Tumor degeneration control in curative cancer treatment
By applying RF energy to the non-insulated ablation portion of the RF probe and combining it with temperature and cooling control, the problem of determining the tumor destruction time in RFA is solved, enabling curative treatment of cancer tumors and killing adjacent cells, thus reducing the risk of tumor seeding.
Patent Information
- Application Number
- CN202511328712.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2021-05-06
- Filing Date
- 2022-05-06
- Publication Date
- 2025-12-26
AI Technical Summary
Current radiofrequency ablation (RFA) is mainly used for palliative treatment, but it is difficult to determine when the tumor is completely destroyed and it is difficult to control the temperature within the tumor.
By applying RF energy between one electrode and another on the non-insulated ablation portion of the RF probe, combined with a temperature measuring device, a cooling device, and an RF generator, the temperature of the treatment area is monitored and controlled, and the vascular coagulation time point is determined to end the RFA treatment.
It achieves curative treatment of cancer tumors, precisely controls the temperature of the treatment area, ensures complete destruction of the tumor and killing of adjacent cells, and reduces the risk of tumor seeding.
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Figure CN121196709A_ABST
Abstract
Description
[0001] This application is a divisional application of application No. 202280046910.6, titled "Tumor denaturation control in curative cancer treatment", filed with the State Intellectual Property Office on May 6, 2022, which has a filing date of May 6, 2022. TECHNICAL FIELD
[0002] The present disclosure relates generally to systems and methods for minimally invasive curative treatment of cancer tumors. BACKGROUND
[0003] The most common treatments for cancer tumors are surgery, radiation therapy and / or chemotherapy, but other treatment means have also been proposed. Hyperthermia is a cancer treatment in which a tumor is exposed to temperatures of around 43°C. Studies described in the article "Heating the patient: a promising approach?" by van der Zee, Annals of Oncology 13(8): 1173-1184, 2002, for example, show that temperatures of around 43°C can destroy and kill cancer cells with minimal damage to normal tissue.
[0004] Radiofrequency ablation (RFA) is a medical procedure that uses heat generated by medium-frequency alternating current to ablate tissue. Monopolar RFA can be used to treat tumors by inserting an RF probe directly into the tumor to be treated and applying a neutral electrode to the outer surface of the body, for example in the form of a large sheet or foil on which the patient lies. When radiofrequency (RF) energy is applied between the neutral electrode and the RF probe (used as a counter electrode), an electrical current path is established between the electrodes. The current density at the neutral electrode will be much smaller than the current density at the RF probe, so the neutral electrode does not actually heat the body as long as there is good contact between the body and the neutral electrode. In bipolar RFA, RF energy is instead applied between an electrode located on the RF probe and another electrode also located on the RF probe (the same RF probe or another RF probe).
[0005] The heating of the tissue surrounding the RF probe by the RF energy is caused by the electrical resistance of the tissue. The output power of the RF source regulates the temperature generated in the tissue. It is the heat that destroys the tumor cells. The denatured tumor cells can then be absorbed by the body. RFA is primarily used for palliative treatment.
[0006] EP1639956 describes a monopolar RFA device for tumor treatment, comprising an RF probe intended to be inserted into a tumor, a neutral electrode intended to be applied to the outer surface of the body, and an RF generation device intended to be used to apply RF energy between the RF probe and the neutral electrode in order to generate heat in the tissue surrounding the RF probe, wherein the heat is in the hyperthermia temperature range (70-95°C).
[0007] Problems of the prior art
[0008] RFA is currently mainly used for palliative treatment. One reason for this is that it is difficult to determine when a tumor has been completely destroyed. This is not necessary for palliative treatment.
[0009] There is therefore a need for an improved system for curative treatment of cancer tumors. SUMMARY
[0010] The above problems are solved by the claimed system for curative RFA treatment of a treatment zone comprising at least a part of a cancer tumor by applying RF energy between an electrode arranged on a non-insulated ablation part of an RF probe and another electrode. The system can comprise a control device, a temperature measuring device arranged to measure the temperature of the RF probe and based thereon provide an estimate of the temperature of the treatment zone to the control device, a cooling device arranged to be controlled by the control device to cool the RF probe, and an RF generating device controlled by the control device to provide the RF probe with an amount of RF energy needed to maintain a desired temperature of the treatment zone based on the estimated temperature of the treatment zone. The RF energy provided by the RF generating device to the RF probe can be monitored and the RF generating device can be arranged to be turned off at a point in time when the output power of the RF generating device is no longer substantially decreasing.
[0011] The above problems are further solved by the claimed method for determining a point in time when blood vessels within a treatment zone have been coagulated in a system for curative RFA treatment of a treatment zone comprising at least a part of a cancer tumor by applying RF energy between an electrode arranged on a non-insulated ablation part of an RF probe and another electrode. The method can comprise measuring the temperature of the RF probe using a temperature measuring device and based thereon estimating the temperature of the treatment zone, cooling the RF probe using a cooling device, providing the RF probe with an amount of RF energy needed to maintain a desired temperature of the treatment zone based on the estimated temperature of the treatment zone using an RF generating device, monitoring the RF energy provided by the RF generating device to the RF probe, and determining a point in time when the output power of the RF generating device is no longer substantially decreasing in order to end the RFA treatment by turning off the RF generating device after this point in time.
[0012] This is an accurate method of determining that a tumor has been denatured and thus curative treatment is complete.
[0013] In embodiments, determining the point in time at which the output power of the RF generating device is no longer substantially decreasing involves determining when the derivative of the RF generating device output power is within a predetermined threshold close to zero. Since at the early stages of the treatment process, the derivative of the RF generating device output power will also be zero at the high points of the curve, any automated system for determining when the output power of the RF generating device is no longer substantially decreasing from the derivative of the output power curve needs to distinguish between these points. This can be done for example based on a certain treatment time having passed or based on the derivative first being negative.
[0014] The control device can be arranged to switch off the RF generating device and the cooling device at selected time intervals for a selected off period, so that the treatment zone temperature T is equalized, so that the treatment zone temperature can be more accurately estimated by the temperature measuring device. This enables precise control of the temperature of the treatment zone.
[0015] In embodiments, the treatment zone temperature is estimated based on the shape of the measured RF probe temperature curve, for example based on determining the derivative of the measured RF probe temperature curve until the end of the off period. This means that there is no need to wait for the RF probe temperature to be completely stable, so that the off period can be greatly shortened.
[0016] In embodiments, the cooling device is arranged to cool the RF probe by circulating a cooling liquid, and is switched off by stopping the circulation of the cooling liquid. This is a simple way of controlling the cooling of the RF probe.
[0017] In embodiments, the probe measuring device comprises a thermocouple comprising a conductor arranged inside the RF probe and connected to the uninsulated ablation portion of the RF probe. This is a simple temperature measuring device.
[0018] In embodiments, the cooling device comprises a cooling liquid supply channel arranged inside the RF probe to supply cooling liquid to the uninsulated ablation portion of the RF probe. This ensures that cooling liquid is supplied to the entire uninsulated ablation portion of the RF probe.
