Classifications

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  • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
  • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
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• • A—HUMAN NECESSITIES
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  • G01R33/44—Arrangements or instruments for measuring magnetic variables involving magnetic resonance using nuclear magnetic resonance [NMR]
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  • A61B2018/00636—Sensing and controlling the application of energy
  • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
  • A61B2018/00672—Sensing and controlling the application of energy using a threshold value lower
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  • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
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  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N5/067—Radiation therapy using light using laser light

Definitions

• the present invention relates to the field of the treatment of a biological tissue by a localized variation of the temperature under guidance by intraoperative imaging.
• the invention relates to an assembly and a method making it possible to quantify in real time and in 3D the temporal evolution of the heat treatment of the targeted biological tissue.
• the heat treatment assembly and the associated method can be used during the intraoperative phase, in order to be able to display in real time quantitative information indicating the volume in which a temperature variation has been induced in a target region and/or or in regions neighboring the target region.
• a first category of heat treatment which consists in depositing a dose of energy in a target zone of a biological tissue via means of energy generators positioned at a distance (focused ultrasound or radiofrequency by induction ) or in the target area by percutaneous or vascular route (radiofrequencies, laser, microwaves, cryotherapy).
• energy generators positioned at a distance (focused ultrasound or radiofrequency by induction ) or in the target area by percutaneous or vascular route (radiofrequencies, laser, microwaves, cryotherapy).
• Most devices offer a predefined implementation aimed at achieving a given volume a priori. However, the volume actually treated can vary substantially due to physiological/physiopathological parameters (perfusion, thermal diffusivity, energy absorption, presence of nearby large vessels, tissue and cellular heterogeneity).
• a phase known as the "preoperative planning phase” aims to evaluate the 3D extension of the pathological zone using suitable imaging techniques, for example by computed tomography (which may be designated by “CT throughout this description) or by Magnetic Resonance Imaging (which may be referred to as "MRI” throughout this description), capable of determining the size, number, location and shape of the target region(s).
• CT computed tomography
• MRI Magnetic Resonance Imaging
• a ballistic phase consists of positioning the energy-generating device with regard to the region to be treated. This positioning is usually performed iteratively using intermittent imaging guidance.
• the energy deposition is generally carried out with monitoring (ultrasound, physiological signals, sensors integrated into the treatment device) which does not make it possible to precisely quantify the 3D distribution of the temperature in the region to be treat.
• monitoring ultrasound, physiological signals, sensors integrated into the treatment device
• the temperature variation in the region to be treated is visualized in summary form and the energy deposit can be interrupted when it deviates from the setpoint. From the temperature imagery, it is possible to calculate a thermal dosimetry which is a reliable indicator of the treatment, provided that the uncertainty on the thermometry is less than or equal to 1°C in each pixel of the image .
• the deviation between the planned and actual energy deposition in the different regions can be accentuated by ballistic errors, for example an imperfect positioning of the energy applicator with regard to the region to be treated.
• the energy deposition may substantially deviate from that which has been planned.
• thermotherapies in particular the precise repositioning of the energy applicator to complete the treatment with one or more successive additional energy deposits in the region(s) not yet treated.
• the practitioner evaluates the effectiveness of the treatment a posteriori, i.e. immediately after the procedure or up to several weeks after the procedure), which does not allow optimal treatment in a single procedure, resulting in a loss of efficiency and a risk of loss of opportunity for the patient).
• An object of the invention is therefore to propose an assembly and a method which allow, during the intraoperative treatment phase, real-time monitoring, with a refresh rate of one second or better, in 3D by encompassing the completeness of the biological tissue to be treated and its environment and quantitative temperature.
• the heat treatment assembly of the present invention allows quantitative and dynamic monitoring of the treatment of the targeted biological tissue by proposing quantitative indicators linked to the treatment. Its objective is to improve the effectiveness of heat treatment as well as its safety and therefore to increase the benefit/risk balance of these heat therapies. Another expected consequence of the present invention is to increase the number of patients eligible for these therapies having fewer side effects than conventional surgery and better efficacy than drug treatments.
