Control device for ablation and ablation assembly

Abstract

The application provides a control device and an ablation assembly for ablation, the control device is in direct or indirect communication with a temperature detection part for detecting needle internal temperature information of an ablation needle; the control device is used for: after the ablation needle completes cryoablation and rewarming, based on the needle internal temperature information, controlling a heating part to heat the ablation needle, and heating the outer wall temperature of the ablation needle to a hemostatic temperature range.

Description

TECHNICAL FIELD

[0001] The present application relates to the medical field, and in particular to a control device for ablation and an ablation assembly. BACKGROUND

[0002] Cryoablation therapy refers to a clinical medicine that uses low-temperature instruments to make lesion tissues undergo temperature reduction, freezing and rewarming in a controlled manner to cause irreversible damage to tumor cells and thus necrosis. Currently, there are mainly two systems applied to cryotherapy: a liquid nitrogen system and a gas throttling system.

[0003] Cryoablation is based on the principle of coldness, which is actually a cold-heat cycle. It uses argon and nitrogen to circulate. Nitrogen instantly lowers the temperature of the tissue to an ablation temperature (for example, minus one hundred and forty degrees Celsius), and then rapidly rewarms the tissue to a rewarming temperature (for example, fifty degrees Celsius) in a very short time. By using the principle of thermal expansion and contraction, the tissue rapidly expands and rapidly contracts, and through two or three cycles, the tumor cells burst.

[0004] When the ablation assembly for implementing the above cryoablation is used, if the ablation needle is directly removed, the patient's blood will flow out of the needle channel, which is not conducive to the patient. SUMMARY

[0005] The present application provides a control device for ablation and an ablation assembly to solve the problem of bleeding from the needle channel.

[0006] According to a first aspect of the present application, a control device for ablation is provided, which directly or indirectly communicates with a temperature detection unit for detecting needle-in temperature information of an ablation needle.

[0007] The control device is configured to:

[0008] After the ablation needle completes cryoablation and rewarming, based on the needle-in temperature information, the control device controls a heating unit to heat the ablation needle, and heats the outer wall temperature of the ablation needle to a hemostatic temperature range, and the lower limit value of the hemostatic temperature range is not less than 60 degrees Celsius.

[0009] Optionally, the hemostatic temperature range is an interval range of 80 degrees Celsius to 100 degrees Celsius.

[0010] Optionally, in the case where the ablation needle is heated to the hemostatic temperature range, the ablation needle can cause the tissue through which the ablation needle passes to adhere during the process of being pulled out.

[0011] Optionally, based on the needle-in temperature information, the control device controls the heating unit to heat the ablation needle, and heats the outer wall temperature of the ablation needle to a hemostatic temperature range, which includes:

[0012] control the heating part to heat the ablation needle at a first power, so that the temperature information in the needle reaches a preset first temperature; the first temperature can make the outer wall temperature rise to the hemostatic temperature range;

[0013] By controlling the heating part, the temperature information in the needle is cooled to a second temperature and maintained, and the second temperature can make the outer wall temperature maintain in the hemostatic temperature range within a specified time length.

[0014] Optionally, the control of the heating part to heat the ablation needle at a first power comprises: controlling the heating part to heat the ablation needle at full power.

[0015] Optionally, by controlling the heating part, the temperature information in the needle is cooled to a second temperature and maintained, comprising: controlling the heating part by a preset PID algorithm, so that the temperature information in the needle is cooled to a second temperature and maintained.

[0016] Optionally, the control device is further used for controlling a gas supply part to supply gas into the ablation needle, the heating part is in the ablation needle, and the heat of the heating part can be conducted to the needle wall of the ablation needle through the gas supplied into the ablation needle by the gas supply part.

[0017] Optionally, the control device comprises an MCU, a detection feedback circuit and a temperature regulation circuit.

[0018] The MCU acquires the signal detected by the temperature detection part through the detection feedback circuit, and controls the heating part through the temperature regulation circuit.

