Bone tumor in-situ thermal inactivation device and thermal inactivation method

Abstract

The invention relates to the field of tumor treatment equipment, and discloses a bone tumor in-situ thermal inactivation device and a thermal inactivation method, the bone tumor in-situ thermal inactivation device comprises a wrapping module, a heating module and a monitoring module; the wrapping module comprises a cylinder, sealing devices are arranged on the two sides of the cylinder, and a sealing cavity used for containing the diseased bone is formed in the cylinder. The heating module comprises a driving assembly and a heating assembly, the driving assembly is connected with the heating assembly and the barrel, the heating assembly is used for heating and storing a heating medium, and the driving assembly is used for driving the heating medium to flow between the barrel and the heating assembly; the monitoring module is used for monitoring the external surface temperature of bone cortex of a diseased bone, the central temperature of a diseased marrow cavity and the surface temperature of a vascular nerve tract of the diseased bone; according to the tumor inactivation device, the affected bone is contained in the cylinder body in a sealed mode, then hot normal saline is introduced into the cylinder body to achieve tumor inactivation, the peristaltic pump and the heating assembly are matched with the temperature sensor to control the temperature, the inactivation efficiency and effect are improved, the treatment difficulty is reduced, and the adverse effect in the inactivation process is reduced.

Description

Technical Field

[0001] This invention relates to the field of tumor treatment equipment, and in particular to an in situ thermal inactivation device and method for bone tumors. Background Technology

[0002] Traditional bone tumor inactivation treatment typically employs extracorporeal high-temperature treatment technology, which involves cutting the affected bone and placing the cut bone in a 65°C water bath to inactivate tumor cells. After inactivation, the cut bone is then re-implanted into the patient and fixed.

[0003] However, the above-mentioned treatment plan involves cutting off the affected bone, which disrupts the continuity of the bone cortex and its mechanical support structure, leading to an increased risk of postoperative fracture. Furthermore, the process of cutting off the affected bone requires stripping the neurovascular bundles on the affected bone, which is not only complex and time-consuming, but also easily causes symptoms such as sensory disturbances in the lower limbs. In addition, the in vitro inactivation of the affected bone is time-consuming and inefficient, and it is impossible to effectively monitor the temperature in the core of the medullary cavity, which can easily lead to residual tumor cells and damage the blood supply to the replanted bone, thus greatly prolonging the postoperative bone healing time. Summary of the Invention

[0004] The technical problem to be solved by the present invention is: how to improve the efficiency and quality of bone tumor inactivation. In order to solve the above technical problem, the present invention provides an in situ thermal inactivation device for bone tumors, including a wrapping module, a heating module and a monitoring module; the wrapping module includes a cylinder, and sealing devices are provided at both ends of the cylinder. A closed accommodating cavity is provided inside the cylinder, which is used to accommodate the affected bone and the heating medium used for inactivation treatment. The heating module includes a driving component and a heating component. The driving component is connected to the heating component and the cylinder respectively. The heating component is used to heat and store the heating medium. The driving component is used to drive the heating medium to flow between the cylinder and the heating component. The monitoring module includes a first temperature sensor, a second temperature sensor, and a third temperature sensor; the first temperature sensor is used to monitor the temperature of the outer surface of the cortical bone of the affected bone, the second temperature sensor is used to monitor the temperature of the center of the medullary cavity of the affected bone, and the third temperature sensor is used to monitor the temperature of the surface of the vascular bundle of the affected bone.

[0005] Preferably, the cylindrical body includes a first shell and a second shell, both of which are semi-circular structures. The first side of the first shell is hinged to the second shell, and the second side of the first shell is detachably and sealed to the second shell. The first shell and the second shell are fastened together to form the accommodating cavity.

[0006] Preferably, the packaging module further includes a locking device, which includes a first half-ring and a second half-ring, the first half-ring and the second half-ring being respectively sleeved on the outside of the first housing and the second housing; one end of the first half-ring is hinged to the second half-ring, and the other end of the first half-ring is bolted to the second half-ring.

[0007] Preferably, the sealing device includes a sealing layer, which is sleeved on the end of the cylinder. The first end of the sealing layer is fixedly disposed on the inner side of the cylinder, and the second end of the sealing layer is fixedly connected to a slider. The slider is fixedly connected to the first semi-ring, and the outer wall of the first housing is provided with a spiral guide groove corresponding to the slider.