• An assembly for the heat treatment of a target region of a biological tissue comprising:
• an energy applicator coupled to said generator and configured to deposit thermal energy in said target region so as to induce a temperature variation
• an MRI image acquisition device configured to generate at least one anatomical MRI image (IMG_IRM_A) and at least one phase image (IMG_IRM_P);
• a planning unit comprising an MRI image processing means configured to define the target region Rc, a region to be preserved Rp and a neutral region Rn on said at least one anatomical MRI image (IMG_IRM_A), said means for processing MRI images also being configured to assign a heat treatment setpoint to each of the three regions and an acceptable temperature measurement uncertainty to each of the three regions;
• a heat treatment state progress monitoring unit configured to receive data from the planning unit and data from the MRI image acquisition device in real time during a heat treatment phase , said monitoring unit comprising means for generating temperature images from said at least one phase image (IMG_IRM_P), means for calculating a reliability indicator of the temperature variation indicated on the image of temperature and a means of calculating an indicator of the state of the heat treatment in each of the three regions, - the means for calculating a quantitative indicator of the state of the heat treatment (12) being configured for:
• the practitioner can follow during the heat treatment in real time and continuously the evolution of the quantitative indicators in the three regions.
• the signal is presented for example in the form of a 2D or 3D map, or a graphical representation.
• the dynamic display of the number of pixels having reached the predefined temperature set point and/or the thermal dose set point allows it to follow the progress of the treatment not only in the target region but also in the region to be preserved and the neutral region and help him make a decision in real time during treatment.
• the number of pixels that satisfy the predefined heat treatment setpoint can be compared to the number of predefined pixels in the target region before the start of the treatment in order to provide a percentage of volume treated.
• the number of pixels which satisfy the predefined heat treatment setpoint can be compared to the number of predefined pixels in this region in order to provide a percentage of alteration volume, which should ideally remain as close as possible to zero.
• a warning signal for example an audible alert signal can be given for example when 80% of the lethal thermal dose is reached in one or more pixels of this region, or even when the temperature approaches a few degrees from the authorized limit temperature.
• the alert signal can also be given with similar or different alert signals, but with less criticality, since it is acceptable (even if not desirable) to violate the instructions in this region.
• warning signals make it possible to warn the practitioner in real time of the risk of creating alterations in the neutral and critical regions to be preserved before the setpoints are reached or exceeded in the neutral and critical regions to be preserved.
• the heat treatment status indicator signals generated in real time at each new temperature and thermal dose measurement can be visual or audible to indicate the treatment status in the three regions.
• the assembly further comprises a second image acquisition device configured to generate at least one anatomical image (IMG_A).
• IMG_A anatomical image
• the planning unit further comprises an anatomical image processing means configured to define the three regions on said anatomical image (IMG_A), a registration means configured to spatially match the anatomical image with the image Anatomical MRI from the MRI image acquisition device.
• IMG_A anatomical image processing means configured to define the three regions on said anatomical image
• registration means configured to spatially match the anatomical image with the image Anatomical MRI from the MRI image acquisition device.
• the means of calculating a reliability indicator is configured for:
• the means for calculating a quantitative indicator of the state of the heat treatment is configured to exclude the pixels whose measured temperature variation is not usable or reliable. This makes it possible to increase the reliability of the quantitative indicator generated by the calculation means, in particular by avoiding the generation of untimely warning signals during processing.
• the heat treatment setpoint assigned to the target region Rc corresponds to a minimum temperature to be reached, a minimum thermal dose to be reached, or a predefined temperature change curve over time.
• the heat treatment setpoint assigned to the region to be preserved Rp corresponds to a maximum temperature not to be exceeded or a maximum thermal dose not to be exceeded.
• the heat treatment setpoint assigned to the neutral region corresponds to a maximum temperature not to be exceeded or a maximum thermal dose not to be exceeded.
• the energy applicator is a laser beam applicator, a microwave applicator, a radiofrequency wave applicator, a focused ultrasound applicator or an energy applicator. cryogenic.
• the assembly further comprises a display unit configured to display the quantitative indicators of the state of the processing in each of the three regions.
• the method further comprises a planning phase carried out before the thermal pretreatment phase, said planning phase comprising the following steps: - generating at least one anatomical image (IMG_A);
• the pre-processing phase further comprises a registration step between the image anatomical image and the anatomical MRI image to define the three regions on the anatomical MRI image.
• the display step generates a visual and/or sound indicator indicating that the heat treatment is finished in the Rc region when the number of pixels of said Rc region satisfying the processing instruction reaches a predefined threshold.
