BACKGROUND OF THE DISCLOSURE

Field of the Disclosure

[0001] The present disclosure relates to photodynamic therapy.

Description of the Related Art

[0002] Light therapy can be used for the treatment of conditions in multiple ways. For example, light therapies involve the delivery of a therapeutic light through a fiber optic device placed proximal to or within a target tumor.

[0003] Light therapies can be combined with prior administration of light sensitizing medication (i.e., photosensitizer) that absorbs the therapeutic light and interacts with surrounding tissue constituents (e.g., oxygen) to generate reactive species that can destroy the target tissue. This form of therapy is known as photodynamic therapy ("PDT").

[0004] One embodiment of a prior art PDT system is shown with reference to FIG. 1 which includes an applicator flap 1 shown in cross section. Applicator flap 1 includes source emitters 2-5 and optional detector fibers 6-9. In this configuration, source emitting devices in the form of source emitters 2-5 and optional detector fibers 6-9 are positioned within channels 10-13 of flap 1. The number of channels and their position are predetermined by the manufacture. Some known applicator flaps include a Freiburg flap manufactured by Elekta and a H.A.M. applicator available from Mick Radio-Nuclear Instruments. In addition to the size and number of channels, the light transmissibility characteristics are similarly predetermined by the manufacturer. In certain embodiments of PDT, the emitted light 14 is not sufficiently diffused to provide the desired illumination pattern on a target area of tissue 15. In other cases, the number of channels 10-13 may be too great or too few for a particular PDT procedure. In addition, the overall size, shape and surface of flap 1 may not be suitable for a particular PDT procedure. In still other instances, the size, in terms of diameter and length, channels 10-13 may not be suitable to accommodate light emitters and detectors. Such limitations of prior art PDT systems hamper a physician’s ability to deliver effective therapeutic treatment. In some prior art embodiments, a separate diffusion layer 17 is positioned between applicator flap 1 and tissue to produce a scattered light pattern 18. The addition of separate diffusion layer 17 increases the complexity of the system and could lead to possible errors at least having to do with positioning of the applicator flap.

[0005] Some prior art PDT is set forth in the paper titled “An Optical Surface Applicator for Intraoperative Photodynamic Therapy”, by Sarah Chamberlain, et al, published in Lasers in Surgery and Medicine, 2019, the contents of which are incorporated herein in its entirety.

[0006] What is needed is an improved applicator and monitoring system to overcome the shortcomings of the prior art.

SUMMARY OF THE DISCLOSURE

[0007] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.