[0019] According to the second aspect of the present application, an ablation assembly is provided, comprising the control device of the first aspect and the optional solutions thereof, the heating part, the temperature detection part, the ablation needle, and a gas supply part for supplying gas into the ablation needle.

[0020] Optionally, the heating part comprises an electric heating wire, the temperature detection part comprises a T-type thermocouple, and the control device is directly or indirectly electrically connected with the heating wire and the T-type thermocouple.

[0021] The control device for ablation and the ablation assembly provided by the present application can heat the outer wall temperature of the ablation needle to the hemostatic temperature range after the ablation needle completes the cryoablation and rewarming, the lower limit value of the hemostatic temperature range is not less than 60 degrees Celsius, and then, the adhesion of the tissue inner wall to a certain extent can be helped to achieve a certain hemostatic effect, and the phenomenon of needle tract bleeding is reduced or avoided. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to make the technical solutions in the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description only need to be some embodiments of the present application, and for those skilled in the art, other drawings can be obtained without creative labor.

[0023] Fig. 1 is a schematic view of the configuration of the ablation assembly in an embodiment of the present application;

[0024] Fig. 2 is a schematic view of the configuration of the ablation assembly in another embodiment of the present application;

[0025] Fig. 3 is a schematic view of the configuration of the ablation assembly in still another embodiment of the present application.

[0026] Explanation of reference signs:

[0027] 11 - control device;

[0028] 110 - control circuit board;

[0029] 111 - MCU;

[0030] 112 - detection feedback circuit;

[0031] 113 - temperature adjustment circuit;

[0032] 12 - ablation needle;

[0033] 13 - temperature detection part;

[0034] 14 - heating part;

[0035] 15 - gas supply part;

[0036] 151 - gas cylinder;

[0037] 152 - gas pressure adjustment device. DETAILED DESCRIPTION

[0038] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the present application.

[0039] In the description of the present application, it should be understood that the terms "upper", "lower", "upper end", "lower end", "lower surface", "upper surface" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0040] In the description of the present application, the terms "first", "second" are only for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features.

[0041] In the description of the present application, the meaning of "a plurality of" is a plurality, for example, two, three, four, etc., unless otherwise explicitly specified and limited.

[0042] In the description of the present application, unless otherwise explicitly specified and limited, the term "connection" and the like should be broadly understood, for example, it can be fixedly connected, or detachably connected, or integrated; it can be mechanically connected, or electrically connected, or can communicate with each other; it can be directly connected, or indirectly connected through an intermediate medium, it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above-mentioned terms in the present application can be understood according to the specific circumstances.

[0043] The technical solutions of the present application will be described in detail below with specific examples. The following specific examples can be combined with each other, and the same or similar concepts or processes can not be described in some examples.

[0044] Please refer to Figs. 1 to 3 The embodiment of the present application provides a control device 11 for ablation, and also provides an ablation assembly comprising the control device.

[0045] The control device 11 directly or indirectly communicates with a temperature detection part 13, which is used to detect the temperature information inside the ablation needle; further, the temperature information inside the needle detected by the temperature detection part 13 can be fed back to the control device 11;

[0046] The temperature information inside the needle can be any information that can describe the temperature inside the ablation needle, which can be at least one of temperature value, temperature range, temperature grade, etc. The temperature detection part 13 can be arranged in the ablation needle 14, so as to realize the detection of temperature, and in some examples, the temperature detection part can also be partially or entirely arranged outside the ablation needle. In one example, the temperature information inside the needle can be the temperature of the inner wall of the ablation needle.

[0047] In an example, the temperature detecting unit 13 comprises a sensor that measures temperature by using the principle that the resistance value of a conductor or semiconductor changes with temperature, and can specifically be a T-type thermocouple, and the control device 11 is directly or indirectly electrically connected to the T-type thermocouple.

