Method for determining ablation parameters for ablation therapy

Abstract

The invention relates to a method for determining ablation parameters for ablation therapy, comprising:-receiving (100) sensor data acquired by at least two sensors (10) spatially arranged along a shaft (5) of an ablation probe (2), each sensor having a different sensor position (11, T1, T2, T3, T4), the sensor data for the at least one measured parameter comprises two measured values obtained at different sensor positions (11, T1, T2, T3, T4); -determining (200) an ablation parameter on the basis of the sensor data and / or measured values of the same measurement parameter at different sensor locations (11, T1, T2, T3, T4); -providing (300) the determined ablation parameters.

Description

Technical Field

[0001] Ablation therapy refers to medical procedures that use various techniques to remove or destroy tumors or abnormal tissue. The goal of ablative therapy is to eliminate or reduce the size of a tumor, thereby treating or relieving symptoms of cancer. This approach is often used for localized tumors that may not be amenable to surgical removal. There are several ablative therapies, and the choice of technique depends on factors such as the size and location of the tumor and the patient's overall health. Some common types of ablative therapy include:

[0002] Radiofrequency ablation (RFA): This technique uses high-frequency electrical current to generate heat, which destroys cancerous tissue. A special needle or probe is inserted into the tumor, and the heat generated by the radiofrequency waves kills the cancer cells.

[0003] -Microwave ablation: Similar to RFA, microwave ablation uses microwaves to generate heat and destroy cancerous cells. The procedure involves inserting a probe into the tumor, and then using microwaves to heat the tissue.

[0004] - Cryoablation: This procedure involves freezing cancer cells. A probe is inserted into or near the tumor and uses extremely cold gas or liquid to freeze and destroy the abnormal tissue. Background Art

[0005] Ablation therapy is often considered for patients who are not suitable for surgery or who are unable to undergo surgery. Ablation therapy can be used to treat various types of cancer, including liver cancer, kidney cancer, lung cancer, and prostate cancer. However, the suitability of ablation therapy depends on the specific characteristics of the tumor and the individual patient's condition.

[0006] When using a needle probe for tumor ablation, various technical and adjustable factors are crucial to the success of the procedure. These factors include power, temperature, position, safety margins, timing, and other considerations specific to the chosen ablation technique. Optimizing these technical factors requires the expertise of the medical team, aiming to achieve effective tumor destruction while minimizing complications and protecting surrounding healthy tissue.

[0007] Power settings are crucial in radiofrequency ablation (RFA), where the energy delivered per unit time affects the size of the ablation zone. Similarly, microwave ablation requires careful adjustment of power and frequency to ensure optimal tissue heating. Temperature control is important, especially in cryoablation, where the freezing temperature of the cryoprobe determines the extent of tissue freezing. Monitoring and regulating temperature is crucial to achieving therapeutic effects while minimizing damage to surrounding healthy tissue. In RFA, temperature monitoring ensures that the target temperature for effective ablation is reached.

[0008] Accurate positioning of the needle probe within or near the tumor is fundamental to successful ablation. Real-time imaging guidance (such as ultrasound, CT, or MRI) facilitates precise placement. Establishing a safety margin is very important to account for microscopic disease and reduce the risk of local recurrence. This involves ensuring that the ablation area extends beyond the visible tumor margins. The duration of energy delivery, or freezing time, is a key factor. Striking a balance between achieving effective ablation and mitigating the risk of overheating or freezing is crucial. In the case of larger tumors, the use of multiple probes, either simultaneously or sequentially, can be considered to achieve a wider ablation zone. For cryoablation, controlling the circulation of the cryoprobe coolant helps to regulate the extent and depth of tissue freezing.

[0009] Solid organ tumors often exhibit heterogeneity that cannot be fully discerned by conventional imaging modalities employed in planning image-guided needle ablation. Needle trajectory and ablation settings (including required power and time) are typically based on tumor size and location as observed on planning scans, such as contrast-enhanced CT or cone-beam CT.

[0010] During needle insertion, low-resolution CT / X-ray images are taken to confirm the position of the ablation probe. The primary goal is to accurately position the ablative energy emitter within the tumor stalk, even when the tumor margins are not well visualized on planning or interventional scans. Sometimes, low-resolution scans are used to verify the ablation probe position after registration with the planning CT scan. Current imaging technologies lack the ability to provide detailed information about the surrounding environment where the ablation probe is located. This information is critical to the success of the ablation procedure. Registration with previous images has limitations because the tumor may have moved during the probe insertion process.

[0011] Blood flow (perfusion) into the tumor acts as a cold / heat sink, reducing the effectiveness of the ablation probe. This sink effect results in a smaller area of ​​necrosis after ablation than initially planned. The magnitude of this sink effect is proportional to the tumor's vascularity. While microwave ablation can coagulate blood vessels and counteract the heat sink effect, cryoablation and radiofrequency ablation are susceptible to these effects, compromising overall outcomes. Advanced imaging modalities such as dual-energy CT, iodine mapping, MR perfusion, and MR transparency can provide information about tumor perfusion. However, for practical reasons, physicians lack real-time access to these advanced imaging or post-processing tools during interventional needle ablation procedures. It is crucial to tailor the heat or cold energy used for tissue ablation to the tumor's vascularity and the most recent probe position. It would be extremely beneficial if physicians could obtain this information during the procedure without relying on advanced imaging tools.

[0012] Current needle ablation procedures face challenges such as limited visualization of tumor margins during insertion, potential placement inaccuracies due to tumor metastasis, and the inability to monitor tumor perfusion in real time. Furthermore, the lack of real-time access to advanced imaging tools hinders the customization of ablation energy based on the tumor's vascularity and the probe's current position. Summary of the Invention

[0013] This invention provides a comprehensive solution to the challenges associated with needle ablation procedures for solid organ tumors. By introducing innovative technologies, it addresses the limitations of current procedures, providing real-time visualization of tumor margins, precise monitoring of the tumor during insertion, and real-time access to tumor physiology. This advancement enables physicians to tailor ablation parameters, such as energy, based on real-time information, significantly improving the precision and efficacy of needle ablation for solid organ tumors.

[0014] Regardless of the grammatical use of the term, individuals with masculine and feminine identities are included within the term.

