Multilayer dosimetry systems, and a process for measuring a point dose radiation thereof

Abstract

This present disclosure provides a multilayer dosimetry system, comprising: (a) a mounting layer, wherein the mounting layer is an optically clear polymer film having two sides coated with an optically clear first adhesive; (b) at least two active layers, wherein the mounting layer is sandwiched between active layers by affixing to the optically clear first adhesive; and (c) (i) an optically clear top base layer affixed to upper side of the sandwiched structure of (b), and (ii) a bottom base layer affixed to bottom side of the sandwiched structure of (b). The present disclosure also provides a point dose measurement device comprising a multilayer dosimetry system. The present disclosure further provides an integrated system to measure point dose radiation and a process for measuring point dose radiation.

Description

Docket No.: 4412PCTMULTILAYER DOSIMETRY SYSTEMS, AND A PROCESS FOR MEASURING A POINT DOSE RADIATION THEREOFFIELD OF THE INVENTION

[0001] The presently disclosed process(es), procedure(s), method(s), product(s), result(s), and / or concept(s) (collectively referred to hereinafter as the “present application, present disclosure or present invention”) relates generally to a multilayer dosimetry system, a point dose measurement device, a process for measuring a point dose radiation and an integrated system to measure the point dose radiation.BACKGROUND OF THE INVENTION

[0002] This invention relates to a multilayer dosimetry system, a point dose measurement device, a process of measuring point dose radiation and an integrated system to measure a point dose radiation.

[0003] In facilities where radiation emitting sources are used, for example, in hospitals where patients receive radiation treatments or in blood banks where blood products are irradiated, various methods are used to quantitatively determine the radiation dose delivered by the source. The methods practiced include the use of thermoluminescent dosimeters (TLD's), ionization-type radiation detectors, photographic film, and radiochromic materials. TLD's are inconvenient because they require a complicated and time-consuming read-out process. Ionization-type radiation detectors are awkward and unwieldy and require a complicated setup. Photographic film requires a time-consuming chemical processing procedure before read-out. Radiochromic materials are preferred because they do not require any post-exposure processing and they are capable of measuring radiation doses with a high spatial resolution, but they are inconvenient in current practice because the calculation of the dose requires a complex sequence of steps, subject to error.

[0004] U.S. Pat. No. 5,637,876 describes a radiation dosimeter, exemplarily for use in determining a level of radiation to which a patient is subjected during radiation treatment, which comprises a substrate provided with a layer of radiation sensitive material. The radiation sensitive material has an optical density which varies systematically in accordance with the degree of radiation exposure. The dosimeter may take the form of a card or a flexible substrateDocket No.: 4412PCT which is positionable on the patient or other irradiation subject and which is also positionable in, or slidable through a slot in, a dose reader which includes a reflection or transmission densitometer.

[0005] The radiation sensitive material of a radiation dosimeter may be comprised of microcrystalline pentacosadiynoic acid (PCD A) dispersed in a polymer matrix. Subjecting monomeric PCDA crystals, or related compounds such as metal salts of PCD A, to ionizing radiation results in progressive polymerization, the degree of polymerization increasing with radiation dose. The amount of polymerization (and hence, the radiation dose) can be determined by measuring either the optical density or the spectral absorption of the exposed dosimeter. However, it has been found that these parameters also vary with both the temperature of the device when measured as well as the thickness of PCDA dispersion and the moisture content of the polymer matrix. Maximum accuracy of dose measurement must account for the temperature and thickness and moisture effects.

[0006] Radiation dosimetry film provides a means for measuring radiation exposure at a point, but its principal utility is in obtaining a two-dimensional map of radiation exposure, i.e. radiation exposure at multiple points in a two-dimensional array. A typical user may measure an 8"* 10" size film in one, or more, color channels at a spatial resolution of 75 dpi, generating a map of radiation doses at 450,000 points. Of course, other resolutions can be used to generate the radiation exposure map.

[0007] In practice, there is a problem presented by the measurement of the radiation sensitive film at a multiplicity of points. The problem is the availability and cost of means to make the measurements. Measurements of optical absorbance of the active component of a film (e.g. PCDA or the lithium salt of PCDA, LiPCDA) at the primary absorbance peak and other components at predetermined wavelengths would require the use of a scanning spectrophotometer. Such equipment is not readily available and would be of high cost. Furthermore the speed of operation would be slow because of the low intensity of the light source at the specific wavelengths where measurement is required.

[0008] A possible solution to the problem is to employ a film or document scanner to collect measurements of the film. The advantage of such means is that these scanners are widely available, they are of relatively low cost (often <$1000), they scan at high spatial resolution (upDocket No.: 4412PCT to 2400 dpi), they are rapid in operation (8"xl 0" scan at 75 dpi resolution in <30 seconds), and they are adapted to measure color.

[0009] The multilayer dosimetry system provides an accurate, reliable, single-use and easy-to- use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure patient dose, the system is used to provide a secondary verification of radiation dose as a means of Quality Control for the primary dose calculation method. The output of the Point Dose system is not used to adjust the dose to the patient

[0010] A multilayer dosimetry system of present application has advantages, including: precise and accurate dose values + / -5% accuracy levels, high spatial resolution, allowing for detailed dose measurements in two dimensions with a portable film scanner device, relative ease of handling and analyzing, making it convenient for dose measurements, and film-based dosimeters also have the potential for real-time applications, for point / surface-based in vivo dosimetry.

[0011] A film scanner is not like a spectrophotometer. It does not measure absorbance at specific wavelengths, but rather measures over a band of wavelengths. The band of wavelengths over which a specific model of scanner operates is defined by a combination of factors including the spectral output of a light source, the spectral absorbance of optical filters in the light path and the spectral response of the detector. A scanner adapted for color measurement typically will assess light absorbance integrated over three bands of wavelengths defining red, green and blue portions of the visible spectrum. The contribution of light absorbance at each wavelength to the total signal within a color band varies wavelength by wavelength. The weight at each wavelength is not user-defined, but rather depends on the aforesaid factors of spectral output of a light source, the spectral absorbance of optical filters in the light path and the spectral response of the detector.SUMMARY OF THE INVENTION

[0012] One aspect of the present application is to provide a multilayer dosimetry system, comprising: (a) a mounting layer, wherein the mounting layer is an optically clear polymer film having two sides coated with an optically clear first adhesive; (b) at least two active layers, wherein the mounting layer is sandwiched between active layers by affixing to the optically clearDocket No.: 4412PCT first adhesive; and (c) (i) an optically clear top base layer affixed to upper side of the sandwiched structure of (b), and (ii) a bottom base layer affixed to bottom side of the sandwiched structure of (b). The optical clarity of the polymer film, of the first adhesive and / or of the top base layer is preferably determined in accordance with ASTM DI 003 or ASTM DI 746.

[0013] Another aspect of the present application is to provide a point dose measurement device, comprising: a) a top layer having AIDC indicia; b) a middle layer comprising the multilayer dosimetry system, wherein the AIDC label adjoining top side of the multilayer dosimetry system with a second adhesive; and c) a bottom layer is a double coated adhesive tape having a central polymer layer, wherein one side of the tape is affixed to top side of the multilayer dosimetry system of (b) with a third adhesive, and the second side of the of the tape is having a fourth adhesive with a release liner.

