System for visual guidance of electromagnetic radiation based medical treatments

Abstract

Various embodiments are described herein for a device and method for an integrated electromagnetic radiation treatment system comprising a sheath device and an electromagnetic radiation treatment delivery device for precise delivery of treatment to lesions on mucosal surfaces within body lumens. The system ensures accurate positioning of treatment applicators for brachytherapy and photodynamic therapy with simple visual confirmation, facilitating simple, low-tech, targeted treatment. The invention is particularly beneficial in settings where advanced imaging technologies are not available, offering a cost-effective and time-efficient solution for treatment planning and delivery.

Description

SYSTEM FOR VISUAL GUIDANCE OF ELECTROMAGNETIC RADIATION BASED MEDICAL TREATMENTSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of United States Provisional Patent Application No. 63 / 642,843, filed May 5, 2024, and the entire contents of United States Provisional Patent Application No. 63 / 642,843 is hereby incorporated by reference in its entirety.FIELD

[0002] The invention pertains to medical devices and systems for delivering treatment using electromagnetic radiation within body lumens, particularly for brachytherapy and phototherapeutic applications (e.g., photodynamic therapy, PDT, photothermal therapy, PTT, etc.).BACKGROUND

[0003] Therapies like Brachytherapy and phototherapies like photodynamic therapy (PDT) are established methods for treating various body diseases, including cancer. Brachytherapy uses ionizing radiation to kill tumor cells by placing radioactive sources close to or within the tumor, minimizing exposure to surrounding healthy tissues. Phototherapy involves light activation of a photosensitizer that is either administered to the patient, generated by the body in response to a precursor, selectively accumulating in cancer cells, or exploits the body’s endogenous tissue properties to treat disease. The precise positioning of the treatment applicator is crucial to maximize treatment efficacy and minimize damage to healthy tissue.

[0004] However, the positioning of the brachytherapy and phototherapy devices, which may be considered to be electromagnetic radiation (EMR) devices, poses challenges. Image guidance technologies, such as magnetic resonance imaging (MRI) or computed tomography (CT), are used to accurately position brachytherapy applicators or PDT devices. Despite their effectiveness, these methods are expensive, time-consuming, and not widelyavailable, particularly in low- and middle-income countries (LMICs), where brachytherapy is often preferred due to the high cost of external beam radiotherapy.

[0005] Furthermore, for rectal and vaginal cancers, mucosal tumours may not be visible on MR or CT but mucosal disease is visible using optical (speculum examination) or endoscopic examination. In addition, MR, CT, and other cross-sectional imaging modalities provide information at a single point in time, which may be more useful for applications in body structures that are relatively immobile (e.g., skull, chest), but these modalities are less useful when targeting disease in mobile areas of the body (e.g., abdomen).SUMMARY OF VARIOUS EMBODIMENTS

[0006] In one aspect, in at least one embodiment described in accordance with the teachings herein, there is provided an electromagnetic radiation (EMR) treatment delivery system for a body lumen. In at least one embodiment, the EMR treatment delivery system comprises a sheath device having: a transparent body defining an interior channel, the body being permeable to electromagnetic radiation; and a coordinate mapping system located at the body for providing at least one set of coordinates for at least one object of the body lumen during visualization and / or imaging. In at least one embodiment, the EMR treatment delivery system further comprises an EMR treatment device that is removably insertable within the sheath device in a desired orientation for providing targeted EMR treatment to the at least one object of the body lumen identified by the at least one set of coordinates obtained during the visualization and / or imaging. In at least one embodiment, the body of the sheath device is sized to slidingly receive the EMR treatment device.

[0007] In at least one embodiment, the sheath device further comprises a sheath locking component and the EMR treatment device comprises a treatment locking component that releasably engages the sheath locking component to prevent longitudinal and rotational movement of the EMR treatment device relative to a longitudinal axis of the sheath device.

[0008] In at least one embodiment, the sheath locking component comprises a notch or an aperture and the treatment locking component includes a clip, a post or a fastener.

[0009] In at least one embodiment, the sheath and treatment locking components are adapted so that the treatment device is inserted into the sheath device in only the desired orientation.

[0010] In at least one embodiment, radial and longitudinal dimensions of the sheath device and the treatment device are such that there is an air gap between an inner diameter of the sheath device and an outer diameter of the treatment device.

[0011] In at least one embodiment, the air gap is about 0.05 mm to about 2 mm wide.

[0012] In at least one embodiment, the sheath device is constructed from a biologically inert material and / or a medical-grade material.

[0013] In at least one embodiment, the sheath device is made of material that is translucent.

[0014] In at least one embodiment, the sheath device is made of material that has a transparency value greater than about 90%, preferably greater than about 95%, and to provide an attenuation of electromagnetic (EM) radiation less than about 50%, preferably less than 5%.

[0015] In at least one embodiment, the sheath device is made of material having a compressive strength for withstanding muscular strength of various physiological luminal structures without breaking.

[0016] In at least one embodiment, the material of the sheath device is selected for undergoing sterilization without having its physical characteristics compromised.

[0017] In at least one embodiment, the material of the sheath device is selected for withstanding ionizing radiation up to about 50 Gy.

[0018] In at least one embodiment, the sheath device has a length of about 15 cm to about 25 cm and an outer diameter of about 1 cm to about 5 cm.

[0019] In at least one embodiment, a distal tip of the sheath device is tapered to a blunt point or has a hemispherical shape, and the distal tip has optical properties that are the same as the body of the sheath device.

[0020] In at least one embodiment, the sheath device is dimensioned to receive an imaging and / or visualization device.

[0021] In at least one embodiment, the imaging and / or visualization device includes an endoscope and / or a light source.

[0022] In at least one embodiment, the sheath device further comprises an external component for manipulation and attachment with other tools.

[0023] In at least one embodiment, the sheath device has a symmetrical shape that allows for ambidextrous use; and preferably the shape is cylindrical.

[0024] In at least one embodiment, the sheath device and the treatment device are shaped to minimize air gaps therebetween for reducing any attenuation of EMR transmission from the treatment device to the sheath device.

[0025] In at least one embodiment, the coordinate mapping system on the sheath device includes vertical and horizontal gridlines for mapping positional data for at least one object in the body lumen.

[0026] In at least one embodiment, the coordinate mapping system comprises a plurality of markings placed at regular marking intervals at the body of the sheath device.

[0027] In at least one embodiment, the marking intervals range from about 1 mm to about 5 mm.

[0028] In at least one embodiment, the coordinate mapping system uses alphanumeric coordinates.

[0029] In at least one embodiment, the coordinate mapping system comprises a grid, preferably the grid including longitudinal alphabet lettering and latitude roman numeral numbering.

[0030] In at least one embodiment, the EMR treatment device is a Multichannel Applicator (MCA).

[0031] In at least one embodiment, the latitude numbering of the coordinate mapping system corresponds to a number of channels in the MCA.

[0032] In at least one embodiment, the EMR treatment device is a phototherapy probe for providing phototherapy such as photodynamic therapy or photothermal therapy.

[0033] In at least one embodiment, the phototherapy probe comprises: a body having a circumferential wall defining a hollow space therein, the body having a distal tip and a longitudinal axis; and a plurality of support members located within the lumen and attached to the circumferential walls spaced apart from one another along the longitudinal axis of the body, each of the plurality of support members having apertures arranged in a grid.

[0034] In at least one embodiment, the phototherapy probe comprises a plurality of treatment light sources where each of the treatment light sources are positioned at various locations on the support members in the body of the phototherapy probe so that the light sources are arranged in a pattern to generate treatment light for photodynamic therapy where the pattern corresponds with the at least one set of coordinates that identify a location of the at least one object of the body lumen that is a target region for receiving light therapy.

[0035] In at least one embodiment, the body of the phototherapy probe is made of material that is at least partially optically transparent in a wavelength range of the treatment light and intensity of the light sources is increased to compensate for any treatment light attenuation due to the body of the phototherapy device.

[0036] In at least one embodiment, the body of the phototherapy probe is optically transparent in the wavelength range of the treatment light.

[0037] In at least one embodiment, the body of the phototherapy probe has an optical transmission of at least about 95% in the wavelength range of the treatment light.

[0038] In at least one embodiment, the plurality of treatment light sources are LEDs and / or optical fibers.

[0039] In at least one embodiment, the optical fibers extend longitudinally through the body of the phototherapy probe via apertures that are at different support members and are axially aligned to one another.

[0040] In at least one embodiment, the plurality of treatment light sources each have an independently controllable tunable intensity.

[0041] In at least one embodiment, the plurality of support members are radial plates that span a length of the phototherapy probe.

[0042] In at least one embodiment, the phototherapy probe device is dimensioned to be introduced through a lumen of a rigid proctoscope or a sheath device described herein.

[0043] In at least one embodiment, some of the optical fibers are dosimetry fibers for measuring a fluorescence or absorption of a photosensitizer, tissue oxygenation and / or tissue optical properties where the measurements are used to optimize delivery of the light therapy.

[0044] In at least one embodiment, the body of the phototherapy probe has a light-scattering portion made of a light-scattering material.

[0045] In at least one embodiment, the body of the phototherapy probe has a non-light-scattering portion made of a non-light-scattering material.

[0046] In at least one embodiment, a number and placement of the treatment light sources, an optical power of the treatment light sources, and a length of each treatment light source is selectable to provide a uniform light dose delivery to the target region in the body.