[0015] The present invention relates to a method for determining ablation parameters for ablation therapy, comprising:

[0016] - receiving sensor data, wherein the sensor data is acquired by a sensor, wherein the sensor data is acquired by at least two sensors, the sensors being spatially arranged along the shaft of the ablation probe and each sensor having a different sensor position, wherein the sensor data for at least one measurement parameter comprises two measurement values ​​obtained at different sensor positions,

[0017] - determining ablation parameters based on sensor data and / or measured values ​​of the same measured parameter at different sensor locations;

[0018] - Output ablation parameters.

[0019] The present invention relates to a technique for establishing ablation parameters in the context of ablation therapy. The method can be performed by a computer, an ablation system or a cloud computing environment. The purpose of the method is to determine and / or provide at least one ablation parameter. These parameters may include energy, position, time, safety margin, verification of needle position, verification of ablation success, etc. The ablation therapy targeted by the method is specifically focused on tumor ablation, with an emphasis on RF (radio frequency), cryotherapy or thermal (thermal) ablation methods. The present invention represents a major advancement in the field of medical procedures, especially regarding tumor ablation. The method of the present invention is specifically designed to accurately determine key ablation parameters, thereby improving the accuracy and effectiveness of ablation therapy.

[0020] The disclosed method includes receiving sensor data acquired by at least two sensors. The sensors are strategically positioned along the shaft of the ablation probe to capture important information about the treatment environment. The ablation probe is, for example, configured as a needle and / or has a slender or elongated shape. For thermal ablation, the ablation probe typically contains a heating element or heat source at its tip and / or distal end. This element can be activated to generate heat, which is then applied to the target tissue to induce coagulation or necrosis. In the case of cryoablation, the probe is equipped with a cooling mechanism, typically involving the use of liquid nitrogen or argon gas. The tip and / or distal end of the ablation probe becomes extremely cold, causing the target tissue to freeze and ultimately lead to cell destruction. Temperature sensors are also crucial in cryoablation probes, allowing for precise control of the freezing process for optimal treatment results. For radiofrequency ablation, the ablation probe features an electrode or electrode array at its tip. When an electric current is applied, it generates high-frequency radio waves that generate localized heat. This heat is directed to the target tissue, causing coagulation and ablation. Radiofrequency ablation probes may include impedance monitoring systems to assess tissue properties and ensure effective energy delivery.

[0021] The sensors in the ablation probe are preferably positioned along its length, particularly concentrated around the needle portion and / or near the distal end. This configuration ensures that the sensors are in the optimal position to capture relevant data before, during and / or after the ablation procedure. It is preferred to place the sensors around, before and / or after the active element, which can be a heating element for thermal ablation, a cooling portion for cryoablation, or a radiofrequency transmitter for radiofrequency ablation. This arrangement improves the accuracy of data acquisition because it allows for comprehensive monitoring of temperature changes and other relevant parameters near the active element and / or the distal end, thereby providing a more accurate representation of the ablation procedure and / or the guidance of the ablation probe.

[0022] The sensors along the ablation probe and / or subsections of the ablation probe are preferably arranged at spatial intervals, preferably at equidistant intervals. This careful arrangement ensures an even distribution along the length of the probe, facilitating comprehensive and evenly sampled data collection during the ablation procedure. The spatial positioning of these sensors becomes particularly apparent in medical imaging modalities such as CT scans. This visibility enables medical professionals to precisely observe and analyze the spatial relationship between the sensors and the target tissue, thereby facilitating accurate monitoring and control of the ablation procedure. The equidistant spacing adds an element of consistency, facilitating systematic evaluation of the treatment environment and helping to improve the overall efficacy of the medical intervention.

[0023] The ablation probe can include various sensor types, wherein for each sensor type, at least two sensors of the same type are spaced apart. Specifically, different sensor types are paired, wherein at least two sensors are designed to measure the same measurement parameter. Sensor types can be configured to measure different measurement parameters, such as temperature, oxygen, glucose, or other variables. However, at least two sensors are always dedicated to capturing the same measurement parameter.

[0024] The sensor is designed to determine a measured value of a measurement parameter at a sensor location and / or time. Since sensors are arranged in pairs to measure the same measurement parameter, two measured values ​​at different sensor locations are captured and provided and / or received at the same point in time. Preferably, the measured values ​​are received together with the associated sensor location and / or point in time. In other words, the sensor data includes at least two measured values ​​for at least one measurement parameter, wherein the at least two measured values ​​are acquired and / or measured at different sensor locations.

[0025] The method comprises the step of determining an ablation parameter based on sensor data and / or measured values ​​of the same measured parameter at different sensor positions. In other words, at least one ablation parameter is determined, calculated and / or generated based on at least two measured values ​​of the same measured parameter, wherein the at least two measured values ​​are associated with different sensor positions. For example, the ablation parameter is determined based on the difference in the measured values ​​of the same parameter at different sensor positions. For example, for a measured parameter, the measured value in the tumor or target area is higher than the measured value in the surrounding tissue. Based on the measured value of the parameter, the position of the tumor or target area can be identified as an ablation parameter. For example, the ablation parameter can be the relative distance of the active element or the distal end to the area with the highest measured value, such as a tumor. The determination may involve indicating that the tumor or target area is closer to the sensor with the higher measured value.

[0026] The ablation parameters can be determined based on an analysis function that utilizes the measurements or sensor data. Alternatively and / or additionally, the determination of the ablation parameters can be based on machine learning, deep learning, and / or neural networks, with the sensor data and / or measurements as input. For example, the analysis function can establish the ablation parameters by expressing the relationship between the measurements at different sensor locations. On the other hand, machine learning methods can involve training a model to recognize patterns in the sensor data or measurements so that it can predict the ablation parameters based on these patterns.

[0027] The method includes the steps of providing and / or outputting the determined ablation parameters. The term "providing" is preferably interpreted as the act of providing the determined ablation parameters digitally or in tangible form to relevant stakeholders or systems involved in the medical process. This may involve transmitting data to a user interface, a control unit or other components of the medical device for further analysis or action. On the other hand, the term "outputting" preferably includes displaying or presenting the determined ablation parameters, providing an understandable representation of the value or information. This may involve presenting the parameters on a graphical user interface, a monitor or any suitable output medium to provide real-time feedback to medical professionals. By clearly defining the methods for providing and outputting ablation parameters, the present patent ensures that this critical information is seamlessly integrated into the medical workflow, ultimately improving the accuracy and efficiency of the ablation process.