[0048] The control device 11 can also be directly or indirectly in communication with the heating unit 14, and further, the heating unit 14 can be controlled by the control device 11 to heat the ablation needle, which can heat the space inside the ablation needle, and further conduct heat to the needle wall of the ablation needle, and other parts, for example, also do not exclude the way of directly heating the needle wall of the ablation needle by using the heating unit 14.

[0049] In an example, the heating unit can be an electric heating wire arranged in the ablation needle, and the control device is directly or indirectly electrically connected to the heating wire.

[0050] The electric heating wire is a component that generates heat when current passes through the conductor, and the amount of heat generated is directly proportional to the current, voltage and resistance of the conductor itself. In a specific example, the maximum use temperature of the electric heating wire is 240 degrees, and it is maintained for 4 hours. The specific formula is Q = I^2RT, (Q (heat) I (current) R (resistance) T (time)).

[0051] The ablation needle can be any needle component that can achieve ablation, and any ablation needle in the art can be used as an optional solution.

[0052] In an example of using the ablation needle, the ablation needle can be punctured to the tumor site under the guidance of B-ultrasound or CT, and the tumor in the tissue is rapidly frozen by low-temperature gas, and the frozen tumor is rapidly thawed by high temperature, and after several cycles, the tumor cells are irreversibly necrotic. This process can be understood as the process of freezing ablation and rewarming of the ablation needle, and this method has very little effect on other tissues, improves the immunity of the patient's body, and inhibits the spread of tumor cells.

[0053] In the embodiment of the application, the control device 11 is used to:

[0054] After the ablation needle completes the process of freezing ablation and rewarming, the heating unit is controlled to heat the ablation needle based on the temperature information in the needle, and the outer wall temperature of the ablation needle is heated to a hemostatic temperature range, and the lower limit value of the hemostatic temperature range is not less than 60 degrees Celsius.

[0055] In specific examples, the hemostatic temperature range is an interval range of 80 degrees Celsius to 100 degrees Celsius. In other examples, the lower limit of the hemostatic temperature range can be any one of the following: 65 degrees Celsius, 70 degrees Celsius, 75 degrees Celsius, 80 degrees Celsius, 85 degrees Celsius, etc.; and the upper limit of the hemostatic temperature range can be any one of the following: 85 degrees Celsius, 90 degrees Celsius, 95 degrees Celsius, 100 degrees Celsius, 105 degrees Celsius, etc.

[0056] As long as the tissue contacted by the ablation needle can be coagulated to a certain extent, it does not deviate from the scope of the embodiments of the present application.

[0057] In specific examples, when the ablation needle is heated to the hemostatic temperature range, the ablation needle can coagulate the tissue through which the ablation needle passes during extraction.

[0058] In the above scheme, the control device can heat the outer wall temperature of the ablation needle to the hemostatic temperature range after the ablation needle completes the cryoablation and rewarming, and the lower limit of the hemostatic temperature range is not less than 60 degrees Celsius, thereby helping to coagulate the inner wall of the tissue to a certain extent, achieving a certain hemostatic effect, and reducing or avoiding the phenomenon of needle tract bleeding.

[0059] In one embodiment, please refer to Fig. 2 , the ablation assembly further comprises a gas supply part 15, and the control device is further configured to control the gas supply part 15 to supply gas into the ablation needle 12. In the case that the heating part (such as an electric heating wire) is in the ablation needle, the heat of the heating part can be conducted to the gas in the ablation needle through the gas supply part 15, and then to the needle wall of the ablation needle.

[0060] The gas supply part 15 can include a gas source 151 (such as a gas cylinder), and in some schemes, it can also include a gas pressure adjusting device 152. The gas source 151, the gas pressure adjusting device 152, and the ablation needle can be connected at one time.

[0061] The gas pressure adjusting device 152 can be understood as any device capable of adjusting the gas pressure in the ablation needle, for example, it can include a gas valve. By opening and closing the gas valve, the gas pressure in the ablation needle can be changed. In some examples, the gas pressure adjusting device can also change the speed of the supplied gas, thereby achieving pressure regulation.