[0047] In at least one embodiment, the selection is done according to pretreatment planning based on radiological and / or endoscopic imaging of the target region.

[0048] In at least one embodiment, at least a portion of the body is coated with a light-absorbing material around at least a portion of a circumference of the body wherein the light-absorbing material prevents non-target regions of the body lumen from receiving the treatment light.

[0049] In at least one embodiment, at least a portion of the body is coated with a light-reflecting material around at least another portion of the circumference of the probe wherein the light reflecting material prevents nontarget regions of the body lumen from receiving the treatment light and increasing an amount of the treatment light delivered to a target region of the body lumen by reflecting the treatment light thereto.

[0050] In at least one embodiment, the phototherapy probe is used to deliver light therapy to a rectal lesion for the purposes of photodynamic therapy.

[0051] In another aspect, in at least one embodiment described in accordance with the teachings herein, there is provided a method of mapping and treating at least one object in a body lumen using a sheath device and an Electromagnetic Radiation (EMR) treatment device, wherein the method comprises: placing a sheath device in the body lumen, placing the imaging device inside the sheath device; using the coordinate mapping system of the sheath device to obtain at least one set of coordinates for at least a portion of the body lumen being a target region during the visualization and / or imaging; and placing the EMR treatment device inside the sheath device for providing targeted electromagnetic treatment to the target region of the body lumen identified by the set of coordinates provided during imaging. In at least one embodiment, the sheath device has a transparent body defining an interior channel, the body being permeable to electromagnetic radiation; and a coordinate mapping system located at the body for providing at least one set of coordinates for at least one object of the body lumen during imaging and / orvisualization, wherein the body of the sheath device is sized to slidingly receive a visualization device, an imaging device, and / or the EMR treatment device.

[0052] In at least one embodiment, the method further comprises: sliding the EMR treatment device lengthwise into the body of the sheath device, and locking the EMR treatment device to the sheath device to prevent longitudinal and rotational movement of the EMR treatment device relative to the sheath device.

[0053] In at least one embodiment, the locking is performed using locking components to hold the treatment device in the sheath device in a consistent orientation.

[0054] In at least one embodiment, the method comprises using the sheath device for performing MCA treatment without MR-guidance.

[0055] In at least one embodiment, wherein the EMR treatment device is a Multichannel Applicator (MCA).

[0056] In at least one embodiment, the method comprises using the sheath device and the MCA for vaginal brachytherapy or rectal brachytherapy.

[0057] In at least one embodiment, the EMR treatment device is a phototherapy probe for providing phototherapy such as photodynamic therapy or photothermal therapy.

[0058] In at least one embodiment, the method comprises using the sheath device and the phototherapy probe to deliver light therapy to a rectal lesion, a sigmoid colon lesion, or a vaginal lesion.

[0059] In another aspect, in at least one embodiment described in accordance with the teachings herein, there is provided a phototherapy probe for delivering light therapy to a target region of a body lumen; the phototherapy probe comprising: a body having a circumferential wall defining a hollow space therein, the body having a distal tip and a longitudinal axis; a plurality of support members located within the lumen and attached to the circumferential walls spaced apart from one another along the longitudinal axis of the body, each ofthe plurality of support members having apertures arranged in a grid; and a plurality of treatment light sources where each of the treatment light sources are positioned at various locations on the support members in the body of the phototherapy probe so that the light sources are arranged in a pattern to generate treatment light for photodynamic therapy where the pattern corresponds with the at least one set of coordinates that identify a location of the at least one object of the body lumen that is a target region for receiving light therapy.

[0060] Further aspects of the phototherapy probe may be implemented according to any of the embodiments described herein.

[0061] In another aspect, in at least one embodiment described in accordance with the teachings herein, there is provided a sheath device for mapping at least one object in a body lumen, wherein the sheath device comprises: a transparent body defining an interior channel, the body being permeable to electromagnetic radiation; and a coordinate mapping system located at the body for providing at least one set of coordinates for at least one object of the body lumen during imaging and / or visualization, wherein the body of the sheath device is sized to slidingly receive a visualization device, an imaging device and / or an Electromagnetic Radiation (EMR) treatment device.

[0062] Further aspects of the sheath device may be implemented according to any of the embodiments described herein.

[0063] In another aspect, in at least one embodiment described herein, there is provided a method of delivering light therapy using a phototherapy probe, wherein the method comprises: visualizing at least one target region of a body lumen using a proctoscope; calibrating the phototherapy probe to determine location data for the at least one target region of a body lumen; inserting one or more light sources into a one or more apertures of the phototherapy probe in treatment positions corresponding to the location data for delivering the light therapy to the at least one target region; introducing the phototherapy probe into the body lumen so that the treatment positions of the one or more light sources abut the at least one target region; and illuminatingthe one or more light sources to deliver light therapy to the at least one target region in the body lumen.

[0064] In at least one embodiment, the method comprises providing one or more fiber optics and / or one or more LEDS as the one or more light sources.

[0065] In at least one embodiment, the method comprises operating the phototherapy probe to provide PDT where the phototherapy probe is defined according to the teachings herein.

[0066] In at least one embodiment, the method comprises operating the phototherapy probe to provide photothermal treatment where the phototherapy probe is defined according to the teachings herein.

[0067] Other features and advantages of the present application will become apparent from the following detailed description taken together with the accompanying drawings. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the application, are given by way of illustration only, since various changes and modifications within the spirit and scope of the application will become apparent to those skilled in the art from this detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0068] For a better understanding of the various embodiments described herein, and to show more clearly how these various embodiments may be carried into effect, reference will be made, by way of example, to the accompanying drawings which show at least one example embodiment, and which are now described. The drawings are not intended to limit the scope of the teachings described herein.

[0069] FIG. 1 is a front view of a sheath device, according to an example embodiment.

[0070] FIG. 2 is a front view of an electromagnetic radiation (EMR) treatment delivery system including a sheath device and an example of a treatment device, according to an example embodiment.

[0071] FIG. 3 is a block diagram of an electromagnetic radiation (EMR) treatment delivery system and apparatus for visualizing a portion of the body lumen using a computer-implemented treatment-planning system, according to an example embodiment.

[0072] FIGs. 4-5 are top perspective and front views, respectively, of a sheath device, according to an example embodiment.

[0073] FIG. 6 is a front view of a sheath device shown with a scale ruler to indicate size, according to an example embodiment.

[0074] FIG. 7 is a front view of two sheath devices and two EMR treatment devices, according to two example embodiments.

[0075] FIG. 8 is a front view of the sheath devices and EMR treatment devices of FIG. 7 with a scale ruler to indicate size, according to an example embodiment.

[0076] FIGs. 9A-9B are bottom-perspective views of an electromagnetic radiation (EMR) treatment delivery system, respectively, according to two example embodiments.

[0077] FIG. 10 is a front view of an electromagnetic radiation (EMR) treatment delivery system shown with a scale ruler to indicate size, according to an example embodiment.

[0078] FIG. 11 is a partial view of an electromagnetic radiation (EMR) treatment delivery system, according to an example embodiment, with a locking component removed.

[0079] FIGs. 12-15 are images of a body lumen showing an internal view of a sheath device, according to example embodiments.

[0080] FIG. 15 is an image provided by an example of a computer- implemented treatment-planning system, according to an example embodiment.

[0081] FIG. 16 is an image provided by an example of a computer- implemented treatment-planning system, according to an example embodiment.

[0082] FIG. 17 is an image of a body lumen showing an internal view of a sheath device, according to an example embodiment.

[0083] FIG. 18 show images provided by an example of a computer- implemented treatment-planning system, according to an example embodiment.

[0084] FIG. 19 is an image provided by an example of a computer- implemented treatment-planning system, according to an example embodiment.

[0085] FIG. 20 is a front view of a probe device, according to an example embodiment, with a portion of a wall of the probe device removed.

[0086] FIG. 21 is a cut-out view of a probe device to show the internal components, according to an example embodiment.

[0087] FIG. 22 shows front views of a probe device, illuminated to show the device in an active mode, according to an example embodiment.

[0088] FIGS. 23A-23B show two sketches illustrating that the sheath device can be rotated to map the target lesion with a smaller number of units of the coordinate mapping system results in a smaller treatment margin.

[0089] Further aspects and features of the example embodiments described herein will appear from the following description taken together with the accompanying drawings.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0090] Various embodiments in accordance with the teachings herein will be described below to provide an example of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices, systems or methods having all of the features of any one of the devices, systems ormethods described below or to features common to multiple or all of the devices, systems or methods described herein. It is possible that there may be a device, system or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

[0091] Furthermore, it will be appreciated that for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein may be practiced without these specific details. In other instances, well- known methods, procedures and components have not been described in detail so as not to obscure the embodiments described herein. Also, the description is not to be considered as limiting the scope of the embodiments described herein.

[0092] It should also be noted that the terms “coupled”, or “coupling” as used herein can have several different meanings depending in the context in which these terms are used. For example, the terms coupled, or coupling can have a mechanical, electrical or fluidic connotation. For example, as used herein, the terms coupled or coupling can indicate that two elements or devices can be directly connected to one another or connected to one another through one or more intermediate elements or devices via an electrical signal, electrical connection, fluidic pathway or a mechanical element depending on the particular context.

[0093] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as,“comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to”.