[0028] In particular, the ablation parameters have significant utility by serving as essential settings for the ablation device during ablation therapy. Preferably, the term "providing" extends to seamlessly communicating the calculated ablation parameters to the ablation device, thereby establishing a direct link between the determined parameters and the operational settings of the device. This integration ensures that the ablation therapy is precisely customized because the device utilizes the provided ablation parameters as configurable parameters or guidelines. These settings from the ablation parameters enable the ablation device to adjust its energy delivery, duration or spatial orientation to suit the specific characteristics of the target area (e.g., a tumor). As a result, medical practitioners can benefit from a higher level of customization and control over the ablation process, thereby optimizing treatment efficacy and patient outcomes. This innovative functionality embodies a complex and adaptive approach to medical intervention and makes a novel and valuable contribution to the field of ablation technology.

[0029] The innovative method is characterized in that ablation parameters are provided and determined based on sensor data, which includes measured values ​​of the same measurement parameter obtained at various locations within the ablation probe. This new method allows the use of variables that were previously undetermined or inaccurately measured to accurately determine ablation parameters. In particular, this makes it possible to determine ablation parameters that were previously overlooked or inaccurately assessed. Utilizing these provided ablation parameters helps to achieve better, safer and more accurate ablation treatments. Accurately adjusting the ablation parameters based on sensor data at different locations within the ablation probe leads to optimized control of the ablation process, ultimately resulting in good results in medical treatment.

[0030] Specifically, the step of determining ablation parameters includes determining the ablation parameters based on differences and / or comparisons of measured values ​​of the same measured parameter at different sensor locations. In other words, the process of determining the ablation parameters may involve evaluating differences or comparing measured values ​​of the same measured parameter at different sensor locations. The method is designed to exploit variations in the measured parameters at different locations to provide valuable information for establishing ablation parameters. By focusing on differences or comparisons, the method aims to discern specific patterns or gradients in the measured parameters, which can indicate proximity to a target area or specific conditions. For example, consider a scenario in which measured values ​​of a temperature parameter at various sensor locations within tissue exhibit a distinct increase in a specific area. The differences or comparisons of these values ​​help identify temperature gradients, thereby indicating the presence of a tumor or target area. In this case, the calculated ablation parameter may be the temperature difference between the region of interest and its surroundings, indicating the optimal setting for ablation therapy. Another example may involve measuring electrical conductivity, oxygen concentration, and / or glucose concentration within the tissue. If the conductivity values, oxygen concentration, and / or glucose concentration show significant differences at different sensor locations, the calculated ablation parameter may be a comparison of the conductivity, oxygen concentration, and / or glucose concentration, thereby guiding the ablation device to apply targeted energy to areas with different conductivity, oxygen concentration, and / or glucose concentration characteristics. This targeted approach improves the accuracy and effectiveness of ablation therapy.

[0031] According to an embodiment of the present invention, the sensor data includes temperature as a measurement parameter, a measured first temperature as a measurement value, and a measured second temperature, wherein the first temperature is related to the first temperature sensor and the first temperature sensor position, and the second temperature is related to the second temperature sensor and the second temperature sensor position, wherein the step of determining the ablation parameter includes determining the ablation parameter based on the first and second temperatures.

[0032] In the case of temperature as a measurement parameter, the sensor data includes two measurements: a first temperature obtained from a first temperature sensor located at a specific location, and a second temperature obtained from a second temperature sensor located at another location. The determination of the ablation parameters depends on these two temperature values. For example, consider a situation where the temperature in the tumor is higher than the temperature in the surrounding tissue. In this case, having these temperature values ​​allows for corrective adjustments to the position of the ablation probe. This correction can be achieved by utilizing knowledge of the sensor position within the probe and an understanding of the temperature peaks in the tumor. In addition, knowledge of the temperature surrounding the tumor can be used to calculate the required radio frequency (RF) heating power and / or duration of the ablation therapy. For example, if the temperature gradient around the tumor is known, it will provide valuable information for optimizing the RF power and duration required to effectively treat the target area. This ensures that the ablation therapy is precisely tailored to the specific temperature characteristics of the tumor and its surroundings, thereby maximizing the efficacy of the treatment.

[0033] Temperature sensors used in ablation probes or needles come in various types, each with a specific purpose, allowing for accurate temperature measurement during medical procedures. Ablation probes preferably include thermocouples as temperature sensors. A thermocouple, consisting of two dissimilar metal wires that generate a voltage based on a temperature difference, can be embedded in ablation probes for real-time temperature monitoring. Ablation probes can include a thermistor and its temperature-sensitive resistor, providing a varying resistance to measure temperature changes within the ablation probe. Ablation probes may also include infrared (IR) sensors that detect emitted infrared radiation, providing a non-contact option for monitoring tissue temperature surrounding the ablation probe. Alternatively, ablation probes can include fiber optic temperature sensors that can be integrated into ablation needles, leveraging changes in optical properties to obtain accurate temperature readings. Furthermore, ablation probes may include resistance temperature detectors (RTDs), leveraging the relationship between resistance and temperature to provide a precise temperature indication within the ablation probe. This variety of sensors allows for customized temperature measurement methods, ensuring optimal control and efficacy during ablation treatments.

[0034] According to an embodiment of the present invention, for oxygen values, e.g. oxygen concentration, as a measured parameter, the sensor data comprises a measured first oxygen value and a measured second oxygen value as measured values, wherein the first oxygen is associated with a first oxygen sensor and a first oxygen sensor position, and the second oxygen is associated with a second oxygen sensor and a second oxygen sensor position, wherein the step of determining the ablation parameter comprises determining the ablation parameter based on the first and second oxygen values.