• the display step generates a visual and/or sound indicator indicating that the security instruction in the region Rp is not respected when the number of pixels of the region to be preserved does not satisfy the predefined instruction. exceeds a predefined threshold.
• FIG. 1 A block diagram illustrating an exemplary computing environment in accordance with the present invention.
• FIG. 1 Figure 1 schematically shows a heat treatment assembly according to one embodiment
• FIG. 2 Figure 2 schematically shows a heat treatment assembly according to another embodiment
• FIG. 3 is a flowchart showing the heat treatment monitoring method according to one embodiment
• Fig. 4 is a flowchart showing the heat treatment monitoring method according to another embodiment.
• target region means a region comprising the pathological tissue to be treated visible in imaging and a region that surrounds the pathological tissue.
• the extent of the neighborhood around the pathological tissue is variable and is defined by the practitioner.
• the target region must undergo a temperature variation in order to treat the pathological tissue.
• the region is denoted by Rc in Figure 1.
• critical region to be preserved means a region in which the biological tissue is healthy and which must not undergo a deleterious temperature variation during the heat treatment.
• the region is denoted by Rp in Figure 1.
• neutral region means a region in which the biological tissue is healthy and should ideally not undergo a temperature variation during the heat treatment. However, a possible variation in temperature is not considered critical for the patient.
• the region is denoted by Rn in Figure 1.
• a 3D anatomical image is a reconstructed image representing the anatomy of the target region and its environment. This 3D anatomical image can be obtained by different imaging techniques.
• the Magnetic Resonance Imaging (MRI) device is a device configured to provide information concerning the target, critical and neutral regions. This information may be of an anatomical and/or functional nature, it may in particular relate to the temperature variations of the tissues contained in the aforementioned regions.
• the magnetic resonance imaging device generates 3D MRI images and associates with each voxel of the MRI image (elementary unit of volume of each region) a complex number Mb f , where M is the module and f the phase of the magnetization vector in this voxel.
• Mb f complex number
• the term “pixel” of an image represents one or more information items of the associated voxel.
• the module M in each pixel of the image allows the construction of an anatomical MRI image IMG_IRM_A.
• the phase difference between two consecutive phase MRI images IMG_IRM_P is directly proportional to a temperature difference, thus allowing the construction of a temperature image.
• the “thermal dose” corresponds to the integration of the temperature over time.
• a map of thermal doses it is possible to obtain from a temperature map, a map of thermal doses.
• the temperature and thermal dose maps obtained during the treatment are indicators of the biological effect induced by the latter.
• FIG. 1 an assembly 1 for heat treatment of a target region Rc to be treated of a biological tissue according to one embodiment of the invention. It comprises a thermal treatment device comprising an applicator 2 coupled to a thermal energy generator 3, an MRI image acquisition device 4, a planning unit 5 (UNIT PLANIF 1), a monitoring unit 9 (UNIT PLANIF SURV) in real time of the state of the heat treatment by generating at least one quantitative indicator of the state of the heat treatment and a display unit 13 (UNIT VIS).
• a thermal treatment device comprising an applicator 2 coupled to a thermal energy generator 3, an MRI image acquisition device 4, a planning unit 5 (UNIT PLANIF 1), a monitoring unit 9 (UNIT PLANIF SURV) in real time of the state of the heat treatment by generating at least one quantitative indicator of the state of the heat treatment and a display unit 13 (UNIT VIS).
• a thermal treatment device comprising an applicator 2 coupled to a thermal energy generator 3, an MRI image acquisition device 4, a planning unit 5
• the thermal energy applicator 2 is configured to induce a temperature variation in the target region Rc to be treated of the biological tissue. It can be a radio frequency wave applicator, a microwave applicator, a focused ultrasound applicator, a laser beam applicator or a cryogenic energy applicator. In FIG. 1, it is schematized by a percutaneous applicator positioned within the target region Rc to be treated.
• the thermal energy applicator 2 is powered by the energy generator 3.
• the thermal energy applicator can also be in the form of a non-invasive extracorporeal transmitter (focused ultrasound, inductive radiofrequency) which is suitable for focusing a deposit of thermal energy in the target region.
• the MRI image acquisition device 4 is used during a preprocessing phase to generate anatomical MRI images (IMG_IRM_A).
• the pretreatment phase is a phase carried out just before the start of the heat treatment.
• the anatomical MRI images (IMG_IRM_A) are then transmitted to the planning unit 5.