[0008] In one general aspect, an optical light delivery device may include an optical surface applicator having a length, a width and a thickness and a plurality of channels positioned therein. The optical light delivery device may also include the plurality of channels are distributed across the width of the optical surface applicator. Device may furthermore include a plurality of therapy light emitters disposed within the plurality of channels. Device may in addition include a plurality of therapy light detectors disposed within the plurality of channels. Device may moreover include where each of the plurality of therapy light detectors are paired in optical communication with a respective one of each of the plurality of therapy light emitters. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0009] Implementations may include one or more of the following features. The optical light delivery device where the optical surface applicator may include an application side and a back side and where at least a portion of the application side is configured to be light transmissive and is further configured to be applied to a target tissue of a patient and where the back side is configured to be any of at least partially light reflective and light blocking. The optical light delivery device where the portion of the application is configured to be light transmissive may include a delivery window area. The optical light delivery device where the delivery window area may include a scattering material configured to produce a highly uniform irradiance pattern. The optical light delivery device where the plurality of channels may include a first set of channels and a second set of channels positioned parallel and adjacent to the first set of channels, the plurality of therapy light emitters disposed within the first set of channels, and the plurality of therapy light detectors disposed in the second set of channels. The optical light delivery device may include, a plurality of isolation tubes having a light blocking material, and where each of the plurality of therapy light detectors and paired respective one of each of the plurality of therapy light emitters are at least partially positioned within a respective one of the plurality of isolation tubes. The optical light delivery device may include, an optical surface applicator signal monitor having a tube having a light reflective coating positioned on an outside surface thereof, one of the plurality of therapy light emitters positioned within the tube, and one of the plurality of therapy light detectors positioned within the tube in light communication with the one of the plurality of therapy light emitters. The optical light delivery device may include a therapy light source in selective optical communication with the plurality of therapy light emitters, a detector in optical communication with the plurality of therapy light detectors, an opto-electronic controller coupled to the detector and the therapy light source configured to control the therapy light source in response to a signal from the plurality of therapy light detectors. The optical light delivery device may include the plurality of therapy light emitters configured to emit a therapy light onto the target tissue, and the plurality of therapy light detectors configured to detect a tissue reflected light from the target tissue. The optical light delivery device may include a delivery optical switch in electrical communication with the controller and in selective communication with the therapy light source and the plurality of therapy light emitters, and a detector optical switch in electrical communication with the controller and in selective communication with the detector and the plurality of therapy light detectors. The optical light delivery device may include a power supply, the therapy light source may include a plurality of lasers, a plurality of driver boards coupled to the power supply and the controller and where one of the driver boards is coupled to a respective one of the plurality of lasers, where one of the lasers is coupled to a respective one of the plurality of the therapy light emitters, the detector may include a plurality of detectors where one of the detectors is coupled to a respective one of the plurality of the therapy light detectors and where the plurality of detectors is electrically coupled to the controller. The optical light delivery device may include a thermo-electric cooler coupled to the plurality of lasers. Implementations of the described techniques may include hardware, a method or process, or a computer tangible medium.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] So that the manner in which the above-recited features of the present disclosure can be understood in detail, a more particular description of the disclosure, briefly summarized above, may be had by reference to embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this disclosure and are therefore not to be considered limiting of its scope, for the disclosure may admit to other equally effective embodiments.

[0011] Figure 1 is a schematic representation of a cross section of a PDT system of the prior art; [0012] Figure 2 is a schematic representation of PDT delivery system in accordance with the present invention;

[0013] Figure 3 is an isometric view of a customizable optical surface applicator in accordance with the present invention;

[0014] Figure 4 is cross-section view of the customizable optical surface applicator of FIG.

3 taken substantially along cut line 4-4 in accordance with the present invention;

[0015] Figure 5 is an isometric view of a customizable optical surface application in accordance with the present invention;

[0016] Figure 6 is cross-section view of the customizable optical surface applicator of FIG.

5 taken substantially along cut line 6-6 in accordance with the present invention;

[0017] Figure 7 is a graphical representation of a digital image of a target area of a patient in accordance with the present invention;

[0018] Figure 8 is an isometric view of a customizable optical surface applicator in accordance with the present invention;

[0019] Figure 9 is an isometric view of a customizable optical surface applicator in accordance with the present invention;

[0020] Figure 10 is schematic representation of an optical surface applicator signal monitor in accordance with the present invention;

[0021] Figure 11 is cross-section view of the optical surface applicator signal monitor of FIG. 10 taken substantially along cut line 10-10 in accordance with the present invention;

[0022] Figure 12 is schematic representation of a PDT system utilizing an integrated emitter monitor in accordance with the present disclosure;

[0023] Figure 13 is a schematic representation of PDT delivery system in accordance with the present invention; [0024] Figure 14 is a top view of a customizable optical surface applicator in accordance with the present invention; and

[0025] Figure 15 is an isometric view of a customizable optical surface applicator in accordance with the present invention.

DETAILED DESCRIPTION

[0026] In the following detailed description of the embodiments, reference is made to the accompanying drawings, which form a part hereof, and within which are shown by way of illustration specific embodiments by which the examples described herein may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the disclosure.

[0027] The present disclosure relates to an optical light therapy application and monitoring system which can be configured to optimized for a particular PDT procedure and can produce a known and controllable dosimetry. Such a system is useful in the treatment of cancerous tumors as well as residual abnormal tissue following surgical resection of a tumor. The present disclosure includes a customizable optical surface applicator (optical surface applicator) and an optical surface applicator signal monitoring system.