[0035] In an embodiment of the present invention, the sensor data relates to oxygen concentration as a measurement parameter, comprising two measurement values: a first oxygen value measured from a first oxygen sensor positioned at a specific location, and a second oxygen value measured from a second oxygen sensor positioned at another location. The determination of ablation parameters depends on these two oxygen values. For example, consider a situation where the oxygen concentration in a tumor exceeds that in surrounding tissue. The increase in oxygen concentration in a tumor may be attributed to increased vascularity or increased metabolic activity. After measuring the oxygen concentration, a correction adjustment can be made to the position of the ablation probe. This correction relies on an understanding of the sensor position within the probe and an understanding of the peak oxygen concentration within the tumor. In addition, knowing the oxygen concentration around the tumor is very valuable for calculating the required radiofrequency (RF) heating power and / or the duration of the ablation therapy. For example, if the gradient in oxygen concentration around the tumor is known, this information helps to optimize the RF power and duration, ensuring effective and targeted ablation therapy. This customized approach takes advantage of the specific oxygen characteristics of the tumor and its surrounding environment, thereby improving the accuracy and success rate of ablation therapy.

[0036] The ablation probe may include several types of oxygen sensors to accurately measure oxygen concentration during multiple procedures. For example, the ablation probe may include a Clark electrode as an oxygen sensor, which uses the polarographic principle to electrochemically reduce oxygen at its working electrode. Alternatively and / or additionally, an optical oxygen sensor with a luminescent material that responds to changes in oxygen concentration can be seamlessly integrated into the probe, providing non-invasive and continuous monitoring capabilities. In addition, the ablation probe may feature an amperometric sensor to measure oxygen levels using the current generated during the electrochemical reaction between oxygen and the working electrode. Another viable option may be a fluorescence-based oxygen sensor, which is known for its sensitivity to changes in oxygen concentration, providing accurate and reliable detection capabilities close to the probe.

[0037] According to an embodiment of the present invention, for glucose concentration as a measurement parameter, the sensor data includes a measured first glucose value and a measured second glucose value as measurement values, wherein the first glucose is related to the first glucose sensor and the first glucose sensor position, and the second glucose is related to the second glucose sensor and the second glucose sensor position, wherein the step of determining the ablation parameter includes determining the ablation parameter based on the first and second glucose values.

[0038] In an embodiment of the present invention, the sensor data includes glucose concentration as a measurement parameter, which has two measurement values: a first glucose value from the measurement of a first glucose sensor positioned at a specific location, and a second glucose value from the measurement of a second glucose sensor positioned at another location. The determination of the ablation parameters involves these two glucose values. For example, if the glucose concentration in the tumor is higher than the glucose concentration in the surrounding tissue, then this may be due to increased metabolic activity within the tumor. After measuring the glucose concentration, the position of the ablation probe can be adjusted based on the knowledge of the sensor position within the probe and the understanding that the glucose value in the tumor is the highest. In addition, knowing the glucose value around the tumor is very valuable for calculating the required radio frequency (RF) heating power and / or the duration of the ablation therapy. For example, if the gradient in the glucose concentration around the tumor is known, then this information helps to optimize the RF power and duration, ensuring effective and targeted ablation treatment. This customized approach takes advantage of the specific glucose properties of the tumor and its surrounding environment, thereby improving the accuracy and success rate of ablation therapy.

[0039] The ablation probe can be integrated with multiple types of glucose sensors for continuous sensing during the intervention. For continuous glucose monitoring, the probe can include a continuous glucose monitoring (CGM) sensor, which is a device implanted subcutaneously that measures glucose levels in the interstitial fluid. Alternatively, an implantable fluorescence-based glucose sensor can be used that uses the principle of changing fluorescence properties based on glucose concentration to achieve real-time and continuous monitoring capabilities. In addition, the ablation probe can include a biosensor-based glucose sensor that can continuously monitor by detecting glucose-specific reactions with enzymes or proteins. This biosensor approach provides real-time feedback on glucose levels. Additionally, an optical coherence tomography (OCT)-based glucose sensor can be integrated that uses changes in light scattering properties to continuously measure glucose concentration. Each of these sensors contributes to the probe's ability to continuously sense glucose levels during the ablation process, allowing for precise adjustment for optimal therapeutic efficacy.

[0040] In particular, the method comprises the step of determining a metabolic activity parameter, wherein the metabolic activity parameter is determined based on at least one of the measured values, wherein ablation parameters are determined and / or validated based on the metabolic activity parameter. The metabolic activity parameter is preferably derived from the measured temperature, oxygen level, and glucose concentration. In particular, throughout the present invention and / or in the specification, oxygen concentration is used equivalently to oxygen value and / or glucose concentration is used equivalently to glucose value. Differences emerge in the complex field of tumor metabolism and normal tissue metabolism. Tumors typically exhibit higher metabolic activity than surrounding healthy tissue, a phenomenon known as the Warburg effect. Elevated metabolism in tumors is associated with increased glucose consumption, altered oxygen dynamics, and temperature changes. The outlined method identifies these differences and utilizes the metabolic activity parameter to inform the determination and validation of ablation parameters tailored to the unique metabolic characteristics of the target tissue. Understanding these metabolic nuances is crucial for developing effective and precise medical interventions in tumor treatment.

[0041] In a preferred embodiment, the method includes the step of receiving a medical image of the examination subject. The medical image is preferably a real-time image. The medical image can be configured as an image stream. The medical image can be provided by an imaging system, such as a computed tomography system, an X-ray device, a C-arm X-ray system, a magnetic resonance tomography system, an ultrasound system, or other medical imaging system. The medical image is, for example, an X-ray image, a CT image, an MR image, or an ultrasound image. The medical image is acquired of the examination subject, particularly a patient. The medical image includes and / or depicts a target region of the examination subject and a portion of a shaft of an ablation probe. The target region includes a target, such as a tumor or an object to be treated. The portion of the shaft included in the medical image includes and / or depicts a sensor. In other words, the medical image depicts a portion of the patient, the target (e.g., a tumor), and the sensor of the ablation probe. The step of providing the determined ablation parameters includes generating and / or providing an overlay image, wherein the overlay image combines the medical image with measured values ​​of the relevant parameters and / or ablation parameters. The overlay image preferably seamlessly integrates the medical image with the relevant parameters or the associated measured values ​​of the ablation parameters. As an example, such an overlay image might visually represent a heat map superimposed on a medical image, depicting temperature variations within the tissue. Another example might involve combining oxygen concentration data with a medical image to create a composite visualization highlighting areas with varying oxygen levels. The configuration of these overlay images serves as a valuable tool, providing a comprehensive and intuitive representation of the relationship between medical images and measured parameters in the context of an ablation procedure.