• the MRI image acquisition device 4 is also used to generate phase images (IMG_IRM_P) from a sequence of images sensitive to the temperature variation acquired throughout the duration of the heat treatment.
• the MRI imaging device 4 is configured to obtain dynamic temperature imaging encompassing the three predefined regions Rc, Rp and Rn, throughout the duration of the heat treatment. This dynamic imaging is obtained using a fast acquisition sequence, of the order of a second or less for each volume acquired, with a spatial resolution of the order of a millimeter or better.
• the phase images (IMG_IRM_P) are transmitted to the monitoring unit 9.
• the planning unit 5 comprises an anatomical MRI image processing means 6 (TRAIT IMG_IRM_A) which is configured to define on the 3D anatomical MRI image the target region Rc, the critical region to be preserved Rp and the region neutral Rn.
• TRAIT IMG_IRM_A an anatomical MRI image processing means 6
• FIG. 1 schematically represents a biological tissue comprising a target region, named Rc, surrounded by a critical region to be preserved, named Rp and a neutral region, named Rn.
• the target region Rc must contain the entire pathological zone to be treated and not include the critical region to be preserved.
• the anatomical MRI image processing means 6 is capable of segmenting the 3D anatomical MRI image in order to determine the target pixels in the Rc region, in the critical region to be preserved the pixels to be preserved , in the neutral region the neutral pixels.
• the anatomical MRI image processing means 6 is also configured to define a heat treatment setpoint in each of the three regions. More precisely, the MRI image processing means 6 is configured to assign to each of the pixels of each of the three regions a set temperature and/or thermal dose to be respected.
• the heat treatment setpoint can be either a minimum temperature to be reached, or a minimum thermal dose to be reached, either a predefined temperature change curve over time, or a combination of several temperature and thermal dose setpoints.
• the heat treatment setpoint can be either a maximum temperature not to be exceeded, or a maximum thermal dose not to be exceeded.
• the heat treatment setpoint can be either a maximum temperature not to be exceeded, or a maximum thermal dose not to be exceeded.
• the anatomical MRI image processing means 6 is also configured to define an uncertainty of the acceptable temperature measurements in each of three regions. More precisely, it is configured to assign to each of the pixels determined in each of the three regions Rc, Rp and Rn an acceptable uncertainty for the temperature measurement.
• the value of the uncertainty can be linked to the predefined temperature set point. For example, when a temperature variation of 5°C is defined in the Rc region, it is not acceptable for example to have an uncertainty greater than 3°C.
• the anatomical MRI images (IMG_IRM_A) with the information associated with each of the three regions are transmitted to the monitoring unit 9.
• the associated information is the temperature and/or thermal dose setpoints and the uncertainties of the acceptable temperature measurements attributed to each of the pixels determined in the three regions Rc, Rp and Rn.
• the monitoring unit 9 is configured to receive in real time during the thermal treatment phase images (IMG_IRM_P) coming from the MRI image acquisition device 4 and to generate a quantitative indicator of the progress of the treatment.
• thermal in real time during thermal treatment from anatomical MRI images (IMG_IRM_A) and phase images (IMG_IRM_P).
• the monitoring unit 9 is also configured to receive measurements originating from the internal sensors integrated into the heat treatment device (not illustrated in FIG. 1) and from additional external sensors (not illustrated in FIG. 1).
• Internal sensors can be example of the sensors integrated into the thermal energy applicator 2 to transmit information on its position in space relative to the target region, the thermal energy sent by the applicator and/or point measurements of the temperature by temperature sensors.
• the measurements coming from the additional external sensors can comprise for example physiological measurements, for example measurements relating to the respiration, the cardiac activity and to the position of the patient.
• the monitoring unit 9 is configured to process the data it receives in real time.
• the monitoring unit is configured so that the data analysis and processing rate is greater than that of the acquisition of the phase images by the MRI image acquisition device 4 to generate dynamically and with latency minimum the quantitative indicator representative of the evolution of the state of the heat treatment during the treatment phase.
• the monitoring unit 9 comprises means for generating temperature images 10 (IMG T) from the phase images (IMG_IRM_P) acquired by the MRI image acquisition device 4.
• the means for generating temperature imager 10 further comprises an algorithm adapted to compensate for motion, temporal and spatial drift artifacts of the MRI imaging device and also integrates the analysis of data from the external sensors of the thermal treatment device and the data from additional sensors, for example physiological sensors.