[0014] Another aspect of the present application is to provide a process for measuring a point dose radiation, comprising the steps of: i. exposing the point dose measurement device, to an irradiation of an unknown dose; ii. scanning the AIDC indicia, and the processing and storing image the data in a display device; iii. placing the irradiated multilayer dosimetry system of the point dose measurement device in a film scanner surface using a template provided for orientation and to initiate scanning of the multilayer dosimetry system; iv. establishing a correlation of the dose and the scanner response using a preinstalled software of the film scanner; v. measuring a data of the unknown dose for a point dose verification using the software of the film scanner; vi. processing and storing image data using the preinstalled software of the film scanner in an image format; vii. displaying the image and identification data in numerical format and / or lingual format in a display means attached to the film scanner and AIDC scanner; and optionally, viii. printing the image and identification data in numerical format and / or lingual format with a printing means.Docket No.: 4412PCT

[0015] One more aspect of the present application is to provide an integrated system to measure a point dose radiation, comprising: a point dose measurement device, a radiation emitting source to expose point dose measurement device to a predetermined radiation, a flatbed film scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device, to convert a scanned image into a digital data format and to establish correlation of radiation dose using a preinstalled software of the film scanner, and an AIDC indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner, a display means attached to the AIDC scanner and to the flat bed film scanner, to display the image data and identification data in numerical format and / or lingual format in the display source, and optionally, a printing means to print the image and identification data in a numerical format and / or lingual format.

[0016] Another aspect of the present application is to provide an integrated system to measure a point dose radiation, comprising: a template to keep the point dose measurement device, a radiation emitting source to expose the template to a predetermined radiation, a flatbed scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device and to establish correlation of radiation dose using a preinstalled software of the film scanner, an AIDC indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner, a display means attached to the AIDC scanner and to the flat bed film scanner, to display the image data and identification data in numerical format and / or lingual format in a display source, and optionally, a printing means to print the image and identification data in a numerical format and / or lingual format.Docket No.: 4412PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 : A multilayer dosimetry system (side view)

[0018] FIG. 2a: Jig for a multilayer dosimetry system

[0019] FIG. 2b: Point dose measurement device (side view)

[0020] FIG. 2c: Point dose measurement device (top view)

[0021] FIG. 3: Point dose measurement device (bottom view)

[0022] FIG. 4: Schematic representation of Point Dose Measurement Process

[0023] FIG. 5: Median dose along with confidence intervals were measured for 3cGy film

[0024] FIG. 6: Median dose along with confidence intervals were measured for 25cGy film

[0025] FIG. 7: Median dose along with confidence intervals were measured for 50cGy film

[0026] FIG. 8: Median dose along with confidence intervals were measured for lOOcGy film

[0027] FIG. 9: Median dose along with confidence intervals were measured for 200cGy film

[0028] FIG. 10: Median dose along with confidence intervals were measured for 450cGy film

[0029] FIG. 11: Median dose along with confidence intervals were measured for 25cGy film

[0030] FIG. 12: Median dose along with confidence intervals were measured for 50cGy film

[0031] FIG. 13: Median dose along with confidence intervals were measured for lOOcGy film

[0032] FIG. 14: Median dose along with confidence intervals were measured for 200cGy film

[0033] FIG. 15: Median dose along with confidence intervals were measured for 450cGy filmDocket No.: 4412PCTDETAILED DESCRIPTION OF THE INVENTION

[0034] It is to be understood that the disclosed and / or claimed inventive concept(s) is not limited in its application to the details of construction and the arrangement of the components or steps or methodologies set forth in the following description or illustrated in the drawings. The disclosed and / or claimed inventive concept(s) is capable of other aspects or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0035] As utilized in accordance with the disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings.

[0036] Unless otherwise defined herein, technical terms used in connection with the disclosed and / or claimed inventive concept(s) shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0037] The singular forms “a”, “an”, and “the” include plural forms unless the context clearly dictates otherwise specified or clearly implied to the contrary by the context in which the reference is made.

[0038] For purposes of the following detailed description, other than in any operating examples, or where otherwise indicated, numbers that express, for example, quantities of ingredients used in the specification and claims are to be understood as being modified in all instances by the term "about". The numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties to be obtained in carrying out the invention.

[0039] All percentages, parts, proportions and ratios as used herein, are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore; do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.

[0040] The term “radiochromic film” as used herein generally refers to film that changes color and produces a visible for a naked eye or using a reader when exposed to ionizing radiation, butDocket No.: 4412PCT experiences insignificant change from exposure to visible light or other forms of non-ionizing radiation.

[0041] The term “Dose volatility” is standard deviation of the dose.

[0042] The term “scanner” as used herein is generally employed to refer to a device that can be used to optically scan a multidimensional film and output a multidimensional image relating the optical transmittance or reflectance of the film at an array of locations.

[0043] The term “flatbed scanner” is used to describe a scanner for scanning film in a two- dimensional plane. The flatbed scanner includes a RGB color scanner.

[0044] The term “CCD scanner OR automatic identification and data capture (AIDC) scanner” is used to describe a scanner in which the sensor device is an array of charge coupled elements. The device used to scan and detect information encoded in bar codes, RFID (Radio Frequency Identification), optical character recognition (OCR), and QR Codes.

[0045] The terms “RGB scanner” and “RGB color scanner” as used herein generally refer to scanners that produce an image composed of response values in color channels comprising the red, green and blue portions of the visible color spectrum.

[0046] The term “color channel” as used herein is generally employed to refer to one of the output response bands of an optical color scanner.

[0047] The term “component color channel” as used herein is generally used to refer to one of the color channels within an image composed of a multiplicity of color channels.

[0048] The terms “response value” and “scanner response value” as used herein generally refer to a measure of the light intensity transmitted or reflected at a location on a film as determined by an optical scanner.

[0049] The term “pixel value” as used herein generally refers to the response value for an individual pixel within a digital image.

[0050] The term “marker dye” as used herein generally refers to a colored substance impervious to exposure by ionizing radiation that is incorporated in the active layer of a radiation sensitive film to provide a reference response value in at least one color channel proportional to the thickness of the active layer.Docket No.: 4412PCT

[0051] The term “reference channel” as used herein refers to the color channel in which the marker dye provides the greatest response.

[0052] The term “triple channel correction” as used herein refers to the correction method in which the responses of three color channels are used to correct the response of a radiation sensitive film for differences in the thickness of the radiation.

[0053] The term ‘display device’ covers at least one of a smart phone, a smart pad, a tablet PC, a kiosk, a monitor, a wall display, a music player, a desktop computer, a smart table, a TV, and a laptop computer.

[0054] In the present disclosure the term “radiation” refers to ionizing or non-ionizing radiation that carries enough energy to liberate electrons from atoms or molecules, thereby ionizing them. Radiation may include, but is not limited to, X-rays, y rays, electrons, protons, neutrons, ions, or any combination thereof. Non-ionizing radiation refers to any type of electromagnetic radiation that does not carry enough energy per quantum (photon energy) to ionize atoms or molecules, that is, to completely remove an electron from an atom or molecule. Non-ionizing radiation may include, but is not limited to, ultraviolet (UV), visible, or infrared (IR) light, or any combination thereof.

[0055] The term “ionizing radiation” as used herein generally refers to radiation with a level of energy that is high enough to cause atoms to lose electrons and become charged or ionized. Ionizing radiation may be in the form of high energy particles, like alpha and beta particles, protons and neutrons, or in the form of electromagnetic waves, like gamma rays or X-rays. High energy particles and electromagnetic waves are released from the nuclei of radioactive atoms that are decaying or may be created by causing accelerated electrons to strike a metal target.

[0056] As used herein, the term "insect sterilization” is a biological control process. In this process, for example, a large amount of male insects are sterilized by a radiation process. These insects are then released in the wild and compete to fertilize wild female insects. Because these sterile insects are competing with fertile insects, the total insect population is more controlled and potentially reduced.