[0062] The gas supplied by the gas supply part 15 can be, for example, argon, nitrogen, etc.

[0063] In one embodiment, please refer to Fig. 2 , the control device 11 includes a control circuit board 110, so that Fig. 3 For example, the control circuit board 110 can be provided with an MCU 111, a detection feedback circuit 112, and a temperature adjusting circuit 113.

[0064] The MCU 111 acquires the signal detected by the temperature detection unit 13 (which can be understood as a signal capable of representing the temperature information in the needle) through the detection feedback circuit 112, and controls the heating unit through the temperature regulation circuit 113. The detection feedback circuit 112 can be understood as a temperature detection unit (i.e., a temperature sensor) signal acquisition circuit, which can acquire the state of the temperature sensor and enable the control circuit board to acquire the temperature information in the needle. At the same time, since the heating control of the heating unit can be achieved by controlling the power and voltage during heating, the temperature regulation circuit 113 can be understood as a power and voltage regulation circuit.

[0065] In addition, the MCU 111 of the control single-chip microcomputer control circuit board 110 can also be provided with an ablation needle connection circuit, a dial switch, an RS485 communication module, a power supply, etc. The power supply can supply power to other devices in the control circuit board 110, and the dial switch and the RS485 communication module can be connected to the MCU to feed back the switch gear of the dial switch and the signal transmitted by the RS485 line to the MCU. At the same time, the detection feedback circuit 112 and the temperature regulation circuit 113 can be connected to the temperature detection unit 13 and the heating unit 14 in the ablation needle through the ablation needle connection circuit.

[0066] The control process realized by the control device can also be understood as the process realized under the control of the MCU 111.

[0067] In one embodiment, based on the temperature information in the needle, the heating unit is controlled to heat the ablation needle, and the outer wall temperature of the ablation needle is heated to the hemostasis temperature range, including:

[0068] The heating unit is controlled to heat the ablation needle at a first power, so that the temperature information in the needle reaches a preset first temperature; the first temperature can cause the outer wall temperature to rise to enter the hemostasis temperature range;

[0069] Through the control of the heating unit, the temperature information in the needle is cooled to a second temperature and maintained, and the second temperature can cause the outer wall temperature to remain in the hemostasis temperature range within a specified time.

[0070] In one embodiment, the control of the heating unit to heat the ablation needle at a first power includes controlling the heating unit to heat the ablation needle at full power. In this way, the ablation needle can be quickly heated to reach the first temperature as soon as possible, and the processing efficiency of the heating process in the hemostasis process can be improved.

[0071] The temperature information in the needle is cooled to the second temperature and kept by controlling the heating part, including: the temperature information in the needle is cooled to the second temperature and kept by controlling the heating part through a preset PID algorithm. Further, through the precise control of the PID algorithm, the outer wall temperature can accurately meet the requirements of the hemostasis process.

[0072] It can be seen that in the above control process, the processing efficiency and temperature accuracy requirements can be effectively considered during the hemostasis process.

[0073] The PID algorithm is used to control the temperature of the heating part (such as an electric heating wire). Under the control of the PID algorithm, the control is relatively accurate, which is more conducive to ablation and hemostasis. The high-temperature hemostasis of the needle channel has high requirements for temperature and time accuracy. Only the operation within a reasonable temperature and time can effectively ensure the hemostasis effect. The use of the PID algorithm can meet this demand.

[0074] The process of using the ablation assembly may, for example:

[0075] After the user connects the device and completes the pre-cooling, inserts the ablation needle into the tumor position of the patient, and then starts the freezing process. After the freezing is completed, the rewarming process is started. According to the tumor condition of the patient, the cycle is repeated several times, which can destroy the tumor cells. Before pulling out the ablation needle, the needle of the ablation needle is quickly heated to a temperature of 80-100 degrees Celsius (i.e. the hemostasis temperature range), and then the ablation needle is slowly pulled out from the patient. When the high-temperature ablation needle is pulled out, the tissue through which the needle passes will be adhered, and blood cannot flow out, achieving the effect of hemostasis.