• the monitoring unit 9 includes means for calculating the reliability indicator of the thermometry 11 (FIAB).
• Thermometry refers to the temperature variation shown on the temperature image generated from the phase MRI images.
• the calculation of the reliability indicator of the thermometry is implemented before the deposit of energy by the energy applicator.
• the calculation means 11 is configured to determine the uncertainty of the temperature in each pixel from a variance of the temperature measured on, for example, a series of several successive temperature images. By way of example, the series may comprise ten successive temperature images to calculate the variance.
• the reliability indicator calculation means can generate a 2D or 3D map representing the pixels which satisfy the predefined acceptable uncertainties in the planning unit 5.
• the calculation means 11 is able to determine the reliability indicator, that is to say the number or the percentage of pixels which satisfy the predefined uncertainties in the planning unit 5.
• the reliability indicator calculation means 11 is configured to compare the determined reliability indicator with a threshold predefined by the practitioner.
• the reliability indicator calculation means 11 when the reliability indicator is below a predefined threshold, the reliability indicator calculation means 11 is capable of generating a control signal to indicate that the temperature variation indicated on the temperature image is not reliable for calculating the quantitative indicator of heat treatment status and for starting heat treatment monitoring.
• the control signal is a visual signal transmitted to the display unit 13 and/or an audible signal. The monitoring process is stopped and it is not possible for the practitioner to start the heat treatment.
• the reliability indicator calculation means 11 when the reliability indicator is lower than the predefined threshold, the reliability indicator calculation means 11 generates a signal indicating that the temperature variation indicated on the temperature image is not reliable for calculating the quantitative indicator of heat treatment status and for starting heat treatment monitoring. However, the decision to start the heat treatment or not is made by the practitioner.
• the reliability indicator calculation means 11 is able generating a signal prompting the practitioner to modify the MRI image acquisition parameters and/or to apply filtering to reduce the value of the variance of the measured temperature. In this way, the practitioner can manually adjust the various parameters to find acceptable thermometry conditions to start the monitoring and carry out the heat treatment.
• the monitoring unit 9 includes means for calculating a quantitative indicator of the state of the heat treatment 12 (IND QUANT) from the images of temperature and anatomical MRI images with associated information from the planning unit 5.
• IND QUANT a quantitative indicator of the state of the heat treatment 12
• the quantitative indicator calculation means 12 determines the temperature and the thermal dose in each of the pixels of the regions Rc, Rp and Rn. To do this, the calculation means puts in spatial correspondence the anatomical MRI image generated before the heat treatment coming from the planning unit 5 and the temperature images generated during the heat treatment. In this way, the pixels defined in the three regions Rc, Rp and Rn on the anatomical MRI image are associated with the pixels of the generated temperature images.
• the quantitative indicator calculation means 12 determines in real time during the heat treatment the number or the percentage of pixels satisfying the processing instructions predefined in the planning unit for the three regions. Rc, Rp and Rn.
• the quantitative indicator calculation means 12 compares, pixel by pixel on the temperature image, the value of the temperature variation with respect to the temperature setpoint assigned to the pixel of the corresponding region.
• the calculation means 12 is capable of excluding the pixels considered as having no usable or reliable temperature measurement. Excluded pixels, for example, have an uncertainty greater than the predefined uncertainty in the planning unit. According to another example, the excluded pixels have a signal-to-noise ratio of the module close to zero and therefore with an indefinite phase. It is therefore not possible to provide reliable information on compliance with the instruction in these pixels. This information is transmitted to the practitioner so that he can make a decision on the conduct of the treatment.
• the calculation means 12 is configured in such a way as to obtain a processing speed of the data coming from the MRI imaging device 4 and data coming from the planning unit 5 faster than the speed of acquisition of the module and phase images in order to be able to process the temperature images dynamically and without latency.
• the monitoring unit 9 transmits in real time to the display unit 13 all the data output from the monitoring unit, such as the temperature and thermal dose maps, the quantitative indicator of the status of the thermal treatment, as well as the data of the physiological sensors and those of the sensors integrated in the thermal treatment device, for a real-time display to the practitioner so that he can follow the evolution of the thermal treatment, to decide on the continuation or a possible stoppage of the heat treatment depending on the state of the heat treatment corresponding to the predefined treatment instructions.