[0008] Preferably, the heating assembly includes a storage chamber, and at least one ceramic thin-film heater is disposed inside the storage chamber; the storage chamber contains the heating medium, which includes physiological saline. The drive assembly includes an infusion pump and a suction pump; the two ends of the infusion pump are respectively connected to the inlet of the storage chamber and the liquid outlet of the cylinder; the two ends of the suction pump are respectively connected to the outlet of the storage chamber and the liquid outlet of the cylinder.

[0009] Preferably, the first temperature sensor includes a ring thermocouple array, and the first temperature sensor is sleeved on the outer surface of the affected bone; The second temperature sensor includes a flexible optical fiber probe and is disposed at the tumor site inside the affected bone; the third temperature sensor includes a micro-thin film sensor and is attached to the vascular nerve bundles at both ends of the affected bone.

[0010] The present invention also provides a method for in situ thermal inactivation of bone tumors, using the bone tumor in situ thermal inactivation device described above, comprising the following steps: S1. Peel away the soft tissue in the tumor area of ​​the affected bone to expose the surface of the affected bone; implant a second temperature sensor in the medullary cavity of the affected bone, install a first temperature sensor on the surface of the affected bone, attach a third temperature sensor at the neurovascular bundle of the affected bone; and unfold the cylinder so that the affected bone is sealed and wrapped inside the cylinder. S2. The driving component drives the initial temperature heating medium to flow between the heating component and the cylinder. The heating component continues to heat the heating medium until the temperature inside the medullary cavity reaches the first preset target value. S3. When the temperature inside the medullary cavity reaches the first preset target value, the second temperature sensor continuously monitors the temperature of the affected medullary cavity to provide feedback control of the working power of the heating component and the drive component, and continues for a preset time. S4. After inactivation, control the power of the heating component to reduce the temperature of the heating medium to the second preset target value and maintain it for the second preset time, then stop heating to complete the treatment.

[0011] Preferably, in S2, the second temperature sensor continuously monitors the temperature inside the bone marrow cavity. If the temperature inside the bone marrow cavity is lower than a third preset target value, the operating power of the heating component is increased to the first power. If the temperature inside the bone marrow cavity is higher than the third preset target value but lower than the first preset target value, the operating power of the heating component is reduced to the second power.

[0012] Preferably, in S3, after the temperature inside the medullary cavity reaches the first preset target value, the working power of the heating component and the driving component is controlled to be increased until the heating medium reaches the fourth preset target value. Then, the working power of the heating component and the driving component is controlled to be decreased until the heating medium stabilizes at the fifth preset target value, thereby stably maintaining the working power of the heating component and the driving component.

[0013] Preferably, when the temperature value monitored by the third temperature sensor is not less than the preset danger temperature value, the operating power of the drive component is reduced and an alarm is issued; When the temperature value monitored by the third temperature sensor is not less than the preset danger temperature value and exceeds the preset danger time, the heating component is stopped and low-temperature coolant is injected into the cylinder.

[0014] Compared with the prior art, the in-situ thermal inactivation device and method for bone tumors provided in this embodiment of the invention have the following advantages: In this invention, the tumor-bearing bone is encased in a cylindrical body with a closed accommodating cavity without cutting the bone, reducing the difficulty of treatment and improving the efficiency of bone tumor treatment. The multiple sensors in the monitoring module can more comprehensively detect the temperature status inside and on the surface of the bone, thereby providing guidance for adjusting the working power of the heating and driving components. This allows doctors to more accurately grasp the temperature status of various parts of the bone during the entire treatment process, achieving precise treatment of bone tumors. This not only improves the efficiency and quality of tumor treatment but also avoids the problem of residual tumor cells due to incomplete tumor treatment. Furthermore, it reduces the damage to normal areas of the bone caused by the heating medium during tumor treatment, thereby reducing postoperative risks and recovery time for patients. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the internal structure of the present invention; Figure 3 This is a flowchart illustrating the present invention.