[0028] Referring to FIG. 2, there is shown there is shown an optical light delivery system 20 in accordance with certain embodiments of the current disclosure including optoelectronic controller 21 , light source 22, delivery optical switch 23, optical surface applicator 24, detector optical switch 25, and detector 26. As will be disclosed in more detail herein after, optical surface applicator 24 comprises a customizable optical surface applicator and includes a plurality of cylindrical light diffusers fixedly positioned therein and an optical surface applicator signal monitor. In the example shown, the plurality of cylindrical light diffusers, namely cylindrical light diffusers 27, 28, 29 are optically coupled to optical output channels of delivery optical switch 23 by delivery optical fibers 31 , 32, 33 respectively, optical surface applicator signal monitor 39 is comprised of cylindrical light diffuser 30 optically coupled to optical output channels of delivery optical switch 23 by delivery optical fiber 34 and detector optical fiber 38 optically connected to an optical input channel of detector optical switch 25. As shown in the figure, cylindrical light diffusers 27, 28, 29, 30 all have the same lengths and thereby produce the same output. As will be disclosed herein after, CLDs 27, 28, 29 contribute to the configuring of a desired irradiance pattern while CLD 30, together with detector optical fiber 38, is used to monitor the power output. One embodiment of a suitable delivery optical fiber is a 125-micron multi-mode graded index fiber. Optical light delivery system 20 further includes detector optical fibers 35, 36, 37 optically connected to respective optical input channels of detector optical switch 25 and adapted to detect at least one optical parameter of actual therapy light emitted from cylindrical light diffusers 27, 28, 29, 30 respectively. In some embodiments, detector optical fibers 35, 36, 37, 38 can comprise a 200-micron core. One embodiment of a suitable detector optical fiber is an isotropic probe, for example Model IP-85 available from Rakuten Medical. Optical parameters can include the presence of light, power level, energy level, wavelength, diffusion pattern, etc. It should be noted that in this embodiment of optical light delivery system 20, the position of cylindrical light diffusers 27, 28, 29, 30 and detector optical fibers 35, 36, 37, 38 are fixed relative to each other respectively and within optical surface applicator 24. In the embodiment shown, each of the detector fibers has a paired respective cylindrical light diffuser wherein cylindrical light diffuser 27 is paired with detector optical fiber 35, cylindrical light diffuser 28 is paired with detector optical fiber 36, cylindrical light diffuser 29 is paired with detector optical fiber 37, and cylindrical light diffuser 30 is paired with detector optical fiber 38. In this particular embodiment, the single light source 22 is optically coupled to delivery optical switch 23 and detector optical switch 25 is optically coupled to a single detector 26. Controller 21 is configured to control delivery optical switch 23 and detector optical switch 25 in coordination such that the matched pairs of cylindrical light diffusers and detector optical fibers are in optical communication with light source 22 and optical detector 26 respectively. A suitable embodiment of light source 22 comprises a laser light source which can comprise a single semiconductor laser. The light controller of optical control instrument 21 is configured to receive irradiance signals from detector 26 (both irradiance pattern and fluence rate) delivered by the plurality of light emitters as well as being configured to control laser 22 to output a wide range of fluence rates from 5 mVF/cm ² to 300 m /cm ² . Cylindrical light diffusers 27, 28, 29, 30 can be comprised of flexible cylindrical optical diffusers. Although this embodiment includes four cylindrical light diffusers 27, 28, 29, 30, other embodiments are contemplated having N diffusers wherein N can be four, more than four and fewer than four. It should be noted that cylindrical light diffusers 27, 28, 29, 30 are configured to cause light to spread evenly across a surface and are also known as light diffusers in many prior art illumination applications. Light flap 24 can comprise any suitable material having the flexibility to conform to a tissue surface and having the light transmissibility qualities to allow light emanating from cylindrical light diffusers 27, 28, 29, 30. Controller 21 includes a computer processor, a light device controller, software, and storage capability and is in electrical communication with light source 22, delivery optical switch 23, detector optical switch 25 and detector 26. Prior to use during a PDT procedure, the pairs of cylindrical light diffusers and detector optical fibers are calibrated to characterize the output power of the cylindrical light diffuser versus the detected power measured from the detector optical fiber.