[0019] In embodiments, the impact device is arranged to push the RF probe into the tumor with a distinct impact. The impact device can be arranged to comprise an impact apparatus arranged inside the impact housing to fire towards an impact spike extending from the connecting end portion of the RF probe, so that the impact between the impact apparatus and the impact spike pushes the RF probe forward a distance with a very high acceleration, the distance being defined by the length of the impact spike extending into the impact housing. The impact device can also be arranged to comprise a spring apparatus, the impact spike interacting with the spring apparatus, wherein the spring apparatus pushes the RF probe away from the impact device, so that the length of the impact spike extending into the impact housing depends on the force applied to the RF probe to counteract the spring force in the spring apparatus. This is a simple and effective way of arranging the impact device.
[0020] In embodiments, the RF probe is provided to be included in a probe device, which further comprises an insertion tube and a biopsy needle. In embodiments, the insertion tube is provided to be inserted into the tumor together with the biopsy needle; to remain inserted into the tumor when the biopsy needle is withdrawn; and to allow the RF probe to be inserted into a cavity in the tumor formed by the biopsy needle. This enables to take tissue samples at the exact location that receives curative RFA treatment.
[0021] In embodiments, the RF generation device comprises an oscillator, a balanced modulator, and an RF amplifier.
[0022] In embodiments, an isolation transformer is provided between the RF generation device and the RF probe.
[0023] The RF probe temperature is preferably measured by a temperature sensing device included in the temperature measurement device. The treatment zone temperature can be estimated based on the measured RF probe temperature by a processing device included in the temperature measurement device or a processing device included in the control device.
[0024] The RFA treatment can be monopolar RFA treatment or bipolar RFA treatment. If the RFA treatment is monopolar RFA treatment, the other electrode is preferably a neutral electrode. If the RFA treatment is monopolar RFA treatment, the other electrode can be provided on a separate RF probe or on a non-insulated ablation portion of the same RF probe. The RFA treatment can also be a combination of monopolar RFA treatment and bipolar RFA treatment.
[0025] The RFA treatment can be for treating both human tumors and animal tumors.
[0026] The scope of the application is defined by the claims, which are incorporated in this section by reference. Those skilled in the art will further appreciate the embodiments of the application and realize additional advantages thereof upon reading the following detailed description of one or more embodiments with reference to the accompanying drawings, of which:
[0027] BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Figure 1 A system for curative treatment of a treatment zone comprising at least a portion of a cancer tumor according to one or more embodiments described herein is schematically illustrated.
[0029] Figure 2a Cell survival curves at different temperatures are shown.
[0030] Figure 2b An RF probe for insertion into a treatment zone comprising a cancer tumor according to one or more embodiments described herein is schematically illustrated.
[0031] Figures 3a-3b Different aspects of an RF probe for curative treatment of at least a portion of a cancerous tumor, according to one or more embodiments described herein, are illustrated.
[0032] Figures 4a-4c A probe device for curative treatment of at least a portion of a cancerous tumor is shown according to one or more embodiments described herein.
[0033] Figure 5a The diagram schematically illustrates how the output power of the RF generator changes during RFA treatment.
[0034] Figure 5b This schematically illustrates how the measured RF probe temperature is typically affected by shutting down the RF generator and cooling device.
[0035] Figure 6 A method is schematically illustrated in a system for curative treatment of at least a portion of a cancerous tumor, according to one or more embodiments described herein.
[0036] Figure 7 A method for curative treatment of at least a portion of a cancerous tumor, according to one or more embodiments described herein, is illustrated schematically.
[0037] The embodiments of this disclosure and their advantages can be best understood by referring to the following detailed description. It should be understood that the same reference numerals are used to identify the same elements shown in one or more of the figures. Detailed Implementation
[0038] RFA is currently primarily used for palliative care. One reason is the difficulty in determining when a tumor has been completely destroyed, which is not essential for palliative treatment.
[0039] Another reason is the difficulty in controlling the temperature within the tumor during RFA treatment. It is important to ensure that the temperature throughout the treatment area is high enough to kill cancer cells, but not so high that there is a risk of coagulated tissue bursting.
[0040] The temperature required to kill cancer cells depends on the duration of treatment. Figure 2a Cell survival curves of mammalian cells heated at different temperatures for different durations are shown (redrawn from Dewey WC, Hopwood LE, Sapareto SA, Gerweck LE: *Radiology* 123: 463-474, 1977). Based on these curves, hyperthermia therapy was proposed, in which the tumor was exposed to a temperature of approximately 43°C. However, as... Figure 2aAs shown, at such temperatures a very long treatment time is required. Furthermore, hyperthermia technology is highly sensitive to small temperature variations, thus requiring extremely sensitive temperature control.
[0041] The present invention relates to curative RFA treatment in the hyperthermia temperature range (60-90°C). From Figure 2a It can be seen from Figure 2a It can be clearly seen from
[0042] Embodiments of the disclosed solution are presented in more detail in connection with the appended drawings.
[0043] System embodiments
[0044] Figure 1 A system 100 for curative treatment of a treatment zone 300 comprising at least a part of a cancer tumor using RFA is schematically shown. The system 100 comprises an electrode provided on a non-insulated ablation portion 124 of an RF probe 120, and a further electrode in the form of a neutral electrode 160 on which a patient to be treated lies. The system 100 further comprises an RF generating device 150 arranged to provide RF energy to the RF probe 120 such that an electrical current path is established between the RF probe 120 and the neutral electrode 160 when the RF probe 120 is inserted into the treatment zone 300 in the patient. This causes tissue surrounding the non-insulated ablation portion 124 of the RF probe 120 in the treatment zone 300 to be heated due to the electrical resistance of the tissue. If the patient has good contact with the neutral electrode 160, the current density at the neutral electrode 160 will be much lower than at the RF probe 120, and thus the skin in contact with the neutral electrode 160 will not in fact be heated. The treatment zone 300 preferably comprises at least a part of a tumor (breast tumor). It is preferably ensured that the RF probe 120 does not move relative to the tumor once it has been inserted into the tumor. To ensure this, means can be used to keep the patient still, or means to ensure that the RF probe 120 moves with the patient if the patient moves.
[0045] Figure 1The shown system 100 further comprises a control device 110, a temperature measuring device 130 and a cooling device 140, which is arranged to cool the RF probe 120. The temperature measuring device 130 is arranged to measure the RF probe temperature and based thereon provide an estimate of the treatment zone temperature T to the control device 110, so that the control device 110 can monitor that the treatment zone temperature T is maintained within the hyperthermia temperature range (60-90°C) throughout the treatment zone 300. If the RF probe 120 is not cooled, it is unlikely that a sufficiently high temperature is maintained throughout the treatment zone 300 without the temperature at the surface of the RF probe 120 becoming so high that there is a risk of e.g. coagulation of tissue explosions. Due to the cooling of the RF probe 120, the highest temperature in the treatment zone will not occur in the vicinity of the RF probe 120, but further away in the treatment zone 300. The control device 110 controls the cooling device 140 to cool the RF probe 120.