[0094] It should also be noted that, as used herein, the wording “and / or” is intended to represent an inclusive-or. That is, “X and / or Y” is intended to mean X or Y or both, for example. As a further example, “X, Y, and / or Z” is intended to mean X or Y or Z or any operable combination thereof. Accordingly, the term “any combination thereof” is meant to cover any operable combination of the elements which precede the phrase. For example, the phrase “A, B, C, D or any combination thereof” includes A; B; C; D; A and B; A and C; A and D; B and C; B and D; C and D; A, B and C; A, B and D; A, C and D; B, C and D as well as A, B, C and D assuming that all such combinations are operable (i.e., they can be used together in practice in a working embodiment).

[0095] It should be noted that terms of degree such as "substantially", "about" and "approximately" as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree may also be construed as including a deviation of the modified term, such as by 1 %, 2%, 5% or 10%, for example, if this deviation does not negate the meaning of the term it modifies.

[0096] Furthermore, the recitation of numerical ranges by endpoints herein includes all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term "about" which means a variation of up to a certain amount of the number to which reference is being made if the end result is not significantly changed, such as 1 %, 2%, 5%, or 10%, for example.

[0097] Reference throughout this specification to “one embodiment”, “an embodiment”, “at least one embodiment” or “some embodiments” means that one or more particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, unless otherwise specified to be not combinable or to be alternative options.

[0098] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its broadest sense, that is, as meaning “and / or” unless the content clearly dictates otherwise.

[0099] Throughout this specification and the appended claims, infinitive verb forms are often used. Examples include, without limitation: “to detect,” “to provide,” “to transmit,” “to communicate,” “to process,” “to route,” and the like. Unless the specific context requires otherwise, such infinitive verb forms are used in an open, inclusive sense, that is as “to, at least, detect” “to, at least, provide,” “to, at least, transmit,” and so on.

[0100] A portion of the example embodiments of the systems, devices, or methods described in accordance with the teachings herein may be implemented as a combination of hardware or software. For example, a portion of the embodiments described herein may be implemented, at least in part, by using one or more computer programs, executing on one or more programmable devices comprising at least one processing element, and at least one data storage element (including volatile and non-volatile memory). These devices may also have at least one input device (e.g., a keyboard, a mouse, a touchscreen, other input elements or any operable combination thereof) and at least one output device (e.g., a display screen, a printer, a wireless radio, other output elements or any operable combination thereof) depending on the type of device.

[0101] It should also be noted that there may be some elements that are used to implement at least part of the embodiments described herein that may be implemented via software that is written in a high-level procedural language such as object-oriented programming. The program code may be written in C, C++or any other suitable programming language and may comprise modules or classes, as is known to those skilled in object-oriented programming. Alternatively, or in addition thereto, some of these elements implemented viasoftware may be written in assembly language, machine language, or firmware as needed.

[0102] At least some of the software programs used to implement at least one of the embodiments described herein may be stored on a storage media or a device that is readable by a general or special purpose programmable device. The software program code, when read by the programmable device, configures the programmable device to operate in a new, specific and predefined manner in order to perform at least one of the methods described herein.

[0103] Furthermore, at least some of the programs associated with the systems and methods of the embodiments described herein may be capable of being distributed in a computer program product comprising a computer readable medium that bears computer usable instructions, such as program code, for one or more processors. The program code may be preinstalled and embedded during manufacture and / or may be later installed as an update for an already deployed computing system. The medium may be provided in various forms, including non-transitory forms such as, but not limited to, one or more diskettes, compact disks, tapes, chips, and magnetic and electronic storage. In alternative embodiments, the medium may be transitory in nature such as, but not limited to, wire-line transmissions, satellite transmissions, internet transmissions (e.g., downloads), media, digital and analog signals, and the like. The computer useable instructions may also be in various formats, including compiled and non-compiled code.

[0104] Accordingly, any device described herein that executes software instructions may include or otherwise have access to computer readable media such as storage media, computer storage media, or data storage devices (removable and / or non-removable) such as, for example, magnetic disks, optical disks, or tape. Computer storage media may include volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data. Examples of computerstorage media include RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information, and which can be accessed by an application, module, or both. Any such computer storage media may be part of the device or accessible or connectable thereto.

[0105] The various embodiments described herein generally relate to medical devices and systems for delivering treatment using electromagnetic radiation within body lumens, which may be used for performing various treatments, such as, but not limited to, brachytherapy and phototherapeutic applications including photodynamic and / or phototherapy applications.

[0106] Various method and system embodiments described herein allow for precise positioning of the EMR treatment device within body lumens, using a sheath device, are taught herein. The positioning of the EMR treatment device is crucial to maximize treatment efficacy and minimize damage to healthy tissue.

[0107] It should be noted that the term “body lumen" includes various physiological lumens, such as in various “hollow organs” (e.g., organs having channels or pathways, in a human or an animal.

[0108] In at least one embodiment, the sheath device may be used in conjunction with an EMR treatment device, such as a vaginal multi-channel applicator (MCA) to deliver radiation to a tumor or lesion using high-dose rate (HDR) brachytherapy. In such cases, the sheath device has a body having at least a portion that is preferably made of material that does not attenuate, or minimally attenuates the electromagnetic radiation provided by the EMR treatment device. However, in either case the generated radiation dose or treatment light may be adjusted in intensity to address any attenuation due to the sheath device.

[0109] Alternatively, in at least one embodiment, the sheath device may be used in conjunction with an EMR device, such as a Phototherapy probe (e.g., PT probe), to deliver light therapy to a tumour or lesion. In such cases, the body of the sheath device has a portion that is preferably made of material that does not attenuate or has minimal attenuation in the light wavelengths used for light therapy.

[0110] Alternatively, in at least one embodiment, a single sheath device may be used with at least two EMR treatment devices where one of the EMR treatment devices generates radiation during radiation treatment, such as an MCA, and one of the EMR treatment devices generates light during light treatment, such as a phototherapy probe. In such cases, the body of the sheath device has a portion that is preferably made of material that does not attenuate, or minimally attenuates, the electromagnetic radiation or light therapy provided by the EMR treatment device.

[0111] In any of the embodiments of the sheath devices described herein that may be used with different types of EMR treatment devices, the sheath device has features that improve the treatment planning and placement of the EMR treatment device such that the treatment delivery more closely aligns with the location of a target region that needs treatment such as a tumor or lesion, for example. An EMR treatment device, such as an MCA for High Dose Rate (HDR) brachytherapy for example, is a device which is cylindrical with multiple longitudinal channels that is inserted into a body lumen, such as a vagina or rectum, for example. Catheters are inserted into channels and connected to the HDR delivery device. Radiation treatment delivery plans are created by assigning / defining which catheters are used, which dwell positions with-in each catheter are used (the delivery device can position the HDR source at multiple positions within each catheter), and how long the source stays at each dwell position.

[0112] Typically, the radiation is delivered in multiple fractions. Although devices are used at the proximal end of the EMR treatment device to ensure insertion reproducible depth of the EMR treatment device, there is stillpositional uncertainty. For example, a body lumen, such as the vagina, is a flexible organ and the EMR treatment device can be inserted at different angles, rotations, or depths thus altering the original relationship between the target region (e.g., tumor) and EMR treatment device. Without real-time imaging, a margin must be included in treatment planning. This increases dose to the organs being treated which increases risk of damage for tissues that surround the target region, including, but not limited to, the vaginal mucosa in the case of vaginal treatment. However, using a sheath device, that is defined according to the teaching herein, a physician can accurately place the EMR treatment device for each fraction, ensuring correct placement (or at least reducing placement error) which results in reducing any extra radiation dose that may be otherwise needed when using conventional techniques.

[0113] Another challenge is that mucosal disease that is less than ~2mm thick is difficult to see on MRI and CT scans because of the lack of tissue contrast and limited resolution. However, using a sheath device described according to the teachings herein, may allow for better visualization and location of the target region and then using the sheath device in conjunction with an EMR treatment device during treatment allows for the development of HDR treatment plans that ensure, or at least improve the accuracy of, treatment delivery to the location of the mucosal disease in the body lumen.

[0114] Typically, the usage of EMR treatment devices such as MCAs is limited to clinical centres that are able to use MRI or CT for image guidance using the MCA. However, using a system taught herein, which includes an EMR treatment device such as the MCA and the sheath device, clinicians without access to radiological imaging will still be able to use EMR treatment devices for accurate delivery of HDR radiation therapy.

[0115] The sheath devices described herein therefore allow, under direct visualization, the insertion and planning of standard EMR treatment devices including but not limited to: an HDR brachytherapy device, an MCA device, a PDT device, etc. for improved radiation delivery.

[0116] Referring now to FIG. 1 , shown therein is a front view of a sheath device 100, according to an example embodiment. The sheath device 100 may be a cylindrical tube 102 with a hemispherical cap 106 at a first end thereof. The cylindrical tube 102 provides a body for the sheath device 100 defining an interior channel for receiving an Electromagnetic Radiation (EMR) treatment device, an imaging device (e.g., an endoscope) or a visualization device (e.g., a light source). The sheath device 100 is designed such that the EMR treatment device can be slidingly, and removably inserted inside the interior channel of the body in a snug manner such that any air gap between the outer surface of the EMR treatment device and the inner surface of the body of the sheath device 100 is minimal. For example, the internal diameter of the body of the sheath device 100 may be selected to provide an air gap when the EMR device is inserted such that a user can insert and remove the EMR treatment device from the sheath device with little physical resistance between the devices while also keeping the air gap small to reduce any attenuation effects during transmission of radiation from the EMR treatment device to the target region of the body lumen.