[0029] Referring now to FIGS. 3, 4 there is shown a customized optical surface applicator 40 having four hollow channels 41 -44 defined therein. Although optical surface applicator 40 is shown as having four hollow channels 41 -44 of equal length, an optical surface applicator of the current disclosure is not limited to the number of channels or the length of channel and can be customized as will be disclosed in more detail herein after, optical surface applicator 40 is shown in this embodiment having a physical size that is a generally rectangular shape having a length, a width and a thickness selected for a specific PDT therapy plan. The shape, length and width can be selected based on an image of a tumor, resection area or other image of a patient for an area of treatment. The image can be a CAT scan, a PET scan, an x-ray, an MRI scan and the like. In some embodiments the image can comprise a digital file and the digital file can used to produce optical surface applicator 40 using additive manufacturing techniques such as 3D printing. The thickness is selected to produce channels 41 -44 to accommodate optical components such as optical fibers, CLDs, detector optical fibers and an optional optical surface applicator signal monitor therein. In certain embodiments, the optical components can be embedded into optical surface applicator 40 during the additive manufacturing process. In addition to physical size of optical surface applicator 40, the material properties can also be inventively customized to meet a specific therapy plan and a given optical light delivery system 20 (FIG. 2). For instance a material can be selected having a particular stiffness or flexibility to allow contouring of the optical surface applicator to the target area of therapy for a patient. For instance, the material can be selected based on optical properties such as transmissibility, scattering, reflectance and blocking. In addition, a composite of two or more materials can be used to produce optical surface applicator having different optical properties along any of its length, width and thickness. In some embodiments, application side 45 can include a scattering material configured to produce a highly uniform irradiance pattern. Such a scattering material can be selected from a group of materials having a scattering coefficient greater than 5 cm-1 and applied during an additive manufacturing process to a window area of optical surface applicator 40 on application side 45 intended for the application of light therapy to a patient. The portion of channels 41 -44 nearest backside 46 of optical surface applicator 40 can be comprised of a material that reflects therapy light and redirects the therapy light to the window area of optical surface applicator 40 on application side 45 intended for the application of light therapy to a patient. In addition, back side 46, front end 47 and back end 48 of optical surface applicator 40 can be comprised of a material selected from a group of materials that block therapy light such that no therapy light is transmitted through these areas of the optical surface applicator.

[0030] Now referring to FIG. 5, 6 there is shown another embodiment of a customized optical surface applicator in the form of optical surface applicator 50. optical surface applicator 50 is shown as having eight hollow channels 51 -58 of various lengths, an application side 59 and a back side 60. optical surface applicator 50 is shown in this embodiment having a physical size that is a generally trapezoid shape having a length, a width and a thickness selected for a specific PDT therapy plan, optical surface applicator 50 can be produced similar to that disclosed herein above with reference to optical surface applicator 40 (FIGS. 4, 5). In this particular case, and with further reference to FIG. 7, the shape, length and width can be selected based on digital image 70 of a patient for an area of treatment. In this particular example, with the X-Y coordinates of digital image 70 and optical surface applicator 50 in coordination the shape of the optical surface applicator can be tailored to produce an irradiance pattern that matches the image. It can be seen from FIG. 5, with window 61 on application side of optical surface applicator 50 that digital image 70 can be accurately capture within the physical confines of the optical surface applicator. It should be appreciated by those skilled in the art that a transmissible and scattering material can be applied during an additive manufacturing process to delivery window area 61 of optical surface applicator 50 on application side 59 to produce an irradiance pattern that matches digital image 70. It should be further appreciated that the areas of optical surface applicator 50 outside of window 61 can be at least partially comprised of a light blocking material that block therapy light such that no therapy light is transmitted through these areas of the optical surface applicator.

