiation source to the delivery source of the device.
  • photo-radiation can be emitted from, for example, a distal end of the device from which the photo-radiation is applied to a target tissue site in a subject.
  • the photo-radiation can be emitted from a photo-radiation source positioned on the distal end of the device from which the photo-radiation is applied to a target tissue in a subject.
  • Optics 316 can be placed between the photo-radiation source 318 and delivery source 306 to direct the therapeutic radiation.
  • optics 316 incorporated into the device include, but are not limited to, optical fibers, liquid light guides, dichroic mirrors, lenses, filters, apertures, shutter devices, diffusers, mirrors, digital micromirror devices, LCD's, scanning mirrors, or combinations thereof.
  • the sensor 302 can be adapted and configured to interpret reflected photo-radiation from the target surface or site. For example, when the sensor 302 is a photo-detector it can measure the intensity of the reflected radiation from the target surface. The intensity of the reflected radiation is a result of the distance to the target tissue, the angle of the target surface relative to radiation beam, and the reflective qualities of the tissue surface.
  • the sensor 302 can also detect the spectrum of the reflected therapeutic photo-radiation. Differences between the spectrum of the radiation source and reflected radiation are detected and used to control treatment parameters. [0038] Instead of, or in addition to, measuring reflected radiation, the sensor 302 can measure other properties of the target tissue such as temperature.
  • the target tissue may, for example, have a different temperature than non-target tissue. For example, a nasal polyp that is less vascularized than surrounding nasal mucosa might have a lower temperature than the surrounding tissue area. Conversely, a target tissue that is inflamed or is highly vascularized might have a higher temperature than the surrounding tissue area.
  • This information can be used to determine the shape and position of the target tissue. Additionally, it may also determine the type of tissue and/or whether the tissue is appropriate for treatment.
  • a temperature sensor can be used to measure an increase or decrease in temperature of target tissue as it is being treated or in relation to surrounding tissue. Measuring a temperature change in the target tissue, or a temperature change relative to surrounding tissue, can be assessed to determine if a sufficient amount of radiation has been delivered to the target tissue.
  • Suitable sensors include, but are not limited to image sensors, such as charge-coupled devices (CCD' s) and CMOS sensors; photodetectors, such as photodiodes, photocells, and phototransistors; infrared sensors; reflectometers, capacitive sensors; acoustic detectors; microwave antennaes; acoustic sensors; temperature sensors; or a combination thereof, as well as any other suitable electronic device that can be adapted and configured to sense a target parameter.
  • Information from a sensor 302 can be used to obtain a measurement of distance. The sensor may provide the intensity of the reflected radiation, or simply provide the response time from the sensor radiation source to the sensor via reflection off the target surface.
  • the distance measurement can be computed using a CPU that is, or is not, part of the controller that controls the delivery source.
  • a single radiation source can provide both the sensing radiation and therapeutic radiation; alternatively, the sensing radiation source can be a second radiation source.
  • the photo-radiation source 318 can have multiple wavelengths, including both therapeutic radiation and sensing radiation.
  • a second radiation source could communicate with the delivery source 306 and provide the sensing radiation.
  • the delivery source 306 provides the sensing radiation.
  • other sensing radiation configurations can be used without departing from the scope of the invention.
  • the sensor 302 can be configured to include a laser source and an imaging camera. This combination would be adapted to use a method of triangulation to determine the distance to the target tissue surface.
  • the imaging camera can be an imaging device such as a CCD or CMOS sensor.
  • the imaging camera can be integrated with the phototherapeutic device or can be a separate device used in conjunction with the phototherapeutic device, such as an endoscope.
  • a laser shines on the target tissue and exploits a camera to look for the location of the laser dot.
  • the laser dot appears at different places in the camera's field of view. This technique is called triangulation because the laser dot, the camera and the laser emitter form a triangle from which can be calculated the distance to the treatment surface.
  • the information is processed, for example, by a controller, such as a CPU, and is used to dictate treatment parameters such as treatment time, therapeutic photo-radiation intensity or illumination pattern.
  • the sensor 302 can also be a combination that comprises a photo-radiation source and an imaging camera which, together, are adapted and configured to determine the contour of a target surface using a method called structured photo-radiation.
  • the photo-radiation source could project a pattern of photo-radiation on the target tissue surface, and assess the deformation of the pattern on the surface with an imaging camera in a structured photo-radiation method.