[0117] As described previously, the sheath device 100 may be made of material so that a portion of the body of the sheath device 100 is transparent to the light wavelengths used during phototherapy. In at least one embodiment, the sheath device is transparent and highly transmissive in the optical spectrum for the purposes of visualizing the organ mucosa. In at least one embodiment, a portion of the body of the sheath device 100 is alternatively or additionally permeable to electromagnetic radiation so that there is minimal attenuation of radiation doses provided by EMR treatment devices such as an MCA during treatment.

[0118] The sheath device 100 further includes a coordinate mapping system located at the body 102. The coordinate mapping system can be used to obtain at least one set of coordinates for at least one portion of the body lumen (e.g., the target region) during imaging using an imaging device or visualization which may be done using the human eye.

[0119] In at least one embodiment, the coordinate mapping system has a grid pattern of lines including at least one horizontal line 104 that circumnavigates the diameter of the sheath device body 102.

[0120] In at least one embodiment, the coordinate mapping system has a grid pattern of lines including at least one vertical line 108 that are located along the length of the sheath device body.

[0121] In at least one embodiment, the grid pattern of lines may include multiple vertical lines 108 located along the circumference of the sheath device body; and multiple horizontal lines 104 can be located along the length of the sheath device body to form a grid pattern.

[0122] In at least one embodiment, the grid is marked to identify the depth of the horizontal lines 104, and the rotation of each vertical line relative to a reference point.

[0123] In at least one embodiment, the number of vertical lines 108 corresponds to the number of catheters in the corresponding EMR treatment device.

[0124] The vertical lines 108 can be placed at regular intervals, for example, spaced 1 mm to 50 mm apart from one another. The horizonal lines 104 can be placed at regular intervals, for example, spaced 1 mm to 50 mm apart from one another.

[0125] In at least one embodiment, the sheath device further includes an aperture 110 to allow for releasable coupling of the sheath device body to the EMR treatment device so that the EMR treatment device is always at the same orientation when it is inserted into and coupled (i.e., locked) with the sheath device 100.

[0126] In at least one embodiment, the body of the sheath device is made of acrylic (also known as polymethyl methacrylate (PMMA)), polysulfone (PSU), polycarbonate, or polyetherimide (PEI), or any other suitable polymer, composite, or glass material. In at least one embodiment, the body of the sheath device can be 3D-printed and subsequently coated to show thegridlines. In at least one embodiment, the applicator can be constructed of a flexible material to allow the sheath to be easily inserted and maneuvered within a physiological cavity. For example, the sheath device can have a degree of flexibility of around 20°.

[0127] Referring now to FIG. 2, shown therein is a front view of an electromagnetic radiation (EMR) treatment delivery system 200, according to an example embodiment. The electromagnetic radiation (EMR) treatment delivery system 200 comprises the sheath device 100, according to the embodiment described in FIG. 1 (although other sheath device embodiments may be used); and a EMR treatment device 207.

[0128] The EMR treatment device 207 comprises a locking component 209 for removably coupling with the aperture 110 of the sheath device. The locking component 209 can be removably affixed to the EMR treatment device 207, such as by a screw mechanism or magnetic mechanism. The EMR treatment device 207 is removably insertable within the sheath device body 102 by removing the locking component 209, placing the EMR treatment device within the sheath device body 102; aligning the aperture 110 with the aperture on the EMR treatment device (not pictured); and inserting the locking component 209 into the aperture 110 and the aperture on the EMR treatment device. The locking component prevents longitudinal and rotational movement of the EMR treatment device relative to a longitudinal axis of the sheath device.

[0129] In at least one embodiment, the locking component comprises a notch 203 and clip so that the treatment device can be inserted into the sheath device in only one orientation (e.g., a desired orientation) with each use.

[0130] The ability to lock the EMR treatment device with the sheath device in the same orientation for every use allows for the EMR treatment device to be calibrated / setup so that the elements of the EMR treatment device that generate the radiation dose or light therapy are fixed in position relative to the at least one set of coordinates for at least one portion of the body lumen (e.g., the target region) that requires treatment based on the mapping done using the sheath device 100.

[0131] The EMR treatment device can be any suitable EMR device capable of delivering radiation. In at least one embodiment, the EMR device can be a Multi-channel Applicator (MCA) device or a Phototherapy device, examples of which are described herein. The controls of the EMR device can be accessible through the base 205 of the EMR device 207.

[0132] Referring now to FIG. 3 shown therein is a block diagram of an electromagnetic radiation (EMR) treatment delivery system 200 and apparatus for visualizing a portion of the body lumen using a computer-implemented treatment-planning system 300, according to an example embodiment.

[0133] In the embodiment shown in FIG. 3, the EMR treatment device is inserted into the sheath device to form the EMR treatment delivery system 200. The distance between the sheath device and the EMR treatment device is shown by numeral 303, showing an airgap. The distance (i.e. , airgap) between the sheath device and EMR treatment device can be preferably even on all sides. In at least one embodiment, the distance 303 between the sheath device and the EMR treatment device should be negligible, or almost 0 mm once the EMR treatment device is inserted and fixed in place. In at least one embodiment, the distance 303 between the sheath device and the EMR treatment device should be minimized once the EMR treatment device is inserted and fixed in place. In at least one embodiment, the EMR treatment device can smoothly and tightly fit the inner diameter of the body of the sheath device such that there is almost no air gap between these devices.

[0134] In at least one embodiment, the radial and longitudinal dimensions of the sheath device and the treatment device are such that there is an air gap between an inner diameter of the sheath device and an outer diameter of the treatment device where the air gap is less than about 2 mm.

[0135] The treatment-planning system 300 can be computer implemented. The treatment-planning system can be coupled to an imaging device that is coupled to the EMR treatment delivery system 200 to provide precise positioning of the EMR treatment device. The sheath device is used to position the delivery of electromagnetic treatment, while the EMR treatmentdevice provides the treatment itself. The system 200 can be used with a visualization device or an imaging device that allows a lesion that is present on the mucosal surface to be seen, either with the naked eye or an optical scope or superficial imaging system (e.g., white light endoscopy or fluorescence endoscopy, etc.).

[0136] Visualization may mean locating the lesion / target region for the purposes of mapping it onto the coordinate system of the sheath device. For example, one may visualize with a video endoscope if it is used to find / view the lesion / target region and map it to the coordinate system. One may also visualize using a white light source and using their eyes to find / view the lesion / target region and map it to the coordinate system.

[0137] Imaging may mean recording an image of the lesion / target region to obtain its location. In at least one embodiment, the imaging device refers to device that captures an image, such as, but not limited to, a camera endoscope, a video endoscope, an MRI device or a CT device, for example.

[0138] In at least one embodiment, when a set of coordinates of the sheath device align with the target area, the coordinates can be recorded. In at least one embodiment, the coordinates can be recorded in an electronic manner, and / or by pen-and-paper and / or by a manner that does not include the optical image.

[0139] The system 200 allows for precise positioning of EMR treatment devices and applicators thereby facilitating targeted treatment to a target region in the body, such as a suspected cancerous lesion, while reducing the risk to healthy tissue in a body lumen.

[0140] When the EMR treatment delivery system 200 is coupled to an imaging device that is coupled to the treatment-planning system 300, the coordinate mapping system 202 located on the sheath device is displayed on a display / screen of the computing device, such as, for example an image 302 of the coordinate mapping system on the computing device. Therefore, lesionsand other target areas on the body lumens can be associated with a set of coordinates on the coordinate mapping system.

[0141] Thereafter, when the EMR treatment device is activated, the physician can use the same coordinate system as a guide to locate the lesion and deliver focused EMR treatment to only the target region that requires treatment. In at least one embodiment, the at least one set of coordinates for at least one portion of the body lumen (e.g., the target region) that is determined using the coordinate mapping system 202 corresponds to the dwell position of the catheter or light sources within the EMR device used to deliver the radiation dose or light therapy. As such, the physician can activate the treatment sources (e.g., light sources or radiation sources) corresponding to the target region and deactivate the lights corresponding to the remaining healthy regions of the lumen. This helps reduce the risk of electromagnetic radiation to healthy tissue in a body lumen.

[0142] Referring now to FIGs. 4, 5 and 6, shown therein are various views of the sheath device, according to an example embodiment. As previously described, the sheath device 400 includes a transparent cylindrical tube 402 with a hemispherical cap 406 at a first end thereof. The cylindrical tube 402 consists a transparent body defining an interior channel for receiving an Electromagnetic Radiation (EMR) treatment device.

[0143] The sheath device further includes a coordinate mapping system 404, 408 located on the body 402. The coordinate mapping system on the sheath device includes vertical gridlines 408 and horizontal gridlines 404 for precise positioning. In at least one embodiment, the coordinate mapping system comprises a plurality of markings being placed at regular intervals on the body of the sheath device. In at least one embodiment, the coordinate mapping system appears on an interior surface of the sheath device with marking intervals ranging between, and including about 1 mm to about 5 mm. In at least one embodiment, the coordinate mapping system on the sheath device is identified with alphanumeric coordinates for accurate locationreferencing. In at least one embodiment, the coordinate mapping system comprises a grid with longitudinal alphabet lettering and latitude numbering.

[0144] The surface of the sheath device features a mapping system for targeting. In at least one embodiment the mapping system is a grid with alphanumeric markings at increments. In at least one embodiment the alphanumeric markings are seen normally from the interior and in mirror image when viewed through the transparent side of the sheath from the exterior. In at least one embodiment the markings start from a zero-point aligned with the part of the sheath that would align with the anal verge in treatments of the rectum. In one embodiment, typically useful for PDT applications, the radial and vertical increments are spaced at 5 mm intervals. In at least one other embodiment, typically useful for brachytherapy applications, the radial and vertical increments are spaced at 1 mm intervals. In at least one embodiment, the coordinate map is printed on the surface. In another embodiment the map is etched onto the surface. The outer surface of the sheath must be smooth without sharp edges or ridges of any kind. Consequently, if the map is etched, it must be etched on the inner surface of the sheath.

[0145] In at least one embodiment, the sheath device is constructed from a biologically inert and medical-grade material that is transparent to electromagnetic radiation ensuring both visualization of mucosal lesions and delivery of optical radiation. The sheath device has minimal attenuation of EM radiation, and has high transparency. In at least one embodiment, the transparency refers to the visual distinctness of an object when viewed through a material. Having a high transparency can be preferred in the embodiments when the device is used to visualize objects.

[0146] The optimal therapeutic window for certain phototherapeutic applications, such as PDT, is with light between 600 to 800 nanometers (nm) in wavelength. The visible spectrum of light encompasses wavelengths from 400-700 nm. In at least one embodiment, at least a portion of body of the sheath device is transparent to electromagnetic radiation in the light wavelength range of 400 to 900 nm equally in both directions (i.e. light traveling in / out ofthe transparent wall). In at least one other embodiment, the transparency of at least a portion of the body of the sheath depends on the direction of the light travel, allowing white light or fluorescent light to enter the sheath to allow the lesion to be visualized while allowing phototherapy activation wavelengths to travel from the interior of the sheath outwards to the lumen to allow the lesion to be treated. The sheath material minimally attenuates EM radiation and in at least one embodiment has over about 95% transmission. In at least one embodiment, the sheath device has minimal attenuation of EM radiation, and has a transparency value greater than 90%, and preferably greater than 95%. In at least one embodiment, the attenuation value is less than 5%.

[0147] The sheath device material is selected so that it is preferably strong enough to withstand the muscular strength of the relevant body luminal structure that it is inserted into without breaking. In at least one embodiment, the sheath device material is selected so that it may undergo various rounds of sterilization without, or minimally, compromising physical integrity of the sheath device body. In at least one embodiment, when used in a brachytherapy application, the sheath material is preferably selected to withstand common treatment doses of ionizing radiation, such as up to about 50 Gy, delivered multiple times (<20) without compromising its physical characteristics.

[0148] In at least one embodiment, the body of the sheath device is made of acrylic (also known as polymethyl methacrylate (PMMA), polysulfone (PSU), polycarbonate, or polyetherimide (PEI), or any other suitable polymer, composite, glass material.

[0149] In at least one embodiment, the material used for the body of the sheath device may be selected so that the sheath device meets and / or exceeds the minimum medical industry standards (such as ISO standards, European Medical Device Directives, etc.) for medical devices for mechanical properties, strength, sterilization, and radiation.

[0150] In at least one embodiment, the sheath device can be made of a material that can be sterilized using standard methods.

[0151] In at least one embodiment, the sheath device further comprises an external component that is attached to the sheath device and allows for manipulation and attachment of other tools, such as the EMR treatment device or a visualization device, for example. In at least one embodiment, the external component comprises a handle-like device (of the appropriate size and shape to be firmly and ergonomically grasped by a human hand) that attaches to and interlocks with a portion of the body of the sheath device. The external component allows the user to insert and rotate the sheath device, such that the mucosal lesion in question (e.g., target region) is encompassed in as few coordinate system units as possible. This enables precise targeting of the lesion in question, by allowing for rotating the coordinate system of the sheath device to obtain a set of coordinates with the smallest footprint to map the lesion with as little margin as possible, so that treatment with the EMR treatment device is more aligned with the lesion while limiting off-target irradiation. An example of this is shown in FIGS. 23A and 23B, wherein in FIG. 23A the sheath device 2302 is oriented such that the lesion / target region 2304 occupies 4 units of the coordinate mapping system which would result in a larger margin if the EMR treatment device is configured to provide treatment to the region of the body lumen associated with (e.g. located at) these 4 units of the coordinate mapping system. However, if the orientation of the sheath device 2302 was rotated, as in FIG. 23B, so that the lesion / target region 2304 occupies 2 units (instead of 4 units) of the coordinate mapping system then the result is a smaller margin when the EMR treatment device was configured to provide treatment to the region of the body lumen associated with the location of these 2 units of the coordinate mapping system. In at least one embodiment, the external component may be a white light source, a camera or a video endoscope, that can help facilitate direct visualization of any mucosal lesions within the body lumen. In at least on embodiment, the white light source or camera may be built integrated with the external component.

[0152] Referring now to FIG. 7, shown therein is two pairs of a sheath device and an EMR treatment device, according to an example embodiment. In the embodiment shown in the left side of FIG., the EMR treatment device 407a hasa larger relative circumference than the EMR treatment device 407b shown in the right side of FIG. 1 . As such, the sheath device 400a is slightly larger than the sheath device 400b. The measurements of the sheath device 400 are selected to accommodate treatment within body lumens such as the vagina or rectum being sufficiently wide that it fits snugly into patients but not so large that it causes trauma. In at least one embodiment, the sheath device may have a length between about 25 cm and about 15 cm and an outer diameter of up to about one of the following: 5 cm, 4 cm, and 3 cm. In at least one embodiment, the distal tip of the sheath device is tapered to a blunt point or hemispherical shape 406 to avoid injury to body tissues, maintaining the same optical properties as the rest of the device. FIG. 8 shows a sheath device and an EMR treatment device, according to example embodiments, along with a scale ruler to show an example of the sizes of these devices.

[0153] Referring now to FIGs. 9A and 9B shown therein is a bottomperspective view of an electromagnetic radiation (EMR) treatment delivery system, according to two example embodiments. The EMR treatment device can be any suitable EMR device capable of delivering radiation. In at least one embodiment, the EMR device can be a Multi-channel Applicator (MCA) device; or a Photo-therapy (PT) device. The treatment device for brachytherapy can be a commercially available multi-channel applicator (MCA). In at least one embodiment, the sheath device can be dimensioned or designed to accommodate and internally receive the commercial MCA. The controls of the EMR device can be accessible through the base 405 of the EMR device 407.

[0154] The EMR devices shown in FIGs. 9A and 9B are Multi-channel Applicator (MCA) devices. The MCA device comprises a plurality of channels 413 that are accessible by the base of the device 405. The MCA device further comprises a larger channel located at the core of the device 411 for accessing the body lumen or for provided an imaging source such as a camera or imaging light source.

[0155] In at least one embodiment, the sheath device facilitates cointroduction with an endoscope or light source (i.e., within the lumen of thesheath). In at least one embodiment, the sheath device is designed for ambidextrous use, by using a body that has as a symmetrical shape, allowing easy insertion and manipulation with either hand (e.g., ambidextrous use).

[0156] In at last one embodiment, the treatment device preferably fits snugly into the sheath device, minimizing air gaps that may otherwise affect the transmission of the electromagnetic spectrum while also not fitting so tightly that air or material resistance or friction can make it difficult for an operator to insert the treatment device into the sheath device. In at least one embodiment the gap is 1 mm or less. The treatment device generally includes a mechanism that prevents rotation of the treatment device relative to the sheath device.

[0157] Referring now to FIGs. 10 and 11 , shown therein is a front view and partial front view, respectively, of an electromagnetic radiation (EMR) treatment delivery system shown with a rule scale to indicate size, according to an example embodiment.

[0158] The EMR treatment device 1107 comprises a locking component 1109 for removably coupling with the aperture 1110 of the sheath device. The locking component can be activated / used to prevent movement along the length of the sheath or radial rotation once the treatment device is in its proper place. The locking component 1109 can be removably affixed to the EMR treatment device 1107. In at least one embodiment the locking component 1109 is a screw. In at least another embodiment, the locking component 1109 is a magnet.

[0159] The EMR treatment device 1107 is removably insertable within the sheath device body 1102 by removing the locking component 1109, placing the EMR treatment device within the sheath device body 1102; aligning the aperture 1110 with the aperture on the EMR treatment device 1107, and inserting the locking component 1109 into the aperture 1110 and the aperture on the EMR treatment device 1107. The locking component prevents longitudinal and rotational movement of the EMR treatment device relative to a longitudinal axis of the sheath device.

[0160] In at least one embodiment, the sheath device can include a lengthwise groove and the treatment device can have a protrusion that fits within the groove allowing it to slide along as the treatment device is inserted into the sheath device.

[0161] Referring now to FIG. 12 shown therein is an image of a body lumen showing an internal view of a sheath device, according to an example embodiment.

[0162] When the EMR treatment delivery system is coupled to an imaging device that is coupled to the treatment-planning system, the coordinate mapping system located on the sheath device is displayed on a display / screen connected to or integral with the computing device so that the display / screen shows an image 1202 of the coordinate mapping system on the computing device. Therefore, lesions and other target areas on the body lumens can be associated with a set of coordinates on the coordinate mapping system and with the treatment device.