[0031] Still referring to FIG. 6, there is shown CLD/detector optical fiber pairs 62a/63a- 62h/63h positioned within respective channels 51 -58 of optical surface applicator 50. It can be seen from the figure that therapy light emitted from CLDs 62a-62h will be directed to application side 50 of optical surface applicator 50 and to delivery window area 61 (FIG. 5) of the optical surface applicator 50 to produce an irradiance pattern that matches digital image 70. It should be appreciated by those skilled in the art that detector optical fibers 63a-63h can be used to monitor optical parameters of the CLDs which optical parameters can include the presence of light, power level, energy level, wavelength, diffusion pattern, etc. The detector optical fibers feed back a portion of the CLD output to controller 21 (FIG. 2) for power control. With reference also to FIGS. 8, 9 therapy light 80 is emitted from application side 59 of optical surface applicator 50. One problem that has been discovered is that a portion of the emitted therapy light 80, referred to as tissue reflected light 82, will be reflected back towards application side 59 of optical surface applicator 50 from tissue 83 of a patient. The tissue reflected light 83 is transmitted into channels 51 - 58 and can be detected by detector optical fibers 63a-63h. In certain situations, the detection of tissue reflected light 83 can erroneously be counted as part of the dosimetry light when in reality the tissue reflected therapy light was not delivered to the tissue of a patient. One method to account for this error is to estimate or simulate the tissue reflected light 83, calibrate the light delivery system using such estimates and simulations and make adjustments to laser 22 power control using controller 22 (FIG. 2).

[0032] Referring now to FIGS. 10, 11 there is shown optical surface applicator signal monitor 39 of FIG. 2 which is comprised of cylindrical light diffuser 30 and detector optical fiber 38 positioned within tube 90 wherein the tube is coated with a highly reflective coating 91 . As part of the present disclosure, tube 90 and reflective coating 91 are configured to reflect all of therapy light emitted by CLD 30 back to detector optical fiber 38. When positioned within optical surface applicator 24 as shown in FIG. 2, optical surface applicator signal monitor 39 replicates the all the optical features and losses of CLDs 27-29. However, because none of therapy light is emitted to tissue 83 (FIG. 9) optical surface applicator signal monitor 39 does not experience the aforementioned tissue reflected light that detector optical fibers 35-37 experience. It is contemplated by the present disclosure that customizable optical surface applicator can include a channel specifically provided for housing optical surface applicator signal monitor 39 adjacent to CLDs emitting therapy light to the tissue of a patient. In embodiments of the present disclosure having optical surface applicator signal monitor 39 provided within an optical surface applicator CLD 30 is optically coupled to laser 22 and therefor emits the light from the laser having the same optical properties as CLDs 27-29. In addition, detector optical fiber 38 is selected to have the same properties as detector optical fibers 35-37 and therefor collect light emitted from the CLD in the same manner and it is further optically coupled to detector 26. In this manner optical surface applicator signal monitor 39 provides a real time reference of the true dosimetry of therapy light being delivered to tissue 83 (FIG. 9) of a patient. As an example, if a treatment plan for a patient required a fluence rate 100 mVF/cm ² from any of the CLDs 27-29, controller 21 of optical light delivery system 20 can be configured to power laser 22 to provide the requisite power and detector optical fibers 35-37 and detector 26 can provide feedback the reported fluence rate. In operation, during treatment of patent with optical surface applicator 24 applied to a target are of a patient, optical switch 23 can be selected to transmit therapy light to optical surface applicator signal monitor 39 wherein detector optical fiber 38 and detector 25 can be monitored by controller 21 to ensure that CLD 30 is emitting therapy light at a fluence rate 100 mVF/cm ² . Optical switch 23 can then be selected to transmit therapy light to CLD 27 wherein detector optical fiber 35 and detector 25 can be used to measure a reported therapy light. If tissue reflected light 81 is reflected back to detector optical fiber 35 then the reported therapy light signal received by controller 21 would be greater a fluence rate 100 mVF/cm ² . If for example, the fluence rate the reported therapy light signal received by controller 21 indicated that 10% of the therapy light was reflected by tissue 83 (a fluence rate 100 mW /cm ² ) the controller can adjust the power of laser 22 to appropriate level to ensure that the planned fluence rate being absorbed by tissue 83 was equal to the fluence rate 100 mW /cm ² . This method can be applied to the plurality of CLDs/Detector pairs positioned within the optical surface applicator and can be further performed during the entire PDT procedure.