[0016] In the diagram: 1. Cylinder; 11. Receiving cavity; 12. First shell; 13. Second shell; 14. First half-ring; 15. Second half-ring; 16. Bolt; 2. Sealing device; 21. Sealing adhesive layer; 22. Slider; 23. Spiral guide groove; 3. Drive components; 31. Infusion pump; 32. Suction pump; 4. Heating components; 41. Storage compartment; 42. Ceramic thin-film heater; 5. First temperature sensor; 6. Second temperature sensor; 7. Third temperature sensor; 8. Bone injury. Detailed Implementation

[0017] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0018] like Figure 1 and Figure 2 As shown, a preferred embodiment of the present invention provides an in situ thermal inactivation device for bone tumors, which includes a wrapping module, a heating module and a monitoring module; The encapsulation module includes a cylindrical body 1, with sealing devices 2 at both ends of the cylindrical body 1, and a closed accommodating cavity 11 inside the cylindrical body 1. The accommodating cavity 11 is used to accommodate the affected bone 8 and the heating medium used for inactivation treatment. The heating module includes a driving component 3 and a heating component 4. The driving component 3 is connected to the heating component 4 and the cylinder 1 respectively. The heating component 4 is used to heat and store the heating medium. The driving component 3 is used to drive the heating medium to flow between the cylinder 1 and the heating component 4. The monitoring module includes a first temperature sensor 5, a second temperature sensor 6 and a third temperature sensor 7. The first temperature sensor 5 is used to monitor the temperature of the outer surface of the cortical bone of the affected bone 8. The second temperature sensor 6 is used to monitor the temperature of the center of the medullary cavity of the affected bone 8. The third temperature sensor 7 is used to monitor the temperature of the surface of the vascular bundle of the affected bone 8.

[0019] Specifically, in this embodiment, the affected bone 8 with a tumor does not need to be severed from the patient's body, but is treated directly in situ. During the actual treatment process, the surface tissue of the tumor-affected area of ​​the affected bone 8 needs to be removed first to expose the area requiring treatment. Then, the cylinder 1 is fitted over the outside of the affected bone 8, and both ends of the cylinder 1 are sealed using the sealing device 2, thus forming a closed cavity 11. The driving component 3 then delivers the heating medium located within the heating component 4 to the closed cavity 11, and drives the heating medium to circulate between the heating component 4 and the cylinder 1, thereby achieving treatment of the affected bone 8. By gradually heating up the temperature to ultimately inactivate the tumor on the affected bone 8, this invention achieves in-situ inactivation of the affected bone 8 through the closed accommodating cavity 11 on the cylinder 1 in conjunction with the heating component 4 and the driving component 3. This eliminates the need to cut the affected bone 8 for separate inactivation, thereby greatly reducing the difficulty of inactivating the affected bone 8 and improving the efficiency of inactivation. At the same time, since it is not necessary to cut the affected bone 8, it reduces the patient's postoperative pain and the risk of postoperative complications such as fractures of the affected bone 8. It also reduces the difficulty of postoperative recovery for the patient, enabling the patient's affected bone 8 to recover faster and better after surgery.

[0020] Furthermore, the monitoring module in this embodiment also includes a first temperature sensor 5, a second temperature sensor 6, and a third temperature sensor 7. The second temperature sensor 6 monitors the temperature within the medullary cavity of the affected bone 8, facilitating the adjustment of the heating component 4's operating power to control the tumor inactivation temperature. This achieves precise tumor inactivation, avoiding incomplete inactivation that could lead to tumor cell residue and recurrence, thus improving the quality of tumor treatment. The first temperature sensor 5 monitors the surface temperature of the affected bone 8. Multiple first temperature sensors 5 can be installed on the affected bone 8, allowing control of the driving component 3's operating efficiency to prevent uneven temperature distribution near the tumor, further improving the inactivation effect. Simultaneously, it monitors temperature changes, preventing excessively rapid heating that could damage other healthy areas of the affected bone 8. The third temperature sensor 7 monitors the temperature of healthy areas and critical nerve bundles, preventing excessively high temperatures in these critical areas from damaging healthy and critical regions, ensuring the targeted and reliable nature of tumor treatment, and avoiding harm to the patient. In one preferred embodiment, the heating medium is preferably physiological saline.

[0021] In some embodiments, the cylinder 1 includes a first housing 12 and a second housing 13. Both the first housing 12 and the second housing 13 are semi-circular structures. The first side of the first housing 12 is hinged to the second housing 13, and the second side of the first housing 12 is detachably and sealed to the second housing 13. The first housing 12 and the second housing 13 are fastened together to form an accommodating cavity 11.