[0042] Preferably, the measured parameter relates to and / or is sodium concentration, potassium concentration, sodium-potassium ratio, pH, and / or lactate concentration. For the measured parameter, the sensor data includes a first steady-state value and a second steady-state value as measured values. The first steady-state value is associated with a first steady-state sensor and a position of the first steady-state sensor. The second steady-state value is associated with a second steady-state sensor and a position of the second steady-state sensor, wherein the step of determining the ablation parameter comprises determining the ablation parameter based on the first and second steady-state values.

[0043] This embodiment is based on the observation that the balance of sodium and potassium ions in the extracellular fluid is maintained by active pumping of sodium-potassium pumps on the cell membrane. Due to the action of these pumps, the sodium concentration in the extracellular fluid is maintained high and the potassium concentration inside the cell is maintained high. These pumps can only work when the cells are alive and the cell membranes are intact. In the case of cryoablation, the freeze-thaw mechanism causes damage to the cell membrane, thereby disrupting the ion balance on the cell membrane. Therefore, after cell lysis occurs, the concentration of potassium in the extracellular space will increase. The higher the concentration of potassium in the extracellular fluid, the greater the possibility of nearby cells lysing. If the potassium concentration or sodium / potassium ratio can be measured at different locations within the tumor before and after cryoablation, then this can reveal the effectiveness of the ongoing / completed cryoablation.

[0044] Furthermore, the examples demonstrate that it can be used to detect the presence of glucose in the extracellular space as an indicator of cell membrane rupture. This is critical for identifying potential damage to cell integrity. Secondly, the mapping enables assessment of Na / K concentration levels before and after cell explosion, providing valuable insights into the health of the cell membrane. Monitoring these concentrations helps understand membrane stability and function. Furthermore, this mapping technique allows for early detection of complications that may arise due to the sudden release of potassium ions, such as "acute lysis syndrome." This early identification is particularly important during ongoing ablation procedures, potentially avoiding serious consequences. Furthermore, the mapping helps monitor the accumulation of lactate / pH values, which reflect processes such as coagulation, decreased perfusion, or cell death. These parameters provide a window into cellular changes occurring during ablation, aiding in treatment assessment and adjustment. Furthermore, the ability to aspirate fluid before and after ablation and analyze its biochemical composition enhances process understanding and optimization. Furthermore, the possibility of using the aspiration needle handle itself for biopsy provides a simplified method for tissue sampling, thereby improving process efficiency and accuracy.

[0045] The method preferably comprises the step of determining a measurement value distribution and / or a measurement value interpolation of measurement values ​​of a measurement parameter measured by sensors at different sensor positions, wherein the step of providing the determined ablation parameters comprises generating and / or providing an overlay image, wherein the overlay image combines the medical image with the measurement value distribution and / or measurement value interpolation.

[0046] Preferably, the method includes the step of receiving a medical image of an examination subject, such as described above. The medical image includes a target region of the examination subject and a portion of a shaft of an ablation probe, wherein the target region is characterized by a different average value of a measured parameter than its surroundings. The target region is characterized by different average values, particularly such that, generally or as a priori knowledge, the target region and / or tissue in the target region inherently have different average values ​​of the measured values. For example, the target or target region is a tumor, wherein the tumor inherently has a higher temperature, oxygen level, glucose concentration, and / or metabolism than normal tissue. The step of determining an ablation parameter includes determining, as an ablation parameter, position check information for the ablation probe based on the measured values ​​of the measured parameter. The position check is based on the concept that by measuring the parameter at different locations along the shaft, the position of the target relative to the ablation probe can be determined based on the measured values. For example, by using rules and / or knowledge, the target or tumor must be closer to a sensor location with a higher temperature, oxygen level, glucose concentration, or metabolism than to a sensor location with a lower measured value.

[0047] Furthermore, the step of determining ablation can include determining a safety margin for ablation as an ablation parameter based on the measured values ​​of the measured parameter. This can be based on knowledge of the distribution of the measured values, for example by estimating or determining metabolism, diffusion, or blood circulation based on the measured values. For example, for targets with high diffusion and / or blood circulation, a high heat sink effect is expected, where a higher safety margin may be useful. For example, the grade of a tumor can be determined based on the measured values, where the safety margin is determined based on the grade.

[0048] Furthermore, the step of determining the ablation parameters preferably includes determining residual examination information of the ablation as the ablation parameters based on the measured values ​​of the measured parameters. The success and / or efficiency of the ablation treatment can be determined based on the measured values ​​(e.g., temperature, oxygen, or glucose concentration). When the tumor or target is completely and successfully treated, the measured values ​​of the measured parameters after the ablation treatment should be similar to those of surrounding tissue and / or normal tissue. If the ablation is not completely successful, the measured values ​​(e.g., temperature, oxygen, and / or glucose concentration) should be different from those of normal tissue because active tumor tissue is still present.

[0049] In an optional embodiment, it may be provided that, instead of having spatially separated sensors along the ablation probe, the ablation probe comprises only one such sensor for measuring the measured value of the measurement parameter. The first measured value is recorded at a different time than the second measured value. The ablation parameter to be determined can then refer to the ablation value or characteristic that varies over time. This means that the design of the ablation probe may comprise only one sensor, rather than a plurality of sensors spaced apart along the length of the probe. This single sensor will take measurements at different times, the first and second measurements being taken at different points in time. The parameter determined by these measurements may be a value that varies over time.

[0050] In another optional embodiment of the present invention, it is conceivable that the ablation probe, in particular the handle, is variably designed, for example, so that it can assume two different functional and / or structural states and be switchable between these two states. For example, the ablation probe can assume a treatment state and a measurement state. In the treatment state, the ablation probe is equipped with an active element for ablation, such as a radiofrequency generator, while in the measurement state, the ablation probe is equipped with a sensor for measuring a "measured value." To this end, the ablation probe can be hollow, in particular designed as a hollow needle, into which sensors and / or active elements can be inserted, depending on the state.

[0051] Another optional embodiment of the present invention provides that a sensor along the ablation probe, in particular along the handle, can be positioned, moved, and / or displaced. For example, based on imaging, the sensor can be positioned so that it is close to a sensitive area and / or area to be supported, such as the spine, and can ensure that the area is not damaged during the ablation treatment.