[0076] The hemostasis process may, for example:

[0077] PID algorithm is to make the temperature of the outer wall of the ablation needle reach 80-100 degrees Celsius (i.e. the hemostatic temperature range) quickly, because the temperature of the outer wall is caused by the heating of the internal heating wire, so the temperature of the outer wall rises slower than the temperature inside the ablation needle, at this time, PID control is used to quickly raise the internal temperature and then slowly return to the target temperature of hemostasis (i.e. the hemostatic temperature range), at this time, the outer wall temperature maintains a stable temperature interval. After the low-temperature freeze-thaw cycle, the hemostatic function can be started. When the hemostatic function is started, in order to make the temperature of the outer wall of the ablation needle reach 80 degrees Celsius quickly, the internal temperature of the needle will reach a temperature A (i.e. the first temperature) quickly with full power, at this time, the outer wall of the needle will also reach 80 degrees Celsius (e.g. the lower limit of the hemostatic temperature range) quickly. In order to make the outer wall of the ablation needle maintain between 80-100 degrees Celsius (e.g. the hemostatic temperature range), the internal temperature of the needle will be slowly adjusted to a temperature B (i.e. the second temperature) by PID algorithm, and maintained. Because the needle is connected to the gas, after the internal temperature of the ablation needle reaches temperature B, the outer wall temperature of the needle will also be maintained at 80-100 degrees Celsius within a few minutes, so that the needle can be pulled out slowly after the hemostatic effect on the tissue in the needle hole is achieved, and then the hemostatic function is turned off.

[0078] The hemostatic function is completed before the ablation needle is pulled out after the rewarming. After the rewarming function is completed, the temperature of the ablation needle is in the temperature range of the body temperature of the patient. When the hemostatic function is started, according to the maximum working voltage of the two ends of the electric heating wire on the circuit board, the hemostatic function starts to heat the heating wire with full voltage and full power, and the temperature reaches a higher temperature A (i.e. the first temperature) and then slowly returns to a temperature B (i.e. the second temperature) by PID algorithm. Full power is used to heat the heating wire because the temperature of the heating wire rises quickly in the early stage, and the internal wall temperature of the ablation needle can reach temperature A (i.e. the first temperature) in a few seconds, at the same time, the temperature of the outer wall of the ablation needle will quickly rise to about 80 degrees Celsius, which reduces the preheating time and makes the ablation needle quickly reach the hemostatic temperature range.

[0079] The PID parameter settings can be, for example:

[0080] The temperature adjustment period is 100 ms, the target temperature value B, the proportional coefficient P = 10, the integral coefficient I = 0.1, and the differential coefficient D = 1.0. Because PID starts to adjust from high temperature to low temperature, in order to make the temperature decrease smoothly, the accumulated amount of PID is also set to an initial value of 100000. After PID adjustment, the temperature will slowly rise, but the temperature of the outer wall of the ablation needle will not exceed 100 degrees Celsius within a few minutes, and the temperature will be maintained between 80-100 degrees Celsius, which can achieve the ideal hemostatic effect. After the hemostatic function is completed, the heating of the electric heating wire is stopped. The gas passing through the ablation needle will carry away part of the heat, and the gas source is selected as nitrogen, and the gas pressure is selected as 370 psi.

[0081] For different gas sources or gas pressure selection, the values of temperature A and temperature B are different, and can be set according to specific experimental data.

[0082] Kp*e(t)+Ki*∑e(t)+Kd*(e(t)-e(t-1)),proportional coefficient Kp, integral coefficient Ki, differential coefficient Kd, Pout(t) is an output power or a signal capable of characterizing the output power, e(t) is an error at t time, e(t-1) is an error at t-1 time;Among them, the values can be changed according to the needs, so as to achieve the ideal hemostasis effect.