[0057] As used here, the term "phytosanitary application" refers to a process that is intended to protect humans against harmful pests and diseases that can be found on plants.Docket No.: 4412PCT

[0058] As used herein, the term "medical device sterilization" refers to medical device or component to withstand sterilization and functional characteristics and mechanical properties without significant loss of capacity. Sterilizing comprises sterilizing process during exposure to radiation such as gamma ray and / or X-ray can withstand radiation sterilization and functional characteristics without substantial loss of medical device or parts thereof can be referred to as "radiation". Examples of high-energy photon sterilizing process comprises exposing the medical device to self-isotope source such as cobalt 60 emitted by the isotope source throughout the medical device generating ionized or electronic damage (those fracturing). Sterilization may also comprise ethylene oxide sterilization, electronic beam sterilization, autoclaving (steam sterilization), plasma sterilization, dry heat sterilization, chemical sterilization and X-ray beam sterilization.

[0059] The term “radiation sensitive film or radiochromic film” refers to a radiochromic dosimetry film comprises a substrate covering with an active layer, the film is designed for the quantitative measurement of absorbed dose of high-energy photons. Key technical features include: (i) dynamic dose range: 10 Gy to 50,000 Gy, (ii) develops in real time without postexposure treatment; (iii) energy-dependence: minimal response difference from 100 keV into the MV range; (iv) near tissue equivalent; (v) high spatial resolution - can resolve features to 5 ppm, or less; (vi) active coating exposed for detection of low energy photon and electron; (vii) proprietary new technology incorporating a marker dye in the active coating: enables nonuniformity correction by using triple-channel dosimetry and decreases UV light sensitivity; and (viii) stable at temperatures up to 60 °C.

[0060] Gafchromic™ RADIOCHROMIC is useful as an active layer for the radiation dosage indicator of the present disclosure. Gafchromic™ RADIOCHROMIC has an asymmetrical cross section. Measurements indicate that the response of scanner or densitometer may be dependent on which side of the film is facing the light source. It is advised that active layer be consistently measured with the same side of the film facing the light source regardless of whether landscape or portrait orientation is used.

[0061] The term "about" refers to a range of values + 10% of a specified value. For example, the phrase "about 200" includes ± 10% of 200, or from 180 to 220.Docket No.: 4412PCT

[0062] All percentages, ratio, and proportions used herein are based on a weight basis unless other specified.

[0063] In accordance with one aspect of the present invention, the present application relates to a multilayer dosimetry system, comprising: (a) a mounting layer, wherein the mounting layer is an optically clear polymer film having two sides coated with an optically clear first adhesive; (b) at least two active layers, wherein the mounting layer is sandwiched between active layers by affixing to the optically clear first adhesive; and (c) (i) an optically clear top base layer affixed to upper side of the sandwiched structure of (b), and (ii) a bottom base layer affixed to bottom side of the sandwiched structure of (b).

[0064] The present invention comprises a multilayer dosimetry system having at least five layers as shown in FIG. 1. The a multilayer dosimetry system, comprising: (a) a mounting layer (102), wherein the mounting layer is an optically clear polymer film having two sides coated with an optically clear first adhesive; (b) at least two active layers (101a and 101b), wherein the mounting layer is sandwiched between active layers by affixing to the optically clear first adhesive; and (c) (i) an optically clear top base layer (100) affixed to upper side of the sandwiched structure of (b), and (ii) a bottom base layer(103) affixed to bottom side of the sandwiched structure of (b).

[0065] The multilayer dosimetry system mounting layer (102), wherein the mounting layer is an optically clear polymer film.

[0066] In accordance with one aspect of the present invention, the optically clear polymer film is a polyester.

[0067] In accordance with one more aspect of the present invention, the polyester is selected from the group consisting of polyethylene terephthalate, polyethylene napthalate, polyethylene isothalate, polybutalene terephthalate, polyethylene cocyclohexane dimethylterephthalate, polyethanol codimethanol cyclohexane napthalate, and copolymers thereof.

[0068] In accordance with another aspect of the present invention, the mounting layer is PermaTrans ® PUV-3100 from MacTac. Also, other suitable mounting layers are FasFlex from Avery and Cushion-Mount™ Plus Plate Mounting Tape El 115 from 3M.Docket No.: 4412PCT

[0069] In accordance with one more aspect of the present invention, the mounting layer is having a thickness ranging from about 25 .m to about 200 pm.

[0070] In accordance with one more aspect of the present invention, the mounting layer is having a thickness ranging from about 25 pm to about 50 pm, from about 51 pm to about 100 pm, from about 101 pm to about 150 pm, or from about 151 pm to about 200 pm.

[0071] In accordance with one aspect of the present invention, the mounting layer (102) is sandwiched between two active layers (101a, 101b) by affixing to the optically clear first adhesive.

[0072] In accordance with one more aspect of the present invention, the first adhesive is a pressure sensitive adhesive.

[0073] In accordance with one aspect of the present invention, the active layer is a composition comprising a microcrystalline dispersion of a substantially crystalline image receptive polyacetylenic compound.

[0074] The active layer material of a radiation dosimeter may be comprised of microcrystalline pentacosadiynoic acid (PCDA), or other diacetylenic compounds and other compounds that exhibit dose responsive chemical changes, dispersed in a polymer matrix. Subjecting monomeric PCDA crystals, or related compounds such as the metal salts of PCDA, to ionizing radiation results in progressive polymerization. The degree of polymerization increase with radiation dose. The amount of polymerization (and hence, the radiation dose) can be determined by measuring either the optical density or the spectral absorption of the exposed dosimeter. However, it has been found that these parameters also vary with both the temperature of the device when measured, as well as the thickness of PCDA dispersion and the moisture content of the polymer matrix. Maximum accuracy of dose measurement must account for the temperature and thickness and moisture effects.

[0075] In accordance with one aspect of the present invention, the polyacetylenic compound has the structure: A-(CH2)n — C=C — C=C — (CH2)m — B, wherein m and n are both independently an integer from 6 to 14 and A and B are independent from one another and are selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or diDocket No.: 4412PCT valent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triyn or tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and a conjugated structure, and combinations thereof. Active component comprises a substantially crystalline image receptive polyacetylenic compound having the structure:A-(CH2)n— C=C— C=C— (CH2)m— B wherein m and n are both independently an integer from 6 to 14 and A and B are independent from one another and are selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or di-valent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triyn or tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and a conjugated structure, and combinations thereof

[0076] In accordance with one aspect of the present invention, the active component is filamentary particles of lithium salt of a conjugated polymerizable polyacetylene having at least one terminal carboxylic acid or carboxylate group and a mixture of said polyacetylenes; said filamentary particles having a length to width ratio of at least 5: 1; said filamentary particles having no platelet particles mixed therewith. The active component is further described in U.S. Pat. Nos. 7,445,880 and 8,212,203, each of which is hereby incorporated by reference in its entirety.

[0077] In accordance with one aspect of the present invention, the polyacetylenic compound is selected from the group consisting of pentacosa-10,12-diynoic acid; tricosa-10, 12-diynoic acid, heneicosa-10,12-diynoic acid and combinations thereof.

[0078] In accordance with one aspect of the present invention, the polyacetylenic compound is Gafchromic films. Examples including but not limited to gafchromic™ EBT4 and EBT-XD .

[0079] In accordance with one aspect of the present invention, the active layer is formed by a single pass coating on the mounting layer.

[0080] In accordance with one aspect of the present invention, the active layer is coated on the mounting layer in a form dispersion.

[0081] In accordance with one more aspect of the present invention, the active layer is coated on the mounting layer in a coatable fluid dispersions.Docket No.: 4412PCT

[0082] In accordance with one aspect of the present invention, the active layer is having a thickness ranging from about 5 pm to about 100 pm.