[0022] Specifically, in actual use, the second side of the first housing 12 is disconnected from the second housing 13, forming an opening between them. The affected bone 8 is then placed between the first housing 12 and the second housing 13 through this opening, and the first housing 12 and the second housing 13 are then fastened together, thus completely containing the area of ​​the affected bone 8 to be treated with heat within the receiving cavity 11. Finally, both ends of the cylinder 1 are sealed, thus sealing the receiving cavity 11. It is understood that sealing elements are provided on the second side of the first housing 12 and between the first side and the second housing 13 to prevent leakage of the heating medium. These sealing elements can be sealing strips with sealing grooves, or other structures capable of achieving a stable seal.

[0023] In other embodiments, multiple cylinders 1 can be provided, and multiple cylinders 1 can be sealed and spliced ​​along the axial direction to extend the cylinder 1 to adapt to different bones and meet different usage needs.

[0024] In some embodiments, the packaging module further includes a locking device, which includes a first half-ring 14 and a second half-ring 15. The first half-ring 14 and the second half-ring 15 are respectively sleeved on the outside of the first housing 12 and the second housing 13. One end of the first half-ring 14 is hinged to the second half-ring 15, and the other end of the first half-ring 14 is bolted to the second half-ring 15.

[0025] Specifically, after the first housing 12 and the second housing 13 are fastened together, the first half ring 14 and the second half ring 15 need to be fastened together and locked with bolts 16. The first half ring 14 and the second half ring 15 apply pressure to the first housing 12 and the second housing 13, so that the connection between the first housing 12 and the second housing 13 is tighter and more reliable, and the sealing is better. The connection between the first housing 12 and the second housing 13 is not easy to loosen due to external factors, thus ensuring that the entire treatment process is more stable, safe and reliable.

[0026] Of course, in some other embodiments, multiple locking devices may be provided along the axis of the cylinder 1 to ensure the comprehensiveness and reliability of the sealing connection of the cylinder 1 and to avoid problems such as unstable connection and unreliable sealing in local areas of the cylinder 1. In other embodiments, the locking device may also be a snap-fit ​​structure on the side of the first housing 12, which can also achieve a sealing connection between the first housing 12 and the second housing 13.

[0027] In some embodiments, the sealing device 2 includes a sealing layer 21, which is sleeved on the end of the cylinder 1. The first end of the sealing layer 21 is fixedly disposed on the inner side of the cylinder 1, and the second end of the sealing layer 21 is fixedly connected to a slider 22. The slider 22 is fixedly connected to the first half-ring 14, and the outer wall of the first housing 12 is provided with a spiral guide groove 23 corresponding to the slider 22.

[0028] Specifically, when sealing the end of the cylinder 1, the first half-ring 14 is rotated around the central axis of the cylinder 1, causing the first half-ring 14 to rotate relative to the first housing 12. This drives the slider 22 to move along the spiral guide groove 23, thereby moving the second end of the sealing layer 21. This causes the second end of the sealing layer 21 to twist relative to its first end, resulting in the middle of the sealing layer 21 twisting and tightly adhering to the affected bone 8. This achieves the sealing of the internal accommodating cavity 11 of the cylinder 1 without affecting the position of the affected bone 8. Furthermore, it should be noted that in a preferred embodiment, the structure of the first half-ring 14 and the second half-ring 15 located at the end of the cylinder 1 can be modified and widened to accommodate the slider 22, while also serving a locking and sealing function.

[0029] In some embodiments, the heating component 4 includes a storage chamber 41, and at least one ceramic thin film heater 42 is disposed inside the storage chamber 41; the storage chamber 41 contains a heating medium, which includes physiological saline. The drive assembly 3 includes an infusion pump 31 and a suction pump 32; the two ends of the infusion pump 31 are respectively connected to the inlet of the storage chamber 41 and the cylinder 1; the two ends of the suction pump 32 are respectively connected to the outlet of the storage chamber 41 and the cylinder 1.