• the data output from the monitoring unit such as the temperature and thermal dose maps, the quantitative indicator of the status of the thermal treatment, as well as the data of the physiological sensors and those of the sensors integrated in the thermal treatment device, for a real-time display to the practitioner so that he can follow the evolution of the thermal treatment, to decide on the continuation or a possible stoppage of the heat treatment depending on the state of the heat treatment corresponding to the predefined treatment instructions.
• the display of the quantitative indicators of the heat treatment can take various forms.
• the pixels having reached the temperature set point defined in the target region Rc are for example represented with a predefined colorimetric coding, allowing a 2D or 3D visualization with a high reading precision of the volume treated during the treatment.
• This information is complementary to the display of temperature and thermal dose maps superimposed on the anatomical MRI images.
• the display unit 13 further comprises means for generating visual and/or audible indicators indicating:
• FIG. 2 illustrates a heat treatment assembly 20 according to another embodiment.
• the thermal treatment assembly 20 comprises a thermal treatment device comprising an applicator 2 coupled to a thermal energy generator 3, an MRI image acquisition device 4 for generating images by magnetic resonance, an imaging device 21 for generating anatomical images (IMG_A), a planning unit 25 (UNIT PLANIF 2), a monitoring unit 9 (UNIT SURV) in real time of the state of the heat treatment in generating a quantitative indicator of the state of the heat treatment and a display unit 13 (UNIT VIS).
• a thermal treatment device comprising an applicator 2 coupled to a thermal energy generator 3, an MRI image acquisition device 4 for generating images by magnetic resonance, an imaging device 21 for generating anatomical images (IMG_A), a planning unit 25 (UNIT PLANIF 2), a monitoring unit 9 (UNIT SURV) in real time of the state of the heat treatment in generating a quantitative indicator of the state of the heat treatment and a display unit 13 (UNIT VIS).
• the thermal energy applicator 2 is configured to induce a temperature variation in the target region Rc to be treated of the biological tissue.
• the MRI 4 image acquisition device is used during a pre-processing phase to generate anatomical MRI images (IMG_IRM_A) and phase images (IMG_IRM_P) during heat treatment.
• the anatomical MRI images (IMG_IRM_A) are transmitted to the planning unit 25 and the phase MRI images (IMG_IRM_P) are transmitted to the monitoring unit 9.
• the imaging device 21 may for example be another MRI image acquisition device, a computed tomography (CT) or an ultrasonic echography (US).
• CT computed tomography
• US ultrasonic echography
• the anatomical image (IMG_A) can thus be generated, for example, during a planning phase, before the day of the heat treatment.
• the anatomical images can also be generated from a 3D model precalculated from imaging data or other data, such as for example a 3D map of the cardiac electrical signal.
• the anatomical images (IMG_A) are transmitted by the imaging device 21 to the planning unit 25.
• the planning unit 25 comprises an anatomical image processing means 22 (TRAIT IMG_A), a registration means 23 (RECAL) and an MRI image processing means 24 (TRAIT IMGJRM).
• TRAIT IMG_A anatomical image processing means 22
• RECAL registration means 23
• TRAIT IMGJRM an MRI image processing means 24
• the anatomical image processing means 22 is configured to define the three regions Rc, Rp and Rn on the anatomical image IMG_A generated by the imaging device 21 during the planning phase. More precisely, the anatomical image processing means 22 is suitable for segmenting the anatomical image IMG_A in order to determine in the region Rc the target pixels, in the region to be preserved the pixels to be preserved and in the neutral region the neutral pixels.
• the anatomical image IMG_A with the three delimited regions is transmitted to the registration means 23.
• the registration means 23 is configured to spatially match the anatomical image (IMG_A) with the MRI anatomical image (IMG_IRM_A) generated just before the start of treatment by the MRI imaging device 4, so as to define the three regions Rc, Rp and Rn on the anatomical MRI image (IMG_IRM_A).
• the anatomical MRI image with the three defined regions is then transmitted to the MRI image processing means 24.
• the MRI image processing means 24 is configured to define a heat treatment setpoint and an uncertainty of the temperature measurements that are acceptable in each of the three regions defined on the anatomical MRI images.
• the anatomical MRI images (IMG_IRM_A) with the information associated with each of the three regions are then transmitted to the monitoring unit 9.