[0052] This means that the ablation probe can be switched between two states: a treatment state, in which the ablation probe is equipped with active elements for ablation (such as a radiofrequency generator), and a measurement state, in which the ablation probe is equipped with sensors for measurement. The probe can be designed as a hollow needle, allowing the insertion of sensors or active elements as needed. In addition, the sensor can be moved or adjusted along the probe, allowing it to be positioned close to sensitive areas (such as the spine) to ensure that these areas are not damaged during the ablation process.

[0053] Another subject of the present invention is a tumor ablation device comprising:

[0054] an ablation probe, comprising a treatment section for freezing, hyperthermia, heating or radiofrequency treatment of a tumor, wherein the ablation probe can be positioned or inserted into the body of a patient to be treated,

[0055] - characterized in that the ablation probe comprises at least two sensors, wherein the at least two sensors are configured for acquiring sensor data, wherein the sensors are spatially arranged along the shaft of the ablation probe, each sensor having a different sensor position, wherein the sensor data for at least one measurement parameter comprises two measurement values ​​obtained at different sensor positions.

[0056] Tumor ablation devices, particularly ablation probes, are configured to treat a patient's tumor using cryotherapy, hyperthermia, heating, and / or radiofrequency ablation. A tumor is also referred to as a target, and / or an area within a patient's body containing a tumor may also be referred to as a target area. The ablation probe can be configured as an ablation needle. The ablation probe includes a distal end and a proximal end. The distal end is the end of the probe farthest from the starting point or closest to the target tissue within the patient's body. It is the end that comes into direct contact with the tissue to be treated or ablated. The proximal end is the end of the probe closer to the starting point or located outside the patient's body. This end is connected, for example, to a control unit, interface module, and / or monitoring device used by the medical professional performing the procedure. The ablation probe is configured so that its distal end can be inserted into the patient's body. The treatment segment is preferably located at and / or in the area of ​​the distal end. The treatment segment preferably includes active elements and / or active areas.

[0057] For cryoablation, the treatment section of the probe is typically a cryoprobe that contains a coolant, such as liquid nitrogen or argon. The coolant is used to freeze and destroy the target tissue. For thermal ablation, the treatment section of the probe generates heat to ablate (destroy) the tissue. This can be achieved using different techniques, such as laser ablation, microwave ablation, or high-intensity focused ultrasound (HIFU). The specific components that generate heat vary depending on the method used. Radiofrequency ablation uses high-frequency electrical current to generate heat and ablate tissue. The treatment section of the radiofrequency ablation probe includes electrodes that deliver radiofrequency energy to the target tissue.

[0058] An ablation probe, such as an ablation needle, includes a plurality of sensors. The sensors are preferably located between a distal end and a proximal end. Specifically, the sensors are arranged and / or positioned near and / or closer to the distal end of the ablation probe. The ablation probe has an elongated structure, wherein elongation is defined as from the distal end to the proximal end of the ablation probe. The sensors are spatially arranged along a longitudinal extension direction. The distance between the sensors is preferably at least one millimeter and / or less than five millimeters. The probe includes at least two spatially arranged sensors configured to measure the same measurement parameter. For example, the probe includes at least two temperature sensors spatially arranged along the shaft and / or the probe includes at least two oxygen sensors spatially arranged along the shaft and / or the probe includes at least two glucose sensors spatially arranged along the shaft. Each sensor has a different sensor position, wherein the sensor data for at least one measurement parameter includes two measurement values ​​obtained at different sensor positions.

[0059] A tumor ablation device, such as an ablation probe, includes an interface module. The interface module is connected to exchange data with sensors of the ablation probe. The interface module is configured to provide sensor data to a method for determining ablation parameters and / or to provide the sensor data to an internal or external user or device. The interface module can be configured to provide the sensor data wirelessly and / or wiredly.

[0060] Preferably, the tumor ablation device includes a control unit. The control unit can be configured as a user interface and / or as a computing unit. The control unit is preferably configured to exchange data with the ablation probe and / or the interface unit. The control unit is configured to receive provided ablation parameters and control and / or operate the ablation probe accordingly. Optionally, the control unit is configured to execute a method for determining ablation parameters.

[0061] Another subject of the invention is a computer program product comprising a non-transitory computer-readable medium storing instructions which, when executed by a processor, cause the processor to perform the steps of the method for determining ablation parameters. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Additional advantages, effects and embodiments are apparent from the drawings and their description, by way of example:

[0063] Figure 1 A tumor ablation device including an ablation probe is shown;

[0064] Figure 2 An ablation probe of a tumor ablation device is shown;

[0065] Figure 3 shows data exchange for a tumor ablation device;

[0066] Figure 4 A flow chart illustrating a method for determining ablation parameters;

[0067] Figure 5a 、 Figure 5b Overlay images are shown. DETAILED DESCRIPTION

[0068] refer to Figure 1 Now, a tumor ablation device 1 including an ablation probe 2 constructed according to an embodiment of the present invention is described. The tumor ablation device 1 generally includes an ablation probe 2 configured to be introduced into a patient's body to perform ablative treatment on target tissue, an ablation energy source, and in particular a radio frequency (RF) generator 3, and a cable 4 electrically connecting the ablation probe 2 to the RF generator 3. The ablation energy source may alternatively be a heating element or a cooling element or a cooling system with nitrogen, such as for cryoablation.

[0069] Now refer to Figure 2 The ablation probe 2 is described in further detail. The ablation probe 2 includes an elongated shaft 5 having a proximal end 6a and a distal end 6b. The probe shaft 5 is made of a conductive material, such as stainless steel. The probe shaft 5 has a suitable length, typically in the range of 5 cm to 30 cm, preferably in the range of 10 cm to 25 cm, and has an outer diameter consistent with its intended use, typically in the range of 0.7 mm to 5 mm, and typically in the range of 1 mm to 4 mm.