[0030] Specifically, in this embodiment, the combined use of the infusion pump 31 and the suction pump 32 can more precisely control the flow rate and volume of the heating medium in the cavity 11 of the cylinder 1. By adjusting the flow rate of the heating medium, the temperature of the affected bone 8 and the temperature uniformity of different areas of the affected bone 8 can be adjusted, avoiding the temperature of the affected bone 8 from rising too quickly or too high, and avoiding temperature differences in some areas of the affected bone 8. While ensuring the effect of tumor treatment, it also reduces the impact of the treatment process on other healthy areas of the affected bone 8. In general, when the power of the infusion pump 31 is increased, while the power of the suction pump 32 is reduced or remains unchanged, more heating medium will inevitably be drawn into the cylinder 1 and accumulate on the inlet side of the cylinder 1, thereby causing the temperature on that side of the affected bone 8 to rise, so as to reduce the temperature difference between the two sides of the affected bone 8 and ensure the temperature consistency and uniformity of the affected bone 8. Of course, when the temperature on the other side of the affected bone 8 is lower, the temperature on the other side of the affected bone 8 can be increased by increasing the power of the suction pump 32 or decreasing the power of the infusion pump 31, thereby ensuring the temperature consistency and uniformity of the two sides of the affected bone 8.

[0031] In some embodiments, the first temperature sensor 5 includes a ring thermocouple array, and the first temperature sensor 5 is sleeved on the outer surface of the affected bone 8. The second temperature sensor 6 includes a flexible optical fiber probe and is disposed at the tumor site inside the affected bone 8. The third temperature sensor 7 includes a miniature thin-film sensor, which is attached to the vascular nerve bundles at both ends of the affected bone 8.

[0032] Specifically, multiple first temperature sensors 5 can be arranged along the axis of the affected bone 8, respectively fitted onto different areas of the affected bone 8, to monitor the temperature status of different areas of the affected bone 8. This provides guidance for subsequent adjustment of the working power of the aspiration pump 32 and the infusion pump 31, thereby improving the consistency and uniformity of temperature in different areas of the affected bone 8 during treatment. The annular thermocouple array used can more comprehensively monitor the surface temperature of different areas of the affected bone 8. The second temperature sensor 6 is inserted deep into the interior of the affected bone 8 and placed close to the tumor, thereby monitoring the temperature at the tumor site. This facilitates the adjustment of the working efficiency of the aspiration pump 32, the infusion pump 31, and the heating component 4, thereby achieving precise temperature control and ultimately achieving complete inactivation of the tumor, avoiding residual tumor cells and subsequent tumor metastasis and recurrence. The fiber optic probe used is more accurate and easier to place inside the medullary cavity of the affected bone 8. The third temperature sensor 7 can monitor the temperature of the vascular bundle of the affected bone 8, preventing irreversible damage caused by excessively high temperatures at the vascular bundle and reducing the adverse effects of the treatment process on the healthy areas of the affected bone 8. Multiple third temperature sensors 7 can be set, and they are not limited to the vascular bundle; they can also be set in other important healthy areas of the affected bone 8, thereby further avoiding adverse effects of treatment on healthy areas. The micro-film sensor used is more convenient to install, and its installation and use process has less impact on the healthy areas of the affected bone 8.

[0033] like Figure 3 As shown, the present invention also provides a method for in-situ thermal inactivation of bone tumors, using the bone tumor in-situ thermal inactivation device described above, comprising the following steps: S1. Peel away the soft tissue in the tumor area of ​​the affected bone 8 to expose the surface of the affected bone 8; implant a second temperature sensor 6 in the medullary cavity of the affected bone 8, install a first temperature sensor 5 on the surface of the affected bone 8, attach a third temperature sensor 7 to the vascular nerve bundle of the affected bone 8; and unfold the cylinder 1 so that the affected bone 8 is sealed and wrapped inside the cylinder 1. Before treatment, the doctor first needs to dissect the soft tissue surrounding the affected bone 8 to expose the area to be treated. Then, the tumor boundary is determined, and a 2cm safety zone is marked at the upper and lower edges of the tumor. A hole is drilled 5mm outside the tumor boundary to implant a second temperature sensor 6 into the medullary cavity of the affected bone 8. Simultaneously, a first temperature sensor 5 and a third temperature sensor 7 are installed in preset positions to continuously monitor the temperature in different areas of the affected bone 8, facilitating the subsequent placement of the tube 1 over the treatment area of ​​the affected bone 8. Once all equipment is installed, the system automatically detects the signals from each sensor and displays a three-dimensional temperature distribution map of different areas of the affected bone 8 on the screen. Simultaneously, the algorithm calculates the initial thermal field uniformity. If the temperature difference between different locations near the tumor is greater than 2℃, it indicates uneven heating and potential incomplete inactivation. In this case, an alarm is triggered, and the positions of the probes and other equipment are adjusted to improve thermal field uniformity and ensure more comprehensive and thorough inactivation.

[0034] S2. The driving component 3 drives the heating medium at the initial temperature to flow between the heating component 4 and the cylinder 1. The heating component 4 continuously heats the heating medium until the temperature inside the medullary cavity reaches the first preset target value. In one preferred embodiment, the initial temperature of the saline solution is 45°C. The peristaltic pump injects continuously heated saline solution into the cylinder 1 at a flow rate of 2 ml / s to increase the temperature inside the cylinder 1. The initial heating power of the heating component 4 is 100 watts, thereby ensuring the stability and reliability of the heating process and avoiding drastic temperature fluctuations inside the cylinder 1, which could affect the inactivation effect and subsequent recovery effect. During this stage, it is necessary to control the temperature difference on the surface of the affected bone 8 to be less than 2°C. If the fluctuations and temperature differences are too large, an alarm needs to be issued in time, and the operating power of the two peristaltic pumps and the heating component 4 needs to be adjusted.

[0035] S3. When the temperature inside the medullary cavity reaches the first preset target value, the second temperature sensor 6 continuously monitors the temperature inside the medullary cavity of the affected bone 8 to provide feedback control of the working power of the heating component 4 and the driving component 3, and continues for a preset time. The first preset target value is the optimal temperature for inactivating the tumor. This temperature varies depending on factors such as the actual location and condition of the tumor. When the tumor is at this temperature for a preset time, it can be inactivated relatively thoroughly, and damage and adverse effects on other healthy areas of the affected bone can be minimized.

[0036] S4. After inactivation, control the power of heating component 4 to reduce the temperature of the heating medium to the second preset target value and maintain it for the second preset time, then stop heating to complete the treatment.

[0037] After step SSS3 is completed, the inactivation result needs to be consolidated. Using two peristaltic pumps, the temperature of the heating medium is gradually reduced to the second preset target value of 60℃, and this temperature is maintained for 3 to 10 minutes to consolidate the inactivation effect. During this process, if the temperature change rate is <0.05℃ / s, the system switches to a micro-power adjustment mode, adjusting the operating power of the two peristaltic pumps by ±5%. If the temperature difference on the bone surface is >0.5℃, the local flow rate is automatically calibrated to reduce the temperature difference, for example, by adjusting the power difference between the two peristaltic pumps to adjust the temperature of different areas. When the countdown for the consolidation stage reaches zero, and the temperature fluctuation detected by the first sensor is <0.3℃, the system automatically stops heating and finally allows for natural cooling.

[0038] In some embodiments, in S2, the second temperature sensor 6 continuously monitors the temperature inside the medullary cavity of the affected bone 8. If the temperature inside the medullary cavity of the affected bone 8 is lower than a third preset target value, the operating power of the heating component 4 is increased to a first power. If the temperature inside the medullary cavity of the affected bone 8 is higher than the third preset target value but lower than the first preset target value, the operating power of the heating component 4 is reduced to a second power.

[0039] Specifically, in one specific embodiment, the third preset target value is 50°C. During the S2 preheating stage, the system reads the temperature detected by the second temperature sensor 6 in the medullary cavity every 0.1 seconds. If the temperature is less than 50°C, the system controls the heating power of the heating component 4 to increase to 150W. If the temperature is greater than 50.5°C, the system controls the heating power of the heating component 4 to decrease to 100W until the medullary cavity temperature reaches 64.5°C, which is the first preset target value. At this point, it indicates that the preheating is complete and the S3 inactivation stage can begin.

[0040] In some embodiments, in S3, after the temperature inside the medullary cavity reaches a first preset target value, the operating power of the heating component 4 and the driving component 3 is controlled to be increased until the heating medium reaches a fourth preset target value. Then, the operating power of the heating component 4 and the driving component 3 is controlled to be decreased until the heating medium stabilizes at a fifth preset target value, and the operating power of the heating component 4 and the driving component 3 is stably maintained.