[0046] The control device 110 also controls the output power of the RF generating device 150 to the RF probe 120. The output power of the RF generating device 150 regulates the temperature generated in the treatment zone 300. The control device 110 controls the RF generating device 150 to provide the RF probe 120 with an output power that maintains the required treatment zone temperature T D The amount of RF energy required. The control is preferably PID based.
[0047] Figure 2b The RF probe 120 is schematically shown inserted into the tumor 210. A major advantage of using a hyperthermia temperature range of 60-90°C is that the temperature in the adjacent zone 200 outside the treatment zone 300 will also be elevated. If the temperature throughout the treatment zone 300 is at least 60°C, the temperature in the adjacent zone 200 will be at least e.g. 50°C, thereby ensuring that tumor cells in the adjacent zone 200 are also killed during the RFA treatment. Since tumor cells are more heat sensitive than non-tumor cells, most of the non-tumor cells in the adjacent zone 200 that are damaged will be able to self-repair. This is a major advantage of RFA treatment compared to surgery, where the surgeon always has to choose either to resect too much tissue to ensure that no tumor cells remain, or to risk that not all tumor cells are resected. By using RFA, there is a "safety margin" due to the elevated temperature in the adjacent zone 200.
[0048] The RF generating device 150 can comprise any number and type of device capable of providing a controlled amount of RF energy to the RF probe 120. In an embodiment, the RF generating device 150 comprises an oscillator providing e.g. a frequency of 1 MHz, an RF amplifier which can provide e.g. a power of up to 300 W, and a balance modulator which controls the output of the RF amplifier between 0% and 100%. In this case, the control device 110 can control the balance modulator e.g. using PID control.
[0049] One way of monitoring how the tumor treatment progresses is to monitor the output power of the RF generating device 150. Blood vessels within the tumor are constantly actively removing heat from the tumor, so during the first part of the treatment a relatively high output power of the RF generating device 150 (typically about 60-80 W) will be required. However, when the heat starts to coagulate the blood vessels within the tumor, the output power of the RF generating device 150 required to maintain the desired treatment zone temperature TD becomes lower (typically about 20-30 W). When all blood vessels within the treatment zone 300 have been coagulated, and the tumor cells have thus been denatured, a lower power is required. Thus, the output power of the RF generating device 150 required to maintain the desired treatment zone temperature TD is an indication of the level of blood vessel coagulation, and thus of how far the cells within the treatment zone 300 have been denatured. The denatured cells can then be absorbed by the body.
[0050] Figure 5a The output power of the RF generating device 150 is schematically shown how it varies during an RFA treatment. During a first time period (from t P0 to t P1 ), the output power of the RF generating device 150 typically rises sharply to heat the treatment zone to the treatment zone temperature T D (usually 60-90 °C) required for the RFA treatment. When the treatment zone has reached the desired treatment zone temperature T D , the output power of the RF generating device 150 is gradually reduced to the output power required to maintain the desired treatment zone temperature T D . As shown in Figure 5a , after a certain time (t P2 ), the output power of the RF generating device 150 typically decreases more or less linearly. This indicates that the blood vessels within the tumor gradually coagulate. At a last time point (t P3 ), the output power of the RF generating device 150 no longer decreases, but is more or less stable at a certain level P S . This indicates that all blood vessels within the tumor have been coagulated and no longer actively remove heat from the tumor. The output power of the RF generating device 150 required to maintain the desired treatment zone temperature T D is then typically more or less constant.
[0051] Maintaining the required treatment area temperature T D The point at which the output power of the required RF generator 150 becomes more or less constant marks the point at which tumor degeneration and curative treatment are achieved. This is determined by identifying the point in time (t) when the curve stabilizes. P3 Based on vascular coagulation control, it is possible to determine when the RF generator 150 can be shut off, thereby ending RFA treatment. Determining this time point (t...) P3 One method is to analyze the curve and determine when the output power of the RF generator 150 no longer decreases significantly. In an embodiment, determining the point at which the output power of the RF generator 150 no longer decreases significantly involves determining when the derivative of the output power of the RF generator 150 is within a predetermined threshold close to zero. At this point, i.e., t... P3 The blood vessels within the treatment area 300 have coagulated, and the tumor has been completely destroyed as a result. The RF generator 150 can then be turned off, thus ending the RFA treatment.
[0052] Because in the early stages of the treatment process, at time point t P1 At the peak of the curve, the derivative of the output power of the RF generator 150 will also be zero. Therefore, any automated system used to determine when the output power of the RF generator 150 no longer decreases significantly based on the derivative of the output RF power curve needs to distinguish between these points. This could be based, for example, on a certain treatment time that has passed or on the first time the derivative becomes negative.
[0053] The above-mentioned concept for determining when treatment can be ended has nothing to do with how to estimate the temperature T of the treatment area.
[0054] Figures 3a-3b Aspects of one or more embodiments of an RF probe 120 are shown, the RF probe 120 being adapted to insert into a tumor and heat tissue surrounding a non-insulated ablation portion 124 of the RF probe 120 within, for example, a spherical treatment area 300. The RF probe 120 may, for example, comprise a hollow metal tube made of stainless steel, which may be covered along its length by an insulating cover 126 made of an insulating material such as rubber or plastic. The insulating cover 126 ensures that only the ablation portion 124 of the RF probe contacts the surrounding tissue. The ablation portion 124 of the RF probe 120 is adapted to insert into a tumor and is therefore not covered by any insulating cover 126.
[0055] The size of the treatment zone 300 depends on the length of the uninsulated ablation portion 124 of the RF probe 120 and the diameter of the RF probe 120. The spherical treatment zone 300 will have a rotational diameter determined by the diameter of the RF probe 120 and a length determined by the length of the uninsulated ablation portion 124 of the RF probe 120. Thus, the length of the uninsulated ablation portion 124 and the diameter of the RF probe 120 are preferably adapted to the size of the tumor to be treated. The RF probe diameter corresponding to a certain treatment zone rotational diameter and the ablation portion length corresponding to a certain treatment zone length can for example be determined empirically. The length of the uninsulated ablation portion 124 can for example be 10-30 mm, the diameter of the RF probe 120 can for example be 1-3 mm, for example about 1.5 mm.
[0056] If the insulating cover 126 is movable along the length of the RF probe 120, the length of the uninsulated ablation portion 124 can be adjusted. In this way, the same RF probe 120 can be used for tumors of different sizes and / or shapes (although for certain tumor sizes and / or shapes, different RF probes 120 with different diameters can be needed). The movement of the insulating cover 126 can for example be achieved by simply manually pushing the insulating cover 126 along the length of the RF probe 120. However, in such an embodiment, preferably, there is sufficient friction between the hollow metal tube and the insulating cover 126 to ensure that the insulating cover 126 does not unintentionally move when the RF probe 120 is inserted into the tumor.
[0057] The system 100 preferably comprises a temperature measuring device 130 arranged to measure the RF probe temperature and to estimate the temperature T within the treatment zone 300 on the basis thereof. The treatment zone temperature T can be estimated on the basis of the measured RF probe temperature by processing means comprised in the temperature measuring device 130 or by processing means comprised in the control device 110. The RF probe temperature is preferably measured by temperature sensing means comprised in the temperature measuring device 130. The temperature sensing means can for example comprise a temperature sensor 132 arranged at the uninsulated ablation portion 124 of the RF probe 120.
[0058] In one embodiment, the temperature sensing device is arranged to measure the RF probe temperature using a thermocouple. A thermocouple is an electrical device consisting of two dissimilar electrical conductors that form an electrical junction. The thermocouple generates a temperature dependent voltage, which can be converted into a temperature measurement. If the hollow metal tube is made of stainless steel and a conductor 135 made of the metal alloy constantan is arranged inside the RF probe 120 and connected to the hollow metal tube at a point 132 on the non-insulated ablation portion 124 of the RF probe 120, the voltage U between the hollow metal tube and the conductor 135 can be converted into the RF probe temperature based on the factor 0.050 mV / °C (which applies to thermocouples consisting of iron and constantan). However, the conductor 135 needs to be insulated from the hollow metal tube from the connection point 132 to the voltage measurement point. The conductor can for example be glued to the inside of the hollow metal tube using a resin that insulates it from the hollow metal tube. This also makes the arrangement of the conductor 135 mechanically stable.
[0059] The RF probe 120 preferably further comprises a cooling liquid supply channel 142 arranged inside the hollow metal tube to supply cooling liquid to the non-insulated ablation portion 124 of the RF probe 120. The cooling liquid can for example be supplied to the cooling liquid supply channel 142 at the connection end portion 122 of the RF probe 120. As shown, the connection end portion 122 of the RF probe 120 can comprise a distribution unit 146 in which all connection points to the external system are arranged. The distribution unit 146 can for example be arranged in a shape that is easy to hold during insertion of the RF probe 120 into the patient, so that the physician easily holds the RF probe 120 and applies manual force to it to insert it into the tumor. Figure 3b
[0060] The cooling liquid supply channel 142 preferably extends almost all the way to the tip of the RF probe 120 inside the hollow metal tube. This ensures that cooling liquid is supplied to the entire non-insulated ablation portion 124 of the RF probe 120. The cooling liquid can then flow freely back inside the hollow metal tube to be collected in a cooling liquid return channel 144 connected to the RF probe 120. If a conductor 135 is arranged inside the hollow metal tube, this conductor 135 is preferably isolated from the cooling liquid, for example by being covered by the resin used to glue it to the inside of the hollow metal tube.
[0061] The cooling liquid is preferably cooled before being returned to the cooling liquid supply channel 142, for example using a Peltier cooler. The temperature to which the cooling liquid is cooled can be constant or adjusted according to cooling needs. The cooling liquid can for example be water. The cooling liquid is preferably circulated through the cooling liquid supply channel 142, the hollow tube, the cooling liquid return channel 144 and the cooler, for example by being pumped using a pump, for example a peristaltic pump, which has the advantage that no contaminants accumulate inside the pump. Figure 3b A device 148 for pumping and cooling the cooling liquid is shown schematically.
[0062] It is important to insert the RF probe 120 into the tumor without causing tumor displacement. Tumor treatment typically begins with determining the tumor's location, for example, using medical imaging techniques such as CT, MRI, and / or ultrasound. If the RF probe 120 causes tumor displacement during insertion, the tumor's location will no longer correspond to the determined location.
[0063] If the RF probe 120 is simply pushed into the tumor, there is a high risk that the tumor will be pushed away from the RF probe 120 instead of being penetrated by it, because the density and / or stiffness of the tumor is often higher than that of the surrounding tissue. Therefore, the system 100 preferably includes an impact device 310, which is configured to push the RF probe 120 into the tumor with a significant impact when the physician applies manual force to insert the RF probe 120 into the tumor. Each impact of the impact device 310 propels the RF probe 120 forward a short distance with very high acceleration, and there are intervals between each impact.
[0064] exist Figure 3b In the illustrated embodiment, the impact device 310 includes an impact housing 320, a compressed air source 330, and an impact device 340. The compressed air source 330 is preferably configured to release a compressed air pulse that "launches" the impact device 340 toward an impact pin 350 extending from the connecting end 122 of the RF probe 120 into an opening in the impact housing 320. The elastic impact between the impact device 340 and the impact pin 350 propels the RF probe 120 forward a short distance with very high acceleration. In this configuration, the connecting end 122 of the RF probe 120 can only be pushed a distance defined by the length of the impact pin 350 extending into the impact housing 320.
[0065] Since the impact device 310 is filled with air, this air will act as an "air cushion" for the impact device 340, preventing the impact device 340 from striking the end of the impact device 310 too violently (which could cause vibration). The impact housing 320 is preferably configured to allow air to escape from the impact housing 320 after each pulse of compressed air. Preferably, there are also some devices, such as air valves for compressed air, configured to ensure that the impact device 340 returns to the starting position after each impact. There may also be some devices, such as magnets, configured to ensure that the impact device 340 remains in the starting position when not being fired toward the impact nail 350.
[0066] The impact device 310 preferably comprises a spring device 360 arranged to interact with the impact spike 350. The spring device 360 pushes the RF probe 120 away from the impact device 310. When no force is applied to the RF probe 120, the spring device 360 will not be very compressed, and thus the impact spike 350 will not extend far enough into the impact housing 320 to engage with the impact device 340. Thus, when no force is applied to the RF probe 120, the RF needle 120 will not be pushed forward by the impact device 340.
[0067] However, when the RF probe 120 is pushed towards the tissue in the patient's body, the spring device 360 is compressed to a degree proportional to the applied force. Thus, the length to which the impact spike 350 extends into the impact housing 320 will depend on the force applied to the RF probe 120 to counteract the spring force in the spring device 360. This means that the impact amplitude of the impact device 310 will be proportional to the force applied to the RF probe 120. This arrangement ensures that the RF probe 120 will not move when no force is applied.
[0068] It is advantageous that the impact amplitude of the impact device 310 is proportional to the force applied to the RF probe 120, as this is a simple way for a physician to control the insertion of the RF probe 120 into the tumour using haptic feedback. This increases the haptics of the insertion. If the patient for example feels pain, the physician can simply stop applying force to the RF probe 120, and then the RF probe 120 will no longer be pushed into the tumour. In other embodiments of the impact device 310, there can be other means for ensuring that the impact amplitude of the impact device 310 is proportional to the force applied to the RF probe 120.
[0069] The compressed air source 330 is preferably arranged to release a new pulse of compressed air after a predetermined time to again fire the impact device 340 towards the impact spike 350. Thereby, the RF probe 120 is pushed into the tumour with a distinct impact. The frequency with which the compressed air source 330 releases a pulse of compressed air can also be adapted to the force applied to the RF probe 120 to push it into the tumour. This force can be measured using any suitable sensor, such as a sensor sensing the compression of the spring device 360.
[0070] In Figure 3bIn the illustrated embodiment, the dispensing unit 146 and the impact housing 320 are held together by a rig arrangement 370 that is schematically shown aligning them. In this embodiment, the physician can hold the entire rig 370 during insertion of the RF probe 120 into the patient. However, Wiksell, H. et al., "A new method to gently place biopsy needles or treatment electrodes into tissues with high target precision," Phys. Med. Biol. 2016 May, 32(5):724-7, describes alternative arrangements for transmitting the impact from the impactor 310 to the RF probe 120. In this embodiment, the RF probe 120 can be held by the physician and the impactor 310 can be held by an assistant, and they need not be aligned.
[0071] In embodiments, the RF probe 120 described above can also be used in a device for tissue sampling. Figures 4a-4c A probe device 400 for curative treatment of cancer tumors is shown. The probe device 400 preferably includes an insertion tube 410, an open biopsy needle 430, and an RF probe 120.
[0072] When the probe device 400 is used for tissue sampling, the biopsy needle 430 is inserted into the insertion tube 410, as shown. Figure 4b The probe device 400 is then pushed into the tumor in the same manner as the RF probe 120 described above. The probe device 400 preferably includes an impactor that is configured to push the probe device 400 into the tumor with a high acceleration in a distinct impact (e.g., the impactor 310 described above). As the probe device 400 is pushed into the tumor, a tissue sample 435 from the tumor is pushed into the biopsy needle 430. Because the probe device 400 is distinctly pushed into the tumor, the tissue sample 435 will be retained in the biopsy needle 430.
[0073] If the acceleration is high enough (e.g. 100.000 g) during insertion of the biopsy needle 430 into the tumor, the acceleration / inertial forces exerted by the tip of the biopsy needle 430 to the tissue being penetrated can kill tumor cells by itself, preventing seeding of viable tumor cells by the tissue sampling. However, RF energy can also be used to prevent seeding. In an embodiment, the biopsy needle 430 is connected to the RF generating device 150. If the biopsy needle 430 is insulated along its entire length except at the tip, a very local current can be generated around the tip of the biopsy needle 430. This current generates local heat, killing tumor cells close to the tip, thereby preventing tumor seeding. To ensure that the tissue block inside the biopsy needle is not affected, the RF energy is preferably provided in very short pulses. The biopsy needle 430 will act as a Faraday cage and protect the tissue block inside.
[0074] When the biopsy needle 430 has been retrieved from the insertion tube 410, the RF probe 120 can be inserted instead. Since the biopsy needle 430 has already taken a cylindrical tissue sample and thus left a cavity in the tumor, the RF probe 120 in this embodiment does not have to have a tip (but a tipped RF probe 120 can of course be used anyway). The diameter of the biopsy needle 430 can be slightly smaller than the RF probe 120 to ensure that there is contact between the RF probe 120 and the surrounding tissue.
[0075] The probe device 400 can comprise means to create a negative pressure in the cavity when the RF probe 120 has been inserted, as this creates a better contact between the RF probe 120 and the surrounding tissue. There can be, for example, a channel provided in the insertion tube 410 connected to a vacuum pump, so that the surrounding tissue can be sucked towards the RF probe 120. If the vacuum pump is also activated during the tissue sampling, any tumor cells that can have been loosened when the biopsy needle 430 penetrated the tumor will be sucked into the insertion tube 410, thereby even further reducing the risk of tumor seeding.
[0076] The RF probe 120 can comprise a combination of Figures 3a-3b All features described, although not mentioned here.
[0077] Using the same probe device 400 for tissue sampling and RFA treatment has many advantages:
[0078] • Since the insertion tube 410 remains in its inserted position until the RFA treatment is finished, it can be ensured that the tissue sample is taken from a location in the tumor that has been treated.
[0079] • Since the RFA treatment will kill cancer cells around the non-insulated ablation portion 124 of the RF probe 120, and the insertion tube 410 is not retrieved from the tumor until after the RFA treatment, the risk of seeding of the tumor by the biopsy is greatly reduced.
[0080] • The biopsy needle 430 can also be connected to the RF generating device 150 and thus locally generate heat near the tip, which will further reduce the risk of tumor seeding caused by the tissue sampling.
[0081] • Since the biopsy needle 430 leaves a cavity in the tumor, the RF probe 120 does not have to have a tip.
[0082] As mentioned above, there are clear advantages of inserting the biopsy needle 430 together with the insertion tube 410, compared to inserting the biopsy needle 430 into the insertion tube 410 when the insertion tube 410 has been inserted into the tumor. Since the probe device 400 is clearly pushed into the tumor, the tissue sample 435 will be retained in the biopsy needle 430. Furthermore, if the acceleration is high enough during the insertion of the biopsy needle 430 into the tumor, the acceleration / inertial forces exerted by the tip of the biopsy needle 430 onto the tissue being penetrated can kill tumor cells by itself, thereby preventing the seeding of viable tumor cells caused by the tissue sampling. This will not be the case if the biopsy needle 430 is not inserted into the insertion tube 410 when the insertion tube 410 is pushed into the tumor.
[0083] The distal part of the insertion tube 410 can comprise a guiding device 415 arranged to correctly guide the RF probe 120 into the cavity created by the biopsy needle 430. Such a guiding device 415 can for example comprise a thin rod extending from the insertion tube 410. Such a rod can also help to keep the cavity open between the withdrawal of the biopsy needle 430 and the insertion of the RF probe 120. However, the insertion tube 410 can also simply be shorter than the biopsy needle 430 and the RF probe 120 and not comprise any such guiding device 415.
[0084] The above probe device 400 can be used in any system 100 for RFA treatment, completely independent of for example the way in which the treatment zone temperature T is estimated.
[0085] It is very important to control the temperature in the tumor during RFA treatment. However, the temperature will not be the same throughout the treatment zone 300. The current density is largest at the surface of the RF probe 120 and decreases further in the treatment zone 300. Since the heating is caused by the electrical resistance of the tissue, the heat generated is proportional to the current density. Without cooling the RF probe 120, it is unlikely that a high enough temperature is maintained throughout the treatment zone 300 without the temperature at the surface of the RF probe 120 becoming so high that there is a risk of for example coagulation of tissue explosions. Due to the cooling of the RF probe 120, the highest temperature in the treatment zone will not be near the RF probe 120, but further in the treatment zone 300.
[0086] It is difficult to measure the temperature within the treatment zone 300 accurately, and therefore it is preferred to estimate the treatment zone temperature T based on the measured RF probe temperature. However, to estimate an accurate treatment zone temperature T, it is desirable to let the temperature within the treatment zone 300 equalize to a steady state before the RF probe temperature is measured. If both the RF generating device 150 and the cooling device 140 are turned off, the temperature within the treatment zone 300 will no longer be influenced by any external energy supply, and will therefore equalize. The temperature measured at the surface of the RF probe 120 will then approximately correspond to the temperature within the entire treatment zone 300.
[0087] One way of measuring a temperature at the surface of the uninsulated ablation portion 124 of the RF probe 120 that approximately corresponds to the treatment zone temperature T is therefore to temporarily turn off the RF generating device 150 and the cooling device 140 for a selected "off period". When no current heats the treatment zone 300 and no cooling device 140 cools the probe and adjacent parts of the treatment zone 300, the treatment zone temperature T will equalize, and will therefore approximately correspond to the temperature at the surface of the uninsulated ablation portion 124 of the RF probe 120, i.e. the RF probe temperature. Since these off periods make the total treatment time longer, the off period should preferably be as short as possible.
[0088] Figure 5b The RF probe temperature (measured at the uninsulated ablation portion 124 of the RF probe 120) is schematically shown how it is typically influenced by the RF generating device 150 and the cooling device 140 being turned off. When the RF generating device 150 heats the treatment zone 300 and the cooling device 140 cools the RF probe 120, the measured RF probe temperature is typically different from the general treatment zone temperature T, e.g. Tl, as shown. The measured RF probe temperature can be higher or lower than the treatment zone temperature T, depending on the position of the temperature sensing device and the amount of cooling applied to the RF probe 120. Figure 5b
[0089] If the RF generating device 150 and the cooling device 140 are turned off at time t T1 The RF probe temperature will typically change slowly when the RF generating device 150 and the cooling device 140 are turned off. After a sufficiently long time (t T3 ), the RF probe temperature will typically stabilize at a temperature T3(approximately corresponding to the treatment zone temperature T). However, since the time dependence of the thermal system can approximately follow first order kinetics, the final temperature T3may be estimated based on the shape of the measured RF probe temperature curve, e.g. by determining the derivative of the measured RF probe temperature curve. This means that there is no need to wait for the RF probe temperature to stabilize completely, and the off period can therefore be greatly reduced. T2 The derivative of the measured RF probe temperature curve. This means that there is no need to wait for the RF probe temperature to stabilize completely, and the off period can therefore be greatly reduced.
[0090] In an embodiment, the RF generating device 150 and the cooling device 140 are simultaneously turned off for a selected off-period at selected time intervals. Thereby, the temperature measuring device 130 can periodically estimate the equilibrated treatment zone temperature T. The selected off-period and the time intervals can be adjusted for a particular patient, e.g. based on previous treatments, or can be adjusted during a treatment, e.g. based on the amount of change in the measured RF probe temperature. A typical off-period can e.g. be about 20 seconds. The time intervals are preferably chosen to closely control the treatment without unnecessarily affecting the efficacy of the treatment. A typical time interval can e.g. be 1-2 minutes. The total treatment time can e.g. be 5-20 minutes.
[0091] This enables precise control of the treatment zone temperature T.
[0092] The RF probe temperature is preferably measured by a temperature sensing device comprised in the temperature measuring device 130. The treatment zone temperature T can be estimated based on the measured RF probe temperature by a processing device comprised in the temperature measuring device 130 or a processing device comprised in the control device 110.
[0093] The turning off of the cooling device 140 can involve turning off only the circulation of the cooling liquid, so that the cooling liquid is no longer cooled.
[0094] The system 100 can further comprise a skin temperature sensor, e.g. an infrared thermometer, for measuring the temperature of the patient's skin close to the RF probe 120. In some cases, particularly when the tumour is located close to the surface of the body, the RF energy can also heat the skin. Cooling of the skin can then be required to prevent the skin from being damaged by the high temperatures. Any damage to the skin increases the risk of infection, which reduces the chances of the treatment being successful. The output of the skin temperature sensor can be provided to the control device 110, which can automatically control the cooling of the skin.
[0095] The control device 110 preferably comprises a display on which information is displayed showing the various parameters monitored and adjusted by the control device 110, e.g. in the form of curves in different colours. An operator can monitor these curves and adjust the treatment based on these curves. For example, if the patient's skin starts to feel uncomfortably hot, the operator can reduce the power provided by the RF generating device 150, or if the patient seems to be able to tolerate it, the power can be increased. Alternatively, the control device 110 can be fully automatic and control the various parameters based on pre-programmed parameters. The control device 110 can e.g. be a computer.
[0096] To ensure the system complies with IEC 60-601-1 and other relevant standards, it is necessary to ensure that the patient leakage current (PLC) does not exceed the specified value (e.g., 10 μA) under any circumstances. One way to ensure this is done is by installing an isolation transformer between the RF generator 150 and the RF probe 120. The use of the isolation transformer ensures that there is no conductive path between the RF generator 150 and the RF probe 120.
[0097] Method embodiments
[0098] Figure 6 The diagram schematically illustrates a system 100 for curative RFA treatment of a treatment area, including at least a portion of a cancerous tumor, by applying RF energy between an electrode disposed on a non-insulated ablation portion 124 of an RF probe and another electrode (e.g., a neutral electrode 160), used to determine the time point t at which blood vessels within the treatment area 300 have coagulated. P3 The method. Method 600 may include:
[0099] Step 640: Measure the temperature of the RF probe using the temperature measuring device 130, and estimate the temperature T of the treatment area based on this.
[0100] Step 650: Cool the RF probe 120 using the cooling device 140.
[0101] Step 660: Based on the estimated treatment area temperature T, use the RF generator 150 to supply the RF probe 120 with the temperature T required to maintain the treatment area. D The amount of RF energy required.
[0102] Step 690: Monitor the RF energy supplied by the RF generator 150 to the RF probe 120.
[0103] Step 695: Determine the time point t when the output power of the RF generator 150 no longer decreases significantly. P3 So that by passing through at that time point t P3 The RFA treatment was then terminated by turning off the RF generator 150.
[0104] This is a precise method to determine if a tumor has degenerated, thus enabling curative treatment.
[0105] At time t P3 For example, this can be determined by determining when the derivative of the output power of the RF generator 150 is within a predetermined threshold close to zero. Because in the early stages of the treatment process, at time point t... P1The derivative of the output power of the RF generating device 150 will also be zero at the curve highs of the output RF power curve, so any automated system for determining when the output power of the RF generating device 150 is no longer significantly reduced based on the derivative of the output RF power curve needs to distinguish between these points. This can be done, for example, based on a certain treatment time having elapsed or based on the derivative first being negative.
[0106] The estimation of the treatment zone temperature T can be done in the temperature measuring device 130 or in the control device 110 based on the measurements provided by the temperature measuring device 30.
[0107] In embodiments, the method 600 further comprises at least one of the following steps:
[0108] Step 610: Setting the temperature measuring device 130 to comprise a thermocouple comprising a conductor 135 arranged inside the RF probe 120 and connected to the non-insulated ablation portion 124 of the RF probe 120. This is a simple temperature measuring device.
[0109] Step 615: Arranging a cooling liquid supply channel 142 inside the RF probe 120 to supply cooling liquid to the non-insulated ablation portion 124 of the RF probe 120. This is a simple method of controlling the cooling of the RF probe.
[0110] Step 620: Arranging the impact device 310 to push the RF probe 120 into the tumor with a distinct impact. The impact device 310 can be arranged to comprise an impact apparatus 340 arranged inside the impact housing 320 to fire towards an impact spike 350 extending from the connecting end portion 122 of the RF probe 120, such that an impact between the impact apparatus 340 and the impact spike 350 pushes the RF probe 120 forward a distance defined by the length of the impact spike 350 extending into the impact housing 320 with a very high acceleration. The impact device 310 can also be arranged to comprise a spring apparatus 360, the impact spike 350 interacting with the spring apparatus 360, wherein the spring apparatus 360 pushes the RF probe 120 away from the impact device 310, such that the length of the impact spike 350 extending into the impact housing 320 depends on the force applied to the RF probe 120 to counteract the spring force in the spring apparatus 360. This is a simple and effective method of arranging an impact device.
[0111] Step 625: For the RF probe 120 arranged to be comprised in a probe device 400 further comprising an insertion tube 410 and a biopsy needle 430, arranging the insertion tube 410 to be inserted into the tumor together with the biopsy needle 430.
[0112] Step 630: For the RF probe 120 arranged to be included in the probe device 400 also including the insertion tube 410 and the biopsy needle 430, allow the insertion tube 410 to remain inserted in the tumor when the biopsy needle 430 is withdrawn.
[0113] Step 635: For the RF probe 120 arranged to be included in the probe device 400 also including the insertion tube 410 and the biopsy needle 430, allow the RF probe 120 to be inserted into the cavity in the tumor created by the biopsy needle 430.
[0114] This enables tissue samples to be taken at the exact location of the curative RFA treatment.
[0115] Step 670: Turn off the RF generation device 150 and the cooling device 140 for a selected off-period, so that the treatment zone temperature T is equalized, in order to allow a more accurate estimation of the treatment zone temperature T by the temperature measurement device 130. This enables a precise control of the treatment temperature.
[0116] Step 675: Estimate the treatment zone temperature T based on the shape of the measured RF probe temperature curve, e.g. based on determining the derivative of the measured RF probe temperature curve until the end of the off-period. This means that there is no need to wait for the RF probe temperature to be completely stable, and thus the off-period can be greatly reduced.
[0117] Step 680: Circulate cooling liquid to cool the RF probe 120.
[0118] Step 685: Turn off the cooling device 140 by stopping the circulation of cooling liquid. This is a simple way of controlling the cooling of the RF probe 120.
[0119] Use cases
[0120] One typical use case is a patient diagnosed with breast cancer but not yet spread outside the local primary tumor in the breast. To cure the tumor using RFA, it is first necessary to determine the exact size, shape and location of the tumor, typically using some medical imaging technique, e.g. CT, MRI and / or ultrasound. To treat the tumor using RFA, it is then necessary to define a spherical treatment zone 300, e.g. with a certain rotational diameter and a certain length. The treatment zone 300 is preferably covering the entire tumor, and has a certain margin.
[0121] The RF probe 120 with a diameter that gives the treatment zone 300 the desired rotational diameter then needs to be selected from a set of preferred disposable sterile RF probes 120 with different diameters. The length of the uninsulated ablation portion 124 of the selected RF probe 120 then needs to be adjusted to give the treatment zone 300 the desired length. If the length of the uninsulated ablation portion 124 of the RF probe 120 is not adjustable, the set of RF probes 120 needs to include RF probes 120 with different diameter and ablation length combinations.
[0122] If the shape of the tumor cannot easily be contained in a spherical treatment zone 300, multiple different RF probes 120 can be used simultaneously, resulting in a treatment zone 300 of any desired shape.
[0123] The RF probe 120 is preferably inserted into the tumor using some kind of impact device 310 to ensure that the RF probe 120 is pushed into the tumor with a high acceleration with a distinct impact. If the impact amplitude of the impact device 310 is proportional to the manual force applied to the RF probe 120 by the physician, this gives the physician haptic feedback during the process of inserting the RF probe 120 into the tumor. This increases the haptics of the insertion. If the RF probe 120 and the impact device 310 are held together by a drill device 370 that keeps them aligned, the physician can hold the entire drill device 370. However, in other embodiments, the RF probe 120 can be held by the physician while the impact device 310 can be held by an assistant. However, in this case it is important that the insertion is still controlled by the physician holding the RF probe 120.
[0124] In embodiments where the RF probe 120 is included in a probe device 400 that also includes an insertion tube 410 and a biopsy needle 430, the treatment process can start with the collection of a tissue sample. In this case, the biopsy needle 430 is first arranged in the insertion tube 410, and the probe device 400 is pushed into the tumor with a high acceleration with a distinct impact, as described above. When the biopsy needle 430 is withdrawn, the insertion tube 410 remains inserted to allow the RF probe 120 to be inserted into the cavity in the tumor created by the biopsy needle 430.
[0125] When the RF probe 120 has been inserted into the predetermined treatment position, the RFA treatment is started by turning on the RF generation device 150. The estimated temperature inside the treatment zone 300 is then monitored throughout the treatment, and the output power of the RF generation device 150 is constantly adjusted so that the temperature inside the treatment zone 300 is kept within the desired temperature range (60-90°C). When the output power of the RF generation device 150 is stable, this indicates that the treatment is complete.
[0126] Thus, a typical use case including harvesting of a tissue sample can be described as method 700 for curative treatment of a treatment zone 300 including at least a portion of a cancer tumor by applying RF energy between an electrode disposed on the RF probe 120 and another electrode (e.g., the neutral electrode 160). Figure 7 The method 700 is schematically illustrated and includes the following steps:
[0127] Step 710: Determine tumor location and size (after first diagnosis of a tumor suitable for RFA).
[0128] Step 720: Select a suitable probe device 400.
[0129] Step 730: Insert the probe device 400 into the tumor, with the biopsy needle 430 inserted into the insertion tube 410.
[0130] Step 740: Harvest a tissue sample, then retrieve the biopsy needle 430 from the insertion tube 410.
[0131] Step 750: Insert the RF probe 120 into the insertion tube 410 and begin RFA treatment.
[0132] Step 760: End RFA treatment when the output power of the RF generating device 150 has stabilized.
[0133] Step 770: Retrieve the probe device 400 from the patient.
[0134] The use of local anesthesia is typically required prior to insertion of the RF probe 120 into the tumor. However, it is important to ensure that the release of such local anesthesia does not result in tumor seeding.
[0135] The above disclosure is not intended to limit the application to the exact form or particular use disclosed. It is considered that various alternative embodiments and / or modifications of the application are possible in light of the disclosure, whether explicitly described or implied herein. The disclosure relates to many different curves. It will be appreciated that the actually measured curves are not as smooth as the illustrative curves described, and thus, for example, determination of the derivative of a curve typically involves first smoothing the curve, for example by filtering it to remove high frequency fluctuations. In the disclosure, many different concepts are described. Each of these concepts can be used alone, or in any combination with any other concept. Thus, each inventive concept can be claimed as a separate invention. Although the disclosure describes concepts related to monopolar RFA treatment, the concepts can also be used for bipolar RFA treatment. If the RFA treatment is monopolar RFA treatment, the other electrode is preferably a neutral electrode. If the RFA treatment is monopolar RFA treatment, the other electrode can be provided on a separate RF probe, or on a non-insulated ablation portion of the same RF probe. The RFA treatment can also be a combination of monopolar RFA treatment and bipolar RFA treatment. The RFA treatment can treat both human tumors and animal tumors. Furthermore, not all steps of the claims have to be performed in the order listed. The claims encompass all technically meaningful sequences of steps. Thus, the scope of the application is only limited by the claims.