[0033] Referring next to FIG. 12 there is shown a PDT delivery system 120 including an integrated emitter and monitor (IEM) 121 , laser 122, detector 123 and computer processor 129. IEM 121 is comprised of a source emitter 124, detector optical fiber 125 wherein a portion of the source emitter and the detector are housed within isolation tube 126. Source emitter 124 is optically coupled to laser 122 via source fiber 127 and detector optical fiber 125 is optically coupled to detector 123 via optical fiber 128. Laser 122 delivers therapy light to source emitter 124 in a manner similar to other embodiments disclosed herein above. Isolation tube 126 is comprised of an opaque material and allows a portion of the therapy light from source emitter 124 to be captured within the isolation tube and delivered to detector optical fiber 125. Isolation tube 126 can be comprised of any suitable opaque material such as a medical grade shrink tube including a poly olefin heat shrink tubing material. The amount of therapy light captured within isolation tube 126 is proportional to the total therapy light emitted by source emitter 124 based on the length of the isolation tube and the emitting length of the source emitter. The therapy light captured by detector optical fiber 125 can be delivered to detector 123 to produce a signal relating to an optical property of the therapy light such as the fluence rate. In this particular embodiment the signal from detector 123 can be used by computer processor 129 to adjust the power level of laser 122 in accordance with a predetermined fluence rate of source emitter 124. It should be appreciated by those skilled in the art that IEM 121 can be used to both deliver therapy light to a patient and monitor the therapy light in a single device. Computer processor 129 is configured to use the signal from detector 123 to calculate the total therapy light delivered to a patient by source emitter 124. In some embodiments, source emitter 124 can comprise a cylindrical light diffuser configured to emit therapy along an emitting length including the portion that includes isolation tube 126.

[0034] Now referring to FIG. 13, there is shown a PDT delivery system 130 comprising a plurality of lEMs 121 a-121 d positioned with in optical surface applicator 131 . lEMs 121 a- 121d are similar to IEM 121 disclosed immediately herein above. PDT delivery system 130 further includes therapy light sources 122a-122d and detectors 123a-123d respectively optically coupled to lEMs 121 a-121 d by appropriate optical fibers. Therapy light sources 122a-122d can comprise lasers as disclosed herein before. PDT delivery system 130 further includes driver boards 132a-132d respectively electrically coupled to therapy light sources 122a-122d and to power supply 133. PDT delivery system 130 further includes processor 134 comprised of an interface to electrically couple detectors 123a-123d and driver boards 132a-132d to a controller. Processor 134 can be comprised of an RS232 interface and a computer processer capable of storing data and running software to perform the functions disclosed herein. PDT delivery system 130 optionally includes cooling device 135 electrically coupled to power supply 133 to maintain therapy light sources 122a-122d at a predetermined operating temperature. Cooling device 135 can comprise a thermoelectric cooler and a heat sink other suitable cooling device capable of maintaining therapy light sources 122a-122d at a predetermined operating temperature. In operation, a therapy plan can be determined for a target area of patient that includes a desired irradiance pattern and dosimetry for the pattern. The therapy plan can be entered into processor 134 where algorithms can determine optimum control of the therapy light sources 122a-122d to produce a desired irradiance pattern and dosimetry from the plurality of lEMs 121 a-121 d. The optical surface applicator 131 is positioned against the target area of patient and oriented using methods disclosed herein or other suitable methods. The therapy plan is started by driver boards 132a-132d sending a respective start condition control signal to therapy light sources 122a-122d in intended to produce the desired irradiance pattern and dosimetry. Each of the plurality of lEMs 121 a-121 d provides a monitoring light signal to the respective detectors 123a-123d in real time. Detectors 123a-123d provide a respective monitoring signal to processor 134 wherein the processor compares the start condition control signals to the monitoring signals and sends a respective updated control signal to each of the lEMs 121 a-121 d. It is important to note that not all of the plurality of lEMs 121 a-121 d may be necessary at any point in time during the operation of PDT delivery system 130. The operation of monitoring, comparing and delivering of therapy light is continued until the therapy plan is completed within acceptable limits. Such acceptable limits can be pre-programmed into processor 134 or can be input into the processor by a user. It should be appreciated by those skilled in the art that cooling device 135 limits drift that can occur when lasers are operated for extended periods and can therefore remove one of the variables that can cause PDT delivery system 130 from producing a desired irradiance pattern and dosimetry in accordance with the therapy plan. It should be further noted that the use of lEMs 121 a-121 d enables the system to monitor each of the plurality of light emitting sources in real time taking into account the actual performance of each leg of the PDT delivery system 130.