[0070] The ablation probe 2 may also include a sheath 7 disposed over the probe shaft 5. In the illustrated embodiment, the sheath 7 is secured to the probe shaft 5 and may be applied to the probe shaft 5 using any suitable means. For example, the insulating sheath 7 may be applied to the probe shaft 5 as a heat-shrink tubing or may be extruded onto the probe shaft 5. The sheath 7 is constructed of an electrically insulating material, such as fluorinated ethylene propylene (FEP), and extends the entire length of the probe shaft, except for the distal tip of the probe shaft 5. In this manner, the RF ablation electrode 9 is formed by the exposed portion of the distal tip.

[0071] The handle 5 is visible in X-ray, CT, MR, and / or ultrasound images. The ablation probe 2 includes a plurality of sensors 10. The sensors 10 are positioned along the handle 5, particularly in the distal end region. Each sensor has a sensor position 11, wherein the sensors 10 and the sensor positions 11 are displaced along the handle 5. The sensors 10 and / or the sensor positions are visible in X-ray, CT, MR, and / or ultrasound images.

[0072] Sensors 10 are configured to measure values ​​of measurement parameters. Ablation probe 2 can include different types of sensors 10, such as temperature sensors 10a, oxygen sensors 10b, and / or glucose sensors 10c. Each sensor type used in the probe, particularly for the method according to the present invention, is included at least twice. For example, ablation probe 2 may include at least two displaced temperature sensors 10a, at least two displaced oxygen sensors 10b, and / or at least two displaced glucose sensors 10c. Sensors 10 are configured to acquire sensor data, wherein the sensor data includes measured values ​​of the measurement parameters.

[0073] Tumor ablation apparatus 1 includes an interface module 13. Interface module 13 is connected to sensor 10 and is configured to provide sensor data to a method for determining ablation parameters and / or to provide the sensor data to an internal or external user or device. Tumor ablation apparatus 1 also includes a control unit 14, wherein the control unit 14 is configured to receive the provided ablation parameters and control and / or operate the ablation probe 2 accordingly.

[0074] Figure 3 The present invention depicts a data exchange scenario involving a tumor ablation device 1 and a monitoring system 15 dedicated to overseeing the ablation probe 2 and / or the ablation process. This monitoring system 15 relies on medical image data, particularly X-ray images, to facilitate its functionality. Primarily, the monitoring system 15 is tailored for needle guidance, ensuring that the ablation probe 2 is accurately navigated to the target tumor during the medical imaging procedure.

[0075] Integral to this setup is the connection between monitoring system 15 and ablation device 2, in particular the connection to interface unit 13. Sensor data from ablation device 1 is transmitted to monitoring system 15, enabling real-time feedback and analysis. Furthermore, monitoring system 15 is configured to execute the innovative method for determining optimal ablation probe parameters according to the present invention.

[0076] Once the parameters are determined, the monitoring system 15 seamlessly communicates them back to the tumor ablation device 1, thereby improving its efficacy and accuracy during the ablation procedure. This data exchange mechanism is implemented through the Fast Healthcare Interoperability Resources (FHIR) device, ensuring efficient and standardized communication protocols within the medical environment.

[0077] Figure 4 A flow chart of an embodiment of a method for determining ablation parameters is shown. The method comprises three main steps: receiving (step 100), determining (step 200) and providing (step 300).

[0078] The thermogenic capacity of a tumor is a dynamic variable that changes throughout tumor progression. Two key parameters jointly determine this capacity: tumor cell metabolism, which generates heat as a byproduct, and vascularization within and around the tumor, which provides the oxygen and nutrients necessary for tumor cell proliferation. In the early stages of tumor development, the lack of vascularization limits tumor cell metabolism, tumor growth, and ultimately thermogenic capacity.

[0079] During a receiving step 100, sensor data acquired by at least two sensors 10 are collected. These sensors are spatially arranged along the shaft 5 of the ablation probe 2. Each sensor 10 has a different sensor position. The sensor data includes measurements of at least one parameter, each parameter including two measurement values ​​obtained from different sensor positions.

[0080] The ablation probe 2 is equipped with thermocouples (temperature measurement sensors) at different lengths along the handle of the probe 2. These thermocouples can measure real-time temperature and transmit data to the ablation guidance software. Although the following figures depict three thermocouples, more thermocouples can actually be used.

[0081] In determination step 200, ablation parameters are calculated based on the sensor data and / or measured values ​​of the same parameter at different sensor locations. The ablation parameters may include the tumor margin, the position of the ablation probe relative to the tumor, the grade of the tumor, the distribution of normal and tumor tissue around the probe, ablation power, temperature, and / or an overlay image. In particular, the ablation parameters may be the position of the tumor relative to the sensor and / or the distribution of the measured parameter around the ablation probe and / or relative to the sensor.

[0082] Finally, the determined ablation parameters are provided in step 300. The provision may include a visual presentation and / or a method for controlling the utilization of the ablation probe 2.

[0083] Figure 5a An overlay image 20 based on a medical image 21 (e.g., an X-ray of a patient) is depicted. Overlay image 20 shows a tumor and its surrounding area, as well as an ablation probe 2. Ablation probe 2 is positioned substantially within the tumor, particularly with its distal end housing a radiofrequency transmitter. Adjacent to ablation probe 2 are the sensor locations T1, T2, T3, and T4, as indicated in the overlay. In this configuration, the probe houses four temperature sensors at locations T1, T2, T3, and T4. Overlay image 20 also includes a temperature display 22, which indicates the temperatures 23 measured by these sensor locations T1, T2, T3, and T4.

[0084] As is apparent from the display, T1 and T2 exhibit significantly higher temperatures compared to T3 and T4. This indicates that the ablation probe 2 and the sensors for T1 and T2 are located within or closest to the tumor. In contrast, the positions of sensors T3 and T4 correspond to temperatures that indicate these sensors are located outside the tumor. Overlay image 20 serves as an ablation parameter, providing the user with visual feedback on whether the ablation probe 2 is positioned correctly or if adjustments are needed.

[0085] Figure 5b Shows that basically Figure 5a The corresponding overlay image 20 is shown. However, in contrast, temperatures are not individually assigned locations and are not listed here. Instead, an interpolated temperature value is determined based on the temperatures at T1, T2, T3, and T4, and a temperature distribution 24 along and / or around the ablation probe 2 is depicted as a heat map. The heat map allows the user to discern the location of the tumor, as it is assumed to be located in the area with the highest temperature. The overlay image 20 serves as a display of ablation parameters to the user.

Claims

1. A method for determining ablation parameters for ablation therapy, comprising: - receiving (100) sensor data acquired by at least two sensors (10), said sensors (10) being spatially arranged along a shaft (5) of an ablation probe (2), each sensor having a different sensor position (11, T1, T2, T3, T4), wherein said sensor data for at least one measurement parameter comprises two measurement values ​​obtained at different sensor positions (11, T1, T2, T3, T4); - determining (200) the ablation parameter based on the sensor data and / or measured values ​​of the same measured parameter at different sensor positions (11, T1, T2, T3, T4); - providing (300) the determined ablation parameters.

2. The method according to claim 1, wherein The step of determining (200) the ablation parameter comprises determining the ablation parameter based on differences and / or comparisons of measured values ​​of the same measured parameter at different sensor locations (11, T1, T2, T3, T4).

3. The method according to claim 1 or 2, wherein For temperature as a measurement parameter, the sensor data comprises a measured first temperature and a measured second temperature as measurement values, wherein the first temperature is associated with a first temperature sensor and a first temperature sensor position (11, T1), and the second temperature is associated with a second temperature sensor and a second temperature sensor position (11, T2), wherein the step of determining the ablation parameter comprises determining the ablation parameter based on the first temperature and the second temperature.

4. A method according to any one of the preceding claims, wherein For oxygen concentration as a measured parameter, the sensor data comprises a measured first oxygen value and a measured second oxygen value as measured values, wherein the first oxygen value is associated with a first oxygen sensor and a first oxygen sensor position (11), and the second oxygen value is associated with a second oxygen sensor and a second oxygen sensor position (11), wherein the step of determining the ablation parameter comprises determining the ablation parameter based on the first oxygen value and the second oxygen value.

5. A method according to any one of the preceding claims, wherein For sodium concentration, potassium concentration, sodium-potassium ratio, pH value and / or lactate concentration as measurement parameters, the sensor data includes a measured first steady-state value and a measured second steady-state value as measurement values, wherein the first steady-state value is associated with a first steady-state sensor and a first steady-state sensor position (11), and the second steady-state value is associated with a second steady-state sensor and a second steady-state sensor position (11), wherein the step of determining the ablation parameter includes determining the ablation parameter based on the first steady-state value and the second steady-state value.

6. A method according to any one of the preceding claims, wherein For glucose concentration as a measurement parameter, the sensor data includes a measured first glucose value and a measured second glucose value as measurement values, wherein the first glucose is associated with a first glucose sensor and a first glucose sensor position (11), and the second glucose is associated with a second glucose sensor and a second glucose sensor position (11), wherein the step of determining the ablation parameter includes determining the ablation parameter based on the first glucose value and the second glucose value.

7. The method according to any one of the preceding claims, comprising the step of determining a parameter of metabolic activity, wherein The metabolic activity parameter is determined based on at least one of the measured values, wherein the ablation parameter is determined and / or verified based on the metabolic activity parameter.

8. The method according to any of the preceding claims, comprising the step of receiving a medical image (21) of the object under examination, wherein The medical image (21) includes a target area of ​​the examination object and a portion of the handle (5) of the ablation probe (2), wherein the portion includes the sensor (10), wherein the step of providing (300) the determined ablation parameters includes generating and / or providing an overlay image (20), wherein the overlay image (20) combines the medical image (21) with relevant parameters and / or measured values ​​of the ablation parameters.

9. The method according to claim 8, comprising the step of determining a measured value distribution (23) and / or a measured value interpolation of the measured values ​​of the measurement parameter measured by the sensors (10) at different sensor positions (11, T1, T2, T3, T4), wherein The step of providing (300) the determined ablation parameters comprises generating and / or providing the overlay image (20), wherein the overlay image (20) combines the medical image (21) with the measured value distribution (23) and / or the measured value interpolation.

10. The method according to any of the preceding claims, comprising the step of receiving a medical image (21) of the examination object, wherein The medical image (21) includes a target area of ​​the examination object and a portion of the handle of the ablation probe (2), wherein the target area is characterized in that the average value of the measurement parameter is different from the surrounding environment of the target area, and wherein the step of determining (200) the ablation parameter includes determining the positioning examination information of the ablation probe (2) as the ablation parameter based on the measurement value of the measurement parameter.

11. The method according to any of the preceding claims, comprising the step of receiving a medical image (21) of the object under examination, wherein The medical image (21) includes a target area of ​​the examination object and a portion of the handle (5) of the ablation probe (2), wherein the target area is characterized in that the average value of the measurement parameter is different from the surrounding environment of the target area, and wherein the step of determining the ablation parameter includes determining a safety margin of the ablation as an ablation parameter based on the measured value of the measurement parameter.

12. The method according to any of the preceding claims, comprising the step of receiving a medical image (21) of the examination object, wherein The medical image includes a target area of ​​the examination object and a portion of the handle (5) of the ablation probe, wherein the target area is characterized in that the average value of the measurement parameter is different from the surrounding environment of the target area, and wherein the step of determining the ablation parameter includes determining the residual examination information of the ablation as the ablation parameter based on the measured value of the measurement parameter.

13. A tumor ablation device (1), comprising an ablation probe (2) and an interface module (12), wherein: The ablation probe (2) comprises a treatment section for performing freezing, thermal therapy, heating or radiofrequency therapy on a tumor, wherein the ablation probe can be positioned or inserted into a patient to be treated. It is characterized in that the ablation probe (2) includes at least two sensors (10), wherein the at least two sensors (10) are configured to acquire sensor data, the sensors are spatially arranged along the handle (5) of the ablation probe (2), each sensor (10) has a different sensor position (11, T1, T2, T3, T4), wherein the sensor data for at least one measurement parameter includes two measurement values ​​obtained at different sensor positions, wherein the interface module (12) is configured to provide the sensor data to the method for determining ablation parameters and / or to provide the sensor data to an internal or external user or device.

14. The tumor ablation device (1) according to claim 13, further comprising a control unit (14), wherein: The control unit (14) is configured to receive the provided ablation parameters and control and / or operate the ablation probe (2) accordingly.

15. A computer program product comprising a non-transitory computer-readable medium storing instructions which, when executed by a processor, cause the processor to perform the steps of the method according to any one of claims 1 to 12.

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