• the information is the temperature and/or thermal dose instructions and the uncertainties of the temperature measurements acceptable values assigned to each of the pixels determined in the three regions Rc, Rp and Rn.
• monitoring unit 9 The operation of the monitoring unit 9 is identical to the first embodiment illustrated in Figure 1 and described below and will not be detailed here.
• the invention also relates to a method for real-time monitoring of the state of the heat treatment, by generating in real time a quantitative indicator of the state of the heat treatment, on the volume treated in relation to the total volume of the target region to be treated and to help the practitioner in his decision-making.
• the indicator allows the practitioner to visualize the progression over time of the thermal energy deposition and the treated volume.
• the method comprises a pretreatment phase and a heat treatment phase.
• the planning unit 5 During the preprocessing phase, the planning unit 5 generates anatomical MRI images (IMG_IRM_A) with the three regions Rc, Rp and Rn defined and information associated with each of the pixels determined in the three regions.
• the information includes predefined treatment setpoints for each of the three regions and predefined temperature measurement uncertainties at each of the three regions. This pretreatment phase is carried out just before the heat treatment phase.
• the monitoring unit 9 calculates quantitative indicators on the state of the heat treatment from the data coming from the pre-treatment phase and from the temperature images generated during the heat treatment.
• the pre-processing phase includes a step 101 for acquiring a 3D MRI anatomical image of the target region and its environment. 3D MRI anatomical images are obtained with the MRI 4 imaging device.
• the pre-processing phase includes a step 102 for defining a target region Rc, a critical region to preserve Rp and a neutral region on the anatomical MRI image.
• the method comprises a step of determining the pixels in each of the defined regions 103. This step consists in segmenting the MRI anatomical image so as to determine a first set of target pixels inside the target region, a second set of pixels to be preserved within the region to be preserved, and a third set of neutral pixels within the neutral region.
• the method comprises a step 104 of assigning to each of the pixels a temperature and thermal dose setpoint to be respected for each of the three defined regions.
• the method comprises a step 105 of assigning to each of the pixels an acceptable uncertainty for the temperature measurement for each of the three regions defined on the anatomical MRI images (IMG_IRM_A).
• the anatomical MRI images, the defined temperature setpoints and the temperature measurement uncertainties defined in the three regions Rc, Rp and Rn are transmitted to the monitoring unit 5.
• the method includes a step of calculating the reliability indicator of the thermometry 106 before starting the heat treatment, that is to say just before the deposition of energy by the applicator 2.
• the step of Thermometry reliability indicator calculation includes the following sub-steps:
• the method includes a step 107 of checking the reliability indicator of the thermometry.
• the monitoring unit checks if the reliability indicator of the thermometry is acceptable, that is to say if the number of pixels satisfying the predefined uncertainties is sufficient to start the thermal treatment with quantitative monitoring of the evolution of the heat treatment implemented by the monitoring unit 9.
• the reliability indicator calculation means 11 is able to generate a control signal to indicate that the temperature variation shown on the temperature image is not reliable for calculating the quantitative indicator of the state of heat treatment and for starting monitoring. It is not possible for the practitioner to start the heat treatment. This is the step for stopping processing 111.
• the reliability indicator calculation means 11 is capable of generating a signal inviting the practitioner to modify the MRI image acquisition parameters and/or to apply filtering to reduce the value of the temperature variance. In this way, the practitioner can manually adjust the various parameters to find acceptable thermometry conditions to carry out the heat treatment.
• the practitioner can start the heat treatment.
• the monitoring unit 9 is also activated to monitor the progress of the heat treatment state in real time during the heat treatment.
• the monitoring unit 9 is synchronized with the heat treatment device which deposits the heat energy in the target region so as to start the heat treatment in the target region at the same time as the heat treatment state monitoring.
• the monitoring phase therefore comprises a step 108 in which the generation of the temperature images and the heat treatment are synchronized.
• the temperature images are generated from the phase images transmitted by the MRI imaging device 4 to the monitoring unit 9 in real time during the heat treatment.
• the monitoring phase includes a step of calculating the heat treatment status indicator 109 in real time.
• This indicator corresponds to the number of pixels satisfying the predefined temperature setpoints for the three regions.
• the calculation means 12 puts in spatial correspondence the MRI anatomical image generated before the heat treatment coming from the unit planning and temperature images generated during heat treatment. In this way, the pixels defined in the three regions Rc, Rp and Rn on the 3D MRI anatomical image are associated with the pixels of the generated temperature images.