[0163] Referring now to FIGS. 13 and 14 shown therein are images of a body lumen showing an internal view of a sheath device, according to example embodiments. A physician can insert the EMR treatment delivery system into a body lumen, such as into the vagina. Either by direct visualization with a light source and the naked eye, or with imaging using a camera or endoscope, the clinician may identify the regions on the grid have a set of coordinates that line up with where the disease is present in the body lumen. If a camera or endoscope is used, a digital picture may be acquired to confirm the location of the disease. For example, in the image shown in FIG. 14, the lesion 1302 can be identified around coordinate H-4. The EMR treatment device may then be inserted and locked into place. Using the known relationship of the grid lines and the EMR treatment device, the grid locations that align with the disease 1302 may be used to create a treatment plan. Thereafter, when the EMR treatment device is activated, the physician can use the same coordinate system as a guide to locate the lesion and deliver focused EMR treatment to only the target region that requires treatment. In at least one embodiment, thecoordinate mapping system 1202 corresponds to the catheter or lights within the EMR device. As such, the physician can activate the lights corresponding to the target region 1302 and deactivate the lights corresponding to the remaining healthy regions of the lumen. This helps reduce the risk of electromagnetic radiation to healthy tissue in a body lumen.

[0164] Referring now to FIG. 15, shown therein is an image that may be shown using a computer-implemented treatment-planning system, according to an example embodiment. In this embodiment, a brachytherapy treatment planning software is shown. The radiation sources can be individually controlled and activated based on location of the lesion in reference to the EMR treatment device.

[0165] Referring now to FIG. 16, shown therein is an image that is obtained / displayed using a computer-implemented treatment-planning system, according to another example embodiment. In this embodiment, a brachytherapy treatment planning software is shown, and the planning software can be applied to delivering other types of treatment such as, but not limited to optical radiation via a phototherapy probe. In the embodiments shown in FIGs. 15 and 16, the treatment device shown is a multi-channel applicator (MCA).

[0166] In at least one embodiment, the treatment device can deliver EM radiation treatment to a targeted region while simultaneously excluding other areas from the radiation. The treatment device features at least one EM radiation or light source, preferably a radially arranged grid of sources, that correspond with at least one grid location displayed on the sheath device. Multiple channels in the treatment device enable dose delivery tailored to the spatial extent of the mucosal disease.

[0167] In at least one embodiment, each EM radiation and / or light source is independently controllable. In at least one embodiment the EM radiation sources are radioactive, or forms of ionizing radiation sources. In at least one other embodiment, the EMR treatment device is a PT device and the light sources are LEDs. In another embodiment, , the EMR treatment device is a PT device and the light sources are optical fibers that provide light from a lightemitting source. In at least one embodiment the intensity of the light sources or the radiation sources is tunable. In at least one embodiment the wavelength of light emitted by the light sources is tunable. In at least one embodiment, the duration during which the generated light is transmitted to the target region of the lumen body is adjustable.

[0168] In at least one embodiment, one side of the body of the sheath device may be transparent and the other is opaque, thereby blocking light from reaching healthy tissue. In at least one embodiment the opaque side of the sheath is mirrored.

[0169] In at least one embodiment, the EMR treatment delivery device is made of biologically inert material and medical grade material.

[0170] In at least one embodiment the EMR treatment delivery device is mad of material that can undergo sterilization without compromise to the physical characteristics of the device.

[0171] In various embodiments described herein, the EMR treatment delivery device is electrically insulated and safe to handle.

[0172] In one embodiment, the sheath device and the EMR treatment are functional if submersed in water.

[0173] Referring now to FIG. 17 shown therein is an image of a body lumen showing an internal view of a sheath device, according to an example embodiment. In this example, the lesion is seen between coordinates D1 , F1 , D2 and F2. FIG. 18 shows an image of an example of a computer-implemented treatment-planning system, according to an example embodiment.

[0174] In the treatment planning system, the dwell positions in three channels within the vicinity of D1 and D2 may be activated, i.e. positions where the radiation source would stop for delivery of radiation. Dwell positions in the remaining channels close to grid points D3, D4, D5 are not used. Furthermore, looking along the length of the treatment device, dwell positions within each of these three treatment delivery device channels located between sheath rings C to F may be activated. Dwell positions between sheath rings A to C, and dwellpositions between sheath rings F - O are not activated. FIG. 19 provides a 3-D image of the exemplary planned treatment, according to an example embodiment. As indicated previously, radiation source dwell positions in the treatment delivery channels closest to sheath grid positions D1 , E1 , C2, D2, E2 are activated while all other dwell positions are not activated.

[0175] In at least one embodiment, the system is designed for the treatment of intraluminal diseases, such as cancers, or sites with visible mucosal disease or other conditions that are accessible via natural orifices, or via intraoperative system placement. For example, in at least one embodiment, the system can be used to visualize, map, and treat Barrett’s oesophagus (precancerous lesions), unresectable rectal polyps (precancer), or infections in urologic contexts. Examples include treatment of early and intermediate stage disease that is localized within a body lumen, including but not limited to: rectal wall, vaginal wall, colon, esophagus, ear, nose, throat, or as part of chemoradiation or pre / post-surgery. Treatment is based on visualization of disease, which may include clinical exam (for example, speculum exam), endoscopy, or proctoscopy. Prior diagnostic imaging can be used to define prescription depth into the lumen wall.

[0176] In a clinical scenario for vaginal brachytherapy, a lubricated sheath device is first inserted into the vagina. The transparent sheath device allows for direct visualization of the disease and noting of grid coordinates. The EMR treatment delivery device, such as a commercially available Multichannel Applicator (MCA), is then inserted and secured in place. The aperture on the sheath aligns with the protrusion on the EMR treatment device, ensuring correct radial and / or longitudinal orientation. A treatment plan is optimized to target only the relevant grid coordinates. After quality assurance, the treatment is delivered by instructing the afterloader to execute the treatment plan. This process is repeated for each treatment fraction.

[0177] In an anorectal PDT scenario, the patient may be first injected with Photofrin approximately 2 days before the EMR treatment. At the time of treatment, the lubricated sheath is inserted into the rectum, optionally with thehelp of a speculum. The lesion is visualized, and grid coordinates are noted. Other anatomical markings noted visually through the transparent sheath may also be used to define the extent of bulk disease. The EMR treatment delivery device is then inserted into the sheath, and PDT light therapy is delivered to the coordinates where the lesion appeared.

[0178] In at least one embodiment, the EMR treatment device can be a Phototherapy probe for providing photo-dynamic therapy. Referring now to FIG. 20 shown therein is a front view of a probe device system 2000, according to an example embodiment. The probe device system 2000 comprises a Phototherapy (PT) probe 2002, and a plurality of light sources 2004. The probe device 2002 is a light applicator for phototherapeutic interventions, and may be used for various applications including, but not limited to, photodynamic therapy (PDT) and photothermal therapy, for example. For instance, in one example, the probe device system 2000 may be used for the treatment of rectal malignancy with photodynamic therapy (PDT). The current clinical indications for PDT are limited, and few purpose-built light-delivery devices have been developed; none have been expressly developed for the treatment of certain luminal cancers, such as rectal cancer. The most relevant comparable indications are for the treatment of Barret’s esophagus / esophageal cancer (palliative) and bronchogenic (lung) cancer, as both are luminal cancers requiring intra-luminal light delivery. Currently for these indications light is delivered via a single fibre optic which is passed through the working port of the gastroscope / bronchoscope, and importantly does not allow coordinate mapping and targeted radiation delivery.

[0179] The probe device system 2000 includes a probe 2002 designed to be introduced through the lumen of a rigid proctoscope. The phototherapy probe is then seated into the sheath and the light sources at the coordinates corresponding to the lesion location are activated. In at least another embodiment, the sheath device can replace the rigid proctoscope, with the added benefit of the coordinate mapping system. The phototherapy probe isthen seated into the sheath and the light sources at the coordinates corresponding to the lesion location are activated.

[0180] The probe has a plurality of channels, for example six channels around the inner circumference of the probe, as well as three more located centrally. Other configurations of the channels are also possible, such as but not limited to 2 to 12 channels around the inner circumference, and 2 to 12 channels located in the core of the probe device.

[0181] The design can also include other configurations of channels depending on the tumour size and shape. The channels can span the length of probe and are designed to hold light sources 2004, including but not limited to optical fibres. In at least one embodiment, the position of the LEDs or the portion of the optical fibers that display generated treatment light can be varied in the body of the PT probe to correspond to the set of coordinates determined from mapping using the sheath device. Accordingly, in the case of optical fibers, the length of the optical fibers may be different so that the portion of the optical fibers displaying the generated light is at the right location.

[0182] The probe device can be composed of translucent material so that light passes through it easily with minimal attenuation. The material may also be preferably colourless to deliver the appropriate wavelength of light to the lumen of the body. In either case, the intensity of the generated light may be adjusted to compensate for any attenuation of the body of the probe device.

[0183] In at least one embodiment, the probe material may be either scattering or non-scattering.