[0083] In accordance with one more aspect of the present invention, the active layer is having a thickness ranging from about 5 pm to about 10 pm, from about 11 pm to about 15 pm, from about 16 pm to about 20 pm, from about 21 pm to about 25 pm, from about 26 pm to about 30 pm, from about 31 pm to about 35 pm, from about 36 pm to about 40 pm, from about 41 pm to about 45 pm, from about 46 pm to about 50 pm, from about 51 pm to about 55 pm, from about 56 pm to about 60 pm, from about 61 pm to about 65 pm, from about 66 pm to about 70 pm, from about 71 pm to about 75 pm, from about 76 pm to about 80 pm, from about 81 pm to about 85 pm, from about 86 pm to about 90 pm, from about 91 pm to about 95 pm, or from about 96 pm to about 100 pm.

[0084] In accordance with one aspect of the present invention, the polyacetylenic compound which selectively absorbs incident low energy photon radiation in an amount from about 0.1 to 50.0% by weight of micro-crystalline dispersion of active layer.

[0085] In accordance with one aspect of the present invention, an optically clear top base layer (100) affixed to upper side of the sandwiched structure of mounting layer and active layers, and a bottom base layer (103) is affixed to bottom side of the sandwiched structure.

[0086] In accordance with one aspect of the present invention, the base layer (100 or 103) is a polymer film.

[0087] In accordance with one aspect of the present invention, the polymer is a polyester film.

[0088] In accordance with one aspect of the present invention, the polyester is selected from the group consisting of polyethylene terephthalate, polyethylene napthalate, polyethylene isothalate, polybutalene terephthalate, polyethylene cocyclohexane dimethylterephthalate, polyethanol codimethanol cyclohexane napthalate and copolymers thereof.

[0089] In accordance with one aspect of the present invention, the top base layer (100) is optically transparent.

[0090] The transparency is dependent on the channel used for measurement. For instance, red channel has 60% transparency.Docket No.: 4412PCT

[0091] In accordance with one aspect of the present invention, the top base layer is External Beam Therapy polyethylene terephthalate(EBT PET) Clear Base.

[0092] In accordance with one aspect of the present invention, the top base layer is Melinex® polyester film types from Tekra LLC.

[0093] In accordance with one aspect of the present invention, the bottom base layer (103) is having white or matte appearance.

[0094] In accordance with one aspect of the present invention, the bottom base layer is white coating EBT PET Clear Base.

[0095] In accordance with one aspect of the present invention, the multilayer dosimetry system is having a dynamic dose range from about 3cGy to about 600cGy.

[0096] In accordance with one aspect of the present invention, the multilayer dosimetry system is having a dynamic dose range from about. 3cGy to about 50cGy, 51cGy to about lOOcGy, lOlGy to about 150cGy, 151cGy to about 200cGy, 201cGy to about 250cGy, 251cGy to about 300cGy, 301cGy to about 350cGy, 351cGy to about 400cGy, 401cGy to about 450cGy, 451cGy to about 500cGy, 501cGy to about 550cGy, 551cGy to about 600cGy.

[0097] In accordance with another aspect of the present invention, a point dose measurement device, comprising: a) a top layer having AIDC indicia; b) a middle layer comprising the multilayer dosimetry system, wherein the AIDC label adjoining top side the multilayer dosimetry system with a second adhesive; and c) a bottom layer is a double coated adhesive tape having a central polymer layer, wherein one side of the tape is affixed to top side of the multilayer dosimetry system of (b) with a third adhesive and the second side of the of the tape is having a fourth adhesive with a release liner.

[0098] As shown in FIG.2a, a point dose measurement device comprises three layers. The middle layer is multilayer dosimetry system (201), the top layer (200) having AIDC indicia, and the bottom layer (202) is a double coated adhesive tape having a central polymer layer, wherein one side of the tape is affixed to top side of the multilayer dosimetry system of (b) with a third adhesive and the second side of the of the tape is having a fourth adhesive with a release liner.

[0099] In accordance with another aspect of the present invention, the second, third and fourth adhesives are independently selected from the group consisting of solvent-based adhesives, hot-Docket No.: 4412PCT melt adhesives, emulsion adhesives, pressure sensitive adhesive, radiation cured adhesives and combinations thereof.

[0100] In accordance with another aspect of the present invention, the pressure sensitive adhesive is acrylic pressure sensitive adhesive.

[0101] In accordance with one aspect of the present invention the central polymer layer of the double coated adhesive tape is selected from the group consisting of polyalkylene terephthalates of alkylene number of from C1-4, polyvinyl chloride, polyolefins selected from the group consisting of polyethylene, polypropylene, polybutylene, polyester and polyisobutylene and blends thereof.

[0102] In accordance with another aspect of the present invention, the release liner is selected from the group consisting of polymer and paper.

[0103] In accordance with another aspect of the present invention, the polymer of release liner is a polyester.

[0104] In accordance with another aspect of the present invention, the length of point dose measurement device is about 1 inch, and breadth is 0.5 inch.

[0105] According to another aspect of the present invention, the AIDC indicia is selected from the group consisting of bar codes, RFID (Radio Frequency According to one of the aspect of the present invention, Identification), optical character recognition (OCR), QR Codes and combinations thereof.

[0106] FIG.2b, and FIG.2c represents the top and bottom view of point dose measurement device. FIG.2b shows the QR code of the point dose measurement device. FIG.2c shows the bottom layer double coated adhesive tape’s release layer.

[0107] According to one aspect of the present invention, the middle layer of multilayer dosimetry system (201) is sandwiched between the top layer havingAIDC indicia (200), and a bottom layer is a double coated adhesive tape (202).

[0108] According to one more aspect of the present invention, the middle layer of multilayer dosimetry system (201) is sandwiched between the top layer of QR Codes and AIDC indicia (200) and a bottom layer is a double coated adhesive tape acrylic pressure sensitive adhesive (202).Docket No.: 4412PCT

[0109] According to another aspect of the present invention, the present application relates to a process for measuring point dose radiation, comprising the steps of: exposing the point dose measurement device, to an irradiation of an unknown dose; scanning the AIDC indicia, and processing and storing image data; placing the irradiated multilayer dosimetry system of the point dose measurement device in a fdm scanner surface using a template provided for orientation and to initiate scanning of the multilayer dosimetry system; establishing a correlation of the dose and the scanner response using a preinstalled software of the film scanner; measuring a data of the unknown dose for a point dose verification using the software of the film scanner; processing and storing image data using the preinstalled software of the film scanner in an image format; displaying the image data in numerical format in a display means attached to the film scanner and AIDC scanner; and optionally, printing the image and identification data in numerical format and / or lingual format with a printing means.

[0110] According to one aspect of the present invention, the multilayer dosimetry system subjected to a transmission mode during to the process of measurement.

[0111] According to one aspect of the present invention, the present application relates to storing the image data in red-green-blue (RGB) tagged image file format (TIFF).

[0112] According to one aspect of the present invention, the film scanner is flatbed scanner.

[0113] According to one aspect of the present invention, the flatbed scanner has a maximum resolution range from 120 dpi to 6400 dots per inch (dpi).

[0114] According to one aspect of the present invention, the flatbed scanner has a light source that moves across the film to allow repeated scanning of the film and to calibrate the flatbed scanner.

[0115] According to one aspect of the present invention, the flatbed scanner has a light source of a light emitting diode (LED) or a fluorescent source.

[0116] According to one aspect of the present invention, the light form is white, yellow or red color.