  • the pattern such as a line, is projected onto the tissue surface using a photo-radiation source such as a sweeping laser.
  • a camera offset slightly from the pattern projector, looks at the shape of the line and uses a technique similar to triangulation to calculate the distance of every point on the line.
  • the line is swept across the field of view to gather distance information one strip at a time.
  • a photo- radiation source 318 that combination is capable of controlling the application of photo-radiation in a variable two dimensional profile, such as a scanning mirror, digital micromirror device, LCD, or LED matrix, and the therapeutic photo-radiation can be applied in a manner to achieve controlled or controllable dose distribution to the target surface, such as uniform dose distribution.
  • the controller 304 of the therapy device 300 can be adapted and configured to control at least one of the control parameters of a device.
  • the controller 304 can control or change, for example, the quantity ⁇ e.g., total energy) and intensity (e.g. , power) and spectrum (e.g. wavelengths) and illumination pattern of photo-radiation emitted by the photo- radiation source 318, or combinations thereof over time.
  • the controller 304 determines and/or controls the power from a power supply.
  • the controller 304 can also be configured to control photo-radiation regulating optics such as an aperture which dictates fluence.
  • the controller 304 can also be configured to control the illumination pattern.
  • the illumination pattern can be controlled.
  • the controller 304 can further control the illumination pattern by moving (actively or passively) or otherwise altering optics such as a mirror, a filter or a lens.
  • the controller 304 can further control the time of treatment by, for example, applying power to the photo-radiation source or opening and closing of a shutter device or controlling other optics.
  • the controller 304 can also apply current to the photo-radiation sources at a desired frequency or duty cycle.
  • All of the control parameters for delivering therapy to a site with the device 300 of the invention can be adjusted based upon feedback of the sensor.
  • Delivered photo-radiation radiation, or dose can be defined in units of millijoules per squared centimeter. Treatments could range, for example, from about 10 mJ cm “2 to about 4,000 mJ cm “2 of ultraviolet light to nasal mucosa for the treatment of various inflammatory diseases such as sinusitis, nasal polyps and allergic rhinitis. As will be appreciated by those skilled in the art, the treatment ranges would vary depending upon the therapeutic application and the tissue to be treated.
  • Photo-radiation source 318 and/or delivery source 306 can be configured to produce multiple radiation wavelengths, consisting of both therapeutic wavelength(s) and the wavelength(s) used to detect the reflective qualities of the target tissue.
  • a second radiation source can also be provided which produces radiation at a different wavelength(s) than the therapeutic radiation source.
  • the sensor 302 can be configured to measure reflected radiation of this spectrum by being tuned or calibrated to this spectrum, or alternatively, receive only these wavelength(s) through optics such as filters, or alternatively, be timed such both radiation sources are not active at the same time, or alternatively, have separate optics than the therapeutic radiation.
  • the second radiation source can be monochromatic or multi-wavelength.
  • the second radiation source can be a laser, a laser diode, an incandescent bulb, a gas discharge lamp, an arc lamp, a fluorescent lamp, and a light emitting diode, or a combination thereof.
  • the second radiation source can communicate with the delivery source 306, or can be incorporated into the delivery source 306.
  • the second radiation source is a separate device such as an endoscope.
  • FIG. 4A-B An example of a device 400 for controlling photo-radiation to a tissue site is illustrated in FiG. 4A-B.
  • Photo- radiation is delivered from a device body 412.
  • the device 400 can be configured to access a target or desired treatment site through intracavitary, interstitial, minimally-invasive, or non-invasive techniques known to those skilled in the art.
  • the shaft (also referred to herein as the insertion member) 408 of the device 400 can enclose a variety of components, including an optical fiber, a reflecting tube, or wires for driving a photo-radiation source or transmitting a signal from a sensor at the distal tip 422 of the device 400.
  • the shaft 408 and distal tip 422 of the device 400 can also be incorporated with a handle 428 which is positioned proximally 414.
  • the handle 428 allows the user to comfortably position the device 400 and deliver therapy by hand.
  • a photo-radiation source is generally positioned proximally in or near the handle 428 or shaft 408.
  • control components of the device 400 may be incorporated into the handle 428, limiting the size and equipment that is required to power and run the device 400.
  • the body 412 of the therapy device 400 in combination with the photo-radiation source 440 can be adapted and configured to be held in hand for an extended period of time ⁇ e.g., a therapeutic time) without undue effort or discomfort to the user (e.g., healthcare practitioner delivering therapy to a patient, or patient delivering therapy to him or herself), due to the lightweight, portable design of the device 400.
  • a therapeutic time e.g., a therapeutic time
  • FlGS. 4c-e illustrates a variety of tip 422 designs for the device 400.
  • the tip 422 can be an integral part of the shaft such that the shaft and the tip are one piece, or the tip can be secured to the shaft such that the tip and the shaft act in a unified manner during use.
  • FlGS.4c-E presents a view directly at the tip of the device 400 of FiGS. 4A-B from a distal end facing proximally down the length of the device.
  • the tip 422 at the distal end of the device could comprise both the photo-radiation delivery source 418 and a sensing optics 402.
  • FIG. 4D illustrates an embodiment of the invention incorporating a photo-radiation source 442 at the tip for delivering therapeutic radiation.
  • the photo-radiation source could comprise, for example, an LED, an array of LEDs or another small, compact photo-radiation source.
  • a sensor 402 could be positioned on the distal end of the tip to sense parameters such as photo-reflectance.
  • optics could transmit reflected radiation to a sensor 402 which could be located in a handle or in a separate enclosure.
  • FlG. 4E illustrates a network of fiber optics 460 that can act as both a sensor and a delivery source for photo-radiation.
  • a photo-radiation source is located away from the distal tip of the device and the photo-radiation travels through the fiber optics to the delivery tip.
  • reflected photo-radiation is received by the fiber optics and travels to a sensor located away from the distal tip.
  • a single fiber may be used for the transmission optics.
  • the fiber could be attached to an endoscope to provide the physician with visual guidance for the treatment.
  • the insertion member which can include the tip 422 of the device 400, or the tip in combination with some or all of the shaft 408 of the device, can be configured so that it is flexible and its shape and orientation with respect to the handle is adjustable.
  • the insertion member can be rigid, flexible, semi-flexible or steerable.
  • the tip 522 of a device may be shaped in different manners according to the anatomy of the site being treated.
  • the tip shapes shown in FlGS. 5A-D do not limit the scope of the present invention and are provided by way of example only. Persons of skill in the art will appreciate that a variety of other tip configurations will be appropriate depending upon the actual application of a device made according to the invention.
  • a bent tip shape 542 allows access to a body cavity, such as the nasal cavity or middle ear, for modulating photo-radiation treatment.
  • a two tip device 544 is useful for inserting the device into both nostrils simultaneously with a single device.
  • a tip with a wider surface area 546 that delivers photo-radiation from different surfaces and angles around the tip of the device is useful for treating larger treatment sites and areas where the tip of device may be positioned in the center of the treatment site area.
  • Other configurations of the device involve different shapes providing custom access to different body cavities that may be accessible through an external orifice.
  • An example of one of these embodiments is a tip with multiple bends 548.
  • the tip may also contain optics which direct or condition the therapeutic radiation or reflected photo-radiation transmitting to the sensor.
  • the tip may also be a separable component which is attached to the shaft 408.
  • the tip has photo-radiation input from the proximal end while photo-radiation exits from the distal end.
  • the benefits of this configuration are that the tip could be a single-use component that is provided clean or sterile for the treatment procedure, reducing the burden on the clinic or hospital of re- sterilizing the component. Additionally, multiple tip configurations which attach onto the same handle 428 could be available to a physician providing flexibility in treatment options.
  • Photo-radiation of a body cavity has relied upon delivering photo-radiation without accounting for the differences in anatomical structures and abnormal or complex surfaces.
  • the three turbinates are an irregular area of the tissue.
  • FlGS. 6A-B illustrate the use of a device 600 applied to a target tissue.
  • FIG. 6A illustrates photo-radiation delivered from a device 600 into a nasal cavity 10 which uses positioning of the device 600 and a sensor for detection of the anatomy to provide controlled delivery of the proper therapeutic dose for treatment between the turbinates 22, 24 from the distal tip 622.
  • the photo-radiation 632 from the tip of the device 600 can be delivered at higher power levels or for longer treatment times to treat farther into the nasal cavity.
  • a dashed line 634 signifies the area of the site that receives effective therapeutic photo-radiation.
  • the device 600 is positioned to treat directly towards a turbinate 24. In this scenario, if the objective were to provide all target surfaces with a similar dosage, photo-radiation could be delivered at a lower power or shorter treatment time as compared to FlG. 6A.
  • the intensity of the light decreases as it travels greater distances from its source.
  • the sensor detection which can be used to measure a distance to a target surface as described above — can be used to control the dosage to the target surface.
  • Controllable photo-radiation can also be achieved for a large area without moving the device 600.
  • spatial information can be detected by a sensor (described above) incorporated into the device 600, therapy delivery 632 is modulated to effectively conform to a large area.
  • the effective therapy treatment area is denoted by a dashed line 634.
  • Different control parameters associated with the output of a therapy device can be adapted and configured to control the photo-radiation therapy delivered.
  • Examples of such parameters include, but are not limited to, one or more of power, timing, frequency, duty cycle, spectral output, and illumination pattern.
  • a photo-radiation source can be configured to emit photo-radiation at a different optical power level, or at the same level depending on the position of the device relative to the anatomical structures.
  • the relative output power level of a photo-radiation source may also be adapted and configured over a target surface area.
  • Optical energy, or delivered dosage is generally derived from a power level applied over a period of time. Various optical dosages are desired depending on the disorder being treated and desired biological response and may also depend on the photo-radiation source used to achieve the optical output.
  • Energy density, fluence, or other dosage parameters may be measured at any of a variety of positions with respect to the tip of the therapy device.
  • FlGS. 7 A-B illustrate another view of control of photo-radiation therapy in a target site. From an individual or array of photo-radiation delivery sources, the photo-radiation therapy pattern can be modulated to fit a certain shape and size body cavity. For example, the device 700 and tip 722 of the device 700 are positioned within the site and photo- radiation is emitted into the area according to spatial information acquired by the sensor incorporated into the device.
  • photo-radiation When photo-radiation is delivered, it can be delivered for different durations, energy levels, wavelengths, illumination patterns, frequency, or power levels as demonstrated by the five individual beams illustrated as 752, 754, 756, 758, 759. Individual beams represent either separate beams or different cumulative zones of delivered photo-radiation. As will be appreciated by those skilled in the art, one or more beams can be provided without departing from the scope of the invention.
  • a projection 762 such as a nasal polyp, occurs in the space and the beam delivery photo-radiation to the area 758 can be individually adjusted to modulate therapy delivery throughout the site.
  • a sensor as described above, for detecting photo-reflectance will detect more reflected photo-radiation from the target surface in the area of the projection.
  • the treatment must be modulated.
  • different methods can be utilized including reducing a power level proportional to the measured reflected photo-radiation or adjusting the treatment time.
  • FlG. 8 illustrates a controlled photo-radiation treatment from a device 800 to the respiratory epithelium 29.
  • the figure demonstrates a speculum view of a nasal cavity and the squamous epithelium 28 and respiratory epithelium 29 and the transition zone between the two epithelia that typically occurs 3-12mm inside the nasal cavity.
  • An array of LEDs 442 can be incorporated with the tip of the device 822. After the spatial environment has been detected and processed (for example, mapped) by a sensor or imaging source and controller, the information can then be used to activate a particular LED pattern from the LED array 442 on the tip of the device 822 to match the spatial environment and control therapy.
  • the dose 834 delivered from the device 800 can be controlled to a planned or sensed treatment area, in this example, the respiratory epithelium 29. This allows a more effective photo-radiation therapy dose 834, and avoids treating surrounding tissue.
  • a method of delivering therapy with a device 900 described herein is shown in FlG. 9.
  • the sensor at the distal tip 922 of the device 900 detects the spatial environment surrounding the device 900.
  • the spatial environment may contain odd shaped structures or non-continuous surfaces.
  • a low power wave 980 such as photo- radiation, sound, or microwave, will be emitted into the cavity and the reflection of the wave back to a sensor on the device will be processed by a control system, such as those described above.
  • a device 900 is positioned in a nasal cavity 10.
  • the device 900 and bent tip 922 are adapted to emit a wave for sensing the environment 980 and the properties of reflection to the sensor 982 and reflection away from the sensor 984 of the emitted sensing wave.
  • the amount of the wave that is reflected back to the device 900 is then detected by the sensor incorporated into the device 900 and this information (for example, fluence, flight of travel time) is utilized to understand or assess the spatial environment.
  • Therapy can be controlled with a control system 904 to process information detected by a sensor incorporated within a photo-radiation therapy device 900.
  • the control system 904 can be configured to process the information to determine the spatial environment of target site and control the output of the photo-radiation therapy.
  • the control system can be a basic direct feedback loop, or maybe a central processing unit (CPU) as discussed above.
  • the CPU can use the information from the sensor and then control the photo-radiation source.
  • the CPU can also create a spatial environment map, and then process the map to control the photo-radiation delivery source.
  • FlG. 9 also illustrates the result of modulating therapy from the device 900. Different treatment levels are delivered to different areas of the treatment site. The time of the treatment can be varied, the power level of the therapy 990, 992, 994 can be varied, or combinations thereof, to obtain a more uniform or desired therapeutic dose distribution.
  • the sensor of the devices and methods of the invention is a stereoscopic imaging device which can measure characteristics of the target tissue surface such as distance and contour.
  • the controller system 904 uses this information to determine appropriate radiation delivery.
  • two or more images can be captured of the target tissue. The images are acquired, for example, by placing the tip of the device 900 in two or more different positions relative to the target tissue. These images are then processed by the controller. Target tissue characteristics, including the spatial environment, are calculated and the treatment parameters of the radiation are altered appropriately.
  • the user interprets the imaging, either directly or through controller processing of the imaging, and dictates treatment parameters himself or herself.
  • One method of delivering spatially modulated therapeutic radiation includes monitoring the position of the device 900 as it delivers radiation and comparing the position to the known anatomical geometry of the subject.
  • the controller interprets the position of the device 900, including three dimensional placement in the treatment site and angle of device 900, and directs treatment parameters accordingly.
  • patients frequently undergo a CT scan for diagnostic purposes.
  • the CT scan is a full three dimensional database of the patient's anatomy.
  • Insta-Trak GE Healthcare
  • Coupling the tracking capability of, for example, a CT scan with a photo-radiation therapeutic device would allow further control of treatment parameters during treatment.
  • the physician could determine a specific target tissue to be treated.
  • the radiation device is tracked for position and angle. If the radiation device, for example, were to be placed outside the treatment region, the controller could stop active treatment. Additionally, the distance from the radiation device to the target tissue could be monitored and treatment parameters, such as optical power or treatment time, controlled accordingly.
  • imaging modalities useful for detecting device placement and a spatial environment include, but are not limited to, positron emission tomography (PET), magnetic resonance imaging (MRI), ultrasound, radiography, and photography.
  • PET positron emission tomography
  • MRI magnetic resonance imaging
  • ultrasound ultrasound
  • radiography radiography
  • Embodiments of the invention described herein can be utilized individually or combined for delivery of photo- radiation therapy.
  • the invention includes a kit comprising an embodiment of the device of the invention, a control unit (for example, a CPU), and a power source for driving either the photo-radiation source, delivery source, optics, device, sensor, or a combination thereof.
  • the kit may comprise an imaging modality or an image acquired by an imaging modality.
  • One or more removable tips of different sizes and configurations that are adapted to engage the distal end of the device to provide conforming shapes can also be included in the kits.
  • the tip may also serve as a contamination barrier to prevent biocontamination of the insertion member.
  • a separate sheath, or cover is provided as a contamination barrier to prevent biocontamination of the insertion member.
  • a positioning device such as a clip, stop, or plug, can also be combined with embodiments of the invention to create a kit of the invention.
  • the positioning device is useful for keeping the device in place to allow accurate registration of the spatial environment and the delivered therapeutic photo-radiation.
  • FIG. 10 An example of a system in combination with a target body cavity is depicted in FlG. 10.
  • a typical disease to be treated with this embodiment and method could include otitis media, which causes inflammation, typically from an infection, of the middle ear.
  • Therapeutic photo-radiation could either be germicidal in nature, UVC, in order to sterilize the infection; or could be immuno-modulatory in nature to reduce inflammation, for example with UVB.
  • the tip of the device 1000 would be inserted through the auditory canal 30 beyond the tympanic membrane 32.
  • the shaft of the device 1000 could be constructed of a flexible material.
  • Sensor photo-radiation (not shown) is emitted from the tip of the device 1000 and the reflection of this photo- radiation 1064 would be received through the tip of the device 1000 to a sensor 1002.
  • the photo- radiation conduit would be fiber optics (as described above) that delivers the reflected photo-radiation to a dichroic mirror 1066 farther back in the device 1000. If the therapy photo-radiation 1068 and the sensor photo-radiation 1069 are of different spectra, then dichroic mirror 1066 reflects the sensor photo-radiation and allows the therapy photo-radiation to travel through. The sensor photo-radiation would be sent to a sensor, which in turn would send information about the reflected sensor photo-radiation to a control unit.
  • control unit 1004 would be a CPU with a user interface, such as a handle 1028.
  • the data from the sensor is received and processed by the CPU which, with input commands from the user, would dictate treatment parameters to deliver therapeutic photo-radiation to the middle ear.
  • One treatment parameter for example, might be optical power.
  • the CPU would control an aperture 1076 which regulates the amount of therapeutic photo-radiation being delivered.
  • One method of adjusting the aperture would be to simply open or close the aperture depending on the amount of time needed to deliver therapy. Another method would be to adjust of the opening of the aperture to control the therapeutic photo-radiation fluence.
  • the photo-radiation source in this example would not be controlled by the CPU, but rather would deliver constant therapeutic photo-radiation device 1068 and the modulation of the photo-radiation would be achieved by adjusting the aperture.
  • the therapeutic photo-radiation as controlled then travels through the device 1000 to the tip 1022, where it would be delivered to the tympanic cavity.
  • the controlled amount of therapeutic photo-radiation as determined by controlling the aperture based on feedback from the sensor would deliver a controlled therapeutic dose.
  • the user may place the beam over the target region or a portion of the target region and deliver a single therapeutic dose. If there are additional target regions, the user would perform the same sequence of actions at the new region.
  • the user may also treat multiple target regions in a continuous fashion whereby the therapeutic photo-radiation source continuously delivers therapeutic photo- radiation.
  • the CPU would be continually readjust a treatment parameter to the sensor input as the user manipulates the device to new each new region. For example, if the target surface changes from one closer to one further away, the sensor would detect lower reflection and cause the CPU to increase the aperture size and allow more therapeutic photo-radiation to pass to the target region. This would yield a more uniform dose to the target regions of varying depths.
  • FiG. 11 Another example of a system and method of the invention described herein is illustrated in FiG. 11.
  • a non-flexible device 1100 is inserted into the nasal cavity 10 to treat an area near the turbinates 22, 24. To deliver a more uniform photo-radiation dose, it is necessary to control the illumination pattern of the therapy.
  • sensor photo-radiation (not shown) is emitted into the nasal cavity through a fiber optic network within the device 1100 and reflected back to the fiber optic network at the tip of the device 1100.
  • the fiber optic network sends the reflected photo-radiation 1169 to an area of optics towards the back end of the device 1100.
  • the optics at the back end of the device 1100 may be another set of fiber optics or the same fiber optic network.
  • the reflected photo-radiation 1169 is then detected by an imaging device 1102 such as a CCD.
  • the image of the nasal cavity anatomy relative to the therapeutic device 1100 is sent to a control unit, such as a CPU 1104.
  • the image acquired by the CCD sensor 1102 provides a map of the anatomy surrounding the device 1100 which is then processed by the CPU 1104 and used to plan the delivery of modulated therapeutic photo-radiation.
  • the CPU adjusts the parameters of the photo-radiation source 1106 (for example, a UV- fiber output) and can control a scanning mirror 1178 throughout the delivery of the therapeutic photo- radiation 1168.
  • the variable two-dimensional output of the therapeutic photo-radiation beam 1168 is modulated by the CPU and the scanning mirror and then travels through a fiber optic network 1116 to the tip 1122 of the device 1100.
  • portions of the beam which target a closer surface have lower total fluence than portions of the beam which target a further surface.
  • the portions of the beam which target a closer surface will remain active for a shorter time than portions of the beam which target a further surface.
  • the example of the invention in FlG. 12 illustrates the use of a device 1200 of the invention to deliver blue/violet visible light to treat chronic gastritis and/or gastric ulcers.