• the temperature image generated during the heat treatment is compared pixel by pixel to the predefined temperature setpoints in order to determine the number of pixels satisfying the predefined processing setpoints for the three regions Rc, Rp and Rn.
• the pixels considered as having no exploitable or reliable temperature measurement are excluded in the counting of the number of pixels satisfying the processing instructions.
• the method includes a step 110 of displaying the heat treatment status indicator in the three regions Rc, Rp and Rn.
• the indicators can be expressed in various ways, for example in pixels or volume processed or in percentage of volume processed relative to the volume of the region considered. These indicators are displayed in real time on a display interface to inform the practitioner of the evolution of the state of the heat treatment.
• the pixels having reached the temperature setpoint in the target region are for example represented with a predefined colorimetric coding, allowing a 2D or 3D visualization with a high reading precision of the treated volume during the treatment.
• the dynamic display of the number of pixels having reached the predefined temperature setpoint allows him to follow the evolution of the treatment not only in the target region but also in the region to be preserved and the neutral region and to help him make a decision in depending on the state of the heat treatment.
• the display interface also allows the display of 2D or 3D maps of temperatures and thermal doses superimposed on anatomical images.
• the monitoring unit 9 generates a visual or audible indicator indicating that the heat treatment is finalized when the number of pixels having reached the set point in the target region reaches a predefined threshold (for example 100% of the number of pixels counted in the target region).
• the monitoring unit generates a visual and/or audible indicator signal when one or more pixels do not comply with the instruction in the region critical to preserve Rp, or when the temperature approaches a few degrees from the permitted limit temperature.
• the monitoring unit generates a visual and/or audible indicator signal when the number of pixels not respecting the setpoint in the neutral region reaches a predefined threshold, for example when the percentage of alteration volume is close to 5%.
• the method of quantitative monitoring of the evolution of the state of the heat treatment of the present invention is implemented during the heat treatment, making it possible to provide in real time a cartography of the treated volume.
• the method comprises a planning phase, a pretreatment phase and a heat treatment phase.
• the planning phase is carried out before the day of the heat treatment and includes a step 201 for acquiring 3D anatomical images (IMG_A) for example by a CT or US imaging device or generated from a model 3D pre-computed from imagery data.
• IMG_A 3D anatomical images
• the practitioner also determines the characteristics of the target region in order to plan the treatment: locate the target region, choose the appropriate thermal energy applicator.
• the planning phase includes a step 202 for defining a target region Rc, a critical region to be preserved Rp and a neutral region Rn on the 3D anatomical image by means of anatomical image processing 22.
• the planning phase includes a step 203 for determining target pixels in the target region Rc, pixels to be preserved in the region to be preserved Rp and neutral pixels in the neutral region Rn.
• the pretreatment phase is carried out just before the heat treatment.
• the pre-processing phase includes a step of acquiring anatomical MRI images 204 by an MRI imaging device 4.
• the preprocessing phase includes a registration step 205 to spatially match the anatomical image (IMG_A) acquired during the planning phase with the anatomical MRI image (IMG_IRM_A) so as to define the three regions Rc, Rp and Rn on the anatomical MRI image.
• the preprocessing phase includes a step 206 for defining heat treatment instructions in each of the three regions defined on the anatomical MRI images (IMG_IRM_A). This step is similar to step 104 of the method according to a first embodiment described above.
• the pre-processing phase includes a step for defining temperature measurement uncertainties 207 in each of the three regions defined on the anatomical MRI images (IMG_IRM_A). This step is similar to step 105 of the method according to a first embodiment described above.
• the 3D anatomical MRI images (IMG_IRM_A) with the information associated with each of the three regions are then transmitted to the monitoring unit 9 for the heat treatment phase.
• the information is the temperature and/or thermal dose setpoints and the uncertainties of the acceptable temperature measurements assigned to each of the pixels determined in the three regions Rc, Rp and Rn.
• the different steps forming the processing phase are identical to those of the processing phase of the method according to the first embodiment described above.
• the heat treatment assembly according to the invention with quantitative monitoring of the thermal energy deposit is particularly suitable for any type of treatment by local temperature variation.
• the invention is particularly suitable for a treatment in which the thermal energy is deposited locally by a laser, microwaves, radiofrequency waves, focused ultrasound or cryotherapy.

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