[0184] Additionally, and in at least one embodiment, part of the probe may be coated with either light absorbing or light reflecting material around some part of its circumference in order to restrict the treatment light to only a limited circumferential sector. Absorbing material prevents other angular ranges around the rectal luminal circumference from significant light exposure. Reflecting material achieves the same function, while also maximizing the total light delivered to the target area.

[0185] Selection of the number and placement of the light-delivery fibres, the optical power and energy delivered to each, and the length of each diffusing fibre may be optimized to provide highest uniformity of light dose delivery to the target, using pretreatment planning based on radiological and / or endoscopic imaging of the tumor and rectum.

[0186] The same PT probe can be used to provide photodynamic therapy or photothermal therapy by changing the wavelength, intensity and treatment duration of the generated light based on the type of therapy to be delivered. In another potential application of phototherapy using the PT probe, the PT probe may be operated with a lower intensity for the generated lights relative to the intensity used for PDT which may elicit changes in gene expression, which may be helpful for certain treatments such as cosmetic treatments, for example.

[0187] As another example, to deliver PT irradiation to a rectal lesion, the medical team (attending physician, radiation physicist, etc.) would insert one or more fibre optics into the channels of the light applicator in positions calibrated to deliver the prescribed light dose. In the endoscopy suite or operating room, the physician would then directly visualize the lesion through a proctoscope, noting its depth (distance from the anal verge) and circumferential position (o’clock). The physician may then introduce the PT probe I applicator through the lumen of the proctoscope so that the treatment region of the PT probe I applicator abuts the lesion / target region. The proctoscope may then be withdrawn and the fibre optics or LEDS, depending on implementation, may be illuminated and light delivered. Alternatively, the sheath device may be used for visualizing the lesion and the physician may then introduce the PT probe I applicator into the sheath device so that the PT probe I applicator abuts the lesion / target region.

[0188] Referring now to FIG. 21 shown therein is a cut-out view of a probe 2100 device to show the internal components, according to an example embodiment. The phototherapy probe 2100 includes a body 2102 having a circumferential wall 2106 defining a hollow space 2108 therein. The body 2102 has a distal tip 2110 and a longitudinal axis 2112. In at least one embodiment,the body of the phototherapy device 2100 can be made of material that is optically transparent in a wavelength range of the treatment light.

[0189] The phototherapy probe further includes a plurality of support members 2114 located within the lumen and attached to the circumferential walls 2106. The support members can be spaced apart from one another along the longitudinal axis 2112 of the body 2100. Each of the plurality of support members 2114 can have apertures 2116 arranged in a grid. The apertures 2116 on different support members 2114 can be axially aligned to one another. In at least one embodiment, the plurality of support members can be radial plates that span a length of the phototherapy probe.

[0190] In at least one embodiment, a scattering portion of the body of the probe device is made of a light-scattering material.

[0191] In at least one embodiment, a non-scattering potion of the body of the probe device is made of a non-light-scattering material.

[0192] In at least one embodiment, at least a portion of the body of the probe device can be coated with a light-absorbing material around at least a portion of a circumference of the body of the probe device where the light-absorbing material prevents non-target regions of the body lumen from receiving the treatment light.

[0193] In at least one embodiment, at least a portion of the body is coated with a light-reflecting material around at least another portion of the circumference of the probe wherein the light reflecting material prevents nontarget regions of the body lumen from receiving the treatment light and increasing an amount of the treatment light delivered to a target region of the body lumen by reflecting the treatment light thereto.

[0194] In at least one embodiment, the phototherapy probe can be made of biologically inert material and / or medical grade material. In at least one embodiment, the phototherapy probe can be capable of sterilization without compromise to the physical characteristics of the device. In at least one embodiment, the phototherapy probe can smoothly and tightly fit the innerdiameter of the sheath device. In at least one embodiment, the phototherapy probe can lock into position in the sheath device such that it does not allow movement along the length of the sheath (i.e., sliding in / out), or radial rotation (i.e., spinning within the sheath).

[0195] Referring now to FIG. 22 shown therein is a front view of a probe device, illuminated to show the device 2200 in an active mode, according to an example embodiment. The probe 2202 can include a plurality of treatment light sources 2204 that extend longitudinally through the body via the apertures that are axially aligned. The light sources can be arranged in a pattern to generate treatment light for different types of phototherapy as explained previously. In at least one embodiment, the pattern corresponds with the at least one set of coordinates that identify a location of the at least one object of the body lumen that is a target region for receiving light therapy. In at least one embodiment, the plurality of treatment light sources can have an independently controllable tunable intensity. In at least one embodiment, the plurality of treatment light sources includes at least a plurality of optical fibers. In at least one embodiment, some of the optical fibers are dosimetry fibers for measuring a fluorescence or absorption of a photosensitizer, tissue oxygenation and / or tissue optical properties where the measurements are used to optimize delivery of the light therapy.

[0196] One or more of the probe channels may be used to place dosimetry fibers, for example to monitor the fluorescence or absorption of the photosensitizer, tissue oxygenation and / or tissue optical properties that may be used to optimize the phototherapy treatment delivery.

[0197] In at least one embodiment, a number and placement of the treatment light sources, an optical power of the treatment light sources, and a length of each treatment light source is selectable to provide a uniform light dose delivery to the target region in the body.

[0198] In at least one embodiment, the selection is done according to pretreatment planning based on radiological and / or endoscopic imaging of the target region.

[0199] In at least one embodiment, the phototherapy probe device is dimensioned to be introduced through a lumen of a rigid proctoscope or a sheath device.

[0200] In at least one embodiment, the phototherapy probe is used to deliver light therapy to a rectal lesion.

[0201] The phototherapy probe device allows, under direct visual control, selection and positioning of one or more light delivery fibres or LEDs and mounting positions along the body in order to selectively illuminate the target (tumor + margin) luminal tissue area.

[0202] In at least one embodiment, the phototherapy probe can deliver EM radiation treatment to a targeted region while simultaneously excluding other areas from the radiation. In at least one embodiment, the phototherapy probe can include a radially arranged grid of light sources, preferably LEDs, of tunable intensity and / or wavelength that correspond with the grid locations printed on the sheath component. In at least one embodiment, the phototherapy probe can have mirrors on one side (with the mirrored side facing the light source) as a means of confining EM radiation.

[0203] In at least one embodiment, the light source can be independently controllable (i.e. , any combination of light sources can be turned on / off). In at least one embodiment, the phototherapy probe can be electrically insulated and safe to handle. In at least one embodiment, the phototherapy probe can be functional and safe to handle if submersed in water.

[0204] While the applicant's teachings described herein are in conjunction with various embodiments for illustrative purposes, it is not intended that the applicant's teachings be limited to such embodiments as the embodiments described herein are intended to be examples. On the contrary, those of skill in the art will appreciate that the applicant's teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments described herein, the general scope of which is defined in the appended claims.

Claims

Claims:

1. An electromagnetic radiation (EMR) treatment delivery system for a body lumen, comprising: a sheath device having: a transparent body defining an interior channel, the body being permeable to electromagnetic radiation; and a coordinate mapping system located at the body for providing at least one set of coordinates for at least one object of the body lumen during visualization and / or imaging; and an EMR treatment device that is removably insertable within the sheath device in a desired orientation for providing targeted EMR treatment to the at least one object of the body lumen identified by the at least one set of coordinates obtained during the visualization and / or imaging, wherein the body of the sheath device is sized to slidingly receive the EMR treatment device.

2. The system of claim 1 , wherein the sheath device further comprises a sheath locking component and the EMR treatment device comprises a treatment locking component that releasably engages the sheath locking component to prevent longitudinal and rotational movement of the EMR treatment device relative to a longitudinal axis of the sheath device.

3. The system of claim 2, wherein the sheath locking component comprises a notch or an aperture and the treatment locking component includes a clip, a post or a fastener.

4. The system of claim 2 or claim 3, wherein the sheath and treatment locking components are adapted so that the treatment device is inserted into the sheath device in only the desired orientation.

5. The system of any one of claims 1 to 3, wherein radial and longitudinal dimensions of the sheath device and the treatment device are such that there is an air gap between an inner diameter of the sheath device and an outer diameter of the treatment device.

6. The system of claim 5, wherein the air gap is about 0.05 mm to about 2 mm wide.

7. The system of any one of claims 1 to 6, wherein the sheath device is constructed from a biologically inert material and / or a medical-grade material.

8. The system of any one of claims 1 to 7, wherein the sheath device is made of material that is translucent.

9. The system of any one of claims 1 to 7, wherein the sheath device is made of material that has a transparency value greater than about 90%, preferably greater than about 95% and provide an attenuation of EM radiation less than about 50%, preferably less than 5%.

10. The system of any one of claims 1 to 9, wherein the sheath device is made of material having a compressive strength for withstanding muscular strength of various physiological luminal structures without breaking.

11. The system of any one of claims 1 to 10, wherein the material of the sheath device is selected for undergoing sterilization without having its physical characteristics compromised.

12. The system of any one of claims 1 to 11 , wherein the material of the sheath device is selected for withstanding ionizing radiation up to about 50 Gy.

13. The system of any one of claims 1 to 12, wherein the sheath device has a length of about 15 cm to about 25 cm and an outer diameter of about 1 cm to about 5 cm.

14. The system of any one of claims 1 to 13, wherein a distal tip of the sheath device is tapered to a blunt point or has a hemispherical shape, and the distal tip has optical properties that are the same as the body of the sheath device.