  • the device 1200 in this example is constructed of a flexible material and enters the stomach through the esophageal junction.
  • the tip 1222 of the device 1200 can be positioned anywhere within the stomach 50. Because of the large surface area of the mucosa lining 52 of the stomach 50, a larger tip 1246 shape is illustrated.
  • the larger tip can be adapted to deliver therapeutic radiation 1232 from more angles to a larger surface area 1234.
  • a device would be configured such that it would have a very small profile and could be delivered within a patient (e.g., by swallowing, catheter, or other suitable mechanism). The device could then be activated remotely (e.g., by a wireless remote activation device) to sense a spatial environment of a site within a patient, to delivery therapy to a site within a patient, or sense an effectiveness of therapy delivery, or combinations thereof.
  • a wireless remote activation device e.g., by a wireless remote activation device
  • FIG. 13A-B illustrate a low-profile photo-radiation therapy device 1300 suitable for delivery to a target site of a patient and the device delivering therapy to the target site, depicted the mucosa layer 52 of the stomach 50. As shown in FlG.
  • Patent 5,292,346 to Ceravolo for Bactericidal Therapeutic Throat Gun; U.S. Patent 5,683,436 to Mendes for Treatment of Rhinitus by Biostimulative Illumination; U.S. Patent 6,663,659 to McDaniel for Method and Apparatus for the Photomodulation of Cells; and U.S. Patent 6,890,346 to Ganz for Apparatus and Method for Debilitating or Killing Microorganisms within the Body. Additionally, U.S. Patent Publ. 2002/0029071 to Whitehurst for Therapeutic Light Source and Method; U.S. Patent Publ.

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Abstract

L'invention concerne des dispositifs et des procédés de thérapie pour réguler le photorayonnement vers un site tissulaire chez un sujet. L'apport de photorayonnement comprend l'émission et la propagation de l'énergie de photorayonnement sous la forme de rayons ou d'ondes. L'invention concerne également la modulation de l'apport de photorayonnement par détection d'un événement spatial. La modulation spatiale de la photothérapie conduit à transmettre une dose thérapeutique plus efficace ou inoffensive au site.
PCT/US2007/087803 2006-12-18 2007-12-17 Procédés et dispositifs permettant une photothérapie contrôlable WO2008076986A1 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015052170A1 (fr) * 2013-10-07 2015-04-16 Wetling Holding Aps Dispositif et méthode de traitement d'un site affecté par une pathologie chez un sujet
WO2019134724A1 (fr) * 2018-01-03 2019-07-11 Ines Grosse Dispositif doté d'un bouchon d'oreille
US11298564B2 (en) 2020-03-10 2022-04-12 Dennis M. Anderson Medical, surgical and patient lighting apparatus, system, method and controls with pathogen killing electromagnetic radiation

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US6214034B1 (en) * 1996-09-04 2001-04-10 Radiancy, Inc. Method of selective photothermolysis
US6471716B1 (en) * 2000-07-11 2002-10-29 Joseph P. Pecukonis Low level light therapy method and apparatus with improved wavelength, temperature and voltage control
US20050075703A1 (en) * 2001-01-22 2005-04-07 Eric Larsen Photodynamic stimulation device and methods

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Publication number Priority date Publication date Assignee Title
US6214034B1 (en) * 1996-09-04 2001-04-10 Radiancy, Inc. Method of selective photothermolysis
US6471716B1 (en) * 2000-07-11 2002-10-29 Joseph P. Pecukonis Low level light therapy method and apparatus with improved wavelength, temperature and voltage control
US20050075703A1 (en) * 2001-01-22 2005-04-07 Eric Larsen Photodynamic stimulation device and methods

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015052170A1 (fr) * 2013-10-07 2015-04-16 Wetling Holding Aps Dispositif et méthode de traitement d'un site affecté par une pathologie chez un sujet
US10130826B2 (en) 2013-10-07 2018-11-20 Wetling Ip Lt Ltd Device and a method for treating a pathology-affected site in a subject
WO2019134724A1 (fr) * 2018-01-03 2019-07-11 Ines Grosse Dispositif doté d'un bouchon d'oreille
US11298564B2 (en) 2020-03-10 2022-04-12 Dennis M. Anderson Medical, surgical and patient lighting apparatus, system, method and controls with pathogen killing electromagnetic radiation

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