[0035] Referring next to FIG. 14, there is shown a configurable optical surface applicator (optical surface applicator) 140 having a flap section 141 , a neck section 142 and an access port 143. Flap section 141 includes four parallel channels 144a-144d extending from the intersection between the flap and neck section 142 to the distal end of the flap. The channels are configured receive and position various optical components such as source emitters 2-5 (FIG. 1 ), CLDs 27-29, detector optical fibers 35-37 (FIG. 2), optical surface applicator signal monitor 39 (FIG. 2), and IEM 121 (FIG. 12). Channels 144a- 144d are shown as evenly distributed across the width of flap 141 and are positioned at the same distance from the bottom surface of the flap. This arrangement of the channels enables a uniform irradiance pattern to be achieved when the bottom surface of flap 141 is placed against a target tissue of a patient during PDT treatment. Flap 141 of optical surface applicator 140 further includes tabs 145a-145d positioned near the corners of the flap. Tabs 145a-145d enable a user to suture flap 141 of optical surface applicator 140 against the tissue of a patient to secure it in place during a PDT procedure. Neck section 142 and access port 143 are hollow providing access to channels 144a-144d for the insertion of the various optical components disclosed herein. An optical tether (not shown) can contain the optical fibers delivering therapy light to the emitters from the source and the optical fibers collecting the monitoring light and delivering it to the detectors. The tether can be sealed to access port 143 by applying a medical grade shrink tube.

[0036] Still referring to FIG. 14, in operation, and merely as an example, a user can insert a first CLD connected to a delivery fiber through access port 143, neck section 142 and into channel 144a. The length of the CLD can be chosen to produce a predetermined irradiance pattern and the length can be substantially as long as channel 144a. A user can then insert a first detector fiber connected to an optical fiber through access port 143, neck section 142 and into channel 144a and can be positioned at point 146a in the channel. The insertion process can be repeated for a second, third and fourth pairs of CLDs and detector fibers into channels 144b, 144c and 144d respectively and the detector fibers positioned at points 146b, 146c and 146d respectively. Once the CLDs and detector fiber pairs are positioned within flap 141 the delivery fibers and the optical fibers can be sealed within optical surface applicator 140 by applying a medical grade shrink tube. With the shrink tube applied to an outer surface of access port 143 around the delivery fibers and the optical fibers the internal portion of optical surface applicator 140 is hermetically sealed and the CLDs and detector optical fibers are protected from inadvertent movement if the fibers are tensioned. The placement of optical surface applicator 140 can be based on an image of a tumor, resection area or other image of a patient for an area of PDT treatment. The image can be a CAT scan, a PET scan, an x- ray, an MRI scan and the like. In some embodiments the image can comprise a digital file and the digital file can used to locate optical surface applicator 140. In this particular example, with the X-Y coordinates of digital image 70 and optical surface applicator 140 in coordination the shape of the optical surface applicator can be located to produce an irradiance pattern that matches the image and sutured to the patient using tabs 145a- 145d. Optical surface applicator 140 can be comprised of a single light transmissive material or can be comprised of a composite of materials using, for example, the additive manufacturing techniques disclosed herein above. A PDT procedure can be carried out by developing a therapy plan and controlling the delivery of therapy light via optical surface applicator 140 using processor 134 (FIG 13). In this example, processor 134 includes an algorithm configured to use the light collected by the detector fibers to control the overall irradiance pattern as well as the individual source emitters to match the dosimetry called out in the therapy plan similar to that disclosed with reference to FIG. 6.