[0117] Although the present invention is described herein as it could be used in conjunction with a flatbed scanner, the present invention, as will be described in greater detail below, may be used in conjunction with any of a wide range of other optical Scanner apparatus.Docket No.: 4412PCT

[0118] In accordance with one aspect of the present invention, a radiation dosimetry method is described that facilitates determination of dose response in a manner that accounts for variations in thickness of the radiation sensitive material. In accordance with particular embodiments, the dose response may be calculated using at least two component channels, more particularly using two color channels of a flatbed color scanner. The method then allows for the measured response to be split into two portions, one of which is dose-dependent and the other dose-independent. The dose independent portion contains values proportional to the thickness of the radiation sensitive layer. This portion can be used to correct the dose response derived from the radiation-sensitive active component to account for variations caused by differences in the thickness of the active component.

[0119] According to one aspect of the present invention, the template has a shape selected from the group consisting of circular, rectangular, triangular, semi-circular, and square and combinations thereof.

[0120] FIG.2 indicates a template or jig for a point dose products that are constructed with at two layers where the middle layer of multilayer dosimetry system can be inserted. Bottom layer is a plastic material in which the point dose film (about 0.8 cm2) of the active laminate is placed. Middle layer is the multilayer dosimetry system (about 0.8 cm2) of the active laminate that is placed in the approximate center of the bottom layer. The top layer is a plastic material that will be placed in the cavity of the bottom layer to lock the point dose film in the device.

[0121] According to one aspect of the present invention, the present application relates to an integrated system to measure a point dose radiation, comprising: a point dose measurement device, a radiation emitting source to expose point dose measurement device to a predetermined radiation, a flatbed film scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device, to convert a scanned image into a digital data format and to establish correlation of radiation dose using a preinstalled software of the film scanner, an AIDC indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner, a display means attached to the AIDC scanner and to the flat bed film scanner, to display the image data and identification data in numerical format and / or lingual format in a display source, and optionally, a printing means to print the image and identification data in a numerical format and / or lingual format.Docket No.: 4412PCT

[0122] In accordance with one aspect of the present invention, the present application relates to an integrated system to measure a point dose radiation, comprising: i) a template to keep the point dose measurement device, ii) a radiation emitting source to expose the template to predetermined radiation, iii) a flatbed scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device and to establish correlation of radiation dose using a preinstalled software of the fdm scanner, iv) an automatic identification and data capture (AIDC) indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner, v) a display means attached to the AIDC scanner and to the flat bed film scanner, to process and display the image data and identification data in numerical format and / or lingual format in a display source, and optionally, vi) a printing means to print the image and identification data in a numerical format and / or lingual format.

[0123] In accordance with one aspect of the present invention, an integrated system to measure a point dose radiation, comprising: a point dose measurement device, a radiation emitting source to expose point dose measurement device to a predetermined radiation, a flatbed scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device and to establish correlation of radiation dose using a preinstalled software of the film scanner, and an AIDC indicia scanner to capture and trace data stored in an AIDC indicia related the point dose measurement device.

[0124] Further, certain aspects of the present application are illustrated in detail by way of the following examples. The examples are given herein for illustration of the application and are not intended to be limiting thereof.EXAMPLES

[0125] The application discloses the point dose response of a radiosensitive film solely by making it as multi-layer dosimetry system. The stress testing, Angular Dependency, Energy Dependency, Average dose accuracy, film sensitivity, and film dose is reported. The equipment for the manufacturing of multi-layer laminate is as described below:

[0126] Equipment & Materials:1. X-Ray Cabinet - PANTAK X-Rad 160,Docket No.: 4412PCT . Multi-layer dosimetry system, a) One pass of gafchromic™ EBT4 coating, b) MacTac PermaTrans PUV-3100 mounting film, c) Thin polyester base with a white coating EBT PET Clear Base, and d) Thin polyester base with a white coating EBT PET Clear Base,3. Densitometer - X-rite 310T, Transmission Mode,4. Printer,5. Film Scanner, Epson Optical Scanner V600, Epson Perfection V600 Photo Scanner6. AIDC Scanner (QR Code Scanner), DS4608-SR and DS4608-HC Zebra Bar code scanner7. Jig / Template,8. QR code film,9. Double tape adhesive, and10. Display source.

[0127] Stress Testing of Multilayer Dosimetry System Configuration:

[0128] As a part of evaluating the performance of multilayer dosimetry system configuration for point / surface dose under real clinical environment.

[0129] (i) Objectives:

[0130] Field tests were conducted to evaluate performance and the objectives. The field tests were: a) to asses consistency in film dose accuracy across dose ranges and to establish accuracy tolerances, b) to understand film sensitivity - low to higher dose ranges within which consistent average dose accuracy can be achieved to desired performance levels, and c) to understand energy dependency & angular dependency of the new film configuration.

[0131] (ii) Methodology: Set up, location & duration a) Calibration points:Docket No.: 4412PCT o Low dose calibration values: 0, 5,10,20,40,80, and o High dose calibration values: 0, 80, 160,320,640, and b) Set Up: For the calibration device exposures, 6X beam and 1.5 cm depth was used (most common application parameter).

[0132] (iii) Results: Data collection & Analysis a) Film exposed was analyzed at Ashland Bridgewater lab using Film QA pro software. o Triple channel optimization dosimetry method used for all analysis through Film QA Pro.

[0133] Average dose accuracy (Measured vs. targeted dose) for low dose spectrum (3cGy to 450cGy) were measured.

[0134] The median dose measurements were depicted in from FIG. 5 to FIG. 10 (Low standard deviation range) and FIG.l 1 to FIG. 16 (High standard deviation range).

[0135] FIG. 5 a) Median dose measured = 3. IcGy, b) 25% probability for dose variation on lower / higher side ranging between 2.8 to 3.4cGy, and c) Dose volatility = 0.38cGy.

[0136] FIG. 6 a) Median dose measured = 25.1cGy, b) 25% probability for dose variation on lower / higher side ranging between 24.7 to 25.6cGy, and c) Dose volatility = 0.49cGy.

[0137] FIG. 7: a) Median dose measured = 49.8cGy, b) 25% probability for dose variation on lower / higher side ranging between 49.0 to 50.0cGy, and c) Dose volatility = 0.80cGy.

[0138] FIG.8 a) Median dose measured = 99.9cGy, b) 25% probability for dose variation on lower / higher side ranging between 99.1 to 100.6cGy, and c) Dose volatility = 0.99cGy.

[0139] FIG. 9 a) Median dose measured = 198.1cGy, b) 25% probability for dose variation on lower / higher side ranging between 197.2 to 199.4cGy, and c) Dose volatility = 1. IcGy.

[0140] FIG. 10 a) Median dose measured = 444.5cGy, b) 25% probability for dose variation on lower / higher side ranging between 434.5 to 451.2cGy, and c) Dose volatility = 8.8cGy.

[0141] FIG. 11 a) Median dose measured = 26. IcGy, b) 25% probability for dose variation on lower / higher side ranging between 25.4 to 26.8cGy, and c) Dose volatility = 0.74cGy.Docket No.: 4412PCT

[0142] FIG. 12 a) Median dose measured = 50.3cGy, b) 25% probability for dose variation on lower / higher side ranging between 49.6 to 50.7cGy, and c) Dose volatility = 0.55cGy.

[0143] FIG. 13 a) Median dose measured = 98.1cGy, b) 25% probability for dose variation on lower / higher side ranging between 97.1 to 98.7cGy, and c) Dose volatility = 0.83cGy.

[0144] FIG. 14 a) Median dose measured = 191.2cGy, b) 25% probability for dose variation on lower / higher side ranging between 190.1 to 193.1cGy, and c) Dose volatility = 1.4cGy.

[0145] FIG. 15 a) Median dose measured = 435.9cGy, b) 25% probability for dose variation on lower / higher side ranging between 433.8 to 441.0cGy, and c) Dose volatility = 3.7cGy.

[0146] The results were “As-Is” results prior to applying any correction factors.

[0147] The multilayer dosimetry system developed was clearly performs dose measurements for low and high dose sensitivity profdes. a) Tested Low dose: 3-75cGy (calibration range: 0-80cGy), and b) Tested High dose: 100-450cGy (calibration range: 0-640cGy)

[0148] The accuracy results for the low dose values detailed in the acceptance criteria and passed the criteria of ± 10 cGy. However, the accuracy results for the high dose values detailed in the acceptance criteria and failed the criteria in two data points and made software enhancements to successfully validate in the next run, resulted in an accuracy of outside the criteria of ±5% of the given dose. The tables (1-13) below show the validation process protocol incorporating device testing relative to specification on both the low and high dose ranges. Three dose ranges for two different devices were tested at different energy levels for verification of accuracy, repeatability, energy & angular dependence. All data can be found in tables below. The table below shows the validation process protocol incorporating device testing relative to specification on both the low and high dose ranges. Three dose ranges for two different devices were tested at different energy levels for verification of accuracy, repeatability, energy & angular dependence. All data can be found in tables (1-13) below.

[0149] Table 1: Accuracy Details for 6 MV Xray (high dose failures shown in italic text)Docket No.: 4412PCT

[0150] Table 2: Accuracy Details for 15 MV Xray (high dose failures shown in italic text)

[0151] Table 3: Accuracy Details for 6 Mev Electrons (high dose failures shown in italic text)

[0152] Table 4: Accuracy Details for 9 Mev Electrons (high dose failures shown in italic text)Docket No.: 4412PCT

[0153] Table 5: Accuracy Details for 6 MV Xray V600 (No failures in the accuracy as shown in the table)

[0154] Table 6: Accuracy Details for 6 MV Xray XL Series (No failures in the accuracy as shown in the table)

[0155] Table 7: Accuracy Details for 15 MV Xray V600 (failures shown in italic text)Docket No.: 4412PCT

[0156] Table 8: Accuracy Details for 15 MV Xray XL Series (failures shown in italic text)

[0157] Table 9: Accuracy Details for 6 Mev Electrons V600 (failures shown in italic text)

[0158] Table 10: Accuracy Details for 6 Mev Electrons XL Series (failures shown in italic text)Docket No.: 4412PCT

[0159] Table 11: Accuracy Details for 9 Mev Electrons V600 (failures shown in italic text)

[0160] Table 12: Accuracy Details for 9 Mev Electrons XL Series (failures shown in italic text)Docket No.: 4412PCT

[0161] Table 13: Accuracy Details for 6 MV Xray V600 (failures shown in italic text)

[0162] The above results were “As-Is” analyzed using Film QA Pro triple channel dosimetry method. The following fitting function yielded consistent dose accuracy measurements were reflected in the analysis: a) For low dose, Exponential fitting function was fitted, and b) For high dose, Rational cubic fitting function was fitted.

[0163] Based on analysis, consistent dose accuracy tolerances for the new Gaf Pt device ranges were as follows: a) Low dose = + / - IcGy or + / - 20%, and b) High dose = + / - 15cGy Or + / - 5%

[0164] Angular dependence check was performed rotating the device 360 degrees and the results for dose accuracy was at 93.7% (within a 10% tolerance for high dose ranges). a) Angular dependence was not verified for low dose at this time, and b) Recommend device be used in accordance with instructions for use (IFU).

[0165] Energy Dependency: The energy dependency was measured and provided in Table - 14, below.

[0166] Table 14: Energy DependencyDocket No.: 4412PCT

[0167] Key Highlights of Energy Dependency: a) The film configuration shows <5% variance from targeted dose across both photon & electron energy beams, and b) The film configuration shows <10% variance from targeted dose for flattening filter free (FFF) energy beams (Note: FFF tests conducted on another Linac different that the ones where electron & photon beam tests were conducted)

[0168] The above results are indicative of minimal energy dependency between photon & electron beams.

[0169] Angular Dependency: Angular Dependency was measured in provided the results in Table 15, below.

[0170] Tablel5: Angular Dependency

[0171] Key Highlights Angular Dependency:Docket No.: 4412PCT

[0172] The film configuration was shows <6% variance from targeted dose across multiple angular dependency set ups.

[0173] While the compositions and methods of the disclosed and / or claimed inventive concept(s) have been described in terms of particular aspects, it will be apparent to those of ordinary skill in the art that variations may be applied to the compositions, device and / or 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 disclosed and / or claimed inventive concept(s). 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 disclosed and / or claimed inventive concept(s).

[0174] Embodiment 1 : A multilayer dosimetry system, comprising:(a) a mounting layer, wherein the mounting layer is an optically clear polymer film having two sides coated with an optically clear first adhesive;(b) at least two active layers, wherein the mounting layer is sandwiched between active layers by affixing to the optically clear first adhesive; and(c) (i) an optically clear top base layer affixed to upper side of the sandwiched structure of (b), and (ii) a bottom base layer affixed to bottom side of the sandwiched structure of (b).

[0175] Embodiment 2: The multilayer dosimetry system of embodiment 1, wherein the optically clear polymer film is a polyester.

[0176] Embodiment 3: The multilayer dosimetry system of embodiment 1, wherein the polyester is selected from the group consisting of polyethylene terephthalate, polyethylene napthalate, polyethylene isothalate, polybutalene terephthalate, polyethylene cocyclohexane dimethylterephthalate, polyethanol codimethanol cyclohexane napthalate, and copolymers thereof.

[0177] Embodiment 4: The multilayer dosimetry system of embodiment 1, wherein the mounting layer is having a thickness ranging from 25 pm to 200 pm.Docket No.: 4412PCT

[0178] Embodiment 5: The multilayer dosimetry system of embodiment 1, wherein the first adhesive is a pressure sensitive adhesive.

[0179] Embodiment 6: The multilayer dosimetry system of embodiment 5, wherein the pressure sensitive adhesive is an acrylic pressure sensitive adhesive.

[0180] Embodiment 7: The multilayer dosimetry system of embodiment 1, wherein the active layer is a composition comprising a microcrystalline dispersion of a substantially crystalline image receptive polyacetylenic compound.

[0181] Embodiment 8: The multilayer dosimetry system of embodiment 7, wherein the polyacetylenic compound has the structure:A-(CH2)n— C=C C=C (CH2)m— B : wherein m and n are both independently an integer from 6 to 14 and A and B are independent from one another and are selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or di -valent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triyn or tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and a conjugated structure, and combinations thereof.

[0182] Embodiment 9: The multilayer dosimetry system of embodiment 8, wherein the polyacetylenic compound is selected from the group consisting of pentacosa-10,12-diynoic acid; tricosa-10,12-diynoic acid, heneicosa-10,12-diynoic acid and combinations thereof.

[0183] Embodiment 10: The multilayer dosimetry system of embodiment 1, wherein the active layer is formed by a single pass coating on the mounting layer.

[0184] Embodiment 11 : The multilayer dosimetry system of embodiment 1, wherein the active layer is having a thickness ranging from 5 pm to 100 pm.Docket No.: 4412PCT

[0185] Embodiment 12: The multilayer dosimetry system of embodiment 8, wherein the polyacetylenic compound which selectively absorbs incident low energy photon radiation is present in an amount from about 0.1 to 50.0% by weight of the micro-crystalline dispersion.

[0186] Embodiment 13: The multilayer dosimetry system of embodiment 1, wherein the base layer is a polymer film.

[0187] Embodiment 14: The multilayer dosimetry system of embodiment 13, wherein the polymer is a polyester film.

[0188] Embodiment 15: The multilayer dosimetry system of embodiment 14, wherein the polyester is selected from the group consisting of polyethylene terephthalate, polyethylene napthalate, polyethylene isothalate, polybutalene terephthalate, polyethylene cocyclohexane dimethylterephthalate, polyethanol codimethanol cyclohexane napthalate and copolymers thereof.

[0189] Embodiment 16: The multilayer dosimetry system of embodiment 1, wherein the top base layer is optically transparent.

[0190] Embodiment 17: The multilayer dosimetry system of embodiment 1, wherein the bottom base layer is having white or matte appearance.

[0191] Embodiment 18: The multilayer dosimetry system of embodiment 1, wherein the multilayer dosimetry system is having a dynamic dose range from 3cGy to 600cGy.

[0192] Embodiment 19: The multilayer dosimetry system of any of the embodiment 1, wherein the optical clarity of the polymer film, of the first adhesive and / or of the top base layer is determined in accordance with ASTM DI 003 or ASTM D1746.

[0193] Embodiment 20: A point dose measurement device, comprising: a) a top layer having automatic identification and data capture (AIDC) indicia;Docket No.: 4412PCT b) a middle layer comprising the multilayer dosimetry system of embodiment 1, wherein the AIDC label adjoining top side the multilayer dosimetry system with a second adhesive; and c) a bottom layer is a double coated adhesive tape having a central polymer layer, wherein one side of the tape is affixed to top side of the multilayer dosimetry system of (b) with a third adhesive and the second side of the of the tape is having a fourth adhesive with a release liner.

[0194] Embodiment 21 : The point dose measurement device of embodiment 20, where in the AIDC indicia is selected from the group consisting of bar codes, RFID (Radio Frequency Identification), optical character recognition (OCR), QR Codes and combinations thereof.

[0195] Embodiment 22: The point dose measurement device of embodiment 20, wherein the second, third and fourth adhesives are independently selected from the group consisting of solvent-based adhesives, hot-melt adhesives, emulsion adhesives, pressure sensitive adhesive, radiation cured adhesives and combinations thereof.

[0196] Embodiment 23 : The point dose measurement device of embodiment 20, wherein the pressure sensitive adhesive selected from the group consisting of acrylic pressure sensitive adhesive.

[0197] Embodiment 24: The point dose measurement device of embodiment 20, wherein the central polymer layer of the double coated adhesive tape is selected from the group consisting of polyalkylene terephthalates of alkylene number of from Ci-4, polyvinyl chloride, polyolefins selected from the group consisting of polyethylene, polypropylene, polybutylene, polyester and polyisobutylene and blends thereof.

[0198] Embodiment 25: The point dose measurement device of embodiment 20, wherein the release liner is selected from the group consisting of polymer and paper.

[0199] Embodiment 26: The point dose measurement device of embodiment 25, wherein the polymer is a polyester.Docket No.: 4412PCT

[0200] Embodiment 27: A process for measuring point dose radiation, comprising the steps of: i. exposing the point dose measurement device, to an irradiation of an unknown dose; ii. scanning the automatic identification and data capture (AIDC) indicia, and processing and storing image data; iii. placing the irradiated multilayer dosimetry system of the point dose measurement device in a film scanner surface using a template provided for orientation and to initiate scanning of the multilayer dosimetry system; iv. establishing a correlation of the dose and the scanner response using a preinstalled software of the film scanner; v. measuring a data of the unknown dose for a point dose verification using the software of the film scanner; vi. processing and storing image data using the preinstalled software of the film scanner in an image format; vii. displaying the image and identification data in numerical format and / or lingual format in a display means attached to the film scanner and AIDC scanner; and optionally, ix. printing the image and identification data in numerical format and / or lingual format with a printing means.

[0201] Embodiment 28: The process for measuring point dose radiation of embodiment 27, wherein the multilayer dosimetry system subjected to a transmission mode during to the process of measurement.

[0202] Embodiment 29: The process for measuring point dose radiation of embodiment 27, wherein storing the image data in red-green-blue (RGB) tagged image file format (TIFF).

[0203] Embodiment 30: The process for measuring point dose radiation of embodiment 27, wherein the film scanner is flatbed scanner.Docket No.: 4412PCT

[0204] Embodiment 31 : The process for measuring point dose radiation of embodiment 27, wherein the flatbed scanner has a maximum resolution range from 120 dpi to 6400 dots per inch (dpi).

[0205] Embodiment 32. The process for measuring point dose radiation of embodiment 27, wherein the flatbed scanner has a light source that moves across the film to allow repeated scanning of the film and to calibrate the flatbed scanner.

[0206] Embodiment 33: The process for measuring point dose radiation of embodiment 27, wherein the flatbed scanner has a light source of a light emitting diode (LED) or a fluorescent source.

[0207] Embodiment 34: The process for measuring point dose radiation of embodiment 27, wherein the light form is white, yellow or red color.

[0208] Embodiment 35: The process for measuring point dose radiation, wherein the template has a shape selected from the group consisting of circular, rectangular, triangular, semi-circular, square and combinations thereof.

[0209] Embodiment 36: An integrated system to measure a point dose radiation, comprising: i) a point dose measurement device of embodiment 19, ii) a radiation emitting source to expose point dose measurement device to a predetermined radiation, iii) a flatbed film scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device, to convert a scanned image into a digital data format and to establish correlation of radiation dose using preinstalled software of the film scanner, iv) an automatic identification and data capture (AIDC) indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner,Docket No.: 4412PCT v) a display means attached to the AIDC scanner and to the flat bed film scanner, to process and display the image data and identification data in numerical format and / or lingual format in a display source, and vi) optionally, a printing means to print the image and identification data in a numerical format and / or lingual format.

[0210] Embodiment 37: An integrated system to measure a point dose radiation, comprising: i) a template to keep the point dose measurement device of embodiment 20, ii) a radiation emitting source to expose the template to predetermined radiation, iii) a flatbed scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device and to establish correlation of radiation dose using a preinstalled software of the film scanner, iv) an automatic identification and data capture (AIDC) indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner, v) a display means attached to the AIDC scanner and to the flat bed film scanner, to process and display the image data and identification data in numerical format and / or lingual format in a display source, and optionally, vi) a printing means to print the image and identification data in a numerical format and / or lingual format.

Claims

Docket No.: 4412PCTPatent claims:

1. A multilayer dosimetry system, comprising:(a) a mounting layer, wherein the mounting layer is an optically clear polymer film having two sides coated with an optically clear first adhesive;(b) at least two active layers, wherein the mounting layer is sandwiched between active layers by affixing to the optically clear first adhesive; and(c) (i) an optically clear top base layer affixed to upper side of the sandwiched structure of (b), and (ii) a bottom base layer affixed to bottom side of the sandwiched structure of (b).

2. The multilayer dosimetry system of claim 1, wherein the optically clear polymer film is a polyester.

3. The multilayer dosimetry system of claim 2, wherein the polyester is selected from the group consisting of polyethylene terephthalate, polyethylene napthalate, polyethylene isothalate, polybutalene terephthalate, polyethylene cocyclohexane dimethylterephthalate, polyethanol codimethanol cyclohexane napthalate, and copolymers thereof.

4. The multilayer dosimetry system of any of the proceeding claims, wherein the mounting layer is having a thickness ranging from 25 pm to 200 pm.

5. The multilayer dosimetry system of any of the preceeding claims, wherein the first adhesive is a pressure sensitive adhesive.

6. The multilayer dosimetry system of claim 5, wherein the pressure sensitive adhesive is an acrylic pressure sensitive adhesive.

7. The multilayer dosimetry system of any of the preceeding claims, wherein at least one of the active layers is a composition comprising a microcrystalline dispersion of a substantially crystalline image receptive polyacetylenic compound.

8. The multilayer dosimetry system of claim 7, wherein the polyacetylenic compound has the structure:Docket No.: 4412PCTA-(CH2)n— C=C— C=C— (CH2)m— B : wherein m and n are both independently an integer from 6 to 14 and A and B are independent from one another and are selected from the group consisting of methyl, carboxyl, hydroxy, amido, lower alkyl substituted amido, aliphatic or aromatic carboxylate ester group having up to 10 carbon atoms, mono- or di -valent carboxylate metal salt group, halo, carbamyl, lower alkyl substituted carbamyl or tosyl, triyn or tetrayne products of the above polyacetylenes having from 20 to 60 carbon atoms and a conjugated structure, and combinations thereof.

9. The multilayer dosimetry system of claim 8, wherein the polyacetylenic compound is selected from the group consisting of pentacosa-10,12-diynoic acid; tricosa-10,12-diynoic acid, heneicosa-10,12-diynoic acid and combinations thereof.

10. The multilayer dosimetry system of any of the preceeding claims, wherein at least one of the active layers is formed by a single pass coating on the mounting layer.

11. The multilayer dosimetry system of any of the preceeding claims, wherein at least one of the active layers is having a thickness ranging from 5 pm to 100 pm.

12. The multilayer dosimetry system of any of claims 7 to 11, wherein the polyacetylenic compound which selectively absorbs incident low energy photon radiation is present in an amount from about 0.1 to 50.0% by weight of the micro-crystalline dispersion.

13. The multilayer dosimetry system of any of the preceeding claims, wherein the base layer is a polymer film.

14. The multilayer dosimetry system of claim 13, wherein the polymer is a polyester film.

15. The multilayer dosimetry system of claim 14, wherein the polyester is selected from the group consisting of polyethylene terephthalate, polyethylene napthalate, polyethylene isothalate, polybutalene terephthalate, polyethylene cocyclohexane dimethylterephthalate, polyethanol codimethanol cyclohexane napthalate and copolymers thereof.

16. The multilayer dosimetry system of any of the preceeding claims, wherein the top base layer is optically transparent.Docket No.: 4412PCT17. The multilayer dosimetry system of any of the proceeding claims, wherein the bottom base layer is having white or matte appearance.

18. The multilayer dosimetry system of any of the proceeding claims, wherein the multilayer dosimetry system is having a dynamic dose range from 3cGy to 600cGy.

19. The multilayer dosimetry system of any of the proceeding claims, wherein the optical clarity of the polymer film, of the first adhesive and / or of the top base layer is determined in accordance with ASTM DI 003 or ASTM DI 746.

20. A point dose measurement device, comprising: a) a top layer having automatic identification and data capture (AIDC) indicia; b) a middle layer comprising the multilayer dosimetry system of any of claims 1 to 19, wherein the AIDC label adjoining top side the multilayer dosimetry system with a second adhesive; and c) a bottom layer is a double coated adhesive tape having a central polymer layer, wherein one side of the tape is affixed to top side of the multilayer dosimetry system of (b) with a third adhesive and the second side of the of the tape is having a fourth adhesive with a release liner.

21. The point dose measurement device of claim 20, where in the AIDC indicia is selected from the group consisting of bar codes, RFID (Radio Frequency Identification), optical character recognition (OCR), QR Codes and combinations thereof.

22. The point dose measurement device of claim 20 or 21, wherein the second, third and fourth adhesives are independently selected from the group consisting of solvent-based adhesives, hot-melt adhesives, emulsion adhesives, pressure sensitive adhesive, radiation cured adhesives and combinations thereof.

23. The point dose measurement device of any of claims 20 to 22, wherein the pressure sensitive adhesive selected from the group consisting of acrylic pressure sensitive adhesive.Docket No.: 4412PCT24. The point dose measurement device of any of claims 20 to 23, wherein the central polymer layer of the double coated adhesive tape is selected from the group consisting of polyalkylene terephthalates of alkylene number of from Ci-4, polyvinyl chloride, polyolefins selected from the group consisting of polyethylene, polypropylene, polybutylene, polyester and polyisobutylene and blends thereof25. The point dose measurement device of any of claims 20 to 24, wherein the release liner is selected from the group consisting of polymer and paper.

26. The point dose measurement device of claim 25, wherein the polymer is a polyester.

27. A process for measuring point dose radiation, comprising the steps of: i. exposing the point dose measurement device of any of claims 20 to 26, to an irradiation of an unknown dose; ii. scanning the automatic identification and data capture (AIDC) indicia, and processing and storing image data; iii. placing the irradiated multilayer dosimetry system of the point dose measurement device in a film scanner surface using a template provided for orientation and to initiate scanning of the multilayer dosimetry system; iv. establishing a correlation of the dose and the scanner response using a preinstalled software of the film scanner; v. measuring a data of the unknown dose for a point dose verification using the software of the film scanner; vi. processing and storing image data using the preinstalled software of the film scanner in an image format; vii. displaying the image and identification data in numerical format and / or lingual format in a display means attached to the film scanner and AIDC scanner; and optionally,Docket No.: 4412PCT viii. printing the image and identification data in numerical format and / or lingual format with a printing means.

28. The process for measuring point dose radiation of claim 27, wherein the multilayer dosimetry system subjected to a transmission mode during to the process of measurement.

29. The process for measuring point dose radiation of claim 27 or 28, wherein storing the image data in red-green-blue (RGB) tagged image file format (TIFF).

30. The process for measuring point dose radiation of any of claims 27 to 29, wherein the film scanner is flatbed scanner.

31. The process for measuring point dose radiation of any of claims 27 to 30, wherein the flatbed scanner has a maximum resolution range from 120 dpi to 6400 dots per inch (dpi).

32. The process for measuring point dose radiation of any of claims 27 to 31, wherein the flatbed scanner has a light source that moves across the film to allow repeated scanning of the film and to calibrate the flatbed scanner.

33. The process for measuring point dose radiation of any of claims 27 to 32, wherein the flatbed scanner has a light source of a light emitting diode (LED) or a fluorescent source.

34. The process for measuring point dose radiation of any of claims 27 to 33, wherein the light form is white, yellow or red color.

35. The process for measuring point dose radiation of any of claims 27 to 34, wherein the template has a shape selected from the group consisting of circular, rectangular, triangular, semi-circular, square and combinations thereof.

36. An integrated system to measure a point dose radiation, comprising: i) a point dose measurement device of any of claims 20 to 26, ii) a radiation emitting source to expose point dose measurement device to a predetermined radiation,Docket No.: 4412PCT iii) a flatbed film scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device, to convert a scanned image into a digital data format and to establish correlation of radiation dose using preinstalled software of the film scanner, iv) an automatic identification and data capture (AIDC) indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner, v) a display means attached to the AIDC scanner and to the flat bed film scanner, to process and display the image data and identification data in numerical format and / or lingual format in a display source, and vi) optionally, a printing means to print the image and identification data in a numerical format and / or lingual format. An integrated system to measure a point dose radiation, comprising: i) a template to keep the point dose measurement device of any of claims 20 to 26, ii) a radiation emitting source to expose the template to predetermined radiation, iii) a flatbed scanner to scan a radiation dose response of the multilayer dosimetry of the point dose measurement device and to establish correlation of radiation dose using a preinstalled software of the film scanner, iv) an automatic identification and data capture (AIDC) indicia for tracking and tracing the point dose measurement device using a preinstalled software of the AIDC scanner, v) a display means attached to the AIDC scanner and to the flat bed film scanner, to process and display the image data and identification data in numerical format and / or lingual format in a display source, and optionally, vi) a printing means to print the image and identification data in a numerical format and / or lingual format.

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