15. The system of any one of claims 1 to 14, wherein the sheath device is dimensioned to receive an imaging and / or visualization device.

16. The system of any one of claims 1 to 15, wherein the imaging device and / or visualization device includes an endoscope and / or a light source.

17. The system of any one of claims 1 to 16, wherein the sheath device further comprises an external component for manipulation and attachment with other tools.

18. The system of any one of claims 1 to 17, wherein the sheath device has a symmetrical shape that allows for ambidextrous use; and preferably the shape is cylindrical.

19. The system of any one of claims 1 to 18, wherein the sheath device and the treatment device are shaped to minimize air gaps therebetween for reducing any attenuation of EMR transmission from the treatment device to the sheath device.

20. The system of any one of claims 1 to 19, wherein the coordinate mapping system on the sheath device includes vertical and horizontal gridlines for mapping positional data for at least one object in the body lumen.

21. The system of claim 20, wherein the coordinate mapping system comprises a plurality of markings placed at regular marking intervals at the body of the sheath device.

22. The system of claim 21 , wherein the marking intervals range from about 1 mm to about 5 mm.

23. The system of any one of claims 1 to 22, wherein the coordinate mapping system uses alphanumeric coordinates.

24. The system of claim 23, wherein the coordinate mapping system comprises a grid, preferably the grid including longitudinal alphabet lettering and latitude roman numeral numbering.

25. The system of any one of claims 1 to 24, wherein the EMR treatment device is a Multichannel Applicator (MCA).

26. The system of claim 24, when dependent on claim 23 or 24, wherein the latitude numbering of the coordinate mapping system corresponds to a number of channels in the MCA.

27. The system of any one of claims 1 to 26, wherein the EMR treatment device is a phototherapy device for providing phototherapy including photodynamic therapy or photothermal therapy.

28. The system of claim 27, wherein the phototherapy probe comprises: a body having a circumferential wall defining a hollow space therein, the body having a distal tip and a longitudinal axis; a plurality of support members located within the lumen and attached to the circumferential walls spaced apart from one another along the longitudinal axis of the body, each of the plurality of support members having apertures arranged in a grid; anda plurality of treatment light sources where each of the treatment light sources are positioned at various locations on the support members in the body of the phototherapy probe so that the light sources are arranged in a pattern to generate treatment light for photodynamic therapy where the pattern corresponds with the at least one set of coordinates that identify a location of the at least one object of the body lumen that is a target region for receiving light therapy.

29. The system of claim 28, wherein the body of the phototherapy probe is made of material that is at least partially optically transparent in a wavelength range of the treatment light and intensity of the light sources is increased to compensate for any treatment light attenuation due to the body of the phototherapy device.

30. The system of claim 29, wherein the body of the phototherapy probe is optically transparent in the wavelength range of the treatment light.31 . The system of claim 29, wherein the body of the phototherapy probe has an optical transmission of at least about 95% in the wavelength range of the treatment light.

32. The system of any one of claims 28 to 31 , wherein the plurality of treatment light sources are LEDs and / or optical fibers.

33. The system of claim 32, wherein the optical fibers extend longitudinally through the body of the phototherapy probe via apertures that are at different support members and are axially aligned to one another.

34. The system of any one of claims 28 to 33, wherein the plurality of treatment light sources each have an independently controllable tunable intensity.

35. The system of any one of claims 28 to 34, wherein the plurality of support members are radial plates that span a length of the phototherapy probe.

36. The system of any one of claims 28 to 35, wherein the phototherapy probe device is dimensioned to be introduced through a lumen of a rigid proctoscope.

37. The system of any one of claims 32 to 36, wherein some of the optical fibers are dosimetry fibers for measuring a fluorescence or absorption of a photosensitizer, tissue oxygenation and / or tissue optical properties where the measurements are used to optimize delivery of the light therapy.

38. The system of any one of claims 28 to 37, wherein the body of the PT probe has a light-scattering portion made of a light-scattering material.

39. The system of any one of claims 28 to 37, wherein the body of the PT probe has a non-light-scattering portion made of a non-light-scattering material.

40. The system of any one of claims 28 to 39, wherein a number and placement of the treatment light sources, an optical power of the treatment light sources, and a length of each treatment light source is selectable to provide a uniform light dose delivery to the target region in the body.

41. The system of claim 40, wherein the selection is done according to pretreatment planning based on radiological and / or endoscopic imaging of the target region.

42. The system of any one of claims 28 to 41 , wherein at least a portion of the body is coated with a light-absorbing material around at least a portion of a circumference of the body wherein the light-absorbing material prevents nontarget regions of the body lumen from receiving the treatment light.

43. The system of any one of claims 28 to 41 , wherein at least a portion of the body is coated with a light-reflecting material around at least another portion of the circumference of the probe wherein the light reflecting material prevents non-target regions of the body lumen from receiving the treatment light and increasing an amount of the treatment light delivered to a target region of the body lumen by reflecting the treatment light thereto.

44. The system of any one of claims 28 to 43, wherein the phototherapy probe is used to deliver light therapy to a rectal lesion for the purposes of photodynamic therapy.

45. A method of mapping and treating at least one object in a body lumen using a sheath device and an Electromagnetic Radiation (EMR) treatment device, wherein the method comprises: placing a sheath device in the body lumen, the sheath device having: a transparent body defining an interior channel, the body being permeable to electromagnetic radiation; and a coordinate mapping system located at the body for providing at least one set of coordinates for at least one object of the body lumen during imaging and / or visualization, wherein the body of the sheath device is sized to slidingly receive a visualization device, an imaging device, and / or the EMR treatment device; placing the imaging device inside the sheath device; using the coordinate mapping system of the sheath device to obtain at least one set of coordinates for at least a portion of the body lumen being a target region during the visualization and / or imaging; and placing the EMR treatment device inside the sheath device for providing targeted electromagnetic treatment to the target region of the body lumen identified by the set of coordinates provided during imaging.

46. The method of claim 45, wherein the method further comprises: sliding the EMR treatment device lengthwise into the body of the sheath device, andlocking the EMR treatment device to the sheath device to prevent longitudinal and rotational movement of the EMR treatment device relative to the sheath device.

47. The method of claim 46, wherein the locking is performed using locking components to hold of the treatment device in the sheath device in a consistent orientation.

48. The method of any one of claims 45 to 46, wherein the method comprises using the sheath device for performing MCA treatment without MR- guidance.

49. The method of any one of claims 45 to 48, wherein the sheath device is defined according to any one of claims 2 to 24 and 26.

50. The method of any one of claims 45 to 49, wherein the EMR treatment device is a Multichannel Applicator (MCA).51 . The method of claim 50, wherein the method comprises using the sheath device and the MCA for vaginal brachytherapy or rectal brachytherapy.

52. The method of any one of claims 45 to 49, wherein the EMR treatment device is a phototherapy probe for providing phototherapy such as photodynamic therapy or photothermal therapy, the phototherapy probe being defined according to any one of claims 28 to 44.

53. The method of claim 52, wherein method comprises using the sheath device and the phototherapy probe to deliver light therapy to a rectal lesion, a sigmoid colon lesion, or a vaginal lesion .

54. A phototherapy probe for delivering light therapy to a target region of a body lumen; the phototherapy probe comprising:a body having a circumferential wall defining a hollow space therein, the body having a distal tip and a longitudinal axis; a plurality of support members located within the lumen and attached to the circumferential walls spaced apart from one another along the longitudinal axis of the body, each of the plurality of support members having apertures arranged in a grid; and a plurality of treatment light sources where each of the treatment light sources are positioned at various locations on the support members in the body of the phototherapy probe so that the light sources are arranged in a pattern to generate treatment light for photodynamic therapy where the pattern corresponds with the at least one set of coordinates that identify a location of the at least one object of the body lumen that is a target region for receiving light therapy.

55. The phototherapy probe of claim 54, wherein the phototherapy probe is further defined according to any one of claims 28 to 44.

56. A sheath device for mapping at least one object in a body lumen, wherein the sheath device comprises: a transparent body defining an interior channel, the body being permeable to electromagnetic radiation; and a coordinate mapping system located at the body for providing at least one set of coordinates for at least one object of the body lumen during imaging and / or visualization, wherein the body of the sheath device is sized to slidingly receive a visualization device, an imaging device and / or an ElectroMagnetic Radiation (EMR) treatment device.

57. The sheath device of claim 56, wherein the sheath device is further defined according to any one of claims 2 to 24 and 26.

58. A method of delivering light therapy using a phototherapy probe, wherein the method comprises:visualizing at least one target region of a body lumen using a proctoscope; calibrating the phototherapy probe to determine location data for the at least one target region of a body lumen; inserting one or more light sources into a one or more apertures of the phototherapy probe in treatment positions corresponding to the location data for delivering the light therapy to the at least one target region; introducing the phototherapy probe into the body lumen so that the treatment positions of the one or more light sources abut the at least one target region; and illuminating the one or more light sources to deliver light therapy to the at least one target region in the body lumen.

59. The method of claim 58, wherein the method comprises providing one or more fiber optics and / or one or more LEDS as the one or more light sources.

60. The method of claim 58 or 59, wherein the method comprises operating the phototherapy probe to provide photodynamic therapy where the PT probe is defined according to claim 54 or 55.61 . The method of claim 58 or 59, wherein the method comprises operating the phototherapy probe to provide photothermal applications.

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