[0041] Specifically, in one embodiment, when the temperature inside the medullary cavity of the affected bone 8 reaches 64.5°C but not 64.7°C, the system controls an increase in heating power and flow rate of the heating medium. Specifically, the heating power of heating component 4 is increased by 15%, and the flow rate of the heating medium is increased by 20%. If the temperature exceeds 65.3°C, the system automatically reduces the heating power of heating component 4. When the temperature inside the medullary cavity rises to 64.9°C, the system controls a 5% reduction in the heating power of heating component 4 while maintaining a constant flow rate of the heating medium until the temperature inside the medullary cavity stabilizes at approximately 65.1°C. At this point, the system maintains the heating power of heating component 4 at 120 watts and controls the flow rate of the heating medium at 5 ml / s. This ensures that the temperature fluctuation inside the medullary cavity during the inactivation process is no greater than 0.3°C, and the thermal uniformity is controlled to be no less than 92%, thus ensuring a stable and reliable inactivation effect. The preset time is preferably 10 minutes.

[0042] In some other embodiments, depending on the requirements, the flow rate of the heating medium is between 0.5 ml / s and 10 ml / s, and the heating power of the heating component 4 needs to be controlled below 200 watts.

[0043] In some embodiments, when the temperature value monitored by the third temperature sensor 7 is not less than a preset danger temperature value, the operating power of the drive component 3 is reduced and an alarm is issued. When the temperature value monitored by the third temperature sensor 7 is not less than the preset danger temperature value and exceeds the preset danger time, the heating component 4 is stopped and low-temperature coolant is injected into the cylinder 1.

[0044] Specifically, during the actual use of the equipment, it is necessary to precisely control the temperature of various parts of the affected bone 8 to avoid harming the patient. In a specific embodiment, the preset dangerous temperature value is set to 42.3°C, and the preset dangerous time is 10 seconds. When the temperature value detected by the third temperature sensor 7 is higher than 42.3°C, the system immediately controls the flow rate of the heating medium to be reduced from 5 ml / s to 2.5 ml / s. If the time exceeds 1 second and the temperature has not dropped below 42.3°C, the system immediately controls the power outage of each device and injects 4°C low-temperature coolant into the cylinder 1 to reduce the temperature of the healthy area of ​​the affected bone 8 and prevent the temperature from being too high and causing damage to the healthy area of ​​the affected bone 8.

[0045] In summary, this invention provides an in-situ thermal inactivation device and method for bone tumors. The device seals the treatment area of ​​the affected bone 8 using a cylinder 1, and then introduces heated saline solution into the sealed cavity of the cylinder 1 to inactivate the tumor. During the inactivation process, a peristaltic pump and a heating component 4, along with multiple temperature sensors, control the temperature at different locations of the affected bone 8 at different inactivation stages. This improves inactivation efficiency, reduces treatment difficulty, enhances the quality and effectiveness of tumor inactivation, and minimizes the impact of the inactivation process on healthy areas of the affected bone 8, reducing the possibility of recurrence and the difficulty of postoperative recovery.

[0046] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make several improvements and substitutions without departing from the technical principles of the present invention, and these improvements and substitutions should also be considered within the scope of protection of the present invention.

Claims

1. A bone tumor in situ thermal inactivation device for treating bone tumors, characterized in that, include: The packaging module includes a cylindrical body with sealing devices at both ends and a closed accommodating cavity inside the cylindrical body for accommodating the affected bone and the heating medium for inactivation treatment. A heating module, comprising a driving component and a heating component, wherein the driving component is connected to the heating component and the cylinder respectively, the heating component is used to heat and store the heating medium, and the driving component is used to drive the heating medium to flow between the cylinder and the heating component; The monitoring module includes a first temperature sensor, a second temperature sensor, and a third temperature sensor; the first temperature sensor is used to monitor the temperature of the outer surface of the cortical bone of the affected bone, the second temperature sensor is used to monitor the temperature of the center of the medullary cavity of the affected bone, and the third temperature sensor is used to monitor the temperature of the surface of the vascular bundle of the affected bone.