[0037] Now referencing FIG. 15, there is shown optical surface applicator 150 in accordance with the current disclosure, optical surface applicator 150 is similar to that disclosed immediately herein above with reference to optical surface applicator 140. In this particular embodiment, optical surface applicator 150 includes flap 151 , neck section 152 and access port 153. Flap 151 includes top channels 154a-154d and bottom channels 155a-155d. Channels 154a-154d are shown as evenly distributed across the width of flap 151 and are positioned at near the top surface the same distance from the bottom surface 156 of the flap. Channels 154a-154d are configured to receive therapy light emitters such as source emitters 2-5 (FIG. 1 ), CLDs 27-29 (FIG. 2) and the like. This arrangement of the channels 154a-154d enables a uniform irradiance pattern to be achieved when the bottom surface 156 of flap 151 is placed against a target tissue of a patient during PDT treatment. Channels 155a-155d are shown as evenly distributed across the width of flap 151 and are positioned near bottom surface 156. Channels 155a- 155d are configured to receive therapy light collectors such as detector optical fibers 35- 37 (FIG. 2) and the like. This arrangement of the channels 154a-154d enables a uniform irradiance pattern to be achieved when the bottom surface 156 of flap 151 is placed against a target tissue of a patient during PDT treatment. Flap 151 of optical surface applicator 140 further includes tabs 157a-157d (157d not shown) positioned near the comers of the flap. Tabs 157a-157d enable a user to suture flap 151 of optical surface applicator 150 against the tissue of a patient to secure it in place during a PDT procedure. Neck section 152 and access port 153 are hollow providing access to top channels 154a- 154d and bottom channels 155a-155d for the insertion of the various optical components into flap section 150 as disclosed herein. [0038] All of the methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the apparatus and methods of this disclosure have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosure. In addition, modifications may be made to the disclosed apparatus and components may be eliminated or substituted for the components described herein where the same or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the invention.

[0039] Although the invention(s) is/are described herein with reference to specific embodiments, various modifications and changes can be made without departing from the scope of the present disclosure, as presently set forth in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of the present disclosure. Any benefits, advantages, or solutions to problems that are described herein with regard to specific embodiments are not intended to be construed as a critical, required, or essential feature or element of any or all the claims.

[0040] Unless stated otherwise, terms such as "first" and "second" are used to arbitrarily distinguish between the elements such terms describe. Thus, these terms are not necessarily intended to indicate temporal or other prioritization of such elements. The terms "coupled" or "operably coupled" are defined as connected, although not necessarily directly, and not necessarily mechanically. The terms scatter, diffuse and spread are among the same terms that similar meaning as delivering total available therapy light to a broader area than that of prior art methods. The terms "a" and "an" are defined as one or more unless stated otherwise the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more elements possesses those one or more elements but is not limited to possessing only those one or more elements. Similarly, a method or process that “comprises,” “has,” “includes” or “contains” one or more operations possesses those one or more operations but is not limited to possessing only those one or more operations.

[0041] While the foregoing is directed to embodiments of the present disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow.