Patent Publication Number: US-2005131270-A1

Title: Radiation treatment system utilizing therapeutic agent and associated identifier

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
      This application claims priority to Provisional Application Ser. No. 60/529,124, filed Dec. 12, 2003 and entitled “Modular Coordinating System for Combinatorial Products”. 
    
    
     BACKGROUND  
      1. Field  
      The claimed invention relates generally to medical treatment using a radiation dose-enhancing agent.  
      2. Description  
      According to conventional radiation treatment, a beam of radiation is directed toward a tumor located within a patient. The radiation beam delivers a predetermined dose of therapeutic radiation to the tumor according to a treatment plan. The delivered radiation kills cells of the tumor by causing ionizations within the cells.  
      A kilovoltage radiation treatment system produces a divergent beam of X-ray radiation having energies in the 50 to 150 keV range and focuses the beam on a target site using a lens designed for this purpose. At these energies, most cellular damage caused by the radiation beam is due to photoelectric absorption. The amount of absorption, and the resulting cellular damage, may be magnified by injecting a dose-enhancing biochemical agent into the target site. Some kilovoltage radiation treatment systems employing this technique are described in U.S. Pat. Nos. 6,125,295 and 6,366,801.  
      The dose-enhancing effect of dose-enhancing agents can be beneficial, since cure rates for tumors often increase with increased radiation doses. A dose-enhancing agent should be delivered in prescribed amounts and according to prescribed parameters in order to ensure that particular tissues experience the radiation doses specified by an associated radiation treatment plan. Improved efficiency and/or control of such delivery are desired.  
     SUMMARY  
      To address at least the foregoing, some embodiments of the present invention provide a system, method, apparatus, and means to generate a radiation treatment plan associated with a patient, associate the radiation treatment plan with an identifier and a patient identifier identifying the patient, prepare a radiation treatment agent for delivery to the patient according to the radiation treatment plan, and associate the radiation treatment agent with the identifier. In a further aspect, the identifier associated with the radiation treatment agent is determined, the patient identifier is determined, the radiation treatment plan associated with the identifier and the patient is determined, and the radiation treatment agent is delivered to the patient in accordance with the radiation treatment plan.  
      According to some embodiments, an identifier associated with a radiation treatment agent is determined, a patient identifier is determined, a radiation treatment plan associated with the identifier and the patient identifier is determined, and the radiation treatment agent is delivered to a patient in accordance with the radiation treatment plan.  
      In still further aspects, a system includes a radiation treatment agent to treat tissue in response to received X-ray radiation, and an identifier associated with the radiation treatment agent, wherein the identifier is usable to identify a radiation treatment plan. The system may further include a medium storing the radiation treatment plan in a computer-readable format, wherein the radiation treatment plan is not associated with a particular patient. Alternatively, the system may include a treatment planning system storing the radiation treatment plan, wherein the radiation treatment plan is associated with a patient identifier.  
      The claimed invention is not limited to the disclosed embodiments, however, as those in the art can readily adapt the description herein to create other embodiments and applications. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      The construction and usage of embodiments will become readily apparent from consideration of the following specification as illustrated in the accompanying drawings, in which like reference numerals designate like parts, and wherein:  
       FIG. 1  is a perspective view of a system according to some embodiments;  
       FIG. 2  is a diagram illustrating a radiation treatment room according to some embodiments;  
       FIG. 3  is a block diagram illustrating elements of a radiation treatment system according to some embodiments;  
       FIG. 4  is a flow diagram of process steps according to some embodiments;  
       FIG. 5  is a representative view of a portion of a data table according to some embodiments;  
       FIG. 6  is a perspective view of a delivery device, a radiation treatment agent and an identifier associated with the agent according to some embodiments;  
       FIG. 7  is a flow diagram of process steps according to some embodiments; and  
       FIG. 8  is a flow diagram of process steps according to some embodiments. 
    
    
     DETAILED DESCRIPTION  
      The construction and usage of embodiments will become readily apparent from consideration of the following specification as illustrated in the accompanying drawings, in which like reference numerals designate like parts, and wherein:  
       FIG. 1  is a perspective view of a system according to some embodiments. System  1  comprises container  5  containing radiation treatment agent  10 , and identifier  15  associated with radiation treatment agent  10 . According to some embodiments, identifier  15  is usable to identify a radiation treatment plan. As will be described in detail below, the identified radiation treatment plan might be associated with a patient identifier and/or might not be associated with any particular patient.  
      Radiation treatment agent  10  may comprise any currently- or hereafter-known composition that is capable of treating tissue in response to received X-ray radiation. When subjected to radiation in the kilovoltage energy range, the absorption cross-section of an element having an atomic weight greater than fifty is often significantly higher than elements of which most human tissue is composed. Therefore, if a suitable radiation beam irradiates a tissue volume containing such an element, more photons will be stopped by the volume than would be in the absence of the element. The resulting tissue damage will be greater than tissue damage that would occur without the element, because most of the increased stoppages will be due to photoelectric absorption.  
      Accordingly, radiation treatment agent  10  may comprise a heavy element-carrying biochemical agent in some embodiments. Agent  10  according to some embodiments carries one or more of Iodine, Gadolinium, or Gold. Leukine may be employed as radiation treatment agent  10 , due to its ability to treat tissue in response to received X-ray radiation.  
      Container  5 , agent  10 , and identifier  15  are disposed within package  20 . Also included in package  20  are syringe  25  on which identifier  15  is disposed, needles  30 , software medium  35  and catheter  40 . Syringe  25 , needles  30  and catheter  40  comprise devices for delivering agent  10  to a patient. One or more of syringe  25 , needles  30  and catheter  40  may be particularly suitable to the delivery of a radiation treatment agent having the composition and/or concentration of agent  10 .  
      Software medium  35  may store a radiation treatment plan in a computer-readable format. The radiation treatment plan might not be associated with any particular patient. Software medium  35  may also or alternatively store computer-executable process steps to calculate therapeutic effects of radiation treatment agent  10 . Such steps may comprise steps to model the dissipation of agent  10  within tissue, to calculate a dose enhancement due to the receipt by agent  10  of X-rays having particular energies, or any other agent-related steps.  
      System  1  may include less or more elements than depicted in  FIG. 1 . Non-exhaustive examples of such elements include one or more of patient positioning devices, assays, radiation sources, or other radiation treatment agents. System  1  may also be packaged in suitable manners other than that shown in  FIG. 1 .  
      System  1  may be aggregated by an entity that is to deliver radiation treatment, such as a hospital. An example of the foregoing is provided below with respect to  FIG. 4 . Briefly, a radiation oncologist may generate a radiation treatment plan based on previously-acquired computed tomography scans of a patient and may associate the treatment plan with a patient identifier and identifier  15 . System  1  may then be created with elements  5  through  40  that are selected particularly for execution of the radiation treatment plan. Identifier  15  may therefore be used to confirm that system  1  and radiation treatment agent  10  are associated with the radiation treatment plan.  
      The elements of system  1  may be associated within package  20  by any one or more entities. A manufacturer or reseller of agent  10  may create system  1  and provide system  1  to entities that deliver radiation treatment. According to some of these embodiments, an example of which is described with respect to  FIG. 7 , software medium  35  may store a radiation treatment plan that is not associated with any particular patient. For example, the radiation treatment plan may be suitable for particular-sized tumors at particular tissue locations, and the volume and composition of agent  10  (as well as the selection of elements  25  through  40 ) may be suitable for treating a tumor of the certain size and location. A manufacturer or reseller may also produce system  1  in view of a particular patient as described above.  
      In each of the above cases, identifier  15  is associated with radiation treatment agent  10 . Such an association may provide more efficient and more reliable execution of a radiation treatment plan.  
       FIG. 2  illustrates radiation treatment room  50  according to some embodiments. Radiation treatment room  50  comprises patient  60 , table  70  and delivery system  100 . According to some embodiments, delivery system  100  is used to deliver radiation to patient  60  according to a radiation treatment plan.  
      Radiation unit  110  includes treatment head  111 , C-arm  112 , base  113  and imaging system  114 . Treatment head  111  includes a beam-emitting device such as an X-ray tube for emitting radiation used during calibration, data acquisition and/or treatment. The radiation may comprise electron, photon or any other type of radiation, and may have energies ranging from 50 to 150 keV. The radiation emitted by treatment head  111  may comprise any radiation suitable for data acquisition and/or treatment according to some embodiments. In some embodiments, the radiation is suitable to produce dose-enhancing effects when used in conjunction with a radiation treatment agent that is capable of treating tissue in response to received X-ray radiation.  
      Treatment head  111  also includes a cylinder in which are disposed optics such as a focusing lens for optically processing the emitted radiation. The focusing lens may comprise a lens for producing a convergent radiation beam from radiation emitted by the X-ray tube. Examples of this type of lens are described in U.S. Pat. No. 6,359,963 to Cash, in U.S. Pat. No. 5,604,782 to Cash, Jr., in U.S. Patent Application Publication No. 2001/0043667 of Antonell et al., and/or elsewhere in currently or hereafter-known art. Treatment head  111  may also include beam-shaping devices such as one or more jaws, collimators, reticles and apertures.  
      Imaging device  114  may comprise an image intensifier and a camera. An image intensifier is a vacuum tube that converts X-rays to visible light, which is then detected by the camera to produce an image. Imaging device  114  may comprise a flat-panel imaging device using a scintillator layer and solid-state amorphous silicon photodiodes deployed in a two-dimensional array. The RID1640, offered by Perkin-Elmer®), Inc. of Fremont, Calif., is one suitable device.  
      Imaging device  114  may comprise other types of imaging devices. For example, X-ray radiation may also be converted to and stored as electrical charge without use of a scintillator layer. In such imaging devices, X-rays are absorbed directly by an array of amorphous selenium photoconductors. The photoconductors convert the X-rays directly to stored electrical charge that comprises an acquired image of a radiation field. Imaging device  114  may also comprise a CCD or tube-based camera. Such an imaging device may include a light-proof housing within which are disposed a scintillator, a mirror, and a camera.  
      Treatment head  111  and imaging device  114  may be coupled to C-arm  112  so as to face one another irrespective of any movement of C-arm  112  with respect to base  113 . In this regard, C-arm  112  is slidably mounted on base  113  and can therefore be moved in order to change the position of treatment head  111  with respect to table  70 . Table  70  may also be adjustable to assist in positioning an internal portion of patient  60  with respect to radiation unit  110 . In some embodiments, base  113  includes a high-voltage generator for supplying power used by treatment head  111  to generate kilovoltage radiation.  
      Many C-arm/base configurations may be used in conjunction with some embodiments, including portable configurations, configurations in which base  113  is rotatably mounted to a ceiling of radiation treatment room  50 , configurations in which one C-arm is slidably mounted on another C-arm, and configurations incorporating multiple independent C-arms. Embodiments of radiation unit  110  may comprise one of the SIREMOBIL®, MULTISTAR®, BICOR® and POLYSTAR® systems produced by Siemens Corporation® or other systems designed to emit treatment radiation.  
      Operator station  120  includes processor  121  in communication with keyboard  122 , display  123  and identifier input device  124 . An operator may operate operator station  120  to instruct radiation unit  110  to deliver X-ray radiation to patient  60  according to a radiation treatment plan stored in processor  121 . Operator station  120  may also or alternatively be used to generate the radiation treatment plan. In this regard, operator station  120  may generate the treatment plan by importing computed tomography images and executing inverse treatment planning based on the images. The treatment plan may then be exported to an application for controlling radiation unit  110 .  
      Identifier input device  124  may be used to input information such as identifier  15  and/or patient identifiers to operator station  120 . Identifier input device  124  may comprise one or more of a smart card scanner, a barcode scanner, a fingerprint scanner, a keypad, or any other input device. Information input by identifier input device  124  may be used to identify a radiation treatment plan to be executed.  
      Operator station  120  may be located apart from radiation unit  110 , such as in a different room, in order to protect the operator from radiation. It should be noted, however, that the operation of low-voltage radiation systems does not require protective measures to the extent of those taken during megavoltage radiation treatment, often resulting in less costly treatment.  
       FIG. 3  is a block diagram of elements of radiation treatment room  50  according to some embodiments. As shown, operator station  120  includes several elements for interfacing with other elements of room  50 . Specifically, operator station  120  includes treatment head control  201 , gantry control  202 , table control  203 , and imaging device control  204 . Processor  121  further includes microprocessor  205  and memory  210 .  
      Treatment head control  201  controls treatment head  11  so as to implement particular radiation delivery parameters called for by a radiation treatment plan. These parameters may include an X-ray tube potential, a radiation energy, an X-ray tube current, a scan time and radiation filtration parameters. Gantry control  202 , table control  203  and imaging device control  204  also operate to control C-arm  112 , base  113 , table  70  and imaging device  114  in accordance with a radiation treatment plan.  
      Microprocessor  205  executes processor-executable process steps stored in memory  210 . In this regard, memory  210  stores processor-executable process steps of control program  211 . Control program may comprise a software application to control elements of room  50  based on a radiation treatment plan. In this regard, memory  210  may also store radiation treatment plans  212  and plan identification table  213 . Radiation treatment plans  212  may comprise scripts that are automatically executable by radiation unit  110  and treatment table  70  in order to provide multiple treatment segments. Radiation treatment plans  212  may also comprise any other currently- or hereafter-known types of radiation treatment plan.  
      Plan identification table  213  may associate identifiers and patient identifiers with radiation treatment plans. The identifiers may in turn be associated with radiation treatment agents. In some embodiments, plan identification table  213  may allow for identification of one of radiation treatment plans  212  based on a patient identifier and an identifier associated with a treatment agent. The structure and use of plan identification table  213  according to some embodiments will be described in detail below.  
      The radiation delivery environment illustrated in  FIGS. 2 and 3  may include less or more elements than those shown. In addition, embodiments are not limited to the devices and/or to the illustrated environment.  
       FIG. 4  is a flow diagram of process steps  400  according to some embodiments. Process steps  400  may be embodied, in whole or in part, by hardware of and/or software executed by elements including but not limited to those of radiation delivery system  100 . Software embodying one or more of process steps  400  may be stored by any medium, including a fixed disk, a floppy disk, a CD-ROM, a DVD-ROM, a Zip™ disk, a magnetic tape, or a signal. Some or all of such software may also be stored in one or more devices. One or more of process steps  400  may be performed manually.  
      Initially, at step S 401 , a radiation treatment plan associated with a patient is generated. The radiation treatment plan may be generated based on previously-acquired data stored in a storage device. The previously-acquired data may comprise three-dimensional data representing internal portions of the patient.  
      In some embodiments of step S 401 , a patient is placed in a computed tomography (CT) scanner to obtain CT data representing the patient using currently- or hereafter-known techniques. Such techniques may include producing sets of two-dimensional data obtained at various rotational angle positions with respect to the patient. Attenuation coefficients (Hounsfield numbers) of points within the patient are computed based on the data sets to generate three-dimensional data representing internal portions of the patient. The data represents the attenuative properties of tissues at each point of the represented portions, and may be used to generate a visual representation of the relative densities of each square of material.  
      A radiation oncologist may generate the radiation treatment plan at step S 401  based on the three-dimensional data. The radiation treatment plan may indicate a radiation dose, a radiation target, an amount and concentration of dose-enhancing agent, a C-arm position, and/or any other currently- or hereafter-known treatment plan parameter. The radiation treatment plan may be formatted as required by a treatment planning system that will be used to execute the treatment plan.  
      The radiation treatment plan is associated with an identifier and with a patient identifier at S 402 . The patient identifier may comprise any perceptible article capable of identifying the patient of step S 401 . According to some embodiments, a patient identifier is an alphanumeric code that uniquely identifies the patient. The patient identifier may be created during step S 401  and/or may be associated with all of the patient&#39;s medical records. The identifier will be associated with an agent for treating tissue in response to received radiation. The associated agent may be usable to execute the treatment plan generated at S 401 .  
       FIG. 5  illustrates a tabular representation of a portion of plan identification table  213 . According to some embodiments of S 402 , the radiation treatment plan, the patient identifier and the identifier are associated with one another in a record of plan identification table  213 . A radiation treatment plan is identified in table  213  by a code that may serve as an index to a radiation treatment plan stored among radiation treatment plans  212 . In the present example, it is assumed that record  2133  is created at step S 402 .  
      Next, at step S 403 , an agent is prepared for delivery to the patient according to the treatment plan generated at step S 401 . Preparation at step S 403  may comprise measuring an appropriate amount of agent according to the treatment plan and preparing a delivery device to deliver the agent.  FIG. 6  is a perspective view of agent  10  after some embodiments of step S 403 . Agent  10  has been measured and placed into syringe  25 . Syringe  25  may be particularly suitable to the delivery of agent  10  and/or particularly suitable to delivery as required by the generated treatment plan.  
      The agent is associated with the identifier at step S 404 . Continuing with the foregoing example, barcode  15  is placed on syringe  25  according to some embodiments of step S 404 . Barcode  15  may encode the identifier that was mentioned with respect to step S 402 . Based on record  2133  of table  213 , barcode  15  encodes the identifier “A49773”.  
      Any suitable system for associating an agent with an identifier may be used at step S 404 . As non-exhaustive examples, the identifier may be placed on a container containing the agent such as container  5 , on a package containing the agent and related elements such as package  20 , or on a surgical tray holding the agent and delivery devices used to deliver the agent. The identifier itself may comprise any perceptible article capable of identifying the agent. Such articles include but are not limited to printed patterns, smells, colors, masses, and electronic identification tags.  
      Embodiments of process steps  400  may set the stage for more efficient and/or more reliable execution of a radiation treatment plan than previously available systems. Process steps  700  of  FIG. 7  may also conform to embodiments that provide for increased reliability and/or efficiency of a subsequently-executed radiation treatment plan.  
      Process steps  700  may be embodied, in whole or in part, by hardware of and/or software executed by elements including but not limited to those of radiation delivery system  100 . Software embodying one or more of process steps  700  may be stored by any medium, including a fixed disk, a floppy disk, a CD-ROM, a DVD-ROM, a Zip™ disk, a magnetic tape, or a signal. Some or all of such software may also be stored in one or more devices. One or more of process steps  700  may be performed manually.  
      Process steps  700  may be performed by a manufacturer or a reseller of a radiation treatment agent. According to some embodiments, process steps  700  are executed to produce a package that may be sold to entities that deliver radiation treatment to patients.  
      At step S 701 , a radiation treatment plan associated with a radiation treatment agent is generated. The radiation treatment plan may be generated based on characteristics of the radiation treatment agent, a particular formulation of the radiation treatment agent, a volume of the radiation treatment agent, and/or an intended use of the radiation treatment agent. For example, the radiation treatment plan may be intended to treat lung tumors using a particular radiation treatment agent.  
      The radiation treatment plan may therefore not be associated with a particular patient. The radiation treatment plan generated at step S 701  may be incomplete and later customizable based on a particular patient to whom the plan is to be delivered. A software medium such as medium  35  may be used to store the generated radiation treatment plan.  
      Elements for delivering the radiation treatment plan are associated with the radiation treatment agent at step S 702 . The elements may be particularly called for by the radiation treatment plan.  FIG. 1  illustrates one embodiment for associating the delivery elements with the radiation treatment agent. In this regard, the association at step S 702  may comprise physically collecting the delivery elements with the radiation treatment agent. The elements may also be associated with the agent by placing identical indicia on each element.  
      Next, at step S 703 , an identifier is associated with the radiation treatment agent. The identifier does not identify any particular patient. According to some embodiments, step S 703  comprises placing barcode  15  on syringe  25  as shown in  FIG. 1 . Step S 703  may also comprise placing an indicia on package  20  or any other system for associating an identifier with a radiation treatment agent.  
      Process steps  700  may be used to create a generic kit that may be used to deliver a radiation treatment agent to any individual patient. Process steps  700  may also provide for more reliable delivery of the radiation treatment agent according to a radiation treatment plan.  
      Process steps  800  may be used to deliver a radiation treatment agent according to a radiation treatment plan. Process steps  800  may be embodied, in whole or in part, by hardware of and/or software executed by elements including but not limited to those of radiation delivery system  100 . Software embodying one or more of process steps  800  may be stored by any medium, including a fixed disk, a floppy disk, a CD-ROM, a DVD-ROM, a Zip™ disk, a magnetic tape, or a signal. Some or all of such software may also be stored in one or more devices. One or more of process steps  800  may be performed manually.  
      An identifier associated with a radiation treatment agent is determined at step S 801 . In some embodiments, the identifier is represented by barcode  15  located on syringe  25 . Scanner  124  may determine the identifier by scanning barcode  15 . Any other identifier associated with a radiation treatment agent and system for determining the identifier may be used at step S 801 .  
      A radiation treatment plan is determined at step S 802 . The radiation treatment plan is associated with the identifier and with a patient. Prior to some embodiments of step S 802 , scanner  124  may read a patient identifier from a patient tag or smart card. Accordingly, the identifier and the patient identifier may be used in conjunction with plan identification table  213  to identify a radiation treatment plan from among radiation treatment plans  212 .  
      Records  2131  and  2132  of table  213  show that a same radiation treatment plan and a same radiation treatment agent may be associated with more than one patient. Records  2131  and  2132  may represent a radiation treatment plan that was associated with a radiation treatment agent as described with respect to process steps  700 . Records  2133  through  2135  show radiation treatment plans that are unique to each patient identified therein, which may indicate that these plans were generated as described with respect to process steps  400 . Moreover, records  2134  and  2135  show that a same radiation treatment plan may be associated with more than one radiation treatment agent.  
      The radiation treatment agent is delivered to the patient in accordance with the determined treatment plan in step S 803 . The agent may be delivered via direct injection, intravenous injection, or by other means. In this regard, the identifier may also be associated with delivery devices to be used in the delivery of the agent.  
      Process steps  800  may provide for more reliable and/or efficient delivery of a radiation treatment agent in accordance with a radiation treatment plan. In some embodiments, treatment radiation is delivered according to the radiation treatment plan at the conclusion of process steps  800 . The radiation treatment agent may then treat tissue of the patient in response to the received radiation.  
      Those in the art will appreciate that various adaptations and modifications of the above-described embodiments can be configured without departing from the scope and spirit of the claims. Therefore, it is to be understood that the claims may be practiced other than as specifically described herein.