[0083] The inside of the ablation needle has a vent hole, a temperature measuring line and a rewarming line, and the rewarming line is an electric heating wire. The electric heating wire generates heat by passing through the heating source in the inside of the ablation needle, and the hemostasis temperature is realized by the outer wall of the ablation needle. Therefore, according to the characteristics of the ablation needle itself, the temperature, time and PID parameter setting to be reached are determined through experimental data, so as to achieve good hemostasis effect.

[0084] The temperature and time of hemostasis and other parameters can be adjusted, and experimental data can be obtained according to different positions of different patients, so as to achieve good treatment effect for various parts.

[0085] As can be seen from the above, the specific scheme of the present application can have the following positive effects:

[0086] (1) Convenient operation, only high-temperature hemostasis when pulling out the needle.

[0087] (2) Minimally invasive treatment, reducing the pain of patients, and helping rapid recovery after operation.

[0088] (3) Simple operation, short operation time, and obvious hemostasis effect.

[0089] In the description of the present specification, the description of the reference terms "one embodiment", "one example", "specific implementation process", "one example" and the like means that the specific features, structures, materials or characteristics described in combination with the embodiment or example are contained in at least one embodiment or example of the present application. In the present specification, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the described specific features, structures, materials or characteristics can be combined in any one or more embodiments or examples in a suitable manner.

[0090] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, and are not intended to limit the present application; although the present application has been described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions recorded in the above embodiments can be modified, or some or all of the technical features can be replaced by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A control device for ablation, characterized in that, The control device directly or indirectly communicates with a temperature detection unit configured to detect needle internal temperature information of the ablation needle; The control device is configured to: After the ablation needle completes the cryoablation and rewarming, based on the needle internal temperature information, control a heating unit to heat the ablation needle, and heat the outer wall temperature of the ablation needle to a hemostatic temperature range, a lower limit value of the hemostatic temperature range is not less than 60 degrees Celsius; The control device is further configured to control a gas supply unit to supply gas into the ablation needle, the heating unit is in the ablation needle, and the heat of the heating unit can be conducted to the gas in the ablation needle through the gas supply unit to the needle wall of the ablation needle; Based on the needle internal temperature information, control a heating unit to heat the ablation needle, and heat the outer wall temperature of the ablation needle to a hemostatic temperature range, comprising: Control the heating unit to heat the ablation needle at a first power, so that the needle internal temperature information reaches a preset first temperature; The first temperature can cause the outer wall temperature to rise to enter the hemostatic temperature range; Through the control of the heating unit, the needle internal temperature information is cooled to a second temperature and maintained, and the second temperature can cause the outer wall temperature to remain in the hemostatic temperature range within a specified time.

2. The control device according to claim 1, characterized by The hemostatic temperature range is an interval range of 80 degrees Celsius to 100 degrees Celsius.

3. The control device of claim 1, wherein In the case that the ablation needle is heated to the hemostatic temperature range, the ablation needle can cause the tissue through which the ablation needle passes to adhere during being pulled out.

4. The control device of claim 1, wherein Controlling the heating unit to heat the ablation needle at a first power comprises controlling the heating unit to heat the ablation needle at full power.

5. The control device of claim 1, wherein Through the control of the heating unit, the needle internal temperature information is cooled to a second temperature and maintained, comprising: controlling the heating unit through a preset PID algorithm to cool the needle internal temperature information to a second temperature and maintain.

6. The control device according to any one of claims 1 to 5, characterized by Optionally, the control device comprises an MCU, a detection feedback circuit, and a temperature regulation circuit; The MCU acquires the signal detected by the temperature detection unit through the detection feedback circuit, and controls the heating unit through the temperature regulation circuit.

7. An ablation assembly, comprising: The control device of any one of claims 1 to 6, the heating unit, the temperature detection unit, the ablation needle, and a gas supply unit configured to supply gas into the ablation needle.

8. The ablation assembly of claim 7, wherein, The heating unit comprises an electric heating wire, the temperature detection unit comprises a T-type thermocouple, and the control device directly or indirectly electrically connects the heating wire and the T-type thermocouple.

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