Claims
1. An impact device (310) for inserting a radiofrequency (RF) probe (120) into a tumor for radiofrequency ablation (RFA) treatment, wherein, The impact device (310) is configured to push the RF probe (120) into the tumor with a significant impact, such that there is an interval between each impact of the impact device (340), which is disposed within an impact housing (320) to be fired toward an impact pin (350) extending from the connecting end (122) of the RF probe (120), such that the impact between the impact device (340) and the impact pin (350) propels the RF probe (120) forward with very high acceleration.
2. The impact device (310) according to claim 1, wherein, The device is further configured such that the impact between the impact device (340) and the impact pin (350) propels the RF probe (120) forward a distance defined by the length of the impact pin (350) extending into the impact housing (320).
3. The impact device (310) according to claim 1 or 2, wherein, The impact device (310) includes a spring device (360) with which the impact pin (350) interacts, wherein the spring device (360) pushes the RF probe (120) away from the impact device (310) such that the length of the impact pin (350) extending into the impact housing (320) depends on the force applied to the RF probe (120) to counteract the spring force in the spring device (360).
4. The impact device (310) according to claim 1, wherein, The compressed air source (330) is configured to release a compressed air pulse that propels the impact device (340) toward the impact nail (350).
5. The impact device (310) according to claim 4, wherein, The air filling the impact device (310) will serve as an air cushion for the impact device (340), so that the impact device (340) will not strike the end of the impact device (310) too violently.
6. The impact device (310) according to claim 4 or 5, wherein, The impact housing (320) is configured to allow air to escape from the impact housing (320) after each compressed air pulse.
7. The impact device (310) according to claim 6, wherein, Devices, such as, for example, air valves for compressed air, are configured to ensure that the impact device (340) returns to its starting position after each impact.
8. The impact device (310) according to claim 4, wherein, The compressed air source (330) is configured to release a new compressed air pulse after a predetermined time.
9. The impact device (310) according to claim 8, wherein, The frequency of the compressed air pulses released by the compressed air source (330) is suitable for the force applied to the RF probe (120) to push it into the tumor.
10. The impact device (310) according to claim 9, wherein, The force applied to the RF probe (120) to push it into the tumor is measured using a suitable sensor, such as a sensor that senses the compression of the spring device (360).
11. The impact device (310) according to claim 4, wherein, Includes a device configured to ensure that the impact device (340) remains in the initial position when not being fired toward the impact nail (350).
12. The impact device (310) according to claim 1, wherein, It also includes means for ensuring that the impact amplitude of the impact device (310) is proportional to the force applied to the RF probe (120).
13. The impact device (310) according to claim 3, wherein, When the RF probe (120) is pushed into the tissues of the patient, the spring device (360) is compressed to a degree proportional to the applied force.
14. The impact device (310) according to claim 1, wherein, It also includes a drilling rig (370) configured such that the impact housing (320) and the distribution unit (146) are aligned and held together, wherein all connection points to external systems are provided in the distribution unit (146), which is contained in the RF probe (120).
15. The impact device (310) according to claim 1, wherein, It is also configured to push the biopsy needle (430) and / or RF probe (120) of the probe device (400), the probe device (400) including the RF probe (120), an insertion tube (410) and the biopsy needle (430), and the insertion tube (410) is configured to be inserted into the tumor together with the biopsy needle (430), the insertion tube remaining inserted into the tumor when the biopsy needle (430) is retrieved, and allowing the RF probe (120) to be inserted into the cavity created by the biopsy needle (430) in the tumor.
16. The impact device (310) according to the preceding claim, wherein, The impact device (310) is configured to push the biopsy needle (430) and / or the RF probe (120) into the tumor with a significant impact.
17. A system (100) for curative radiofrequency ablation (RFA) of a treatment area (300) comprising at least a portion of a cancerous tumor by applying radiofrequency (RF) energy between an electrode disposed on a non-insulated ablation portion (124) of an RF probe (120) and another electrode (160), the system (100) further comprising an impact device (310) configured to push the RF probe (120) into the tumor with a pronounced impact, such that there is an interval between each impact by an impact device (340), the impact device (340) being disposed within an impact housing (320) to fire toward an impact pin (350) extending from a connecting end (122) of the RF probe (120), such that the impact between the impact device (340) and the impact pin (350) propels the RF probe (120) forward with very high acceleration.
18. The system (100) according to claim 17, wherein, The device is further configured such that the impact between the impact device (340) and the impact pin (350) propels the RF probe (120) forward a distance defined by the length of the impact pin (350) extending into the impact housing (320).
19. The system (100) according to claim 17 or 18, wherein, The impact device (310) includes a spring device (360) with which the impact pin (350) interacts, wherein the spring device (360) pushes the RF probe (120) away from the impact device (310) such that the length of the impact pin (350) extending into the impact housing (320) depends on the force applied to the RF probe (120) to counteract the spring force in the spring device (360).
20. The system (100) according to any one of claims 17 to 19, wherein, Also includes: Control device (110); A temperature measuring device (130) is configured to measure the temperature of the RF probe and, based thereon, provide an estimate of the temperature (T) of the treatment area to the control device (110); A cooling device (140), configured to be controlled by the control device (110) to cool the RF probe (120); and An RF generator (150), controlled by the control device (110), provides the RF probe (120) with the amount of RF energy required to maintain the desired treatment area temperature (TD) based on the estimated treatment area temperature (T).
21. The system (100) according to claim 20, wherein, The temperature measuring device (130) includes a temperature sensor (132) which is disposed at the non-insulated ablation portion (124) of the RF probe (120).
22. The system (100) according to any one of claims 20 or 21, wherein, The cooling device (140) includes a coolant supply channel (142) disposed inside the RF probe (124) to supply coolant to the non-insulating ablation portion (124) of the RF probe (120).
23. The system (100) according to any one of the preceding claims, wherein, The RF probe (120) is included in a probe device (400), which also includes an insertion tube (410) and a biopsy needle (430). The insertion tube (410) is configured to be inserted into the tumor together with the biopsy needle (430), the insertion tube remaining inserted into the tumor when the biopsy needle (430) is retrieved, and allowing the RF probe (120) to be inserted into the cavity created by the biopsy needle (430) in the tumor.
24. The system (100) according to the preceding claim, wherein, The impact device (310) is configured to push the biopsy needle (430) and / or the RF probe (120) into the tumor with a significant impact.
Citation Information
Patent Citations
Arrangement for therapy ot tumours
EP1639956A1