2. The in-situ thermal inactivation device for bone tumors according to claim 1, characterized in that, The cylindrical body includes a first shell and a second shell. Both the first shell and the second shell are semi-circular structures. The first side of the first shell is hinged to the second shell, and the second side of the first shell is detachably and sealed to the second shell. The first shell and the second shell are fastened together to form the accommodating cavity.

3. The in-situ thermal inactivation device for bone tumors according to claim 2, characterized in that, The packaging module also includes a locking device, which includes a first half-ring and a second half-ring. The first half-ring and the second half-ring are respectively sleeved on the outside of the first housing and the second housing. One end of the first half-ring is hinged to the second half-ring, and the other end of the first half-ring is bolted to the second half-ring.

4. The in-situ thermal inactivation device for bone tumors according to claim 3, characterized in that, The sealing device includes a sealing layer, which is sleeved on the end of the cylinder. The first end of the sealing layer is fixedly disposed on the inner side of the cylinder, and the second end of the sealing layer is fixedly connected to a slider. The slider is fixedly connected to the first semi-ring, and the outer wall of the first housing is provided with a spiral guide groove corresponding to the slider.

5. The in-situ thermal inactivation device for bone tumors according to claim 1, characterized in that, The heating assembly includes a storage chamber, and at least one ceramic thin-film heater is disposed inside the storage chamber; the storage chamber contains the heating medium, which includes physiological saline. The drive assembly includes an infusion pump and a suction pump; the two ends of the infusion pump are respectively connected to the inlet of the storage chamber and the liquid outlet of the cylinder; the two ends of the suction pump are respectively connected to the outlet of the storage chamber and the liquid outlet of the cylinder.

6. The in-situ thermal inactivation device for bone tumors according to claim 1, characterized in that, The first temperature sensor includes a ring thermocouple array, and the first temperature sensor is sleeved on the outer surface of the affected bone; The second temperature sensor includes a flexible optical fiber probe and is disposed at the tumor site inside the affected bone; the third temperature sensor includes a micro-thin film sensor and is attached to the vascular nerve bundles at both ends of the affected bone.

7. A method for in-situ thermal inactivation of bone tumors, employing the in-situ thermal inactivation device for bone tumors as described in any one of claims 1 to 6, characterized in that, Includes the following steps: S1. Peel away the soft tissue in the tumor area of ​​the affected bone to expose the surface of the affected bone; implant a second temperature sensor in the medullary cavity of the affected bone, install a first temperature sensor on the surface of the affected bone, attach a third temperature sensor at the neurovascular bundle of the affected bone; and unfold the cylinder so that the affected bone is sealed and wrapped inside the cylinder. S2. The driving component drives the initial temperature heating medium to flow between the heating component and the cylinder. The heating component continues to heat the heating medium until the temperature inside the medullary cavity reaches the first preset target value. S3. When the temperature inside the medullary cavity reaches the first preset target value, the second temperature sensor continuously monitors the temperature of the affected medullary cavity to provide feedback control of the working power of the heating component and the drive component, and continues for a preset time. S4. After inactivation, control the power of the heating component to reduce the temperature of the heating medium to the second preset target value and maintain it for the second preset time, then stop heating to complete the treatment.

8. The method for in situ thermal inactivation of bone tumors according to claim 7, characterized in that, In S2, the second temperature sensor constantly monitors the temperature inside the bone marrow cavity. If the temperature inside the bone marrow cavity is lower than the third preset target value, the operating power of the heating component is increased to the first power. If the temperature inside the bone marrow cavity is higher than the third preset target value but lower than the first preset target value, the operating power of the heating component is reduced to the second power.

9. The method for in situ thermal inactivation of bone tumors according to claim 7, characterized in that, In S3, after the temperature inside the medullary cavity reaches the first preset target value, the operating power of the heating component and the driving component is increased until the heating medium reaches the fourth preset target value. Then, the operating power of the heating component and the driving component is decreased until the heating medium stabilizes at the fifth preset target value, and the operating power of the heating component and the driving component is stably maintained.

10. The method for in situ thermal inactivation of bone tumors according to claim 7, characterized in that, When the temperature value detected by the third temperature sensor is not lower than the preset danger temperature value, the control reduces the operating power of the drive component and issues an alarm. When the temperature value monitored by the third temperature sensor is not less than the preset danger temperature value and exceeds the preset danger time, the heating component is stopped and low-temperature coolant is injected into the cylinder.

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